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Publication numberCN101969886 A
Publication typeApplication
Application numberCN 200980104189
PCT numberPCT/US2009/000762
Publication date9 Feb 2011
Filing date6 Feb 2009
Priority date8 Feb 2008
Also published asCA2713865A1, CA2713865C, CN101969886B, EP2249746A1, US8852072, US9173984, US9579437, US20090203957, US20140371517, US20160015880, US20170165408, WO2009099644A1
Publication number200980104189.6, CN 101969886 A, CN 101969886A, CN 200980104189, CN-A-101969886, CN101969886 A, CN101969886A, CN200980104189, CN200980104189.6, PCT/2009/762, PCT/US/2009/000762, PCT/US/2009/00762, PCT/US/9/000762, PCT/US/9/00762, PCT/US2009/000762, PCT/US2009/00762, PCT/US2009000762, PCT/US200900762, PCT/US9/000762, PCT/US9/00762, PCT/US9000762, PCT/US900762
Inventors史蒂夫A怀特, 杰弗里A拉鲁斯, 查尔斯R香博
Applicant哈特威尔公司
Export CitationBiBTeX, EndNote, RefMan
External Links: SIPO, Espacenet
Ventricular assist device for intraventricular placement
CN 101969886 A
Abstract
A ventricular assist device includes a pump such as an axial flow pump, an outflow cannula connected to the outlet of the pump, and an anchor element. The anchor element is physically connected to the pump, as by an elongate element. The pump is implanted within the left ventricle with the outflow cannula projecting through the aortic valve but desirably terminating short of the aortic arch. The anchor element is fixed to the wall of the heart near the apex of the heart so that the anchor element holds the pump and outflow cannula in position.
Claims(32)  translated from Chinese
  1. 一种用于哺乳动物对象的心脏中的心室内放置的心室辅助装置,其包括:锚元件,其配置为安装在所述对象的心脏处;延长构件,其具有近端和远端;以及泵,其包括壳体、入口和出口、所述壳体中的转子以及由所述壳体所承载的用于磁力驱动所述转子的电驱动线圈,其中,所述锚元件和所述泵连接于所述延长构件且彼此远离。 A ventricular assist device in a mammalian subject heart ventricle placed, comprising: an anchor element, which is configured to be installed at the heart of the subject; elongate member having a proximal end and a distal end; and a pump comprising a housing, an inlet and an outlet, said housing and a rotor carried by the housing for magnetically driving the rotor of the electric drive coils, wherein said anchoring element and is connected to the pump the elongate member and away from each other.
  2. 2.如权利要求1所述的心室辅助装置,其中,所述锚元件配置为安装在所述对象的心脏的临近心尖的地方。 2. The ventricular assist device according to claim 1, wherein the anchor element is configured to be installed near the apex of the heart where the object.
  3. 3.如权利要求1所述的心室辅助装置,其中,所述泵具有延伸于所述入口和出口之间的轴,且所述延长构件具有从所述泵的所述轴偏离的轴。 1 The ventricular assist device according to claim, wherein, said pump having a shaft extending between said inlet and outlet, and the elongate member having a shaft from the deviation of the pump shaft.
  4. 4.如权利要求3所述的心室辅助装置,其中,所述延长构件的轴基本上与所述泵的轴平行。 The ventricular assist device according to claim 3, wherein the elongate member is substantially parallel with the shaft axis of the pump.
  5. 5.如权利要求1所述的心室辅助装置,其中,所述延长构件包括在其近端和远端方向延伸的孔,该装置还包括通过该孔延伸到所述泵的配线。 5. The ventricular assist device according to claim 1, wherein the elongate member extending bore at its proximal end and includes a distal direction, the apparatus further comprising a wiring extending to the pump through the aperture.
  6. 6.如权利要求1所述的心室辅助装置,其中,还包括安装在所述刚性延长构件上的球体。 The ventricular assist device as claimed in claim 1, wherein, wherein, further comprising a ball mounted on said rigid elongate member.
  7. 7.如权利要求5所述的心室辅助装置,其中,所述锚元件包括适合于与所述球体相配合的球形座,使得该锚元件枢转地安装于该刚性延长构件。 7. The ventricular assist device according to claim 5, wherein the anchoring element comprises a ball adapted to cooperate with said spherical seat, so that the anchor element is pivotally mounted to the rigid elongate member.
  8. 8.如权利要求1所述的心室辅助装置,其中,所述锚元件固定于所述延长构件。 The ventricular assist device as claimed in claim 1, wherein said anchoring element is secured to the elongate member.
  9. 9.如权利要求1所述的心室辅助装置,其中,所述锚元件是适合于固定在心脏壁外表面的环。 9. The ventricular assist device according to claim 1, wherein the anchor element is adapted to be secured in the outer surface of the heart wall of the ring.
  10. 10.如权利要求1所述的心室辅助装置,其中,所述延长构件具有流体力学的外表面。 10. The ventricular assist device as claimed in claim 1, wherein, wherein, the elongate member having an outer surface of the fluid mechanics.
  11. 11.如权利要求1所述的心室辅助装置,其中,所述延长构件是弯曲的。 11. The ventricular assist device as claimed in claim 1, wherein, wherein said elongate member is curved.
  12. 12.如权利要求1所述的心室辅助装置,其中,所述延长构件是管道状的。 12. The ventricular assist device as claimed in claim 1, wherein, wherein, the elongate member is a pipe-shaped.
  13. 13.如权利要求1所述的心室辅助装置,其中,所述装置具有多个锚元件和延长构件。 13. The ventricular assist device as claimed in claim 1, wherein, wherein, said means having a plurality of anchor element and elongate member.
  14. 14.如权利要求1所述的心室辅助装置,其中,所述锚元件的横截面是非圆形的。 14. The ventricular assist device as claimed in claim 1, wherein, wherein the cross-section of the anchor element is non-circular.
  15. 15.如权利要求1所述的心室辅助装置,其中,所述锚元件适合于支撑在心脏壁的内表面上。 15. The ventricular assist device as claimed in claim 1, wherein, wherein said anchoring element is adapted to support on the inner surface of the heart wall.
  16. 16.如权利要求1所述的心室辅助装置,其中,还包括限定出孔的管状流出插管,该孔在其近端处具有连接到所述泵的出口的入口。 16. The ventricular assist device as claimed in claim 1, wherein, wherein, further comprising an aperture defining a tubular outflow cannula, the bore having an outlet of the pump is connected to an inlet at a proximal end thereof.
  17. 17.如权利要求16所述的心室辅助装置,其中,所述流出插管在其远端处包括尖端,该尖端具有多个开口。 17. The ventricular assist device according to claim 16, wherein the outflow cannula includes a tip at its distal end, the tip having a plurality of openings.
  18. 18.如权利要求17所述的心室辅助装置,其中,所述流出插管的所述尖端通过主动脉瓣延伸,但不到主动脉弓就终止。 18. The ventricular assist device according to claim 17, wherein, out of said tip of said cannula extends through the aortic valve, the aortic arch but not terminated.
  19. 19.如权利要求16所述的心室辅助装置,其中,所述流出插管向其末梢方向逐渐变细。 19. The ventricular assist device as claimed in claim 16 wherein, wherein the outflow cannula distally tapering thereto.
  20. 20.如权利要求16所述的心室辅助装置,其中,所述流出插管在接近所述尖端的区域的横截面大体上是三角形。 20. The ventricular assist device according to claim 16, wherein the outflow cannula near the tip of the cross-sectional area is substantially triangular.
  21. 21.如权利要求16所述的心室辅助装置,其中,所述流出插管包括多个侧孔,这些侧孔在该插管的孔和该插管的靠近该插管的尖端的外表面之间延伸。 21. Claim 16 wherein the ventricular assist device in the bore of the cannula and the cannula of the cannula near the tip of the outer surface of the side hole, wherein the outflow cannula includes a plurality of side holes, extending between.
  22. 22.如权利要求1所述的心室辅助装置,其中,所述锚元件是适合于安装在邻近患者心尖处的环,这是通过将该环缝到沿患者心脏壁的组织上而安装的。 22. The ventricular assist device according to claim 1, wherein the anchor element is adapted to be mounted adjacent the patient at the apex of the loop, which is sewn onto the ring through the heart wall tissue along the patient and to install.
  23. 23.如权利要求1所述的心室辅助装置,其中,所述锚元件在所述延长构件的纵向上的位置是可调整的。 23. The ventricular assist device according to claim 1, wherein said anchoring element in position on said longitudinal extension member is adjustable.
  24. 24. —种用于哺乳动物对象的心脏中的心室内放置的心室辅助装置,其包括:环,其配置为安装在邻近患者的心脏的心尖处;刚性延长构件,其具有近端和远端;以及泵,其包括壳体、具有尖端的流出插管,该尖端具有通过所述对象的心脏的主动脉瓣延伸的远端,其中,所述环和所述泵连接到所述刚性延长构件且彼此远离,从而所述刚性延长构件使得所述泵相对于所述环保持在适当的位置。 24. - ventricular assist device types for a mammalian subject is placed in the heart ventricle, comprising: a ring configured for mounting adjacent the apex of a patient's heart; rigid elongate member having proximal and distal ends ; and a pump, comprising a housing, an outflow cannula having a tip, the tip having a distal end extending through the heart of the object of the aortic valve, and wherein said ring and said pump is connected to the rigid elongate member and away from each other, so that the rigid elongate member such that the pump is maintained with respect to the ring in place.
  25. 25.如权利要求24所述的心室辅助装置,其中,所述尖端不到所述对象的心脏的主动脉弓处就终止。 25. The ventricular assist device according to claim 24, wherein the tip is less than the aortic arch at the heart of the object is terminated.
  26. 26. 一种在哺乳动物对象体内安装心室辅助装置的方法,其包括:(a)在所述对象上安装泵,使得该泵的入口与心脏左心室相连通;以及(b)定位该泵的流出插管,使得该流出插管从左心室内通过主动脉瓣延伸,但是不到主动脉弓就终止。 26. A method of mounting in a mammalian subject in vivo ventricular assist device, comprising: (a) mounting the pump on the object, such that the pump inlet in communication with the left ventricle; and (b) positioning the pump outflow cannula such that the outflow cannula extends through the aortic valve from the left ventricle, but less than the termination of the aortic arch.
  27. 27.如权利要求26所述的方法,其中,在所述对象上安装泵的步骤包括在所述心脏左心室内安装该泵。 27. The method of claim 26, wherein the step of mounting the pump on the object comprises a pump installed within the left ventricle of the heart.
  28. 28.如权利要求27所述的方法,其中,该方法还包括:在所述心脏的心尖附近将心脏壁与锚元件相配合,使得该锚元件将该泵和流出插管保持在心脏中合适的位置上。 Suitable maintained in the heart near the apex of the heart in the heart wall will be fitted with an anchor element, such that the anchor element and the pump outflow cannula: 28. The method of claim 27, wherein the method further comprises position.
  29. 29. 一种在哺乳动物对象心脏内将心室辅助装置放置在位的方法,其包括:提供连接于刚性延长构件并彼此远离的锚元件和泵;使所述泵穿过所述对象的心脏的心尖中的壁并进入所述对象的心脏的心室内区域;以及将该锚元件安装在所述对象的心尖处。 29. A heart in a mammalian subject the ventricular assist device is placed in position, comprising: providing a connection to the anchor element and the pump and the rigid elongate member remote from one another; said pump through the heart of the subject apex of the heart wall and into the ventricle of the object region; and the anchor element mounted on the apex of the object.
  30. 30.如权利要求29所述的方法,其中,所述泵包括壳体、入口和出口、所述壳体中的转子以及由所述壳体承载的用于磁力驱动所述转子的电驱动线圈。 30. The method of 29, wherein the electrically driven rotor coil of claim, wherein said pump comprises a housing, an inlet and an outlet, said housing and a rotor carried by said housing for driving said magnetic force .
  31. 31.如权利要求30所述的方法,其中,所述泵还包括限定出孔的管状流出插管,该孔在其近端处具有连接到该泵的出口的入口,其中,该流出插管在其远端处包括尖端,该尖端具有多个开口,其中该流出插管的该尖端通过主动脉瓣延伸。 31. The method of claim 30, wherein said pump further comprises an aperture defining a tubular outflow cannula, the bore is connected to the outlet of the pump having an inlet at its proximal end, wherein the outflow cannula includes a tip at its distal end, the tip having a plurality of openings, wherein the tip of the outflow cannula extends through the aortic valve.
  32. 32.如权利要求29所述的方法,其中,该泵的入口被定位为使得该入口远离所述主动脉瓣,且大体上面向所述心脏的心尖的方向。 32. The method of claim 29, wherein the inlet of the pump is positioned such that the inlet remote from the aortic valve, and facing generally toward the direction of the apex of the heart.
Description  translated from Chinese

用于心室内放置的心室辅助装置 Ventricular assist device for intraventricular placement

背景技术 BACKGROUND

[0001] 本发明涉及心室内放置的心室辅助装置、用于该装置的部件、以及使用该装置的方法。 [0001] The present invention relates to a ventricular assist device for intraventricular placement, parts of the apparatus, and methods of using the apparatus.

[0002] 在某种疾病状态下,心脏缺乏足够的泵送能力以满足身体的需要。 [0002] In certain disease states, cardiac lacks sufficient pumping capacity to meet the body's needs. 可以通过提供称为心室辅助装置(“VAD”)的机械泵送装置来补充心脏泵血作用以缓解这一不足。 Provided by a mechanical pumping device called a ventricular assist device ("VAD") to supplement the heart pumping action to alleviate this deficiency. 人们已经付出相当大的努力以提供可以被植入并能保持数月或数年的运转以使得患者在心脏愈合过程中可以存活的VAD,或者是如果心脏不愈合,该VAD可以永久地保持运转或者一直运转到有可用的合适的捐赠心脏为止。 People have to pay a considerable effort to provide may be implanted and can be maintained for several months or years of operation of the heart so that the healing process in the patient can survive the VAD, or if the heart does not heal, the VAD can permanently remain in operation or has been running to the right until a donor heart is available.

[0003] 该VAD通常连接到心脏,最常见的是连接到左心室。 [0003] The VAD is usually connected to the heart, the most common is connected to the left ventricle. 例如,VAD可包括安装在体内但是在心脏之外的泵。 For example, VAD may include a mounting in the body but outside the heart pumps. 该VAD可具有连接到左心室内部并连接到泵的入口的入口插管。 The VAD may have an inlet connected to the inside of the left ventricle and connected to the pump inlet cannula. 该VAD也可包括连接于泵的出口和主动脉之间的出口管。 The VAD may also include an outlet pipe connected to the pump outlet and between the aorta. 一旦连接,该VAD和心脏都从左心室往主动脉泵血。 Once connected, the VAD and heart have to pump blood from the left ventricle into the aorta.

[0004] 如前所述,例如,在第5376114和6217541号美国专利中设置了某些具有泵的VAD, 使得当VAD被植入患者体内时泵的至少一部分被置入心脏中。 [0004] As described above, for example, No. 5,376,114 and U.S. Patent No. 6,217,541 is provided with certain VAD pump, such that when at least a portion of the patient when the VAD is implanted pump is placed into the heart. 这些VAD与通过延长的传动轴连接到单独的电动机的泵协同工作。 The VAD and connected by an extended drive shaft to separate electric motor pump work. 这种轴驱动的泵有重大缺陷。 This shaft driven pumps have significant drawbacks. 共同转让的未决的第12/072471号美国专利申请的公开内容在此以引用的方式并入本文中,该专利申请公开了一种包含适合于放置在比如主动脉中的动脉系统中的单体的泵和马达的VAD。 The disclosure of commonly assigned copending U.S. Patent Application No. 12/072471 in this manner is incorporated by reference herein, this patent application discloses a composition comprising for example adapted to be placed in the aorta in the arterial system of a single pump and motor body VAD.

[0005] 尽管为了改进VAD已经付出相当大的努力,仍需要进一步的改进。 [0005] In order to improve the VAD has been paid despite considerable efforts, still need further improvement.

发明内容 SUMMARY

[0006] 词语“近端的”和“远端的”此处是用来表示装置和部件的方向和末端。 [0006] The term "proximal" and "distal" as used herein is intended to mean devices and components of the direction and ends. 如这里所使用的,当涉及心室辅助装置或部件时,术语“近端的”指在装置的安装过程中朝向外科医生或其他手术室人员的方向,术语“远端的”含义相反。 As used herein, when referring to a ventricular assist device or component, the term "proximal" refers to the direction toward the installation device surgeon or other operating room personnel, the meaning of the term & opposite "distal."

[0007] 本发明的一方面提供了一种用于在哺乳动物对象心脏中的心室内放置的心室辅助装置。 On the one hand [0007] The present invention provides a ventricular assist device for intraventricular a mammalian subject placed in the heart. 该装置优选地包括锚元件,该锚元件诸如配置为安装在临近对象的心尖处的环,并且最好还包括含有近端和远端的延长构件。 The apparatus preferably comprises an anchor element, the anchor element such as a ring configured to be installed near the apex of the object, and preferably also includes a proximal end and a distal end comprising an extension member. 根据该发明的这方面的装置最好还包括泵,该泵具有壳体、入口和出口、壳体中的转子以及由壳体所承载的用于磁力驱动转子的电驱动线圈。 This aspect of the apparatus according to the invention preferably further comprises a pump having a housing, an inlet and an outlet, a rotor and a housing for the electric drive coil magnetically driven rotor carried by the housing. 优选地,当该装置已被植入心脏时,该锚元件和该泵固定于该刚性延长构件且彼此远距离,从而该刚性延长构件可以使该泵相对于该锚元件处于合适的位置,因此相对于心脏也处于合适的位置。 Preferably, when the device has been implanted in the heart, the anchor element and the pump is fixed to the rigid elongate member and a distance from each other, so that the rigid elongate member may make the pump with respect to the anchoring element is in the right position, so relative to the heart is also in the right place.

[0008] 在根据本发明的这一方面的装置的某些实施例中,该泵可具有在其入口和出口之间延伸的轴,该刚性延长构件可具有从该泵壳体的轴偏离的轴。 [0008] In some embodiments according to this aspect of the apparatus of the present invention, the pump may have a shaft extending between the inlet and the outlet, the rigid elongate member may have a shaft of the pump housing from the deviation of axis. 优选地,该延长构件的延伸方向基本上与该泵的轴平行。 Preferably, the elongate member extending in a direction substantially parallel to the pump shaft.

[0009] 该延长构件可包括在其近端和远端方向延伸的孔,该装置进而包括通过该孔延伸到泵的配线。 [0009] The elongate member may be a bore extending at its proximal end and includes a distal direction, the apparatus further comprises a wire extending into the pump through the aperture. 该装置可进一步包括限定出孔的管状流出插管,该孔在其近端处有连接到该泵出口的入口。 The apparatus may further comprise an aperture defining a tubular outflow cannula, the hole connected to the inlet of the pump outlet at its proximal end. 优选地,该流出插管在其远端包含尖端,该尖端有至少一个开口,并且最好有多个开口。 Preferably, the effluent containing the cannula at its distal end tip, the tip has at least one opening, and preferably a plurality of openings. 优选地,该流出插管的尖端延伸通过主动脉瓣,但是不到主动脉弓就终止。 Preferably, the tip of the outflow cannula extends through the aortic valve, the aortic arch but not terminated.

[0010] 本发明的另一方面提供了一种在哺乳动物对象心脏中的心室内放置的心室辅助装置。 [0010] Another aspect of the present invention provides a mammalian subject ventricular heart ventricle assist device placement. 优选地,该装置包括锚元件,该锚元件例如是配置为安装在临近对象的心脏的心尖处的环,最好还包括具有近端和远端的延长构件。 Preferably, the apparatus comprises an anchor element, which anchor element is configured as a ring, for example mounted at the apex of the heart near the object, preferably also includes a proximal end and a distal end of elongate member. 优选地,根据该发明的本方面的装置还包括泵,所述泵具有壳体以及流出插管,该流出插管优选在其远端处具有尖端。 Preferably, this aspect of the apparatus according to the invention further comprises a pump having a housing and the outflow cannula, the outflow cannula preferably has a tip at its distal end. 流出插管的该尖端优选是通过主动脉瓣延伸,但是不到主动脉弓就终止。 The outflow cannula tip preferably extends through the aortic valve, but less than the termination of the aortic arch. 该环和该泵固定于该刚性延长构件且彼此远离,从而该刚性延长构件可以使该泵相对于该锚元件保持在合适的位置。 The ring and the pump is fixed to the rigid elongate member remote from one another, so that the rigid elongate member may make the pump relative to the anchoring element is held in place.

[0011] 本发明的另一方面提供了一种在哺乳动物对象中安装心室辅助装置的方法。 [0011] Another aspect of the present invention to provide a method of installing a ventricular assist device in a mammalian subject method. 根据本发明的这一方面的该方法最好包括在对象上安装泵,使得该泵的入口与心脏左心室相连通,并对该泵的流出插管进行定位,使得该流出插管从左心室内延伸通过主动脉瓣,但是不到主动脉弓就终止。 According to this aspect of the process of the present invention preferably comprises a pump mounted on the object, such that the pump inlet in communication with the left ventricle and the outflow cannula of the pump are positioned so that the outflow cannula left heart Indoor extends through the aortic valve, but less than the termination of the aortic arch.

[0012] 本发明的另外一个方面提供了在哺乳动物对象心脏中将心室辅助装置放置在位的另外一种方法。 Another aspect of the [0012] present invention provides another method of a mammalian subject in the chambers of the heart assist device is placed in position in the. 根据本发明的本方面的方法最好包括通过给延长构件设置诸如环的锚元件以及泵,该锚元件和泵彼此远离,从而延长构件使得泵相对于锚元件保持在合适的位置, 将该泵穿过对象的心脏的心尖中的开口,并进入对象的心脏的心室内区域,并将该锚元件安装在对象的心脏的心尖处。 According to this aspect of the present invention preferably comprises a member disposed such as to extend through to the anchor element and the pump ring, the anchor element and the pump away from each other, thereby extending the member such that the pump with respect to the anchoring element is held in place, the pump through the heart of the object of the apical opening, and into the heart of the subject area of the ventricle, and the anchor element is mounted at the apex of the heart of the object. 优选地,该泵还包含管状流出插管,该泵和插管通过该锚元件和延长构件来定位,从而该流出插管的尖端延伸通过主动脉瓣,但是不到主动脉弓就终止。 Preferably, the pump further comprises a tubular outflow cannula, the pump and cannula through the anchor member and the elongate member to locate, so that the tip of the outflow cannula extends through the aortic valve, the aortic arch but not terminated.

附图说明 Brief Description

[0013] 图1是根据本发明一个实施例的心室辅助装置的图解立体图。 [0013] Figure 1 is a schematic perspective view of a ventricular assist device in accordance with one embodiment of the present invention.

[0014] 图2是图1中的装置从不同透视角度的图解立体图。 [0014] Figure 2 is a perspective view of the apparatus from different angles diagrammatic perspective view of FIG.

[0015] 图3和图4是用于图1中的装置的某些部件的立体图。 [0015] FIG. 3 and FIG. 4 is a perspective view of certain components of the Figure 1 apparatus.

[0016] 图5和图6是描述图1中所示装置的某些部分的内部立体图。 [0016] FIG. 5 and FIG. 6 is a perspective view of some of the description of the internal parts of the apparatus shown in FIG.

[0017] 图7A、图7B和图7C是描述用于图1中装置的部件的局部视图。 [0017] Figures 7A, 7B and 7C are diagram describing components of the apparatus 1 for partial view.

[0018] 图8A和8B是描述根据本发明的另一实施例的装置的部分的图解立体图。 [0018] Figures 8A and 8B are a perspective view of a portion of the described embodiment illustrating the apparatus according to another embodiment of the invention.

[0019] 图9和图10是图1中心室辅助装置在已安装的情况下与心脏的某些结构相结合的图示。 [0019] FIG. 9 and FIG. 10 is a diagram of a central chamber support device is installed in the case of some of the structures of the heart with the combination shown.

[0020] 图11是描述根据另一实施例的装置的部分的图解立体图。 [0020] FIG. 11 is a part of the apparatus according to another embodiment of the diagrammatic perspective view of FIG.

[0021] 图12是沿图11中线AA的概略剖面图。 [0021] FIG. 12 is a schematic cross-sectional view taken along the center line AA of FIG. 11.

[0022] 图13〜图19是描述根据另一实施例的装置的部分的图解立体图。 [0022] FIG. 13~ 19 is a perspective view illustrating a portion of the device described in another embodiment of FIG. 具体实施方式 DETAILED DESCRIPTION

[0023] 参照附图,其中相同的附图标记表示相同的元件,在图1-2中描述了总体上由附图标记10标示的本发明的心室辅助装置的实施例。 [0023] Referring to the drawings, wherein like reference numerals denote like elements, described in Example ventricular generally indicated by the reference numeral 10 of the present invention, auxiliary apparatus in Figures 1-2. 如图1-2所示,装置10有四个不同的部分,这些部分包括泵20,流出插管40,刚性延长构件60和环80。 1-2, the apparatus 10 has four different parts, which includes a pump 20, the outflow cannula 40, the rigid elongate member 60 and the ring 80.

[0024] 泵20如图2-5所示。 [0024] The pump 20 shown in Figure 2-5. 泵20是轴流泵,该轴流泵具有安置此处称为泵轴的轴19上的入口21和出口23。 20 is an axial flow pump, the axial pump shaft having an axis placed here called the inlet 21 and outlet 23 on 19. 该泵具有由管状壳体22所限定的轴孔29,该轴孔在该入口和该出口之间延伸。 The pump has 29, the axial bore extending from the shaft hole 22 of the tubular housing defined between the inlet and the outlet. 壳体22由诸如陶瓷和如钛等金属的生物相容性材料制成。 Housing 22 is made of a biocompatible material such as a ceramic and a metal such as titanium, or the like. 用于置入下述的电机定子中的该壳体的那些部分的材料最好是诸如陶瓷的非磁性介电材料。 Those portions of the material of the housing for inserting below the motor stator is preferably a non-magnetic dielectric material such as ceramic. [0025] 电机定子24置于管状壳体22的外部周围。 [0025] motor stator 24 is placed around the outside of the tubular housing 22. 通过布置该电机定子以提供旋转磁场。 By arranging the stator to provide a rotating magnetic field. 优选地,定子24同时包含磁性叠片和线圈(未图示)。 Preferably, the stator laminations 24 and contains a magnetic coil (not shown). 电流依次通过线圈以产生必要的旋转电磁场。 Current passes through the coil to generate the necessary rotating electromagnetic field. 定子24可以是传统的有槽或无槽设计或可利用环形设计。 The stator 24 may be a conventional slotted or slotless design or an annular design available.

[0026] 转子26置入图6中所示的孔29中,并与定子24成一直线。 Holes as shown in [0026] rotor 26 into 29 in FIG. 6, and the stator 24 in a straight line. 转子26可由一整块磁化且生物相容的钼钴合金或钼钴硼合金制成。 Magnetized rotor 26 may be a single piece of molybdenum and cobalt-molybdenum-cobalt alloy or boron biocompatible alloy. 该转子具有和泵轴19重合的中心轴,并包括多个叶片34,叶片34从所述轴向外伸出并大体上呈螺旋状地围绕轴弯曲,该螺旋状具有随着转子的轴长而变化的倾斜角度。 The rotor shaft 19 and coincident with the central axis, and comprising a plurality of blades 34, vanes 34 extending from the axially outer and substantially spirally around the shaft is bent, with the helical axis of the rotor having a length The inclination angle change. 该叶片限定了它们之间的流通道36。 The blade defining a flow channel 36 between them. 叶片34可配置为使其圆周表面用作流体力学的轴承。 Blade 34 can be configured so that the circumferential surface serves as a hydrodynamic bearing. 为了在运转中获得更大的流体力学的稳定性,每个叶片上可设有多个流体力学的轴承面,并且所述轴承面沿转子轴长方向隔开。 In order to obtain greater stability of hydrodynamics in operation, the bearing surface may be provided on each blade of the plurality of fluid mechanics, and spaced from the bearing surface along the axial direction of the rotor. 这些转子叶片34可以是磁化的,以与电机定子24磁耦合。 The rotor blades 34 can be magnetized to a magnetic coupling with the motor stator 24. 为了磁极的对称性,转子叶片34的数目优选为两个或四个。 For symmetry poles, the number of rotor blades 34 is preferably two or four. 在运转过程中,转子被驱动以高转速旋转,转速通常为大约8000〜大约40000rpm,优选为在大约15000〜25000rpm之间。 In operation, the rotor is driven at a high rotational speed, the rotational speed is generally about 8000~ about 40000rpm, preferably between about 15000~25000rpm. 该转子叶片在轴向上向着出口23推动壳体内的血液。 The rotor blades in the axial direction toward the outlet 23 to promote blood within the housing.

[0027] 该转子和定子的特征总体上可如上述的共同转让的未决的第12/072471号美国专利申请所述。 [0027] As described above can be commonly assigned copending U.S. Patent Application No. 12/072471 the overall characteristics of the rotor and the stator. 然而,这个实施例中的泵通常比专门安置于动脉之中的泵大。 However, this embodiment is generally larger than the pump placed in the artery among specialized pump. 例如,用于此实施例中的泵外径大约为21毫米,长约34毫米,并可具有外径约为10毫米的转子。 For example, for this embodiment of the pump external diameter of approximately 21 mm, length 34 mm, outer diameter of about 10 mm and having a rotor. 该泵最好配置为在约为100毫米汞柱的压头下提供约4〜6升/分钟的流速。 The pump is preferably configured to provide about 4 ~ 6 liters / min at a flow rate of about 100 mm Hg pressure head. 作为上述的整块磁性转子的替换,也可以使用将磁铁封在由非磁性材料形成的转子中的传统转子设计。 As the magnetic rotor replacement block as described above, may be used to seal the rotor magnet is formed by a non-magnetic material in a conventional rotor designs.

[0028] 该泵还包括扩散叶片28,该扩散叶片28安装在壳体22中转子26的下游,并位于该转子和出口23之间。 [0028] The vane pump further includes a diffuser 28, the diffuser vane 28 is mounted downstream of the rotor 26 in the housing 22, and is located between the rotor and the outlet 23. 在图3,5和6中最容易看出,每个扩散叶片大体上呈板状叶片形式固定在壳体上,并从壳体壁以放射状伸入所述孔中。 In Figure 3, 5 and 6, most easily seen, each of the diffuser blades form a substantially plate-like blade fixed to the casing, and from the housing wall radially into said bore. 在图3中最容易看出,最接近转子26 的扩散叶片28的上游端围绕轴19在圆周的方向上弯曲。 In the most easily seen in Figure 3, the upstream end of the diffuser blades 28 of the rotor 26 is closest to the bent around the shaft 19 in the circumferential direction. 该扩散叶片的弯曲方向与转子叶片的弯曲方向相反。 Bending direction opposite the bending direction of the diffuser vanes and rotor blades. 优选地,扩散叶片的数目与转子叶片的数目不等,且扩散叶片的数目不是泵叶片数目的整数倍或不是泵叶片数目的整除数。 Preferably, the number of diffuser blades is unequal number of rotor blades, and the number of diffuser blades is not an integer multiple of the number of pumping vane pumping vanes or not the number of divisible. 因此,当该转子叶片数目为偶数时,该泵最好有奇数个扩散叶片,比如有三个或五个扩散叶片28。 Therefore, when the number of the rotor blades is an even number, the pump preferably has an odd number of diffuser blades, such as three or five diffuser blades 28. 这种安排有利于在泵运行中使转子的稳定性最大化,而使振动最小化。 This arrangement is conducive to maximizing the stability of the rotor of the pump is running manipulation, leaving the vibration is minimized. 然而,应该认识到也可使用两个、四个或多于五个扩散叶片28。 However, it should also be recognized that the use of two, four or more than five diffuser blades 28. 运转过程中,从转子处流经下游的血液具有由转子所施加的转动惯量。 During operation, flows through the blood at a downstream from the rotor by a rotor having a moment of inertia applied. 当血液遇到扩散叶片时,该转动惯量转化为轴向惯量和压头(pressure head)。 When the blood encounters diffuser blades, the moment of inertia and the inertia is converted to axial pressure head (pressure head). 因此,扩散叶片用于回收产生旋转运动的能量,并将该能量转化为有用的泵作业。 Therefore, the diffusion blades for rotary motion to generate energy recovery, and the pump energy into useful work. 在这个实施例中,该扩散叶片并未在轴处互相连接。 In this embodiment, the diffuser vanes not connected to each other at the axis. 这种安排节省了孔内空间,从而使轴流最大化。 This arrangement saves space hole, so that the axial flow maximization.

[0029] 泵20具有围绕壳体22和电机定子24的外罩。 [0029] The pump 20 has a housing case 22 and around the motor stator 24. 该外罩可由诸如钛的生物相容性金属、陶瓷或生物相容性聚合物形成。 The cover may be a biocompatible metal such as titanium, ceramic, or a biocompatible polymer. 也会利用外部抗血栓涂层来提高血液相容性。 Also use an external anti-thrombotic coating to improve blood compatibility. 该外罩限定了靠近入口21的位于壳体近端的第一连接部分30。 The housing defines an inlet located near the proximal end of the housing 21 of the first connecting portion 30. 该第一连接部分30 (图2)具有凹腔38,该凹腔以平行于泵轴19但偏离于该泵轴的方向延伸进入该外罩。 The first connecting portion 30 (FIG. 2) has a cavity 38, the cavity to be parallel to but offset from the shaft 19 in the direction of the pump shaft extends into the housing.

[0030] 该设备还包含延长构件60,该构件具有近端61、远端63和贯通孔62。 [0030] The apparatus further comprises elongate member 60, the member 61 having a proximal end, a distal end 63 and the through hole 62. 优选地,延长构件60具有沿该构件延伸方向的轴,该轴与该泵体的轴19平行,但是在这两个轴的横向上偏移于轴19。 Preferably, the elongate member 60 having a shaft extending in a direction along the member, the shaft 19 parallel to the pump axis, but in the two axes of the lateral shift in the shaft 19. 在此仅仅通过举例的方式,延长构件60可以是由钛或其他生物相容性的金属制成的管子。 In this only by way of example, elongate member 60 may be a tube made of titanium or other biocompatible metal. 构件60最好是充分刚性的。 Member 60 is preferably sufficiently rigid. 也就是说,当该系统置于心脏内部时,在通常施加于该系统的负载之下,该构件最好是具有足够的刚性以保持该泵20处于合适的位置, That is, when the system is placed inside the heart, usually under a load applied to the system, the member is preferably sufficiently rigid to hold the pump 20 in the proper position,

6相对于环80基本上没有运动。 6 with respect to the ring 80 is substantially no movement. 延长构件60优选为具有球体90,该球体90安装于沿构件60的长度方向远离于远端63的位置。 Elongate member 60 is preferably a sphere 90, the sphere 90 is mounted in the longitudinal direction along the member 60 away from the distal end 63 of the position. 球体90最好是通过例如焊接的方式固定连接于构件60。 Sphere 90 preferably by way of welding, for example fixedly connected to the member 60.

[0031] 构件60的远端63被接纳到泵20的第一连接部分30的凹腔38中。 [0031] 63 of the distal end member 60 is received in the pump cavity 20 of the first connecting portion 30 of the 38. 优选地,构件60的远端是通过永久的、流体密封的连接以连接到该泵的该连接部分,例如通过将构件60 焊接到泵的罩上。 Preferably, the distal member 60 is through a permanent, fluid-tight connection to the connecting portion is connected to the pump, for example by the member 60 is welded to the pump housing. 电源线67从该电机的定子24延伸穿过构件60的孔62,并通过位于该构件近端的配件100延伸到该构件的外面。 The power cord 67 out from the stator 24 of the motor 60 extends through a hole member 62 and extends into the member through the proximal end of the fitting member is located in the 100. 在配件100处,或远端63和泵的所述连接部分的连接处,优选地有流体密封的馈孔(未图示),或者两处都有馈孔。 In the fitting 100, or 63 and a distal end connected to the pump connection portion, preferably has a fluid-tight feed-through (not shown), or have two feed-through. 该电线从配件100延伸出去并延伸到患者身体外部或植入患者身体内部的电源(未图示)上。 The wire extends away from fitting 100 and extends outside the patient's body or implanted in a patient's body internal power supply (not shown). 优选地,该电源是经皮能量传递(transcutaneous energy transfer)或“ΤΕΤ”设备。 Preferably, the power supply is a transcutaneous energy transfer (transcutaneous energy transfer) or "ΤΕΤ" device. 这种设备包含可植入单元,该可植入单元具有电池和电感线圈。 Such apparatus comprises an implantable unit, the implantable unit having a battery and the inductor. 该可植入单元通常被安装于远离心脏靠近患者皮肤的地方。 The implantable unit away from the heart are typically mounted in place near the skin of the patient. 通过患者佩戴的外部单元中包含的电感线圈给该可植入单元的电感线圈提供能量。 Coils external unit worn by the patient included in the inductance coil to the implantable unit provide energy. 该内部电池在患者没有佩戴外部单元期间供应持续的运转。 The internal battery during the patient is not wearing an external unit supply continued operation.

[0032] 流出插管40从泵20的远端27向远处延伸。 [0032] 40 27 outflow cannula extending from the distal end 20 of the pump to the distance. 流出插管40大体呈中空管的形式,具有连接于泵20的近端且与泵的出口23 (图3)相连通。 Outflow cannula 40 forms a generally hollow tube having a proximal end connected to the pump 20 and the pump outlet 23 (FIG. 3) communicates. 该流出插管在远端处具有尖端70。 The outflow cannula having a tip at the distal end 70.

[0033] 优选地,流出插管40是由以下材料制成的单个模制的聚合物,这些材料例如是热塑性聚氨酯(与下列物质嵌段和/或共聚:硅酮(silicone),聚碳酸酯-氨酯,聚醚-氨酯, 脂肪族聚碳酸酯,或其他添加剂),硅酮,聚碳酸酯-氨酯,聚醚-氨酯,脂肪族聚碳酸酯,有或无催化剂金属的硅酮材料或者是磺化苯乙烯聚合物。 [0033] Preferably, outflow cannula 40 is a single molded polymeric material from the following, these materials are for example thermoplastic polyurethane (blocks with the following materials and / or copolymer: silicone (silicone), polycarbonate - urethane, polyether - urethanes, aliphatic polycarbonate, or other additives), silicone, polycarbonate - urethane, polyether - urethanes, aliphatic polycarbonate, with or without catalytic metal silicon ketone or sulfonated styrene polymer material. 为提升弯曲性能和导管在通常的X 光或荧光透视检查(fluoroscopy)下的非侵入性可见性,流出插管40优选地可由含或不含钛丝的结构浇铸。 To enhance the bending properties and catheter in a conventional X-ray or fluoroscopy (fluoroscopy) under non-invasive visibility, outflow cannula 40 is preferably titanium wire may be with or without casting structure. 该流出插管40包含硫酸钡或其他矿物质或金属条带标记,用以在植入患者过程中或植入患者之后通过荧光透视检查、CAT或其他放射性技术来提供可视标示位置。 The outflow cannula 40 contains barium sulfate or other minerals or metal strips labeled for patients after implantation process, or implanted in the patient by fluoroscopy, CAT or other radioactive labeling techniques to provide a visual position.

[0034] 流出插管40可以是直的或弯曲的,最好是有适当的刚度和硬度,以适应固有的心脏和主动脉根部形状,也与组织有非创伤性连接。 [0034] The outflow cannula 40 may be straight or curved, preferably with the appropriate stiffness and hardness to accommodate the inherent shape of the heart and the aortic root, there are also non-invasive tissue connection. 该插管直径可以从泵体20到接近该插管的远端逐渐变细到更小的直径。 The diameter of the cannula from the distal end of the cylinder 20 to close the cannula is tapered to a smaller diameter. 如下文所述,在设备植入患者时该插管的远端将延伸通过主动脉瓣。 As described below, when the device is implanted in a patient the distal end of the cannula extending through the aortic valve. 直径向其自身远端逐渐缩减的插管可以在其近端由于大直径而提供相对较低的流动阻力,同时在主动脉瓣处提供理想的小直径部分。 Diameter distal end tapers to itself due to the large diameter of the cannula may provide a relatively low flow resistance at its proximal end, while providing the desired small diameter portion at the aortic valve. 位于主动脉瓣处的该小直径部分有助于使主动脉瓣关闭不全最小化,例如,会使由于该插管周围三叶密封的不良导致的通过该主动脉瓣的倒流最小化。 The small diameter portion located at the aortic valve helps to minimize aortic regurgitation, for example, can make intubation due to the poor seal around the clover caused by the aortic valve backflow minimized. 该插管横截面最好是圆形,至少在被植入时将要穿过主动脉瓣的接近尖端70的区域中横截面是圆形。 The cannula is preferably a circular cross-section, at least when implanted region to be inserted through the aortic valve close to the tip 70 is circular in cross-section. 圆形横截面形状也可以使主动脉瓣关闭不全最小化。 Circular cross-sectional shape can also minimize aortic regurgitation. 在此仅仅作为举例,可携带5升/分钟血液的插管平均内径约为6毫米。 In this example only, can carry 5 liters / min blood cannula average inner diameter of about 6 mm.

[0035] 从图7A-7C中最容易看出,尖端70具有在远端方向向着该插管的轴往内逐渐变细的圆周面,并进而会聚于该插管的远末端74。 [0035] Figures 7A-7C from the most easily seen, tip 70 having a tapered inner shaft to the cannula in the distal direction toward the circumferential surface, and thus converge at a distal end of the cannula 74. 在所述实施例中,该尖端的远端表面在该尖端的远末端限定了平滑而圆顶状的形状。 In the illustrated embodiment, the distal surface of the tip at the distal end of the tip defines a smooth domed shape. 多个开口72延伸穿过该尖端的圆周面。 A plurality of openings 72 extending through the circumferential surface of the tip. 开口72与该插管的内部孔相连通。 Opening 72 with the internal bore of the tube is connected through. 当血液通过开口72排走时,该流动有径向分量,将为插管40提供流体力学的自对中力。 When the blood drain away through the opening 72, the flow has a radial component, cannula 40 will provide hydrodynamic self-centering force. 该对中作用被认为可以进一步使主动脉瓣关闭不全最小化。 The role of the pair is believed to further minimize aortic regurgitation. 此外, 即使该插管尖端紧靠动脉壁,围绕尖端的外围相互隔开的多个开口仍会提供良好的血液流动。 In addition, even if the cannula tip against the artery wall, around the periphery of the plurality of tips spaced openings will still provide a good blood flow. 该尖端70形状在2008年7月16日提交的名为“CANNULA TIP FOR USE WITH A VAD" 的第61/135004号美国临时专利申请中有更详细的描述,该申请以全文引用的方式并入本 The shape of the tip 70 is described in more detail in U.S. Provisional Patent No. 61/135004 Application July 16, 2008 filed entitled "CANNULA TIP FOR USE WITH A VAD" in the application incorporated by reference in its entirety this

7申请 7 apply

[0036] 可以开发一系列流出插管40的尺寸以更好地适应患者固有的各种心脏尺寸。 [0036] to develop the size range of the outflow cannula 40 to better fit the patient inherent in various cardiac size. 优选地,流出插管被预先附在泵20上;然而,各种插管尺寸可以在植入前被提供给该装置以用于手术室中的连接。 Preferably, the outflow cannula is pre-attached to the pump 20; however, a variety of cannula sizes can be provided to the means for connecting the operating room prior to implantation. 流出插管与泵之间的连接是适合将近端保持在位的任意配置。 The connection between the pump outflow cannula is held in place for the proximal any configuration. 插管的近端可以延伸至泵壳体22的远端,并可以用粘合剂固定在位。 The proximal end of the cannula may extend to the distal end 22 of the pump housing, and can be held in place with an adhesive. 替代地,束缚环可以环绕插管的近端,使得插管壁被保持在束缚环和泵壳体之间。 Alternatively, the restraint ring may surround the proximal end of the cannula, so that the insert wall is held between the ring and the pump casing restraint.

[0037] 在这一实施例中,装置10还包括像环80 —样的锚定元件。 [0037] In this embodiment, the apparatus 10 further includes a like ring 80-- like anchoring element. 优选地,环80适用于围绕环80的周长通过缝到沿患者心脏的壁的组织上的方式来安装在邻近患者心尖处。 Preferably, the ring 80 applies around the perimeter of the ring 80 is mounted adjacent to the apex of the patient by means of sewing along the patient to the heart wall tissue. 例如,环80可以是金属结构,该金属结构具有包括许多洞的外缘,以用于将该环缝或钉到心脏壁。 For example, the ring 80 may be a metal structure, the metal structure has included many of the outer edge of the hole to be used for the ring sewn or stapled to the heart wall. 环80的外围可以被诸如聚酯材料、膨体聚四氟乙烯的织物材料覆盖,经过粘结或类似方式以促进该环之上的组织生长来进一步将该环固定在位。 Peripheral ring 80 may be material such as polyester, expanded polytetrafluoroethylene fabric material covered through bonding or similar means to promote tissue growth over the ring to further the ring in place. 名为“IMPLANTC0NNECT0R”的第11/289,410号美国专利申请讲解了这样的环,且该申请以全文引用的方式并入本申请。 Entitled "IMPLANTC0NNECT0R" No. 11 / 289,410 U.S. Patent Application No. explain such a ring, and which application is incorporated by reference in its entirety herein.

[0038] 环80优选地包含球形座84,该球形座适用于与延长构件60的球体90相配合,使得环80枢转地安装于远离泵20的延长构件60上。 [0038] ring 80 preferably comprises a spherical seat 84, the spherical seat is suitable for the extension 90 of the ball member 60 fitted, so that the ring 80 is pivotally mounted to elongate member 60 remote from the pump 20. 在所述的实施例中,该环与该球体之间的枢转连接可以是制造过程中形成的永久性连接。 In the illustrated embodiment, the ring and the pivotal connection between the sphere may be permanent connection formed in the manufacturing process. 例如,球体90可以陷入在生产中彼此永久连接的环的各个元件之间。 For example, the sphere 90 may be caught in the ring between the various elements in the production of a permanent connection to each other. 环80配置为与心脏壁对齐,但也允许旋转运动,以适应固有的心脏运动。 Ring 80 is configured to align with the heart wall, but also allows for rotational movement, to accommodate the natural movement of the heart.

[0039] 在根据本发明一个实施例的植入方法中,上述设备包括环80、构件60、泵20和流出插管40,该设备是作为预组装单元提供。 [0039] In the method of implanting an embodiment of the invention, the above-described apparatus includes a ring 80, member 60, pump 20 and outflow cannula 40, the device is provided as a pre-assembled unit according to. 外科医生接触到心脏,优选地使用左肋下或左胸廓切口来露出左心室尖端。 The surgeon access to the heart, preferably using lower rib cage or left thoracotomy incision to expose the left ventricular tip. 然后对该泵插入点之上的心外膜圆周地应用脱脂棉囊线缝合。 Then the insertion point above the pump epicardial circumference applied cotton bag suture. 狭长切口或十字或X型的通常称为“十字架”的切口,是使用诸如手术叶(scalpel)的切割工具穿过心尖直至左心室内部形成的。 A slit or a cross or X-type is generally referred to as "cross" of the incision, such as surgery using leaf (scalpel) until the cutting tool through the apex of the left ventricle is formed inside. 泵20、构件60和流出插管40继而通过十字切口或狭长切口插入且置于左心室中,使得插管40通过主动脉瓣延伸到主动脉。 Pump 20, member 60 and the outflow cannula 40 and then through the insertion slit or cross-cut and placed in the left ventricle, such that the cannula 40 extends into the aorta through the aortic valve. 如图9和10所示,环80置于心脏外部。 9 and 10, the ring 80 is placed outside of the heart. 通过荧光镜或其他成像技术可以检查部件是否合适放置。 By fluorescence microscopy or other imaging techniques can check component placement is appropriate. 放置之后,通过施加外部电源或可植入电源供应电能来启动该泵,并使用超声心电图来验证恰当的流量。 After placing, by applying an external power supply or an implantable power supply electric power to start the pump, and using echocardiography to verify proper flow. 验证完流量之后,例如通过缝合来闭合构件60周围的十字切口,且环80被固定于心脏壁的外表面。 After verifying the flow rate, for example by stitching to the closure member 60 around the cross-cut, and the ring 80 is fixed to the outer surface of the heart wall.

[0040] 如图9和10所示,在已植入的情况下,环80安装在临近对象的心尖处。 [0040] Figures 9 and 10, in the case of the implanted, the ring 80 is mounted near the apex of the object. 环80和泵体20连接于延长构件60且互相远离,从而刚性延长构件60使得泵20相对于环80处于合适的位置。 Ring 80 and the cylinder 20 is connected to the elongate member 60 and away from each other, so that the rigid elongate member 60 such that the pump 20 with respect to the ring 80 in the proper position. 这保持该泵和流出插管40相对于心脏处于合适的位置。 This maintains the pump and outflow cannula 40 relative to the heart in the right position.

[0041] 主动脉瓣膜是心脏瓣膜之一。 [0041] The aortic valve is one of the heart valves. 它介于左心室和主动脉之间。 It is between the left ventricle and the aorta. 升主动脉108(图10) 是从左心室基部的上部起始的主动脉的部分。 Ascending aorta 108 (FIG. 10) is the upper part of the left ventricle from the base of the initial portion of the aorta. 主动脉弓110也被称为横向主动脉,其开始于右侧第二胸肋关节上缘水平,运行方向开始向上,向后,并在气管前方向左。 Aortic arch 110 may also be called the transverse aorta, which starts at the upper edge of the right side of the second joint Sternocostal horizontal, running direction upwards, back, and left in front of the trachea. 之后主动脉110弓在气管的左侧向后并最终向下传到身体左侧的第四胸椎,在第四胸椎的下沿它与降主动脉112连接在一起。 After the aortic arch 110 rearwardly and downwardly eventually spread to the left of the fourth thoracic body on the left side of the trachea, in the fourth thoracic along it together with the descending aorta 112.

[0042] 如图9所示,当该设备处于已被植入的状态时,该流出插管40通过主动脉瓣延伸进入升主动脉,但最优选的是终止于靠近该主动脉弓Iio处。 [0042] As shown in Figure 9, when the device has been implanted in the state, the outflow cannula 40 extends through the aortic valve into the ascending aorta, but the most preferred is ending adjacent the aortic arch Iio place. 因此,插管40的尖端70置于对象的心脏中远离主动脉瓣处,但是该尖端的远末端74靠近该主动脉弓。 Therefore, the tip of the cannula 40 70 placed in the heart of the subject away from the aortic valve at the far end of the tip but 74 near the aortic arch. 该流出插管40 的位置的优势在于可以使得流出插管和主动脉壁之间的接触最小化,从而使创伤和血栓形 The position of the outflow cannula 40 can be made of the advantage of the contact between the outflow cannula and aortic wall is minimized, so that the trauma and thrombosis

8成最小化。 80% minimum. 由环80和构件60所提供的泵20和流出插管40相对于心脏的牢固定位有助于让该插管尖端正好定位于远离该主动脉瓣的位置。 Provided by the ring member 80 and the pump 20 and outflow cannula 60 40 is firmly positioned relative to the heart so that the cannula tip helps precisely positioned at a position remote from the aortic valve. 由于该设备牢固地保持在心脏内部适当的位置,该插管相对于心脏的移动不可能使该尖端向靠近心室方向移动进入心室内部。 Since the device is firmly held in an appropriate position inside the heart, the cannula can not move relative to the heart so that the moving direction of the tip closer to the ventricle into the ventricle interior.

[0043] 在已经植入的情况下,该泵的轴19延伸靠近心尖,且泵20的入口21大体上指向朝向心尖的方向。 [0043] In the case of already implanted, the pump shaft 19 extends close to the apex, and the inlet 20 of the pump 21 is substantially directed toward the direction of the apex. 延长构件60的长度使得泵20的入口21远离主动脉瓣。 Elongate member 60 such that the length of the inlet 20 of the pump 21 away from the aortic valve. 这种位置和方位提供了一定的优势。 This position and orientation provides certain advantages. 靠近瓣膜的开口的主动脉瓣的纤维结构不会被吸入泵20的入口。 Close to the opening of the aortic valve of the fibrous structure will not be drawn into the pump inlet 20. 此外,泵的入口不会被心室壁或心脏心室间的隔膜所阻塞。 In addition, the inlet of the pump will not be heart wall or septum between the ventricles of the heart are blocked.

[0044] 根据上述的实施例的心室辅助装置提供了心室内部的、全输出、无需佩戴的血泵, 该泵的尺寸适合于胸廓切开术、肋下的或其他的不需要胸骨切开术的移植方法。 [0044] ventricular assist device according to the above-described embodiment provides a ventricular internal, full output, without wearing the blood pump, the pump is sized to thoracotomy, ribs or other unnecessary sternotomy The transplantation. 该设备的大部分位于左心室内部,并向远端方向的主动脉瓣泵血以提供心脏辅助。 Most located inside the left ventricle, the aortic valve to the distal direction to provide the pumping of the heart assist device. 通常适合植入该设备的患者人群类似于做双心室起搏的人群;药物治疗失败且愿意接受4至6小时的手术过程的充血性心力衰竭患者最多需要大约5天的住院。 Generally suitable for implantation of the device is similar to the patient population of people do biventricular pacing; drug treatment failure and congestive heart failure patients are willing to accept 4-6 hours of surgical procedure can take up to about five days of hospitalization. 这些患者非常虚弱,最初需要4至6升/分钟的支持,长期可能只需要2至3升/分钟的支持。 These patients are very weak, initially need 4-6 liters / minute support, long-term may only need 2-3 liters / minute support.

[0045] 可以对上述讨论的特征做出不同的变化和结合。 [0045] features discussed above can make different variations and combinations. 例如,装置10可以在该泵20、刚性延长构件60和环80的外部周围含有薄硅或其他聚合物的浸渍模制涂层。 For example, device 10 may comprise a thin coating of silicon or other polymer impregnated molded at 20, the rigid elongate member 60 and the outer periphery of the ring 80 of the pump. 浸渍模制聚合物也可以由肝素、抗凝血药物、内皮组织生长因子、抗生素或亲水凝胶来改变。 Dipping molded polymer can also be changed by the growth of heparin, an anticoagulant drug, endothelial tissue factor, antibiotics or hydrophilic gel. 通过上述扩展的浸渍模制处理,该流出插管可以使用一次性内核由相同的浸渍模制处理来生成,该一次性内核在使用该装置之前从该浸渍模制插管中移除。 By impregnating the expanded molding process, the outflow cannula may be used by the same dipping disposable core molding process to generate the one-time kernel is removed from the impregnated molded cannula prior to use of the device. 这种处理可以生成没有接缝的或是无附加装置的插管以作为该泵壳体的一个完整部分,并与上述浸渍涂覆的构件相连。 Such processing may generate no seams or cannula without additional means as an integral part of the pump housing, and is connected to the above-described dip coating member. 该锚定元件可由浸渍模制聚合物形成或覆盖。 The anchoring element may be formed or molded polymer impregnated overlay.

[0046] 在另一变形中,在图1的配置中使用的球体90固定于该环或其他锚定元件的球形座中。 [0046] In another variation, the ball used in the configuration of Figure 1, the spherical seat 90 is fixed to the ring or other anchoring element. 在另一变形中,该球体和座可以被枢转接合所替代,该枢转接合允许该锚定元件仅围绕一个转动轴作枢转运动。 In another variation, the sphere and the seat may be pivotally coupled replaced, which is pivotally coupled to the anchoring element is allowed only around a rotation axis for pivotal movement. 在另一实施例中,该锚定元件的位置沿该延长构件的长度方向是可调的。 In another embodiment, the position of the anchoring member along the longitudinal direction of the elongate member is adjustable. 例如,该锚定元件或环可包括夹子,该夹子被配置为通过旋转或通过使锚定元件的一部分相对于另一部分移动,从而使夹子紧固在延长构件周围,以使得该夹子处于紧固的状态。 For example, the anchoring element or ring may include a clamp which is configured by rotation or by a part of the anchoring element relative to the other portion, thereby moving the clip to extend around the fastening member, so that the clamp is in a tightened state. 例如该锚元件可以包含类似于用于固定机械师的工具的套筒及套筒夹头。 For example, the anchor element may contain fixed sleeve and collet similar mechanic for tools. 在另一变形中,该延长构件可以通过螺纹接合到锚定元件,使得该锚定元件的位置可以通过旋转该锚定元件向着或者远离泵作调整,然后使用锁螺母或其他设备锁定该锚定元件以防止其进一步旋转。 In another variation, the elongate member may be threadedly engaged to the anchoring element, so that the position of the anchoring element can be obtained by rotating the anchoring element is adjusted toward or away from the pump, and a lock nut or other device to lock the anchor member to prevent further rotation. 在另一变形中,该延长构件60可以有相当的柔韧性,同时又有足够的刚性以将该泵和流出插管保持在适当的位置上。 In another variation, the elongate member 60 may have a considerable flexibility, while there are rigid enough to maintain the pump and outflow cannula in place on. 例如,该延长构件60可以是由相对硬的线做成的拉长的螺旋弹簧。 For example, the elongate member 60 may be a line made of relatively stiff elongated helical spring. 在该延长构件内部延伸的电线可以是螺旋的或者以其他方式盘旋的以在伸缩中提高抗疲劳性。 In the extended inner wire extending member may be a coil or otherwise convoluted in order to improve the fatigue resistance of the stretch.

[0047] 图8A和8B显示了该延长构件和锚定元件的两种选择性的配置。 [0047] Figures 8A and 8B show two alternative the elongate member and the anchoring element configuration. 如图8A所示,延长构件160具有设置于其近端处的环或锚定元件102。 8A, the extension member 160 has a ring disposed at the proximal end thereof or the anchoring element 102. 锚定元件102有锥形的远端表面103 和近端表面105,近端表面105大体上与构件160的延长轴方向垂直。 The anchoring element 102 has a tapered distal surface 103 and proximal surface 105, a proximal end surface 105 extend substantially perpendicular to the axial direction of member 160. 在植入过程中,锚定元件102通过十字切口进入心室内部。 In the implantation procedure, the anchoring element 102 into the ventricle through the interior cross-cut. 该切口在围绕构件60的靠近表面105的部分闭合, 使该锚定元件的表面105与心肌层的内表面相接合。 The slit around the portion near the surface 105 of the member 60 is closed, so that the inner surface of the anchoring element surface 105 engages with the myocardium. 心肌外表面上可使用囊线缝合。 The outer surface of the capsule can be used cardiac suture. 锚定元件102与上述的锚定元件或环80以类似的方式阻止该延伸部件、泵和流出插管相对于心脏的轴向位移。 And said anchoring element 102 of the anchoring element or ring 80 in a similar manner to block the extension member, the pump and outflow cannula axial displacement with respect to the heart. 当以这种方式植入时,该心肌层围绕延长构件160的靠近锚定元件102的部分闭合。 When implanted in this way, the elongate member 160 around the myocardium near the anchoring portion 102 of the closure element. 在这一区域,刚性构件60比如通过烧结可选择地设有粗糙的表面,以促进组织向内生长进而止血。 In this region, the rigid member 60 such as optionally provided with a roughened surface by sintering, in order to promote tissue ingrowth and further bleeding. 替代地,该延长构件的这一部分也可以保持平滑。 Alternatively, this portion of the elongate member can be maintained smooth. 可以使用诸如构件102的内部锚定元件来替代或补充上述的诸如环80的外部稳固构件。 You can use an external member such as an internal member 102 securely anchoring element to replace or supplement the above, such as ring 80.

[0048] 如图8B所示的装置与图8A中的装置除了该延长构件包括更大直径的根部104之外,其他部分相似,根部104从锚定元件向着近端延伸。 Means in the apparatus of FIG. 8A is shown in Figure 8B [0048] In addition to the elongate member comprises a larger diameter than the root 104, the other part similar to the anchoring element from the root 104 extends toward the proximal end. 该加大的根部104为组织向内生长提供了更大的表面积。 The enlarged root tissue ingrowth 104 provides greater surface area. 该根部104的表面可经过例如烧结的处理来促进组织向内生长。 The root surface 104 may be subjected to treatment such as sintering to promote tissue ingrowth.

[0049] 在其他配置中,该锚元件可以不是圆环,而是包括一个或多个足,该一个或多个足在靠近该延长构件的近端处从该延长构件横向延伸,该足被配置为接合到心尖附近的心脏壁的内部或者外部,或者内部外部同时接合。 [0049] In other configurations, the anchor element may be not a ring, but includes one or more feet, the one or more foot near the proximal end of the elongate member extending laterally from the elongate member, the foot being configured to engage the heart wall near the apex internal or external, internal or external engagement simultaneously. 替代地,该锚元件的横截面可以是非圆形的。 Alternatively, the anchor element may be non-circular cross-section. 例如,该锚元件可以具有其他的几何外形,比如三角形,卵形,椭圆形或其他几何外形。 For example, the anchor member may have other geometric shapes, such as triangular, oval, elliptical or other geometric shape.

[0050] 该延长构件可具有不同的配置。 [0050] The elongate member may have a different configuration. 应该理解,这些替换的配置只是举例,在不脱离本发明的范围的情况下可以使用不同的配置。 It should be understood that these alternative configurations of example only, can use different configurations without departing from the scope of the present invention is the case. 如图11-12所示,延长构件160具有近端161、 远端163和贯通孔162。 As shown in Figure 11-12, elongate member 160 has a proximal end 161, a distal end 163 and the through hole 162. 在这个实施例中,延长构件160具有沿该构件延伸方向的轴,该轴平行于泵体的轴119,但是在这两个轴的横向上偏离于轴119。 In this embodiment, the extension member 160 has a member extending along the direction of the axis, the axis parallel to the axis of the pump body 119, but in deviation from the two axes transverse to the axis 119. 延长构件160具有流体力学的外表面165,例如如图12中的横截面所示的流线型的表面。 Extension having an outer surface 165 of fluid mechanics, e.g. streamlined surface 12 as shown in cross-section of member 160. 流线型表面165可以促进左心室内部沿横跨延长构件160方向上的流体流动。 Streamlined surface 165 may facilitate extend across the left ventricular internal fluid flow along the 160 direction member.

[0051] 在如图13所示的另一变形中,延长构件260有近端261、远端263和贯通孔262。 [0051] In another variant shown in FIG. 13, the elongate member 260 has a proximal end 261, a distal end 263 and the through hole 262. 延长构件260是管道状的且具有外弯曲表面265和内弯曲表面267。 Elongate member 260 is pipe-shaped and has an outer curved surface 265 and the inner curved surface 267. 远端263优选地连接到泵的入口。 The distal end 263 is preferably connected to the inlet of the pump. 如图14中的延长构件260的立体图所示,外表面265被设计为让血液以该管道中的箭头所指示的沿延长构件260的纵向容易通过,并进入泵的入口。 14 is a perspective view of extension member 260 as shown, the outer surface 265 is designed to allow blood to the conduit along the arrow indicated by the longitudinal extension member 260 easily through, and into the inlet of the pump. 该管道的内径可与该泵入口的直径相似。 The inner diameter of the pipe may be similar to the diameter of the pump inlet. 这种类型的构件可被连接到该泵接近泵轴处的近端,而不阻塞进入该泵的血流。 This type of member may be connected to the pump at the proximal end of the shaft close to, without blocking the blood flow into the pump. 孔262被设计为允许从电机定子延伸出的电源线被安置于孔262中。 Hole 262 is designed to allow the motor stator extending from the power supply line is disposed in the bore 262.

[0052] 如图15所示,延长构件360沿该构件长度方向是弯曲的。 Shown in [0052] Figure 15, extension member 360 along the longitudinal direction of the member is curved. 延长构件360优选地具有允许电源线放置和延伸通过而构造的孔362。 Elongate member 360 preferably has a permit to place the power cord and extends through the hole 362 constructed.

[0053] 如图16所示,该装置可包含多个锚元件80和延长构件60。 [0053] As shown in Figure 16, the apparatus may comprise a plurality of anchor elements 80 and the extension member 60. 在本实施例中,多个延长构件优选在泵20上具有单独的连接点。 In the present embodiment, a plurality of elongate member preferably has a separate point of attachment to the pump 20. 优选地,这个实施例中的延长构件60基本上互相平行。 Preferably, this embodiment of the elongate member 60 is substantially parallel to each other. 在这里,锚元件80和泵固定在延长构件60上并彼此远离,从而该延长构件使该泵相对于该锚元件处于合适的位置。 Here, the anchor element 80 and the pump is fixed on the elongate member 60 and away from each other, so that the elongate member so that the pump with respect to the anchor element in the appropriate position.

[0054] 流出插管40可被本文所述的固定于泵20的移植内腔材料所替代。 [0054] The outflow cannula 40 may be secured to the pump described herein lumen graft material 20 replaced. 该移植内腔可以是具有凝胶结构的同源聚合物,或注入肝素或抗血栓材料,或使用诸如胶原质的目标组织向内生长促进因子来扩张。 The lumen of the target tissue transplantation may be a homologous polymer gel structure, or injection of heparin or antithrombotic material, such as collagen, or the use of growth promoting factors to expand inwardly. 与流出插管40相似,该移植材料可以是逐渐变细的,并与聚合物尖端相配合,或形成终端尖端。 Similar to the outflow cannula 40, the graft material may be tapered and the tip cooperates with the polymer, or the formation of terminal tip. 该移植材料的尖端可配置用于提供上述的流体力学的自对中作用。 The tip of the graft material can be configured to provide the above-mentioned self-centering effect of hydrodynamics for.

[0055] 在另一实施例中,参照图1所描述的流出插管40可以具有侧孔(未图示),这些侧孔在该插管的孔和该插管接近尖端70的外表面之间延伸,在已植入的情况下这些侧孔位于该插管的处于主动脉瓣的内部的区域。 [0055] In another embodiment, described with reference to FIG. 1, the outflow cannula 40 may have a side hole (not shown), the side hole in the cannula bore and close to the outer surface of the cannula tip 70 of the extends between, in the case of these implanted cannula side holes are located in the interior of the aortic valve area. 这种侧孔优选比该插管尖端的开口72具有更大的流动阻力,使得源自该泵的血流的主要部分直接通过该尖端流出该插管。 This side hole preferably opening ratio of the cannula tip 72 has a larger flow resistance, so that the main part of the flow from the pump directly into the cannula through the tip. 然而,来自侧孔的血流趋于减少瓣膜的叶与该插管之间的碰撞,并限制对瓣膜的损坏。 However, the blood flow from the side of the hole tends to reduce the collision of the leaf valve between the cannula and to limit damage to the valve. 此外,在靠近主动脉瓣的叶的位置,插管40可配有垫子或箍带(未图示)。 Further, at a position close to the aortic valve leaf, cannula 40 may be equipped with cushion or cuff (not shown). 这种垫子最好设置为与主动脉瓣根相配合以在该插管上保持对中力,并在一定程度上抑制倒流。 This mat is preferably set to the aortic root cooperate to maintain the force on the cannula, and inhibit backflow to some extent. 然而,这种垫子最好不要完全阻塞通过该主动脉瓣的顺流。 However, this mat is best not completely blocked by the aortic valve downstream.

[0056] 在其他实施例中,该流出插管可以是非圆形的而选择其他的几何外形,比如三角形,卵形,椭圆形或像其他几何外形。 [0056] In other embodiments, the outflow cannula may be non-circular geometry selected other, such as triangular, oval, elliptical or other geometric shapes like. 如图17-18所示,流出插管140横截面大体上是三角形。 Shown in Figure 17-18, the outflow cannula 140 is substantially triangular cross-section. 流出插管140可以是直的或是弯曲的,最好具有适当的刚度和硬度,以适应固有的心脏和主动脉根部形状,同时与组织有非创伤性连接。 Outflow cannula 140 may be straight or curved, preferably with the appropriate stiffness and hardness to accommodate the inherent shape of the heart and the aortic root, while the tissue non-invasive connection. 在这里,该插管的横截面尺寸优选地朝远离泵体20的远端方向逐渐变细。 Here, the cross-sectional dimension of the cannula is preferably towards the distal direction away from the pump housing 20 is tapered. 这里,当装置被植入患者后,该流出插管优选地通过主动脉瓣延伸。 Here, when the device is implanted in a patient, the outflow cannula preferably extends through the aortic valve. 这里,在该主动脉瓣处使用相对小的横截面有利于使主动脉瓣关闭不全最小化, 例如,使由于该插管周围的三叶密封不足导致的通过该瓣膜的倒流最小化。 Here, the use of a relatively small cross-section of the aortic valve in place in favor of aortic regurgitation is minimized, for example, so that due to lack of clover around the cannula seal caused by the backflow valve is minimized.

[0057] 流出插管140的三角形横截面允许插管140的三个单独的外表面中的每一个都与三叶主动脉瓣的各个叶144相配合。 [0057] The outflow cannula 140 allows cannula 140 triangular cross-section of the three separate outer surfaces of each of the respective leaf clover aortic valve 144 cooperates. 插管140的大致三角形横截面配置为允许插管140的外表面和主动脉瓣的叶144进行超级配合。 Cannula 140 is substantially triangular cross-section configured to allow the outer surface 140 of the cannula and aortic valve leaf 144 super fit. 凭借该大体上三角形的横截面形状,主动脉瓣的每个叶都能与该插管的侧表面相配合,该侧表面大体上是平的或者是有大的曲率半径。 With the cross-sectional shape is substantially triangular, each leaf of the aortic valve with the side surface of the cannula can mate, said side surface is substantially flat or has a large radius of curvature. 这增强了瓣膜对于插管的密封能力。 This enhances the sealing capability of the valve to the cannula. 锚元件相对于患者心尖的固定也有助于抑制泵20绕该泵自身的轴19旋转,进而有助于保持该流出插管140处于理想的方位,即流出插管的每一个侧表面面向主动脉瓣的各个叶。 With respect to the fixed anchor element also helps to suppress the patient's apical pump 20 of the pump about their own axes of rotation 19, thereby helping to keep the outflow cannula 140 is in the desired orientation, i.e., each side surface facing the aortic outflow cannula various lobes.

[0058] 在如图19所示意描述的另一实施例中,该泵的扩散叶片128可以连接到公共轮轴131上,该轮轴131沿该泵的轴19延伸。 [0058] FIG. 19 schematically described in another embodiment, the diffusion of the vane pump 128 can be connected to a common axle 131, the axle 131 19 extends along the pump shaft. 该扩散叶片和轮轴可以制成分离的单元,这个单元可以安装在该泵的管状壳体122中远离转子134的位置。 The diffuser blades and the axle may be made of separate units, the pump unit may be mounted in the tubular housing 122 in a position away from the rotor 134.

[0059] 虽然参考具体实施例说明了本发明,应理解这些实施例只是用于说明本发明的原理和应用。 [0059] Although described with reference to specific embodiments of the present invention, to be understood that these examples are illustrative only of the principles and applications of the present invention. 因此应理解,在不脱离由所附权利要求所限定的本发明的精神与范围的情况下, 可对所述说明性的实施例和其他配置作出各种变化。 Should therefore be understood that, without departing from the spirit and scope as defined by the appended claims of the present invention, the can to the illustrative embodiments and that various other changes in the configuration.

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Classifications
International ClassificationA61F2/24
Cooperative ClassificationA61M1/122, A61M1/1008, A61M1/125, A61M1/101, A61M1/1012, A61M1/1031, A61M2210/125, A61M2205/103, A61M2205/04, A61M1/1036
European ClassificationA61M1/10C
Legal Events
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9 Feb 2011C06Publication
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