WO2008000110A1 - Disposable pulse pipe - Google Patents

Disposable pulse pipe Download PDF

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Publication number
WO2008000110A1
WO2008000110A1 PCT/CN2006/003076 CN2006003076W WO2008000110A1 WO 2008000110 A1 WO2008000110 A1 WO 2008000110A1 CN 2006003076 W CN2006003076 W CN 2006003076W WO 2008000110 A1 WO2008000110 A1 WO 2008000110A1
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WO
WIPO (PCT)
Prior art keywords
patient
pulse tube
pulse
arterial
intra
Prior art date
Application number
PCT/CN2006/003076
Other languages
French (fr)
Chinese (zh)
Inventor
Sayed Nour
Original Assignee
Wu, Guifu
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Wu, Guifu filed Critical Wu, Guifu
Publication of WO2008000110A1 publication Critical patent/WO2008000110A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/104Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
    • A61M60/109Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems
    • A61M60/113Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems in other functional devices, e.g. dialysers or heart-lung machines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/122Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/135Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
    • A61M60/139Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20Type thereof
    • A61M60/247Positive displacement blood pumps
    • A61M60/253Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/268Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
    • A61M60/274Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20Type thereof
    • A61M60/295Balloon pumps for circulatory assistance

Definitions

  • the present invention relates to a medical device, and more particularly to a disposable pulse tube for use in a cardiopulmonary bypass machine and an intra-arterial sputum pump for obtaining a stable pulse flow in a patient during cardiopulmonary surgery.
  • CPB cardiac bypass machine
  • IABP intraaortic balloon pump
  • the above-mentioned intra-arterial sputum pump is used to increase myocardial oxygen supply and reduce myocardial oxygen demand, and is used for boosting cardiac output.
  • the above-mentioned cardiopulmonary bypass machine and intra-arterial sputum pump can be combined using a pulstile tube.
  • conventional pulse tubes have the risk of causing contamination to the patient and the risk of gas leakage during operation.
  • conventional pulse tubes are unable to obtain a homogenous pulse flow that is consistent with the physiological pulse flow of the human body.
  • a primary object of the present invention is to provide a disposable pulse tube that reduces contamination and leakage while making patient surgery safer.
  • Another object of the present invention is to provide a disposable pulse tube through which a more homogenous pulse flow can be obtained.
  • a disposable pulse tube for obtaining a pulse flow includes: a tube body; a cardiopulmonary bypass machine end formed at one end of the tube body and connected to a cardiopulmonary bypass machine; formed in the tube The other end of the body is for embedding a patient end in the patient's body; and a double lumen formed between the end of the cardiopulmonary bypass machine and the end of the patient.
  • the dual lumen portion has an integrally formed intra-arterial gas diaphragm.
  • the integrally formed intra-arterial sacral diaphragm is an internal cavity that directly applies pressure to the blood flow of the patient.
  • the integrally formed intra-arterial gas diaphragm is an outer chamber. The outer cavity exerts pressure on the blood flow of the patient by compressing the pulse tube from the outside.
  • the double lumen portion has a length of 45 cm.
  • the pulse tube can be 1.2-1.6 meters long and has a diameter of ll-13 mm.
  • the integrally formed intra-arterial gas diaphragm has a volume of 40 cm 3 and a pulse rate of 10-110 machine pulses per minute.
  • the distance between the patient end and the double lumen portion is 5-10 cm.
  • the integrally formed intra-arterial sacral diaphragm may be mounted to the pulse tube by means of a spiral form, a face-to-face form or a coil form.
  • DRAWINGS 1 is a perspective view of a pulse tube according to an embodiment of the present invention.
  • FIG. 2 is a perspective view of a pulse tube according to another embodiment of the present invention.
  • Fig. 3 is an exploded perspective view showing the pulse tube and the intra-arterial gas tunnel according to an embodiment of the present invention.
  • Figure 4 is a perspective view of the pulse tube and the intra-arterial gas tunnel shown in Figure 3. Detailed ways
  • a disposable pulsatile tube 3 includes a tube body 31; is formed at one end of the tube body 31 and is used with a cardiopulmonary bypass machine (CPB machine, cardiopulmonary) Bypass machine, refer to FIG. 4) a 50-connected cardiopulmonary bypass machine end (CPB end) 34; a patient end 32 formed at the other end of the tube body 31 and for embedding in a patient's body; A double lumen portion 36 between the cardiopulmonary bypass end 34 and the patient end 32.
  • CPB machine cardiopulmonary bypass machine
  • CPB end cardiopulmonary bypass machine end
  • the double lumen portion 36 can be coupled to an external contra pulsation pump (refer to FIG. 4) 60 by means of a passage 38 disposed in the tubular body 31.
  • the external counterpulsor pump 60 regularly provides a suitable gas such as helium or carbon dioxide to cause the dual lumen portion 36 to be inflated or deflated to form a pulse flow that regularly drives the patient's blood.
  • the dual lumen portion 36 preferably includes an integrally formed intraaortic balloon membrane.
  • the integrally formed intrauterine balloon diaphragm is preferably an intraluminal that directly applies pressure to the patient's blood flow.
  • the double lumen portion 36 may have a length of '45 cm.
  • the pulse tube 3 can be 1.2-1.6 meters long and has a diameter of ll-13 mm.
  • the integrally formed intra-arterial gas diaphragm may have a volume of 40 cm 3 and a pulse frequency of 10-110 machine pulses per minute (machine pulse/min)
  • FIG. 3 is a perspective view of a three-dimensional angular separation of a pulse tube and an intraaortic balloon catheter (IAB catheter) according to an embodiment of the present invention.
  • 4 is a perspective view of the pulse tube of FIG. 3 assembled with the intra-arterial gas tunnel.
  • the patient end 32 of the pulse tube 3 is mounted on a linear connector 5, which in turn is connected to a catheter 8.
  • the conduit 8 is in turn connected to another linear connector 6.
  • the linear connector 6 can be suitably placed within the body of the patient to connect the patient end 32 to the patient's body.
  • the cardiopulmonary bypass end 34 cooperates with a Y-connector 4.
  • the Y-shaped connector 4 includes a CBP portion 42' and an intra aortic balloon pump portion (IABP portion) 44.
  • the cardiopulmonary bypass unit 42 is connected to a pediatric cardiopulmonary bypass tube 2, which in turn is connected to a linear connector 9.
  • the linear connector 9 can be coupled to a cardiopulmonary bypass machine 50 such that the cardiopulmonary bypass machine 50 can provide an appropriate 'pulse to the patient's body through the cardiopulmonary bypass end 34 of the pulse tube 3.
  • the intra-arterial pump portion 44 of the Y-shaped connector 4 is mounted on a connector 7, which can be coupled to a pulmonary pump 60 such that the intra-arterial pump 60 and the pulse tube 3
  • the dual lumens (not shown) are connected and form an appropriate pulse within the patient's body.
  • an intra aortic balloon catheter (IAB catheter)! is inserted into the connector bore.
  • the intra-arterial gas tunnel 1 One end can be connected to an external intra-arterial pump.
  • the cardiopulmonary bypass machine and the intra-arterial sputum pump provide a suitable pulse to the patient through the pulse tube 3.
  • the pulse tube of the present invention provides a safer and more homogenous pulse flow.
  • the pulse tube may be mounted on any machine pulsation wind, such as external pumps or intraarterial Nang enhanced counterpulsation apparatus (enhanced external contra pulsation, EECP) 0 pulse tube of the present invention has a wider matching, such as its It can be matched with a cardiopulmonary bypass machine, a heart assist device or an artificial heart to create a downward pulsating homogenous perfusion flow. '
  • the distance between the patient end 32 and the dual lumen portion 36 is sufficiently small to reduce the dead zone between the pulse flow and the patient. In one embodiment, the distance between the patient end 32 and the dual lumen portion 36 is 5-10 cm. '
  • the integrally formed intra-arterial diaphragm can be mounted to the pulse tube by means of a spiral, face to face or coil form. Moreover, the length of the pulse tube can be adjusted as needed. In this case, the channel 38 of the pulse tube must be extractable from the body 31 and be kept at a sufficient distance from the end of the cardiopulmonary bypass, such as 20 cm, in order to re-regulate the length of the pulse tube. Does not cause harm to the patient.
  • the pulse tube is preferably formed from a suitable material such as polyvinyl chloride (PVC) or silicone.
  • PVC polyvinyl chloride
  • the integrally formed intra-arterial diaphragm of the double lumen fistula is made of cardiothane, which reduces red blood cell lysis in the patient.
  • the size of the pulse tube of the present invention may vary depending on the patient.
  • the utility model has a simple structure, which reduces or avoids the side effects of conventional devices such as the existing pulse cardiopulmonary bypass machine.
  • the pulse cardiopulmonary bypass machine has a high operating cost and requires the use of techniques associated with two standard materials that must be used in existing cardiac devices, such as intra-arterial sputum pumps or conventional cardiopulmonary bypass machines.
  • the pulse tube produces a perfusion flow close to physiological pulse pressure, conflicts with pulse pressure/organ perfusion produced by different pulse devices are completely avoided.
  • the pulse tube 3 may have a double lumen portion 36 formed of an integrally formed intra-arterial gas diaphragm.
  • the permanent tube 3 of the month is similar to the above-described pulse tube 3, except that in this embodiment, the integrally formed intra-arterial gas diaphragm of the double lumen portion 36 is an extra luminal.
  • the outer cavity exerts pressure on the blood flow of the patient by compressing the pulse tube from the outside.
  • the operation of the pulse tube 3 is similar to that of the pulse tube 3, and further description is omitted here.

Abstract

A disposable pulse pipe (3) for generating pulsatile flow in the patient comprises a tube (31), a heart-lung bypass machine end (34) which is on one end of the tube (31) and is connected to a heart-lung bypass machine (50), a patient end (32) which is on other end of the tube (31) and is inserted into the body of a patient, and a double-lumen part (36) which is provided between the two ends. The double-lumen part (36) includes an integrated intra-aortic balloon membrane.

Description

一次性脉搏管 技术领域  Disposable pulse tube
本实用新型涉及一种医学设备, 更具体地, 本实用新型涉及一种 在施行心肺手术时用于心肺旁路机及动脉内嚢泵以便在患者体内获 得稳定脉搏流的一次性脉搏管。 背景技术  The present invention relates to a medical device, and more particularly to a disposable pulse tube for use in a cardiopulmonary bypass machine and an intra-arterial sputum pump for obtaining a stable pulse flow in a patient during cardiopulmonary surgery. Background technique
当对患者做手术时, 尤其是在做与心肺有关的手术时, 为确保患 者心脏正常的循环, 通常使用医学辅助设备比如心肺旁路机 When performing surgery on patients, especially when doing cardio-related surgery, in order to ensure the normal circulation of the heart, medical aids such as cardiopulmonary bypass are usually used.
(cardiopulmonary bypass machine, CPB)或动脉内嚢泵 (intra aortic balloon pump, IABP)来在患者体外维持正常的循环。 (cardiopulmonary bypass machine, CPB) or intraaortic balloon pump (IABP) to maintain a normal circulation outside the patient's body.
借助上述心肺旁路机,患者体内的血液暂时性地被转移以便在体 内氧化及循环,从而维持上述循环直到心脏及肺器官能够恢复到正常 的功能。而上述动脉内嚢泵则用于增加心肌氧供应 (myocardial oxygen supply)及减小心肌氧需求 (myocardial oxygen demand) , 并且用于增力口 心输出量 (cardiac output)。  With the cardiopulmonary bypass machine described above, blood in the patient's body is temporarily transferred for oxidation and circulation in the body, thereby maintaining the above cycle until the heart and lung organs are restored to normal functions. The above-mentioned intra-arterial sputum pump is used to increase myocardial oxygen supply and reduce myocardial oxygen demand, and is used for boosting cardiac output.
为了在患者体内获得脉搏流, 可以使用脉搏管 (pulstile tube)将上 述心肺旁路机及动脉内嚢泵结合起来。 然而, 传统脉搏管具有对患者 造成污染的危险及操作过程中造成气体泄漏的危险。 另外,传统脉搏 管无法获得与人体的生理脉搏流接近或同质的 (homogenous)脉搏流。  In order to obtain pulse flow in the patient, the above-mentioned cardiopulmonary bypass machine and intra-arterial sputum pump can be combined using a pulstile tube. However, conventional pulse tubes have the risk of causing contamination to the patient and the risk of gas leakage during operation. In addition, conventional pulse tubes are unable to obtain a homogenous pulse flow that is consistent with the physiological pulse flow of the human body.
因而, 提供一种解决上述问题的一次性脉搏管实为必要。  Therefore, it is necessary to provide a disposable pulse tube that solves the above problems.
1 1
确认本 发明内容 Confirmation Summary of the invention
本实用新型的主要目的是提供一种可以减小污染与泄漏,同时使 得患者手术更加安全的一次性脉搏管。  SUMMARY OF THE INVENTION A primary object of the present invention is to provide a disposable pulse tube that reduces contamination and leakage while making patient surgery safer.
本实用新型的另一个目的是提供一种一次性脉搏管,通过该一次 性脉搏管, 可以获得更加同质的脉搏流。  Another object of the present invention is to provide a disposable pulse tube through which a more homogenous pulse flow can be obtained.
为达到上述目的, 一种用于获得脉搏流的一次性脉搏管包括: 管 体; 形成于所述管体一端并用于与心肺旁路机连接的心肺旁路机端 部; 形成于所述管体另一端用于嵌入患者体内的患者端部; 及形成于 所述心肺旁路机端部与患者端部之间的双内腔部。所述双内腔部具有 一体成形的动脉内气嚢隔膜。 - 在一个实施例中.,所述一体成形的动脉内气嚢隔膜为对患者的血 流直接施加压力的内腔体。在另一个实施例中, 所述一体成形的动脉 内气嚢隔膜为外腔体。该外腔体借助从外部压缩所述脉搏管的方式而 对患者的血流产生压力。  To achieve the above object, a disposable pulse tube for obtaining a pulse flow includes: a tube body; a cardiopulmonary bypass machine end formed at one end of the tube body and connected to a cardiopulmonary bypass machine; formed in the tube The other end of the body is for embedding a patient end in the patient's body; and a double lumen formed between the end of the cardiopulmonary bypass machine and the end of the patient. The dual lumen portion has an integrally formed intra-arterial gas diaphragm. - In one embodiment, the integrally formed intra-arterial sacral diaphragm is an internal cavity that directly applies pressure to the blood flow of the patient. In another embodiment, the integrally formed intra-arterial gas diaphragm is an outer chamber. The outer cavity exerts pressure on the blood flow of the patient by compressing the pulse tube from the outside.
最优地,所述双内腔部的长度为 45cm。所述脉搏管可以为 1.2-1.6 米长并且其直径为 ll-13mm。所述一体成形的动脉内气嚢隔膜的容积 为 40cm3并且其脉搏频率为 10-110机器脉搏 /分钟。 另外, 所述患者 端部与所述双内腔部之间的距离为 5-10cm。 所述一体成形的动脉内 气嚢隔膜可借助螺旋形式、面对面形式或线圈形式安装到所述脉搏管 上。 Most preferably, the double lumen portion has a length of 45 cm. The pulse tube can be 1.2-1.6 meters long and has a diameter of ll-13 mm. The integrally formed intra-arterial gas diaphragm has a volume of 40 cm 3 and a pulse rate of 10-110 machine pulses per minute. In addition, the distance between the patient end and the double lumen portion is 5-10 cm. The integrally formed intra-arterial sacral diaphragm may be mounted to the pulse tube by means of a spiral form, a face-to-face form or a coil form.
下面将结合附图, 通过优选实施例详细描述本实用新型。  The present invention will be described in detail below by way of preferred embodiments with reference to the accompanying drawings.
附图说明 图 1为本实用新型一个实施例所述脉搏管的立体图。 DRAWINGS 1 is a perspective view of a pulse tube according to an embodiment of the present invention.
图 2为本实用新型另一个实施例所述脉搏管的立体图。  2 is a perspective view of a pulse tube according to another embodiment of the present invention.
图 3为本实用新型一个实施例所述脉搏管与动脉内气嚢导管的 立体分解图。  Fig. 3 is an exploded perspective view showing the pulse tube and the intra-arterial gas tunnel according to an embodiment of the present invention.
图 4为图 3.所示脉搏管与动脉内气嚢导管组装后的立体图。 具体实施方式  Figure 4 is a perspective view of the pulse tube and the intra-arterial gas tunnel shown in Figure 3. Detailed ways
现在描述本实用新型的实施例。 参考图 1 , 根据本实用新型的一 个实施例, 一次性脉搏管 3 (disposable pulsatile tube) 包括管体 31 ; 形成于所述管体 31 的一端并用于与一个心肺旁路机 (CPB machine, cardiopulmonary bypass machine,参考图 4) 50连接的心肺旁路机端部 (CPB end) 34;形成于所述管体 31的另一端并用于嵌入患者体内的患 者端部 (patient end) 32; 及形成于所述心肺旁路机端部 34与患者端 部 32之间的双内腔部 (double lumen portion) 36。  Embodiments of the invention are now described. Referring to FIG. 1, according to an embodiment of the present invention, a disposable pulsatile tube 3 includes a tube body 31; is formed at one end of the tube body 31 and is used with a cardiopulmonary bypass machine (CPB machine, cardiopulmonary) Bypass machine, refer to FIG. 4) a 50-connected cardiopulmonary bypass machine end (CPB end) 34; a patient end 32 formed at the other end of the tube body 31 and for embedding in a patient's body; A double lumen portion 36 between the cardiopulmonary bypass end 34 and the patient end 32.
所述双内腔部 36可以借助设置在所述管体 31内的通道 38而与 一个夕卜部反搏泉 (external contra pulsation pump,参考图 4) 60连接。 所述外部反搏泵 60有规律地提供适当气体比如氦气或二氧化碳以便 使得所述双内腔部 36被充气或放气, 从而形成有规律驱动患者血液 的脉搏流。 在这种情况下, 为使得所述双内腔部 36更加自由地被充 气或放气, 所述双内腔部 36 最好包括一体成形的动脉内气嚢隔膜 (intra aortic balloon membrane)。 而且, 所述一体成形的动月 内气嚢隔 膜最好为对患者的血流直接施加压力的内腔体 (intra luminal)。 另外, 所述双内腔部 36的长度可以为 ' 45cm。 所述脉搏管 3可以为 1.2-1.6 米长并且其直径为 ll-13mm。所述一体成形的动脉内气嚢隔膜的容积 可以为 40cm3 并且其脉搏频率为 10-110次机器脉搏 /分钟 (machine pulse/min The double lumen portion 36 can be coupled to an external contra pulsation pump (refer to FIG. 4) 60 by means of a passage 38 disposed in the tubular body 31. The external counterpulsor pump 60 regularly provides a suitable gas such as helium or carbon dioxide to cause the dual lumen portion 36 to be inflated or deflated to form a pulse flow that regularly drives the patient's blood. In this case, to allow the dual lumen portion 36 to be more inflated or deflated, the dual lumen portion 36 preferably includes an integrally formed intraaortic balloon membrane. Moreover, the integrally formed intrauterine balloon diaphragm is preferably an intraluminal that directly applies pressure to the patient's blood flow. In addition, The double lumen portion 36 may have a length of '45 cm. The pulse tube 3 can be 1.2-1.6 meters long and has a diameter of ll-13 mm. The integrally formed intra-arterial gas diaphragm may have a volume of 40 cm 3 and a pulse frequency of 10-110 machine pulses per minute (machine pulse/min)
图 3 为本实用新型一个实施例所述脉搏管与动脉内气嚢导管 (intra aortic balloon catheter, IAB catheter)的立体分角早图。 图 4为图 3 所示脉搏管与动脉内气嚢导管组装后的立体图。 如图所示, 所述脉搏 管 3的患者端部 32安装在一个直线连接器 5上, 该直线连接器 5又 与一个导管 8连接。 所述导管 8又与另一个直线连接器 6连接。该直 线连接器 6可以适当地置于患者身体内, 从而将所述患者端部 32连 接到患者身体。 所述心肺旁路机端部 34与一个 Y形连接器 4配合。 该 Y形连接器 4包括心肺旁路才几部 (CBP portion) 42 '及动脉内嚢泵部 (intra aortic balloon pump portion, IABP portion) 44。所述心肺旁路机部 42与一个儿科心肺旁路机循环管 (pediatric CPB circuit tube) 2连接, 该儿科心肺旁路机循环管 2又与一个直线连接器 9连接。该直线连接 器 9可以一个心肺旁路机器 50连接,从而使得该心肺旁路机器 50可 以通过所述脉搏管 3的心肺旁路机端部 34而对患者的身体提供适当 ' 的脉搏。 所述 Y形连接器 4的动脉内嚢泵部 44安装于连接器 7上, 该连接器 7可以与一个动月 内嚢泵 60连接, 从而使得该动脉内嚢泵 60与所述脉搏管 3的双内腔部 (图未示)连接,并在患者身体内形成适 当脉搏。 参考图 4, 一个动月永内气嚢导管 (intra aortic balloon catheter, IAB catheter)!插入到所述连接器 Ί内。 所述动脉内气嚢导管 1的另 一端可以与一个外部动脉内嚢泵连接。 3 is a perspective view of a three-dimensional angular separation of a pulse tube and an intraaortic balloon catheter (IAB catheter) according to an embodiment of the present invention. 4 is a perspective view of the pulse tube of FIG. 3 assembled with the intra-arterial gas tunnel. As shown, the patient end 32 of the pulse tube 3 is mounted on a linear connector 5, which in turn is connected to a catheter 8. The conduit 8 is in turn connected to another linear connector 6. The linear connector 6 can be suitably placed within the body of the patient to connect the patient end 32 to the patient's body. The cardiopulmonary bypass end 34 cooperates with a Y-connector 4. The Y-shaped connector 4 includes a CBP portion 42' and an intra aortic balloon pump portion (IABP portion) 44. The cardiopulmonary bypass unit 42 is connected to a pediatric cardiopulmonary bypass tube 2, which in turn is connected to a linear connector 9. The linear connector 9 can be coupled to a cardiopulmonary bypass machine 50 such that the cardiopulmonary bypass machine 50 can provide an appropriate 'pulse to the patient's body through the cardiopulmonary bypass end 34 of the pulse tube 3. The intra-arterial pump portion 44 of the Y-shaped connector 4 is mounted on a connector 7, which can be coupled to a pulmonary pump 60 such that the intra-arterial pump 60 and the pulse tube 3 The dual lumens (not shown) are connected and form an appropriate pulse within the patient's body. Referring to Figure 4, an intra aortic balloon catheter (IAB catheter)! is inserted into the connector bore. The intra-arterial gas tunnel 1 One end can be connected to an external intra-arterial pump.
当运行时,所述心肺旁路机及动脉内嚢泵通过所述脉搏管 3而对 患者提供合适的脉搏。 本实用新型脉搏管提供更加安全及更加同质 (homogenous)的脉搏流。 并且, 所述脉搏管可以安装在任何风力脉动 机器上, 比如动脉内嚢泵或增强型外反搏设备 (enhanced external contra pulsation, EECP)0 本实用新型脉搏管具有较广泛的匹配性, 比 如其可以与心肺旁路机、 心脏辅助设备或人造心脏 ¾配, 从而产生向 下的脉动性同质灌注流。 ' When in operation, the cardiopulmonary bypass machine and the intra-arterial sputum pump provide a suitable pulse to the patient through the pulse tube 3. The pulse tube of the present invention provides a safer and more homogenous pulse flow. Further, the pulse tube may be mounted on any machine pulsation wind, such as external pumps or intraarterial Nang enhanced counterpulsation apparatus (enhanced external contra pulsation, EECP) 0 pulse tube of the present invention has a wider matching, such as its It can be matched with a cardiopulmonary bypass machine, a heart assist device or an artificial heart to create a downward pulsating homogenous perfusion flow. '
最优地,所述患者端部 32与所述双内腔部 36之间的距离足够小, 以便减小脉搏流与患者之间的盲区。在一个实施例中, 所述患者端部 32与所述双内腔部 36之间的距离为 5-10cm。'  Optimally, the distance between the patient end 32 and the dual lumen portion 36 is sufficiently small to reduce the dead zone between the pulse flow and the patient. In one embodiment, the distance between the patient end 32 and the dual lumen portion 36 is 5-10 cm. '
所述一体成形的动脉内气嚢隔膜可借助螺旋形式 (spiral)、 面对面 形式 (face to face)或线圈形式 (coil form)安装到所述脉搏管上。 而且, 所述脉搏管的长度可以根据需要调整。在此情况下, 所述脉搏管的通 道 38必须可以从所述管体 31内抽出并与所述心肺旁路机端部保持足 够的距离, 比如 20cm, 以便在脉搏管长度的再调节过程中不会对患 者造成伤害。  The integrally formed intra-arterial diaphragm can be mounted to the pulse tube by means of a spiral, face to face or coil form. Moreover, the length of the pulse tube can be adjusted as needed. In this case, the channel 38 of the pulse tube must be extractable from the body 31 and be kept at a sufficient distance from the end of the cardiopulmonary bypass, such as 20 cm, in order to re-regulate the length of the pulse tube. Does not cause harm to the patient.
为减小污染及气体泄漏 ,所述脉搏管最好由合适材料比如聚氯乙 烯 (PVC)或硅树脂 (silicone)形 。 而且所述双内腔郜的一体成形的 动脉内气嚢隔膜由卡迪森 (cardiothane)制造, 该材料可以减小患者体 内的红血球溶解。 另外, 本实用新型脉搏管的尺寸可以根据不同的患 者而有所改变。 与现有技术比较 ,·本实用新-型脉搏管结构简单, 该简单的结构减 小或避免了传统设备比如现有的脉搏心肺旁路机的副作用。该脉搏心 肺旁路机具有较高的运行成本, 并需要使用与现有心脏设备 (比如动 脉内嚢泵或传统的心肺旁路机)中必须使用的两种标准材料相关的技 术。 而且, 由于脉搏管产生接近生理脉搏压力的灌注流, 因此彻底避 免了和不同脉搏设备产生的脉搏压力 /器官灌注之间的冲突。 To reduce contamination and gas leakage, the pulse tube is preferably formed from a suitable material such as polyvinyl chloride (PVC) or silicone. Moreover, the integrally formed intra-arterial diaphragm of the double lumen fistula is made of cardiothane, which reduces red blood cell lysis in the patient. In addition, the size of the pulse tube of the present invention may vary depending on the patient. Compared with the prior art, the utility model has a simple structure, which reduces or avoids the side effects of conventional devices such as the existing pulse cardiopulmonary bypass machine. The pulse cardiopulmonary bypass machine has a high operating cost and requires the use of techniques associated with two standard materials that must be used in existing cardiac devices, such as intra-arterial sputum pumps or conventional cardiopulmonary bypass machines. Moreover, since the pulse tube produces a perfusion flow close to physiological pulse pressure, conflicts with pulse pressure/organ perfusion produced by different pulse devices are completely avoided.
参考图 2, 根据本实用新型的另一个实施例, 脉搏管 3,可以具有 由一体成形的动脉内气嚢隔膜构成的双内腔部 36,。该 月永搏管 3,与上 述脉搏管 3类似, 区别在于: 在该实施例中, 所述双内腔部 36,的一 体成形的动脉内气嚢隔膜为外腔体 (extra luminal)。该外腔体借助从外 部压缩所述脉搏管的方式而对患者的血流产生压力。 所述脉搏管 3, 的操作与所述脉搏管 3类似, 这里省略了进一步的描述。  Referring to Fig. 2, according to another embodiment of the present invention, the pulse tube 3 may have a double lumen portion 36 formed of an integrally formed intra-arterial gas diaphragm. The permanent tube 3 of the month is similar to the above-described pulse tube 3, except that in this embodiment, the integrally formed intra-arterial gas diaphragm of the double lumen portion 36 is an extra luminal. The outer cavity exerts pressure on the blood flow of the patient by compressing the pulse tube from the outside. The operation of the pulse tube 3 is similar to that of the pulse tube 3, and further description is omitted here.
以上所揭露的仅为本实用新型的优选实施例而已,当然不能以此 来限定本实用新型之权利范围,因此依本实用新型申请专利范围所作 的等同变化, 仍属本实用新型所涵盖的范围。  The above is only the preferred embodiment of the present invention, and the scope of the present invention is not limited thereto. Therefore, the equivalent changes made by the scope of the present invention remain within the scope of the present invention. .

Claims

权 利 要 求 Rights request
1.一种用于在患者体内产生脉搏流的一次性脉搏管, 包括: 管体;  A disposable pulse tube for generating a pulse flow in a patient, comprising: a tubular body;
形成于所述管体一端并用于与一个心肺旁路机连接的心肺 旁路机端部;  a cardiopulmonary bypass machine end formed at one end of the tubular body and for connection to a cardiopulmonary bypass machine;
形成于所述管体另一端用于嵌入患者体内的患者端部; 及 形成于所述心肺旁路机端部与患者端部之间的双内月空部; 其中,  a patient end portion formed at the other end of the tubular body for embedding in a patient; and a double inner moon portion formed between the end of the cardiopulmonary bypass machine and the end of the patient; wherein
所述双内腔部具有一体成形的动脉内气嚢隔膜。  The dual lumen portion has an integrally formed intra-arterial gas diaphragm.
2.根据权利要求 1所述的一次性脉搏管, 其特征在于: 所述一体 成形的动脉内气嚢隔膜为对患者的血流直接施加压力的内腔体。 The disposable pulse tube according to claim 1, wherein the integrally formed intra-arterial sacral diaphragm is an internal cavity that directly applies pressure to a blood flow of a patient.
3.根据权利要求 1所述的一次性脉搏管, 其特征在于: 所述一体 成形的动脉内气嚢隔膜为借助从外部压缩所述脉搏管的方式而对患 者的血流产生压力的外腔体。 The disposable pulse tube according to claim 1, wherein: the integrally formed intra-arterial sacral diaphragm is an external cavity that exerts pressure on a blood flow of a patient by compressing the pulse tube from the outside. body.
4.根据权利要求 1所述的一次性脉搏管, 其特征在于: 所述双内 腔部的长度为 45cm。 The disposable pulse tube according to claim 1, wherein the double lumen portion has a length of 45 cm.
5·根据权利要求 1所述的一次性脉搏管, 其特征在于: 所述脉搏 管为 1.2-1.6米长且其直径为 ll-13mm 5. The disposable pulse tube of claim 1 wherein: said pulse The tube is 1.2-1.6 meters long and its diameter is ll-13mm
6.根据权利要求 1所述的一次性脉搏管, 其特征在于: 所述一体 成形的动脉内气嚢隔膜的容积为 40cm3且其脉搏频率为 10-110次机 器脉搏 /分钟。 The disposable pulse tube according to claim 1, wherein: the integrally formed intra-arterial gas diaphragm has a volume of 40 cm 3 and a pulse frequency of 10 to 110 machine pulses per minute.
7.根据权利要求 1所述的一次性脉搏管, 其特征在于: 所述一体 成形的动脉内气嚢隔膜借助螺旋形式、面对面形式或线圈形式安装到 所述脉搏管上。 The disposable pulse tube according to claim 1, wherein: the integrally formed intra-arterial sacral diaphragm is mounted to the pulse tube by means of a spiral form, a face-to-face form or a coil form.
8.根据权利要求 1所述的一次性脉搏管, 其特征在于: 所述患者 端部与所述双内腔部之间的距离为 5-10cm。 The disposable pulse tube according to claim 1, wherein a distance between the end portion of the patient and the double lumen portion is 5 - 10 cm.
PCT/CN2006/003076 2006-06-20 2006-11-15 Disposable pulse pipe WO2008000110A1 (en)

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