CN104586484B - A kind of backbone implantation unit and preparation method thereof - Google Patents
A kind of backbone implantation unit and preparation method thereof Download PDFInfo
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- CN104586484B CN104586484B CN201310533796.2A CN201310533796A CN104586484B CN 104586484 B CN104586484 B CN 104586484B CN 201310533796 A CN201310533796 A CN 201310533796A CN 104586484 B CN104586484 B CN 104586484B
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- medicine
- backbone
- unit
- stretch section
- silicon rubber
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
- A61B17/7031—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other made wholly or partly of flexible material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Neurology (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Prostheses (AREA)
Abstract
The present invention relates to medical instruments field.Specifically, the present invention relates to a kind of backbone to be implanted into unit, including stretch section, it is characterised in that the fluid silicone rubber containing medicine and curing agent is added in the stretch section, the silicon rubber body for being loaded with medicine is formed after ambient temperature curing.The invention further relates to a kind of method for preparing backbone implantation unit.Present invention implantation unit has pain chronic disease caused by the adhesion for releasing focus point, compressing etc., removes cartilaginous calcification, the function of making it decompose, absorb, and removes ligamentum flavum, the oedema of posterior longitudinal ligament, plump function.
Description
Technical field
The present invention relates to medical instruments field.Specifically, the present invention is applied to fixed network in orthopedic spinal, is related to one
Kind backbone implantation unit and preparation method thereof.
Background technology
Compressing is the big problem of a puzzlement doctor caused by adhesion before and after bone surgery, can influence success rate of operation.Hand
Preoperative adhesion phenomenon brings difficulty and risk to operation, and postoperative adhesion phenomenon causes operative failure, increases secondary hand
The possibility of art.Meanwhile when orthopaedics implant completion mission needs to take out, it can also increase operation risk.If implant carries
There is anti-inflammatory drug and slowly release performance inhibitory action, then adhesion symptom can be mitigated or eliminated.
The problem of being equally a puzzlement doctor is oppressed caused by cartilaginous calcification, rejects that risk is high, and regeneration may during operation
Property is big.If implant is loaded with decomposition, the medicine absorbed, and slowly releases, so that it may is eliminated by treating because calcification is drawn
The compressing risen.
Compressing caused by ligamentum flavum, posterior longitudinal ligament oedema, plumpness caused by inflammation, can be also loaded with by implant after surgery
Anti-inflammation drugs, treated by slowly discharging.
Appropriate control pain is of crucial importance for any postoperative patients, and pain relief assigns patient and significantly given birth to
Reason and psychological benefit.Effective pain of alleviation does not mean only that more smooth happier recovery from illness（For example, mood, sleep, quality of life
Deng）, and it can also reduce the breaking-out of chronic pain syndrome.
With the popularization of bone surgery, higher requirement is proposed to improving postoperative rehabilitation situation.Both at home and abroad with regard to postoperative sense
The common phenomena such as dye, adhesion, pain, focus healing have carried out substantial amounts of research and clinical observation, and a variety of sides have been invented for this
Method is prevented, alleviates, eliminates these postoperative complications, improves surgical quality.
By medicine equipment together with medicine efficient set, conventional Post operation can be replaced to take, inject substantial amounts of antibacterial,
The medicines such as hormone, analgesic, and this local target administration, effect is more preferable, and side effect is smaller.Current existing technology is as follows：
Chinese patent application No.02136332.3, entitled " the insoluble drug release controlling party of implantable medical devices
Method ".The invention combines inorganic material and the respective premium properties of high polymer material, more existing pure organic or purely inorganic
Coating process, there is clear advantage, be suitably adapted for protein drug and other are more sensitive to external conditions such as heat, light
The long-term control release of medicine.
《Biomedical engineering is in progress》The 4th phase of volume 31 in 2010, entitled " the anti-sense of titanium alloy implant surfaces of paper
Contaminate preparation and its In Vitro Bacteriostasis performance study of coating ".The paper with PLA (PDLLA) for carrier, using solvent cast
(solvent-casting) method, the PDLLA for being prepared for carrying mould rope (VCM) through the ages in titanium alloy implant matrix surface are applied
Layer, is expected that by Vancomycin to suppress bacterium infection.
Chinese patent application No.201110232842.6, entitled " Anti-infection medical titanium alloy ".The invention is existing
Have and add appropriate copper on the basis of medical titanium alloy Ti6Al7Nb chemical composition, after special heat resistanceheat resistant processing,
A kind of titanium copper phase is separated out in the matrix of medical titanium alloy, so as to assign medical titanium alloy bacterial-infection resisting function.
Chinese patent application No.200810147918.3, entitled " bacterial inhibition biological active titanium or titanium alloy is implanted into
Material and its preparation method and application ".The invention using bio-medical level titanium or titanium alloy as base material, will analyze it is pure it is chloride from
The material of son adds deionized water and is configured to electrolyte solution, with anodized surface modification treatment technology, in material anode and
Apply DC voltage 1-100V between negative electrode, second processing time 1-200, obtain to surface and generate biocidal property Ti-Cl groups and biology
The biological active titanium or titanium alloy of active Ti-OH groups, these Ti-Cl groups hydrolyze generation under physiological environment has antibacterial kill
- the ClO of bacterium effectxIon.
Chinese patent application No.200910051827.4, a kind of entitled " medicine for vertebral internal fixation screw
Thing coating and preparation and application ".The invention is related to for the medication coat of vertebral internal fixation screw and preparation and application, the medicine
Thing coating layer thickness is 30~300 microns.Screw is soaked in the N- hydroxyls of carbodiimides and 0.05mol/L dissolved with 0.2mol/L
30 minutes in the PBS of base succinimide；Bis phosphoric acid salt and other drugs are dissolved in distilled water, by screw immersion herein
24 hours in solution, produce.The medication coat screw, which can be applicable to, improves bone mass in vertebral internal fixation, reduce risk of fractures
Property.
Chinese patent application No.201110088034.7, entitled " medical apparatus surface is implemented to carry the solid medicine controlled release of medicine
Method ".The invention implements isostatic pressed processing by being either physically or chemically roughened equipment surfaces after carrying out drug coat
Make medicine and apparatus matrix strong bonded, overcome medicine caused by equipment surfaces directly carry medicine and come off, realize control medicine
The purpose of release.
It can be seen that prior art is all to carry out various processing in implant surface, such as medication coat, ooze copper ion, anode
The methods of oxidized surface modification treatment technology, reaches the purpose of antibacterial, but medicine layer is very thin, and time of insoluble drug release is naturally
It is few, it is desirable to keep the medicine of 1 year or so to act on and just do not realize.In addition, because these implants during human body is implanted into
Bone tissue and apparatus have very big friction, screw to be left few medicine after entering in sclerotin, and medicine effect can give a discount greatly
Button.
The content of the invention
The present invention is derived from the first Chinese patent application No.201210248135.0 of applicant, a kind of entitled " ridge
Post dynamic stability is implanted into unit ", the content of the earlier application is introduced into present specification in full, and as the one of disclosure
Part.
Specifically, the present invention is to add specific curative drug, prevention in the silicon rubber part of the implantation unit
Post-operation adhesion, infection and focus treatment.After product implantation human body, silicon rubber pharmaceutical carrier gradually effectively discharges medicine and slow
Diffuse into around body foci, operation consent focus and Post operation produced problem are issued to truly in drug therapy
Cure.
The present invention provides a kind of backbone implantation unit, including stretch section, it is characterised in that contains in the stretch section and is loaded with
The silicon rubber body of medicine.
According to the present invention, the backbone implantation unit is dynamic rod.
According to the present invention, the silicon rubber body for being loaded with medicine is located in the groove and/or through hole set on the stretch section.
According to the present invention, the silicon rubber body for being loaded with medicine is liquid-state silicon of the addition containing medicine and curing agent in stretch section
Rubber, it is ambient temperature curing to form.
According to the present invention, medicine used is corticosteroid hormone or α adrenaline, wherein the corticosteroid
Hormone is selected from clonidine, FA, dexamethasone, sulindac, SASP or its combination.
According to the present invention, medicine used is antiphlogistic, for example, antibiotics.
According to the present invention, the weight ratio of medicine and fluid silicone rubber, can be by being loaded with the silicon rubber of medicine between 10%~50%
The thickness of colloid and the length of slow-release time determine.
According to the present invention, needed depending on patient, the daily rate of release of medicine is can be controlled in less than 100 μ g/kg (patient's bodies
Weight).It will be appreciated by those skilled in the art that the rate of release depends on dose (concentration) used, is loaded with the silicon rubber of medicine
The thickness of colloid and species etc., can arbitrarily it adjust.
According to the present invention, the thickness B of silicon rubber body of medicine is loaded between 1.5mm-5mm.
It will be appreciated by those skilled in the art that in addition to dynamic rod, as long as other backbones implantation unit of the invention contains
Silicon rubber, just silicon rubber can be used as pharmaceutical carrier.
In addition, the present invention does not have particular/special requirement to silicon rubber, as long as it can be chronically implanted human body, meet security requirement,
And it can solidify at normal temperatures.
Dose (concentration) of the invention and the thickness for the silicon rubber body for being loaded with medicine have certain phase with slow-release time
Guan Xing, it can be determined according to being actually needed.For example, in the timing of concentration one, thickness takes large values, and slow-release time can extend.The present invention
Backbone implantation unit in medicament slow release be three months or half a year, even up to 1 year as long as.
The present invention also provides a kind of method for preparing backbone implantation unit, including following operative step：
Backbone implantation unit is provided, the backbone implantation unit includes stretch section,
Backbone implantation unit is cleaned, dried,
The fluid silicone rubber containing medicine and curing agent is injected in the stretch section, ambient temperature curing, formation is loaded with medicine
The silicon rubber body of thing.
According to the present invention, the fluid silicone rubber containing medicine and curing agent is injected in the groove and/or through hole of stretch section.
According to the present invention, the weight ratio between fluid silicone rubber, medicine and curing agent is 100:(10~50):(0.4~
0.6)。
The present invention is used as pharmaceutical carrier by the use of the silicon rubber in implant.Silicon rubber is a kind of porous, adsorbable material,
When curative drug is dissolved in wherein as bioactive substance, Ludox molecule is effectively and uniformly inhaled to its equal can produce
It is attached, extension over time and slowly discharge, and save its corresponding pharmacological property, at the same have chemical property it is stable,
The characteristics of nontoxic.Silicon rubber has good infiltration and permeability, is preferable Thermosensitive Material Used for Controlled Releasing of Medicine.Medicine is exactly to utilize
This characteristic of silicon rubber, effective control release and slowly diffusion are carried out through silicon rubber.In addition, silicon rubber in implant
There is certain thickness, the time than common implant coating insoluble drug release is grown, and silicon rubber body can be considered a medicine storage
Device.
Implant of the present invention have prevent adhesion, pain of alleviation effect, by steroid medicine, α adrenaline or antiphlogistic
It is dispersed in particulate form in silicon rubber matrix, medicine can slowly release, and release time can extend to 1 year or so.This is carried
Medicine implant simpler, medicine and silicon rubber need to only be mixed, curing molding at normal temperatures, expand medicine
The range of choice of thing.
Beneficial effects of the present invention are embodied in：
Implant has pain chronic disease caused by the adhesion for releasing focus point, compressing etc.；
Implant, which has, removes cartilaginous calcification, the function of making it decompose, absorb；
Implant, which has, removes ligamentum flavum, the oedema of posterior longitudinal ligament, plump function.
Brief description of the drawings
In order to more clearly describe technical scheme, briefly introduced below in conjunction with accompanying drawing.It is clear that this
A little accompanying drawings are only some embodiments that the application records.Technical scheme includes but is not limited to these accompanying drawings.
Fig. 1 shows dynamic rod, wherein 1, dynamic rod, 2, helicla flute, 3, through hole.
Fig. 2 shows to be loaded with the silicon rubber body of medicine in stretch section, and wherein thickness is B.
Embodiment
For a further understanding of the present invention, the preferred scheme of the present invention is described below in conjunction with embodiment.These
Description is merely illustrative the feature and advantage of backbone implantation unit of the present invention, the protection domain being not intended to limit the present invention.
Embodiment 1
After the completion of dynamic rod is machined, greasy dirt is cleaned up with supersonic wave cleaning machine, then in 100,000 grades of purification
In workshop, cleaned, dried with supersonic wave cleaning machine progress extreme trace.Dynamic rod is as shown in Figure 1.
From the fluid silicone rubber that can be chronically implanted, first medicine (clonidine) is added in the fluid silicone rubber and fully mixed
It is even, addition and the supporting curing agent of fluid silicone rubber (0.5wt%), after fully mixing thoroughly, form the liquid containing medicine and curing agent
Silicon rubber, syringe is moved into, then be injected in the helicla flute of dynamic rod.Ambient temperature curing 24 hours.Medicine is loaded with after solidification
Silicon rubber body shape as shown in Fig. 2 wherein thickness B is 3mm.
Fluid silicone rubber:Medicine:Curing agent=100:30:0.5（Weight ratio）.
The daily rate of release of medicine is controlled less than 100 μ g/kg (weight in patients), and pharmaceutical release time is up to half a year.
Embodiment 2
It is same as Example 1, in addition to choice of drug α adrenaline and thickness B are 2mm.Dynamic rod is implanted in interverbebral disc
Near, activity and the stress function of interverbebral disc are shared, prevents the further regression of interverbebral disc.Dynamic rod carries upper α adrenaline,
Degenerative disc disease, which can be treated, includes disc herniation.
Embodiment 3
It is same as Example 1, except in the through hole among dynamic rod inject the fluid silicone rubber containing medicine and curing agent,
The weight ratio of medicine and fluid silicone rubber is 40% and thickness is outside 5mm.Injection is containing medicine and curing agent in through hole
Fluid silicone rubber, it is possible to increase drugloading rate, pharmaceutical release time are up to one years.
The explanation of above example is only intended to help the core concept for understanding the present invention.It should be pointed out that for this area
Those of ordinary skill for, under the premise without departing from the principles of the invention, can also to the present invention unit and method carry out
Some improvement and modification, but these are improved and modification is also fallen into the range of the claims in the present invention are claimed.
Claims (7)
1. a kind of backbone is implanted into unit, including stretch section, it is characterised in that contains the silicon rubber for being loaded with medicine in the stretch section
Body；The thickness range for being loaded with the silicon rubber body of medicine is 1.5mm-5mm；The silicon rubber body for being loaded with medicine is in stretch section
The fluid silicone rubber containing medicine and curing agent is added, it is ambient temperature curing to form；Wherein described fluid silicone rubber, medicine and solidification
The weight ratio of agent three is 100:(10~50):(0.4~0.6).
2. backbone as claimed in claim 1 is implanted into unit, it is characterised in that the backbone implantation unit is dynamic rod.
3. backbone as claimed in claim 1 is implanted into unit, it is characterised in that the silicon rubber body for being loaded with medicine is positioned at described
In the groove and/or through hole that are set on stretch section.
4. backbone as claimed in claim 1 is implanted into unit, it is characterised in that the medicine is corticosteroid hormone, on α kidneys
Parathyrine or antiphlogistic.
5. backbone as claimed in claim 4 is implanted into unit, it is characterised in that the corticosteroid hormone be selected from clonidine,
FA, dexamethasone, sulindac, SASP or its combination.
6. a kind of method for preparing backbone implantation unit as claimed in claim 1, including following operative step：
A kind of backbone implantation unit is provided, the backbone implantation unit includes stretch section,
Backbone implantation unit is cleaned, dried,
The fluid silicone rubber containing medicine and curing agent is injected in the stretch section, ambient temperature curing, formation is loaded with medicine
Silicon rubber body.
7. method as claimed in claim 6, it is characterised in that in the groove and/or through hole of stretch section injection containing medicine and
The fluid silicone rubber of curing agent.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310533796.2A CN104586484B (en) | 2013-10-31 | 2013-10-31 | A kind of backbone implantation unit and preparation method thereof |
| PCT/CN2014/088452 WO2015062408A1 (en) | 2013-10-31 | 2014-10-13 | Spine implant unit and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310533796.2A CN104586484B (en) | 2013-10-31 | 2013-10-31 | A kind of backbone implantation unit and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN104586484A CN104586484A (en) | 2015-05-06 |
| CN104586484B true CN104586484B (en) | 2018-03-23 |
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| CN201310533796.2A Active CN104586484B (en) | 2013-10-31 | 2013-10-31 | A kind of backbone implantation unit and preparation method thereof |
Country Status (2)
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| CN (1) | CN104586484B (en) |
| WO (1) | WO2015062408A1 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108852564B (en) * | 2018-05-07 | 2019-08-09 | 福州大学 | Artificial disc after arthroplasty based on metal-rubber |
| WO2020132571A1 (en) | 2018-12-21 | 2020-06-25 | Paradigm Spine, Llc | Modular spine stabilization system and associated instruments |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2607999A (en) * | 1999-02-14 | 2000-08-29 | Shiliang Wang | Sustained release implant, methods for preparation thereof and for treating cancer |
| GB0425546D0 (en) * | 2004-11-20 | 2004-12-22 | Wang Dajue | Spinal prostheses |
| US20110022177A1 (en) * | 2006-02-24 | 2011-01-27 | Paonan Biotech Co., Ltd. | Intervertebral filling for cervical vertebrae |
| CN100423792C (en) * | 2006-10-26 | 2008-10-08 | 上海交通大学医学院附属新华医院 | Slow release type testis prosthesis and its application |
| EP2162079B1 (en) * | 2007-02-14 | 2016-07-06 | Flex Technology Inc. | Flexible spine components |
| US20080208260A1 (en) * | 2007-02-22 | 2008-08-28 | Csaba Truckai | Spine treatment devices and methods |
| CN101130106B (en) * | 2007-09-28 | 2010-06-02 | 清华大学 | Method of producing artificial prosthesis of disci intervertebrales nucleus pulposus |
| US20100247600A1 (en) * | 2009-03-24 | 2010-09-30 | Warsaw Orthopedic, Inc. | Therapeutic drug eluting implant cover and method of making the same |
| US8268382B2 (en) * | 2010-07-12 | 2012-09-18 | Medtronic Vascular, Inc. | Method of making a stent with hollow struts |
| CN102106750B (en) * | 2011-02-17 | 2013-04-03 | 上海微创骨科医疗科技有限公司 | Spinal column dynamic connection rod |
| CN102260410B (en) * | 2011-07-13 | 2014-04-02 | 大连海洋大学 | Long-acting antibacterial organic silicon rubber material and preparation method thereof |
-
2013
- 2013-10-31 CN CN201310533796.2A patent/CN104586484B/en active Active
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Also Published As
| Publication number | Publication date |
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| CN104586484A (en) | 2015-05-06 |
| WO2015062408A1 (en) | 2015-05-07 |
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Address after: 215623 Renmin North Road, Changyin Sand Management Zone, Zhangjiagang City, Suzhou City, Jiangsu Province Co-patentee after: Shanghai Microport Orthopedics Co.,Ltd. Patentee after: SUZHOU MINIMALLY INVASIVE SPINAL TRAUMA MEDICAL TECHNOLOGY CO.,LTD. Address before: 215623 Renmin North Road, Changyin Sand Management Zone, Zhangjiagang City, Suzhou City, Jiangsu Province Co-patentee before: Shanghai Microport Orthopedics Co.,Ltd. Patentee before: SUZHOU HEALTH MEDICAL Co.,Ltd. |
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Effective date of registration: 20190110 Address after: 215000 Workshop B, No. 112 Fangzhong Street, Suzhou Industrial Park, Suzhou City, Jiangsu Province Patentee after: SUZHOU MINIMALLY INVASIVE SPINAL TRAUMA MEDICAL TECHNOLOGY CO.,LTD. Address before: 215623 Renmin North Road, Changyin Sand Management Zone, Zhangjiagang City, Suzhou City, Jiangsu Province Co-patentee before: Shanghai Microport Orthopedics Co.,Ltd. Patentee before: SUZHOU MINIMALLY INVASIVE SPINAL TRAUMA MEDICAL TECHNOLOGY CO.,LTD. |
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