CN107411849B - Anti- perivalvular leakage is through conduit valve system and method for implantation - Google Patents
Anti- perivalvular leakage is through conduit valve system and method for implantation Download PDFInfo
- Publication number
- CN107411849B CN107411849B CN201710733384.1A CN201710733384A CN107411849B CN 107411849 B CN107411849 B CN 107411849B CN 201710733384 A CN201710733384 A CN 201710733384A CN 107411849 B CN107411849 B CN 107411849B
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- Prior art keywords
- valve
- perivalvular leakage
- conduit
- implantation
- fixed part
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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
-
- 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/243—Deployment by mechanical expansion
- A61F2/2433—Deployment by mechanical expansion using balloon catheter
-
- 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
- A61F2/2466—Delivery devices therefor
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- 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)
- Mechanical Engineering (AREA)
- Prostheses (AREA)
Abstract
The present invention provides a kind of through conduit valve system.It is of the invention through conduit valve system, including valve member and with the independent anti-perivalvular leakage part of valve member.Valve member includes valve frame, leaflet, sealed skirt and the suture that leaflet, valve frame are connected with sealed skirt.Anti- perivalvular leakage part is independently of valve member comprising fixed part and hermetic unit, wherein fixed part is used for anti-perivalvular leakage anchoring portions in diseased valve corresponding position, perivalvular leakage part for tamp after valve implantation it is adherent it is bad caused by gap.First anti-perivalvular leakage part is implanted when operation, then valve member implants again, then adherent preferable position, the valve of implantation is compacted anti-perivalvular leakage part hermetic unit；Adherent undesirable part, hermetic unit then not sufficiently compression, can be filled corresponding gap.Of the invention can effectively reduce delivery diameter through conduit valve system, and more effectively different anti-perivalvular leakage parts can be selected to design according to the lesion characteristics of different implantation points, the incidence of the perivalvular leakage after the implantation of conduit valve can be greatly reduced.
Description
Technical field
The invention belongs to the field of medical instrument technology, and in particular to a kind of through conduit valve system.
Background technique
Through conduit valve because needing out chest unlike surgical operation, has many advantages, such as that wound is small, rehabilitation is fast, make in recent years
For a kind of deep favor by doctor of new technology.Mainly pass through transportation system through conduit valve to be conveyed, need before implantation
First valve is mounted in transportation system, needs that valve is transported to diseased region by transportation system in implantation process.
Although having been achieved for fast development through conduit valve, the especially nearest more than ten years.But there are still the height of implantation process
Vascular complication and implantation after high perivalvular leakage incidence the problems such as, particularly with the patient of severe calcification, perivalvular leakage hair
Raw rate is then more serious.Problems directly reduce the late result after valve implantation, increase reoperation following and dead
The incidence died, and limit its application to more extensive crowds such as low danger patients.
At present for the design method of reduction valve perivalvular leakage, there is the anti-valve of Edward SAPIEN3 in commercial product in the world
The internal injection molding inflated design of all skirt designs, Directflow；Include valve frame structural design optimization, increase in the mode of research at present
The modes such as material can be expanded in vivo by adding.But for Direcflow valve, the mode for the sizing being molded in vivo can have really
Effect ground adequately filling valve it is adherent it is bad caused by gap, but because its internal injection molding cause whole valve support strength compared with
Low, there are problems for leaflet folding, this valve Market Feedback is bad at present；The design of other way, because being more than the addition of material,
So that the delivery diameter of whole system is excessively high after the press fitting of valve, the use in small-diameter intravascular is influenced, is easy to increase valve
The vascular complication of implantation process also influence operation when valve recycling and release, therefore be simultaneously as increased material
Balance various aspects influence, can increased sealing material it is preferential, the incidence of perivalvular leakage can be reduced to a certain extent, but still
So have the generation of major part perivalvular leakage incidence.
Furthermore correlative study shows the patient for calcification, and relatively easy, current knot occurs for leaflet pairing position perivalvular leakage
The design of structure, to enable the covering leaflet pairing region completed of anti-perivalvular leakage sealing structure of design, then relative difficulty；Such as
It is completely covered, sealing group's design wants sufficiently high, if excessively high sealed skirt misoperation easilys lead to the blocking of coronary artery mouth.
Summary of the invention
The present invention provides a kind of through conduit valve system and method for implantation, which can effectively reduce delivery diameter and subtract
While few vascular complication, different anti-perivalvular leakage parts can be implanted into according to the lesion characteristics of different implantation points and designed, pole
The incidence of big reduction perivalvular leakage after the implantation of conduit valve.
The present invention provides a kind of through conduit valve system, which is characterized in that including valve member and with valve member independence
Anti- perivalvular leakage part.Valve member includes valve frame, leaflet, sealed skirt and the suture that leaflet, valve frame are connected with sealed skirt.
Anti- perivalvular leakage part is independently of valve member comprising fixed part and hermetic unit, wherein fixed part was used for anti-valve week
Leak anchoring portions in diseased valve corresponding position, perivalvular leakage part for tamp after valve implantation it is adherent it is bad caused by gap.
Further, the anti-perivalvular leakage part, the main body of fixed part are using memory alloy structure, now in vitro
It is installed in the conduit of transportation system, automatically reverts to design structure after release in vivo and is fixed to implantation position.
The main body of the anti-perivalvular leakage part, fixed part can also be arbitrarily available biomaterial, such as cochrome, titanium
Alloy, medical stainless steel, polymer and degradable polymer etc.；It is mounted on foley's tube in vitro now, into internal
Implantation position is fixed to by balloon expandable afterwards.
It further, is a closed-loop construct after anti-its fixed part of perivalvular leakage part release.
In one embodiment, bottom is a closed-loop construct after anti-its fixed part of perivalvular leakage part release, and
The beam that three leaflets hold up the position of zygonema there are three, and towards the direction of valve blood flow.
Further, the hermetic unit is centered around the periphery of fixed part.
Further, the hermetic unit can for biomaterial production fabric, absorb expandable material and it is any its
He has certain elasticity and material that is flexible compressible and can stopping blood.
In addition, the fixed part of above-mentioned anti-perivalvular leakage part, is designed for valve positioning thereon, valve displacement knot is prevented
Structure cooperates with it after valve implantation, prevents valve from shifting.
Further, the fixed part of anti-perivalvular leakage part designs thereon 1-3 positioning hangnail, for grabbing card nature valve
Leaf, convenient for the positioning at anti-perivalvular leakage position.
Method for implantation present invention provides this kind through conduit valve, specifically, when operation, it first will be through conduit valve system
Independent anti-perivalvular leakage of uniting is partially implanted in vivo, then again by implanting through conduit valve, and in the anti-valve being first implanted into
All drain structures are cooperated.
It is of the invention while can effectively reduce delivery diameter through conduit valve system and reduce vascular complication, greatly
Reduction through conduit valve implantation after perivalvular leakage incidence.The lesion characteristics that can be put simultaneously according to different implantation are convenient
The different anti-perivalvular leakage part design of implantation.It is asked more particularly to which severe calcification patient's leaflet pairing position perivalvular leakage is effectively reduced
The problem of inscribing, and the blocking of coronary artery mouth be less likely to occur.
Detailed description of the invention
Fig. 1 is the anti-perivalvular leakage of an embodiment through conduit valve system schematic diagram；
Fig. 2 is the anti-perivalvular leakage of embodiment schematic diagram after the anti-perivalvular leakage part expansion of conduit valve system；
Fig. 3 is the anti-perivalvular leakage of embodiment schematic diagram after the anti-perivalvular leakage part press fitting of conduit valve system；
Fig. 4 is the anti-perivalvular leakage of an embodiment through anti-schematic diagram of the perivalvular leakage part with vertical beam structure of conduit valve system；
Fig. 5 is expansion signal of the anti-perivalvular leakage of another embodiment through the anti-perivalvular leakage part of conduit valve system with three-legged structure
Figure；
Fig. 6, card nature valve valve is grabbed through the anti-perivalvular leakage part band hangnail of conduit valve system for the anti-perivalvular leakage of an embodiment
Impeller structure schematic diagram；
Fig. 7 grabs card nature valve valve through the anti-perivalvular leakage part band hangnail of conduit valve system for the anti-perivalvular leakage of another embodiment
The expanded schematic diagram of impeller structure；
Specific embodiment
To make the object, technical solutions and advantages of the present invention clearer, below in conjunction with attached drawing of the invention and implementation
Example, technical scheme in the embodiment of the invention is clearly and completely described, it is clear that described embodiment is the present invention
A part of the embodiment, instead of all the embodiments.Based on the embodiments of the present invention, those of ordinary skill in the art are not having
Every other embodiment obtained under the premise of creative work is made, shall fall within the protection scope of the present invention.
It is of the invention through conduit valve system in conjunction with shown in Fig. 1 to Fig. 6, including valve member 1 and independent anti-with valve
Perivalvular leakage part 2.Valve member includes valve frame 101, leaflet 102, sealed skirt 103 and for connecting leaflet, valve frame and sealed skirt
Suture 104.It include main part 201 and hermetic unit 202 with the independent anti-perivalvular leakage part of valve.
The valve member through conduit valve system can be in any on the market valve of listing or other exploitations
Any valve that can be matched with anti-perivalvular leakage part, such as using Nitinol valve frame from swollen valve, or use ball
The ball that capsule carries out expansion implantation expands valve.
The anti-perivalvular leakage part through conduit valve system, is divided into main part and hermetic unit, main part is mainly used
In anti-perivalvular leakage part is fixed on the corresponding position of nature valve, hermetic unit is for tamping adherent after valve implantation bad make
At gap.
Fig. 2 and Fig. 3 is respectively status diagram after anti-perivalvular leakage part expansion and compression.The material of main part can select
With memorial alloy, it is made to be designed to that the structure into transportation system can be compressed in vitro, required for being expanded to after implanting
Structure, so that it is fixed on the corresponding position of nature annulus.Its shape can simply be set as the annular shape of closure, preferably round
Ring also can according to need and be designed as part circle or other shapes.Then it is wrapped around one layer of hermetic unit in the outside of annulus,
Hermetic unit is the fabric of any biocompatible material production, and absorbing expandable material and any other has certain elasticity
With it is flexible compressible and the material of blood can be stopped.For example hermetic unit can be for using polyester or polytetrafluoroethylene material
Then manufactured fabric is wound or is sewn into the periphery of main part.In vitro when position, and with main part
The compression divided is also compressed into transportation system simultaneously；After in implantation, after release, main part automatically reverts to the shape of setting
Shape, while also the hermetic unit of periphery being driven to be returned to corresponding shape.Hermetic unit can also use water uptake expansion material, than
Such as hydrogel, the moisture expansion in blood is absorbed after implanting, because gap is bigger, expansion is usually more abundant, therefore
Its sealing performance relative fiber fabric is more preferable.
It after anti-perivalvular leakage part implantation, then will be implanted into through conduit valve, because of the presence of anti-perivalvular leakage part, through conduit valve
Film it is adherent it is bad caused by gap, can be filled by anti-perivalvular leakage part.Main part is softer, and its filling capacity is better, but
Its stationkeeping ability can be poorer.The implantation in advance of anti-perivalvular leakage part is added on valve relative to by anti-perivalvular leakage part, reduces
The material of valve entirety, considerably reduces the delivery diameter of valve, further reduced the incidence of perivalvular leakage.
The anti-perivalvular leakage body part obtains material can also be using the other any available lifes gone out outside Nitinol
Object material, such as cochrome, titanium alloy, medical stainless steel, polymer and degradable polymer；It can be designed as
Structure can be compressed to obtain in vitro, is compressed it on foley's tube in vitro, and internal corresponding position is transported to by foley's tube
It sets, then so that main part is expanded to the shape of design by dilating sacculus, its expansion is made to be fixed to implantation position.
Relatively other positions of backflowing under normal conditions in the presence of calcification, between the seam point valve below of three leaflets at triangle
Setting again can be more serious, or the part more serious for certain calcification points, can correspond to more serious perivalvular leakage position.It is right
In this case, the main body of anti-perivalvular leakage part can be improved to design, for example the influent stream end reference of main body is designed above
For a close ring, three vertical beams then are set in three leaflet corresponding positions, a triangle also can be set
Amount will also be simutaneously arranged corresponding hermetic unit, can thus plant in this section between insertion valve at triangle just on vertical beam
After entering, the anti-raw rate of the perivalvular leakage of three leaflet pairing parts is reduced.For specific calcification situation, can draw in calcification correspondence
Corresponding beam or other structures are arranged in the position of the perivalvular leakage risen, then wrap up corresponding hermetic unit in its periphery, and then drop
The perivalvular leakage at this low position.Its topology example is as shown in Figure 4 and Figure 5.
For the positioning convenient for anti-perivalvular leakage part, corresponding location structure can be designed, make it easier to be fixed to pair
The valve implantation position answered will not be impacted lower displacement by blood flow or can not fix.Such as it can be by the band of Design of Main Structure
There are 3 barb structures, as shown in Figure 6 and Figure 7, the leaflet that can block nature valve prevents anti-perivalvular leakage partial movement.
For example after conduit valve is implanted to aortic position, three barb structures can block the leaflet of three aortas, work as blood
When under flow direction, the intra-ventricle that anti-perivalvular leakage part enters can be effectively prevented.The periphery of barbed portion is usually not provided with sealing
Part.
In addition some structures can also be designed on anti-perivalvular leakage part, for fixed implantation through conduit valve.Such as
Corresponding groove or protrusion are set, corresponding protrusion or groove are also provided on corresponding valve, is fallen on just after being implanted into it
On the corresponding groove of anti-valve circumferential portion or protrusion, playing fixed function to the valve of implantation prevents valve from shifting.It can also be in valve
It is equipped with corresponding barb or buckle on upper or anti-perivalvular leakage part, enables both fixation of working in coordination.
When the valve surgery of the invention, usually independent anti-perivalvular leakage will be first partially implanted in vivo through conduit system,
Then again by implanting through conduit valve, and cooperated in the anti-perivalvular leakage structure being first implanted into.The two can also be set
It counts onto a transportation system, when operation, first discharges anti-perivalvular leakage part, after release, discharge valve member again.
Finally it should be noted that：The above embodiments are only used to illustrate the technical solution of the present invention., rather than its limitations；To the greatest extent
Present invention has been described in detail with reference to the aforementioned embodiments for pipe, those skilled in the art should understand that：Its according to
So be possible to modify the technical solutions described in the foregoing embodiments, or to some or all of the technical features into
Row equivalent replacement；And these are modified or replaceed, various embodiments of the present invention technology that it does not separate the essence of the corresponding technical solution
The range of scheme.
Claims (7)
1. a kind of through conduit valve system, which is characterized in that including valve member and with the independent anti-perivalvular leakage portion of valve member
Point, valve member includes valve frame, leaflet, sealed skirt and the suture that leaflet, valve frame are connected with sealed skirt, anti-perivalvular leakage part
Independently of valve member comprising fixed part and hermetic unit, wherein fixed part is for existing anti-perivalvular leakage anchoring portions
Diseased valve corresponding position, design has 1-3 positioning hangnail on fixed part, for grabbing card nature leaflet, convenient for anti-perivalvular leakage
The positioning at position, anti-perivalvular leakage part for tamp valve implantation after it is adherent it is bad caused by gap.
2. according to claim 1 through conduit valve system, which is characterized in that the anti-perivalvular leakage part, fixed part
The main body divided is to be installed in vitro in the conduit of transportation system now using memory alloy structure, is automatically replied after release in vivo
To design structure and it is fixed to implantation position.
3. according to claim 1 through conduit valve system, which is characterized in that the anti-perivalvular leakage part, fixed part
The main body divided is arbitrarily available biomaterial, such as cochrome, titanium alloy, medical stainless steel, polymer and degradable polymerization
Object etc.；It is mounted on foley's tube in vitro now, is fixed to implantation position by balloon expandable into rear in vivo.
4. according to claim 1 through conduit valve system, which is characterized in that described anti-its fixed part of perivalvular leakage part
It is a closed-loop construct after release.
5. according to claim 1 through conduit valve system, which is characterized in that described anti-its fixed part of perivalvular leakage part
Bottom is a closed-loop construct after release, and the beam holded up in position of three leaflets to zygonema there are three, and towards valve
The direction of blood flow.
6. according to claim 1 through conduit valve system, which is characterized in that the hermetic unit is centered around fixed part
Periphery.
7. according to claim 1 through conduit valve system, which is characterized in that the hermetic unit is biomaterial production
Fabric, absorbing expandable material and other has certain material that is elastic and flexible compressible and can stopping blood.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710733384.1A CN107411849B (en) | 2017-08-24 | 2017-08-24 | Anti- perivalvular leakage is through conduit valve system and method for implantation |
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|---|---|---|---|
| CN201710733384.1A CN107411849B (en) | 2017-08-24 | 2017-08-24 | Anti- perivalvular leakage is through conduit valve system and method for implantation |
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| CN107411849A CN107411849A (en) | 2017-12-01 |
| CN107411849B true CN107411849B (en) | 2018-11-30 |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109259829A (en) * | 2018-11-30 | 2019-01-25 | 谭昌明 | Artificial Intervention valve is adapted to mounting ring |
| CN109259830A (en) * | 2018-11-30 | 2019-01-25 | 谭昌明 | Artificial Intervention valve is adapted to mounting ring |
| CN109985274A (en) * | 2019-03-28 | 2019-07-09 | 北京航空航天大学 | Organizational project with regeneration function is through conduit valve skirt body and preparation method thereof |
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| EP3146938A1 (en) * | 2005-05-27 | 2017-03-29 | Hlt, Inc. | Intravascular cuff |
| CN105232187A (en) * | 2011-09-09 | 2016-01-13 | 安多拉米诺科学公司 | Means for controlled sealing of endovascular devices |
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| Publication number | Publication date |
|---|---|
| CN107411849A (en) | 2017-12-01 |
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