CN106510901B - A kind of new folding sticking patch integration circularizes design - Google Patents
A kind of new folding sticking patch integration circularizes design Download PDFInfo
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- CN106510901B CN106510901B CN201611045190.4A CN201611045190A CN106510901B CN 106510901 B CN106510901 B CN 106510901B CN 201611045190 A CN201611045190 A CN 201611045190A CN 106510901 B CN106510901 B CN 106510901B
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- sticking patch
- folding sticking
- folding
- patch
- loop section
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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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
-
- 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
-
- 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
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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)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Abstract
The present invention relates to a kind of new folding sticking patch, the folding sticking patch includes patch portion and shaping loop section, and patch portion and shaping loop section link into an integrated entity, and shaping loop section is folded by patch portion one end and forms or be connected with other materials.Its advantage is shown:The present invention is by the securing forming ring of the edge fold of sticking patch, unfolded position is as leaflet used in leaflet Enlargement simultaneously, it is designed as arbitrarily reducing structure, because the elasticity of patching material is more than forming ring general at present, surgical effect is improved, while reduces the use of operation forming ring.Anticalcium processing method and the pericardium of dry method Techniques of preserving processing is selected to reduce tissue toxicity's reaction that free aldehyde is brought as patching material simultaneously.
Description
Technical field
The present invention relates to the field of medical instrument technology, are a kind of new sticking patch for possessing shaping ring function specifically.
Background technology
The processing of children's mitral reflux lesion, because the problems such as diversity of lesion mechanism, children are potentially developed, makes
Obtaining it becomes one of difficult point of cardiac operation.
Treatment currently for mitral reflux mainly uses valve reparation and valve replacement;But valve replacement is frequently with machine
Tool valve not only lacks the mechanical prosthetic valve met applied to children in the market, and the mechanical prosthetic valve after displacement can not also meet development in children
Demand, meanwhile, mechanical prosthetic valve needs lifelong anti-freezing, brings additional drug risk.In addition, the rigid structure of mechanical prosthetic valve can not expire
Sole center room relax contracting movement when valve deformability, the later stage destroy ventricular function.And valve reparation art can maximumlly keep valve
The natural structure and form of film, meet children's upgrowth and development, lifelong anti-freezing are not required, therefore children's mitral reflux lesion is adopted more
With prosthetic therapeutic scheme.
Child for treatment mitral reflux generally use adjusts key rope and papillary muscle and the artificial key rope reducing key rope of increase is long
The methods of spending changes prolapse of valve cusp, while increases leaflet pairing area using forming ring ligamentopexis and/or leaflet Enlargement and carry out
The mode of reparation, which reduces, backflows.Forming ring ligamentopexis carries out tightening fixed lobes using valve forming ring to the valve annulus of expansion
Ring, leaflet pairing distance before and after reduction because loopful fixation limits the growth and development of annulus after reparation, are mostly added using semi-ring at present
The scheme of ring after Gu.
Valve forming ring material is relatively hard, and surgical procedure length can not be cut out on demand, and because semi-ring forming ring
Fix the valve annulus position it is still long, existing on the growth of children influences, simultaneously as the use of forming ring add it is additional
Equipment cost.Untreated pericardium item is faced with later stage calcification, the risk degenerated.Leaflet expansion uses more to be handled through glutaraldehyde
Vein graft or pericardium sticking patch, Vein graft or pericardium sticking patch are preserved using liquid glutaraldehyde, the processing of anti-Calcific technology, penta 2
The heavy metal that aldehyde and currently used anti-Calcific technology processing are brought is left to react with potential tissue toxicity, and after presence
Phase degeneration, calcification problem.
The content of the invention
The purpose of the present invention is being directed to deficiency of the prior art, a kind of sticking patch for treating children's mitral reflux is provided.
Another purpose of the present invention is to provide the application of the sticking patch for the treatment of children's mitral reflux.
To achieve the above object, the present invention adopts the technical scheme that:A kind of folding for treating children's mitral reflux is mended
Piece, the folding sticking patch include patch portion and shaping loop section, and patch portion and shaping loop section link into an integrated entity, shape
Loop section is folded by patch portion one end and forms or be connected with other materials.
The forming ring is partially folded into 2~7 layers.
The forming ring is partially folded into 3~5 layers.
Between every layer of the shaping loop section or the outer layer of sticking patch entirety is folded with a floor height molecular material.
The high molecular material is mylar or teflon cloth.
The mylar and teflon cloth have certain elasticity.
The material of the folding sticking patch is pericardium material.
Different interlayers are sewn into an entirety by the shaping loop section by suture, and each stitch is independently formed by knots tied
Independent unit.
To realize above-mentioned second purpose, the present invention adopts the technical scheme that:The folding sticking patch is preparing treatment
Application in the medical instrument of children's mitral reflux.
The invention has the advantages that:
The present invention is by the securing forming ring of the edge fold of sticking patch, while unfolded position is as leaflet Enlargement
Used leaflet is designed as arbitrarily reducing structure, because the elasticity of patching material is more than forming ring general at present, improves
Surgical effect, while reduce the use of operation forming ring.Anticalcium processing method and dry method Techniques of preserving is selected to handle simultaneously
Pericardium as patching material, reduce tissue toxicity's reaction that free aldehyde is brought.
Description of the drawings
Attached drawing 1 is the structure diagram of the new sticking patch of the present invention.
Attached drawing 2 is the fixed schematic diagram of forming ring.
Attached drawing 3 is the schematic diagram of leaflet dilatation and forming ring fixing joint reparation.
Attached drawing 4 is the conventional steps schematic diagram of valve reparation.
Specific embodiment
It elaborates below in conjunction with the accompanying drawings to specific embodiment provided by the invention.
Reference numeral and component involved in attached drawing is as follows:
1st, patch portion
2nd, loop section is shaped
3rd, suture
Embodiment 1
Treatment currently for mitral reflux mainly uses valve reparation and valve replacement method.Valve replacement often uses machine
Tool valve change valve processing, yet with children's annulus area is small, tissue is fragile, be difficult currently on the market find suitable children should
Mechanical prosthetic valve.Even if searching out a kind of mechanical prosthetic valve for meeting Individual Size at that time, in face of the infant of continuous growth and development, machinery
Valve is faced with the problem of causing valvular stenosis again, i.e. mechanical prosthetic valve can not meet the growth and development needs of children.Mechanical valve prosthesis it is firm
Property structure can cause the imbalance of ventricle systolic and diastolic function again, and the left heart function in later stage is caused to decline.Meanwhile the application of mechanical prosthetic valve needs
Lifelong anticoagulant therapy, and for the children developed for one, then need the dosage of constantly adjustment anticoagulant.In addition,
Mechanical prosthetic valve cost is high, and operating substitution not only increases operation risk repeatedly, and brings additional financial burden.
And valve reparation art is maximumlly maintained by carrying out local route repair to the dissection reason for causing mitral reflux
Annulus and the original natural structure of valve and form, ensure that the functionality of valve;Meanwhile the valve of reparation can meet children's life
The needs of long development, in addition, lifelong anticoagulant therapy is not required in valve reparation art.Based on considerations above, valve reparation art by
Gradually become the preferred manner that surgeon treats children's mitral valve disease.
The repairing and treating of mitral reflux substantially uses three-step-march scheme at present:
1) under valve auxiliary equipment (chordae tendineae, papillary muscle) reparation:Improve the leaflet (A, B) of prolapsus, increase the work of leaflet
Dynamic property (C), as shown in Figure 4.
2) ligamentopexis is shaped:The annulus of expansion is tightened, the pairing distance such as attached drawing 2 of leaflet before and after reduction.
3) leaflet Enlargement:The pairing area of leaflet before and after raising, as shown in Figure 3.
In children's mitral reflux mechanism, anterior mitral valve is tediously long, prolapsus, and bicuspid valve back lobe chordae tendineae is short and small, Office blade faces
Product is small, lifts difficulty, and with preceding valve Poor fitness, this often causes the main mechanism to backflow.Annuloplasty ligamentopexis is not
It only tightens widened annulus and consolidates this state, moreover it is possible to raise the height of back lobe annulus, increase the pairing with preceding valve.Therefore,
Annuloplasty ligamentopexis is considered as to treat the most key step of children's mitral reflux.
Simultaneously as loopful fixation limits the further growth development of annulus, therefore, at present mostly using the half of rear annulus
Ring is fixed, with the continued growth of annulus before permission;In addition, the study found that by the use of untreated pericardium item as the fixation of annulus
Material, certain time is interior to find the complete endothelialization of pericardium item, is blended with annulus tissue.
Above-mentioned mitral valve repair scheme has been confirmed to achieve good clinical effectiveness by multinomial center, however, prosthetic
Equally it is faced with the problem performed the operation again.This mainly expands the long-term effect that material and annulus fix material with sticking patch bad has
It closes.
At present, the clinical material commonly used for sticking patch expansion includes:Self or allogeneic pericardium and artificial mesh
Material, and artificial mesh material can be divided into two major class of dacron patch and biological sticking patch.Vein graft good biocompatibility, but number
Measure it is limited, while Vein graft at present be applied to valve Enlargement before often need to be fixed with glutaraldehyde solution, operation could be met
It is required that.And pass through the fixed pericardium of glutaraldehyde, potential tissue toxicity's reaction is not only brought, long term is it has also been found that material can face
The problems such as regression, calcification, allogeneic pericardium material source is extensive, however the immunogenicity between Different Individual limits it
In clinical further application, the allosome pericardium material by acellular can not usually meet the mechanics demand of clinical practice.
Meanwhile the application of allosome material the problems such as also facing Ethic review.Dacron patch is made of synthesis high molecular material, produces skill
Art is ripe, is widely used in heart surgical department field.But the problems such as leakage blood/oozing of blood easily occurs, influences repair efficiency.Its bio-compatible
Property also not as good as self or allosome pericardium and biological sticking patch, inflammatory reaction easily occurs.
Biological sticking patch is typically derived from the pericardium material of healthy ox, is handled by special chemical method, is handed over to tissue
While connection is fixed, its immunogenicity is reduced, is the repairing material of a kind of heart surgical department with preferable biocompatibility generally believed
Material.Bovine pericardium is made of multilayer collagenous fibres, compact structure, the problems such as being not only avoided that oozing of blood, but also due to biocompatibility
Good, inflammatory reaction risk is low, is more advantageous to autologous tissue's growth after repairing.
It is fixed for annulus, valve forming ring material currently on the market is relatively hard, and surgical procedure can not be on demand
Length is cut out, and the long growth on children in fix the valve annulus position has influence.Meanwhile when ventricular contraction, diastole campaign, annulus
Shape can occur to change accordingly, according to the shaping ring material that flexibility is poor, can destroy the original deformation of annulus, cause the heart
Room systolic and diastolic function is disorderly, causes the ventricular dysfunction in later stage.And although untreated pericardium item flexibility is good, ensure that valve
Deformability of the ring when ventricle relaxes contracting movement, certain time is interior it has also been found that the complete endothelialization of pericardium item, mutually melts with annulus tissue
It closes, but it is faced with potential later stage calcification, regression risk.
Present invention employs a kind of new and easy sticking patch forming ring integrated designs.Material through special chemical by handling
Biological sticking patch form, shaping loop section by patching material by repeatedly folding.Sticking patch is repeatedly folded in reserved materials
The toughness of the structure is strengthened while flexibility, plays the role of being equivalent to forming ring in annulus ligamentopexis.The layer of folding
Number generally selects 2-7 layers, and 3-5 layers are optimal.By different layers before by connecting and composing an entirety after folding.What is connected is each
Unit is mutual indepedent, and the firmness for not destroying other connection units can be cut out between each unit.Connection can will not by suture
An entirety is sewn into interlayer, each stitch is independently formed by knots tied independent unit.Doctor can be according to actual needs ruler
It is very little, it is cut out between each stitch by surgical scissors, obtains the size of actual needs.Because each stitch is mutual indepedent, cut out
The behavior burst at the seams is not present in each stitch afterwards, still is able to the firmness for keeping every interlayer connection whole.
Every interlayer of loop section sticking patch folding or the outside of entire folded portion are shaped, high molecular material can be added, led to
It is medical mylar and teflon cloth often to add, and by two kinds of woven relative relaxations of cloth during weaving, has certain elasticity.
The addition of cloth can increase the intensity of sticking patch puckered ring suture, while more conducively growth of the endothelial cell on cloth, promote endothelium
Change.
Meanwhile after the processing, valve member can become more to step up in structure due to the influence of folded portion
It causes, is conducive to surgical procedure.This integrated annulus valve designs, it can also be ensured that surgeon according to actual needs, cuts out
Meet the valve of the optimal size and shape of infant and leaflet structure, applied to different individuals, one kind is provided for mitral valve repair
Extensive material source.
Anticalcium processing method and dry method Techniques of preserving.Treatment process is free of heavy metal, and departing from conventional glutaraldehyde
Liquid is preserved, reduces tissue toxicity's reaction that free aldehyde is brought
The present invention provides a kind of new sticking patch, by the securing forming ring of the edge fold of sticking patch, and meanwhile it is unfolded
Position is designed as arbitrarily reducing structure, because the elasticity of patching material is more than at present as leaflet used in leaflet Enlargement
General forming ring improves surgical effect, while reduces the use of operation forming ring.Select anticalcium processing method simultaneously
Pericardium with the processing of dry method Techniques of preserving reduces tissue toxicity's reaction that free aldehyde is brought as patching material.
Embodiment 2
Attached drawing 1, a kind of folding sticking patch are refer to, the folding sticking patch includes patch portion (1) and shaping loop section
(2), patch portion (1) and shaping loop section (2) link into an integrated entity, and shaping loop section (2) is folded by one end of patch portion (1)
2~7 layers form, and have one layer of mylar or polyvinyl fluoride cloth between every layer of shaping loop section (2), and shaping loop section (2) is logical
It crosses suture (3) and different interlayers is sewn into an entirety, each stitch is independently formed by knots tied independent unit.
Embodiment 3
Attached drawing 1, a kind of folding sticking patch are refer to, the folding sticking patch includes patch portion (1) and shaping loop section
(2), patch portion (1) and shaping loop section (2) link into an integrated entity, and shaping loop section (2) is folded by one end of patch portion (1)
3~5 layers form, and fold one layer of mylar of outer layer covers of sticking patch or polyvinyl fluoride cloth, and shaping loop section (2) passes through suture (3)
Different interlayers are sewn into an entirety, each stitch is independently formed by knots tied independent unit.The material of patch portion (1) is the heart
Packaging material, for the material of patch portion (1) by anti-calcification processing, calcification processing technique is free of heavy metal, and is stored in non-penta
Dialdehyde is impregnated under the dry environment preserved.The shape of patch portion (1) is to preset or arbitrarily cut out by doctor.
The above is only the preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
Member, on the premise of the method for the present invention is not departed from, can also make several improvement and supplement, these are improved and supplement also should be regarded as
Protection scope of the present invention.
Claims (10)
1. a kind of folding sticking patch for treating children's mitral reflux, the folding sticking patch includes patch portion and shaping ring portion
Point, which is characterized in that patch portion and shaping loop section link into an integrated entity, shaping loop section folded by patch portion one end and
Into.
2. folding sticking patch according to claim 1, which is characterized in that the forming ring is partially folded into 2 ~ 7 layers.
3. folding sticking patch according to claim 2, which is characterized in that the forming ring is partially folded into 3 ~ 5 layers.
4. folding sticking patch according to claim 1, which is characterized in that between every layer of the shaping loop section or roll over
The outer layer of folded sticking patch entirety has a floor height molecular material.
5. folding sticking patch according to claim 4, which is characterized in that the high molecular material is mylar or polytetrafluoro
Ethylene cloth.
6. folding sticking patch according to claim 5, which is characterized in that the mylar and teflon cloth have one
Fixed elasticity.
7. folding sticking patch according to claim 1, which is characterized in that the material of the folding sticking patch is pericardium material.
8. folding sticking patch according to claim 7, which is characterized in that the material of the patch portion is by anticalcium
Reason, calcification processing technique are free of heavy metal, and are stored in non-glutaraldehyde and impregnate under the dry environment preserved.
9. folding sticking patch according to claim 1, which is characterized in that the shaping loop section is by suture by different layers
Between be sewn into an entirety, each stitch is independently formed by knots tied independent unit.
10. the application according to claim 1 for folding sticking patch in the medical instrument for preparing treatment children's mitral reflux.
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CN201611045190.4A CN106510901B (en) | 2016-11-21 | 2016-11-21 | A kind of new folding sticking patch integration circularizes design |
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CN201611045190.4A CN106510901B (en) | 2016-11-21 | 2016-11-21 | A kind of new folding sticking patch integration circularizes design |
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CN106510901B true CN106510901B (en) | 2018-06-05 |
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Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
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JP6388463B1 (en) * | 2017-06-08 | 2018-09-12 | 実 田端 | Prosthetic heart valve |
CN115153965A (en) * | 2017-02-17 | 2022-10-11 | 株式会社田端心脏医学研究 | Artificial heart valve |
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US5674279A (en) * | 1992-01-27 | 1997-10-07 | Medtronic, Inc. | Annuloplasty and suture rings |
CN1806775A (en) * | 2000-01-14 | 2006-07-26 | 维亚科公司 | Tissue annuloplasty band and apparatus and method for fashioning, sizing and implanting the same |
CN103491902A (en) * | 2011-04-01 | 2014-01-01 | 爱德华兹生命科学公司 | Compressible heart valve annulus sizing templates |
CN103930069A (en) * | 2011-11-10 | 2014-07-16 | Medtentia国际有限公司 | A device and a method for improving the function of a heart valve |
CN103957842A (en) * | 2011-11-12 | 2014-07-30 | 梅德坦提亚国际有限公司 | Device and method for improving fixation of a medical device |
CN104010593A (en) * | 2013-07-29 | 2014-08-27 | 金仕生物科技(常熟)有限公司 | Heart Valve Prosthesis Forming Ring |
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Publication number | Priority date | Publication date | Assignee | Title |
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US8308797B2 (en) * | 2002-01-04 | 2012-11-13 | Colibri Heart Valve, LLC | Percutaneously implantable replacement heart valve device and method of making same |
AU2011306028B2 (en) * | 2010-09-20 | 2014-07-17 | St. Jude Medical, Cardiology Division, Inc. | Valve leaflet attachment in collapsible prosthetic valves |
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2016
- 2016-11-21 CN CN201611045190.4A patent/CN106510901B/en active Active
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5674279A (en) * | 1992-01-27 | 1997-10-07 | Medtronic, Inc. | Annuloplasty and suture rings |
CN1806775A (en) * | 2000-01-14 | 2006-07-26 | 维亚科公司 | Tissue annuloplasty band and apparatus and method for fashioning, sizing and implanting the same |
CN103491902A (en) * | 2011-04-01 | 2014-01-01 | 爱德华兹生命科学公司 | Compressible heart valve annulus sizing templates |
CN103930069A (en) * | 2011-11-10 | 2014-07-16 | Medtentia国际有限公司 | A device and a method for improving the function of a heart valve |
CN103957842A (en) * | 2011-11-12 | 2014-07-30 | 梅德坦提亚国际有限公司 | Device and method for improving fixation of a medical device |
CN104010593A (en) * | 2013-07-29 | 2014-08-27 | 金仕生物科技(常熟)有限公司 | Heart Valve Prosthesis Forming Ring |
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