CN116135246A - Auxiliary blood circulation system and conveying system thereof - Google Patents

Abstract

Translated fromChinese

本发明的辅助血液循环系统及其输送系统中，辅助血液循环系统包括：支架，其包括网状结构，支架可以径向扩张，以锚定于血管的预定位置；血泵组件，其包括泵壳、转动轴和叶轮，泵壳的远端与所述支架的近端连接，所述叶轮设置于所述转动轴的远端，所述转动轴和所述叶轮容置于所述泵壳中，所述转动轴自转以带动所述叶轮转动，血泵组件可以抽吸血液，帮助心脏做功。如上配置，可通过设置具有径向扩张特性的网状结构的支架将血泵组件固定于血管中，相比现有技术通过垫片与血管内壁接触，本发明中支架与血管的管壁具有更大的接触面积，使得二者固定效果更好，可避免血泵组件在血管中的轴向移动和径向偏转，保证血泵组件在支架的作用下与血管同轴放置。

In the auxiliary blood circulation system and its delivery system of the present invention, the auxiliary blood circulation system includes: a stent, which includes a mesh structure, and the stent can be radially expanded to be anchored at a predetermined position of the blood vessel; a blood pump assembly, which includes a pump housing , a rotating shaft and an impeller, the far end of the pump casing is connected to the proximal end of the bracket, the impeller is arranged at the far end of the rotating shaft, the rotating shaft and the impeller are housed in the pump casing, The rotating shaft rotates on its own to drive the impeller to rotate, and the blood pump assembly can pump blood to help the heart work. As configured above, the blood pump assembly can be fixed in the blood vessel by setting a stent with a radially expanding mesh structure. Compared with the prior art, the spacer is in contact with the inner wall of the blood vessel. In the present invention, the stent and the wall of the blood vessel have a stronger The large contact area makes the fixing effect of the two better, which can avoid the axial movement and radial deflection of the blood pump component in the blood vessel, and ensure that the blood pump component is placed coaxially with the blood vessel under the action of the stent.

Description

Auxiliary blood circulation system and conveying system thereof

Technical Field

The invention relates to the technical field of medical equipment, in particular to an auxiliary blood circulation system and a conveying system thereof.

Background

In the event that the heart loses pumping function (e.g., a stop-beat heart surgery, acute cardiogenic shock, etc.) or is weak, a blood pump may be used in place of the heart to assist in maintaining blood circulation in the human body. Blood pumps can be classified into implantable blood pumps and extracorporeal blood pumps according to implantable and clinical uses. Implantable blood pumps can be implanted in patients to temporarily or chronically maintain blood circulation in the human body, and are used primarily for graft replacement therapy in patients with end-stage heart failure. Extracorporeal blood pumps may be used ex vivo to provide transitional life support and therapy with less trauma.

For implantable blood pumps, it is often necessary to fix the blood pump at a specific position on the vessel wall by means of a stent, and the blood pump can work normally, and if the stent has an undesirable effect on fixing the position of the blood pump, secondary damage can be caused to the patient. In the prior art, a supporting rod is generally adopted to fix a blood pump at a specified position on a blood vessel wall, specifically, the proximal end of the supporting rod is connected with the blood pump, the distal end of the supporting rod is provided with a gasket, and the gasket is directly contacted with the inner wall of the blood vessel, so that the purpose of fixing the position of the blood pump by the supporting rod can be realized through the contact of the gasket and the inner wall of the blood vessel. However, in the prior art, the contact area between the gasket and the vessel wall is relatively small, and the gasket is easy to move in the vessel along the axial direction of the supporting rod and deflect in the vessel along the radial direction of the supporting rod, so that the blood pump moves axially and deflects radially in the vessel, and the specified position of the blood pump and the vessel wall is deviated. In addition, in the prior art, a flexible shaft is generally adopted to finely adjust the position of the blood pump and the position of a bracket for finely adjusting and fixing the blood pump, but the adjustment mode has poor effect and cannot accurately adjust the positions of the blood pump and the bracket corresponding to the blood pump.

Disclosure of Invention

The invention aims to provide an auxiliary blood circulation system and a conveying system thereof, which are used for solving the problem that the fixing mode of a blood pump in a blood vessel wall in the prior art easily causes axial movement and radial deflection of the blood pump.

To solve the above-mentioned technical problem, according to a first aspect of the present invention, there is provided an auxiliary blood circulation system comprising:

a stent comprising a mesh structure, the stent being radially expandable to anchor to a predetermined location of a vessel;

the blood pump assembly comprises a pump shell, a rotating shaft and an impeller, wherein the distal end of the pump shell is connected with the proximal end of the bracket, the impeller is arranged at the distal end of the rotating shaft, the rotating shaft and the impeller are accommodated in the pump shell, and the rotating shaft rotates to drive the impeller to rotate.

Optionally, the auxiliary blood circulation system comprises a plurality of flexible connectors, the distal ends of which are connected to the brackets, and the proximal ends of which extend through the pump housing to connect with an external adjustment system.

Optionally, the distal end of the bracket is provided with at least one protruding structure.

Optionally, when the distal end of the bracket is V-shaped and the opening direction of the V-shape is the direction of the distal end toward the proximal end, the corner of the V-shape is provided with a flexible structure.

Optionally, the pump casing is provided with a window penetrating through the side wall, and the impeller is located at the window.

Optionally, the radial dimension of the stent is greater than or equal to the radial dimension of the pump casing when the stent is constrained from radial expansion by a sheath.

Optionally, after the stent is radially expanded, the radial dimension of the stent gradually decreases from the distal end to the proximal end.

Optionally, the auxiliary blood circulation system comprises a flexible transmission shaft, and the flexible transmission shaft is fixedly connected with the blood pump assembly.

Based on another aspect of the invention, the invention also provides a delivery system for detachable connection with an auxiliary blood circulation system as described above and for carrying the auxiliary blood circulation system into a blood vessel.

Optionally, the delivery system includes a sheath for receiving the secondary blood circulation system and limiting radial expansion of the stent.

In summary, in the auxiliary blood circulation system and the conveying system thereof provided by the present invention, the auxiliary blood circulation system includes: a stent comprising a mesh structure, the stent being radially expandable to anchor to a predetermined location of a vessel; the blood pump assembly comprises a pump shell, a rotating shaft and an impeller, wherein the distal end of the pump shell is connected with the proximal end of the support, the impeller is arranged at the distal end of the rotating shaft, the rotating shaft and the impeller are accommodated in the pump shell, the rotating shaft rotates to drive the impeller to rotate, and the blood pump assembly can suck blood and help the heart to do work. According to the configuration, the blood pump assembly can be fixed in the blood vessel by arranging the support with the net-shaped structure with the radial expansion characteristic, compared with the prior art, the blood pump assembly is contacted with the inner wall of the blood vessel through the gasket, the support has larger contact area with the wall of the blood vessel, so that the fixing effect of the support and the blood vessel is better, the axial movement and the radial deflection of the blood pump assembly in the blood vessel can be avoided, and the blood pump assembly and the blood vessel are ensured to be coaxially placed under the action of the support.

Drawings

It will be appreciated by those skilled in the art that the drawings are provided for a better understanding of the invention and do not constitute any limitation on the scope of the invention. Wherein:

FIG. 1 is a schematic illustration of an auxiliary blood circulation system positioned in a blood vessel in accordance with an embodiment of the present invention;

FIG. 2 is a disassembled view of an auxiliary blood circulation system according to an embodiment of the present invention;

fig. 3 is a schematic view of an auxiliary blood circulation system in a sheath according to an embodiment of the present invention.

In the accompanying drawings:

10-a bracket; 11-a bump structure;

a 20-blood pump assembly; 21-a pump housing; 210-windowing; 22-impeller; 23-rotating shaft;

30-blood vessel;

40-flexible connection;

50-flexible structure;

60-sheath;

70-flexible drive shaft.

Detailed Description

The invention will be described in further detail with reference to the drawings and the specific embodiments thereof in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are not drawn to scale, merely for convenience and clarity in aiding in the description of embodiments of the invention. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments.

As used in this disclosure, the singular forms "a," "an," and "the" include plural referents, the term "or" are generally used in the sense of comprising "and/or" and the term "several" are generally used in the sense of comprising "at least one," the term "at least two" are generally used in the sense of comprising "two or more," and the term "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying any relative importance or number of features indicated. Thus, a feature defining "first," "second," "third," or "third" may explicitly or implicitly include one or at least two such features, with "one end" and "another end" and "proximal end" and "distal end" generally referring to the respective two portions, including not only the endpoints, but also the terms "mounted," "connected," "coupled," and "connected" are to be construed broadly, e.g., as being either a fixed connection, a removable connection, or as being integral therewith; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. Furthermore, as used in this disclosure, an element disposed on another element generally only refers to a connection, coupling, cooperation or transmission between two elements, and the connection, coupling, cooperation or transmission between two elements may be direct or indirect through intermediate elements, and should not be construed as indicating or implying any spatial positional relationship between the two elements, i.e., an element may be in any orientation, such as inside, outside, above, below, or on one side, of the other element unless the context clearly indicates otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

The invention provides an auxiliary blood circulation system and a conveying system thereof, which are used for solving the problem that the axial movement and radial deflection of a blood pump are easily caused by the fixing mode of the blood pump in a blood vessel wall in the prior art.

An auxiliary blood circulation system and a delivery system according to an embodiment of the present invention will be described with reference to the accompanying drawings.

As shown in fig. 1 and 2, fig. 1 is a schematic view of an auxiliary blood circulation system in a blood vessel according to a first embodiment of the present invention, and fig. 2 is a disassembled view of the auxiliary blood circulation system according to the first embodiment of the present invention, where the auxiliary blood circulation system includes: astent 10 comprising a mesh structure, saidstent 10 being radially expandable to anchor to a predetermined location of ablood vessel 30, further thestent 10 extending generally in the direction of the blood vessel; theblood pump assembly 20 comprises apump shell 21, arotating shaft 23 and animpeller 22, wherein the distal end of thepump shell 21 is connected with the proximal end of thebracket 10, theimpeller 22 is arranged at the distal end of the rotatingshaft 23, therotating shaft 23 and theimpeller 22 are accommodated in thepump shell 21, and the rotatingshaft 23 rotates to drive theimpeller 22 to rotate. It is understood that radial expansion of thestent 10 refers to radially outward expansion of thestent 10 in its own right such that the cross-sectional area of thestent 10 increases, and that thestent 10 also has the characteristic of radially contracting, and that radial contraction of thestent 10 refers to radially inward contraction of thestent 10 in its own right such that the cross-sectional area of thestent 10 decreases. Theblood pump assembly 20 may be implanted and secured to a designated location in theblood vessel 30 by anchoring thestent 10 to thevessel 30 at a predetermined location.

Specifically, thepump casing 21 in the present embodiment has a substantially columnar shape, the axial direction of thepump casing 21 is substantially parallel to the axial direction of theblood vessel 30, and the center axis of therotation shaft 23 substantially coincides with the center axis of thepump casing 21. Referring to fig. 2, the blood flow direction in the present embodiment can be specifically set to be in a distal-to-proximal direction, and in addition, at least onewindow 210 penetrating the sidewall is provided on thepump casing 21, and theimpeller 22 is accommodated in thepump casing 21 and is located at thewindow 210. In a practical scenario, therotation shaft 23 rotates to drive theimpeller 22 to rotate, so that power is generated in the blood flow direction, blood is pumped out of the ventricle and flows out of thewindow 210 of the pump shell 21 (see the direction shown in fig. 1 in detail), and thus theimpeller 22 can help the heart to do work and treat the heart failure patient. Regarding the manner of driving therotation shaft 23 to rotate, therotation shaft 23 may be connected to a motor for driving therotation shaft 23 to rotate to drive theimpeller 22 to rotate, that is, the motor transmits torque to theimpeller 22 through therotation shaft 23. The motor may be disposed outside the patient body or inside the patient body, and the present invention is not limited to this, but is not limited to the driving method of the motor, and other similar power components may be used.

In this embodiment, thestent 10 includes a mesh structure, which may be woven according to a plurality of wires, or may be a mesh structure formed by fixing after laser cutting, which is not limited in the present invention. The present embodiment is not limited to the specific form of the mesh structure, and may be, for example, wavy, crown-shaped, irregularly shaped, or the like. The wires woven into the mesh structure may be nitinol wires to ensure thestent 10 has expansibility. Further, when the distal end of thestent 10 having a mesh structure is sharp, it may be preferable to provide aflexible structure 50 at the distal end of thestent 10 to avoid puncturing the vessel wall by the distal end of thesharp stent 10 or to avoid puncturing with a greater depth, thereby avoiding discomfort experienced by the patient. In an exemplary embodiment, referring to fig. 1, for example, when the distal end of thestent 10 is V-shaped and the opening direction of the V-shape is the direction of the distal end toward the proximal end, theflexible structure 50 may be disposed at the corner of the V-shape, and theflexible structure 50 of this embodiment may be made of a silicone material, for example, and theflexible structure 50 may be disposed to protect the wall of theblood vessel 30 after thestent 10 is abutted against the wall of theblood vessel 30.

In addition, the present invention provides a delivery system detachably connected to the auxiliary blood circulation system as described above and used to carry the auxiliary blood circulation system into theblood vessel 30, and also controls the radial expansion and radial contraction of thestent 10. Specifically, the delivery system implants an auxiliary blood circulation system into thevessel 30, controlling the release of thestent 10, i.e., controlling the transition of thestent 10 from a radially contracted state to a radially expanded state, so as to be in anchored engagement with thevessel 30. After thestent 10 is anchored to thevessel 30, theblood pump assembly 20 is further released and finally the delivery system is separated from the auxiliary blood circulation system and withdrawn from the patient. In addition, the doctor can withdraw the auxiliary blood circulation system from the blood vessel through the delivery system, i.e., the doctor can control the recovery of thestent 10 of the auxiliary blood circulation system into the sheath of the delivery system (i.e., thestent 10 is converted from a radially expanded state to a radially contracted state).

Further, referring to fig. 3, fig. 3 is a schematic view of an auxiliary blood circulation system in a sheath according to an embodiment of the present invention, the delivery system includes asheath 60, and thesheath 60 is used to house the auxiliary blood circulation system and limit radial expansion of thestent 10. Specifically, the auxiliary blood circulation system is housed within the sheath 60 (including but not limited to thestent 10 and theblood pump assembly 20 being housed within the sheath 60), and as thesheath 60 is implanted in the patient and is inserted into theblood vessel 30, thestent 10 is constrained from expanding radially by thesheath 60 itself, i.e., thestent 10 is housed within thesheath 60 in a radially contracted state. The physician controls the detachment of thestent 10 from thesheath 60 and release to a predetermined location in thevessel 30 by manipulating the relevant components of the delivery system, thereby detaching theblood pump assembly 20 from thesheath 60, and accordingly, the physician may also control the sequential retraction of theblood pump assembly 20 andstent 10 into thesheath 60 by manipulating the relevant components of the delivery system.

Preferably, the auxiliary blood circulation system comprises a plurality offlexible connectors 40, the distal ends of theflexible connectors 40 being connected to thesupport 10, the proximal ends of theflexible connectors 40 extending through the blood pump assembly 20 (in particular through the pump housing 21) for connection to an external adjustment system. Theflexible connector 40 may be a surgical suture, nitinol wire, or the like. In a practical scenario, an operator can control the flexible connectingpiece 40 in different directions through an external adjusting system, or pull the flexible connectingpiece 40 through other components, so as to accurately adjust the positions of thebracket 10 and theblood pump assembly 20.

Of course, based on the same concept, it is also possible to connect the proximal end of thestent 10 to the distal end of a rigid connector, the proximal end of which is connected to an external adjustment system by a flexible cord (which may be a surgical suture).

Further, the auxiliary blood circulation system includes aflexible drive shaft 70, and theflexible drive shaft 70 is fixedly connected to theblood pump assembly 20. The position of theblood pump assembly 20 andstent 10 in theblood vessel 30 can be macroscopically adjusted by pulling on theflexible drive shaft 70, and fine tuning is then achieved by theflexible connection 40.

Preferably, the radial dimension of thestent 10 is greater than or equal to (preferably greater than) the radial dimension of thepump housing 21 when thestent 10 is constrained from radial expansion by asheath 60, i.e., when thestent 10 is received in thesheath 60. It is understood that the radial dimension herein refers to the radially largest dimension of thecarrier 10/pump housing 21, and the radial dimension refers to the diameter when the cross section of thecarrier 10/pump housing 21 is circular. As configured above, it is possible to ensure that a gap is provided between thepump housing 21 and the wall of thesheath 60 when thestent 10 and theblood pump assembly 20 are retracted in thesheath 60, since the radial dimension of thestent 10 is larger than the radial dimension of thepump housing 21, so that the frictional resistance can be reduced when thestent 10 and theblood pump assembly 20 are delivered and retracted, facilitating the operation.

Preferably, after thestent 10 is radially expanded, the radial dimension of thestent 10 gradually decreases from the distal end to the proximal end, so that the radial dimension of the proximal end portion of thestent 10 is smaller than the radial dimension of the distal end portion of thestent 10, the anchoring and fitting of the distal end portion of thestent 10 and the vessel wall of thevessel 30 are ensured, a gap is formed between the proximal end portion of thestent 10 and the vessel wall of thevessel 30, and the whole of thestent 10 is prevented from being abutted against the vessel wall of thevessel 30 after the radial expansion, which is not beneficial to the subsequent fine adjustment of the position of thestent 10.

Preferably, referring to fig. 1 and 2, the distal end of thestent 10 is provided with at least oneprotrusion 11, and further, theprotrusion 11 is formed to protrude substantially radially outwards (in a direction away from the central axis of the stent 10) of thestent 10, and thestent 10 is radially expanded to support the wall of theblood vessel 30 and is recessed in the wall of the blood vessel, so that the supporting and anchoring effects are better.

In summary, in the auxiliary blood circulation system and the conveying system thereof provided by the present invention, the auxiliary blood circulation system includes: a stent comprising a mesh structure, the stent being radially expandable to anchor to a predetermined location of a vessel; the blood pump assembly comprises a pump shell, a rotating shaft and an impeller, wherein the distal end of the pump shell is connected with the proximal end of the support, the impeller is arranged at the distal end of the rotating shaft, the rotating shaft and the impeller are accommodated in the pump shell, the rotating shaft rotates to drive the impeller to rotate, and the blood pump assembly can suck blood and help the heart to do work. According to the configuration, the blood pump assembly can be fixed in the blood vessel by arranging the support with the net-shaped structure with the radial expansion characteristic, compared with the prior art, the blood pump assembly is contacted with the inner wall of the blood vessel through the gasket, the support has larger contact area with the wall of the blood vessel, so that the fixing effect of the support and the blood vessel is better, the axial movement and the radial deflection of the blood pump assembly in the blood vessel can be avoided, and the blood pump assembly and the blood vessel are ensured to be coaxially placed under the action of the support.

The foregoing description is only illustrative of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention in any way, and any changes and modifications made by those skilled in the art in light of the foregoing disclosure will be deemed to fall within the scope and spirit of the present invention.

Claims (10)

Translated fromChinese

1.一种辅助血液循环系统，其特征在于，包括：1. An auxiliary blood circulation system, comprising:支架，其包括网状结构，所述支架可以径向扩张，以锚定于血管的预定位置；a stent comprising a mesh structure, said stent being radially expandable for anchoring at a predetermined location in a blood vessel;血泵组件，其包括泵壳、转动轴和叶轮，所述泵壳的远端与所述支架的近端连接，所述叶轮设置于所述转动轴的远端，所述转动轴和所述叶轮容置于所述泵壳中，所述转动轴自转以带动所述叶轮转动。A blood pump assembly, which includes a pump casing, a rotating shaft and an impeller, the distal end of the pump casing is connected to the proximal end of the bracket, the impeller is arranged at the distal end of the rotating shaft, the rotating shaft and the The impeller is accommodated in the pump casing, and the rotating shaft rotates to drive the impeller to rotate.2.根据权利要求1所述的辅助血液循环系统，其特征在于，所述辅助血液循环系统包括多个柔性连接件，所述柔性连接件的远端与所述支架连接，所述柔性连接件的近端延伸穿过所述泵壳，以与外部的调整系统连接。2. The auxiliary blood circulation system according to claim 1, characterized in that, the auxiliary blood circulation system comprises a plurality of flexible connectors, the distal ends of the flexible connectors are connected to the bracket, and the flexible connectors The proximal end extends through the pump housing to connect with the external adjustment system.3.根据权利要求1所述的辅助血液循环系统，其特征在于，所述支架的远端设有至少一处凸起结构。3. The auxiliary blood circulation system according to claim 1, wherein at least one protruding structure is provided at the distal end of the stent.4.根据权利要求1所述的辅助血液循环系统，其特征在于，当所述支架的远端呈V形，且V形的开口方向为远端朝向近端的方向时，所述V形的角部设有柔性结构。4. The auxiliary blood circulation system according to claim 1, characterized in that, when the distal end of the stent is V-shaped, and the opening direction of the V-shape is the direction from the distal end to the proximal end, the V-shaped The corners are provided with flexible structures.5.根据权利要求1所述的辅助血液循环系统，其特征在于，所述泵壳设有贯通侧壁的开窗，所述叶轮位于所述开窗处。5 . The auxiliary blood circulation system according to claim 1 , wherein the pump casing is provided with a window penetrating through the side wall, and the impeller is located at the window.6.根据权利要求1所述的辅助血液循环系统，其特征在于，所述支架被一鞘管限制径向扩张时，所述支架的径向尺寸大于或等于所述泵壳的径向尺寸。6 . The auxiliary blood circulation system according to claim 1 , wherein when the radial expansion of the stent is restricted by a sheath, the radial dimension of the stent is greater than or equal to the radial dimension of the pump housing.7.根据权利要求1所述的辅助血液循环系统，其特征在于，所述支架径向扩张后，所述支架的径向尺寸自远端向近端的方向逐渐减小。7 . The auxiliary blood circulation system according to claim 1 , wherein after the stent is radially expanded, the radial dimension of the stent gradually decreases from the distal end to the proximal end.8.根据权利要求1所述的辅助血液循环系统，其特征在于，所述辅助血液循环系统包括柔性传动轴，所述柔性传动轴与所述血泵组件固定连接。8. The auxiliary blood circulation system according to claim 1, characterized in that, the auxiliary blood circulation system comprises a flexible transmission shaft, and the flexible transmission shaft is fixedly connected with the blood pump assembly.9.一种输送系统，其特征在于，所述输送系统用于与权利要求1～8中任一项所述的辅助血液循环系统可拆卸地连接，并用于携带所述辅助血液循环系统介入血管中。9. A delivery system, characterized in that the delivery system is used to detachably connect with the auxiliary blood circulation system according to any one of claims 1 to 8, and is used to carry the auxiliary blood circulation system to intervene in blood vessels middle.10.根据权利要求9所述的输送系统，其特征在于，所述输送系统包括一鞘管，所述鞘管用于容置所述辅助血液循环系统，并限制所述支架的径向扩张。10 . The delivery system according to claim 9 , wherein the delivery system comprises a sheath for accommodating the auxiliary blood circulation system and limiting radial expansion of the stent. 11 .

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