WO2022236928A1 - 心脏植入物假体的锚固装置及包含其的心脏植入物假体 - Google Patents
心脏植入物假体的锚固装置及包含其的心脏植入物假体 Download PDFInfo
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- 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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- anchoring
- fixing member
- polymer coating
- anchoring device
- tissue
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Classifications
-
- 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
一种心脏植入物假体的锚固装置(200),锚固装置(200)包括锚固主体(220),锚固主体(220)固定于植入物的端部;锚固主体(220)表面覆设具有吸液能力的聚合物涂层(230),其中,聚合物涂层(230)吸液后具有膨胀的形态;还公开了一种心脏植入物假体,植入物假体可以为瓣膜假体(100)或腱索假体(100),植入物假体通过锚固主体(220)与心尖外膜、心室壁、***肌等组织附接以提供锚固力,当锚固主体与组织接触的表面出现渗液时,配置于锚固主体表面的聚合物涂层(230)可以吸液膨胀,变得具有柔韧性;且吸液膨胀后的聚合物涂层体积变大,可以辅助密封,防止进一步渗漏;此外,聚合物涂层(230)的亲水性有利于内皮细胞的粘附和增殖,从而有助于锚固主体内皮化。
Description
本发明涉及医疗器械技术领域,特别涉及一种用于心脏植入物假体锚固的锚固装置及包含其的心脏植入物假体。
心脏含有四个腔室,右心房(RA)、右心室(RV)、左心房(LA)和左心室(LV)。在整个心动周期中,心脏的左、右两侧的泵送作用一般同步发生。将心房与心室分开的瓣膜被称为房室瓣,房室瓣起到单向阀的作用,保证心腔内血液的正常流动。左心房与左心室之间的房室瓣是二尖瓣,右心房与右心室之间的房室瓣是三尖瓣。肺动脉瓣将血流导向肺动脉,并从那里流向肺部,血液通过肺静脉返回左心房。主动脉瓣引导血流通过主动脉并从那里流向周边。通常在心室之间或心房之间没有直接连接。
当房室瓣出现问题时,无法正常发挥功能,从而导致不当关闭。虽然二尖瓣瓣膜置换技术飞速发展,但是在瓣膜的设计上仍存在一些公认的难题,比如,瓣膜的锚固。
现有的心脏瓣膜锚固装置,包括将瓣膜假体延伸出一根或多根拉绳固定到心脏组织进行锚固,例如,专利文献CN201480050061中介绍的心尖固定装置。如果这种锚固构件的刚度太大,放在心尖处,可能会与心脏组织的贴合不够好,而产生漏血,或者摩擦心脏组织产生出血等状况。如果这种锚固件的刚度太小,可能会造成锚固力不够,瓣膜假体发生移位的状况。腱索假体的锚固存在类似问题。
发明内容
本发明提供了一种心脏植入物假体的锚固装置及包含其的心脏植入物假体,可以解决现有技术中的上述缺陷。
本发明的技术方案如下:
一种心脏植入物假体的锚固装置,所述锚固装置包括锚固主体,所述锚固主体固定于植入物的端部;所述锚固主体表面覆设具有吸液能力的聚合物涂层,其中,所述聚合物涂层吸液后具有膨胀的形态。
植入物假体可以为瓣膜假体或腱索假体,植入物假体通过该锚固主体与心尖外膜、心室壁、***肌等组织附接以提供锚固力,当锚固主体与组织接触的表面出现渗液时,配置于锚固主体表面的聚合物涂层可以吸液膨胀,变得具有柔韧性;且吸液膨胀后的聚合物涂层体积变大,可以辅助密封,防止进一步渗漏;此外,聚合物涂层的亲水性有利于内皮细胞的粘附和增殖,从而有助于锚固主体内皮化。
在一些实施例中,所述锚固主体包括与组织贴附的第一固定件,所述第一固定件与组织贴附一侧设置有所述聚合物涂层,和/或所述第一固定件背向组织的一侧设置有所述聚合物涂层。
其中,当聚合物涂层配置在与组织贴附一侧时,一方面该聚合物涂层吸液膨胀后从刚性变为弹性,从而在刚性的第一固定件与组织之间形成缓冲层,缓冲层避免了第一固定件与组织的直接接触,可以减少心脏运动过程中第一固定件对心脏组织的摩擦损伤。另一方面,由于聚合物涂层位的缓冲作用,因此相对于未设置该涂层,第一固定件可以选择刚度较大的材料,从而在应用过程中能够提供更牢靠的锚固作用;且聚合物涂层的缓冲作用可以降低第一固定件刚度大对组织的损伤,从而能够更好的解决第一固定件的刚度与锚固力难以平衡的问题。
在一些实施例中,所述锚固主体还包括第二固定件,所述第二固定件与所述第一固定件同轴设置,且所述第二固定件配置在所述第一固定件与所述植入物之间,所述第一固定件和所述第二固定件贴附在组织两侧实现固定。
心脏瓣膜植入时,该锚固主体配置在心尖外膜或心室壁处,为心脏瓣膜提供锚固力,防止心脏收缩时,瓣膜支架受血液冲击而移位至左心室。其中,第一固定件锚固在心尖外膜或室间隔(右心室)处,第二固定件锚固在心尖内膜或室间隔(左心室),第一固定件、第二固定件的配合可以夹紧组织,从 而提供更加牢靠的锚固力。
在一些实施例中,所述第二固定件近所述第一固定件一侧覆设有所述聚合物涂层。
当第二固定件近第一固定近的表面设置该涂层时,一方面组织渗液时涂层吸液膨胀,起到进一步密封的作用,防止渗漏,另一方面,涂层膨胀后柔韧性增加,能够起到缓冲作用,防止第二固定件对于组织的损伤;此外,由于该涂层的存在,使得第二固定件可以选择刚度相对大的材料,从而提高第二固定件的锚固力,且还可以减小第二固定件对组织造成的损伤。
在一些实施例中,所述第二固定件套设于所述连接部,且所述第二固定件以可沿所述连接部长度方向移动的方式配置。其中,在心脏瓣膜释放过程中,可以通过调整第二固定件的位置,使其能够夹紧组织。
在一些实施例中,所述第二固定件构造为顺应心尖内膜的形状。一方面可以减少对组织的损伤,另一方面,这样的构造使得第二固定件能够与组织贴合,从而提供稳定的锚固作用。
在一些实施例中,所述连接部设置有限位件,所述限位件配置于所述第二固定件与所述植入物之间。由于第二固定件可移动的布设于连接部,在心脏瓣膜完全释放后,限位件的设置可以防止第二固定件的非预期移动,起到固位的作用,从而使第二固定件能够始终与第一固定件配合进行锚固,进一步提高了锚固主体的锚固稳定性。
在一些实施例中,所述第一固定件构造为朝向背离植入物的方向凸出,使得第一固定件以及聚合物涂层能够适应心尖外膜的形状,更好的与组织贴合,从而进一步提高锚固稳定性。
在一些实施例中,所述聚合物涂层采用亲水高分子材料制成,所述亲水高分子材料选自:聚环氧乙烷、聚乙烯醇、聚丙烯酸、聚丙烯富马酸-共乙二醇和多肽、琼脂糖、藻酸盐、壳聚糖、胶原、纤维蛋白、明胶和透明质酸、聚甲基丙烯酸羟乙酯、聚-2-甲基丙烯酸羟乙酯以及它们的共聚物、聚乙烯吡咯烷酮、聚-N-乙烯基吡咯烷酮、聚丙烯酰胺中的至少一种。其中,可以根据临床病例的具体情况选择合适的涂层材料。
在一些实施例中,所述第一固定件、所述第二固定件分别采用具有预定刚度的材料制成,该材料选自:镍钛合金、不锈钢、碳纤维、聚酰胺、聚苯硫醚、聚芳基酰胺、聚醚醚酮中的至少一种。相对于未设置聚合物涂层,本实施例中的第一固定件、第二固定件的刚度可以制造的更大,从而能够提高锚固主体的锚固稳定性。
本发明还提供了一种包含如上任一所述锚固装置的心脏植入物假体。
与现有技术相比,本发明的有益效果如下:
第一,本发明的锚固装置,植入物假体可以为瓣膜假体或腱索假体,当锚固主体与组织接触的表面出现渗液时,配置于锚固主体表面的聚合物涂层可以吸液膨胀,变得具有柔韧性;且吸液膨胀后的聚合物涂层体积变大,可以辅助密封,防止进一步渗漏;此外,聚合物涂层的亲水性有利于内皮细胞的粘附和增殖,从而有助于锚固主体内皮化。
第二,本发明的锚固装置,第一固定件与组织贴附以提供锚固力,当聚合物涂层配置在第一固定件与组织贴附一侧时,一方面该聚合物涂层吸液膨胀后从刚性变为弹性,从而在刚性的第一固定件与组织之间形成缓冲层,避免了第一固定件与组织的直接接触,可以减少心脏运动过程中第一固定件对心脏组织的摩擦损伤;另一方面,由于聚合物涂层的缓冲作用,因此相对于未设置该涂层,第一固定件可以选择刚度较大的材料,从而在应用过程中能够提供更牢靠的锚固作用,锚固稳定性好;且聚合物涂层的缓冲作用可以降低第一固定件刚度大对组织的损伤,从而能够更好的解决第一固定件的刚度与锚固力难以平衡的问题。
第三,本发明的锚固装置,第一固定件锚固在心尖外膜或室间隔(右心室)处,第二固定件锚固在心尖内膜或室间隔(左心室),第一固定件、第二固定件的配合可以夹紧组织,从而提供更加牢靠的锚固力;当第二固定件近第一固定近的表面设置聚合物涂层时,一方面组织渗液时涂层吸液膨胀,起到进一步密封的作用,防止渗漏,另一方面,涂层膨胀后柔韧性增加,能够起到缓冲作用,防止第二固定件对于组织的损伤;此外,第二固定件可以选择刚度相对大的材料,锚固稳定性好。
第四,本发明的锚固装置,第一固定件向背离植入物的方向凸出,所述第二固定件构造为顺应心尖内膜的形状,一方面可以减少对组织的损伤,另一方面,这样的构造使得第一固定件第二固定件能够与组织贴合,从而提供更好的锚固作用;此外,在植入物完全释放后,限位件的设置可以防止第二固定件的非预期移动,起到固位的作用,从而使第二固定件能够始终与第一固定件配合进行锚固,进一步提高了锚固主体的锚固稳定性。
当然,实施本发明的任一产品并不一定需要同时达到以上所述的所有优点。
图1是本发明实施例1的心脏瓣膜的结构示意图;
图2a是本发明实施例1的心脏瓣膜的一个锚固装置的结构示意图;
图2b是本发明实施例1的心脏瓣膜的另一锚固装置的结构示意图;
图3是本发明实施例1的心脏瓣膜植入过程的结构示意图;
图4是本发明实施例2的腱索假体的结构示意图。
附图标记:瓣膜部分100;第一区域101;第二区域102;第三区域103;瓣膜支架110;锚固装置200;连接部210;锚固主体220;第一固定件220a;第二固定件220b;聚合物涂层230。
房室瓣是复杂的结构,通常包括瓣环、瓣叶、腱索和支持结构。各心房通过心房前庭与其瓣膜连接。在心室充盈(舒张)开始时,主动脉瓣和肺动脉瓣关闭,以防止从动脉进入心室的回流。此后不久,房室瓣打开以允许从心房进入相应心室的无阻碍流动。在心室收缩期(即,心室排空)开始后不久,三尖瓣和二尖瓣正常关闭,从而形成防止从心室回流进入相应心房的密封。
二尖瓣具有两个瓣叶,并且各瓣叶的相应表面彼此间的附着或接合有助于提供瓣膜的关闭或密封,从而防止血液在错误的方向上流动。在心室收缩 期间瓣叶不能密封被称为接合不良,可使血液通过瓣膜反向流动(返流)。心脏瓣膜关闭不全可对患者产生严重的后果,往往导致心脏衰竭、减少血流量、降低血压,和/或减少到达人体组织的氧流量。二尖瓣关闭不全还可引起血液从左心房流回肺静脉,从而造成充血。严重的瓣膜关闭不全,如果不进行治疗,可导致永久性残疾或死亡。经导管二尖瓣置换手术(TMVR)就是采用导管介入的方法,将人工瓣膜在体外压缩到输送***,沿着血管路径或穿心尖,送达人体二尖瓣瓣环处,并将人工瓣膜释放固定在二尖瓣瓣环处替换原生瓣膜。与外科手术相比,TMVR无须体外循环辅助装置,创伤小、病人恢复快,术后患者血流动力学指标可以得到明显改善。
本发明一方面提供一种心脏瓣膜以及心脏瓣膜的锚固装置,用于替代原生瓣膜以起到打开或关闭血流通道的作用,以解决现有技术中瓣膜的锚固问题。
另一方面,本发明还提供一种腱索假体及其锚固装置。
具体的,以下均以二尖瓣瓣膜为例进一步阐述本发明,当然,该心脏瓣膜也可以为三尖瓣、主动脉瓣或肺动脉瓣。
在本发明的描述中,需要说明的是,术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。此外,术语“第一”、“第二”、“第三”仅用于描述目的,而不能理解为指示或暗示相对重要性。
在本发明的描述中,需要说明的是,除非另有明确的规定和限定,术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通。对于本领域的普通技术人员而言,可以具体情况理解上述术语在本发明中的具体含义。
实施例1
本实施例提供一种二尖瓣瓣膜假体,该二尖瓣瓣膜假体包括瓣膜部分100和锚固装置200,瓣膜部分100包括瓣膜支架110、裙边和人工瓣叶。如图1所示,瓣膜支架110纵向可分为第一区域101、第二区域102和第三区域103。二尖瓣瓣膜假体100植入人体后,第一区域101贴附在心脏原生二尖瓣瓣环上,防止瓣膜假体从左心房坠入左心室,第二区域102用于承载人工瓣叶130,同时依靠支撑在组织上,起到一定的固定和密封的作用;第三区域103为二尖瓣假体在左心室内的锚固部分,防止假体在闭合时,被血液冲击到左心房。
瓣膜支架110能够为心脏瓣膜假体100提供若干功能,包括用作瓣膜假体的主体结构、承载内部人工瓣叶、用作抑制二尖瓣瓣膜假体100和原生瓣膜之间的瓣周漏的密封件、与输送***连接的连接结构(例如挂耳或者固定耳)等等。可选地,瓣膜支架110编织或切割而成,可选地,瓣膜支架110采用镍钛合金或其他具有形状记忆特性的生物相容材料制成,也可以选择可弹性或可塑性变形的材料,如球囊可扩张的材料。
人工瓣叶在打开和闭合两种状态间动态切换,人工瓣叶在所述闭合状态中,人工瓣叶以密封抵接的方式合紧或会合。人工瓣叶可以由任意合适的材料或材料的组合形成。在一些实施例中,可选择生物组织例如来自动物(如猪)的心脏瓣膜的化学性稳定的组织,或者是动物的心包组织例如牛(牛心包)或羊(羊心包)或猪(猪心包)或马(马心包),优选牛心包组织。人工瓣叶也可以由小肠粘膜下组织制成。此外,合成材料也可以用于人工瓣叶。例如,膨体聚四氟乙烯或聚酯。可选地,还包括热塑性聚碳酸酯聚氨酯、聚醚聚氨酯、分段聚醚聚氨酯、有机硅聚醚聚氨酯、有机硅-聚碳酸酯聚氨酯、以及超高分子量聚乙烯。另外的生物相容的聚合物能够可选地包括聚烯烃、弹性体、聚乙二醇、聚醚砜、聚砜、聚乙烯基吡咯烷酮、聚氯乙烯、其它的含氟聚合物、有机硅聚酯、硅氧烷聚合物和/或低聚物、和/或聚内酯、以及使用它们的嵌段共聚物。可选地,瓣叶具有抗凝剂进行处理(或与之反应)的表面,所述抗凝剂包括但不限于肝素化聚合物。
裙边可以为单层结构,也可以为内外双层结构,可选择针织、梭织、编织的聚酯织物,PTFE,ePTFE等材料,主要起密封的作用,防止反流。
所述瓣膜支架110构造为网格状框架结构,其可以为单层框架结构,如CN202010680119.3中所公开的主体部的结构或框架部的结构,也可以采用双层框架的结构,如CN202010680119.3中的支架,或CN202010680139.0中公开的支架结构,瓣膜支架并不用于限制本发明的范围。其中,瓣膜支架110能够压缩装载进入输送装置内,释放后能够自膨胀为目标形状。
本实施例的锚固装置用于瓣膜支架110的锚固,所述锚固装置200包括锚固主体220,所述锚固主体220通过连接部210固定于所述瓣膜支架110的端部;所述锚固主体220表面覆设具有吸液能力的聚合物涂层230,其中,所述聚合物涂层230吸液后具有膨胀的形态。
本实施例的心脏瓣膜植入时,该锚固主体220配置在心尖外膜或室间隔处,为心脏瓣膜提供锚固力,防止心脏收缩时,瓣膜支架110受血液冲击而移位至左心室。其中,当锚固主体220与组织接触的表面出现渗液时,配置于锚固主体220表面的聚合物涂层230可以吸液膨胀,变得具有柔韧性;且吸液膨胀后的聚合物涂层230体积变大,可以辅助密封,防止进一步渗漏。
所述锚固主体220包括与组织贴附的第一固定件220a,在一些实施例中,所述第一固定件220a近所述瓣膜部分100一侧设置有所述聚合物涂层230,如图2a所示。
其中,当聚合物涂层230配置在靠近瓣膜部分100一侧时,一方面该聚合物涂层230吸液膨胀后从刚性变为弹性,从而在刚性的第一固定件220a与组织之间形成缓冲层,缓冲层避免了第一固定件220a与组织的直接接触,可以减少心脏运动过程中,固定件对心脏组织的摩擦损伤。另一方面,由于聚合物涂层230的缓冲作用,因此相对于未设置该涂层,第一固定件220a可以选择刚度较大的材料,从而在应用过程中能够提供更牢靠的锚固作用;且聚合物涂层230的缓冲作用可以降低第一固定件220a刚度大对组织的损伤,从而能够更好的解决第一固定件220a的刚度与锚固力难以平衡的问题。
具体的,所述聚合物涂层230可以覆盖所述第一固定件220a近瓣膜部分100一侧的整个表面,或者覆盖所述第一固定件220a近瓣膜部分100一侧的部分表面。
在一些可选实施例中,所述第一固定件220a远离所述瓣膜支架110一侧设置有所述聚合物涂层230。
在一些具体实施例中,第一固定件220a为圆形或椭圆形。优选地,第一固定件220a构造为朝向背离瓣膜部分100的方向凸出,也即第一固定件220a为盘形,具有凹入的内表面区域(向瓣膜部分100的反方向凸出),使用时,该区域绕心尖外膜弯曲并且大致顺应于心尖外表面,这样可以减少对心尖部分的应力损伤。第一固定件220a与连接部210固定连接,例如,第一固定件220a还包括中心孔,连接部210穿设中心孔打结固定。或者,第一固定件220a与连接部210焊接,两者固定方式不做特殊限定。
在一些实施例中,第一固定件220a由网格状框架结构包覆不渗透材料制备而成。框架结构可选镍钛合金、不锈钢、碳纤维、聚酰胺(PA)、聚苯硫醚(PPS)、聚芳基酰胺(IXEF)、聚醚醚酮(PEEK)或一些高分子复合材料等刚度较大的材料制备,以提供稳定的锚固力。不渗透材料可选聚四氟乙烯(PTFE)、膨胀型聚四氟乙烯(ePTFE)、聚丙烯、聚酯、动物心包组织等材料制备。
在一些实施例中,第一固定件220a也可以为一整片结构,选用刚性材料,镍钛合金、不锈钢、碳纤维、聚酰胺(PA)、聚苯硫醚(PPS)、聚芳基酰胺(IXEF)、聚醚醚酮(PEEK)等材料制备。
在一些实施例中,所述锚固主体220还包括第二固定件220b,如图2b、图3所示,所述第二固定件220b与所述第一固定件220a同轴设置,且所述第二固定件220b配置在所述第一固定件220a与所述瓣膜支架110之间。其中,第一固定件220a锚固在心尖外膜或室间隔(右心室)处,第二固定件220b锚固在心尖内膜或室间隔(左心室),第一固定件220a、第二固定件220b的配合可以夹紧组织,从而提供更加牢靠的锚固力。
在一些实施例中,所述第二固定件220b靠近所述第一固定件220a的表面设置有所述聚合物涂层230。当第二固定件220b近第一固定近的表面设置该涂层时,一方面组织渗液时涂层吸液膨胀,起到进一步密封的作用,防止渗漏,另一方面,涂层膨胀后柔韧性增加,能够起到缓冲作用,防止第二固定件220b对于组织的损伤;此外,第二固定件220b可以选择刚度相对大的 材料,从而提高第二固定件220b的锚固稳定性,且由于聚合物涂层230的存在,可以减小第二固定件220b的刚度对组织造成的损伤。当然,在一些替换实施例中,所述聚合物涂层230也可以设置在所述第二固定件220b靠近所述瓣膜支架110的一侧表面。
具体的,所述第二固定件220b套设于所述连接部210,且所述第二固定件220b以可沿所述连接部210长度方向移动的方式配置。其中,在心脏瓣膜释放过程中,可以通过调整第二固定件220b的位置,使其能够夹紧组织。
在一些实施例中,所述第二固定件220b构造为顺应心尖内膜的形状。一方面可以减少对组织的损伤,另一方面,这样的构造使得第二固定件220b能够与组织贴合,从而提供更好的锚固作用。
在一些实施例中,所述连接部210设置有限位件240,所述限位件240配置于所述第二固定件220b与所述瓣膜支架110之间。由于第二固定件220b可移动的布设于连接部210,在心脏瓣膜完全释放后,限位件240的设置可以防止第二固定件220b的非预期移动,起到固位的作用,从而使第二固定件220b能够始终与第一固定件220a配合进行锚固,进一步提高了锚固主体220的锚固稳定性。
具体的,限位件240可以配置为连接部210上的凸出结构,如图2b所示,从而起到限位作用,防止第二固定件220b进一步向瓣膜支架110移动。在一些实施例中,限位件240也可以配置为卡固结构,当第二固定件220b释放后调整至卡紧组织的位置,再通过限位件将第二固定件220b卡紧固定。
具体的,第二固定件220b为圆形或椭圆形。优选地,第二固定件220b为盘形,可选地,第二固定件220b由网格状框架结构包覆不渗透材料制备而成,或第二固定件220b也可为片状结构。第二固定件220b可选镍钛合金、不锈钢、碳纤维、聚酰胺(PA)、聚苯硫醚(PPS)、聚芳基酰胺(IXEF)、聚醚醚酮(PEEK)或一些高分子复合材料等刚度较大的材料制备,以提供稳定的锚固力。不渗透材料可选聚四氟乙烯(PTFE)、膨胀型聚四氟乙烯(ePTFE)、聚丙烯、聚酯、动物心包组织等材料制备。将该聚合物涂层230施加到锚固主体220表面的方法包括喷涂、静电纺丝、滚压等。
第二固定件220b与连接部210半固定连接(指的是上下两个方向具有自由度,前后左右四个方向的自由度被固定)。第二固定件220b设置中心孔,第二固定件220b通过中心孔套设在连接部210上,到达目标位置后,根据需要调整位置,以达到与第一固定件夹紧固定的目的。
其中,第一固定件220a、第二固定件220b的大小、形状、结构、材料可以相同,也可以不同,可以根据实际临床需求设置。
本实施例中,聚合物涂层230是交联的亲水性大分子的三维网络,其能够溶胀并包含约20wt%至约95wt%的水(或体液)。聚合物涂层230可以采用天然高分子材料制成,或采用合成高分子材料制成。天然高分子材料包括纤维蛋白、胶原、弹性蛋白等。水凝胶聚合物可以是粉末、泡沫等形态。在一些情况下,聚合物涂层230能够吸收大于其干重的50%、大于75%、大于100%、大于150%等的水(或体液,例如血液)。在脱水或低体积状态下,聚合物涂层230可以有一定的刚性;随着吸收液体含量的增加,该高分子聚合物涂层可以显示出逐渐增加的柔韧性(弹性)。
具体的,所述聚合物涂层230采用亲水高分子材料制成,所述亲水高分子材料选自:聚环氧乙烷、聚乙烯醇、聚丙烯酸、聚丙烯富马酸-共乙二醇和多肽、琼脂糖、藻酸盐、壳聚糖、胶原、纤维蛋白、明胶和透明质酸、聚甲基丙烯酸羟乙酯、聚-2-甲基丙烯酸羟乙酯以及它们的共聚物、聚乙烯吡咯烷酮、聚-N-乙烯基吡咯烷酮、聚乙烯醇、聚丙烯酰胺、中的至少一种。其中,可以根据临床病例的具体情况选择合适的涂层材料。
本实施例中,连接部210连接锚固主体220与瓣膜支架110,连接部210可以由诸如生物相容性聚合物材料制成,包括但不限于PTFE(聚四氟乙烯)、聚丙烯、超高分子量聚乙烯(UHMWPE)、尼龙、丝、聚酯、PVDF(聚偏二氟乙烯)等。连接部210可以无弹性,以提供更稳固的支架锚固力;也可以有弹性,以便在心动周期期间提供更高程度的牵拉顺应性。可选的,连接部210可以由生物可吸收材料制成,并且由此提供暂时固定,直到假体和组织之间内皮化以足以提供瓣膜假体的锚固力。可选地,连接部分包括拉绳、连接线或连接杆等。
实施例2
本实施例提供一种腱索假体的锚固装置,如图4所示,所述锚固装置包括锚固主体,所述锚固主体固定于腱索假体100的端部;所述锚固主体表面覆设具有吸液能力的聚合物涂层,其中,所述聚合物涂层吸液后具有膨胀的形态。
腱索假体用于替换损伤的腱索,腱索假体一端固定至瓣叶,另一端通过该锚固主体进行锚固,如锚固主体可以附接至心尖外膜或***肌。
本实施例中的锚固主体可以采用与实施例1任一实施方式相类似的结构,从而实现对腱索假体100的锚固。
需要说明的是,以上实施例中的聚合物涂层一方面吸液膨胀起到进一步密封的作用,另一方面吸液膨胀后的涂层柔韧性增加,能够起到缓冲作用,防止植入物对于组织的损伤;此外该聚合物涂层的亲水特性使其更加有利于内皮化。因此,该聚合物涂层还可应用于夹持瓣叶的瓣叶夹子,或者应用于封堵组织缺损的封堵器,这些植入物通过聚合物涂层与组织接触,在保证植入物自身功能的同时,还能够使植入物能够发挥更佳的效果。
以上公开的仅为本发明优选实施例,优选实施例并没有详尽叙述所有的细节,应该理解,这些实施例仅用于说明本发明,而不用于限定本发明的保护范围,本发明仅受权利要求书及其全部范围和等效物的限制。
本说明书选取并具体描述这些实施例,是为了更好地解释本发明的原理和实际应用,从而使所属领域技术人员能很好地利用本发明。在实际应用中本领域技术人员根据本发明做出的改进和调整,仍属于本发明的保护范围。以上不同实施例中的技术特征在不发生相互冲突的前提下可以任意的结合。
Claims (13)
- 一种心脏植入物假体的锚固装置,其特征在于,包括锚固主体,所述锚固主体固定于植入物的端部;所述锚固主体表面覆设具有吸液能力的聚合物涂层,其中,所述聚合物涂层吸液后具有膨胀的形态。
- 根据权利要求1所述的心脏植入物假体的锚固装置,其特征在于,所述植入物构造为用于置换原生瓣膜的瓣膜支架,所述锚固主体通过连接部固定于瓣膜支架的端部。
- 根据权利要求1所述的心脏植入物假体的锚固装置,其特征在于,所述植入物构造为腱索假体,所述锚固主体通过连接部固定于腱索假体的端部。
- 根据权利要求1或2或3所述的心脏植入物假体的锚固装置,其特征在于,所述锚固主体包括与组织贴附的第一固定件,所述第一固定件与组织贴附一侧设置有所述聚合物涂层,和/或所述第一固定件背向组织的一侧设置有所述聚合物涂层。
- 根据权利要求4所述的心脏植入物假体的锚固装置,其特征在于,所述锚固主体还包括第二固定件,所述第二固定件与所述第一固定件同轴设置,且所述第二固定件配置在所述第一固定件与所述植入物之间,所述第一固定件和所述第二固定件贴附在组织两侧实现固定。
- 根据权利要求5所述的心脏植入物假体的锚固装置,其特征在于,所述第二固定件近所述第一固定件一侧覆设有所述聚合物涂层。
- 根据权利要求5所述的心脏植入物假体的锚固装置,其特征在于,所述第二固定件套设于所述连接部,且所述第二固定件以可沿所述连接部长度方向移动的方式配置。
- 根据权利要求5、6或7所述的心脏植入物假体的锚固装置,其特征在于,所述第二固定件构造为顺应心尖内膜的形状。
- 根据权利要求5所述的心脏植入物假体的锚固装置,其特征在于,所述连接部设置有限位件,所述限位件配置于所述第二固定件与所述植入物 之间。
- 根据权利要求1所述的心脏植入物假体的锚固装置,其特征在于,所述第一固定件构造为朝向背离植入物的方向凸出。
- 根据权利要求1所述的心脏植入物假体的锚固装置,其特征在于,所述聚合物涂层采用亲水高分子材料制成,所述亲水高分子材料选自:聚环氧乙烷、聚乙烯醇、聚丙烯酸、聚丙烯富马酸-共乙二醇和多肽、琼脂糖、藻酸盐、壳聚糖、胶原、纤维蛋白、明胶和透明质酸、聚甲基丙烯酸羟乙酯、聚-2-甲基丙烯酸羟乙酯以及它们的共聚物、聚乙烯吡咯烷酮、聚-N-乙烯基吡咯烷酮、聚丙烯酰胺、中的至少一种。
- 根据权利要求5所述的心脏植入物假体的锚固装置,其特征在于,所述第一固定件、所述第二固定件分别采用具有预定刚度的材料制成,该材料选自:镍钛合金、不锈钢、碳纤维、聚酰胺、聚苯硫醚、聚芳基酰胺、聚醚醚酮中的至少一种。
- 一种包含如权利要求1-12任一所述锚固装置的心脏植入物假体。
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