Heart valve prosthesis

Abstract

The present invention provides a heart valve prosthesis, relating to the field of medical device technology. The heart valve prosthesis comprises: an inner stent and an outer stent; the inner stent comprises: a thin channel and a thick channel; a prosthetic valve leaflet is arranged in the thin channel; the top opening of the outer stent is sutured to the thin channel through a membrane, and the bottom opening of the outer stent is sutured to the thick channel, and the outer stent acts as a buffer to prevent the prosthetic valve leaflet from being damaged by the heart contraction squeezing the thin channel; the outer stent is provided with an inward depression, the top of the depression is covered with a brim, and the depression is used to avoid the patient's native tissue; the brim covers the top of the depression and acts as a seal to prevent the heart valve prosthesis from leaking around the depression; the inner stent and / or the outer stent are provided with elastic hooks, which fix the native valve leaflet, playing both a positioning role and a sealing role to prevent paravalvular leakage; the heart valve prosthesis is implanted in the patient's body through minimally invasive surgery, has a long service life, causes little damage to surrounding tissue, is easy to operate, and has few complications.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a heart valve prosthesis. Background Art

[0002] The human body has valves in the heart and major blood vessels. Their function is to ensure unidirectional blood flow, with arterial blood flowing centrifugally and venous blood flowing centripetally. Valve damage can disrupt blood flow and lead to illness. An ideal valve is highly compatible with the human body, preventing mechanical failure and blood clots. When heart valve stenosis or insufficiency due to various causes impacts hemodynamics, valve replacement therapy is indicated.

[0003] If a person's native heart valve has a fundamental problem and cannot be repaired surgically, a replacement surgery is needed to replace the native valve with a heart valve prosthesis. Typically, a mechanical valve made of synthetic materials or a bioprosthetic valve made of biological tissue is used to replace the native valve.

[0004] However, current heart valve prostheses are easily damaged by the effects of cardiac contraction and compression, have a short service life, and are prone to interfering with the patient's native tissues, such as the atrioventricular node, conduction bundle, outflow tract, etc., causing great damage to the patient's native tissues and easily leading to complications. Summary of the Invention

[0005] (1) Technical problems solved

[0006] In view of the deficiencies of the prior art, the present invention provides a heart valve prosthesis, which solves the problem that heart valve prostheses are prone to cause complications.

[0007] (2) Technical solution

[0008] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0009] A heart valve prosthesis, comprising: an inner stent and an outer stent;

[0010] The inner support comprises: a thin channel and a thick channel;

[0011] The thin channel is communicated with the thick channel, and a prosthetic valve leaflet is arranged in the thin channel;

[0012] The top opening of the outer support is sutured to the thin channel through a membrane, and the bottom opening of the outer support is sutured to the thick channel;

[0013] The outer support is provided with an inward depression, the top of the depression is covered with a brim, and the depression avoids the patient's native tissue.

[0014] Preferably, the inner support and the outer support both comprise: a skeleton and a soft sealing membrane;

[0015] The soft sealing membrane is attached to the frame, allowing the heart valve prosthesis to establish a single blood channel formed by the inner stent.

[0016] Preferably, the skeleton comprises: a bone mesh and a plurality of struts;

[0017] The struts are arranged along the axial direction of the heart valve prosthesis and are connected through the bone mesh.

[0018] Preferably, the middle section of the struts in the recess is provided with an inward bend, and the number of the struts bent inward in the recess is not less than three.

[0019] Preferably, the skeleton is provided with a notch at the recess, and the soft sealing film seals and covers the notch.

[0020] Preferably, a bottom eave is provided at the bottom end of the notch.

[0021] Preferably, the bone mesh is formed by connecting a number of polygonal unit grids and / or elliptical unit grids.

[0022] Preferably, the bone mesh is formed by a plurality of diamond-shaped unit grids connected to each other.

[0023] Preferably, the inner bracket and / or the outer bracket are provided with a plurality of elastic hooks, the middle sections of the elastic hooks are bent inwards, so that under the action of their own elastic force, the middle sections of the elastic hooks come into contact with the outer wall of the outer bracket.

[0024] Preferably, the elastic hook passes through the gap between the tendons and hooks the native leaflet upwards. The native leaflet is rolled up at the end of the elastic hook, and the tendons pull the native leaflet downward so that the native leaflet wraps around the external stent.

[0025] Preferably, the head end of the elastic hook presses against the valve ring.

[0026] Preferably, the elastic hooks are attached with anti-slip braided fabric.

[0027] Preferably, the elastic hook is arranged to avoid the recess.

[0028] Preferably, the recess and the elastic hook are both provided with a plurality of developing structures.

[0029] Preferably, a spring is provided between the head end and the middle section of the elastic hook.

[0030] Preferably, a sensor is provided on the inner bracket and / or the outer bracket.

[0031] (3) Beneficial effects

[0032] The present invention provides a heart valve prosthesis. Compared with the prior art, it has the following beneficial effects:

[0033] In the present invention, the heart valve prosthesis comprises: an inner stent and an outer stent; the inner stent comprises: a thin channel and a thick channel; the thin channel is connected to the thick channel, and a prosthetic valve leaflet is disposed in the thin channel; the outer stent is a cylindrical stent, the top opening of the outer stent is sutured to the thin channel via a membrane, and the bottom opening of the outer stent is sutured to the thick channel, so that a sealed cavity is formed between the thin channel and the outer stent, avoiding the situation where a false cavity may cause thrombosis. The outer stent also acts as a buffer to prevent heart contraction from squeezing the thin channel and causing damage to the prosthetic valve leaflet, thereby increasing the service life; the outer stent is provided with an inward depression, the top of the depression is covered with a brim, and the depression is used to avoid the patient's native tissue, which includes: the heart's conduction system and outflow tract, and the heart's conduction system includes: the atrioventricular node, conduction bundle, etc.; the brim covers the top of the depression and acts as a seal to prevent the heart valve prosthesis from causing paravalvular leakage in the depression; the heart valve prosthesis is implanted in the patient's body through minimally invasive surgery, has a long service life, causes little damage to surrounding tissue, is easy to operate, and has few complications. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0035] Figure 1 This is a top axonometric exploded view of the heart valve prosthesis in Example 1 of the present invention;

[0036] Figure 2 This is a bottom-view axonometric exploded view of the heart valve prosthesis in Example 1 of the present invention;

[0037] Figure 3 Schematic diagram of the skeleton structure of the external support in Example 1 of the present invention;

[0038] Figure 4 This is a schematic diagram of the assembly of the heart valve prosthesis in Example 1 of the present invention;

[0039] Figure 5 This is a schematic diagram of the partial assembly of the heart valve prosthesis in Example 1 of the present invention;

[0040] Figure 6 Schematic diagram of the structure of the elastic hook in Example 2 of the present invention;

[0041] Figure 7 Schematic diagram of the assembly of the sensor in Example 3 and Example 4 of the present invention;

[0042] Figure 8 Schematic diagram of the structure of the skeleton in Example 5 of the present invention;

[0043] Figure 9 This is another structural diagram of the skeleton in Example 5 of the present invention;

[0044] Figure 10 Schematic diagram of the structure of the skeleton and the soft sealing membrane in Example 5 of the present invention. DETAILED DESCRIPTION

[0045] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention are clearly and completely described. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0046] The embodiment of the present application solves the problem that heart valve prostheses are prone to causing complications by providing a heart valve prosthesis.

[0047] The technical solution in the embodiments of the present application is to solve the above technical problems, and the overall idea is as follows:

[0048] In an embodiment of the present invention, the heart valve prosthesis comprises an inner stent and an outer stent; the inner stent comprises a thin channel and a thick channel; the thin channel is connected to the thick channel, and a prosthetic valve leaflet is disposed in the thin channel; the outer stent is a cylindrical stent, the top opening of the outer stent is sutured to the thin channel via a membrane, and the bottom opening of the outer stent is sutured to the thick channel, thereby forming a sealed cavity between the thin channel and the outer stent, avoiding the formation of thrombus caused by the false cavity. The outer stent also acts as a buffer to prevent damage to the prosthetic valve leaflet caused by compression of the thin channel by cardiac contraction, thereby increasing the service life; the outer stent is provided with an inward depression, the top of the depression being covered with a brim, the depression being used to avoid the patient's native tissue, the native tissue including the heart's conduction system and outflow tract, the heart's conduction system including the atrioventricular node, conduction bundle, etc.; the brim covers the top of the depression and acts as a seal to prevent paravalvular leakage of the heart valve prosthesis at the depression; the heart valve prosthesis is implanted in the patient's body via minimally invasive surgery, has a long service life, causes little damage to surrounding tissue, is easy to operate, and has few complications.

[0049] In order to better understand the above technical solution, the above technical solution will be described in detail below with reference to the accompanying drawings and specific implementation methods.

[0050] Example 1:

[0051] like Figures 1 to 3As shown, the present invention provides a heart valve prosthesis, which includes: an inner stent 10 and an outer stent 20;

[0052] The inner support 10 includes a thin channel 11 and a thick channel 12;

[0053] The thin channel 11 is connected to the thick channel 12, and a prosthetic valve leaflet 13 is provided in the thin channel 11;

[0054] The outer stent 20 is a cylindrical stent. The top opening of the outer stent 20 is sutured to the thin channel 11 through a membrane, and the bottom opening of the outer stent 20 is sutured to the thick channel 12, so that a sealed cavity is formed between the thin channel 11 and the outer stent 20, avoiding the situation where a false lumen causes thrombosis. The outer stent 20 also acts as a buffer to prevent the heart contraction from squeezing the thin channel 11 and causing damage to the prosthetic valve leaflets 13, thereby increasing the service life.

[0055] The outer support 20 is provided with an inward recess 21, the top of the recess 21 is covered with a brim 22, and the recess 21 is used to avoid the patient's native tissue, which includes: the conduction system and outflow tract of the heart, and the conduction system of the heart includes: atrioventricular node, conduction bundle, etc.

[0056] In the prior art, if a patient also has devices such as a pacemaker installed in his body, the circuits of these devices need to pass between the prosthetic leaflets 13, which may damage the prosthetic leaflets 13. In the present invention, the circuits of the above-mentioned devices can pass through the heart valve prosthesis through the recess 21, thereby avoiding damage to the prosthetic leaflets 13.

[0057] The brim 22 covers the recess 21 and plays a sealing role to prevent the heart valve prosthesis from having paravalvular leakage at the recess 21.

[0058] The brim 22 is a soft membrane with a built-in soft support. The brim 22 can extend outside the side wall profile of the outer support 20 or be confined within the side wall profile of the outer support 20.

[0059] The heart valve prosthesis is implanted into the patient's body through minimally invasive surgery, has a long service life, causes little damage to surrounding tissues, is easy to operate, and has few complications.

[0060] like Figures 1 to 3 As shown, the inner support 10 and the outer support 20 both include: a skeleton and a soft sealing membrane;

[0061] The soft sealing membrane is attached to the frame, so that the heart valve prosthesis establishes a single blood channel formed by the inner stent 10, and the soft sealing membrane increases the friction between the outer stent 20 and the heart tissue, making the heart valve prosthesis support and installation more secure.

[0062] like Figures 1 to 3As shown, the skeleton comprises: a bone mesh and a plurality of struts;

[0063] The struts are arranged along the axial direction of the heart valve prosthesis and are connected through the bone mesh to ensure the stability of the skeleton.

[0064] like Figure 3 As shown, the middle section of the strut at the recess 21 is provided with an inward bend, and the number of the struts bent inward at the recess 21 is not less than three, thereby ensuring the structural stability of the recess 21.

[0065] The bone mesh is formed by connecting a plurality of polygonal unit grids and / or elliptical unit grids.

[0066] like Figures 1 to 3 As shown, the bone mesh is composed of several diamond unit grids connected to each other. The advantage of the diamond unit grid is that the stress and strain resistance provided in the axial and circumferential directions are basically consistent, which can reduce the deformation and strain applied during manufacturing, making the skeleton more stable.

[0067] The skeleton is made of elastic metal, and the soft sealing membrane includes: a polymer material membrane and / or a biological material membrane;

[0068] The elastic metal includes: Nitinol, elastic stainless steel and the like.

[0069] The polymer material film includes: PET, TPU, PU, ​​PE, PA, PP, PS, etc.

[0070] The biomaterial membrane includes: bovine pericardium biomembrane, porcine pericardium biomembrane, horse pericardium biomembrane and the like.

[0071] like Figure 1 、 Figure 2 、 Figure 4 、 Figure 5 As shown, the inner bracket 10 and / or the outer bracket 20 are provided with a plurality of elastic hooks 14, the middle sections of the elastic hooks 14 are bent inwardly, so that the middle sections of the elastic hooks 14 are in contact with the outer wall of the outer bracket 20 under the action of their own elastic force;

[0072] The elastic hook 14 passes through the gap between the tendons and hooks the native leaflet upwards. The native leaflet is rolled up at the end of the elastic hook 14, and the tendons pull the native leaflet downward, so that the native leaflet wraps around the external support 20. The native leaflet seals the recess 21, which not only plays a positioning role but also prevents paravalvular leakage.

[0073] like Figure 4 As shown, the head end of the elastic hook 14 presses against the valve ring, further enhancing the positioning stability of the heart valve prosthesis.

[0074] The elastic hook 14 is attached with anti-slip braided fabric, which can increase the friction with the native leaflet.

[0075] like Figure 1 、 Figure 2 As shown, the elastic hook 14 is arranged to avoid the recess 21 to prevent the elastic hook 14 from interfering with the native tissue.

[0076] The recess 21 and the elastic hook 14 are both provided with a plurality of imaging structures, which extend longitudinally or transversely, making it easier for doctors to observe the state and angle of the heart valve prosthesis in the delivery system and in the human body, thereby increasing the accuracy of heart valve prosthesis implantation.

[0077] Example 2:

[0078] like Figure 6 As shown, a spring is provided between the head end and the middle section of the elastic hook 14, so that the head end of the elastic hook 14 can support the valve ring, and the elastic potential energy of the spring can further enhance the connection stability between the elastic hook 14 and the valve ring.

[0079] Example 3:

[0080] like Figure 7 As shown, a sensor 30 is provided on the inner bracket 10 and / or the outer bracket 20 . The sensor 30 has a built-in power supply and transmits information wirelessly.

[0081] The sensor 30 is a pressure sensor, which is arranged on the outer support 20 corresponding to the recess 21 to detect the pressure intensity of the outer support 20 on the native tissue. If the pressure intensity is too high, an alarm is triggered.

[0082] The sensor 30 is disposed on the inner support 10 to detect the transvalvular pressure difference.

[0083] Example 4:

[0084] The sensor 30 is a flow sensor, which is disposed on the outer support 20 to detect paravalvular leakage.

[0085] The sensor 30 is arranged on the inner support 10 and can detect valve damage and regurgitation in a timely manner.

[0086] Example 5:

[0087] like Figures 8-10 As shown, the frame is provided with a notch at the recess 21, and the notch is sealed and covered by a soft sealing film.

[0088] Example 6:

[0089] like Figure 9As shown, a bottom brim 23 is provided at the bottom end of the notch, and the bottom brim 23 and the brim 22 are sewn together to achieve sealing of the notch.

[0090] In summary, compared with the prior art, the present invention has the following beneficial effects:

[0091] In an embodiment of the present invention, the heart valve prosthesis comprises an inner stent and an outer stent; the inner stent comprises a thin channel and a thick channel; the thin channel is connected to the thick channel, and a prosthetic valve leaflet is disposed in the thin channel; the outer stent is a cylindrical stent, the top opening of the outer stent is sutured to the thin channel via a membrane, and the bottom opening of the outer stent is sutured to the thick channel, thereby forming a sealed cavity between the thin channel and the outer stent, avoiding the formation of thrombus caused by the false cavity. The outer stent also acts as a buffer to prevent damage to the prosthetic valve leaflet caused by compression of the thin channel by cardiac contraction, thereby increasing the service life; the outer stent is provided with an inward depression, the top of the depression being covered with a brim, the depression being used to avoid the patient's native tissue, the native tissue including the heart's conduction system and outflow tract, the heart's conduction system including the atrioventricular node, conduction bundle, etc.; the brim covers the top of the depression and acts as a seal to prevent paravalvular leakage of the heart valve prosthesis at the depression; the heart valve prosthesis is implanted in the patient's body via minimally invasive surgery, has a long service life, causes little damage to surrounding tissue, is easy to operate, and has few complications.

[0092] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply the existence of any such actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article, or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or device. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or device comprising the element.

[0093] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A heart valve prosthesis, characterized in that: The heart valve prosthesis comprises: an inner stent (10) and an outer stent (20); The inner support (10) comprises: a thin channel (11) and a thick channel (12); The thin channel (11) is in communication with the thick channel (12), and a prosthetic valve leaflet (13) is provided in the thin channel (11); The top opening of the outer support (20) is sutured with the thin channel (11) through a membrane, and the bottom opening of the outer support (20) is sutured with the thick channel (12), so that a sealed cavity is formed between the thin channel (11) and the outer support (20); The outer support (20) is provided with an inward depression (21), the top of the depression (21) is covered with a brim (22), and the depression (21) avoids the patient's native tissue; The inner support (10) and the outer support (20) both comprise: a skeleton and a soft sealing membrane; The soft sealing membrane is attached to the frame, so that the heart valve prosthesis establishes a single blood channel formed by the inner stent (10); The skeleton is provided with a notch at the recess (21), and the soft sealing film seals and covers the notch.

2. The heart valve prosthesis according to claim 1, wherein: The skeleton comprises: a bone mesh and a plurality of struts; The struts are arranged along the axial direction of the heart valve prosthesis and are connected through the bone mesh.

3. The heart valve prosthesis according to claim 2, wherein: The middle section of the strut at the recess (21) is provided with an inward bend, and the number of the struts bent inward at the recess (21) is not less than three.

4. The heart valve prosthesis according to claim 1, wherein: A bottom eave (23) is provided at the bottom end of the notch.

5. The heart valve prosthesis according to claim 2, wherein: The bone mesh is formed by connecting a plurality of polygonal unit grids and / or elliptical unit grids.

6. The heart valve prosthesis according to claim 5, wherein: The bone mesh is formed by connecting a plurality of diamond-shaped unit grids.

7. The heart valve prosthesis according to claim 2, wherein: The inner bracket (10) and / or the outer bracket (20) are provided with a plurality of elastic hook claws (14), wherein the middle sections of the elastic hook claws (14) are bent inwards, so that the middle sections of the elastic hook claws (14) come into contact with the outer wall of the outer bracket (20) under the action of their own elastic force.

8. The heart valve prosthesis according to claim 7, wherein: The elastic hook (14) passes through the gaps between the tendons and hooks the native leaflet upwards. The native leaflet is rolled up at the end of the elastic hook (14), and the tendons pull the native leaflet downwards, so that the native leaflet wraps around the external stent (20).

9. The heart valve prosthesis according to claim 7, wherein: The head end of the elastic hook (14) presses against the valve ring.

10. The heart valve prosthesis according to claim 7, wherein: The elastic hook (14) is attached with an anti-slip braid.

11. The heart valve prosthesis according to claim 7, wherein: The elastic hook (14) is arranged to avoid the recess (21).

12. The heart valve prosthesis according to claim 7, wherein: A plurality of developing structures are provided at the recess (21) and the elastic hook (14).

13. The heart valve prosthesis according to claim 9, wherein: A spring is provided between the head end and the middle section of the elastic hook (14).

14. The heart valve prosthesis according to claim 1, wherein A sensor (30) is provided on the inner bracket (10) and / or the outer bracket (20).

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