CN107212950B

CN107212950B - A kind of heart valve prosthesis with clamping device

Info

Publication number: CN107212950B
Application number: CN201710563455.8A
Authority: CN
Inventors: 陈志�; 李佳楠; 曹鹏; 李毅斌; 徐志云; 宋智钢
Original assignee: Ningbo Jianshi Biological Science & Technology Co Ltd
Current assignee: Jenscare Scientific Co Ltd
Priority date: 2017-07-12
Filing date: 2017-07-12
Publication date: 2019-10-18
Anticipated expiration: 2037-07-12
Also published as: CN107212950A

Abstract

The present invention relates to a kind of heart valve prosthesis with clamping device, including bracket and artificial valve, bracket includes atrium section, valve sews section and at least one clamping device, artificial valve is fixedly connected in valve sewing section, the proximal end of atrium section is fixedly connected with the distal end of valve sewing section, enhancing structure is provided in the section of atrium, one end is fixedly connected in the section of atrium or is fixedly connected at the material for reducing or preventing blood to flow through being fixedly connected with the atrium section, in its natural state, external opening of its other end to valve sewing section, after artificial valve prosthese is completely released, enhancing structure and the material abut self annulus tissue and/or atrial tissue together, under natural conditions, a part of clamping device is abutted to the outer surface of valve sewing section, at least one is provided on clamping device to valve Film sews the curved bending section in inside of section, and a part of bending section enters in valve sewing segment mesh gap.

Description

A kind of heart valve prosthesis with clamping device

Technical field:

The invention belongs to medical instruments fields, and in particular to a kind of heart valve prosthesis with clamping device.

Background technique:

Mitral position in left ventricle, bicuspid valve include preceding valve (frontal lobe), back lobe (rear leaf) and junctional area (preceding junctional area and Junctional area afterwards), it is connected on the papillary muscle of front and back by chordae tendineae under valve, there is no chordae tendineae attachment in interventricular septum.Due to its complicated life Manage structure, also referred to as Mitral valve structure.Annulus of mitral valve is the fibroid taeniae telarum for being attached to left room room bore edges, is irregular " D " shape shape, the preceding one third of mitral annulus are the continuous part of preceding valve and aorta, the corresponding atrium of front and back valve with Mitral annulus is formed by that angle is also different, and there are also the attachments of left auricle of heart at atrium.Mitral valve function is not all most common Mitral valve insufficiency caused by one of heart disease, such as mitral valve prolapse illness, such as the valve caused by rheumatic inflammation Mitral stenosis caused by damaging etc..

And for the treatment skill of bicuspid valve intubation intervention, though at present have a small number of products percutaneously intervention mitral valve at It is applied on shape and neoplasty, but in terms of percutaneously intervention mitral valve replacement, is not there is mature product to come out in the world, In numerous technologies, the FORTIS support system of Edwards Lifesciences company, U.S. research and development has entered clinic Trial period, still, there are still certain problems for this technology, below by the defect to the relevant technologies in technique and industry It is analyzed.

Patent CN102639179B and patent US8449599 describes one kind two of Edwards Lifesciences company Cusp displacement prosthetic appliance, for implantation into the natural bicuspid valve region of heart, the natural bicuspid valve have native annulus and Native valve leaflets, the prosthetic appliance include: tube-shaped main body comprising flow through chamber, atrial end and the heart therein for blood Room end, and being configured for placement in the native annulus, the main body can be radially compressed to radial compression, with deliver into In the heart, and radial expanded state can be self-expanded into from the compressive state；It is connected with the main body and is located at institute At least one anchor log of body exterior is stated, the anchor log is connected with the main body, to be in expansion when the main body When state, at least one described anchor log is configured as hooking around native leaflet, at least one described anchor log and described Leaflet-reception space is limited between main body；It is described with the annular flange portion to extend radially outwardly from the atrial end of the main body Annular flange portion includes atrium sealing element, and when the prosthetic appliance is implanted, the atrium sealing element prevents blood flow More than the atrial end of the main body on the body exterior.Fixed form used by the technology, by institute in its sovereignty description The anchor log limited is positioned at the outside of the main body, and the native leaflet will be by flat Stent Implantation main body blood Between the lateral surface in channel and the medial surface of the anchoring device, cause fixed firmness place one's entire reliance upon the anchor log with Frictional force between the main body, and after clamped, native valve is constantly in the leaflet open position in diastole period And unfolded state, the large area annular barrier blood flow of left ventricular outflow tract, so that part should be in this period from the left heart The blood flow that room flows into aorta is stopped by a part, left ventricle is back to, after being chronically implanted, it may appear that the illnesss such as heart failure.It should The chucking power of kind method, is based primarily upon the overlapping area of the anchoring device medial surface Yu the bracket blood channel lateral surface, And made since the bar of bracket is extended the deadline, cause contact area not too large, or even such as patent CN102639179B institute in embodiment Description, since the anchor log is in the body exterior, curved state will lead to native valve and be consolidated by more point-like contacts It is scheduled between the anchor log and the main body, so that there is unsteady risks for the fixation of the device.

In patent US8465540, Jenavalve discloses a expandable stent, with multiple positioning arcuation parts and Multiple holding arcuation parts, the positioning arcuation part are located at the side of native valve valve Dou Chu and native valve, the holding arcuation Part is located at the other side of native valve, and the expandable stent further includes multiple radial deposition parts, each positioning arcuation part by Single radial direction arcuation part is radially connected, includes several curved edges on each holding arcuation part, and each curved edge is constituted Bending point between two adjacent stems.The deficiency of the design is, since bracket is using one cutting, the positioning arcuation part It is not overlapped necessarily with the cutting room for keeping arcuation part, native valve is clamped in the positioning arcuation part and described It is only the line contact of several shafts, gap of the native valve under blood flow effect between shaft when keeping between arcuation part In still have shake by a relatively large margin, influence the proper motion of artificial valve prosthese, reduce effective vent area, and position arcuation Part and the clamping for keeping line contact type between arcuation part will lead to chucking power deficiency, be easy to cause artificial valve prostheses migration

In conclusion above-mentioned fixed form, it is fixed not firm enough that one of defect is that the structure design of fixing piece causes Firm, the two of defect are, when these technologies are treated by application with bicuspid valve, after native valve is clamped, along annulus circumferential direction The left ventricular outflow tract area that the state of expansion will lead to large area is blocked, and is easily caused after being chronically implanted a series of concurrent Disease.

Summary of the invention:

The purpose of the present invention is being to improve and make up the defect of the prior art, propose that one kind can effectively solve above-mentioned ask A kind of heart valve prosthesis with clamping device of topic.Technology of the invention have accurate positionin, firm clamping, secured detent, Reduce the features such as left ventricular outflow tract area stops and reduces perivalvular leakage, solves prosthese in the prior art and be not fixed firmly and prosthese Occur the problem of perivalvular leakage after being implanted, can reduce after native valve is fixed and the blood flow of left ventricular outflow tract is blocked, subtract Few complication.

The purpose of the present invention is what is be achieved through the following technical solutions:

A kind of heart valve prosthesis with clamping device, including bracket and artificial valve, the bracket include atrium section, valve Film sews section and at least one clamping device, and the artificial valve is fixedly connected in the valve sewing section, the valve The central axis for sewing the blood flow direction of section is referred to as the axial line of the valve sewing section, the cross section of the valve sewing section Radial direction is referred to as the radial direction of the valve sewing section, and the valve sewing section is close to the circumferential surface of the axial line Inner surface, the circumferential surface of the valve sewing section far from the axial line is outer surface, the proximal end of the atrium section and the valve The distal end of film sewing section is fixedly connected, and the atrium section is greater than in the projected area in the radial direction of valve sewing section etc. It is connected and fixed section in being provided on radially projecting's area of valve sewing section, the proximal part of the valve sewing section, institute It states and is provided with connection cooperation section on the proximal part of clamping device, the valve sewing section and the clamping device pass through the company Fixed section is connect to be fixedly connected with connection cooperation section, the distal end of the clamping device is free to be known as free-end, under natural conditions, A part of the clamping device is abutted to the outer surface of valve sewing section, is provided at least one on the clamping device To the curved bending section in inside of valve sewing section, in its natural state, a part of the bending section enters the valve Film sews in the grid-gap of section.

One object of the present invention can also be further realized by technical solution below:

In some embodiments, it is provided with enhancing structure in the atrium section, one end of the enhancing structure is fixed company It connects in the atrium section or is fixedly connected at and be used to reducing or preventing blood stream with what the atrium section was fixedly connected On the material crossed, in its natural state, external opening of the other end of the enhancing structure to valve sewing section, when described Heart valve prosthesis is completely released to target position, and the enhancing structure and the material abut self annulus tissue together And/or atrial tissue.

In some embodiments, the distalmost end of the other end of the enhancing structure and the axial line distal direction are formed Angle is greater than or equal to the angle that the atrium section adjacent with the enhancing structure is formed with the axial line distal direction Maximum value.

In some embodiments, the atrium section sews the Projection Line Segment length of the radial direction of section most in the valve Big value is greater than the enhancing structure in the Projection Line Segment length of the radial direction of valve sewing section.

In some embodiments, the enhancing structure is the combination of wave or bar or both, the proximal end quilt of the enhancing structure Be fixedly connected in the section of the atrium, the enhancing structure be arranged on be fixedly connected with the atrium section for reducing or Prevent on the material that flows through of blood, after the heart valve prosthesis is completely released to target position, the enhancing structure and The material abuts the atrial surface of the corresponding annulus tissue in junctional area of the native valve and the position of atrial tissue together.? In some preferred embodiments, the enhancing structure is made of shape-memory alloy wire.

In some embodiments, it is provided on the proximal part of the clamping device and is stitched in its natural state towards the valve The structure opened or arched upward outside section processed.

In some embodiments, in its natural state, the proximal part of the valve sewing section has fills with the clamping The proximal part set is together with equal angular towards the external structure opened or arched upward of valve sewing section, so that natural shape Under state, the valve sewing section does not influence the opening of the clamping device or the degree that arches upward.

In some embodiments, it is provided on the proximal part of the clamping device and is filled in its natural state towards the clamping The curved arcuate segment of blood flow direction central axis set.

In some embodiments, in its natural state, a part of the clamping device is to outside valve sewing section Surface abuts, and the valve that is projected in that the clamping device abuts against the outer surface part of the valve sewing section sews section The face formed on outer surface is known as perspective plane, and other regions of the outer surface of the valve sewing section are non-perspective plane, described Retaining structure, one end of the retaining structure and the valve are provided in the region of the corresponding valve sewing section in non-perspective plane Film sewing section is fixedly connected, and in its natural state, the retaining structure is stitched towards the direction far from the axial line to the valve Section outer bend, protrusion or opening processed.

In some embodiments, the clamping device further includes gripping section and adaptive section, one end of the gripping section with One end of the connection cooperation section is fixedly connected, and the adaptive section is fixedly connected with the gripping section, the adaptive section One end is the free-end, and under natural conditions, the gripping section is drawn close to the outer surface of valve sewing section, the clamping Bending section on device is arranged on the gripping section, and the adaptive section is less than institute in the support force of the direction of axis line Gripping section is stated in the support force of the direction of axis line, after the heart valve prosthesis is released into target position, the folder It holds device and plays fixed function.

In some preferred embodiments, the adaptive section is subtracted the metallic rod system of power structure by wire or be provided with At the power of the subtracting structure is in variable-diameter structure, S-shaped structure, bow character form structure, zigzag structure, notching construction and open-celled structure One or more.In other preferred embodiments, the distal end to the clamping device is set on the gripping section The bar or wave or the two combination that either proximal end extends, to increase the chucking power of the gripping section.

In some embodiments, when the heart valve prosthesis be used to treat mitral lesion, the bracket includes Atrium section, valve sewing section and two clamping devices, it is described after the heart valve prosthesis is completely released to target position Two clamping devices fix self mitral frontal lobe and rear leaf, the clamping of fixed self mitral frontal lobe respectively The blood flow direction central axis of device is before the projection in self mitral frontal lobe plane is located at the self bicuspid valve Ye Shang, the blood flow direction central axis of the clamping device of fixed self mitral rear leaf is in the self rear Ye Ping Projection on face is located in the self mitral valve.

In some embodiments, in its natural state, the bending section on the clamping device is stitched into the valve Part in the grid-gap of section processed is less than or equal to 5mm along the radial direction Projection Line Segment length of valve sewing section.

In some embodiments, in its natural state, the proximal end of the clamping device is drawn close towards the axial line, is prevented Injury of myocardium tissue under natural conditions.

In some embodiments, when the heart valve prosthesis be used to treat mitral lesion, in the atrium section On be provided with and subtract power structure, after the heart valve prosthesis is completely released to target position, the power of the subtracting structure abuts institute It states the corresponding annulus tissue of self mitral frontal lobe and/or atrial tissue, the power of the subtracting structure includes the bar in the bracket One of the variable-diameter structure of upper setting, S-shaped structure, bow character form structure, zigzag structure, notching construction and open-celled structure or It is a variety of, to reduce the compressing to aorta.

In some embodiments, when the heart valve prosthesis be used to treat mitral lesion, the bracket includes Atrium section, valve sewing section and three clamping devices, after the artificial valve prosthese is completely released to target position, wherein The fixed self mitral frontal lobe of one clamping device, other two described clamping device is fixed described self respectively Mitral junctional area is symmetric along valve sewing section circumferential direction by symmetry axis of axial line；Or in which one The fixed self mitral frontal lobe of the clamping device, other two described clamping device fix self two point respectively The rear leaf of valve, and the blood flow direction central axis of other two clamping device is in self mitral rear leaf plane Projection be located at it is described it is self it is mitral after on leaf, along the axial line in circumferential symmetrical.

In some embodiments, in its natural state, the distal portions of the clamping device be inverted V-shaped, it is inverted U-shaped or fall Mastoid process shape.

In some embodiments, in its natural state, the distal end of the clamping device is drawn close towards axial line bending.

In some embodiments, it is provided at least two on the heart valve prosthesis and heaves device, it is described to heave dress It sets and is made of shape-memory alloy wire, be fixed on the circumferential direction of the valve sewing section, atrium section or both junction Outer surface, in its natural state, the junctional area for heaving device in the circumferential respectively against the native valve and the friendship The corresponding annulus tissue in battery limit (BL), and arch upward or open towards the outside of valve sewing section.

In some embodiments, the clamping device is the combination of one or more of silk, bar, pipe.

In some embodiments, the section and connection cooperation section of being connected and fixed is to inlay cooperation, is fixed by casing Connection.

In some embodiments, described be connected and fixed in section or connection cooperation section is provided with position limiting structure, or Position limiting structure is provided in described be connected and fixed in section and connection cooperation section, it is described to be connected and fixed section and the connection is matched Section overlapping is closed, is fixedly connected by casing.

In some embodiments, integrally cutting or integrated woven form the clamping device with valve sewing section.

In some embodiments, clamping device surface film, to increase chucking power.

In some embodiments, it is additionally provided with hangnail on the clamping device, in its natural state, the hangnail dissociates The direction towards the inside of the bracket is held to open to increase chucking power.

In some embodiments, auxiliary fixing structure is additionally provided on the artificial valve prosthese.

Compared with the existing technology, it is the advantages of above-mentioned technical proposal:

1, it is curved curved to the inside of valve sewing section to be provided at least one on the clamping device by the present invention Tune, in its natural state, a part of the bending section enter in the grid-gap of valve sewing section.When the prosthese It is used to treat the patient of bicuspid valve or tricuspid insufficiency, when the prosthese is partially compressed, it is therefore an objective to so that described External opening of inside of the free-end of clamping device far from valve sewing section to valve sewing section, the trip Opposite side from the closing face that end is placed in the native leaflets.A part of heretofore described bending section enters the valve The structure design in the grid-gap of section is sewed, is enabled to when the heart valve prosthesis is partially compressed, the heart Valve prosthesis radial diameter reduces, and the grid-gap is compressed, and the bending section is able to maintain under natural conditions at this time Shape, the bending section and valve sewing section the offseting in the radial direction in valve sewing section by compression section, Due to the interaction force that this offsets, so that the distance apart from the axial line is more after the free-end of the clamping device opens Greatly, the opposite side that the free-end is placed in the closing face of the native leaflets is easily facilitated, it can be in the fortune of the heart of beating heart During dynamic, the transformation of the size and shape of the self annulus is more adapted to.

Moreover, the valve sewing section and the clamping device are together after the heart valve prosthesis is completely released The native leaflets and connected self chordae tendineae are gripped.Bending section described in the present invention is replied as wherein A part enters the structure in the grid-gap of valve sewing section, at this point, the bending section and the valve sew section Grid carries out dislocation to the native leaflets and connected self chordae tendineae together and grips, and sews section in the valve Cross-sectional direction on, due to the bending section a part enter the valve sewing section grid-gap in so that described Bending section is different with the distance of grid to the axial line of valve sewing section, so that in valve sewing section Circumferentially, axially and radially combine and the native leaflets and connected self chordae tendineae are fixed on three directions.? In traditional leaflet clamping technique, clamped only with the flat expansion of leaflet, the design of clamping piece and bracket usually can only all guarantee Holding area is line area, and chucking power is smaller, and the frictional force along self annulus circumferential direction is only leaned on to fix to leaflet, of the present invention Bending section structure setting is able to solve existing so that the fixed form in the present invention is much better than the method for clamping in traditional technology Defect present in technology.

2, in technical solutions according to the invention, projection in the radial direction of the atrium section in valve sewing section Area is greater than or equal to radially projecting's area of valve sewing section, is provided with enhancing structure, the increasing in the atrium section Strong structure is the combination of wave or bar or both, and one end of the enhancing structure is fixedly connected at the atrium section above or is consolidated Surely it is connected to the material for reducing or preventing blood to flow through being fixedly connected with the atrium section, in its natural state, External opening of the other end of the enhancing structure to valve sewing section, the distalmost end of the other end of the enhancing structure with The angle that the axial line distal direction is formed is greater than or equal to the atrium section adjacent with the enhancing structure and the axis The maximum value for the angle that heart line distal direction is formed, this angle design enable to the enhancing structure more to press the reduction Or the material for preventing blood from flowing through, the contact for keeping it even closer with autologous tissue, prevent it from generating with the flowing of blood Fine motion is reduced and is especially in the atrium of the heart valve prosthesis of the junctional area corresponding position of native valve section Perivalvular leakage phenomenon.

Further, since the irregular shape and the complicated shape structure at the atrium of the self annulus, the atrium Section needs certain length and preset shape to adapt to the two structure, while must take into account again and prevent perivalvular leakage Effect, this increases difficulty requirement to the structure design of the artificial valve prosthese, and the setting of the enhancing structure, can be with So that the atrium section and the relatively independent performance effect of the enhancing structure.Therefore, in the present invention, the atrium section is in institute The maximum value for stating the Projection Line Segment length of the radial direction of valve sewing section is greater than the enhancing structure and sews section in the valve Radial direction Projection Line Segment length so that atrium section can according to the physiological structure in the atrium come design structure, Meanwhile the angle between the enhancing structure and the axial line limits, and can make the enhancing structure not by the atrium Section structure influence and the material for reducing or preventing blood to flow through abut together the self annulus tissue with/ Or atrial tissue, preferably play the role of preventing perivalvular leakage.

On the other hand, the enhancing structure can make the heart valve prosthesis of its corresponding position have higher branch Support force, the heart valve prosthesis enable keep the artificial valve while adapting to the irregular form of diseased region The good opening and closing function of film.

3, in technical solutions according to the invention, due to the heart valve prosthesis be using the clamping device with it is described Valve sews section synergy to clamp the fixed form of leaflet, so that when the native leaflets are after clamped fixed, it can It is naturally formed with adjacent ventricle wall and stops sinus, play the role of preventing perivalvular leakage, but in the native leaflets junctional area, Due to not forming the blocking sinus, higher perivalvular leakage risk is had, therefore, in some embodiments of the invention, for The position of the enhancing structure proposes following setting, after the prosthese is completely released to target position, the enhancing knot Structure and the material for reducing or preventing blood to flow through abut the corresponding annulus in junctional area of the native leaflets together The atrial surface and atrial tissue of tissue, set is advantageous in that in this way, increases surplus when borrowed structure design, so that The atrium section can do more structure designs.

4, on the basis of above-mentioned advantage, the present invention further includes having clamping in the clamping device in some embodiments Section and adaptive section, the adaptive section are less than the gripping section in the axial line side in the support force of the direction of axis line To support force, in some preferred embodiments, the adaptive section is subtracted the metal of power structure by wire or be provided with Bar is made, and in other preferred embodiments, the distal end or proximal end to the clamping device are arranged on the gripping section The bar or wave or the two of extension combine.The design of this structure is advantageous in that, by being provided with to described on the gripping section The bar or wave or the two combination that the distal end of clamping device or proximal end extend, increase the gripping section, valve sewing Contact area between section and the native valve increases frictional retaining force；Simultaneously as realizing the adaptive section in institute State direction of axis line support force be less than the gripping section in the support force of the direction of axis line, can be to avoid as described below Disadvantage: since the prosthese can be subjected to very high pressure difference percussion when in use, the prosthese is on direction of axis line Fine motion can be generated so that the free-end of the clamping device can constantly be hit with heartthrob native valve root, from Body annulus tissue and autologous tissue's wall, after being chronically implanted, above-mentioned position can gradually wear, rupture, and cause inflammation, complication Deng.The structure of the adaptive section is designed in this technology, it can be weakened under the premise of guaranteeing the gripping section fixed force In the support force of the direction of axis line, the damage to native valve root, self annulus tissue and autologous tissue's wall is reduced.

5, the present invention in some embodiments, is provided with court in its natural state on the proximal part of the clamping device The external structure opened or arched upward of the valve sewing section.It is used to treat bicuspid valve for the heart valve prosthesis to close Infull patient is closed, when the heart valve prosthesis is partially released, and the opening or the structure to arch upward are still limited, by In the shape that the structure is preset, after opening the free-end using lever principle, apart from the bracket axial line Distance can be bigger, the free-end is easier to be placed in the opposite side of the closing face of self mitral leaflet, meanwhile, when the knot After structure is released, the clamping device can restore to abut to part of it to the outer surface of valve sewing section, play folder Hold fixed effect.Simultaneously as this structure is arranged on the proximal part of the clamping device, it can be by itself and the valve Influence between film sewing section is reduced to minimum, and making it not influences the support force and structure of the valve sewing section.

6, in some embodiments, the corresponding valve in non-perspective plane of the valve sewing section sews section to the present invention Retaining structure is provided in region, one end of the retaining structure is fixedly connected with valve sewing section, the retaining structure It is false in the heart valve towards the direction far from the axial line to valve sewing section outer bend, protrusion or opening After body is completely released, the retaining structure is placed in the annulus and ventricle intersection.On the one hand the position of the retaining structure Restriction is set to allow to the enhancing structure corresponding with the junctional area and be formed in gripping for the direction of axis line, The perivalvular leakage of the junctional area is prevented while increasing fixed force；On the other hand, when the artificial valve prosthese be used to treat When having the patient of leaflet calcification, since calcification is more hard, the position restriction of the retaining structure can make its not with the folder It holds device formation to interfere with each other, is hindered to fix by the calcified tissue.

7, the present invention in some embodiments, is provided in the atrium section and subtracts power structure, when the heart valve prosthesis When be used to treat mitral lesion, after it is completely released to target position, the power of the subtracting structure abuts described self two The corresponding annulus tissue of the frontal lobe of cusp and atrial tissue, due to the mitral annulus the frontal lobe a part with it is described Aorta part is close to the power of the subtracting structure can reduce the heart valve on the basis of not influencing the function of remaining atrium section Compressing of the film prosthese to aorta.

8, the present invention is in some embodiments, in its natural state, described each of on each clamping device of restriction Bending section enters the part in valve sewing segment mesh gap along the radial direction projection line segment length of valve sewing section Degree is less than or equal to 5mm, can prevent the bending section from influencing the fatigue and proper motion of the artificial valve.

Detailed description of the invention

Fig. 1 a-1t be heart valve prosthesis of the invention schematic diagram, wherein Fig. 1 a be heretofore described axial line, institute State the closing face of self mitral leaflet and radial direction, the inner surface and the institute of closing face opposite side, valve sewing section State the schematic diagram of outer surface；Fig. 1 b is the schematic diagram of heretofore described heart valve prosthesis；Fig. 1 c-1d is institute in the present invention The clamping device schematic diagram stated, wherein Fig. 1 d is the side view of Fig. 1 c；Fig. 1 e-1g is the effect of heretofore described bending section Schematic illustration；Fig. 1 h is another embodiment schematic diagram of the clamping device；Fig. 1 i-1k is clamping of the present invention dress The distal portions structural schematic diagram set；Fig. 1 l-1o is the schematic diagram of the present invention for being connected and fixed section and connection cooperation section, Middle Fig. 1 m is the side view of Fig. 1 l, and Fig. 1 o is the detail of construction of Fig. 1 n；Fig. 1 p- Fig. 1 t is the schematic diagram of the enhancing structure, Middle Fig. 1 s-1t is angle schematic diagram of the enhancing structure apart from the axial line distal direction.

Fig. 2 a-2f is that the heart valve prosthesis discharges process schematic.

Fig. 3 a-3i is clamping device fixed effect schematic diagram, and wherein Fig. 3 a is clamping effect in the prior art；Fig. 3 b is The clamping effect schematic diagram of one embodiment in the present invention；Fig. 3 c is Section X-X schematic diagram in Fig. 3 b；Fig. 3 d is of the invention The clamping effect schematic diagram of another embodiment；Fig. 3 e-3i is the clamping effect schematic diagram of other embodiments of the invention.

Fig. 4 a-4d is the cross section signal that heart valve prosthesis of the present invention fixes position on self bicuspid valve Figure.

Fig. 5 a-5j is other embodiment schematic diagrams in the present invention, and wherein Fig. 5 a is a kind of band clamping of the present invention The heart valve prosthesis embodiment schematic diagram of device；Fig. 5 b is another angle schematic diagram of Fig. 5 a, and the artificial valve is not shown Show；Fig. 5 c is that the atrium section and the valve sew section schematic diagram；Fig. 5 d is Fig. 5 a partial enlargement structural representation；Fig. 5 e is One embodiment schematic diagram of the clamping device；Fig. 5 f is one embodiment schematic diagram for being connected and fixed section；Fig. 5 g is One embodiment schematic diagram of the connection cooperation section；Fig. 5 h is connected and fixed end for described in and the connection cooperates section fixed Embodiment schematic diagram；Fig. 5 i-5j is one embodiment schematic diagram of the arcuate segment of the clamping device.

Fig. 6 a-6d is the embodiment schematic diagram of the retaining structure, and wherein Fig. 6 b-6d is some detent knots of partial enlargement The embodiment schematic diagram of structure.

Fig. 7 a-7i is some embodiment schematic diagrams for subtracting power structure and the enhancing structure, wherein Fig. 7 a and Fig. 7 b The respectively embodiment schematic diagram of different structure；Fig. 7 c is another angle schematic diagram of Fig. 7 b；Fig. 7 d is to subtract power described in Fig. 7 a The enlarged diagram of structure；Fig. 7 e-7h is the various embodiments schematic diagram for subtracting power structure；Fig. 7 i is the implementation of the enhancing structure It illustrates and is intended to.

Fig. 8 a-8g is other embodiment schematic diagrams of heart valve prosthesis of the invention, and wherein Fig. 8 a is with described Heave the structural schematic diagram of device；Fig. 8 b-8c is some embodiment schematic diagrams of the clamping device；Fig. 8 e-8f is the card Some embodiment schematic diagrams of bit architecture；Fig. 8 g is the auxiliary fixing structure embodiment schematic diagram.

Specific embodiment:

To make the objectives, technical solutions, and advantages of the present invention more comprehensible, right hereinafter, referring to the drawings and the embodiments, The present invention is further described.

Heretofore described distal end refers to one end far from the apex of the heart, and the proximal end refers to one end close to the apex of the heart.

Specific embodiment one:

When the heart valve prosthesis be used to treat mitral valve disease, Fig. 1 a shows left ventricle diagrammatic cross-section, Wherein, a1-a2 is the blood flow direction central axis that the valve sews section, the axial line of the also referred to as described valve sewing section, B1-b2 is the blood flow direction central axis of the clamping device, and a1-a2 is parallel with b1-b2, and face A is the self bicuspid valve valve The closing face of leaf, face B are the opposite side of the closing face of the self mitral leaflet, the cross section radial direction side of the valve sewing section To the radial direction of the referred to as described valve sewing section, the valve sewing section is interior table close to the circumferential surface of the axial line Face, the circumferential surface of the valve sewing section far from the axial line is outer surface.

In one embodiment of the invention, as shown in Figure 1 b, a kind of heart valve prosthesis 1000 with clamping device, packet Bracket 1100 and artificial valve 1200 are included, the bracket 1100 is made of marmem, including atrium section 1110, valve seam Section 1120 processed and two clamping devices 1130, the artificial valve 1200 are fixedly connected in the valve sewing section 1120, The axial line of the valve sewing section 1120 is a1-a2, and blood flow can be prevented by being also sewn in the valve sewing section 1120 By macromolecule or animal derived material (not shown), atrium section 1110 is with valve sewing section 1120 by shape Integrally cutting pre-setting forms memory alloy pipes, and the proximal end of the atrium section 1110 and the distal end of valve sewing section 1120 are solid Fixed connection, the atrium section 1110 are more than or equal to the valve in the projected area in the radial direction of valve sewing section 1120 Film sews radially projecting's area of section 1120, is sewn the height that can reduce or prevent blood flow to pass through in the atrium section 1110 Molecule or animal derived material are provided with enhancing structure 1112, the enhancing knot as illustrated in figure 1p in the atrium section 1110 Structure 1112 is the combination of wave or bar or both, and the proximal end of the enhancing structure 1112 is fixedly connected at the atrium section 1110 On, and be connected with the material sewing that can be used in reducing or blood flow is prevented to pass through, as shown in Fig. 1 l-1o, the valve seam It is provided on the proximal part of section 1120 processed and is connected and fixed section 1121, as illustrated in figure 1 c, the clamping device 1130 is remembered by shape Recall alloy cutting to be formed, connection cooperation section 1131, the valve are provided on the proximal part of the clamping device 1130 Sewing section 1120 and the clamping device 1130 are connected and fixed section 1121 described in and the connection cooperates section 1131 is fixed to connect It connecing, the distal end of the clamping device 1130 is free to be known as free-end 1133, as shown in figs. lb-1d, and in its natural state, the folder A part of device 1130 is held to abut to the outer surface of valve sewing section 1120, be provided on the clamping device 1130 to The few one curved bending section 1132 in inside to valve sewing section 1120, in its natural state, the bending section 1132 A part enter the valve sewing section 1120 grid-gap in, as shown in Fig. 1 d-1e, the bending section 1132 enter institute State valve sewing section grid-gap in part along the valve sewing section radial direction Projection Line Segment length L1 be less than or Equal to 5mm, prevent it from wearing the artificial valve.As shown in Figure 1 f, when the prosthese is partially compressed, the valve sewing The grid-gap of section 1120 is compressed, and the bending section 1132 is able to maintain curved shape under natural conditions at this time, described Bending section 1132 and valve sewing section 1120 the offseting in the radial direction in valve sewing section by compression section, by In the interaction force that this offsets, so that distance L2 of the free-end 1133 apart from the axial line a1-a2 increases, such as Fig. 1 g It is shown, it is compared compared with the structure design for not having bending section in technology, the free-end 1133 of clamping device is apart from the axial line The distance L3 of a1-a2 is less than L2, therefore design of the invention easily facilitates the free-end 1133 and is placed into self two point The opposite side of the closing face of valve leaflet, in the motion process of the heart of beating heart, clamping device of the invention can be adapted to more The transformation of the size and shape of the self annulus.After the heart valve prosthesis is completely released, the valve sews section The native leaflets and the self chordae tendineae being attached thereto are gripped together with the clamping device.At this point, institute in the present invention 1132 structure of bending section of description replys the structure in the grid-gap for entering valve sewing section 1120 for a portion.

In one embodiment, the clamping device 1130 is formed by marmem cutting, as shown in figure 1h, The free-end 1133 of the clamping device is fixed in its natural state, draw close towards the axial line a1-a2, so as to the trip Fixed force can be increased more against the outer surface of valve sewing section from end 1133.In another embodiment, the folder The bar surface for holding device 1130 is fixed covering terylene (not shown), can increase the clamping device 1130 and described self two Frictional force between cusp leaflet improves chucking power.In some embodiments, the clamping device 1130 is by marmem Silk is made, and the distal portions of the clamping device are fixed in its natural state, along the circumferential court of valve sewing section The clamping device blood flow direction central axis b1-b2 is collapsed, such as inverted V-shaped (as shown in figure 1i), inverted U-shaped (as shown in fig. ij) Or the shape of falling mastoid process (as shown in figure 1k), such structure design can be convenient for being partially compressed in the heart valve prosthesis When, the distal portions of the clamping device 1130 have the length of the lesser circumferential direction along valve sewing section, make The free-end 1133 for obtaining the clamping device is more easier to enter described across the intensive staggered self chordae tendineae of mitral valve The opposite side of the closing face of self mitral leaflet, convenient for after the heart valve prosthesis is completely released, the valve is sewed Section and the clamping device together grip the self mitral leaflet and the self chordae tendineae of mitral valve being attached thereto, and subtract Few operating time and the injury to autologous tissue can also wrap on the distal portions of the clamping device in order not to injury tissue It is wrapped with soft macromolecule or animal derived material.

In one embodiment, described to be connected and fixed section 1121 and connection cooperation 1131 weight of section as shown in Fig. 1 l-1m Folded, added metal casing 1122 grips, and the valve sewing section and the clamping device are connected and fixed section described in 1121 are fixedly connected with connection cooperation section 1131, this kind of overlap mode fixation is advantageous in that, when the heart valve is false When body is partially compressed, after the free-end of the clamping device opens, the distance apart from the axial line is bigger, easily facilitates institute State the opposite side that free-end is placed in the closing face of the self mitral leaflet.In another embodiment, such as Fig. 1 n-1o institute Show, it is described be connected and fixed section 1121 and the connection cooperation section 1131 inlay cooperation, added metal casing 1122 grips, this Kind mode fixation is advantageous in that, can be reduced the artificial valve prosthese by compressed diameter, be reduced delivery sheath diameter. As shown in Fig. 1 p-1q, maximum value of the atrium section 1110 in the Projection Line Segment length of the radial direction of valve sewing section Projection Line Segment length greater than the enhancing structure 1112 in the radial direction of valve sewing section, the enhancing structure 1112 For wave (as illustrated in figure 1p) or bar (as shown in Fig. 1 q), the proximal end of the enhancing structure 1112 and the fixed company of atrium section 1110 It connects.It is in another embodiment, described in order to reduce the sizing difficulty and tired risk of marmem as shown in Fig. 1 r Enhancing structure 1112 is made of shape-memory alloy wire, is connected in the atrium section 1110 by coiling, or be fixedly connected It is fixedly connected on the material for reducing or preventing blood to flow through sewed in the atrium section and then with the atrium section (not shown).As shown in Fig. 1 s-1t, the atrium section has the shape and angle of scheduled type, in its natural state, the increasing External the opening of strong structure 1112 and the not connected one end of atrium section 1110 to valve sewing section 1120, this end it is remote End part is more than or equal to the heart adjacent with the enhancing structure 1112 with the angle [alpha] that the axial line a1-a2 distal direction is formed The maximum value for the angle beta that the distal portions of room section and the axial line a1-a2 distal direction are formed, in another embodiment, Angle [alpha] is greater than 90 °.This kind of angle setting enables to the enhancing structure 1112 more to compress for reducing or preventing blood stream Perhaps animal derived material prevents or reduces its fine motion generated with the flowing of blood to the macromolecule crossed, to more step up The autologous tissue contacted therewith is pasted, the perivalvular leakage phenomenon at this is reduced.After the heart valve prosthesis is completely released, institute The distal portions of 1110 parts of the self corresponding atrium section of mitral frontal lobe are stated apart from the axial line a1-a2 far end party To angle revert to the γ angle of scheduled type, the γ angle is arranged to acute angle, and is less than β angle, more adapts to Physiological structure angle at the corresponding atrium of the self mitral anterior lobe, make the atrium section 1110 more adapt to it is described from The irregular shape organized at the nearly atrium of body bicuspid valve, and further ensure to reduce the heart valve prosthesis simultaneously to described The influence of aorta petal tissue physiology structure, here it is seen that only between the enhancing structure 1112 and atrium section 1110 Vertical structure setting, can enable the heart valve prosthesis to be equipped with different α, β and γ angles, can meet respectively The physiology and appearance of the autologous tissue and the requirement for reducing perivalvular leakage.Further, in order to reserve more design margins and subtract Few fatigue risk, since the fixed form of heretofore described heart valve prosthesis clamping leaflet enables to self two point Valve leaflet forms with adjacent left ventricular wall after clamped fix and naturally stops sinus, play the role of preventing perivalvular leakage；But It is, due to not forming the blocking sinus, to have higher perivalvular leakage risk, therefore this hair in the self mitral commissure area The position of the bright enhancing structure 1112 is set here, after the heart valve prosthesis is completely released to target position, The enhancing structure and the material for reducing or preventing blood to flow through abut self mitral preceding friendship together The corresponding annulus tissue in battery limit (BL) and rear junctional area and/or atrial tissue.

Specific embodiment two:

In order to preferably illustrate the working principle of the invention, it will gradually illustrate artificial valve prosthese of the present invention below Release process:

As shown in Figure 2 a, when the heart valve prosthesis be used to treat mitral valve disease, the heart valve prosthesis By transportation system 2300 from apex of the heart approach.As shown in Figure 2 b, the transportation system 2300 includes handle 2310, outer sheath 2320 The clamping device being placed in the outer sheath 2320 is discharged by operating the handle 2310 with interior sheath 2330 1130, in the present embodiment, the quantity of the clamping device 1130 is one, at this point, the bracket and the artificial valve still by It is partly or completely compressed in the interior sheath 2330.As shown in Fig. 2 c-2d, the free-end of the clamping device 1130 1133 inside far from the bracket are opened to the external of the bracket, and shape is at α angle, described due to the presence of the bending section After free-end 1133 opens, α angle can be bigger, easily facilitates the free-end 1133 and is placed in the self mitral leaflet Closing face the opposite side face B, enable the operation in the motion process of the heart of beating heart, more adapt to it is self two point The transformation of the size and shape of valve annulus reduces operating time, increases surgical facilitation；In another embodiment, such as Fig. 2 e Shown, 1130 quantity of clamping device is two, described two free-ends 1133 be respectively disposed in it is described it is self it is mitral before The face B of leaf and rear leaf；As shown in figure 2f, by continuing to move to the interior sheath 2330, the bracket 1100, phase are further discharged Between cooperate the movement of the transportation system 2300 so that the atrium section is tight when the heart valve prosthesis is completely released Paste the self mitral annulus and left atrial tissue thereon, the valve sewing section 1120 and the clamping device 1,130 1 It rises and grips the self mitral leaflet and/or self chordae tendineae of mitral valve, the artificial valve replaces the self valve Film realizes valve opening and closing function.

In the prior art, as shown in Figure 3a, by taking self mitral frontal lobe 2400 as an example, when the heart valve prosthesis Completely after release, be clamped in the frontal lobe 2400 is flat between the clamping device 1130 and the bracket, only by this three Frictional force between person is fixed, and fixed effect is loosely.The clamping effect of heretofore described one embodiment such as Fig. 3 b- Shown in 3c, in its natural state, Xiang Suoshu valve sews the inside bending of section 1120 to the bending section 1132, and a part enters institute In the grid-gap for stating valve sewing section 1120, the grid of section 1120 is sewed together using the bending section 1132 and the valve The self mitral leaflet 2400 and/or self chordae tendineae of mitral valve 2410 are gripped, sew section in the valve Cross-sectional direction on, due to the bending section 1132 a part enter the valve sewing section 1120 grid-gap in, So that the bending section 1132 is different with the distance of grid rods to the axial line a1-a2 of valve sewing section 1120, from And make on circumferential direction (direction F1), axial (a1-a2) and radial (direction F2) three directions that the valve sews section, joint The self mitral leaflet 2400 and/or self chordae tendineae of mitral valve 2410 are fixed, so that fixed form in the present invention Fixed force and firmness be much better than the method for clamping in traditional technology.Further, the mode of such dislocation clamping, can Reduce the self mitral leaflet to block the blood flow of the left ventricular outflow tract, is able to solve present in the prior art and lacks It falls into.In order to further increase holding area and firm grip degree, in further embodiments, the clamping device further includes Gripping section, one end of the gripping section are fixedly connected with one end of the connection cooperation section, as shown in Figure 3d, are filled in the clamping It sets and is additionally provided with bar 1134 on 1130 gripping section, the bar 1134 extends to the distal end of the clamping device 1130；For another example scheme Shown in 3e-3f, it is provided with bar 1134 on the gripping section of the clamping device 1130, the bar 1134 is to the clamping device 1130 proximal end extends；For another example it shown in Fig. 3 g-3h, is additionally provided on the bar 1134 curved to the inside of valve sewing section Bent bending section 1135, the design of these structures can more press clamped object.As shown in figure 3i, in some embodiments In, the clamping device further includes gripping section and adaptive section, one end of one end of the gripping section and the connection cooperation section One cutting is fixedly connected, by being worked out by shape-memory alloy wire of extending of oriented its distal end of coiling on the gripping section Wave, the adaptive section are located at the distal end of the gripping section, are also wave, by thinner sub-thread shape-memory alloy wire coiling At the adaptive section coiling, which is connected on the distal portions of the gripping section or is sewn, is being covered on the clamping device On high molecular material on, the distal end of the adaptive section is the free-end, and the adaptive section is more soft, so as not to damage The evil mitral annulus tissue, the wave 1137 positioned at the 1130 middle section part of clamping device is by multiple thread strands or thicker silk It is made, it is harder, enhance the chucking power of the 1130 middle section part of clamping device.Macromolecule is sewed on the clamping device 1130 Material increases chucking power.In another embodiment, the heart valve prosthesis (is not shown by transportation system from atrium approach Show).

In one embodiment, the quantity of the clamping device 1130 is two, when the heart valve prosthesis discharges completely Afterwards, as shown in fig. 4 a, described two clamping devices 1130 fix self mitral frontal lobe and rear leaf respectively, it is fixed described in The blood flow direction central axis b1-b2 of the clamping device of self mitral frontal lobe is flat in self mitral frontal lobe Projection on face is located on described self two sharp frontal lobes, and divides self mitral frontal lobe equally；Fixed self two point Throwing of the blood flow direction central axis b1-b2 of the clamping device of the rear leaf of valve in self mitral rear leaf plane Shadow is located in the self mitral valve, and divides self mitral rear leaf equally.In another embodiment, the folder The quantity for holding device 1130 is one, after the heart valve prosthesis discharges completely, as shown in Figure 4 b, the clamping device 1130 For fixing self mitral frontal lobe.In another embodiment, the quantity of the clamping device 1130 is three, works as institute It states after heart valve prosthesis discharges completely, as illustrated in fig. 4 c, fixed self two point of one of them described clamping device 1130 The frontal lobe of valve, and projection of its blood flow direction central axis b1-b2 in the self mitral anterior lobe plane be located at it is described from On the mitral frontal lobe of body, divide the self mitral anterior lobe equally, other two described clamping device 1130 is fixed self respectively Mitral junctional area is symmetric along valve sewing section circumferential direction using the axial line a1-a2 as symmetry axis.? In another embodiment, the quantity of the clamping device 1130 is three, after the prosthese discharges completely, as shown in figure 4d, In the fixed self mitral frontal lobe of the clamping device 1130, and its blood flow direction central axis b1-b2 is in institute It states the projection in self mitral frontal lobe plane to be located on described self two sharp frontal lobes, divides the self mitral anterior lobe equally, The fixed self mitral rear leaf of other two described clamping device 1130, three clamping devices 1130 are along the valve It is circumferentially symmetrical that film sews section circumferential direction.

Specific embodiment three:

In one embodiment of the invention, as shown in Fig. 5 a-5b, a kind of heart valve prosthesis with clamping device 1000, including bracket 1100 and artificial valve 1200, the bracket 1100 be made of marmem, including atrium section 1110, valve sewing section 1120 and two clamping devices 1130, the artificial valve 1200 are fixedly connected at the valve seam In section 1120 processed, the axial line a1-a2 of the valve sewing section 1120 is as shown in Figure 5 a, the atrium section 1110 and the valve Sewing section 1120 is integrally cut, and the proximal end of the atrium section 1110 is connect with the distal end of valve sewing section 1120, institute It states and is sewn the macromolecule that can reduce or prevent blood flow to pass through or animal derived material (not shown) in atrium section 1110, External opening of the atrium section 1110 to valve sewing section, the atrium section 1110 is in valve sewing section 1120 Projected area in the radial direction is greater than radially projecting's area of valve sewing section 1120, the distal end of the atrium section 1110 It is drawn close towards the axial line a1-a2, in order to avoid damaging the atrial tissue, is provided with enhancing structure in the atrium section 1110 1112, the enhancing structure 1112 is wave, and proximal end is fixedly connected in the atrium section 1110, in its natural state, institute State external opening of the distal end of enhancing structure 1112 to valve sewing section 1120, distalmost end and the axial line a1-a2 The angle that is formed of distal direction be greater than adjacent with the enhancing structure 1112 atrium section 1110 and axial line a1- The maximum value for the angle that a2 distal direction is formed, after the artificial valve prosthese 1000 is completely released to target position, institute State enhancing structure 1112 and the material for reducing or preventing blood to flow through abut together the self annulus tissue and/ Or atrial tissue, it is provided on the proximal part of valve sewing section 1120 and is connected and fixed section.The clamping device 1130 by Shape-memory alloy wire is formed, and connection cooperation section, the valve are provided on the proximal part of the clamping device 1130 Section is connected and fixed described in the clamping device 1130 for sewing section 1120 and the connection cooperates section to be fixedly connected, the folder Hold device 1130 distal end it is free be known as free-end 1133, in its natural state, a part of the clamping device 1130 is to institute The outer surface for stating valve sewing section 1120 abuts, and there are two sew to the valve for setting on each described clamping device 1130 The curved bending section 1132 in inside of section 1120, a part of the bending section 1132 enter the net of valve sewing section 1120 In lattice gap, the proximal part of the clamping device 1130 is additionally provided with the external knot opened towards valve sewing section 1120 Structure 1136, during the heart valve prosthesis is conveyed and discharged by the transportation system, when the heart valve prosthesis quilt A part release, when the structure 1136 of the opening of the clamping device is still limited by the transportation system, due to the opening The shape for the opening that structure 1136 is preset, the effect based on lever principle, α angle as shown in Figure 2 c can be bigger, described Free-end is easier to be placed in the opposite side of the closing face of the self mitral leaflet, meanwhile, when the structure 1136 of the opening After being released, the clamping device can restore to abut to part of it to the outer surface of valve sewing section.Such as Fig. 5 c institute Show, the proximal part of the valve sewing section 1120 has together with the proximal part of the clamping device 1130 towards the valve The external structure 1123 opened of section is sewed, so that under natural conditions, the valve sewing section does not influence the clamping device Opening degree.As fig 5d, the structure 1136 of the opening of the clamping device can be used as the pull head of the heart valve prosthesis, For being detachably connected the transportation system and the heart valve prosthesis.In another embodiment, as depicted in fig. 5e, described The proximal part of clamping device 1130 is provided with the structure 1136 to arch upward towards the outside of valve sewing section 1120, so that described While valve sewing section does not influence the opening degree of the clamping device, the proximal end of the clamping device is leaned on towards the axial line Hold together, damages adjacent heart tissue to prevent it.As shown in figure 5f, the section 1121 that is connected and fixed is designed to be cut with limited step, As shown in fig. 5g, it is to be connected and fixed the adaptable limited step of section 1121 with described that the clamping device 1130, which is scheduled type, such as It is described to be connected and fixed after section 1121 and the clamping device 1130 be overlapped shown in Fig. 5 h, pass through described sleeve pipe 1122 and clamps detent Step is fixed.As shown in Fig. 5 b and 5h, it is additionally provided with arcuate segment 1137 in the distal end of the structure 1136 of the opening, in natural shape Under state, the blood flow direction central axis b1-b2 of the arcuate segment 1137 towards the clamping device 1130 is bent, the arcuate segment 1137 be arc or fold-line-shaped, on the one hand can be as the step of fixed described sleeve pipe 1122, another aspect, such as Fig. 5 i institute Show, when the artificial valve prosthese is partially compressed, the arcuate segment 1137 is in the circumferential direction side of valve sewing section 1120 It offsets upwards, under the mating reaction of the transportation system 2300 as shown in figure 5j, the bar of the clamping device does not interlock, no Overlapping, maintains preferable form, and reduce the size of the outer sheath.In further embodiments, the clamping device surface Film, to increase chucking power (not shown).

As shown in Figure 5 b, in the present embodiment, a part of the clamping device 1130 is in its natural state to the valve The outer surface of film sewing section 1120 abuts, and the clamping device 1130 abuts against the outer surface part of the valve sewing section 1120 It is projected in the face formed on the outer surface of the valve sewing section 1120 and is known as perspective plane 1500, as shown in Figure 6 a, in the valve It is non-perspective plane that film, which sews other regions on the outer surface of section 1120, and the corresponding valve in the non-perspective plane sews section In 1120 regions, it is provided with and retaining structure 1124 made of the 1120 one cutting sizing of valve sewing section, the detent The both ends of structure 1124 are fixedly connected with valve sewing section 1120, and in its natural state, the retaining structure 1124 is separate The axial line a1-a2 sews the outer projection of section 1120 to the valve, when the heart valve prosthesis is released to target When position, the retaining structure 1124 works close to the ventricular side of the autologous tissue 3420 with the atrium section 1110, It is fixed in the detent that is proximally and distally further formed of the annulus tissue 3420, thus reach more firm fixation, so that The heart valve prosthesis 1000 will not be shaken due to atrium and ventricle pressure difference in target position during heart movement, Reduce perivalvular leakage.In another embodiment, the quantity of the retaining structure is four or two.In another embodiment, such as Shown in Fig. 6 b, the distal end of the retaining structure 1124 is fixedly connected with valve sewing section 1120, the retaining structure 1124 Proximal end it is free.In another embodiment, as fig. 6 c, the retaining structure 1124 proximally and distally all with the valve Film sewing section 1120 is fixedly connected, and the middle section part of the retaining structure 1124 is truncated.In another embodiment, such as Fig. 6 d Shown, the distal end of the retaining structure 1124 is free, and the proximal end of the retaining structure 1124 and valve sewing section 1120 are solid Fixed connection.

In further embodiments, in the region on the corresponding perspective plane 1500 of valve sewing section 1120, may be used also It is provided with hangnail or arches upward, to increase chucking power.

Specific embodiment four:

When the heart valve prosthesis be used to treat mitral valve disease, since the self anterior mitral valve is close to main Arterial valve, in order to reduce influence of the heart valve prosthesis to aorta petal tissue physiology structure, of the invention one In a embodiment, as shown in Fig. 7 a and 7d, the atrium section 1110 is connected waveform configuration, is set in the atrium section 1110 It is equipped with and subtracts power structure 1111, in its natural state, the power of the subtracting structure 1111 is corresponding against self mitral frontal lobe Annulus tissue and/or atrial tissue, the power of the subtracting structure 1111 is by cutting S-shaped structure system on the bar of the atrium section 1110 At so that the support force of bar weakens compared with adjacent stems herein.In another embodiment, as shown in Fig. 7 b-7c, the atrium section 1110 be independent rod structure, is provided in the atrium section 1110 and subtracts power structure 1111, and in the distal end of the independent bar It is provided with and subtracts power structure 1111, the power of the subtracting structure is that S-shaped cuts structure.In further embodiments, the power of the subtracting structure is Bow character form structure (Fig. 7 e), zigzag structure (Fig. 7 f), notching construction (Fig. 7 g), open-celled structure (Fig. 7 h) and variable-diameter structure are (not One or more of display).In another embodiment of the present invention, as shown in Fig. 7 b and Fig. 7 i, due to the atrium Section 1110 is independent rod structure, and be equipped with it is described subtract power structure 1111, in order to enhance the integral strength of the atrium section, prevent Only perivalvular leakage is provided with enhancing structure 1112 at two in atrium section 1110 as shown in Figure 7b, in its natural state at two Enhancing structure 1112 is close to the macromolecule that blood flow can be prevented to pass through or animal derived material being sewn in the atrium section Material, to be close to atrial surface and the atrium of self mitral preceding junctional area and the corresponding annulus tissue in rear junctional area respectively Tissue, or as shown in figure 7i, the corresponding annulus tissue of the frontal lobe mitral self and/or atrium sinistrum are abutted in addition to described Tissue subtracts outside power structure 1111, is both provided with the enhancing structure 1112 at other circumferential directions of the atrium section 1110.

Specific embodiment five:

In one embodiment of the invention, as shown in Figure 8 a, a kind of heart valve prosthesis 1000 with clamping device, packet Bracket 1100 and artificial valve 1200 are included, the atrium section 1110 is independent bar, and what is be sewn thereon can prevent blood flow from passing through Macromolecule or animal derived material (not shown), be provided with enhancing structure 1112, the enhancing in atrium section 1110 Structure 1112 is wave, and proximal end is fixedly connected in the atrium section 1110, has been sewn in the valve sewing section 1120 The macromolecule that blood flow can be prevented to pass through or animal derived material (not shown), exist with the difference of specific embodiment one In being provided with one on the heart valve prosthesis 1000 and heave device 1600, be located at atrium section 1110 and the valve Sew the circumferential exterior surface of the intersection of section 1120, the branch heaved device 1600 and sew the radial direction of section in the valve Support force is less than the radial support power of valve sewing section, and in one embodiment, the device of heaving is pouch-shaped, and inside is filled out Elasticity or self-expanding material are filled, in another embodiment, the device 1600 of heaving serves as bone by shape-memory alloy wire Frame, the outside of the skeleton towards valve sewing section 1120 is arched upward or is opened, skeleton surface quilt in its natural state Overlay film, the film are made of animal tissue or terylene, polytetrafluoroethylene (PTFE), polyurethane or silica gel.It is false in the heart valve Body is completely released when being fixed to target position, and the ventricular side heaved device 1600 and abut the self annulus tissue subtracts The probability of few perivalvular leakage, meanwhile, the device of heaving can also reduce the model for being implanted object, so that when the heart valve is false When body is applied to treatment mitral valve disease, the model of the valve sewing section can be smaller, has lesser radial diameter, from And make valve sewing section close to the self front leaflet and left ventricular outflow tract partial distance left ventricular outflow tract compared with Far, the biggish left ventricular outflow tract area in vacant place reduces the blocking to left ventricular outflow tract, prevents from hindering normal blood flow power It learns, and the device of heaving can be set to have elasticity or toughness, it is certain in valve sewing section having Radial direction support force while, and there is certain radial flexibility so that its have can adapt to it is described self While mitral annulus irregular shape, the form of the valve sewing section is not influenced, maintains the normal of the artificial valve It closes.In another embodiment, the device quantity of heaving is three, is fixed on the atrium section and valve seam respectively The circumferential exterior surface of the intersection of section processed, and it is corresponding respectively against the junctional area and/or its of the native valve in the circumferential Annulus tissue plays the role of preventing the junctional area perivalvular leakage.In another embodiment, the device quantity of heaving is Two, it is fixed on the circumferential exterior surface of the intersection of the atrium section and valve sewing section respectively, and distinguish in the circumferential Against self mitral junctional area and/or its corresponding annulus tissue, the work for preventing the junctional area perivalvular leakage is played With.

It in order to increase fixed force, is also differ in that with specific embodiment one, as shown in Figure 8 b, in addition to described every It is provided on each bar of one clamping device 1130 outside the bending section 1132, in the every of the clamping device 1130 Distal portions on one bar are additionally provided with a curved bending section 1138 in inside to valve sewing section, to increase folder Hold fixed force and stability.In another embodiment, as shown in Figure 8 c, the clamping device 1130 is by marmem pipe Cutting is formed, and the distal portions on each bar of the clamping device 1130 are additionally provided with hangnail 1139, increases folder Fixed force and stability are held, it is in another embodiment, as shown in figure 8d, described in order to reduce the tired risk of cutting sizing Bending section 1132 is made of marmem pipe.

Likewise, in order to increase fixed force, with specific embodiment three the difference is that, as shown in Fig. 8 e-8f, in institute It states and is additionally provided with hangnail 1125 on retaining structure 1124, the hangnail is located at the outer surface of the retaining structure 1124, Xiang Suoshu Valve sews the external of section and opens.

For the patient of mitral stenosis, when the self mitral leaflet and/or the self mitral annulus are serious When calcification, the clamping device role is limited, at this point, in another embodiment, as illustrated in fig.8g, the heart valve Auxiliary fixing device 1700 is connected on film prosthese 1000, the auxiliary fixing device 1700 is made of line or silk, when described Heart valve prosthesis 1000 is completely released to target position, and the proximal part 1710 of the auxiliary fixing device 1700 is connected The proximal end for being fixed on heart of patient is connect, fixed effect is on the one hand played, on the other hand, when adjusting its length, is adjustable institute State the closeness of contact of heart valve prosthesis 1000 Yu the target position.

Technology of the invention can be applicable to the patient for the treatment of tricuspid disease.

Finally it should be noted that the foregoing is merely preferred embodiments of the invention, not to limit this Invention, any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in this hair Within bright protection scope.

Claims

1. a kind of heart valve prosthesis with clamping device, including bracket and artificial valve, which is characterized in that the bracket includes Atrium section, valve sewing section and at least one clamping device, the artificial valve are fixedly connected in the valve sewing section, The central axis of the blood flow direction of the valve sewing section is referred to as the axial line of the valve sewing section, and the valve sews section Cross section radial direction be referred to as the radial direction of valve sewing section, the valve sewing section is close to the axial line Circumferential surface is inner surface, and the circumferential surface of the valve sewing section far from the axial line is outer surface, the proximal end of the atrium section It is fixedly connected with the distal end of valve sewing section, the atrium section is on the perspective plane in the radial direction of valve sewing section Product is greater than or equal to radially projecting's area of valve sewing section, is provided with connection on the proximal part of the valve sewing section Fixed section is provided with connection cooperation section, the valve sewing section and the clamping device on the proximal part of the clamping device It is connected and fixed section and the connection by described section is cooperated to be fixedly connected, be additionally provided on the proximal part of the clamping device Under natural conditions towards the curved arcuate segment of blood flow direction central axis of the clamping device, the distal end of the clamping device is free Referred to as free-end, under natural conditions, a part of the clamping device are abutted to the outer surface of valve sewing section, the folder The curved bending section in inside that at least one is provided on device to valve sewing section is held, it is in its natural state, described curved A part of tune enters in the grid-gap of valve sewing section.

2. a kind of heart valve prosthesis with clamping device according to claim 1, which is characterized in that in the atrium section It is provided with enhancing structure, one end of the enhancing structure is fixedly connected in the atrium section or is fixedly connected at and institute State the material for reducing or preventing blood to flow through that atrium section is fixedly connected, in its natural state, the enhancing structure External opening of the other end to valve sewing section, after the heart valve prosthesis is completely released to target position, The enhancing structure and the material abut self annulus tissue and/or atrial tissue together.

3. a kind of heart valve prosthesis with clamping device according to claim 2, which is characterized in that the enhancing structure The other end the angle that is formed of distalmost end and the axial line distal direction be greater than or equal to it is adjacent with the enhancing structure The maximum value for the angle that the atrium section is formed with the axial line distal direction.

4. a kind of heart valve prosthesis with clamping device according to claim 2, which is characterized in that the atrium section exists The maximum value of the Projection Line Segment length of the radial direction of the valve sewing section is greater than the enhancing structure and sews in the valve The Projection Line Segment length of the radial direction of section.

5. a kind of heart valve prosthesis with clamping device according to claim 2, which is characterized in that the enhancing structure For the combination of wave or bar or both, the proximal end of the enhancing structure is fixedly connected in the atrium section, the enhancing structure It is arranged on the material for reducing or preventing blood to flow through being fixedly connected with the atrium section, when the heart valve Prosthese is completely released to target position, and the junctional area that the enhancing structure and the material abut native valve together is corresponding Annulus tissue atrial surface and atrial tissue position.

6. a kind of heart valve prosthesis with clamping device according to claim 1, which is characterized in that the clamping device Proximal part on be provided in its natural state towards opening outside valve sewing section or the structure that arches upward.

7. a kind of heart valve prosthesis with clamping device according to claim 6, which is characterized in that in nature Under, the proximal part of valve sewing section has together with the proximal part of the clamping device with equal angular towards the valve The external structure opened or arched upward of film sewing section, so that under natural conditions, the valve sewing section does not influence the clamping The opening of device or the degree that arches upward.

8. a kind of heart valve prosthesis with clamping device according to claim 1, which is characterized in that in nature Under, a part of the clamping device is abutted to the outer surface of valve sewing section, and the clamping device abuts against the valve The face formed on the outer surface for being projected in the valve sewing section of the outer surface part of film sewing section is known as perspective plane, the valve Other regions that film sews the outer surface of section are non-perspective plane, in the region of the corresponding valve sewing section in the non-perspective plane It is inside provided with retaining structure, one end of the retaining structure is fixedly connected with valve sewing section, in its natural state, described Retaining structure sews section outer bend, protrusion or opening towards the direction far from the axial line to the valve.

9. a kind of heart valve prosthesis with clamping device according to claim 1, which is characterized in that the clamping device Further include gripping section and adaptive section, one end of the gripping section is fixedly connected with one end of the connection cooperation section, it is described from Section is adapted to be fixedly connected with the gripping section, one end of the adaptive section is the free-end, under natural conditions, the folder Section to be held to draw close to the outer surface of valve sewing section, the bending section on the clamping device is arranged on the gripping section, The adaptive section the direction of axis line support force be less than the gripping section the direction of axis line support force, when After the heart valve prosthesis is released into target position, the clamping device plays fixed function.

10. a kind of heart valve prosthesis with clamping device according to claim 1, which is characterized in that when the heart When valve prosthesis be used to treat mitral lesion, the bracket includes atrium section, valve sewing section and two clamping devices, when The heart valve prosthesis is completely released to target position, described two clamping devices respectively it is fixed self it is mitral before Leaf and rear leaf, the blood flow direction central axis of the clamping device of fixed self mitral frontal lobe is described self two Projection in the frontal lobe plane of cusp is located in the self mitral anterior lobe, fixes the described of self mitral rear leaf Projection of the blood flow direction central axis of clamping device in the self rear leaf plane is located in the self mitral valve.

11. a kind of heart valve prosthesis with clamping device according to claim 1, which is characterized in that in nature Under, the part that the bending section on the clamping device enters in the grid-gap of valve sewing section is stitched along the valve The radial direction Projection Line Segment length of section processed is less than or equal to 5mm.

12. a kind of heart valve prosthesis with clamping device according to claim 1, which is characterized in that in nature Under, the proximal end of the clamping device is drawn close towards the axial line, prevents injury of myocardium tissue in its natural state.

13. a kind of heart valve prosthesis with clamping device according to claim 1, which is characterized in that when the heart It when valve prosthesis be used to treat mitral lesion, is provided in the atrium section and subtracts power structure, when the heart valve is false Body is completely released to target position, the power of the subtracting structure against the corresponding annulus tissue of self mitral frontal lobe and/or Atrial tissue, the power of the subtracting structure include the variable-diameter structure being arranged on the bar of the bracket, S-shaped structure, bow character form structure, saw One or more of tooth-shape structure, notching construction and open-celled structure, to reduce the compressing to aorta.