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Número de publicaciónCN1204242 A
Tipo de publicaciónSolicitud
Número de solicitudCN 96199063
Número de PCTPCT/US1996/016483
Fecha de publicación6 Ene 1999
Fecha de presentación11 Oct 1996
Fecha de prioridad11 Oct 1996
Número de publicación96199063.5, CN 1204242 A, CN 1204242A, CN 96199063, CN-A-1204242, CN1204242 A, CN1204242A, CN96199063, CN96199063.5, PCT/1996/16483, PCT/US/1996/016483, PCT/US/1996/16483, PCT/US/96/016483, PCT/US/96/16483, PCT/US1996/016483, PCT/US1996/16483, PCT/US1996016483, PCT/US199616483, PCT/US96/016483, PCT/US96/16483, PCT/US96016483, PCT/US9616483
InventoresP·C·埃瓦特, J·C·弗拉赫蒂, J·T·加里博托, P·E·麦考利, T·R·麦克霍尔德, J·马科韦, J·B·惠特, C·A·维达尔, R·J·雷德蒙, T·班克斯
Solicitante血管转换公司
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Method and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures
CN 1204242 A
Resumen  traducido del chino
本发明是用于在哺乳类体内血管的或非血管的体内位置处血管再造,和/或施行其它医学操作的方法、部件、和系统。 The present invention is a non-vessel revascularization body position for mammalian blood vessels and / or implementation of other medical procedures methods, components, and systems. 该方法一般包含从一条血管至一个血管的或非血管的目标位置的至少一条血管外通路的形成。 The method generally comprises forming a blood vessel or vessels from one destination to a vessel of at least one extravascular pathway. 在该血管再造方法中,血管外通路被用作供接近或在血管的或非血管的目标位置施行操作的导管。 In this revascularization method, extravascular path is used for the purposes of close or operate in non-vascular catheter destination vessels. 公开的还有可用于形成本发明的血管外通路的导管部件(100,103)和系统(138),以及供修正,维持和/或关闭这种血管外通路的装置。 Also disclosed herein can be used to form the catheter assembly of the present invention, the outer vessel passage (100, 103) and system (138), and for correction, maintenance and / or devices such extravascular passageway is closed.
Reclamaciones(94)  traducido del chino
1. 1. 一种血管再造的方法,所述方法包含下列步骤:a)在一条血管上的第一位置和一条血管上的第二位置间形成一条血管外通路,以使含PO2至少50的血液流过所述血管外通路。 A revascularization, said method comprising the steps of: between a) on a vessel of the first position and a second position on the formation of a blood vessel extravascular path to PO2 containing at least 50 blood flow through the said extravascular passageway.
2. 2. 权利要求1的方法,其中所述第一位置和第二位置位于至少一条心脏血管上。 The method of claim 1, wherein said first and second positions are located on the at least one cardiovascular.
3. 3. 权利要求1的方法,其中所述第一位置和第二位置位于相同血管上。 The method of claim 1, wherein said first and second positions are located on the same vessel.
4. 4. 权利要求1的方法,其中所述第一位置和所述第二位置位于不同血管上。 The method of claim 1, wherein said first position and said second position is located on a different vessel.
5. 5. 权利要求4的方法,其中所述血管是一条动脉和一条静脉。 The method of claim 4, wherein said blood vessel is an artery and a vein.
6. 6. 权利要求4的方法,其中所述血管是一条静脉和一条静脉。 The method of claim 4, wherein said blood vessel is a vein and a vein.
7. 7. 权利要求4的方法,其中所述血管是一条动脉和一条动脉。 The method of claim 4, wherein said blood vessel is an artery and an artery.
8. 8. 权利要求4的方法,其中多数所述血管外通路形成于所述血管间。 The method of claim 4, wherein the majority of the extravascular passageway is formed between said vessel.
9. 9. 权利要求1的方法,其中所述血管外通路为给阻塞的,损伤的或患病的血管节段加设旁路而形成。 The method of claim 1, wherein said extravascular passageway for a blocked blood vessel segment plus injury or illness bypassing formed.
10. 10. 权利要求1的方法,其中所述第一位置位于动脉上而所述第二位置位于静脉上,从而使血液将从所述动脉,通过所述血管外通路而进入所述静脉。 The method of claim 1, wherein said first position is located on the artery and the vein is located on the second position, such that the blood from the artery, through the extravascular passageway into the vein.
11. 11. 权利要求10的方法,其中已通过所述血管外通路进入所述静脉的血液随后被引致通过所述静脉流动以便通过静脉血管系统逆向灌注组织。 Blood method of claim 10, wherein the vein has been entered by the extravascular passageway is then caused to flow through the vein by reverse perfused tissue vein system.
12. 12. 权利要求11的方法,其中所述血液被引致经该静脉流动以便通过静脉血管系统逆向灌注组织,这种逆向灌注是通过:b)在邻近所述血管外通路的位置阻断所述静脉以引起通过所述血管外通路流入所述静脉的血液经过所述静脉,按照将导致经静脉血管系统的所述组织逆向灌注的方向流动。 The method of claim 11, wherein the blood is caused to flow through the vein through the venous vasculature reverse perfused tissue, such reverse perfused via: b) blocking the vein to cause the position adjacent to the extravascular passageway blood flow through the veins of the extravascular passageway through the vein, according to the lead through the vein tissue perfusion system reverse direction.
13. 13. 权利要求1的方法,其中在步骤a中形成的血管外通路是形成于第一血管和第二条血管间的第一条血管外通路,以使含PO2至少50的血液从第一血管,通过所述血管外通路流动并进入第二血管。 The method of claim 1, wherein the extravascular passageway formed in step (a) is formed between the first vessel and the second vessel first extravascular access to PO2 containing at least 50 blood vessels from the first through the The extravascular passageway and flows into the second vessel.
14. 14. 权利要求13的方法,其中所述方法还包含下述步骤:b)在所述第二血管和心脏的另一条血管间形成至少一条,第二血管外通路以使经过第一血管外通路进入第二血管的血液经过所述第二血管外通路随后流入另一条血管。 The method of claim 13, wherein said method further comprises the steps of: b) between the second vessel and another vessel to form at least one of the heart, so that the second extravascular passageway through the first passage into the first extravascular Blood vessels passing through the two second extravascular pathway then flows another vessel.
15. 15. 权利要求14的方法,其中所述血流被引致经过第二血管外通路流入其它血管,其法为:c)在邻近第二血管外通路处阻断第二血管,以引起所述血液从所述第二血管经过所述第二血管外通路流回所述另一条血管。 The method of claim 14, wherein said blood flow is caused through the second passage flows into the extravascular other vessels, which method is: c) blocking the second vessel in the extravascular passageway adjacent to the second place, to cause the blood from the said second vessel through said second passage back into the extravascular another vessel.
16. 16. 权利要求1的方法,其中至少所述第一和第二位置之一位于一条血管上,该血管是其中一条血管存在阻塞、损伤或患病片段的一个血管系统之一部分。 The method of claim 1, at least one of said first and second position which is located on a vessel, the vessel is one of the vascular obstructions, damaged or diseased part of the vascular system of a fragment.
17. 17. 权利要求1的方法,其中所述方法的步骤a如下施行:ⅰ)提供包含延伸的可弯曲导管体的通路形成导管部件,该可弯曲导管体具有一个可从那里通过的组织穿通元件,以穿过所述导管体所插入的血管壁;ⅱ)将所述导管体插入血管系统并放置所述导管体以使组织穿通元件位于将形成所述血管外通路的位置附近;ⅲ)将所述组织穿通元件从所述导管体通过以便按照所述方法的步骤a形成所述血管外通路。 The method of claim 1, wherein said step of a method implemented as follows: ⅰ) comprises providing conduits extending flexible catheter body passage forming member, the flexible catheter body having a tissue penetrating from there through the elements to wear The catheter is inserted through the body of the vessel wall; ⅱ) the catheter body into the blood vessel system and placing the catheter body to the tissue penetrating element is located close to the location formed extravascular passage; ⅲ) the organization penetrating element from the body through a catheter in order to follow the steps of the method of forming the extravascular a pathway.
18. 18. 权利要求17的方法,其中步骤ⅰ还包含:提供一种定位方法,用于定位所述第一和第二位置并确定导管部件的方向以便导管的组织穿通元件从所述第一位置通过而到达所述第二位置,从而在一条血管上的所述第一位置和一条血管上的所述第二位置间形成所述血管外通路。 The method of claim 17, wherein the step ⅰ further comprising: a direction to provide a positioning method for positioning the first and second positions and determining the catheter member so as tissue penetrating catheter element from the first position reaches through said second position, whereby said extravascular passageway between the blood vessels in a first position and the second position on a blood vessel formation.
19. 19. 权利要求17的方法,其中步骤ⅰ中提供的部件的组织穿通元件还结合一个腔,在用所述组织穿通元件产生所述血管外通路时一根导丝可通过该腔,并且其中所述方法还包含下述步骤:使一根导丝通过所述腔并允许所述导丝在所述导管的退出和去除后保留延伸在所述血管外通路中,从而准备好经所述通路,在所述导丝上随后推进一或多种其它装置。 The method of claim 17, wherein the step ⅰ organization member provided in the through element also incorporates a chamber, when generating said extravascular passageway by said tissue penetrating element through which a guide wire lumen, and wherein the method further comprising the steps of: a guidewire through the guide wire lumen and allows the exit and, after the removal of the catheter retained in the extravascular passageway extends, whereby the ready through passage, in the then promote one or more other devices on said guide wire.
20. 20. 在有动脉和静脉形成于其中的哺乳类心脏中冠状血管再造的一种方法,所述方法包含下列步骤:提供用来在两条血管间形成血管外通路的通路形成导管;将所述导管插入外周血管并将所述导管推进入心脏的血管;使用所述导管在导管所在的心脏血管和另一条心脏血管间形成至少一条第一血管外通路,以使血液从一条血管经过血管外通路而流入另一条血管。 There are formed in the arteries and veins to the heart of a mammal which method coronary revascularization, said method comprising the steps of: providing a pathway for the formation of the extravascular passageway between two conduits in angiogenesis; the catheter is inserted Peripheral vascular push the catheter into the heart and blood vessels; the use of the catheter in the heart where the blood vessels between the catheter and the other cardiovascular least one first extravascular passageway formed in the blood vessels from a vessel through the outer passage and flows Another vessel.
21. Twenty one. 权利要求20的方法,其中所述至少一种通路形成于一条心脏动脉和一条心脏静脉间,以使来自动脉的血液经过至少一条所述血管外通路进入心脏静脉。 The method of claim 20, wherein said at least one passageway formed between a heart artery and a cardiac vein, so that the blood from the artery through the at least one of said extravascular passageway vein into the heart.
22. Twenty two. 权利要求21的方法,其中从心脏动脉流入心脏静脉的动脉血随后被促使通过静脉流动从而通过心脏静脉血管系统逆向灌注心脏组织。 The method of claim 21, wherein the heart arteries from the arterial vein into the heart through a vein and then the flow is caused thereby reverse heart tissue perfusion by cardiac vein system.
23. Twenty three. 权利要求22的方法,其中所述动脉血被促使经静脉流动,从而通过在邻近血管外通路处阻断相反方向的经静脉流动而通过心脏静脉血管系统逆向灌注心脏组织。 The method of claim 22, wherein the arterial blood is caused to flow through the vein, so that by blocking the extravascular passageway adjacent the opposite direction of the flow through the heart via the vein system vein reverse perfused heart tissue.
24. Twenty four. 权利要求21的方法,其中该方法还包含:使用所述导管以形成从所述心脏静脉至所述心脏动脉的至少一条第二血管外通路,以使进入所述心脏静脉的动脉血会随后流经所述至少一条第二血管外通路并进入一条心脏动脉,从而通过心脏动脉血管系统灌注心脏组织。 The method of claim 21, wherein the method further comprises: using the catheter from the heart to form a cardiac vein to the artery at least one second extravascular passageway, such that cardiac vein into the arterial blood flow will then through the at least one second extravascular passageway and into a heart artery, thereby cardiac tissue perfusion system through the heart arteries.
25. 25. 权利要求20的方法,其中所述方法是为了实现为一段阻塞的,损伤的或患病心脏动脉节段加设旁路的目的。 The method of claim 20, wherein the method is to achieve a period of obstruction or diseased heart arteries segment injury plus bypassing purposes.
26. 26. 权利要求25的方法,其中所述血管再造在具有旋转动脉,心脏大静脉,前室间静脉和左前降动脉的哺乳类心脏中施行,目的是为阻塞的、损伤的、或患病的旋转动脉节段加设旁路,其中所述方法还包含:ⅰ. The method of claim 25, wherein said at having a rotary artery revascularization, cardiac vein, anterior interventricular vein and the left anterior descending artery of the mammalian heart purposes, the purpose is blocked, damaged, or diseased artery rotation segment plus bypassed, wherein the method further comprises: ⅰ. 在左前降动脉和前室间静脉间形成第一血管外通路;ⅱ. In between the left anterior descending artery and vein of the first front chamber between extravascular passage forming; ⅱ. 在心脏大静脉和旋转动脉之阻塞、受损或患病节段的下游处一个位置间形成第二血管外通路;和ⅲ. In blocked heart artery vein and rotation of damaged or diseased segment downstream of an extravascular passageway between the position of the second form; and ⅲ. 使血液从左前降动脉经第一血管外通路,经前室间静脉流入心脏大静脉,并经第二血管外通路进入旋转动脉之阻塞,受损或患病节段的下游处。 From the left anterior descending artery blood vessels outside through the first passage through the anterior vena cava vein into the heart, and by the second path into the extravascular arterial occlusion rotation of damaged or diseased downstream segment.
27. 27. 权利要求26的方法,其中步骤ⅲ通过在邻近第一血管外通路的位置阻断前室间静脉腔来完成。 The method of claim 26, wherein the step between the front position ⅲ by extravascular passageway adjacent the first blocking chamber to complete the vena cava.
28. 28. 权利要求27的方法,其中步骤ⅲ还通过在邻近第二血管外通路的位置阻断心脏大静脉腔来完成。 The method of claim 27, wherein the step of further passing position ⅲ extravascular passageway adjacent to the second blocking chamber to complete cardiac vein.
29. 29. 权利要求28的方法,其中所述血管再造在具有旋转动脉,心脏大静脉,前室间静脉和左前降动脉的哺乳类心脏中施行目的是为阻塞的,受损的或患病的左前降动脉节段加设旁路,其中所述方法还包含:ⅰ. The method of claim 28, wherein said at having a rotary artery revascularization, cardiac vein, anterior interventricular vein and the left anterior descending artery of the mammalian heart is intended for blocking purposes, damaged or diseased left anterior descending artery segment plus bypassed, wherein the method further comprises: ⅰ. 在旋转动脉和心脏大静脉间形成第一血管外通路;ⅱ. Between the heart and great arteries and veins rotation first extravascular passage forming; ⅱ. 在前室间静脉和左前降动脉之阻塞,受损或患病节段的下游处一个位置间形成第二血管外通路;ⅲ. Between the front compartment occlusion of the left anterior descending artery and vein, the damaged or diseased segment downstream of an extravascular passageway between the position of the second form; ⅲ. 促使血液从旋转动脉,经第一血管外通路,经心脏大静脉流入前室间静脉,并经第二血管外通路进入左前降动脉之阻塞,受损或患病节段下游。 Cause arterial blood from the rotation, the first extravascular passageway, through a large vein between inflow chamber cardiac vein, and by the second extravascular passageway into the left anterior descending artery occlusion, the damaged or diseased sections downstream.
30. 30. 权利要求29的方法,其中步骤ⅲ通过在邻近第一血管外通路的位置阻断心脏大静脉腔来完成。 The method of claim 29, wherein the step of blocking the heart and great vein lumen ⅲ position adjacent the first vessel through the outer passage to complete.
31. 31. 权利要求30的方法,其中步骤ⅲ还通过在邻近第二血管外通路的位置阻断前室间静脉腔来完成。 The method of claim 30, wherein the step between the front ⅲ through extravascular passageway adjacent to the second position to complete the blocking chamber vena cava.
32. 32. 一种用于在哺乳类体内在一个体内目标位置施行医学操作的方法,所述方法包含下列步骤:a)在血管内安置一个导管部件,该部件包含:ⅰ)具有一个近端末端和一个远端末端的可弯曲导管体;ⅱ)一个组织穿通元件,它可在所述导管体上通过到第一位置外,以形成从导管所在的血管延伸至所述血管外体内目标位置的一条血管外通路;b)使导管体的第一位置相对于体内目标位置定向,以使组织穿通元件可运送到导管体的第一位置外而形成所述血管和所述体内目标位置间的一条血管外通路;c)使组织穿通元件通过到导管体外以形成所述血管和所述体内目标位置间的所述血管外通路;和d)经所述血管外通路运送至少一种操作实施装置,并使用该操作实施装置在所述体内目标位置实施所述医学操作。 A method for in vivo mammalian purposes of medical operations in the body of a target position, said method comprising the following steps: a) placement of an intravascular catheter member, the member comprising: ⅰ) having a proximal end and a far end Flexible-terminal end of the catheter body; ⅱ) a tissue penetrating element which may be on the catheter body to a first position by the outside, to form a conduit extending from the vessel to the extravascular where the body of an extravascular target location path; b) the first position of the catheter body relative to the target position within orientation to the tissue penetrating element can be transported into the first position of the catheter body is formed outside of the vessel and the one extravascular passageway between the target position within provided; c) tissue penetrating element through the catheter body to form the extravascular passage of the blood vessels and the body between the target position; and d) the delivery pathway through the extravascular least one embodiment of the device, and use the Operating device according to the embodiment of the medical operation in the target body position.
33. 33. 权利要求32的方法,其中所述医学操作是输送一种可流动物质,并且其中所述操作实施装置包含一个管状套管,通过此套管所述可流动物质可被运送至所至所述血管外位置。 The method of claim 32 vessel, wherein the medical procedure is conveying a flowable substance, and embodiments wherein the operating means comprises a tubular sleeve through which said flowable substance cannula may be transported to the actions external position.
34. 34. 权利要求32的方法,其中所述医学操作是植入一种可植入性药物运送装置,并且其中所述操作实施装置是一种用于将所述药物运送装置通过所述血管外通路传递,并将所述运送装置植入所述血管外位置的植入装置。 The method of claim 32, wherein the medical implant operation is an implantable drug delivery device, and wherein said operating means is an embodiment of the drug delivery device for the extravascular passageway passing through, and the transport device is implanted outside the vascular implant device location.
35. 35. 权利要求32的方法,其中所述医学操作是植入供放射治疗的放射活性物质,并且其中所述操作实施装置是一种用于将该放射活性物质通过所述血管外通路传递,并将所述放射活性物质植入所述血管外位置的植入装置。 The method of claim 32, wherein the implant is a medical procedure for radioactivity radiation therapy, and wherein said operating means is an embodiment for the radioactivity to pass through the extravascular passageway, and the said radioactivity vascular implant device implanted in the outer position.
36. 36. 权利要求32的方法,其中所述医学操作是植入一种刺激器装置并且其中所述操作实施装置包含一种用于将所述刺激器装置通过所述血管外通路传递并用于将所述刺激器装置植入所述血管外位置的植入装置。 The method of claim 32, wherein the medical procedure is an implantable stimulator device and wherein the operation of one embodiment of apparatus comprises means for transmitting the stimulation by the extravascular passageway and for the stimulation means implanting the vascular implant device outside position.
37. 37. 权利要求32的方法,其中所述医学操作是植入一种感受器装置并且其中所述操作实施装置包含用于将所述感受器装置通过所述血管外通路传递并用于将所述感受器装置植入所述血管外位置的植入装置。 The method of claim 32, wherein the implant is a medical procedure, and wherein said susceptor means comprises means for operating embodiments of the susceptor outer passage means passing through said vessel and means for the implantation of the susceptor The implantable device said extravascular location.
38. 38. 权利要求32的方法,其中所述医学操作是植入一种电极装置并且其中所述操作实施装置包含用于将所述电极装置通过所述血管外通路传递并用于将所述电极装置植入所述血管外位置的植入装置。 The method of claim 32, wherein the implant is a medical procedure, and wherein said electrode means comprises means for operating embodiment the outer electrode means to pass through the vessel passages and said electrode means for implantation The implantable device said extravascular location.
39. 39. 权利要求32的方法,其中所述医学操作是植入一种发射器装置,并且其中所述操作实施装置包含用于将所述发射器装置通过所述血管外通路传递并用于将所述发射器装置植入所述血管外位置的植入装置。 The method of claim 32, wherein the implant is a medical procedure a transmitter device, and wherein said operating means comprises means for the implementation of the transmitter means through said extravascular passageway and means for transmitting the transmitter The vascular implant device is implanted outside the device location.
40. 40. 权利要求32的方法,其中所述医学操作是植入一种接受器装置,并且其中所述操作实施装置包含用于将所述接受器装置通过所述血管外通路传递并且于将所述接受器装置植入所述血管外位置的植入装置。 In the receptacle method of claim 32, wherein the implant is a medical operation device receptacle, and wherein said operating means comprises means for the implementation of the receptacle means to pass through said passageway and extravascular The vascular implant device is implanted outside the device location.
41. 41. 权利要求32的方法,其中所述医学操作是植入一种应答器装置,并且其中所述操作实施装置包含用于将所述应答器装置通过所述血管外通路传递并用于将所述应答器装置植入所述血管外位置的植入装置。 The method of claim 32, wherein the implant is a medical procedure a transponder device, and wherein said operating means comprises means for the implementation of the transponder by transmitting means and said extravascular passageway for the transponder The vascular implant device is implanted outside the device location.
42. 42. 权利要求32的方法,其中所述医学操作是植入一种支持元件装置并且其中所述操作实施装置包含用于将所述支持元件装置通过所述血管外通路传递并用于将所述支持元件装置植入所述血管外位置的植入装置。 The method of claim 32, wherein the medical procedure is transmitted to the support member by means of said extravascular passageway means and said support member for implanting a support member, and wherein said apparatus comprises means for the implementation of the operation The extravascular implant position the implant device.
43. 43. 权利要求32的方法,其中所述支持元件是一种斯坦特固定模,它在通过该血管外通路时首先采取一种紧凑构型,以后则展开为一种操作构型以对位于所述血管外位置的至少一种形态学结构产生结构支持。 The method of claim 32, wherein the support element is a stent that, in the extravascular passageway through the first to take a compact configuration, then later expanded to an operational configuration to the blood vessel located at least one location outside of the morphological structure of generating structural support.
44. 44. 权利要求32的方法,其中所述医学操作是植入一种标记装置并且其中所述操作实施装置包含用于将所述标记装置通过所述血管外通路传递并用于将所述标记装置植入所述血管外位置的植入装置。 The method of claim 32, wherein the implant is a medical operation and a marking apparatus wherein said operating means comprises means for the implementation of the marking device to pass through the outer passage for the vessel and implanting the marker The implantable device said extravascular location.
45. Forty five. 权利要求44的方法,其中所述标记由放射显像可视材料形成。 The method of claim 44, wherein the mark is formed by a radiation imaging visual material.
46. 46. 权利要求32的方法,其中所述医学操作是组织消磨,并且其中所述操作实施装置是一种组织消磨装置。 The method of claim 32, wherein the medical procedure is to kill tissue, and wherein said operating means is an organizational spend embodiment apparatus.
47. 47. 权利要求32的方法,其中所述医学操作是组织破坏,并且其中所述操作实施装置是一种组织破坏装置。 The method of claim 32, wherein the tissue damage is a medical procedure, and wherein said operating means is an embodiment of tissue destruction device.
48. 48. 权利要求32的方法,其中所述医学操作是组织切割,并且其中所述操作实施装置是一种组织切割装置。 The method of claim 32, wherein said medical procedure is a tissue cutting, and wherein said operating means is an embodiment of the cutting apparatus tissue.
49. 49. 权利要求48的方法,其中医学操作是神经的横断,并且其中所述操作实施装置是神经横断装置。 The method of claim 48, wherein the medical procedure is transected nerve, and wherein said operating means is implemented nerve transection device.
50. 50. 权利要求32的方法,其中医学操作是生物性流体的取样,并且其中所述操作实施装置是可通过其将生物学流体样本从所述血管外位置吸出的套管。 The method of claim 32, wherein the medical procedure is a biological fluid sample, and wherein said operating means is implemented by which the biological fluid sample from said extravascular location aspirated sleeve.
51. 51. 权利要求32的方法,其中医学操作是固体物质的取样,并且其中所述操作实施装置是一种用于从所述血管外位置将固体物质样本移去的装置。 The method of claim 32, wherein the medical procedure is the sampling of solid material, and wherein said operating means is an embodiment for the vessel from a location outside the solid matter is removed the sample means.
52. 52. 权利要求51的方法,其中所述医学操作是一种组织活检,并且其中所述操作实施装置是一种用于将组织片段从所述血管外位置切断并获取的一种活检工具。 The method of claim 51, wherein said medical procedure is a biopsy, and wherein said operating means is an embodiment of a biopsy instrument for tissue fragments severed from the extravascular location and acquired.
53. 53. 权利要求32的方法,其中所述方法还包含:在实施所述医学操作后从血管系统中抽出所述导管。 The method of claim 32, wherein the method further comprises: extracting from the catheter in the vascular system of the embodiment after medical procedures.
54. 54. 权利要求32的方法,还包含:将一个管状套管置于所述血管外通路中并使所述管状套管在所述管状套管抽出和去除后保持存在于所述血管外通路中。 The method of claim 32, further comprising: a tubular sleeve disposed within said extravascular passageway and the tubular sleeve after the extraction and removal of the tubular sleeve remains present in the extravascular passageway.
55. 55. 权利要求54的方法,其中所述存在于内的管状套管从所述血管外位置延伸至一处体内位置,以便从所述血管外位置向所述第二位置引流流体。 The method of claim 54, wherein the presence of the tubular sleeve extending from the extravascular position to a location in the body, in order to position the drainage from the extravascular fluid to the second position.
56. 56. 权利要求54的方法,其中所述存在于内的管状套管可从任何体外位置接近,以允许所期望的物质经过所述套管被运送至所述血管外位置。 The method of claim 54, wherein the presence of the tubular sleeve body may be accessible from any location to allow the desired material is transported through the cannula to the extravascular location.
57. 57. 权利要求56的方法,其中所述套管经过所述血管外通路,并经过血管系统延伸,并连接至可从体外位置接近的一个皮下注射开口,以允许可流动物质经皮注射入所述注射开口并通过所述存在于内的套管被运送至所述血管外位置。 The method of claim 56, wherein said cannula through said extravascular passageway and extending through the vascular system, and can be connected to a location accessible from outside a hypodermic opening to permit the flowable material percutaneously injected into the injection and by the presence of an opening in the casing is transported to the extravascular position.
58. 58. 权利要求53的方法,其中所述方法还包含:在所述医学操作完成后,血管外通路从所形成的血管中的开口的关闭。 The method of claim 53, wherein the method further comprises: after the medical procedure is completed, the extravascular passageway is closed from the blood vessel in the formed opening.
59. 59. 权利要求58的方法,其中血管中所述开口的关闭是通过展开一种血管壁关闭装置进行的,该装置选自由下列组成的一组装置:能量发射部件;烧灼器部件;缝合部件;订合部件(stapling device);血管内移植物;斯坦特固定膜性血管内移植物;球囊;线圈;一条凝血产生材料;微纤维胶原;明胶(collagen sponge);纤维素凝胶;和其组合。 The method of claim 58, wherein the closed vessel to expand an opening in the vessel wall is closed by means of the device means selected from the group consisting of: energy emitting member; burning member; suture member; stapling means (stapling device); endovascular grafts; internal stents membranous vascular grafts; balloon; coil; a coagulation producing material; microfibrillar collagen; gelatin (collagen sponge); cellulose gel; and combinations thereof.
60. 60. 一种可插入血管并可用于形成血管外通路的导管部件,该通路经过导管部件所插入的血管管壁延伸至一个体内目标位置,所述导管装置包含:具有近端和远端末端的可弯曲导管体;可穿出导管体上的第一位置以形成所述血管外通路的组织穿通元件;和用于至少确定导管体的旋转定向以易化导管体上第一位置的恰当定位的定向工具,以使组织穿通元件从导管体的随后穿出将形成所述血管和所述体内目标位置间的所述血管外通路。 A catheter insertable member for forming vascular and extravascular passageway, the passageway through a catheter inserted in the blood vessel wall member extends to a target position within said conduit means comprises: having a proximal end and a distal end of the flexible a catheter body; a first piercing position on the catheter body to form the extravascular tissue through-passage member; and means for determining at least the rotational orientation of the catheter body of the catheter body to easily locate the proper orientation of the first position of the tool so that the tissue penetrating element from the catheter body piercing will subsequently form the extravascular passage of the blood vessels and the body between the target position.
61. 61. 权利要求60的部件,其中所述第一位置是在所述导管体远端中形成的一个出口小孔且所述组织穿通元件可穿出所述出口小孔,而其中所述组织穿通元件适合在其穿出形成于所述导管体远端末端的所述出口小孔时按第一方向弯曲,从而穿通导管所插入的血管管壁。 Member of claim 60, wherein said first location is an outlet aperture at the distal end of the catheter body and the tissue formed through said piercing element through the outlet orifice, and wherein said tissue penetrating element adapted bent in a first direction when its piercing formed in the distal end of the catheter body orifice, which is inserted through a catheter through the blood vessel wall.
62. 62. 权利要求60的部件,其中所述第一位置是在所述导管体侧壁中形成的一个出口小孔;其中所述组织穿通元件,当穿出位于所述导管体侧壁中的所述出口小孔时会穿透导管所插入的血管壁。 When the piercing is located in the sidewall of the catheter body outlet wherein the tissue penetrating member; member of claim 60, wherein said first location is an outlet aperture in the side wall of the catheter body formed will be inserted through the catheter when the vessel wall holes.
63. 63. 权利要求60的部件,其中所述组织穿通元件包含一个在其中安装有一个具锐远端尖端和一个预弯回弹针元件的延伸的柔韧针头,所述针元件可有效地引起所述柔韧针头按第一方向屈曲。 Member of claim 60, wherein said tissue penetrating element comprises an installation in which there is a flexible needle having a sharp distal tip and a pre-bent resilient member extending needle, said needle member is effective to cause said pliable needle Buckling in a first direction.
64. 64. 权利要求60的部件,其中所述组织穿通元件是一种延伸的元件,它包含:ⅰ)具有远端末端的柔韧近端长柄,和ⅱ)由刚性材料形成并安装在所述柔韧近端长柄的远端上的具锐尖端元件。 Member of claim 60, wherein the tissue penetrating element is an extension element, which comprises: ⅰ) having a flexible distal end of the proximal end of long-handled, and ⅱ) formed and mounted on the proximal end of a rigid flexible material skillet with sharp tip element on the distal end.
65. 65. 权利要求60的部件,其中所述组织穿通元件包含一个带有具锐远端尖端的弹性预弯元件。 Member of claim 60, wherein said tissue penetrating member comprising a sharp distal tip having a pre-bent resilient member.
66. 66. 权利要求65的部件,其中所述针头由一种当插入哺乳类体内时为超弹性的材料形成。 The member of claim 65, wherein when the needle is made of a mammalian body when the insertion of super-elastic material.
67. 67. 权利要求66的部件,其中所述超弹性材料为一种镍钛合金。 The member of claim 66, wherein the superelastic material is a nickel-titanium alloy.
68. 68. 权利要求66的部件,其中所述预弯回弹元件是在其中纵行延伸有一个空腔的空心针头。 The member of claim 66, wherein said pre-bent resilient member is one in which there is a longitudinal cavity extending hollow needle.
69. 69. 权利要求66的部件,其中所述预弯回弹元件是一种实体针。 The member of claim 66, wherein said pre-bent resilient member is a solid needle.
70. 70. 权利要求60的部件,其中所述组织穿通元件包含在其远端上形成了一个套管尖端的延伸元件,与一个围绕所述针元件配置并可相对于所述针元件纵行移动的管鞘。 Member of claim 60, wherein said tissue penetrating element comprises at its distal end a sleeve formed on the tip of the extension element, and a configuration around said pin member and movable relative to the longitudinal movement of the needle element sheath tube .
71. 71. 权利要求60的部件,其中所述组织穿通元件包含一个具有一个能量发射远端尖端形成于其上的延伸元件,所述能量发射远端尖端能有效发射能量而易化所述组织穿通元件的经组织穿通。 Member of claim 60, wherein said tissue penetrating element comprises an energy emitting distal tip having an extending member formed thereon, said energy-emitting distal tip of effectively emitting the energy they pass through tissue penetrating member tissue penetrating.
72. 72. 权利要求60的部件,其中在所述组织穿通元件上的能量发射远端尖端选自一组能量发射装置,包含:电阻加热尖端;单极电烙器尖端;双极电烙器尖端;超声发射尖端元件;和其可能的组合。 Member of claim 60, wherein the tissue penetrating energy transmission on the distal tip element selected from the group of energy-emitting device comprising: a resistive heating tip; monopolar electrocautery tip; bipolar electrocautery tip; ultrasound transmitter and possible combinations thereof; tip element.
73. 73. 权利要求60的部件,其中所述组织穿通元件包含一个具有带有一个形成于其上的旋转组织切割装置的远端的延伸元件。 Member of claim 60, wherein said tissue penetrating element comprises an extending member having a distal end formed thereon rotary tissue cutting device having.
74. 74. 权利要求60的部件,其中所述组织穿通元件是能够穿出形成于所述导管体中的所述出口开口的一种能量流。 Member of claim 60, wherein the tissue penetrating element is an energy capable of piercing the outlet conduit is formed in the opening of the flow body.
75. 75. 权利要求60的部件,其中所述能量流选自包含下列的一组能量类型;激光;热;超声;和其可能的组合。 Member of claim 60, wherein the energy flow is selected from a group comprising the type of energy; laser; heat; and possible combinations thereof; ultrasound.
76. 76. 权利要求60的部件,其中所述组织穿通元件包含一个具有一个穿过其中纵行延伸的管腔的延伸元件,所述管腔能与负压源相连接,以通过所述组织穿通元件的远端将组织吸入该管腔。 Member of claim 60, wherein said tissue penetrating element comprises an extending member having a through lumen which extends longitudinally of the row, the lumen can be connected to a negative pressure source, through the distal tissue penetrating element The suction end of the lumen tissue.
77. 77. 权利要求60的部件,其中所述组织穿通元件包含:具有开放远端的预弯回弹管鞘;和具有具锐远端尖端的延伸元件,所述延伸元件被安置在所述管鞘内并沿其向前推进,以使尖锐远端尖端暴出到管鞘的开放远端末端外;所述延伸元件由足够柔韧而能适应管鞘的预弯构型的材料所构建。 Member of claim 60, wherein said tissue penetrating element comprises: an open distal end pre-bent resilient sheath tube; having a sharp distal tip of the extension element, the extension element is arranged in the tube and sheath along which to move forward, so that the distal tip of a sharp bursts out into the open distal end of the outer sheath tube; the extension element is made sufficiently flexible and able to adapt sheaths of pre-bent configuration of material constructed.
78. 78. 权利要求60的部件,还包含:连接于可弯曲导管体的至少一处远端部分的侧管(car)装置,所述侧管装置被构建以在其中能接受一种成像导管以使成像导管能够用来观察组织穿通元件以导管体上的第一位置的穿出。 Member of claim 60, further comprising: a distal end connected to the at least one portion of the flexible catheter body side tube (car) apparatus, said side tube means is constructed to accept therein an imaging catheter such that the imaging catheter It can be used to observe tissue penetrating element to the first position on the catheter body piercing.
79. 79. 权利要求78的部件,其中所述侧管是由一种对成像部件所利用的能量至少部分不可通透的材料形成,并且其中所述侧管还包含:在所述侧管中紧邻导管体上所述第一位置处形成并允许所述成像部件能观察所述组织穿通元件穿出导管体上的所述第一位置并穿过导管所在血管管壁的窗口。 The member of claim 78, wherein the side tube is a kind of energy utilized by the imaging member at least partially non-transparent material, and wherein the side of the tube further comprising: on the side of the tube adjacent to the catheter body formed at said first position and allowing the imaging member can be observed through the tissue piercing element through the catheter body and a first position where the blood vessel through the catheter wall window.
80. 80. 权利要求79的部件,其中所述窗口被定位于在产生所述血管外通路时所述组织穿通元件会经过的方向上;所述窗口从而包含所述定向工具的至少一部分,所述导管体第一位置的定向从而可通过旋转导管部件直至位于侧管中的成像装置能够看到拟定要形成通路的目标部位来控制,从而保证在组织穿通元件穿出出口小孔前导管部件处于适当的旋转定向。 The member of claim 79, wherein said window is positioned in a direction at the time of generating the passage of the extravascular tissue penetrating element will pass; whereby said window comprises at least a portion of the orientation of the tool, the catheter body section thereby directed one position in the image forming apparatus side tube by rotating conduit member located until the formulation is to be formed can be seen via the target site to control, in order to ensure the tissue penetrating element before piercing the outlet orifice of the conduit member is in the proper rotational orientation .
81. 81. 权利要求60的部件,其中导管体由可弯曲塑性材料形成,并且其中在所述导管体管腔的一部分周围,邻近出口小孔处被安置了一种刚性导管加固元件,以防止组织穿通元件退入导管体内时组织穿通元件停留在与导管体的可弯曲塑性材料接触状态。 Member of claim 60, wherein the catheter body is formed of a flexible plastic material, and wherein the peripheral portion of the lumen of the catheter body, adjacent the outlet orifice of the catheter was placed a rigid reinforcing member to prevent tissue penetrating element back tissue penetrating element when the catheter body to stay in contact with the flexible plastic material of the catheter body state.
82. 82. 权利要求60的部件,它还包含:安装在所述导管体近端末端的一个手持部分,所述手持部分具有一个与所述组织穿通元件相连接的驱动按钮,所述驱动按钮可向第一方向前进以推进所述组织穿通元件离开所述出口小孔,并可向第二方向后退以使所述组织穿通元件退入所述导管体的管腔。 Member of claim 60, further comprising: a holding portion mounted on the proximal end of the catheter body, the holding portion having a tissue penetrating the drive member connected to the button, the button can be driven to the first direction to advance the tissue penetrating element away from said orifice, and the second direction reverse to allow the tissue penetrating element back into the lumen of the catheter body.
83. 83. 包含权利要求60通路形成导管部件的一种系统,它还结合:能与所述定向工具共同使用以进一步易化导管体上第一位置的适当定位的成像装置。 Including the claims 60 to form a system via a catheter components, it combined: with the directional tool commonly used to further facilitated properly positioned on the first position of the catheter body imaging device.
84. 84. 权利要求83的系统,其中所述成像装置选自下列一组成像装置,包括:超声成像装置;多普勒成像装置;放射显像成像装置;磁共振成像装置;电磁成像装置;和其可能的组合。 Doppler imaging apparatus;; radioimaging imaging apparatus; magnetic resonance imaging apparatus; electromagnetic imaging apparatus; ultrasonic imaging apparatus and its possible: The system of claim 83, wherein said image forming means is selected from the image composition means, comprising combination.
85. 85. 权利要求84的系统,其中所述装置是一种成像导管。 The system of claim 84, wherein said image forming means is a catheter.
86. 86. 权利要求85的系统,其中通路形成导管部件还包含连接于可弯曲导管体的至少一处远端部分的侧管装置,所述侧管装置被构建以便在其中接受成像导管,从而使成像导管可以用来观察组织穿通元件从导管体上第一位置的通过;并且,所述成像导管至少部分地被置于所述侧管装置内。 The system of claim 85, wherein the passage forming member further comprises conduit means connected to the side of the flexible tube catheter body at the distal end of the at least one portion of said side tube means is constructed so as to accept therein the imaging catheter, so that the imaging catheter may be used to observe tissue penetrating member from the first position through the catheter body; and, the imaging catheter at least partially disposed within the side of the tube means.
85. 85. 权利要求84的系统,其中所述侧管装置由一种像导管所使用的能量至少部分可通透的材料形成,并且其中所述侧管装置还包含:在所述侧管装置中紧邻导管体上所述第一位置处形成以允许所述成像导管观察所述组织穿通元件穿出导管体上的第一位置并穿过导管所在的血管管壁的窗口;以及位于所述侧管中邻近所述窗口处以便限制通过所述成像导管观察的视野至通过所述窗口可观察到的视野的所述成像导管。 The system of claim 84, wherein said energy means from one side of the tube as a catheter used in at least partially transparent material, and wherein the side tube means further comprising: a catheter body adjacent the side tube means forming on said first position to permit said imaging catheter to observe the tissue piercing member penetrating the first position of the catheter through the catheter body and the vascular wall where the window; and located on the side adjacent to the tube through the window at the above in order to limit the field of vision to observe the imaging catheter can be observed through the window field of view of the imaging catheter.
86. 86. 权利要求85的系统,其中所述通路形成导管部件是可旋转的以使该导管部件可根据意愿旋转直至成像导管能够通过所述窗口看到目标区域,从而保证在组织穿通元件穿出所述导管体上第一位置前导管体上的第一位置是处于正确的旋转位置。 The system of claim 85, wherein the passage forming member is rotatable conduit so that the conduit member may be able to see the target area through said window in accordance with the wishes of the rotation until the imaging catheter, in order to ensure piercing the tissue penetrating catheter device the body of the first position of the first position on the front of the catheter body is in the correct rotational position.
87. 87. 包含权利要求58的导管部件的系统,其中组织穿通元件包含一个有一个通过其纵行延伸的导丝腔的延伸元件,以使导丝可在所述组织穿通元件形成所述血管外通路时沿所述腔前进,所述系统包含:进一步与延伸的可弯曲导丝结合的所述权利要求58的导管部件,该导丝可通过所述组织穿通元件的所述导丝腔。 Conduit means comprising a system of claim 58, wherein the tissue penetrating element comprises an element which has an extension line extending longitudinally through the guide wire lumen, so that when the guide wire along the tissue penetrating member said extravascular passageway is formed advancing the cavity, the system comprising: a catheter member 58 is further claimed guidewire extending bendable binding requirements, the guidewire through the tissue penetrating element of the guide wire lumen.
88. 88. 一种纵行压迫装置,它可用于纵行压迫形成于第一和第二有腔管状形态学管道中的开口周围的组织,其中所述第一和第二管状形态学通道互相侧侧并排在一起以使所述开口互相排成一线,所述纵行压迫装置包含:可放置于围绕着其中的开口的第一管状形态学导管的腔表面附近的第一部分;可放置于围着形成于其中的开口的第二管状形态学导管腔表面附近的第二部分;将所述第一和第二部分互相连接,以便纵行压迫围绕排成一线的第一和第二形态学导管开口的组织和居于其间的任何血管外组织的工具。 A longitudinal compression device, which can be used to oppress wale formed in the first and second tubular morphology has a cavity in the pipe surrounding tissue opening, wherein the first and second tubular morphology channel side by side with each other side to side together so that the openings aligned with each other, the longitudinal compression device comprising: a first portion can be placed in the cavity surface which surrounds the opening of the first tubular morphology catheter nearby; can be placed around the formed therein The second portion of the second tubular morphology of the luminal surface of the catheter near the opening; the first and second parts connected to each other so that the longitudinal oppression around the aligned first and second tissue morphology conduit opening and any tools extravascular tissue of living in between.
89. 89. 权利要求88的纵行压迫装置,其中所述第一和第二部分包含可置于所述腔表面附近的环状元件。 The compression device 88 wales claim, wherein said first and second portions comprises an annular member disposed near the surface of the cavity.
90. 90. 权利要求88的纵行压迫装置,其中第一和第二部分包含以柱状排列形成并经所述第一和第二开口延伸的延伸丝元件的对侧末端,所述丝元件的所述对侧末端向外弯曲以便紧靠并约束所述第一和第二形态学导管的腔表面。 The opposite side of the longitudinal compression device according to claim 88, wherein the first and second part contains columnar form and contralateral arrangement of the first and second ends extending opening extending wire element, the wire element end bent outwardly to close and said first and second morphological constraints luminal surface of the catheter.
91. 91. 权利要求90的纵行压迫装置,其中所述丝元件为预弯回弹丝元件,当被置于所述第一和第二开口中并去除外部束缚时,该元件将采取所述弯曲构型。 Longitudinal compression device according to claim 90, wherein the wire element is pre-bent resilient wire element, when placed in the first and second openings and remove the external restraint, this element will take the curved configuration .
92. 92. 权利要求90的纵行压迫装置,其中所述丝元件是塑性可变形的,并且其中所述部件还包含一个压力施加工具,该工具在所述丝元件被置于所述第一和第二开口中后可用来弯曲所述丝元件的对侧端。 Longitudinal compression device as claimed in claim 90, wherein said wire member is plastically deformable, and wherein said member further comprises a pressure applying tool, the tool of the wire element is disposed in said first and second openings After bending can be used to opposite ends of the wire element.
Descripción  traducido del chino
为动脉阻塞物加设旁路和/或其他经血管操作的方法和装置 Method and apparatus for arterial blockage plus bypassing and / or other actions through the blood vessels

相关申请本申请要求1995年10月13日提交的美国临时申请60/005,164号和1996年2月2日提交的60/010,614号申请的优选权。 RELATED APPLICATIONS This application claims the United States October 13, 1995 filed provisional application No. 60 / 005,164, and February 2, 1996 filed No. 60 / 010,614 filed the preference. 临时申请第60/005,164号和60/010,614号的全部公开内容在此并入本文作为参考。 Provisional Application No. 60 / 005,164 and 60 / 010,614 the entire disclosure of which is incorporated herein by number as a reference.

发明领域本发明主要涉及医疗方法,部件,系统,尤其涉及在a)血管再造和/或b)哺乳动物体内施行血管或非血管的医疗操作的方法,设备,系统。 Field of the Invention The present invention relates generally to medical methods, components, systems, and more particularly in a) revascularization and / or b) the purposes of the vascular or nonvascular mammal medical operation methods, devices, systems.

发明背景A. A. Background of the Invention 涉及到血管再造操作的背景在现代医学实践中,常常需要为被阻塞的患病的及损伤的动脉的部分加设旁路。 Related to revascularization operations background in modern medical practice, it is often necessary to partially blocked artery disease and injury plus bypassing. 用于为这些阻塞的,患病的,损伤的血管加设旁路的典型手术操作需要动脉的开放手术暴露,将管状移植物连接(例如:缝合)到受损的动脉(例如:自体移值,异体移植,同族异体移植,修复或生物修复移植)以使移植物的一端连接于阻塞,患病,损伤部位的上游,移植物的另一端,在其下游连接于该动脉。 Open surgery is used for these blocked, diseased, damaged blood vessels plus bypassing the typical surgical procedure requires exposure of the artery, the tubular graft connection (for example: suture) into the damaged artery (for example: autograft , allograft, allograft same family, repair or bioremediation transplant) to one end of the graft is connected to the obstruction, the sick, the upstream site of injury, the other end of the graft, at its downstream connected to the artery. 在这种方法中动脉血通过旁路移植物开通道,因而恢复被阻塞的,患病的或损伤动脉远端部位的血流,以预防组织缺血,梗塞和其他由于经过患病动脉的受损血流造成的后果。 In this method, the arterial bypass grafts open channel, and thus restore blood flow in diseased arteries blocked or distant sites of injury to prevent tissue ischemia, infarction and other diseased arteries because after receiving Loss of blood flow consequences.

虽然外科动脉旁路移植已经在体内各个部位施行,但其最典型的动脉加设旁路操作是用于进行以下的治疗:ⅰ. Although artery bypass graft surgery has been practiced in various parts of the body, but its most typical artery bypass operation plus set for the following treatment: ⅰ. 冠状动脉疾病或ⅱ. Coronary artery disease or ⅱ. 影响下肢的周围血管疾病。 Peripheral vascular disease affecting the lower extremities.

ⅰ. Ⅰ. 冠状动脉病冠状动脉病一直是全世界发病率和死亡率的主要原因之一。 Coronary artery disease, coronary artery disease has been one of the main reasons of morbidity and mortality worldwide. 冠状动脉病的典型病因是在冠状动脉内形成动脉粥样硬化斑,这种动脉硬化斑的堆积易于导致冠状动脉血流的全部或部分阻塞,如果不治疗可导致心肌局部缺血、梗塞和死亡。 A typical cause of coronary artery disease is the formation of atherosclerotic plaque in the coronary arteries, which tends to result in the accumulation of atherosclerotic plaque blockage of coronary blood flow in whole or in part, if not treated can lead to myocardial ischemia, infarction and death .

许多年以来,传统的冠状动脉病的外科治疗一直是采用冠状动脉加设旁路手术。 For many years, the conventional surgical treatment of coronary artery disease has been established coronary artery bypass surgery plus. 其中病人通常被麻醉,放置心肺旁路(体外循环),并且病人的心脏暂时停止工作。 Where the patient is usually anesthetized, placed cardiopulmonary bypass (CPB), and the patient's heart is temporarily stopped. 进行开胸(例如:正中胸骨切开)用外科解剖的方式暴露阻塞的冠状动脉,用一条或更多的病人的人隐静脉或乳内动脉做旁路移植。 Open chest (for example: median sternotomy) exposed blocked coronary arteries with a surgical dissection of the way, with one or more of the patients who saphenous vein or internal mammary artery bypass grafts done. 将收集的动脉或静脉部分吻合到阻塞的冠状动脉,以围绕动脉的阻塞形成旁路导管。 Arterial or venous anastomosis part collected to blocked coronary arteries to clog arteries around the formation of a bypass conduit. 这种传统的冠状动脉加设旁路的外科治疗方法是昂贵的,极度具有创伤性的,这种手术与术中的术前的合并症有明显的关系。 This traditional surgical treatment of coronary artery bypass plus set is expensive, extremely invasive nature of this surgery with intraoperative complications before surgery was significantly related.

对传统的冠状动脉加设旁路的外科治疗的一种替代方式是球囊血管成形术。 Plus the traditional setting of coronary artery bypass surgical treatment is an alternative to balloon angioplasty. 在球囊血管成形术中,一个柔韧的引导导管,经皮插进周围动脉(如:股动脉),且通过管腔推进穿过血管,直到导管的远端抵达被阻塞的冠状动脉的开口处为止。 In balloon angioplasty, a flexible guide catheter, is inserted percutaneously peripheral arterial (eg: femoral artery) and advanced through the blood vessel through the lumen until the distal end of the catheter arrival opening blocked coronary arteries so far. 此后,一个球囊导管穿过引导导管并进入阻塞的损伤部位。 Thereafter, a balloon catheter through the guide catheter and into the lesion blocked. 将球囊导管的球囊一次或更多次地充盈,以扩张阻塞损伤区域的冠状动脉。 The balloon catheter balloon filling one or more times, to expand the area blocked coronary artery lesions. 这些球囊血管成形术比传统的冠状动脉加设旁路的外科治疗方法,花费少且损伤少。 Surgical treatment of these balloon angioplasty plus set than traditional coronary bypass, spending less and less damage. 然而,这种球囊血管成形术的方法有相当比率的血管形成部位发生再狭窄的病例。 However, this method of balloon angioplasty have restenosis of cases ratios considerably angiogenesis portion occurs. 这种再狭窄的原因和机制一直是不断在研究的题目。 This restenosis causes and mechanisms have been constantly studying the subject. 但是,这种再狭窄通常被归因于:a)动脉壁上的团块增大(例如:新内膜形成),b)动脉壁的增厚,而团块中基本没有改变。 However, this restenosis is usually attributed to: a) increased arterial wall mass (e.g.: neointima formation), b) thickening of the arterial wall, and substantially no change in mass. (如:血管重塑)和/或c)经球囊扩张操作产生的动脉壁裂痕和裂隙在恢复时经球囊扩张的动脉壁呈辅射状收缩。 (Eg: vascular remodeling) and / or c) the operation of the arterial wall after balloon cracks and fissures created by the balloon when the recovery was secondary arterial wall radially shrink.

另一种传统的冠状动脉加设旁路手术治疗方法是冠状动脉内阻塞物质的血管腔内去除术(例如:动脉切开术)或削磨术(例如:超声,激光)。 Another conventional treatment plus setting of coronary artery bypass surgery, coronary occlusion material within endovascular ablation (for example: the arteriotomy) or cut atherectomy (for example: ultrasound, laser). 这些血管腔内去除或削磨操作是通过导管放置去除或削磨装置穿过血管系统到达冠状动脉的阻塞部位。 These endovascular removal or sharpening operation is to remove or sharpening device is placed through the vascular system to the site of coronary occlusion through a catheter. 这种导管放置的去除或削磨装置是利用切,刮,声波,粉碎或气化或另外方式从冠状动脉腔内消磨阻塞物质。 This catheter placement or removal device is the use of sharpened cutting, scraping, sonic, crushed or vaporized or otherwise spend blocking substance from transluminal coronary angioplasty. 这种操作过程必须小心谨慎以避免对动脉壁造成穿孔或损害,因为这种穿孔或损害能够引起出血或过多的疤痕和继发的动脉腔的再闭塞。 This procedure must be careful to avoid causing perforation or damage to the arterial wall, because this can cause perforation or damage Reocclusion bleeding or excessive scarring and secondary arterial lumen. 此外,这些削磨操作,至少在一些情况下,由于需要小心地控制和去除被从阻塞物上除掉或分离出的碎片,以预防这种阻塞物的碎片避免进入病人的循环系统,使这个过程显得混乱。 In addition, these sharpening operations, at least in some cases, because of the need to carefully control and removal are removed or separated from the debris blockage to prevent such obstructions to avoid the debris into the patient's circulatory system to make this process appears confusing.

动脉切开术的导管和其他导管放置的切除装置的实例已经被描述于美国专利第3,433,226号(Boyel),3,823,717号(Pohlman,等),4,808,153号(Parisi),4,936,281号(Stasz),3,565,062号(Kuris),4,924,863号(Stener),4,370,953号(Don Michael,等),5,069,664号(Suess,等),4,920,954号(Alliger,等)和5,100,423k号(Fearnot),以及外国专利/专利公开文献EP0347098A2(Shiber),WO87-05739(Cooper),WO89-06515(Bernstein,等),WO90-0130(Sonic Needle Corp.),EP316789(DonMicheal,等),DE3,821,836(Schubert),DE2438648 (Pohlman),和EP0443256A1(Barush)。 No. 4,808,153 instance removal device arteriotomy catheters and other catheter placement has been described in US Patent No. 3,433,226 (Boyel), No. 3,823,717 (Pohlman, etc.) (Parisi), 4,936,281 Number (Stasz), No. 3,565,062 (Kuris), No. 4,924,863 (Stener), 4,370,953 Number (Don Michael, etc.), 5,069 No. 664 (Suess, etc.), No. 4,920,954 (Alliger, etc.) and 5,100,423k number (Fearnot), and foreign patent / patent publication EP0347098A2 (Shiber), WO87-05739 (Cooper), WO89-06515 (Bernstein, etc.), WO90-0130 (Sonic Needle Corp.), EP316789 (DonMicheal, etc.), DE3,821,836 (Schubert), DE2438648 (Pohlman), and EP0443256A1 (Barush).

其他替代传统的冠状动脉旁路的外科治疗方法还包括:最小创伤性的内窥镜操作,至少是直接地,在病人胸壁上的切一个小切口(如:1-3cm)将胸腔镜和相关的手术器械穿过这个切口进行手术。 Other alternatives to traditional surgical treatment of coronary artery bypass include: minimally-invasive endoscopic procedures, at least directly, cutting the patient a small incision in the chest wall (eg: 1-3cm) will thoracoscopy and related surgical instruments through the incision surgery. 这种最小创伤性冠状动脉加设旁路操作已在美国专利第5,452,733号(Sterman等)中描述。 This minimally-invasive coronary artery bypass operation described set plus U.S. Patent No. 5,452,733 (Sterman et al.). 假如这些最小创伤性的冠状动脉旁路操作是完美的,进行这种最小创伤操作的病人相对于进行传统动脉旁路手术治疗者可以减少不舒服感和缩短恢复时间。 If these minimally-invasive coronary artery bypass operation is perfect for such patients minimally invasive operations with respect to the conduct of traditional artery bypass surgery can reduce the discomfort and recovery time. 然而,这种典型的内窥镜外科手术操作需要大量的操作者技术和训练。 However, such a typical endoscopic surgical procedure requires a lot of operators and technical training. 而且,与用传统的冠状动脉加设旁路的手术方法一样,这些胸腔镜的操作过程一般是在全身麻醉下进行的,一般需要一个或多个胸管在手术后的一段时间里被留在固定的位置以引流从移植吻合口漏出的任何血液,并减少气胸的发生。 Moreover, unlike traditional surgical methods bypassing coronary plus, like these thoracoscopic procedure is generally performed under general anesthesia, usually require one or more chest tube in a period of time following surgery was left in fixed position to drain from graft anastomotic leak of any blood, and reduce the occurrence of pneumothorax. 这种气胸是由于在胸壁上全层切口的形成而引起的。 This pneumothorax is due to the formation of full-thickness incision in the chest wall caused. 此外这种胸腔镜的冠状动脉旁路的一些操作需要病人被放置心脏旁路且病人的心脏暂停止工作。 In addition, some operations such thoracoscopic coronary artery bypass patients need to be placed cardiac bypass and the patient's heart temporarily stopped working. 另外一些这种胸腔镜操作意在不放置病人的心肺旁路且不停止心脏工作时能够被使用。 In addition some of these thoracoscopic operation intended to put the patient without cardiopulmonary bypass without stopping the heart work can be used. 然而,这种意在没有心肺旁路和心脏停止跳动的能够被使用的胸腔镜的操作是相对复杂的操作,并且一般需临时挟闭或结扎将被加设旁路的冠状动脉。 However, this meant no cardiopulmonary bypass and cardiac arrest can be used thoracoscopic operations are relatively complex operation, and generally will be temporarily closed or ligation rely on will be added bypassing the coronary arteries. 因此,甚至这种没有心肺旁路/心脏停止工作下可以被使用的胸腔镜操作也由于操作的复杂性和需要暂停止挟住或结扎被加设旁路的冠状动脉而易有独特的和显著的危险性和困难。 Thus, even this is no cardiopulmonary bypass / heart stopped thoracoscopic operations can be used also because of the complexity of the operation and the need to temporarily stop being pinched or ligation plus bypassing coronary easily understood with a unique and significant working risks and difficulties. 这样,与传统的冠状动脉手术有关的许多弊端,以及附加的潜在的弊端,可以与这些最小创伤的胸腔镜操作相关联。 Thus, unlike conventional coronary surgery related to many drawbacks, as well as additional potential drawbacks, it may be minimally invasive thoracoscopic these associated operations.

另一种上文提到过的实际上没有为冠状动脉阻塞加设旁路但是仍然可以被用于改善心肌缺血区域的血流的操作过程,是被称为经心肌血管再造术(TMR)的操作。 Another mentioned above, plus virtually no coronary occlusion bypassed but still can be used to improve blood flow in the process of myocardial ischemic area of operation is known by myocardial revascularization (TMR) operation. 在TMR操作中利用一根能穿透组织的探针,如激光探针形成许多全层穿过缺血心脏壁的穿透通道进入左心室腔。 The use of the probe can penetrate tissue in a TMR operations, such as forming a plurality of laser probe through the full thickness of the heart wall ischemia through passages into the left ventricle cavity. 来自左心室的氧合血液隙后向外流,通过这个穿透通道,以便灌注缺血的心肌。 After oxygenation of blood from the left ventricle to the outflow gap, penetrating through this channel to the ischemic myocardium. 这种经心肌血管再造术操作的实例被描述于美国专利第5,554,152号(Aita等),5,380,316号(Aita等),和5,125,926号(Linbares等)。 Examples of this kind after myocardial revascularization operations are described in U.S. Patent No. 5,554,152 (Aita, etc.), No. 5,380,316 (Aita, etc.), and No. 5,125,926 (Linbares etc.).

一种改进的TMR操作需要从左心室到阻塞的冠状动脉,阻塞的下游处形成一种加瓣膜的和/或内部加斯坦特固定膜的经心肌道路(例如:在心肌壁形成的一种组织间隙隧道)。 An organization formed in the myocardial wall: an improved TMR operations require from the left ventricle into the blocked coronary arteries, blocking the formation of downstream myocardium road through an addition valve and / or internal Vegas Tante fixed film (for example, gap tunnel). 这种改进的TMR的操作被描述于美国专利第5,287,861号(Wilk),5,409,019号(Wilk),和5,429,114号(Wilk)。 This improved TMR operations are described in U.S. Patent No. 5,287,861 (Wilk), No. 5,409,019 (Wilk), and number (Wilk) 5,429,114.

ⅱ. Ⅱ. 周围血管病周围血管病通常是由动脉粥样硬化斑的形成和/或血栓物质在周围动脉内导致。 Peripheral vascular disease, peripheral vascular disease is usually caused by the formation of atherosclerotic plaque and / or thrombus in the peripheral arteries cause substance. 在许多情况下,当下肢动脉由于周围血管病形成阻塞时,即产生称为一种间歇跛行的现象。 In many cases, when the lower limb arterial obstruction due to the formation of peripheral vascular disease, which produce the phenomenon known as an intermittent claudication. 间歇跛行是以用力(即走路或跑步)时,患腿出现疼痛和进行性乏力为特点的。 Intermittent claudication is a force (ie walking or running), the risk of leg pain and progressive weakness characterized.

对周围血管病治疗的一般外手术方法,特别是对表现出间歇跛行症状的病人中,是用经手术暴露患病的动脉并吻合一种管道的旁路移植物(例如,一种编织的聚酯或膨胀的聚四氟乙烯(ePTFE)形成的管)到患病的动脉,以使这种移植物的一端被连结于阻塞物的上游,移植物的另一端连结于阻塞物的下游。 For the treatment of peripheral vascular disease in general outside the surgical method, especially for exhibiting symptoms of intermittent claudication patients, it is exposed with diseased arteries by surgery and bypass graft anastomosis of a pipeline (for example, a woven poly tube) to the diseased arteries, so that one end of the graft is connected to an upstream blockage, and the other end connected to graft obstruction downstream ester or expanded polytetrafluoroethylene (ePTFE) formed. 用这种方式,动脉血将流给管状旁路移植物并绕过动脉阻塞,从而恢复血流到动脉阻塞的下游。 In this way, the arterial blood flow to bypass the tubular bypass graft and artery occlusion, thereby restoring blood flow to the artery downstream of the blockage.

治疗下肢周围血管病的传统的动脉旁路移植手术的一种替代方法,是称为原位静脉旁路加设的方法。 An alternative to traditional methods of treatment of lower extremity arterial bypass graft surgery, peripheral vascular disease, is called in situ vein bypass erection of methods. 这种原位静脉加设旁路操作的施行是通过在腿部至少形成两个(2)开放的切口以在阻塞的上游和下游位置暴露患病动脉。 Such add-situ vein bypass operation purposes is provided by forming at least two leg portions (2) to open a cut in the upstream and downstream position blocking exposures diseased artery. 伸展经过腿部大体平行于患病的动脉的一条周围静脉,随后通过将一种器械插入静脉去溶解或破坏位于这根静脉的静脉瓣进行准备。 After extending substantially parallel to the diseased leg arteries of a peripheral vein, then by incorporating an instrument is inserted into the vein to dissolve or destroy the vein located in the root of vein graft to prepare. 此后从该静脉延伸的任何侧枝被切断、结扎或通过栓塞阻塞。 Thereafter any collateral extending from the vein is cut, ligation or blocked by embolization. 这根经准备的静脉被嫁接于动脉阻塞之上和之下的位置,这根被嫁接的静脉末端被放置使接触并直接缝合于动脉于阻塞的上游和下游位置。 This warp preparation vein was grafted to a position above and below the blockage in the artery, which is the root of the vein graft is placed end to make contact with and directly sutured to the upstream and downstream positions in the blocked artery. 用这种方法,动脉血流流过经准备的静脉节段,这个经准备的静脉节的将作为旁路管道绕过动脉阻塞物。 In this way, the arterial blood flow through the vein segments through preparation of this section by the preparation of the vein as a bypass pipeline will bypass arterial blockages. 最新的原位静脉旁路操作的实例被描述于White,R. Examples of the latest in-situ vein bypass operation is described in White, R. A和Fogarty,T. A and Fogarty, T. J. J. ,周围血管内介入法Pgs,166-169,Mosby&CO. The inner peripheral vascular interventional Pgs, 166-169, Mosby & amp; CO. (1996)。 (1996).

ⅲ. Ⅲ. 损害动脉血流的创伤和其它疾病身体的各种动脉可以被创伤损害(例如:撒裂伤,挤压损伤,钝性胶部创伤)或被血管外病症(例如:相邻的肿瘤的增生和向内生长)侵裂或挤压。 All kinds of arterial damage artery trauma and other diseases of the body can be traumatic damage (for example: Caesar laceration, crush injuries, blunt trauma glue) or extravascular disorders (for example: the adjacent tumor proliferation and ingrowth) invasion crack or extrusion. 治疗被这种创伤或疾病影响的动脉的典型手术方法是手术暴露和分离患病的动脉节段,并随后a)切除并且重新连结或b)为患病的动脉节段加设旁路,以恢复动脉血流流经或绕过患病的动脉节段。 This method of treatment is typically surgical trauma or disease affects the arteries is surgically exposed artery segment and the separation of diseased and subsequently a) removal and re-link or b) for the diseased arterial segments bypassed added to restore arterial blood flow through or bypass the diseased artery segments. 在许多情况下,被损伤和疾病影响的动脉节段可以是很大以致手术不可能进行单纯切除,患病段的除去和邻近动脉断端的端-端吻合。 In many cases, the artery segments were affected by injuries and illness can be so large that simple surgical excision is not possible to remove the diseased section of the artery and the adjacent ends of end - to - end anastomosis. 因此在这种切除的和端-端吻合是不合适的选择的情况下,在患病的动脉上连接一种管状旁道移植物,(如由编织聚乙烯,orePTET形成的管状移植物)对患病的动脉节段加设旁路可能是合乎需要的。 Therefore, in this cut and end - end anastomosis is the case of inappropriate choice, in the diseased artery connecting a tubular bypass graft (such as woven tubular graft made of polyethylene, orePTET formation) to The prevalence of arterial segments plus bypassing may be desirable.

虽然上述许多手术操作代表相对最新的进展,与传统手术方法相关的侵裂性和危险已经被缓和,本领域仍需求,即为被阻塞的损伤的和患病的动脉节段加设通路而发展新的、安全的、可靠的、最小创伤和/或透过管膜的操作。 While many of these surgical procedures represent the latest developments relative, invasive and dangerous crack method associated with traditional surgery have been eased, this field still needs to be blocked is damaged and diseased arterial segments plus set path and development new, safe, reliable, minimally invasive and / or through the tube membrane operation.

B. B. 涉及到其他血管外手术/介入操作的背景手术和介入操作的许多类型已经在身体的器官,组织或体腔范围内预先形成。 It involves other extravascular surgical / interventional surgery and background operations many types of interventional procedures have been previously formed in the organ, tissue or body cavity of the body range. 传统地,进入到这种器官,组织或体腔是通过一个或更多身体的开放外科切口来完成的,从而使患病的器官,组织或体腔被外科地暴露。 Traditionally, into this organ, tissue or body cavity through one or more of the body open surgical incision to complete, so that the diseased organ, tissue or body cavity is exposed surgically.

近些年,已进行实质性的努力去发展“最小创伤”的手术技术,因而一个或更多的内窥镜被利用于观察患病的器官,组织或体腔,手术器械或其它装置被插入体内以通过相对小的“最小通路”(例如:小于3cm)切口完成要求的手术或介入操作。 In recent years, substantial efforts have been made to develop "minimally invasive" surgical technique, therefore one or more of the endoscope to be used to observe the diseased organ, tissue or body cavity, surgical instruments or other device is inserted into the body by relatively small "minimum access" (for example: less than 3cm) incision to complete the required surgery or interventional procedures.

虽然这些内窥镜“最小通路”手术方法的出现,其优越性超过传统的开放式的手术技术,即它们可以使手术切口缩到最小的范围内,因此可以导致最小的手术后不适,但这种内窥镜方法常被限制于通过身体的管腔和体腔可接近的操作,这种管腔或体腔可以被清亮的体液充满或用气体吹入以提供一个开放的区域放置手术内窥镜和器械于其中。 The "minimum access" While these endoscopic surgical procedures, its advantages over traditional open surgical technique that they can make the incision reduced to a minimum range, it can cause discomfort after minimal surgery, but Species endoscopic methods are often limited by the body lumen and a body cavity accessible operation, this lumen or body cavity can be filled with clear fluid or gas is blown into the area to provide an open and endoscopic surgical placement instrument therein.

鉴于与即使是最现代的“最小通道”手术和介入操作相关的限制,在本领域中仍然需要发展用于接近肿瘤,器官,组织和其他身体内血管外位置的新方法和装置,以不必在体内形成任何开放式手术切口而施行手术和/或介入性操作。 In view of even the most modern "minimum access" surgery and interventional procedures related restrictions, there remains a need in the art for the development of close tumors, new methods and means of organs, tissues and other body extravascular position for to do not in vivo formation of any open surgical incision and the implementation of surgery and / or invasive procedures.

发明概要一般来说,本发明提供应用哺乳动物体内的血管系统作为一种管道以施行各种类型的医学操作的方法。 SUMMARY OF THE INVENTION Generally, the present invention provides a vascular system of a mammal applied as a conduit for the purposes of the method of the various types of medical procedures. 由于遍布全身的导管管道的广泛分布,血管系统提供一种通路,通过这个通道,部件能够被移动到达选择的治疗部位,否则这些部位只可以通过一个直接切口到达。 Since the widely distributed throughout the vascular system of the body of the catheter tube providing a passage through the channel member can be moved reach the selected treatment site, otherwise these parts can only arrive via a direct incision. 本发明的特殊方法包括a)血管再造方法,和b)在体内血管外位置进行各种类型的医疗操作的方法。 Special methods of the present invention comprises a) revascularization method, and b) the method for various types of medical procedures performed in vivo extravascular position.

本发明的血管再造方法一般包括在血管之间,在相同血管的不同位置间,或一条血管和另一种容纳血的形态学结构(例如:心脏的腔)间,一个或更多的血管外通路的形成,以使血液流经这些通路。 Revascularization method of the present invention are generally comprised between blood vessels, between different locations of the same blood vessel or a blood vessel and another receiving morphological structures (e.g.,: the heart chamber) between one or more of the extravascular forming a passage so that blood flows through these passages. 在本发明的许多应用中,氧合血(即:pO2大于50的血)被携带通过血管外通路,以达到提供或增加组织灌注的目的是所期望的。 In many applications of the present invention, the oxygenated blood (ie: pO2 greater than the blood of 50) are carried through the blood vessels outside access, in order to achieve or increase tissue perfusion is desirable purpose. 按照本发明的血管再造方法形成的血管外通路可用经皮,经管腔方法形成,这种方法避免了在哺乳动物体内形成开放手术切口。 Extravascular access revascularization method according to the present invention forms available transdermal, administered by the chamber method of forming, this approach avoids the formation in mammals open incision. 本发明的这种血管再造方法可以适用于周围血管和/或冠状血管。 This revascularization method of the present invention can be applied to peripheral vascular and / or coronary artery.

按照本发明的血管再造方法,提供了为提供动脉血流到达由于在动脉节段中存在阻塞,损伤或疾病而丧失了血流的组织的方法。 Revascularization method according to the present invention, there is provided to provide a blocked artery to reach due to damage or disease in the arterial segments in loss of tissue blood flow approach. 这种方法通常包含:在容纳动脉血的形态学通道(例如:一个动脉或左心腔)和一个将灌注血流丧失组织的血管之间形成第一血管外通路的步骤这样动脉血将通过该血管外血流道路并且进入该血管,以通过此血管去灌注血流丧失的组织。 This method generally comprises: accommodating arterial morphological channel (for example: an artery or the left heart chamber) and a first step to lose blood perfusion passage formed between extravascular vascular tissue so through the arterial extravascular blood flow path and into the blood vessels, in order to go through this vascular tissue blood perfusion loss. 在本方法的一些应用中,第一血流通路将在一种动脉和一种邻近的静脉间被形成,这样血液将从动脉流进邻近的静脉,并随后逆行通过这条静脉以通过静脉血管系统逆向灌注组织。 In some applications of the method, the first flow path is formed between an artery and a nearby vein, artery so blood from flowing into the adjacent vein and then retrograde through this vein by vein system reverse perfused tissue. 此外,第二血流通路可以在静脉和阻塞,损伤或疾病所存在的动脉间被形成,这样已经进入静脉的动脉血将再进入该动脉,于其阻塞,创伤或被疾病影响的节段的下游,从而通过阻塞,损伤或疾病影响的节段所在的内源动脉灌注血流丧失的组织。 Further, the second flow path may be formed between the vein and the occlusion, the presence of damage or disease arterial, venous arterial blood has entered so that a further access to the artery, obstruction thereof, segments of trauma or disease affecting Downstream, so that by blocking segment where the injury or disease affect endogenous arterial blood flow loss. 本发明的医学操作方法主要包括,从一条血管到另一种体内位置(例如:血管组织,器官,体腔,肿瘤等)的至少一种血管外通路的形成步骤,和随后经血管外通路传递一种物质或装置,以在所选择的体内位置上进行所期望的医疗操作。 Medical method of operation of the present invention includes, from a vessel to another location in the body (e.g.: vascular tissues, organs, body cavities, tumors, etc.) the step of forming at least one extravascular passageway, and subsequently passed through an extravascular passageway substances or devices to perform a desired medical procedure in the selected position on the body.

进一步按照本发明,提供一种部件,这种部件能够插进血管并能用于形成血管外通路,这种血管外通路从导管部件所插入的血管延伸至一个目标位点,(例如:a)另外的血管,b)另外的容纳血液的形态学结构(例如:心脏的腔),c)同一血管的另一个位置或d)一个血管外的位置(例如:器官,肿瘤,体腔等)。 In further accordance with the present invention, there is provided a member, such member can be inserted into the blood vessels and can be used to form the extravascular passageway, such extravascular passageway extending from the conduit member is inserted through a blood vessel target site, (example: a) Further blood vessels, b) receiving additional blood morphological structures (e.g.: another location or d heart chamber), c) the same blood vessel) an extravascular location (e.g.: organ, tumor, a body cavity, etc.). 通过这个导管部件形成的血管外通路可用于施行本发明的方法,如上文所概述。 Extravascular passageway formed by the catheter component can be used in the implementation process of the invention, as outlined above. 这种通路形成导管部件可以包括一种具有一个组织穿通元件(例如,一种元件,部件或能量流)的延伸的,易弯的导管体,这种元件能从导管体穿出,以通过导管所在的血管管壁,并通过位于血管和期望该通路延伸至的目标位置(例如:其他血管,解剖结构,血管外的位置,或同一血管上的其他位置)之间的任何其他组织形成通路。 Such passage forming member may include a catheter having a tissue penetrating element extending (e.g., a device, component or energy flow) of, pliable catheter body, this body piercing element from the catheter, through the catheter where the vessel wall and through the blood vessels and is located in the passageway extends to the desired target position: forming a via any other organization (such as other vascular anatomy position extravascular, or other locations on the same vessel) between. 这种组织穿通元件可包含:一种适当类型的组织穿通元件,部件或能量流,包括但不必限于中空和/或实体的针,套管针(带或不带一种包绕的柔韧的鞘),激光束,激光发射元件,电烙器的探头,热尖探针,旋转组织穿通装置,或超声消磨探针。 This tissue penetrating element may comprise: a suitable type of tissue penetrating elements, components, or energy flow, including but not necessarily limited to the hollow and / or entities needle, trocar (with or without a surrounding flexible sheath ), the laser beam, the laser probe emitting element, electrocautery, the hot tip probes, rotary feedthroughs organization, or spend ultrasound probe. 任选地,导管部件可装备上吸引腔,可膨胀的球囊或其他结构特征或能用于易化或辅助组织穿通元件(例如元件,装置,能量流)从血管至所选择的目标位置的通过的装置。 Optionally, the catheter may be equipped with suction housing member, the balloon or other inflatable or structural features that can be used facilitated or assisted tissue penetrating element (e.g., element, device, energy flow) from the blood vessels to the selected target position It means adopted. 也可以任选,导管部件的组织穿通元件可以结合一种导丝腔,或供通过由组织穿通元件形成的血管外通路传递导丝的其它工具。 Also optionally, tissue penetrating element of the catheter member may be bonded to a guidewire lumen, or other tools for tissue penetrating element by the formation of extravascular passageway passing the guide wire.

进一步按照本发明,这种具有上述特性的通路形成导管部件可结合一种或多种供使组织穿通元件定向,以保证血管外通路在它预期的位置被形成的元件。 In further accordance with the present invention, which has the above features via a catheter components can be combined with one or more for the tissue penetrating element orientation to ensure that member extravascular pathway in its intended position is formed is formed. 这种定向装置可以安装在通路形成导管上或结合在其中,或可以与通路形成导管分离地形成,并与来自任何适合的体内的和/或体外位置的导管结合使用。 This orientation means may be mounted on a passage formed therein or in combination, or may be formed with a passage conduit is formed separately, and used in conjunction with any suitable catheter from the body and / or the location of the catheter in vitro. 这种定向装置可以包含各种类型的主动和/被动装置,包括,但不限于,体外或体内的超声装置,体外或体内的多普勒装置,体内或体外放射显像装置,磁共振成像装置,X线断层照像装置,感应线圈,电磁部件,和各种具有导管的标记,这种标记能够通过放射显像,声,超声,照像术,MRI或其他方法辩认。 This orientation means may comprise various types of active and / or passive means, including, but not limited to, in vitro or in vivo ultrasound apparatus, in vitro or in vivo Doppler apparatus, in vitro or in vivo radioimaging device, a magnetic resonance imaging apparatus , X-ray radiographic tomography apparatus, an induction coil, electromagnetic means, and a variety of catheters having marking, which can be labeled by radio-imaging, sound, ultrasound, photographic technique, MRI or other methods recognizable.

仍然进一步按照本发明,为去除组织,加衬,斯坦特固定模化,纵向压迫和/或通过本发明形成的血管外通路的其它修正提供通路修正部件。 Still further in accordance with the present invention for removing tissue lining, a stent-based, longitudinal oppression and other modifications / or formed by the present invention to provide a path extravascular path correction means.

本发明的进一步目的和优点对本领域的技术人员,在阅读下文详细描述的优选实施方案后是显而易见的,其中某些本发明的优选实施方案和实例被详细提出。 Further objects and advantages of the present invention to those skilled in the art after reading the following detailed description of the preferred embodiments will be apparent, in which a preferred embodiment of the present invention and some examples are presented in detail.

附图简述图1a是一种人类心脏的前面透视图,显示冠状动脉和其上的静脉的典型位置。 BRIEF DESCRIPTION Figure 1a is a front perspective view of a human heart, showing the typical position of the coronary arteries and veins on it.

图1b是一种人类心脏的后面透视图,显示动脉和其上的静脉的典型的位置。 Figure 1b is a rear perspective view of a human heart, showing a typical position of the artery and venous on.

图1c是通过位于图1a的1c节段中相邻的冠状动脉和冠状静脉的纵剖图,其中按照本发明的血流通路已经形成,以为冠状动脉内的阻塞加设旁路。 Figure 1c is a longitudinal sectional view through Figure 1a 1c of segments located adjacent coronary artery and coronary vein, wherein the flow path in accordance with the present invention have been formed, that within the coronary artery occlusion plus bypassed.

图1d是一种通过图1c的1d-1d线的横剖图。 Figure 1d is a through line 1d-1d in Fig. 1c is a cross-sectional view.

图1e是一种Brouck-Moscheau三角的简图,该三角为一种通过人类心脏的某些冠状动脉和冠状静脉限定的解剖学界标。 Fig. 1e is a schematic of a Brouck-Moscheau triangle, anatomical landmarks of the triangle defined by the human heart as a certain coronary arteries and coronary veins. 可在右前斜位X光片上看到。 It can be seen on the right anterior oblique X-rays.

图1f是本发明的另一种血管再造方法透视图,其中血管外组织间隙通路从血管上的第一位置(阻塞的上游)向同一血管上的第二位置(阻塞的下游)形成。 Figure 1f is another perspective view of revascularization method of the present invention, wherein the extravascular tissue (downstream occlusion) gap passage from the first position (blocked upstream) to the second position on the vessel in the same blood vessel formation.

图1f′是图1f中所示血管的一种透视图,本发明的血管再造方法的已完全运用以形成绕过阻塞的旁路通道。 Figure 1f 'is shown in FIG. 1f a perspective view of the blood vessel, revascularization method of the present invention have been fully apply to form a bypass passage bypassing the obstruction.

图2是一种人体的透视图结合按照本发明用于在体内一个血管外位置上施行医学操作的经血管的方法的一种图解说明。 Figure 2 is a perspective view illustrating a combination of the body according to the invention for the purposes of medical operations in the body an extravascular position through the blood vessels of the method.

图2a是一种图2的目标组织的放大的透视图,显示组织穿通元件从通路形成导管穿入目标组织的方式。 Figure 2a is an enlarged perspective view of FIG. 2 in a target tissue showing tissue penetrating element from the catheter passage is formed to penetrate the target tissue.

图2a′是一种图2的目标组织的放大图,显示一种接近管道,这种管道已经被推进通过和/或被交换进入血管外通路进入目标组织。 Figure 2a 'is the goal of the organization 2 an enlarged view of a diagram showing a close pipeline, this pipeline has been advanced by and / or exchanged into the extravascular passageway into the target tissue.

图2b是一种具有皮下注射开口内在传递/取样套管的示意图,这种套管用于重复输注/抽出物质,或监测目标区域中的条件。 Figure 2b is a schematic view of the internal opening subcutaneous delivery / sampling sleeve having, for repeating this infusion cannula / extraction material, or to monitor the conditions in the target area.

图2c是经血管外通路插入的导管的示意图,该导管被用于临时展开一种部件进入目标区域,监测目标区域中的条件,或向目标区域输注/或从中抽出物质。 Figure 2c is a schematic view of a catheter inserted through the extravascular passageway, the catheter is used to expand a temporary member into the target area, the target area monitoring condition, or the target area infusion / or withdrawn therefrom substance.

图2d是利用本发明的血管外通路永久放置的部件(如,流体引流分流器)的示意图。 Figure 2d is a schematic diagram of the present invention utilizing extravascular passage permanent placement of components (eg, fluid drainage shunt) is.

图2e是一种导管的示意图,该导管经过本发明的血管外通路插入并进入另一条管状形态学通路的管腔,用于取样,接近或在管状形态学通路中施行手术或介入操作。 Figure 2e is a schematic view of a catheter, the catheter through the blood vessels of the present invention is inserted into the outer path and into the lumen of the tubular morphology another path for sampling approach or an operation or interventional procedures in the tubular morphology path.

图2f是按照本发明施行血管外微手术的经血管操作的示意图。 Fig. 2f is a schematic view of the implementation of micro-vascular surgery through the blood vessels outside the operation in accordance with the present invention.

图3a是显示按照本发明形成的未修正血流通路的纵剖图。 Figure 3a is a longitudinal sectional view of the uncorrected flow path formed in accordance with the present invention display.

图3b是显示按照本发明形成的内部加衬血流通路的纵剖图。 Figure 3b is a display in accordance with the present invention is formed in the inside lining of a longitudinal sectional view of flow path.

图3c是显示按照本发明形成的纵行压迫血流通路的纵剖图。 Figure 3c is a longitudinal sectional view according to the present invention is formed of longitudinal flow path of oppression display.

图3d是具有非突出的斯坦特固定膜或斯坦特固定膜性移植物置于其中的本发明的血流通路纵剖图。 Figure 3d is a non-protruding film or stents Stent graft membrane disposed flow path wherein a longitudinal sectional view of the present invention.

图3d′是一种透视图,显示任意选择的凸缘和/或任意选择的凸出物,它们可以被结合入可置于按照图2d的本发明的血流通路中的非突出斯坦特固定膜或斯坦特固定膜性移植物。 Figure 3d 'is a perspective view showing the flange optionally and / or optionally projections, they may be incorporated may be placed in accordance with the present invention, FIG flow path 2d in the non-protruding stents film or membrane graft stents.

图3e是通过本发明的血流通路的剖面图,在该血流通路中具有半突出的或突出的斯坦特固定膜或斯坦特固定膜性移植物的第一实施方案。 Figure 3e is a sectional view through the flow passage of the present invention having a first embodiment of the semi-protruding or projecting stents or stents film membrane graft in the flow path.

图3f是通过本发明的第一和第二血流通路的剖面图,在该血流通路中具有突出的斯坦特固定膜或斯坦特固定膜性移植物的第二实施方案。 Figure 3f is a flow path through the first and second cross-sectional view of the invention, a second embodiment of the outstanding stents film or stents membrane graft in the flow path.

图4a是按照本发明形成动静脉血流通路的第一方法的图示。 4a is in accordance with the present invention, arterial and venous blood flow passage illustrating a first method of forming.

图4b是按照本发明形成动静脉血流通路的第二方法的图示。 4b is an illustration of arterial and venous blood flow path in accordance with a second method of the present invention is formed.

图4c是按照本发明形成动静脉血流通路的第三方法的图示。 Figure 4c is a diagram of the arterial and venous blood flow path in accordance with the third method of the present invention is formed.

图4d是按照本发明形成动静脉血流通路的第四方法的图示。 Figure 4d is in accordance with the present invention, arterial and venous blood flow path illustrating a fourth method of forming.

图4e是按照本发明形成动静脉血流通路的第五方法的图示。 Figure 4e is an illustration of arterial and venous blood flow path of the fifth method according to the present invention is formed.

图5a是一种两个(2)相邻血管的纵剖图,阐明了为定向,瞄准并引导一种组织穿通元件以形成按照本发明的动静脉血通路的第一方法。 Figure 5a is a two (2) adjacent a longitudinal sectional view of the blood vessel, to clarify the directional, targeted and guided to a tissue penetrating element forming method according to a first passage of the arterial and venous blood of the present invention.

图5b是一种邻近动脉和静脉的纵剖图,阐明了为定向,瞄准,并引导一种组织穿通元件以形成按照本发明的动静脉血流通路的第二方法。 Figure 5b is a longitudinal cross-sectional view of a neighboring arteries and veins to clarify for the orientation, targeting, and guide an organization-through element to form a second method according to the present invention, arterial and venous blood flow passage.

图5c是一种邻近动脉和静脉的纵剖图,阐明了为定向,瞄准,并引导一种组织穿通元件以形成按照本发明的动静脉血流通路的第三方法。 Figure 5c is a vertical cross-sectional view of a neighboring arteries and veins to clarify for the orientation, targeting, and guide a tissue penetrating member to form a third method according to the present invention, arterial and venous blood flow passage.

图5d是一种邻近动脉和静脉的纵剖图,阐明了为定向,瞄准,并引导一种组织穿通元件以形成按照本发明的动静脉血通路的第四方法。 Figure 5d is a neighboring arteries and veins longitudinal sectional view, illustrates the orientation, targeting, and guide an organization follow-through element to form an arteriovenous passage of a fourth method of the present invention.

图5e是一种图示,阐明一种为利用被动的放射显像可见的标记物去定向,瞄准和/或引导一种组织穿通元件去形成按照本发明的血管血管外通路的方法。 Figure 5e is a diagram to clarify a developer to take advantage of passive radiation visible to the directional markers, targeting and / or guide an organization through-element forming method according to the present invention, the outer vessel vascular pathways.

图5e′说明一种按照图5e可以被利用的放射显像标记的第一类型。 Figure 5e 'in Figure 5e illustrates a first type of radiation can be utilized imaging markers.

图5e″说明一种按照图5e可以被利用的放射显像标记的第二类型。 Figure 5e "describe a second type can be used as shown in Figure 5e radiation imaging markers.

图5e说明一种按照图5e可以被利用的放射显像标记的第三类型。 Figure 5e described a third type can be used as shown in Figure 5e radiation imaging markers.

图5f是一种图示,说明一种利用超声可见标记去瞄准,校直和/或引导一种组织穿通元件以形成按照本发明的血管外通路的方法。 Figure 5f is an illustration shows an ultrasonic visible mark to aim, alignment and / or guide an organization through-element forming method according to the present invention extravascular passage.

图5f′是图5f中所示超声可见标记的透视图。 Figure 5f 'is shown in Figure 5f ultrasound shows a perspective view of the mark.

图5g是一种用MRI去定向,瞄准或引导一种组织穿通元件,以形成按照本发明的血管外通路的方法的示意图。 Figure 5g is a use MRI to orient or guide an organization aimed at penetrating elements to form a schematic diagram of the method according to the present invention, the outer vessel passage.

图5g′是一种用磁共振成像(MRI)可见标记易化定向,瞄准和/或引导组织穿通元件形成按照本发明的一种血管外通路的第一实施方案的透视图。 Figure 5g 'is a magnetic resonance imaging (MRI) visible mark facilitated orientation, targeting, and / or guided tissue penetrating element forming a perspective view of a blood vessel in accordance with the present invention, the outer path of the first embodiment.

图5g″是一种用磁共振成像(MRI)可见标记易化定向,瞄准和/或引导组织穿通元件形成按照本发明的一种血管外通路的第二实施方案的透视图。 Figure 5g "is a visible mark facilitated orientation, targeting, and / or guided tissue penetrating element forming a perspective view of a blood vessel in accordance with the present invention, the outer path of the second embodiment with magnetic resonance imaging (MRI).

图5h是一种图示,说明利用多普勒装置易化定向,瞄准和/或引导组织穿通元件以形成按照本发明的一种血管外通路的方法。 Figure 5h is a diagram, explain the use of the Doppler device facilitated orientation, targeting, and / or guided tissue penetrating element forming method according to the present invention, a blood vessel outside the path.

图5i是一种图示,说明压力感受装置易化组织穿通元件的定向,瞄准和/或引导以按照本发明形成血管外通路的方法。 Figure 5i is an icon, a pressure sensing means easy to explain organization-through element orientation, targeting, and / or guidance to the method according to the present invention is formed extravascular pathway.

图5j是一种图示,说明利用发射器和接受器装置来定向,瞄准和/或引导组织穿通元件以按照本发明形成一种动静脉血流通路的方法。 Figure 5j is an icon, indicating the use of a transmitter and a receiver device orientation, targeting, and / or guided tissue penetrating element to form in accordance with the present invention a method of arterial and venous blood flow path.

图5k是一种图示,说明利用发射和感应线圈装置来定向,瞄准和/或引导一种组织穿通元件以按照本发明形成动静脉血流通路的方法。 Fig 5k is a diagram, explain the use of the transmission and induction coil means to orient, aiming and / or guide an organization formed in the method according to the present invention, arterial and venous blood flow passage-through element.

图5l是一种图示,说明利用磁性装置定向,瞄准和/或引导一种组织穿通元件以按照本发明形成一种动静脉血流通路的方法。 Figure 5l is a diagram shows the use of a magnetic device orientation, targeting, and / or guide an organization to form according to the present invention a method of arterial and venous blood flow path through pass element.

图6a是本发明的穿血管的组织穿通导管的一部分的纵剖图,说明组织穿通元件从导管中退出的第一方法。 Figure 6a is wearing a blood vessel tissue penetrating catheter of the present invention is a vertical cross-sectional view of a portion, a first method of tissue penetrating member exit from the catheter.

图6b是本发明的穿血管的组织穿通导管的一部分的纵剖图,说明组织穿通元件从导管中退出的第二方法。 Figure 6b is wearing vascular tissue of the present invention the through longitudinal sectional view of a portion of the catheter, a second method of tissue penetrating member exit from the catheter.

图6c是本发明的穿血管的组织穿通导管的一部分的纵剖图,说明组织穿通元件从导管中退出的第三方法。 6c is a vascular tissue of the present invention through the through longitudinal sectional view of a portion of the catheter, a third method of tissue penetrating member exit from the catheter.

图6d是本发明的穿血管的组织穿通导管的一部分的纵剖图,说明组织穿通元件从导管中退出的第四方法。 Figure 6d is wearing a blood vessel tissue penetrating catheter of the present invention is a vertical cross-sectional view of a portion of tissue penetrating elements described exit from the catheter fourth method.

图6d′是通过图6d所示导管部件的远端末端的透视图。 Figure 6d 'is illustrated by Figure 6d a perspective view of the distal end of the catheter member.

图6e是本发明的穿血管的组织穿通导管的一部分的纵剖图。 Figure 6e is wearing a blood vessel tissue penetrating catheter of the present invention is a vertical cross-sectional view of a part. 说明组织穿通元件从导管中退出的第五方法。 The fifth method described tissue penetrating element exits from the catheter.

图6f是本发明的穿血管的组织穿通导管的一部分的纵剖图,说明组织穿通元件从导管中退出的第六方法。 Figure 6f is wearing vascular tissue of the present invention the through longitudinal sectional view of a portion of the catheter, indicating tissue penetrating member exit from the catheter sixth methods.

图6g是本发明的穿血管的组织穿通导管的一部分的纵剖图,说明组织穿通元件从导管中退出的第七方法。 Figure 6g wear vascular tissue of the present invention, the through longitudinal sectional view of a portion of the catheter, indicating tissue penetrating element seventh exit from the catheter method.

图6h是本发明的穿血管的组织穿通导管的一部分的纵剖图,说明组织穿通元件从导管中退出的第八方法。 Figure 6h wear vascular tissue of the present invention, the through longitudinal sectional view of a portion of the catheter, indicating tissue penetrating member exit from the catheter method eighth.

图6i是本发明的穿血管的组织穿通导管的一部分纵剖图,说明组织穿通元件从导管中退出的第九方法。 Figure 6i is wearing a blood vessel tissue penetrating catheter of the present invention is part of a longitudinal section view showing the tissue penetrating element exits from the catheter method ninth.

图7a是按照本发明的组织穿通元件的第一实施方案的远端部分纵剖图。 7a is a longitudinal sectional view of the distal end portion through-element of the first embodiment of the present invention according to the organization.

图7a′是一种沿图7a的7a′-7a′连线的横剖图。 Figure 7a 'of Figure 7a along a 7a'-7a' wiring cross-sectional view.

图7b是按照本发明的组织穿通元件的第二实施方案的远端部分纵剖图。 7b is a distal penetrating element of the second embodiment according to the organization partial longitudinal sectional view of the present invention.

图7c是按照本发明的组织穿通元件的第三实施方案的远端部分纵剖图。 7c is a longitudinal sectional view of the distal end portion of the through element according to the third embodiment of the present invention the organization.

图7d是按照本发明的组织穿通元件的第四实施方案的远端部分纵剖图。 Fig. 7d is a longitudinal sectional view of the distal end portion of the through element according to the fourth embodiment of the present invention the organization.

图7d′是图7d沿7d′-7d′连线的横剖图。 Fig. 7d '7d 7d'-7d is a view along the' cross-sectional view of the wire.

图7e是按照本发明的组织穿通元件的第五实施方案的远端部分的纵剖图。 Fig. 7e is a vertical cross-sectional view of the distal part of the organization in accordance with the present invention, the through elements of the fifth embodiment.

图7e′是图7e沿7e′-7e′连线的横剖图。 Fig. 7e 'is a view along 7e 7e'-7e' cross-sectional view of wiring.

图7e″是通过图7e中所示部件的替换实施方案的横剖图,它包含有一种实性的管心针位于其中的一种中空管。 Fig. 7e "is a cross-sectional view through parts shown in Fig. 7e alternative embodiment, which includes a solid stylet positioned therein a hollow tube.

图7f是按照本发明的组织穿通元件的第六实施方案的远端部分的纵剖图。 Fig. 7f is a vertical cross-sectional view of the distal part of the organization in accordance with the present invention, the through element of the sixth embodiment.

图7f′是形成图7f中所示组织穿通元件一部分的尖端带套管的延伸元件的透视图。 Figure 7f 'is a perspective view of a portion of the extension member with the cannula tip element organization formed as shown in Fig. 7f-through.

图7g是按照本发明的组织穿通元件的第七实施方案的远端部分的纵剖图。 Figure 7g is organized in accordance with the present invention, a vertical cross-sectional view of the distal portion of the seventh embodiment of elements penetrating.

图7h是按照本发明的组织穿通元件的第八实施方案的远端部分的纵剖图。 Figure 7h is a vertical cross-sectional view of the distal part of the organization in accordance with the present invention, the through elements of the eighth embodiment.

图7i是按照本发明的组织穿通元件的第九实施方案的远端部分的纵剖图。 Figure 7i is a vertical cross-sectional view of the distal part of the organization in accordance with the present invention, the through element ninth embodiment.

图7j是按照本发明的组织穿通元件的第十实施方案的远端部分的纵剖图。 Figure 7j is a vertical cross-sectional view of the distal part of the organization in accordance with the present invention, the through elements of the tenth embodiment.

图7k是按照本发明的组织穿通元件的第十一实施方案的远端部分的纵剖图。 Figure 7k is a vertical cross-sectional view of the distal part of the organization in accordance with the present invention, the through element eleventh embodiment.

图7l是按照本发明的组织穿通元件的第十二实施方案的远端部分纵剖图。 Figure 7l is a longitudinal section view of the distal portion of the organization in accordance with the present invention, the through twelfth embodiment of the element.

图7m是按照本发明的组织穿通元件的第十三实施方案的远端部分纵剖图。 Figure 7m is a longitudinal section view of the distal portion of the organization in accordance with the present invention, the through element thirteenth embodiment.

图8a是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第一实施方案。 Figure 8a is a longitudinal sectional view, which shows a first embodiment of the apparatus for modifying tissue according to the present invention, a gap is formed passage.

图8b是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第二实施方案。 Figure 8b is a longitudinal sectional view, which shows a second embodiment according to the present invention for correcting tissue gap formed passage means.

图8c是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第三实施方案。 Figure 8c is a longitudinal sectional view, which shows a third embodiment according to the present invention for correcting tissue gap formed passage means.

图8d是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第四实施方案。 Figure 8d is a longitudinal sectional view, which shows a fourth embodiment of the apparatus for modifying tissue according to the present invention, a gap is formed passage.

图8e是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第五实施方案。 Figure 8e is a longitudinal sectional view, which shows a fifth embodiment of the organization in accordance with the present invention for correcting the gap formed passage means.

图8f是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第六实施方案。 Figure 8f is a vertical cross-sectional diagram, which shows the sixth embodiment according to the present invention for correcting tissue gap formed passage means.

图8g是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第七实施方案。 Figure 8g is a longitudinal sectional view, which shows a seventh embodiment of the organization in accordance with the present invention for correcting the gap formed passage means.

图8h是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第八实施方案。 Figure 8h is a longitudinal sectional view, which shows the eighth embodiment according to the present invention for correcting tissue gap formed passage means.

图8h′是图8h部件的正视图,该部件被用于修正按照本发明形成的动静脉血流通路。 Figure 8h 'is a front view of FIG. 8h member, the member according to the invention is used to correct the arterial and venous blood flow path formed.

图8i是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第九实施方案。 Figure 8i is a longitudinal sectional view, which shows a ninth embodiment of the organization in accordance with the present invention for correcting the gap formed passage means.

图8j是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第十实施方案。 Figure 8j is a longitudinal sectional view, which shows a tenth embodiment of the present invention according to the Organization for correcting the gap formed passage means.

图9a是一种部件的第一实施方案的正视图,该部件能够用于纵行压缩按照本发明形成的动静脉通路。 9a is a front view of a first embodiment of a component of FIG, the longitudinal member can be used to compress arteriovenous passage formed in accordance with the present invention.

图9a′图9a中所示的部件的部件分解透视图。 Figure 9a 'component parts shown in Figure 9a an exploded perspective view.

图9b是一种部件的第二实施方案的正视图,该部件能够用于纵行压缩按照本发明形成的动静脉血流通路。 9b is a front view of a second embodiment of a component of FIG, the longitudinal member can be used in accordance with the present invention, compression of the arterial and venous blood flow passage is formed.

图9b′是安装于一种传递导管内的图9b部件的部分纵剖图。 FIG. 9b 'is mounted to a partial longitudinal sectional view of the catheter of the inner member of Figure 9b to pass.

图9b″是部分地弹出其运送导管的图9b部件的一种透视图。 Figure 9b "is a perspective view of a partially ejecting its delivery catheter of Figure 9b member.

图9b是完全地弹出其运送导管的图9b部件的一种透视图。 Figure 9b is a perspective view of a completely eject its delivery catheter Figure 9b member.

图9c是一种部件的第三实施方案的正视图,该部件能够用于纵行压缩按照本发明的动静脉血流通路。 Figure 9c is a front view of a part of a third embodiment of the FIG., The longitudinal member can be used to compress the present invention in accordance with the arterial and venous blood flow path.

图9d是一种部件的第四实施方案的正视图,该部件能够用于纵行压缩按照本发明的动静脉血流通路。 Figure 9d is a front view of a part of a fourth embodiment of FIG, the part can be used for longitudinal compression arterial and venous blood flow path in accordance with the present invention.

图9e是一种部件的第五实施方案的正视图,该部件能够用于纵行压缩按照本发明的动静脉血流通道。 Figure 9e is a front view of a part of a fifth embodiment of the FIG, the part can be used for longitudinal compression in accordance with the present invention, arterial and venous blood flow path.

图9f是一种部件的第六实施方案的正视图,该部件能够用于纵行压缩按照本发明的动静脉血流通路。 FIG. 9f is a front view of a part of a sixth embodiment of FIG, the component can be used in accordance with the longitudinal compression arterial and venous blood flow path of the present invention.

图9f′是安装于一种运送导管内的图9f部件的部分纵剖图。 Figure 9f 'is installed in a partial longitudinal cross-sectional view of the catheter of FIG. 9f component within the delivery.

图9f″是一种图9f部件在其被安装于其运送导管内时的透视图。 FIG. 9f "Figure 9f is a perspective view of a component when it is transported within the catheter mounted thereon.

图9f是部分地展开至其运送导管外的图9f部件的纵剖图。 Figure 9f partially unfold to its longitudinal section view of the delivery catheter of FIG. 9f outer member.

图9f″″是充分展开至其运送导管外的图9f部件的横剖图。 Figure 9f "" is fully expanded to a cross-sectional view of the delivery catheter outside its Figure 9f member.

图10a是一种本发明的经血管组织穿通导管部件的第一实施方案的透视图。 10a is a perspective view of an invention of the vascular tissue through the through the catheter member of the first embodiment.

图10b是通过图10a的10b-10b连线的纵剖图。 Figure 10b is a longitudinal sectional view of Figure 10a through connection 10b-10b.

图10c是通过图10a的10c线的纵剖图。 Figure 10c is a longitudinal sectional view through the line 10c of Figure 10a.

图10d是通过图10a的10d-10d连线的横剖图。 Figure 10d is a cross-sectional view of Fig. 10a through 10d-10d wiring.

图10c′是一种可任选的导丝/鞘推进装置的示意图,这种装置可以被结合进本发明的经血管组织穿通导管的任何实施方案。 Figure 10c 'is a schematic diagram of an optional guidewire / sheath propulsion device, this device can be incorporated into the present invention by the vascular tissue penetrating any of the embodiments of the catheter.

图10c″是导管部件的组织穿通元件正在穿通组织时图10c′的装置的示意图。 Figure 10c "is a schematic diagram 10c 'means the tissue penetrating catheter component elements are penetrating tissue.

图10c是这种组织穿通元件已经穿通组织和进入一种血管管腔或开放腔之后图10c部件的示意图。 This organization is a schematic diagram 10c after penetrating element has worn through the organization and into the lumen of a blood vessel or cavity open part of Figure 10c.

图11a是通过本发明的经血管组织穿通导管部件的第二实施方案的手持组成部位的纵剖图。 Consisting of a vertical cross-sectional view of the handheld portion 11a is a through vascular tissue of the present invention through the through the catheter member of the second embodiment.

图11b是通过本发明的经血管组织穿通导管部件的第二实施方案的远端部分的部分纵剖图。 Partial longitudinal cross-sectional view of the distal portion of Fig. 11b by the present invention by the vascular tissue penetrating catheter component of the second embodiment.

图11c是显示组织穿通操作第一阶段期间图11b部件的纵剖图。 Figure 11c is a longitudinal sectional view of the through tissue during the first phase of the operation display section 11b in FIG.

图11c是显示组织穿通操作第二阶段期间图11b部件的纵剖图。 Figure 11c is a longitudinal sectional view of the through tissue during the second phase of the operation display section 11b in FIG.

图11d是图11c的节段11d的放大纵剖图。 Figure 11d is an enlarged longitudinal sectional diagram sections 11c and 11d of FIG.

优选实施方案的详细描述下列详细描述和其所提及的附图仅仅是为描述本发明的某种当前优选的实施方案的目的而提供,并不意在以任何方式限制本发明的范围。 A detailed description of the preferred embodiments of the following detailed description and the accompanying drawings to which it refers only for the purpose of describing certain presently preferred embodiments of the present invention to provide, is not intended in any way to limit the scope of the invention. 事实上,应理解到下面所提出的详细描述和实例仅仅是作为本发明可以被利用或实践的某些方法的实例或说明。 In fact, it should be understood to the following detailed description and examples presented merely as the present invention may be utilized or examples illustrate certain methods or practices. 这些实例和说明并不意在穷尽描述本发明所有可能的实施方案和实例,而是意在阐述本发明可被应用于的一些但不是所有应用。 These examples and illustrations are not intended to be exhaustive description of all possible embodiments and examples of the present invention, but is intended to set forth some, but not all applications of the present invention can be applied. A. A. 本发明的方法ⅰ. The method of the present invention ⅰ. 血管再造方法广义地说,本发明的血管再造方法提供了一种建立一或多条通路10的方法,通过该通路血液可流出或流出至少一条血管。 Method revascularization Broadly speaking, revascularization method of the present invention provides a method of establishing a pathway 10 or more, can flow in or out of at least one passageway through which blood vessels. 在多数情况下,流经该通路的血液将优选含有大于约50的pO2。 In most cases, the blood flowing through the passage will preferably contain greater than about 50 of pO2.

在某些情况下,该血管外通路10将被用于为动脉的阻塞,受损或患病节段加设旁路。 In some cases, the extravascular passageway 10 will be used as a blocked artery, damaged or diseased segments plus bypassed. 在本发明的某些实施方案中,只有一条第一血流通路(例如,从阻塞上游的动脉开始的通路)会形成于一条阻塞的、受损的或患病的动脉(或另一条未受损动脉或一种充满血液的形态学结构如心腔),和一条静脉之间,从而允许动脉血经该静脉逆向流动,以便通过静脉血管系统逆向灌注组织。 In certain embodiments of the present invention, the only one of the first flow path (for example, from blocking the artery upstream of the start of the path) will be formed in a blocked, damaged or diseased artery (or another were not damaged artery or a blood-filled structures such as the heart chamber morphology), between a vein and allowing the reverse flow of arterial blood through the veins in order to reverse perfused tissue by vein system. 在本发明的其它实施方案中,一或多条第二血流通路也会形成于阻塞的动脉与该静脉间,阻塞的下游处,以使通过第一血流通路进入静腔管腔的动脉血能随后在阻塞的下游处进入或重新进入该动脉的管腔,从而通过被阻塞动脉的剩余(即,未阻塞的)部分灌注组织。 In other embodiments of the present invention, one or more of the second flow path will be formed between the blocked artery and the vein, downstream of the blockage, so quiet through the first flow path into the lumen of the artery lumen downstream from the obstruction of blood can then enter or re-enter the lumen of the artery, so that by remaining blocked arteries (ie, unblocked) section perfused tissue.

虽然图1a和1b中提供的解剖图是冠状血管系统特有的,但应理解到本发明方法可应用于全身的血管而不必限于阻塞的冠状动脉的治疗(例如,股区域,主动脉髂动脉区域,等)。 Although Figures 1a and 1b are provided in the coronary system anatomy is unique, but it should be understood that the method of the present invention may be applied to the body's blood vessels and not necessarily limited to the treatment of coronary artery occlusion (for example, stock area, aortic iliac region , etc.).

参照附图,图1a和1b提供了人类心脏正常血管解剖学的详细图示,其中冠状动脉基本平行并邻近于冠状静脉。 Referring to the drawings, Figures 1a and 1b provides a detailed illustration of the normal vascular anatomy of the human heart, wherein the coronary substantially parallel and adjacent to the coronary vein. 图1a,1b和1e中显示的特殊解剖学结构按照下列图例标记: Fig. 1a, 1b and 1e special anatomical structure shown marked in accordance with the following legend:

A 主动脉AIV 前室间静脉CA 冠状动脉CV 冠状静脉CS 冠状窦CIR 旋转动脉IVC 下腔静脉LAD 左前降动脉SVC 上腔静脉PA 肺动脉PV 肺静脉TA 外膜TM 中膜TI 内膜GCV 心脏大静脉图1c-1d阐述本发明的一项特殊应用,其中阻塞OB位于心脏左前部分的一条冠状动脉内。 A front compartment between the aorta AIV CA coronary vein coronary vein CV CS coronary sinus rotation CIR IVC inferior vena cava artery LAD left anterior descending artery vena cava SVC PA pulmonary artery pulmonary vein PV TA TI intimal medial membrane TM GCV cardiac vein Fig. 1c-1d describes a particular application of the invention, in which a coronary obstruction OB is located in the heart of the left front portion. 如图所示,阻塞的冠状动脉CA位于邻近于,并通常平行于,一条冠状静脉CV处。 As shown, the blocked coronary arteries CA is located adjacent to and generally parallel to, a coronary vein CV at. 第一血流通路10a形成于冠状动脉CA和临近冠状静脉CV之间,位于动脉阻塞OB的上游处。 The first flow path 10a is formed between the coronary artery CA and the adjacent coronary vein CV, located upstream of clogged arteries OB. 而且,在图1C的显示中,一条可任选的第二血流通路10b形成于冠状静脉CV的管腔与冠状动脉CA的管腔之间,位于阻塞OB的下游处。 Further, in the display of FIG. 1C, optionally a second flow path 10b is formed between the lumen and the lumen of the coronary artery CA vein CV located downstream of the obstruction OB. 而且,在这些图中,显示了可选择的栓塞元件12a,12b被置于冠状静脉CV的管腔中第一血流通路10a近端和可选择的第二血流通路10b的远端处的位点。 Further, in these figures, showing an alternative plug element 12a, 12b is placed in the distal end of the second blood flow in the lumen of the coronary vein CV first flow path 10a and the proximal end 10b of the alternative pathway at site. 这些可选择的栓塞元件被用于引导进入冠状动脉CA的动脉血流通过第一血流通路10a,通过邻近冠状静脉CV的一个节段,并通过第二血流通路10b,以使动脉血在阻塞OB的下游重新进入冠状动脉CA的管腔。 These alternative artery embolization element is guided into the coronary artery CA to a first flow path through 10a, through a segment of the adjacent coronary vein CV, and through the second flow path 10b, so that the arterial blood OB downstream blocking re-enters the lumen of the coronary CA. 可选择的栓塞元件12a,12b可为足以阻断或阻止流动的部件之任何一种或组合,这些部件如线圈;止血材料如胶原,凝胶泡沫TM或纤维蛋白,被包被的斯坦特固定膜或框架,可拆开的球囊,瓣结构如夹,扣件或栓,等。 Optional plug elements 12a, 12b may be sufficient to block or prevent any one or combination of components of the flow of these components such as coils; hemostatic materials such as collagen, fibrin gel or foam TM is fixed Coated Stent film or frame, detachable balloon, valve structures such as clips, fasteners or bolts, and so on. 另外这些元件所起到的功能可通过使用各种方法包括结扎,熔接,凝结,或其它手术方法完成。 In addition, these functional elements may comprise played ligation, fusion, condensation, or other surgical methods accomplished by using various methods.

如图1d的横断面图中所示,本发明的每一条血流通路10基本上是通过一条动脉(如冠状动脉CA)的管壁通过邻近静脉(如冠状静脉CV)的管壁并通过可能位于冠状动脉CA和冠状静脉CV间的任何结缔组织或膜性组织延伸的一条组织间隙隧道。 1d is a cross sectional view shown in FIG 10 is substantially through an artery (such as coronary artery CA) through the adjacent vein wall (e.g. coronary vein CV) of the wall of each flow path by the present invention may located in any connective tissue or membrane tissue and coronary vein coronary artery CA CV extends between an interstitial tunnel. 以此方式,各条血流通路10是作为冠状动脉CA和冠状静脉CV的管腔间的一条流导管。 In this way, each strip flow path 10 is a coronary vein coronary artery CA and CV of a flow conduit between the lumen.

图1e是称为Brouck-Moscheau三角的冠状血管系统的一部分的示意图。 Fig. 1e is a schematic of a portion called Triangle of Brouck-Moscheau coronary vascular system. 如图所示,Brouck-Moscheau三角由左前降冠状动脉LAD,旋转冠状动脉CIR,前室间静脉AIV和心脏大静脉GCV限定。 As shown in Figure, Brouck-Moscheau triangle by the left anterior descending coronary artery LAD, rotating coronary CIR, the anterior cardiac vein AIV and large vein GCV limited. 动脉粥样硬化斑块形成所导致的阻塞常见于左前降动脉LAD和/或旋转动脉CIR的近端部分中。 Obstructive atherosclerotic plaque formation caused common in the left anterior descending artery LAD and / or proximal portion of the rotation or artery CIR. 本发明的血管再造方法可用于通过Bouck-Moscheau三角周围的动脉和静脉间形成适当的血流通路10而治疗左前降动脉LAD和/或旋转动脉CIR的这种阻塞。 Revascularization method of the present invention can be used path 10 and the left anterior descending artery LAD and / or rotation CIR arterial blockage through this triangle between Bouck-Moscheau peripheral arteries and veins form a proper blood flow. 例如,如果阻塞出现在左前降动脉LAD的近端部分中,则可在心脏大静脉GCV和旋转动脉CIR间形成第一血流通路10a并在左前降动脉LAD和前室间动脉AIV间位于阻塞下游处形成第二血流通路10b。 For example, if the blockage occurs in the left anterior descending artery LAD proximal portion can be formed in the first flow path 10a between the heart and great arteries vein GCV and rotation CIR and the left anterior descending artery in inter-LAD artery AIV and the front room located at the block forming a second flow path downstream 10b. 一种管腔阻塞元件12可置于心脏大静脉GCV中,第一血流通路10a近端处和/或置于前室间静脉AIV中第二血流通路10b远端处,以使来自旋转动脉CIR的动脉血通过第一血流通路10a,通过心脏大静脉GCV,通过前室间静脉AIV流动,并进入左前降动脉LAD,阻塞下游处。 A lumen obstruction element 12 may be placed in a large vein GCV heart, the first flow path 10a at the proximal end and / or placed in the anterior interventricular vein AIV second flow path 10b at the distal end, so that from the rotation CIR arterial artery through the first flow path 10a, through the heart of a large vein GCV, through the anterior vein AIV flow, and into the left anterior descending artery LAD, blockage downstream. 另外,在阻塞出现于旋转动脉CIR的情况中,第一血流通路10a和第二血流通路10b可以反过来,以便通过左前降动脉LAD流动的血液将通过前室间静脉AIV,通过心脏大静脉GCV流动并进入旋转动脉CIR中,阻塞的下游处。 In addition, the rotation of the arterial blockage occurs in the case of CIR, the first flow path 10a and the second flow path 10b can be reversed, so that by the left anterior descending artery LAD flow of blood through the anterior interventricular vein AIV, through the heart and great GCV flow vein and artery into the rotation CIR, the downstream occlusion. 按照这些实例,应理解到本发明的血管再造方法可以以下述方式使用,即从一条动脉或从任何其它来源(例如,左心室)获得动脉血并将这种动脉血送入另一条动脉。 According to these examples, it should be understood revascularization method of the present invention to be used in such a manner that from an artery or arterial and obtained from any other source (e.g., the left ventricle) that arterial blood into another artery. 而且,按照本发明的血管再造方法,应理解第二血流通路10b至少在某些情况下可被取消并且动脉血可通过经前室间静脉AIV或心脏大静脉GCV的逆向灌注而提供给心肌的缺血区域。 Moreover, according to revascularization method of the invention is to be understood at least a second flow path 10b may be canceled and arterial blood, in some cases through the front room by room or cardiac vein AIV large vein GCV reverse perfusion to the myocardium The ischemic area.

应理解到在本发明的血管再造方法的一些应用中,血管外通路10可包含从相同血管上的第一位置延伸至第二位置的一种组织间隙隧道。 It should be understood that in some applications revascularization method of the present invention, the extravascular passageway 10 may include the same blood vessel extending from the first position to the second position on an interstitial tunnel. 如图1f中所示,具有阻塞OB形成于其中的一条血管BV可利用本发明的通路形成导管100加设旁路,这种加设旁路是通过将一种组织穿通元件102穿过阻塞上游处的血管管壁,通过邻近组织,并随后通过阻塞下游处的血管管壁。 As shown in Fig 1f, obstruction OB having formed therein a blood vessel BV may utilize the present invention is formed via conduit 100 plus bypassed, provided that the bypass is formed by adding a tissue penetrating member 102 passes through the upstream blocking vascular wall at by adjacent tissues, and subsequently by blocking blood vessel wall at the downstream. 以此方式,图1f′中所示组织间隙通路10在血管BV中阻塞OB周围形成一条旁路导管。 In this way, the formation of a bypass conduit Figure 1f 'organization as shown in the gap passage 10 blocked blood vessels BV in OB around.

ⅱ. Ⅱ. 在血管外位置施行手术或介入操作的方法除上述血管再造方法外,本发明还包括用于在体内血管外位置施行各种手术或介入操作的方法。 An operation in extravascular location or method of operation in addition to the interventional revascularization methods, for the purposes of the present invention also includes a variety of surgical or interventional procedures in vivo method extravascular position. 本发明的这些方法通过从一条血管向一种血管外位置(如器官,组织,体腔,等)形成一或多条血管外通路并随后通过该血管外通路送入用于在血管外位置完成所期望的手术或介入操作的一或多种操作施行装置来完成。 Complete the extravascular position in the methods of the invention by providing an extravascular location (such as organs, tissues, body cavities, etc.) one or more blood vessels are formed outside the passage from one vessel and then fed through the extravascular passageway for one or more operating purposes means surgery or interventional procedures expected to complete. 可按照本发明的这种方法施行的手术或介入操作的类型包括:运送治疗物质·可流动药物的运送;·一种可植入药物运送装置(例如,微球,等)的植入;·医学治疗流体的运送;·用于继续给药的接近导管的植入;·遗传学材料,细胞,微生物或病毒载体,等的植入。 Types According to this method of the present invention for the purposes of surgical or interventional procedures include: transport transport therapeutic substances · flowable substances; · an implantable drug delivery devices (eg, microspheres, etc.) implants; · the delivery of medical treatment fluid; * for the continued administration of approaching catheter implantation; Genetics materials, cells, microorganisms or viral vectors, such as implantation.

部件的临时或永久展开·刺激器(电的或物理的)的植入;·感受器的植入; · Receptors implanted; temporary or permanent expansion · stimulator member (electrical or physical) of the implant;

·电极的植入;·发射器,接受器或应答器的植入;·支持元件(如斯坦特固定膜)的植入;·标记物(如放射显像可视标记物,或溶液)的植入。 Electrode implant; · transmitters, receiver or transponder implanted; Support elements (such as stents film) implantation; · markers (such as radiation imaging visual marker, or solution) implantation.

组织切除术,切割术或消磨术·组织消磨术或破坏术;·组织(如,神经,纤维)的切割或横切;·肿瘤,患病组织等的切除和去除;·内源组织的扩张,伸张或其它修正以恢复开放,流动,构型,或功能。 Tissue resection, excision or kill tissue surgery · kill or destroy surgery technique; · Organization (eg, nerve fibers) or cross-cutting; · tumor resection and removal, and other diseased tissue; endogenous tissue expansion * , or other modifications done to restore open, mobile, configuration, or functionality.

取样应用·组织的取样(如,活检);·固体物质(如,结石,痛风石,等)的取样;监测应用·测定在目标区域可测的压力,pH,温度,氧饱合度,溶解气体的分压,ECG,EEG,激发电位,或其它变量。 Sample application tissue samples (eg, biopsy); · solid material (eg, stones, gout, stone, etc.) sampling; monitoring application can be measured in the target area measured pressure, pH, temperature, oxygen saturation, dissolved gases partial pressure, ECG, EEG, excitation potential, or other variables.

提供图2-2f的目的为进一步详述和阐明可按照本发明的这种实施方案实施的一些特殊介入和/或手术操作。 Some special intervention for the purpose of providing further detail FIG 2-2f and clarified in accordance with this embodiment of the present invention is implemented and / or surgical procedures. 图2显示人体的示意图,其中一个本发明的通路形成导管装置100已被经皮插入一条血管(例如,股静脉)并已通过腔静脉,颈内静脉和大脑大静脉前进至邻近血管外目标区域(例如,脑室)的所期望位置。 Figure 2 shows a schematic view of the body, wherein the passageway forming catheter of the present invention, apparatus 100 has been inserted into a blood vessel percutaneously (e.g., the femoral vein) and has passed the vena cava, internal jugular vein and cerebral vein proceeds to extravascular target adjacent region (e.g., the ventricles) of the desired position. 随后,组织穿通元件102从导管100穿过导管100的远端部分所在的大脑血管管壁并且该组织穿通元件穿过邻近大脑组织前进至脑中的一个血管外目标位置T。 Subsequently, the tissue penetrating element 102 from catheter 100 through the distal end portion of the catheter 100 where the brain tissue of vascular walls and the punch-through element through the adjacent brain tissue into the brain of an advance extravascular target location T. 以此方式,一条血管外通路10在大脑血管到血管外目标位置T间形成。 In this way, an extravascular passage 10 vessels in the brain between the extravascular target location T form. 在需要时,最初通过组织穿通元件102形成的通路10可按照显示于图8a-8h并在下文中详述的通路修正装置和方法进行组织切除,扩张或修正。 When required, the initial passage through tissue penetrating element 102 10 formed in accordance with the display device and the path correcting method in Figure 8a-8h and detailed below are organized resection, expansion or modification.

图2a是目标区域T和通路形成导管部件100所进入的邻近血管BV的放大图。 Figure 2a is a target region T and the passage forming member 100 into the conduit adjacent an enlarged view of the blood vessel BV. 最初通路形成导管部件100的组织穿通元件102被推进至导管100外,通过血管BV的管壁,并通过位于血管BV和目标区域T之间的组织。 Initially passage forming catheter 100 member organizations of the through element 102 is pushed to the outer tube 100, BV through the vessel wall, and through the organization BV and the target area is located between T vessel. 此种应用中使用的组织穿通元件102优选结合一个管腔114,第二导丝GW2可通过该管腔前进至目标区域T。 Such tissue for use in applications-through element 102 is preferably combined with a lumen 114, the second guidewire GW2 can be advanced to the target area of the lumen through T. 随后,组织穿通元件102可与通路形成导管100一起退出和去除,而将第二导丝GW2留在适当位置。 Subsequently, tissue penetrating member 102 may be formed with a passage 100 along conduit exit and removal, while leaving the second guidewire GW2 in place.

如图2a中所述,一种接近套管103可随后沿预置的第二导丝GW2前进,以使套针103通过血管系统延伸,通过由组织穿通元件102形成的血管外通路10而进入目标区域T。 As described in Fig. 2a, a close casing 103 then proceeds along a preset second guidewire GW2, so that the trocar 103 extending through the vascular system, through the blood vessels from the tissue penetrating element 102 is formed in the outer passage 10 and into the target area T. 此接近套管可随后被用作导管用于药物的导入,部件的植入,取样,监测,手术装置的展开或按照上述在血管外位置施行手术或介入操作的方法的其它应用。 This close to the sleeve can then be used as a conduit for the implantable drug import, components, sampling, monitoring, expand the surgical apparatus or method according to an operation or interventional procedures in extravascular position of the other applications.

图2b-2f阐述可按照本发明的这一方面施行的血管外手术或介入操作的几类特定实例。 Figure 2b-2f forth may be imposed in accordance with this aspect of the invention extravascular surgical or interventional procedures several class-specific instance.

参照图2b,一种皮下开口装置105可安置于接近套管103的近端,并可用于经该接近套管103注射或抽出可流动物质(例如,药物,医学治疗流体,放射显像对比溶液,细胞,遗传学材料,微生物或病毒载体等),进入目标区域T。 Referring to Figure 2b, one kind subcutaneous opening device 105 may be disposed near the proximal end of the cannula 103 can be used to close the casing 103 through the injection or withdrawal of flowable material (e.g., a drug, medical fluid treatment, radiation imaging contrast solution , cellular, genetic material, microorganisms or viral vectors, etc.), into the target area T. 另外,开口装置105和套管103可用来在目标区域T完成压力或其它条件的定期监测(例如,通过用流体填充套管103并将一根连接至压力传感器的针插入开口装置105,可获得目标区域T处的压力读数)。 In addition, opening means 105 and the sleeve 103 may be used to complete the pressure in the target area T or regular monitoring of other conditions (e.g., by a fluid-filled cannula is connected to the pin 103 and the pressure sensor device is inserted into the opening 105 can be obtained Pressure readings at the target region T). 因此,图2b阐明了具有位于皮下的注射开口105的内在接近套管103可被用于连续地将可流动物质注入/抽出目标区域T的方法。 Thus, Figure 2b illustrates with a subcutaneous injection openings located close to the inner sleeve 105 103 may be used to continuously flowable material injection / extraction target area T method. 可通过将药物反复输注至体内特定目标区域T治疗的疾病类型的特殊实例包括帕金氏病,癫痫,高血压,肿瘤,抑郁症,阿采默病,睡眠疾患,行为疾患,运动障碍,等。 By repeating the infusion of the drug to specific examples of the specific target region T in vivo treatment of disease including Parkinson 's disease type, epilepsy, hypertension, cancer, depression, mining A silent disease, sleep disorders, behavioral disorders, movement disorders, and so on. 另外,接近套管103和注射开口105可用作一种用于定期输注替代流体或溶液以实现各种类型替代治疗的工具。 In addition, close to the injection sleeve 103 and the opening 105 can be used as substitute for a regular infusion fluid or solution to implement various types of alternative treatment tool. 这些应用也可用图2c中所示部件施行。 These application components shown in Fig. 2c can also be implemented.

图2c显示另一种安排,其中该接近套管103被从腹中取出并被用作将临时部件106送入目标区域T的导管。 Figure 2c shows another arrangement, in which the sleeve 103 is removed from near the belly and are used as a temporary member 106 into the target region T of the catheter. 该部件106可被连接至能发送某些形式的能量至部件106或从部件106接受信息的体外装置107。 The member 106 may be connected to some form of energy can be transmitted to the receiving member 106 or the external device 106 from the member 107. 可使用的体外装置107的类型的实例包括,但不必限于,电信号产生器,电烙器装置,放射频率信号产生器,低温装置,超声产生器,示波器的类型,监视器,图表记录器,电流计,激光,观察仪器,其它仪器,等。 Examples of types of extracorporeal device 107 that may be used include, but are not necessarily limited to, electrical generator, electrocautery devices, radiation frequency signal generator, a low temperature apparatus, the ultrasonic generator, the type of the oscilloscope, a monitor, a chart recorder, galvanometer, laser, observation instruments, other instruments, and so on. 可通过临时放置的部件106被送至目标区域T的治疗类型的特殊实例包括组织的无线电频率切割(例如,心脏内的神经束或致心律不齐传导束)低温组织破坏(例如,肿瘤的),电烧灼术(例如,为止血或消磨组织),等。 106 may be sent to a special instance of the target area T type of treatment include the organization of radio frequency cut (for example, nerve bundles within the heart rhythm or arrhythmia caused tracts) cryogenic tissue damage (eg, tumors) by temporary placement of components electric cautery (for example, bleeding or kill tissue), and the like. 几类可与临时放置的部件106一起使用的监测或信息回收操作的实例包括局部EEG测定法,局部ECG测定法,电流计反应记录,氧饱和度测定,溶于流体中的气体分压测定,pH测定,特殊电解质或其它化学物质浓度的电极测定,等。 Examples of information to monitor or recovery operations for use with several types of temporary placement member 106 include topical assay EEG, ECG partial assay, the reaction galvanometer recorded oxygen saturation measurement, fluid dissolved gas partial pressure measurement, pH measurement Electrode special electrolyte concentration or other chemical substances, and so on.

图2d显示本发明的一种应用,其中接近套管103被用于从目标区域T持续地引流流体。 Figure 2d show an application of the invention, which is used to close the sleeve 103 continuously draining fluid from the target area T. 在此方式中,接近套管103的近端上设有许多出口小孔109,以使在目标区域T中收集的过量流体通过接近套管103的管腔向近端引流并引流到出口小孔109外。 In this manner, the sleeve has a plurality of exit apertures approaching 109 on the proximal end 103, so that excess fluid collected in the target area T and the drainage through the drainage lumen 103 close to the proximal end of the cannula outlet orifice 109 outside. 在其中有出口小孔109形成的接近套管103的近端部分可从腹中取出以使过量流体被引流至一种在体外放置的容器或器皿,或者替代地被植入体内(如腹膜腔)的另一个位置以使过量的流体会流入这种身体的其它区域,在那里通过自然的生理功能被吸收而不对身体引起损伤或危害。 In which the outlet orifice 109 is formed near the proximal portion of the cannula 103 can be removed from the belly to drain the excess fluid to be placed in vitro to a container or vessel, or alternatively be implanted in the body (e.g., the peritoneal cavity ) to another position so that excess fluid will flow into other areas of the body where it is absorbed without causing damage or harm to the body through a natural physiological function. 这种应用的一个实例是使用套管103作为一种内部分流或从脑室引流过量脑脊液至体内的第二位置(如,腹膜腔)。 An example of such an application is the use of the sleeve 103 as an internal shunt or ventricular drainage of excess cerebrospinal fluid from the body to a second position (e.g., peritoneal cavity). 由于套管103是通过血管系统和通过按照本发明产生的血管外通路10植入的,植入套管103使用的技术可经皮实施,而不象利用植入用于治疗脑积水和其它疾病的流体引流分流部件的其它方法那样典型地需要大的手术切口。 Since the casing 103 through the vascular system and extravascular passageway by following the present invention produce 10 implanted, implanting cannula 103 using techniques may be implemented transdermally, unlike the use of implants for the treatment of hydrocephalus, and other Other methods of diversion fluid drainage as part of the disease typically require a large incision.

图2e显示本发明的另一种特殊应用,其中接近套管103从血管BV延伸,通过本发明的血管外通路10并进入第二管状形态学通路或导管的管腔111,即本应用中的目标T。 Figure 2e show another special application of the invention, which extends from the blood vessels near the casing 103 BV, through the blood vessels of the present invention, the outer passage 10 and into the second tubular morphology passage or lumen of the catheter 111, which in this application Target T. 几类可形成本发明的这项应用中的目标T的管状通路或导管包括血管,生殖泌尿管道,外分泌管道,内分泌管道和淋巴管道。 A tubular passage of several types of this application of the invention target T or catheter including vascular, genitourinary pipes, pipe exocrine, endocrine and lymphatic channels pipeline. 在接近套管103被置于目标管道或通路T的腔111中后,此方法学的任何上述所述应用均可使用,包括样本的抽出或药物的输注,部件的展开,等。 Cannula 103 is placed near the target pipe or passage T of the chamber 111, any of the above-mentioned application of this methodology can be used, including the expanded sample extraction or drug infusion, parts, and so on.

图2f阐明本发明的应用的另一种特殊实例,其中接近套管103通过血管系统,通过本发明的血管外通路10延伸,并进入一个目标区域T,以使一或多种手术器械113可被送至目标区域T以实现在目标区域T中施行手术(例如,微手术)操作。 Figure 2f illustrate specific examples of another application of the present invention, wherein close vascular system through the cannula 103, through the blood vessels of the present invention the outer passage 10 extends, and into a target area T, so that one or more surgical instruments 113 It is sent to the target region T in order to achieve an operation (e.g., micro-surgical) operation in the target region T. 以此方式,被从腹中取出的控制系统115可被连接至手术器械113并可用于在目标区域T中行使手术器械113的所期望操作和处理。 In this way, been removed from the belly of the control system 115 may be connected to the surgical instrument 113 can be used in the exercise of surgical instruments in the target area T in the handling and processing of the desired 113.

ⅲ. Ⅲ. 通路的类型图3a-3f和以下提出的详细描述,描述了按照本发明形成的血管外通路10的某些类型。 A detailed description of the type of path Figure 3a-3f and presented below, are described in accordance with the present invention is the formation of blood vessels outside of certain types of passage 10. 图3a-3f所示以及以下的详细描述,只仅仅是被做为可以形成的通路的类型的实例而提出,并不意在穷尽描述按照本发明可以应用的通路10的所有可能的类型。 As well as the following detailed description shown in Figure 3a-3f, but can only be used as examples of the type of path formed proposed are not intended at all possible an exhaustive description of the type of path 10 according to the present invention can be applied. 此外,应当认识到,尽管图3a-3f所示标明通路10形成于一条静脉和动脉之间,图3a-3f阐明的通路的多种修正可以被广泛应用于按照本发明形成的任何或全部类型的血管外通路10,只要这种修正合适的话。 In addition, it should be appreciated that although FIG. 3a-3f between FIG indicated a passage 10 formed in the veins and arteries, Fig. 3a-3f illustrate various modifications of the passage may be applied to any or all of the type widely according to the present invention is formed The extravascular passageway 10, as long as such amendment, if appropriate. 实际上,图3a-3f所示以及以下详细描述的通路10并不局限于动脉和静脉之间,而且可以广泛应用于本发明的所有通路10中。 In fact, as shown in Figure 3a-3f and the following detailed description of the passageway 10 between the artery and vein is not limited, and can be widely used in all channels 10 of the present invention.

如图3a所示,通路10包括非斯坦特固定膜性,无衬里的组织间隙的隧道(图3a)。 3a, the passage 10 includes a non stents membrane, interstitial unlined tunnels (Figure 3a). 另外,如图3b-3f所示,这种通路10可以配备有各种类型的表面修正或辅助装置,例如管状衬里(图3b)、纵行约束夹子(图3c)、或局限于通路10之内的斯坦特固定膜或斯坦特固定膜性移植片(图3d),或自起超出通路10的斯坦特固定膜或斯坦特固定膜性移植片(图3e-3f)。 Further, as shown in FIG. 3b-3f, the passage 10 may be equipped with various types of surface correction or the auxiliary means, such as a tubular liner (FIG. 3b), longitudinal restraint clip (Fig. 3c), or the restricted passage 10 stents, or stents film within the film of the graft (Fig. 3d), or from outside the film 10 via stents or stents membrane graft (Figure 3e-3f).

特别参照图3a,显示了在两条血参间延伸的通路10,它没有任何斯坦特固定膜、衬里、管材、包被、瓣膜、表面修正、布置于通路10内的物质或装置。 With particular reference to Figure 3a, showing the passage extending between the two blood parameters 10, it has no stents film, liners, tubing, coating, valves, surface correction, substance or device 10 arranged in the inner passage. 在这点上,这种非斯坦特固定膜性、无衬里的、未修正的通路10仅仅是一条延伸于二条血管间的组织间隙的隧道(例如,一条穿刺通道或隧道),从而血液可以由一条血管的管腔流进另一条血管的管腔。 In this regard, such a non-membrane stents, unlined, uncorrected merely a passage 10 extending between the two vascular interstitial tunnel (e.g., a biopsy channel or tunnel), so that the blood can be made a vessel lumen flows into another vessel lumen.

图3b显示了一条形成于二条血管之间的通路10,有一个管状内衬20置于其中。 Figure 3b shows the formation of a passage between the two vessels 10, there is a tubular liner 20 disposed therein. 这种内部衬里20可以包括一段刚性的或易弯的塑料管,一层生物可容性聚合物包被,一层不同于周围组织类型的细胞(例如,内皮细胞层生物组织移植片等),一层可以通过激光处理、电烙术等条形成修正厚度的组织,或任何与非斯坦特固定膜性且未加衬里的通路10本身内表面类型不同的物质。 This inner liner 20 may comprise a section of rigid or pliable plastic tube, a layer of biocompatible polymer coating, a layer of type different from the surrounding tissue cells (e.g., endothelial cell layer of biological tissue grafts, etc.), one layer of tissue thickness corrected by laser treatment, electrocautery and other pieces, or any non-stents and did not increase membrane lining the inner surface of passage 10 itself different types of substances. 通路10内的这种衬里20可以被用来:a)易化血流以层流而非端流通过通路10,或b)避免缘于周围肌肉自然收缩的不必要通路关闭或组织向通路10内生长。 This passage 10 within the liner 20 may be used to: a) facilitation of blood flow in a laminar flow through the flow passage 10 instead of the end, or b) prevent natural shrinkage due to the surrounding muscle or tissue off unnecessary passage 10 to the passage ingrowth. 在衬里20是通过对通路10的壁应用可流动物质或能量(例如,产生可控制的组织化学灼伤或生物相容性聚合物包被的化学物质,内皮细胞悬浮液,等等)而形成的情况中,参照本发明的部件,可以通过应用诸如图8h-8h″所示以及以下更全面描述的部件来完成应用这些可流动物质于通路10的壁。 In the wall of the liner 20 is a passageway 10 through the application of flowable substances or energy (e.g., generating histochemical controlled burns or biocompatible polymer coating chemicals, endothelial cell suspension, and the like) and the formation of case, the reference member of the present invention, can be applied as shown in FIG. 8h-8h "means more fully described below, and to complete application of the flowable material to the wall 10 of the passage.

图3c显示通路10,其中安置了纵行约束装置22以便纵行压迫通路10的相对端互相接近,从而使位于血管间的任何组织(例如,疏松结缔组织)变紧密。 Figure 3c shows the path 10, which housed 22 to the opposite end of the longitudinal passage oppression longitudinal restraint apparatus 10 close to each other, so that any organization (for example, loose connective tissue) is located between the blood vessel becomes closer. 这种纵行约束装置22也可以被安置,来为通路10提供幅射状支持,和/或维持开口状态。 This longitudinal restraint apparatus 22 may also be arranged to provide support for the radiation-shaped passage 10, and / or maintain the open state. 在通路10所连接的血管位于器官表面(例如,位于心脏表面的冠状动脉和静脉)、或位于海绵状或疏松组织(例如,疏松结缔组织)、或动脉和静脉间存在开放空隙时,在本发明的这些应用中,约束装置22纵行压迫通路10的应用可能特别重要。 In the blood vessels connecting passage 10 is located an organ surface (for example, located on the surface of the heart and coronary veins), or in the spongy or loose tissue (for example, loose connective tissue), or the existence of an open gap between the arteries and veins when, in the present These applications invention, the restraining means 22 wale application oppression path 10 may be particularly important. 这些海棉状或疏松组织的存在可以允许流动于通路10中的血液渗进动脉和静脉之间的这些组织或空隙,因而可能导致血肿形成。 The presence of these spongy or loose tissue may allow blood flow 10 infiltrated these organizations or voids between arteries and veins in the path, which may lead to hematoma formation. 可以被用于纵行压迫如图2c所示的血流通路10或易化通过向侧吻合连接二条血管的约束装置22的特定类型的实例,图示于图9a-9f,并参照9a-9f更全面地描述于下文。 2c bloodstream can be shown in FIG passage for longitudinal compression 10 or facilitated by instances of a particular type of lateral constraint means connecting two vascular anastomosis 22, shown in FIG. 9a-9f, 9a-9f and reference more fully described below.

图3d显示本发明的通路10,有一个非凸出的斯坦特固定膜或斯坦特固定膜性移植片24置于通路10之内。 Figure 3d shows path 10 of the present invention, there is a non-protruding film stents or stents graft membrane 24 disposed within the passage 10. 这种斯坦特固定膜或斯坦特固定膜性移植片24可以包括一个压力可扩张或自行扩张的栓状斯坦特固定膜或框架,并且可选择地,可以被诸如由编织聚酯或扩张的聚四氟乙烯(ePTFE)的柔韧节段的连续管状元件所覆盖。 Such stents or stents film membrane graft 24 may include a pressure expandable or self-expanding stents film or a plug-like frame, and optionally, can be made, such as woven polyester or expanded polyethylene tetrafluoroethylene (ePTFE) of continuous tubular element flexible segments covered. 安置这种斯坦特固定膜或斯坦特固定膜性移植片24于通路10内,可以用以维持通路10处于基本上开放的形状,以易化非湍流血流流过通路10。 Such placement of stents or stents film membrane graft 24 within passage 10, can be used to maintain a substantially open passage 10 is in the shape of a non-turbulent flow to easily flow through the passage 10. 斯坦特固定膜或斯坦特固定膜性移植片24可以由任何合适的材料形成,包括,但并不限于,各种类型的压力可扩张或自行扩张的丝网或互相编织的聚合材料条带。 Stent film or membrane graft stents 24 may be formed from any suitable material, including, but not limited to, various types of pressure expandable or self-expandable braided mesh or another polymeric material strips. 在斯坦特固定膜性移植片24被应用的情况下,斯坦特固定膜性移植片24上的管状移植片覆盖可以是连续的或部分的,从而斯坦特固定膜只有一部分被覆盖。 In the case of stents membrane graft 24 is applied, the tubular graft 24. Stent graft membrane covering may be continuous or in part, so that stents film only partially covered.

应当理解,当应用一个凸出的斯坦特固定膜性移植片(例如,被覆盖的斯坦特固定膜26或28)时,可以不必要再安置可选的栓塞元件12于斯坦特固定膜性移植片26、28延伸其内的血管管腔之内,因为斯坦特固定膜性移植片上的管状外覆盖将被用来限定一个通过血管管腔的闭合流动导管,并将基本上阻断通过那部分血管内部的血流,因此不需要单独的栓塞元件12。 It should be understood that when applying a projected stents membrane graft (for example, stents coated film is 26 or 28), you can plug an optional unnecessary relocation element 12 in stents membrane transplantation sheets 26, 28 extending therein within the lumen of the blood vessel, because the outer membrane covering the tubular graft stents will be used on the blood vessel lumen defined by a closed flow conduit, and the portion is substantially blocked by blood flow inside the blood vessels, and therefore does not require a separate plug element 12.

图3d′显示斯坦特固定膜或斯坦特固定膜性移植片24a的修正,包括一个凸缘25和/或自斯坦特固定膜或斯坦特固定膜性移植片24a的一端或二端延伸的垂直凸起27,以保持斯坦特固定膜性移植片24a在通路10中处于基本上固定的纵行位置。 Figure 3d 'show stents film or membrane graft stents 24a amendment includes a flange 25 and / or vertically from one end of stents film or membrane graft stents 24a or both ends of the extension or projections 27 to maintain membrane graft stents 24a in a substantially fixed position in the longitudinal passageway 10.

图3e显示半凸起或凸起的斯坦特固定膜或斯坦特固定膜性移植片26,它可以按照如图3d所示的非凸起的斯坦特固定膜或斯坦特固定膜性移植片24的同样方式被设置,但与图3d所示不同的是它在通路10末端之外凸出或延伸,进入动脉A和静脉的毗邻部分。 Figure 3e show semi-projection or projection film or stents Stent graft membrane 26, as shown in Fig. 3d it can follow a non-protruding film or stents Stent graft membrane 24 It is set in the same manner, but different from FIG. 3d shows that it protrudes or extends beyond the end of the passage 10, into the artery and vein adjacent to the A section. 如图3e所示,当如此展开时,这个斯坦特固定膜或斯坦特固定膜性移植片26将基本上采取“S”形状,以易化层状、非湍流的血流沿所期望的方向通过通路10。 As shown in Figure 3e, when so expanded, the stents film or membrane graft stents 26 will basically take the "S" shape to facilitation layered, non-turbulent blood flow along a desired direction through the passage 10. 图3e的点状线阐明了斯坦特固定膜或斯坦特固定膜性移植片26的一个“半凸起的”实施方案,其中,其一端与通路10的一端对齐,同时其另一端延伸进入邻近通路10解剖结构(例如,静脉)。 The dotted line in Figure 3e illustrates a film or stents Stent graft membrane 26 "half raised" an embodiment, in which one end is aligned with the path end 10, while its other end extending into the adjacent passage 10 anatomical structures (e.g., intravenous). 斯坦特固定膜或斯坦特固定膜性移植片26的这种“半凸起的”实施方案,可以被应用,从而不阻塞任何可能穿过动脉A的血流,并且,对于那些阻塞OB是不完全的患者和仍有些动脉血流通过动脉A的患者而言,将特别有可用性。 Such stents film or membrane graft stents 26 "half raised" an embodiment, can be applied so as not to block any blood flow through the artery A possible, and, for those who are not blocking OB patient and still complete some arterial blood flow through the artery A patient is concerned, would be particularly availability. 对于阻塞OB是完全性的其它患者,应用斯坦特固定膜或斯坦特固定膜性移植片26的完全“凸起的”方案可能比较合适,如图3e中的点状线所示,其中,这些斯坦移固定膜或斯坦特固定膜性移植片26从通路10的二端延伸而出,进入邻近的解剖结构(即,静脉和动脉)。 For obstruction OB is complete "raised" program may be appropriate in other patients with complete application stents film or membrane graft stents 26, as shown in dotted line 3e, in which these Stan shift fixed film or membrane graft stents 26 from the second end of the passageway 10 extends out into adjacent anatomical structures (ie, veins and arteries).

图3f显示另外一种凸起的斯坦特固定膜或斯坦特固定膜性移植片28,它延伸贯穿第一条血流通路10a,并且它另外凸起穿过动脉A和静脉V邻近部分的可选的第二条血流通路10b,由此形成一条连续“U”形导管,通过它的官腔,层状非端流血流可以通过通路10a和10b。 Figure 3f Show stents film a projection or stents membrane graft 28, which extend through the first flow path 10a, and which additionally raised through the arteries and veins V A proximal portion may selected second flow path 10b, thereby forming a continuous "U" shaped tube, through its bureaucratic, non-layered blood flow through the passage ends 10a and 10b.

应当理解,一个或多个瓣膜也可以形成于斯坦特固定膜或斯坦特固定膜性移植片24、26、28的任何一个实施方案,或管状衬里20中,或纵向约束装置22中,或通路10中,以易化血流以所期望的方向通过通路10,同时减少或避免血液沿与所期望方向的反方向通过通路10返流。 It should be understood that one or more of the valves may be formed on the stents, or stents film membrane graft of any of the embodiments 24, 26, or tubular liner 20, or 22 in the longitudinal restraint device, or pathway 10 in order to facilitated flow in the desired direction through the passage 10, while reducing or avoiding the blood along a direction opposite a desired direction through the passage 10 and reflux.

ⅳ. Ⅳ. 用于在二条血管间形成通路的穿血管方法图4a-4e和随后的详细描述,是为阐明某些方法而提出的,这些方法可被用来在二条血管间形成血管外通路10,以完成本发明的某些血管再造方法。 And the following detailed description of the method through blood vessels in Figure 4a-4e are formed between the two vessels for passage, is to illustrate some of the methods proposed, these methods may be used between two vessels extravascular passageway 10 is formed to complete Some revascularization method of the present invention. 图4a-4e所示以及随后的详细描述并不意在穷尽阐明可以用来形成通路10的所有可能的方法,而只是提供了用于这些操作的目前已知的方法的实例。 As well as the following detailed description of FIG. 4a-4e is not intended to be exhaustive of all possible paths that can be used to clarify the method 10 is formed, but only provided examples of known methods used for these operations. 此外,尽管在图4a-4e所示阐明的应用中,阻塞OB存在于一条血管内,这些图中所阐明的基本方法可以应用于多种血管再造方法中,这些方法中,通路10的形成并非用于绕过阻塞的目的,或者其中阻塞OB位于远离通路10形成地点的位置。 Furthermore, although stated in the application shown in Figure 4a-4e, the obstruction OB is present within a blood vessel, the basic method set forth in these figures may be applied to a variety of revascularization methods, these methods, passage 10 is not formed for the purpose of bypassing the obstruction, wherein the obstruction OB or passage 10 is formed at a position away from the site. 此外,应当理解,图4a-4c阐明的方法不必形成于二条血管之间或一条动脉与静脉之间。 Further, it should be understood that the method set forth in Figures 4a-4c need not be formed between the two vessels or between an artery and vein. 实际上,这些方法可以应用于任何血管和任何其它中空解剖结构之间,并可用作静脉到静脉、动脉到动脉或静脉到动脉通路10。 In fact, any of these methods may be applied between the blood vessels and any other hollow anatomical structure, and can be used to venous vein, artery to artery or vein into the arterial passage 10.

图4a显示一种方法,其中,导管100通过管腔向前进入一条动脉A,组织穿通元件102从导管100穿过,通过动脉A管壁,通过动脉A和静脉V之间的组织,通过静脉的管壁,形成第一通路10a。 Figure 4a shows a method in which the lumen of the catheter 100 through an artery into the forwardly A, tissue penetrating element from the catheter 102 through 100, A through the artery wall, through the organization of the arterial and venous V between A, by intravenous wall, forming a first passage 10a. 用这种方式形成第一血流通路10a后,一条导丝可以通过组织穿通元件102或通过导管100,并通过新形成的第一通路10a。 After forming in this manner a first flow path 10a, a guide wire can pass through element 102 through tissue or through the catheter 100, through the first passage 10a and the newly formed. 然后,停用组织穿通元件(例如,退回到导管100中),将导管沿导丝向前,通过第一通路10a,进入静脉管腔,越过毗邻动脉A中阻塞OB的位置。 Then, disable tissue penetrating element (e.g., back to the conduit 100), the catheter along the guide wire forwardly through the first passage 10a, into the vein lumen, across the artery adjacent to the position A in the occlusion OB. 然后,在导管远端位于静脉管腔中的情况下,再次将组织穿通元件102向前穿出导管100,形成延伸穿过静脉壁、任何位于静脉和动脉A之间的组织和动脉A壁的第二血流通路102。 Then, the distal end of the catheter venous lumen located in the case, once again the organization forward through-piercing element 102 catheter 100 extends through the vein wall is formed, any organization and arterial A wall located between the veins and arteries A The second flow path 102. 然后,可再次将组织穿通元件102退回到导管100内,并可将导管从血管中退出并退出体外。 Then, the tissue can be re-penetrating element 102 to return to the inner conduit 100, and the catheter is withdrawn from the vessel and exit the body. 用这种方式,如图4a所示的方法,完成了在动脉阻塞OB上游形成第一血流通路10a和在动脉阻塞下游形成第二血流通路10b。 In this manner, the method shown in FIG. 4a, arterial occlusion OB completed in the first flow path 10a is formed upstream and downstream of the blockage in the artery to form a second flow path 10b.

图4b显示了一种可替换的方法,其中,将导管100通过管腔向前进入一条静脉管腔,将导管远端置于将要形成第一血流通路10a的位置附近。 Figure 4b shows an alternative method in which, through the lumen of the catheter 100 is advanced into a venous lumen, the distal end of the catheter to be placed in a position near the first flow path 10a is formed. 然后,将组织穿通元件102穿出导管100,形成通过静脉V管壁、静脉V和动脉A之间的任何组织以及动脉A管壁的第一血流通路10a。 Then, the tissue penetrating catheter 100 piercing element 102, formed by any V vein wall tissue, venous and arterial V A A between the arterial wall and the first flow path 10a. 然后,停用组织穿通元件102(例如,退回到导管100中),并将导管通过静脉V进一步向前,直到导管远端达到将要形成的第二血流通路10b的位置附近。 Then, disable tissue penetrating element 102 (e.g., back to the conduit 100), and V by intravenous catheter further forward, near the second flow path 10b until the distal end of the catheter reaches the location to be formed. 然后,再次将组织穿通元件102穿出导管100,通过静脉V管壁、静脉V和动脉A之间的组织以及动脉A管壁,形成所期望的第二通路10b。 Then, again, the tissue penetrating element 102 piercing catheter 100, through the wall of the vein V, A wall of the arterial tissue and venous and arterial V A between the formation of the desired second passage 10b. 然后,再次停用组织穿通元件102(例如,退回到导管100中)并可以将导管100退出静脉组织并移出。 Then, again deactivate organization feedthrough element 102 (for example, return to the conduit 100) and may withdraw venous catheter 100 and out of the organization. 用这种方式,如图4b描述的方法,仅仅通过静脉V的插管和经管腔导管术,完成了在动脉阻塞OB下游形成第一血流通路10a和在动脉阻塞OB上游形成第二血流通路10b。 In this manner, the method described in Figure 4b, only the vein V through lumen cannula and administered catheterization, the arterial obstruction OB completed a first flow path 10a is formed downstream and upstream of the arterial obstruction OB is formed a second blood flow path 10b.

图4c所示为另一种可选的方法,导管100经管腔向前进入一条动脉A,导管100远端置于将要形成第一血流通路10a的位置附近。 Figure 4c shows an alternative method, the catheter 100 is advanced into an artery administered chamber A, the distal end of catheter 100 placed near the position to form a first flow path 10a. 然后,组织穿通元件102穿出导管100,通过动脉壁、动脉A和静脉V之间的任何组织以及静脉V管壁,形成第一血流通路10a。 Then, tissue penetrating element 102 piercing tube 100, through the artery wall, as well as any organization arterial wall of the vein V A and V between veins, forming a first flow path 10a. 然后,停用组织穿通元件102(例如,退回到导管100中),并将导管通过动脉A管腔进一步向前,穿过阻塞OB,直到导管100远端达到将要形成第二血流通路10b的位置附近。 Then, disable tissue penetrating element 102 (e.g., back to the conduit 100), and the catheter through the arterial lumen A further forwardly, through obstruction OB, until it reaches the distal end of the catheter 100 is to be formed in the second flow path 10b nearby location. 导管100通过阻塞OB的这种前进,典型地需要先将一根导丝通过阻塞OB,以易化随后将导管100向前穿过阻塞OB。 OB catheter 100 by blocking this forward, typically first need a guide wire by blocking OB, with facilitated subsequent catheter 100 forward through blocking OB. 在阻塞OB是部分性的,或阻塞物柔软到能允许导丝通过的情况下,这种预先将导丝通过阻塞OB的途径可以完成。 Blocking OB is part of, or soft obstruction to allow the guide wire through under the circumstances, this advance will approach the guide wire can be done by blocking OB. 然而,在阻塞OB是完全性的,或形成钙化斑或其它坚硬物质的情况下,图4c所示的方法可能不可行,在这种情况下,操作者典型地选择图4a或4b所示的方法之一。 However, the obstruction OB is complete or when forming calcified plaque or other hard substance, the method shown in Figure 4c may not be feasible, in which case, the operator typically selected as shown in FIG. 4a or 4b, One of the ways. 然而,在如图4c所示导管100成功地穿过了阻塞OB的情况下,将再次将组织穿通元件102穿出导管100,通过动脉10a管壁、动脉A和静脉V之间的任何组织以及静脉V管壁,形成第二血流通路10b。 Under However, catheter 100 shown in Figure 4c successfully passed through the obstruction OB case, will be organized again penetrating element 102 piercing catheter 100, through the artery wall 10a of any organization and arterial and venous V between A, V vein wall, forming a second flow path 10b. 然后,停用组织穿通元件102(例如,退回到导管100中),将导管退出动脉组织并移出体外。 Then, disable the organization-through element 102 (for example, return to the conduit 100), the catheter exit the arterial tissue and removed from the body. 用这种方式,图4c所示的方法,按照本发明,完成了形成第一血流通路10a和第二血流通路10b。 In this manner, the method shown in FIG. 4c, according to the present invention, the completion of the formation of the first flow path 10a and the second flow path 10b.

图4d所示的另一种可选的方法中,其中提供了带有正压泵104的导管100,用来向导管泵入正压流体(如盐水),并通过近导管100远端管体形成的多个正压出口小孔106溢出。 An alternative method shown in Figure 4d, which is provided with a positive pressure pump 104 of the catheter 100, guide tube to a positive pressure pump into a fluid (e.g. saline), and through the catheter 100 near the distal end of the tubular body a plurality of positive pressure orifice 106 formed overflow. 在导管邻近正压出口小孔106处形成一个近端封闭元件108(例如,一个完全阻断血管腔的球囊)。 Positive pressure in duct near the outlet orifice 106 to form a closed proximal end 108 (for example, a completely blocked artery lumen balloon) components. 将一个单独的远端封闭(如,一个球囊)110置于静脉V管腔内将要形成第二血流通路10b的位置的稍上游处。 The distal end of a separate closure (eg, a balloon) 110 is placed to be formed within the lumen of the vein V second flow path 10b is slightly upstream position. 将导管100通过静脉V管腔向前,直到导管远端达将要形成第二血流通路10b的位置附近。 100 V through intravenous catheter lumen forward until the distal end of the catheter to a position near the second flow path 10b is to be formed. 然后,将近端封闭元件108展开(例如,充气),从而将邻近导管100上正压出口小孔106的静脉V完全封闭。 Then, the proximal end of the closure member 108 will expand (e.g., inflated), so that a positive pressure on the catheter 100 near the outlet orifice of the vein V 106 is completely closed. 然后,将正压流体(例如,盐水)通过导管管腔并由正压出口小孔106溢出,导致静脉V中压力P1上升,最好基本与动脉A中的平均压力P2相等。 Then, the pressurized fluid (e.g., saline) through the catheter lumen by pressurized overflow outlet orifice 106, resulting in vein pressure P1 rises V, A is preferably substantially the average arterial pressure P2 equal. 这种静脉V管腔中压力形成,为辨别各种静脉侧枝SB的存在提供了可行的方法,静脉侧枝可能需要结扎、关闭或栓塞,以避免从新形成的静脉旁路管道内任何显著失血。 This vein lumen pressure V formed as to identify the presence of various venous collaterals SB provides a feasible method may require collateral vein ligation, closed or embolism, in order to avoid any significant loss of blood in the vein bypass conduit newly formed. 另外,在组织穿通元件102穿出导管100,通过静脉V管壁和动脉A管壁,形成本发明的通路10时,静脉V腔内的压力形成可以维持。 Further, the tissue penetrating element 102 piercing catheter 100, through the wall of veins and arteries V A wall, forming passages 10 of the invention, the venous pressure chamber V is formed can be maintained. 静脉V内压力P1和动脉内压力P2的这种相等,还被用来在通路10形成后,避免血液从动脉A管腔向静脉V管腔快速喷涌或流动。 Intravenous V internal pressure P1 and P2 of this intra-arterial pressure equal, was also used in the passage 10 is formed, the risk of blood from the arterial lumen A fast flow to the vein V spewing or lumen.

图4e所示的另一种可选的方法中,将第一导管100推进动脉A,第二导管推进静脉V。 An alternative method shown in Fig. 4e, the first advance artery catheter 100 A, a second catheter is advanced vein V. 在某些情况下,将第一、第二导管100置于基本上相对的位置,如图4e所示。 In some cases, the position disposed substantially opposite to the first, second conduit 100, shown in Figure 4e. 然后,如图所示,用各个导管100的组织穿通元件102在动脉A和静脉V之间形成第一和第二备血流通路10a、10b。 Then, as shown in organizations with each catheter 100 penetrating element 102 A between the arterial and venous V Preparation of the first and second flow path 10a is formed, 10b. 然后,停用组织穿通元件102(例如,退回到导管100中),并将导管100退出血管并移出体外。 Then, disable tissue penetrating element 102 (e.g., back to the conduit 100), and the vascular catheter 100 and exit out of the body. 用这种方式,图4e所示的方法,按照本发明,完成了在所期望的血管间第一和第二血流通路10a和10b的形成。 In this way, the method shown in Figure 4e, according to the present invention, has completed the first and second flow path 10a and 10b are formed between the desired blood vessel.

Ⅴ. Ⅴ. 控制、瞄准和引导用来形成血管外通路的组织穿通元件和/或辅助部件的方法和装置图5a-5l显示装置的实例,当组织穿通元件102自本发明的导管100向前,形成所期望的血管外通路10时,该装置被用来定向、瞄准、控制和/或引导组织穿通元件102。 The method of control, targeting and guidance for the formation of extravascular tissue through-passage element and / or auxiliary member and the apparatus of Fig. 5a-5l show examples of the device, when the tissue penetrating element 102 from 100 forward catheter of the present invention, to form the desired The extravascular passageway 10, the device is designed to orient, targeting, control and / or guided tissue penetrating element 102. 一般地,这些定向、瞄准、控制和引导装置被用来定位导管100,从而,组织穿通元件102穿出导管100时,将接触到并穿入导管100所位于的血管的管壁。 Typically, these orientation, targeting, control and guide means are used to position the catheter 100, whereby tissue penetrating catheter 100 piercing element 102, and will be exposed to the blood vessel wall penetrating catheter 100 is located. 应当理解,图5a-5l提出的图示,以及随后的详细描述,仅仅是提供了应用本发明的各种定向、瞄准、控制和/或引导装置的实例,并不意味着穷尽显示或描述了可以用于这些目的所有可能的装置。 It should be understood, shown in Figure 5a-5l presented, as well as the following detailed description merely provides a variety of targeted application of the invention, targeting, control and / or guiding device instance, does not mean exhaustive shown or described in the These purposes can be used for all possible devices. 另外,应当理解为,任何或全部如图5a-5l所示和如下描述的装置,可以与这里描述的本发明的其它任何元件结合,形成一个“系统”,由此,本发明的通路形成导管100可被定向、瞄准、控制或引导。 Further, it should be understood that any or all as shown in FIG. 5a-5l and apparatus described below, any other elements described herein may be combined with the present invention, the formation of a "system", whereby the present invention is formed via conduit 100 may be oriented, targeting, control or guidance.

图5a显示一种方法,其中,一个主动成像部件50被安置于本发明的导管100所在的同一条血管中。 Figure 5a shows a method in which an active imaging member 50 is disposed in the catheter 100 of the present invention, where the same vessel. 这种主动成像部件50可以包括任何合适类型的导管容受的成像部件,包括,但不限于,血管内超声装置(IVUS导管),多普勒装置,血管内镜,等等。 This active imaging unit 50 may comprise any suitable type of catheter suffer imaging components, including, but not limited to, intravascular ultrasound device (IVUS catheter), Doppler devices, vascular endoscopy, and so on. 在许多情况下,主动成像部件50将有一个感受器(例如,超声传感器,声波传感器,成像-接受镜头,等等)形成于其上的特定位置。 In many cases, the active imaging unit 50 will have a receptor (for example, ultrasonic sensors, acoustic sensors, imaging - to accept the lens, etc.) form a specific position thereon. 典型地期望这种感受器52被安置于紧密邻近组织穿通元件102通过血管壁的位置,以便提供对组织穿通元件102的所期望的观察、瞄准和引导。 Typically expect this susceptor 52 is placed at a position closely adjacent tissue penetrating element 102 through the vessel wall in order to provide the desired element 102 penetrating observation organization, targeting and guidance. 应当理解,主动成像装置50可装置于通路形成导管100之上,或形成于通路形成导管100之内,可以载于导管100内的单轨或侧管中(图9-10),或者可以定位于完全独立和分开的管体内,如图5a所示。 It should be appreciated that the active imaging device 50 may be formed on the via conduit means 100, or formed in the passageway formed in the conduit 100, or may be contained in the side of the monorail catheter tube 100 (FIG. 9-10), or may be positioned completely independent and separate from the tubular body, shown in Figure 5a. 在通路形成导管100中至少安置主动成像部件50的远端部分,体现这种方法的通路形成导管100的实施方案,特别显示于图9-10,并参照这些图示如下全面描述。 In the passage forming catheter 100 in place at least a distal portion of the imaging unit 50 of the initiative, this method reflects the passage forming catheter embodiment 100, in particular, it is shown in Figure 9-10, and are fully described with reference to these figures.

用于观察、瞄准和引导组织穿通元件102的一种可替换的方法显示于图5b,其中主动成像部件50被安置于通路形成导管100的组织穿通元件102将要通过的血管内。 For observation, aiming and guiding organizational methods-through a replaceable element 102 is shown in to Figure 5b, where the active imaging member 50 is placed in the passageway formed organization intravascular catheter 100 pass-through element 102 will be adopted. 如图5b所示,主动成像部件50的感受器52可以被安置于紧密邻近将要形成的通路10的位置,从而,在组织穿通部件102从导管100向主动成像部件50的的感受器52延伸时,感受器可以瞄准和引导它。 5b, the active imaging unit 50 of the susceptor 52 can be placed at a position in close proximity to the path 10 to be formed, so that, in the organization of insertion member 102 extends from conduit 100 to the active imaging unit 50 of the susceptor 52, the susceptor You can aim and guide it.

图5c显示另外一种可替换的方法,除原来的主动成像部件50之外,合并应用第二成像装置54(例如,一个被动或协主动装置)。 Figure 5c shows another alternative method, in addition to the original active imaging unit 50, the combined application of the second imaging device 54 (for example, a passive or active device HS). 这个第二成像装置可以形成于通路形成导管100上,或组织穿通元件102本身上,并能够与原来的成像装置50通讯或被其感受。 The second imaging device 100 may be forming on the catheter, or tissue penetrating element 102 itself in the path, and to work with the original image forming apparatus 50 communications or their feelings. 原来的成像部件50有一个感受器52,被安置于通路形成导管100所在血管的邻近血管中。 The original imaging unit 50 has a receptor 52, it was placed in the passageway formed vascular catheter 100 is located adjacent to the vessel. 主动成像部件50将要与第二成像装置54感受或通讯,从而提供观察、瞄准和引导组织穿通元件102的直接方法。 Active imaging unit 50 will be the second imaging device 54 or communications experience to provide observations, direct method of targeting elements 102 and guided tissue penetrating. 在这个实施方案中,第二成像装置54可以包括能够被主动成像部件50所询问、显像或分辨的任何合适类型的物质或装置。 In this embodiment, the second image forming apparatus 54 may include the ability to be asked of the active imaging member 50, or distinguish a substance or imaging means of any suitable type. 例如,主动成像部件50的感受器52可能包括一个无线电频率发射器,通路形成导管100上的第二成像装置54可能包括一个无线电频率应答器,可以被询问,并将对主动成像装置50的无线电频率发射器发出的无线电信号发出应答信号。 For example, the active imaging unit 50 of the susceptor 52 may include a radio frequency transmitter, channel 54 form a second catheter imaging device 100 may include a radio frequency transponder can be queried, and active imaging device 50 of the radio frequency transmitter emits a radio signal emitted response signal. 可选择地,在主动成像部件50是荧光镜、血管内超声(IVUS)部件或多普勒的实施方案中,位于通路形成导管100上的第二成像装置54可以包括一个不传导无线电的标志,反射表面或声音小孔,由此,可以将无线电波、声音或超声能量反射回主动成像部件50。 Alternatively, the active member 50 is a fluoroscopic imaging, intravascular ultrasound (IVUS) part or Doppler embodiment, the second imaging device is located in passageway 54 formed on the catheter 100 may include a non-conductive radio sign, reflective surface or sound holes, thus, can be radio waves, sound or ultrasonic energy reflected back to the active imaging unit 50. 形成于导管100体部或组织穿通元件102上,以增强其被主动成像部件50所显现的声音小孔或表面的类型的实例,在美国专利第4,977,897(Hurwitz)号中有描述。 100 formed in the catheter body or tissue penetrating element 102 to enhance the sound holes or instances of the type of surface being revealed its active imaging unit 50, are described in U.S. Patent No. 4,977,897 (Hurwitz) numbers .

图5d显示一个系统,其中,磁体57a、57b被安置于修正的通路形成导管101a中,用来协同具有尖锐远端尖端107的组织穿通导丝103,在所显示的二条血管BV1和BV2之间形成通路10,导管101a、101b的每一条有磁体57a、57b放置于其一侧。 Figure 5d a display system, wherein the magnets 57a, 57b are arranged in the modified passage 101a formed in the catheter, having a sharp distal end for cooperative tissue penetrating tip 107 of guide wire 103, shown in the two vessels between BV1 and BV2 forming a passage 10, the conduit 101a, 101b each have a magnet 57a, 57b disposed on one side thereof. 一条中空管腔109延伸通过每一个磁体以及形成于导管体内部的邻近插入物、在这种方式中,磁体57a、57b内的答腔开口可以被安置成彼此直接排成一线,利用磁体57a、57b的吸引力完成这种排成一线的位置。 A hollow lumen 109 extending through the insert and adjacent each magnet is formed inside the catheter body, in this way, the magnets 57a, 57b then spoke inside openings may be arranged in a straight line aligned with each other, the use of magnets 57a, 57b attraction accomplish this aligned position. 然后,具有尖锐远端尖端107的组织穿通导丝103可以被推向前,通过第一导管101a的导丝管腔109a,穿出导管101a的磁体57a内的管腔开口,通过第一条血管BV1的管壁,通过第一条血管BV1和第二条血管BV2之间的任何组织,通过第二条血管BV2的管壁,进入另一条通路形成导管101b的磁体57b的管腔开口。 Then, with a sharp distal tip 107 lumen tissue penetrating guide wire 103 can be pushed forward through the first conduit 101a of the guide wire lumen 109a, 101a of the magnet piercing catheter in the opening 57a, through the first vessel BV1 wall, through any organization first and second vessels BV1 BV2 between vessels through the second wall of the blood vessel BV2 into the other path 101b formed catheter lumen opening 57b of the magnet. 用这种方法,组织穿通导丝103将形成第一条血管BV1和第二条血管BV2之间的通路10。 In this way, tissue penetrating guide wire 103 will be formed passage 10 first and second vessels BV1 BV2 between vessels. 应当理解,组织穿通导丝103的远端尖端107可以包括能够退回到导丝内的尖锐远端尖端,从而在导管101a、101b退出后,导丝GW可以留在血管内。 It should be appreciated, tissue penetrating distal end 103 of guide wire tip 107 may include the ability to return to the sharp distal tip of the guidewire within the catheter whereby 101a, 101b after the exit, the guidewire GW may be left in the blood vessel. 可以替换地,组织穿通导丝103可以是激光丝、热丝或其它任何类型适于形成所期望的通路10的组织穿通元件。 Can be replaced, the tissue penetrating guide wire 103 can be organized via laser wire, hot wire, or any other type suitable for forming the desired 10-through element.

图5e-5e显示方法和装置,通过这些方法和装置,在本发明的通路形成导管100上形成被动放射显像成像可见标志,在每一个血管外通路10形成之前,可以被用来实现导管100的精确旋转定位。 FIG. 5e-5e display method and apparatus, by these methods and apparatus are formed of passive radiation imaging of visible marks on the catheter 100 is formed in the passageway of the present invention, before each extravascular passageway 10 is formed, the catheter can be used to implement precise rotary positioning 100. 图5e显示,在计划的方式中,一条通路形成导管100安置于第一条血管BV1中,打算按照本发明,自第一条血管BV1进入邻近的目标T(例如,一个体腔,一团组织或另一条血管),形成一条通路10。 Figure 5e shows in the way plan, a path forming catheter 100 placed in the first vessel BV1, the intention according to the present invention, since the first vessel BV1 into the adjacent target T (for example, a body cavity, a mass organization or another vessel), a passage 10 is formed. 一个放射成像装置118,如荧光镜或X线部件之类,被用来在屏幕120(例如,一个X线片盒或荧光屏)上,提供第一条血管BV1和第二条血管BV2的放射图像。 118, such as fluoroscopy or X-ray components like a radiation imaging device, is used to screen 120 (for example, an X-ray film cassette or the screen), providing radiation image first and second vessels BV1 BV2 of vessels .

图5e′显示一条导管100,在这条导管100有放射成像可见的(例如,不透过射线或放射发亮的)标记122a、122b纵行分开安置于导管100的相对侧。 Figure 5e 'displays a catheter 100, catheter 100 in this visible radioactive imaging (e.g., not illuminated by rays or radiation) labeled 122a, 122b disposed apart longitudinally opposite sides of the conduit 100. 如图所示,这些放射成像可见标记122a和122b优选位于,相对于导管100的高度H而言,相同高度的位置,但却纵行分开。 As illustrated, the radiology visible marks 122a and 122b is preferably located, with respect to the height H of the conduit 100, the same height, but apart wales. 因此,如图5e′的下部方框所示,通过使这些放射成像可见标记122a、122b在屏幕120上与相应高度刻度直接连成一线的方法,导管100可以被精确地旋转定位。 Thus, as shown in the lower portion of block 5e 'shown by these radiological imaging visible indicia 122a, 122b and 120 on the screen corresponding to a line height scale direct method, the catheter 100 may be rotated precisely positioned.

图5e″显示了另一种类型的被动标记系统,它可以被用来获得导管100的精确旋转定位。参照图5e″,在通路形成导管100的一侧有一个环状放射成像可见标记124,且有一个盘状或点状放射成像标记126在另一侧,与环状标记124直接相对。 Figure 5e "shows another type of passive tag system, which can be used to obtain precise rotational positioning catheter 100. Referring to FIG. 5e", one side in the conduit passageway 100 is formed an annular radioimaging visible mark 124, and has a disc-like or point-like radiation imaging marker 126 on the other side, and the annular marking 124 directly opposite. 用这种方式,通过将盘状或点状标记126变成在屏幕120上显示为位于环状标记124之内的方法获得导管100的精确旋转定位。 In this manner, by the disc or dot-like mark 126 is shown as located into the annular marker 124 obtained by the method of precise rotational positioning of the catheter 100 at 120 on the screen.

还有另外一种可以用于获得导管100精确旋转定位的放射成像可见标志显示于图5e。 Radiography there is another conduit 100 can be used to obtain precise rotary positioning of the visible signs are shown in Figure 5e. 参照图5e,所提供的导管100有两(2)个基本上大小相同的放射透过小孔128a、128b,位于导管100上的相对侧面,互相直接相对。 Referring to FIG. 5e, provided the conduit 100 has two (2) of substantially the same size as the radiation through holes 128a, 128b, located on opposite sides of the conduit 100, directly opposite each other. 用这种方式,通过旋转导管100,直至第一个和第二个放射透过小孔128a和128b变成互相直接连成一线,从而如图5e的侧框中所阐明,在屏幕120看到它们好象一个单一开口,从而可以获得导管100的精确旋转定位。 In this way, by rotating the catheter 100 until the first and second radiation through holes 128a and 128b into directly with each other in a line, thus enunciated 5e side of the box as shown in the screen 120 to see They seem to a single opening, which can obtain precise rotational positioning of the catheter 100.

图5f-5f′显示一种方式,其中,通路形成导管100上形成一个超声可见标记130,它结合应用一个体外放置的超声成像传感器132,实现导管100的精确旋转定位。 Figure 5f-5f 'a display mode, in which the passage forming an ultrasound catheter 100 visible indicia 130, which combines the application of an ultrasonic imaging sensor 132 disposed in vitro, precise rotational positioning of the catheter 100. 如图所示那样,超声可见标记130形成于导管100的特定位置上,这一特定位置与组织穿通元件102将要穿出导管100的位置和方向有已知的关系。 As shown in Fig, ultrasound visible mark 130 is formed to a specific location on the catheter 100, this particular location and tissue penetrating element 102 will be piercing position and orientation of the catheter 100 has a known relationship. 体外超声成像传感器132置于身体上,从而,通路形成导管100所位于的血管BV1和导管100的组织穿通元件102将要穿入的目标(例如第二条血管,组织块,或其它目标位置),都能显像。 In vitro ultrasonic imaging sensor 132 is placed on the body, thereby forming a vascular access catheter BV1 and catheter 100 organization is located 100 penetrating element 102 will penetrate the target (such as a second blood vessels, tissue blocks, or other target) You can imaging. 然后,旋转导管100,直到超声可见标记130被传感器132清晰和完全地显像。 Then, rotate the catheter 100 until the ultrasonic sensor 132 visual marker 130 is a clear and complete imaging. 这种超声可见标记130的定位,被用来确定导管放置于其适当的旋转定向,使组织穿通元件穿入目标T。 This ultrasound shows the positioning mark 130 is used to determine the catheter is placed in its proper rotational orientation, the tissue penetrating member penetrates the target T.

图5g-5g″阐明的方式,其中,通路形成导管100上的被动标记被用来与磁共振显像(MRI)系统联合,实现导管100的精确纵行和旋转定位,也用来确定导管100所在的血管与目标T之间的距离,由此提共一种方法,确定组织穿通元件102为在血管BV1和目标T之间形成所需的通路而所需移动的距离。在这个实施方案中,导管100管体由可通过MRI显示的材料形成。另外,在导管100管体的特定位置,形成可辨别的MRI标记134。该标记可能包括一个感应线圈134a或一个小物质块134b,它不同于导管100管体的材料,以便在MRI上特别显示。 Figure 5g-5g "articulated manner, wherein the passage duct is formed on the passive marker 100 is used jointly with a magnetic resonance imaging (MRI) system, catheter rotation and precise positioning wales 100, catheter 100 is also used to determine the the distance between the vessel and the target T is located, thereby providing a total of a method to determine the distance to move the desired tissue penetrating element 102 to the desired path between the vessel and the target T BV1 form. In this embodiment, , the catheter body 100 may be formed of a material shown by MRI. In addition, in a specific location of the catheter body 100, is formed discernable MRI marker may comprise a marker 134. The induction coil 134a or a small physical block 134b, it is different the material of the catheter body 100 so special is displayed on the MRI.

特别参照图5g′,将感应线圈134a置于导管100上或壁内的特定位置,并与一条延伸通过导管到达一个外在位置的丝135相连,在那里它们可以连接到合适的电源,示波器和/或其它监测系统。 With particular reference to FIG. 5g ', the induction coil 134a in a specific location on the catheter 100 or the wall, and with a reach extending a wire through the conduit 135 is connected to the external location where they can be connected to a suitable power supply, oscilloscope and / or other monitoring systems. 由此,线圈134a中的电磁场的电流、相位和振幅可以被监测。 Thus, the coil 134a of the electromagnetic current, phase and amplitude can be monitored. 用这种方式,MRI扫描器135范围内的导管100的移动,将导致线圈134a在MRI系统形成的可变但已知的磁场内改变位置。 In this manner, the catheter 100 moved within the scope of the MRI scanner 135, variable coil 134a will result in the formation of the MRI system but changing the position of a known magnetic field. 用这种方式,导管100在MRI场中的每一次移动,将导致电流,相位和振幅的变化。 In this manner, the catheter 100 to move in every field of MRI, will lead to changes in current, phase and amplitude. 然后,自线圈134a接受到的电流相位和振幅信息,被用来确定线圈134a相对于目标T的精确位置。 Then, since the current phase and amplitude information received coil 134a, is used to determine the exact position of the coil 134a with respect to the target T. 而且,如果线圈134a变成定位于MRI扫描器135所显示的特定平面之外,将表明导管100已经纵向移出了所期望的平面。 Furthermore, if the coil 134a becomes positioned in the MRI scanner 135 is displayed outside the specific plane, it will indicate that the catheter 100 has been removed from the desired longitudinal plane. 用这种方式,线圈134a可被用于导管100的精确纵向和旋转定向。 In this manner, the coil 134a can be used for precise longitudinal and rotational orientation of the catheter 100. 而且,从线圈134a获得的信息可被用于确定线圈134a和目标T之间的确切距离,由此提供信息,使操作者能够以适合将要形成的通路10的长度的方法,控制组织穿通元件102。 Furthermore, information obtained from the coil 134a can be used to determine the exact distance between the coils 134a and target T, thereby providing information, so that the operator method can be adapted to the length of the path 10 to be formed, the control tissue penetrating element 102 .

特别参照图5g″,一个替代的MRI标记134b包括一块独立的材料,它不同于导管100管体的材料,且能被MRI显示。用这种方式,MRI可显示的标记134b可以精确地显示于MRI显像,并可以被用来可视化地调整导管100相对于目标T之间的纵行或旋转定向和定位。而且,观察到的标志134b和目标T之间的距离,可用被用来使操作者能够控制组织穿通元件102的路径,以在导管100所在的血管BV1和目标T之间,形成期望长度的通路10。 With particular reference to FIG. 5g ", an alternative MRI marker 134b includes a separate material, which is different from the material of the catheter body 100, and can be displayed MRI. In this manner, tag 134b MRI can accurately be displayed on display MRI imaging, and can be used to visually adjust the catheter 100 relative to the target T between the longitudinal or rotational orientation and positioning. Further, from the observed signs and 134b between the target T, is available to the operator organizations can control the path-through element 102 to 100 is located between the catheter and the blood vessel BV1 target T, to form the desired length of path 10.

图5h-5l显示了“主动”成像装置具体类型的实例,它可以与通路形成导管100相关联、安装于其上或结合于其中,易化导管100在血管中的精确旋转定向。 Figure 5h-5l shows "active" Examples of specific types of image forming apparatus, which can be associated with the catheter passageway 100 is formed, mounted thereon or incorporated therein, facilitated precise rotational orientation of the catheter 100 in the blood vessel.

参照图5h,主动成像装置的一种是多普勒装置136,它可以与通路形成导管100相关联、安装于其中或合并于其内,例如合并于一种可以从商业途径获的部件中,名为Smart Needle,CardiovascularDynamics,Inc,Sunnyvale,加利福尼亚。 Referring to Figure 5h, an image forming apparatus is active Doppler device 136, which can be associated with the catheter passage 100 formed therein or mounting thereon the merger, e.g., can be combined in a commercially from eligible member, called Smart Needle, CardiovascularDynamics, Inc, Sunnyvale, California.

参照图5h,多普勒装置136安装于导管100上或置于其中,并被从侧面方向(例如,垂直于导管100的长轴)瞄准或指引。 Referring to Figure 5h, Doppler device 136 is mounted on the conduit 100 or disposed therein, and from the side direction (e.g., perpendicular to the long axis of the catheter 100) or guidelines aimed. 多普勒装置136在定位和辨别目标T的流体或其它物质的流动时有用。 Doppler device 136 useful for locating and tracing the flow of fluids or other substances T time. 因此,在目标T包括流体或其它物质流动于内的血管或其它解剖结构时,图5h所示的实施方案是有用的。 Thus, when the target T includes a fluid flow or other substances within the blood vessel or other anatomical structures, embodiment shown in Fig. 5h are useful. 由多普勒装置136提供的信号振幅和其它可辨别的信息,使操作者能够:a)纵向定位导管,从而多普勒装置136显示期望的目标T内的流动特征(例如,一个阻塞的下游和一条动脉);b)旋转定向导管,使多普勒信号振幅达到峰值,从而表明多普勒装置136瞄准目标T内的流动中心(例如,血管腔的中心)。 Flow characteristics (for example, a blocking downstream targets within T a) longitudinal guide tubes, thereby displaying a desired Doppler device 136: 136 signal amplitude, and other identifiable information provided by the Doppler device, so that the operator can and an artery); b) the rotational orientation of the catheter, so that the peak amplitude of the Doppler signal, thereby indicating that the central flow Doppler device 136 (e.g., the center of the vessel lumen) within the target T targeting. 和c)确定多普勒装置136和目标T内的流动中心之间的距离。 And c) to determine the distance of 136 Doppler flow within the center of the target T and between devices. 多普勒装置136和目标T内的流动中心(例如,腔道中心)之间距离的这种确定,将使操作者能够控制组织穿通元件102,从而,组织穿通元件102将从导管100只通过或延伸所期望的距离,由此形成一个进入目标的流动中心(例如腔道)的通路10,而不至于移动太远而可能穿刺或穿孔目标T的对侧壁。 Doppler flow device 136 and within the center of the target T (for example, cavity center) that determines the distance between, will enable the operator to control tissue penetrating element 102, and thus, tissue penetrating element 102 from the conduit 100 through or extending a desired distance, thereby forming a flow into the target site (for example cavity) of the path 10, which is not moving too far may puncture or perforation target T on the side walls.

在导管100安置于第一条血管BV1内后,多普勒装置136将被活化,且导管100将被纵行移动,和/或旋转,直至多普勒信号显示目标T的被显示部分内所期望的流动,而且多普勒信号振幅已达峰值,从而,表明多普勒装置136已直接与目标T排成一线。 After the catheter 100 disposed within the first blood vessel BV1, Doppler apparatus 136 will be activated, and the conduit 100 is longitudinal moved and / or rotated until the display target T Doppler signal is displayed within the section desired flow, and reached the peak amplitude of the Doppler signal, thereby indicating that the Doppler device 136 is directly aligned with the target T. 然后,多普勒装置136的频率输出可能变化,产生峰振幅反应的频率将表示多普勒装置136与目标T之间的距离。 Then, the Doppler frequency of the output device 136 may vary a peak amplitude frequency response of the Doppler device 136 and the distance between the target T. 在这个实施方案中,目标T必须是一条血管或其它内有流动物质的解剖结构,从而可被声音(例如,多普勒)装置所辨别。 In this embodiment, the target T must be a blood vessel or other anatomical structure within the flow material, so that the sound can be distinguished (e.g., Doppler) apparatus.

在图5i显示的实施方案中,一个血管内超声成像装置138安置于通路形成导管100的导管100一侧的特定位置。 In the embodiment shown in FIG. 5i, a vascular ultrasound imaging device 138 is formed to a specific position of the catheter 100 positioned on one side of the catheter 100 to passage. 超声成像装置100的这种特定位置,优选离组织穿通元件102将要穿出导管100的位置有已知的直线距离和旋转距离。 This particular position the ultrasound imaging apparatus 100, preferably from tissue penetrating element 102 will wear a catheter position 100 with a known linear distance and rotation distance. 在导管100放置于第一条血管BV1内之后,可以旋转导管100,直到目标T(如,血管,搏动组织或其它能被超声成像显示的目标位置)直接形成一线,并被超声装置138直接显示,从而表示导管100被纵向及旋转定向,使得组织穿通元件102如愿地穿过第一条血管BV1管壁,并进入目标T。 After the catheter 100 is placed within the first vessel BV1, you can rotate the catheter 100 until the target T (eg, blood vessels, tissue or other pulse ultrasound imaging can show the target position) is directly formed line, and ultrasonic device 138 direct display , thereby indicating that the catheter 100 is vertical and rotational orientation, enabling organizations to do so penetrating element 102 through the first wall of the blood vessel BV1, and enter the target T.

图5j所示的方式,其中,应用第一个发射器/接受器线路140a和第二个发射器线路140b来完成通路形成导管100的精确旋转定向。 As shown in Fig. 5j, wherein application of a transmitter / receiver circuit 140a and the second transmitter circuit 140b to complete the formation of the precise rotational orientation of the catheter passage 100. 如图所示,在通路形成导管100的一侧的特定位置上,第一个发射器或接受器线路140a被放置于导管上,或置于其壁内。 As illustrated, the passage forming a specific position on the side of the catheter 100, the first transmitter or receiver circuit 140a are placed on a catheter, or placed in its wall. 这个第一发射器或接受器线路140a最好紧密邻近组织穿通元件102将要穿出导管100的位置。 The first transmitter or receiver in close proximity to the best line 140a tissue penetrating element 102 will be piercing the position of the catheter 100. 第二发射器或接受器线路140b放置于目标T中(例如,第二条血管、目标组织或通路形成导管100的组织穿通元件将要穿入的其它位置)。 A second transmitter or receiver circuit 140b placed in the target T (e.g., the second vessel, the target tissue, or other location passageway formed tissue penetrating element of the catheter 100 to be penetrated). 在导管100进入第一条血管BV1后,旋转导管,同时发射器或接受器线路140a、140b之一发出信号,从而,这种信号可以被发射器或接受器线路140a、140b的另一个接受。 In the conduit 100 into the first blood vessel BV1, rotate the catheter, and the transmitter or receiver circuit 140a, 140b of a signal, so that the signal can be a transmitter or receiver circuit 140a, 140b of the acceptance of the other. 用这种方式,持续旋转导管,直到发射器/接受器140a、140b接受的信号振幅达到峰值,由此,表示第一发射器/接受器线路140a和第二发射器接受器线路140b处于最接近的点,由此,提示导管100在第一条血管BV1中处于所期望的旋转定向的位置上。 In this manner, continued rotation of the catheter, until the transmitter / receiver 140a, 140b received peak signal amplitude, whereby a first transmitter / receiver circuit 140a and the second transmitter receiver circuit 140b is in the closest point, thereby prompting the catheter 100 is in the desired blood vessel BV1 in the first rotational orientation position. 另外,接受器线路140a、140b的一个或全部2个可以放置在不同的血管BV1和/或目标区域T内,当监测到的线路140a、140b之间的信号如此表示时,实现血管BV1内导管100的所期望的纵行定位。 In addition, the receiver circuit 140a, 140b of one or all of the two can be placed in different vessels BV1 and / or within the target area T, when the signal monitored line 140a, 140b between said so, the realization of intravascular catheter BV1 desired longitudinal positioning 100.

图5k显示可替换的布置,其中,感应线圈142位于通路形成导管100上或其壁内的特定位置,该位置与组织穿通元件102将要穿出导管100的位置相对应。 Figure 5k to display an alternative arrangement in which the induction coil 142 is located in a specific location on the catheter passage 100 is formed within the wall thereof, and the position of the through tissue piercing element 102 will correspond to the location of the catheter 100. 一个发射器线路144放置于目标T之内(例如,第二条血管,目标组织或导管100的组织穿通元件102打算穿过的其它位置)。 A transmitter circuit 144 is placed (e.g., the second vessel, the target tissue or tissue 100 of the catheter member 102 penetrating therethrough intended other locations) of the target T. 给予发射器线路144以能量,从而发射一个电磁信号,而且感应线圈142也获得了能量。 Transmitter circuit 144 to give energy to emit an electromagnetic signal, and the induction coil 142 also received energy. 然后,旋转导管100,直到感应线圈142内的信号的相位和振幅提示感应线圈142位于它与发射器线路100的最近点,由此,证实导管100被放置于适当的旋转定向,以引起组织穿通元件102自导管100经过,通过第一条BV1管壁,进入目标T。 Then, rotating the catheter 100 until the phase and amplitude of the induction coil 142 prompts the induction coil 142 is located within the signal and its closest point transmitter circuit 100, whereby the catheter 100 is placed on the confirmed proper rotational orientation to cause the tissue penetrating element 102 from the conduit 100 passes through the first BV1 wall, into the target T.

图5l阐明的方式中,第一和第二磁体146a-146b被用来实现通路形成导管100的精确旋转定位。 Figure 5l stated, the first and second magnets 146a-146b are used to achieve precise rotational positioning path forming catheter 100. 第一磁体146a放置于通路形成导管100上或其壁内的特定位置,该位置与组织穿通元件102将要穿出导管100的位置相对应。 Placed in the path of the first magnet 146a is formed on the catheter 100 or a specific location within the wall, the location and organization-through element 102 will wear a catheter position 100, respectively. 第二磁体146b放置于穿入目标T的另一条导管148上(例如,第二条血管、目标组织或组织穿通元件102将要穿过的其它位置)。 The second magnet 146b penetrate the target T is placed on another of the catheter 148 (e.g., the second position of the other vessel, the target tissue or tissue penetrating element 102 will pass through). 通路形成导管100被旋转,或被允许自行旋转,直到第一磁体146a和第二磁体146b连接一线,而且互相尽可能地接近,由此,表明通路形成导管100被放置于正确的旋转定向,使组织穿通元件102穿过第一条血管BV1,进入目标T。 Passage forming catheter 100 is rotated, or allow yourself rotation until the first magnets 146a and 146b connected to the second magnet line, and as close as possible to each other, thus indicating that the passage forming catheter 100 is placed on the correct rotational orientation, so tissue penetrating element 102 through the first vessel BV1, enter the target T. B. B. 本发明的部件图6到12显示本发明的部件,它们可以用于按照本发明形成血管外通路10,或者修正或装备这种通路10。 Part view of the invention 6-12 display member of the present invention, they can be used in accordance with the present invention 10 is formed, or amend or equipment extravascular access this path 10. 应当理解,图6-12所示以及以下提出的详细描述,只是打算描述和图解某些实例和目前优选的部件的实施方案,并不意在穷尽列举和描述本发明可能采取的有形形式的全部可能的部件或实施方案。 It should be understood that the detailed description set forth below and as shown in Figure 6-12, is intended to describe and illustrated some examples and presently preferred embodiments of the components and are not intended to be exhaustive list and description of the present invention may take physical form of all possible components or implementation.

ⅰ. Ⅰ. 易化组织穿通元件退出导管体的退出方案图6a-6i显示了布置和装备的实例,由此,本发明用于开始时形成血管外通路10的组织穿通元件102,可以由位于血管腔内的通路形成导管100内退出,而使组织穿通元件102穿过导管100所在的血管壁,从而建立所期望的血管外通路10。 Facilitated tissue penetrating element of the catheter body exit exit of Figure 6a-6i illustrates an example of the arrangement and equipment, thus, the present invention is formed at the beginning of the path 10 extravascular tissue penetrating element 102, it may be made for endovascular located passage is formed within the conduit 100 exits, leaving tissue penetrating element 102 through the conduit 100 where the vessel wall, thereby establishing a desired outer vascular access 10.

以下提出的对图6a-6i的详细描述,涉及不同类型的组织穿通元件102。 The following detailed description of the proposed Figure 6a-6i, the organizations involved in different types of punch-through element 102. 本文应用术语“组织穿通元件”意味着包括可以用于穿通组织的延伸元件、部件或装置、能量流(例如,热,激光束等)的全部可能类型。 In this paper, the term "tissue penetrating element" is meant to include all possible types can be used to extend the tissue penetrating element, component, or device, energy flow (e.g., thermal, laser beam, etc.). 因此,当描述到组织穿通元件102“穿”出导管100时,这种描述将不必然意味着一个固体元件穿出导管管体,而是也可以包括以能生成所期望的血管外通路10的方式和方向,来自导管管体的组织穿通装置的操作或能量流(例如,热,激光)的穿出。 Thus, when the catheter 100 is described to tissue penetrating element 102 "wear out", this description would not necessarily mean a solid element piercing catheter body, but also can include can generate the desired extravascular path 10 mode and direction of the organization from the catheter tube feedthroughs operation or energy flow (for example, thermal, laser) piercing. 另外,应当理解,图6a-6i所显示以及提供的与这些图有关的描述,并不意在描述或阐明本发明可用于使组织穿通元件102穿出通路形成导管100的全部的可能的安排或装置。 Additionally, it should be understood that Figure 6a-6i displayed as well as the figures relating to the description provided is not intended to all possible arrangements or apparatus of the present invention can be used to organize the through passage forming catheter piercing element 102 100 or clarify the description . 另外,以下的详细描述涉及某些包括“预弯回弹元件”的组织穿通元件102。 In addition, the following detailed description relates to certain including the "pre-bent resilient element," the organization-through element 102. 术语“预弯回弹元件”意味着一种元件,当它不被约束时将采取弯曲或曲线的形状,但具有足够的弹性,可以被退回并约束于导管部件100腔内,而不导致元件的塑形变形。 The term "pre-Bending device" means a device, when it is not bound to take the bent or curved shape, but with sufficient flexibility, can be returned and constrained to 100 lumen catheter member without causing element The plastic deformation. 能用于形成本发明的某些组织穿通元件102的预弯回弹元件的材料实例,包括在体温或在这些部件将被应用的温度下有回弹性、弹性或超弹性的材料。 It can be used to form certain tissues of the present invention, the through pre-bent resilient element element 102. Examples of materials, including body temperature or elasticity at temperatures of these components will be applied, the elastic or super-elastic material. 这些材料的实例包括某些不锈钢,某些塑料和某些超弹性合金和聚合物,如镍钛合金。 Examples of such materials include certain stainless steel, certain plastics and certain superelastic alloy and polymers, such as Nitinol.

图6a所示的通路形成导管100a的实施方案中,管腔112a通过导管100a纵行延伸,在远端小孔114处停止。 Embodiment shown in Fig. 6a passage 100a formed in the catheter, the lumen 112a via conduit 100a extending longitudinal stop aperture 114 at the distal end. 组织穿通元件102包括上述定义过的预弯回弹元件。 Tissue penetrating element 102 includes a pre-bent resilient element as defined above before. 当退回管腔112内时,组织穿通元件102的这一实施方案采取基本上直的、非弯曲或最小弯曲的形状,以适应导管100a的周壁。 When retracted within lumen 112, tissue penetrating element 102 of this embodiment taken substantially straight, non-bent or curved shape smallest, to accommodate the catheter circumferential wall 100a. 然而,当组织穿通元件102向前穿出导管100a远端的出口小孔114a时,组织穿通元件102将采取其预弯形状,从而组织穿通元件102的远端将穿过导管100a所在的血管管壁。 However, when the tissue penetrating element 102 forward piercing catheter distal orifice 100a 114a, tissue penetrating element 102 will be taken to its pre-bent shape, so the distal tissue penetrating element 102 will pass through the blood vessels where the catheter tube 100a wall. 应当理解,关于这一实施方案,以及本文描述的本发明的全部其它实施方案,组织穿通元件102可以被塑形以形成任何形状或大小的通路10。 It should be understood that, with respect to this embodiment, as well as all other embodiments of the present invention described herein, the tissue penetrating element 102 may be shaped to form any shape or size of the passageway 10. 因此,在其中组织穿通元件102包括一个预弯回弹元件的实施方案中,组织穿通元件的预弯形状可以是连续曲线、部分直线、部分曲线,多重曲线,或适于形成所期望的大小和形状的初始血管外通路10的任何其它预弯形状。 Thus, where the tissue penetrating element 102 includes a pre-bent resilient element embodiment, the tissue penetrating element may be pre-curved shape continuous curve, a straight line portion, part of the curve, multiple curve, or adapted to form a desired size and any other pre-curved shape of the original 10 vessels shaped outer path. 而且,如以下将要更详尽描述的那样,可能应用不同种类的通路修正部件,去除组织、扩大、扩张或修正通路的大小和/或形状,从而最终产生的通路10的形状可能基本上不同于组织穿通元件102第一次穿通后形成的初始通路。 Moreover, as will be described in more detail above, may apply different types of path correction member, removal of tissue, expanding, or expanding the size and / or shape modification pathway, ultimately resulting shape of the passage 10 may be substantially different from the organization The initial path penetrating element 102 after the first through-formation.

图6b显示的通路形成导管部件100b,有一个纵行延伸并终止于远端侧壁出口小孔114b的管腔112。 6b shows the passage forming catheter member 100b, and has a longitudinal extending side wall terminating in a distal end 114b of the outlet orifice 112 lumen. 在侧壁小孔114b和管腔112b的对侧表面之间,一个偏导器表面115形成于管道112b内。 Between the opposite side surface of the sidewall holes 114b and 112b of the lumen, a deflector surface 115 formed in the pipe 112b. 以柔韧材料制成的组织穿通元件102在退回管腔112b时,基本上是直的形状。 Made of flexible material in a tissue penetrating element 102 at the time of return lumen 112b, substantially straight shape. 然而,当沿远端方向向前时,该组织穿通元件102的远端将被偏导器表面115偏转,并通过侧壁小孔114b穿出导管100b管腔。 However, when the forward distal direction, the distal tissue penetrating element 102 will be deflected deflector surface 115 and the side wall of the hole 114b piercing through the lumen of the catheter 100b. 用这种方式,组织穿通元件可以以相对于导管100b的纵轴LA的侧方方向穿出导管100b的管体。 In this manner, tissue penetrating member relative to the catheter 100b may be the direction of the longitudinal axis LA of piercing the side of the tubular body conduit 100b.

图6c显示导管部件100c有一个沿纵轴延伸并终止于远端侧壁出口小孔114c的管腔112c。 Figure 6c display 100c has a catheter member extending along a longitudinal axis and terminating in a distal side wall 114c of the outlet orifice lumen 112c. 组织穿通元件102可以是一个预弯回弹元件,且在完全退回到导管100c的管腔112c时,基本上是直的形状。 Tissue penetrating element 102 may be a pre-bent resilient member, and, when fully retracted into the catheter lumen 100c 112c, substantially straight shape. 然而,当该组织穿通元件102沿远端方向向前时,由于其寻求它的预弯形状的固有倾向,该预弯回弹元件102的远端将自行定位,并穿出出口小孔114c,而不需要管腔112c壁上的任何表面的提起或偏转。 However, when the organization-through element 102 in a distal direction forward, due to its inherent tendency to seek its pre-bent shape of the distal end of the pre-Bending element 102 will be self-positioning, and out the outlet orifice 114c, lumen wall without any surface 112c of the institution or deflection.

图6d和6d′显示一个导管部件100d,它有一个纵向延伸的管腔112d,终止于远端出口小孔114d。 Figure 6d and 6d 'displays a catheter member 100d, which has a longitudinally extending lumen 112d, terminating at the distal outlet aperture 114d. 一个砧板元件180安置于导管100d远端前方间隔的距离,并通过整合形成的支柱182而与导管相接触。 A cutting board element 180 placed in front of the distal end of the catheter 100d spaced apart and formed by the integration of the pillars 182 and in contact with the catheter. 砧板元件180有一个远端钝面184和偏转表面186形成于其近侧,与导管100d的管腔112d的远端出口小孔114d直接排成一线。 Chopping element 180 has a distal end 184 and the deflecting surface blunt proximal surface 186 formed thereon, the distal end of the catheter outlet lumen 100d 112d 114d directly aligned apertures. 本实施方案中,组织穿通元件102包括一个柔韧元件,或回弹、预弯元件,并如所示那样,采取基本上直的或最小弯曲的形状,以适应和能够退回到导管的腔114d。 In this embodiment, the tissue penetrating element 102 includes a flexible element, or rebound, pre-bending element, and as shown, to take a substantially straight or minimum curved shape to fit and be able to return to the lumen of the catheter 114d. 然而,当穿通元件102穿出导管的远端开口114d时,组织穿通元件102的远端尖端将拱向砧板元件180的偏转器表面186,并针因而被偏转、被引导或产生弯曲或在侧方向成曲线,从而组织穿通元件将如图示那样穿过血管BV1的管壁。 However, when penetrating the distal end of the catheter piercing element 102 opening 114d, the distal tip tissue penetrating element 102 will arch to the chopping block element deflector surface 180 of 186, and thus the needle is deflected by the guide or bending or the side direction of the curve, so that tissue penetrating element as shown that pass through the wall of the blood vessel BV1.

优选地,砧板元件180的偏转器表面186不与导管100d的管腔112d的内表面相连续。 Deflector surface is preferably, chopping element 180 186 is not consistent with the inner surface of the catheter lumen 112d, 100d continuously.

图6e所示导管部件100e的另一种实施方案,其中导管部件100e包括一个可退回的外导管鞘190,和一个延伸内在元件192,一个预弯回弹管194形成于元件192内或安装于其远端部分内。 Figure 6e member 100e of the catheter shown another embodiment, wherein the catheter member 100e includes a returnable outer catheter sheath 190, and an internal extension member 192, a pre-bend formed in the resilient tube 194 is attached to member 192 or the distal end portion thereof. 延伸内在元件192有一个远端钝头196,并在其内形成一个延伸侧开口198,从而当外导管鞘190在近端方向上被退回时,如图所示,预弯回弹管状元件194将向外弹出到其预弯的侧曲形状。 Extending inner element 192 has a blunt distal end 196, and forms an extension of the side opening 198 therein, so that when the outer sheath 190 is retracted in a proximal direction, as shown in the pre-Bending tubular element 194 will pop out to the side of the curved shape of the pre-bent. 本实施方案中的组织穿通元件102可以是一个柔韧元件或预弯回弹元件,在它向前穿出内在管状元件194远端上的远端开口114e时,它将采取预弯形状。 When this embodiment of tissue penetrating member 102 may be a flexible element or pre-Bending element in its forward piercing the inner tubular member 194 on the distal end of the distal end opening 114e, it will take a pre-curved shape. 用这种方式,当导管鞘190在近端方向上退回时,预弯管状元件194可以形成第一角A1,当预弯回弹组织穿通元件102向前穿出预弯管状元件194的远端开口114e时,它可以形成第二角A2,从而,在组织穿通元件102远端尖端瞄准的方向和导管100e的纵轴LA之间,第一角A1和第二角A2将联合,结果形成第三角A3。 In this way, when the catheter sheath 190 retracted in a proximal direction, the pre-elbow-like element 194 may form a first angle A1, when the pre-Bending tissue penetrating element 102 bends forward piercing the pre-shaped member 194 When the distal opening 114e, which may form a second angle A2, and thus, the distal element 102 organizations aiming tip direction and a longitudinal axis LA of penetrating catheter 100e, the first angle A1 and the second angle A2 will join, the results Formation of Triangle A3. 如以上所详细解释的那样,组织穿通元件102的远端尖端和导管100e纵轴LA之间的角A3并不必然指定或限定了组织穿通元件102将要形成通路102的确切角度。 As explained above in detail, the organization-through element 102 and the catheter distal tip angle between the longitudinal axis LA A3 100e does not necessarily define the organization designated or the exact angle penetrating element 102 will be formed via 102. 实际上,组织穿通元件102可以是任何合适的形状,包括将形成连续曲线通路的连续曲线形状。 In fact, the organization-through element 102 may be any suitable shape, including the formation of a continuous curved shape continuous curve path.

图6f显示了导管部件100f的另一种实施方案,其中,导管部件100f包括一个可以在近端方向上退回的管状外鞘202,以及一个具有远端钝头206和一个形成于其上的侧面开口208的延伸内在元件204。 Figure 6f shows the catheter member 100f another embodiment, wherein the catheter member includes an 100f retracted in a proximal direction of the tubular sheath 202, and a side surface thereon and a distal blunt tip 206 is formed having the extension of the inner element 208 opening 204. 组织穿通元件102最好是一个安装于延伸元件104内的预弯回弹元件,紧密邻近侧面开口208,从而,当导管外鞘202向前而覆盖侧面开口208时,组织穿通元件102将采取基本上直的或最小弯曲的形状,以便适应导管部件100f的内腔112f,并被约束于其内。 Tissue penetrating element 102 is preferably attached to a pre-bent resilient member extending within the member 104, closely adjacent the side opening 208 so that, when the catheter sheath 202 forwardly to cover the side opening 208, tissue penetrating element 102 will take the basic straight or minimum curved shape to accommodate the lumen of the catheter member 100f 112f, and is constrained therein. 然而,当外鞘202在近端方向上退回以暴露侧面开口208时,组织穿通元件102将向外弹回其预弯形状,从而,组织穿通元件的远端指向,或将恰恰接触到,导管部件100f将要插入的血管BV的管壁。 However, when the outer sheath 202 retracted in a proximal direction to expose the side of the opening 208, tissue penetrating element 102 will spring outwardly back to its pre-bent shape, whereby the distal tissue penetrating element point, or will just come into contact with the catheter member 100f to be inserted in the blood vessel wall BV. 至少在某些实施方案中,组织穿通元件可以随后在远端方向上被推向前,从而穿过血管壁和任何期望的血管外组织,按照本发明形成血管外通路10。 In at least some embodiments, the tissue penetrating element may then be pushed forward in the distal direction, thereby passing through the vessel wall and any desired extravascular tissue, formed in accordance with the present invention, the extravascular passageway 10.

图6g显示另外一个实施方案,通路形成导管部件100g包括一个管状导管管体,它有一个中空腔112g纵行延伸通过,并开口于远端开口114g。 Figure 6g displays another embodiment, the catheter passage forming member 100g comprises a tubular catheter body, which has a hollow cavity extending through the wales 112g, and an opening in the distal opening 114g. 导管100g的远端管体可以向侧方弯曲,如图6g的点状线所示。 100g of the distal end of the catheter tube can be bent sideways, 6g dotted line in Fig. 导管部件100g在侧方的这种弯曲将引起出口小孔114g变成指向导管部件100g所在血管的管壁,从而,组织穿通元件102随后向前穿出导管部件100g的远端开口114g,导致组织穿通元件102接触并穿过导管部件100g所在血管BV的管壁。 100g catheter member in this side of the bend will cause the orifice 114g 100g catheter member into point where the vessel wall, and thus, tissue penetrating element 102 then forwards piercing member distal catheter opening 100g 114g, leading to tissue 102 contact element penetrating through the wall of the catheter member 100g and where the vessel BV. 在形状记忆合金、拉丝、反电磁线圈或能引起导管尖端弯曲的任何其它合适的机械、装置或材料的存在下,导管100g的可弯曲远端可以由其直的形状变成其曲线或弯曲的形状。 When the shape memory alloy, drawing, anti-electromagnetic coil or bending can cause the catheter tip to any other suitable machinery, equipment or material exists, 100g bendable distal end of the catheter may be its shape into a straight or curved its curve shape.

图6h显示通路形成导管部件100h的另一个实施方案,它包含一个管状导管100h,它有一个可从其中穿过的组织穿通元件102。 Figure 6h display catheter passage forming member 100h of another embodiment, it comprises a tubular conduit 100h, which has therethrough a tissue penetrating element 102. 一个可充盈球囊210形成于导管部件100h的一侧,与血管BV管壁上将要形成的血管外通路10的位置相对。 Filling a balloon 210 is formed on one side of the catheter member 100h, the location of 10 vessels and vessel BV will be formed in the outer wall opposite path. 在组织穿通元件102向前进之前或向前进期间,球囊210的充盈将:a)当组织穿通元件102向前穿过血管BV的管壁时,阻止或防止导管100h弹回和压向血管BV的对侧壁,和b)用来稳定和保持导管部件100h的远端部分在血管BV的管腔内处于基本固定的位置,从而,在组织穿通元件102向前进或穿过血管BV管壁时,可以应用增强的力量或压力于其上。 In tissue penetrating element 102 to the period before proceeding or to move forward, filling the balloon 210 will: a) When the tissue penetrating element 102 forwardly through the wall of the blood vessel BV, stop or prevent catheter 100h rebound and pressure to the blood vessel BV The pair of side walls, and b) to stabilize and maintain the distal portion of the catheter member 100h within the lumen of the blood vessel BV in a substantially fixed position, thereby, advance or at the time through a blood vessel wall tissue penetrating element BV 102 It can be applied to enhance the strength or pressure thereon. 在图6h所示的实施方案中,导管部件有一个远端出口开口114h,组织穿通元件102是一个预弯回弹元件,在穿出远端出口114h时,它采取侧向弯曲或曲线的形状。 In the embodiment shown in FIG. 6h, the catheter has a distal outlet opening part 114h, tissue penetrating member 102 is a pre-bent resilient member, when the outlet piercing distal end 114h, it takes the shape of the curve or bend laterally . 然而,应当理解,图6h所示的侧球囊210可以与图6a-6i所示的任何类型的导管结合或联合使用,包括那些其中组织穿通元件穿出导管部100h侧壁的侧出口小孔。 However, it should be understood that as shown in FIG. 6h side balloon 210 may be combined or used in conjunction with any type of catheter shown in FIG. 6a-6i, include those wherein the tissue penetrating catheter device piercing the side wall portion 100h of side outlet apertures .

图6i显示另外一种实施方案,通路形成导管部件100i包含一个延伸的、可弯曲的、管状导管管体,它有一个沿纵向延伸的中空管腔114i;和一个旋转安装于管状导管管体远端的钝体尖端元件212。 Figure 6i display another embodiment, 100i passage forming member comprises a conduit extending, flexible, tubular catheter body, which has a hollow lumen extending longitudinally along a 114i; and rotatably mounted on a tubular catheter tube away the tip end of the bluff body element 212. 远端尖端元件212有一个弯曲管腔214延伸通过,其近端与导管100i的管腔114i连成一线,其远端终止于远端头部元件112一侧的侧出口小孔114i。 Distal tip element 212 has a curved lumen 214 extends through the proximal end of the catheter lumen 100i 114i in a line, which terminates at the distal side of the distal end of the outlet orifice 114i head element 112 side. 本实施方案中的组织穿通元件102可以包括一个柔韧元件或回弹预弯元件。 The embodiment of the organization through-member 102 may include a flexible element or rebound pre-bending element. 在任一情况下,组织穿通元件102可以先前进到中间位置,其中,组织穿通元件的远端尖端置于远端头部元件212的弯曲管腔214内。 In either case, the tissue penetrating element 102 may advance to the first intermediate position, wherein the tissue penetrating distal tip member distal tip member 212 disposed within lumen 214 is bent. 当组织穿通元件102处于这种中间位置时,组织穿通元件102可以被旋转。 When the tissue penetrating element 102 is in this middle position, the organization-through element 102 can be rotated. 由于其在远端尖端元件121的弯曲管腔214内的摩擦接触,组织穿通元件102的这种旋转将引起远端尖端元件212同时旋转。 Due to its frictional engagement element 121 at the distal tip 214 of a curved lumen, the tissue penetrating element 102, such rotation causes the distal tip member 212 will rotate simultaneously. 在这种方法中,组织穿通元件102的部分前进和旋转可以用来做为一种方法,旋转移动远端尖端元件212,以适应侧出口小孔114i的旋转定向,从而指引组织穿通元件以期望的侧向方向,在期望的地点,形成本发明的血管外通路10。 In this method, the tissue penetrating member and the rotating portion 102 proceeds can be used as a kind of method, the rotational movement of the distal tip member 212, in order to adapt the outlet side of the orifice 114i rotational orientation, thus guidance to a desired tissue penetrating element lateral direction, in the desired location, formation of blood vessels outside the path 10 of the present invention. 用这种方式,在达到期望的远端尖端元件212的旋转定向后,组织穿通元件102进一步向前穿出侧出口小孔114i,将使组织穿通元件穿过导管100i所在的血管BV的管壁,形成期望的血管外通路10。 In this manner, after reaching the desired rotational orientation of the distal tip member 212, tissue penetrating member 102 further forward side outlet piercing holes 114i, tissue penetrating element will pass through the conduit 100i where vascular wall BV , angiogenesis desired outer passage 10.

ⅱ. Ⅱ. 可以结合于通路形成导管的组织穿通元件的类型下列图7a-7m和下文中提出的相关的详细描述,打算描述和阐明可按照本发明应用的某些类型的组织穿通元件102。 Tissue may be bonded to the passage forming member through-conduit type following figures 7a-7m and the associated detailed description presented below, intended to describe and illustrate certain types of tissue in accordance with the present invention is applied penetrating member 102. 应当认识并理解到,以下描述和图7a-7m显示的组织穿通元件102的特定类型,并不意在穷尽列举和描述可应用的组织穿通元件102的所有可能的类型,而是意在提供可以应用的组织穿通元件102的类型的实例。 It should be appreciated and understood that the following description and drawings 7a-7m organization show the through specific types of element 102 is not intended to organize an exhaustive list and description can be applied to the through all possible types of element 102, but is intended to provide applicable Examples of tissue penetrating element 102 types. 如上解释,术语“组织穿通元件”并不限于固体元件,也可以包括不同的装置、部件、或能量流。 As explained above, the term "tissue penetrating element" is not limited to solid components, it may also include different devices, components, or energy flow. 而且,术语“回弹、预弯元件”应当按照以上提出的这一术语的定义来解释。 Furthermore, the term "rebound, pre-bending element" according to the definition of the term should be put forward to explain the above.

参照图7a-7m,显示了可用于本发明的通路形成导管100的组织穿通元件102的不同类型。 Referring to FIG. 7a-7m, shows the different types can be used in the present invention is formed via tissue penetrating catheter 100 of member 102. 这些组织穿通元件102被设计成穿出可弯曲导管管体,穿入导管100所在的血管管壁,必要时穿过邻近血管外组织,形成本发明所期望的血管外通路10。 These tissue penetrating element 102 is designed to be bent catheter body piercing, penetrating the wall of the blood vessel where the catheter 100 through the adjacent extravascular tissue, if necessary, forming the present invention, the desired extravascular passageway 10.

图7a和7a′显示了组织穿通元件102a的第一个实施方案。 7a and 7a 'shows the organization of penetrating element 102a of the first embodiment. 这个组织穿通元件102a包括一个由柔韧材料,例如可从商业途径获得的Microlumen. This organization feedthrough Microlumen element 102a comprises a flexible material, such as available from commercial sources. Inc. Inc. ,Tampa,弗洛里达州的聚酰亚胺(Polyimide)管制成的延伸的、柔韧的针,和一个形成于其上的尖锐的、倾斜的远端尖端300。 , Tampa, Florida State polyimide (Polyimide) tubing extending, flexible needles, and a sharp formed thereon, slanted distal tip 300. 一个可选的管腔302可以沿穿通元件102a纵行延伸。 An optional lumen 302 may extend along the longitudinal 102a-through element. 一个预弯、回弹元件304,或者一条拉丝,纵行安置于组织穿通元件102a内。 A pre-bent, resilient element 304, or a drawing, longitudinal placement within the tissue penetrating element 102a.

当元件102a退回到通路形成导管100管腔之内时,回弹针元件304a将被引致采取基本上直的或最小弯曲的形状,适应导管管腔的形状,允许组织穿通元件102被完全退回进入导管管腔。 When the inner lumen of the catheter 100 back to the path when the element 102a is formed, resilient pin element 304a is caused to take a substantially straight or curved shape minimum, conform to the shape of the catheter lumen, allowing organizations penetrating element 102 is fully retracted into the lumen catheter. 然而,当组织穿通元件露出或向前穿出通路形成导管100时,预弯针元件304的远端部分将在侧方弯曲或呈曲线,由此使整个柔韧的组织穿通元件102a采取如图7a的剖视线所标示的那样的侧向弯曲或曲线的形状。 However, when the tissue penetrating element is exposed or forward piercing passage forming catheter 100, a distal portion of the pre-curved needle element 304 will be bent or curved in the side, whereby the entire organization flexible penetrating element 102a taken in Figure 7a as indicated on the side of the section line bent or curved shape. 以此方式,预弯回弹针元件304将引起柔韧或可弯曲的组织穿通元件体部采取期望的侧向弯曲或曲线的形状。 In this way, the pre-Bending pin element 304 will cause the shape of a flexible or bendable lateral tissue penetrating member body adopted a desired bent or curved. 在某些情况下,这种安置也可以允许组织穿通元件102a的柔韧体部围绕预弯回弹针元件304a旋转或转动,以易化或加强推进组织穿通元件进入血管管壁或邻近组织。 In some cases, this arrangement also allows flexible body tissue penetrating element 102a around the pre-Bending pin element 304a rotating or turning to facilitated or strengthened to promote the organization penetrating element into the blood vessel wall or adjacent tissue.

图7b显示组织穿通元件102b的另外一种实施方案它包含一条柔韧的延伸近端长柄306,它有一个刚性、尖锐远端尖端元件308安置于近端长柄306远端上或加入其中。 Figure 7b shows the tissue penetrating element 102b is another embodiment it includes a proximal shank 306 extending flexible, it has a rigid, sharp distal tip member 308 disposed on the proximal or distal shank 306 added thereto. 在这个实施方案中,组织穿通元件102b的近端长柄306足够柔韧和可弯曲,以通行于扭曲的解剖曲线或导管管腔内的曲线,同时刚性远端尖端部分308由刚性材料形成,如不锈钢,从而维持基本上尖锐的远端尖端310穿入并穿过血管管壁和期望的血管外组织,按照本发明形成血管外通路10。 In this embodiment, the tissue penetrating element 102b shank proximal end 306 sufficiently flexible and can be bent to pass in anatomical distortion curve or curves within the catheter lumen, while the rigid distal tip portion 308 is formed from a rigid material, e.g. stainless steel, so as to maintain a substantially sharp distal tip 310 and penetrates through the blood vessel wall and the desired extravascular tissue, formed in accordance with the present invention extravascular passageway 10.

图7c显示组织穿通元件102c的另外一种实施方案它包含一个延伸的实性或中空的带有尖锐远端尖端312的针,由预弯回弹材料形成,如超级弹性镍钛合金,或在组织穿通元件102c正常使用时可能遇到的温度范围内,表现为有回弹性、弹性或超弹性的其它合金。 Figure 7c shows tissue penetrating element 102c of another embodiment which comprises a solid or hollow needle extending tip with a sharp distal end 312, is formed by a pre-bent resilient material, such as super-elastic nitinol, or tissue penetrating inside may encounter when element 102c normal temperature range, the performance has resilience, elasticity or other super-elastic alloy. 由预弯回弹材料形成的组织穿通元件102c的这个实施方案,在退回到通路形成导管100的管腔112内时,将采取基本上直的或最小弯曲的形状,从而整个组织穿通元件102c可以完全退回管腔112。 When the resilient material by the tissue pre-bending element is formed of the through 102c of this embodiment is formed within the catheter lumen 112 to 100 in the return passage, it will take a minimum or substantially straight curved shape, so that the entire tissue penetrating element 102c can lumen 112 is fully retracted. 然而,当组织穿通元件102c向前穿出导管100的出口小孔114c时,组织穿通102c将采取其预弯形状,从而在侧方弯曲或曲折,相对于导管的纵轴LA形成角A,由此,有利于组织穿通元件102c的远端部分向前穿过血管管壁和任向邻近组织,以形成按照本发明所期望的血管外通路10。 However, when the tissue penetrating element 102c 114c forward piercing the outlet orifice of the catheter 100, through-102c organization will take its pre-bent shape, thereby bending or winding on a side, with respect to the longitudinal axis LA conduit forms an angle A, the This is conducive to tissue penetrating member distal end portion 102c of the forward through the blood vessel wall and to any adjacent tissue, according to the present invention to form a desired extravascular passageway 10.

图7d显示,组织穿通元件102d的另外一种实施方案它包含一个具有尖锐的(例如,斜切过的)远端尖端314和纵向延伸通过的导丝通路管腔316的中空针。 Figure 7d shows another embodiment of the tissue penetrating element 102d having it comprises a sharp (e.g., chamfered over) the distal tip 314 and the guidewire passage lumen extending longitudinally through the hollow needle 316. 应当理解,按照图6a-6i列举和以上详细描述的组织穿通元件穿出方案的不同,中空针可以由预弯、回弹材料或柔韧材料形成。 It should be understood that, in accordance with Figure 6a-6i organization described in detail above and include the through piercing element different programs, a hollow needle may be bent by the pre, resilient material or flexible material is formed. 图7d显示的穿刺元件102d的实施方案,具有允许导丝GW通过导丝通路管腔316向前进的优势。 Piercing element embodiment shown in Fig. 7d 102d, with a guidewire GW allow passage through the guide wire lumen 316 to advance advantage. 按照本方式,导丝GW可以在远端方向上间歇性向前,或可以被置于持续向远端的压力之下,从而,当组织穿通元件102d的尖锐远端尖端314进入另一条血管的管腔或其它空腔时,导丝GW将在远端方向上很快向前,由此标志着组织穿通元件102d的尖锐远端尖端314已经进入该血管管腔或空腔。 According to the present mode, the guide wire GW may intermittently forward in distal direction, or may be placed under constant pressure to the distal end, whereby, when the sharp distal tissue penetrating element 314 into the tip 102d of the other tube vessels When the chamber or other cavity, guidewire GW will soon forward in the distal direction, thereby marking the tissue penetrating element 102d sharp distal tip 314 has entered the lumen of the blood vessel or cavity. 因此,在本发明的血管再造方法中,形成二条血管间的血管外通路10时,或在本发明的另外的血管外步骤中,形成一条血管与一个包括另一条血管或其它中空体腔的目标T之间的血管外通路10时,穿通元件102d的这种实施方案特别有用。 Thus, in the revascularization process of the present invention, the formation of extravascular passageway two vessels between 10, or in another extravascular step of the present invention, the formation of a blood vessel and includes another vessel or other hollow body cavity target T extravascular passageway 10 between the punch-through element 102d of this embodiment is particularly useful. 施加于导丝GW的指向远端的压力可以手工施加,或应用如图10c′、10c″和10c所示以及如下全面详细描述的压力施加安全装置。 Pressure is applied to the distal end of the guidewire GW's point can be applied by hand, or use as shown in Figure 10c ', 10c "and shown 10c and pressure is applied as fully described in detail the safety device.

图7e还显示了组织穿通元件102e的另外一种实施方案它包含一个有尖锐(例如,斜切过的)远端尖端318的实性针。 Figure 7e shows the organization also penetrating element 102e of another embodiment which comprises a sharp (e.g., chamfered over) the distal end 318 of the needle tip solid. 如图7e′所示,本实施方案的穿刺元件102e可以由一个连续的实性延伸元件,例如一条丝形成。 FIG. 7e ', the puncture element 102e of the present embodiment may be formed of a continuous solid extending element, such as a wire is formed. 可以替换地,如图7e″所示,本实施方案的组织穿通元件可以包含一个具有纵行延伸通过的中空管腔114e″的外部管状元件102e″,和一个可同轴插入穿刺元件102e″的中空管腔114e″的可移除实性管心针元件320,从而,管状穿通元件102e″连同实性管心针元件320将基本上形成了一个实性针结构,与图7e'所示的实性延伸穿刺元件102e'结构相似。 May alternatively, as shown in 7e ", the organization of the present embodiment, the through member may comprise a hollow lumen extending longitudinally through 114e having" outer tubular member 102e ", and a coaxially inserted piercing element 102e" of hollow lumen 114e "removable solid stylet element 320, and thus, the tubular feedthrough element 102e" along with solid stylet element 320 will essentially forming a solid pin structure, as shown in Fig. 7e 'of Solid extending piercing element 102e 'structural similarity.

图7f显示组织穿通元件102f的另外一种实施方案它由2个部分联合组成,一个具有形成于其远端的尖锐套管针尖端324的延伸实性或管状元件322,和一个环绕的、可纵向向前进的外鞘326。 Figure 7f tissue-penetrating element 102f in another embodiment which consists of a joint composed of two portions, a solid extension or the distal end of the tubular member formed thereon a sharp trocar tip 324 having a 322 and a surrounding, can Portrait of an outer sheath 326 forward. 外鞘326的远端部分可以逐渐变细,未显示,从而它可以覆盖和防护延伸元件322的尖锐套管针尖端324。 The distal end portion of the outer sheath 326 can be tapered, not shown, so that it can extend coverage and protection element sharp tip of the trocar 322 324. 然而,当沿血管管壁或其它组织向前进时,尖锐套管针尖端324将露出外鞘326远端开口之外,从而通过血管管壁和/或其它组织穿入和前进。 However, along the blood vessel wall or other tissue when advancing to the sharp tip of the trocar 324 is exposed outside of the outer sheath 326 distal opening, so that by the vascular wall and / or other tissues penetrate and move forward. 当套管针尖端进入另一条血管管腔或其它中空体腔时,外鞘326可以响应施加于外鞘326上的间歇或连续指向远端的压力而向前。 When the trocar tip into the lumen of another blood vessel or other hollow body cavity, the outer sheath 326 may respond intermittently applied to the outer sheath 326 or distal end of the continuous pressure and pointing forward. 这种指向远端的压力可以手工施加,或用如图10c′、10c″和10所示及如下全面描述的持续压力施加安全部件施加。 This points to the distal end of the pressure can be applied by hand, or by applying safety components in Figure 10c ', 10c "and 10 shown and continuing pressure exerted fully described below.

图7g显示组织穿通元件102g的另一种实施方案,包括一个具有能量发射远端尖端330形成于其远端的延伸管状元件328。 Figure 7g tissue-penetrating element 102g another embodiment, includes a distal tip having an energy-emitting distal end 330 is formed thereon extending tubular member 328. 一条或多条能量发射丝或元件332可以自管状元件328发出,并与能量发射远端尖端330相连,从而向远端尖端330释放期望形式的能量。 One or more energy emitting filament or element 332 from the tubular member 328 may be issued, and the energy emission is connected to the distal tip 330, thereby releasing the desired form of energy tip 330 distally. 按照本方式,能量发射远端尖端可以发射任何适当类型的能量,这些能量将切除、切割或易化按照本发明的方法推动元件328通过血管和其它血管外组织。 According to this way, the energy emitted distal tip may emit any suitable type of energy, which will be removed, cut or facilitated pushing element 328 through the blood vessels and other extravascular tissue according to the method of the present invention. 可以从能量发射远端尖端330发射的能量类型的实例包括热(例如,电阻热或激光热形成“热尖部”)、单极电烙器(electrocautery)、双极电烙器、超声,等等。 Energy can be emitted from the distal tip 330 examples of the type of energy emitted include heat (for example, resistance to heat or laser heat to form a "hot tip"), monopolar electrocautery (electrocautery), bipolar electrocautery, ultrasonic, etc. and so on.

图7h显示组织穿通元件102h的另一种实施方案它包含一个延伸可弯曲导管100,一个纵行延伸通过的管腔112和一个置于其远端的可旋转的通路形成尖端336。 Figure 7h tissue-penetrating element 102h another embodiment which comprises a flexible conduit 100 extends, a longitudinal lumen extending therethrough into which a distal end 112 and a rotatable tip passage 336 is formed. 一个可旋转驱动元件338通过导管100的管腔112纵行延伸,在期望推进组织穿通元件102h穿过血管管壁或其它组织时,操作此可旋转驱动元件以旋转远端尖端336。 When one rotatable drive element 338 112 lumen catheter 100 extends longitudinally in advance desired tissue penetrating element 102h through the blood vessel wall or other tissue by operating the rotatable drive member to rotate the distal tip 336. 旋转的远端尖端336可以是任何合适的形状,以在旋转时形成期望形状的通过组织的隧道或通路。 Rotating the distal tip 336 may be of any suitable shape to form the desired shape while rotating through the tissue tunnel or passageway. 在这一点上,旋转尖端336的外表面可以装备一个尖锐的螺旋刀片或螺纹元件件337或其它组织切割或扩张的装置,以易化可旋转尖端336所期望的组织旋转钻孔、切割或扩张。 At this point, it can be equipped with a sharp blade or spiral threaded element or other tissue cutting member 337 or the outer surface of the expansion means for rotating the tip 336 to easily tip 336 of the rotatable desired tissue rotary drilling, cutting or expansion .

图7i显示另外一种组织穿通元件102i的实施方案。 Figure 7i show another embodiment of the tissue penetrating element 102i's. 在本实施方案中,组织穿通元件102i包括从形成于导管100内的小孔或透镜覆盖口114i发出的一来脉冲或连续激光。 In this embodiment, the tissue penetrating element 102i to include a pulsed or continuous laser from the hole formed in the catheter or within the lens 100 covering the mouth 114i issued. 一个诸如光导纤维之类的激光传导元件340通过导管100的管腔112纵行延伸,终止于靠近一个诸如镜子之类的反射表面341处,并与之排成一线,自激光传导元件340远端发来的激光由此被反射出侧面小孔或开口114i。 A laser such as a fiber or the like conductive element lumen 112 of catheter 100 extending wales, terminating in a reflective surface 341 close to the mirror and the like such as, and aligned therewith through 340, conductive element 340 from the distal end of the laser sent a laser thereby reflecting side holes or openings 114i. 因此,在这一特定的实施方案中,组织穿通元件120i不是由固体物质或是可展开的组织穿通装置所形成,而是包括能够汽化或切开血管管壁和其它血管外组织,以形成本发明所期望的血管外通路10的脉冲或连续激光束。 Thus, in this particular embodiment, the tissue penetrating element 120i is not formed by the solid material or expandable tissue penetrating device, but can be vaporized or incision comprising vascular wall and other extravascular tissues, to form the present pulsed or continuous laser beam 10 of the invention desired extravascular pathway.

应当理解,本实施方案中的组织穿通元件102i可以被以不同方法修正。 It should be understood that this embodiment of the tissue penetrating element 102i may be modified in different ways. 例如,在反射表面341处,一个连续能量向导(例如,光导纤维)可以通过导管管体延伸,终止于导管侧壁上的出口或透镜内,从而,能量流(例如,激光)将自导管侧方穿出。 For example, the reflective surface 341, a continuous energy Wizard (for example, optical fiber) can extend through the catheter body and terminates in the outlet conduit or a lens on the side walls, so that the energy flow (for example, a laser) will from the catheter side Party piercing. 可替换地,一个能量发射装置可以安置于导管侧壁上或置于其内,从而可以从导管的侧外方向发射期望的能量流。 Energy Alternatively, an energy emitting device may be disposed on the side walls or catheter placed therein, thereby emitting a desired direction from the side of the outer conduit flow. 另外,图7i特别显示的实施方案以及以上提到的其变化,将不限于激光能,也可以应用任何合适的能量流,包括热、超声、激光,等等。 Further, FIG. 7i particular embodiment shown and the change mentioned above, is not limited to the laser energy to be applied to any suitable energy flow, including heat, ultrasound, laser, and the like.

图7j显示另外一种实施方案,组织穿通元件102j可与本发明的通路形成导管100相结合。 Figure 7j show another embodiment, tissue penetrating element 102j catheter 100 can be combined with passage of the present invention is formed. 在本实施方案中,组织穿通元件102j包括一个延伸激光传导元件,激光能可沿此通过,从而,激光能将自延伸激光传导元件102j的远端343发出。 In the present embodiment, the tissue penetrating element 102j includes a conductive element extending laser, laser energy along this passage, whereby, the laser can extend from the distal end of the laser conducting element 343 102j issued. 延伸激光传导元件102j可以是预弯的,从而当它自导管100的远端开口114穿出时,它将在侧方自动曲折或弯曲,因而接触导管100所在的血管BV的管壁,以允许发自激光传导元件102j的远端343的激光能量在血管管壁和其它血管外组织内形成期望的血管外通路10。 Laser 102j extending conductive element may be pre-bent so that the distal end of the catheter when it is self-piercing 100 of opening 114, it will automatically tortuous or curved side, thus contacting the catheter 100 is located in the blood vessel wall BV, to allow Vascular laser energy from the bottom of the distal end of the laser conducting element 343 102j in the blood vessels form the desired wall and other extravascular tissue outside the path 10. 另外,应当理解,按照所有图示于图6a-6i和如上全面描述的所有组织穿通元件102的适当的出口方案,多种其它的出口方案可应用于激光传导元件102j,例如,形成于导管100的侧壁小孔。 Further, it should be understood that in accordance with all shown in FIG. 6a-6i and all organizations as fully described feedthrough appropriate outlet program element 102, various other programs can be used in laser outlet conductive element 102j, for example, is formed on the catheter 100 sidewall holes.

图7k显示可用于本发明的通路形成导管100的组织穿通元件102k的另一种实施方案。 Figure 7k show passage of the present invention may be used to form another embodiment of the catheter tissue penetrating element 100 102k's. 图7k所示的组织穿通元件102k,包括一个延伸中空针,它有一个管腔316纵行延伸通过,和一个尖锐远端尖端。 Organization shown in Fig. 7k feedthrough member 102k, comprising a hollow needle extends, which has a lumen 316 extending through the wales, and a sharp distal tip. 一个真空源(例如,吸引器)344附着于组织穿通元件102k的管腔316的近端,从而,在组织穿通元件的远端被推向前穿通血管BV或其它组织以形成本发明的血管外通路10时,将拖或拉组织进入管腔316。 A vacuum source (for example, suction) 344 attached to the lumen of the proximal tissue penetrating element 316 102k, whereby the distal end of the tissue penetrating element is pushed forward pass through the blood vessel BV or other tissue to form blood vessels outside the present invention channel 10, the drag or pull tissue into the lumen 316. 一个可选的封闭袖口317,它可包括一个安装于组织穿通元件102k外,面与其上的尖锐远端尖端分开一些距离的可充盈环状球囊,可以放置于毗邻血管BV管壁,从而形成封闭,它将避免管腔316应用吸引器而引起从血管BV管腔中漏出或吸出血液。 An optional closed cuff 317, which may include an installation in the tissue penetrating element 102k, the sharp tip on its distal face of some distance apart may be an annular balloon filling can be placed next to the wall of the blood vessel BV to form Closed, it will avoid the sucker lumen 316 applications caused leakage or aspiration of blood from the lumen of the blood vessel BV. 用这种方式,在组织穿通元件102k向前穿过血管壁组织或其它血管外组织时,可选的封闭袖口317可以易化将血管管壁BV或其它血管外组织拉或吸入管腔316的远端。 In this way, in the organization-through element 102k forwardly through the vessel wall tissue or other extravascular tissue, the optional 317 closed cuff blood vessel wall can be facilitated BV or other extravascular tissue pull or suction lumen 316 distal end.

图7l显示了可用于本发明的通路形成导管100的组织穿通元件102l的另外一种实施方案。 Figure 7l shows another embodiment of the present invention may be used via catheter 100 formed tissue penetrating element of 102l. 参照图7l,提供了一个组织穿通元件102l,与标准组织穿通元件102相结合,例如具有尖锐远端尖端的实性或中空针,和具有回弹、预弯远端部分347和纵行延伸通过的中空管腔349的环绕管状鞘346。 Referring to FIG. 7l, provides an organization-through element 102l, and standards organizations combine penetrating element 102, for example, a sharp distal tip of solid or hollow needle, and has rebound, pre-bent distal end portion 347 and the vertical line extending through The hollow lumen of the tubular sheath surrounds 346 349. 内有组织穿通元件102的鞘346沿导管100的管腔112被推向前。 Organized within the through element 102 along the lumen of the catheter sheath 346 112 100 is pushed forward. 当鞘346的远端部分347向前穿出导管100的远端开口114时,鞘的预弯远端部分347向侧方自动弯曲或折弯,如图7l的点状线所示。 When the distal end portion of the sheath 346 347 100 forward piercing distal opening of the catheter 114, the pre-curved distal end portion of the sheath 347 automatic curved or bent sideways, 7l dotted line in Fig. 然后,柔韧或预弯组织穿通元件102将被沿鞘346的管腔349推向前,穿过血管BV的管壁或其它血管外组织,按照本发明形成所需的血管外通路10。 Then, the pre-curved flexible or tissue penetrating element 102 will be along the lumen 349 of the sheath 346 to the front, wall or other extravascular tissue through the blood vessel BV, according to the present invention is to form the desired extravascular passageway 10. 任选地,真空源345可与鞘346的管腔349的近端相连结,以牵拉血管BV管壁与鞘346的远端部分347接触,从而易化组织穿通元件102前进和穿过血管管壁或其它组织。 Optionally, the vacuum source 345 with the lumen of the proximal end 349 of the sheath 346 with links to pull the blood vessel wall and BV 346 of the distal portion of the sheath 347 contacts, which facilitated tissue penetrating element 102 forward and through the blood vessel wall or other tissue.

图7m显示组织穿通元件102m的另一种实施方案。 Figure 7m tissue-penetrating element 102m of another embodiment. 参照图7m,提供的导管100具有一个侧壁开口114形成于其中和一个中空管腔112纵行延伸通过,并终止于侧壁开口114。 Referring to FIG 7m, conduit 100 provided with an opening 114 formed in the side wall and wherein a hollow lumen 112 extending longitudinally through the side wall opening 114 and terminates. 一个诸如尖头的中空或实性针的组织穿通元件102,可以通过导管100的管腔112向前进并穿出侧壁开口114。 A hollow or solid, such as needle tip tissue penetrating element 102, 100 through 112 lumen catheter forward and out through the side wall opening 114. 一个真空源350(例如,吸引器)放置于管腔112的近端,如图7m所示,吸引器被用来牵拉血管BV管壁向下与侧边小孔114接触。 A vacuum source 350 (for example, suction) is placed in the lumen of the proximal end 112, as shown in Figure 7m, suction is used to pull down the wall of the blood vessel BV in contact with the sides of the hole 114. 这种由吸引器引起的血管BV管壁与侧面小孔114的接触,易化组织穿通元件102实现向前并穿过血管BV管壁,形成按照本发明所期望的血管外通路10。 This contact with the side wall of the blood vessel BV is caused by the suction holes 114, facilitation tissue penetrating member 102 for forward and through the blood vessel wall BV, formed in accordance with the present invention, a desired extravascular passageway 10. 而且,这种吸收器附着帮助保持被穿入的组织处于紧绷状态,因而易化穿通这些组织。 Moreover, such an absorber attached to help keep the organization was penetrated in tight state, and thus facilitated the through these organizations.

ⅲ. Ⅲ. 通路修正装置图8a-8h和以下提出的详细描述,显示了多种类型的装置,可用于处理、扩大、去除组织、扩张、排列、包被或修正起初由组织穿通元件102形成的血管外通路10。 DETAILED DESCRIPTION FIG path correcting means 8a-8h and presented below, shows the various types of devices can be used for processing, expanded, remove tissue, expansion, arrangement, or corrected initially coated by the tissue penetrating element 102 formed extravascular passageway 10. 应当认识并理解,图8a-8h所示以及以下的详细描述是意在描述和阐明,根据本发明可用的通路修正装置类型的代表性实例,而不是意在全部列举和描述按照本发明可用的每一种可能的通路修正装置。 It should be appreciated and understood, as shown in Figure 8a-8h and the following detailed description are intended to describe and illustrate, according to representative examples of the type of path correction apparatus of the present invention can be used, and is not intended to enumerate and describe all available in accordance with the present invention, every possible path correction means.

图8a显示通路修正装置500a的第一种实施方案,它包含一个延伸管状元件,在其远端有一个环状尖锐远端切割尖端502,和一个中空管腔504a纵行延伸通过。 Figure 8a shows path correction means 500a of the first embodiment, which comprises a tubular element extending, at its distal end has an annular sharp distal cutting tip 502, and a hollow lumen extending longitudinally through 504a. 本实施方案的通路修正装置500a可以沿着穿过由组织穿通元件102形成的初始通路或通道的导丝GW向前,从而环状远端切割尖端502将切除组织或扩大由组织穿通元件102形成的初始通路或通道,以便提供所期望大小和形状的血管外通路10。 Guidewire GW path correction device 500a of the present embodiment along through the through element 102 by the organization formed forward initial path or channel, thereby annular distal cutting tip 502 will cut tissue or extended by the tissue penetrating element 102 is formed The initial path or channel, in order to provide the desired size and shape of the blood vessel outer passage 10. 应当理解,吸引器或真空管可用于本实施方案的通路修正装置500a的远端管腔504a,以易化远端切割尖部502挖除组织,从而,环状远端切割尖部502切割的组织将被牵拉以朝向近端的方向进入管腔504a,并可以由一个合适的收集管收集以随后进行病理检查。 It should be appreciated that the vacuum may be used to attract or distal passage 500a correcting apparatus according to the present embodiment the lumen 504a, to facilitated distal cutting tip 502 excavation tissue, thereby cutting the distal tip of the annular portion 502 severed tissue It will be pulled in the direction toward the proximal end into the lumen 504a, and may consist of a suitable collection tube collected for subsequent histological examination.

图8b显示通路修正装置500b的另外一种实施方案,它包含一个逐渐变细的扩张器,它有一个基本上圆柱形的近端部分506,和一个逐渐变细的远端部分508。 Figure 8b shows the path correction means 500b of another embodiment, which comprises a tapered dilator, which has a substantially cylindrical proximal portion 506, and a tapered distal portion 508. 一个中空管腔504b通过本实施方案的通路修正装置500b纵行延伸,从而,通路修正装置500b可以沿一条插入由通路形成元件102形成的初始通路或通道的导丝GW向前。 A hollow passageway through lumen 504b correcting apparatus of the present embodiment 500b extending wales, thus, may access correction apparatus 500b along the guide wire GW is inserted a passage forming member 102 is formed by the initial forward channel or passage. 当该通路修正装置500b向前通过这种初始形成的通路或通道时,逐渐变细的远端部分508将扩张通路或通道达到装置500b的近端部分506的较大直径。 When the path correcting means 500b forwardly through such passageway or channel initially formed, the tapered distal portion 508 of the expansion path or channel means 500b to reach the larger diameter portion 506 of the proximal end. 一个可选的能量发射带510可安置于装置500b的近端部分506,从而在装置500b向前穿过时,它发出热或其它能量来进一步修正通路10的表面。 An optional band energy emission device 510 may be disposed on the proximal end 500b of the portion 506, so that when the device 500b through forward, it issues a further heat or other energy to the surface 10 of the correction path.

图8c显示通路修正装置500c的第三种实施方案,它包含一个延伸管状元件,它有一个与以上图8a所示的实施方案的远端切割尖端502相似的环状尖锐远端切割尖端512,但更加适合发射能量(例如,热,震动,激光等)。 Figure 8c show the third embodiment of the path correction means 500c, which comprises a tubular extension member, which has a distal end shown in FIG. 8a above embodiment is similar to cutting tip 502 of the annular sharp distal cutting tip 512, but more suitable for emitting energy (e.g., heat, vibration, laser, etc.). 在本装置500c的实施方案中,一个能量传导丝或元件514延伸穿过装置500c的管状近端部分,并与环状远端切割尖端512相连,从而,传导电能、超声震动、或任何其它合适的能量形式到远端尖端512,以易化推动远端尖端512到达期望的血管管壁或其它血管外组织。 In an embodiment of the apparatus 500c, an energy conducting wire or a proximal portion of the tubular member 514 extending through the apparatus 500c, and the annular cutting tip 512 is connected to the distal end, whereby electricity conduction, ultrasonic vibration, or any other suitable forms of energy to the distal tip 512 to push the distal tip 512 facilitated reach the desired blood vessel wall or other extravascular tissue. 贯穿装置500c形成的中空管腔504允许装置500c沿着被置于由组织穿通元件形成的初始通路或通道内的导丝向前。 500c formed through the device allows the device to 500c hollow lumen 504 along the guide wire is placed through-element formed by the organization of the initial path or passage forward. 在装置500c前进时,电流或其它能量将通过能量传导丝或元件514,从而,由远端尖端发出热或其它能量会易化装置500c穿过组织的通路和前进。 500c when the device forward, current or other energy will be conducting element 514 by wire or energy, thus, heat or other energy issue will be facilitated through the organization of access devices 500c and advancing the distal tip. 应当理解,一个真空源(例如,吸引器)可以附着于管腔504c的近端,进一步易化装置500c穿过组织的通路和前进,并牵拉任何挖掉的组织通过管腔504c,从而,去除的组织可以被收集到收集管中,被送去做相应的病理研究。 It should be understood that a vacuum source (for example, suction) may be attached to the proximal end of the lumen 504c, 500c means further facilitated through the organization's path and move forward, and pull any organization to dig through the lumen 504c, thereby, removed tissue can be collected into a collection tube, sent to do the appropriate pathological study.

图8d显示通路修正装置500d的第四种实施方案,它包含一个延伸管状导管516,它有一条中空管腔504d纵行延伸通过,并有一个环状球囊518安置于其外表面。 Figure 8d is displayed via the fourth embodiment 500d of the correction means, which comprises a tubular catheter 516 extends, which has a hollow lumen extending longitudinally through 504d, and an annular balloon 518 disposed on its outer surface. 一个独立的球囊充盈管腔(未显示)将延伸穿过导管516的近端部分,以允许充盈流体被注入球囊518里面或被抽出。 Filling a separate balloon lumen (not shown) extending through the proximal portion of the catheter 516 to allow fluid to be injected into the balloon 518 filling inside or withdrawn. 本实施方案的通路修正装置500d,可以沿着置于组织穿通元件造成的初始通路或通道内的导丝GW,被向前推,直到未充盈的球囊518置于这个初始形成的通路或通道内。 Path correction device 500d of the present embodiment, can be placed along the tissue penetrating guidewire GW element caused by the initial passage or passage, it is pushed forward until the filling of the balloon 518 is not placed in this initial form of passage or passages inside. 然后,球囊518可以被充盈,以扩张或伸展初始形成的通路或通道,提供一个具有期望的直径和/或形状的修正的血管外通路10。 Then, the balloon 518 may be filling to expand or extend the initial formation of a passage or channel, providing a modified vessel having a desired diameter and / or shape of the outer passage 10.

图8e显示通路修正装置500e的第5种实施方案,它包含一条延伸柔韧导管体,它由互相纵行排成一线的近端部分520′和远端部分520″组成。近端和远端部分520′和520″互相通过两(2)条延伸的、可弯曲的切割丝522连接。 Figure 8e show path correction means 500e of the fifth embodiment, which includes an extension of the flexible catheter body, it arranged by a mutual longitudinal line of the proximal portion 520 'and a distal portion 520 "component. Proximal and distal portions 520 'and 520 "each other two (2) extending flexible cutting wire 522 connection. 一个中空管腔504e延伸通过装置500e的近端520′和远端520″部分,从而,沿着插入在组织穿通元件102初始造成的通路或通道内的导丝GW,装置500e可以被推向前。一条牵拉丝(未显示),或导丝本身,可以被包容于导管体的近端部分520″内,从而,导管体的远端部分可以被拉向近端,由此减小导管体近端部分520′和远端部分520″之间的间隙。这将引起切割丝522向外弓起,如图8e的幻影线所示。在操作中,装置500e将沿着导丝GW并穿过初始形成的通路或通道向前。然后,导管体的远端部分520″被拉向近端方向,缩短了导管体近端部分520′远端和远端部分520″之间的距离,由此引起切割丝522向外弓起。可选地,电流可以通过切割丝以便增强丝的切割作用。然后,装置500e将向近端方向退出由组织穿通元件102初始形成的通路或通道,从而,向外弓起的切割丝522将扩大初始形成的通路或通道,由此,按照本发明,将通路或通道变成扩大了的狭缝样的血管外通路10。 A hollow lumen extending through the device 500e 504e proximal end 520 'and a distal end 520 "section, which, along inserted tissue penetrating element 102 within the initial cause of path or channel guide wire GW, device 500e can be pushed forward . A pull drawing (not shown), or the guide wire itself, may be tolerant to the proximal end of the catheter body portion 520 'inside, whereby the distal end portion of the catheter body may be pulled proximally, thereby reducing the catheter body gap proximal portion 520 'and the distal portion 520 "between. This will lead to cutting wire 522 outward arch, 8e of the phantom line in Fig. In operation, the device will follow the guide wire GW 500e and wear initially formed over the forward passage or channel. Then, the distal end of the catheter body portion 520 'is pulled in the proximal direction, shortening the catheter body proximal end portion 520' distal end and a distal portion 520 "between the distance from This causes the cutting wire 522 outward bowing Alternatively, current can be cut in order to enhance the cutting action silk yarn. Then, 500e will exit the proximal direction means penetrating element 102 by the organization initially formed path or channel, thereby, outwardly arched cutting wire 522 will expand initially formed passageway or passage, whereby, in accordance with the present invention, the channel or channels into a slit-like expanded extravascular passageway 10.

图8f显示通路修正装置500f的第六种实施方案,它包含一个延伸长柄元件530,其远端上安置了一个拉回切割装置532。 Figure 8f show path correction device 500f of the sixth embodiment, which includes an extension of long-handled element 530, which placed a pullback on the distal end of the cutting device 532. 拉回切割装置532包括一个具有钝性远端表面534和环状近端切割边缘536的刚性元件。 Back cutting means 532 comprises a blunt distal surface 534 and a proximal end having an annular cutting edge 536 of the rigid element. 一个中空管腔504f纵行延伸通过长柄530和拉回切割元件532,从而,沿着插入在由组织穿通元件102形成的初始通路或通道内的导丝GW,装置500f可以被推向前。 A hollow lumen extending longitudinally through 504f skillet back to the cutting element 530 and 532, which, along inserted into the tissue penetrating element 102 is formed of an initial path or channel guide wire GW, device 500f can be pushed forward. 在拉回切割元件532全部进入初始形成的通路或通道内后,它将被向近端方向退回,从而近端切割表面536将切除组织,以便扩大或去除通路的组织。 In the back of the cutting element 532 all entered initially formed after passage or passages within, it will be returned in the proximal direction, thereby cutting the proximal surface 536 will be excised tissue to expand or remove tissue pathway. 可选择地,在拉回元件532退回时,切割表面536可以被旋转,以利于切割组织。 Alternatively, when the back member 532 retracted, the cutting surface 536 may be rotated to facilitate cutting tissue. 而且,可选择地,一地砧板(未显示)可以被放置于通路10的对侧端,以提供相对切割边缘536的对向压力,由此易化拉回切割元件532切割组织。 And, optionally, a land chopping block (not shown) may be placed on opposite ends of the passageway 10 to provide cutting edge relative to the pressure, which facilitated the cutting element 532 cut back to 536 organizations. 被近端切割表面536从通路壁上切除的组织,将被收集到拉回切割元件532的内腔538内。 Proximal cutting surface 536 is removed from the channel wall tissue will be collected into the back of the cutting element 538 lumen 532.

图8g显示通路修正装置500g的第七种实施方案,它包含一个延伸长柄540,其远端上安置了一个推前切割元件542。 Figure 8g display path correction means 500g of the seventh embodiment, which includes a shank 540 extending its distal end on the placement of a push before cutting element 542. 一条中空管腔504g纵行延伸通过长柄540和切割元件542,从而,沿着插入由组织穿通元件102形成的初始通路或通道之内的导丝GW,装置500g可被前推。 504g of a hollow lumen extending longitudinally through long-handled cutting elements 540 and 542, which, along the guide wire GW is inserted within the tissue penetrating element 102 is formed in the initial path or channel, the device 500g can be pushed forward. 切割元件542包括具有基本上圆柱形外表面的远端部分542′,和具有向外逐渐减少外表面的近端部分542″。一个尖锐环状切割边缘544形成于远端部分542′的远端,从而,当装置500g向远端方向前进时,切割边缘544将切下一块基本上圆柱形的组织,因而扩大了装置500g向前穿过的初始形成的通路或通道。可选择地,在装置500g前进时,尖锐环状切割边缘544可以被旋转。而且。一个可选用的砧板(未显示)可以被放置于通路10的对侧端,以相对切割边缘544提供反向压力,因而有利于装置500g切割组织。 Cutting element 542 includes a distal end having a substantially cylindrical outer surface portion 542 ', and having gradually reduced outwardly of the outer surface of the proximal portion 542. "A sharp annular cutting edge portion 544 formed at the distal end 542' of the distal end so that, when the apparatus 500g advancing in the distal direction, the cutting edge 544 to cut a piece of tissue is substantially cylindrical, thereby expanding the initial path or channel forming apparatus 500g forwardly therethrough. Alternatively, the apparatus When forward 500g, sharp annular cutting edge 544 can be rotated and. An optional chopping block (not shown) can be placed on opposite ends of passageway 10, the cutting edge 544 to provide the relative counter pressure, thereby facilitating means 500g cutting tissue.

图8h显示通路修正装置500h的第八种实施方案,它包含有一条管腔504h纵行延伸通过的一个延伸管状元件550。 Figure 8h passage display correction device 500h of the eighth embodiment, which includes a lumen extending 504h wale extending through the tubular member 550. 多个外溢小孔554形成于管状元件550,其范围局限于距管状元件550远端的一段间隔距离。 A plurality of apertures 554 formed in the spill tubular element 550, its scope limited to the period of separation distance from the distal end of the tubular element 550. 而且,一个远端导丝出口小孔形成于元件550的远端,从而,沿着插入到组织穿通元件102形成的初始通路或通道内的导丝GW,装置500h可被推向前。 Further, a distal guidewire outlet aperture 550 formed in the distal end of the element, whereby the guide wire is inserted into the tissue along the through-passage member 102 or formed in the initial passage of GW, apparatus 500h can be pushed forward. 近端和远端封闭球囊552′、552″形成于管状元件550的外表面,位于外溢小孔554的近侧和远侧。如图8h″所示,管状元件550可以沿导丝GW向前,直到外溢小孔534被置于将被可流动流体物质所处理的通路10之内。 Closing the proximal and distal balloon 552 ', 552 "are formed on the outer surface of the tubular member 550, overflow orifice 554 located proximal and distal As 8h", the tubular member 550 along the guide wire can GW before, until the spill holes 534 is disposed within the flow of the fluid substance can be processed by passage 10. 然后,环状封闭球囊552′、552″将被充盈,以封闭通路10的相对端。然后,预期的可流动物质将通过管状元件550的管腔504h,由此,它流出外溢小孔554,并充满仍然被封闭球囊552′、552″所封闭的通路10之内。 Then, the looped closed balloon 552 ', 552 "will be filling, to close the opposite ends of the passage 10. Then, the desired substance can flow through the lumen of the tubular member 504h 550, whereby it flows spill orifice 554 within, and fills balloon 552 remains closed ', 552 "of the closed path 10. 在可流动物质对通路10壁实现了所期望的处理后,负压可以被应用于管腔504h,以从通路10之内抽回可流动物质。 In the passage of the flowable material 10 to achieve the desired wall after treatment, the negative pressure may be applied to the lumen 504h, to withdraw from the passage 10 of the flowable material. 然后,封闭球囊522′、522″将被去除充盈,且装置500h将被退回并移出通路10。图8h′显示一种可替换的修正,装置500h′,其中管状元件550上不形成流体外溢小孔554,而是一个诸如丝的能量传导元件(未显示)延伸通过管状元件550的元件体,而且在管状元件550上封闭球囊552′、552″之间的区域将安装一个电极、电烙器装置、阻热器、激光或其它能量发射装置,从而,按照上述参照图8h和8h″的方式,当装置500h″变成位于通路之内时,管状元件550上封闭球囊552′、552″之间的外表面将变热或发射能量,此处理通路10的壁。 Then, closing the balloon 522 ', 522 "will be removed filling, and the device will be returned and removed 500h path 10. Figure 8h' show an alternative amendment means 500h ', in which the tubular element 550 does not form a fluid spill apertures 554, but a conductive element such as a power wire (not shown) extending through the tubular member 550 of the body member, and the balloon 552 on the tubular closure element 550 ', the region 552' will be installed between the one electrode, electrically branded device, thermal resistance, laser or other energy emitting device, thus, in accordance with the above-mentioned reference to FIG. 8h and 8h "approach, when the device 500h" is located in the passage of time becomes, the tubular member 550 closing the balloon 552 ' the outer surface 552 "between the hot or emit energy, the walls 10 of the processing path.

ⅳ. Ⅳ. 供形成于两血管间的血管外通路的纵行压迫和/或支持的装置在本发明血管外通路10形成于两(2)血管间的应用中(如在许多上述血管再生步骤中),血管壁间存在海绵状或疏松组织可能引起问题,即通过通路10的血流可能易于渗透入这种海绵状或疏松组织,从而产生血液漏出和/或血肿形成。 Wales repression and / or support means for the formation of extravascular passageway between the two blood vessels in the blood vessels of the present invention is formed in the outer passage 10 two (2) applications between vessels (as in many of the blood vessel regeneration step), vascular intramural presence spongy or loose tissue may cause problems, namely through the flow path 10 may be easier to penetrate into this spongy or loose tissue, resulting in leakage of blood and / or hematoma formation.

阻止血液向组织或附近血管壁间的间隙渗透的方法是在通路10内置入纵行通路压迫装置22,从而防止血液向其中渗入。 To prevent blood vessel wall space or near the tissue penetration method is built into the longitudinal passage 10 via the compression device 22, thus preventing blood to where infiltration. 而且,在通路10中配置这种纵行压迫装置22可额外提供通路内的结构支持,以维持通路的开放并防止由于附近组织的运动而使通路弯曲或关闭。 Moreover, such a path 10 arranged in longitudinal compression means 22 may provide additional structural support within the passage, in order to maintain an open passageway adjacent tissue and prevent movement or leaving a curved path closed. 然而,应理解到,任何这种纵行压迫装置22将如此构建以提供防止血液渗入附近组织的足够纵行压迫,但这种压迫又不会引起组织的过分压迫而导致内源性缺血和可能的组织坏死。 However, it should be understood that any such longitudinal compression device 22 thus constructed to provide close to prevent blood infiltration of organized oppression wales enough, but this oppression without causing too much oppression caused by endogenous tissue ischemia and possible tissue necrosis. 图9a-9f指向特殊纵行压迫装置22的实例,该装置可被置于本发明的血管外通路中以防止血液的组织渗透和/或提供通路内的结构支持。 Figure 9a-9f point to specific instances of longitudinal compression device 22, the device can be placed in the extravascular passageway of the present invention to prevent tissue penetration of blood and / or to provide structural support passage. 应该理解到,图9a-9f和下列详述并不意在完全列举和描述可按照本发明使用的纵行压迫装置22的所有可能类型。 It should be understood that FIG. 9a-9f and the following detailed description are not intended to be exhaustive and described in accordance with the longitudinal compression of the present invention may be used in all types of devices 22. 勿宁说,这些图和下列详细描述仅是可使用的纵行压迫装置22类型的一些实例。 Do not rather say, these figures are only the following detailed description and longitudinal compression of the device can be used a number of examples of 22 types.

显示于图9a-9f并在下文中描述的纵行压迫装置22的应用不必限于本发明的血管外通路10,而是也可与其它方法联合使用,用于形成身体的相邻管状形态学通路如血管,输卵管等间的侧侧连接(如,吻合术)。 Shown in Figure 9a-9f longitudinal compression device and applications described below vessel 22 of the present invention is not necessarily limited to the outer passage 10, but may also be used in combination with other methods for forming the body passage adjacent the tubular morphology A side side of the vessel, fallopian tubes and other inter-connections (eg, anastomosis).

图9a-9a′显示纵行压迫装置22a的第一实施方案,它包含一个第一环状元件600和一个第二环状元件602,它们可直接互相联合和互相连接以便纵行压迫围绕两血管BV1和BV2间形成的通路10的血管壁和其它组织。 Figure 9a-9a 'show longitudinal compression device 22a of the first embodiment, which includes a first annular member 600 and a second ring member 602, which may be combined with each other and connected to each other directly for the oppressed around the two vessels wales vessel wall formed between BV1 and BV2 path 10 and other organizations. 第一环状元件600具有许多从其一侧伸出的腿状元件604。 A first annular member 600 having a plurality of leg-like member 604 extending from a side thereof. 第二元件602具有许多接受小孔606,这些小孔的位置和结构适合接受腿状元件604于其中。 The second element 602 has a number of receiving holes 606, the location and structure of these holes are adapted to receive the leg-shaped member 604 therein. 每一腿状元件604在其中形成一个刺刀状连接器608或其它类型的连接器,以使腿状元件604插入接受小孔606时,连接器608将约束在接受小孔606中形成的相应元件或表面以便锁住并固定第一和第二环状元件600,602,这种固定方式引起对血管BV1和BV2的管壁部分和其它围绕通路10的居中组织的纵行压迫。 When each of the leg-like member 604 which is formed in a bayonet-like connector 608 or other types of connectors, so that the leg-like member 604 inserted into the receiving hole 606, the connector 608 will be constrained in the corresponding receiving element 606 formed in the orifice or surface to lock and secure the first and second ring elements 600, 602, this fixation causes vascular wall portion BV1 and BV2 and other organizations around the middle passage 10 wale oppression.

图9b-9b显示纵行压迫装置22b的第二实施方案,它包含一个已弯曲为图9b中所示的构型的回弹(如超弹的)线圈,该线圈具有两个上部弓形片段610′,610″和两个下部弓形片段612′和612″,如图所示。 Figure 9b-9b show longitudinal compression device 22b of the second embodiment, it contains an already bent as shown in Figure 9b configuration rebound (such as super bombs) coil which has two upper arcuate segments 610 ', 610' and two lower arcuate segments 612 'and 612', as shown. 装置22b最初被安装在管状导管616的管腔614中。 It means 22b is initially installed in the lumen of the tubular conduit 614 616. 内部导管元件618远端部分内径减小,该部分被同轴地置于外部导管616的腔614中,以使装置22b的纵行延伸的下部弓形部分612′,612″被捕获并通过摩擦力约束在内部管状导管618的远端减小直径部分的外表面与外部导管616的内腔表面之间,如图9b′所示。外部导管616最初通过通路10插入,装置22b在其中展开,随后将内部导管616向远方推进,以将纵行延伸的上部弓形部分610′,610″推出导管616的远端开口外,以便使上部弓形部分610′,610″向外回弹弯曲从而位于第一血管BV1的腔表面。随后,将内部导管618向后拉以释放纵行延伸的下部弓形部分612、612′、612″,形成摩擦力约束并被捕获于内部导管618和外部导管616间,并且退出外部导管616以使下部弓形部分612′、612″能穿出导管616的开放远端并向外回弹弯曲以便紧靠并约束第二血管BV2的管壁和位于其间的海绵状或疏松组织,参见图9b。形成装置22b的环状线形元件可为任何适合的回弹类型材料,优选的材料可包含在装置22b在哺乳动物体内展开和植入期间将会遇到的温度范围内表现超塑性或高度可弯曲特性的镍钛合金或多聚体。 618 inside the inner diameter of the distal portion of the catheter element is reduced, the part is coaxially disposed outside the catheter lumen 614 616, so that means wale 22b extends lower arcuate portion 612 ', 612' is captured and by friction Constraints in the inner tubular conduit between the distal end 618 of the reduced diameter portion of the outer surface and the outer surface of the catheter lumen 616, as shown in 9b 'shown in the external conduit 616 initially inserted through the passage 10, the device 22b in which to start, followed by The internal catheter 616 advance to the distance to the upper arcuate portion 610 extending wales', 610 "launched outside the distal end of the catheter opening 616 so that the upper arcuate portion 610 ', 610' so that in the first outwardly curved spring luminal surface of the blood vessel BV1. Subsequently, the inner catheter 618 is pulled back to release the wale extending lower arcuate portions 612,612 ', 612 ", and is trapped in a friction-constraint inner catheter 618 and outer catheter 616, and Exit external catheter to the lower arcuate portion 616 612 ', 612' can wear open distal end of the catheter 616 and outwardly curved spring to close and restrict blood vessel BV2 second wall and in between spongy or loose tissue See Figure 9b. 22b forming apparatus annular thread-like elements can be any type of suitable resilient material, preferably a material may be contained within device 22b in mammals will experience during expansion and implantation performance over a temperature range Plastic or highly bendable characteristics nitinol or polymer.

图9c显示包含一个第一环形球囊620和一个第二环形球囊622的纵行压迫装置22c的第三实施方案。 Figure 9c show includes a first annular balloon 620 and a second annular balloon compression device 622 wale 22c of the third embodiment. 第一和第二环形球囊620,622互相纵行排成一线并通过许多纵行连接器元件624相连接。 The first and second annular balloon 620, 622 aligned with each other longitudinally and by a number of longitudinal connector element 624 is connected. 装置22c最初被置于通路内而使去充盈的第一环形球囊620紧临第一血管BV1的腔面放置而去充盈的第二环形球囊622紧临第二血管BV2的腔面放置,并且连接器元件624通过通路10纵行延伸。 Means 22c initially placed in the path leaving to filling a first annular balloon 620 close to the first blood vessel BV1 away filling the cavity surface placed second annular balloon 622 close to the second vessel BV2 the cavity surface placement, and the connector element 624 extends through the longitudinal passageway 10. 随后,第一和第二环形气囊620,622被充盈以便纵行压迫围绕通路10的血管BV1和BV2之管壁部分以及位于其间的组织部分,如图9c所示。 Subsequently, the first and second ring 620, 622 are filling the balloon so that the longitudinal compression of blood vessels around the path 10 and BV1 BV2 of the wall portion and the portion located therebetween organization, shown in Figure 9c. 环形球囊元件620,622可用胶状或可医用多聚体物质充盈,这些物质在环状球囊元件620,622被充盈后将完全或部分固化,从而避免沿管线的漏出或环形球囊元件620,622去充盈。 Annular balloon member 620, 622 can be used for medical gel or polymer material filling, these substances in the ring after filling the balloon member 620, 622 is completely or partially cured, so as to avoid leakage or annular balloon member along the pipeline 620, 622 to the filling.

图9d显示纵行压迫装置22d的第四实施方案,它包含一个环状第一磁体626和一个环状第二磁体628,它们通过许多纵行连接元件630连接。 Figure 9d display apparatus 22d longitudinal compression of the fourth embodiment, it includes an annular first magnet 626 and an annular second magnet 628, the connection member 630 are connected by a number of wales. 该装置22d最初被展开于通路10中,以便第一环状磁体626被紧临第一血管BV1的腔表面放置并且第二环状磁体628被紧临第二血管BV2的腔表面放置。 The device 22d was originally launched in path 10 so that the first ring magnet 626 is close to the luminal surface of the blood vessel BV1 placed first and second ring magnet 628 is close to the luminal surface of the second vessel BV2 placement. 这些环状磁体626,628通过磁力相向运动从而与纵行连接器元件630接触并纵行地连接磁体,从而压迫环绕通路10的血管BV1,BV2之管壁部分以及位于其间的任何组织。 The ring magnet 626, 628 by the magnetic force opposing movement so as to contact with the longitudinal connector element 630 and connected wales magnet, thus oppression surround blood vessels BV1 10 passages, the wall portion of BV2 and any organization in between.

图9e显示纵行压迫元件22e的第五实施方案,它包含可被向内压迫并通过第一和第二球囊640,642的被充盈而连接的第一环状元件632和第二环状元件634。 The first annular element Figure 9e show wale oppression member 22e of the fifth embodiment, it contains the oppressed and inwardly through the first and second balloon 640, 642 are connected to the filling and 632 and the second ring element 634. 至少一个连接器元件636从第一环状元件632的内侧伸出。 At least one connector member 636 extends from the inner side 632 of the first annular member. 在第二环状元件634中形成至少一个对应接受小孔(未显示),并且这种接受小孔的大小和结构适合接受连接器元件636,并与连接器元件636上所形成的锯齿或其它可接合表面进行连接。 Formed with the serration 636 on the connector member is formed at least one corresponding receiving orifice (not shown), and the size and structure of this receiving apertures adapted to receive the connector member 636, and a second annular member, or other 634 engagement surfaces can be connected. 装置22e在通路10中如此放置,首先在球囊640、642去充盈时插入导管638,通过通路直至上部环状元件632紧靠第一血管BV1的腔表面,并且第二环状元件634紧靠第二血管BV2的腔表面。 Means 22e in the path 10 so placed, the first balloon catheter 640, 642 to 638 at the time of filling the cavity through the passage until 632 against the upper surface of the first vessel BV1 ring member and the second ring member 634 abuts BV2 the luminal surface of the second vessel. 随后,气囊640、642被同时被充盈以驱使环状元件632、634内向相向运动。 Subsequently, the airbag 640, 642 are simultaneously filling the annular element 632, 634 to drive within the opposite movement. 当环状元件被向内驱动时,第一环状元件632的腿636将进一步向前进入第二环状元件634的接受小孔,并且腿636上的锯齿将通过摩擦力被约束并固定在这种接受小孔(未显示)中。 When the cyclic element is inwardly driven, the first leg of the ring member 636 632 will be further forward into the second ring member 634 receiving apertures and serrated leg 636 will be constrained by friction and fixed such acceptance hole (not shown). 当达到对血管BV1、BV2壁和位于其间并环绕通路10的组织的期望量压迫时,球囊640、642可去充盈,并将带有去充盈的气囊640、642的导管638撤去,将装置22e留在通路10中的适当位置。 When reached for vessels BV1, BV2 wall and positioned therebetween and compressing tissue surrounding the passage of the desired amount of time 10, 640, 642 can go to filling the balloon, and the balloon catheter with a filling of 638 to 640, 642 are removed, the device 22e place to stay in the path 10.

图9f-9f″″显示纵行压迫装置22f的第六实施方案,可按照本发明,将它安置在形成于两血管BV1、BV2间的血管外通路10中。 Figure 9f-9f "" show a sixth embodiment of the longitudinal compression device 22f, in accordance with the present invention, will place it in the formation of blood vessels in both BV1, BV2 between extravascular passageway 10. 如图所示,该装置22f包含许多基本平行的、延伸的、预弯回弹丝元件646,通常排列为柱形。 As shown, the apparatus comprises a number of substantially parallel 22f, extending wire pre-bent resilient member 646, arranged generally cylindrical. 任选地,由刚性或柔韧材料形成的柱状连接元件648可被连接于每一个单一丝元件646,以使它们保持所期望的柱状排列。 Optionally, the cylindrical connecting element is formed by a rigid or flexible material 648 may be connected to each single trace element 646, so that they maintain the desired columnar arrangement. 每一丝元件646都是预弯的,从而,当不受压时,每一丝元件646的对端将向外弯曲而使丝元件基本成为“C”形构型,如图9f″中点状线所示。开始时,将装置22f安置在管状运送导管650的腔652中。将一个内部管状导管元件654同轴地置于运送导管650的腔652中。该内部导管654具有外径减小的远端部分656。装置22f被安置在导管656的管腔652中,从而使每个单一丝元件646被限制并以基本垂直的构型被固定。丝元件646的近端被捕获于内部导管654的远端部分656之外表面与外部导管650的内腔壁之间,如图9f′所示。装置22f被如此植入通路10中,首先将导管650放入通路10,以使运送导管远端与第一血管BV1的腔表面平齐,如图9f′所示。随后,将内部管状导管654向远端方向推进以使丝元件646的远端超出外部导管650的远端,从而使丝元件646的远端向外弯曲并紧靠或压迫性地插入第一血管BV1的腔表面,如图9f中所示。随后,将内部导管654向近端方向稍微后退,以使丝元件646的近端透镜从摩擦接触中释放,并捕获于内部导管654的远端部分656和外部管650的内部腔面间。随后,将整个导管650向近端方向退出,从而将整个装置22f从环绕的导管650的限制中释放,并允许丝元件646的近端弯曲并紧靠或压迫性地插入第二血管BV2的腔表面,如图9f所示。以此方式,装置22f可在围绕通路10的区域压迫血管BV1,BV2的管壁和其间任何组织。另外,如图9f中所示,应理解到,在采用柱状连接器元件648的实施方案中,这种柱状连接器元件可包含一段合成的或生物修复移植材料以便在通路10中形成为一层基本为柱状的内衬,如图9f″″中所示。 Every trace elements 646 are pre-bent, which, when not under pressure, every trace of the peer element 646 will bend outward leaving the wire element basically become "C" shaped configuration, as shown in Figure 9f "by dotted line shown at the beginning, the unit 22f disposed in the tubular lumen delivery catheter 650 652 would be an internal tubular conduit element 654 is placed coaxially delivery catheter 650 lumen 652. The inner catheter 654 having an outer diameter reduced the distal end portion 656. The apparatus 22f is placed in the catheter lumen 652 656, so that each single trace element 646 is limited and the configuration is substantially perpendicular to the fixed proximal end of the wire element 646 is captured in the inner catheter 654 The distal portion of the catheter between the outer surface of the inner cavity wall 650, as shown in Figure 9f than 656 'in FIG. 22f apparatus is so implanted in the passage 10, the conduit 650 into the first passage 10, so that the delivery conduit away end of the cavity surface flush with the first blood vessel BV1, FIG. 9f 'in Fig. Subsequently, the inner tubular catheter 654 to advance in the distal direction so that the distal end 646 of the wire member beyond the distal end of the outer tube 650, so that the wire the distal end member 646 and bent outwardly against or inserted into the compression chamber of the first surface of the blood vessel BV1, 9f as shown in Fig. Subsequently, the inner catheter 654 back slightly in the proximal direction, so that the wire element 646 The proximal end of the lens is released from the friction contacts, and trapped in the distal portion of the catheter 656 between the internal and the external surface of the internal cavity 650 of the tube 654. Subsequently, the entire catheter 650 exits the proximal direction, so that the entire device from the surround 22f limit release conduit 650, and allows the proximal end of the wire element 646 against bending or compression and inserted into the luminal surface of the second blood vessel BV2, shown in FIG. 9f this manner, the apparatus may be around passage 22f Regional vascular compression of BV1 10, BV2 wall and any tissue therebetween. Further, as shown in FIG. 9f should be understood that, in using the cylindrical connector element 648 of the embodiment, the cylindrical member may comprise a connector or some synthetic graft material to bioremediation shown substantially cylindrical lining layer, as shown in Figure 9f "" is formed in the passage 10.

应理解到,虽然装置22f在上文中被描述为一预弯回弹结构,但丝元件646也可由韧性金属或其它压力可变形材料形成,并在导入插管650中配备一种适当的变形工具如可扩张球囊以便使线性元件646的末端在穿出插管导管650时按意愿使其压力变形,从而提供所期望的预弯“C”构型。 It should be understood that, although in the above apparatus 22f is described as a pre-bent resilient structure, but the toughness of the wire member 646 may also be a metal or other pressure deformable material, and with an appropriate modification tools introduced into the cannula 650 such as an expandable balloon so linear element 646 at the end of the cannula piercing catheter 650 according to the wishes of its pressure deformed to provide the desired pre-curved "C" configuration.

ⅴ. Ⅴ. 一种优选的通路形成导管和系统图10a-11d显示优选通路形成导管的两种基本实施方案,以及相伴的装置,按照本发明,它们结合在一起而形成通路形成系统。 A preferred conduit passage is formed and the display system of Figure 10a-11d are formed preferably via two basic embodiments of the catheter, and accompanying apparatus according to the present invention, they are bonded together to form a passage forming system. 图12a-13b提供了一个优选方法利用图10a-11d所示通路形成导管和系统以在两条邻近血管BV1,BV2间形成血管外通路10的分步图示。 Figure 12a-13b provides a preferred method of forming catheters and systems to form an extravascular between two adjacent vessels BV1, BV2 path 10-step illustrated using passages 10a-11d shown in FIG.

参照图10a-10c,显示了优选通路形成导管装置100p的第一实施方案,它包含一个有一个腔702的延伸的可弯曲导管体700,该腔702纵行穿过该导管体,并在该导管体的远端终止于一个远端出口小孔704。 Conduit means forming a first embodiment with reference to FIG 100p 10a-10c, show the preferred path, which contains a flexible catheter body has a lumen extending 702 700, the chamber 702 through the catheter body wales, and in that the distal end of the catheter body terminates in a distal orifice 704. 一个包括图7a-7k中所示和在上文中描述的任何适当组织穿通元件102被配置于导管体700的腔702中。 Shown and includes any appropriate organization described hereinabove 7a-7k penetrating element 102 is disposed in the conduit 700 in the body cavity 702. 应认识到,出口小孔704和腔702的构型可被修正以适合将组织穿通元件穿出出口小孔704的任何适当出口方案,包括在图6a-6i中特别显示并在上文中详细描述的那些穿通元件出口方案。 It should be appreciated that the configuration of the outlet orifice 704 and chamber 702 can be modified to suit the tissue penetrating element piercing the outlet aperture 704 of any appropriate export programs, including particularly shown and described in detail above in Figure 6a-6i in Those elements penetrating export program.

易弯曲导管体700优选由易弯曲多聚体材料如尼龙,pebax,聚乙烯等,或柔软金属管材如薄壁hypotubing形成。 Flexible catheter body 700 is preferably made of flexible polymer material such as nylon, pebax, polyethylene and the like, or a soft metal pipe such as thin-walled hypotubing form. 金属编织物或其它加固材料可镶嵌于导管体700的壁上或形成于其壁内,以提供结构上的加固并使导管体700能够被旋转或扭曲而不适当的变形或卷曲。 Metal braid or other reinforcing material can be mounted on the wall of the catheter body 700 or formed in its wall, in order to provide structural reinforcement and catheter body 700 can be rotated or twisted without proper deformation or curl. 另外,在组织穿通元件102包含一个预弯回弹元件或针的实施方案中,一个刚性的管加固元件701可被设置于导管体700的腔702的远端部分附近,如图10b所示,以便在穿通元件102退入导管体700的腔702时为穿通元件102的预弯远端部分提供刚性约束。 Further, the tissue penetrating element 102 includes a pre-bent resilient element or embodiment of a needle, a rigid tubular reinforcing member 701 may be disposed in the vicinity of the distal end portion of the catheter body 700 of the cavity 702, shown in Figure 10b, so penetrating element 102 back into the lumen of the catheter body 700 penetrating element 702 is pre-bent distal end portion 102 to provide a rigid constraint. 这种导管加固元件701的存在可防止组织穿通元件102上的任何锐利远端头损伤或穿刺入制成导管体700的相对软的塑料材料。 The existence of such a catheter reinforcement element 701 prevents any sharp distal tissue penetrating head trauma or puncture element 102 into the catheter body made of a relatively soft plastic material 700.

手持部分706安装在可弯曲导管体700的近端。 Handheld section 706 mounted on the proximal end 700 of the flexible catheter body. 手持部分706包含一个刚性外壳,在其中形成一个基本为柱状的,中空内腔712。 Holding portion 706 comprises a rigid housing, which is formed in a substantially cylindrical, hollow interior 712. 组织穿通元件102的近端部分延伸入手持部分706的空腔712。 Tissue penetrating element proximal portion 102 extends into the handheld portion 706 of the cavity 712. 一个驱动按钮710与组织穿通元件102相连接,如图10c中所示。 Button 710 and a drive tissue penetrating element 102 is connected, as shown in Fig 10c. 驱动按钮710可被按下并向远端方向前进以引起组织穿通元件102穿出出口小孔704,达到形成本发明的血管外通路10的目的。 Driver button 710 may be pressed to the distal direction to cause tissue penetrating element 102 piercing the orifice 704, to achieve the purpose of forming blood vessels of the present invention, the outer path 10. 随后,驱动按钮710可向近端方向后退,以使组织穿通元件退入可弯曲导管体700的腔702中。 Subsequently, the drive button 710 may be back in the proximal direction, so that the tissue penetrating element back into the flexible catheter body cavity 700 of 702.

任选地,一种成像导管侧管720可连接于可弯曲导管体700的远端部分,此成像导管侧管720包含一个延伸管,在该延伸管中有一个腔722沿其纵行延伸。 Optionally, an imaging catheter 720 may be connected to the side tube bendable distal portion of the catheter body 700, the imaging catheter 720 comprises a side tube extension tube, there is a cavity in the extension tube 722 extending along the wale. 在紧邻出口小孔704处,有一个窗口724形成于侧管720的上侧壁。 In close orifice 704, there is a window 724 formed on the side wall side of the tube 720. 一种成像导管50,例如可商购自BostonScientific/心血管成像公司,马萨诸塞;Endosonics公司pleasonton,加利福尼亚:和Hewlett-Packard,North Andover,马萨诸塞的数种型号的血人超声导管,可插入到侧管720的腔722中,以使感受器部分52(例如,成像超声波发射和接受的部分)被置于窗口724旁。 An imaging catheter 50, such as commercially available from BostonScientific / Cardiovascular Imaging, Massachusetts; Endosonics company pleasonton, California: and Hewlett-Packard, North Andover, Massachusetts several types of blood people ultrasound catheter can be inserted into the side tube 720 of the chamber 722 to make the receptor portion 52 (for example, the imaging ultrasonic transmitting and receiving portion) 724 is placed next to the window. 制造侧管720的材料优选一种防止成像导管50所利用的能量类型(如,超声)传递的材料,但是窗口724可以是一个开放孔,或被一种可被成像导管50所利用的能量穿透的材料所覆盖。 Material of the side tube 720 to prevent the image forming material is preferably a catheter 50 of the type of energy utilized (e.g., ultrasound) delivered, but the window 724 may be an open hole, or may be an energy utilized by the imaging catheter 50 through covered with transparent material. 以这种方式,成像导管50的感受器部分52将只接受与窗口724成直线排列的区域的图像。 In this manner, the imaging catheter 50 of the susceptor portions 52 will only accept the image area 724 into a straight line with the window arrangement. 另外,窗口724优为直角构型并且被限制于紧邻可弯曲导管体700的出口小孔704的侧管720侧壁。 In addition, the window 724 is preferably rectangular configuration and is limited to the near side of the flexible catheter body orifice tube 700 704 720 sidewall. 通过这种方式,这种窗口724的特定大小,结构和位置,可允许使用者按下述方法完成导管装置100p的精确旋转定位,即,通过简单地旋转装置100p直到目标组织(例如,其它血管)可经窗口724,通过成像导管清晰地看到,从而表明出口小孔704定位正确,以使组织穿通元件102经出口小孔740的随后穿出可导致组织穿通元件102穿过导管装置100p所在的血管壁,并进入目标组织(例如,其它血管)。 In this way, the window 724 of a particular size, structure and location, can allow the user to perform precise rotation as follows positioning catheter device 100p, i.e., by simply rotating means 100p until the target tissue (e.g., other vascular ) through the window 724 can clearly be seen through the imaging catheter, thereby indicating that the outlet orifice 704 is correctly positioned in the tissue penetrating element 102 through the orifice 740 and then piercing can lead to tissue penetrating element 102 through the catheter device 100p location vessel wall and into the target tissue (eg, other blood vessels). 而且,窗口724的这种定位将允许管50被用于观察组织穿通元件102的实际运动和穿通,从而保证血管外通路在所期望的位置形成。 Moreover, this positioning window 724 will allow the tube 50 to be used for observing tissue penetrating element 102 and the actual movement of punch-through, thus ensuring the extravascular passageway is formed in a desired position.

作为可在侧管720内分离的位置形成窗口724的另一选择,侧管720的远端可位于组织穿通元件102穿出导管体700的位置附近,并且成像导管50的感受器部分52可简单地伸出并伸到侧管720的远端以外,从而使它能够清晰地显示组织穿通元件102的展开和运动。 Can be isolated as the position in the side of the tube 720 forms a window 724 Alternatively, the distal end side of the tube 720 may be positioned through the tissue through piercing element 102 near the location of the catheter body 700, and the imaging catheter 50 of the susceptor portions 52 may simply extends and extends beyond the distal end of the side tube 720, so that it can clearly show the tissue penetrating element 102 to expand and sports. 在这一可选择设置中,成像导管50显示的视野将不再受窗口724的限制或约束,而且成像导管50能够对侧管720的远端周围全方位360°范围成像。 In this alternative arrangement, the field of view imaging catheter 50 will no longer be displayed in the window 724 of the restrictions or constraints, and the opposite side of the imaging catheter tube distal end 50 can be around 720 full-range of 360 ° imaging. 因而,任何适当类型的标记装置或标记材料可形成于导管装置100p或组织穿通元件102p上,以便在放置或启动组织穿通元件102前使成像导管550可以用来行使所期望的功能,即确定导管装置100p的正确旋转定位。 Thus, any suitable type of marker or tag material may be formed on the catheter apparatus 100p or tissue penetrating element 102p, in order to place or starting tissue penetrating element 102 before the image forming catheter 550 may be used to exercise the desired function, i.e., to determine the catheter proper rotation of the positioning device 100p.

另外,如上所述,导丝腔726可通过组织穿通元件102纵行延伸并可在远端终止于一个在组织穿通元件102远端形成的导丝出口小孔728。 Further, as described above, the guide wire lumen 726 through tissue penetrating member 102 extending wales and terminates in a distal end of the guide wire in the tissue penetrating element outlet aperture 102 formed in the distal end 728. 以此方式,导丝GW可通过组织穿通元件102延伸并可前进到导丝出口小孔728外。 In this way, the guide wire GW by tissue penetrating element 102 extends and advances to the guide wire orifice 728 outside.

在远端被提供导丝腔726和导丝出口小孔728的组织穿通元件102的实施方案中,腔726中导丝GW的存在可被用作一种手段以精确测定组织穿通元件102的远端何时已穿入目标血管腔或其它腔或开放区域。 Is provided at the distal guide wire lumen 726 and guide wire orifice 728 tissue penetrating element embodiment 102, the presence of the guide wire lumen 726 GW can be used as a means to accurately determine the tissue penetrating element away 102 end when it has penetrated the target vessel lumen or other cavities or open area. 为完成这一点,当组织穿通元件102穿过导管装置100p所在的血管的壁时和穿过通路10所要通过的任何其它血管外组织时,连续的或间断的向远端方向的压力将会被加在导丝GW上。 To accomplish this, when no other vascular tissue penetrating element 102 through the vascular catheter device 100p where the walls and through the passageway 10 when to be adopted outside the organization, continuous or intermittent pressure in the distal direction will be applied to the guidewire GW. 只要组织穿通元件102的末端紧靠组织,导丝GW就不会露出或穿出远端导丝出口小孔728,并且,相应地,应用于导丝GW的向远端方向的压力将会遇到由于存在紧靠导丝出口小孔728的组织引起的阻力。 As long as the organization-through element tip 102 abuts against the organization, guide wire GW will not expose or piercing distal guide wire orifice 728, and, accordingly, be applied to the distal end of the guide wire GW will encounter pressure direction Due to the resistance against the guide wire orifice 728 organizations caused. 然而,当组织穿通元件102进入目标血管腔或其它开放空间时,由于向其施加了向远端方向的压力,导丝出口小孔728将立即打开,并且导丝GW将会快速穿出导丝出口小孔728。 However, when the tissue penetrating element 102 into the target vessel lumen or other open space, due to which pressure is applied in the distal direction, the guide wire orifice 728 will immediately open, and a guide wire GW will quickly wear a guidewire orifice 728. 这种导丝GW的快速推进将提示操作者组织穿通元件102的远端实际上已进入目标血管腔或其它开放空间。 This rapid advance guidewire GW will prompt the operator to the distal tissue penetrating element 102 has actually been into the target vessel lumen or other open space. 在此时,组织穿通元件102的推进可有意地停止,以避免组织穿通元件穿透目标血管的对侧壁或通路10在其中延伸的开放区域另一侧其它组织的任何可能性。 At this time, the organization promoting the penetrating element 102 can be intentionally stopped to prevent tissue penetrating element through the target vessel sidewalls or access any possibility of extending an open area 10 in which the other side of the other organizations.

图10c′-10c提供了可合并入通路形成导管100p以对导丝GW给予连续的或间断的指向远端的压力的装置示意图,如上所述,用于确定组织穿通元件102的远端何时已进入目标血管腔或其它开放空间。 Figure 10c'-10c incorporated provides a path to form catheter 100p Schematic guidewire GW to give continuous or intermittent pointing distal pressure, as described above, it is used to determine the tissue penetrating distal element 102 HO When has entered the target vessel lumen or other open space. 参阅图10c′-10c,装置800包含一或多个弹簧802(springs),这些弹簧通过连接器元件804连接至突出于导管体700的近端之外的导丝GW的一部分。 See Figure 10c'-10c, device 800 comprises one or more springs 802 (springs), which is connected to the spring portion 700 protrudes beyond the proximal end of the catheter body through the guidewire GW connector element 804. 应理解到,装置800可合并入手持部分706的内腔712中,或制成可安装在手持部分706的近端的独立单位。 It should be understood that the device 800 may be incorporated into the pistol grip portion 706 of cavity 712, or may be formed in a separate mounting unit 706 of the proximal end of the holding portion.

如图10c中所示,在操作开始前,导丝GW可自由伸出组织穿通元件102的远端的出口小孔728,从而使装置800的弹簧元件802成一种松弛(例如,收紧的)状态。 As shown in FIG. 10c, before the operation begins, the guide wire GW freely extendable distal tissue penetrating element 102 of the orifice 728, so that the device 800 of spring element 802 into a relaxation (for example, to tighten) state.

图10c″显示,当组织穿通元件102通过组织推进时,导丝GW的远端将与出口小孔728保持平齐,并且装置800的弹簧元件802将由于导丝GW的远端对邻近组织所施加的指向远端的压力而成张紧(例如,被拉长)状态。 Figure 10c "shows that when the tissue penetrating element 102 through the organization forward, the distal end of the guide wire GW will be maintained flush with the outlet orifice 728, and the device 800 is a spring element 802 due to the distal end of the guidewire GW to neighboring organizations directed pressure from the tension applied to the distal end (e.g., stretched) state.

图10c显示,当组织穿通元件102的远端尖部出现在血管腔或其它开放区域中时,导丝GW将立即前进到导丝出口小孔728外,从而允许装置800的弹簧元件802再次成松弛的(例如,缩短的)状态。 FIG 10c display, when the tissue penetrating distal tip member 102 appears in the vascular cavity or other open area, the guide wire GW will proceed immediately to the guide wire orifice 728, the device 800 allowing spring member 802 re- a relaxation (e.g., shortened) state. 导丝的这种突然前进和弹簧元件802的放松将向操作者显示,组织穿通元件102已达到血管腔或其它开放空间内,并且应停止进一步推进组织穿通元件102。 This sudden advance a guide wire and a spring element 802 will relax operator display, organization-through element 102 has reached the vessel lumen or within other open spaces, and should refrain from further promote tissue penetrating element 102.

如上所述,应认识和理解到,图10c′-图10c中描述和显示的压力施加装置是任选的,不必包括在导管部件100p中。 As described above, should be recognized and understood that pressure map 10c'- described and shown in FIG 10c applying means is optional, need not be included in the catheter assembly 100p. 而且,应理解和认识到,向远端方向持续地或间断地驱动导丝GW可人工完成(即,手工操作),而不需要使用任何装置。 Also, it should be understood and appreciated that the distal direction continuously or intermittently driven guidewire GW may be done manually (ie, manual), without using any device.

图11a-11d显示优选通路形成导管和系统100p可被修正以适合在图7f中显示并在上文中详述的特殊类型组织穿通元件102f的方法。 Figure 11a-11d display the special type of tissue and the catheter system can be modified to fit 100p shown in Figure 7f and described in detail in the above method is preferably through-passage forming member 102f. 这种特殊组织穿通元件由一个内部穿透元件322和一个纵行可推进外鞘326组成。 This special tissue penetrating element by an internal penetrating element 322 and a vertical row to advance the sheath 326 components.

图11a-11d显示一种经修正的优选导管装置100P′,象导管装置100P的上述实施方案一样,该导管装置包含一个可弯曲导管体700(有一个腔702通过该可弯曲管体纵向延伸),一个手持部分706(有一个内部腔712形成于其中),和一个成像导管侧管(有一个腔722和窗口724形成于其中),所有这些已在上文中详述。 Figure 11a-11d display preferably a catheter apparatus amended 100P ', like the above-described embodiments of the catheter apparatus 100P as the conduit means comprises a flexible catheter body 700 (there is a cavity 702 extending longitudinally through the flexible pipe body) , a holding portion 706 (712 has an internal cavity formed therein), and a side tube imaging catheter (722 has a cavity formed therein and a window 724), all of which have been described in detail hereinabove.

在导管装置100P′的这项实施方案中,手持部分706被修正以结合第一和第二驱动按钮710a,710b。 In the catheter device 100P 'of this embodiment, the handheld section 706 is amended to combine the first and second drive buttons 710a, 710b. 第一驱动按钮710a被连接于在其远端上具有锐利套针尖端324的预弯回弹内部元件322。 The first drive is connected to the button 710a has a sharp trocar tip 324 pre-Bending internal element 322 at its distal end. 第二驱动按扭710b连接于一个逐渐变细的可弯曲鞘326,该鞘以上文中详细描述的方式可在内部元件322上纵向地推进,参阅图7f。 The second drive is connected to a button 710b tapering flexible sheath 326, the sheath manner described above in detail can longitudinally advance the internal elements 322, see Figure 7f. 因此,在导管装置100P′的这项经改变的实施方案中,内部元件322和围绕的鞘326可利用驱动按钮710a,710b独立地推进和后退。 Thus, the catheter device 100P 'of this embodiment altered, the internal elements 322 and 326 can be used around the sheath drive button 710a, 710b independently advance and retreat.

应理解到,当内部元件326无任何导丝腔时,可任选是否向外部鞘326施加连续的或间断的指向远端的压力以实现相同的管腔穿通信号功能,参阅图10c′-10c。 It should be understood that, when the inner element 326 when no guidewire lumen may optionally be applied whether continuous or intermittent pointing distal lumen pressure to achieve the same number through the communication function to the outer sheath 326, see Figure 10c'- 10c. 相应地,恒定或间断压力弹簧装置800可连接于导管部件100p′的这项实施方案中鞘326,以便以图10c′-10c中导丝GW中所述相同方法向远端方向推动鞘326,或者,也可通过手工技术来完成(如果希望的话)。 In this embodiment, the sheath Accordingly, constant or intermittent pressure spring device 800 may be connected to the catheter member 100p '326, with the figure for the guide wire GW 10c'-10c pushing in the same manner as in the distal direction of the sheath 326 or, alternatively, it can be done (if desired) by manual techniques.

导管部件100和本文所述其它部件和装置可以多种方式结合以形成实施本发明的方法的独特系统。 Conduit member 100 and other components and devices described herein may be combined to form a method of the present invention unique system in various ways. 本文所述这系统应被理解为所述各种逐条列记的功能性组成部分的一或多种的组合。 This system is described herein to be understood as a combination of one or more of the various functional components itemized. 这些系统的组成部分可在相互之间机械的或暂时的关系中被使用,以实现本文描述的新方法,而且也可以在能够实现所述目标的许多组合可能的任意一种中使用。 These systems may be an integral part of each other or in relation temporary machine is used to implement the new methods described herein, but may be used in combination to achieve many of the objectives of any one of the possible. 这种系统可包括一个尺寸上适合放入血管,并且可推进至紧邻血管外目标或邻近血管目标处的导管体。 Such a system may include a size to fit within a blood vessel, and can advance to the next to the catheter body extravascular target or surrounding vessels at the target. 该导管还可以某种方式结合一个或多个所述主动或被动定位方法,以帮助导管在血管中相对于目标的正确定位。 The catheter can also be combined in some way with one or more of the active or passive positioning methods to help the catheter in a blood vessel relative to the target properly positioned. 而且,导管可结合至少一种组织穿通元件从而可以形成从血管到目标的通路。 Moreover, the catheter can be combined with at least one tissue penetrating element can be formed from the vessel to the target path. 该系统还可结合一种被设计好尺寸可插入通路中的导丝,且该导丝能通过导管导入以便其进入通路并提供通向目标的轨道。 The system can also be designed in combination with one dimension can be inserted via the guide wire and the guide wire through the catheter into the path so that it enters the orbit and provides access to the target. 本系统也可结合一种或多种可通过导丝放置或插入的部件的安置,例如管道依尺寸制造成维持工具或供完成治疗或诊断终点的其它部件。 This system can also be combined with one or more guidewire placed through placement or insertion member, e.g., a pipe manufactured according to the size of the tool or for the maintenance of other components to complete the therapeutic or diagnostic endpoint. 另外,本系统可包括一或多种的各种血管阻断方法,以使与本发明的血管外通路有效相关的血管可被阻断或关闭而允许血液再定路线。 In addition, the system can include a variety of methods to block one or more vessels, in order to make the extravascular passageway of the present invention effectively associated blood vessels can be blocked or closed and allow the blood and then set routes.

ⅵ. Ⅵ. 通路形成导管和系统的优选实施方案的操作图12a-12d提供了使用图10-10c所示组织穿通导管部件和系统100p的第一实施方案的优选方法的逐步图示。 Operation FIG passage forming conduit and a preferred embodiment of the system 12a-12d is provided as shown using FIG 10-10c stepwise illustrating a preferred method of tissue penetrating catheter system components and 100p of the first embodiment.

图13a-13b提供了使用优选通路形成导管部件和系统100p′的第二实施方案的优选方法的逐步图示。 Figure 13a-13b illustrates a preferred method provides a step by step using preferred passage forming member and the conduit system 100p 'of the second embodiment.

参照图12a-12d,成像导管50被插入侧管720的腔722以便导管50的成像感受器部分52被置于窗口724附近。 Referring to FIG. 12a-12d, the imaging catheter 50 is inserted into the side tube lumen 720 of the catheter 722 so that the imaging portion 52 of the susceptor 50 is placed in the vicinity of the window 724. 以此方式,成像导管50与通路形成导管部件100′的结合形成了按照本发明的一个“系统”。 In this manner, the imaging catheter 50 and the passage 100 'binding member forming a conduit according to the present invention, a "system." 在组织穿通元件102退入可弯曲导管体700的腔704以使组织穿通元件102的远端尖端藏入管状加固元件701中的情况下,包含导管装置100p和成像导管50的系统被插入哺乳类患者的血管,并推进直至导管体700的远端和侧管720的远端被置于邻近第二血管BV2处的第一血管BV1内,目的在于形成第一血管BV1和第二血管BV2间的通路10。 In tissue penetrating element 102 can be bent back into the lumen of the catheter body 700 704 to the tissue penetrating element into the possession of the distal tip 102 of the tubular reinforcement element 701 in the case, including 100p and imaging catheter device is inserted into the catheter system 50 mammals patient's blood vessel, and advancing the catheter until the distal side of the distal end 700 of the tube 720 and is disposed within the first blood vessel BV1 adjacent the second blood vessel BV2 at the aim of forming the first blood vessel BV1 and BV2 between the second vessel passage 10.

导管部件100p随后被旋转直至通过成像导管50经窗口724看到的成像野IF清晰地看到通路10将会延伸入的第二血管BV2。 100p catheter member is rotated until then by the imaging catheter 50 clearly see the path 10 will extend into the second vessel BV2 see through the window 724 of the imaging field IF. 这表明导管部件100t已置于正确的旋转定向以允许组织穿通元件102在所期望的位置形成通路10,而使它延伸入第二血管BV2。 This indicates that the catheter member 100t is in the correct rotational orientation to allow the tissue penetrating member 102 is formed at a desired position path 10, and it extends into the second blood vessel BV2. 随后,驱动按钮710将向前推进直至组织穿通元件102的远端尖端开始穿过第一血管BV1壁。 Subsequently, the drive button 710 will move forward until the tissue penetrating distal tip member 102 start through the first wall of the blood vessel BV1. 任选地,在组织穿通元件102继续前进时,间断的或持续的指向远端的压力可通过手(即手动地)或通过压力施加装置800施加于导丝GW。 Optionally, the tissue penetrating element 102 continues to move forward, intermittent or persistent pressure by pointing to the distal end of the hand (ie manually) or by pressure means 800 is applied to the guidewire GW is applied.

参照图12b,一旦组织穿通元件102的远端尖端进入第二血管BV2的管腔,导丝GW将立即向远端方向前进,从而提示操作者组织穿通元件702的推进应该停止。 Referring to Figure 12b, once the distal tissue penetrating tip member 102 into the second blood vessel BV2 lumen, the guide wire GW will immediately advance to distal direction, thereby advancing tips 702 of tissue penetrating member operator should stop. 在那时,操作者将不再继续驱动按钮710的推进。 At that time, the operator will no longer continue to drive the button 710 forward.

随后,驱动按钮710将被退至其最近端,以便将组织穿通元件102退入导管体700的腔702中,而让导丝GW保持延伸于新形成的通路10并进入第二血管BV2的管腔。 Subsequently, the drive button 710 is to retreat into its recent end to the tissue penetrating element 102 back into the catheter body cavity 702 700, and let the guidewire GW extends to maintain the newly formed passage 10 and into the second vessel BV2 tube cavity.

如图12c中所示,通路形成导管部件100p和相伴的成像导管50可随后从体内抽出并去除,留下导丝GW经第一血管BV1,穿过通路10并进入第二血管BV2放置。 As shown in Figure 12c, the catheter passage forming member 100p and accompanying imaging catheter 50 may then be withdrawn and removed from the body, leaving the guidewire GW via the first blood vessel BV1, through the passage 10 and into the second blood vessel BV2 placed.

如图12d中所示,一种通路修正装置500,例如图8a-8h中所示任何类型的通路修正装置500,可随后沿导丝GB向前推进以修正(例如扩大,组织切除,处理,包被等)通路10。 As shown in Figure 12d, a path correction means 500, such as shown in Fig. 8a-8h correcting any type of access device 500, can then move forward along the guide wire to fix GB (e.g. enlarged, tissue removal, processing, coated, etc.) via 10.

应理解到,在图12v中所示步骤完成后,导丝GW可留在通路10中原位以允许图9a-9f中所示任何所需斯坦特固定模(stents),斯坦特固定膜性移植物,或通路限制装置22在通路10中展开。 It should be understood that, in the step shown in FIG 12v is completed, the guidewire GW may be left in place to allow passage 10 shown in Fig. 9a-9f any desired stents (stents), membrane graft stents thereof, or restrict access device 22 to start the path 10.

图13a-13e阐明了用于利用图11a-11b中所示通路形成导管部件和系统100p的经修正实施方案的逐步优选方法。 Figure 13a-13e illustrate a preferred method for utilizing progressive 11a-11b shown in FIG passage forming member and the conduit system 100p amended embodiment.

最初,所期望的成像导管50被插入侧管720的腔722,以便显像导管50和通路形成导管装置100p′结合在一起而成为一个通路形成“系统”。 Initially, the desired imaging catheter 50 is inserted into the cavity 722 side tube 720 to the conduit 50 and the passage forming imaging catheter device 100p 'become a channel together form a "system."

通路形成导管100p和相伴的成像导管50被随后推进血管系统至导管体700和侧管720的远端位于第一血管BV1紧邻第二血管BV2处,在这两条血管间将形成一条通路10。 100p and accompanying passage forming catheter imaging catheter 50 is then advance to the distal end of the catheter body vascular system 700 and side tube 720 is positioned adjacent to the first vessel BV1 BV2 at second vessel, in between these two vessels will form a path 10. 成像导管50然后被加予能量以使成像导管的感受器部分52能通过窗口724在成像野IF内接受影像。 Imaging catheter 50 is then applied to the energy for the imaging catheter 52 through the window portion 724 receptors to accept the image within the imaging field IF. 成像部件100p′随后被旋转直至通路10要延伸入的第二血管BV2经窗口724通过成像导管50清晰地成像。 Imaging unit 100p 'then rotated until the passage 10 to extend into the second vessel BV2 724 through the window clear image through the imaging catheter 50. 这表明导管部件100p′的正确旋转定向和定位已经获得。 This indicates that the catheter member 100p 'proper rotational orientation and positioning has been obtained. 而且,导管装置100p′可纵行移动直至在成像野IF中观察到第二血管BV2中的所期望的流动特征,从而表明导管部件100p是在其正确的纵行位置。 Moreover, the catheter device 100p 'wale may move up to the second vessel BV2 observed in a desired flow characteristics in the imaging field IF, so show 100p catheter member is in its correct longitudinal position. 另外,成像导管50可被用来确定第一血管BV1和第二血管BV2间的距离,以便限定组织穿通元件102f形成所期望的从第一血管BV1至第二血管BV2的通路10而应展开的距离。 In addition, the imaging catheter 50 can be used to determine the distance between the first and second vessels BV1 BV2 between vessels so as to define the organization through-102f form the desired element from the first vessel to a second vessel BV1 BV2 passage 10 but should be expanded distance.

如图13a所示,在导管100p′被纵行地和旋转地定位后,组织穿通元件102f被展开到导管体700外,并开始穿过第一血管BV1壁推进。 Shown in Figure 13a after the catheter 100p 'is wales ground and rotationally positioned tissue penetrating element 102f is expanded to the catheter body 700 outside, and began advancing through the first wall of the blood vessel BV1. 组织穿通元件102f的外鞘326将处于轻微后退的位置以使套管针尖端324延伸出鞘326的远端以完成所期望的经组织穿通。 Tissue penetrating element 102f of the outer sheath 326 will be in a position to make a slight retreat trocar tip 324 extending distal sheath 326 to complete the desired punch-through by the organization.

在图13a中所示组织穿通元件102f的前进中,手动压力或通过装置800施加的压力可被用于向鞘326施加指向远端的压力。 In the tissue penetrating element 13a shown in FIG 102f in advance, manual pressure, or the pressure exerted by the device 800 may be used to apply pressure to the distal end of the sheath 326 to point. 以此方式,当组织穿通元件102f的套管针尖端324进入第二血管BV2腔时,鞘326将立即前进进入第二血管BV2腔,从而提示操作者所期望的通路10已经形成并且应停止组织穿通元件102f的进一步前进。 In this way, when the tissue penetrating element 102f trocar tip 324 into the second vessel BV2 lumen sheath 326 will immediately advance into the second vessel BV2 chamber, thereby prompting the operator to the desired path 10 has been formed and the organization should be stopped Further advancement of penetrating element 102f.

图13b所显示,在鞘326进入第二血管BV2腔后,延伸的带套管针尖元件322可被抽出并去除,从而留下鞘326作为通过通路10的管道。 Figure 13b shows, after entering the second vessel BV2 lumen sheath 326 with tip elements extending sleeve 322 may be withdrawn and removed, leaving the sheath 326 as a conduit through the passage 10.

如图13c所显示,导丝GW可随后穿过鞘326的腔并进入第二血管BV2。 Shown in Figure 13c, the guidewire GW may then pass through the lumen of the sheath 326 and into the second vessel BV2.

然后,如图13d所示,通路形成导管部件100p′和相伴的成像导管50可从导管体抽出和去除,从而使导丝GW留在原位,并且经过第一血管BV1腔,穿过通路10延伸进入第二血管BV2。 Then, as shown in FIG. 13d, passageway forming catheter component 100p 'and accompanying imaging catheter 50 can be withdrawn from the catheter body and removed, so that the guidewire GW to remain in place, and after the first blood vessel BV1 chamber 10 through the passage extends into the second blood vessel BV2.

之后,如图13e所示,任何适当类型的通路修正装置500可沿预先定位的导丝GW前进以达到所期望的通路10修正效果。 Thereafter, as shown in FIG. 13e, any suitable type of path correction means 500 along the pre-positioned guidewire GW proceeds in order to achieve the desired effect correction path 10.

应理解到本发明已在上文仅通过参考某些特定实施方案和实施例进行详述。 It should be understood that the present invention has been described above only by reference to certain specific embodiments and examples described in detail. 未尽力穷尽描述本发明的所有可能实施方案,或提供本发明可被实践的每一方法。 Not trying to be exhaustive description of the present invention all possible embodiments or to provide every method of the invention practiced. 事实上,本领域技术人员可认识到,可对上述实施方案和实施例进行各种添加,消减,修正和改变而不离开本发明意指的精神和范围。 In fact, one skilled in the art may recognize that the embodiments described above and may be various embodiments added, subtracted, modifications and variations of the present invention without departing from the spirit and scope of the meaning. 因而,应意在将所有这种添加,消减,修正和改变包括在下述权利要求书的范围中。 Accordingly, all such should be intended to add, cut, modifications and changes are included in the following claims range.

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Clasificaciones
Clasificación internacionalA61B17/00
Eventos legales
FechaCódigoEventoDescripción
6 Ene 1999C06Publication
20 Ene 1999C10Request of examination as to substance
6 Oct 2004C02Deemed withdrawal of patent application after publication (patent law 2001)