A cardiac implant

Abstract

The application relates to the field of medical devices, in particular to a heart implant, which comprises an anti-reflux prosthesis, a fixing member and a limiting member, the anti-reflux prosthesis is anchored on atrial tissue through the fixing member, one end of the limiting member is connected with the anti-reflux prosthesis, and the other end of the limiting member is fixed on apical tissue, the anti-reflux prosthesis comprises a closing aid and a barrier, the distal end of the barrier is fixed on the middle region of the closing aid, the proximal end of the barrier is connected with the limiting member, and the proximal end part of the closing aid is free; the application not only can increase the coaptation area with adjacent native leaflets to achieve ideal repair effect, but also can avoid the closing aid from floating into the atrium, and has good clinical significance.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, and more particularly to a heart implant. BACKGROUND

[0002] The mitral valve is located at the left atrioventricular orifice, and is composed of five parts, i.e. the annulus, the leaflets, the chordae tendineae, the papillary muscles, and the junction. Its accurate name in anatomy is the mitral apparatus or the mitral complex.

[0003] The tricuspid valve is located at the right atrioventricular orifice, and has three triangular sail-like leaflets. The base of the valve is attached to the fibrous ring of the atrioventricular orifice. In terms of function, the fibrous ring, the valve, the chordae tendineae, and the papillary muscles can be regarded as the tricuspid valve complex.

[0004] Mitral regurgitation can be divided into two types: 1. Rheumatic mitral regurgitation, which is mainly caused by incomplete closure of the mitral valve, and can cause blood to flow backward, thereby mixing different blood and causing the heart to pump blood and oxygen function to decrease. 2. Non-rheumatic mitral regurgitation, which generally refers to different degrees of mitral regurgitation caused by abnormalities of the mitral valve itself and its surrounding anatomical structures, etc. in addition to rheumatic valve disease. The causes of non-rheumatic mitral regurgitation are various, and the more common ones are: mitral valve prolapse, papillary muscle dysfunction or chordae tendineae rupture, left atrial myxoma, valve ring calcification, congenital valve malformation, infective endocarditis, etc. Mitral regurgitation can also be divided into functional, degenerative or mixed types. The most common ones are degenerative and functional mitral regurgitation. Functional mitral regurgitation is generally secondary to left ventricular wall motion dysfunction, left ventricular dilation, and papillary muscle dysfunction, and is generally seen in patients with heart failure. This part of patients also includes ischemic mitral regurgitation secondary to coronary heart disease and mitral regurgitation related to non-ischemic cardiomyopathy. Degenerative mitral regurgitation disease is generally considered to be pathological changes in the structure of the valve or the pathological changes in the structure below the valve, including abnormal extension or rupture of the chordae tendineae.

[0005] Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricular enlargement, and tricuspid annulus dilation. After the occurrence of tricuspid regurgitation, the symptoms of right heart failure such as fatigue, ascites, edema, liver pain, indigestion, poor appetite, etc. are aggravated. Tricuspid valve insufficiency can be mainly divided into functional tricuspid valve insufficiency and organic tricuspid valve insufficiency. The organic tricuspid valve insufficiency caused by rheumatic fever is very few, and most of them are functional insufficiency. The most common cause is the enlargement of the right ventricle caused by pulmonary hypertension, which leads to the enlargement of the tricuspid annulus and the relative insufficiency of the tricuspid valve, while the structure of the valve itself is normal. Examples include rheumatic mitral valve disease, congenital cardiovascular disease, and pulmonary heart disease.

[0006] Patent CN2014103225948 discloses a kind of prosthesis for preventing valve regurgitation, including fixed unit, connecting piece and auxiliary closing piece, fixed unit includes fixing piece and anchor, connecting piece is flexible, its distal end part is connected with the proximal end part of the fixing piece, its proximal end part is connected with the distal end part of the auxiliary closing piece, fixing piece is fixed on the patient atrial wall or valve ring by anchor, the width of fixing piece unfolding is less than 2 / 3 of the circumference of valve tissue, auxiliary closing piece is located between patient's native valve leaflet in free state, the maximum width of the auxiliary closing piece is less than the maximum width of the native valve leaflet unfolding, the proximal end of anchor is provided with anti-drop end.In this technical solution, adjustment device is used to limit the tip portion of auxiliary closing piece to drift towards atrium, which means that adjustment device limits the drifting stroke of the tip portion of auxiliary closing piece, resulting in insufficient coaptation area of auxiliary closing piece with native valve leaflet, or if the drifting stroke is too long, auxiliary closing piece will still drift towards atrium, affecting the treatment effect.

[0007] Patent CN202210259928.6 discloses a kind of repair device for preventing valve regurgitation, including fixed unit, auxiliary closing piece and adjustment piece, the fixed unit is connected with the auxiliary closing piece, the fixed unit is anchored at atrial tissue or native valve ring, the auxiliary closing piece is provided with first skeleton, one end of the adjustment piece is connected with the first skeleton, the proximal end of the adjustment piece is fixed on apex or ventricular tissue, and when the auxiliary closing piece moves with native valve leaflet, the adjustment piece slides relative to the first skeleton;Adjustment piece and first skeleton can slide relative to each other, so that auxiliary closing piece can adjust the orientation in real time along the direction of blood flow impact when twisting or recovering;Although the adjustment piece in this patent solution can adapt to the twisting stroke of the auxiliary closing piece and make adaptive stroke changes, the drifting stroke of the tip portion of the auxiliary closing piece does not change, resulting in difficulty in controlling the coaptation area of the auxiliary closing piece with native valve leaflet when coaptation.

[0008] In summary, the existing technology repair device at least has the following technical difficulties:

[0009] 1.If the repair device does not design adjustment device, then the repair piece (auxiliary closing piece) will drift into the atrium due to blood flow pressure, thereby losing the repair effect;

[0010] 2.After setting the adjustment device in the existing repair device, the adjustment device can limit the repair piece (auxiliary closing piece) from drifting into the atrium, but it also limits the movement stroke of the repair piece (auxiliary closing piece), and the length of the movement stroke allowed by the adjustment device determines the coaptation area of the repair piece (auxiliary closing piece) with native valve leaflet, thereby affecting the repair effect, and because the anatomical structure of each patient is different, it is difficult to control the distance to make the repair piece (auxiliary closing piece) coapt with native valve leaflet well and avoid the repair piece (auxiliary closing piece) from drifting into the atrium, achieving ideal repair effect. Summary of the Invention

[0011] This application is made in view of the above and other ideas.

[0012] One of the purposes of this application is to overcome the shortcomings of the prior art, such as the limitation of the closure aid's swing stroke by the limiting component in the prior art, making it difficult to control its contact area, thereby seriously affecting its repair effect, and to provide a cardiac implant.

[0013] The technical solution adopted to solve the technical problem of the present invention is to provide a cardiac implant, including an anti-reflux prosthesis, a fixation member, and a restraint member. The anti-reflux prosthesis is anchored to the atrial tissue by the fixation member. One end of the restraint member is connected to the anti-reflux prosthesis, and the other end of the restraint member is fixed to the apical tissue. The anti-reflux prosthesis includes a closure aid and a barrier member. The distal end of the barrier member is fixed to the middle region of the closure aid member, the proximal end of the barrier member is connected to the restraint member, and the proximal portion of the closure aid member is free.

[0014] As a further improvement of the present invention, the closure aid includes a fixing part and an occlusal part, the fixing part being anchored to the atrial tissue by the fixing part, and the occlusal part including a first occlusal part and a second occlusal part, wherein the second occlusal part is free.

[0015] As a further improvement of the present invention, the material of the mating part includes, but is not limited to, animal pericardium (bovine pericardium, pig pericardium), polyester, etc.

[0016] As a further improvement of the present invention, the fixation part is made of metal shape memory alloy, which can prevent the closure aid from curling up and being difficult to unfold during implantation.

[0017] As a further improvement of the present invention, the connection method between the barrier and the first mating part includes, but is not limited to, stitch connection, adhesive connection, and membrane connection.

[0018] As a further improvement of the present invention, the axial length of the barrier is greater than or equal to the axial length from the connection point of the barrier with the first mating portion to the proximal end of the second mating portion.

[0019] As a further improvement of the present invention, the axial length of the mating part is in the range of 15 to 45 mm, and preferably in the range of 20 to 40 mm.

[0020] As a further improvement of the present invention, the maximum width of the first mating portion is 5 to 50 mm, and preferably the maximum width range of the first mating portion is 10 to 45 mm.

[0021] As a further improvement of the present invention, the axial length from the connection point of the barrier member with the first mating portion to the proximal end of the second mating portion is 3 to 15 mm, and preferably 5 to 10 mm.

[0022] As a further improvement of the present invention, the width of the centerline of the mating part is in the range of 5~50mm, and preferably in the range of 10~40mm.

[0023] As a further improvement of the present invention, the closure aid is made of a flexible material, and the stiffness of the barrier is greater than that of the closure aid.

[0024] As a further improvement of the present invention, the barrier is a mesh structure woven or cut from shape memory metal wires, and the metal coverage of the barrier is 4 to 10%.

[0025] As a further improvement of the present invention, the barrier is provided with an arched structure, and the barrier arches towards the atrium; the advantage of this design is that when the autologous valve closes, the blood in the ventricle is squeezed into the atrium, making the tip of the valve leaflet very prone to backflow. The barrier arches from the ventricle to the atrium, which can cover the blood and prevent backflow. This design conforms to hemodynamics and has good clinical significance.

[0026] As a further improvement of the present invention, the distal end of the limiting member is connected to the blocking member, the distal end of the limiting member is a closed-loop structure, and when the closure aid moves with the autologous leaflet, the limiting member and the blocking member slide relative to each other.

[0027] As a further improvement of the present invention, the limiting member is a linear member, and the number of the limiting members is at least three, and the proximal portions of the three limiting members are merged into one strand.

[0028] According to another aspect of the present invention, a method for operating a cardiac implant according to the above-described invention involves operating the cardiac implant into the heart via a transapical approach;

[0029] The fixation part is positioned at the autologous valve ring, and the fixation member is further released so that the fixation member passes through the fixation part and inserts into the tissue to achieve anchoring;

[0030] The occlusion portion is gradually released from the distal end to the proximal end, and the proximal end of the restraint is fixed to the apical tissue. At this time, the anti-regurgitation prosthesis replaces the function of a single autologous valve and achieves occlusion with the adjacent autologous valve leaflets.

[0031] Remove the cardiac implant delivery device.

[0032] Compared with the prior art, the advantages of the technical solution of this application include at least the following:

[0033] While existing adjustment devices can prevent the closure aid from drifting into the atrium, they also limit its swing range, making it difficult to control the occlusion area between the closure aid and the autologous valve leaflet. Furthermore, due to differences in each patient's physiological anatomy, the repair effect is severely affected. According to a concept in this application, the closure aid includes a first occlusion portion and a second occlusion portion, wherein the second occlusion portion is in a free state, and a barrier is placed in the dorsal region of the second occlusion portion. After the closure aid is implanted, the second occlusion portion drifts towards the atrium and... The second occlusive part adapts to the adjacent autologous leaflet, while the limiting component is fixed to the blocking component and restricts the entire occlusive part from drifting into the atrium. This effectively increases the occlusive area between the second occlusive part and the adjacent autologous leaflet, while preventing the entire occlusive part from drifting into the atrium. Furthermore, because the second occlusive part can adapt to the adjacent autologous leaflet, this anti-reflux prosthesis can adapt to the physiological structure of most patients, achieving ideal repair results while significantly reducing the product's size, making it suitable for industrial mass production and possessing significant clinical value.

[0034] According to a concept of this application, the stiffness of the barrier element is greater than that of the closure aid element. The barrier element can effectively ensure that when the autologous valve closes and the second occlusal part is impacted by blood flow, the barrier element can effectively prevent the second occlusal part from twisting when it occludes with the adjacent autologous valve leaflet, thereby affecting the occlusion effect.

[0035] According to a concept of this application, the barrier arches from the ventricle to the atrium. The advantage of this design is that when the autologous valve closes, the blood in the ventricle is squeezed into the atrium, making it very easy for backflow to occur at the tip of the valve leaflet. The barrier arches from the ventricle to the atrium, which can cover the blood and prevent backflow. This design is in line with hemodynamics and has good clinical significance.

[0036] According to a concept of this application, when the closure aid is impacted by blood flow, the distal end of the limiting member and the blocking member will slide relative to each other, so that the closure aid can adapt to the impact of blood flow and avoid long-term impact of blood flow on a certain area of ​​the closure aid, which would lead to stress fatigue. At the same time, the blocking member can help the closure aid to restore its shape, and the limiting member adapts to the change and avoids interfering with it.

[0037] 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

[0038] The above-described features and advantages of these embodiments, as well as other features and advantages, and the ways in which they are implemented, 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:

[0039] Figures la-d This is a schematic diagram of the overall anti-backflow prosthesis of the present invention, wherein... Figure la Front view of the prosthesis to prevent backflow. Figure lc Rear view of the prosthesis to prevent backflow. Figure Id This is a schematic diagram of the barrier component.

[0040] Figure 2a and Figure 2b A schematic diagram of the overall structure of the anti-reflux prosthesis of the present invention positioned in the heart.

[0041] Figure 3a and Figure 3b In another embodiment of the anti-backflow prosthesis of the present invention, wherein Figure 3a Front view of the prosthesis to prevent backflow. Figure 3b Rear view of the prosthesis to prevent backflow.

[0042] The features represented by the numbers in the attached diagram are as follows:

[0043] 1-Anti-backflow prosthesis, 11-Auxiliary closure component, 111-Fixing part, 112-Matching part, 1121-First mating part, 1122-Second mating part, 12-Blocking component, 2-Fixing component, 3-Restricting component. Detailed Implementation

[0044] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0045] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of this application without departing from the scope or spirit of this disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0046] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and any additional items.

[0047] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0048] In this application, the terms "other end" or "proximal end" or "proximal side" refer to the end or side closer to the centrifuge tip, and "one end" or "distal end" or "distal side" refer to the end or side farther from the centrifuge tip.

[0049] One of the objectives of the embodiments described below is to address the aforementioned deficiencies, as well as other problems.

[0050] Example 1

[0051] like Figures la-d The illustration shows a cardiac implant according to an embodiment of this application, including an anti-regurgitation prosthesis 1, a fixation member 2, and a restraint member 3. The anti-regurgitation prosthesis 1 is anchored to the posterior valve annulus by the fixation member 2, which can be an anchoring pin. One end of the restraint member 3 is connected to the anti-regurgitation prosthesis 1, and the other end of the restraint member 3 is fixed to the apical tissue. The anti-regurgitation prosthesis 1 includes a closure aid 11 and a barrier member 12. The distal end of the barrier member 12 is fixed to the middle region of the closure aid 11, and the proximal end of the barrier member 12 is connected to the restraint member 3 to limit the swing stroke of the closure aid 11 and prevent the closure aid 11 from drifting into the atrium. Furthermore, the proximal portion of the closure aid 11 is free. When the autologous valve closes, the proximal portion of the closure aid 11 drifts and can cover the lower edge of the anterior valve leaflet to achieve closure and prevent regurgitation.

[0052] In this embodiment, the closure aid 11 includes a fixing part 111 (the fixing part 111 is made of a metal shape memory alloy, which can prevent the closure aid 11 from curling up and being difficult to unfold during implantation) and an occlusive part 112 (the occlusive part 112 is made of bovine pericardium). The fixing part 111 is anchored to the posterior valve annulus by the fixing member 2. The occlusive part 112 includes a first occlusive part 1121 and a second occlusive part 1122. The second occlusive part 1122 is free. When the autologous valve closes, the free lower edge of the second occlusive part 1122 can effectively cover the lower edge of the occlusive anterior leaflet, further preventing blood backflow.

[0053] In this embodiment, the distal end of the barrier 12 is connected to the proximal edge of the first mating portion 1121, and the maximum width of the barrier 12 is greater than or equal to the width at the connection between the barrier 12 and the first mating portion 1121, such as...Figure lb As shown, the connection methods between the barrier 12 and the first mating part 1121 include, but are not limited to, stitch connection, adhesive connection, and membrane connection.

[0054] In this embodiment, the axial length of the mating portion 112 is 15mm, and the maximum width of the first mating portion 1121 is 5mm.

[0055] In this embodiment, the axial length from the connection point of the barrier 12 and the first mating portion 1121 to the proximal end of the second mating portion 1122 is 3 mm.

[0056] In this embodiment, the centerline width of the mating portion 112 is 5 mm.

[0057] In this embodiment, the closure aid 11 is made of a flexible material, and the stiffness of the barrier 12 is greater than that of the closure aid 11. The barrier 12 is a mesh structure woven or cut from shape memory metal wire, and the metal coverage of the barrier 12 is 4%.

[0058] In this embodiment, the barrier 12 is an arched structure, as shown in Figure 1, and the barrier 12 arches towards the atrium. The advantage of this design is that when the autologous valve closes, the blood in the ventricle is squeezed into the atrium, making it very easy for backflow to occur at the tip of the valve leaflet. The barrier 12 arches from the ventricle to the atrium, which can cover the blood and prevent backflow. This design conforms to hemodynamics and has good clinical significance.

[0059] In this embodiment, the distal end of the limiting member 3 is connected to the blocking member 12, and the distal end of the limiting member 3 has a closed-loop structure, such as... Figure lb As shown, when the closure aid 11 follows the movement of the self-leaf, the restrictor 3 and the barrier 12 can slide relative to each other.

[0060] In this embodiment, the limiting member 3 is a linear member, and there are 3 limiting members 3 in total, and the proximal portions of the 3 limiting members 3 are merged into one strand.

[0061] The following is an exemplary procedure for repairing the mitral valve using a cardiac implant in this embodiment:

[0062] 1. The delivery system is accessed via the transapical approach, passing through the patient's left ventricle to reach the left atrium;

[0063] 2. Position the fixation part 111 at the autologous valve annulus, and further release the fixation member 2 so that the fixation member 2 passes through the fixation part 111 and inserts into the tissue to achieve anchoring;

[0064] 3. Gradually release the occlusion portion 112 from distal to proximal, and fix the proximal end of the restraint 3 to the apical tissue. At this time, the anti-regurgitation prosthesis 1 replaces the function of a single autologous valve and achieves occlusion with adjacent autologous valve leaflets, as shown. Figure 2a and 2b As shown;

[0065] 4. Remove the cardiac implant delivery device.

[0066] Example 2

[0067] Embodiment 2 is largely the same as Embodiment 1, except that the dimensions of the mating portion 112 and the fixing position of the barrier 12 and the mating portion 112 are different in this embodiment. Figure 3a and 3b As shown.

[0068] In this embodiment, the axial length of the mating portion 112 is 45 mm.

[0069] In this embodiment, the maximum width of the first mating portion 1121 is 50 mm.

[0070] In this embodiment, the axial length from the connection point of the barrier 12 and the first mating portion 1121 to the proximal end of the second mating portion 1122 is 15 mm.

[0071] In this embodiment, the centerline width of the mating portion 112 is 50 mm.

[0072] In this embodiment, the barrier 12 is a mesh structure woven or cut from shape memory metal wires, and the metal coverage of the barrier 12 is 10%.

[0073] 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.

[0074] The foregoing description of the embodiments described above is 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. Clearly, 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 cardiac implant comprising an anti-reflux prosthesis, a fixation element, and a restraint element, wherein the anti-reflux prosthesis is anchored to atrial tissue via the fixation element, one end of the restraint element is connected to the anti-reflux prosthesis, and the other end of the restraint element is fixed to apical tissue, characterized in that: The anti-backflow prosthesis includes an apprehension component and a barrier component. The distal end of the barrier component is fixed to the middle region of the apprehension component, and the proximal end of the barrier component is connected to the restrictor component. The proximal end is the end closer to the centrifugal tip, and the distal end is the end farther from the centrifugal tip. Furthermore, the proximal portion of the apprehension component is free.

2. A cardiac implant according to claim 1, characterized in that: The closure aid includes a fixing part and an occlusal part. The fixing part is anchored to the atrial tissue by the fixing part, and the occlusal part includes a first occlusal part and a second occlusal part, wherein the second occlusal part is free.

3. A cardiac implant according to claim 2, characterized in that: The axial length of the barrier is greater than or equal to the axial length from the connection point of the barrier with the first mating portion to the proximal end of the second mating portion.

4. A cardiac implant according to claim 2, characterized in that: The axial length of the mating part ranges from 15 to 45 mm.

5. A cardiac implant according to claim 2, characterized in that: The axial length of the mating part ranges from 20 to 40 mm.

6. A cardiac implant according to claim 2, characterized in that: The maximum width of the first mating part is 5 to 50 mm.

7. A cardiac implant according to claim 2, characterized in that: The maximum width of the first mating part ranges from 10 to 45 mm.

8. A cardiac implant according to claim 2, characterized in that: The axial length from the connection point of the barrier member with the first mating part to the proximal end of the second mating part is 3 to 15 mm.

9. A cardiac implant according to claim 2, characterized in that: The axial length from the connection point of the barrier member and the first mating part to the proximal end of the second mating part is 5-10 mm.

10. A cardiac implant according to claim 1, characterized in that: The closure aid is made of a flexible material, and the stiffness of the barrier is greater than that of the closure aid.

11. A cardiac implant according to claim 2, characterized in that: The barrier is a mesh structure woven or cut from shape memory metal wires, and the metal coverage of the barrier is 4 to 10%.

12. A cardiac implant according to claim 11, characterized in that: The barrier is an arched structure, and the barrier arches towards the atrium.

13. A cardiac implant according to claim 12, characterized in that: The distal end of the limiting member is connected to the blocking member. The distal end of the limiting member is a closed-loop structure. When the closure aid moves with the autologous leaflet, the limiting member and the blocking member slide relative to each other.

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