CN106510901A - Integral forming ring design of novel folding patch - Google Patents

Integral forming ring design of novel folding patch Download PDF

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Publication number
CN106510901A
CN106510901A CN201611045190.4A CN201611045190A CN106510901A CN 106510901 A CN106510901 A CN 106510901A CN 201611045190 A CN201611045190 A CN 201611045190A CN 106510901 A CN106510901 A CN 106510901A
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CN
China
Prior art keywords
sticking patch
patch
forming ring
folding
folding sticking
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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.)
Granted
Application number
CN201611045190.4A
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Chinese (zh)
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CN106510901B (en
Inventor
殷猛
张海波
刘静
金大为
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Jinshi Biotechnology (Changshu) Co., Ltd.
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Shanghai Childrens Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
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Priority to CN201611045190.4A priority Critical patent/CN106510901B/en
Publication of CN106510901A publication Critical patent/CN106510901A/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2409Support rings therefor, e.g. for connecting valves to tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2412Heart 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

Abstract

The invention relates to a novel folding patch, which comprises a patch part and a forming ring part. The patch part and the forming ring part are connected into a whole; and the forming ring part is formed by folding one end of the patch part or connecting other materials in a matching way. The novel folding patch has the advantages that an edge of the patch is folded to be used as a forming ring for fixing, meanwhile, an unfolded part is used as a valve leaflet for valve leaflet enlargement operation, a free cutting structure is designed, and the elasticity of a patch material is larger than that of a currently general forming ring, so that an operation effect is improved, and meanwhile, the usage of the operation forming ring is reduced. Meanwhile, a pericardium processed through an anti-calcification processing method and a dry-method storage technology is selected as the patch material, so that tissue toxicity reaction brought by free aldehyde is reduced.

Description

A kind of new folding sticking patch integration circularizes design
Technical field
The present invention relates to technical field of medical instruments, specifically, is a kind of new sticking patch for possessing shaping ring function.
Background technology
The process of children's mitral reflux pathological changes, because the problems such as multiformity of pathological changes mechanism, children are potentially developed, makes Obtaining which becomes one of difficult point of cardiac operation.
Treatment currently for mitral reflux mainly adopts valve repair and valve replacement;But valve replacement is frequently with machine Tool lobe, not only lacks on market and meets the mechanical prosthetic valve for being applied to children, and the mechanical prosthetic valve after displacement cannot also meet development in children Demand, meanwhile, mechanical prosthetic valve needs lifelong anticoagulant, brings extra drug risk.Additionally, the rigid structure of mechanical prosthetic valve cannot be expired Sole center room relax contracting motion when valve deformability, the later stage destruction ventricular function.And valve repair art can substantially keep lobe The natural structure and form of film, meets children's upgrowth and development, it is not necessary to lifelong anticoagulant, therefore adopts children's mitral reflux pathological changes more Use prothesiss therapeutic scheme.
Child for treatment mitral reflux is generally using adjustment key rope and papillary muscless, and the artificial key rope reduction key rope of increase is long The methods such as degree change prolapse of valve cusp, while increase leaflet pairing area using forming ring fixation and/or leaflet Enlargement carrying out The mode of reparation reduces backflowing.Forming ring fixation carries out tightening fixed lobes to the valve annulus expanded using valve forming ring Ring, leaflet pairing distance before and after reduction are because loopful fixes the growth promoter for limiting annulus after reparation, more at present to be added using semi-ring Gu the scheme of rear ring.
Valve forming ring material is relatively hard, and operation process length can not be cut out on demand, and because semi-ring forming ring Fix the valve annulus position it is still long, the growth of children is present to be affected, simultaneously as the use of forming ring increased it is extra Apparatus cost.Undressed pericardium bar is faced with later stage calcification, the risk degenerated.Leaflet expansion is more using the process of Jing glutaraldehydes Vein graft or pericardium sticking patch, Vein graft or pericardium sticking patch are preserved using liquid glutaraldehyde, calcification PROCESS FOR TREATMENT, penta 2 The heavy metal that aldehyde and calcification PROCESS FOR TREATMENT conventional at present are brought is left and is reacted with potential tissue toxicity, and after existing Phase degeneration, calcification problem.
The content of the invention
The purpose of the present invention is for deficiency of the prior art, there is provided a kind of sticking patch for treating children's mitral reflux.
Another purpose of the present invention is to provide the application of the sticking patch for the treatment of children's mitral reflux.
For achieving the above object, the present invention is adopted the technical scheme that:A kind of folding for treating children's mitral reflux is mended Piece, described folding sticking patch include that patch portion and shaping loop section, patch portion and shaping loop section link into an integrated entity, and shape Loop section is folded to form or be connected with other materials by patch portion one end and is formed.
Described forming ring is partially folded into 2~7 layers.
Described forming ring is partially folded into 3~5 layers.
Between per layer of described shaping loop section or fold the overall outer layer of sticking patch there is a floor height molecular material.
Described macromolecular material is mylar or teflon cloth.
Described mylar and teflon cloth have certain elasticity.
The material of described folding sticking patch is pericardium material.
Different interlayers are sewn into an entirety by suture by described shaping loop section, and each stitch is independently formed by knots tied Independent unit.
To realize above-mentioned second purpose, the present invention is adopted the technical scheme that:Described folding sticking patch is preparing treatment Application in the medical apparatus and instruments of children's mitral reflux.
The invention has the advantages that:
The present invention by the edge fold of sticking patch securing forming ring, while unfolded position is used as leaflet Enlargement The leaflet for being used, is designed as arbitrarily reducing structure, because the elasticity of patching material is improved more than forming ring general at present Surgical effect, while reducing the use of operation forming ring.Calcification processing method and dry method Techniques of preserving is selected to process simultaneously Pericardium as patching material, reduce tissue toxicity's reaction that free aldehyde is brought.
Description of the drawings
Accompanying drawing 1 is the structural representation of the new sticking patch of the present invention.
Accompanying drawing 2 is the schematic diagram that forming ring is fixed.
Accompanying drawing 3 is the schematic diagram that leaflet dilatation and forming ring fixing joint are repaired.
Accompanying drawing 4 is the conventional steps schematic diagram of valve repair.
Specific embodiment
Below in conjunction with the accompanying drawings the specific embodiment that the present invention is provided is elaborated.
The reference and ingredient being related in accompanying drawing is as follows:
1st, patch portion
2nd, shape loop section
3rd, suture
Embodiment 1
Treatment currently for mitral reflux mainly adopts valve repair and valve replacement method.Valve replacement often uses machine Tool lobe carries out changing lobe process, yet with children's annulus area is little, tissue is fragile, in the market it is difficult to 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 the face of the infant of continuous growth promoter, machinery Lobe is faced with the growth promoter needs that the problem for causing valvular stenosiss, i.e. mechanical prosthetic valve cannot meet children again.Mechanical valve prosthesiss it is firm Property structure can cause the imbalance of ventricle systolic and diastolic function again, cause the left heart function in later stage to decline.Meanwhile, the application of mechanical prosthetic valve needs Lifelong anticoagulant therapy, and for a child for developing, then need constantly to adjust the dosage of anticoagulant.Additionally, Mechanical prosthetic valve spends high, and operating substitution not only increases operation risk repeatedly, and brings extra financial burden.
And valve repair art carries out local route repair by the dissection reason to causing mitral reflux, substantially maintain Annulus and the original natural structure of valve and form, it is ensured that the feature of valve;Meanwhile, the valve of reparation can meet children's life The needs of long development, in addition, valve repair art does not need lifelong anticoagulant therapy.Based on considerations above, valve repair art by Gradually become the preferred manner that surgeon treats children's mitral valve disease.
The repairing and treating of mitral reflux substantially adopts three-step-march scheme at present:
1) under valve auxiliary equipment (chordae tendineae, papillary muscless) reparation:Improve leaflet (A, B), the work of increase leaflet prolapsed Dynamic property (C), as shown in Figure 4.
2) shape fixation:The annulus of expansion are tightened, the pairing distance such as accompanying 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, blade face Product is little, lifts difficulty, and with front lobe Poor fitness, this often causes the main mechanism for backflowing.Annuloplasty fixation is not Only tighten the annulus of expansion and consolidate this state, moreover it is possible to raise the height of back lobe annulus, increase the pairing with front lobe.Therefore, Annuloplasty fixation is considered as to treat the most key step of children's mitral reflux.
Simultaneously as loopful fixes the further growth development for limiting annulus, therefore, it is many at present using the half of rear annulus Ring is fixed, to allow the continued growth of front annulus;Additionally, research find, with undressed pericardium bar as annulus fixation The complete endothelialization of pericardium bar is found in material, certain hour, is blended with annulus tissue.
Above-mentioned mitral valve repair scheme is confirmed to achieve good clinical effectiveness by multinomial center, however, prothesiss The difficult problem performed the operation again is faced with equally.This mainly expands material and annulus with sticking patch fixes the long-term effect of material not good has Close.
At present, it is clinical for the material that sticking patch expansion is most frequently with includes:Autologous or allogeneic pericardium and artificial mesh Material, and artificial mesh material can be divided into two big class of dacron patch and biological sticking patch.Vein graft good biocompatibility, but number Amount is limited, while often needing to be fixed with glutaraldehyde solution before Vein graft is applied to valve Enlargement at present, could meet operation Require.And the pericardium fixed through glutaraldehyde, potential tissue toxicity's reaction is not only brought, it is at a specified future date also to find that material face The problems such as regression, calcification, allogeneic pericardium material source is extensive, but the immunogenicity between Different Individual limits which In clinical further application, the mechanics demand of clinical practice cannot be usually met through the allosome pericardium material of acellular. Meanwhile, the problems such as the application of allosome material also faces Ethic review.Dacron patch is constituted by macromolecular material is synthesized, and produces skill Art is ripe, is widely used in Cardiac Surgery field.But the problems such as being susceptible to Lou blood/oozing of blood, affects repair efficiency.Its bio-compatible Also easily there is inflammatory reaction not as good as autologous or allosome pericardium and biological sticking patch in property.
Biological sticking patch is typically derived from the pericardium material of healthy cattle, processes through special chemical method, and tissue is being handed over While connection is fixed, its immunogenicity is reduced, be that the class Cardiac Surgery with preferable biocompatibility for generally believing repairs material Material.Bovine pericardium is made up of multilamellar collagen fiber, compact structure, the problems such as be not only avoided that oozing of blood, and due to biocompatibility Good, inflammatory reaction risk is low, the autologous tissue's growth after being more beneficial for repairing.
For annulus are fixed, valve forming ring material in the market is relatively hard, and operation process can not be on demand Length is cut out, and the long growth on children in fix the valve annulus position is present to be affected.Meanwhile, when ventricular systole, diastole campaign, annulus Shape can occur corresponding change, according to the shaping ring material that pliability 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.Although and undressed pericardium bar pliability is good, it is ensured that lobe Deformability of the ring when ventricle relaxes contracting motion, is also found the complete endothelialization of pericardium bar, is mutually melted with annulus tissue in certain hour Close, but which is faced with potential later stage calcification, regression risk.
Present invention employs a kind of new and easy sticking patch forming ring integrated design.Material is processed by Jing special chemicals Biological sticking patch constitute, shaping loop section is formed by repeatedly folding by patching material.Sticking patch is repeatedly folded in reserved materials The toughness of the structure is strengthened while flexibility, is played a part of equivalent to forming ring in annulus fixation.The layer of folding Number generally selects 2-7 layers, and 3-5 layers are optimal.After folding by before different layers by connecting and composing an entirety.Each of connection Unit is separate, 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 chi It is very little, cut out by surgical scissorses between each stitch, obtain the size being actually needed.Because each stitch is separate, cut out There is no the behavior burst at the seams in each stitch afterwards, still be able to the firmness for keeping every interlayer connection overall.
Every interlayer or the outside of whole folded portion that shaping loop section sticking patch is folded, can add macromolecular material, lead to Often addition for medical mylar and teflon cloth, by two kinds of cloth woven relative relaxation during weaving, with certain elasticity. The addition of cloth can increase the intensity of sticking patch puckered ring suture, while more conducively growth of the endotheliocyte on cloth, promotes endothelium Change.
Meanwhile, after the process, valve member can become more to step up due to the impact of folded portion in structure Cause, be conducive to operation technique.This integrated annulus valve designs, it can also be ensured that surgeon according to actual needs, cuts out Meet the valve and leaflet structure of the optimal size and shape of infant, be applied to different individualities, one kind provided for mitral valve repair Extensive material source.
Calcification processing method and dry method Techniques of preserving.Handling process does not contain heavy metal, and departing from conventional glutaraldehyde Liquid is preserved, tissue toxicity's reaction that free aldehyde is brought is reduced
The present invention provides a kind of new sticking patch, by the edge fold of sticking patch securing forming ring, while unfolded The leaflet used as leaflet Enlargement by position, is designed as arbitrarily reducing structure, because the elasticity of patching material is more than current General forming ring, improves surgical effect, while reducing the use of operation forming ring.Calcification processing method is selected simultaneously The pericardium processed with dry method Techniques of preserving reduces tissue toxicity's reaction that free aldehyde is brought as patching material.
Embodiment 2
Accompanying drawing 1 is refer to, a kind of to fold sticking patch, described folding sticking patch includes patch portion (1) and shaping loop section (2), patch portion (1) and shaping loop section (2) links into an integrated entity, and shapes loop section (2) and is folded by one end of patch portion (1) 2~7 layers form, and shape, and shaping loop section (2) is led to Cross suture (3) and different interlayers are sewn into into an entirety, each stitch is independently formed by knots tied independent unit.
Embodiment 3
Accompanying drawing 1 is refer to, a kind of to fold sticking patch, described folding sticking patch includes patch portion (1) and shaping loop section (2), patch portion (1) and shaping loop section (2) links into an integrated entity, and shapes loop section (2) and is folded by one end of patch portion (1) 3~5 layers form, and fold one layer of mylar of outer layer covers or polyvinyl fluoride cloth of sticking patch, and shaping loop section (2) is by suture (3) Different interlayers are sewn into into an entirety, each stitch is independently formed by knots tied independent unit.The material of patch portion (1) is the heart Packaging material, through calcification process, calcification processing technique does not contain heavy metal to the material of patch portion (1), and is stored in non-penta Under the dry environment that dialdehyde immersion is preserved.Patch portion (1) is shaped as presetting or is 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 without departing from the inventive method, can also make some improvement and supplement, and these improve 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, described folding sticking patch include patch portion and shaping ring portion Point, it is characterised in that patch portion and shaping loop section link into an integrated entity, and shaping loop section is folded by patch portion one end and formed Or be connected with other materials and form.
2. folding sticking patch according to claim 1, it is characterised in that described forming ring is partially folded into 2~7 layers.
3. folding sticking patch according to claim 2, it is characterised in that described forming ring is partially folded into 3~5 layers.
4. folding sticking patch according to claim 1, it is characterised in that between per layer of described shaping loop section or roll over The overall outer layer of folded sticking patch has a floor height molecular material.
5. folding sticking patch according to claim 4, it is characterised in that described macromolecular material is mylar or polytetrafluoro Ethylene cloth.
6. folding sticking patch according to claim 5, it is characterised in that described mylar and teflon cloth have Fixed elasticity.
7. folding sticking patch according to claim 1, it is characterised in that the material of described folding sticking patch is pericardium material.
8. folding sticking patch according to claim 7, it is characterised in that the material of described patch portion is at calcification Reason, calcification processing technique do not contain heavy metal, and are stored under the dry environment that non-glutaraldehyde immersion is preserved.
9. folding sticking patch according to claim 1, it is characterised in that described 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 for folding sticking patch in the medical apparatus and instruments for preparing treatment children's mitral reflux according to claim 1.
CN201611045190.4A 2016-11-21 2016-11-21 A kind of new folding sticking patch integration circularizes design Active CN106510901B (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018151247A1 (en) * 2017-02-17 2018-08-23 実 田端 Artificial heart valve
JP6388463B1 (en) * 2017-06-08 2018-09-12 実 田端 Prosthetic heart valve

Citations (8)

* Cited by examiner, † Cited by third party
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
US20120071969A1 (en) * 2010-09-20 2012-03-22 St. Jude Medical, Cardiology Division, Inc.d/b/a St. Jude Medical, Cardiovascular Division Valve leaflet attachment in collapsible prosthetic valves
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
US20150018943A1 (en) * 2002-01-04 2015-01-15 Colibri Heart Valve Llc Percutaneous prosthetic heart valve

Patent Citations (8)

* Cited by examiner, † Cited by third party
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
US20150018943A1 (en) * 2002-01-04 2015-01-15 Colibri Heart Valve Llc Percutaneous prosthetic heart valve
US20120071969A1 (en) * 2010-09-20 2012-03-22 St. Jude Medical, Cardiology Division, Inc.d/b/a St. Jude Medical, Cardiovascular Division Valve leaflet attachment in collapsible prosthetic valves
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

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018151247A1 (en) * 2017-02-17 2018-08-23 実 田端 Artificial heart valve
JP6388463B1 (en) * 2017-06-08 2018-09-12 実 田端 Prosthetic heart valve
JP2018202132A (en) * 2017-06-08 2018-12-27 実 田端 Artificial heart valve

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Effective date of registration: 20190411

Address after: 215500 No. 9 Panjin North Road, Changshu City, Suzhou City, Jiangsu Province

Patentee after: Jinshi Biotechnology (Changshu) Co., Ltd.

Address before: No. 1678 Dongfang Road, Pudong New Area, Shanghai, 200127

Patentee before: Shanghai Jiaotong University Medical College subsidiary Shanghai Children's Medi