A heart valve prosthesis secured by the interventricular septum

Abstract

The application relates to the field of medical devices, in particular to a heart valve prosthesis fixed through an interventricular septum, comprising a valve support and a fixing device, the valve support comprising a valve sewing section and an artificial valve, the artificial valve being fixedly connected to the valve sewing section, the fixing device comprising a fixing support section and a fixing member, one end of the fixing support section being connected to a proximal end portion of the valve sewing section, the other end of the fixing support section being connected to the interventricular septum of a patient through the fixing member to support the heart valve prosthesis and limit axial movement of the heart valve prosthesis.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, specifically relating to a heart valve prosthesis fixed via the ventricular septum. Background Technology

[0002] Traditional treatments for mitral and tricuspid valve disease include medication for mild to severe regurgitation and surgical procedures when indicated. Surgical procedures include valve replacement and valve repair. However, typical open-heart surgery is highly invasive, requires cardiopulmonary bypass, and carries a high risk of complications and infection. Many patients cannot tolerate the significant surgical risks and are left with no choice but to await death.

[0003] Following the report of the first aortic valve replacement surgery, numerous companies have conducted extensive research in interventional aortic valve technology, which has become increasingly mature. However, a significant gap remains in the field of interventional treatment for atrioventricular valves. Although a few products for interventional treatment of atrioventricular valves have been applied in transcatheter valve repair and angioplasty, no mature products have yet been launched internationally for transcatheter valve replacement.

[0004] Current clinical results indicate that there is no ideal product for interventional atrioventricular valve replacement. The main reason is that both the mitral and tricuspid valves have special physiological structures and complex physiological environments below the valve annulus, making accurate positioning and fixation of the product very difficult. The problems of existing technologies can be summarized as follows: (1) Current anchoring techniques mostly rely on the support force of the stent on the atrioventricular valve annulus. Doctors often choose a valve size larger than the patient's own atrioventricular valve annulus to match the mitral valve tissue contour. Not only will the huge stent itself affect the outflow tract, but it will also easily compress the surrounding tissues, further obstructing the blood flow of the left ventricular outflow tract; (2) In current technologies, the stent part located in the atrium is mostly in the form of a mesh, and its huge support force can easily compress the heart tissue; (3) For mitral valve replacement, if the stent size is too large, the anterior mitral valve leaflet is easily pushed into the left ventricular outflow tract, and in order to fix the mitral valve, the stent size is too large. The clamping leaflet design introduced by the anterior leaflet of the cusp valve makes the release procedure very complicated and is affected by the degree of leaflet calcification, which affects the success rate of the operation; (4) Under the current non-radial force support fixation method of the ventricular septum, the distal end of the fixation support segment does not fit the contact part with the ventricular septum plane, resulting in anchoring failure of the fixation piece; forced anchoring may cause excessive stress, resulting in damage to the ventricular septum muscle tissue and the fixation piece being pulled out and falling off; (5) Due to the presence of the original leaflet, the adaptive covered stent does not fit tightly, and the artificial valve of the atrioventricular valve replacement will have paravalvular leakage at the junction of the original leaflet. (6) Due to the differences in heart size and structure between adults, children and people of different races, in order to achieve ventricular septum fixation, a very large European-sized fixation support segment needs to be set up, which has high manufacturing and management costs.

[0005] In conclusion, although the techniques described above have certain effects on atrioventricular valve replacement, they still have shortcomings. In the field of surgical treatment of valvular diseases, there is an urgent need for a new type of heart valve prosthesis to solve these problems. Summary of the Invention

[0006] This application is made in view of the above and other ideas.

[0007] The purpose of this invention is to overcome the limitations of existing technologies and propose a cardiac valve prosthesis fixed via the ventricular septum for patients requiring interventional valve replacement due to mitral or tricuspid regurgitation or stenosis. This invention solves the problem of radially expanding the patient's own valve annulus in existing anchoring techniques. While ensuring the anchoring effect of the implanted valve, it can reduce the impact on the outflow tract after stent release and avoid traction on the patient's own valve annulus.

[0008] The objective of this invention is achieved through the following technical solution:

[0009] A heart valve prosthesis fixed via the interventricular septum includes a valve stent and a fixation device. The valve stent includes a valve suture segment and an artificial valve, the artificial valve being fixedly connected to the valve suture segment. The fixation device includes a fixation support segment and a fixator. One end of the fixation support segment is connected to the proximal portion of the valve suture segment, and the other end of the fixation support segment is connected to the patient's interventricular septum via the fixator to support the heart valve prosthesis and restrict axial movement of the heart valve prosthesis.

[0010] The objective of this invention can also be further achieved through the following technical solutions:

[0011] Preferably, the fixed support section is provided with a curved section, so that the proximal part of the fixed support section can conform to the patient's interventricular septum.

[0012] More preferably, the portion of the fixed support section that contacts the patient's interventricular septum is a straight segment.

[0013] Preferably, the fixed support section is made of one or more rods / wires, one end of which is connected to the valve suture section, and the other end of which is provided with a part that cooperates with the fixation member, and is connected to the patient's interventricular septum through the fixation member.

[0014] Preferably, on the circumferential arc at the outer edge of the valve suture segment, the maximum arc length formed by the connection point of the multiple rods or filaments with the valve suture segment is greater than or equal to one-quarter of the circumference of the valve suture segment.

[0015] Preferably, the fixed support section is provided with a structure that facilitates torsional deformation;

[0016] Preferably, the structure that facilitates torsional deformation is a curved concave structure.

[0017] Preferably, the fixed support section is provided with a telescopic structure that facilitates length adjustment.

[0018] Preferably, the fixed support segment is formed by extending the skeleton from the proximal end of the valve suture segment.

[0019] Preferably, the heart valve prosthesis further includes an adaptive endovascular stent, which is connected to the valve suture segment and, in its free state, is located within the patient's atrium. The distal portion of the adaptive endovascular stent that abuts and is fixedly connected to the valve stent is circular, the middle portion of the adaptive endovascular stent is D-shaped, and the proximal portion of the adaptive endovascular stent that contacts the atrial tissue is elliptical or nearly elliptical. The self-expanding stent of the adaptive endovascular stent is integrally woven from filaments, and the endovascular membrane on the self-expanding stent is made of a flexible polymer material, such as a PTFE membrane or a polyester membrane.

[0020] Preferably, the heart valve prosthesis further includes a leaflet lifting and blocking device, one end of which is fixed to the valve stent, and the other end is disposed on the outside of the valve stent and / or the adaptive covered stent.

[0021] Preferably, the leaflet lifting and blocking device is positioned corresponding to the junction of the autologous leaflet.

[0022] Preferably, the fixing member is an anchoring pin, and the tail of the anchoring pin is provided with a limiting member.

[0023] Preferably, in a cross-section perpendicular to the central axis of the artificial valve, the cross-sectional area of ​​the valve suture segment is smaller than the cross-sectional area of ​​the patient's own valve annulus, so that the valve suture segment does not radially expand the patient's own valve annulus.

[0024] Preferably, in the free state, the cross-sectional area of ​​the adaptive endovascular stent is larger than the cross-sectional area of ​​the patient's own valve annulus, and the adaptive endovascular stent can conform to the uneven contour of the atrial cavity wall or the patient's own valve annulus without restricting the contractile function of the atrium.

[0025] Preferably, in a cross-section perpendicular to the central axis of the artificial valve, the center of the valve suture segment does not coincide with the center of the adaptive covered stent.

[0026] Another objective of this invention is achieved through the following technical solution:

[0027] A method for delivering and releasing the aforementioned transventricular septal fixation heart valve prosthesis includes the following steps:

[0028] a. Insert the delivery catheter containing the heart valve prosthesis into the atrioventricular valve annulus;

[0029] b. Operate the delivery conduit to release the fixing device;

[0030] c. Operate the delivery catheter to release the valve suture segment;

[0031] d. Manipulate the delivery catheter so that the fixation element is inserted into the patient's interventricular septum;

[0032] e. Remove the delivery catheter from the body.

[0033] Preferably, the following steps are included between step c and step d:

[0034] c1. The valve suture segment is partially released from the delivery catheter without being completely detached from the delivery catheter;

[0035] c2. Operate the delivery conduit to release the adaptive covered stent, and use the adaptive covered stent for positioning;

[0036] c3. Operate the delivery catheter to fully release the valve suture segment.

[0037] Compared with the prior art, the advantages of the present invention are:

[0038] 1. Unlike most existing products that use stents to support valve annulus, the fixed support segment in this invention is fixed to the patient's ventricular septum by the fixing member. This anchoring method allows the stent to obtain sufficient anchoring force without radially expanding the patient's own valve annulus.

[0039] 2. Because radial support from the valve stent is not used, the projected area of ​​the valve suture segment is smaller than the projected area of ​​the patient's own valve annulus on a cross-section perpendicular to the central axis of the artificial valve. This prevents the valve suture segment from radially expanding the patient's own valve annulus. To ensure that the fixed support segment connected to the valve suture segment conforms to the patient's ventricular septum, the fixed support segment has a curved section. This allows the proximal portion of the fixed support segment to conform to the patient's ventricular septum, while the distal portion of the fixed support segment that contacts the patient's ventricular septum is a straight segment. This design maximizes the contact area between the fixed support segment and the patient's ventricular septum, enhancing the anchoring effect.

[0040] 3. In this invention, on the circumferential arc at the outer edge of the valve suture segment, the maximum arc length formed by the connection points of the multiple rods and the valve suture segment is greater than or equal to one-quarter of the circumference of the valve suture segment. The advantage of this design is that it ensures that the fulcrum of the fixed support segment on the valve suture segment can provide sufficient support strength and rigidity, and prevents the valve suture segment from tilting.

[0041] 4. In actual surgery, after the valve stent is deployed, due to significant differences in human heart structure, the distal end of the fixation support segment often does not align with the ventricular septum plane. Directly fixing the support segment with a fixator may result in difficulty securing it to the ventricular septum, leading to fixation failure. Even if the distal end of the fixation support segment is forcibly aligned with the ventricular septum, further failure may occur. Even worse, because the fixation support segment uses multiple rods or wires at the fixed end, the maximum arc length formed by the connection point with the valve suture segment is greater than or equal to the... The setting of one-quarter of the circumference of the valve suture segment results in excessive stiffness of the fixation support segment. If the distal end of the fixation support segment is forcibly fixed to the patient's ventricular septum by a fixator, the fixation support segment will exert a certain tensile force on the fixator fixed to the ventricular septum in order to recover from deformation. This, combined with the pressure on the artificial heart valve during heartbeat, causes the fixator to continuously pull on the ventricular septum. This results in the ventricular septum muscle group being constantly damaged, causing tissue injury, and may even lead to the fixator being pulled out of the ventricular septum tissue, causing the valve stent to lose its fixation and fail. This invention creatively employs a structure in the fixed support section that facilitates torsional deformation. Even when the distal end of the fixed support section does not conform to the ventricular septum plane, only a small force is required to deform the fixed support section, thus avoiding the risk of fixation failure or being pulled off. Furthermore, the presence of the structure that facilitates torsional deformation (especially when the structure is a curved and concave structure) transforms the rigid connection between the valve stent and the fixation point into a semi-rigid connection with a certain degree of buffering elasticity. During ventricular contraction and when the artificial valve is compressed, the pulling and shearing forces exerted by the valve stent on the fixation are reduced, significantly improving the durability of the artificial valve.

[0042] 5. Unlike existing technologies, in this invention, the fixed support section is provided with a structure that facilitates torsional deformation. While ensuring that the anchor point remains unchanged, the actual length of the material of the fixed support section will be increased, providing a larger adjustment range for the telescopic structure of the fixed support section that facilitates length adjustment. In addition, with the selection of the cross-sectional diameter of the material of the fixed support section, a single specification of the heart valve prosthesis can be adapted to more patients, thereby significantly reducing production and management costs.

[0043] 6. Unlike existing technologies, this invention incorporates multiple leaflet lifting and blocking devices: on one hand, these devices lift the leaflets and fix them together with the ventricular septum, providing multi-point support for the valve stent and ensuring uniform support force; on the other hand, the leaflet lifting and blocking devices are positioned corresponding to the junction of the autologous leaflets, allowing the adaptive covered stent to fit more tightly at the junction, thereby reducing paravalvular leakage at the junction of the autologous leaflets.

[0044] 7. Unlike the concentric structures of most existing products, in this invention, the center of the valve suture segment does not coincide with the center of the adaptive endovascular stent on a cross-section perpendicular to the central axis of the artificial valve. When the heart valve prosthesis is used for mitral valve replacement, the central axis of the valve suture segment is biased towards the posterior leaflet region of the patient's mitral valve, which can further reduce obstruction of the left ventricular outflow tract; when the heart valve prosthesis is used for tricuspid valve replacement, the central axis of the valve suture segment is biased towards the septal leaflet region of the patient's tricuspid valve, which helps the fixation support segment to fit snugly against the target anchoring area, resulting in a more ideal anchoring effect and more stable valve movement.

[0045] 8. Unlike most existing products that use stents to support the valve annulus, in this invention, the projected area of ​​the valve suture segment on the cross-section perpendicular to the central axis of the artificial valve is smaller than the projected area of ​​the patient's own valve annulus. This prevents the valve suture segment from radially expanding the patient's own valve annulus. This not only reduces the impact of stent release on the outflow tract and avoids traction on the original valve annulus, but also ensures that the valve opening area does not change excessively due to the large differences between patient valve annulus, thus optimizing valve performance. At the same time, manufacturers can reduce product specifications, alleviating the inventory pressure on manufacturers.

[0046] 9. Unlike existing technologies where stents located in the atrium are mostly in the form of a mesh, which can easily cause pressure on the heart tissue due to their huge supporting force and have poor leakage prevention effect, the adaptive covered stent in this invention is located in the patient's atrium and fits the patient's own valve annulus. The adaptive covered stent can conform to the uneven contour of the atrial cavity wall or the patient's own valve annulus, thus improving the leakage prevention effect.

[0047] The embodiments of this application can achieve other advantageous technical effects not listed one by one. These other technical effects may be partially described below and can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0048] The above-described features and advantages, as well as other features and advantages, and the ways in which they are implemented, of these embodiments will become more apparent and the embodiments of this application will be better understood by referring to the following description in conjunction with the accompanying drawings, in which:

[0049] Figure 1 A schematic diagram of the overall structure of the heart valve prosthesis of the present invention.

[0050] Figure 2 This is a schematic diagram showing the connection between the valve suturing section and the fixed support section of the present invention.

[0051] Figure 3 This is a diagram showing the implantation status of the heart valve prosthesis of the present invention within the heart.

[0052] Figure 4 This is a top view of the heart valve prosthesis after implantation according to the present invention, with the leaflet lifting and blocking device located at the leaflet junction.

[0053] Figure 5 This is another embodiment of the heart valve prosthesis of the present invention.

[0054] Figure 6 and Figure 7 This is a schematic diagram of the torsion of the curved concave structure of the present invention. The valve suture section remains stationary while the curved concave structure rotates.

[0055] Figure 8 and Figure 9 This is a schematic diagram of a telescopic structure according to another embodiment of the present invention.

[0056] The features represented by the numbers in the attached diagram are as follows:

[0057] 1-Valve stent, 11-Valve suture segment, 12-Artificial valve, 2-Fixing device, 21-Fixing support segment, 211-Bending segment, 212-Straight segment, 213-Bending concave structure, 214-Telescopic structure, 22-Fixing component, 3-Adaptive endovascular stent, 4-Leaflet lifting and blocking device. Detailed Implementation

[0058] To make the objectives, technical solutions, and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments.

[0059] In this invention, the distal end refers to the end furthest from the apex of the heart, and the proximal end refers to the end closest to the apex of the heart. Specific Implementation Example 1

[0060] like Figure 1 and Figure 2 The illustration shows a heart valve prosthesis fixed via the ventricular septum according to an embodiment of this application, including a valve stent 1 and a fixation device 2. The valve stent 1 includes a valve suture segment 11 and an artificial valve 12, the artificial valve 12 being fixedly connected to the valve suture segment 11. The fixation device 2 includes a fixation support segment 21 and a fixation member 22. One end of the fixation support segment 21 is connected to the proximal portion of the valve suture segment 11, and the other end of the fixation support segment 21 is connected to the patient's ventricular septum via the fixation member 22 to support the heart valve prosthesis and restrict axial movement of the heart valve prosthesis.

[0061] In this first embodiment, the fixed support section 21 is provided with a curved section 211, such as... Figure 2 As shown, this allows the proximal portion of the fixed support section 21 to conform to the patient's interventricular septum.

[0062] In this first embodiment, the portion of the fixed support section 21 that contacts the patient's interventricular septum is a straight segment 212, such as... Figure 3 As shown.

[0063] In this first embodiment, the fixed support section 21 is made of one or more rods / wires. One end of the one or more rods / wires is connected to the valve suture section 11, and the other end of the one or more rods / wires is provided with a part that cooperates with the fixation member 22. The fixation member 22 is connected to the patient's interventricular septum.

[0064] In this first embodiment, on the circumferential arc at the outer edge of the valve suture segment 11, the maximum arc length formed by the connection point of the multiple rods or filaments with the valve suture segment 11 is greater than or equal to one-quarter of the circumference of the valve suture segment 11.

[0065] In this first embodiment, the fixed support segment 21 is formed by extending the skeleton at the proximal end of the valve suture segment 11.

[0066] In this embodiment, the heart valve prosthesis also includes an adaptive endovascular stent 3, which is connected to the valve suture segment 11. In its free state, the adaptive endovascular stent 3 is located within the patient's atrium. The distal portion of the adaptive endovascular stent 3 that is abutted and fixedly connected to the valve stent 1 is circular, the middle portion of the adaptive endovascular stent 3 is D-shaped, and the proximal portion of the adaptive endovascular stent 3 that contacts the atrial tissue is elliptical or nearly elliptical. The self-expanding stent of the adaptive endovascular stent 3 is integrally woven from filaments, and the endovascular membrane on the self-expanding stent is made of a flexible polymer material, such as a PTFE membrane or a polyester membrane.

[0067] In this embodiment, the heart valve prosthesis also includes a leaflet lifting and blocking device 4. One end of the leaflet lifting and blocking device 4 is fixed on the valve stent 1, and the other end is disposed on the outside of the valve stent 1 and / or the adaptive covered stent 3.

[0068] In this first embodiment, the leaflet lifting and blocking device 4 is positioned corresponding to the junction of the autologous leaflet, such as... Figure 4 As shown.

[0069] In this first embodiment, the fixing member 22 is an anchoring pin, and the tail of the anchoring pin is provided with a limiting member.

[0070] In this embodiment, on a cross-section perpendicular to the central axis of the artificial valve 12, the cross-sectional area of ​​the valve suture segment 11 is smaller than the cross-sectional area of ​​the patient's own valve annulus, so that the valve suture segment 11 will not radially expand the patient's own valve annulus.

[0071] In this first embodiment, in the free state, the cross-sectional area of ​​the adaptive endovascular stent 3 is larger than the cross-sectional area of ​​the patient's own valve annulus. The adaptive endovascular stent 3 can conform to the uneven contour of the atrial cavity wall or the patient's own valve annulus without restricting the contractile function of the atrium.

[0072] In this first embodiment, on a cross-section perpendicular to the central axis of the artificial valve 12, the center of the valve suture segment 11 does not coincide with the center of the adaptive covered stent 3, as shown below. Figure 4 As shown. Example 2

[0073] Example 2 is largely the same as Example 1, except that the fixed support section 21 is provided with a structure that facilitates torsional deformation, such as... Figure 5 As shown.

[0074] This embodiment introduces a heart valve prosthesis fixed via the interventricular septum, comprising a valve stent 1 and a fixation device 2. The valve stent 1 includes a valve suture segment 11 and an artificial valve 12, the artificial valve 12 being fixedly connected to the valve suture segment 11. The fixation device 2 includes a fixation support segment 21 and a fixation member 22. One end of the fixation support segment 21 is connected to the proximal portion of the valve suture segment 11, and the other end of the fixation support segment 21 is connected to the patient's interventricular septum via the fixation member 22 to support the heart valve prosthesis and restrict the axial movement of the heart valve prosthesis.

[0075] In this second embodiment, the structure that facilitates torsional deformation is a curved concave structure 213. This curved concave-convex structure 213 adapts to interventricular septa with different deflection angles, such as... Figure 6 and Figure 7 As shown.

[0076] In this regard, the relevant construction and concept of Embodiment 2 are similar to those of Embodiment 1, and therefore will not be described again here. Example 3

[0077] Example 3 is largely the same as Example 1, except that the fixed support section 21 described above is provided with a telescopic structure 214 that facilitates length adjustment.

[0078] This embodiment introduces a heart valve prosthesis fixed via the interventricular septum, comprising a valve stent 1 and a fixation device 2. The valve stent 1 includes a valve suture segment 11 and an artificial valve 12, the artificial valve 12 being fixedly connected to the valve suture segment 11. The fixation device 2 includes a fixation support segment 21 and a fixation member 22. One end of the fixation support segment 21 is connected to the proximal portion of the valve suture segment 11, and the other end of the fixation support segment 21 is connected to the patient's interventricular septum via the fixation member 22 to support the heart valve prosthesis and restrict the axial movement of the heart valve prosthesis.

[0079] In this third embodiment, the telescopic structure 214 provides a larger adjustment range for the fixed support section 21, adjusting the distance between the anchoring area and the valve suture section 11, such as... Figure 8 and Figure 9 As shown, this allows for a single size of heart valve prosthesis to be suitable for more patients.

[0080] In this regard, the relevant construction and concept of Embodiment 3 are similar to those of Embodiment 2, and therefore will not be described again here.

[0081] The foregoing description of several embodiments of this application has been provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed; obviously, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its equivalents are intended to be defined by the appended claims.

Claims

1. A heart valve prosthesis secured by the interventricular septum, characterized by: The heart valve prosthesis comprises a valve stent and a fixing device, the valve stent comprises a valve sewing segment and an artificial valve, the artificial valve is fixedly connected to the valve sewing segment, the fixing device comprises a fixing support segment and a fixing member, one end of the fixing support segment is connected to a proximal end portion of the valve sewing segment, the other end of the fixing support segment is connected to a patient's interventricular septum through the fixing member to support the heart valve prosthesis and limit axial movement of the heart valve prosthesis, and the fixing support segment is provided with a structure facilitating torsional deformation.

2. The heart valve prosthesis secured by the interventricular septum according to claim 1, characterized in that The fixing support segment is provided with a curved segment, so that the proximal end portion of the fixing support segment can be attached to the patient's interventricular septum.

3. The heart valve prosthesis secured by the interventricular septum according to claim 1, characterized in that: The fixing support segment is made of one or more rods / wires, one end of each of the one or more rods / wires is connected to the valve sewing segment, and the other end of each of the one or more rods / wires is provided with a part matched with the fixing member and connected to the patient's interventricular septum through the fixing member; on a circumferential arc where an outer edge of the valve sewing segment is located, a maximum arc length formed by connection points of the plurality of rods or wires to the valve sewing segment is greater than or equal to one fourth of a circumference of the valve sewing segment.

4. The heart valve prosthesis secured by the interventricular septum according to claim 1, characterized in that: The structure facilitating torsional deformation is a curved concave structure.

5. The heart valve prosthesis secured by the interventricular septum according to claim 1, characterized in that: The fixing support segment is provided with a telescopic structure facilitating length adjustment.

6. The heart valve prosthesis secured by the interventricular septum according to claim 1, characterized in that: The heart valve prosthesis further comprises a self-adapting covered stent.

7. The heart valve prosthesis secured by the interventricular septum according to claim 6, characterized in that: The heart valve prosthesis further comprises a leaflet pulling and blocking device.

8. The heart valve prosthesis secured by the interventricular septum according to claim 7, characterized in that: One end of the leaflet pulling and blocking device is fixed to the valve stent, and the other end is arranged outside the valve stent and / or the self-adapting covered stent; the arrangement position of the leaflet pulling and blocking device corresponds to a junction of an autologous leaflet.

9. The heart valve prosthesis secured by the interventricular septum according to claim 1, characterized in that: In a cross section perpendicular to a central axis of the artificial valve, a cross-sectional area of the valve sewing segment is smaller than a cross-sectional area of a valve annulus of a patient's autologous valve, so that the valve sewing segment cannot radially expand the valve annulus of the patient's autologous valve.

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