CN109394393A - Heart valve prosthesis - Google Patents
Heart valve prosthesis Download PDFInfo
- Publication number
- CN109394393A CN109394393A CN201710714230.8A CN201710714230A CN109394393A CN 109394393 A CN109394393 A CN 109394393A CN 201710714230 A CN201710714230 A CN 201710714230A CN 109394393 A CN109394393 A CN 109394393A
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- CN
- China
- Prior art keywords
- heart valve
- valve prosthesis
- rack body
- armed lever
- outer male
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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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
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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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
Abstract
The present invention provides a kind of heart valve prosthesis, the heart valve prosthesis is for substituting the intracorporal native valve of people, the native valve includes annulus, and the heart valve prosthesis includes rack body, the outer male structure that is fixed on the artificial leaflet on the rack body and is arranged on the rack body side wall；After the heart valve prosthesis is placed into human body, the outer male structure is used to be arranged in the top of the annulus, to limit the position of the heart valve prosthesis.The present invention is arranged in the top of the annulus by outer male structure, to limit the position of the heart valve prosthesis, the top that annulus is resisted against below outer male structure can be relied in unfoldable shape, prevent heart valve prosthesis to ventricle play, under the conditions of valve root is effectively solved without calcification, for heart valve prosthesis in the anchorage problem of releasing position, that realizes heart valve prosthesis stablizes implantation.
Description
Technical field
The present invention relates to the field of medical instrument technology, in particular to a kind of heart valve prosthesis.
Background technique
Currently it is mainly used for the treatment of severe aortic stenosis through conduit aortic valve replacement (abbreviation TAVR), and leads
The TAVR treatment of arterial valve reflux is but among exploring.Aortic regurgitation refer to heart in diastole, aorta petal because
Closure does not cause sternly the blood for having been flowed into aorta to flow back into left ventricle.The aortic regurgitation of light moderate may be without obvious disease
Shape, middle severe aortic valves in patients with aortic regurgitation can undergo a Cardiac compensation phase, and losing compensatory rear Average Survival is only 2 to 5 years.
Existing TAVR valve is by bracket self-expanding mode mostly (using Medtronic Core-Valve as representative)
Or balloon expandable stent (using Edwards Sapien as representative), bracket and the leaflet of calcification, annulus are fixed；In aorta
In narrow patient, after bracket itself expansion, the leaflet or annulus of calcification can embrace bracket securely, by calcified tissue and
The radial support power of bracket, which is realized, fixes.And in terms of the anatomical features of aortic regurgitation, primary leaflet and aortic root
It is in certain flexibility often not necessarily with severe calcification, therefore tradition TAVR valve can not be real by way of radial support power
Now fix.Although there is some be based on using tradition TAVR valve (radial support power mode is fixed) for aortic regurgitation treatment
Report, the phenomenon that but overall effect is bad, and valve easily occurs to ventricular outflow tract play, such as Medtronic Core-
Valve, DFM, Lotus.Just because of this, become industry problems for treating the TAVR valve of aortic regurgitation.
In recent years, start to study the TAVR treatment of aortic regurgitation both at home and abroad, occur some available
In the novel valve of aortic regurgitation treatment.It is all by bracket such as Jena Valve and Medtronic Engager
Primary leaflet is clamped between clip and valve bodies by three clips, realizes that valve is fixed；J-Valve uses same general
It reads, the difference is that its clip and valve bodies and non-integral.Three uses to be implanted into through apex of the heart mode, compared to tradition
The mode that TAVR valve is implanted into through femoral artery, there is the big disadvantages of wound.And Edwards HELIO+XT system is then in original
On the basis of some Edwards Sapien-XT valve prosthesis, a rigid clip (HELIO) is added, when implantation first puts clip
It is placed in aortic sinus, then discharges Sapien-XT valve prosthesis, primary leaflet is clamped to realize admittedly by clip and valve
It is fixed.It is anti-that the mode that PCR2013 reports through stock implantation clip and through apex of the heart implantation Sapien-XT valve combination treats aorta petal
Stream, and contemplating in the future may be simultaneously by being implanted into the implementation of clip and valve through stock mode.It can be found that such production
Strain system is complicated for operation and more demanding to the operation of doctor, and there is clearly disadvantageous.
Summary of the invention
The purpose of the present invention is to provide a kind of heart valve prosthesis, when so that heart valve prosthesis treating valvular regurgitation,
Effectively realize and self fix that there is preferable effect.
The object of the invention is also to provide a kind of heart valve prosthesis, when so that heart valve prosthesis treating valvular regurgitation
Wound is small, easy to operate.
In order to solve the above technical problems, the present invention provides a kind of heart valve prosthesis, the heart valve prosthesis is for replacing
For the intracorporal native valve of people, the native valve includes annulus, the heart valve prosthesis include expandable rack body,
The outer male structure for being fixed on the artificial leaflet on the rack body and being arranged on the rack body side wall；When the heart
After dirty valve prosthesis is placed into human body, the outer male structure is used to be arranged in the top of the annulus, to limit the heart
The position of valve prosthesis.
Optionally, in the heart valve prosthesis, the rack body is net column structure, the net column structure
It is formed by multiple mesh, the mesh is connected by node to be formed, and the rack body includes first end and the second end, described
First end is for strutting in the annulus, and the second end is equipped with auxiliary unit, for connecting delivery sheath；When described
When rack body is compressed, the outer male structure is collapsed in the mesh.
Optionally, in the heart valve prosthesis, the quantity of the outer male structure is multiple, each outer umbo
Structure includes at least two first armed lever structures and the second armed lever structure identical with the first armed lever number of structures, each described
One end of first armed lever structure connects the net column structure；The other end of each first armed lever structure connects described in one
The other end of one end of the second armed lever structure, each second armed lever structure is all connected with each other.
Optionally, in the heart valve prosthesis, the number of the first armed lever structure and the second armed lever structure
Amount is all two, and the junction and two the second armed lever knots of the first armed lever structure and the second armed lever structure
The junction of structure all has arc structure；The outer male structure relative to the rack body front projection in inverted V-shape or
Inverted u-shaped structure.
Optionally, in the heart valve prosthesis, the native valve further includes primary leaflet, described at least one
Outer male structure further includes cantilever lever, and the cantilever lever is from the other end of the second armed lever structure towards the first end
Extend, for being pierced into the primary leaflet.
Optionally, in the heart valve prosthesis, the axis of the extending direction of the cantilever lever and the rack body
To parallel.
Optionally, in the heart valve prosthesis, the angle between the first armed lever structure and first direction is in
30 °~90 °, the angle between the second armed lever structure and the first direction is in -60 °~60 °, and the first direction is institute
State first end to the second end direction and the first direction it is parallel with the axial direction of the rack body.
Optionally, in the heart valve prosthesis, multiple second armed lever structures to the rack body away from
From being 2mm~6mm.
Optionally, in the heart valve prosthesis, the first armed lever structure connects one end of the rack body
Distance to the bottom of the first end of the rack body is 5mm~15mm.
Optionally, in the heart valve prosthesis, the heart valve prosthesis further includes skirt border structure, the skirt
Structure is sewn on the rack body inner sidewall, and is located at the artificial leaflet close to the side of first end.
Optionally, in the heart valve prosthesis, the material of the rack body is Nitinol.
Optionally, in the heart valve prosthesis, the rack body is integrally formed with the outer male structure.
The outer male structure is of an L-shaped structure relative to the side projection of the rack body.
In heart valve prosthesis provided by the invention, the top of the annulus is arranged in by outer male structure, to limit
The position for making the heart valve prosthesis can prevent in unfoldable shape by the top for being resisted against annulus below outer male structure
Only play occurs for heart valve prosthesis, and under the conditions of effectively solving native valve root without calcification, heart valve prosthesis is in release position
The anchorage problem set, that realizes heart valve prosthesis stablizes implantation.Rack body and evagination structural volume in the present invention is small, fits
For be implanted into through stock mode etc. it is a variety of through conduit implantation, wound is small, it is easy to operate.
Detailed description of the invention
Fig. 1 is the heart valve prosthesis entirety schematic elevation view of one embodiment of the invention；
Fig. 2 is the heart valve prosthesis entirety schematic top plan view of one embodiment of the invention；
Fig. 3 is the heart valve prosthesis and aorta entirety schematic elevation view of one embodiment of the invention；
Fig. 4 is the heart valve prosthesis and aorta entirety schematic top plan view of one embodiment of the invention；
Fig. 5 is the heart valve prosthesis entirety schematic elevation view of another embodiment of the present invention；
Fig. 6 is the conical form heart valve prosthesis entirety schematic elevation view of another embodiment of the present invention；
Fig. 7 is the conical form heart valve prosthesis entirety schematic top plan view of another embodiment of the present invention；
Fig. 8 is the wine glass formation heart valve prosthesis entirety schematic elevation view of another embodiment of the present invention；
Fig. 9 is the wine glass formation heart valve prosthesis entirety schematic top plan view of another embodiment of the present invention；
Figure 10 is the schematic diagram that the heart valve prosthesis of another embodiment of the present invention is assemblied in sheath；
It is as shown in the figure:
1- rack body；The artificial leaflet of 2-；The outer male structure of 3-；31- the first armed lever structure；32- the second armed lever structure；33-
Cantilever lever；4- skirt border structure；The primary leaflet of 5-；6- annulus；7- Wa Shi sinus；8- aorta；9- sheath；10- auxiliary unit.
Specific embodiment
Present inventor is used to treat master the study found that using valve fixed by radial support power merely
The problems such as arterial valve reflux cannot obtain preferable effect, be in particular in unstable in the presence of anchoring, easy play, cannot reach good
Therapeutic effect.Using the novel valve of clamping leaflet mode, using through apex of the heart mode for treating aortic regurgitation, wound
Greatly, and it is complicated for operation, it is in particular in the structure using clip clamping leaflet, valve overall dimensions are larger, need using careful
Sharp mode is implanted into, and for being implanted into compared to traditional TAVR valve through stock, wound is larger, is unfavorable for the post-operative recovery of elderly patient.Make
It is complicated for operation in addition to compared to the wound disadvantage through stock with the mode for being successively implanted into clip and valve through apex of the heart mode, it is right
Doctor is more demanding.
Therefore, this field needs a kind of new heart valve prosthesis, to realize heart valve prosthesis in treatment aorta petal
In reflux, can effectively realize that prosthese is fixed self, suitable for be implanted into through stock mode etc. it is a variety of through conduit implantation, wound is small, behaviour
Make simple.
To realize above-mentioned thought, the embodiment of the invention provides a kind of heart valve prosthesis, the heart valve prosthesis is used
In the substitution intracorporal native valve of people, the native valve includes annulus, and the heart valve prosthesis includes rack body, fixation
In the artificial leaflet on the rack body and the outer male structure being arranged on the rack body side wall；When the heart valve
After film prosthese is placed into human body, the outer male structure is used to be arranged in the top of the annulus, to limit the heart valve
The position of prosthese, the root for effectively solving native valve are being discharged without insertion type artificial cardiac valve prosthese under the conditions of obvious calcification
The anchorage problem of position；The prosthese can be intervened through stock simultaneously, and wound is small, and the heart valve prosthesis release is easy to operate, can
It is effectively improved operation time and post-operative recovery time.
Certainly, it will be appreciated by those skilled in the art that, the heart valve prosthesis that proposes not only is applicable in the present invention
In aortic valve, it is also applied for bicuspid valve, tricuspid valve and pulmonary valve.
Heart valve prosthesis proposed by the present invention is described in further detail below in conjunction with the drawings and specific embodiments.Root
According to following explanation and claims, advantages and features of the invention will be become apparent from.It should be noted that attached drawing be all made of it is very simple
The form of change and use non-accurate ratio, only for the purpose of facilitating and clarifying the purpose of the embodiments of the invention.
As shown in Figures 1 to 3, a kind of heart valve prosthesis is present embodiments provided, the heart valve prosthesis is for substituting
The intracorporal native valve of people, such as substitute primitive aorta valve, bicuspid valve or tricuspid valve etc. between aorta and ventricle.
Primitive aorta valve is selected in the present embodiment as an example, the native valve includes annulus 6 and the Wa Shi that is connected with annulus 6
Sinus 7, the other end of Wa Shi sinus 7 are connected to aorta 8, and Wa Shi sinus 7 outwardly protrudes relative to annulus 6 and aorta 8.The heart
Valve prosthesis includes rack body 1, the artificial leaflet 2 being fixed on the rack body 1 and is arranged in the rack body 1
Outer male structure 3 on side wall, in which: the artificial leaflet 2 be used for when blood flows to aorta from ventricle opening, blood from
Closure when aorta flows to ventricle；After the heart valve prosthesis is placed into human body, the outer male structure 3 is for being resisted against institute
The top of annulus 6 is stated, so that the position of the heart valve prosthesis is limited, as shown in figure 3, the outer male structure 3 extends up to
The Wa Shi sinus 7 for being completely or partially placed in 6 top of annulus is formed by space, and the lower edge of outer male structure 3 can paste
It is attached on 7 lower wall of Wa Shi sinus or aortic valvular ring 6, gives rack body by the support of 7 lower wall of Wa Shi sinus or aortic valvular ring 6
1 one supporting roles prevent the downward play of rack body 1, realize the fixation of valve prosthesis.Those skilled in the art can manage
Solution is petal-like structures above annulus, although not having if substituting bicuspid valve or tricuspid valve using the heart valve prosthesis
There is Wa Shi sinus, outer male structure 3 can also be placed in petal design, and be resisted against above annulus, to limit the heart valve
The position of film prosthese.
In heart valve prosthesis provided in this embodiment, the top of the annulus is resisted against by outer male structure 3, thus
Limiting the position of the heart valve prosthesis, i.e., the described outer male structure is stuck in Wa Shi sinus 7 and is formed by space for extending up to,
When blood flows back from aorta 8 to ventricle, the artificial leaflet 2 is closed, and outer male structure 3 can rely on evagination in unfoldable shape
The lower section of structure 3 is resisted against 6 top of annulus, offsets the pressure that blood backflow generates artificial leaflet 2 to ventricle, prevents heart valve
Film prosthese is to ventricle play, and under the conditions of effectively solving aortic valve root without calcification, heart valve prosthesis is in releasing position
Anchorage problem, that realizes heart valve prosthesis stablizes implantation.When heart valve prosthesis does not discharge, rack body and outer male structure
3 are collapsed by compression, are contained in the gap of neighboring grid cells, additional shared small in size in the sheath of conveying prosthese, fit
For be implanted into through stock mode etc. it is a variety of through conduit implantation, wound is small, it is easy to operate.
As shown in figs. 34, the rack body 1 is net column structure, and the net column structure is formed by multiple mesh,
The mesh is connected by node to be formed, and the rack body includes first end and the second end, and the first end is for supportting
It is opened in the annulus 6, provides radial support power, the second end is equipped with auxiliary unit 10, for connecting delivery sheath.Institute
Stating native valve further includes primary leaflet 5, and primary leaflet 5 is extended from annulus 6, primitive aorta valve in the present embodiment
In, the length of the rack body 1 is greater than the length of the Wa Shi sinus 7, and the rack body 1 is from the aortic valvular ring 6
The Wa Shi sinus 7 is extended to, and further extends into aorta 8, the rack body 1 has elasticity, by the primary leaflet 5
It is expressed to by Wa Shi sinus 7.The artificial leaflet 2 is fixed on the inner sidewall of rack body 1, for substituting primary leaflet 5.
Specifically, as shown in Fig. 1~10, in the heart valve prosthesis, the quantity of the outer male structure be it is multiple,
Each outer male structure 3 includes at least two first armed lever structures 31 and identical with the first armed lever 31 quantity of structure the
One end of two armed lever structures 32, each first armed lever structure 31 connects the net column structure, each first armed lever
The other end of structure 31 connects one end of the second armed lever structure 32, the other end of each second armed lever structure 32
All it is connected with each other.
Preferably, the quantity of the first armed lever structure 31 and the second armed lever structure 32 is all two, and described
The junction of the junction and two the second armed lever structures 32 of one armed lever structure 31 and the second armed lever structure 32 is all
With arc structure, blood vessel side wall and annulus, side of the outer male structure 3 relative to rack body 1 are concentrated and damaged to avoid stress
Face projection is of an L-shaped structure, see the partial enlarged view of lower section in Fig. 1, certainly it will be understood to those skilled in the art that this place
The L-type of finger be it is generally L-shaped, the angle between the first armed lever structure 31 and the second armed lever structure 32 is not necessarily straight
Angle, as long as the top of the second armed lever structure 32 is pierced into blood vessel side wall towards the second end of rack body 1；It is described
First armed lever structure 31 and the second armed lever structure 32 relative to the rack body 1 front projection in inverted V-shape or U
Font structure, as shown in Figure 1, the outer male structure 3 that paper is faced in figure is shown in the partial enlarged view being located above in inverted V-shape,
For clarity of illustration, the portion support ontology of outer 3 rear side of male structure is not drawn into the partial enlarged view.
In addition, in other embodiments, as shown in figure 5, at least one described outer male structure 3 further includes cantilever lever 33, institute
Cantilever lever 33 is stated from the other end of the second armed lever structure 32, the i.e. one end interconnected of the second armed lever structure 32, court
The first end extend, for being pierced into the primary leaflet 5, it is preferred that in each outer male structure 3, two or more
The node that a second armed lever structure 32 is connected extends cantilever lever 33, and the cantilever lever 33 is pierced into the primary leaflet
5, realize the dual fixation heart valve prosthesis, in Fig. 5, the extending direction of the cantilever lever 32 and the rack body 1
Axial direction it is parallel.
It further, by the direction definition of the first end to the second end is here first direction, and institute
It is parallel with the axial direction of the rack body 1 to state first direction, between the first armed lever structure 31 and the first direction
Angle is in 30 °~90 °, and the angle between the second armed lever structure 32 and first direction is in -60 °~60 °, that is, the second arm
The direction that rod structure 32 can be drawn close to rack body 1 extends, and extends away from the direction of rack body 1, described second
The distance of armed lever structure 32 to the rack body 1 is 2mm~6mm.The first armed lever structure 31 connects the rack body 1
One end to the rack body 1 be located at first end bottom distance be 5mm~15mm.In general, the quantity of outer male structure 3
It to be multiple, preferably 4, is uniformly arranged on the outer peripheral surface of rack body 1, the first arm included by all outer male structures 3
The junction of rod structure 31 and the rack body 1 is respectively positioned on radial same plane, it is preferred that the first armed lever structure two-by-two
31 are uniformly distributed on the cross section of rack body 1, more specifically, the first armed lever structure 31 and the third on rack body 1
Cribbing point is connected, and the third cribbing point refers to that several third rankings are in same since the first end bottom of rack body 1
Node on week.
The material of the rack body 1 is preferably Nitinol, has the function of material memory, in addition also has good bullet
Property, 1 deformation of rack body caused by blood pressure can be prevented, the rack body 1 is integrally formed with the outer male structure 3, makes
Entire heart valve prosthesis structure is relatively reliable, and surface is smooth, does not damage to blood vessel.The artificial leaflet includes three lists
Leaf, described three single leaves are for example prepared by the Pigs Hearts packaging material Jing Guo anti-calcification processing, and by way of suturing or being bonded
It is fixed on the rack body, is mainly distributed on first end (flowing into road) region of rack body.As shown in Figure 1, institute
In the heart valve prosthesis stated, the heart valve prosthesis further includes skirt border structure 4, and the skirt border structure 4 is sewn to the branch
On 1 inner sidewall of frame ontology, and it is located at the artificial leaflet 2 close to the side of first end, perivalvular leakage can be prevented.It is described artificial
Leaflet 2 is cloverleaf valve, and Fig. 2 illustrates it and overlooks form, and skirt border structure 4 can be prepared for the polymer of biocompatibility,
Such as polyethylene terephthalate (PET), it is also possible to the preparation of homologous or heterologous biomaterial.
The rack body 1 also has auxiliary unit 10 close to the first end of aorta, as shown in Figure 10, the auxiliary
Unit 10 be used for by rack body 1 with the guide bar in sheath 9 in conjunction with and fixation, make sheath 9 that heart valve prosthesis is passed through stock
Artery is input in blood vessel.The rack body 1 is self-expansion type, has the retracted configuration of conveying and the expansion shape of release
State.
Further, one end of each first armed lever structure 31 connects on the node of the net column structure, with institute
Mesh where stating the node of the first armed lever structure 31 connection is greater than the profile after the outer male structure 3 is unfolded, i.e., adjacent to evagination
The mesh of the network of structure 3 is larger, so that the outer male structure 3 can be strapped in rack body 1 in retracted configuration
In the gap of net column structure, the outer dimension of 1 retracted configuration of rack body can be transported to through femoral artery and release without obviously becoming larger
Put position.
In the present embodiment, the rack body 1 is fixed to cylindrical conformation (as shown in Fig. 1~5).In other implementations
In example, the rack body 1 can also be fixed to conical form (as shown in figs. 6-7), and rack body is that taper is 2~5 °
Centrum, which can further avoid the upward play of rack body, realize the effective anchoring or the bracket sheet of rack body
Body 1 can also be fixed to wine glass formation (as shown in Fig. 8~9), i.e. the efferent tract of rack body is fixed to bigbore flower
Lobed state.After rack body release, structure can improve rack body and aorta against aorta ascendens vascular wall at this
Annulus to neutrality, improve the anchoring property of rack body.
In all embodiments, the rack body 1 is all inflatable, has the retracted configuration and release of conveying
Unfoldable shape.The outer male structure 3 is in the gap that retracted configuration can be strapped in the grid cell of rack body 1, branch
The outer dimension of 1 retracted configuration of frame ontology can be transported to releasing position through stock without obviously becoming larger.The rack body 1 is adopted
It is made of Nitinol, it is preferred that made of NiTi superelastic alloy, deformation reaches 8%, can restore completely, avoid blood
The effect of pressure causes deformation to rack body.
Fig. 3 illustrates the exemplary valve prosthesis of the present invention in the anchoring effect of aortic root.Valve prosthesis is in aorta
After the release of root, the first end (flowing into road) of rack body cooperates at aortic valvular ring, passes through the radial direction branch of rack body
Support force expands aortic valvular ring；The 3 second armed lever structure of outer male structure that rack body flows into road region can squeeze primary leaflet,
Valve prosthesis passes through the synthesis fixed effect of radial support power and outer male structure, is anchored at aortic root, realizes valve prosthesis
Steady operation.Fig. 4 is the top view of anchoring effect, as seen from Figure 4, after valve release, the pitch diameter of the outer formation of male structure 3
Much larger than annulus diameter, outer male structure 3 can be effectively resisted against on Wa Shi sinus lower wall and aortic valvular ring, realize valve prosthesis
Reliable anchoring.
Outer male structure 3 is arranged to bending shape, after the first armed lever structure 31 is extended from the node of grid, at flat
It is connect toward external extension with the second armed lever structure 32, the second armed lever structure 32 is configured to the second end to rack body
(efferent tract) direction extends, and outer male structure is integrally similar to the petal opened outside one.Above-mentioned evagination structural distance rack body
The bottom level of one end is 5~15mm, is capable of the height of the good primary leaflet of adaptation, guarantees that outer male structure can be accurate
It is matched to aortic valvular ring, on Wa Shi sinus lower wall.
Further, above-mentioned first armed lever structure 31 is straight-bar, is extended respectively from the node of grid, correspondingly, the second arm
Rod structure 32 is straight-bar, has the second armed lever structure 32 of respective numbers to connect with the first armed lever structure 31, and second armed lever
The other end of structure 32 intersects.
After the rack body 1 expansion, above-mentioned outer male structure extends from the main structure unit of rack body, evagination
The outline diameter of structure is increased compared to the outline diameter of rack body body first end (flowing into road), it is preferred that outer
The outline diameter of male structure is 4~12mm bigger than rack body first end (flowing into road) diameter.
In an embodiment of the present invention, the rack body 1 uses nickel-titanium alloy, preferably uses NiTi superlastic
Property tubing cutting production, the unfoldable shape of diagram is shaped to after technical process by being heat-treated, polishing etc..By Nitinol institute
The shape memory characteristic having, the rack body 1 possess the characteristic of self-expanding, have the retracted configuration of conveying and release
Unfoldable shape.
In the retracted configuration of rack body, the outer male structure can be strapped in the gap of grid cell, therefore be propped up
The outer dimension of frame ontology retracted configuration can be transported to releasing position through stock without obviously becoming larger.Figure 10 illustrates rack body
The retracted configuration of transport status is contained in the gap of neighboring grid cells, rack body after outer male structure 3 is collapsed by compression
It can fully be strapped in the sheath 9 of transportation system.
Heart valve prosthesis of the invention can be intervened through stock, discharged in aortic root, be situated between compared to through the apex of the heart
Enter, wound is small, can effectively improve post-operative recovery time.Compared to the release operation of existing clamping valve, valve of the present invention
Film prosthese is an integral structure, and rack body only needs the i.e. releasable valve prosthesis of post-tensioning sheath, easy to operate, Neng Gouyou when discharging
Effect improves operation time.
To sum up, the various configuration of heart valve prosthesis is described in detail in above-described embodiment, and certainly, the present invention includes
But be not limited in above-mentioned implementation cited configuration, it is any converted on the basis of configuration provided by the above embodiment in
Hold, belongs to the range that the present invention is protected.Those skilled in the art can draw inferences about other cases from one instance according to the content of above-described embodiment.
Each embodiment in this specification is described in a progressive manner, the highlights of each of the examples are with other
The difference of embodiment, the same or similar parts in each embodiment may refer to each other.Foregoing description is only to the present invention
The description of preferred embodiment, not to any restriction of the scope of the invention, the those of ordinary skill in field of the present invention is according to above-mentioned
Any change, the modification that disclosure is done, belong to the protection scope of claims.
Claims (13)
1. a kind of heart valve prosthesis, the heart valve prosthesis is for substituting the intracorporal native valve of people, the native valve
Including annulus, which is characterized in that the heart valve prosthesis includes expandable rack body, is fixed on the rack body
Artificial leaflet and the outer male structure that is arranged on the rack body side wall；When the heart valve prosthesis is placed into human body
Afterwards, the outer male structure is used to be arranged in the top of the annulus, to limit the position of the heart valve prosthesis.
2. heart valve prosthesis as described in claim 1, which is characterized in that the rack body is net column structure, described
Net column structure is formed by multiple mesh, and the mesh is connected by node to be formed, and the rack body includes first end and
Two ends, the first end is for strutting in the annulus, and the second end is equipped with auxiliary unit, for connecting conveying
Sheath；When the rack body is compressed, the outer male structure is collapsed in the mesh.
3. heart valve prosthesis as claimed in claim 2, which is characterized in that the quantity of the outer male structure be it is multiple, each
The outer male structure includes at least two first armed lever structures and the second armed lever knot identical with the first armed lever number of structures
One end of structure, each first armed lever structure connects the net column structure；The other end of each first armed lever structure
One end of the second armed lever structure is connected, the other end of each second armed lever structure is all connected with each other.
4. heart valve prosthesis as claimed in claim 3, which is characterized in that the first armed lever structure and second armed lever
The quantity of structure is all two, and the junction of the first armed lever structure and the second armed lever structure and two described
The junction of two armed lever structures all has arc structure；The outer male structure is in fall relative to the front projection of the rack body
V-shape or inverted u-shaped structure.
5. heart valve prosthesis as claimed in claim 3, which is characterized in that the native valve further includes primary leaflet, until
A few outer male structure further includes cantilever lever, and the cantilever lever is from the other end of the second armed lever structure towards institute
First end extension is stated, for being pierced into the primary leaflet.
6. heart valve prosthesis as claimed in claim 5, which is characterized in that the extending direction of the cantilever lever and the bracket
The axial direction of ontology is parallel.
7. heart valve prosthesis as claimed in claim 4, which is characterized in that between the first armed lever structure and first direction
Angle be in 30 °~90 °, angle between the second armed lever structure and the first direction is in -60 °~60 °, described first
Direction be the first end to the second end direction and the first direction it is equal with the axial direction of the rack body
Row.
8. heart valve prosthesis as claimed in claim 3, which is characterized in that multiple second armed lever structures to the bracket
The distance of ontology is 2mm~6mm.
9. heart valve prosthesis as claimed in claim 3, which is characterized in that the first armed lever structure connects the bracket sheet
One end of body to the rack body first end bottom distance be 5mm~15mm.
10. heart valve prosthesis as claimed in claim 2, which is characterized in that the heart valve prosthesis further includes skirt knot
Structure, the skirt border structure are sewn on the rack body inner sidewall, and are located at the artificial leaflet close to the one of first end
Side.
11. heart valve prosthesis as described in claim 1, which is characterized in that the material of the rack body is Nitinol.
12. heart valve prosthesis as described in claim 1, which is characterized in that the rack body is with the outer male structure
It is integrally formed.
13. heart valve prosthesis as described in claim 1, which is characterized in that the outer male structure is relative to the bracket sheet
The side projection of body is of an L-shaped structure.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710714230.8A CN109394393A (en) | 2017-08-18 | 2017-08-18 | Heart valve prosthesis |
| PCT/CN2018/099680 WO2019033989A1 (en) | 2017-08-18 | 2018-08-09 | Cardiac valve prosthesis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710714230.8A CN109394393A (en) | 2017-08-18 | 2017-08-18 | Heart valve prosthesis |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109394393A true CN109394393A (en) | 2019-03-01 |
Family
ID=65362379
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710714230.8A Pending CN109394393A (en) | 2017-08-18 | 2017-08-18 | Heart valve prosthesis |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN109394393A (en) |
| WO (1) | WO2019033989A1 (en) |
Cited By (5)
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| CN110279495A (en) * | 2019-06-25 | 2019-09-27 | 陈翔 | A kind of self-expanding heart valve prosthesis |
| CN113545890A (en) * | 2021-07-07 | 2021-10-26 | 云南省阜外心血管病医院 | Novel transcatheter mitral valve |
| CN113662716A (en) * | 2021-09-27 | 2021-11-19 | 广东脉搏医疗科技有限公司 | Device for implanting tricuspid valve |
| CN113730039A (en) * | 2021-10-08 | 2021-12-03 | 广东脉搏医疗科技有限公司 | Stent valve |
| WO2022016837A1 (en) * | 2020-07-21 | 2022-01-27 | 江苏臻亿医疗科技有限公司 | Valve stent and artificial heart valve containing same |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114081669A (en) * | 2020-08-25 | 2022-02-25 | 北京市普惠生物医学工程有限公司 | Prosthetic valve and valve delivery system |
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Also Published As
| Publication number | Publication date |
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| WO2019033989A1 (en) | 2019-02-21 |
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