CN108403258A - A kind of stop rebuilding type artificial bone-head for shoulder tucks inside the sleeve sticking patch and its manufacturing method - Google Patents

A kind of stop rebuilding type artificial bone-head for shoulder tucks inside the sleeve sticking patch and its manufacturing method Download PDF

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Publication number
CN108403258A
CN108403258A CN201810568980.3A CN201810568980A CN108403258A CN 108403258 A CN108403258 A CN 108403258A CN 201810568980 A CN201810568980 A CN 201810568980A CN 108403258 A CN108403258 A CN 108403258A
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China
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sticking patch
tendon
layer
stop
middle layer
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Granted
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CN201810568980.3A
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CN108403258B (en
Inventor
黄成龙
赵松
崔文国
李亚民
蒋佳
许运
齐进
邓廉夫
赵金忠
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SHANGHAI BONE FRACTURE RESEARCH INST
Shanghai Sixth Peoples Hospital
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SHANGHAI BONE FRACTURE RESEARCH INST
Shanghai Sixth Peoples Hospital
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Priority to CN201810568980.3A priority Critical patent/CN108403258B/en
Publication of CN108403258A publication Critical patent/CN108403258A/en
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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
    • A61F2/08—Muscles; Tendons; Ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A61L2300/414—Growth factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/10—Materials or treatment for tissue regeneration for reconstruction of tendons or ligaments
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

A kind of manufacturing method of stop rebuilding type artificial bone-head for shoulder sleeve sticking patch, is as follows：By sticking patch middle layer of the electrostatic spinning structure with nanofibrous structures, or by weaving sticking patch middle layer of the structure with netted knitted body structure, the supportive body as entire sticking patch；The both ends of sticking patch middle layer are respectively tendon portion and stop portion, in the tendon portion of sticking patch middle layer package one sticking patch tendon portion middle layer of crosslinking, in the stop portion of sticking patch middle layer package one sticking patch stop portion middle layer of crosslinking；Coating is corresponded in the upper surface of sticking patch tendon portion's middle layer and sticking patch stop portion middle layer and is crosslinked with sticking patch upper layer；In the lower surface of sticking patch tendon portion's middle layer and sticking patch stop portion middle layer, correspondence coats and is crosslinked with sticking patch tendon subordinate layer and sticking patch stop subordinate's layer, constitutes entire stop rebuilding type artificial bone-head for shoulder sleeve sticking patch.Shoulder sleeve sticking patch provided by the invention can repair shoulder sleeve defect while rebuild tendon bone stop, while have good mechanical strength and good biocompatibility.

Description

A kind of stop rebuilding type artificial bone-head for shoulder tucks inside the sleeve sticking patch and its manufacturing method
Technical field
The present invention relates to surgical patch technical fields, and in particular to a kind of stop rebuilding type artificial bone-head for shoulder tucks inside the sleeve sticking patch and its manufacture Method.
Background technology
Rotator cuff injury is one of orthopaedics common disease, is the common original for leading to shoulder arthralgia, limitation of activity, miopragia Because incidence gradually increases with advancing age.The patient and large area Patients with Rotator Cuff Injury After invalid to expectant treatment is led to It often needs to tear shoulder sleeve by operative repair, to mitigate pain, restores shoulder joint function, but postoperative effect is unsatisfactory, lose It is 20%~70% to differ to lose revision rate, this with patient's rotator cuff tear range, it is tendon contracture, fatty infiltration, postoperative inappropriate The factors such as reconditioning are related, but it is main cause that postoperative tendon-bone interface, which is not easy healing,.Normal shoulder tucks inside the sleeve stop by tendon, fibre Cartilage, mineralising cartilage and the gradual transitional structure composition of this four layers of bone tissue are tieed up, is conducive to mechanotransduction and is less likely to occur to tear It splits.Shoulder after repairing is tucked inside the sleeve can not restore normal tendon-bone stop between bone tissue, can only restore continuous by scar healing Property, it is easy to happen and tears again.Huge Patients with Rotator Cuff Injury After and the longer tendon of damage post burn occur the patient of regression retraction, It is difficult that the shoulder sleeve of retraction tearing is fixed on stop footmark area in art, needs to return with the shoulder sleeve structure enhancing technical finesse broken ends of fractured bone Contracting, can not stop the problem of rebuilding, to improve success rate of operation, improve patient's shoulder joint function.
It is common shoulder sleeve structure enhancing technology, especially suitable big rotator cuff tear and chronic shoulder sleeve that shoulder sleeve sticking patch, which reinforces technology, Damage is with tendon retraction patient.With the continuous improvement of tissue engineering technique, the research and development and application of shoulder sleeve sticking patch enter one In the new stage, numerous patching materials show good performance, but there are still certain deficiencies.Common shoulder sleeve patching material includes Synthetic material sticking patch and biomaterial sticking patch.
Synthetic material shoulder sleeve sticking patch includes two class of degradable and non-degradable type, and main component is polymer.Common Non-degradable type sticking patch synthetic material includes polypropylene, polyester, polytetrafluoroethylene (PTFE) and nylon etc., these sticking patch have good anti- Tensile property provides stable mechanics guarantee for the healing of host tissue.Degradable sticking patch synthetic material includes left-handed poly- breast The copolymer etc. of acid, lactic-glycolic acid, polycaprolactone and polypropylene glycol, can be by tissue degradation, while can also provide certain journey The mechanical strength of degree, but there may be certain cytotoxicities for catabolite.Synthetic material shoulder sleeve sticking patch biocompatibility at present Not good enough, postoperative there are the risks of body foreign matter rejection so that the clinical application of this kind of sticking patch is subject to certain restrictions.
Biomaterial sticking patch is broadly divided into autograft, same mostly from tissue graft material, according to its source Kind allograft, acellular tissue grafts etc..Autograft material is mainly derived from the fascia late of itself, the upper arm two Long head tendon of flesh etc., great advantage is good biocompatibility, but can bring additional wound when materials, is caused for area's disease damage.Together Kind of allograft material be typically derived from allogeneic shoulder sleeve, anterior tibial muscle tendon, kneecap tendon, with tendinous tissue etc., although postoperative shoulder Joints' movement range and muscular strength improve mechanical strength that is apparent, but lacking stable, easy to produce immunological rejection after transplanting, deposit In the risk of infectious disease, and limited source.Acellular tissue grafts mainly include heteroplasm transplanting and it is of the same race different Body tissue is transplanted, such as animal dermis, small intestine, pericardium, with intrinsic collagen, non-collagen, three-dimensional structure etc. for holder, Promote the functional reconstruction of postoperative collagenous fibres and revascularization and tendon-bone interface, although with good biocompatibility and Ductility, but its mechanical strength cannot be satisfied the Mechanical loading intensity of shoulder sleeve.
Shoulder sleeve patching material is because of the factors such as its histocompatbility, biomechanical strength, tissue-derived and safety, limit at present Make its application clinically.In addition to this, all shoulder sleeve sticking patch can not rebuild tendon-bone stop by tendon, fibrocartilage, mine Cartilage and bone tissue this four layers of gradual transitional structures, therefore can to rebuild tendon-bone stop, mechanical strength excellent, raw for design The good shoulder sleeve sticking patch of object compatibility has important clinical value for treatment rotator cuff injury.
Invention content
In view of this, the object of the present invention is to provide a kind of stop rebuilding type artificial bone-head for shoulder sleeve sticking patch and corresponding manufacturers Method, shoulder sleeve sticking patch can rebuild tendon-bone stop, while use the material of non-degradable material and good biocompatibility, and one Aspect improves mechanical strength, on the other hand also has good biocompatibility.
In order to achieve the above objectives, the technical solution adopted by the present invention is：
A kind of manufacturing method of stop rebuilding type artificial bone-head for shoulder sleeve sticking patch, is as follows：
S1, it selects the synthetic material of human body nonabsorable and hydrogel to be mixed and made into spinning solution, passes through electrostatic spinning The sticking patch middle layer with nanofibrous structures is built, or the synthetic material of human body nonabsorable is selected to have by weaving structure The sticking patch middle layer of netted knitted body structure, the supportive body as entire sticking patch；
S2, sticking patch middle layer both ends be respectively tendon portion and stop portion, wrap up crosslinking in the tendon portion of sticking patch middle layer One sticking patch tendon portion middle layer, and in sticking patch tendon portion middle layer addition at tendon active medicine or at tendon Active Growth because Son in the stop portion of sticking patch middle layer package one sticking patch stop portion middle layer of crosslinking, and adds in sticking patch stop portion middle layer At cartilage active medicine or at cartilage active growth factor；
S3, it corresponds to coating in the upper surface of sticking patch tendon portion's middle layer and sticking patch stop portion middle layer and is crosslinked on sticking patch Layer, and added at tendon active medicine or at tendon active growth factor in sticking patch upper layer；
S4, it corresponds to coating in the lower surface of sticking patch tendon portion's middle layer and sticking patch stop portion middle layer and is crosslinked with sticking patch flesh Tendon subordinate layer and sticking patch stop subordinate's layer, and in the subordinate's layer addition of sticking patch tendon at tendon active medicine or at tendon Active Growth The factor constitutes entire stop rebuilding type people in sticking patch stop subordinate's layer addition osteogenic activity drug or osteogenic activity growth factor Work shoulder sleeve sticking patch.
Preferably, the synthetic material in the step S1 is that polypropylene, polyester, polytetrafluoroethylene (PTFE) and nylon are therein One or more compound compositions.
Preferably, the sticking patch tendon portion's middle layer and the package crosslinking of sticking patch stop portion middle layer in the step S2 exist Structural adhesive layer is formed through frozen dried behind the both ends of sticking patch sticking patch middle layer, and in sticking patch tendon portion's middle layer and sticking patch stop portion Interbed is respectively formed multiple the first micropores and the second micropore grown into for human body cell during frozen dried inside it, and The inner wall coating of first micropore contains at tendon active medicine or at tendon active growth factor at tendon inducing layer, second The inner wall of micropore is coated with and includes into cartilage active medicine or at cartilage active growth factor at chondrocyte induction layer, the sticking patch Tendon portion middle layer and sticking patch stop portion's middle layer are made of the composite material with biocompatibility, and the composite material is bright Glue, collagen, hyaluronic acid, chitosan and sodium alginate one or more of which.
Preferably, the sticking patch upper layer in the step S3 coats forms structural adhesive layer after being crosslinked through frozen dried, and Sticking patch upper layer forms multiple third micropores grown into for human body cell during frozen dried inside it, and in third micropore Inner wall, which is coated with, includes into tendon active medicine or at tendon active growth factor at tendon inducing layer, the sticking patch upper layer by Composite material with biocompatibility is constituted, and the composite material is gelatin, collagen, hyaluronic acid, chitosan and alginic acid Sodium one or more of which.
Preferably, the sticking patch tendon subordinate layer and sticking patch stop subordinate's layer in the step S4 coat after being crosslinked through freezing Dry-cure forms structural adhesive layer, and sticking patch tendon subordinate layer and sticking patch stop subordinate's layer are distinguished during frozen dried inside it Multiple the 4th micropores and the 5th micropore grown into for human body cell are formed, and contains in the coating of the inner wall of the 4th micropore and lives at tendon Property drug or at tendon active growth factor at tendon inducing layer, be coated in the inner wall of the 5th micropore and include osteogenic activity medicine The osteogenic induction layer of object or osteogenic activity growth factor, the sticking patch tendon subordinate layer and sticking patch stop subordinate's layer are by having biology The composite material of compatibility is constituted, and the composite material is gelatin, collagen, hyaluronic acid, chitosan and sodium alginate wherein one Kind is a variety of.
A kind of stop rebuilding type artificial bone-head for shoulder sleeve sticking patch, using manufacturing method as described above, the stop are also provided simultaneously Rebuilding type artificial bone-head for shoulder tucks inside the sleeve sticking patch as multilayered structure, including sticking patch tendon portion, sticking patch stop portion and sticking patch middle layer, in the sticking patch The both ends of interbed are respectively tendon portion and stop portion, and sticking patch tendon portion includes in sticking patch tendon portion upper layer, sticking patch tendon portion Interbed and sticking patch tendon subordinate's layer, sticking patch stop portion includes sticking patch stop portion upper layer, sticking patch stop portion's middle layer and sticking patch Stop subordinate layer, sticking patch tendon portion upper layer and sticking patch stop portion upper layer composition sticking patch upper layer, among sticking patch tendon portion Layer and sticking patch stop portion middle layer wrap up crosslinking in the tendon portion and stop portion of sticking patch middle layer respectively, and in sticking patch tendon portion The coating of the upper surface of middle layer and sticking patch stop portion middle layer is crosslinked the sticking patch upper layer, in sticking patch tendon portion's middle layer and sticking patch The lower surface of stop portion middle layer corresponds to coating and is crosslinked the sticking patch tendon subordinate layer and sticking patch stop subordinate's layer.
Preferably, the sticking patch middle layer, which is the electrostatic spinning liquid made of synthetic material and hydrogel, passes through electrostatic It is that the synthetic material degraded by human body nonabsorable leads to that spinning structure, which is formed by nanofibrous structures or the sticking patch middle layer, It crosses braiding structure and is formed by netted knitted body structure, and constitute the supportive body of stop rebuilding type artificial bone-head for shoulder sleeve sticking patch, it is described Synthetic material is one such or a variety of compound constitute by polypropylene, polyester, polytetrafluoroethylene (PTFE) and nylon.
Preferably, sticking patch tendon portion middle layer is with biocompatibility and interior added at tendon active drug Object or the structural adhesive layer that is cross-linked to form of composite material at tendon active growth factor, sticking patch tendon portion middle layer is by bright Glue, collagen, hyaluronic acid, chitosan and sodium alginate is one such or a variety of composite crosslinkings are constituted, sticking patch tendon portion Also there are multiple the first micropores grown into for human body cell, the inner wall of first micropore, which is coated with, includes into tendon in middle layer Active medicine or at tendon active growth factor at tendon inducing layer.
Preferably, sticking patch stop portion middle layer is with biocompatibility and interior added at cartilage active drug Object or the structural adhesive layer that is cross-linked to form of composite material at cartilage active growth factor, sticking patch stop portion middle layer is by bright Glue, collagen, hyaluronic acid, chitosan and sodium alginate is one such or a variety of composite crosslinkings are constituted, sticking patch stop portion Also there are multiple the second micropores grown into for human body cell, the inner wall of second micropore, which is coated with, includes into cartilage in middle layer Active medicine or at cartilage active growth factor at chondrocyte induction layer.
Preferably, the sticking patch upper layer is with biocompatibility and interior added at tendon active medicine or at flesh The structural adhesive layer that the composite material of tendon active growth factor is cross-linked to form, the sticking patch upper layer by gelatin, collagen, hyaluronic acid, Chitosan and sodium alginate is one such or a variety of composite crosslinkings are constituted, also has multiple thin for human body in the sticking patch upper layer The third micropore that born of the same parents grow into, the inner wall of the third micropore be coated with include into tendon active medicine or at tendon Active Growth because Son at tendon inducing layer.
Preferably, sticking patch tendon subordinate layer is with biocompatibility and interior added at tendon active medicine Or the structural adhesive layer that is cross-linked to form of composite material at tendon active growth factor, the sticking patch tendon subordinate layer is by gelatin, glue Original, hyaluronic acid, chitosan and sodium alginate is one such or a variety of composite crosslinkings are constituted, in the sticking patch tendon subordinate layer Also there are multiple the 4th micropores grown into for human body cell, the inner wall of the 4th micropore, which is coated with, includes into tendon active medicine Or at tendon active growth factor at tendon inducing layer.
Preferably, sticking patch stop subordinate layer for biocompatibility and it is interior added with osteogenic activity drug or The structural adhesive layer that the composite material of osteogenic activity growth factor is cross-linked to form, sticking patch stop subordinate layer is by gelatin, collagen, thoroughly Bright matter acid, chitosan and sodium alginate is one such or a variety of composite crosslinkings are constituted, also have in the sticking patch stop subordinate layer There are multiple the 5th micropores grown into for human body cell, the inner wall of the 5th micropore, which is coated with, includes osteogenic activity drug or skeletonization The osteogenic induction layer of active growth factor.
Compared with prior art, a kind of stop rebuilding type artificial bone-head for shoulder sleeve sticking patch provided by the invention and corresponding manufacturer The material that the sticking patch middle layer of method, wherein shoulder sleeve sticking patch is degraded by human body nonabsorable is constituted, and it is strong can to provide enough mechanics Degree, stable mechanics guarantee is provided for the healing of tissue.The good material of crosslinked biocompatible can above and below the middle layer of sticking patch To avoid rejection caused by intermediate layer material, the advantages of different materials, is combined, passes through compound non-degradable material With the material of good biocompatibility so that artificial bone-head for shoulder's sleeve sticking patch is provided simultaneously with good mechanical strength and good bio-compatible Property.By building three-decker at sticking patch stop end, compound different material, biologically active drug and growth factor, divide respectively Not Mo Ni tendon layer, cartilage layers and bone tissue layer, middle cartilage layers are because the histocyte ingredient difference of upper and lower interface can be distinguished Break up to mineralising cartilage and fibrocartilage, to rebuild normal shoulder sleeve tendon-bone stop.
Description of the drawings
In order to more clearly explain the embodiment of the invention or the technical proposal in the existing technology, to embodiment or will show below There is attached drawing needed in technology description to be briefly described, it should be apparent that, the accompanying drawings in the following description is only this Some embodiments of invention for those of ordinary skill in the art without creative efforts, can be with Obtain other attached drawings according to these attached drawings.
Fig. 1 is a kind of structural schematic diagram of stop rebuilding type artificial bone-head for shoulder sleeve sticking patch provided by the invention.
Reference numeral involved in attached drawing and component part explanation：
1, sticking patch middle layer；2, sticking patch tendon portion middle layer；3, sticking patch tendon subordinate layer；4, sticking patch stop portion middle layer； 5, sticking patch stop subordinate layer；6, sticking patch upper layer.
Specific implementation mode
Technical scheme of the present invention will be clearly and completely described by specific implementation mode below.Obviously, it is retouched The embodiment stated is only a part of the embodiment of the present invention, instead of all the embodiments.Based on the embodiments of the present invention, originally The every other embodiment that field those of ordinary skill is obtained without creative efforts, belongs to the present invention The range of protection.
A kind of manufacturing method of stop rebuilding type artificial bone-head for shoulder sleeve sticking patch, is as follows：
S1, it selects the synthetic material of human body nonabsorable and hydrogel to be mixed and made into spinning solution, passes through electrostatic spinning The sticking patch middle layer with nanofibrous structures is built, or the synthetic material of human body nonabsorable is selected to have by weaving structure The sticking patch middle layer of netted knitted body structure, the supportive body as entire sticking patch.
Wherein synthetic material is polypropylene, polyester, polytetrafluoroethylene (PTFE) and nylon is one such or a variety of compound compositions, should Kind of synthetic material is the material of human body nonabsorable degradation, so the sticking patch middle layer of structure provided for the healing of tissue it is stable Mechanics guarantee.
S2, sticking patch middle layer both ends be respectively tendon portion and stop portion, wrap up crosslinking in the tendon portion of sticking patch middle layer One sticking patch tendon portion middle layer, and in sticking patch tendon portion middle layer addition at tendon active medicine or at tendon Active Growth because Son in the stop portion of sticking patch middle layer package one sticking patch stop portion middle layer of crosslinking, and adds in sticking patch stop portion middle layer At cartilage active medicine or at cartilage active growth factor.
Sticking patch tendon portion's middle layer and the package crosslinking of sticking patch stop portion middle layer pass through behind the both ends of sticking patch sticking patch middle layer Frozen dried forms structural adhesive layer, and sticking patch tendon portion's middle layer and sticking patch stop portion's middle layer are during frozen dried in it Portion is respectively formed multiple the first micropores and the second micropore grown into for human body cell, and the coating of the inner wall of the first micropore containing at Tendon active medicine or at tendon active growth factor at tendon inducing layer, the inner wall of the second micropore be coated with include into it is soft Bone active drugs or at cartilage active growth factor at chondrocyte induction layer.
Sticking patch tendon portion's middle layer and sticking patch stop portion's middle layer are made of the composite material with biocompatibility, described Composite material is gelatin, collagen, hyaluronic acid, chitosan and sodium alginate one or more of which
Sticking patch stop portion's middle layer is contacted with the cartilaginous tissue of human body, and cartilaginous tissue cell enters among sticking patch stop portion In second micropore of layer, simulate human body cartilage layers, in sticking patch stop portion middle layer and in the second micropore inwall at soft What is contained in self-bone grafting layer can induce the formation of tendon-bone stop cartilage at cartilage active medicine or cartilage-derived growth active factors.
S3, it corresponds to coating in the upper surface of sticking patch tendon portion's middle layer and sticking patch stop portion middle layer and is crosslinked on sticking patch Layer, and added at tendon active medicine or at tendon active growth factor in sticking patch upper layer.
Structural adhesive layer is formed through frozen dried after the coating crosslinking of sticking patch upper layer, wherein sticking patch upper layer is during frozen dried It is formed with the third micropore grown into for human body cell inside it, and is coated in the inner wall of third micropore and includes into tendon active drug Object or at tendon active growth factor at tendon inducing layer.
Sticking patch upper layer is made of the composite material with biocompatibility, composite material be gelatin, collagen, hyaluronic acid, Chitosan and sodium alginate one or more of which.It can be to avoid in sticking patch sticking patch using the preferable composite material of biocompatibility Rejection caused by interlayer material increases the biocompatibility of patching material.
Sticking patch upper layer is contacted with the tendon tissue of human body, and tendon tissue cell enters the third micropore on sticking patch upper layer, is mended The tendon layer of human body is simulated on piece upper layer, in sticking patch upper layer and in third micropore inwall at being added in tendon inducing layer The ability for repairing tendon fiber can be improved at tendon active medicine or at tendon active growth factor.
S4, it corresponds to coating in the lower surface of sticking patch tendon portion's middle layer and sticking patch stop portion middle layer and is crosslinked with sticking patch flesh Tendon subordinate layer and sticking patch stop subordinate's layer, and in the subordinate's layer addition of sticking patch tendon at tendon active medicine or at tendon Active Growth The factor constitutes entire stop rebuilding type people in sticking patch stop subordinate's layer addition osteogenic activity drug or osteogenic activity growth factor Work shoulder sleeve sticking patch.
After sticking patch tendon subordinate layer and the subordinate's layer coating crosslinking of sticking patch stop structural adhesive layer, and sticking patch are formed through frozen dried Tendon subordinate layer and sticking patch stop subordinate's layer are respectively formed during frozen dried inside it multiple to be grown into for human body cell 4th micropore and the 5th micropore, and the inner wall of the 4th micropore coating containing at tendon active medicine or at tendon Active Growth because Son at tendon inducing layer, the inner wall of the 5th micropore be coated with include osteogenic activity drug or osteogenic activity growth factor at Self-bone grafting layer.
Sticking patch tendon subordinate layer and sticking patch stop subordinate's layer are made of the composite material with biocompatibility, described compound Material is gelatin, collagen, hyaluronic acid, chitosan and sodium alginate one or more of which, increases the biofacies of patching material Capacitive.
Sticking patch tendon subordinate's layer is contacted with the tendon tissue cell of human body, and tendon tissue cell enters sticking patch tendon subordinate In 4th micropore of layer, the tendon layer of sticking patch tendon subordinate layer simulation human body is micro- in sticking patch tendon subordinate's layer and positioned at the 4th On the inner wall of hole at being added in tendon inducing layer into tendon active medicine or reparation flesh can be improved at tendon active growth factor The ability of tendinous fibres.
Sticking patch stop subordinate's layer is contacted with the osteogenic tissue of human body, and osteogenic tissue's cell enters sticking patch stop subordinate's layer In 5th micropore, the bone tissue layer of sticking patch stop subordinate layer simulation human body, sticking patch stop subordinate layer and in the 5th micropore The osteogenic activity drug or osteogenic activity growth factor that are added in osteogenic induction layer on wall can induce the shape of tendon-bone stop skeletonization At.
Due to sticking patch stop portion middle layer simulated person's body cartilage layers, because the histocyte ingredient difference of upper and lower interface can Break up respectively to mineralising cartilage and fibrocartilage, to rebuild normal shoulder sleeve tendon-bone stop.
Corresponding above-mentioned manufacturing method, it is shown in Figure 1, a kind of stop rebuilding type artificial bone-head for shoulder sleeve sticking patch is provided.The stop Rebuilding type artificial bone-head for shoulder tucks inside the sleeve sticking patch as multilayered structure, including sticking patch tendon portion, sticking patch stop portion and sticking patch middle layer 1, among sticking patch The both ends of layer 1 are respectively tendon portion and stop portion, and sticking patch tendon portion includes sticking patch tendon portion upper layer, sticking patch tendon portion middle layer 2 With sticking patch tendon subordinate layer 3, sticking patch stop portion includes sticking patch stop portion upper layer, sticking patch stop portion middle layer 4 and sticking patch stop portion Lower layer 5, sticking patch tendon portion upper layer and sticking patch stop portion upper layer composition sticking patch upper layer 6, sticking patch tendon portion middle layer 2 and sticking patch stop Portion's middle layer 4 wraps up crosslinking in the tendon portion and stop portion of sticking patch middle layer 1 respectively, and in 2 He of sticking patch tendon portion middle layer The upper surface coating crosslinking sticking patch upper layer 6 of sticking patch stop portion middle layer 4, in sticking patch tendon portion middle layer 2 and sticking patch stop portion The lower surface of interbed 4 corresponds to coating crosslinking sticking patch tendon subordinate layer 3 and sticking patch stop subordinate layer 4.
Specifically, sticking patch middle layer 1, which is the electrostatic spinning liquid made of synthetic material and hydrogel, passes through electrostatic spinning structure It is that the synthetic material degraded by human body nonabsorable passes through braiding structure to build and be formed by nanofibrous structures or sticking patch middle layer 1 It builds and is formed by netted knitted body structure, and constitute the supportive body of stop rebuilding type artificial bone-head for shoulder sleeve sticking patch, synthetic material is by gathering Propylene, polyester, polytetrafluoroethylene (PTFE) and nylon is one such or a variety of compound compositions.
Sticking patch tendon portion middle layer 2 be with biocompatibility and it is interior added at tendon active medicine or at tendon activity The structural adhesive layer that the composite material of growth factor is cross-linked to form, sticking patch tendon portion middle layer 2 is by gelatin, collagen, hyaluronic acid, shell Glycan and sodium alginate is one such or a variety of composite crosslinkings are constituted.Wherein, also have in sticking patch tendon portion middle layer 2 multiple For the first micropore (not shown) that human body cell is grown into, the inner wall of the first micropore be coated with include into tendon active medicine or At tendon active growth factor at tendon inducing layer (not shown).
Sticking patch stop portion middle layer 4 be with biocompatibility and it is interior added at cartilage active medicine or at cartilage activity The structural adhesive layer that the composite material of growth factor is cross-linked to form, sticking patch stop portion middle layer 4 is by gelatin, collagen, hyaluronic acid, shell Glycan and sodium alginate is one such or a variety of composite crosslinkings are constituted.Wherein, also have in sticking patch stop portion middle layer 4 multiple For the second micropore (not shown) that human body cell is grown into, the inner wall of the second micropore be coated with include into cartilage active medicine or At cartilage active growth factor at chondrocyte induction layer (not shown).
Sticking patch upper layer 6 is with biocompatibility and interior added at tendon active medicine or at tendon active growth factor The structural adhesive layer that is cross-linked to form of composite material, sticking patch upper layer 6 by gelatin, collagen, hyaluronic acid, chitosan and sodium alginate its In one or more composite crosslinkings constitute.Also have multiple third micropores grown into for human body cell (in figure in sticking patch upper layer 6 It is not shown), the inner wall of third micropore, which is coated with, includes into tendon active medicine or luring at tendon at tendon active growth factor Conducting shell (not shown).
Sticking patch tendon subordinate layer 3 is with biocompatibility and interior added with being given birth at tendon active medicine or at tendon activity The structural adhesive layer that the composite material of the long factor is cross-linked to form, sticking patch tendon subordinate's layer 3 is by gelatin, collagen, hyaluronic acid, chitosan And sodium alginate is one such or a variety of composite crosslinkings are constituted.Wherein, also have in sticking patch tendon subordinate layer 3 multiple for human body The 4th micropore (not shown) that cell is grown into, the inner wall of the 4th micropore, which is coated with, includes into tendon active medicine or at tendon Active growth factor at tendon inducing layer (not shown).
Sticking patch stop subordinate layer 5 for biocompatibility and it is interior added with osteogenic activity drug or osteogenic activity growth because The structural adhesive layer that the composite material of son is cross-linked to form, sticking patch stop subordinate's layer 4 is by gelatin, collagen, hyaluronic acid, chitosan and sea Mosanom is one such or a variety of composite crosslinkings are constituted.Wherein, also have in sticking patch stop subordinate layer 5 multiple for human body cell The 5th micropore (not shown) grown into, the inner wall of the 5th micropore, which is coated with, includes osteogenic activity drug or osteogenic activity growth The osteogenic induction layer (not shown) of the factor.
A kind of stop rebuilding type artificial bone-head for shoulder sleeve sticking patch provided by the invention and corresponding manufacturing method, which tucks inside the sleeve sticking patch can It repairs shoulder sleeve defect and rebuilds tendon-bone stop simultaneously, use the material of non-degradable material and good biocompatibility, on the one hand carry On the other hand high strength also has good biocompatibility.
The foregoing description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, as defined herein General Principle can be realized in other embodiments without departing from the spirit or scope of the present invention.Therefore, of the invention It is not intended to be limited to the embodiments shown herein, and is to fit to and the principles and novel features disclosed herein phase one The widest range caused.

Claims (12)

  1. The manufacturing method of sticking patch 1. a kind of stop rebuilding type artificial bone-head for shoulder tucks inside the sleeve, it is characterised in that：It is as follows：
    S1, it selects the synthetic material of human body nonabsorable and hydrogel to be mixed and made into spinning solution, is built by electrostatic spinning Sticking patch middle layer with nanofibrous structures, or select the synthetic material of human body nonabsorable by weaving structure with netted The sticking patch middle layer of knitted body structure, the supportive body as entire sticking patch；
    S2, sticking patch middle layer both ends be respectively tendon portion and stop portion, in the tendon portion of sticking patch middle layer, package crosslinking one is mended Piece tendon portion middle layer, and in sticking patch tendon portion middle layer addition at tendon active medicine or at tendon active growth factor, In the stop portion of sticking patch middle layer package one sticking patch stop portion middle layer of crosslinking, and added at soft in sticking patch stop portion middle layer Bone active drugs or at cartilage active growth factor；
    S3, it corresponds to coating in the upper surface of sticking patch tendon portion's middle layer and sticking patch stop portion middle layer and is crosslinked with sticking patch upper layer, And it is added at tendon active medicine or at tendon active growth factor in sticking patch upper layer；
    S4, it corresponds to coating in the lower surface of sticking patch tendon portion's middle layer and sticking patch stop portion middle layer and is crosslinked with sticking patch tendon portion Lower layer and sticking patch stop subordinate layer, and the subordinate's layer addition of sticking patch tendon at tendon active medicine or at tendon Active Growth because It is artificial to constitute entire stop rebuilding type in sticking patch stop subordinate's layer addition osteogenic activity drug or osteogenic activity growth factor for son Shoulder sleeve sticking patch.
  2. The manufacturing method of sticking patch 2. a kind of stop rebuilding type artificial bone-head for shoulder according to claim 1 tucks inside the sleeve, it is characterised in that：It is described Synthetic material in step S1 is polypropylene, polyester, polytetrafluoroethylene (PTFE) and nylon is one such or a variety of compound compositions.
  3. The manufacturing method of sticking patch 3. a kind of stop rebuilding type artificial bone-head for shoulder according to claim 1 tucks inside the sleeve, it is characterised in that：It is described Sticking patch tendon portion's middle layer and the package crosslinking of sticking patch stop portion middle layer in step S2 is behind the both ends of sticking patch sticking patch middle layer Freeze-dried processing forms structural adhesive layer, and sticking patch tendon portion's middle layer and sticking patch stop portion's middle layer during frozen dried its Inside is respectively formed multiple the first micropores and the second micropore grown into for human body cell, and contains in the coating of the inner wall of the first micropore At tendon active medicine or at tendon active growth factor at tendon inducing layer, it is coated with and includes into the inner wall of the second micropore Cartilage active medicine or at cartilage active growth factor at chondrocyte induction layer, sticking patch tendon portion's middle layer and sticking patch stop Portion's middle layer is made of the composite material with biocompatibility, and the composite material is gelatin, collagen, hyaluronic acid, shell are poly- Sugar and sodium alginate one or more of which.
  4. The manufacturing method of sticking patch 4. a kind of stop rebuilding type artificial bone-head for shoulder according to claim 1 tucks inside the sleeve, it is characterised in that：It is described Structural adhesive layer is formed through frozen dried after sticking patch upper layer coating crosslinking in step S3, and sticking patch upper layer is during frozen dried Its internal multiple third micropore grown into for human body cell of formation, and be coated in the inner wall of third micropore and include into tendon activity Drug or at tendon active growth factor at tendon inducing layer, the sticking patch upper layer is by the composite material with biocompatibility It constitutes, the composite material is gelatin, collagen, hyaluronic acid, chitosan and sodium alginate one or more of which.
  5. The manufacturing method of sticking patch 5. a kind of stop rebuilding type artificial bone-head for shoulder according to claim 1 tucks inside the sleeve, it is characterised in that：It is described Structural adhesive layer is formed through frozen dried after sticking patch tendon subordinate layer and the subordinate's layer coating crosslinking of sticking patch stop in step S4, and is mended Piece tendon subordinate layer and sticking patch stop subordinate's layer are respectively formed during frozen dried inside it multiple to be grown into for human body cell The 4th micropore and the 5th micropore, and in the coating of the inner wall of the 4th micropore containing at tendon active medicine or at tendon Active Growth The factor at tendon inducing layer, be coated in the inner wall of the 5th micropore and include osteogenic activity drug or osteogenic activity growth factor Osteogenic induction layer, the sticking patch tendon subordinate layer and sticking patch stop subordinate's layer are made of the composite material with biocompatibility, The composite material is gelatin, collagen, hyaluronic acid, chitosan and sodium alginate one or more of which.
  6. The sticking patch 6. a kind of stop rebuilding type artificial bone-head for shoulder tucks inside the sleeve, is tucked inside the sleeve using a kind of stop rebuilding type artificial bone-head for shoulder described in Claims 1 to 5 The manufacturing method of sticking patch, it is characterised in that：The stop rebuilding type artificial bone-head for shoulder tucks inside the sleeve sticking patch as multilayered structure, including sticking patch tendon The both ends of portion, sticking patch stop portion and sticking patch middle layer, the sticking patch middle layer are respectively tendon portion and stop portion, the sticking patch flesh Tendon portion includes that sticking patch tendon portion upper layer, sticking patch tendon portion's middle layer and sticking patch tendon subordinate's layer, sticking patch stop portion include mending Piece stop portion upper layer, sticking patch stop portion's middle layer and sticking patch stop subordinate's layer, sticking patch tendon portion upper layer and sticking patch stop portion Upper layer forms sticking patch upper layer, and sticking patch tendon portion's middle layer and sticking patch stop portion middle layer wrap up crosslinking among sticking patch respectively In the tendon portion and stop portion of layer, and crosslinking institute is coated in the upper surface of sticking patch tendon portion's middle layer and sticking patch stop portion middle layer Sticking patch upper layer is stated, corresponding to coating in the lower surface of sticking patch tendon portion's middle layer and sticking patch stop portion middle layer is crosslinked the sticking patch flesh Tendon subordinate layer and sticking patch stop subordinate's layer.
  7. The sticking patch 7. a kind of stop rebuilding type artificial bone-head for shoulder according to claim 6 tucks inside the sleeve, it is characterised in that：The sticking patch middle layer Nanofibrous structures or institute are formed by by electrostatic spinning structure for the electrostatic spinning liquid made of synthetic material and hydrogel It is that the synthetic material degraded by human body nonabsorable is formed by netted knitted body structure by weaving structure to state sticking patch middle layer, And constitute stop rebuilding type artificial bone-head for shoulder tuck inside the sleeve sticking patch supportive body, the synthetic material by polypropylene, polyester, polytetrafluoroethylene (PTFE) and Nylon is one such or a variety of compound compositions.
  8. The sticking patch 8. a kind of stop rebuilding type artificial bone-head for shoulder according to claim 6 tucks inside the sleeve, it is characterised in that：Sticking patch tendon portion Middle layer is with biocompatibility and interior added at tendon active medicine or at the composite material of tendon active growth factor The structural adhesive layer being cross-linked to form, sticking patch tendon portion's middle layer is by gelatin, collagen, hyaluronic acid, chitosan and sodium alginate One such or a variety of composite crosslinkings are constituted, and are also had in sticking patch tendon portion middle layer and multiple to be grown into for human body cell First micropore, the inner wall of first micropore, which is coated with, includes into tendon active medicine or at tendon active growth factor at flesh Tendon inducing layer.
  9. The sticking patch 9. a kind of stop rebuilding type artificial bone-head for shoulder according to claim 6 tucks inside the sleeve, it is characterised in that：Sticking patch stop portion Middle layer is with biocompatibility and interior added at cartilage active medicine or at the composite material of cartilage active growth factor The structural adhesive layer being cross-linked to form, sticking patch stop portion's middle layer is by gelatin, collagen, hyaluronic acid, chitosan and sodium alginate One such or a variety of composite crosslinkings are constituted, and are also had in sticking patch stop portion middle layer and multiple to be grown into for human body cell Second micropore, the inner wall of second micropore, which is coated with, includes into cartilage active medicine or at cartilage active growth factor at soft Self-bone grafting layer.
  10. The sticking patch 10. a kind of stop rebuilding type artificial bone-head for shoulder according to claim 6 tucks inside the sleeve, it is characterised in that：The sticking patch upper layer For with biocompatibility and it is interior added at tendon active medicine or at tendon active growth factor composite material be crosslinked shape At structural adhesive layer, the sticking patch upper layer is one such or more by gelatin, collagen, hyaluronic acid, chitosan and sodium alginate Kind composite crosslinking is constituted, and also has multiple third micropores grown into for human body cell, the third micropore in the sticking patch upper layer Inner wall be coated with include into tendon active medicine or at tendon active growth factor at tendon inducing layer.
  11. The sticking patch 11. a kind of stop rebuilding type artificial bone-head for shoulder according to claim 6 tucks inside the sleeve, it is characterised in that：The sticking patch tendon Subordinate's layer is with biocompatibility and interior added at tendon active medicine or at the composite material of tendon active growth factor The structural adhesive layer being cross-linked to form, sticking patch tendon subordinate layer by gelatin, collagen, hyaluronic acid, chitosan and sodium alginate its In one or more composite crosslinkings constitute, also there are multiple four grown into for human body cell in sticking patch tendon subordinate layer Micropore, the inner wall of the 4th micropore, which is coated with, includes into tendon active medicine or luring at tendon at tendon active growth factor Conducting shell.
  12. The sticking patch 12. a kind of stop rebuilding type artificial bone-head for shoulder according to claim 6 tucks inside the sleeve, it is characterised in that：The sticking patch stop Subordinate's layer is with biocompatibility and the interior composite material crosslinking added with osteogenic activity drug or osteogenic activity growth factor The structural adhesive layer of formation, the sticking patch stop subordinate layer are therein by gelatin, collagen, hyaluronic acid, chitosan and sodium alginate One or more composite crosslinkings are constituted, also have in the sticking patch stop subordinate layer it is multiple grown into for human body cell it is the 5th micro- Hole, the inner wall of the 5th micropore, which is coated with, includes osteogenic activity drug or the osteogenic induction layer of osteogenic activity growth factor.
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CN109758260A (en) * 2019-03-07 2019-05-17 上海白衣缘生物工程有限公司 A kind of solid rotator cuff biological sticking patch and its preparation method and application
CN112107390A (en) * 2019-06-20 2020-12-22 北京博辉瑞进生物科技有限公司 Composite tendon repair material and preparation method thereof
CN114732948A (en) * 2022-03-25 2022-07-12 上海工程技术大学 Rotator cuff patch and preparation method thereof
CN114732949A (en) * 2022-03-25 2022-07-12 上海工程技术大学 Rotator cuff patch with oriented structure and preparation method thereof

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