CN106420114B - A kind of heart valve prosthesis - Google Patents
A kind of heart valve prosthesis Download PDFInfo
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- CN106420114B CN106420114B CN201610921112.XA CN201610921112A CN106420114B CN 106420114 B CN106420114 B CN 106420114B CN 201610921112 A CN201610921112 A CN 201610921112A CN 106420114 B CN106420114 B CN 106420114B
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
- A61F2/2448—D-shaped rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The present invention relates to a kind of heart valve prosthesis,Including stent and artificial valve,The stent includes atrium section and valve sews section,The artificial valve is fixedly connected in the valve sewing section,The skeleton of the distal portions of the valve sewing section extends to form supporting section,The supporting section is structure as a whole with valve sewing section,One end of the atrium section is connect with the distal end of the supporting section,Another end dissociative of the atrium section,On the cross section of the artificial valve central axes,The valve sewing section is located in the supporting section,The center and the center of the supporting section of the valve sewing section are misaligned,The cross-sectional area of the supporting section is more than the cross-sectional area of valve sewing section,The cross-sectional area of the atrium section is more than the cross-sectional area of the supporting section,The cross-sectional area of the valve sewing section is less than the cross-sectional area of autologous patient valve annulus,In free state, the supporting section is at least partially disposed between autologous patient annulus.
Description
Technical field：
The invention belongs to medical instruments fields, and in particular to a kind of heart valve prosthesis.
Background technology：
Mitral position is made of annulus, leaflet, chordae tendineae, papillary muscle, five parts of connection that have a common boundary, is solving in left atrioventricular orifice
It is Mitral valve structure (mitral apparatus) or mitral complex (mitral to cut open the exact name on learning
complex).Annulus of mitral valve is the fibroid taeniae telarum for being attached to left room room bore edges, for irregular " D " shape shape, bicuspid valve
Continuous part of preceding 1/3rd of annulus for preceding valve and aorta, the corresponding atrium of front and rear valve are formed with mitral annulus
Angle it is also different, also have the attachment of left auricle of heart at atrium.Mitral valve function is not all one of most common heart disease, such as two
Bicuspid valve caused by mitral valve insufficiency caused by mitral valve prolapse illness, such as valve lesions caused by rheumatic inflammation is narrow
It is narrow etc..
Mitral valve insufficiency can be divided into three kinds of functional, degeneration or Combination.Most commonly degeneration and work(
It can property mitral valve insufficiency.Functionality is generally damaged secondary to left ventricular wall motion function, left ventricular dilatation, nipple muscular function are different
Often, it is generally found from heart failure patient.This part patient also includes the ischemic mitral regurgitation secondary to coronary heart disease
And the mitral valve insufficiency that Nonischemic cardiolmyopathy is related.Degeneration mitral regurgitation disease is generally considered to be valve structure
Pathologic variation occurs or valve lower structure pathology sexually revises, abnormal extension or fracture including chordae tendineae.
Mitral stenosis is most common type in rheumatic heart valve disease, wherein 40% patient is pure bicuspid valve
It is narrow.Due to the rheumatic fever that repeated, early stage bicuspid valve is at valve commissure and its basal part oedema, inflammation and neoplasm
Based on (exudate) is formed, the later stage gradually forms front and rear valve in agglutination since fibrinous deposition and fibroid become
The adhesion of leaf intersection, fusion, valve thickens, is coarse, hardening, calcification and chordae tendineae shortens and stick to each other, limitation valve activity
Ability and opening cause valve stenostomia.Other rare causes of disease include calcification, congenital stenosis and knot under senile annulus of mitral valve or ring
Form tissue disease etc..
The traditional treatment means of mitral valve disease include being suitable for slightly to the drug therapy of severe reflux and having corresponding
The surgical method of surgical indication.Wherein, surgical method further includes mitral valve replacement and mitral valve repair.In surgery hand
In art method, it is invasive excessive typically to open chest, open heart operation, needs to establish extracorporal circulatory system, and there is higher complication to occur
Rate and infection risk.Patient it is many it is resistance to can't stand huge surgery risk and can only helpless waiting for death.In order to reduce operation wind
Danger, displacement and repairing operation method through intubation intervention are developed.
For treatment skill of the bicuspid valve through intubation intervention, though there are a small number of products through intubation intervention mitral valve at present
It is applied on forming and neoplasty, but in terms of through intubation intervention mitral valve replacement, there has been no ripe productions in the world
Product come out.Nevertheless, numerous percutaneous intervention mitral valve replacement technologies are still presented on everybody at the moment one after another, these technologies are most
It is in zoopery or clinic trial, respective technology has respective limitation.
Patent CN102639179B and patent US8449599 describes one kind two of Edwards Lifesciences companies
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, including flowing through chamber therein, atrial end and the heart 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 fixing piece of body exterior is stated, the fixing piece is connected with the main body, and expansion is in work as the main body
During state, at least one fixing piece is configured as hooking around native leaflet, at least one fixing piece and described
Leaflet-reception space is limited between main body；The annular flange portion to extend radially outwardly with the atrial end from the main body, it is described
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 fixing piece 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 medial surface of the lateral surface of channel and the anchoring device, cause fixed firmness place one's entire reliance upon the fixing piece 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 should be in this period from left ventricle stream
The blood flow for entering 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.
Patent CN201180020556 describes a mitral of Medtronic companies, which includes having
Downstream part and the inner supporting structure of upstream portion, wherein, the upstream portion has the cross section more than the downstream part
Area, the inner supporting structure is configured in the atrial side for being positioned at least partially at the native valve association, and is applied
Towards the axial force of left ventricle；And outer supporting structure, the outer supporting structure have two or more engagement arms, wherein,
The engagement arm is connected to the inner supporting structure, wherein, the prosthese is configured to the leaflet of native valve when it is transplanted
A part be clipped between the inner supporting structure and the engagement arm.It is similar with the design of Edwards, by with larger horizontal stroke
Sectional area upstream portion is resisted against on mitral annulus, and captures original two point of patient by the engagement arm of outer supporting structure
Valve.The stent integrally still takes cylindric symmetrical structure, therefore doctor still needs to select larger specification during operation
Valve enough support forces are provided, huge valve diameter greatly blocks the blood supply of left ventricular outflow tract, aorta
Valve mouth flow velocity increases, and pressure increases, and is susceptible to heart failure situation in the past for a long time.Meanwhile larger valve diameter is directly all pasted
Sympetalous ring will be oppressed near including aortic valvular ring and be organized.
Patent CN201610074782 provides a kind of D-shaped insertion type artificial cardiac valve, including stent, is set to stent
The leaflet of inside and the overlay film being set on stent body wall, stent include sequentially connected first submounts, the second submounts and
Third submounts, the first submounts are webmaster, and the second submounts are the webmaster that cross section is D-shaped, and the third submounts are in loudspeaker
Shape webmaster.The maximum caliber of first submounts is identical with the caliber of second submounts, the third submounts
Minimum pipe is identical with the caliber of second submounts.Although it is claimed to through so-called D-shaped webmaster and two point in situ
The accommodating space shape that the primary body wall of valve surrounds matches, and is circular stent relative to section, is avoided that stent to not rounded
The excessive compressing of the bicuspid valve profile of shape causes the efferent tract of heart to become narrow.The problem of technology, is, even stent
Cross section is changed to D-shaped, directly contacts mitral annulus using total-grid structure, but still surrounding tissue can be caused to oppress；
Meanwhile the maximum caliber of the first submounts described in the technology is identical with the caliber of second submounts, it is meant that stent is horizontal
Section still in itself can still have the influence of efferent tract at least equal to mitral annulus diameter, huge stent；Finally, should
The second submounts are arranged to D-shaped in technology, and leaflet is sewn on stent, after non-circular region must influence leaflet suture
Fit-state.Although the technology there is no the specific open mode for stitching valve, from its figure we still it can be seen that its
Leaflet is three flaps.Therefore, non-circular suture will be unfavorable for leaflet closing performance and long-term leaflet fatigue.
Patent US20160074160 discloses a kind of valve bracket structure, is made including one by marmem
The outside support of expansion and an internal stent made by marmem；The internal stent is made of two parts, first
First part is the structure of expansion during beginning state, and second part is the structure of compression, and artificial valve is arranged on internal stent
First part, second part are additionally provided with tether；Internal stent connect fixation with outside support.The problem of program, is, incites somebody to action
Inside and outside two layers of stent is reconnected after processing respectively and is fixed, and is bound to cause stent overlapping, is on the one hand increased the diameter into sheath, another
The ladder that aspect junction is formed is unfavorable for back into sheath and returns receipts, can increase the wind of junction failure in finally overlapping connection
Danger, such as suture breaks, stent contact corrosion etc..
Clinical effectiveness shows there is not a ideal product for being used to intervene mitral valve displacement at present.It is main former
Because being that mitral complex has special physiological structure, and there is complicated physiological environment below annulus, cause product
It is accurately positioned and fixation is extremely difficult.The technical issues of having sums up as follows：Valve bracket is designed as symmetrical structure, and doctor is often
It selects and is equal with patient's bicuspid valve itself annulus or the valve specification of bigger caters to mitral valve tissue profile, it is not only huge
Stent in itself can have an impact efferent tract, and directly can be to surrounding tissue using total-grid structure contact mitral annulus
It causes to oppress, further blocks the blood flow of left ventricular outflow tract；Stent is divided into inside and outside two parts in current techniques
It is reconnected after processing respectively, stent will certainly be caused to be overlapped, on the one hand increase the diameter into sheath, another aspect junction shape
Into ladder be unfavorable for back into sheath and receipts are returned, the risk that junction is failed, such as suture can be increased in finally overlapping connection
Fracture, stent contact corrosion etc.；Mainstream technology on the market fails to fully achieve the reentry sheath function of stent at present, if into
Enter to release section components inside heart and cannot recall, once stent is problematic can only promptly to turn surgery open chest surgery, perform the operation
Risk is high.
In conclusion although technology described above has certain effect respectively on mitral valve replacement,
Still in place of Shortcomings, in the field of surgery for the treatment of valve disorder, there is an urgent need for a kind of new heart valve prosthesis to solve
Problem above.
Invention content：
The purpose of the present invention is overcoming the limitation of the prior art, for mitral valve insufficiency or narrow result in the need for being situated between
Enter to change the patient of valve, propose a kind of heart valve prosthesis, the asymmetric eccentric structure that the present invention uses can not only reduce stent
To the influence of left ventricular outflow tract view after release, and it can ensure that the opening area of valve will not be because of between patient's mitral annulus
Greatest differences and change excessive, manufacturer can reduce product specification while optimizing valve performance, and can realize position
Adjustable, accurate positioning and the purpose of secure anchorage, Product Safety of the invention are high.
The purpose of the present invention is what is be achieved through the following technical solutions：
A kind of heart valve prosthesis, including stent and artificial valve, the stent includes atrium section and valve sews section, institute
It states artificial valve to be fixedly connected in the valve sewing section, the skeleton of the distal portions of the valve sewing section extends to form
Supporting section, the supporting section and the valve sewing section are structure as a whole, and one end of the atrium section is remote with the supporting section
End connection, another end dissociative of the atrium section, on the cross section of the artificial valve central axes, the valve stitches
Section processed is located in the supporting section, and the center and the center of the supporting section of the valve sewing section are misaligned, the supporting section
Cross-sectional area be more than the cross-sectional area of valve sewing section, the cross-sectional area of atrium section is more than the horizontal stroke of the supporting section
Sectional area, the cross-sectional area of the valve sewing section is less than the cross-sectional area of autologous patient valve annulus, in free state when institute
Supporting section is stated to be at least partially disposed between autologous patient annulus.
The purpose of the present invention can also further be realized by following technical solution：
In one embodiment, on the cross section of the artificial valve central axes, the supporting section relative to
The valve sewing section is eccentric structure, after the heart valve prosthesis is placed to target location, before native leaflets
The distance at the outer of the supporting section in valve region to the center of valve sewing section is greater than or equal to after native leaflets
The outer of the supporting section in valve region sews the distance at the center of section to the valve.
In one embodiment, on the cross section of the artificial valve central axes, the projection of the supporting section
For loop configuration, the loop configuration is cirque structure, oval ring structure or D-ring structure.
In one embodiment, it is provided in the cirque structure, oval ring structure or D-ring structure scarce
Mouthful.
In one embodiment, on the cross section of the artificial valve central axes, the valve sews section
Outer is inscribed within the outer of the supporting section.
In one embodiment, the valve sewing section is the network of tubular or valve sewing section is cylinder
The wavy shaped configuration of shape.
In one embodiment, the supporting section is shaped by the local skeleton of valve sewing section distal portions.
In a preferred embodiment, the supporting section is by the part in the skeleton of valve sewing section distal portions
Rod piece is shaped or the supporting section is shaped by the subwave in the skeleton of valve sewing section distal portions.
It is furthermore preferred that reinforcement wave is provided between the adjacent rod piece, to strengthen the cross-brace power between the rod piece.
In a preferred embodiment, the rod piece is located at adjacent in the wavy shaped configuration of valve sewing section
Between wave or the rod piece sews the extension of the wave crest in the network of section for the valve.
In one embodiment, hangnail is provided on the supporting section, the hangnail is pierced into patient certainly in free state
In body mitral valve tissue.
In one embodiment, multiple bending sections are provided on the supporting section, the supporting section one in free state
Part is located in autologous patient annulus, and another part is located at below autologous patient annulus, the institute below autologous patient annulus
The deployment diameter for stating supporting section is more than the diameter of autologous patient annulus.
In one embodiment, overlay film on the supporting section.
In one embodiment, the atrium section is structure as a whole with the supporting section, and the atrium section is the support
The extension of Duan Yuanduan.
In one embodiment, the periphery of the atrium section is additionally provided with leak-proof device, and the leak-proof device has shape
Skeleton made of memorial alloy and film, the leak-proof device are flexibility, can comply with the uneven profile of mitral annulus.
In one embodiment, in the axial direction of the heart valve prosthesis, the distalmost end of the artificial valve is higher by institute
It states supporting section and sews 1 to 10 millimeter of section connecting place with the valve.
In one embodiment, the atrium section can comply with the uneven wheel of patient's intrinsic atrial cavity wall and valve annulus
It is wide.
In one embodiment, the proximal end of the valve sewing section is provided with necking component, the distal end of the necking component
It is connect with the proximal end of valve sewing section, the proximal diameter of the necking component is less than the diameter of valve sewing section.
In a preferred embodiment, the necking component and valve sewing section are to be detachably connected.
In a preferred embodiment, the necking component is made or the necking component portion of degradation material
It is divided into degradation material to be made.
In one embodiment, the necking component sews the extension of the proximal end skeleton structure of section, institute for the valve
The proximal end for stating necking component is connected to one, and in free state, the proximal end of the necking component is fixed on target location
On.
In a preferred embodiment, the necking component is flexibility.It is furthermore preferred that the necking component is wavy
Structure.It is furthermore preferred that the necking component is line.
In one embodiment, the necking component sews the extension of the proximal end skeleton structure of section for the valve,
The end set of the necking component has connecting rod, and one end of the connecting rod is connect with the end of the necking component,
The other end of the connecting rod is fixed on target location during free state.
In a preferred embodiment, the connecting rod be flexible link or the connecting rod be flexible member and just
The combination of property rod piece.It is furthermore preferred that the connecting rod is made of degradation material or the connection bar part is degradable material
Material is made.
In a preferred embodiment, the connecting rod is arranged to the soft of spring-like structures or the connecting rod
Property rod piece be spring-like structures.It is furthermore preferred that the spring-like structures surface is covered with polymeric membrane.It is furthermore preferred that in the bullet
Be provided with non-telescoping component in spring shape structure, the both ends of the non-telescoping component respectively with the spring-like structures
Both ends are connected so that the spring-like structures cannot generate axial stretching.
In a preferred embodiment, the proximal part of the connecting rod is provided with fixing piece.
In a preferred embodiment, the fixing piece stent small for the big centre in both ends, the stent are closed for NiTi
Spun gold braiding is shaped.
In a preferred embodiment, the proximal part of the connecting rod is hollow pipe, on the tube wall of the hollow pipe
Hole is provided with, in free state, the distalmost end of the fixing piece is pierced by from the hole is pierced into target location.
In one embodiment, the necking component is wire-like members, rod component or ribbon-shaped members.It is furthermore preferred that
Combination of the necking component for flexible piece and rigid member.In free state, one end that the necking component dissociates is fixed
On target location.Preferably, the necking component is made of degradation material or the necking component part is degradable
Material is made.
In one embodiment, the proximal end of the valve sewing section is provided with leaflet clamping piece, the leaflet clamping piece
Proximal end and the valve sewing section are fixedly connected, under natural conditions, autologous patient leaflet be clamped in the leaflet clamping piece with
Between the valve sewing section.
In one embodiment, the distal end of the leaflet clamping piece is provided with connecting line, passes through the traction of the connecting line
It can realize that the leaflet clamping piece is overturn around the junction of the leaflet clamping piece and valve sewing section.
In one embodiment, it is provided with hangnail on the leaflet clamping piece.
In a preferred embodiment, one end of the connecting line and the distal end of the leaflet clamping piece detachably connect
It connects.
Compared with the existing technology, the advantage of the invention is that：
1st, the skeleton of the distal portions of heretofore described valve sewing section extends to form supporting section, perpendicular to the people
On the cross section of work valve central axes, valve sewing section is located in the supporting section, the center of the valve sewing section and
The center of the supporting section is misaligned, and the supporting section is eccentric structure relative to valve sewing section so that the valve
Sewing section is biased to the mitral back lobe region of patient in free state, caused by it is asymmetrical bias effect can not only reduce
The requirement of cross-sectional area after being discharged to stent itself can reduce valve and set to reduce the influence to left ventricular outflow tract view
The relevance of meter and implant site tissue contours, manufacturer can reduce product specification while optimizing valve performance.When described
When heart valve prosthesis is for tricuspid valve intervention displacement, valve sewing section be biased in free state patient's tricuspid valve every
Valve region, the thick and solid region of musculature can be adjacent to by being conducive to stent, and anchoring effect is more preferable, and valve movement is more stable.
2nd, heretofore described supporting section is structure as a whole with valve sewing section, is different from the prior art by inside and outside
Two layers of stent be overlapped again after processing respectively, stitches the structure for tying up connection, on the one hand the structure of integral type reduces the diameter into sheath, and one
The design of the no step of aspect cause back into sheath and return receive it is more convenient, finally prevented the risk of suture breaks, improve
Safety.
3rd, the cross-sectional area of heretofore described valve sewing section is less than the cross-sectional area of autologous patient valve annulus, described
The extension of local skeleton, the sizing of the distal portions of valve sewing section form supporting section, the supporting section in free state at least
Part is between autologous patient annulus.It is different from setting for most product utilization whole cradle fits annulus in the prior art
Meter, especially when the heart valve prosthesis is for tricuspid valve intervention displacement, because patient's Tricuspid annulus size is very big, such as
Fruit is supported on using valve sewing section in patient's Tricuspid annulus merely, the hardly possible realization from engineering viewpoint, even if exerting oneself
Strong realize can also substantially reduce valve life.The present invention only contacts annulus with local skeleton extension sizing, is ensureing to support
Compressing surrounding tissue can be avoided while power, ensure that the blood flow space of ventricular outflow tract, while valve can be optimized
Function.
4th, in the present invention in the axial direction, the artificial valve distalmost end is higher by the supporting section and is sewed with the valve
1 to 10 millimeter of connecting place of section, is different from the deep and narrow gap formed between interior support arm in the prior art, the present invention can be very big
Ground improves blood flow movement, it is not easy to form vortex and thrombus, thrombus is avoided to fall into body-internal-circulation blood vessel and forms embolism, improve peace
Quan Xing.
5th, the proximal end of heretofore described valve sewing section is provided with necking component, can play the role of controlled release,
And allow stent that can reentry sheath and recall, greatly improve the safety of product.After stent discharges completely, the necking
Connecting rod on component or necking component can be fixed on apex of the heart tissue either in other heart tissues or operative incision pad
On piece can prevent stent migration from slipping, and strengthen the effect of anchoring.
6th, heretofore described necking component and valve sewing section are to be detachably connected.In this way design ensure it is described
Stent can be under the premise of controlled release, and the necking component can be withdrawn from vivo, greatly reduced implantation material, reduced to the heart
The contact and stimulation in room, facilitate transport system to withdraw human body, and eliminate the limitation of the implantation to day back lobe mesopetalum.
7th, the periphery of heretofore described atrium section is additionally provided with leak-proof device, and the leak-proof device is closed with shape memory
Skeleton made of gold and film, and the leak-proof device is flexibility, therefore can comply with the uneven profile of mitral annulus,
The compressing to aorta and left atrial wall can be mitigated while mitigating and backflowing.
8th, the proximal end of heretofore described valve sewing section is provided with leaflet clamping piece, can clamp patient's leaflet, prevent
Autologous patient leaflet is pushed to left ventricular outflow tract view, is further reduced the influence to efferent tract.In addition, the leaflet clamping piece end
Be provided with connecting line, described connecting line one end is connected to the distal end of the leaflet clamping piece, the other end of the connecting line with it is defeated
Handle is sent to connect, the leaflet clamping piece can be realized around the leaflet clamping piece and the valve by the traction of the connecting line
The junction overturning of film sewing section, designing in this way is advantageous in that and can repeatedly be clamped according to leaflet clamping effect, and make
Sheath can be reentried by obtaining whole device, improve operation safety.
Description of the drawings
Fig. 1 a- Fig. 1 c show a kind of schematic diagram of preferred embodiment of the present invention, and wherein Fig. 1 b are bowing for Fig. 1 a
View.
Fig. 2 a and Fig. 2 b show the schematic diagrames that the present invention is located at patient's bicuspid valve implantation position.
Fig. 3 a- Fig. 3 e show the schematic diagram of the numerous embodiments of the present invention.
Fig. 4 a- Fig. 4 e show the schematic diagram of the numerous embodiments of the present invention, and the stent that wherein Fig. 4 c are Fig. 4 d is cut
Figure.
Fig. 5 a- Fig. 5 c show the schematic diagram of the numerous embodiments of atrium section in the present invention.
Fig. 6 a- Fig. 6 c show the schematic diagram of the numerous embodiments of the present invention.
Fig. 7 a- Fig. 7 c show the schematic diagram of another preferred embodiment of the present invention, and wherein Fig. 7 b are Fig. 7 a's
Vertical view.
Fig. 8 a- Fig. 8 c show the stent cutting drawing of the numerous embodiments of the present invention, and Fig. 8 d- Fig. 8 e show the present invention
Numerous embodiments schematic diagram.
Fig. 9 a- Fig. 9 d show the schematic diagram of the numerous embodiments of the present invention.
Figure 10 a- Figure 10 c show the schematic diagram of the numerous embodiments of the present invention.
Figure 11 a- Figure 11 d show the schematic diagram of the numerous embodiments of the present invention.
Figure 12 a- Figure 12 b show the schematic diagram of another embodiment of the invention.
Figure 13 a- Figure 13 e show the schematic diagram of another preferred embodiment of the present invention, and wherein Figure 13 b are figure
The stent cutting drawing of 13a, Figure 13 c are the vertical view of Figure 13 a.
Figure 14 a- Figure 14 c show the schematic diagram of the numerous embodiments of the present invention.
Figure 15 a- Figure 15 g show the schematic diagram of the numerous embodiments of the present invention.
Figure 16 a- Figure 16 e show the schematic diagram of the numerous embodiments of the present invention.
Figure 17 a- Figure 17 d show the schematic diagram of one embodiment of the present invention.
Figure 18 a- Figure 18 d show the schematic diagram of one embodiment of the present invention.
Specific embodiment：
To make the objectives, technical solutions, and advantages of the present invention more comprehensible, develop simultaneously embodiment referring to the drawings, right
The present invention is further described.
Distal end of the present invention 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：
As illustrated in figures la-c, a kind of heart valve prosthesis 100, including stent 110 and artificial valve 120, the stent 110
Including atrium section 111 and valve sewing section 112, the artificial valve 120 is fixedly connected in the valve sewing section 112,
The skeleton of the distal portions of the valve sewing section 112 extends to form supporting section 113, and the supporting section 113 is stitched with the valve
Section 112 processed is structure as a whole, and one end of the atrium section 111 is connect with the distal end of the supporting section 113, the atrium section 111
Another end dissociative, on the cross section of 120 central axes of artificial valve, the supporting section 113 is projected as ring
Shape structure, valve sewing section 112 are located among the supporting section 113, the valve sew 112 center 1120 of section with it is described
The center 1130 of supporting section 113 is misaligned, and the cross-sectional area of the supporting section 113 is more than the transversal of valve sewing section 112
Area, the cross-sectional area of the atrium section 111 are more than the cross-sectional area of the supporting section 113, the horizontal stroke of the valve sewing section 112
Sectional area is less than the cross-sectional area of autologous patient valve annulus, and in free state, the supporting section 113 is at least partially disposed at trouble
Between the self annulus of person.Existing Edwards and Medtronic patented technology (referring to CN102639179B and
CN201180020556 in), stent integrally still takes cylindric symmetrical structure, therefore doctor needs to select during operation
The valve of larger specification provides enough support forces, and huge valve diameter greatly blocks the confession of left ventricular outflow tract
Blood, aorta petal mouth flow velocity increase, and pressure increases, and is susceptible to heart failure situation in the past for a long time.Meanwhile larger valve diameter is straight
All fitting annulus are connect, will oppress near including aortic valvular ring and organize.In embodiments of the present invention, such as Fig. 2 a
Shown in Fig. 2 b, on the cross section of the artificial valve central axes, the supporting section 113 is stitched relative to the valve
Section 112 processed is eccentric structure so that the valve sewing section 112 is biased to the mitral back lobe region of patient in free state.
Designing in this way is advantageous in that, asymmetrical eccentric structure not only reduces the requirement of the cross-sectional area after being discharged to stent itself
To reduce the influence to left ventricular outflow tract view, but also the relevance of valve designs and implant site tissue contours can be reduced, it is excellent
Manufacturer can reduce product specification while having changed valve performance.In other implementations, when the heart valve prosthesis
When intervening displacement for tricuspid valve, the valve sewing section is biased to the septal leaflet region of patient's tricuspid valve in free state, favorably
The thick and solid region of musculature can be adjacent in stent, anchoring effect is more preferable, and valve movement is more stable.It is further, since described
Valve sewing section 112 need not be excessive, and the present invention simplifies release step under the effects equivalent for ensuring to stop left ventricular outflow tract view
Suddenly, success rate of operation is improved.
As a preferred embodiment, as shown in figs 3 a-3 c, perpendicular to the transversal of the artificial valve central axes
On face, the supporting section 113 is projected as loop configuration, and the loop configuration is cirque structure or oval ring structure,
The geometric center 1130 of the loop configuration and the center 1120 of valve sewing section 112 are misaligned.Implement as another kind
Mode, as shown in Figure 3d, after the heart valve prosthesis is placed to target location, perpendicular to the artificial valve axis
On the cross section of line, the outer of the supporting section 113 in valve region to valve sewing section center before native leaflets
The outer that 1120 distance is greater than or equal to the supporting section 113 positioned at native leaflets back lobe region sews section to the valve
The distance at center 1120, such as the loop configuration are D-ring structure, in free state, the flat region of the D-ring structure
Mitral preceding valve region is biased in domain in circumferential direction, and the arc area of the D-shape configuration is biased to two points in circumferential direction
The back lobe region of valve, such design more match the physiological anatomic architecture of patient's mitral annulus, can further avoid to valve
The overdistension of ring, so as to reduce the influence to aortic valvular ring and other adjacent tissues.In one embodiment, such as Fig. 3 e
It is shown, it is set in the cirque structure, oval ring structure or D-ring structure 113 jagged.
As a preferred embodiment, as shown in figures 4 a and 4b, the valve sewing section 112 is the grid of tubular
Structure or the wavy shaped configuration that valve sewing section 112 is tubular.As shown in Fig. 4 c and 4d, the supporting section 113 is by institute
The local skeleton for stating valve sewing 112 distal portions of section is further shaped.For example, the supporting section 113 is by the valve
Part rod piece 1121 in the skeleton of sewing 112 distal portions of section is shaped or the supporting section 113 is stitched by the valve
Subwave 1122 in the skeleton of 112 distal portions of section processed is shaped, and the wave 1122 is zigzag or waveform.Such as Fig. 4 e
It is shown, hangnail 1131 is provided on the supporting section 113, the hangnail is pierced into autologous patient mitral valve tissue in free state
In.
As a preferred embodiment, as shown in figure 5, atrium section 111 weaves for marmem
Petal-like structures (Fig. 5 a), star structure (Fig. 5 b), wavy shaped configuration (Fig. 5 c) or network.As shown in Figure 6 a, it is described
One end of atrium section 111 is connected on the distal end of the supporting section 113, another end dissociative of the atrium section 111.As one kind
Preferred embodiment as shown in Figure 6 b, connecting hole 1132, the atrium is provided on the skeleton of 113 distal end of supporting section
One end of section 111 is connected to by the connecting hole 1132 on the distal end of the supporting section 113.As fig. 6 c, the atrium
Section 111 in the circumferential with the angle different from of artificial valve plane, positioned at the atrium in anterior mitral valve region section 111 with
The 112 axial angle α of valve sewing section is less than to be stitched positioned at the atrium in bicuspid valve back lobe region section 111 with the valve
The axial angle β of section 112 processed, since the space structure of mitral annulus is saddle-shaped configuration, design is so that the atrium in this way
Section 111 can be close to patient's atrial tissue in free state, comply with the uneven of patient's intrinsic atrial cavity wall and valve annulus
Profile.111 films of the atrium section, the membrane material include metal material, polytetrafluoroethylene (PTFE), polyethylene, polypropylene, terylene
Or animal derived material.
Specific embodiment two：
As shown in figs. 7 a-c, a kind of heart valve prosthesis 200, including stent 210 and artificial valve 220, the stent 210
Including atrium section 211 and valve sewing section 212, the artificial valve 220 is fixedly connected in the valve sewing section 212,
The skeleton of the distal portions of the valve sewing section 212 extends to form supporting section 213, and the supporting section 213 is stitched with the valve
Section 212 processed is structure as a whole, compared with the prior art in inside and outside two layers of stent is processed respectively after be overlapped again, stitch the knot for tying up connection
On the one hand structure, integral structure of the invention reduce diameter into sheath, on the other hand without the design of step cause back into
Sheath and returning is received more convenient, has finally prevented the risk of suture breaks, has improved safety.One end of atrium section 211 with
The distal end connection of the supporting section 213, another end dissociative of the atrium section 211, perpendicular to 220 axis of artificial valve
On the cross section of line, the supporting section 213 is projected as loop configuration, the center 2120 of the valve sewing section 212 with it is described
The center 2130 of loop configuration is misaligned, and the outer of the valve sewing section 212 is inscribed within the outer of the supporting section 213, this
Sample design, which is advantageous in that, maximizes the eccentric effect of the supporting section 213, and the valve sews section 212 in free state
It is adjacent to the mitral back lobe region of patient so that stent is more firm in mitral annulus, improves anchoring effect, avoids position
The supporting section in back lobe region has activity space so as to damage back lobe and ventricle wall.The cross-sectional area of the supporting section 213
More than the cross-sectional area of valve sewing section 212, the cross-sectional area of the atrium section 211 is more than the horizontal stroke of the supporting section 213
Sectional area, in free state, the supporting section 213 is at least partially disposed between autologous patient annulus.
In one embodiment, the valve sews section 212 as the wavy shaped configuration of tubular or the network of tubular,
The supporting section 213 is shaped by the part rod piece 2121 in the local skeleton of valve sewing 212 distal portions of section, institute
Supporting section 213 is stated to be at least partially disposed in free state between autologous patient annulus.It is different from most in the prior art
The design of product utilization whole cradle fits annulus, especially when the heart valve prosthesis is for tricuspid valve intervention displacement, because
It is very big for patient's Tricuspid annulus size, if be supported in patient's Tricuspid annulus using valve sewing section merely, from work
Hardly possible realization in journey angle, even if valve life can also be substantially reduced reluctantly by realizing.The present invention is only with local skeleton
Extension shapes to contact mitral annulus, and compressing surrounding tissue can be avoided while support force is ensured, also ensures the left heart
The blood flow space of ventricular outflow tract view, while valvular function can be optimized.As figures 8 a and 8 b show, the rod piece 2121 is located at
Between adjacent wave in valve sewing 212 wavy shaped configuration of section or the rod piece 2121 sews section for the valve
The extension of wave crest in 212 networks.In another embodiment, as shown in Figure 8 c, the adjacent rod piece 2121 it
Between be provided with strengthen wave 2123, to strengthen the cross-brace power between the rod piece 2121.213 film of supporting section,
The membrane material includes metal material, polytetrafluoroethylene (PTFE), polyethylene, polypropylene, terylene or animal derived material.
In another embodiment, as shown in figure 8d, multiple bending sections 2131 are provided on the supporting section 213,
213 part of supporting section is located in autologous patient annulus 280 during free state, and another part is located at autologous patient annulus
It is straight to be more than autologous patient annulus 280 positioned at the deployment diameter of the supporting section 213 of 280 lower section of autologous patient annulus for 280 lower sections
Diameter plays the role of positioning action, and enhancing anchoring effect is played after stent discharges completely.
In another embodiment, as figure 8 e shows, the supporting section 213 is structure as a whole with atrium section 211.
Multiple bending sections 2131 are provided on the supporting section 213.
In one preferred embodiment, the atrium section 211 is structure as a whole with the supporting section 213, the heart
Room section 211 is the extension of 213 distal end of supporting section.As illustrated in fig. 9, the periphery of the atrium section 211 is additionally provided with anti-neglected loading
230 are put, the leak-proof device 230 has skeleton 2301 made of marmem and film, and the leak-proof device 230 is
Flexibility can comply with the uneven profile of mitral annulus, can mitigate to aorta and left atrial wall while mitigation is backflowed
Compressing.As shown in Fig. 9 b and Fig. 9 c, the skeleton 2301 of the leak-proof device 230 by more support bar groups into or it is described anti-
The skeleton 2301 of leakage device 230 is the wavy shaped configuration or zigzag structure that metal memory material filament winding system forms.The metal
Memory material silk is Nitinol, and diameter is in the range of 0.1-0.6mm.As shown in figure 9d, the skeleton of the leak-proof device 230
It is mutually wound between 2301 adjacent bar, forms close structure, to provide the elastic-restoring force of bigger.
In one embodiment, as shown in Figure 10 a, in the axial direction of the heart valve prosthesis 200, the artificial valve
The distalmost end of film 220 is higher by the supporting section 213 and sews 1 to 10 millimeter of 212 connecting place of section (L) with the valve.It is different from existing
There is the deep and narrow gap formed between interior support arm in technology, design is advantageous in that the supporting section 213 and the valve in this way
Gap between film sewing section 212 is shallower, can significantly improve blood flow movement, it is not easy to form vortex and thrombus, avoid blood
Bolt, which is fallen into body-internal-circulation blood vessel, forms embolism, improves safety.As shown in Figure 10 b and Figure 10 c, the valve sews section 212
By partially or fully overlay film.Preferably, the membrane material includes metal material, polytetrafluoroethylene (PTFE), polyethylene, polypropylene, terylene
Or animal derived material.
In one embodiment, as shown in Figure 11 a and Figure 11 b, the proximal end of the valve sewing section 212 is provided with necking
Component 240, the distal end of the necking component 240 are connect with the proximal end of valve sewing section 212, the necking component 240
Proximal diameter is less than the diameter of valve sewing section 212.In one embodiment, as shown in fig. 11c, the choke
Part 240 sews the extension of the proximal end skeleton structure of section 212 for the valve, and the necking component 240 is flexibility.It is furthermore preferred that
The necking component 240 is wavelike structure.As illustrated in fig. 11d, the proximal end of the necking component 240 is connected to one,
The proximal end of the necking component 240 is fixed in interventricular septum during free state.
In another embodiment, the necking component 240 is wire-like members, rod component or ribbon-shaped members.Institute
It is the combination that flexible or described necking component 240 is flexible piece and rigid member to state necking component 240.In free state, institute
It states the free one end of necking component 240 and is fixed on apex of the heart tissue either in other heart tissues or operative incision gasket
On.Preferably, the necking component 240 is made of degradation material or 240 part of necking component is degradation material
It is made.The necking component 240 is advantageous in that using degradation material：As figure 12 a shows, the heart valve prosthesis 200
It works early period in patient's body, necking component 240 is still undegraded made of degradation material, and the necking component 240 is free
One end be fixed on apex of the heart tissue either in other heart tissues or on operative incision gasket, it can be ensured that heart valve is false
Body, which will not shift, to come off, and enhances anchoring effect；As shown in Figure 12b, as Implantation Time increases, stent is gradually climbed by endothelium to be covered,
The anchoring effect of stent and mitral annulus more enhances, and the necking component 240 is more weakened by the tractive force of valve, together
When, heart valve prosthesis prosthese may consequently contribute to patient's ventricle level back to normal after working normally, i.e., from preoperative larger ventricle
Chamber is restored to normal ventricle size, further reduced tractive force of the valve to the necking component.Degradation material at this time
Degradation will so that either other heart tissues or operative incision gasket are detached from for the necking component 240 and apex of the heart tissue, are kept away
The strength of heartbeat is exempted to pass to heart valve prosthesis, reduces the volume of ventricle implant, reduces thrombus generation
Stimulant and landing point are beneficial to the long-term function of the postoperative valve of patient, improve safety.
Specific embodiment three：
As shown in figures 13 a-e, a kind of heart valve prosthesis 300, it is described including stent 310 and artificial valve (not shown)
Stent 310 includes atrium section 311 and valve sewing section 312, and the artificial valve is fixedly connected at the valve sewing section 312
On, the skeleton of the distal portions of the valve sewing section 312 extends to form supporting section 313, the supporting section 313 and the valve
Sewing section 312 is structure as a whole, and one end of the atrium section 311 is connect with the distal end of the supporting section 313, the atrium section
311 another end dissociative, on the cross section of the artificial valve central axes, the supporting section 313 is projected as ring
Shape structure, the valve sewing section 312 are located among the supporting section 313, the center of the valve sewing section 312 and the branch
The center for supportting section 313 is misaligned, and the cross-sectional area of the supporting section 313 is more than the cross-sectional area of valve sewing section 312, institute
The cross-sectional area for stating atrium section 311 is more than the cross-sectional area of the supporting section 313.In free state the supporting section 313 to
Small part is between autologous patient annulus.The proximal end of the valve sewing section 312 is provided with necking component 340, the contracting
Mouthpiece 340 sews the extension of the proximal end skeleton structure of section 312 for the valve, is set in the end of the necking component 340
Connecting rod 342 is equipped with, one end of the connecting rod 342 is connect with the end of the necking component 340, in free state when institute
The other end for stating connecting rod 342 is fixed on apex of the heart tissue either in other heart tissues or on operative incision gasket.This
The design of sample can play the role of controlled release, and allow stent that can reentry sheath and recall, and greatly improve product
Safety.It after stent discharges completely, can prevent stent migration from slipping, strengthen the effect of anchoring.
In one embodiment, the connecting rod 342 is wire-like members, rod component or ribbon-shaped members.The connection
The combination that bar 342 is flexible link or the connecting rod 342 is flexible member and rigid bar.Preferably, the connecting rod
342 are made or 342 part of the connecting rod is made of degradation material of degradation material.The connecting rod 342 uses
Degradation material is advantageous in that：The heart valve prosthesis 300 works early period in patient's body, by the degradation material system
Into connecting rod it is still undegraded, one end of the connecting rod 342 be fixed in apex of the heart tissue or other heart tissues or
On person's operative incision gasket, it can be ensured that heart valve prosthesis, which will not shift, to come off, and enhances anchoring effect；As Implantation Time increases
Add, stent is gradually climbed by endothelium to be covered, and the anchoring effect of stent and mitral annulus more enhances, and the connecting rod is by valve
Tractive force more weakens, meanwhile, patient's ventricle level back to normal is may consequently contribute to after heart valve prosthesis prosthese normal work, i.e.,
Normal ventricle size is restored to from preoperative larger ventricular chamber, further reduces tractive force of the valve to the connecting rod.This
When degradation material degradation will cause the necking component 340 and apex of the heart tissue either other heart tissues or operative incision
Gasket is detached from, and the strength of heartbeat is avoided to pass to heart valve prosthesis, reduces the volume of ventricle implant, reduces
The stimulant and landing point of thrombus generation, are beneficial to the long-term function of the postoperative valve of patient, improve safety.
As shown in Figure 14 a and Figure 14 b, in another embodiment, the connecting rod 342 is arranged to spring-like knot
Structure or the flexible member of the connecting rod 342 are spring-like structures.Preferably, the spring-like structures surface is covered with high score
Sub- film.As shown in figure 14 c, non-telescoping silk or bar 3420, the silk or bar 3420 are provided in the spring-like structures
Both ends of the both ends respectively with the spring-like structures be connected so that the spring-like structures cannot generate axial stretching.
As shown in fig. 15 a, the proximal part of the connecting rod 342 is provided with fixing piece 350.The fixing piece 350 is silk
Shape, threadiness or strip, one end of the fixing piece 350 are fixed in the connecting rod 342, another end dissociative.In free state
When, the free-end of the fixing piece 350 is fixed on apex of the heart tissue either in other heart tissues or operative incision gasket
On.
As illustrated in fig. 15b, the proximal part of the connecting rod 342 is hollow pipe, is provided on the tube wall of the hollow pipe
Hole 3421, in free state, the distalmost end of the fixing piece 350 is pierced by from the hole 3421, be pierced into apex of the heart tissue or
Other heart tissues of person.The distalmost end of the fixing piece 350 is tip shape, and the distal portions of the fixing piece 350 are scheduled shape,
The distal portions of the fixing piece 350 are scheduled combination of the shape for one or more of following shape：Spiral shape, circumference
Shape, arc, the combination shape of camber line and straight line, bifurcated double hook shape, 3D Curveds, multistage Curved, the distal end of the fixing piece 350
Without hangnail or with one or more hangnail.
As shown in fig. 15 c, the fixing piece 350 be adapt to apex of the heart profile suction discoid component, the connecting rod 342 it is near
End, which is set up separately, is equipped with screw thread, is provided with threaded hole on the fixing piece 350, the proximal part of the connecting rod 342 with it is described solid
Determine 350 thread fitting of part.
As shown in Figure 15 d-f, the fixing piece 350 is the suction discoid component for adapting to apex of the heart profile, on the fixing piece 350
It is provided with pillar 3501, fastener 3502 and nut 3503.The pillar 3501 is hollow, and the fastener 3502 is located at described convex
In column 3501,3501 inner surface of pillar is provided with screw thread.The fastener 3502 is hollow, the outer diameter of the fastener 3502
Match with the internal diameter of the pillar 3501, the internal diameter of the fastener 3502 is interior with the proximal part of the connecting rod 342
Diameter matches, and the connecting rod 342 is located in the fastener 3502, and 3502 top of fastener is provided with inclined-plane, described
Fastener 3502 is provided with parallel cutting seam 3504 in the axial direction.It is provided in the nut 3503 more than the fastener
The inclined-plane of 3502 top bevel angles, when the nut 3503 and 3501 thread fitting of pillar, the fastener 3502
On cutting seam 3504 gap become smaller so that the connecting rod 342 is fixed between the fastener 3502.
As shown in fig.15g, the fixing piece 350 stent small for the big centre in both ends, the stent are compiled for nitinol alloy wire
It knits and shapes.After the instrument discharges completely, cardiomyopathy musculature is clamped in the stent both ends.
Specific embodiment four：
As shown in fig 16 a and fig 16b, a kind of heart valve prosthesis 400, it is described including stent 410 and artificial valve 420
Stent 410 includes atrium section 411 and valve sewing section 412, and the atrium section 411 can comply with patient's intrinsic atrial cavity wall and valve
The uneven profile of film annulus, the artificial valve 420 are fixedly connected in the valve sewing section 412, the valve seam
The skeleton of the distal portions of section 412 processed extends to form supporting section 413, and the supporting section 413 is one with valve sewing section 412
Body structure, the atrium section 411 are structure as a whole with the supporting section 413, and another end dissociative of the atrium section 411 is hanging down
Directly on the cross section of the artificial valve central axes, the valve sewing section 412 is located in the supporting section 413, the valve
The center and the center of the supporting section 413 of film sewing section 412 are misaligned, and the cross-sectional area of the supporting section 413 is more than described
Valve sews the cross-sectional area of section 412, and the cross-sectional area of the atrium section 411 is more than the cross-sectional area of the supporting section 413,
The supporting section 413 is at least partially disposed between autologous patient annulus during free state.The proximal end two of the valve sewing section 412
Side is both provided with leaflet clamping piece 415, and the proximal end of the leaflet clamping piece 415 is fixedly connected with valve sewing section 412, from
Under right state, autologous patient leaflet 481 is clamped between the leaflet clamping piece 415 and valve sewing section 412.In this way
Design, which is advantageous in that, can clamp patient's leaflet 481, and autologous patient leaflet is prevented to be pushed to left ventricular outflow tract view, is further reduced
Influence to efferent tract.
In one embodiment, as shown in figure 16 c, the proximal end of the valve sewing section 412 is provided with necking component
440, extension of the necking component 440 for the proximal end of the leaflet clamping piece 415, at the end of the necking component 440
Portion is provided with connecting rod 442, and one end of the connecting rod 442 is connect with the end of the necking component 440, in free state
The other end of Shi Suoshu connecting rods 442 is fixed on apex of the heart tissue.
In another embodiment, as shown in figure 16d, the proximal end of the valve sewing section 412 is provided with necking component
440, the necking component 440 sews the extension of the proximal end of section 412 for the valve, at the end of the necking component 440
Portion is provided with connecting rod 442, and one end of the connecting rod 442 is connect with the end of the necking component 440, in free state
The other end of Shi Suoshu connecting rods 442 is fixed on apex of the heart tissue.
In another embodiment, as shown in figure 16e, the proximal end of the valve sewing section 412 is close to anterior mitral valve
Side be provided with leaflet clamping piece 415.Guide rail 4122, the leaflet clamping piece 415 are provided in the valve sewing section 412
It is pierced by from the guide rail 4122, such design enables the leaflet clamping piece 415 to sew section 412 with the valve and divides
Step release.And the leaflet clamping piece 415 can reentry sheath, help to clamp self anterior mitral valve.
In another embodiment, as shown in Figure 17 a and Figure 17 b, 415 end set of leaflet clamping piece has connection
Line 4150, described 4150 one end of connecting line are connected to the distal end of the leaflet clamping piece 415, the other end of the connecting line 4150
It is connect with conveying handle, can realize that the leaflet clamping piece 415 is pressed from both sides around the leaflet by the traction of the connecting line 4150
Gripping member 415 and the junction of valve sewing section 412 are overturn.As shown in fig. 17 c, when the heart valve prosthesis 400 needs
During by compression loaded in delivery sheath, by the traction of the connecting line 4150 by the leaflet clamping piece 415 around the valve
The junction of leaf clamping piece 415 and the valve sewing section 412 is overturn, and designs that be advantageous in that can be by sheath pipe diameter most in this way
Smallization.As shown in Figure 17 d, when the heart valve prosthesis 400 is gradually discharged, by controlling the connecting line 4150, make
It obtains the leaflet clamping piece 415 to restore to clamp autologous patient leaflet 481 to precalculated position, can lead to if clamping effect is undesirable
It crosses the connecting line 4150 and the leaflet clamping piece 415 is sewed into section 412 around the leaflet clamping piece 415 and the valve again
Junction overturning.This process can repeat, until clamping effect meets operation requirement.Moreover, such design makes
Sheath can be reentried by obtaining whole device, improve operation safety.As a preferred embodiment, the connecting line 4,150 1
End and the distal end of the leaflet clamping piece 415 are detachably connected, when the leaflet clamping piece 415 restores patient to precalculated position
After native leaflets 481 are clamped, the connecting line 4150 is withdrawn, to reduce patient's body implantation material.In another embodiment,
As shown in figure 18 a, the necking component 440 and valve sewing section 412 are to be detachably connected.In this way design ensure it is described
Stent can be under the premise of controlled release, and the necking component 440 can be withdrawn from vivo, greatly reduce implantation material, reduces
Contact and stimulation to atrium, facilitate transport system to withdraw human body, and eliminate the limitation of the implantation to day back lobe mesopetalum.Such as figure
Shown in 18b, the proximal end of valve sewing section 412 is provided with cavernous structure 4125, the distal end of the necking component 440 staggeredly into
Enter in the cavernous structure 4125, lock hole 4401 is provided on the distal end of the necking component 440, in the lock hole 4401
Middle insertion locking level 4126 realizes locking；It is described when the locking level 4126 detaches the lock hole 4401 as shown in Figure 18 c
The distal end of necking component 440 is detached from from the cavernous structure 4125 of valve sewing section 412, realizes the necking component
440 sew the dismounting of section 412 with the valve.In another embodiment, as shown in Figure 18 d, 413 overlying of supporting section
Film 4132, the film 4132 are made by high-molecular fabric or by polytetrafluoroethylene (PTFE), are provided with down on the leaflet clamping piece 415
Thorn 4152, when the leaflet clamping piece 415 overturns clamping native leaflets 481, the hangnail 4152 passes through native leaflets 481 simultaneously
It is pierced into the film 4132 on the supporting section 413, chucking power can be improved in this way, prevent native leaflets 481 from the leaflet
It comes off between clamping piece 415 and the supporting section 413.
The technology of the present invention applies also for the patient for the treatment of tricuspid disease except applying in addition to bicuspid valve.
Finally it should be noted that the foregoing is merely the present invention preferred embodiment, not limiting this
Invention, all any modification, equivalent and improvement made all within the spirits and principles of the present invention etc., should be included in this hair
Within bright protection domain.
Claims (17)
1. a kind of heart valve prosthesis, including stent and artificial valve, which is characterized in that the stent includes atrium section and valve
Section is sewed, the artificial valve is fixedly connected in the valve sewing section, the bone of the distal portions of the valve sewing section
Frame extends and locally sizing forms supporting section, and in the axial direction of the heart valve prosthesis, the distalmost end of the artificial valve is high
Go out 1 to 10 millimeter of the supporting section and valve sewing section connecting place, the supporting section is integrated with valve sewing section
Structure, one end of the atrium section are connect with the distal end of the supporting section, another end dissociative of the atrium section, perpendicular to institute
On the cross section for stating artificial valve central axes, the valve sewing section is located in the supporting section, in the valve sewing section
The center of the heart and the supporting section is misaligned, and the cross-sectional area of the supporting section is more than the cross-sectional area of valve sewing section,
The cross-sectional area of the atrium section is more than the cross-sectional area of the supporting section, and the cross-sectional area of the valve sewing section is less than patient
The cross-sectional area of native valve annulus, in free state, the supporting section is at least partially disposed between autologous patient annulus.
2. a kind of heart valve prosthesis according to claim 1, which is characterized in that perpendicular to the artificial valve axis
On the cross section of line, the supporting section is eccentric structure relative to valve sewing section, when the heart valve prosthesis is put
It puts to after target location, the outer of the supporting section in valve region to the center of valve sewing section before native leaflets
Distance is greater than or equal to the outer to the center of valve sewing section of the supporting section positioned at native leaflets back lobe region
Distance.
3. a kind of heart valve prosthesis according to claim 1, which is characterized in that the supporting section is perpendicular to the people
Loop configuration is projected as on the cross section of work valve central axes, the loop configuration is cirque structure, oval ring structure
Or D-ring structure.
4. a kind of heart valve prosthesis according to claim 3, which is characterized in that in the cirque structure, ellipse
It is set in loop configuration or D-ring structure jagged.
5. a kind of heart valve prosthesis according to claim 1, which is characterized in that perpendicular to the artificial valve axis
On the cross section of line, the outer of the valve sewing section is inscribed within the outer of the supporting section.
6. a kind of heart valve prosthesis according to claim 1, which is characterized in that be provided on the supporting section multiple curved
Tune, in free state, the supporting section part is located in autologous patient annulus, and another part is located at autologous patient annulus
Lower section, the deployment diameter of the supporting section below autologous patient annulus are more than the diameter of autologous patient annulus.
7. a kind of heart valve prosthesis according to claim 1, which is characterized in that the atrium section is with the supporting section
Integral structure, the atrium section are the extension of the supporting section distal end.
8. a kind of heart valve prosthesis according to claim 1, which is characterized in that the periphery of the atrium section is additionally provided with
Leak-proof device, the leak-proof device have skeleton made of marmem and film.
A kind of 9. heart valve prosthesis according to claim 1, which is characterized in that the proximal end setting of the valve sewing section
There is necking component, the distal end of the necking component is connect with the proximal end of valve sewing section, and the proximal end of the necking component is straight
Diameter is less than the diameter of valve sewing section.
10. a kind of heart valve prosthesis according to claim 9, which is characterized in that the necking component and the valve
Sewing section is is detachably connected.
11. a kind of heart valve prosthesis according to claim 9, which is characterized in that the necking component is degradable material
Material is made or the necking component part is made of degradation material.
12. a kind of heart valve prosthesis according to claim 9, which is characterized in that the necking component is the valve
The extension of the proximal end skeleton structure of film sewing section, has a connecting rod in the end set of the necking component, and the one of the connecting rod
End is connect with the end of the necking component, and in free state, the other end of the connecting rod is fixed on target location
On.
13. a kind of heart valve prosthesis according to claim 12, which is characterized in that the connecting rod is degradation material
It is made or the connection bar part is made of degradation material.
14. a kind of heart valve prosthesis according to claim 12, which is characterized in that the close end of the connecting rod sets up separately
It is equipped with fixing piece.
15. a kind of heart valve prosthesis according to claim 1, which is characterized in that the proximal end of the valve sewing section is set
Leaflet clamping piece is equipped with, the proximal end of the leaflet clamping piece is fixedly connected with valve sewing section, and under natural conditions, patient is certainly
Body leaflet is clamped between the leaflet clamping piece and valve sewing section.
16. a kind of heart valve prosthesis according to claim 15, which is characterized in that the distal end of the leaflet clamping piece is set
Connecting line is equipped with, the leaflet clamping piece can be realized around the leaflet clamping piece and the valve by the traction of the connecting line
The junction overturning of film sewing section.
17. a kind of heart valve prosthesis according to claim 1, which is characterized in that the atrium section can comply with patient
The uneven profile of intrinsic atrial cavity wall and valve annulus.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610921112.XA CN106420114B (en) | 2016-10-24 | 2016-10-24 | A kind of heart valve prosthesis |
| PCT/CN2017/107380 WO2018077143A1 (en) | 2016-10-24 | 2017-10-23 | Heart valve prosthesis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610921112.XA CN106420114B (en) | 2016-10-24 | 2016-10-24 | A kind of heart valve prosthesis |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN106420114A CN106420114A (en) | 2017-02-22 |
| CN106420114B true CN106420114B (en) | 2018-06-08 |
Family
ID=58175798
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610921112.XA Active CN106420114B (en) | 2016-10-24 | 2016-10-24 | A kind of heart valve prosthesis |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN106420114B (en) |
| WO (1) | WO2018077143A1 (en) |
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Also Published As
| Publication number | Publication date |
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| WO2018077143A1 (en) | 2018-05-03 |
| CN106420114A (en) | 2017-02-22 |
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Address after: Building 5, area B, 777 Binhai Fourth Road, Hangzhou Bay New District, Ningbo City, Zhejiang Province, 315336 Patentee after: Ningbo Jianshi Technology Co.,Ltd. Address before: 315336 zone B, No. 558 Binhai 4th Road, Hangzhou Bay New Area, Ningbo, Zhejiang Patentee before: NINGBO JENSCARE BIOTECHNOLOGY Co.,Ltd. |