WO2022236928A1 - Dispositif d'ancrage pour prothèse d'implant cardiaque et prothèse d'implant cardiaque le comprenant - Google Patents

Dispositif d'ancrage pour prothèse d'implant cardiaque et prothèse d'implant cardiaque le comprenant Download PDF

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Publication number
WO2022236928A1
WO2022236928A1 PCT/CN2021/101843 CN2021101843W WO2022236928A1 WO 2022236928 A1 WO2022236928 A1 WO 2022236928A1 CN 2021101843 W CN2021101843 W CN 2021101843W WO 2022236928 A1 WO2022236928 A1 WO 2022236928A1
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Prior art keywords
anchoring
fixing member
polymer coating
anchoring device
tissue
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PCT/CN2021/101843
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English (en)
Chinese (zh)
Inventor
赵婧
闻靖
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上海臻亿医疗科技有限公司
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Priority claimed from CN202110500037.0A external-priority patent/CN113017930A/zh
Priority claimed from CN202120972734.1U external-priority patent/CN218832965U/zh
Application filed by 上海臻亿医疗科技有限公司 filed Critical 上海臻亿医疗科技有限公司
Publication of WO2022236928A1 publication Critical patent/WO2022236928A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body

Definitions

  • the invention relates to the technical field of medical devices, in particular to an anchoring device for heart implant prosthesis anchoring and a heart implant prosthesis comprising the same.
  • the heart contains four chambers, the right atrium (RA), right ventricle (RV), left atrium (LA) and left ventricle (LV).
  • the pumping action of the left and right sides of the heart generally occurs simultaneously throughout the cardiac cycle.
  • the valve that separates the atria from the ventricles is called the atrioventricular valve.
  • the atrioventricular valve acts as a one-way valve to ensure the normal flow of blood in the heart chambers.
  • the atrioventricular valve between the left atrium and left ventricle is the mitral valve
  • the atrioventricular valve between the right atrium and right ventricle is the tricuspid valve.
  • the pulmonary valve directs blood flow to the pulmonary artery and from there to the lungs, where blood returns to the left atrium through the pulmonary veins.
  • the aortic valve directs blood flow through the aorta and from there to the periphery. Usually there is no direct connection between the ventricles or between the atria.
  • mitral valve replacement technology has developed rapidly, there are still some recognized difficulties in the design of the valve, such as the anchoring of the valve.
  • Existing cardiac valve anchoring devices include extending the valve prosthesis with one or more drawstrings and fixing it to the heart tissue for anchoring, for example, the apical fixation device introduced in patent document CN201480050061. If the anchoring member has too much rigidity and is placed at the apex of the heart, it may not adhere well to the heart tissue, resulting in bleeding, or rubbing against the heart tissue to cause bleeding. If the stiffness of the anchor is too small, the anchoring force may be insufficient and the valve prosthesis may be displaced. Anchoring of chordal prostheses presents similar problems.
  • the present invention provides an anchoring device for a cardiac implant prosthesis and a cardiac implant prosthesis containing the same, which can solve the above-mentioned defects in the prior art.
  • An anchoring device for a cardiac implant prosthesis includes an anchoring body, the anchoring body is fixed at the end of the implant; the surface of the anchoring body is covered with a polymer coating with liquid absorption capacity, Wherein, the polymer coating has a swollen form after absorbing liquid.
  • the implant prosthesis can be a valve prosthesis or a tendon prosthesis.
  • the implant prosthesis is attached to tissues such as the epicardium, ventricular wall, and papillary muscle through the anchoring body to provide anchoring force.
  • tissues such as the epicardium, ventricular wall, and papillary muscle through the anchoring body to provide anchoring force.
  • the polymer coating arranged on the surface of the anchor body can absorb liquid and swell and become flexible; and the volume of the polymer coating after liquid absorption and swelling becomes larger, which can assist in sealing and prevent further leakage ; moreover, the hydrophilicity of the polymer coating favors the adhesion and proliferation of endothelial cells, thereby facilitating endothelialization of the anchoring body.
  • the anchoring body includes a first fixer attached to the tissue, the side of the first fixer attached to the tissue is provided with the polymer coating, and/or the first fixer The side of the piece facing away from the tissue is provided with the polymer coating.
  • the polymer coating when the polymer coating is arranged on the side attached to the tissue, on the one hand, the polymer coating changes from rigidity to elasticity after absorbing liquid and swelling, thereby forming a buffer layer between the rigid first fixing member and the tissue, The buffer layer avoids the direct contact between the first fixing member and the tissue, and can reduce the frictional damage of the first fixing member to the heart tissue during the heart movement.
  • the first fixing member can choose a material with higher rigidity than that without the coating, so as to provide a more reliable anchoring effect during the application process; and the polymer
  • the cushioning effect of the material coating can reduce the tissue damage caused by the high rigidity of the first fixing member, thereby better solving the problem that the stiffness of the first fixing member and the anchoring force are difficult to balance.
  • the anchoring body further includes a second fixing part, the second fixing part is arranged coaxially with the first fixing part, and the second fixing part is arranged between the first fixing part and the first fixing part. Between the implants, the first fixing member and the second fixing member are attached to both sides of the tissue to achieve fixation.
  • the anchoring body When the heart valve is implanted, the anchoring body is arranged on the apical epicardium or the wall of the ventricle to provide anchoring force for the heart valve and prevent the valve stent from being displaced to the left ventricle by the impact of blood when the heart contracts.
  • the first fixing part is anchored at the apical epicardium or interventricular septum (right ventricle)
  • the second fixing part is anchored at the apical endocardium or interventricular septum (left ventricle)
  • the cooperation of the first and second fixing parts can clamp Tight tissue, thus providing a more secure anchoring force.
  • a side of the second fixing member near the first fixing member is covered with the polymer coating.
  • the coating When the coating is provided on the surface of the second fixing member close to the first fixing part, on the one hand, the coating absorbs liquid and expands when the tissue seeps, which plays a role of further sealing and prevents leakage; on the other hand, the coating is flexible after swelling Increased resistance can play a buffering role and prevent the second fixer from damaging the tissue; in addition, due to the existence of the coating, the second fixer can choose a material with relatively high rigidity, thereby improving the anchoring force of the second fixer , and can also reduce the damage to the tissue caused by the second fixing member.
  • the second fixing part is sleeved on the connecting part, and the second fixing part is configured to be movable along the length direction of the connecting part. Wherein, during the release process of the heart valve, the position of the second fixing member can be adjusted so that it can clamp the tissue.
  • the second fixture is configured to conform to the shape of the apical intima.
  • the damage to the tissue can be reduced; on the other hand, such a structure enables the second fixing member to fit the tissue, thereby providing a stable anchoring effect.
  • the connecting portion is provided with a limiting member, and the limiting member is disposed between the second fixing member and the implant. Since the second fixing part is movably arranged on the connecting part, after the heart valve is completely released, the setting of the limiting part can prevent the second fixing part from moving unexpectedly and play a role of retention, so that the second fixing part can Always cooperate with the first fixing member for anchoring, further improving the anchoring stability of the anchoring body.
  • the first fixing member is configured to protrude toward the direction away from the implant, so that the first fixing member and the polymer coating can adapt to the shape of the epicardium of the apex and better fit the tissue, Thereby further improving the anchoring stability.
  • the polymer coating is made of a hydrophilic polymer material selected from the group consisting of: polyethylene oxide, polyvinyl alcohol, polyacrylic acid, polypropylene fumaric acid- Coglycol and peptides, agarose, alginate, chitosan, collagen, fibrin, gelatin and hyaluronic acid, polyhydroxyethylmethacrylate, poly-2-hydroxyethylmethacrylate and their copolymers At least one of compound, polyvinylpyrrolidone, poly-N-vinylpyrrolidone, polyacrylamide.
  • the appropriate coating material can be selected according to the specific conditions of clinical cases.
  • the first fixing part and the second fixing part are respectively made of materials with predetermined rigidity, and the materials are selected from: nickel-titanium alloy, stainless steel, carbon fiber, polyamide, polyphenylene sulfide, At least one of polyarylamide and polyether ether ketone.
  • the rigidity of the first fixing part and the second fixing part in this embodiment can be made larger, so that the anchoring stability of the anchoring body can be improved.
  • the present invention also provides a cardiac implant prosthesis comprising any one of the anchoring devices described above.
  • the implant prosthesis can be a valve prosthesis or a chordal prosthesis.
  • the polymer coating arranged on the surface of the anchoring body can absorb The liquid swells and becomes flexible; and the volume of the polymer coating swelled after absorbing the liquid becomes larger, which can assist in sealing and prevent further leakage; in addition, the hydrophilicity of the polymer coating is conducive to the adhesion and adhesion of endothelial cells. Proliferate, thereby contributing to endothelialization of the anchoring body.
  • the first fixing member is attached to the tissue to provide anchoring force.
  • the polymer coating absorbs liquid After expansion, it changes from rigidity to elasticity, thereby forming a buffer layer between the rigid first fixing part and the tissue, avoiding direct contact between the first fixing part and the tissue, and reducing the impact of the first fixing part on the heart tissue during heart movement.
  • the first fixing member can choose a material with higher stiffness than that without the coating, so as to provide a more reliable anchoring effect during the application process, The anchoring stability is good; and the cushioning effect of the polymer coating can reduce tissue damage caused by the high stiffness of the first fixing member, thereby better solving the problem that the stiffness of the first fixing member and the anchoring force are difficult to balance.
  • the first fixing member is anchored at the apical epicardium or interventricular septum (right ventricle), and the second fixing member is anchored at the apical endocardium or interventricular septum (left ventricle).
  • the cooperation of the two fixing parts can clamp the tissue, thereby providing a more reliable anchoring force; when the second fixing part is provided with a polymer coating on the surface close to the first fixing part, on the one hand, the coating absorbs liquid and expands when the tissue seeps, and plays a role.
  • the flexibility of the coating increases after expansion, which can play a buffer role and prevent the second fixer from damaging the tissue; in addition, the second fixer can choose a relatively large rigidity material, good anchoring stability.
  • the first fixing member protrudes away from the implant, and the second fixing member is configured to conform to the shape of the apical endocardium, which can reduce damage to the tissue on the one hand, and on the other hand , such a configuration enables the first fixer and the second fixer to fit the tissue, thereby providing a better anchoring effect; in addition, after the implant is completely released, the setting of the limiter can prevent the second fixer from non-stopping.
  • the expected movement plays a role of retention, so that the second fixing part can always cooperate with the first fixing part for anchoring, further improving the anchoring stability of the anchoring body.
  • Fig. 1 is the structural representation of the heart valve of embodiment 1 of the present invention
  • Fig. 2a is a schematic structural view of an anchoring device of a heart valve according to Embodiment 1 of the present invention
  • Fig. 2b is a schematic structural view of another anchoring device of the heart valve according to Embodiment 1 of the present invention.
  • Example 3 is a schematic structural view of the heart valve implantation process in Example 1 of the present invention.
  • Fig. 4 is a schematic structural view of the chord prosthesis of Example 2 of the present invention.
  • valve part 100 first region 101; second region 102; third region 103; valve support 110; anchoring device 200; connection part 210; anchoring body 220; ; polymer coating 230 .
  • the atrioventricular valve is a complex structure that typically includes an annulus, leaflets, chordae, and supporting structures. Each atrium is connected to its valve by the atrial vestibule. At the onset of ventricular filling (diastole), the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricles. Shortly thereafter, the atrioventricular valves open to allow unimpeded flow from the atria into the corresponding ventricle. Shortly after the onset of ventricular systole (ie, ventricular emptying), the tricuspid and mitral valves normally close, forming a seal that prevents backflow from the ventricle into the corresponding atrium.
  • the mitral valve has two leaflets, and the attachment or coaptation of the respective surfaces of the leaflets to one another helps to provide closure or sealing of the valve, preventing blood from flowing in the wrong direction.
  • the failure of the leaflets to seal during ventricular systole is called malcoaptation, which allows blood to flow backward through the valve (regurgitation).
  • Heart valve insufficiency can have serious consequences for patients, often leading to heart failure, reduced blood flow, lower blood pressure, and/or reduced oxygen flow to body tissues. Mitral regurgitation can also cause blood to flow from the left atrium back into the pulmonary veins, causing congestion. Severe valve insufficiency can lead to permanent disability or death if left untreated.
  • Transcatheter Mitral Valve Replacement is to use the method of catheter intervention to compress the artificial valve to the delivery system outside the body, along the vascular path or through the apex, and deliver it to the annulus of the human mitral valve, and release the artificial valve. Fixed in the mitral annulus to replace the native valve. Compared with surgery, TMVR does not require an extracorporeal circulation assist device, has less trauma, and the patient recovers faster, and the postoperative hemodynamic indicators of the patient can be significantly improved.
  • One aspect of the present invention provides a heart valve and an anchoring device for the heart valve, which are used to replace the original valve to open or close the blood flow channel, so as to solve the valve anchoring problem in the prior art.
  • the present invention also provides a chordal prosthesis and its anchoring device.
  • the present invention will be further described below using a mitral valve as an example.
  • the heart valve can also be a tricuspid valve, an aortic valve or a pulmonary valve.
  • connection should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. Connected, or integrally connected; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention in specific situations.
  • the mitral valve prosthesis includes a valve part 100 and an anchoring device 200.
  • the valve part 100 includes a valve support 110, a skirt and an artificial valve leaflet.
  • the valve stent 110 can be divided into a first area 101 , a second area 102 and a third area 103 longitudinally.
  • the first area 101 is attached to the original mitral valve annulus of the heart to prevent the valve prosthesis from falling from the left atrium into the left ventricle, and the second area 102 is used to carry the artificial valve leaflets 130, at the same time relying on the support on the tissue to play a certain role of fixation and sealing;
  • the third area 103 is the anchoring part of the mitral valve prosthesis in the left ventricle, preventing the prosthesis from being impacted by blood to the left atrium when it is closed .
  • the valve stent 110 can provide several functions for the heart valve prosthesis 100, including serving as the main structure of the valve prosthesis, carrying the internal prosthetic valve leaflets, and serving as a mechanism for inhibiting paravalvular leakage between the mitral valve prosthesis 100 and the native valve. Seals, connection structures (such as hanging lugs or fixing lugs) to the conveying system, etc.
  • the valve stent 110 is braided or cut.
  • the valve stent 110 is made of nickel-titanium alloy or other biocompatible materials with shape memory properties, or elastically or plastically deformable materials, such as Balloon expandable material.
  • the artificial leaflets are dynamically switched between open and closed states, and in the closed state, the artificial leaflets are tightly closed or converged in a sealed abutting manner.
  • the prosthetic leaflet may be formed from any suitable material or combination of materials.
  • a biological tissue such as a chemically stable tissue from a heart valve of an animal (such as a pig), or pericardial tissue of an animal such as bovine (bovine pericardium) or sheep (ovine pericardium) or porcine (porcine pericardium) may be selected. ) or horse (equine pericardium), preferably bovine pericardium tissue.
  • Prosthetic leaflets can also be made from the submucosal tissue of the small intestine.
  • synthetic materials can also be used for artificial valve leaflets.
  • synthetic materials can also be used for artificial valve leaflets.
  • thermoplastic polycarbonate urethanes, polyether urethanes, segmented polyether urethanes, silicone polyether urethanes, silicone-polycarbonate urethanes, and ultra-high molecular weight polyethylenes are also included.
  • Additional biocompatible polymers can optionally include polyolefins, elastomers, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, other fluoropolymers, silicone poly Esters, silicone polymers and/or oligomers, and/or polylactones, and block copolymers using them.
  • the leaflet has a surface that is treated with (or reacts with) an anticoagulant, including but not limited to heparinized polymers.
  • the skirt can be a single-layer structure, or it can be a double-layer structure inside and outside. You can choose knitted, woven, woven polyester fabrics, PTFE, ePTFE and other materials, which mainly play a sealing role to prevent reflux.
  • the valve stent 110 is configured as a grid-like frame structure, which can be a single-layer frame structure, such as the structure of the main body or frame part disclosed in CN202010680119.3, or a double-layer frame structure, such as CN202010680119 .
  • the stent in 3, or the stent structure disclosed in CN202010680139.0, the valve stent is not intended to limit the scope of the present invention.
  • the valve stent 110 can be compressed and loaded into the delivery device, and can self-expand into a target shape after being released.
  • the anchoring device of this embodiment is used for anchoring the valve stent 110, and the anchoring device 200 includes an anchoring body 220, and the anchoring body 220 is fixed to the end of the valve stent 110 through the connecting portion 210; the surface of the anchoring body 220 A polymer coating 230 with liquid absorption capability is applied, wherein the polymer coating 230 has a swollen form after absorbing liquid.
  • the anchoring body 220 When the heart valve in this embodiment is implanted, the anchoring body 220 is disposed at the apical epicardium or interventricular septum to provide anchoring force for the heart valve and prevent the valve support 110 from being displaced to the left ventricle by blood impact during systole.
  • the polymer coating 230 disposed on the surface of the anchor body 220 can absorb liquid and swell to become flexible; and the polymer coating 230 after absorbing liquid and swelling Increased volume assists with sealing and prevents further leakage.
  • the anchoring body 220 includes a first fixing member 220a attached to the tissue.
  • the first fixing member 220a is provided with the polymer coating 230 near the side of the valve part 100, as shown in FIG. 2a shown.
  • the polymer coating 230 when the polymer coating 230 is arranged on the side close to the valve part 100, on the one hand, the polymer coating 230 changes from rigidity to elasticity after absorbing liquid and swelling, thereby forming a rigidity between the rigid first fixing member 220a and the tissue. Buffer layer.
  • the buffer layer avoids direct contact between the first fixing member 220a and the tissue, and can reduce the frictional damage of the fixing member to the heart tissue during heart movement.
  • the first fixing member 220a can choose a material with higher rigidity, so as to provide a more reliable anchoring effect during application; and
  • the cushioning effect of the polymer coating 230 can reduce tissue damage caused by the high stiffness of the first fixing member 220a, thereby better solving the problem that the stiffness of the first fixing member 220a is difficult to balance with the anchoring force.
  • the polymer coating 230 may cover the entire surface of the first fixing member 220a near the valve portion 100 , or cover a part of the surface of the first fixing member 220a near the valve portion 100 .
  • the polymer coating 230 is provided on a side of the first fixing member 220 a away from the valve support 110 .
  • the first fixing member 220a is circular or oval.
  • the first fixing part 220a is configured to protrude toward the direction away from the valve part 100, that is, the first fixing part 220a is disc-shaped and has a concave inner surface area (convex to the opposite direction of the valve part 100), In use, this region curves around the apical epicardium and generally conforms to the outer surface of the apex, which reduces stress damage to the apical portion.
  • the first fixing part 220a is fixedly connected with the connecting part 210, for example, the first fixing part 220a further includes a central hole, and the connecting part 210 passes through the central hole and is fixed by knotting.
  • the first fixing member 220 a is welded to the connecting portion 210 , and the way of fixing them is not particularly limited.
  • the first fixing member 220a is made of a grid-like frame structure coated with an impermeable material.
  • the frame structure can be selected from nickel-titanium alloy, stainless steel, carbon fiber, polyamide (PA), polyphenylene sulfide (PPS), polyarylamide (IXEF), polyether ether ketone (PEEK) or some polymer composite materials with higher rigidity. Large material preparation to provide stable anchoring force.
  • the impermeable material can be prepared from materials such as polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polypropylene, polyester, and animal pericardium tissue.
  • the first fixing member 220a can also be a one-piece structure, using rigid materials such as nickel-titanium alloy, stainless steel, carbon fiber, polyamide (PA), polyphenylene sulfide (PPS), polyarylamide ( IXEF), polyetheretherketone (PEEK) and other materials.
  • rigid materials such as nickel-titanium alloy, stainless steel, carbon fiber, polyamide (PA), polyphenylene sulfide (PPS), polyarylamide ( IXEF), polyetheretherketone (PEEK) and other materials.
  • the anchoring body 220 further includes a second fixing member 220b, as shown in FIG. 2b and FIG.
  • the second fixing part 220b is disposed between the first fixing part 220a and the valve support 110 .
  • the first fixing member 220a is anchored at the apical epicardium or the interventricular septum (right ventricle)
  • the second fixing member 220b is anchored at the apical endocardium or the interventricular septum (left ventricle)
  • the first fixing member 220a, the second fixing member 220b The fit can clamp the tissue, thus providing a more secure anchoring force.
  • the surface of the second fixing member 220b close to the first fixing member 220a is provided with the polymer coating 230 .
  • the coating absorbs liquid and expands when the tissue seeps, which plays a role of further sealing and prevents leakage; on the other hand, after the coating expands, The increased flexibility can play a buffering role and prevent the second fixing member 220b from damaging the tissue; in addition, the second fixing member 220b can choose a material with relatively high rigidity, thereby improving the anchoring stability of the second fixing member 220b, and because The existence of the polymer coating 230 can reduce the tissue damage caused by the rigidity of the second fixing member 220b.
  • the polymer coating 230 may also be disposed on a surface of the second fixing member 220 b close to the valve support 110 .
  • the second fixing part 220b is sleeved on the connecting part 210 , and the second fixing part 220b is configured to be movable along the length direction of the connecting part 210 . Wherein, during the release process of the heart valve, the position of the second fixing member 220b can be adjusted so that it can clamp the tissue.
  • the second fixing member 220b is configured to conform to the shape of the apical endocardium. On the one hand, the damage to the tissue can be reduced; on the other hand, such a structure enables the second fixing member 220b to fit the tissue, thereby providing better anchoring effect.
  • the connecting portion 210 is provided with a limiting member 240 , and the limiting member 240 is disposed between the second fixing member 220 b and the valve support 110 . Since the second fixing part 220b is movably arranged on the connecting part 210, after the heart valve is completely released, the setting of the limiting part 240 can prevent the second fixing part 220b from moving unexpectedly, and play a role of retention, so that the first The second fixing piece 220b can always cooperate with the first fixing piece 220a for anchoring, which further improves the anchoring stability of the anchoring body 220 .
  • the limiting member 240 can be configured as a protruding structure on the connecting portion 210, as shown in FIG.
  • the limiting member 240 can also be configured as a clamping structure, and after the second fixing member 220b is released, it is adjusted to a position of clamping tissue, and then the second fixing member 220b is clamped and fixed by the limiting member.
  • the second fixing member 220b is circular or oval.
  • the second fixing part 220b is in the shape of a plate.
  • the second fixing part 220b is made of a grid-like frame structure covered with an impermeable material, or the second fixing part 220b can also be a sheet-like structure.
  • the second fixing member 220b can be selected from nickel-titanium alloy, stainless steel, carbon fiber, polyamide (PA), polyphenylene sulfide (PPS), polyarylamide (IXEF), polyetheretherketone (PEEK) or some polymer composite materials Prepared with materials with high rigidity to provide stable anchoring force.
  • the impermeable material can be prepared from materials such as polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polypropylene, polyester, and animal pericardium tissue.
  • PTFE polytetrafluoroethylene
  • ePTFE expanded polytetrafluoroethylene
  • polypropylene polypropylene
  • polyester polyester
  • animal pericardium tissue animal pericardium tissue.
  • the second fixing member 220b is semi-fixedly connected to the connecting portion 210 (meaning that there are degrees of freedom in the two directions of up and down, and the degrees of freedom in the four directions of front, rear, left and right are fixed).
  • the second fixing part 220b is provided with a central hole, and the second fixing part 220b is sleeved on the connecting part 210 through the central hole. After reaching the target position, the position is adjusted as required to achieve the purpose of clamping and fixing with the first fixing part.
  • the size, shape, structure, and material of the first fixing member 220a and the second fixing member 220b may be the same or different, and may be set according to actual clinical needs.
  • the polymer coating 230 is a three-dimensional network of cross-linked hydrophilic macromolecules, which is capable of swelling and contains about 20 wt% to about 95 wt% water (or body fluid).
  • the polymer coating 230 can be made of natural polymer materials or synthetic polymer materials. Natural polymer materials include fibrin, collagen, elastin, etc. Hydrogel polymers can be in the form of powder, foam and the like.
  • polymeric coating 230 is capable of absorbing greater than 50%, greater than 75%, greater than 100%, greater than 150%, etc. of water (or bodily fluids, such as blood) of its dry weight. In a dehydrated or low-volume state, the polymer coating 230 can have a certain rigidity; as the content of absorbed liquid increases, the polymer coating can exhibit gradually increasing flexibility (elasticity).
  • the polymer coating 230 is made of a hydrophilic polymer material selected from the group consisting of: polyethylene oxide, polyvinyl alcohol, polyacrylic acid, polypropylene fumaric acid-coethylene Diols and peptides, agarose, alginate, chitosan, collagen, fibrin, gelatin and hyaluronic acid, polyhydroxyethylmethacrylate, poly-2-hydroxyethylmethacrylate and their copolymers, At least one of polyvinylpyrrolidone, poly-N-vinylpyrrolidone, polyvinyl alcohol, and polyacrylamide.
  • the appropriate coating material can be selected according to the specific conditions of clinical cases.
  • the connecting part 210 connects the anchoring body 220 and the valve support 110, and the connecting part 210 can be made of such as biocompatible polymer materials, including but not limited to PTFE (polytetrafluoroethylene), polypropylene, ultra-high Molecular weight polyethylene (UHMWPE), nylon, silk, polyester, PVDF (polyvinylidene fluoride), etc.
  • the connecting portion 210 may be inelastic to provide a stronger stent anchoring force, or elastic to provide a higher degree of traction compliance during the cardiac cycle.
  • the connecting portion 210 may be made of a bioabsorbable material and thereby provide temporary fixation until the endothelialization between the prosthesis and tissue is sufficient to provide anchoring force for the valve prosthesis.
  • the connecting part includes a pull cord, a connecting wire or a connecting rod and the like.
  • This embodiment provides an anchoring device for a chordal prosthesis. As shown in FIG. A polymer coating capable of absorbing liquid, wherein the polymer coating has a swollen morphology after absorbing liquid.
  • chordal prosthesis is used to replace the damaged chordae.
  • One end of the chordal prosthesis is fixed to the valve leaflet, and the other end is anchored through the anchoring body.
  • the anchoring body can be attached to the apical epicardium or papillary muscle.
  • the anchoring body in this embodiment can adopt a structure similar to that of any embodiment in Embodiment 1, so as to realize the anchoring of the chordal prosthesis 100 .
  • the polymer coating in the above examples can absorb liquid and swell to further seal; For tissue damage; in addition, the hydrophilic nature of the polymer coating makes it more conducive to endothelialization. Therefore, the polymer coating can also be applied to leaflet clips for clamping leaflets, or occluders for occluding tissue defects. These implants are in contact with the tissue through the polymer coating, ensuring that the implant While improving its own function, it can also make the implant perform better.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif d'ancrage (200) pour une prothèse d'implant cardiaque, le dispositif d'ancrage (200) comprenant un corps principal d'ancrage (220), le corps principal d'ancrage (220) est fixé à une partie d'extrémité d'un implant ; une surface du corps principal d'ancrage (220) est recouverte d'un revêtement polymère (230) ayant une capacité d'absorption de liquide ; et le revêtement polymère (230) est sous une forme gonflée après absorption de liquide. L'invention concerne en outre une prothèse d'implant cardiaque, qui peut être une prothèse de valvule (100) ou une prothèse de cordages tendineux (100) et est fixée à des tissus tels que l'épicarde apical, la paroi ventriculaire et le muscle papillaire au moyen du corps principal d'ancrage (220) pour fournir une force d'ancrage. Lorsqu'il y a un exsudat sur la surface du corps principal d'ancrage en contact avec le tissu, le revêtement polymère (230) configuré sur la surface du corps principal d'ancrage peut absorber le liquide et gonfler pour devenir flexible, et le revêtement polymère qui a absorbé le liquide et gonflé augmente en volume et peut mettre en œuvre une étanchéité auxiliaire pour empêcher une fuite supplémentaire. De plus, l'hydrophilie du revêtement polymère (230) facilite l'adhésion et la prolifération de cellules endothéliales, ce qui est favorable à l'endothélialisation du corps principal d'ancrage.
PCT/CN2021/101843 2021-05-08 2021-06-23 Dispositif d'ancrage pour prothèse d'implant cardiaque et prothèse d'implant cardiaque le comprenant WO2022236928A1 (fr)

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CN202110500037.0A CN113017930A (zh) 2021-05-08 2021-05-08 心脏植入物假体的锚固装置及包含其的心脏植入物假体
CN202110500037.0 2021-05-08
CN202120972734.1 2021-05-08
CN202120972734.1U CN218832965U (zh) 2021-05-08 2021-05-08 心脏植入物假体的锚固装置及包含其的心脏植入物假体

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020169359A1 (en) * 1997-01-02 2002-11-14 Myocor, Inc. Methods and devices for improving cardiac function in hearts
US20150122687A1 (en) * 2013-11-06 2015-05-07 Edwards Lifesciences Corporation Bioprosthetic heart valves having adaptive seals to minimize paravalvular leakage
CN105377191A (zh) * 2013-03-15 2016-03-02 瓣膜医学有限公司 用于密封经皮瓣膜的系统和方法
CN105473107A (zh) * 2013-06-14 2016-04-06 心脏解决方案有限公司 二尖瓣隔离物及其植入系统和方法
WO2020086427A1 (fr) * 2018-10-22 2020-04-30 Opus Medical Therapies, LLC Ensemble d'ancrage transcathéter pour une valvule mitrale, valvule mitrale et procédés associés
WO2020160141A1 (fr) * 2019-01-30 2020-08-06 Edwards Lifesciences Corporation Ensembles d'étanchéité de valvule cardiaque
US20200261219A1 (en) * 2019-02-14 2020-08-20 4C Medical Technologies, Inc. Hydrophilic skirt for paravalvular leak mitigation and fit and apposition optimization for prosthetic heart valve implants
WO2020236417A1 (fr) * 2019-05-22 2020-11-26 Edwards Lifesciences Corporation Ancrage expansible pour dispositifs de réparation de valvules cardiaques

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020169359A1 (en) * 1997-01-02 2002-11-14 Myocor, Inc. Methods and devices for improving cardiac function in hearts
CN105377191A (zh) * 2013-03-15 2016-03-02 瓣膜医学有限公司 用于密封经皮瓣膜的系统和方法
CN105473107A (zh) * 2013-06-14 2016-04-06 心脏解决方案有限公司 二尖瓣隔离物及其植入系统和方法
US20150122687A1 (en) * 2013-11-06 2015-05-07 Edwards Lifesciences Corporation Bioprosthetic heart valves having adaptive seals to minimize paravalvular leakage
WO2020086427A1 (fr) * 2018-10-22 2020-04-30 Opus Medical Therapies, LLC Ensemble d'ancrage transcathéter pour une valvule mitrale, valvule mitrale et procédés associés
WO2020160141A1 (fr) * 2019-01-30 2020-08-06 Edwards Lifesciences Corporation Ensembles d'étanchéité de valvule cardiaque
US20200261219A1 (en) * 2019-02-14 2020-08-20 4C Medical Technologies, Inc. Hydrophilic skirt for paravalvular leak mitigation and fit and apposition optimization for prosthetic heart valve implants
WO2020236417A1 (fr) * 2019-05-22 2020-11-26 Edwards Lifesciences Corporation Ancrage expansible pour dispositifs de réparation de valvules cardiaques

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