CN108578787A - A kind of absorbable bone anchoring device and preparation method thereof - Google Patents

A kind of absorbable bone anchoring device and preparation method thereof Download PDF

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Publication number
CN108578787A
CN108578787A CN201810888658.9A CN201810888658A CN108578787A CN 108578787 A CN108578787 A CN 108578787A CN 201810888658 A CN201810888658 A CN 201810888658A CN 108578787 A CN108578787 A CN 108578787A
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CN
China
Prior art keywords
anchoring device
bone anchoring
matrix
ceramic
bone
Prior art date
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.)
Pending
Application number
CN201810888658.9A
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Chinese (zh)
Inventor
竺亚斌
何斌
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ningbo Bao Ting Biotechnology Co Ltd
Original Assignee
Ningbo Bao Ting Biotechnology Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Ningbo Bao Ting Biotechnology Co Ltd filed Critical Ningbo Bao Ting Biotechnology Co Ltd
Priority to CN201810888658.9A priority Critical patent/CN108578787A/en
Publication of CN108578787A publication Critical patent/CN108578787A/en
Priority to PCT/CN2018/121388 priority patent/WO2020029502A1/en
Pending legal-status Critical Current

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Classifications

    • 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • A61L31/06Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02Inorganic materials
    • A61L31/026Ceramic or ceramic-like structures, e.g. glasses
    • 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148Materials at least partially resorbable by the body

Abstract

The invention discloses a kind of absorbable bone anchoring device and preparation method thereof, feature is the matrix for including material for polyester polymer, and cavity is provided in matrix, Ca-P ceramic is filled in cavity;Advantage is to fill Ca-P ceramic composition in polyester polymer with physical method, so that the weight ratio of Ca-P ceramic composition reaches as high as 80% or so in bone anchoring device, this aspect can keep the microstructure of polymer, can reach high intensity using a small amount of polymer;On the other hand, promoting the additive amount of the Ca-P ceramic of bone uptake can be added according to actual needs.And after the bone anchoring device enters in vivo, material neutralizes for the acid alkaline Ca-P ceramic that can be filled formed after the matrix degradation of polyester polymer, to prevent inflammatory reaction, Ca-P ceramic therein can also play the function of induction osteocyte/bone growth simultaneously, accelerate the reparation and healing of bone, avoid formation empty in Regenerated Bone, it is ensured that the intensity of Regenerated Bone.

Description

A kind of absorbable bone anchoring device and preparation method thereof
Technical field
The present invention relates to used in clinical treatment bone fixation instrument more particularly to a kind of absorbable bone anchoring device And preparation method thereof.
Background technology
Adsorbable bone fixing device based on polylactic acid is more and more widely used in clinical treatment.It is bone, soft Polylactic acid-based absorbable fixed instrument is used extensively in the connection and fixation of bone, tendon, ligament etc..Polylactic acid is in vivo in environment Lactic acid can be degraded to:D-lactic acid can be metabolized as carbon dioxide and water in human body by tricarboxylic acid cycle, and body is finally discharged Outside;L-lactic acid can be excluded through kidney.Polylactic acid-based bone fixation medical instrument alternative metals class instrument can remove patient experience from Second operation takes out pain and the financial burden of metal.But the bone anchoring devices such as pure made nail of polylactic acid material make With finding that there are still problems in the process:(1), polylactic acid catabolite in acidity, easily cause caused by acidity in vivo Inflammatory reaction hinders symphysis and reparation;(2), polylactic acid catabolite habitat be due to osteocyte/bone tissue can not be grown into Cavity is formed, and then reduces the intensity of new bone, there are the risks of second fracture;(3), poly-lactic acid material mechanical property to heat it is non- Often sensitive, on the one hand the melting injection molding method routinely used accelerates the thermal degradation of polylactic acid ontology, substantially reduce its molecule Amount, on the other hand, because polylactic acid crystallization rate itself is slow, conventional injection molding cooling allows it that can not form effective crystallization(Crystallinity It is directly proportional to product strength), the intensity that the factor of these two aspects results in polylactic acid-based bone anchoring device is low, cannot meet orthopaedics Demand.
Invention content
Technical problem to be solved by the invention is to provide inflammatory reaction caused by a kind of acidity of avoidable catabolite, The reparation and healing for accelerating bone prevent cavity in bone, and are greatly improved the absorbable bone anchoring device of device intensity And preparation method thereof.
Technical solution is used by the present invention solves above-mentioned technical problem:A kind of absorbable bone anchoring device, including Material is the matrix of polyester polymer, and cavity is provided in the matrix, Ca-P ceramic is filled in the cavity.
Further, the shape of the matrix is round bar shape or plate.
Further, the outer surface of the matrix of the round bar shape is provided with external screw thread.
Further, the polyester polymer is poly-epsilon-caprolactone, Poly L-lactic acid, ploy DL lactic caid, polyethanol At least one of acid, wherein:The molecular weight of poly-epsilon-caprolactone>80000.
Further, the Ca-P ceramic is at least one of tricalcium phosphate, hydroxyapatite, bio-vitric.
A kind of preparation method of absorbable bone anchoring device, including step in detail below:
(1), take solid polyester polymer to be processed into round bar shape or plate, as matrix;
(2), on matrix trepanning to form inner cavity;
(3), fill Ca-P ceramic in the lumen, obtain bone anchoring device.
Further, the step(1)In, screw thread is processed in the outer surface of the matrix of round bar shape, forms screw.
Further, the polyester polymer is poly-epsilon-caprolactone, Poly L-lactic acid, ploy DL lactic caid, polyethanol At least one of acid, wherein:The molecular weight of poly-epsilon-caprolactone>80000.
Further, the Ca-P ceramic is at least one of tricalcium phosphate, hydroxyapatite, bio-vitric.
Compared with prior art, it is an advantage of the invention that:
(1), due to material be polyester polymer matrix cavity in fill Ca-P ceramic, with physical method in polyesters Ca-P ceramic composition is filled in polymer so that the weight ratio of Ca-P ceramic composition reaches as high as 80% or so in bone anchoring device, This aspect can keep the microstructure of polymer, can reach high intensity using a small amount of polymer;On the other hand, promote bone life The additive amount of long Ca-P ceramic can be added according to actual needs.
(2), after the bone anchoring device enters in vivo, material be polyester polymer matrix degradation after the acidity that is formed can The alkaline Ca-P ceramic that is filled neutralizes, to prevent inflammatory reaction, while Ca-P ceramic therein can also play induction osteocyte/ The function of bone growth accelerates the reparation and healing of bone, avoids formation empty in Regenerated Bone, it is ensured that Regenerated Bone it is strong Degree.
Description of the drawings
Fig. 1 is the structural diagram of the present invention.
Specific implementation mode
Below in conjunction with attached drawing embodiment, present invention is further described in detail.
As shown, a kind of absorbable bone anchoring device, including matrix 1 that material is polyester polymer, in matrix 1 It is provided with cavity, Ca-P ceramic 2 is filled in cavity.
In above-described embodiment, the shape of matrix can be round bar shape or plate, also can be in the outer surface of the matrix of round bar shape External screw thread is set, it is made to be used as nail;In addition, polyester polymer is poly-epsilon-caprolactone, Poly L-lactic acid, poly- racemization breast At least one of acid, polyglycolic acid, wherein:The molecular weight of poly-epsilon-caprolactone>80000;Ca-P ceramic is tricalcium phosphate, hydroxyl At least one of apatite, bio-vitric.
The preparation method of above-mentioned absorbable bone anchoring device, including step in detail below:
(1), take solid polyester polymer to be processed into round bar shape or plate, as matrix 1;
(2), on matrix 1 trepanning to form inner cavity;
(3), in the lumen fill Ca-P ceramic 2, obtain bone anchoring device.
When needing using bone anchoring device as nail in use, in step(1)In, in the outer surface of the matrix 1 of round bar shape Process screw thread.

Claims (9)

1. a kind of absorbable bone anchoring device, it is characterised in that including the matrix that material is polyester polymer, the base It is provided with cavity in vivo, Ca-P ceramic is filled in the cavity.
2. a kind of absorbable bone anchoring device as described in claim 1, it is characterised in that:The shape of the matrix is circle Stick or plate.
3. a kind of absorbable bone anchoring device as claimed in claim 2, it is characterised in that:The matrix of the round bar shape Outer surface is provided with external screw thread.
4. a kind of absorbable bone anchoring device as described in claim 1, it is characterised in that:The polyester polymer is At least one of poly-epsilon-caprolactone, Poly L-lactic acid, ploy DL lactic caid, polyglycolic acid, wherein:The molecular weight of poly-epsilon-caprolactone >80000。
5. a kind of absorbable bone anchoring device as described in claim 1, it is characterised in that:The Ca-P ceramic is phosphoric acid At least one of tricalcium, hydroxyapatite, bio-vitric.
6. a kind of preparation method of absorbable bone anchoring device, it is characterised in that including step in detail below:
(1), take solid polyester polymer to be processed into round bar shape or plate, as matrix;
(2), on matrix trepanning to form inner cavity;
(3), fill Ca-P ceramic in the lumen, obtain bone anchoring device.
7. a kind of preparation method of absorbable bone anchoring device as claimed in claim 6, it is characterised in that:The step (1)In, screw thread is processed in the outer surface of the matrix of round bar shape, forms screw.
8. a kind of preparation method of absorbable bone anchoring device as claimed in claim 6, it is characterised in that:The polyester Type of Collective object is poly-epsilon-caprolactone, Poly L-lactic acid, ploy DL lactic caid, at least one of polyglycolic acid, wherein:Poly- ε-is in oneself The molecular weight of ester>80000.
9. a kind of preparation method of absorbable bone anchoring device as claimed in claim 6, it is characterised in that:The calcium phosphorus Ceramics are at least one of tricalcium phosphate, hydroxyapatite, bio-vitric.
CN201810888658.9A 2018-08-07 2018-08-07 A kind of absorbable bone anchoring device and preparation method thereof Pending CN108578787A (en)

Priority Applications (2)

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CN201810888658.9A CN108578787A (en) 2018-08-07 2018-08-07 A kind of absorbable bone anchoring device and preparation method thereof
PCT/CN2018/121388 WO2020029502A1 (en) 2018-08-07 2019-01-30 Absorbable bone fixation device and preparation method thereof

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020029502A1 (en) * 2018-08-07 2020-02-13 宁波宝亭生物科技有限公司 Absorbable bone fixation device and preparation method thereof

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