CN101721746A - Medical implant from the animal - Google Patents

Medical implant from the animal Download PDF

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Publication number
CN101721746A
CN101721746A CN 200910253019 CN200910253019A CN101721746A CN 101721746 A CN101721746 A CN 101721746A CN 200910253019 CN200910253019 CN 200910253019 CN 200910253019 A CN200910253019 A CN 200910253019A CN 101721746 A CN101721746 A CN 101721746A
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CN
China
Prior art keywords
medical implant
animal
skin
implant
valve
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Pending
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CN 200910253019
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Chinese (zh)
Inventor
M·W·斯泰克
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Laboratoires Perouse SAS
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Laboratoires Perouse SAS
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Publication of CN101721746A publication Critical patent/CN101721746A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/507Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/362Skin, e.g. dermal papillae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3641Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
    • A61L27/3645Connective tissue
    • A61L27/3662Ligaments, tendons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/02Treatment of implants to prevent calcification or mineralisation in vivo

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Botany (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Zoology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rehabilitation Therapy (AREA)
  • Rheumatology (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention relates to a medical implant (10), comprising a skin of an animal moving by swimming or creeping, or a part of the skin comprising subepithelial collagen.

Description

Be derived from the bio-medical implant of animal
Technical field
The present invention relates to a kind of bio-medical implant that is derived from animal, especially relate to valve and replace.
Background technology
More existing at present strategies use the field of replacing in the treatment of individual defect(ive) structure.From in the broadest sense, can distinguish and be the use of non-bioimplant on the one hand and be the use of bioimplant on the other hand, the use of bioimplant can be homologous (when they be derived from quilt treated individual of the same race individual the time) or nonhomologous (donor and receptor be not for of the same race).Yet at present, these methods are all not exclusively satisfactory.
Like this, the defective cardiac valve is replaced the field in human body more specifically, and the use of abiotic implant often because body causes the thrombosis problem to the reaction of implant, generally need be carried out secular anticoagulation to receptor and handle.Advantageously, bioimplant does not generally have the thrombosis problem.Further, for homology valve implant in the human body, their durability is gratifying, although they often have rejection.Yet organ donor quantity is few and make that their availability is limited.Certainly, this problem of availability does not appear in the nonhomologous implant.Like this, have only two kinds of materials to form the major part of non-homogeneous valve implant, one side is bovine pericardial tissue and is the porcine aortic valve tissue on the other hand.These implants generally are non-thrombosis, still compare with the homology bioimplant to have lower durability, especially owing to the progressively calcification of implant in the midium or long term.
For trial solution low relatively this problem of durability of homology implant by no means, U.S. Pat 6165216 proposes to use the semilunar valve (aortal or lung) that is derived from other animal varietiess (being marine mammal).Yet the significant relatively thickness of these valves can make resistance increase, and limits their flexibility simultaneously.Further, the effectiveness of this type of implant is also without clinical verification, thereby stayed such problem, and whether the material that promptly is derived from except cattle or pig can be used as effective succedaneum.
Summary of the invention
Therefore, the inventor has shown surprisingly that at present the skin of Anguillar japonica is particularly suited for making medical implant, as valve, blood vessel restoration or ligament.Advantageously, combine the durability and the significant flexibility of raising based on the implant of Anguillar japonica skin.
Do not wish to be sticked to a certain particular theory, the inventor thinks that Anguillar japonica skin makes its special nature that is suitable for making medical implant be derived from the structure of collagen layer under the epidermis, and this structure allows the skin of these animals as an outside tendon.This characteristic especially has the squama animal common for very large-scale, and especially those are by means of the animal of swimming or the mode of creeping moves.
Therefore, the present invention relates to a kind of medical implant, this medical implant comprises by means of swimming or the skin that the squama animal is arranged that moves of the mode of creeping, or comprises the part of this skin of collagen under the epidermis, in particular for the replacement of defect(ive) structure.
Can comprise one or more following characteristics according to implant of the present invention, independent or according to any technical possible combination:
-implant is used to replace the tissue that suffers the repetition mechanical stress;
-implant is selected from the group of being made up of cardiac valve, blood vessel restoration or ligament;
-this implant forms cardiac valve, comprises the valve supporter, and this valve supporter is fixed to the wall of blood circulation blood vessel and the lobe leaf that is carried by this valve supporter, and this lobe leaf is formed by dermal composition;
-valve supporter comprises tubular inner prosthesis;
-animal is selected from the group of being made up of reptile and fish;
-animal is an Anguillar japonica;
-implant is handled through crosslinking and curing agent;
-crosslinking and curing agent is selected from the group of being made up of glutaraldehyde, epoxy radicals material, formaldehyde or their mixture; With
-fat deposit and deep layer collagen layer are removed from the part of skin.
The invention still further relates to by means of swimming or the mode of creeping move the squama animal skin is arranged or comprises collagen under the epidermis this application of the zoodermic part of squama in the preparation that is particularly useful for the medical implant that individual defect(ive) structure replaces arranged.
The invention still further relates to by using and replace the method that defect(ive) structure is treated the individuality of defectiveness tissue according to medical implant of the present invention.
Description of drawings
Fig. 1 is the optical microscopic image of Anguillar japonica skin cross section.When the inboard, lateral of animal is seen, can see that wherein embedding collagen layer, fat deposit under the epidermis of scale, the epidermis, be the deep layer collagen layer then.
Fig. 2 is 3/4ths front elevational view according to first embodiment of the replaceable valvular implant of composition of the present invention;
Fig. 3 is the plane graph of the valve of Fig. 2;
Fig. 4 is the view according to second embodiment of the implant of valve in the composition of the present invention; With
Fig. 5 is the plane graph according to the 3rd implant of the implant of composition blood vessel restoration of the present invention.
The specific embodiment
Term " has the squama animal " and in this article refers to the animal that skin has scale (that is, from the outstanding hard sheet of corium).
Phrase " by means of the mode of swimming or creeping " is meant any type of moving, in moving, the part that animal is moved required energy not only conducts to each several part or mobile limb by skeleton but also by the skin as outside tendon from muscle, and wherein outside tendon is for the inside tendon that muscle is connected to skeleton.The method that moves by means of walking do not got rid of in this phrase, and under the situation of for example Amphibian, walking can or be creeped and carry out in conjunction with swimming, or with the operational phase of the swimming or the isolating animal of stage that creeps during carry out.
Preferably, the squama animal that has of moving by means of the mode of swimming or creep according to the present invention is reptile or fish.More preferably, they are Anguillar japonicas, and Anguilla (Anguilla genus) Anguillar japonica especially is as European eel (Anguilla anguilla) or America anguilla japonica (Anguilla rostrata).
Will appreciate that by way of example, the skin that the squama animal is arranged that moves by means of swimming or the mode of creeping comprises (i) epidermal area 2 at least from the outside of animal to the inboard, the (ii) ground floor 3 of collagen, be called collagen layer under the epidermis, (iii) fat deposit 4, (iv) second collagen layer 5 is called the deep layer collagen layer.By way of example, figure 1 illustrates the structure of Anguillar japonica skin, this structure has been exaggerated five times and by the scarlet dyeing of day wolf.
In order to make according to implant of the present invention, the preparation of skin can realize as follows.
After killing Anguillar japonica, its head is fixed on the hook.Form a circular skin incision with scalpel at the Anguillar japonica neck area.Skin is reversed and removes following afterbody up to animal subsequently.Skin is installed on the supporter with suitable diameter, is dipped into subsequently in the container that comprises firming agent.
Usually, the thin layer that comprises the collagen fibers that one deck at least is substantially parallel according to the subcuticle of the collagen that the squama animal is arranged that moves by means of swimming or the mode of creeping of the present invention.The subcuticle of collagen can specifically be made up of the thin layer of at least 10 layers (more specifically by at least 20 layers) substantially parallel synergetic collagen fibers.Collagen fibers in the thin layer longitudinal axis of animal relatively has at an angle orientation, and is concrete from 30 °-60 °, more specifically from 40 °-50 °.Particularly, two successive thin layers can have two independently angles, these two independently angle have opposite relative value and identical absolute value.
Collagen layer has huge effect for the durability and the flexibility of medical implant of the present invention under the epidermis; Therefore, when medical implant of the present invention only comprised skin a part of, this part completely or partially comprised collagen layer under the epidermis.
Like this, in the preferred embodiment of medical implant of the present invention, it does not have fat deposit or deep layer collagen layer.
Epidermis generally is retained.If desired, it can be removed by mechanical grinding.Fat deposit is handled significantly by silanization and is reduced, and can remove lipid by oxolane simultaneously.Internal layer (deep layer collagen and fat deposit) also can be removed by mechanical grinding after silanization is handled or cut into chunks.
In another preferred embodiment of the present invention, medical implant is handled by crosslinking and curing agent, as glutaraldehyde or epoxy radicals preparation, as formaldehyde or triglycidyl group amine or other preparations.
The advantage of crosslinking and curing agent is that the protection implant avoids rejection or calcification.
Preferably, skin in the glutaraldehyde of concentration between 0.1% percentage by weight and 1% percentage by weight, especially be cured in the glutaraldehyde of 0.625% percentage by weight at least two months, curing solution upgraded in per two days in initial 10 days, and latter two moon upgrades once weekly.After bimestrial curing, Anguillar japonica skin is carried out silanization handle.
In a variation, no longer do anti-calcification processing.
Sterilization comprises the immersion of Anguillar japonica skin and is stored in the glutaraldehyde solution.In the french application of same Applicant number 0755890 or European application number 08104444, this processing has been described.
Preferably, medical implant of the present invention is used to replace the tissue that suffers the repetition mechanical stress, as heart valve, blood vessel wall or ligament.
What therefore, medical implant of the present invention was concrete is cardiac valve.The operation process that medical equipment of the present invention is implanted does not comprise the particular refinement of the process of prior art, and can be carried out easily by those skilled in the art.
Mode by way of example, Fig. 2 and 3 has illustrated according to first implant 10 of the present invention, has been used to form the replacement cardiac valve.This implant 10 comprises valve supporter 12 and lobe leaf (shutter) 14, and this valve supporter 12 is used for fixing in the blood circulation blood vessel of human body, and lobe leaf 14 is made of the above-mentioned skin that the squama animal is arranged that moves by means of the mode of swimming or creep.
In known mode, supporter 12 comprise have axis A-A ' flexible ring 16 and three vertical flanges 18, this flexible ring 16 is fixed on the wall of the blood circulation blood vessel that for example is positioned at natural cardiac valve place, and three vertical flanges 18 are distributed in the circumference place of ring 16 angledly.Flange 18 relative axis A-A ' substantially parallel outstanding.
Ring 16 and flange 18 define in inside and are used for sanguimotor passage 19, and lobe leaf 14 places in it.
As mentioned above, lobe leaf 14 is made of the skin thin layer.It has generally basic for piped form and have axis A-A '.It comprises along ring 16 inner periphery with the fixed cylindrical base 20 of sealing means with longitudinally be fixed to the thin layer 21 of flange 18.
On each thin layer 21 lateral fixation to two adjacent ribs 18.Thereby each thin layer 21 has free top edge 22, and it can be relative to axis A-A ' radially move.
Under the effect of blood flow, thin layer 21 can be at the obstruction structure that is used for occlude blood circulation central passage 19 and is used to discharge between the release structure of passage 19 of blood flow and moves relative to each other, in blocking structure, free edge 22 is towards axis A-A ' move towards each other (being represented by the solid line among Fig. 3), in discharging structure, free edge 22 is away from axis A-A ' radially mobile and release channel 19.
As shown in Figure 3, in a variation of implant 28 according to the present invention, valve supporter 12 is tubular inner prosthesis, or " support ", and the lobe leaf 14 of above-mentioned skin is fixed thereon.
This tubular inner prosthesis 30 is formed by the tubular armature 32 of opening, and tubular armature 32 comprises the trellis of the silk thread with class spring property.Skeleton 32 obtains by the silk thread that weaves at least one rustless steel, marmem or polymer.In a variation, skeleton 32 is by obtaining with laser, water-jet or other technologies cutting catheter.
Skeleton 32 can move between contraction state and extended mode, and at contraction state, skeleton 32 has than minor diameter in order to be directed in the blood circulation blood vessel, and in extended mode, skeleton 32 constitutes its resting states, has than major diameter.
Advantageously, skeleton 32 can spontaneously configuration between its contraction state and extended mode.
Further, be similar to shown in Fig. 2, lobe leaf 14 is fixed on the inner surface that is limited by skeleton 32.
Figure 5 illustrates the 3rd embodiment according to implant 50 of the present invention.Implant 50 is based on the blood vessel restoration that the above-mentioned skin thin layer that the squama animal is arranged 52 that moves by means of the mode of swimming or creep forms.Thin layer 52 has the thickness much smaller than other dimension, as less than at least 5 times of other dimension of this thin layer 52 such as length or width.
Implant 50 can be sewn onto blood vessel wall, especially in order to strengthen this wall or to stop up hole on this wall.

Claims (9)

1. medical implant (10; 28; 50), this medical implant comprises the skin that the squama animal is arranged that moves by means of the mode of swimming or creep; This medical implant is selected from the group of being made up of cardiac valve, blood vessel restoration and ligament.
2. according to the medical implant (10 of claim 1; 28; 50), this medical implant is used to replace the tissue that suffers the repetition mechanical stress.
3. according to the medical implant (10 of claim 2; 28), it is characterized in that this medical implant forms cardiac valve, this cardiac valve comprises valve supporter (12) and lobe leaf (14), described valve supporter (12) is fixed on the wall of blood circulation blood vessel, described lobe leaf (14) is by supporter (12) carrying, and described lobe leaf (14) is made of described skin.
4. according to the medical implant (28) of claim 3, it is characterized in that described valve supporter (12) comprises tubular inner prosthesis (30).
5. according to the medical implant (10 of above-mentioned arbitrary claim; 28; 50), wherein said animal is selected from the group of being made up of reptile and fish.
6. according to the medical implant (10 of above-mentioned arbitrary claim; 28; 50), wherein said animal is an Anguillar japonica.
7. according to the medical implant (10 of above-mentioned arbitrary claim; 28; 50), this medical implant is handled by crosslinking and curing agent.
8. according to the medical implant (10 of claim 7; 28; 50), wherein said crosslinking and curing agent is selected from the group of being made up of glutaraldehyde, epoxy radicals material, formaldehyde or its mixture.
9. according to the medical implant (10 of above-mentioned arbitrary claim; 28; 50), wherein fat deposit and deep layer collagen layer are removed from the part of skin.
CN 200910253019 2008-10-22 2009-10-21 Medical implant from the animal Pending CN101721746A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0857178A FR2937253A1 (en) 2008-10-22 2008-10-22 Medical implant e.g. heart replacement valve, for replacing deficient tissues in individual, has skin of animal moving by swimming or creeping, or part of skin comprising subepithelial collagen, where part does not comprise adipose layer
FR0857178 2008-10-22

Publications (1)

Publication Number Publication Date
CN101721746A true CN101721746A (en) 2010-06-09

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Family Applications (1)

Application Number Title Priority Date Filing Date
CN 200910253019 Pending CN101721746A (en) 2008-10-22 2009-10-21 Medical implant from the animal

Country Status (4)

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CN (1) CN101721746A (en)
DE (1) DE102009050252A1 (en)
FR (1) FR2937253A1 (en)
IT (1) IT1397012B1 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105578991A (en) * 2013-05-29 2016-05-11 M阀门技术有限公司 Cardiac valve support device fitted with valve leaflets
WO2019206343A1 (en) * 2018-04-24 2019-10-31 中国医学科学院生物医学工程研究所 Biological valve material, preparation method therefor and application thereof, and crosslinking agent and application thereof

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1891703A (en) 1932-05-27 1932-12-20 Aluminum Colors Inc Method of coating
JP2529112B2 (en) * 1987-08-31 1996-08-28 株式会社 高研 Biological valve
WO1997000651A1 (en) 1995-06-20 1997-01-09 Agathos Efstathios A Human valve replacement with marine mammal valve
JP3747412B2 (en) * 2000-05-26 2006-02-22 エンゲルハード・リヨン Use of collagen from aquatic animals to produce carriers designed for tissue engineering and the carriers and biomaterials obtained thereby

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105578991A (en) * 2013-05-29 2016-05-11 M阀门技术有限公司 Cardiac valve support device fitted with valve leaflets
CN105578991B (en) * 2013-05-29 2017-11-14 M阀门技术有限公司 It is equipped with valve leaflets heart valve support device
WO2019206343A1 (en) * 2018-04-24 2019-10-31 中国医学科学院生物医学工程研究所 Biological valve material, preparation method therefor and application thereof, and crosslinking agent and application thereof

Also Published As

Publication number Publication date
FR2937253A1 (en) 2010-04-23
IT1397012B1 (en) 2012-12-20
DE102009050252A1 (en) 2010-04-29
ITTO20090801A1 (en) 2010-04-23

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Open date: 20100609