CN114795587A

CN114795587A - Prosthetic heart valve system

Info

Publication number: CN114795587A
Application number: CN202210433374.7A
Authority: CN
Inventors: 金昌�; 王浩; 王陆洋
Original assignee: Xinyi Medical Technology Beijing Co ltd
Current assignee: Xinyi Medical Technology Beijing Co ltd
Priority date: 2022-04-24
Filing date: 2022-04-24
Publication date: 2022-07-29

Abstract

The invention provides a prosthetic heart valve system. The heart valve prosthesis system comprises a valve part and a delivery system part, wherein the valve part comprises a valve frame, valve leaflets and a sealing skirt, the valve frame comprises an atrium part, a ventricle part (18), an anchoring part (19) and a first connecting piece (20), the anchoring part (19) is connected with the first connecting piece (20), the anchoring part (19) extends towards the atrium part, the first connecting piece (20) is provided with a pressing section (25), and the delivery system part is provided with a fixing part for accommodating the pressing section of the valve frame. The artificial heart valve system can improve the clamping and anchoring of the artificial heart valve system after being implanted into a human body, and is beneficial to reducing the operation difficulty and the complications of the artificial heart valve system after being implanted.

Description

Prosthetic heart valve system

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a heart valve prosthesis system.

Background

Valvular disease is a common heart valve disease with increasing incidence with age. For a diseased valve, a surgical operation is usually adopted to replace a prosthetic heart valve system, but some patients cannot be subjected to the surgical operation due to the age and the like, and intervention valves can be adopted for the patients, so that the diseased valve has the advantages of small wound, quick recovery and the like because chest opening is not needed, and the diseased valve is more and more widely paid attention and paid attention.

Interventional aortic valves have advanced well over the last two decades and are now the standard treatment for non-surgical or surgical high risk patients. However, the mitral valve and the tricuspid valve, which are atrioventricular valves, have relatively slow development after being implanted into the body due to the complex anatomical structure of the valve position. Different from the narrow lesion caused by the main degenerative lesion of the aortic valve, the regurgitation lesion caused by various reasons of the atrioventricular valve, the calcified plaque around the valve of the regurgitation lesion is less, and the fixation after the intervention valve implantation is difficult. Meanwhile, atrioventricular valves are usually subjected to forces in two directions, namely, when the heart contracts, the ventricular blood impacts the valve in the direction of the atrium, and when the heart contracts, the ventricular blood impacts the valve in the direction of the ventricle. Therefore, to increase the security of the atrioventricular valve fixation, fixation assemblies are often added to both the atrial and ventricular faces of the interventional valve to achieve anchoring of the valve at the implantation site. For the ventricular surface, the fixing structure design is relatively complex considering the structures such as valve leaflets and key cables of the natural valve existing in the ventricular surface.

The currently adopted ventricular surface anchoring mode comprises a barb structure, a girdling structure, a traction structure and other modes. The barb mode realizes positioning by hooking and clamping the valve leaf, the positioning is firmer, and the damage to the heart is less; but the complexity of the structure under the valve makes the release control of the barb structure more tedious, and the barb design of the anchoring is limited in outward turning expansion in the release process, so that the valve leaf is difficult to grasp and clamp, the operation difficulty is increased by the tedious and repeated grasping and clamping operation, and the risk of infirm valve anchoring is increased. After the valve is implanted into a human body, the clamping is not firm or the valve is loosened, and serious postoperative complications can be caused. The delivery system portion is typically provided with multiple layers of catheters arranged to enable the different levels of the catheter to be moved back and forth by manipulation of its handle to effect release and anchoring of the valve. How under multistage complicated operation, the degree of the inflation evagination of the maximize realization barb mode valve rivet structure makes the valve anchor the time realize more easily grabbing card anchor to natural leaflet, further simplifies the partial design of conveying system, and to improving doctor's operation maneuverability, reduce valve postoperative complication then has very practical application meaning.

Disclosure of Invention

In order to solve the above problems, the present invention provides a prosthetic heart valve system, which can improve the effective clamping position of the prosthetic heart valve system after being implanted into a human body, simplify the operation, and reduce the complications of the prosthetic heart valve system after being implanted.

According to one aspect of the invention, a heart valve prosthesis system is provided, which includes a valve portion and a delivery system portion, wherein the valve portion includes a valve frame, valve leaflets and a sealing skirt, the valve frame includes an atrium portion, an anchor portion and a first connecting member, the anchor portion is connected to the first connecting member, the anchor portion extends toward the atrium portion, the first connecting member has a pressing section, the anchor portion connected to the first connecting member is outwardly opened when the pressing section is acted by the delivery system portion, the delivery system portion has a fixing portion, the fixing portion is used for accommodating the pressing section of the valve frame, a head fixing frame is arranged on one side of the fixing portion close to the atrium portion, the head fixing frame includes first fixing grooves, the first fixing grooves are alternately arranged along the circumferential direction of the fixing portion, and the pressing section of the first connecting member can be accommodated in the first fixing grooves.

Preferably, the valve frame further includes a plurality of second connectors each connected to the ventricular part and alternately arranged in a circumferential direction of the ventricular part, and the protruding length of the first connector may be shorter than, longer than, or equal to the protruding length of the second connector, and preferably, the protruding length of the first connector is shorter than the protruding length of the second connector.

Preferably, when the valve is released, the first connector is released when the corresponding part of the delivery system is slid to the first position, and then the second connector is released when the corresponding part is slid to the second position.

Preferably, the head mount further includes second fixing grooves alternately arranged with the first fixing grooves in a circumferential direction of the head mount, and the second connecting member is installed in the second fixing grooves.

Preferably, the side surface of the first fixing groove close to the heart chamber part is formed with an inclined surface, the pressing section presses against the inclined surface, and the anchoring part can be expanded outwards under the action of the inclined surfaces of the delivery system part and the first fixing groove when the delivery system part releases the valve.

Preferably, the first connecting member and/or the pressing section may be arranged in an axially parallel, axially inclined towards the centre of the axis or axially inclined outwards or in an everted configuration.

Preferably, when the pressing section expands the anchoring part, the atrium part and the ventricle part are in an incomplete expanding state or a contraction state, and the anchoring part is expanded on the outer peripheral side of the atrium part, and preferably, the atrium part is in the contraction state.

Preferably, one end of the anchoring portion is connected to the first connecting member, and the other end extends toward the atrial portion to form a cantilever structure, which may be at least one of a linear type, a V-type, and a polygonal type.

Preferably, part or all of the cantilever structure is located outside of the corresponding valve frame beam of the ventricular part, and preferably, the part of the cantilever structure adjacent to the first connecting component is located outside of the valve frame.

Preferably, the tube sac sleeved outside the fixing part of the delivery system part and the tube sac of the contracting valve part are the same tube sac or mutually independent tube sacs.

This kind of artificial heart valve system, the anchor portion of valve frame links to each other with first connecting piece, and be provided with specially and be used for controlling the open section of suppressing of anchor portion, install back on the conveying system part at artificial heart valve system, can utilize the conveying system part to exert the extrusion effort to the section of suppressing, make the section of suppressing change direction under system's extrusion and the outer expanding effort of valve frame, and then drive the anchor portion and turn up, thereby guarantee that anchor portion can increase the angle of turning up as far as possible, be convenient for improve the effective screens of artificial heart valve system after implanting the human body, simplify the operation, reduce the complication after the artificial heart valve system implantation.

Drawings

FIG. 1 is a schematic representation of a prosthetic heart valve system according to an embodiment of the present invention with the anchor portion of the valve frame released and neither the connector nor the end of the valve frame distal from the connector released;

FIG. 2 is a schematic view of a valve frame of another prosthetic heart valve system according to an embodiment of the present invention;

FIG. 3 is a cross-sectional view of a portion of the anterior end of a delivery system of a prosthetic heart valve system according to an embodiment of the present invention;

FIG. 4 is a schematic structural view of a valve portion of a prosthetic heart valve system according to an embodiment of the present invention;

FIG. 5 is a schematic structural view of a valve portion of a prosthetic heart valve system according to another embodiment of the present invention;

FIG. 6 is a schematic structural view of a valve portion (different second attachment) of a prosthetic heart valve system according to another embodiment of the present invention;

FIG. 7 is a perspective view of a portion of a mounting bracket of a delivery system for a prosthetic heart valve system according to an embodiment of the present invention;

FIG. 8 is a cross-sectional view of a portion of a mounting bracket of a corresponding delivery system of a prosthetic heart valve system according to an embodiment of the present invention;

FIG. 9 is a schematic view of a compressed state of the lower valve portion according to an embodiment of the present invention;

FIG. 10 is a schematic view of a lower delivery system according to an embodiment of the present invention prior to partial release of the valve;

FIG. 11 is a schematic view of a valve of a prosthetic heart valve system according to an embodiment of the present invention with the connectors in an unreleased state;

FIG. 12 is a schematic view of a prosthetic heart valve system of an embodiment of the present invention with the valve fully released;

description of reference numerals:

3. barbs, 4, atrial part, 5, first delivery part; 8. a third conveying section; 9. tip head; 12. a second conveying section; 13. an end fixture; 15. a connecting pipe; 16. a head mount; 18. a heart chamber portion; 19. an anchoring portion; 20. a first connecting member; 21. a second connecting member; 22. connecting the fixing part; 23. a large head section; 24. a small head section; 25. a pressing section; 26. a first fixing groove; 27. and a second fixing groove.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings and the embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Referring collectively to fig. 1-12, in accordance with an embodiment of the invention, a prosthetic heart valve system is characterized by comprising a valve portion and a delivery system portion, wherein the valve portion comprises a valve frame, leaflets and a sealing skirt (this illustration does not show the valve skirt and leaflet portion, which can be set with reference to any prior art), the valve frame comprises an atrial portion 4, a chamber portion 18, an anchor portion 19 and a first connector 20, the atrial portion is connected to the head of the chamber portion 18, generally in the shape of a corolla, the first connector 20 is connected to the tail of the chamber portion 18, the anchor portion 19 is connected to the first connector 20, the anchor portion 19 extends toward the atrial portion, the first connector 20 has a pressing section 25, the pressing section 25 is acted upon by the delivery system portion, the anchor portion 19 connected to the first connector 20 is flared, the delivery system portion has a fixation portion for receiving the pressing section 25 of the valve frame, the side of the fixing portion close to the heart chamber portion 18 is provided with a head mount 16, the head mount 16 comprises first fixing grooves 26, the first fixing grooves 26 are alternately arranged along the circumferential direction of the fixing portion, and the pressing sections 25 of the first connecting members 20 can be accommodated in the first fixing grooves 26. As shown in fig. 3 and 4.

Figures 3, 8 and 10 show schematic views of corresponding portions of a delivery system according to embodiments of the present invention (this view only shows the distal end of the delivery system portion and the valve engaging portion, the remainder of which may be referred to any of the prior art). The conveying system comprises a first conveying part 5, a second conveying part 12 and a third conveying part 8; and the head fixing frame 16, wherein the far end of the head fixing frame 16 is provided with an inclined plane matched with the pressing section 25 of the valve frame. When the valve is assembled, the pressing section 25 of the first connecting piece 20 is correspondingly assembled on the corresponding inclined surface of the head fixing frame 16, and then the second conveying part moves towards the far end to fix and press the pressing section on the corresponding inclined surface. Then operating the conveying system part to assemble and sleeve the valve ventricle part into the corresponding tube sac of the first conveying part 5; and the atrial portion fits into a corresponding pocket of the third delivery portion corresponding to the distal tip head 9, as shown in fig. 10. When the valve is released, the first delivery part 5 is withdrawn by operating the delivery system part, and the valve is exposed, because the atrium part is still restrained in the corresponding capsule of the tip head 9, and the ventricle part is also partially restrained, as shown in fig. 1; the corresponding anchoring portions 19 of the cage are thus expanded outwardly by the combined forces applied to the delivery system portion and the ventricular portion 18 by the first connectors 20 and the abutment sections 25.

When the abutting section 25 opens the anchoring part 19, the ventricle part 18 of the valve frame is not completely unfolded at the moment, and is not expanded to the maximum radius, under the condition, the anchoring part 19 is driven to be unfolded under the action of the abutting section 25, so that the unfolding radius of the anchoring part 19 is obviously larger than the current unfolding radius of the ventricle part 18, and therefore, the anchoring part 19 can be smoothly in contact fit with the natural valve leaflets of the human body in advance of the ventricle part 18, the interference of the ventricle part 18 is avoided, the stable clamping of the artificial heart valve system can be ensured, the loosening phenomenon is effectively prevented, the installation stability of the artificial heart valve system is improved, and the problems that under the existing medical condition, the barb of the artificial heart valve system is not enough to be unfolded, and the clamping or the clamping is not firm or loosened after the artificial heart valve system is implanted into the human body are effectively solved.

When the anchoring portion 19 is expanded by the pressing section 25, it is preferable that both the atrial portion and the ventricular portion 18 shown in fig. 1 are in an incompletely expanded state or in a contracted state. Alternatively, the structure shown in FIG. 11 may be adopted, in which the atrium portion is substantially fully expanded and a part of the ventricle portion is in a constrained state; in this state, because the atria have been substantially fully expanded, the extent of outward expansion of the corresponding barbs in the anchoring portion is limited. But is more convenient for certain procedures, such as secondary recovery after valve release. The design can also completely arrange the valve in the corresponding tube sac of the first delivery part 5, the third delivery part is not arranged any more to be movable, and the tube sac for accommodating the valve is not added in the distal tip head 9; the design and operating logic of the transport system sections is further simplified. The valve system is now operated such that the valve is fully loaded into the corresponding capsule of the first delivery segment 5 during assembly, and upon release, the first delivery segment is released directly until the barbs on the anchor portion spring out, and the system is then operated to snap the anchor portion into place and then the second delivery segment is released to release the first connector from the head mount 16 to complete the final release of the valve, as shown in fig. 12.

The head mount 16 further includes second fixing grooves 27, the second fixing grooves 27 and the first fixing grooves 26 are alternately arranged along a circumferential direction of the head mount 16, and the second coupling members 21 are installed in the second fixing grooves 27.

To further simplify the transport system section, the second transport section can also be replaced by the first transport section; the first connecting part 20 and the pressing section 25 are now fixed by the head mount 16 by the tube sac corresponding to the first transport section 5. Namely, the tube sac is sleeved outside the fixing part of the conveying system part, and the tube sac of the contracting valve part can be the same tube sac. But based on the independence of the control, to prevent malfunctions, it is recommended to use a separate capsule design, i.e. a design with a separate second delivery section. Meanwhile, the diameter of the second conveying part is further reduced when the first connecting piece and the pressing section 25 are bound; the magnitude of the flaring of the valve anchoring portion can be further increased.

The side surface of the first fixing groove 26 close to the ventricle portion 18 is formed with an inclined surface, the pressing section 25 presses against the inclined surface, and when the valve is released by the delivery system portion, the anchoring portion 19 can be expanded outwards under the action of the inclined surfaces of the delivery system portion and the first fixing groove 26.

The first connecting member 20 and/or the pressing section 25 may be provided in an axially parallel, axially inclined toward the center of the axis or axially outwardly inclined or everted configuration.

In addition, the inclination of the inclined plane corresponding to the head fixing frame 16 can be adjusted according to the range required by the barb eversion of the anchoring part; while also being set in a non-tilted state. For this case, the structure of the first connecting member 20 and the pressing section 25 may be arranged in an everted form as shown in fig. 2. The eversion form is arranged so that the corresponding barbs of the anchoring parts form a distinct eversion even when the pressing sections are fixed in parallel. Also, even in non-everted parallel fixation, the barbs of the anchoring portion of the delivery system will naturally splay out to some extent under the low pressure segment, due to the presence of the low pressure segment, and the fact that the fixation portion of the delivery system portion will typically be much smaller in diameter than the expanded valve. Therefore, the part can be combined with the inclined angle of the inclined surface of the fixed part according to the actual requirement of the eversion degree. Such as arranging the barbed portions of the anchoring of the first connector 20 and the pressing section 25 in an everted, parallel or even inverted configuration; it is even contemplated that the anchor barbs themselves may be arranged in an everted, parallel or even inverted configuration.

The second conveying part 12 is provided with an end fixing piece 13 matched with the head fixing frame 16, an accommodating space is formed between the end fixing piece 13 and the inclined surface of the head fixing frame 16, and the pressing section 25 is positioned in the accommodating space.

When the abutting section 25 expands the anchoring portion 19, the atrial portion and the ventricular portion 18 are in an incompletely expanded state or a contracted state, and the anchoring portion 19 is expanded on the outer peripheral side of the ventricular portion 18, and preferably, the atrial portion is in a contracted state.

The anchoring portion 19 of this embodiment has one end connected to the first connector 20 and the other end extending towards the side of the atrial portion and forming a cantilever structure. Part or all of the cantilevered structure is located outside of the ventricular chamber portion 18 corresponding to the petal mount beams, and preferably the portion of the cantilevered structure adjacent the first connector 20 is located outside of the petal mount. The specific shape of the cantilever structure can be a straight line shape, a V shape, a polygonal shape or other shapes, fig. 2 shows a structure formed by combining 2V shapes, fig. 5 shows a straight line shape, and the specific structure of the part is not limited. Meanwhile, the top end of the barb part is preferably arranged to be arc-shaped, and the structure is shown in fig. 2, so that damage to the heart can be reduced, the larger the diameter of the arc part is, the smaller the damage is, the arc part can be even arranged to be a large split body, and then the barb part and other parts of the barb are connected in various modes, and meanwhile, the top end of the barb and other beams of the valve frame can also be arranged in different circumferential planes. Meanwhile, the V-shaped structure or the polygonal structure is easier to increase the contact area of the anchoring part and the natural valve leaflet and increase the stability. Simultaneously, in order to further increase the riveting capability of the valve, barbs can be arranged on the valve frame, so that the riveting function of the valve is further increased. As shown in fig. 2. While the first connector 20 and/or the abutting section 25 may be provided directly as part of the anchoring portion, even as part of the barb portion; instead of providing separate first connectors and low pressure sections; however, in view of making it easier to position the valve abutment section fixed to the fixation portion of the delivery system portion, it is preferred to have the first attachment means and the abutment section separately. In addition, the first connector may be provided with a connecting fixing part 22 to further increase the connecting strength of the valve and the fixing part of the delivery system part, and prevent the abutting section of the anchoring part or the valve itself from being separated from the delivery system part. The shape of the connecting and fixing portion 22 is not particularly limited, and may be a T-shaped structure, or a shape similar to a T-shape or other shapes with a large end and a small end, as shown in fig. 6. . The first connecting member 20 and the low-pressure section 25 may be provided in the same structure, or in the same structure as the connection fixing portion 22. Typically, the portion of the delivery system that can be controlled to cause the stent anchoring portion to expand can be configured or defined as a low pressure segment.

The third conveying part of the conveying system also comprises a connecting pipe 15, and the connecting pipe 15 is connected with the Tip head 9.

The valve frame may further be provided with a plurality of second connectors 21, the plurality of second connectors 21 are connected to the first connectors 20 and the second connectors 21 on the ventricular portion 18 and are alternately arranged along the circumferential direction of the ventricular portion 18, and the length of the second connectors 21 in the direction away from the ventricular portion 18 may be greater than, equal to, or shorter than the length of the first connectors 20 in the direction; preferably greater than the length of the first connecting member 20 in that direction. The second connecting piece 21 comprises a connecting fixing part 22, and when the inclined pressing section 25 is pressed to open the anchoring part 19, the second connecting piece 21 is connected and fixed through the connecting fixing part 22 and keeps a binding state.

When the length of the second connector 21 in the direction of the heart chamber portion 18 is greater than the length of the first connector 20 in that direction, it is possible to make the second connector 21 have a longer fixed length with respect to the fixed portion, such as the fixing groove shown in fig. 7, and thus when the release of the heart valve prosthesis system is performed, the second connector 21 remains in the fixed state after the first connector 20 is released. The number of the first connecting members 20 and the second connecting members 21 may be two, three, or other numbers, and may be uniformly distributed or non-uniformly distributed, and preferably, 2 to 3 are uniformly distributed.

First and the connection fixed part that the second connecting piece corresponds all can set up big head section 23 and little head section 24, little head section 24 is connected with ventricle portion 18, big head section 23 is connected in the one end of 24 distant centrifugation chambeies of little head section, the card is established and is formed backstop structure in the notch that conveying system part fixed part corresponds during the assembly, thereby make big head section 23 establish when connecting the fixed part outside at the conveyer pipe cover, can form the backstop, avoid connecting the fixed part and deviate from the conveyer pipe, guaranteed that the connection fixed part can not release along the conveyer pipe axial, can only follow the radial release of conveyer pipe, consequently, when conveyer pipe breaks away from big head section 23 place scope completely, it just can release completely to connect the fixed part, and then realize the complete release of artificial heart valve system. The connecting and fixing part can be in a T-shaped structure, or in a shape similar to a T shape or other shapes with a big end and a small end.

In addition, in order to further prevent the barb part of the valve anchoring part from entering the valve frame during the assembly compression process and influencing the release of the anchoring part, the anchoring part of the valve can be arranged on the outer side of the surrounding valve frame beam, so that the anchoring part is automatically positioned on the outermost layer of the valve frame when the valve frame is compressed, and the release of the anchoring part is facilitated. Other designs of the present invention may refer to any existing technology, for example, the valve frame may be configured as a D-shaped structure, and the valve frame may be configured as a compressible grid structure, and the material may be configured as nitinol with shape memory function, etc.

The foregoing has outlined rather broadly the subject matter of the present invention in connection with the embodiments and the accompanying drawings, and in part, further details and sub-aspects of the present invention may be found in the detailed description. Such details are available to the skilled person in the art after having obtained the teachings herein, according to common knowledge or customary practice in the art.

Those skilled in the art will readily appreciate that the specific embodiments presented herein are merely exemplary ways to achieve relative or synchronous movement between the components of the catheter sections of the present invention. For example, in order to move the member a and the member B relative to each other, the member a may be held stationary and the member B may be moved, or the member a may be moved in the opposite direction while the member B is held stationary. These different embodiments are either equivalent to the embodiments described above or further modifications, but do not depart from the essence of the corresponding technical solution, as defined in the claims.

Claims

1. A prosthetic heart valve system, characterized in that it comprises a valve part and a delivery system part, wherein the valve part comprises a valve frame, valve leaflets and a sealing skirt, the valve frame comprises an atrium part, a ventricle part (18), an anchoring part (19) and a first connecting part (20), the anchoring part (19) is connected with the first connecting part (20), the anchoring part (19) extends towards the atrium part, the first connecting part (20) is provided with a pressing section (25), the anchoring part (19) connected with the first connecting part (20) is outwards expanded when the pressing section (25) is acted by the delivery system part, the delivery system part is provided with a fixing part which is used for accommodating the pressing section (25) of the valve frame, one side of the fixing part close to the ventricle part (18) is provided with a head fixing frame (16), the head fixing frame (16) comprises first fixing grooves (26), the first fixing grooves (26) are alternately arranged along the circumferential direction of the fixing part, and the pressing sections (25) of the first connecting pieces (20) can be accommodated in the first fixing grooves (26).

2. The heart valve prosthesis system of claim 1, wherein the valve frame further comprises a plurality of second connectors (21), the plurality of second connectors (21) are connected to the heart chamber portion (18) and are alternately arranged along the circumference of the heart chamber portion (18), and the protruding length of the first connector (20) can be shorter than, longer than or equal to the protruding length of the second connector (21), preferably, the protruding length of the first connector (20) is shorter than the protruding length of the second connector (21).

3. Prosthetic heart valve system according to claim 2, characterized in that the first connector (20) is released when the delivery system partial counterpart is slid to a first position when the valve is released, and then the second connector (21) is released when it is slid to a second position again.

4. The heart valve prosthesis system according to claim 2, wherein the head mount (16) further includes second fixing grooves (27), the second fixing grooves (27) and the first fixing grooves (26) being alternately arranged in a circumferential direction of the head mount (16), the second connectors (21) being installed in the second fixing grooves (27).

5. The heart valve prosthesis system according to claim 1, wherein a side surface of the first fixing groove (26) close to the heart chamber portion (18) is formed with an inclined surface, the pressing section (25) presses against the inclined surface, and the anchoring portion (19) can be expanded outward by the inclined surfaces of the delivery system portion and the first fixing groove (26) when the delivery system portion releases the valve.

6. Prosthetic heart valve system according to claim 1, wherein the first connector (20) and/or the pressing section (25) are arranged in an axially parallel, axially centred or axially outwardly inclined or everted configuration, preferably in an everted configuration.

7. Prosthetic heart valve system according to claim 1, wherein the atrial part and the ventricular part (18) are in an incompletely opened state or in a constricted state when the anchoring part (19) is opened by the pressing section (25), the anchoring part (19) being opened at an outer circumferential side of the ventricular part (18), preferably the atrial part being in a constricted state.

8. The heart valve prosthesis system of claim 1, wherein the anchoring portion (19) is connected at one end to the first connector (20) and extends at the other end towards the atrial portion to form a cantilever structure, the cantilever structure being at least one of a straight type, a V-type and a polygonal type.

9. The prosthetic heart valve system of claim 8, wherein part or all of the cantilever structure is located outside of the corresponding valve frame beam of the ventricular portion (18), preferably the part of the cantilever structure adjacent the first connector component (20) is located outside of the valve frame.

10. The heart valve prosthesis system of claim 1, wherein the tube sac sleeved outside the fixing portion of the delivery system portion is the same tube sac as the tube sac of the pinch valve portion or is independent of the tube sac of the pinch valve portion; preferably a self-contained tube balloon.