CN104586484A - Spinal implantation unit and preparation method thereof - Google Patents

Spinal implantation unit and preparation method thereof Download PDF

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CN104586484A
CN104586484A CN 201310533796 CN201310533796A CN104586484A CN 104586484 A CN104586484 A CN 104586484A CN 201310533796 CN201310533796 CN 201310533796 CN 201310533796 A CN201310533796 A CN 201310533796A CN 104586484 A CN104586484 A CN 104586484A
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implantation
unit
spinal
drugs
elastic
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CN 201310533796
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Chinese (zh)
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CN104586484B (en )
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田芳
高耀平
林忠
陈伟
张静
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苏州海欧斯医疗器械有限公司
上海微创骨科医疗科技有限公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7019Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A61B17/7031Longitudinal 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7019Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7097Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants

Abstract

The invention relates to the field of medical equipment, in particular to a spinal implantation unit. The spinal implantation unit comprises an elastic section and is characterized in that liquid state silicone rubber containing drugs and curing agents is added into the elastic section, and a silicone rubber body carried with drugs is formed at a normal temperature after curing is completed. The invention further relates to a method for preparing the spinal implantation unit. The spinal implantation unit has the functions of relieving pain diseases caused by focus point adhesion, compression and the like, eliminating chondral calcification, enabling the drugs to be decomposed and absorbed, and removing the edema and hypertrophy of ligamentum flavum and posterior longitudinal ligament.

Description

一种脊柱植入单元及其制备方法 A spinal implant unit and preparation method

技术领域 FIELD

[0001] 本发明涉及医疗器械领域。 [0001] The present invention relates to the field of medical devices. 具体而言,本发明应用于骨科脊柱内固定领域,涉及一种脊柱植入单元及其制备方法。 Specifically, the present invention is applied to the field of orthopedic spinal fixation unit and relates to a method for preparing a spinal implant.

背景技术 Background technique

[0002] 骨科手术前后粘连造成的压迫是一个困扰医生的大问题,会影响手术成功率。 [0002] a big problem before and after orthopedic surgery oppression caused by adhesions is a troubled doctor will affect the success rate. 手术前的粘连现象给手术带来难度和风险,而手术后的粘连现象造成手术失败,增加二次手术的可能性。 Adhesion phenomenon before surgery to bring about the difficulty and risks of surgery, and post-surgical adhesions phenomenon caused by surgical failure, increase the possibility of secondary surgery. 同时,在骨科植入物完成使命需要取出时,也会加大手术风险。 At the same time, the orthopedic implants need to be removed to complete the mission, will also increase the risk of surgery. 如果植入物载有抗炎药物并缓慢释放出来发挥抑制作用,则可减轻或消除粘连症状。 If the implant contains anti-inflammatory drugs and slow release inhibition play, you can reduce or eliminate symptoms of adhesions.

[0003] 软骨钙化造成的压迫同样是一个困扰医生的问题,手术时剔除风险高,再生可能性大。 Oppression [0003] calcified cartilage is also caused a problem plagued by a doctor, excluding high-risk surgery, the possibility of large regeneration. 如果植入物载有分解、吸收的药物,并且缓慢释放出来,就可通过治疗消除因钙化引起的压迫。 If the implant contains decomposition, drug absorption, and slow release, by the treatment can eliminate pressure caused by calcification.

[0004] 炎症引起的黄韧带、后纵韧带水肿、肥厚造成的压迫,也可在手术后由植入物载有消炎药物,通过缓慢释放进行治疗。 [0004] inflammation yellow ligament, posterior longitudinal ligament edema, hypertrophy oppression caused by the implant may contain anti-inflammatory drugs after surgery, treated by slow release.

[0005] 适当的控制疼痛对于任何手术后患者来说极其重要,疼痛缓解赋予患者显著的生理和心理益处。 [0005] adequate pain control is extremely important for any patient after surgery, pain relief given to patients with significant physical and psychological benefits. 有效缓解疼痛不仅意味着更顺利更愉快的痊愈(例如,情绪、睡眠、生活质量等),而且其还可以减少慢性疼痛综合征的发作。 Effective pain relief not only means smoother more pleasant recovery (for example, mood, sleep, quality of life, etc.), but it can also reduce the onset of chronic pain syndromes.

[0006] 随着骨科手术的普及,对提高术后康复状况提出了更高的要求。 [0006] With the popularity of orthopedic surgery, to improve the rehabilitation of post-op conditions put forward higher requirements. 国内外就术后感染、粘连、疼痛、病灶治愈等常见现象进行了大量的研究和临床观察,并为此发明了多种方法来预防、缓解、消除这些手术后遗症,提高手术质量。 At home and abroad have done a lot of research and clinical observation on the common phenomenon of postoperative infection, adhesions, pain, heal lesions, etc., and to this end invented a variety of methods to prevent, mitigate and eliminate these surgical complications and improve the quality of surgery.

[0007] 将医疗器械与药物有效集合在一起,可代替常规的手术后服用、注射大量的抗菌、激素、止痛等药物,而且这种局部靶向给药,效果更好,副作用更小。 [0007] The pharmaceutical active set together with the medical device, the operation can take place of conventional, large injection antibacterial, hormones, analgesics and other drugs, such local and targeted drug delivery, better, the smaller side. 目前已有的技术如下: Currently available techniques are as follows:

[0008] 中国专利申请N0.02136332.3,发明名称为“植入式医疗器械用的药物释放控制方法”。 [0008] Chinese Patent Application N0.02136332.3, entitled "implantable medical device with a drug release controlling method." 该发明将无机材料和高分子材料各自的优良性能结合起来,较现有的纯有机或纯无机涂层方法,具有明显的优点,可适合于蛋白质类药物及其他对热、光等外界条件较为敏感的药物的长期控制释放。 The invention inorganic materials and polymer materials each combine good performance than conventional pure organic or purely inorganic coating method, has obvious advantages, may be adapted to other drugs and proteins to heat, light and other external conditions are more sensitive to the drug's long-term controlled release.

[0009]《生物医学工程学进展》2010年第31卷第4期,论文名称为“钛合金植入体表面抗感染涂层的制备及其体外抑菌性能研究”。 [0009] "Progress in Biomedical Engineering" 2010 Vol. 31 No. 4, the paper entitled "Synthesis and antibacterial activity in vitro anti-infective titanium implant surface coatings." 该论文以聚乳酸(PDLLA)为载体,采用溶剂浇铸(solvent-casting)的方法,在钛合金植入物基体表面制备了载万古霉索(VCM)的F1DLLA涂层,期望通过缓释万古霉素来抑制细菌感染。 The paper polylactic acid (of PDLLA) as a carrier, a solvent casting method (solvent-casting), the substrate surface contained titanium implant vancomycin (VCM) is F1DLLA coatings made, by sustained release desired vancomycin always inhibit bacterial infection.

[0010] 中国专利申请N0.201110232842.6,发明名称为“抗感染医用钛合金”。 [0010] Chinese Patent Application N0.201110232842.6, entitled "anti-infective medical titanium alloys." 该发明在现有医用钛合金Ti6A17Nb的化学成分基础上添加适量的铜元素,经过特殊的抗热处理后,在医用钛合金的基体中析出一种钛铜相,从而赋予医用钛合金抗细菌感染功能。 The invention is added to titanium alloys the conventional medical composition based on the amount of copper Ti6A17Nb, resistant to heat treatment through a special, one titanium copper phase precipitated in the matrix alloy in the medical, biomedical titanium alloy to impart functions against bacterial infections .

[0011] 中国专利申请N0.200810147918.3,发明名称为“抑菌性生物活性钛及钛合金植入材料及其制备方法和应用”。 [0011] Chinese Patent Application N0.200810147918.3, entitled "Antibacterial titanium and titanium bioactive implant material and its preparation method and application." 该发明以生物医用级钛或钛合金为基底材料,将分析纯含氯离子的物质加入去离子水配制成电解质溶液,用阳极氧化表面改性处理技术,在材料阳极和阴极间施加直流电压1-1OOV,处理时间1-200秒,得到表面产生了抑菌性T 1-Cl基团和生物活性T1-OH基团的生物活性钛或钛合金,这些T1-Cl基团在生理环境下水解产生具有抑菌杀菌作用的-C1x离子。 The invention in biomedical grade titanium or titanium alloy as base material, a substance containing chlorine ions analytically pure deionized water is added into the electrolyte solution prepared by anodizing a surface modification technique, a DC voltage is applied between the anode and the cathode material -1OOV, the processing time of 1-200 seconds, to obtain a surface generated bacteriostatic T 1-Cl group and a titanium or titanium alloy bioactive bioactive T1-OH groups, these groups T1-Cl hydrolyzed under physiological conditions -C1x ion generating bacteriostatic bactericidal action.

[0012] 中国专利申请N0.200910051827.4,发明名称为“一种用于脊柱内固定术螺钉的药物涂层及制备和应用”。 [0012] Chinese Patent Application N0.200910051827.4, entitled "a pharmaceutical preparation and coating application and fixation of the spinal screws for." 该发明涉及用于脊柱内固定术螺钉的药物涂层及制备和应用,该药物涂层厚度为30〜300微米。 The invention relates to a pharmaceutical preparation and coating application and fixation of the spinal screws, the drug coating thickness of 30~300 m. 螺钉浸泡于溶解有0.2mol/L的碳化二亚胺和0.05mol/L的N-羟基琥珀酰亚胺的PBS中30分钟;将双磷酸盐类与其他药物溶解于蒸馏水中,将螺钉浸泡在此溶液中24小时,即得。 Screw soaked in PBS were dissolved with a 0.2mol / L carbodiimide and 0.05mol / L of N- hydroxysuccinimide in 30 minutes; the bisphosphonates and other drugs were dissolved in distilled water, soaked in a screw this solution for 24 hours to obtain. 该药物涂层螺钉可应用在脊柱内固定术中提高骨质量,降低骨折危险性。 The drug coating may be applied in a spinal screw fixation in increasing bone mass, reduced fracture risk.

[0013] 中国专利申请N0.201110088034.7,发明名称为“医疗器械表面实施载药固药控释的方法”。 [0013] Chinese Patent Application N0.201110088034.7, entitled "Method embodiments the medical device surface drug controlled release solid drug." 该发明通过物理或化学方法使器械表面粗糙化,进行药物涂覆后实施等静压处理使药物与器械基体牢固结合,克服了器械表面直接载药导致的药物脱落,实现了控制药物释放的目的。 The invention enables the instrument by physical or chemical method of surface roughening, after drug coated drug embodiments isostatic pressing firmly bound to the instrument base body, to overcome the drug directly to the surface of drug-induced shedding device, to achieve the purpose of controlling the drug release .

[0014] 可见,现有技术都是在植入物表面进行各种处理,例如药物涂层、渗铜离子、阳极氧化表面改性处理技术等方法来达到抗菌的目的,但药物层很薄,药物释放的时间自然就少,想要保持I年左右的药物作用就实现不了。 [0014] it is seen that the prior art implant surface are various processes, for example the drug coating, a copper ion infiltration, anodized surface modification techniques and other methods to achieve the purpose of the antibacterial, but the drug layer is very thin, drug release less time naturally, want to keep the drug in around I would not be achieved. 另外,因这些植入物在植入人体的过程中与骨组织和器械有很大的摩擦,螺钉进入骨质里后可能剩下不多的药物,药物作用会大打折扣。 Further, because these implants implanted in the body in the process of bone tissue and the instrument with great friction, the screw may enter the few remaining drug after bone, the drug will be greatly reduced.

发明内容 SUMMARY

[0015] 本发明源自申请人的在先中国专利申请N0.201210248135.0,发明名称为“一种脊柱动态稳定植入单元”,该在先申请的内容全文引入本申请说明书中,并作为公开内容的一部分。 [0015] The applicant of the present invention from the prior Chinese Patent Application N0.201210248135.0, entitled "A spinal implant dynamic stability unit", the contents of which prior application is incorporated in the present specification, the disclosure as a part of.

[0016] 具体而言,本发明是在所述植入单元的硅橡胶部分加入特定的治疗性药物,预防术后粘连、感染和病灶治疗。 [0016] Specifically, the present invention is to add a particular therapeutic drug in the silicone rubber portion of the implant unit, the prevention of postoperative adhesions, and foci of infection treatment. 产品植入人体后,硅橡胶药物载体逐渐有效的释放药物并缓慢扩散进入人体病灶周围,手术前病灶和手术后出现的问题在药物治疗下达到真正意义上的治愈。 After the product implanted in the body, silicone rubber effective drug carriers gradually release the drug slowly diffuse into the surrounding body lesions, lesions prior to surgery and after surgery to cure the problem in the true sense in drug treatment.

[0017] 本发明提供一种脊柱植入单元,包括弹性段,其特征在于,所述弹性段内含有载有药物的硅橡胶体。 [0017] The present invention provides a spinal implant unit comprises an elastic section, which is characterized by containing a drug contained within the body of a silicone rubber elastic segment.

[0018] 根据本发明,所述脊柱植入单元为动态棒。 [0018] According to the invention, the unit is a dynamic spinal implant rod.

[0019] 根据本发明,所述载有药物的硅橡胶体位于所述弹性段上设置的槽和/或通孔中。 [0019] According to the invention, the drug-loaded silicone rubber material is located in the groove and / or through holes provided in the elastic segment.

[0020] 根据本发明,载有药物的硅橡胶体是在弹性段内加入含有药物和固化剂的液态硅橡胶,常温下固化而成。 [0020] According to the present invention, the drug-loaded silicone rubber material is added to the liquid silicone rubber and a curing agent containing the drug in the elastic section, obtained by curing at room temperature.

[0021]根据本发明,所用的药物为皮质类固醇激素或者α肾上腺素,其中所述皮质类固醇激素选自可乐定、氟轻松、地塞米松、舒林酸、柳氮磺吡啶或其组合。 [0021] The pharmaceutical of the present invention, used is α corticosteroids or epinephrine, wherein the corticosteroid is selected from clonidine, fluocinolone, dexamethasone, sulindac, sulfasalazine, or combinations thereof.

[0022] 根据本发明,所用的药物为消炎药,例如,抗生素类药物。 [0022] According to the present invention, the drug used as anti-inflammatory drugs, e.g., antibiotics.

[0023] 根据本发明,药物与液态硅橡胶之重量比在10%〜50%之间,可由载有药物的硅橡胶体的厚度以及缓释时间的长短确定。 [0023] In the present invention, the weight of drug and liquid silicone rubber, and determining the thickness ratio of the length of time of release is between 10% ~ 50%, may be drug-loaded silicone rubber material according to.

[0024] 根据本发明,视患者需要,药物每天的释放速度可控制在小于100μ g/kg(患者体重)。 [0024] According to the present invention, depending on patient needs, drug release rate can be controlled to less than 100μ g / kg (patient body weight) per day. 本领域技术人员能够理解,该释放速度取决于所用的药量(药浓度)、载有药物的硅橡胶体的厚度以及种类等,可随意调节。 Those skilled in the art will appreciate that the drug release rate depending on the amount used (concentration), drug-loaded silicone rubber and the thickness of the kind of body, can be adjusted.

[0025] 根据本发明,载有药物的娃橡胶体的厚度B在1.5mm-5mm之间。 [0025] According to the invention, contains a rubber body between the baby thickness B in a pharmaceutical 1.5mm-5mm.

[0026] 本领域技术人员能够理解,除动态棒之外,本发明的其他脊柱植入单元只要含有硅橡胶,就能将硅橡胶用作药物载体。 [0026] Those skilled in the art will appreciate that in addition to the dynamic bar, other spinal implant unit according to the present invention contains a silicone rubber, the silicone rubber can be used as a drug carrier.

[0027] 另外,本发明对硅橡胶没有特殊要求,只要其能长期植入人体,满足安全性需求,并且能在常温下固化即可。 [0027] Further, the present invention has no special requirements on the silicone rubber as long as it can be implanted in the human long to meet security requirements, and can be cured at room temperature can be.

[0028] 本发明的药量(药浓度)和载有药物的硅橡胶体的厚度与缓释时间具有一定的相关性,可根据实际需要确定。 [0028] Dose (concentration) of the present invention and the thickness of the release time of drug-loaded silicone rubber material having a certain correlation can be determined according to actual needs. 例如,在药浓度一定时,厚度取大值,缓释时间可延长。 For example, when a certain concentration, thickness whichever is greater, release time can be prolonged. 本发明的脊柱植入单元中药物缓释可长达三个月或半年,甚至长达一年之久。 The present invention spinal implant drug delivery unit for up to three months or six months, or even up to a year.

[0029] 本发明还提供一种制备脊柱植入单元的方法,包括下列操作步骤: [0029] The present invention also provides a process for preparing a spinal implant unit, comprising the following steps:

[0030] 提供脊柱植入单元,所述脊柱植入单元包括弹性段, [0030] The spinal implant providing unit, the spinal implant includes an elastic section unit,

[0031 ] 对脊柱植入单元进行清洗,烘干, [0031] The spinal implant unit for cleaning, drying,

[0032] 在所述弹性段内注入含有药物和固化剂的液态硅橡胶,常温下固化,形成载有药物的硅橡胶体。 [0032] injected into the liquid silicone rubber elastic segment containing the drug and a curing agent, cured at room temperature to form a drug-loaded silicone rubber material.

[0033] 根据本发明,在弹性段的槽和/或通孔中注入含有药物和固化剂的液态硅橡胶。 [0033] According to the invention, comprising injecting a liquid silicone rubber and a curing agent in a pharmaceutical grooves and / or through holes in the elastic segment.

[0034] 根据本发明,液态硅橡胶、药物和固化剂之间的重量比为100: (10〜50): (0.4〜0.6)。 [0034] The weight ratio between the present invention, liquid silicone rubber, the curing agent is a pharmaceutical and 100: (10~50): (0.4~0.6).

[0035] 本发明利用植入物中的硅橡胶作为药物载体。 [0035] The present invention uses a silicone rubber implant as drug carriers. 硅橡胶是一种多孔、可吸附的材料,当治疗性药物作为生物活性物质溶解于其中时,硅溶胶分子对其均能产生有效均匀的吸附,随着时间的延长而缓慢的释放,且保存了其相应的药理特性,同时具有化学性质稳定、无毒无害的特点。 Silicone rubber is a porous, adsorbent material may be, when used as therapeutic drugs biologically active substance dissolved therein, silica its molecule can produce a uniform effective adsorption with time and slow release, and save their respective pharmacological properties, while having chemically stable, non-toxic characteristics. 硅橡胶具有良好的渗透及透过性,是理想的药物缓释材料。 Silicone rubber has good permeability and permeability, is an ideal drug carrier material. 药物正是利用了硅橡胶的这种特性,透过硅橡胶进行有效的控制释放和缓慢扩散。 This feature is the use of drugs silicone rubber, effective controlled release and slow diffusion through a silicone rubber. 另外,植入物中硅橡胶有一定的厚度,可比普通的植入物涂层药物释放的时间长,硅橡胶体可视为一个药物储存器。 Further, a silicone rubber implant has a certain thickness, length than normal implants coated drug release time can be regarded as a body of silicone rubber drug reservoir.

[0036] 本发明植入物具有防粘连、缓解疼痛功效,将类固醇药物、α肾上腺素或者消炎药以微粒形式分散在硅橡胶基质中,药物会缓慢释放出来,释放时间可延长至I年左右。 [0036] The implant of the present invention has an anti-blocking, pain relief effect, steroid drugs, adrenergic [alpha] or anti-inflammatory drugs in the form of fine particles dispersed in a silicone rubber matrix, the drug is slowly released, the release time may be extended to I of . 此载药植入物制造方法比较简单,只需将药物和硅橡胶混匀、在常温下固化成型即可,扩大了药物的选择范围。 This medicated implant manufacturing method is relatively simple, simply mixing the drug and silicone rubber, can be cured at room temperature molding, expanding the selection range of the drug.

[0037] 本发明的有益效果体现在: [0037] Advantageous effects of the present invention are embodied in:

[0038] 植入物具有解除病灶点的粘连、压迫等产生的疼痛顽症; [0038] implant having releasing blocking foci, chronic pain oppression generated;

[0039] 植入物具有清除软骨钙化,使其分解、吸收的功能; [0039] calcified cartilage implant having a clear, decomposed, the absorption function;

[0040] 植入物具有清除黄韧带、后纵韧带的水肿、肥厚的功能。 [0040] The implant has a clear yellow ligament, posterior longitudinal ligament edema, hypertrophy function.

附图说明 BRIEF DESCRIPTION

[0041] 为了更清楚地描述本发明的技术方案,下面将结合附图作简要介绍。 [0041] In order to more clearly describe the technical solutions of the present invention, will now be briefly described in conjunction with the accompanying drawings. 显而易见,这些附图仅是本申请记载的一些具体实施方式。 Clearly, these figures are only some specific embodiments described in the present application. 本发明的技术方案包括但不限于这些附图。 Aspect of the present invention include, but are not limited to these drawings.

[0042] 图1示出动态棒,其中1、动态棒,2、螺旋槽,3、通孔。 [0042] Figure 1 shows a dynamic rod, wherein a dynamic rod, 2, spiral grooves 3, the through-hole.

[0043] 图2示出弹性段内载有药物的硅橡胶体,其中厚度为B。 [0043] Figure 2 illustrates a drug-loaded silicone rubber elastic body section, wherein a thickness of B.

具体实施方式 detailed description

[0044] 为了进一步理解本发明,下面将结合实施例对本发明的优选方案进行描述。 [0044] For a further understanding of the present invention, the following in conjunction with preferred embodiments of the present invention will be described. 这些描述只是举例说明本发明脊柱植入单元的特征和优点,而非限制本发明的保护范围。 The description is only illustrative features and advantages of the present invention the spinal implant unit, and not to limit the scope of the present invention.

[0045] 实施例1 [0045] Example 1

[0046] 动态棒经机加工完成后,用超声波清洗机把油污清洗干净,然后在十万级的净化车间内,用超声波清洗机进行末道清洗、烘干。 After [0046] Dynamic bar machined completed, ultrasonic cleaning machine to clean the oil, and then one hundred thousand in the purification plant, for finisher washed with ultrasonic cleaning machine, and drying. 动态棒如图1所示。 Dynamic bar as shown in FIG.

[0047] 选用可长期植入的液态硅橡胶,先将药物(可乐定)加入该液态硅橡胶中充分拌匀,加入与液态硅橡胶配套的固化剂(0.5wt%),充分拌匀后,形成含有药物和固化剂的液态硅橡胶,移入注射器,再注射至动态棒的螺旋槽中。 [0047] The selection may be chronically implanted liquid silicone rubber, the first drugs (clonidine) was added to the liquid silicone rubber in the full mix is ​​added liquid silicone rubber and a curing agent package (0.5wt%), the full mix, forming liquid silicone rubber and a curing agent containing the drug, into the syringe and then injected into the spiral groove dynamic bar. 常温下固化24小时。 Curing at room temperature for 24 hours. 固化后的载有药物的硅橡胶体形状如图2所示,其中厚度B为3mm。 Drug-loaded silicone rubber after curing the shape shown in Figure 2, wherein the thickness B of 3mm.

[0048] 液态硅橡胶:药物:固化剂=100:30:0.5 (重量比)。 [0048] Liquid silicone rubber: Drug: curing agent = 100: 30: 0.5 (weight ratio).

[0049] 药物每天的释放速度控制在小于100μ g/kg(患者体重),药物释放时间可达半年。 [0049] The release rate of the drug per day controlled to less than 100μ g / kg (body weight of patient), drug release time up to six months.

[0050] 实施例2 [0050] Example 2

[0051] 与实施例1相同,除药物选用α肾上腺素和厚度B为2mm之外。 [0051] As in Example 1, except α-adrenergic agent of choice and thickness B than 2mm. 动态棒植入于椎间盘附近,分担椎间盘的活动和受力功能,防止椎间盘进一步的退变。 Dynamic rods implanted adjacent the disc, sharing activities and functions of disc force, preventing further disc degeneration. 动态棒携带上α肾上腺素,可以治疗退行性椎间盘疾病包括椎间盘突出。 Dynamic bar carrying the α-adrenergic, treat degenerative disc disease including disc herniation.

[0052] 实施例3 [0052] Example 3

[0053] 与实施例1相同,除在动态棒中间的通孔内注入含有药物和固化剂的液态硅橡胶、药物与液态硅橡胶之重量比为40%、以及厚度为5mm之外。 [0053] As in Example 1, except injecting liquid silicone rubber and a curing agent containing the drug in the middle of the dynamic rod through hole with the liquid silicone rubber pharmaceutical weight ratio of 40%, and the thickness was changed to 5mm. 通孔内注入含有药物和固化剂的液态硅橡胶,可增大载药量,药物释放时间长达一年之久。 Through hole injecting liquid silicone rubber and a curing agent containing the drug, drug loading may increase the drug release for up to a year.

[0054] 以上实施例的说明只是用于帮助理解本发明的核心思想。 [0054] The above description of embodiments merely for understanding the core idea of ​​the present invention. 应当指出,对于本领域的普通技术人员而言,在不脱离本发明原理的前提下,还可以对本发明的单元和方法进行若干改进和修饰,但这些改进和修饰也落入本发明权利要求请求保护的范围内。 It is noted that those of ordinary skill in the art, without departing from the principles of the present invention is provided, further improvements and modifications may be made to the means and methods of this invention, but these improvements and modifications also fall within the claims of the invention the request within the scope of protection.

Claims (9)

  1. 1.一种脊柱植入单元,包括弹性段,其特征在于,所述弹性段内含有载有药物的硅橡胶体。 A spinal implant unit comprises an elastic section, which is characterized by containing a drug contained within the body of a silicone rubber elastic segment.
  2. 2.如权利要求1所述的脊柱植入单元,其特征在于,所述脊柱植入单元为动态棒。 2. The spinal implant unit according to claim 1, wherein said unit is a dynamic spinal implant rod.
  3. 3.如权利要求2所述的脊柱植入单元,其特征在于,载有药物的硅橡胶体的厚度范围为1.5mm-5mm。 3. The spinal implant unit according to claim 2, characterized in that the thickness range of drug-loaded silicone rubber material is 1.5mm-5mm.
  4. 4.如权利要求1所述的脊柱植入单元,其特征在于,所述载有药物的硅橡胶体位于所述弹性段上设置的槽和/或通孔中。 4. The spinal implant unit according to claim 1, wherein the drug-loaded silicone rubber material is located in the groove and / or through holes provided in the elastic segment.
  5. 5.如权利要求1所述的脊柱植入单元,其特征在于,所述药物为皮质类固醇激素、α肾上腺素或者消炎药。 5. The spinal implant unit according to claim 1, wherein the medicament is a corticosteroid hormones, adrenergic [alpha] or anti-inflammatory drugs.
  6. 6.如权利要求5所述的脊柱植入单元,其特征在于,所述皮质类固醇激素选自可乐定、氟轻松、地塞米松、舒林酸、柳氮磺吡啶或其组合。 6. The spinal implant as claimed in claim 5, wherein the unit, wherein said corticosteroid is selected from clonidine, fluocinolone, dexamethasone, sulindac, sulfasalazine, or combinations thereof.
  7. 7.一种制备如权利要求1所述的脊柱植入单元的方法,包括下列操作步骤: 提供一种脊柱植入单元,所述脊柱植入单元包括弹性段, 对所述脊柱植入单元进行清洗,烘干, 在所述弹性段内注入含有药物和固化剂的液态硅橡胶,常温下固化,形成载有药物的硅橡胶体。 A method of preparing spinal implant as claimed in claim 1 unit, comprising the steps of: providing a spinal implant unit, the unit comprises elastic segment spinal implant, the spinal implant unit washing, drying, injected into the liquid silicone rubber elastic segment containing the drug and a curing agent, cured at room temperature to form a drug-loaded silicone rubber material.
  8. 8.如权利要求7所述的方法,其特征在于,在弹性段的槽和/或通孔中注入含有药物和固化剂的液态硅橡胶。 8. The method according to claim 7, characterized in that the injection of liquid silicone rubber and a curing agent containing a pharmaceutical groove elastic segment and / or through holes.
  9. 9.如权利要求7所述的方法,其特征在于,所述液态硅橡胶、药物和固化剂三者的重量比为100: (10 〜50): (0.4 〜0.6)。 9. The method according to claim 7, wherein the weight ratio of the liquid silicone rubber, curing agent, and the three drugs is 100: (10 ~ 50): (0.4 ~0.6).
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