CN203970617U - A kind of property implanted Cardiac valve prosthesis forming ring - Google Patents
A kind of property implanted Cardiac valve prosthesis forming ring Download PDFInfo
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- CN203970617U CN203970617U CN201420389204.4U CN201420389204U CN203970617U CN 203970617 U CN203970617 U CN 203970617U CN 201420389204 U CN201420389204 U CN 201420389204U CN 203970617 U CN203970617 U CN 203970617U
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- inner core
- cardiac valve
- forming ring
- valve prosthesis
- ring
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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
- A61F2/2442—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
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic 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
This utility model relates to Implantable Medical Device field, relates in particular to a kind of property implanted Cardiac valve prosthesis forming ring.This implantation Cardiac valve prosthesis forming ring comprises the inner core of being made up of fiber-reinforced polymer and is wrapped in the flexible jacket on inner core, the shape of the shape of described inner core and cardiac valve lobe ring is consistent, by regulating the content of fortifying fibre and then the rigidity of capable of regulating forming ring, forming ring can be complied with periodic metamorphosis in recovering lobe ring normal size and shape, and myocardial compliance is good; The flexible jacket of inner core outer wrapping, breaking of the platelet that while being conducive to reduce valve-open or close, blood eddy generation causes and hemocyte, prevent the generation of haemolysis, and Cardiac valve prosthesis forming ring of the present utility model can injection mo(u)lding, processing technique is simple.
Description
Technical field
This utility model relates to Implantable Medical Device field, relates in particular to a kind of property implanted Cardiac valve prosthesis forming ring.
Background technology
As everyone knows, human heart comprises four valves, is respectively aortic valve, Bicuspid valve, valve of pulmonary trunk and Tricuspid valve, and four valves all dispose one-way valve to be guaranteed not flow with wrong direction during blood cardiac cycle.In cardiac valvuloplasty field, artificial valve's forming ring is used to repair or rebuild the cardiac valve lobe ring of pathological changes, the case of pure valve (mainly the referring to Bicuspid valve) incompetence that be applicable to that valve and lobe undertissue pathological changes are light, lobe leaf mobility better, mainly causes because of lobe widening of the ring.
Studies show that, annulus of mitral valve is to be nonplanar " shape of a saddle " steric configuration, and along with cardiac cycle generation solid shape and big or small variation, this rate of change reaches 20%-35%, and forming ring mainly contains soft ring, ring and elastic ring three classes firmly in the market.Soft ring is complied with the motion of natural valve lobe ring sphincter in cardiac cycle, size and shape that can Unlimited cyclomorphosis lobe ring, more meet normal physiological situation and anatomical structure compliance, Chinese patent notification number CN2561368Y, disclose the soft ring of a kind of bicuspid valve shaping ring, there is good compliance, but its support and shaping effect are slightly poor, use the patient of soft ring in the process of following up a case by regular visits to, to find to be prone to mitral incompetence recurrence, the higher phenomenon of operability.Although and the hard ring long-term effect of metal hard inner core is stable, can significantly reduce the incidence rate of operation again, destroy physiological annulus of mitral valve solid shape, lose periodic variation, the area on AO and blood flow rate impact are larger.
Desirable forming ring is when better support strength is provided, can effectively adapt to the compound movement of cardiac cycle, reinvent normal mitral annulus structure, therefore research starts to turn to the elastic ring between soft ring and hard ring, to overcome soft ring and hard ring shortcoming separately.But, existing elastic ring or adopt metal laser cutting and punch forming, complex process, or sheet metal is made to helical structure or spring to reach the object that regulates rigidity, there is equally the problem of processing technique complexity; Separately have technical scheme to regulate rigidity by the number of plies of controlling sheet metal strip, its weak point is that the rigidity of sheet metal strip own is larger, and unsatisfactory by number of plies control rigidity effect, the elastic ring myocardial compliance processing is poor.
Therefore,, for above deficiency, this utility model provides a kind of implantation Cardiac valve prosthesis forming ring.
Utility model content
(1) technical problem that will solve
The purpose of this utility model is to provide is a kind ofly convenient to processing and the good implantation Cardiac valve prosthesis forming ring of myocardial compliance with the formability that solves existing forming ring and exist and myocardial compliance cannot be taken into account and the problem of difficult processing.
(2) technical scheme
In order to solve the problems of the technologies described above, this utility model provides a kind of implantation Cardiac valve prosthesis forming ring, it comprises the inner core be made up of fiber-reinforced polymer and is wrapped in the flexible jacket on inner core, and the shape of the shape of described inner core and cardiac valve lobe ring is consistent.
Wherein, the material of described flexible jacket is biocompatibility flannelette.
Wherein, the shape of the shape of described inner core and heart mitral annulus is consistent, and described inner core comprises the front lobe ring and the back lobe ring that are connected.
Wherein, the minimum point of described inner core is the junction of front lobe ring and back lobe ring, and the middle part of described front lobe ring and back lobe ring is bent upwards.
Wherein, described front lobe hoop inside bend.
Wherein, the cross section of described inner core is oval.
Wherein, described inner core is the hollow of solid or lateral opening.
Wherein, the fortifying fibre in described fiber-reinforced polymer is carbon fiber or superhigh molecular weight polyethylene fibers; Polymer in described fiber-reinforced polymer is polyether-ether-ketone, politef, polyamide or polymethyl methacrylate.
Wherein, described fiber-reinforced polymer includes 5%～30% developing agent.
Wherein, the thickness of described flexible jacket is 0.2～0.5mm.
(3) beneficial effect
Technique scheme tool of the present utility model has the following advantages: the implantation Cardiac valve prosthesis forming ring that this utility model provides, because adopting fiber-reinforced polymer, makes inner core, can injection mo(u)lding, simple with respect to metal working process, the design of core shape and structure is abundanter.The rigidity that can adjust forming ring by adjusting the content of fortifying fibre, obtains desirable elastic ring, and forming ring can be complied with periodic metamorphosis in recovering lobe ring normal size and shape, and myocardial compliance is good; Inner core outer wrapping flexible jacket, while being conducive to reduce valve-open or close, blood eddy generation causes breaking of platelet and cell, prevents the generation of haemolysis.
Brief description of the drawings
Fig. 1 is the axonometric chart of this utility model property implanted Cardiac valve prosthesis forming ring embodiment 1;
Fig. 2 is the cross sectional representation of the Cardiac valve prosthesis of the property implanted shown in Fig. 1 forming ring;
Fig. 3 is Bicuspid valve simulation configuration schematic diagram;
Fig. 4 is the cross sectional representation of the property implanted Cardiac valve prosthesis forming ring in this utility model embodiment 2.
In figure, 1: inner core; 2: flexible jacket; 3: front lobe ring; 4: back lobe ring; 5: mitral annulus low spot portion; 6: the first high some portions; 7: the second high some portions.
Detailed description of the invention
Below in conjunction with drawings and Examples, detailed description of the invention of the present utility model is described in further detail.Following examples are used for illustrating this utility model, but are not used for limiting scope of the present utility model.
In description of the present utility model, it will be appreciated that, term " middle part ", " on ", orientation or the position relationship of the instruction such as D score, 'fornt', 'back', " left side ", " right side ", " vertically ", " level ", " top ", " end " " interior ", " outward " be based on orientation shown in the drawings or position relationship, only this utility model and simplified characterization for convenience of description, instead of indicate or imply that the device of indication or element must have specific orientation, construct and operation with specific orientation, therefore can not be interpreted as restriction of the present utility model.In addition, term " first ", " second " be only for describing object, and can not be interpreted as instruction or hint relative importance.
Embodiment 1
As shown in Figure 1, Figure 2 and Figure 3, the implantation Cardiac valve prosthesis forming ring that this utility model provides comprises the inner core 1 of being made up of fiber-reinforced polymer and is wrapped in the flexible jacket 2 on inner core 1, the shape of the shape of described inner core 1 and cardiac valve lobe ring is consistent, and the material of described flexible jacket 2 is biocompatibility flannelette.This forming ring is implanted to cardiac valve place, because inner core 1 adopts fiber reinforced polymer composites, polymer (engineering plastics) wherein has high-modulus, low creep, the feature that fatigue strength is high, can make forming ring comply with the motion of natural valve lobe ring sphincter in cardiac cycle, meet normal physiological situation, in the polymer of inner core 1, added high-performance fiber to strengthen simultaneously, good support strength is provided, pathological changes lobe ring is effectively reinvented, stablize lobe ring structure, eliminate the risk of recurrence distortion, reach good long-term effect, and the flexible jacket of inner core 1 outer wrapping (being biocompatibility flannelette), breaking of the platelet that while being conducive to reduce valve-open or close, blood eddy generation causes and cell, prevent the generation of haemolysis.
Particularly, the shape of described inner core 1 is the result of simulation Bicuspid valve complicated morphological change in cardiac cycle, and consistent with the shape of mitral annulus, described inner core 1 comprises the front lobe ring 3 and the back lobe ring 4 that are connected; The minimum point of described inner core 1 is the junction of front lobe ring 3 and back lobe ring 4, and the middle part of described front lobe ring 3 and back lobe ring 4 is bent upwards.Certainly, the shape of forming ring it is also conceivable that according to other valvular shape design, for the reparation of other lobe ring.Wherein, as shown in Figure 3, Bicuspid valve is three-dimensional saddle configuration, instead of two dimensional surface configuration, being depicted as Bicuspid valve simulation configuration, it comprises front lobe ring portion and back lobe ring portion, the junction of front lobe ring portion and back lobe ring portion is mitral annulus low spot portion 5, the middle part of front lobe ring portion is bent upwards and has the first high some portion 6, and the middle part of back lobe ring portion is bent upwards and has the second high some portion of high some portion 7, the first 6 higher than the second high some portion 7.Like this, above-mentioned forming ring is according to the three-dimensional shape of a saddle structure of Bicuspid valve design, can obviously reduce lobe leaf stress, reduces the risk of ring opening.
Particularly, described front lobe ring 3 is bending to the inside.Like this, be mainly to consider outstanding at systole aortic valve-Bicuspid valve curtain of Bicuspid valve, thereby make forming ring consistent with the form of aortic root-Bicuspid valve curtain projection, prevent that forming ring from causing slightly and blocking aorta efferent tract; Meanwhile, the front lobe ring 3 of inner core 1 and the junction of back lobe ring 4 are the minimum point of inner core 1, and this is mainly to consider that Bicuspid valve is at systole, the moving down of boundary, the junction fibrous triangle body of mitral front lobe ring portion and back lobe ring portion.Usually, the cross section of described inner core 1 is oval.
Particularly, the inner core 1 of fiber-reinforced polymer is carbon fiber reinforced polyether-ether-ketone, wherein also includes developing agent, and flexible jacket 2 is sewed up and overlapped for polyester velvet; Wherein, in carbon fiber reinforced polyether-ether-ketone, the ratio of carbon fiber accounts for 8wt%, and the ratio of developing agent barium sulfate accounts for 8wt%, injection mo(u)lding; Inner core 1 width 2.0mm, thickness 1.4mm, solid, 3 D stereo configuration, 3 sections of 6.0mm that raise up of front lobe ring, the 2.0mm that curves inwardly, back lobe ring 4 3.0mm that raises up; Sewing up cover thickness is 0.3mm, and in stitching cover is wrapped in bracing frame inner core 1, forming ring external diameter is 40.1mm, and forming ring internal diameter is 34mm, and girth is 98.7mm.
Embodiment 2
As shown in Figure 2 and Figure 4, implantation Cardiac valve prosthesis forming ring structure in implantation Cardiac valve prosthesis forming ring and embodiment 1 that this embodiment provides is basic identical, mainly there is following difference in it: what inner core 1 was lateral opening is hollow, and the fortifying fibre in the inner core 1 that fiber-reinforced polymer is made is superhigh molecular weight polyethylene fibers; Polymer in described fiber-reinforced polymer is implantable politef, polyamide or polymethyl methacrylate, and these polymer have high-modulus, low creep, feature that fatigue strength is high.In described fiber-reinforced polymer, also include developing agent barium sulfate, to facilitate postoperative X light to observe lobe ring-type condition.
Particularly, wherein superhigh molecular weight polyethylene fibers accounts for 12wt%, the ratio of developing agent barium sulfate is 15wt%, when inner core 1 injection mo(u)lding, add barium sulfate, inner core 1 width 2.0mm, thickness 1.8mm, inner core 1 is hollow along joining edge opening, 3 D stereo configuration, 3 sections of 6.0mm that raise up of front lobe ring, the 1.0mm that curves inwardly, 4 sections of 3.0mm that raise up of back lobe ring, sewing up cover thickness is 0.4mm, in stitching cover is wrapped in bracing frame inner core 1, forming ring external diameter is 31.8mm, and internal diameter is 26mm, and girth is 78.3mm.Certainly, the thickness of described flexible jacket 2 can be 0.2～0.5mm; The ratio of developing agent barium sulfate can be 5%～30%.
In sum, the implantation Cardiac valve prosthesis forming ring that this utility model provides, inner core 1 adopts fiber-reinforced polymer to make, by adjusting the content of fortifying fibre and then the rigidity of capable of regulating forming ring, processing technique is simple, and in the process of inner core 1 injection mo(u)lding, adds developing agent to facilitate clinical follow lobe ring-type condition; Inner core 1 outer wrapping flexible jacket 2, while being conducive to reduce valve-open or close, blood eddy generation causes breaking of platelet and cell, prevents the generation of haemolysis; Inner core 1 is the rigidity that solid or hollow selection can auxiliary adjustment forming ring, in the hollow situation that inner core 1 is lateral opening, while sewing up flexible jacket 2, facilitates inserting needle along opening in the outside of inner core 1.
The above is only preferred implementation of the present utility model; should be understood that; for those skilled in the art; do not departing under the prerequisite of this utility model know-why; can also make some improvement and modification, these improve and modification also should be considered as protection domain of the present utility model.
Claims (10)
1. the property implanted a Cardiac valve prosthesis forming ring, is characterized in that: described forming ring comprises the inner core of being made up of fiber-reinforced polymer and be wrapped in the flexible jacket on inner core, and the shape of the shape of described inner core and cardiac valve lobe ring is consistent.
2. implantation Cardiac valve prosthesis forming ring according to claim 1, is characterized in that: the material of described flexible jacket is biocompatibility flannelette.
3. implantation Cardiac valve prosthesis forming ring according to claim 1, is characterized in that: the shape of the shape of described inner core and heart mitral annulus is consistent, described inner core comprises the front lobe ring and the back lobe ring that are connected.
4. implantation Cardiac valve prosthesis forming ring according to claim 3, is characterized in that: the minimum point of described inner core is the junction of front lobe ring and back lobe ring, and the middle part of described front lobe ring and back lobe ring is bent upwards.
5. implantation Cardiac valve prosthesis forming ring according to claim 4, is characterized in that: described front lobe hoop inside bend.
6. implantation Cardiac valve prosthesis forming ring according to claim 1, is characterized in that: the cross section of described inner core is for oval.
7. implantation Cardiac valve prosthesis forming ring according to claim 6, is characterized in that: described inner core is the hollow of solid or lateral opening.
8. implantation Cardiac valve prosthesis forming ring according to claim 1, is characterized in that: the fortifying fibre in described fiber-reinforced polymer is carbon fiber or superhigh molecular weight polyethylene fibers; Polymer in described fiber-reinforced polymer is polyether-ether-ketone, politef, polyamide or polymethyl methacrylate.
9. implantation Cardiac valve prosthesis forming ring according to claim 1, is characterized in that: described fiber-reinforced polymer includes 5%～30% developing agent.
10. implantation Cardiac valve prosthesis forming ring according to claim 1, is characterized in that: the thickness of described flexible jacket is 0.2～0.5mm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201420389204.4U CN203970617U (en) | 2014-07-14 | 2014-07-14 | A kind of property implanted Cardiac valve prosthesis forming ring |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201420389204.4U CN203970617U (en) | 2014-07-14 | 2014-07-14 | A kind of property implanted Cardiac valve prosthesis forming ring |
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| Publication Number | Publication Date |
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| CN203970617U true CN203970617U (en) | 2014-12-03 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201420389204.4U Active CN203970617U (en) | 2014-07-14 | 2014-07-14 | A kind of property implanted Cardiac valve prosthesis forming ring |
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| CN (1) | CN203970617U (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3406225A1 (en) * | 2017-05-23 | 2018-11-28 | Medtentia International Ltd Oy | Annuloplasty implant |
| CN109415678A (en) * | 2016-06-03 | 2019-03-01 | 乔治-奥古斯特-哥廷根公法基金会大学的大学医学院 | Orifice plate |
-
2014
- 2014-07-14 CN CN201420389204.4U patent/CN203970617U/en active Active
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109415678A (en) * | 2016-06-03 | 2019-03-01 | 乔治-奥古斯特-哥廷根公法基金会大学的大学医学院 | Orifice plate |
| CN109415678B (en) * | 2016-06-03 | 2022-06-14 | 乔治-奥古斯特-哥廷根公法基金会大学的大学医学院 | Orifice plate |
| EP3406225A1 (en) * | 2017-05-23 | 2018-11-28 | Medtentia International Ltd Oy | Annuloplasty implant |
| WO2018215494A1 (en) * | 2017-05-23 | 2018-11-29 | Medtentia International Ltd Oy | Annuloplasty implant |
| CN110785147A (en) * | 2017-05-23 | 2020-02-11 | 梅德坦提亚国际有限公司 | Annuloplasty implant |
| JP2020520729A (en) * | 2017-05-23 | 2020-07-16 | メドテンティア・インターナショナル・リミテッド・オサケユキチュアＭｅｄｔｅｎｔｉａ Ｉｎｔｅｒｎａｔｉｏｎａｌ Ｌｔｄ Ｏｙ | Annuloplasty implant |
| US11510781B2 (en) | 2017-05-23 | 2022-11-29 | Medtentia International Ltd Oy | Annuloplasty implant |
| CN110785147B (en) * | 2017-05-23 | 2023-02-17 | 梅德坦提亚国际有限公司 | Annuloplasty implant |
| JP7318163B2 (en) | 2017-05-23 | 2023-08-01 | エイチブイアール カーディオ オーイー | annuloplasty implant |
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |