CN106264793A - A kind of adaptive heart valve prosthesis - Google Patents

Abstract

The present invention relates to a kind of adaptive heart valve prosthesis, including support and artificial valve, described support includes anti-leakage ring and valve sewing section, described anti-leakage ring is connected with described valve sewing section, described artificial valve is fixedly connected in described valve sewing section, described valve sewing section is at least partially disposed between autologous patient leaflet, on the cross section being perpendicular to described artificial valve axis, the cross-sectional area of described valve sewing section is less than the cross-sectional area of described autologous patient valve annulus, described valve sewing section is made will not directly radially to expand described autologous patient valve annulus, in a free state, the cross-sectional area of described anti-leakage ring is more than the cross-sectional area of described autologous patient valve annulus, described anti-leakage ring can comply with atrium cavity wall or the uneven profile of patient's native valve annulus.

Description

A kind of adaptive heart valve prosthesis

Technical field:

The invention belongs to medical instruments field, be specifically related to a kind of adaptive heart valve prosthesis.

Background technology:

Mitral position, in left atrioventricular orifice, is connected five parts formed by annulus, leaflet, chordae tendineae, papillary muscles, boundary, and it is solving Cuing open the exact name on is Mitral valve structure (mitral apparatus) or mitral complex (mitral complex).Annulus of mitral valve is the fibrous tissue band being attached to left atrioventricular orifice edge, for irregular " D " shape shape, Bicuspid valve Front 1/3rd of annulus is the continuous part of front valve and aorta, atrium that front lobe, back lobe are corresponding and mitral annulus institute The angle formed is the most different, also has the attachment of left auricle at atrium.Mitral valve function is not all one of modal heart disease, example The mitral incompetence caused such as mitral valve prolapse disease, two points such as caused by the valve lesions caused by rheumatic inflammation Lobe is narrow etc..

Mitral incompetence can be divided into functional, degeneration or Combination three kinds.It is most commonly that degeneration and merit Can property mitral incompetence.Functional generally it is secondary to that left ventricular wall motion function is impaired, left ventricular dilatation, papillary muscles function are different Often, it is generally found from heart failure patient.This part patient also includes the ischemic mitral regurgitation being secondary to coronary heart disease And the mitral incompetence that Nonischemic cardiolmyopathy is relevant.Degeneration mitral incompetence disease is generally considered to be valve structure Pathologic change occurring, or under valve, structure pathologic changes, the exception including chordae tendineae extends or fracture.

Mitral stenosis is modal type in valvular heart disease, and wherein 40% patient is pure Bicuspid valve Narrow.Due to the rheumatic fever happened over and over again, Bicuspid valve is with at valve commissure and basilar part edema, inflammation and vegetation in early days (exudate) is formed as main, and the later stage becomes due to fibrinous deposition and fibroid in agglutination, gradually forms before and after's lobe Leaf intersection adhesion, fusion, valve thickens, coarse, hardening, calcification, and chordae tendineae shortens and inter-adhesive, limits valve movable Ability and opening, cause lobe stenostomy.Other causes of disease rare include calcification under senile annulus of mitral valve or ring, congenital stenosis and knot Form tissue disease etc..

Tricuspid valve is positioned at right atrioventricular orifice, and common morbidity is tricuspid incompetence, i.e. systole blood flow backflows from right ventricle Entering right atrium, cause right atrium height to expand, pressure raises, venous backflow obstacle.Owing to right ventricle load increases, compensatory And plump, it is susceptible to right heart failure.

Tritubercular cycloid is typically by pulmonary hypertension, and right ventricle expands, and tricuspid annulus expansion causes, clinically often with Tricuspid valve Showing as of the cause of disease (left heart failure, pulmonary hypertension etc.) backflowed is common, after there is tritubercular cycloid, weak, ascites, edema, Hepatalgia, dyspepsia, the right heart failure exacerbation of symptoms such as poor appetite.Tricuspid valve mild reflux there is no obvious clinical symptoms, but works as Operative treatment is needed when seriously backflowing.

Traditional treatment means for Bicuspid valve and Tricuspid valve disease include that being applicable to the slight medicine to severe reflux controls Treat, and have the surgical method of corresponding surgical indication.Wherein, surgical method also includes that prosthetic valve replacement and valve are repaiied Mend art.In surgical method, typically open breast, open heart operation invasive excessive, need to set up extracorporeal circulation, have higher Complication rate and infection risk.Patient is the most resistance to can't stand huge surgery risk and can only helpless waiting for death.

Along with the first aortic valve gets involved the report of replacement, numerous companies have done greatly at intervention aortic valve technical elements Amount work, technology reaches its maturity.But, in terms of the interventional therapy of atrioventricular valves (A V valves), the most still have bigger blank.Although pin at present Minority product is had to be applied on intubation intervention valve forming and kposthesis the interventional therapy of atrioventricular valves (A V valves), but at warp Intubation intervention valve replacement aspect, the most not yet has the product of maturation to come out.We will enumerate several for Bicuspid valve below Percutaneous get involved valve replacement technology, these technology are in zoopery or clinic trial mostly, and respective technology all has limitation.

Patent CN102639179B and patent US8449599 describe the one two of Edwards Lifesciences company Cusp displacement prosthetic appliance, for implantation into the natural Bicuspid valve region of heart, described natural Bicuspid valve have native annulus and Native valve leaflets, described prosthetic appliance includes: tube-shaped main body, and it includes flowing through chamber therein, atrial end and the heart for blood Room end, and being configured for placement in described native annulus, described main body can be radially compressed to radial compression, with deliver into In described heart, and radial expanded state can be self-expanded into from described compressive state；It is connected with described main body and is positioned at institute Stating at least one fixing device of body exterior, described fixing device is connected with described main body, in order to when described main body is in During swelling state, at least one fixing device described is configured to hook around native leaflet, at least one fixing dress described Put restriction lobule-reception space between described main body；The annular flange flange extended radially outwardly with the atrial end from described main body Part, described annular flange portion includes atrium sealing member, and when described prosthetic appliance is implanted, described atrium sealing member stops Blood flows beyond the atrial end of described main body on described body exterior.The fixed form that this technology is used, due to its sovereignty Described fixing device defined in description is in the outside of described main body, and described native leaflet will be propped up by smooth inserting Between lateral surface and the medial surface of described anchoring device of frame body blood channel, the firmness fixed is caused to place one's entire reliance upon institute Stating the frictional force between fixing device and described main body, and after held, native valve is constantly in diastole period Leaflet open position and deployed condition, the blood flowing of large area annular barrier left ventricular outflow tract so that should be at this moment The blood flow that phase flows into aorta from left ventricle is stopped by a part, is back to left ventricle, after being chronically implanted, it may appear that heart failure etc. Disease.Especially when autologous patient leaflet exists heavier calcification, native leaflets folder lobe mechanism increases the difficulty of operation technique, In the clinical practice of this product of Edwards, having many cases to be because autologous patient leaflet cannot correctly be captured and be caused hands Art failure, apparatus displacement and promptly turn surgery open chest surgery, this kind of patient is finally by dead or face the risk of death.Finally, The technology of clamping native leaflets certainly will have impact on the reentry sheath function of support, once i.e. can not recall after release, and operation risk is big.

Patent CN201180020556 describes a mitral of Medtronic company, and this prosthese includes having Downstream part and the inner supporting structure of upstream portion, wherein, described upstream portion has the cross section more than described downstream part Area, described inner supporting structure is configured to be positioned at least partially in the atrial side of described native valve association, and applies Axial force towards left ventricle；And outer supporting structure, described outer supporting structure have two or more engage arm, wherein, Described joint arm is connected to described inner supporting structure, and wherein, described prosthese is configured to the lobule of native valve when it is transplanted A part be clipped between described inner supporting structure and described joint arm.Design with Edwards is similar, by having bigger horizontal stroke Sectional area upstream portion is resisted against on mitral annulus, and captures original two points of patient by the joint arm of outer supporting structure Lobe.This support entirety still takes the symmetrical structure of cylindrical shape, and therefore doctor still needs to select bigger specification when operation Valve enough support force is provided, huge valve diameter greatly blocks the blood supply of left ventricular outflow tract, aorta Lobe mouth flow velocity strengthens, and pressure increases, and heart failure situation easily occurs for a long time in the past.Meanwhile, bigger valve diameter is the most all pasted Sympetalous ring, by compressing tissue around including aortic valvular ring.

Patent CN201610074782 provides a kind of D-shaped insertion type artificial cardiac valve, including support, is arranged at support The leaflet of inner side and be arranged at the overlay film on support body wall, the first submounts that support includes being sequentially connected with, the second submounts and 3rd submounts, the first submounts is webmaster, the second submounts be cross section be the webmaster of D-shaped, described 3rd submounts is loudspeaker Shape webmaster.The maximum caliber of described first submounts is identical with the caliber of described second submounts, described 3rd submounts Minimum pipe is identical with the caliber of described second submounts.Although it claims to by so-called D-shaped webmaster and two point in situ The accommodation space shape that the primary body wall of lobe surrounds matches, and is circular support relative to cross section, is avoided that support is to not rounded The excessively compressing of the Bicuspid valve profile of shape causes the efferent tract of heart to become narrow.This technology problematically, even support Cross section changes D-shaped into, directly utilizes total-grid form touch mitral annulus and still surrounding tissue can be caused compressing；With Time, the maximum caliber of the first submounts described in this technology is identical with the caliber of described second submounts, it is meant that support is transversal Face still can be at least equal to mitral annulus diameter, and the impact of efferent tract is still existed by huge support itself；Finally, this skill In art, the second submounts is arranged to D-shaped, and leaflet is sewn on support, after non-circular region must affect leaflet stitching Fit-state.Although the not concrete open mode stitching lobe of this technology, but we are still it can be seen that its lobe from its figure Leaf is three flap.Therefore, non-circular stitching thread will be unfavorable for that leaflet closes performance and long-term leaflet is tired.

Patent US20160074160 discloses a kind of valve bracket structure, makes by marmem including one The outside support of expansion, and an internal stent made by marmem；This internal stent is made up of two parts, just During beginning state, Part I is the structure of expansion, and Part II is the structure of compression, and artificial valve is arranged on internal stent Part I, Part II is additionally provided with tether；Internal stent is connected fixing with outside support.The program problematically, expand The outside support opened still is supported in original annulus and is radially expanded original annulus, the biggest support cross section Amass and necessarily efferent tract is impacted.It addition, the part that outside support is positioned on mitral annulus can not comply with atrium cavity wall Or the uneven profile of patient's native valve annulus, compressing aorta or other heart tissues, and leak preventing effect is the best.

Clinical effectiveness shows at present, does not have a preferably for getting involved the product of atrioventricular valves (A V valves) valve replacement.The most former Because being either Bicuspid valve or Tricuspid valve, it is respectively provided with special physiological structure, and below annulus, has the physiologic ring of complexity Border, causes product to be accurately positioned and fixes extremely difficult.The problem of existing technology is summed up as follows: (1) anchoring techniques at present is many Relying on the support support force to atrioventricular valve ring, doctor often selects the valve specification bigger than patient atrioventricular valves (A V valves) self annulus to meet Closing mitral valve tissue profile, the hugest support itself can produce impact to efferent tract, and easily causes surrounding tissue Compressing, blocks the blood flowing of left ventricular outflow tract further；(2) current technology is positioned at the many employings of holder part in atrium Grid configuration, heart tissue is easily caused compressing, and can not comply with atrium cavity wall or trouble completely by its huge support force The uneven profile of person's native valve annulus, leak preventing effect dispatches a person by force to anticipate；(3) for mitral valve replacement, support specification mistake Greatly, anterior mitral valve is easily pushed to left ventricular outflow tract view, the clamping leaflet design introduced to fix anterior mitral valve so that Release steps is extremely complex, and is affected by leaflet calcification degree, have impact on success rate of operation.

In sum, although technology described above has certain effect on atrioventricular valves (A V valves) is replaced respectively, but its Still in place of Shortcomings, in the field of surgery for the treatment of valve pathological changes, need badly more than a kind of new heart valve prosthesis solves Problem.

Summary of the invention:

It is an object of the invention to overcome the restriction of prior art, for Bicuspid valve or tricuspid incompetence or narrow lead The patient of lobe is changed in the intervention that needs caused, and proposes a kind of adaptive heart valve prosthesis.The present invention solves existing anchoring techniques The middle problem needing radial dilatation autologous patient annulus and cause, on the basis of guaranteeing to implant valve anchoring effect, is possible not only to Reduce the impact on efferent tract after support discharges, it is to avoid the tractive to native valve annulus, and ensure that the opening of valve Area will not change excessive because of the greatest differences between patient's annulus, optimizes valve performance, alleviates production firm and produces The stock pressure of product specification.Meanwhile, anti-leakage ring can comply with atrium cavity wall or the uneven profile of patient's native valve annulus, it is possible to Reduce the compressing to heart tissue and improve leak preventing effect.

It is an object of the invention to be achieved through the following technical solutions:

A kind of adaptive heart valve prosthesis, including support and artificial valve, it is characterised in that described support includes preventing Leakage ring and valve sewing section, described anti-leakage ring is connected with described valve sewing section, and described artificial valve is fixedly connected at described In valve sewing section, described valve sewing section is at least partially disposed between autologous patient leaflet, is being perpendicular to described artificial valve On the cross section of axis, the cross-sectional area of described valve sewing section is less than the cross-sectional area of described autologous patient valve annulus, Described valve sewing section is made will not directly radially to expand described autologous patient valve annulus, in a free state, described leakproof The cross-sectional area of ring is more than the cross-sectional area of described autologous patient valve annulus, and described anti-leakage ring can comply with atrium cavity wall or trouble The uneven profile of person's native valve annulus.

The purpose of the present invention can also realize the most further:

Preferably, on the cross section being perpendicular to described artificial valve axis, the center of described anti-leakage ring and described lobe The center of film sewing section is misaligned.

Preferably, described anti-leakage ring includes that autologous annulus adapts to section and atrial tissue adapts to section, and described autologous annulus adapts to Section adapts to the section distal portions respectively with described valve sewing section and is connected with described atrial tissue.

Preferably, described anti-leakage ring includes that autologous annulus adapts to section and atrial tissue adapts to section, and described atrial tissue adapts to Section adapts to section with described autologous annulus and is connected, and described autologous annulus adapts to section and is connected with the distal portions of described valve sewing section.

It is furthermore preferred that described autologous annulus adapts to section and described atrial tissue adapts to section and is structure as a whole.

It is furthermore preferred that the cross section that described autologous annulus adapts to section is D-shape configuration.

It is furthermore preferred that described autologous annulus adapts to section is provided with linkage section, it is D that described autologous annulus adapts to the cross section of section Shape structure, the cross section of described linkage section is circular configuration, and described autologous annulus adapts to section by described linkage section and described lobe Film sewing section connects.

It is furthermore preferred that it be ellipse or circular configuration or D-shape configuration that described atrial tissue adapts to the cross section of section.

It is furthermore preferred that on the longitudinal section being parallel to described artificial valve axis, described atrial tissue adapts to the throwing of section Shadow is disk-like structure or bowl structure.

Preferably, described valve sewing section is the network of tubular, or described valve sewing section is the wave of tubular Shape structure.

Preferably, one end skeleton of described valve sewing section is provided with extension.So design makes the described support can Controllable release.It is furthermore preferred that described extension and described valve sewing section are for removably connecting.So design is guaranteeing described Frame can be on the premise of controllable release, and described extension can be withdrawn from internal, greatly reduces implant, reduces atrium Contact and stimulation, and eliminate the implantation to day back lobe mesopetalum and limit.

Preferably, the near-end skeleton part of described valve sewing section extends.So design makes the near-end of described support exist Maintaining under compressive state, described anti-leakage ring can take the lead in expanding, beneficially adjusting pole position, because propping up during preventing from adjusting Frame near-end struts and blood vessel wall of stabbing.

Preferably, described anti-leakage ring has the skeleton that marmem is made, described skeleton by part or all of overlay film, Described membrane material includes metal material, politef, polyethylene, polypropylene, terylene or animal derived material.

It is furthermore preferred that described skeleton is made up of many support bars, or described skeleton be metal memory material filament winding system and Wavy shaped configuration, zigzag structure or the network become.The width of described support bar or described metal memory material silk The diameter of (such as nitinol alloy wire) is in the range of 0.1-0.6mm.

Preferably, described anti-leakage ring being provided with agnail, described agnail thrusts in autologous patient tissue when free state.

Preferably, described anti-leakage ring reconnects into a single integrated structure after separating independent making with described valve sewing section.

Preferably, described anti-leakage ring is structure as a whole with described valve sewing section.

Preferably, also to include that fixing device, described fixing device one end are fixedly connected on described for described heart valve prosthesis In valve sewing section, the other end of described fixing device is fixed on patient's atrial tissue, or another of described fixing device End is fixed in patient vessel, or the other end of described fixing device is fixed on cardiomyopathy, or described fixing dress The other end put is fixed on patient's apex of the heart tissue.

Preferably, described fixing device is line or bar.

Preferably, described fixing device is structure as a whole with described valve sewing section.

It is furthermore preferred that described fixing device is rigidity, described fixing device is prolonged by the skeleton of described valve sewing section near-end Stretch and form, or described fixing device is formed by the part rod member sizing in the near-end skeleton of described valve sewing section.More preferably , it is provided with between adjacent described rod member and adds high-amplitude wave, in order to strengthen the cross-brace power between described rod member.It is furthermore preferred that Between described rod member adjacent wave in the network of described valve sewing section, or described rod member is the sewing of described valve The extension of the crest in the network of section.

Preferably, described fixing device is provided with bending section so that the proximal part of described fixing device can be fitted Cardiomyopathy.

Preferably, described fixing device is triangular structure, or described fixing device is arcuate structure, or described solid Determining device is fenestral fabric.It is furthermore preferred that be provided with enhancing bar in described fixing device.

Preferably, described fixing device is additionally provided with fixture.

Preferably, described fixture is structure as a whole with described fixing device, and described fixture is agnail, or described solid Locking member is tip shape structure.

Preferably, described fixture is grappling pin, and the afterbody of described grappling pin is provided with locating part.

It is furthermore preferred that be provided with guide rail in described fixing device, described rail end reducing, described grappling pin is arranged on In described guide rail, the tip portion of described grappling pin passes from described guide rail and penetrates patient's heart tissue, described locating part Diameter is more than the bore of described reducing.

It is furthermore preferred that be provided with connector on described locating part, described connector is wire-like members, the one of described connector End is connected in described fixing device, and the other end of described connector is connected on described locating part.So it is mainly designed to really Protect implantation instrument and supplying system removably connects, improve the precision of acupuncture treatment, prevent grappling pin deviation predetermined acupuncture treatment point.

Preferably, described fixing device is inverted cone-shaped structure, and one end of described fixing device major diameter is stitched with described valve The near-end of section processed connects, and one end of described fixing device minor diameter is connected with connecting rod, and described connecting rod is rigidity, described connection The proximal part of bar is provided with fixture, and when free state, described fixing device is fixed on heart group by described fixture Knit.

It is furthermore preferred that the proximal part of described connecting rod is hollow pipe, tube wall is arranged porose, when free state, institute State the distalmost end of the fixture described hole from described hollow pipe passes and thrust heart tissue.The distalmost end of described fixture is Tip shape, the distal portions of described fixture is scheduled shape, and it is in following shape that the distal portions of described fixture is scheduled shape One or more combination: spiral type, circumferential, arc, camber line and the combination shape of straight line, bifurcated double hook shape, 3D bending Shape, multistage Curved, the far-end of described fixture is without agnail or with one or more agnail.

It is furthermore preferred that described fixture is the suction discoid component adapting to apex of the heart profile, the proximal part of described connecting rod Surface configuration has screw thread, and described fixture is provided with screwed hole, the proximal part of described connecting rod and described fixture screw thread Coordinate.

It is furthermore preferred that described fixture be adapt to apex of the heart profile suction discoid component, described fixture is provided with projection, Securing member and nut, described projection hollow, described securing member is positioned at described projection, and described projection outer surface is provided with screw thread, Described securing member hollow, the external diameter of described securing member is suitable with the internal diameter of described projection, the internal diameter of described securing member and described company The proximal part of extension bar is suitable, and described connecting rod is positioned at described securing member, and described fastener tip is provided with inclined-plane, described tightly Firmware is provided with parallel cutting seam in the axial direction, is provided with more than described fastener tip bevel angle in described nut Inclined-plane, when described nut and described projection threaded engagement, the gap of the cutting seam on described securing member diminishes so that described company Extension bar is fixed between described securing member.

It is furthermore preferred that described fixture is the support that big centre, two is little, marmem sizing form.

It is furthermore preferred that described fixture is the support of tubular.

Preferably, the outer surface of described valve sewing section is additionally provided with filling device.

Preferably, described filling device has the skeleton that marmem is made, and described skeleton is partly or entirely covered Film, described membrane material includes metal material, politef, polyethylene, polypropylene, terylene or animal derived material.

Preferably, on the cross section being perpendicular to described artificial valve axis, described filling device be projected as annular Structure, described loop configuration includes cirque structure or D-ring structure.

Preferably, described filling device is structure as a whole with described anti-leakage ring.

Preferably, the proximal part of described valve sewing section is provided with holder.

Compared with the existing technology, it is an advantage of the current invention that:

1, most product utilization support it is different from prior art to support the design of annulus, especially when described heart Valve prosthesis is when Tricuspid valve gets involved displacement, because patient's Tricuspid annulus size is very big, if utilizing merely valve to stitch Section processed is supported in patient's Tricuspid annulus, hardly possible realization from engineering viewpoint, also can be significantly even if achieving reluctantly Reduce valve life.In the present invention, on the cross section being perpendicular to artificial valve axis, the cross-sectional area of valve sewing section is little Cross-sectional area in autologous patient valve annulus so that valve sewing section will not directly radially expand autologous patient valve annulus, It is possible not only to the impact on efferent tract after minimizing support discharges, it is to avoid the tractive to native valve annulus, and ensure that lobe The aperture area of film will not change excessive because of the greatest differences between patient's annulus, optimizes valve performance, simultaneously manufacturer Product specification can be reduced, alleviate the stock pressure of production firm.

2, being different from prior art the support many employings grid configuration being positioned in atrium, its huge support force is the most right Heart tissue causes compressing (atrial systole can be hindered to affect blood supply time more serious) and leak preventing effect to dispatch a person by force to anticipate, in the present invention Anti-leakage ring is positioned at patient atrium autologous patient valve annulus of fitting, and anti-leakage ring can comply with atrium cavity wall or patient's native valve The uneven profile of annulus and be not intended to the contractile function in atrium, leak preventing effect is improved.

3, it is different from the concentric structure of existing most product, in the present invention, is perpendicular to artificial valve axis On cross section, the center of valve sewing section is misaligned with the center of anti-leakage ring.When described heart valve prosthesis is situated between for Bicuspid valve When entering to replace, deflection patient mitral back lobe region, axis of valve sewing section, it is possible to reduce further and left room is flowed out The obstruct in road；When described heart valve prosthesis gets involved displacement for Tricuspid valve, the axis deflection patient three of valve sewing section The septal leaflet region of cusp, beneficially fixing device can be adjacent to target anchor region, and anchoring effect is more preferable, and valve moves more Stable.

4, in the present invention, the distal bone of described valve sewing section sets up and is equipped with extension, described extension and described valve Sewing section is for removably connecting.So design is guaranteeing that described support can be on the premise of controllable release, and described extension is permissible Withdraw from internal, greatly reduce implant, reduce the contact to atrium and stimulation, facilitate induction system to withdraw human body, and Eliminate the implantation to day back lobe mesopetalum to limit.

5, in the present invention, described autologous annulus adapts to section and is provided with linkage section, and described autologous annulus adapts to the cross section of section For D-shape configuration, the cross section of described linkage section is circular configuration, and described anti-leakage ring is sewed with described valve by described linkage section It is strong with the connection of described valve sewing section that section connection, so design are advantageous in that one side improves described autologous annulus adaptation section Degree, on the other hand make described autologous annulus adapt to section can be designed to more be adjacent to patient's annulus, ensure that valve simultaneously Aperture area will not change excessive because of the greatest differences between patient's annulus.

Accompanying drawing explanation

Fig. 1 a-1c shows the schematic diagram of one embodiment of the present invention.

Fig. 2 a-2g shows the schematic diagram of the numerous embodiments of the present invention.

Fig. 3 a-3d shows the schematic diagram of the numerous embodiments of anti-leakage ring in the present invention.

Fig. 4 a-4f shows the schematic diagram of the numerous embodiments of the present invention.

Fig. 5 a-5g shows the schematic diagram of the numerous embodiments of the present invention.

Fig. 6 a-6e shows the schematic diagram of the numerous embodiments of the present invention.

Fig. 7 a-7e shows the schematic diagram of the numerous embodiments of the present invention.

Fig. 8 a-8c shows the schematic diagram of the numerous embodiments of the present invention.Wherein Fig. 8 b is the sectional view of Fig. 8 a.

Fig. 9 a-9d shows a kind of schematic diagram carrying embodiment of the present invention.

Figure 10 a-10d shows the schematic diagram of the another kind of conveying embodiment of the present invention.

Figure 11 a-11d shows the schematic diagram of another embodiment of the invention, and wherein Figure 11 c and Figure 11 d is Figure 11 a Sectional view.

Detailed description of the invention:

For making the purpose of the present invention, technical scheme and advantage clearer, develop simultaneously embodiment referring to the drawings, right The present invention further describes.

Far-end of the present invention refers to one end of the apex of the heart, and described near-end refers to the one end close to the apex of the heart.

Specific embodiment one:

For a long time, either Edwards company or Medtronic company, Ge great valve producer all uses amplification The stent anchors power that frame-annulus radial dilatation is enough than obtaining, this gets involved displacement and valve of pulmonary trunk at aortic valve Film is got involved and is fully applied in displacement field and become common recognition (typically with 10%-15% for ideal perimeter divergence ratio).And arrive Jenavalve company later and Symetic company, be all that clamping leaflet mechanism is applied in product, be still that trouble Person's valve has certain divergence ratio.But, atrioventricular valves (A V valves) (including Bicuspid valve and Tricuspid valve) is due to the physiological structure of its complexity and trouble Pathogenesis system, often results in product and is accurately positioned and fixes extremely difficult.Get involved in the technology of displacement currently for atrioventricular valves (A V valves), as Edwards company, Medtronic company and Tiara company, the radial dilatation ratio being required to provide certain bar none is expired Foot grappling demand, although they use leaflet clamped design to improve anchoring effect, but also be only by radial dilatation ratio Slightly reduce.Generally speaking, the current anchoring techniques many dependences support support force to atrioventricular valve ring, doctor often selects and compares patient The valve specification that atrioventricular valves (A V valves) self annulus is bigger caters to mitral valve tissue profile, and the hugest support itself can be to efferent tract Produce impact, and easily surrounding tissue is caused compressing, block the blood flowing of left ventricular outflow tract further；For two For cusp displacement, support specification is excessive, and anterior mitral valve is easily pushed to left ventricular outflow tract view, in order to fix anterior mitral valve The clamping leaflet design introduced so that release steps is extremely complex, and is affected by leaflet calcification degree, have impact on operation Success rate；For Tricuspid valve gets involved displacement, because patient's Tricuspid annulus size is very big, if utilizing merely valve to stitch Section processed is supported in patient's Tricuspid annulus, hardly possible realization from engineering viewpoint, also can be significantly even if achieving reluctantly Reduce valve life.Additionally, be positioned at holder part many employings grid configuration in atrium in current technology, its huge support force holds Easily heart tissue is caused compressing, and atrium cavity wall or uneven wheel of patient's native valve annulus can not be complied with completely Exterior feature, leak preventing effect by force dispatch a person meaning, these defects are appeared in the newspapers in the clinical report of current above-mentioned technology repeatly.

Therefore, we have proposed a kind of novel heart valve prosthesis that can solve the problem that the problems referred to above.At an embodiment In, as shown in Fig. 1 a-Fig. 1 c, a kind of adaptive heart valve prosthesis 100, get involved replacement therapy for Tricuspid valve, including propping up Frame 110 and artificial valve 120, described support 110 includes anti-leakage ring 111 and valve sewing section 112, described artificial valve 120 quilt Being fixedly connected in described valve sewing section 112, described valve sewing section 112 is at least partially disposed between autologous patient leaflet. On the cross section being perpendicular to described artificial valve 120 axis, the cross-sectional area of described valve sewing section 112 is less than described trouble The cross-sectional area of person's native valve annulus 180 so that described valve sewing section 112 will not autologous patient valve described in radial dilatation Annulus 180, so design are possible not only to the impact after minimizing support discharges on efferent tract, it is to avoid lead native valve annulus Draw, and ensure that the aperture area of valve will not change excessive because of the greatest differences between patient's annulus, optimize Valve performance, manufacturer can reduce product specification simultaneously, alleviates the stock pressure of production firm.Described valve sewing section 112 For the network of tubular, described anti-leakage ring 111 be projected as cirque structure, described valve sewing section 112 is positioned at described anti- Among leakage ring 111, in a free state, described anti-leakage ring 111 is positioned at patient atrium autologous patient valve annulus of fitting 180, described anti-leakage ring 111 can be complied with atrium cavity wall or the uneven profile of patient's native valve annulus and be not intended to the receipts in atrium Contracting function, on the one hand improves leak preventing effect, on the other hand avoids heart tissue is caused compressing.Described heart valve prosthesis 100 also include that fixing device 113, described fixing device 113 one end are connected in described valve sewing section 112, described fixing dress Put the other end of 113 to be fixedly connected on cardiomyopathy 183.The distal bone of described valve sewing section 112 sets up and is equipped with prolongation Section 1121, so design make described support can controllable release, raising positioning precision.

Described fixing device 113 is structure as a whole with described valve sewing section 112, in one embodiment, described fixing Device 113 is the extension of described valve sewing section 112 near-end skeleton, and described fixing device 113 is rigidity.Such design is main Allowing for utilizing fixing device by whole instrument supports in target location, being designed to of rigidity guarantees grappling function.

In one embodiment, as shown in Figure 2 a and 2 b, described fixing device 113 is triangular structure, described solid Determine to be provided with on device 113 bending section 1130 so that the proximal part of described fixing device 113 can be fitted cardiomyopathy. Being additionally provided with fixture 114 in described fixing device 113, described fixture 114 is grappling pin, the far-end of described grappling pin 114 The scheduled shape of part, it is spiral type, circumferential or arc that the tip portion of described grappling pin 114 is scheduled shape, described grappling The tip portion of pin 114 is with multiple agnails.The afterbody of described grappling pin 114 is provided with locating part 1140, described locating part The diameter of 1140 is more than the pin footpath of described grappling pin 114.Overlay film 1131 in described fixing device 113, the material of described film 1131 Including metal material, politef, polyethylene, polypropylene, terylene or animal derived material, described grappling pin 114 described Tip portion passes from described film 1131 and penetrates patient's heart tissue.

In another embodiment, as shown in Fig. 2 c and Fig. 2 d, described fixing device 113 is arcuate structure, described solid It is provided with enhancing bar 1132, so design in determining device 113 and is advantageous in that the rigidity improving described fixing device, it is ensured that grappling Function.Described fixture 114 is grappling pin, and the distal portions of described grappling pin 114 is scheduled shape, the pin of described grappling pin 114 It is camber line and the combination shape of straight line or bifurcated double hook shape that nose part is scheduled shape, the tip portion of described grappling pin 114 with One agnail.The afterbody of described grappling pin 114 is provided with locating part 1140.Porose 1133 are arranged, institute in described fixing device 113 State the described tip portion of grappling pin 114 from described hole 1133 through penetrating patient's heart tissue, described locating part 1140 Diameter more than the aperture in described hole 1133.

In another embodiment, as shown in Fig. 2 e and Fig. 2 f, described fixing device 113 is fenestral fabric.Described Fixture 114 is grappling pin, and the distal portions of described grappling pin 114 is scheduled shape, and the tip portion of described grappling pin 114 is by advance Be shaped to 3D Curved or multistage Curved, the tip portion of described grappling pin 114 without agnail, described grappling pin 114 Afterbody is provided with locating part 1140.Guide rail 1134 it is provided with, end 1135 quilt of described guide rail 1134 in described fixing device 113 Reducing, described grappling pin 114 is arranged in described guide rail 1134, by grappling pin 114 described in pusher (not shown) Tip portion is from described guide rail 1134 through penetrating patient's heart tissue, and the diameter of described locating part 1140 is more than described reducing Bore.

In another embodiment, as shown in Figure 2 g, described locating part 1140 is provided with connector 1141, described company Fitting 1141 is wire-like members.One end of described connector 1141 is connected in described fixing device 113, described connector 1141 The other end be connected on described locating part 1140.So it is mainly designed to guarantee that implantation instrument and supplying system detachably connect Connect, improve the precision of acupuncture treatment, prevent grappling pin deviation predetermined acupuncture treatment point.

Being different from existing product the holder part many employings grid configuration being positioned at atrium, its huge support force is the most right Heart tissue causes compressing and leak preventing effect to dispatch a person by force to anticipate, and in the present invention, anti-leakage ring is positioned at patient atrium autologous patient of fitting Valve annulus, anti-leakage ring can be complied with atrium cavity wall or the uneven profile of patient's native valve annulus and be not intended to the contraction in atrium Function, leak preventing effect is improved.In one embodiment, as shown in Figure 3 a, described anti-leakage ring 111 includes that autologous annulus is fitted The section of answering 1115 and atrial tissue adapt to section 1116, and described autologous annulus adapts to the diameter of section 1115 and adapts to less than described atrial tissue Section 1116, described autologous annulus adapts to section 1115 and described atrial tissue adapts to section 1116 and sews section 112 with described valve respectively Distal portions be connected.On the longitudinal section being parallel to described artificial valve axis, described atrial tissue adapts to section 1116 It is projected as disk-like structure.As shown in Fig. 3 b-d, described anti-leakage ring 111 has the skeleton 1111 that marmem is made, described Skeleton 1111 by whole overlay films 1112, the material of described film 1112 include metal material, politef, polyethylene, polypropylene, Terylene or animal derived material.Described skeleton 1111 is the wavy shaped configuration of metal memory material filament winding system, zigzag knot Structure or network, a diameter of 0.3mm of described metal memory material silk (such as nitinol alloy wire).Described anti-leakage ring 111 Linked into an integrated entity structure by suture again after separate independent making with described valve sewing section 112.

Specific embodiment two:

In one embodiment, as shown in figures 4 a and 4b, a kind of adaptive heart valve prosthesis 200, for two Cusp gets involved replacement therapy, and including support 210 and artificial valve's (not shown), described support 210 includes anti-leakage ring 211 and valve Sewing section 212, described artificial valve is fixedly connected in described valve sewing section 212, described anti-leakage ring 211 and described valve Sewing section 212 connects, and in a free state, described anti-leakage ring 211 is positioned at patient atrium and is seated in autologous patient valve lobe On ring 280, described anti-leakage ring 211 can be complied with atrium cavity wall or the uneven profile of patient's native valve annulus and be not intended to atrium Contractile function, described valve sewing section 212 be at least partially disposed between autologous patient leaflet, be perpendicular to described artificial valve On the cross section of axis, the cross-sectional area of described valve sewing section 212 is less than the transversal of described autologous patient valve annulus 280 Area so that described valve sewing section 212 will not autologous patient valve annulus 280 described in radial dilatation.Described cardiac valve is false Body 200 also includes that fixing device 213, described fixing device 213 one end are connected to the proximal part of described valve sewing section 212 On, the other end of described fixing device 213 is provided with fixture 214 and by described fixture 214 and patient's cardiac muscle muscle Connect.

In one embodiment, as illustrated in fig. 4 c, described fixing device 213 is sewed section 212 near-end bone by described valve Part rod member 2123 sizing in frame forms.Such as, the saw during described rod member 2123 is described valve sewing section 213 network The extension of the crest of shape ripple.Described fixture 214 is structure as a whole with described fixing device 213, and described fixture 214 is described The tip shape structure of rod member 2123 end.It is provided with bending section 2130 so that the institute of described rod member 2123 on described rod member 2123 State tip shape structure can penetrate in patient's annulus tissue.

In another embodiment, as shown in figure 4d, described fixing device 213 is sewed section 212 near-end by described valve Part rod member 2123 sizing in skeleton forms, and described rod member 2123 is positioned at the phase in described valve sewing section 213 network Between adjacent saw ripple or adjacent wavy shaped configuration, it is provided with between described rod member 2123 and adds high-amplitude wave 2124, in order to strengthen State the cross-brace power between rod member 2123.Described fixture 214 is structure as a whole with described fixing device 213, described fixing Part 214 is one or more agnail.It is provided with bending section 2130 so that described fixing device 213 on described rod member 2123 Proximal part can be fitted patient's heart tissue, such as annulus tissue, valve or chordae tendineae, and described agnail is hooked into above-mentioned heart group Knit and realize firm fixing.

In one embodiment, as shown in Fig. 4 e and Fig. 4 f, described anti-leakage ring 211 with described valve sewing section 212 is Integrative-structure, described anti-leakage ring 211 has the skeleton 2111 that marmem is made, and described skeleton 2111 is by whole overlay films 2112, described skeleton 2111 is made up of many support bars, and described support bar is part rod member sizing in described valve sewing section 212 Forming, the width of described support bar is 0.4mm.It is furthermore preferred that described support bar 2111 is wavy shaped configuration, so design is good Place is to improve the compliance of described skeleton 2111 so that anti-leakage ring 211 can comply with atrium cavity wall or patient's native valve annulus Uneven profile, leak preventing effect is improved.Described anti-leakage ring 211 includes that autologous annulus adapts to section 2115 and atrial tissue is fitted The section of answering 2116, described atrial tissue adapts to section 2116 and is connected with described autologous annulus adaptation section 2115, and described autologous annulus adapts to Section 2115 is connected with the distal portions of described valve sewing section 212, on the cross section being perpendicular to described artificial valve axis, It is " D " shape structure that described autologous annulus adapts to the cross section of section 2115, the center of described anti-leakage ring 211 (two dotted lines in Fig. 4 f Intersection point) with described valve sewing section 212 center 2120 misaligned.In a preferred embodiment, described autologous annulus is fitted The section of answering and described atrial tissue adapt to section and are structure as a whole.When the heart valve prosthesis of the present invention is used for Tricuspid valve field, The center 2120 of described valve sewing section 212 is arranged on described autologous annulus and adapts to the center of section 2115 and described autologous lobe Ring adapts between the straightway of section 2115 " D " shape.When the heart valve prosthesis of the present invention is used for Bicuspid valve field, vertically On the cross section of described artificial valve axis, the center of described valve sewing section is arranged on described autologous annulus and adapts to section Center and described autologous annulus adapt to section " D " shape arc between.So design is advantageous in that, when prosthese is employed When replacement of tricuspid valves, beneficially fixing device can be adjacent to target anchor region, and anchoring effect is more preferable, and valve moves more Stable.

Specific embodiment three:

In one embodiment, as shown in Figure 5 a, a kind of adaptive heart valve prosthesis 300, it is situated between for Tricuspid valve Entering replacement therapy, including support 310 and artificial valve's (not shown), described support 310 includes anti-leakage ring 311 and valve sewing section 312, described artificial valve is fixedly connected in described valve sewing section 312, and described valve sewing section 312 is the wave of tubular Shape structure, described fixing device 313 is inverted cone-shaped structure, and one end of described fixing device 313 major diameter sews with described valve Connecting proximally by known technologies such as stitching, snapping or welding of section 312, one end of described fixing device 313 minor diameter sets Being equipped with connecting rod 315, described connecting rod 315 is rigidity, and described connecting rod 315 one end connects with the end of described fixing device 313 Connecing, the proximal part of described connecting rod 315 is provided with fixture 314, and when free state, described fixing device 313 is by described Fixture 314 is fixed on apex of the heart tissue 384.Described anti-leakage ring 311 is connected, at free shape with described valve sewing section 312 Under state, described anti-leakage ring 311 is positioned at patient atrium autologous patient valve annulus of fitting, and described anti-leakage ring 311 can comply with the heart Room cavity wall or the uneven profile of patient's native valve annulus and be not intended to the contractile function in atrium, described valve sewing section 312 Being at least partially disposed between autologous patient leaflet, on the cross section being perpendicular to described artificial valve axis, described valve stitches The cross-sectional area of section 312 processed is less than the cross-sectional area of described autologous patient valve annulus so that described valve sewing section 312 will not Autologous patient valve annulus described in radial dilatation.

The proximal part of described connecting rod 315 is hollow pipe, and tube wall arranges porose 3150.Described fixture 314 is Far-end is tip shape, and the distal portions of described fixture 314 is scheduled shape, and the distal portions of described fixture 314 is scheduled shape One or more combination in following shape: spiral type, circumferential, arc, camber line and the combination shape of straight line, bifurcated pair Hook-type, 3D Curved, multistage Curved, the far-end of described fixture 314 is without agnail or with one or more agnail. When free state, the distalmost end of described fixture 314 passes in the described hole 3150 from described hollow pipe 315 and thrusts the apex of the heart On tissue 384.

In another embodiment, as shown in Figure 5 b, described fixture 314 is the sucker shape structure adapting to apex of the heart profile Part, the outer surface of the proximal part of described connecting rod 315 is provided with screw thread, described fixture 314 is provided with screwed hole, described The proximal part of connecting rod 315 and described fixture 314 threaded engagement.

In another embodiment, as shown in Fig. 5 c-e, described fixture 314 is the sucker shape structure adapting to apex of the heart profile Part, described fixture 314 is provided with projection 3141, securing member 3142 and nut 3143.Described projection 3141 hollow, described tightly Firmware 3142 is positioned at described projection 3141, and described projection 3141 inner surface is provided with screw thread.Described securing member 3142 hollow, institute The external diameter stating securing member 3142 is suitable with the internal diameter of described projection 3141, the internal diameter of described securing member 3142 and described connecting rod The diameter of the proximal part of 315 is suitable, and described connecting rod 315 is positioned at described securing member 3142, described securing member 3142 top Being provided with inclined-plane, described securing member 3142 is provided with parallel cutting seam 3144 in the axial direction.Arrange in described nut 3143 There is the inclined-plane more than described securing member 3142 top bevel angle, when described nut 3143 and described projection 3141 threaded engagement Time, the gap of the described cutting seam 3144 on described securing member 3142 diminishes so that described connecting rod 315 is fixed on described fastening Between part 3142.

In one embodiment, as shown in Fig. 5 f and Fig. 5 g, described anti-leakage ring 311 includes that autologous annulus adapts to section 3115 Adapting to section 3116 with atrial tissue, on the cross section being perpendicular to described artificial valve axis, described atrial tissue adapts to section 3116 be projected as ellipse or circular configuration or D-shape configuration.In the longitudinal section being parallel to described artificial valve axis On, described atrial tissue adapt to section 3116 be projected as bowl structure, the rim of a bowl is supported in patient atrium 381.Described anti-leakage ring 311 have the skeleton 3111 that marmem is made, and described skeleton 3111 is by part overlay film 3112, and this is to prevent from supporting Described anti-leakage ring 311 in the cavity wall of atrium blocks coronary sinus vein, superior vena cava and postcava.Described film 3112 material bag Include metal material, politef, polyethylene, polypropylene, terylene or animal derived material.In another one embodiment, As shown in fig. 5g, the proximal part of described valve sewing section 312 is provided with holder 370 for clamping native leaflets 389, To strengthen anchoring effect.

Specific embodiment four:

In one embodiment, as shown in Figure 6 a, a kind of adaptive heart valve prosthesis 400, it is situated between for Tricuspid valve Enter replacement therapy.Different from specific embodiment three being, described fixture 414 is the support that big centre, two is little, shape remember Recalling alloy sizing to form, when free state, described fixture 414 is fixed on interventricular septum 483.

In one embodiment, it is different from the concentric structure of existing most product, in the present invention, is being perpendicular to people On the cross section of work valve axis, the center of described valve sewing section 412 is misaligned with the center of described anti-leakage ring 411, institute State anti-leakage ring 411 to be set for the eccentric relative to described valve sewing section 412.As shown in Figure 6 b, use when described heart valve prosthesis When Bicuspid valve gets involved displacement, the back lobe district of axis deflection patient's Bicuspid valve (dotted portion) of described valve sewing section 412 Territory 485, it is possible to reduce the obstruct to left ventricular outflow tract view further；As fig. 6 c, when described heart valve prosthesis is for tricuspid When lobe gets involved displacement, the septal leaflet region 486 of axis deflection patient's Tricuspid valve (dotted portion) of described valve sewing section 412, Being conducive to described fixing device can be adjacent to target anchor region, anchoring effect is more preferable, and valve motion is more stable.

In one embodiment, as shown in Fig. 6 d and Fig. 6 e, described anti-leakage ring 411 sews section 412 points with described valve Reconnect into a single integrated structure after opening independent making.Porose 4123 are arranged, described anti-leakage ring on the skeleton of described valve sewing section 412 411 utilize stitching thread 4113 to be connected in described valve sewing section 412 by described hole 4123.Described anti-leakage ring 411 has shape The skeleton that shape memory alloys is made, described skeleton is by whole overlay films, on the longitudinal section being parallel to described artificial valve axis, Described atrial tissue adapt to section 4116 be projected as disk-like structure.It is provided with agnail 4114, when described anti-on described anti-leakage ring 411 Leakage ring 411 fit autologous patient valve annulus time, described agnail 4114 thrusts in autologous patient tissue.

Specific embodiment five:

In one embodiment, as illustrated in figs. 7 a and 7b, unlike the embodiments above being, described cardiac valve is false Body 500 includes multiple described fixing device 513.One of them described fixing device 513a is inverted cone-shaped structure, is positioned at described lobe The near-end of film sewing section 512, one end of described fixing device 513a major diameter and described valve sewing section 512 proximally by seam The known technologies such as conjunction, snapping or welding connect, and one end of described fixing device 513a minor diameter is provided with connecting rod and (does not shows Show).Fixing device 513b described in another one is line or bar, and described fixing device 513b one end is connected to described valve sewing section On 512, the other end of described fixing device 513b is fixed on patient's atrial tissue.So design is advantageous in that in employing The mode of lower limit prevents implant displacement or comes off, and strengthens the grappling firmness of implant.

In another embodiment, as shown in Figure 7 c, described fixing device 513b is additionally provided with fixture 514, institute Stating fixture 514 is the little support in big centre, two, marmem sizing form, the described fixing dress when free state Put 513b to be fixed in atrial walls 581 by described fixture 514.In another embodiment, as shown in figure 7d, described Fixture 514 is the support of tubular, and when free state, described fixing device 513b is fixed on by described fixture 514 In caval vein 582.In another embodiment, as shown in figure 7e, described heart valve prosthesis 500 includes multiple described solid Determining device 513 (513a, 513b, 513c, 513d), described fixing device 513 is rod member, the end of described rod member sharp-pointed and with Agnail, described rod member 513a, 513b, 513c are separately fixed on right ventricle muscle meat tissue.

In another embodiment, as shown in Figure 8 a, the outer surface of described valve sewing section 512 is additionally provided with filling dress Put 518.On the cross section being perpendicular to described artificial valve 520 axis, as shown in Figure 8 b, the throwing of described filling device 518 Shadow is loop configuration, and described loop configuration includes that cirque structure or D-ring structure, so design are advantageous in that increase and oneself The contact of body leaflet, improves leak preventing effect.Described filling device 518 has the skeleton that marmem is made, described skeleton By part or all of overlay film, described membrane material includes metal material, politef, polyethylene, polypropylene, terylene or animal sources Property material.In another embodiment, as shown in Figure 8 c, described filling device 518 is integrated knot with described anti-leakage ring 511 Structure.Near-end skeleton 5120 part of described valve sewing section 512 extends.So design makes the near of described valve sewing section 512 End can be under maintaining compressive state, and described anti-leakage ring 511 takes the lead in expanding, and beneficially adjusting pole position prevents adjustment process In stab because mount proximal end struts blood vessel wall.

In one embodiment, as shown in Fig. 9 a-9d, described heart valve prosthesis 500 through conduit from patient's right atrium Entering patient's heart Tricuspid valve region, and progressively discharge, last described heart valve prosthesis 500 is by described fixing device 513 (513a, 513b) be separately fixed at cardiomyopathy 583 and atrial tissue 581 on.

In another embodiment, as shown in figures 10 a-10d, described heart valve prosthesis 500 through conduit from patient's heart Point enters patient's heart Bicuspid valve region, and progressively discharges, and last described heart valve prosthesis 500 is by described fixing device 513 are fixed at patient's apex of the heart 584.

Specific embodiment six:

In one embodiment, as shown in Figure 11 a-11d, described autologous annulus adapts to section 6115 and is provided with linkage section 6117, it is D-shape configuration that described autologous annulus adapts to the cross section of section 6115, and the cross section of described linkage section 6117 is circular knot Structure, described autologous annulus is adapted to section 6115 and is connected with described valve sewing section 612 by described linkage section 6117, so designs It is advantageous in that on the one hand improving described autologous annulus adapts to the bonding strength of section 6115 and described valve sewing section 612, the opposing party Face make described autologous annulus adapt to section 6115 can be designed to more be adjacent to patient's annulus.

In another embodiment, as shown in figure 11b, the distal bone of described valve sewing section 612 sets up and is equipped with prolongation Section 6121, described extension 6121 and described valve sewing section 612 are for removably connecting.So design is guaranteeing described support energy On the premise of enough controllable release, described extension 6121 can be withdrawn from internal, greatly reduces implant, reduces atrium Contact and stimulation, facilitate induction system to withdraw human body, and eliminate the implantation to day back lobe mesopetalum and limit.Described extension The near-end of 6121 is provided with cavernous structure 6125, and the far-end skeleton of described valve sewing section 612 is staggered enters described cavernous structure In 6125, the far-end skeleton of described valve sewing section 612 is provided with lock hole 6126, described lock hole 6126 inserts lock Fixed pole 6127 realizes locking；When described securing rod 6127 detaches described lock hole 6126, the distal bone of described valve sewing section 612 Frame departs from from the described cavernous structure 6125 of described extension 6121, it is achieved described extension 6121 sews section with described valve The dismounting of 612.

Last it should be noted that, the foregoing is only the preferred embodiment of the present invention, not in order to limit this Invention, all any amendment, equivalent and improvement etc. made within the spirit and principles in the present invention, should be included in this Within bright protection domain.

Claims (15)

1. an adaptive heart valve prosthesis, including support and artificial valve, it is characterised in that described support includes leakproof Ring and valve sewing section, described anti-leakage ring is connected with described valve sewing section, and described artificial valve is fixedly connected at described lobe In film sewing section, described valve sewing section is at least partially disposed between autologous patient leaflet, in being perpendicular to described artificial valve On the cross section of axis, the cross-sectional area of described valve sewing section, less than the cross-sectional area of described autologous patient valve annulus, makes Obtain described valve sewing section and will not directly radially expand described autologous patient valve annulus, in a free state, described anti-leakage ring Cross-sectional area more than the cross-sectional area of described autologous patient valve annulus, described anti-leakage ring can comply with atrium cavity wall or patient The uneven profile of native valve annulus.

The adaptive heart valve prosthesis of one the most according to claim 1, it is characterised in that be perpendicular to described manually On the cross section of valve axis, the center of described anti-leakage ring is misaligned with the center of described valve sewing section.

The adaptive heart valve prosthesis of one the most according to claim 1, it is characterised in that described anti-leakage ring includes certainly Body annulus adapts to section and atrial tissue adapts to section, and described autologous annulus adapts to section and described atrial tissue adapts to section respectively with described The distal portions of valve sewing section is connected.

The adaptive heart valve prosthesis of one the most according to claim 1, it is characterised in that described anti-leakage ring includes certainly Body annulus adapts to section and atrial tissue adapts to section, and described atrial tissue adapts to section and is connected with described mesh body annulus adaptation section, described Autologous annulus adapts to section and is connected with the distal portions of described valve sewing section.

The adaptive heart valve prosthesis of one the most according to claim 4, it is characterised in that described autologous annulus adapts to Section and described atrial tissue adapt to section and are structure as a whole.

6. according to the adaptive heart valve prosthesis of the one described in claim 3 or 4, it is characterised in that described autologous annulus The cross section adapting to section is D-shape configuration.

7. according to the adaptive heart valve prosthesis of the one described in claim 3 or 4, it is characterised in that described atrial tissue The cross section adapting to section is ellipsoidal structure or circular configuration or D-shape configuration.

8. according to the adaptive heart valve prosthesis of the one described in claim 3 or 4, it is characterised in that described autologous annulus Adapting to section and be provided with linkage section, it is D-shape configuration that described autologous annulus adapts to the cross section of section, and the cross section of described linkage section is circle Shape structure, described autologous annulus is adapted to section and is connected with described valve sewing section by described linkage section.

The adaptive heart valve prosthesis of one the most according to claim 1, it is characterised in that described heart valve prosthesis Also include that fixing device, described fixing device one end are fixedly connected in described valve sewing section, another of described fixing device End is fixed on patient's atrial tissue, or the other end of described fixing device is fixed in patient vessel, or described fixing The other end of device is fixed on cardiomyopathy, or the other end of described fixing device is fixed on patient's apex of the heart tissue.

The adaptive heart valve prosthesis of one the most according to claim 9, it is characterised in that described fixing device with Described valve sewing section is structure as a whole.

The 11. adaptive heart valve prosthesis of one according to claim 9, it is characterised in that in described fixing device It is additionally provided with fixture.

The 12. adaptive heart valve prosthesis of one according to claim 1, it is characterised in that described valve sewing section Outer surface is additionally provided with filling device.

The 13. adaptive heart valve prosthesis of one according to claim 1, it is characterised in that described valve sewing section One end of skeleton is provided with extension.

The 14. adaptive heart valve prosthesis of one according to claim 13, it is characterised in that described extension and institute State valve sewing section for removably connecting.

The 15. adaptive heart valve prosthesis of one according to claim 1, it is characterised in that sew at described valve It is provided with holder on the proximal part of section.