WO2023071858A1

WO2023071858A1 - Catheter device

Info

Publication number: WO2023071858A1
Application number: PCT/CN2022/125819
Authority: WO
Inventors: 颜翊凡; 李本帅
Original assignee: 苏州心擎医疗技术有限公司
Priority date: 2021-10-25
Filing date: 2022-10-18
Publication date: 2023-05-04
Also published as: CN113995952A; CN113995952B

Abstract

The present invention provides a catheter device, comprising: a motor; a catheter; a driving shaft rotatably passing through the catheter and driven by the motor; a pump assembly which can be conveyed to an expected position of the heart by means of the catheter to pump blood and comprises a pump housing connected to the distal end of the catheter, and an impeller accommodated in the pump housing, the impeller being driven by the rotating shaft to rotate; and a poking member which is connected to the distal end of the pump housing, is at least partially made of a flexible and elastic material, and has a folded state and an unfolded state, wherein in the unfolded state, the whole poking member is located on one side of the axis of the catheter, and obliquely extends towards the distal-end direction of the catheter.

Description

a catheter device

technical field

The invention relates to the technical field of ventricular assist devices, in particular to a catheter device.

Background technique

Ventricular assist devices are devices used to assist the heart of a mammalian subject (eg, a human patient). A typical left ventricular assist device includes a pump that is inserted into the subject's body. A pump typically has an inlet connected to a source of blood to be circulated, and an outlet connected to an artery. Most typically, the inlet of the pump is connected to the interior of the left ventricle and the outlet of the pump is connected to the aorta so that the pump operates in parallel with the left ventricle to push blood into the aorta.

Before the inlet of the pump enters the left ventricle, it crosses the aortic valve (valve) between the left ventricle and the aorta. The function of the aortic valve is similar to that of a one-way valve, which prevents the backflow of blood and ensures that the blood flow of the heart flows forward in one direction, from the left ventricle to the aorta. In the prior art, the pump generally achieves valve spanning through the guide wire in the pigtail (pigtail structure) at its distal end. The above-mentioned way of achieving valve spanning through the guide wire has the defects of complex structure and cumbersome operation.

Therefore, it is necessary to improve the prior art to overcome the defects in the prior art.

technical problem

The purpose of the present invention is to provide a catheter device, which does not need to use a guide wire to achieve valve crossing during the process of delivering the pump assembly to the heart, and has the advantages of simple structure and convenient use.

technical solution

In order to solve the above technical problems, the present invention provides a catheter device, including: a motor; a catheter; a drive shaft that is rotatably inserted in the catheter and driven by the motor; a pump assembly that can be driven by the catheter through the catheter. pumping blood to the desired position of the heart, including a pump casing connected to the distal end of the catheter, an impeller accommodated in the pump casing, and the impeller is driven to rotate by the drive shaft; a pusher is connected to the The distal end of the pump casing is at least partly made of flexible elastic material, and has a folded state and an unfolded state; wherein, in the unfolded state, the push-off part is located on one side of the axis of the catheter as a whole, and faces as a whole The distal direction of the catheter extends obliquely.

Preferably, in the above-mentioned catheter device, in the deployed state, the pushing member has a first outer contour portion close to the axis and a second outer contour portion far away from the axis; In the direction from the end to the distal end, the first outer contour portion warps toward the second outer contour portion in a state of gradually deviating from the catheter axis, and the second outer contour portion gradually deviates from the catheter axis The posture is bent toward the first outer contour portion.

Preferably, in the above-mentioned catheter device, in the deployed state, the first outer contour portion and the second outer contour portion transition smoothly at the junction of the distal end.

Preferably, in the deployed state of the above-mentioned catheter device, the changing trend of the first outer contour portion and the second outer contour portion is monotonous in the direction from the proximal end to the distal end.

Preferably, in the above-mentioned catheter device, in a deployed state, the region of the second outer contour part near the distal end is gentler than the region near the proximal end.

Preferably, in the above-mentioned catheter device, in the folded state, the first outer contour portion extends substantially straight along the axial direction.

Preferably, in the above-mentioned catheter device, in the unfolded state, the opening member has a sheet-like structure.

Preferably, in the above-mentioned catheter device, in the direction along the first outer contour portion to the second outer contour portion, the thickness of the opening member gradually decreases.

Preferably, in the above-mentioned catheter device, in the collapsed state, the second outer contour portion is wound outside the first outer contour portion.

Preferably, in the above-mentioned catheter device, in the unfolded state, the opening member (200) has a ring structure.

Preferably, in the above-mentioned catheter device, the opening member includes an elastic membrane disposed between the first outer contour portion and the second outer contour portion, and the elastic membrane is configured to provide tension to the annular structure , so as to define the shape of the opening member in the unfolded state.

Preferably, in the above-mentioned catheter device, in the collapsed state, the second outer contour part and the first outer contour part are at least partially in contact with each other along the axial direction and bonded together.

Preferably, in the above-mentioned catheter device, the thickness of the opening member decreases gradually along the direction from the proximal end to the distal end of the catheter.

Preferably, in the catheter device described above, a developing component is arranged on the opening member.

Preferably, in the above conduit device, the developing component is disposed close to the area of the second outer contour portion; or, the developing component is disposed close to the edge of the opening member.

Preferably, in the above-mentioned catheter device, the opening member is configured to be in a deployed state during delivery in a vessel of a subject.

Preferably, in the above-mentioned catheter device, an axially slidable restraint is provided outside the catheter, and the opening member responds to the axial movement of the restraint to switch between the folded state and the unfolded state. switch between; the restraint is configured as a short sheath.

Preferably, in the catheter device described above, the pump housing has a suction port, and the opening member is configured to be supported on the inner wall of the ventricle during the operation of the pump assembly, so that the suction port is separated from the inner wall of the ventricle. open.

Preferably, in the above-mentioned catheter device, the opening member is configured to use its own shape to open the heart valve and guide the pump assembly into the ventricle.

Beneficial effect

The present invention utilizes the feature that the opening part is located on one side of the axis of the catheter and extends obliquely toward the distal end of the catheter as a whole to realize the spanning of the heart valve without using a guide wire, and has the advantages of simple structure and convenient use.

Description of drawings

Fig. 1 is a structural schematic diagram when the opening part of the catheter device proposed by the present invention is in a sheet-like structure in an unfolded state;

Fig. 2 is a schematic structural view of the opening part in Fig. 1;

Fig. 3 is a schematic cross-sectional structure diagram of a push-away part in Fig. 1;

Fig. 4 is a schematic diagram of the opening part in Fig. 1 when it is in a folded state;

Fig. 5 is a schematic structural view of the opening part of the catheter device proposed by the present invention when it is in a ring-shaped structure in the unfolded state;

Fig. 6 is a schematic structural view of the opening part in Fig. 5;

Fig. 7 is a schematic diagram of the opening part in Fig. 5 when it is in a folded state;

Fig. 8 is a schematic diagram of the opening part in Fig. 5 when it has an internal hollow ring structure;

Fig. 9 is a schematic diagram when the opening part in Fig. 5 is in a solid ring structure;

Fig. 10 is a schematic diagram of the case where an elastic film is provided on the opening part in Fig. 5 .

Embodiments of the present invention

The present invention will be described in detail below in conjunction with specific embodiments shown in the accompanying drawings. However, these embodiments do not limit the present invention, and any structural, method, or functional changes made by those skilled in the art according to these embodiments are included in the protection scope of the present invention.

The terms "near", "rear" and "far" and "anterior" used in the present invention are relative to clinicians. The terms "proximal" and "posterior" refer to the part relatively close to the clinician, and the terms "distal" and "anterior" refer to the part relatively far away from the clinician.

The terms "inner" and "outer" used in the present invention are relative to the axially extending centerline, the direction relatively close to the centerline is "inner", and the direction relatively far away from the centerline is "outer".

It should be understood that the orientations of "near", "far", "rear", "front", "inner", and "outer" are definitions for convenience of description. However, the catheter device can be used in many orientations and positions, and thus these terms expressing relative positional relationships are not limiting and absolute.

In the present invention, terms such as "connected" and "connected" should be interpreted in a broad sense unless otherwise specified and limited. For example, it can be a fixed connection, a detachable connection, a movable connection, or an integral body; it can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two components or two components. interaction relationship. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.

Referring to FIGS. 1 to 4 , the present invention provides a catheter device, including: a motor 500 , a catheter 100 , a drive shaft, a pump assembly 400 and a pusher 200 . The device can at least partially assist the pumping function of the heart, and achieve the effect of at least partially reducing the burden on the heart.

In an exemplary scenario, the device can be used as a left ventricular assist, and its pump assembly 400 can be inserted into the left ventricle, and the pump assembly 400 can pump the blood in the left ventricle to the ascending aorta when working .

It should be noted that the use of left ventricular assistance in the above example is only a feasible application scenario of the catheter device. In other feasible scenarios that cannot be explicitly excluded, the above-mentioned catheter device can also be used as a right ventricular assist, and the pump assembly 400 can be inserted into the right ventricle, and the pump assembly 400 can pump blood in the vein to the right ventricle during operation .

The following will mainly use the above-mentioned catheter device as left ventricular assistance as the main scenario for illustration. However, based on the above description, it can be seen that the protection scope of the embodiments of the present invention is not limited thereby.

In the present invention, the catheter 100 is a hose, and the drive shaft includes a flexible shaft. The axis of the catheter 100 or the drive shaft refers to the axis when the catheter 100 or the drive shaft is adjusted to extend straight.

The motor 500 is configured to be located outside the body of the subject. The proximal end of catheter 100 is connected to motor 500 . The driving shaft is rotatably passed through the catheter 100 , and the proximal end is connected with the output shaft of the motor 500 to be driven by the motor 500 .

The pump assembly 400 can be delivered to the desired position of the subject's heart through the catheter 100 to pump blood, including a pump housing 410 connected to the distal end of the catheter 100 and having a suction port 411 and a liquid outlet 412, housed in the pump housing 410 and An impeller (not shown) that is drivingly connected to the distal end of the drive shaft. The impeller is driven to rotate by the drive shaft to draw blood into the pump housing 410 from the suction port 411 and discharge it from the liquid outlet 412 .

The dial 200 is connected to the distal end of the pump housing 410 . The opening member 200 is at least partially made of flexible elastic material. That is, the pull-off member 200 is soft so as not to injure the subject's tissue.

The opening member 200 has a folded state and an unfolded state. The opening part 200 stores energy when it is folded, and when the external constraint is removed, the energy storage of the opening part 200 is released, so that the opening part 200 is unfolded. That is to say, the opening part 200 is folded with the help of external constraints, and after the constraint is removed, the opening part 200 realizes self-deployment.

In this embodiment, the "folded state" refers to the state in which the opening member 200 is constrained radially. That is to say, the opening member 200 is radially compressed and folded into a state of a minimum radial size by an external force. The "expanded state" refers to the state in which the opening member 200 is not radially constrained. That is to say, the radially outer side of the opening member 200 is expanded to a state of the largest radial dimension.

In the unfolded state, referring to FIG. 1 and FIG. 2 , the opening member 200 is located on one side of the axis of the catheter 100 and extends obliquely toward the distal end of the catheter 100 as a whole. In the folded state, please refer to FIG. 4 , the opening member 200 is in a one-dimensional state under the effect of external constraints, and is roughly in the shape of a straight line extending along the axis of the catheter 100 .

It should be noted that the push-off part 200 is in a retracted state during the movement of the restraint part 300 to the body of the subject (for example, the femoral artery) described below. During this process, the restraining member 300 exerts a radial restraining effect on the opening member 200 to keep it in a folded state.

And once the opening part 200 passes through the restraining part 300, the above-mentioned constraint is lost, and the opening part 200 will be automatically unfolded. Therefore, in this embodiment, the opening member 200 is in an unfolded state during the process of moving to the desired position of the heart in the subject's body. Alternatively, the pusher 200 is moved toward a desired location of the heart in a deployed configuration.

Further, in the unfolded state, the opening member 200 is in a sheet-like structure. In this embodiment, the above-mentioned sheet structure refers to a sheet structure in which the opening member 200 extends continuously in any direction. That is to say, there is no hole or hollow structure on the opening member 200 .

In this embodiment, the pusher 200 has a first outer contour portion 210 close to the axis and a second outer contour portion 220 far away from the axis. The first outer contour portion 210 and the second outer contour portion 220 constitute the outer contour of the pusher 200 .

Wherein, in the direction along the proximal end to the distal end of the catheter 100, the first outer contour portion 210 is in a state of gradually deviating from the axis of the catheter 100 and warps toward the second outer contour portion 220, and the second outer contour portion 220 is gradually deviating from the axis of the catheter 100. The posture of the axis of the catheter 100 is bent toward the first outer profile portion 210 . Also, in the direction from the proximal end to the distal end of the catheter 100 , the thickness of the poking member 200 gradually decreases.

Thus, the poking member 200 has a substantially lancet-shaped shape. When preparing to straddle the valve, the front end of the opening member 200 can be quickly introduced into the valve leaf gap of the valve, which helps to guide the pump assembly 400 into the left ventricle, thereby achieving rapid and effective valve spanning.

In this embodiment, the opening member 200 uses the characteristics of its own shape to open the heart valve and guide the pump assembly 400 into the ventricle, which effectively reduces the number of parts (no guide wire) and simplifies the structure ( There is no need to consider the threading of the guide wire), and it has the advantages of simple structure and convenient operation. Among them, in the prior art, the crossing of the heart valve is realized through a guide wire, and the guide wire needs to pass through the drive shaft, the impeller of the pump assembly and the pigtail structure, the overall structure is relatively complicated, and the operation is inconvenient.

During the intervention process, the pusher 200 is located at the forefront of the conveying direction and is the leader of the whole device. The distal end of the pusher 200 is located at the front end of the pusher 200, and the shape of the distal end of the pusher 200 greatly affects the safety of the pusher 200 in the vessel of the subject and the reliability of valve crossing. sex.

In order to enable the opening member 200 to open the left ventricular valve conveniently, and to prevent the outer contour of the distal end of the opening member 200 from damaging the vessel of the subject. In this embodiment, in the deployed state, the first outer contour portion 210 and the second outer contour portion 220 transition smoothly at the intersection of the distal end, wherein the area of the second outer contour portion 220 near the distal end is relatively close to The proximal area is flat.

Moreover, in the unfolded state, in the direction from the proximal end to the distal end, the changing trend of the first outer contour portion 210 and the second outer contour portion 220 is monotonous. The above "monotonous" means that the distances between the first outer contour portion 210 and the second outer contour portion 220 and the axis gradually increase. Alternatively, the first outer contour portion 210 and the second outer contour portion 220 extend obliquely from the proximal end to the distal end, without a detour toward the proximal end.

The opening part 200 can form a smooth curved profile at its distal end by adopting the above-mentioned outer contour shape, and form a shape that is roughly narrow at both ends and wide in the middle, which helps the opening part 200 to open the left ventricular valve, so that the pump assembly 400 into the left ventricle to achieve valve spanning. At the same time, it is also possible to avoid forming a sharp shape at the distal end of the detachment member 200 , so that the distal end of the detachment member 200 can be delivered in the vessel of the subject in a non-invasive or non-damaging manner.

When the pump assembly 400 enters the left ventricle to work, the distal end of the pusher 200 is supported on the inner wall of the ventricle in a non-invasive or non-damaging manner, thereby separating the suction port 411 of the pump assembly 400 from the inner wall of the ventricle, preventing the pump assembly 400 from being in the left ventricle. During the working process, due to the reaction force of the fluid (blood), the suction port 411 of the pump assembly 400 is attached to the inner wall of the ventricle to ensure the effective area of pumping.

Please refer to FIG. 3 , the thickness of the opening member 200 gradually decreases along the direction from the proximal end to the distal end of the catheter 100 (direction of the X-axis). The purpose of such arrangement is to reduce the hardness of the distal end of the opening member 200 in the unfolded state, so that the distal end of the opening member 200 has better flexibility.

Therefore, the distal end of the opening member 200 is thinner, which helps to open the valve. At the same time, the distal end of the pusher 200 can also be delivered in the subject's vessel in a non-invasive or non-damaging manner, which is not easy to damage the subject's vessel.

In this embodiment, please continue to refer to FIG. 3 , in the direction along the first outer contour portion 210 to the second outer contour portion 220 (Y-axis direction), the thickness of the opening member 200 gradually decreases. That is to say, the thickness of the first outer contour portion 210 of the pusher 200 is greater than the thickness of the second outer contour portion 220 .

The thicker thickness of the first outer contour portion 210 is for supporting the second outer contour portion 220 in the collapsed state. The thickness of the second outer contour portion 220 is smaller than the thickness of the first outer contour portion 210 in order to have a guiding function in the folded state, so that the opening member 200 is folded into a preset shape.

Specifically, in the folded state, as shown in FIG. 4 , the second outer contour portion 220 is wound outside the first outer contour portion 210 of the opening member 200 under the action of external constraints. Wherein, the first outer contour portion 210 generally extends straight along the aforementioned axis direction.

In the above discussion, the second outer contour part 220 can be wound outside the first outer contour part 210 because the thickness of the second outer contour part 220 is smaller than that of the first outer contour part 210. The second outer contour portion 220 is deformed prior to the first outer contour portion 210 , so that the second outer contour portion 220 has a deformation tendency to wrap around the first outer contour portion 210 .

The reasons why the first outer contour portion 210 deforms behind the second outer contour portion 220 are as follows: first, the thickness of the first outer contour portion 210 is greater than the thickness of the second outer contour portion 220, and during the folding process of the opening member 200 , the second outer contour portion 220 is more likely to be curled by external constraints than the first outer contour portion 210 ; second, the first outer contour portion 210 is closer to the axis of the catheter 100 than the second outer contour portion 220 .

In this embodiment, the above-mentioned external constraint is a constraint member 300 slidably disposed on the outside of the catheter 100 along the axial direction of the catheter 100 . The restraint 300 is used to collapse the pump assembly 400 and the flip 200 . That is to say, the restraining member 300 can perform a folding or unfolding operation on the pump assembly 400 and the opening member 200 . Wherein, the opening member 200 is switched between the folded state and the unfolded state in response to the axial movement of the restraining member 300 .

Further, the restriction member 300 is configured as a short sheath, and the short sheath may specifically be a tubular structure. As described above, different from using a long sheath to constrain the pump assembly 400 and the pusher 200 during the entire intervention process and after intervention in the heart, the short sheath is only used when the sheath is inserted (the sheath is inserted in the pre-opened position) In the wound of the subject's body, which communicates with the vasculature of the subject such as the femoral artery, and a hemostatic valve is provided on it), the pump assembly 400 and the opening part 200 are folded during the intervention process. Once the pump assembly 400 and the opening part After the 200 enters the subject for a certain length, it breaks away from the constraints of the sheath tube and unfolds, so that the pusher 200 intervenes into the ventricle in the unfolded state.

It can be understood that the distal end of the restricting member 300 first acts on the pump assembly 400, and when the restricting member 300 is continuously moving toward the push-off member 200 along the axis, the pump assembly 400 is subjected to the restraining force from the restricting member 300 and is locked. Folding, and then the opening part 200 is also forced into a folded state under the action of the restraining part 300 . At this time, the second outer contour portion 220 is wound outside the first outer contour portion 210 , and the pulling member 200 is approximately in a one-dimensional straight shape.

In this embodiment, the opening member 200 is in an unfolded state during delivery in the subject, but it is not limited thereto. In practice, the pusher 200 can also be transported forward in the vasculature of the subject in a collapsed state. It can be understood that, regardless of whether the push-off member 200 is in the folded state or the unfolded state, the size of the push-off member 200 is smaller than the diameter of the vessel of the subject, so that it can be ensured that the push-off member 200 is in the vessel of the subject delivery.

Further, the pusher 200 is configured to be in a deployed state during delivery in a vessel of a subject. The purpose of such setting is: when the opening member 200 is in the unfolded state, the opening member 200 is roughly in a two-dimensional state, and the overall hardness of the opening member 200 is relatively small and soft. The opening member 200 has a good elastic deformation ability, and can reduce the force between it and the vessel, so as to realize delivery in a non-invasive or non-damaging manner.

Considering that when the opening member 200 intervenes, it is necessary to know the intervention position of the opening member 200 in time. In this embodiment, a developing component is also provided on the opening member 200 , by setting the developing unit, the real-time intervention position of the opening member 200 can be grasped, so that the opening member 200 can be smoothly inserted into the ventricle.

In a possible implementation manner, the developing component may be metal, and may be attached to the outer surface of the opening member 200 . In another possible implementation manner, the developing component may be a developable substance dispersed in the material of the opening member 200 , such as barium sulfate.

Further, the developing component is disposed close to the edge of the opening member 200 . When the opening part 200 hits the inner wall of the vessel, its outer contour will produce a certain amount of deformation. The operator can easily judge whether the opening part 200 touches the inner wall of the vascular tissue by observing the change of the shape of the opening part 200, and then Correct intervention. For example, by rotating the proximal end of the catheter 100, the orientation of the poking member 200 is adjusted.

Considering that the thickness of the second outer contour portion 220 of the pusher 200 is smaller than the thickness of the first outer contour portion 210, the second outer contour portion 220 is easier to deform than the first outer contour portion 210, that is, through the second outer contour portion 210 The deformation of the second outer contour portion 220 is easier to observe. Preferably, the developing component is disposed close to the area of the second outer contour portion 220 .

Therefore, compared with the prior art, the present invention can not only grasp the intervention position of the opening member 200 through the above-mentioned developing component, but also know whether the opening member 200 touches the vascular tissue, and has the advantages of stable and reliable intervention operation .

Furthermore, the opening member 200 of the present invention also has another structural form when it is in the unfolded state. Specifically, please refer to FIG. 5 to FIG. 7 , in the unfolded state, the opening member 200 has a ring-shaped structure, which is different from the above-mentioned structural form when the opening member 200 is in a sheet-like structure.

The ring structure of the opening member 200 means that holes or openings are provided on the opening member 200 . That is to say, the opening member 200 is not a sheet structure extending continuously in any direction.

It is worth noting that although the opening member 200 in this embodiment is not a sheet structure extending continuously in any direction, the opening member 200 itself is in the shape of a sheet. The flake-like setting of the opening member 200 helps to open the valve, and then guide the pump assembly 400 into the left ventricle.

The above-mentioned flake shape means that the dimension in the thickness direction is much smaller than the dimension in the length and width directions. Wherein, the above-mentioned length direction can be understood as a dimension in the X-axis direction, the above-mentioned width direction can be understood as a dimension in the Y-axis direction, and the thickness direction can be understood as a dimension in the Z-axis (not shown) direction.

The opening member 200 may be a solid ring structure, or a hollow ring structure. Accompanying drawing 8 is a schematic diagram when the opening part 200 has an internal hollow ring structure, and accompanying drawing 9 is a schematic diagram when the opening part 200 is a solid ring structure.

Considering that the opening member 200 is at least partially made of flexible elastic material, after the opening member 200 adopts a ring structure, it is difficult to maintain the shape of the opening member 200 in a predetermined shape during the intervention.

Please refer to FIG. 10 , the opening member 200 further includes an elastic film 230 disposed between the first outer contour portion 210 and the second outer contour portion 220 . The elastic membrane 230 is configured to provide tension to the above-mentioned annular structure, so as to define the shape of the opening member 200 in the unfolded state.

In this embodiment, when the opening member 200 is in the folded state, the second outer contour portion 220 and the first outer contour portion 210 are at least partially in contact with each other along the axial direction and bonded together, so that the opening member 200 is radially Towards the compressed state folded to the smallest radial dimension.

The above is only a specific embodiment of the present invention, and any other improvements made on the premise of the concept of the present invention are regarded as the protection scope of the present invention.

Claims

A catheter device, characterized in that it comprises:

motor(500);

catheter (100);

a drive shaft rotatably passed through the catheter (100) and driven by the motor (500);

The pump assembly (400), which can be delivered to the desired position of the heart through the catheter (100) to pump blood, includes a pump housing (410) connected to the distal end of the catheter (100), housed in the pump housing ( 410), the impeller is driven to rotate by the drive shaft;

The opening part (200), connected to the distal end of the pump casing (410), is at least partially made of flexible elastic material, and has a folded state and an unfolded state;

Wherein, in the unfolded state, the pusher ( 200 ) is entirely located on one side of the axis of the catheter ( 100 ), and extends obliquely toward the distal end of the catheter ( 100 ) as a whole.
The catheter device of claim 1, wherein:

In the unfolded state, the pusher (200) has a first outer contour portion (210) close to the axis and a second outer contour portion (220) away from the axis;

Wherein, in the direction from the proximal end to the distal end of the catheter (100), the first outer contour portion (210) gradually deviates from the axis of the catheter (100) toward the second outer contour portion (220) is warped, and the second outer contour portion (220) is bent toward the first outer contour portion (210) in a state of gradually deviating from the axis of the catheter (100).
The catheter device according to claim 2, characterized in that, in the deployed state, the first outer contour portion (210) and the second outer contour portion (220) transition smoothly at the intersection of the distal ends.
The catheter device according to claim 2 or 3, characterized in that, in the expanded state, in the direction from the proximal end to the distal end, the changes of the first outer contour portion (210) and the second outer contour portion (220) Trends are monotonic.
The catheter device according to claim 2 or 3, characterized in that, in the expanded state, the area near the distal end of the second outer contour portion (220) is gentler than the area near the proximal end.
The catheter device according to claim 2, characterized in that, in the folded state, the first outer profile portion (210) extends substantially straight along the axial direction.
The catheter device according to claim 2, characterized in that, in the unfolded state, the opening member (200) has a sheet-like structure.
The catheter device according to claim 7, characterized in that, in the direction along the first outer contour portion (210) to the second outer contour portion (220), the opening member (200) The thickness gradually decreases.
The catheter device according to claim 8, characterized in that, in the collapsed state, the second outer contour part (220) is wound outside the first outer contour part (210).
The catheter device according to claim 2, characterized in that, in the unfolded state, the opening member (200) has a ring structure.
The catheter device according to claim 10, characterized in that, the opening member (200) comprises an elastic film arranged between the first outer contour part (210) and the second outer contour part (220), The elastic membrane is configured to provide tension to the annular structure to define the shape of the opening member (200) in a deployed state.
The catheter device according to claim 11, characterized in that, in the collapsed state, the second outer contour part (220) is in at least partial contact with the first outer contour part (210) along the axial direction and fit together.
The catheter device according to claim 1, characterized in that, in the direction from the proximal end to the distal end of the catheter (100), the thickness of the pushing member (200) decreases gradually.
The catheter device according to claim 1, characterized in that, a developing component is arranged on the opening member (200).
The catheter device according to claim 14, characterized in that, the developing part is set close to the area of the second outer contour part (220); or, the developing part is set close to the edge of the opening part (200) .
The catheter device according to claim 1, wherein the decoupling member (200) is configured to be in a deployed state during delivery in a vessel of a subject.
The catheter device according to claim 1, characterized in that, the catheter (100) is externally provided with an axially slidable restraint (300), and the opening member (200) responds to the restraint ( 300) to switch between the collapsed state and the expanded state; the constraint (300) is configured as a short sheath.
The catheter device according to claim 1, characterized in that, the pump housing (410) has a suction port (411), and the opening member (200) is configured to be supported by the ventricle during the operation of the pump assembly on the inner wall, so that the suction port (411) is separated from the inner wall of the ventricle.
The catheter device according to claim 1, characterized in that, the opening member (200) is configured to use its own shape to open the heart valve and guide the pump assembly into the ventricle.