CN113995952B

CN113995952B - Catheter device

Info

Publication number: CN113995952B
Application number: CN202111240563.4A
Authority: CN
Inventors: 颜翊凡; 李本帅
Original assignee: Magassist Inc
Current assignee: Xinqing Medical Suzhou Co ltd
Priority date: 2021-10-25
Filing date: 2021-10-25
Publication date: 2022-11-04
Anticipated expiration: 2041-10-25
Also published as: CN113995952A; WO2023071858A1

Abstract

The present invention provides a catheter device comprising: a motor; a conduit; a driving shaft rotatably inserted in the guide tube and driven by the motor; a pump assembly, deliverable through a catheter to a desired location of the heart, for pumping blood, comprising a pump housing connected to a distal end of the catheter, an impeller housed within the pump housing, the impeller being driven in rotation by a drive shaft; a deployment member, connected to the distal end of the pump housing, at least partially made of a flexible, resilient material, having a collapsed state and an expanded state; wherein, in the unfolding state, the poking and opening piece is wholly positioned at one side of the axis of the catheter and wholly extends towards the far end direction of the catheter in an inclined way.

Description

Catheter device

Technical Field

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

Background

Ventricular assist devices are devices used to assist the heart of a mammalian subject (e.g., a human patient). A typical left ventricular assist device includes a pump that is inserted into the body of the subject. The 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, such that the pump operates in parallel with the left ventricle to push blood into the aorta.

The aortic valve (valve) is crossed between the left ventricle and the aorta before the pump inlet enters the left ventricle. The aortic valve acts like a one-way valve, preventing blood from flowing back, ensuring 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 implements valve crossing by a guide wire in the Pigtail (pig tail structure) at the distal end of the pump, and the above-mentioned manner of implementing valve crossing by the guide wire has the defects of complex structure and complex operation.

Accordingly, there is a need for improvements in the art that overcome the deficiencies in the prior art.

Disclosure of Invention

The invention aims to provide a catheter device which does not need a guide wire to realize valve crossing in the process of conveying a pump assembly to the heart and has the advantages of simple structure and convenience in use.

To solve the above technical problem, the present invention provides a catheter device comprising: a motor; a conduit; a drive shaft rotatably disposed through the conduit and driven by the motor; a pump assembly, deliverable through the catheter to a desired location of the heart, comprising a pump housing connected to a distal end of the catheter, an impeller housed within the pump housing, the impeller being driven in rotation by the drive shaft; a deployment member, attached to the distal end of the pump housing, at least partially made of a flexible, resilient material, having a collapsed state and an expanded state; wherein, in the unfolding state, the poking part is wholly positioned at one side of the axis of the catheter and wholly extends towards the far end direction of the catheter in an inclined way.

Preferably, in the above-mentioned catheter device, in the deployed state, the toggle part has a first outer profile part close to the axis and a second outer profile part far from the axis; wherein, in a direction from the proximal end to the distal end of the catheter, the first outer profile portion is warped in a direction gradually deviating from the catheter axis toward the second outer profile portion, and the second outer profile portion is curved in a direction gradually deviating from the catheter axis toward the first outer profile portion.

Preferably, in the catheter device, the first outer contour and the second outer contour smoothly transition at a junction of the distal ends in the deployed state.

Preferably, the catheter device described above, in the deployed state, has a monotonous trend of the first and second outer contours in the proximal-to-distal direction.

Preferably, in the above catheter device, in the deployed state, the second outer profile is flatter in a region near the distal end portion than in a region near the proximal end.

Preferably, in the collapsed state, the first outer profile portion extends substantially straight along the axis.

Preferably, in the above catheter device, in the deployed state, the poke-out member is of a sheet-like structure.

Preferably, in the above-mentioned catheter device, the thickness of the poke-out member is gradually reduced in a direction from the first outer contour part to the second outer contour part.

Preferably, in the folded state, the second outer contour portion is wound around the first outer contour portion.

Preferably, in the above catheter device, the deployment element (200) has a ring-like structure in the deployed state.

Preferably, in the catheter device of the above, the deployment element comprises an elastic membrane disposed between the first and second outer profile portions, the elastic membrane being configured to provide tension to the loop-like structure to define the shape of the deployment element in the deployed state.

Preferably, in the folded state, the second outer contour portion is at least partially in contact with and attached to the first outer contour portion along the axial direction.

Preferably, in the catheter device, the thickness of the poke-out member is gradually reduced along the direction from the proximal end to the distal end of the catheter.

Preferably, in the above catheter device, the opening member is provided with a developing member.

Preferably, in the above catheter apparatus, the developing member is disposed adjacent to an area of the second outer contour portion; alternatively, the developing member is disposed near an edge position of the pull-out member.

Preferably, the catheter apparatus described above, the deployment member is configured to be deployed during vascular delivery of the subject.

Preferably, in the above-mentioned catheter device, the catheter is provided with a constraining member slidable in the axial direction, and the poking member is switched between the folding state and the unfolding state in response to the axial movement of the constraining member; the restraint is configured as a short sheath.

Preferably, in the above catheter apparatus, the pump housing has an intake port, and the kick-out member is configured to be supported on an inner wall of a ventricle during operation of the pump assembly such that the intake port is spaced apart from the inner wall of the ventricle.

Preferably, the above catheter device, wherein the deployment element is configured to deploy the heart valve and guide the pump assembly into the ventricle using its own profile.

Compared with the prior art, the invention has the following beneficial effects:

the invention realizes the crossing of the heart valve by utilizing the appearance characteristic that the poking part is integrally positioned at one side of the axis of the catheter and integrally extends towards the far end direction of the catheter in an inclined way, does not need to use a guide wire, and has the advantages of simple structure and convenient use.

Drawings

FIG. 1 is a schematic view of the deployment element of the catheter device of the present invention in a deployed, sheet-like configuration;

FIG. 2 is a schematic view of the construction of the toggle member of FIG. 1;

FIG. 3 is a schematic cross-sectional view of the deployment element of FIG. 1;

FIG. 4 is a schematic view of the opening member of FIG. 1 in a collapsed state;

FIG. 5 is a schematic view of the deployment element of the catheter device of the present invention in a deployed configuration in the form of a loop;

FIG. 6 is a schematic view of the construction of the toggle member of FIG. 5;

FIG. 7 is a schematic view of the opening member of FIG. 5 in a collapsed state;

FIG. 8 is a schematic view of the FIG. 5 release element in the form of an internally hollow ring;

FIG. 9 is a schematic view of the toggle member of FIG. 5 in a solid ring configuration;

fig. 10 is a schematic view of the poke-out member of fig. 5 with an elastic membrane.

Detailed Description

The present invention will be described in detail below with reference to specific embodiments shown in the drawings. These embodiments are not intended to limit the present invention, and structural, methodological, or functional changes made by those skilled in the art according to these embodiments are included in the scope of the present invention.

The terms "proximal", "posterior" and "distal", "anterior" as used herein are relative to the clinician. The terms "proximal" and "posterior" refer to portions that are relatively close to the clinician, and the terms "distal" and "anterior" refer to portions that are relatively far from the clinician.

As used herein, the terms "inner" and "outer" are used with respect to an axially extending centerline, with the direction being "inner" relative to the centerline and "outer" relative to the direction away from the centerline.

It is to be understood that "proximal", "distal", "rear", "front", "inner", "outer", and these orientations are defined for convenience of description. However, catheter devices may be used in many orientations and positions, and thus these terms are not intended to be limiting and absolute.

In the present invention, the terms "connected" and "connected" are to be interpreted broadly, unless explicitly defined or limited otherwise. For example, the connection can be fixed connection, detachable connection, movable connection or integration; they may be directly connected or indirectly connected through intervening media, or may be connected through the use of two elements or the interaction of two elements. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

Referring to fig. 1 to 4, the present invention provides a catheter device, including: motor 500, conduit 100, drive shaft, pump assembly 400, and dial-out piece 200. The device can at least partially assist the blood pumping function of the heart and realize the effect of at least partially reducing the burden of the heart.

In an exemplary scenario, the device may be used as a left ventricular assist device, with a pump assembly 400 being introduced into the left ventricle, the pump assembly 400 being operable to pump blood from the left ventricle into the ascending aorta.

It is noted that the above example is used as a left ventricular assist, but is only one possible application scenario for a catheter device. In other possible and not explicitly excluded scenarios, the catheter device described above may also be used as a right ventricular assist, and the pump assembly 400 may be introduced into the right ventricle into which the pump assembly 400 is operated to pump blood in the veins.

The following will be explained mainly in the context of the use of the above-described catheter device as a left ventricular assist. It will nevertheless be understood that no limitation of the scope of the embodiments of the invention is thereby intended, as illustrated in the accompanying drawings.

In the present invention, the guide tube 100 is a flexible tube, the driving shaft includes a flexible shaft, and the axis of the guide tube 100 or the driving shaft refers to the axis of the guide tube 100 or the driving shaft when the driving shaft is adjusted to extend linearly.

Motor 500 is configured to be located outside of the subject. The proximal end of the catheter 100 is connected to a motor 500. The drive shaft is rotatably disposed through the catheter 100, and the proximal end is coupled to the output shaft of the motor 500 and driven by the motor 500.

Pump assembly 400, which may be delivered to a desired location of a subject's heart via catheter 100, includes a pump housing 410 connected to the distal end of catheter 100 and having an intake port 411 and an outlet port 412, an impeller (not shown) received within pump housing 410 and drivingly connected to the distal end of a drive shaft. The impeller is driven to rotate by the drive shaft to suck blood into the pump housing 410 from the suction port 411 and discharge the blood from the discharge port 412.

Deployment element 200 is attached to the distal end of pump housing 410. The deployment element 200 is at least partially made of a flexible and resilient material. That is, the deployment member 200 is flexible to ensure that the subject's tissue is not harmed.

The deployment member 200 has a collapsed state and an expanded state. The pulling-out member 200 stores energy when being folded, and when the external restraint is removed, the stored energy of the pulling-out member 200 is released, so that the pulling-out member 200 is unfolded. That is, the opener 200 is folded by external restraint, and the opener 200 is self-deployed after the restraint is removed.

In the present embodiment, the "collapsed state" refers to a state in which the opening member 200 is radially constrained. That is, the opener 200 is compressed radially to be folded into a state of minimum radial dimension by the external force. "deployed state" refers to a state in which the deployment member 200 is not radially constrained. That is, the kickoff 200 is deployed radially outward to a maximum radial dimension.

In the deployed state, referring to fig. 1 in combination with fig. 2, deployment element 200 is generally positioned on one side of the axis of catheter 100 and extends generally obliquely toward the distal end of catheter 100. In the collapsed state, please refer to fig. 4, the deployment element 200 is in a one-dimensional state under the external constraint, and is substantially a linear strip extending along the axial direction of the catheter 100.

Notably, deployment element 200 is in a collapsed state during movement of a restraint element 300 (described below) into a subject's body (e.g., the femoral artery). In this process, the constraining member 300 exerts a radial constraint on the deployment element 200, keeping it in the collapsed state.

Once the pull-out member 200 is pulled out of the restraint member 300, the restraint is lost and the pull-out member 200 automatically deploys. Thus, in this embodiment, paddle 200 is in a deployed state during movement within the subject to a desired position within the heart. Alternatively, deployment member 200 is moved in the deployed configuration to the desired location of the heart.

Further, in the deployed state, the deployment element 200 is a sheet-like structure. In this embodiment, the sheet-like structure is a sheet-like structure in which the opening member 200 continuously extends in any direction. That is, no holes or hollow-out structures are provided on the opening member 200.

In this embodiment, the stripper 200 has a first outer profile 210 close to the axis and a second outer profile 220 remote from the axis. The first outer contour portion 210 and the second outer contour portion 220 form the outer contour of the toggle-out element 200.

Wherein, in a direction from the proximal end to the distal end of the catheter 100, the first outer contour portion 210 is warped towards the second outer contour portion 220 in a state of gradually deviating from the axis of the catheter 100, and the second outer contour portion 220 is curved towards the first outer contour portion 210 in a state of gradually deviating from the axis of the catheter 100. Also, in a proximal to distal direction along catheter 100, the thickness of pull-out piece 200 gradually decreases.

Thus, the opener 200 has a substantially lancet-like shape. In preparation for valve crossing, the leading end of deployment element 200 can be quickly introduced into the valve leaflet crevice, helping to guide pump assembly 400 into the left ventricle for quick and efficient valve crossing.

In this embodiment, the poking member 200 pokes the heart valve and guides the pump assembly 400 into the ventricle by using the feature of its own shape, so as to effectively reduce the number of parts (no guide wire), simplify the structure (no guide wire is needed to be inserted) and have the advantages of simple structure and convenient operation compared with the prior art. In the prior art, the crossing of the heart valve is realized through the guide wire, the guide wire needs to pass through the driving shaft, the impeller of the pump assembly and the pigtail structure, the whole structure is complex, and the operation is inconvenient.

During the intervention, the kickoff 200 is at the forefront in the direction of delivery and is the leader of the entire device. While the distal end of the deployment element 200 is located at the forwardmost end of the deployment element 200, the shape of the distal end of the deployment element 200 greatly affects the safety of delivery of the deployment element 200 in the vessel of the subject and the reliability of valve crossing.

To enable the deployment member 200 to conveniently deploy the left ventricular valve and avoid damage to the subject's vasculature by the outer contour of the distal end of the deployment member 200. In this embodiment, in the deployed state, the first outer contour 210 and the second outer contour 220 smoothly transition at the intersection of the distal ends, wherein the area of the second outer contour 220 near the distal end portion is flatter than the area near the proximal end.

Also, in the deployed state, the trend of the first outer contour portion 210 and the second outer contour portion 220 is monotonous in the proximal-to-distal direction. The "monotonous" refers to a situation where the distances between the first outer contour portion 210 and the second outer contour portion 220 and the axis gradually increase. Alternatively, first outer contour 210 and second outer contour 220 extend obliquely from proximal to distal without a proximally circuitous configuration.

Deployment member 200, which adopts the outer profile shape described above, can form a smoothly curved profile at its distal end and a shape that is generally narrow at both ends and wide in the middle, which helps deployment member 200 deploy the left ventricular valve to guide pump assembly 400 into the left ventricle for valve crossing. At the same time, the formation of a sharp profile at the distal end of the deployment member 200 can be avoided, thereby allowing the distal end of the deployment member 200 to be delivered in a non-invasive or non-invasive manner through the subject's vasculature.

When the pump assembly 400 enters the left ventricle to work, the distal end of the pull-out member 200 is supported on the inner wall of the ventricle in a non-invasive or non-invasive manner, so as to separate the suction inlet 411 of the pump assembly 400 from the inner wall of the ventricle, thereby preventing the suction inlet 411 of the pump assembly 400 from being attached to the inner wall of the ventricle due to the reaction force of fluid (blood) in the working process of the pump assembly 400, and ensuring the effective pumping area.

Referring to fig. 3, the thickness of toggle 200 decreases in a direction from the proximal end to the distal end of catheter 100 (the X-axis direction). The purpose of this setting is: the stiffness of the distal end of the deployment element 200 in its deployed state is reduced, allowing for greater flexibility of the distal end of the deployment element 200.

Thus, the distal end of deployment element 200 is thinner, facilitating deployment of the valve. Meanwhile, the distal end of the pusher-pull 200 can also be delivered in the subject's vessel in a non-invasive or non-invasive manner, which does not easily damage the subject's vessel.

In the present embodiment, please continue to refer to fig. 3, the thickness of the pulling-out member 200 gradually decreases along the direction from the first outer contour portion 210 to the second outer contour portion 220 (Y-axis direction). That is, the thickness of the toggle 200 at the first outer profile portion 210 is greater than the thickness at the second outer profile portion 220.

The greater thickness at the first outer profile portion 210 is to support the second outer profile portion 220 in the collapsed state. The thickness of the second outer contour portion 220 is smaller than that of the first outer contour portion 210 for guiding the opening member 200 in the folded state to be folded into a predetermined shape.

Specifically, in the collapsed state, please continue to refer to fig. 4, the second outer contour portion 220 is wound outside the first outer contour portion 210 by the external constraint of the toggle opening 200. Wherein the first outer contour portion 210 extends substantially straight along the axial direction.

In the above discussion, the second outer contour portion 220 can be wound outside the first outer contour portion 210 because the thickness of the second outer contour portion 220 is smaller than that of the first outer contour portion 210, and the second outer contour portion 220 is deformed before the first outer contour portion 210 under the external constraint, so that the second outer contour portion 220 has a deformation tendency to be wound outside the first outer contour portion 210.

The reason why the first outer contour portion 210 is deformed after the second outer contour portion 220 is as follows: first, the thickness of the first outer contour portion 210 is greater than that 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 easily constrained from curling than the first outer contour portion 210; second, first outer profile 210 is closer to the axis of catheter 100 than second outer profile 220.

In the present embodiment, the external restraint is a restraint member 300 slidably disposed outside the catheter 100 in the axial direction of the catheter 100. The restraint 300 is used to collapse the pump assembly 400 and the kickoff 200. That is, the restraint 300 may perform a collapsing or expanding operation on the pump assembly 400 and the deployment member 200. Wherein the toggle member 200 is switched between the collapsed state and the expanded state in response to the axial movement of the restraint member 300.

Further, the restriction 300 is configured as a short sheath, which may particularly be of tubular configuration. As described above, unlike the long sheath constraint that allows the pump assembly 400 and the deployment member 200 to be collapsed during the entire intervention and after the intervention into the heart, the short sheath only collapses the pump assembly 400 and the deployment member 200 during the transcatheter intervention (the sheath is inserted into a wound previously placed in the body of the subject and is in communication with the vasculature of the subject, such as the femoral artery, and has a hemostatic valve disposed thereon), and once the pump assembly 400 and the deployment member 200 have entered the subject for a certain length, they are deployed out of the sheath constraint, thereby allowing the deployment member 200 to be introduced into the ventricle in the deployed state.

It will be understood that the distal end of the restraining member 300 acts first on the pump assembly 400, and as the restraining member 300 is continuously moved in the axial direction toward the deployment member 200, the pump assembly 400 is collapsed by the restraining force from the restraining member 300, and then the deployment member 200 is also forced into the collapsed state by the restraining member 300. At this time, the second outer contour portion 220 is wound around the first outer contour portion 210, and the opener 200 is substantially in the form of a one-dimensional straight bar.

In the present embodiment, the pusher 200 is in the deployed state during the course of being transported in the subject, but is not limited to this. In practice, the deployment member 200 may also be delivered in a collapsed state forward in the vasculature of the subject. It will be appreciated that whether the deployment member 200 is in the collapsed or deployed state, the deployment member 200 is sized to be smaller than the vessel diameter of the subject's vessel, thus ensuring that the deployment member 200 is delivered within the subject's vessel.

Further, paddle 200 is configured to be in a deployed state during vascular delivery of a subject. The purpose of this setting is: when the opening member 200 is in the expanded state, the opening member 200 is in a two-dimensional state, the overall rigidity of the opening member 200 is small, the opening member is relatively soft, and when the opening member is in contact with a vessel of a subject, the elastic deformation capacity of the opening member 200 is good, so that the acting force between the opening member and the vessel can be reduced, and therefore the opening member can be delivered in a non-invasive or non-invasive manner.

It is contemplated that the interventional site of the deployment member 200 may need to be known in time during the procedure in which the deployment member 200 is being introduced. In this embodiment, the poking member 200 is further provided with a developing part, and the real-time intervention position of the poking member 200 can be grasped by the developing part, so that the poking member 200 can smoothly intervene in the ventricle.

In one possible implementation, the developing member may be metal and may be affixed to the outer surface of the pull-out member 200. In another possible implementation, the developing component may be a developable substance, such as barium sulfate, dispersed in the material of the opener 200.

Further, the developing member is disposed near an edge position of the pull-out member 200. When the poking-out piece 200 is pushed to the inner wall of the vessel, the outer contour of the poking-out piece generates a certain deformation amount, and an operator can conveniently judge whether the poking-out piece 200 touches the inner wall of the vessel tissue by observing the change of the shape of the poking-out piece 200 so as to correct the interventional operation. For example, by rotating the proximal end of catheter 100, the orientation of deployment element 200 is adjusted.

Considering that the thickness of the second outer contour portion 220 of the toggle-out piece 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, the amount of deformation is easier to observe through the second outer contour portion 220. Preferably, the developing member is disposed adjacent to an area of the second outer contour portion 220.

Therefore, compared with the prior art, the invention can not only grasp the intervention position of the poking member 200 through the developing part, but also know whether the poking member 200 touches vascular tissues or not, and has the advantages of stable and reliable intervention operation.

Further, the deployment element 200 of the present invention has another configuration when in the deployed state. Specifically, referring to fig. 5 to 7, in the unfolded state, the opener 200 is in a ring structure, which is different from the structural form when the opener 200 is in a sheet structure.

The annular structure of the opening member 200 means that the opening member 200 is provided with a hole or an opening. That is, the opening member 200 is not a sheet-like structure extending continuously in any direction.

It should be noted that the opening member 200 in this embodiment is not a sheet-like structure extending continuously in any direction, but the opening member 200 itself is in a sheet shape. The flap 200 is provided in a sheet-like arrangement to assist in the opening of the valve and thus the introduction of the pump assembly 400 into the left ventricle.

The sheet-like shape means that the dimension in the thickness direction is much smaller than the dimension in the length and width directions. Here, the longitudinal direction may be understood as a dimension in the X-axis direction, the width direction may be understood as a dimension in the Y-axis direction, and the thickness direction may be understood as a dimension in the Z-axis (not shown).

The opening member 200 may have a solid ring structure or a ring structure having a hollow interior. Fig. 8 is a schematic view of the opener 200 in the form of a hollow ring structure inside, and fig. 9 is a schematic view of the opener 200 in the form of a solid ring structure.

Considering that deployment element 200 is made at least partially of a flexible, resilient material, once deployment element 200 is in a ring configuration, it is difficult to maintain the shape of deployment element 200 in a given shape during an intervention.

Referring to fig. 10, the opening member 200 further includes an elastic membrane 230 disposed between the first outer contour portion 210 and the second outer contour portion 220. Elastic membrane 230 is configured to provide tension to the loop structure described above to define the shape of the deployment element 200 in the deployed state.

In the present embodiment, in the collapsed state of the opener 200, the second outer contour portion 220 and the first outer contour portion 210 are at least partially in contact and fit together along the axial direction, so that the opener 200 is radially compressed and folded into the state of minimum radial dimension.

The above is only one embodiment of the present invention, and any other modifications based on the concept of the present invention are considered as the protection scope of the present invention.

Claims

1. A catheter device, comprising:

a motor (500);

a catheter (100);

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

a pump assembly (400) that can be delivered to a desired location of the heart through the catheter (100), comprising a pump housing (410) connected to a distal end of the catheter (100), an impeller housed within the pump housing (410), the impeller being driven in rotation by the drive shaft;

a deployment member (200) attached to a distal end of the pump housing (410), at least partially made of a flexible, resilient material, having a collapsed state and an expanded state;

wherein, in the unfolding state, the poke-out piece (200) is wholly positioned at one side of the axis of the catheter (100) and wholly extends towards the far end direction of the catheter (100) in an inclined way;

in the deployed state, the toggle member (200) has a first outer profile portion (210) proximal to the axis and a second outer profile portion (220) distal to the axis;

wherein, in a direction from the proximal end to the distal end of the catheter (100), the first outer contour part (210) is warped in a direction of the second outer contour part (220) with a tendency to deviate gradually from the axis of the catheter (100), and the second outer contour part (220) is curved in a direction of the first outer contour part (210) with a tendency to deviate gradually from the axis of the catheter (100).

2. The catheter device as claimed in claim 1, wherein in the deployed state the first outer contour (210) and the second outer contour (220) smoothly transition at a junction of distal ends.

3. The catheter device as claimed in claim 1 or 2, characterized in that the trend of the first outer contour (210) and the second outer contour (220) in the proximal-distal direction is monotonous in the deployed state.

4. The catheter device as claimed in claim 1 or 2, characterized in that in the deployed state the area of the second outer contour (220) near the distal end portion is flatter than the area near the proximal end.

5. The catheter device as claimed in claim 1, characterized in that the first outer contour (210) extends substantially straight in the axial direction in the collapsed state.

6. The catheter device according to claim 1, wherein in the deployed state, the deployment element (200) is of sheet-like construction.

7. Catheter device according to claim 6, wherein the thickness of the toggle-out element (200) decreases in a direction along the first outer contour (210) to the second outer contour (220).

8. The catheter device as claimed in claim 7, characterized in that the second outer contour portion (220) is rolled out of the first outer contour portion (210) in the collapsed state.

9. The catheter device according to claim 1, wherein in the deployed state, the deployment element (200) is in the form of a ring.

10. Catheter device according to claim 9, wherein the toggle out-piece (200) comprises an elastic membrane provided between the first outer profile portion (210) and the second outer profile portion (220), the elastic membrane being configured to provide tension to the ring-like structure to define the shape of the toggle out-piece (200) in the deployed state.

11. The catheter device as claimed in claim 10, characterized in that in the collapsed state the second outer contour portion (220) is at least partially in contact with and fits together with the first outer contour portion (210) in the axial direction.

12. The catheter device of claim 1, wherein the thickness of the toggle member (200) decreases in a proximal-to-distal direction along the catheter (100).

13. The catheter device according to claim 1, wherein the poke-out member (200) is provided with a visualization member.

14. The catheter device according to claim 13, wherein the visualization member is arranged close to an area of the second outer contour portion (220); alternatively, the developing member is disposed near an edge position of the pull-out member (200).

15. The catheter apparatus of claim 1, wherein the toggle member (200) is configured to be in a collapsed state during vascular delivery of the subject.

16. The catheter device as claimed in claim 1, characterized in that the catheter (100) is externally provided with an axially slidable constraint (300), the deployment element (200) being switchable between the collapsed state and the deployed state in response to an axial movement of the constraint (300); the restraint (300) is configured as a short sheath.

17. The catheter device as claimed in claim 1, characterized in that the pump housing (410) has an intake opening (411), the kick-off (200) being configured to bear against an inner wall of a heart chamber during operation of the pump assembly, such that the intake opening (411) is spaced from the inner wall of the heart chamber.

18. The catheter device of claim 1, wherein the deployment member (200) is configured to deploy a heart valve and guide a pump assembly into a heart chamber using its own profile.