CN106473787A - A kind of porous PEEK holdfast - Google Patents

A kind of porous PEEK holdfast Download PDF

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Publication number
CN106473787A
CN106473787A CN201611141229.2A CN201611141229A CN106473787A CN 106473787 A CN106473787 A CN 106473787A CN 201611141229 A CN201611141229 A CN 201611141229A CN 106473787 A CN106473787 A CN 106473787A
Authority
CN
China
Prior art keywords
holdfast
peek
main body
porous peek
porous
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
CN201611141229.2A
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Chinese (zh)
Inventor
刘继强
赵学东
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.)
Yun Yi (beijing) Medical Equipment Co Ltd
Original Assignee
Yun Yi (beijing) Medical Equipment 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 Yun Yi (beijing) Medical Equipment Co Ltd filed Critical Yun Yi (beijing) Medical Equipment Co Ltd
Priority to CN201611141229.2A priority Critical patent/CN106473787A/en
Publication of CN106473787A publication Critical patent/CN106473787A/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0642Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
    • 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
    • A61L31/14Materials 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
    • A61L31/146Porous materials, e.g. foams or sponges
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B33ADDITIVE MANUFACTURING TECHNOLOGY
    • B33YADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00Products made by additive manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties

Abstract

The invention discloses a kind of porous PEEK holdfast, described holdfast includes main body and micropore, and described main body is made up of PEEK material, is provided with multiple described micropores on the body,, between 20% to 85%, the diameter of described micropore is between 0.1mm to 1mm for the porosity of described holdfast.The porous PEEK holdfast of the present invention, has preferable biocompatibility, and new bone growth effect is good, does not allow easy to fall off in use, and manufacture process is simple, low cost.

Description

A kind of porous PEEK holdfast
Technical field
The present invention relates to surgical implant, more particularly, to soft tissue one of are connected porous PEEK holdfast with bone.
Background technology
Band wire holdfast is generally used for repairing soft tissue injury, by suture by the soft tissue tearing off and Bone Defect Repari, then uses anchor The fixing suture of nail, in bone, reaches the purpose of tendon-knitting.The band wire holdfast clinically using now typically have metal anchoring nail and Two kinds of absorbable holdfast.The poor biocompatibility of metal anchoring nail, easily produces rejection.And it can absorb holdfast in different human body All there is larger difference in interior infiltration rate and absorbable degree, therefore surgical effect is unstable.And, both holdfasts often have Come off, cause the situation of solid failure.
Accordingly, it is desirable to provide a kind of porous PEEK holdfast is to solve the above problems.
Content of the invention
In order to solve this problem, the invention discloses a kind of porous PEEK holdfast, described holdfast includes main body and micropore, institute State main body to be made up of PEEK material, be provided with multiple described micropores on the body, the porosity of described holdfast arrives 20% Between 85%, the diameter of described micropore is between 0.1mm to 1mm.
The porosity of described holdfast is preferably 30% to 50%.More preferably, the porosity of described holdfast is 40%.
It is preferred that the diameter of described micropore is between 0.4mm to 0.6mm.
It is preferred that the surface roughness of described main body is between 0.2 micron to 10 microns.
It is preferred that described main body is threaded screw shape.
It is preferred that the shape of described main body is selected from cylinder, cone or cuboid.
It is preferred that the rear end of described main body also sets up handle hole.
It is preferred that being additionally provided with through wires hole on the body, suture is connected on described holdfast.
Above-mentioned holdfast can pass through laser sintered PEEK powder, is manufactured by 3D printing.
The porous PEEK holdfast of the present invention, has preferable biocompatibility, and new bone growth effect is good, in use Do not allow easy to fall off, manufacture process is simple, low cost.
Introduce a series of concept of reduced forms in Summary, this will specific embodiment partly in enter One step describes in detail.Present invention part is not meant to attempt to limit the crucial special of technical scheme required for protection Seek peace essential features, more do not mean that the protection domain attempting to determine technical scheme required for protection.
Below in conjunction with accompanying drawing, describe advantages and features of the invention in detail.
Brief description
Fig. 1 is the schematic diagram of porous PEEK holdfast according to an embodiment of the invention.
Specific embodiment
In the following description, a large amount of concrete details are given to provide more thorough understanding of the invention.So And, it will be apparent to one skilled in the art that the present invention can one or more of these details and be able to Implement.In other examples, in order to avoid obscuring with the present invention, some technical characteristics well known in the art are not entered Row description.
In order to thoroughly understand the present invention, detailed structure will be proposed in following description.Obviously, the execution of the present invention is simultaneously It is not limited to the specific details that those skilled in the art is familiar with.Presently preferred embodiments of the present invention is described in detail as follows, but In addition to these describe in detail, the present invention can also have other embodiment.
Below in conjunction with accompanying drawing, embodiments of the invention are described in detail.
With reference to Fig. 1, it is the schematic diagram of porous PEEK holdfast according to an embodiment of the invention.The holdfast of the present invention, adopts Manufactured with PEEK (polyether-ether-ketone).PEEK material has excellent biocompatibility and mechanical property, can be chronically implanted human body And do not cause human body to repel.PEEK density of material is low, and the PEEK material of porous more can reduce the quality of implant, in addition, The elastic modelling quantity of PEEK material, close to human Cortex's bone, can be good at stimulating osteanagenesis.
The porous PEEK holdfast of the present invention includes main body 1, and in FIG, main body 1 is threaded screw shape.Due to adopting With the shape of screw, when using, without punching in advance, can directly pierce.But it is understood that, the present invention's is many The shape not limited to this of the main body 1 of hole PEEK holdfast, it would however also be possible to employ other shapes, such as cylinder, cone, cuboid Deng.When there is no the main body of self tapping effect using other it may be necessary to punch in advance in implant site.
In the rear end of main body 1, handle hole can also be set.Handle hole can combine with other utensils, is sent holdfast with facilitating Enter position to be implanted.It is additionally provided with through wires hole on the body 1, suture is connected on holdfast.
It is provided with multiple micropores 2 on the body 1, the porous PEEK holdfast of the present invention can be good at inducing new bone in holdfast Surface and tumor growth.
For the setting of micropore, if the quantity of setting is excessive, the overall intensity of holdfast can be affected, if the quantity of setting Very few, then telling on of new bone can be made not good.Therefore, select suitable porosity particularly important.It is total that porosity is hole Volume accounts for the ratio of small product size.Its calculation is as follows:
In formula:P is porosity (%), drFor material actual density (g/cm3), dthFor materials theory density (g/cm3).
Through overtesting, it has been found that the selection of porosity can obtain preferably new bone life between 25%-85% Long.Test is as follows:
1. adopt 3D printing PEEK technology, using laser sintered PEEK powder, produce the porous PEEK holdfast of the present invention. The length of holdfast is 9mm, a diameter of 5mm at screw thread, a diameter of 3mm at non-threaded, and pore diameter is chosen as 0.5mm.Above-mentioned Under parameter identical parameter, prepare respectively porosity be 25%, 30%, 40%, 50%, 85% holdfast.
2. subjects adopt healthy adult domesticated dog, and body weight is about 13 kilograms.It is divided into five groups, every group 4.Wherein A group is adopted The holdfast being 25% with porosity, B group porosity is 30%, C group porosity is 50%, E group hole for 40%, D group porosity Rate is 85%.
3. above-mentioned subjects are manufactured Cranial defect, defect area and holdfast size one in condylus lateralis femorises centre Cause.Implantation holdfast finishes rear sewing-up cut.
4., after performing the operation 3 months, take subjects condylus lateralis femorises specimen.Freshman bone tissue at Cranial defect is carried out with quantitative point Analysis.Calculation is:
Gross area x100% in N=osseous tissue area/visual field.
Wherein N is freshman bone tissue's area ratio.
When carrying out quantitative analyses, image acquisition can be carried out using the full microscope on market, and pass through image Analysis software (such as Image pro etc.) carries out quantitative analyses.Result is as follows:
It can be seen from the results above that porosity is higher, then the growth of new bone is better, and the setting that micropore is described is really to new The growth of bone is effective.Therefore, if do not considered the factors such as intensity, the higher holdfast of porosity can be selected.But, if porosity Too high, then intensity is affected.It is therefore advantageous to, porosity selects in 30%-50%.More excellent is chosen as 40%.
The aperture of above-mentioned micropore 2 can select between 0.1mm-1mm.Preferably, aperture is 0.4mm-0.6mm.
In addition, for the adhesion promoting platelet attachment and fibrin block, providing initial stablizing for getting up early bone formation Environment, roughness R on the surface of the holdfast in the present inventionaSelect more than 0.2 micron and be less than 10 microns.
As described above, the preparation of the holdfast of the present invention can adopt laser sintered 3D printing PEEK technology, burnt using laser Knot PEEK powder, " printing " goes out porous PEEK holdfast.The preparation of the holdfast of the present invention only need to use PEEK powder, compared to PEEK Section bar, the cost of powder substantially reduces, and is lost low.And preparation process does not need to add pore creating material, clear thus without occurring The clean pollution totally not caused is topic, and process is simple, low cost.
The porous PEEK holdfast of the present invention, has preferable biocompatibility, and new bone growth effect is good, in use Do not allow easy to fall off, manufacture process is simple, low cost.
The present invention is illustrated by above-described embodiment, but it is to be understood that, above-described embodiment is only intended to Citing and descriptive purpose, and be not intended to limit the invention in described scope of embodiments.In addition people in the art Member, it is understood that the invention is not limited in above-described embodiment, can also make more kinds of according to the teachings of the present invention Variants and modifications, within these variants and modifications all fall within scope of the present invention.Protection scope of the present invention by The appended claims and its equivalent scope are defined.

Claims (10)

1., it is characterised in that described holdfast includes main body and micropore, described main body is by PEEK material system for a kind of porous PEEK holdfast Become, be provided with multiple described micropores on the body, the porosity of described holdfast between 20% to 85%, described micropore Diameter is between 0.1mm to 1mm.
2. according to the porous PEEK holdfast described in claim 1 it is characterised in that the porosity of described holdfast preferably 30% arrives 50%.
3. according to the porous PEEK holdfast described in claim 1 it is characterised in that the porosity of described holdfast is 40%.
4. according to the porous PEEK holdfast described in claim 1 it is characterised in that the diameter of described micropore is in 0.4mm to 0.6mm Between.
5. according to the porous PEEK holdfast described in claim 1 it is characterised in that the surface roughness of described main body is micro- 0.2 Rice is between 10 microns.
6. according to the porous PEEK holdfast any one of claim 1-5 it is characterised in that described main body is threaded Screw shape.
7. according to the porous PEEK holdfast any one of claim 1-5 it is characterised in that the shape of described main body is selected from Cylinder, cone or cuboid.
8. according to the porous PEEK holdfast any one of claim 1-5 it is characterised in that the rear end of described main body also sets Put handle hole.
9. according to the porous PEEK holdfast described in claim 8 it is characterised in that being additionally provided with threading on the body Hole, suture is connected on described holdfast.
10. porous PEEK holdfast according to claim 1 is it is characterised in that described holdfast passes through laser sintered PEEK powder End, is manufactured by 3D printing.
CN201611141229.2A 2016-12-12 2016-12-12 A kind of porous PEEK holdfast Pending CN106473787A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
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Application Number Priority Date Filing Date Title
CN201611141229.2A CN106473787A (en) 2016-12-12 2016-12-12 A kind of porous PEEK holdfast

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10575886B2 (en) 2018-05-09 2020-03-03 Warsaw Orthopedic, Inc. Bone screw and method of manufacture
US10993753B2 (en) 2018-05-09 2021-05-04 Warsaw Orthopedic, Inc. Bone screw and method of manufacture
US11191582B2 (en) 2018-05-09 2021-12-07 Warsaw Orthopedic, Inc. Bone screw and method of manufacture
US11224470B2 (en) 2018-05-09 2022-01-18 Warsaw Orthopedic, Inc. Bone screw and method of manufacture

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CN102143721A (en) * 2008-08-14 2011-08-03 阿科玛股份有限公司 Customized implants for bone replacement
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US20150305737A1 (en) * 2014-04-25 2015-10-29 DePuy Synthes Products, Inc. Flexible suture anchor threader and suture anchor kit
CN106178104A (en) * 2016-08-29 2016-12-07 上海交通大学 A kind of medical medicine-carried porous polyether-ether-ketone and manufacture method thereof and application
CN206761724U (en) * 2016-12-12 2017-12-19 运怡(北京)医疗器械有限公司 A kind of porous PEEK holdfasts

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10575886B2 (en) 2018-05-09 2020-03-03 Warsaw Orthopedic, Inc. Bone screw and method of manufacture
US10993753B2 (en) 2018-05-09 2021-05-04 Warsaw Orthopedic, Inc. Bone screw and method of manufacture
US11191582B2 (en) 2018-05-09 2021-12-07 Warsaw Orthopedic, Inc. Bone screw and method of manufacture
US11224470B2 (en) 2018-05-09 2022-01-18 Warsaw Orthopedic, Inc. Bone screw and method of manufacture
US11589907B2 (en) 2018-05-09 2023-02-28 Warsaw Orthopedic, Inc. Bone screw and method of manufacture
US11857233B2 (en) 2018-05-09 2024-01-02 Warsaw Orthopedic, Inc. Bone screw and method of manufacture

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