US20070250084A1 - Components, systems, and methods for forming anastomoses using magnetism or other coupling means - Google Patents
Components, systems, and methods for forming anastomoses using magnetism or other coupling means Download PDFInfo
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- US20070250084A1 US20070250084A1 US11/818,360 US81836007A US2007250084A1 US 20070250084 A1 US20070250084 A1 US 20070250084A1 US 81836007 A US81836007 A US 81836007A US 2007250084 A1 US2007250084 A1 US 2007250084A1
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- H01F41/02—Apparatus or processes specially adapted for manufacturing or assembling magnets, inductances or transformers; Apparatus or processes specially adapted for manufacturing materials characterised by their magnetic properties for manufacturing cores, coils, or magnets
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Abstract
Anastomotic components may be attached to hollow bodies or vessels by magnetic or mechanical force to create an anastomosis, form a port in a vessel, or repair a diseased vessel lumen. Anastomoses are created by coupling a first connection to an end of a vessel and then attracting it to a second connector secured to the side wall of another vessel. The connection between the first and second connectors may be solidly magnetic, solely mechanical, or a combination thereof. Also disclosed are methods and devices for treating diseased vessel lumens, for example abdominal aortic aneurysm. A plurality of docking members is attached to the vessel at solicited positions, and then one or more grafts is secured to the docking members in any suitable manner.
Description
- The present application is a continuation-in-part of application Ser. No. 09/638,805, filed Aug. 12, 2000, which is a continuation-in-part of application Ser. No. 09/562,599, filed Apr. 29, 2000, now U.S. Pat. No. 6,352,543. This application also claims priority from provisional application Ser. No. 60/255,635, filed Dec. 13, 2000, and application Ser. No. 09/851,400, filed May 7, 2001. The entire disclosure of each of the above-referenced patent applications is expressly incorporated herein by reference.
- 1. Field of the Invention
- The invention relates to treating hollow anatomical structures having a lumen. More specifically, the invention relates to treating one or more diseased body lumens, creating anastomoses between such hollow body structures, and using magnetism to secure anastomotic components to such structures, for example, in conjunction with creating an anastomosis.
- 2. Description of Related Art
- Despite the considerable advances that have been realized in both interventional cardiology and cardiovascular surgery, heart disease remains the leading cause of death throughout much of the world. Coronary artery disease, or arteriosclerosis, is the single leading cause of death in the United States today. As a result, those in the cardiovascular field continue to search for new treatments and improvements to existing treatments.
- Coronary artery disease is currently treated by interventional-procedures such as percutaneous transluminal coronary angioplasty (PTCA), coronary stenting and atherectomy, as well as surgical procedures including coronary artery bypass grafting (CABG). The goal of these procedures is to reestablish or improve blood flow through occluded (or partially occluded) coronary arteries, and is accomplished, for example, by enlarging the blood flow lumen of the artery or forming a bypass that allows blood to circumvent the occlusion. What procedure(s) is used typically depends on the severity and location of the blockage. When successful, these procedures restore blood flow to myocardial tissue that had not been sufficiently perfused due to the occlusion.
- Another proposed treatment places the target vessel, e.g., a coronary artery, in direct fluid communication with a heart chamber containing blood, for example, the left ventricle. Blood flows from the ventricle into a conduit that is in fluid communication with the artery; as such, this treatment may be described as a ventricular bypass procedure. Benefits of this procedure include obviating the need to manipulate the aorta, for example, as is done when a side-biting clamp is used in a typical CABG procedure to create a proximal anastomosis between the bypass graft and the aorta. Clamping or otherwise manipulating the aorta places the patient at risk in some cases due to the likelihood that such manipulation will release embolic material into the bloodstream. Some challenges associated with this procedure include delivering and deploying the conduit in the patient's body in proper position with respect to the heart chamber and the coronary vessel.
- A particularly challenging task that must be performed during many of these and other revascularization procedures is suturing one hollow structure to another hollow structure. For instance, one end of a graft vessel is sutured to a source of blood, such as the aorta, a heart chamber or another blood vessel, while another end of the graft vessel is sutured to a target vessel, such as a coronary artery having an occluded lumen. The small diameter of the hollow structures involved, typically from 1 mm to 4 mm, makes forming a handsewn anastomosis a highly technical and time-consuming procedure. The difficulty in forming the sutured anastomosis is exacerbated when access to the target vessel is restricted or limited, as in a minimally invasive or percutaneous procedure. This problem can also arise in non-cardiovascular applications that utilize handsewn anastomoses, for example, treating peripheral vascular disease or injury, creating AV (arteriovenous) shunts, etc.
- While those in the art have proposed various anastomotic coupling, none has performed well enough to receive any significant level of acceptance in the field. Many of the proposed couplings penetrate or damage the wall of the hollow structures, do not remain patent, fail to produce a fluid-tight seal between the conduit and vessel, or are simply too cumbersome and difficult to deliver or deploy.
- It should be noted, though, that a more recently proposed technology which uses magnetism to treat hollow anatomical structures has enjoyed clinical success in creating an anastomosis between a graft blood vessel and a coronary artery. This anastomotic technology, which was developed by Ventrica, Inc., of Fremont, Calif., and is referred to as the MVP™ (Magnetic Vascular Positioner) anastomotic system, provides considerable benefits over other proposed technologies. Nevertheless, there remains room in the art for improvement with respect to a number of technological and procedural areas.
- For example, it is desirable to maximize the ability of the technology to be used in a minimally invasive manner, such as in a procedure performed by a robotic system. As another example, it is desirable to minimize the amount of foreign material in the blood flow path so as to decrease the chance of thrombosis. Achieving this goal, however, must be balanced with the need to form a secure, connection between the anastomotic components, or between a component and a hollow body structure.
- One embodiment of the invention provides a method for forming an anastomosis between two blood vessels using magnetism and includes steps of securing a first component to a first blood vessel and securing a second component to a side wall of a second blood vessel in alignment with an opening in the side wall. Further steps include placing the first component in contact with at least one of the second component and the side wall of the second blood vessel, positioning an intimal surface of the first blood vessel adjacent an intimal surface of the second blood vessel, and using magnetism to couple the first and second components.
- Another embodiment of the invention provides a method for forming an anastomosis between two blood vessels with steps of securing a first component to an end portion of a first blood vessel securing a second component to a side wall of a second blood vessel with an opening in the second component substantially aligned with an opening in the side wall, placing the first component and the end portion of the first blood vessel through the opening in the second component and the opening in the side wall of the second blood vessel, and coupling the first and second components to form an anastomosis between the first and second blood vessels. Another embodiment of the invention provides a method with steps of providing an anastomotic component including a sleeve defining a lumen, securing an end portion of a blood vessel to the anastomotic component by passing the end portion through the sleeve, placing an edge of the blood vessel in substantial alignment with an edge of the anastomotic component, and passing a fastener through the end portion of the blood vessel and into locking engagement with the sleeve, the fastener leaving an exposed intimal surface that extends substantially around the sleeve.
- Another embodiment of the invention provides a method for securing an anastomotic component to a side wall of a blood vessel and has steps of providing an anastomotic component including a non-expandable portion and an expandable portion, the anastomotic component comprising a wire shaped to define a lumen and multiple tissue engaging portions, forming an opening in a side wall of a blood vessel, collapsing the expandable portion of the anastomotic component by collapsing the wire, expanding the expandable portion of the anastomotic component by expanding the wire, and securing the anastomotic component to the blood vessel by engaging the tissue engaging portions with the vessel side wall.
- Another embodiment of the invention provides a method for treating a lumen defined by a hollow structure in a patient's body and includes steps of providing a docking member configured to be secured to tissue, providing a prosthesis configured to be magnetically coupled to the docking member, the prosthesis having a lumen, securing the docking member to a vessel in a patient's body, the vessel having a lumen with a diseased portion, and magnetically coupling the prosthesis to the docking member to place the prosthesis lumen in sealing engagement with the vessel lumen.
- Still another embodiment of the invention provides a method for repairing an aneurysm located in a patient's body lumen and includes steps of providing a prosthesis having an outer surface and a lumen, locating a body lumen having an aneurysm, placing the prosthesis in a desired position with respect to the aneurysm so that the prosthesis lumen sealingly engages the body lumen, and using magnetism to secure the prosthesis in the selected position.
- Yet another embodiment of the invention provides an anastomotic component including a sleeve having a lumen adapted to receive a first vessel, and a plate extending away from the sleeve, the plate having an opening communicating with the sleeve lumen wherein at least one of the sleeve and plate includes a locking portion configured to lockingly engage another anastomotic component secured to a second vessel.
- Other features, benefits and advantages of the invention will become apparent from the following detailed description of preferred embodiments thereof, taken in conjunction with the accompanying Figures, wherein:
-
FIGS. 1A-1C are sequential perspective views showing a vessel being attached to an anastomotic component according to one embodiment of the invention; -
FIGS. 2A-2B are sectional views corresponding toFIGS. 1A and 1C , wherein a second anastomotic component provided on a target vessel is coupled to the anastomotic component shown inFIG. 1A ; -
FIG. 3A is an exploded perspective view of a vessel and an anastomotic component constructed according to another embodiment of the invention; -
FIGS. 3B and 3C show the anastomotic component ofFIG. 3A being attached to the end of the vessel; -
FIG. 4A is an exploded perspective view of the anastomotic component shown inFIGS. 3B and 3C . -
FIG. 4B is an elevation view, in section, of the anastomotic component shown inFIG. 4A ; -
FIG. 5 is a lower plan view of an anastomotic component constructed according to another embodiment of the invention; -
FIG. 6 is an exploded perspective view of the anastomotic component shown inFIG. 5 ; -
FIG. 7 is a perspective view of the anastomotic component shown inFIGS. 5 and 6 partially assembled; -
FIG. 8 is an upper plan view of the anastomotic component shown inFIG. 7 ; -
FIG. 9 is a lower plan view of the anastomotic component shown inFIG. 7 ; -
FIG. 10 is a lower plan view of the anastomotic component shown inFIG. 9 with securing portions of the component being indicated in phantom; -
FIG. 11 is a perspective view of a delivery device constructed according to one embodiment of the invention, wherein the anastomotic components shown inFIGS. 1-10 are loaded on the device; -
FIG. 12 is a perspective view showing the delivery device closed with the first and second anastomotic components locked in place, wherein the device includes a tissue removal mechanism; -
FIG. 13 is a perspective view of the delivery device shown inFIG. 12 after the tissue removal mechanism has been removed from the delivery device; -
FIG. 14 is a perspective view showing the delivery device ofFIG. 13 shifted relative to the second anastomotic component; -
FIG. 15 is a perspective view showing the first anastomotic component moved into locking engagement with the second anastomotic component; -
FIG. 16 shows the delivery device opened to release the now-coupled first and second anastomotic components. -
FIG. 17 is an exploded perspective view showing first and second anastomotic components constructed according to another embodiment of the invention; -
FIG. 18 is an upper plan view of the second anastomotic component shown inFIG. 17 ; -
FIG. 19 is a perspective view corresponding toFIG. 17 wherein the second anastomotic component has been actuated to its tissue securing position; -
FIG. 20 is a sectional view showing the first and second components ofFIG. 19 coupled; -
FIG. 21 is an exploded perspective view, in section, of the two components shown inFIG. 18 modified according to another embodiment of the invention; -
FIGS. 22, 23A and 23B are sequential perspective views, partially in section, showing a device constructed according to another embodiment of the invention being used to treat a diseased lumen in a patient's body; -
FIGS. 24A and 24B are sequential perspective views, in section, showing a device constricted according to another embodiment of the invention being used to repair a body lumen; -
FIGS. 25A and 25B are sequential perspective views showing the device ofFIGS. 24A-24B being used to secure a vascular prosthesis to a vessel; -
FIGS. 26A-26C are elevation views, in section, of lumen repair devices constructed according to the other embodiments of the invention; -
FIGS. 27A-27E are elevation views, in section, of lumen repair devices constructed according to the other embodiments of the invention; -
FIGS. 28A-28B and 29A-29B are perspective sectional views showing a vessel repair device constructed according to another embodiment of the invention; and -
FIGS. 30A-30B and 31 are views showing magnetic components constructed according to another embodiment of the invention. - With reference to
FIGS. 1A-1C , a first embodiment of the invention is shown alongside a first vessel, organ, or part thereof, indicated byreference numeral 10. The various embodiments may be used to form an anastomosis between vessels, organs, or any anatomical structure having a lumen, for example. The invention also encompasses devices and methods for repairing a diseased body lumen. - It will be appreciated that the invention has applications beyond the specific uses mentioned above. Additional exemplary applications for the invention are disclosed in the aforementioned priority applications, the entire subject matter of each application being expressly incorporated herein by reference.
- A
first anastomotic component 12 comprises a body which, in the illustrated embodiment, is anannular member 14 having anopening 16. Theanastomotic component 12 also includes asleeve 18 with a lumen 20 (FIG. 1A ). Anend portion 22 of thefirst vessel 10 is passed through thelumen 20 of the sleeve 18 (FIG. 1B ), and aportion 24 of thevessel 10 that extends beyond thesleeve 18 is trimmed even with the sleeve end 26 (FIG. 1C ). It will be appreciated that thefirst vessel 10 and theanastomotic component 12 may be secured in a different relative position than that shown inFIG. 1C . For example, the end of thevessel 10 may extend beyond and be everted (not shown) over theend 26 of thesleeve 18. - The
vessel 10 may be attached to theanastomotic component 12, and preferably thesleeve 18, by any suitable means, e.g., adhesive, staples, clips, pins, suture, etc.FIG. 2A shows the firstanastomotic component 12 secured to thefirst vessel 10. As can be seen, aportion 28 of thevessel 10 extends along the length of thesleeve 18. In this embodiment, the exterior of thevessel portion 28 is partially or entirely adhesively secured to the inner surface of thesleeve 18. Aportion 30 of thesleeve 18 extends beyond theannular member 14 and terminates at thevessel end 32. This exposes anintimal surface 32 of thefirst vessel 10 at theend 26 of thesleeve 18 of the component 12 (FIG. 2A ). -
FIG. 2A also shows asecond anastomotic component 36 positioned next to thefirst component 12. Thesecond component 36 comprises a pair ofannular members second vessel 42. In this embodiment, magnetic force secures thesecond component members second vessel 42; magnetic force also secures the first and secondanastomotic components - As seen in
FIG. 2A , themembers respective openings opening 48 in the wall ofsecond vessel 42. The firstanastomotic component 12 is magnetically coupled to thesecond anastomotic component 36, with theannular member 14 engaging the annular member 38 (FIG. 2B ). Theextended portion 30 of thesleeve 18 is positioned through theopenings second component members opening 48 in the side wall of thesecond vessel 42. The first andsecond components second component member 40 is exposed to blood, as shown inFIG. 2B . Minimizing the amount of foreign material in the blood flow path is desirable because it decreases the possibility of thrombosis and thus improves patency of the anastomotic connection. - In the illustrated embodiment, the thickness T1 of the second component, including the thickness of the
second vessel wall 42, is equal (or approximately equal) to the length L1 of the extendedportion 30 of thefirst component 12. As a result, as shown inFIG. 2B , theend 26 of thesleeve 18 and theintimal surface 32 offirst vessel 10 are substantially flush with the inner surface of theannular member 40. This configuration allows thefirst vessel 10 to extend only through themembers second vessel wall 42, thereby removing themembers - As noted above, magnetic or nonmagnetic force may be used to secure the anastomotic components of the invention to a selected vessel. With reference to
FIG. 3A throughFIG. 4B , an embodiment using a mechanical, nonmagnetic attachment will be described. -
FIGS. 3A-3C show afirst vessel 50 having asidewall 52 and anend 54. Ananastomotic component 56 comprises abase 58 and a locking member for securing the base 58 to thevessel 50. In the illustrated embodiment, the locking member is in the form of afastener 60. Thefastener 60 and the base 58 are configured to lock together, preferably in any of a plurality of positions, so as to attach thevessel 50 to thebase 58. - Referring to
FIG. 3A , thebase 58 comprises acollar 62 extending from anannular plate 64. The illustratedcollar 62 has multiple layers, namely, aninner sleeve 66, amiddle sleeve 68 and an outer sleeve (omitted fromFIGS. 3A-3C for clarity, but designated byreference numeral 70 inFIGS. 4A and 4B ). Theinner sleeve 66 is sized and configured to receive thevessel 50. Themiddle sleeve 68 is configured to lockingly engage thefastener 60. Theouter sleeve 70 provides a cover and, preferably, means (FIGS. 4A and 4B ) for securing theanastomotic component 56 to another anastomotic component (not shown). - The
middle sleeve 68 of thecollar 62 has a plurality of pairedarms 72, each pair is defining aspace 74. Thefastener 60 comprises abase 76 and a plurality ofprongs 78 configured to enter thespaces 74. Eachprong 78 has anend 80 andmultiple locking elements 82. The lockingelements 82 carried by theprongs 78 engage theends 73 of thearms 72 to lock thefastener 60 to thebase 58. It will be appreciated that the specific manner of locking thebase 58 andfastener 60 together may be different from that shown. As an example, rather than using an integrally formed fastener withseveral prongs 78, a plurality of individual, discrete prongs (e.g., staples) could be used to secure the base 58 to thevessel 50. - The manner in which the first
anastomotic component 56 is secured to thevessel 50 will now be described. Theend 54 of thevessel 50 is passed through the bore of theplate 64 and theinner sleeve 66 to a position adjacent the end of thecollar 62. Theend 54 ofvessel 50 may be turned outwardly, as shown inFIG. 3B , which exposes the intimal surface of the vessel. It will be understood that theend 54 of thevessel 50 could also be turned and everted over thecollar 62, i.e., back toward theplate 64, rather than simply flared over the end of thecollar 62, as shown inFIGS. 3B-3C . - Referring to
FIG. 3C , thefastener 60 is moved toward thebase 58 and the sharpened ends 80 of theprongs 78 pass through the tissue ofvessel 50. Each prong end 80 then enters thespace 74 between a pair ofarms 72. Theprong locking elements 82 lockingly engage theends 73 of thearms 72 in ratchet-like fashion. Thefastener 60 is moved farther toward the base 58 until thefastener base 76 presses thevessel end 54 against the end of thecollar 62, and in particular against the ends of the middle andouter sleeves prong locking elements 82 and the arm ends 73 maintain thebase 58 andfastener 60 in the desired relative position vis-à-vis thevessel 50. -
FIGS. 4A-4B show the locking relationship between thefastener 60 and an anastomotic component that is designated byreference numeral 56′ in view of structural differences from theanastomotic component 56 shown inFIGS. 3A-3C . In particular, theanastomotic component 56′ ofFIGS. 4A-4B is provided with a coupling mechanism (described below) that locks with a complementary mechanism on another component. It should be noted that the specific construction of either component may be varied from the exemplary configurations illustrated in the Figures. -
FIGS. 4A-4B show the multiple sleeves of thecollar 62 of the base 58′. In particular,FIG. 4B shows thesleeves prongs 78 offastener 60. The means for coupling thecomponent 56 to another component are, in the illustrated embodiment, carried by theouter sleeve 70 and comprises arim 70A extending around thecollar 62. Therim 70A cooperates with theplate 64′ (modified from theplate 64 ofFIGS. 3A-3C ) to form arecess 70B. Thisrecess 70B is configured to engage a portion of another anastomotic component (not shown) in a snap-fit manner to create a fluid-tight anastomotic connection. These Figures show only one possible means for coupling theanastomotic component 56 to a second anastomotic component (not shown). - The anastomotic components of the embodiments of
FIGS. 1A-2B andFIGS. 3A-4B are adapted to be secured to the end of a vessel and may be used to create various types of anastomoses (e.g., end-to-side or end-to-end). The present invention also encompasses anastomotic components that are designed to be secured to the side wall of a vessel (rather than its end). An exemplary embodiment of such a component will be described with respect toFIGS. 5-10 . -
FIG. 5 is an assembly view of ananastomotic component 84 which is configured to be secured to the sidewall of a vessel according to one embodiment of the invention. Theanastomotic component 84 comprises abase 86, abody 88 and aretention plate 90. Thecomponent 84 is provided with a vessel attachment mechanism which, in the illustrated embodiment comprises awireform coupling structure 92. Thecoupling structure 92 includes a plurality of vessel engagement members preferably in the form of a plurality offirst wire loops 94. Thefirst wire loops 94 extend from one end of acoil portion 96, which defines a lumen L passing through the component. A plurality ofsecond wire loops 98 extend from the other end of the coil portion 96 (FIG. 6 ). The second set ofwire loops 98 is used to secure thecoil portion 96 andcoupling structure 92 to thebase 86 andbody 88 of theanastomotic component 84. - The
coupling structure 92 is formed to permit the first, vessel-engagingloops 94 to selectively collapse and expand, as explained below.FIGS. 5-10 show thecoupling structure 92 with thevessel engaging loops 94 in their expanded, unbiased orientation.FIG. 11 shows thecoupling structure 92 with thevessel engaging loops 94 biased to their collapsed or low profile orientation. In the illustrated embodiment, theloops 94 assume an axial position that is generally parallel to the lumen L of theanastomotic component 84; however, it will be appreciated that theloops 94 could be collapsed in a different manner or to a different extent than shown in the figures. -
FIG. 6 shows one preferred manner of constructing theanastomotic component 84 it will be recognized, of course, that the specific configuration shown and described herein is made for sake of example and for purposes of making a complete disclosure, and is not intended to limit the scope of the present invention as defined by the claims. - Referring to
FIG. 6 , thebase 86,body 88,retention plate 90 andcoupling structure 92 of theanastomotic component 84 are annularly shaped so that when assembled they form a lumen L (FIG. 5 ) that extends through thecomponent 84. The second set ofwire loops 98 of thecoupling structure 92 are positioned within complimentarily-shapedopenings 100 formed in the body 88 (FIG. 7 ). The ends 104 of the coil that formsportion 96 andloops body 88. Thebody 88 is then attached tobase 86, and theretention plate 90 is placed over the tissue-engagingloops 94, preferably while theloops 94 are biased to their collapsed orientation (FIG. 11 ). - The
retention plate 90 has a plurality of slots 102 (FIG. 6 ) that are positioned to overlie theopenings 100 in thebody 88. Theslots 102 receive the legs of eachloop 98 and position theloops 94 away from theretention plate 90, as shown best inFIGS. 5, 7 and 10.FIG. 9 shows theretention plate 90 secured to the remaining elements of theanastomotic component 84. -
FIGS. 11-16 show theanastomotic component 56 ofFIGS. 3A-4B after it has been secured to the end of the vessel 50 (shown in phantom). These Figures also show theanastomotic component 84 ofFIGS. 5-10 prior to its attachment to the side wall of a vessel (not shown). The twocomponents delivery device 106 arranged to deploy one or both components to form the anastomosis. The exemplary embodiment connects two vessels via an end-to-side anastomosis; however, it should be appreciated that the invention may be used to make other types of connections, for example, end-to-end and side-to-side anastomoses. - The
delivery device 106 includes acradle 108 which receives the firstanastomotic component 56 and thefirst vessel 50. Thecradle 108 comprises a pair ofjaws 110 movable between open (FIG. 11 ) and closed (FIG. 12 ) positions in order to mount the firstanastomotic component 56 andvessel 50 in thedelivery device 106.FIG. 11 shows thesecond anastomotic component 84 with thetissue engaging loops 94 of thecoupling structure 92 collapsed for delivery, whileFIG. 12 shows thecoupling structure 92 expanded for engaging tissue (now shown) - As shown in
FIGS. 11 and 12 , thedelivery device 106 may include atissue removal mechanism 114 for forming an opening in a vessel that is placed in communication with the lumen L (FIG. 13 ) of theanastomotic component 84. Thetissue removal mechanism 114 comprises a tissue holding element in the form of abarbed needle 116, and atissue cutting tube 118 that is rotated in order to remove a desired amount of tissue. The tissue holding element is retractable in order to retract theneedle 116 and pull the cut tissue into thetube 118 for removal. The means for moving theneedle 116 and cuttingtube 118 axially, and for rotating thetube 118, are not shown but may comprise any suitable drive or transmission assembly. Themechanism 114 is slidably disposed in abore 120 in the delivery device 106 (FIG. 12 ). - The
tissue removal mechanism 114 is removed from device 106 (FIG. 13 ) after forming an opening in the vessel, and thesecond anastomotic component 84 is secured to the vessel (not shown) by expanding thehelical loops 94. Thesecond anastomotic component 84 is then aligned with thefirst component 56 by moving thedevice 106 andfirst component 56 relative to the second component 84 (and the second vessel). The twoanastomotic components FIGS. 11-13 . Thedelivery device 106 is moved from the position shown inFIG. 13 to the position shown inFIG. 14 , which shifts the firstanastomotic component 56 andfirst vessel 50 into alignment with thesecond anastomotic component 84. - The
jaws 110 of thecradle 108 are provided with grooves 112 (FIG. 11 ) configured to receive thebase 86 of thesecond anastomotic component 84 in a sliding manner. This facilitates controlled movement of thedevice 106 with respect to thesecond anastomotic component 84, from the position shown inFIG. 13 to the position shown inFIG. 14 . - After being aligned, the first and second
anastomotic components anastomotic component 56 distally from the position shown inFIG. 14 to the position shown inFIG. 15 , which movescomponent 56 into engagement with thesecond anastomotic component 84, as shown inFIG. 14 . More specifically, thecollar 62 of the firstanastomotic component 56 is moved into the lumen L of thesecond anastomotic component 84 and enters thecoil portion 96 of thewireform coupling structure 92. This moves theplate anastomotic component base 86 of thesecond anastomotic component 84. -
FIG. 16 shows thedelivery device 106 after thejaws 110 ofcradle 108 have been opened to release the first and secondanastomotic components grooves 112 of thedevice 106 release thebase 86 of thesecond anastomotic component 84, which has been secured to its vessel. Thedelivery device 106 is removed from coupledcomponents - The anastomotic components of the invention may be secured together by any suitable means which, as noted above, may use mechanical or magnetic force (or both) to achieve coupling. In the illustrated embodiment, the anastomotic components are secured to the vessels as they are secured to each other, namely, mechanically. In another embodiment, for instance, the first component is attached to its vessel mechanically but is coupled to the second component magnetically, for example, in accordance with any of the teachings in the aforementioned priority applications. An exemplary mechanism for securing the anastomotic components will now be described with respect to
FIGS. 17-21 . -
FIG. 17 shows the firstanastomotic component 56′, which includes the modifiedplate 64′ and rim 70 that define therecess 70B. The construction of theanastomotic component 56′ is described above with respect toFIGS. 4A and 4B . The second anastomotic component is designated byreference numeral 84′ as it, unlike thecomponent 84, includes a mechanism for coupling the components. The illustrated mechanism is in the form ofspring wires 122 which are located around the lumen L of thecomponent 84′. SeeFIG. 18 .FIG. 19 shows the first andsecond components 56′, 84′ ofFIG. 17 after thecomponent 84′ has been deployed and thewire loops 94 are in their expanded orientation. -
FIG. 20 shows the first and secondanastomotic components 56′, 84′ after they have been coupled, which, in this example, is done mechanically. As can be seen thespring wires 122 are received within therecesses 70B, preferably in tight locking fashion, for example, via a spring or snap fit engagement. Other possible locking mechanisms may of course be used. -
FIG. 21 shows one alternative coupling mechanism or structure carried by a firstanastomotic component 130. Specifically, thecomponent 130 includes a multilayer collar comprising aninner layer 132, amiddle layer 134 and anouter layer 136. Theinner layer 132 is carried by aplate 138, andsurface 140 is configured to rest on theplate 86 of thecomponent 84. Theouter layer 136 has one or more slots orgrooves 137 configured to lockingly engage structure carried by thesecond anastomotic component 84. Thesecond anastomotic component 84 includesplate 86 with an edge 142 (FIG. 21 ) that is received in some or all of the slot(s) 137 in theouter layer 136 of the firstanastomotic component 130. It will be appreciated that the exact manner that theplate 86 engages the slot(s) 137 may vary widely while still providing a secure, sealed connection. - Additional aspects of the invention will be described with respect to
FIG. 22 throughFIG. 29B , which show various systems, devices and methods for treating body lumens, i.e., hollow anatomical structures having a lumen, for example, a blood vessel.FIG. 22 shows a body structure in the form of a blood vessel, and more specifically, the abdominal aorta. The vessel is designated generally by thereference numeral 150 and includes alumen 152 defined by awall 154. Thewall 154 has ananeurysm 156 where thelumen 152 is enlarged and thewall 154 is thinner (although not in the Figures). Thevessel 150 hasside branches 158 and a Y-shapedsection 160. -
FIG. 22 also shows a pair ofdocking devices 162 secured to thewall 154 of thevessel 150, the devices being in the form of mesh structures expanded against the surface of thevessel wall 154. Also shown is adevice 164 preferably in the form of a stent graft with abody 166 andattachment members 168 configured to engageattachment members 170 provided on thedocking devices 162. -
FIGS. 23A and 23B show thestent graft 166 being collapsed for delivery into thelumen 152 of thevessel 150. After being passed into thelumen 152 thegraft body 166 is expanded and theattachment members 168 are coupled to theattachment members 170 of thedocking devices 162. In the illustrated embodiment, theattachment members 168 and themembers 170 are magnetically attracted so that upon being moved into proximity to each other they become securely connected. As a result, as shown inFIG. 23B , thedevice 164 extends through the aneurysmal section of thevessel 150 so that itslumen 172 replaces the diseased lumen. Thedocking devices 162 are in sealing contact with thevessel wall 154 and thestent graft 166 is in sealing contact with the docking devices. As such, blood flow past the aneurysm must take place throughlumen 172 of the prosthesis. -
FIGS. 24A and 24B show another embodiment of the invention comprising a pair ofproximal docking members 180 and a pair ofdistal docking members 182. Thedocking members vessel 150 ofFIG. 22 andFIGS. 23A-23B and may be constructed in any suitable manner that facilitates their attachment to a vessel wall, for instance, expansion against the vessel wall as described above with respect to thedocking members 162 of the previous embodiment. - The proximal docking members each have a stent-
like body 184 and anattachment portion 186, while the distal members each have a stent-like body 188 with anattachment portion 190.FIG. 24B shows the fourdocking members members 180 secured to sidebranches 158 andmembers 182 secured to the Y-shapedsection 160 of thevessel 150. The number and position of docking members used may vary upon application or user preference. Two different, exemplary approaches are shown inFIGS. 23B and 24B . Once thedocking members FIG. 24B , a vascular prosthesis (not shown) is secured to therespective attachment portions members -
FIG. 25A shows another configuration whereinseveral docking members 200 are constructed and used much in the manner described above. Eachdocking member 200 hasattachment portions 202 and is attached to aside branch 204 of thevessel 206.FIG. 25B shows thevessel 206 after avascular prosthesis 208 has been secured to thedocking members 200. Theexemplary prosthesis 208 comprises agraft body 210 withattachment structure 212 provided adjacent proximal anddistal openings graft attachment structure 212 is secured to complimentarily-formedattachment portions 202 of thedocking members 200 to sealingly connect thegraft lumen 218 with the lumens of all fourside branches 204, as shown inFIG. 25B . The diseased lumen L of thevessel 206 is thereby replaced by thelumen 218 of thegraft body 210. - The means for connecting the docket
member attachment portions 202 and thegraft attachment structures 212 may utilize magnetic force, mechanical force, or a combination of the two. In the illustrated embodiment, thedocking members 200 are provided with permanent magnets configured to be coupled to corresponding permanent magnets on theprosthesis 208. In addition, aproximal end 220 of thegraft body 210 is provided with anadditional coupling device 222 having anopening 224, thedevice 222 being expanded securely against the wall ofvessel 206. -
FIGS. 26A-26C show for sake of example, various vascular graft configurations according to other embodiments of the invention. The illustrated grafts are suitable for use with diseased vessels with or without side branches.FIG. 26A shows agraft 230 comprising first andsecond portions first portion 232 hasattachment members 236 while the second portion 238 hasattachment members 240, the use of which is explained above. The twoportions mating members 236 a and 240 a thereon. -
FIG. 26B shows a prosthesis orgraft 250 having a first portion 252 and asecond portion 254 attachable thereto. The first portion 252 has multiple attachment portions 256 (including main and several side branches or lumens). Thesecond portions 254 each haveattachment portions 258 and anattachment portion 258 a, the latter being securable tomating portions 256 a provided on two legs of the first portion 252 of thegraft 250. -
FIG. 26C shows aprosthesis 260 with first, second andthird portions portions graft 260 are respectively provided withseveral attachment portions portions -
FIGS. 27A-27E show various docking members constructed according to additional embodiments of the invention. The docking members have an expandable body to allow engagement with a vessel wall (not shown) in order to secure the member thereto. It will be recognized that other ways of securing a docking member to a vessel may be used without departing from the principles of the present invention. -
FIG. 27A shows adocking member 280 with acollapsed body 282 andprosthesis attachment structure 284 comprisingsections 206 of a suitable magnetic material. Thesections 286 are relatively movable to and from the position ofFIG. 27A . Thebody 282 of thedocking members 280 is expanded to the position ofFIG. 27B and into engagement with a vessel wall (not shown). This moves thesections 286 of theattachment structure 284 away from each other to the position ofFIG. 27B , which forms a plurality ofgaps 288 betweenadjacent sections 286. -
FIG. 27B also shows a portion of a prosthesis such as avascular graft 290. Oneend 292 of thegraft 290 is provided with a plurality ofattachment members 294 spaced from each other and sized to be received in thegaps 288 of thedocking member sections 286. Themembers 294 are placed in thegaps 288 to mechanically and magnetically couple thedocking member 280 and thegraft 290. -
FIG. 27C shows adocking member 300 with anexpandable body 302 and anend 304 provided withattachment structure 306. Theattachment structure 306 comprises a plurality ofsections 308 which engages corresponding structure on a graft (not shown) to fix the graft to thedocking member 300, for example, via magnetic, mechanical or other means. -
FIG. 27D shows adocking member 310 comprising an expandable body 312 andattachment structure 314 at one end thereof. Thestructure 314 is similar to thestructure 306 of the previous embodiment in that it includes the plurality of spacedsections 316. Theattachment sections 316, though, are disposed within thelumen 318 of the body 312 of thedocking member 310. A graft (not shown) having mating attachment structures (i.e., spaced segments) is then secured to themember 310, much in the same manner as discussed above. -
FIG. 27E shows adocking member 320 comprising anexpandable body 322 andattachment structure 324 at an end thereof. Theattachment structure 324 is in the form offerromagnetic element 326 which may be, for example, asteel coil 326 capable of being compressed and expanded. Thecoiled element 326 is preferably ferromagnetic for being magnetically coupled to a graft-carried magnet (not shown). -
FIGS. 28A-28B show another embodiment of the invention for use in securing a prosthesis to a vessel that is diseased at or near a side branch. Anexemplary vessel 330 with aside branch 332 is shown inFIG. 28A along with a prosthesis orgraft 334 and aprosthesis fixation device 336. Thegraft 334 is preferably tubular and is configured to be secured to thewall 338 ofvessel 330 such that thelumen 340 of thegraft 334 replaces the diseased lumen 342 of thevessel 330. - The
graft 334 has anopening 344 sized and configured for alignment with thelumen 346 of the vessel-side branch 332 once thegraft 334 has been secured to thevessel 330. The area surrounding or adjacent to the 344 ofgraft 334 is provided with one ormore attachment members 348 for securing the graft to thefixation device 336, as explained below. As shown inFIG. 28A , thefixation device 336 comprises atubular graft body 350 with a flaredend 352. Thegraft body 350, in whole or in part, is expandable, for example, as described above with respect to docking members of the previous embodiments. Thetubular graft body 350 passes through theopening 344 in thegraft 334 and is expanded against thewall 354 of theside branch 332 to secure thegraft 350 to the vessels as shown inFIG. 28B . - This places the
lumen 346 of theside branch 332 in sealing communication with thelumen 340 of thegraft body 350, which itself is in sealing communication with thelumen 340 of thegraft 334 and the lumen 342 of thevessel 330. The flaredend 352 of thegraft fixation device 336 includes attachment structure in the form of segments orportions 354 configured and arranged to be coupled with theattachment portions 348 provided on the graft 334 (as shown inFIG. 28B ). -
FIGS. 29A-29B show still another embodiment of the invention that provides a collapsible/expandable prosthesis or graft for use in treating a diseased vessel. The illustratedgraft 370 comprises atubular body 372 with at least oneend 374 thereof provided with anattachment structure 376 for securing thegraft end 374 to a docking member that has been placed in a desired position with respect to a vessel (not shown). Thebody 372 of thegraft 370 may comprise only graft material, such as EPTFE, or graft material reinforced by suitable means, for example a stent. -
FIG. 29A shows the end of 374 of thegraft body 372 in its collapsed orientation. Theattachment structure 376 comprises a plurality ofpermanent magnets 378 which, in the collapsed orientation ofFIG. 29A , are disposed next to each other. The polarity of themagnets 378 is shown inFIG. 29B , which also shows thegraft body 372 disposed betweenadjacent magnets 378. For delivery and docking theend 374 ofgraft 370 is collapsed (FIG. 29A ) and then expanded (FIG. 29B ) into engagement with corresponding attachment structure carried by the docking members. Themagnets 378 repel each other such that thegraft end 374 assumes the position ofFIG. 29B (when unbiased). Themagnets 378 place the graft in the desired position and sever to secure thegraft 370 to a docking member (not shown). It will be recognized that the illustrated structure for securing a graft to a docking member represents only one of many possible constructions. -
FIGS. 30A-30B show acomponent 380 comprising anattachment portion 382 that is preferably in the form ofscrew threads 384. The component has acoupling portion 386 preferably comprising apermanent magnet 388. Thethreads 384 are used to fix thecomponent 380 to tissue (or bone, etc.) so as to present themagnet 388 for coupling to a prosthesis (not shown), another component, etc. Theattachment portion 382 andcoupling portion 386 may be separate elements that are fixed to one another, or they be integrally formed with the component; which is preferably provided with a corrosion-resistant biocompatible coating or layer. -
FIG. 30B shows anexemplary delivery device 390 for deploying thecomponent 380. The device includes adrive shaft 392 and acatheter sheath 394 and may be used in a minimally invasive manner to deliver thecomponent 380. This embodiment may used in many applications, e.g., AAA repair, percutaneous valve repair, etc.FIG. 31 shows a plurality ofcomponents 380 fixed to a hollow body, such as the abdominal aorta AA, in a desired pattern. A prosthesis, such asstent graft 396, hasmembers 398 that are magnetically coupled to themagnets 388 ofcomponents 380, which couples the prosthesis to the aorta, as shown inFIG. 31 . - Other features, aspects and advantages of the invention beyond those specifically discussed will be apparent to those skilled in the art. Modifications, alterations and variations of the illustrated embodiments may be made without departing from the spirit of the invention.
Claims (8)
1. A method for forming an anastomosis between two blood vessels using magnetism, the method comprising the steps of:
securing a first component to a first blood vessel;
securing a second component to a side wall of a second blood vessel with an opening in the second component substantially aligned with an opening in the side wall of the second blood vessel;
placing the first component in contact with at least one of the second component and the side wall of the second blood vessel;
positioning an intimal surface of the first blood vessel adjacent an intimal surface of the second blood vessel; and
using magnetism to couple the first and second components and form an anastomosis between the first and second blood vessels.
2-37. (canceled)
38. A method for forming an anastomosis between two blood vessels, the method comprising the steps of:
securing a first component to an end portion of a first blood vessel, wherein the first component and the end portion of the first blood vessel have substantially the same length and an intimal surface of the first blood vessel is uncovered by the first component;
securing a second component to a side wall of a second blood vessel with an opening in the second component substantially aligned with an opening in the side wall of the second blood vessel;
placing the first component and the end portion of the first blood vessel through the opening in the second component and the opening in the side wall of the second blood vessel, wherein the uncovered intimal surface of the first blood vessel is disposed adjacent an intimal surface of the side wall of the second blood vessel; and
coupling the first and second components to form an anastomosis between the first and second blood vessels.
39. A method for securing an anastomotic component to an end of a blood vessel, the method comprising steps of:
providing an anastomotic component including a sleeve defining a lumen;
securing an end portion of a blood vessel to the anastomotic component by passing the end portion through the lumen of the sleeve;
placing an edge of the blood vessel in substantial alignment with an edge of the anastomotic component; and
passing a fastener through the end portion of the blood vessel and into locking engagement with the sleeve, the fastener leaving an exposed intimal surface that extends substantially around the sleeve.
40. A method for securing an anastomotic component to a side wall of a blood vessel, the method comprising steps of:
providing an anastomotic component including a non-expandable portion and an expandable portion, the anastomotic component comprising a wire shaped to define a lumen and multiple tissue engaging portions;
forming an opening in a side wall of a blood vessel;
collapsing the expandable portion of the anastomotic component by collapsing the wire;
expanding the expandable portion of the anastomotic component by expanding the wire; and
securing the anastomotic component to the blood vessel by engaging the tissue engaging portions with the side wall of the blood vessel.
41. A method for treating a lumen defined by a hollow structure in a patient's body, the method comprising steps of:
providing a docking member configured to be secured to tissue;
providing a prosthesis configured to be magnetically coupled to the docking member, the prosthesis having a lumen;
securing the docking member to a vessel in a patient's body, the vessel having a lumen with a diseased portion; and
magnetically coupling the prosthesis to the docking member to place the prosthesis lumen in sealing engagement with the vessel lumen.
42. A method for repairing an aneurysm using magnetism, the aneurysm being located in a patient's body lumen, the method comprising steps of:
providing a prosthesis having an outer surface and a lumen;
locating a body lumen having an aneurysm;
placing the prosthesis in a desired position with respect to the aneurysm so that the prosthesis lumen sealingly engages the body lumen; and
using magnetism to secure the prosthesis in the selected position.
43. An anastomotic component comprising:
a sleeve having a lumen adapted to receive a first vessel;
a plate extending away from the sleeve, the plate having an opening communicating with the sleeve lumen;
at least one of the sleeve and plate including a locking portion configured to lockingly engage another anastomotic component secured to a second vessel.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US11/818,360 US20070250084A1 (en) | 2000-04-29 | 2007-06-14 | Components, systems, and methods for forming anastomoses using magnetism or other coupling means |
Applications Claiming Priority (4)
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US09/562,599 US6352543B1 (en) | 2000-04-29 | 2000-04-29 | Methods for forming anastomoses using magnetic force |
US09/638,805 US6719768B1 (en) | 2000-04-29 | 2000-08-12 | Magnetic components for use in forming anastomoses, creating ports in vessels and closing openings in tissue |
US10/444,501 US7241300B2 (en) | 2000-04-29 | 2003-05-23 | Components, systems and methods for forming anastomoses using magnetism or other coupling means |
US11/818,360 US20070250084A1 (en) | 2000-04-29 | 2007-06-14 | Components, systems, and methods for forming anastomoses using magnetism or other coupling means |
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US7241300B2 (en) | 2007-07-10 |
US20040116945A1 (en) | 2004-06-17 |
WO2004105693A2 (en) | 2004-12-09 |
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STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |