CN105832392A - Degradable shape memory rib internal fixing body - Google Patents

Degradable shape memory rib internal fixing body Download PDF

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CN105832392A
CN105832392A CN 201510016063 CN201510016063A CN105832392A CN 105832392 A CN105832392 A CN 105832392A CN 201510016063 CN201510016063 CN 201510016063 CN 201510016063 A CN201510016063 A CN 201510016063A CN 105832392 A CN105832392 A CN 105832392A
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body
fixing
shape
rib
end
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CN 201510016063
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Chinese (zh)
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周永新
梅运清
单颖军
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上海市同济医院
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Abstract

A degradable shape memory rib internal fixing body relates to medical equipment for thoracic surgery or orthopedics, and particularly relates to a fracture fixation device for achieving rib fracture internal fixation by using a degradable shape memory material. The degradable shape memory rib internal fixing body includes a main body portion with a plurality of barbs and blunt end cone-shaped head portions arranged at two ends of the main body portion. When the temperature of the fixing body is less than the phase inversion temperature, the fixing body keeps a temporary shape, and is of a cylindrical body with a flat outer peripheral surface and the blunt end cone-shaped head portions at two ends of the main body portion, and the fixing body can be smoothly arranged in a marrow cavity of the rib from a fraction end; the fixing body returns to an initial shape after being arranged in the marrow cavity, and then the fixing body become the cylindrical body with the outer peripheral surface having the bards and inverse thorns at two ends of the cylindrical body, the bards and the inverse thorns penetrate to the inner wall of the marrow cavity of the rib, and then ribs at two sides of the fraction end are fixed on the two ends of the main body portion. Through the shape memory effect, internal fixation of the fraction end can be achieved, connection is firm and is not prone to displacement, placement operation is easy to operate without special surgical instruments, the medical cost can be decreased, and the pain of a patient can be relieved.

Description

一种可降解形状记忆肋骨内固定体 A degradable shape memory within the fixed body rib

技术领域 FIELD

[0001] 本发明涉及胸外科或骨科医疗器械或器材,尤其涉及一种利用可降解形状记忆材料实现肋骨骨折内固定的骨折固定器材。 [0001] The present invention relates to a thoracic surgery or orthopedic medical device or equipment, in particular, relates to a biodegradable shape memory material to achieve a fixed internal fracture fixation devices rib fractures.

背景技术 Background technique

[0002] 肋骨骨折是胸部外伤中最常见的外伤类型,约占胸部外伤的60%以上。 [0002] chest trauma, rib fractures are the most common type of injury, accounting for more than 60% of chest trauma. 肋骨骨折治疗的方法较多,有保守治疗及手术治疗两大类。 Methods of treatment of rib fractures are more conservative treatment and surgical treatment of two categories. 对于肋骨对位对线不理想的肋骨骨折,特别是未作解剖学复位的连枷胸患者,往往需要手术内固定。 Position on the line for the ribs of rib fracture undesirable, especially not for the flail chest anatomy reset patients often require internal fixation.

[0003]目前手术内固定肋骨骨折的方法有多种,如克氏针内固定、钢丝、陶瓷钉和肋骨钢板、钢丝捆绑固定、记忆合金环抱器肋骨固定、可吸收肋骨钉内固定等。 [0003] There are various methods of internal fixation rib fractures, such as fixed Kirschner wire, steel, ceramic pins and steel ribs, fixing steel wires, shape memory alloy embracing fixing ribs, the ribs can be absorbed fixation nails. 其中可吸收肋骨钉内固定治疗肋骨骨折是一种损伤小,无需二次手术取出的方法,已被临床医师广泛接受。 Wherein the absorbable screw fixation rib rib fracture is a small injury, surgical methods without secondary withdrawn, has been widely accepted by clinicians. 目前临床使用的可吸收肋骨钉包括聚左旋乳酸可吸收肋骨髓内钉、刚子(GRANDFIXTM)可吸收肋骨钉等,术中通过扩髓后置入可吸收肋骨钉,再对位拉拢肋骨后缝线加固骨折断端。 Currently in clinical use absorbable staples ribs include ribs PLLA absorbable intramedullary nail, just the child (GRANDFIXTM) ribs absorbable nails, into the reamed nailing can be absorbed by the ribs, and then the posterior rib stitch draw line consolidation of fracture fragments. 中国实用新型专利“可吸收肋骨髓内钉”(实用新型专利号:ZL201020547119.8,授权公布号:CN201894668U)公开了一种由可降解吸收的医用镁合金制成的可吸收肋骨髓内钉,所述肋骨髓内钉呈两端翘起的弧形结构,钉体表面设有防脱倒刺,所述防脱倒刺与钉体呈一定夹角,由两边向钉体中心收拢,所述钉体两端为锥状钝头结构。 Chinese utility model patent "absorbable intramedullary nail ribs" (Utility Model Patent No.: ZL201020547119.8, Authorization Publication Number: CN201894668U) discloses absorbable intramedullary nail ribs made of an alloy of magnesium medical biodegradable absorbable, the intramedullary nail arcuate rib structure at both ends tilt, the surface of the staple is provided with retaining barbs, the barbs retaining a substantially constant angle with the staple, the staple folded to the center of the sides, the staple ends blunt tapered body structure. 该实用新型具有可塑性,可根据肋骨弧度任意成型,并且可在体内降解吸收,吸收后胸部CT、MRI检查无影响;组织相容性好,无须再次手术取出。 The invention has plasticity, rib curvature can be arbitrarily shaped according to, and can be degraded and absorbed in the body, absorption chest CT, MRI examination no effect; tissue compatibility, need surgery to remove again. 这些器材虽然具有防滑横纹或防脱倒刺,但都没有自动收缩固定的功能,存在固定不够牢靠,易移位,往往需要再缝线加固骨折断端,这样不但会影响骨膜的血供,影响骨折的愈合,也会影响使位于肋骨下缘的肋间神经受压,引起术后疼痛。 Although these devices or retaining lug having a non-slip barbs, but are not fixed systolic function automatically, there is a fixed less robust, easy to shift, often need to suture reinforcement fracture site, it will not only affect the supply of blood to the periosteum, impact fracture healing, will also affect the lower edge positioned so that the intercostal nerve compression ribs, causing postoperative pain. 中国发明专利申请“一种可吸收骨折固定体”(发明专利申请号:201310033265.7)、“一种组合式肋骨固定器”(发明专利申请号:201110269350.4)和“可降解肋骨固定器”(发明专利申请号:201110363086.0),公开了一些通过整体包裹骨折外侧的方法来固定骨折部位的肋骨骨折固定器材,这些器材的使用同样存在影响骨膜的血供、影响骨折愈合及术后引起疼痛的问题。 Chinese invention patent application "A fracture fixation absorbent body" (invention patent application number: 201310033265.7), "a combined rib holder" (patent application number: 201110269350.4) and "degradable rib holder" (patent application number: 201110363086.0), discloses a number of fixed fracture site by the method of wrapping the entire outer rib fractures fracture fixation devices, there are also affect the periosteal blood supply using these devices, the impact of problems caused by fracture healing and postoperative pain. 由于这些器材的固定体位于肋骨外侧,还会造成固定部位不平整影响美观。 Since these equipment fixing member located outside the rib, will cause uneven fixing points affect the appearance.

[0004]中国发明专利“双向形状记忆聚合物复合材料及其制备方法”(发明专利号:ZL200610136572.8授权公告号:CN101164770B)公开了一种具有双向形状记忆效应的聚合物复合材料及其制备方法,该聚合物复合材料由具有形状记忆功能的聚合物材料与能够主动回复的弹性材料叠加粘和而成,具有双向形状记忆效应。 [0004] Chinese patent "two-way shape memory polymer composite material and its preparation method" (patent number: ZL200610136572.8 Publication No. Authorization: CN101164770B) discloses a polymer composite material having two-way shape memory effect and their preparation method, the polymer composite adherend is superimposed and made of a polymer material having shape memory and can actively respond to an elastic material, having a two-way shape memory effect. 该聚合物复合材料的形状记忆回复温度范围大,可以通过选用不同的形状记忆聚合物获得不同形状回复温度的双向形状记忆功能,同时形变量大,具有较好的双向形状记忆功能,而且其双向形状记忆性能可以通过调节形状记忆聚合物厚度与弹性材料的厚度等获得。 The shape memory polymer composite restoring a wide temperature range, to obtain a different shape recovery temperature by two-way shape memory different selected shape memory polymer, while the amount of deformation, having a good two-way shape memory, and its bidirectional shape memory properties can be obtained by adjusting the thickness and shape memory polymer elastic material and the like. 但是,该聚合物复合材料不属于可生物降解材料,因其不具备组织相容性而不能用于制造可降解吸收的骨科固定器材。 However, the polymer composite materials are not biodegradable, because it does not have tissue compatibility can not be used for manufacturing biodegradable absorbable orthopedic fixation devices.

发明内容 SUMMARY

[0005] 本发明的目的是提供一种可降解形状记忆肋骨内固定体,利用可生物降解高分子复合材料的形状记忆功能,实现骨折断端的自我复位收缩固定作用,解决肋骨骨折的髓内稳定固定的技术问题。 [0005] The object of the present invention is to provide a shape memory biodegradable inner rib fixing member, using a biodegradable polymer of the shape memory composites, the fracture ends of the self-contraction fixation, intramedullary solution rib fracture stable fixed technical problems.

[0006] 本发明解决上述技术问题所采用的技术方案是: [0006] aspect of the present invention to solve the above technical problem is:

[0007] —种可降解形状记忆肋骨内固定体,由带有若干倒钩的主体部和位于主体部两端的钝头锥状头部构成,其特征在于: [0007] - the kind of biodegradable shape memory rib fixing member, composed of a body portion and a body portion located at both ends of the blunt conical head portion with several barbs, characterized in that:

[0008] 所述的固定体由可生物降解形状记忆高分子复合材料制成,其相转变温度高于医用冷藏箱冷藏温度且低于正常人体体温; [0008] The fixed body made of a biodegradable composite material made of a shape memory polymer which is higher than the phase transition temperature of the medical freezer and refrigeration temperatures lower than normal body temperature;

[0009] 当所述固定体的温度低于相转变温度时,所述的固定体保持在形状记忆的暂时形状;当所述的固定体置入肋骨的髓腔内后,其温度升高到相转变温度以上,所述的固定体受到温度刺激,自动从暂时形状回复到形状记忆的初始形状; [0009] When the temperature of the fixing member is lower than the phase transition temperature of the fixing holder in the temporary shape of the shape memory; when said fixing body into the medullary cavity ribs, the temperature was raised to above the phase transition temperature, the temperature of the fixing member being stimulated, auto-reply from the temporary shape to the original shape of a shape memory;

[0010] 处于暂时形状的固定体呈现为外周表面平整、两端带有钝头锥状头部的柱状体,可顺利通过骨折断端置入肋骨的髓腔内;所述固定体的主体部拉伸延长,其径向尺度收缩至小于骨折部位的髓腔内径;所述的倒钩呈收拢状态,平整地贴附到主体部的外表面,主体部两端的多根倒刺合拢,形成钝头锥状的头部; Fixed body [0010] The temporary shape is rendered smooth outer peripheral surface, with both ends of the columnar body tapered blunt head can be passed into the fracture fragments ribs canal; main body portion of the fixed body tensile extension, the inner diameter of the medullary cavity radially contracted to less than the scale of the fracture site; the barbs form a collapsed state, affixed to the outer surface of the flat portion of the main body, a plurality of barbs at both ends of the body portion closed to form a blunt head tapered head portion;

[0011] 处于初始形状的固定体呈现为外周表面带有倒钩、两端带有向外周伸张的倒刺的柱状体,所述的倒钩和倒刺同时刺入肋骨的髓腔内壁,将骨折断端两侧的肋骨牢固固定在主体部的两端;在形状记忆效应的回复力作用下,所述的倒钩伸出主体部外表面,主体部两端的头部分裂为向外周伸张的多根倒刺,所述固定体的主体部径向膨胀并长度缩短,牵引骨折断端两侧的肋骨互相靠近并牢固合拢。 [0011] The fixed body presenting in its original shape as the outer peripheral wall with canal surface of the barbs, the barbs at both ends of the columnar body with stretching of the outer periphery of the barbs and barb ribs while piercing the ribs on both sides of the fracture site is firmly fixed to both ends of the body portion; under the restoring force of the shape memory effect, said barbs projecting outer body surface portion, both ends of the main body portion of the split head to the outer periphery of the stretched a plurality of barbs, the body portion radially expands the fixed body and shorter length, pulling both ends of the rib fractures close to each other and firmly closed.

[0012] 本发明的可降解形状记忆肋骨内固定体的一种较佳的技术方案,在所述主体部的两端各有2〜8个倒钩,分布在主体部靠近头部的外周表面,形成可自动刺入肋骨髓腔内壁的连接点。 [0012] A shape-memory biodegradable inner rib fixing member of the present invention, the preferred technical solution, both ends of the body portion each have barbs 2~8, distributed in the body portion close to the outer circumferential surface of the head portion , forming the point of attachment rib automatic penetration of the inner wall of the medullary cavity.

[0013] 本发明的可降解形状记忆肋骨内固定体的一种更好的技术方案,其特征在于所述主体部设计为实心或中空结构,其横截面为园形、椭圆形、矩形或多边形,以满足骨折内固定的力学要求或者形状记忆功能要求。 [0013] A better aspect of the degradable shape memory rib fixing member of the present invention, wherein said body portion is designed to be solid or hollow structures, the cross section is circular, elliptical, rectangular or polygonal to meet the requirements of fracture mechanics fixed or shape memory requirements.

[0014] 本发明的可降解形状记忆肋骨内固定体的一种改进的技术方案,其特征在于所述可生物降解形状记忆高分子复合材料的相转变温度为25〜35°C,可在医用冷藏箱内冻结并保持暂时形状,并且在置入体内后在体温状态下自动回复初始形状。 [0014] An improved technical solution of the biodegradable shape memory rib fixing member of the present invention, wherein the biodegradable shape memory polymer phase transition temperature of the composite material is 25~35 ° C, may be in a medical freezer and kept frozen temporary shape, and in vivo after implantation automatic reply initial shape at body temperature state.

[0015] 本发明的可降解形状记忆肋骨内固定体的一种优选的技术方案,其特征在于所述的可生物降解形状记忆高分子复合材料是丙烯酸十八酯与甲基丙烯酸酯的共聚物制成的热致型形状记忆聚合物。 [0015] A preferred aspect of the degradable shape memory rib fixing member of the present invention, wherein the biodegradable shape memory polymer composite material is a copolymer of stearyl acrylate and methacrylate made of thermotropic shape memory polymer.

[0016] 本发明的可降解形状记忆肋骨内固定体的另一种优选的技术方案,其特征在于所述的可生物降解形状记忆高分子复合材料是聚乳酸与己二异氰酸酯、1,4-丁二醇嵌段聚合得到的聚乳酸类复合热致型形状记忆聚合物。 [0016] Another preferred aspect of the degradable shape memory rib fixing member of the present invention, wherein the biodegradable shape memory polymer composite material is a polylactic acid and hexamethylene diisocyanate, 1,4 the polylactic acid based heat-butylene block polymeric compound obtained activated shape memory polymer.

[0017] 本发明的有益效果是: [0017] Advantageous effects of the present invention are:

[0018] 1、本发明的可降解形状记忆肋骨内固定体,利用形状记忆效应实现骨折断端的内固定,连接牢固不易移位,置入手术操作简便,无需特殊手术器械,可降低医疗成本。 [0018] 1, the degradable shape memory rib fixing member of the present invention, utilizing the shape memory effect to achieve fixation of fracture fragments, easy to shift firmly connected, into the operation is simple, no special surgical instrument, can reduce health care costs .

[0019] 2、本发明的可降解形状记忆肋骨内固定体,依靠形状记忆效应的回复力牢固合拢骨折断端,不需要缝线加固,既不会因缝线影响骨膜的血供而影响骨折愈合,又可以避免肋骨下缘的肋间神经受压引起术后疼痛,减轻患者痛苦。 [0019] 2, the shape-memory biodegradable rib fixing member of the present invention, relying on the restoring force of the shape memory effect of the fracture fragments firmly closed, no reinforcement sutures, the suture will not affect the blood supply due to impact fracture and periosteum healing, and also avoid the lower edge of the rib intercostal nerve compression caused by postoperative pain, alleviate the suffering of patients.

[0020] 3、本发明的可降解形状记忆肋骨内固定体采用可生物降解的高分子材料制成,可以逐渐降解吸收,无须二次手术取出,不影响后期胸部CT、MRI检查。 [0020] 3, the shape-memory biodegradable rib fixing member of the present invention using a biodegradable polymer materials, may be gradually degraded and absorbed, without second operation to remove, do not affect the post chest CT, MRI examination.

附图说明 BRIEF DESCRIPTION

[0021] 图1是本发明的可降解形状记忆肋骨内固定体的暂时形状示意图; [0021] FIG. 1 is a schematic view of the temporary shape of the shape memory biodegradable rib fixing member of the present invention;

[0022] 图2是本发明的可降解形状记忆肋骨内固定体的初始形状示意图; [0022] FIG. 2 is a schematic view of the initial shape of the shape-memory biodegradable rib fixing member of the present invention;

[0023] 图3是本发明的可降解形状记忆肋骨内固定体的使用状态示意图。 [0023] FIG. 3 is a schematic view of the state of use of biodegradable shape memory rib fixing member of the present invention.

[0024] 图中,1-主体部,2-头部,21-倒刺,3-倒钩,4_肋骨,5_骨折断端。 [0024] FIG, 1 main body portion, 2 a head, the barbs 21, barbs 3-, rib 4_, 5_ fracture fragments.

具体实施方式 detailed description

[0025] 为了能更好地理解本发明的上述技术方案,下面结合附图和实施例进行进一步地详细描述。 [0025] In order to better understand the above technical solutions of the present invention, the following drawings and examples be described in further detail in conjunction.

[0026] 本发明的可降解形状记忆肋骨内固定体,由带有若干倒钩的主体部I和位于主体部I两端的钝头锥状头部2构成,由带有若干倒钩的主体部I和位于主体部I两端的钝头锥状头部2构成,如图1和图2所示; [0026] The shape-memory biodegradable inner rib fixing member of the present invention, a main body portion with several barbs I of the main body portion I and the blunt ends of the tapered head portion 2 constituted by a main body portion having a plurality of barbed I I located at both ends of the main body portion of the head 2 blunt tapered configuration, as shown in FIGS. 1 and 2;

[0027] 所述的固定体由可生物降解形状记忆高分子复合材料制成,其相转变温度Ttrans高于医用冷藏箱冷藏温度且低于正常人体体温; [0027] The fixed body made of a biodegradable composite material made of a shape memory polymer which is higher than the phase transition temperature Ttrans medical freezer and refrigeration temperatures lower than normal body temperature;

[0028] 当所述固定体的温度低于相转变温度Ttrans时,所述的固定体保持在暂时形状(Temporary Shape);当所述的固定体置入肋骨4的髓腔内后,其温度升高到相转变温度Ttrans以上,所述的固定体受到温度刺激,自动回复到形状记忆的初始形状(InitialShape); [0028] When the temperature is lower than the fixed body phase transition temperature Ttrans, the temporary shape is fixed in a holder (Temporary Shape); when the intramedullary member into a fixed rib 4, the temperature rises above the phase transition temperature Ttrans, the fixed body by thermal stimulation, automatically returns to its original memorized shape (InitialShape);

[0029] 处于暂时形状的固定体呈现为外周表面平整、两端带有钝头锥状头部的柱状体,可顺利通过骨折断端5置入肋骨4的髓腔内;所述固定体的主体部I拉伸延长,其径向尺度收缩至小于骨折部位的髓腔内径,所述的倒钩3呈收拢状态,平整地贴附到主体部I的外表面,主体部I两端的多根倒刺21合拢,形成钝头锥状的头部2 ;如图1所示; [0029] The temporary shape is fixed to an outer circumferential surface of the body appears in a smooth, blunt ends columnar body with a conical head, fracture fragments can be passed into the medullary cavity 5 of the ribs 4; the fixed body I tensile body portion extended radially to less than the inner diameter of the medullary cavity downscaling the fracture site, the barbs 3 was folded state, be attached to the flat outer surface of the body portion I of the main body portion at both ends of a plurality of I 21 barbs collapse, forming blunt tapered head portion 2; shown in Figure 1;

[0030] 处于初始形状的固定体呈现为外周表面带有倒钩3、两端带有向外周伸张的倒刺21的柱状体,所述的倒钩3和倒刺21同时刺入肋骨4的髓腔内壁,将骨折断端5两侧的肋骨4牢固固定在主体部I的两端;在形状记忆效应的回复力作用下,所述的倒钩3伸出主体部I外表面,主体部I两端的头部2分裂为向外周伸张的多根倒刺21,所述固定体的主体部I径向膨胀并长度缩短,牵引骨折断端5两侧的肋骨4互相靠近并牢固合拢,如图2和图3所示。 [0030] The fixing member is in the initial shape of the outer circumferential surface of the rendering barbed 3, both ends of the columnar body with the outer periphery 21 of the extendable barbs, the barbs 21 simultaneously piercing barbs 3 and the ribs 4 medullary cavity inner wall 5 on both sides of the fracture fragments ribs 4 fixedly secured at both ends of the body portion I; under the restoring force of the shape memory effect, said projecting barbs 3 I outer body surface portion, the body portion I split across the head 2 of a plurality of outwardly extendable circumferential barbs 21, the body portion of the fixed body radially expanded and reduced length I, traction fracture fragments 5 close to each other on both sides of the ribs 4 and is firmly closed, such as As shown in FIGS. 2 and 3.

[0031] 根据本发明的可降解形状记忆肋骨内固定体的实施例,在所述主体部I的两端各有2〜8个倒钩3,分布在主体部I靠近头部2的外周表面,形成可自动刺入肋骨4髓腔内壁的连接点。 [0031] According to an embodiment the degradable shape memory rib fixing member of the present invention, both ends of the body portion I of each 2~8 barbs 3, the outer circumferential surface of the distribution body 2 close to the head portion of the I , 4 forming a connection point automatic penetration rib inner wall of the medullary cavity. 在图1〜2中,主体部I的两端各有4个倒钩3,在骨折断端5的两侧分别形成4个刺入肋骨4髓腔内壁的连接点,参见图3中用双点划线表示的肋骨4和骨折断端5。 In FIG 1 to 2, the body portion 4 at both ends of each of the barbs I 3, 4 are formed four piercing the inner wall of the medullary cavity ribs on both sides of the connection point of fracture fragments. 5, see FIG. 3 by the double the dotted line indicates rib fracture fragments 4 and 5.

[0032] 根据本发明的可降解形状记忆肋骨内固定体的实施例,所述主体部I设计为实心或中空结构,其横截面为园形、椭圆形、矩形或多边形,以满足骨折内固定的力学要求或者形状记忆功能要求。 [0032] According to an embodiment the degradable shape memory rib fixing member of the present invention, the main body section I is designed to be solid or hollow structures, the cross section is circular, elliptical, rectangular or polygonal, in order to satisfy the internal fixation It requires mechanical or shape memory requirements.

[0033] 根据本发明的可降解形状记忆肋骨内固定体的实施例,所述可生物降解形状记忆高分子复合材料的相转变温度Ttrans为25〜35°C,可在医用冷藏箱内冻结并保持暂时形状,并且在置入体内后在体温状态下自动回复初始形状。 [0033] According to an embodiment the degradable shape memory rib fixing member of the present invention, the biodegradable shape memory polymer phase transition temperature Ttrans composite is 25~35 ° C, it can be frozen in freezer and medical holding temporary shape, and in vivo after implantation automatic reply initial shape at body temperature state.

[0034] 根据本发明的可降解形状记忆肋骨内固定体的一个实施例,所述的可生物降解形状记忆高分子复合材料是丙烯酸十八酯与甲基丙烯酸酯的共聚物制成的热致型形状记忆聚合物(Thermo-1nduced shape memory polymers)。 [0034] According to one embodiment the degradable shape memory rib fixing member of the present invention embodiment, the biodegradable shape memory polymer composite material is made of heat-octadecyl acrylate copolymer and methacrylic acid ester-induced shape-memory polymers (Thermo-1nduced shape memory polymers).

[0035] 根据本发明的可降解形状记忆肋骨内固定体的另一个实施例,所述的可生物降解形状记忆高分子复合材料是聚乳酸与己二异氰酸酯(HDI)、1,4-丁二醇(BDO)嵌段聚合得到的聚乳酸类复合热致型形状记忆聚合物。 [0035] According to another embodiment the degradable shape memory rib fixing member of the present invention, the biodegradable shape memory polymer composite material is a polylactic acid and hexamethylene diisocyanate (HDI), 1,4- butylene alcohol (BDO) block obtained by polymerizing the polylactic acid-based composite thermotropic shape memory polymer.

[0036] 本发明的可降解形状记忆肋骨内固定体使用方法的实施例: [0036] The method of the fixed body provided with ribs biodegradable shape memory embodiment of the present invention:

[0037] 首先,利用可生物降解的高分子材料制成的热致型形状记忆聚合物(Thermo-1nduced shape memory polymers),根据不同部位肋骨骨髓腔的大小,制成不同型号的可降解形状记忆肋骨内固定体,其初始形状(Initial Shape)如图2所示。 [0037] First, the thermotropic polymers made from a shape memory biodegradable polymer materials (Thermo-1nduced shape memory polymers), depending on the size of different parts of the medullary cavity ribs, made of different types of shape-memory biodegradable internal rib fixed body, its original shape (initial shape) as shown in FIG.

[0038] 作好肋骨内固定体置入术的术前准备,分离骨折断端5,并根据骨髓腔的大小在两侧的骨髓腔内钻孔,选择适当型号的可降解形状记忆肋骨内固定体,在体外将其加热到可施加应力变形的相转变温度(Ttrans)以上,施加应力使其改变到图1所示的暂时形状(Temporary Shape):将主体部I两端的多根倒刺21合拢,形成钝头锥状的头部2 ;将主体部I拉伸使其长度延长,其径向尺度收缩至稍小于骨折部位的髓腔内径,同时施加压力使所有的倒钩3平整附贴到主体部I的外表面;将主体部I弯曲成与肋骨4骨折部位一致的弧形。 The [0038] inner ribs make fixed body preparation before implantation surgery, fracture fragments isolated 5, and in accordance with the size of the marrow cavity of the bone marrow cavity on both sides of the borehole, to select the appropriate types of biodegradable shape memory fixation ribs body, it is heated in vitro application of stress to a deformable phase transition temperature (Ttrans) above, so that stress is applied to temporarily change the shape (temporary shape) shown in Figure 1: the plurality of barbs 21 at both ends of the body portion I collapse, forming blunt tapered head portion 2; the length of the main body portion so as to extend the stretch I, its radial dimension slightly smaller than the inner diameter of the intramedullary canal contraction to the fracture site while pressure is applied so that all three barbs affixed flat to an outer surface of the body portion I; I the body portion 4 is bent to conform with the arcuate rib fracture site. 随后将变形为暂时形状的肋骨内固定体迅速降温到Ttrans以下的低温区,使其冻结保存为变形后的暂时形状。 Subsequently deformed to the temporary shape of the ribs fixed body quickly cooled to a low temperature region below Ttrans, frozen and stored temporarily so that the deformed shape.

[0039] 然后,迅速将保存为暂时形状的固定体植入骨折的两个断端并暂时固定,待固定体温度抵达体内温度,固定体回复到初始形状,即:固定体的主体部I径向自动膨胀回复到初始形状的径向尺度,两端的头部2分裂成向外周伸张的多根倒刺21,刺入肋骨4的髓腔内壁,同时,主体部I两端的倒钩3伸出主体部I外表面,刺入肋骨4的髓腔内壁,骨折断端5两侧的肋骨4在倒刺21和倒钩3的共同作用下,牢固固定在主体部I的两端;同时,所述主体部I沿轴向缩短回复到初始形状的长度,在形状记忆效应的回复力牵引下,骨折断端5两侧的肋骨4互相靠近并牢固合拢。 [0039] Then, quickly saved as temporary shape two ends fracture fixation implant and temporarily secured until the fixing temperature of the body temperature of the arrival, the fixed body returns to its original shape, namely: a main body portion fixed diameter I reply to the self-expanding radial dimension to the original shape, both ends of the head portion 2 is split into a plurality of outwardly extendable circumferential barbs 21, penetrating the inner wall ribs 4 of the medullary cavity, while both ends of the main body portion barbs projecting I 3 an outer surface of the body portion I, medullary cavity inner wall 4 of the puncturing ribs, the ribs on both sides of the fracture fragments 5 4 under the action of barbs 21, and barbs 3, securely fixed to both ends of the body portion I; the same time, the I said body portion axially shortened length returns to its original shape, under the restoring force of the shape memory effect traction rib fracture fragments 5 and 4 on both sides close to each other securely closed. 骨折断端5固定牢靠不易移位,不需要缝线加固骨折端,不会因缝线影响骨膜的血供而影响骨折愈合,也不会造成肋骨下缘的肋间神经受压引起术后疼痛。 5 is fixed firmly fracture site easy to shift, no fracture reinforced suture, the suture is not affected by the periosteum of the affected blood supply fracture healing, it does not cause the edge of the lower rib intercostal nerve compression caused by postoperative pain . 骨折断端5愈合后,本发明的可降解形状记忆肋骨内固定体可以逐渐降解吸收,无须二次手术取出,吸收后胸部CT、MRI检查无影响。 After healing of the fracture fragments 5, the shape-memory biodegradable rib fixing member of the present invention may be gradually degraded and absorbed, without second operation to remove, chest CT, MRI examination no effect upon absorption.

[0040] 本技术领域中的普通技术人员应当认识到,以上的实施例仅是用来说明本发明的技术方案,而并非用作为对本发明的限定,任何基于本发明的实质精神对以上所述实施例所作的变化、变型,都将落在本发明的权利要求的保护范围内。 [0040] skilled in the art should recognize that the above embodiments are only used to describe the technical solutions of the present invention, and not as a definition of the use of the present invention, based on any of the true spirit of the present invention described above changes made to the embodiment, modifications, are within the scope of the invention as claimed in claim fall.

Claims (6)

  1. 1.一种可降解形状记忆肋骨内固定体,由带有若干倒钩的主体部和位于主体部两端的钝头锥状头部构成,其特征在于: 所述的固定体由可生物降解形状记忆高分子复合材料制成,其相转变温度高于医用冷藏箱冷藏温度且低于正常人体体温; 当所述固定体的温度低于相转变温度时,所述的固定体保持在形状记忆的暂时形状;当所述的固定体置入肋骨的髓腔内后,其温度升高到相转变温度以上,所述的固定体受到温度刺激,自动从暂时形状回复到形状记忆的初始形状; 处于暂时形状的固定体呈现为外周表面平整、两端带有钝头锥状头部的柱状体,可顺利通过骨折断端置入肋骨的髓腔内;所述固定体的主体部拉伸延长,其径向尺度收缩至小于骨折部位的髓腔内径;所述的倒钩呈收拢状态,平整地贴附到主体部的外表面,主体部两端的多根倒刺合拢,形成 A degradable shape memory internal ribs fixed body includes a body portion and a body portion located at both ends of the blunt conical head portion with several barbs, characterized in that: said fixed body is made of biodegradable shape memory polymer composite material, which is higher than the phase transition temperature of the medical freezer and refrigeration temperatures lower than normal body temperature; when the temperature of the fixed body below the phase transition temperature of the fixing holder in the shape memory temporary shape; when said fixing body into the medullary cavity ribs, to raise its temperature above the phase transition temperature, the temperature of the fixing member being stimulated, auto-reply from the temporary shape to the original shape of a shape memory; in the temporary shape is fixed to an outer circumferential surface of the body presents a flat, blunt ends with columnar body a conical head can be smoothly inserted through the fracture site of the rib intramedullary; main body portion of the fixed body stretching extension, shrink to its radial dimension smaller than the inner diameter of the intramedullary canal of the fracture site; the barbs form a collapsed state, affixed to the outer surface of the flat portion of the main body, a plurality of barbs close both end portions of the main body, is formed 头锥状的头部; 处于初始形状的固定体呈现为外周表面带有倒钩、两端带有向外周伸张的倒刺的柱状体,所述的倒钩和倒刺同时刺入肋骨的髓腔内壁,将骨折断端两侧的肋骨牢固固定在主体部的两端;在形状记忆效应的回复力作用下,所述的倒钩伸出主体部外表面,主体部两端的头部分裂为向外周伸张的多根倒刺,所述固定体的主体部径向膨胀并长度缩短,牵引骨折断端两侧的肋骨互相靠近并牢固合拢。 Head tapered head portion; fixed body presents in its initial shape, the columnar body having an outer circumferential surface of the barb, with the outer periphery at both ends extendable barbs, the barbs and rib marrow piercing barbs simultaneously cavity wall, the ribs on both sides of the fracture site is firmly fixed to both ends of the body portion; under the restoring force of the shape memory effect, said barbs projecting outer body surface portion, the head ends of the main body portion is split stretch outer periphery a plurality of barbs, the body portion radially expands the fixed body and shorter length, pulling both ends of the rib fractures close to each other and firmly closed.
  2. 2.根据权利要求1所述的可降解形状记忆肋骨内固定体,在所述主体部的两端各有2〜8个倒钩,分布在主体部靠近头部的外周表面,形成可自动刺入肋骨髓腔内壁的连接点。 The inside of the shape-memory biodegradable 1 rib fixing member as claimed in claim, both ends of the body portion each have 2~8 barbs distributed in the outer circumferential surface of the body portion close to the head is formed automatically stab ribs into the medullary cavity of the inner wall of the connection point.
  3. 3.根据权利要求1所述的可降解形状记忆肋骨内固定体,其特征在于所述主体部设计为实心或中空结构,其横截面为园形、椭圆形、矩形或多边形,以满足骨折内固定的力学要求或者形状记忆功能要求。 Biodegradable shape memory within the rib fixing member according to claim 1, wherein said body portion is designed to be solid or hollow structures, the cross section is circular, elliptical, rectangular or polygonal, to meet fracture fixed or mechanical requirements shape memory requirements.
  4. 4.根据权利要求1所述的可降解形状记忆肋骨内固定体,其特征在于所述可生物降解形状记忆高分子复合材料的相转变温度为25〜35°C,可在医用冷藏箱内冻结并保持暂时形状,并且在置入体内后在体温状态下自动回复初始形状。 The inside of the shape-memory biodegradable 1 rib fixing member as claimed in claim, wherein the biodegradable shape memory polymer phase transition temperature of the composite material is 25~35 ° C, may be frozen in a medical freezer and holding temporary shape, and in vivo after implantation automatic reply initial shape at body temperature state.
  5. 5.根据权利要求1至4之任一权利要求所述的可降解形状记忆肋骨内固定体,其特征在于所述的可生物降解形状记忆高分子复合材料是丙烯酸十八酯与甲基丙烯酸酯的共聚物制成的热致型形状记忆聚合物。 1 to 4, according to any of the degradable shape memory of the ribs of a fixing member as claimed in claim claim, wherein said polymer composite material is a shape memory biodegradable stearyl acrylate and methacrylate thermotropic shape memory polymer comprising a copolymer.
  6. 6.根据权利要求1至4之任一权利要求所述的可降解形状记忆肋骨内固定体,其特征在于所述的可生物降解形状记忆高分子复合材料是聚乳酸与己二异氰酸酯、1,4-丁二醇嵌段聚合得到的聚乳酸类复合热致型形状记忆聚合物。 1 to 4, according to any of the degradable shape memory of the ribs of a fixing member as claimed in claim claim, wherein said biodegradable shape memory polymer composite material is a polylactic acid and hexamethylene diisocyanate, 1, the polylactic acid based heat-butanediol block polymeric compound obtained activated shape memory polymer.
CN 201510016063 2015-01-13 2015-01-13 Degradable shape memory rib internal fixing body CN105832392A (en)

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6281262B1 (en) * 1998-11-12 2001-08-28 Takiron Co., Ltd. Shape-memory, biodegradable and absorbable material
US20030060788A1 (en) * 2001-07-24 2003-03-27 Topolkaraev Vasily A. Methods of making disposable products having humidity activated materials with shape-memory
US6575973B1 (en) * 2000-10-26 2003-06-10 Safedrip Ltd. Self locking intramedullary nail
CN1569261A (en) * 2004-05-13 2005-01-26 哈尔滨工业大学 Novel use of ploy-L-lactic acid as medical shape memory material
US20060190036A1 (en) * 2003-07-30 2006-08-24 Eberhard-Karls-Universitaet Teubingen Sealing plug for an opening in a wall of a vessel or hollow organ
CN201064479Y (en) * 2007-08-09 2008-05-28 王平山 Anatomy type caput radius intramedullary nail with lock
CN101730551A (en) * 2007-04-19 2010-06-09 史密夫和内修有限公司 orientated polymeric devices
CN101953709A (en) * 2010-09-29 2011-01-26 上海交通大学医学院附属第三人民医院 Absorbable rib intramedullary nail
CN204500924U (en) * 2015-01-13 2015-07-29 上海市同济医院 The degradable shape memory rib internal fixation body

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6281262B1 (en) * 1998-11-12 2001-08-28 Takiron Co., Ltd. Shape-memory, biodegradable and absorbable material
US6575973B1 (en) * 2000-10-26 2003-06-10 Safedrip Ltd. Self locking intramedullary nail
US20030060788A1 (en) * 2001-07-24 2003-03-27 Topolkaraev Vasily A. Methods of making disposable products having humidity activated materials with shape-memory
US20060190036A1 (en) * 2003-07-30 2006-08-24 Eberhard-Karls-Universitaet Teubingen Sealing plug for an opening in a wall of a vessel or hollow organ
CN1569261A (en) * 2004-05-13 2005-01-26 哈尔滨工业大学 Novel use of ploy-L-lactic acid as medical shape memory material
CN101730551A (en) * 2007-04-19 2010-06-09 史密夫和内修有限公司 orientated polymeric devices
CN201064479Y (en) * 2007-08-09 2008-05-28 王平山 Anatomy type caput radius intramedullary nail with lock
CN101953709A (en) * 2010-09-29 2011-01-26 上海交通大学医学院附属第三人民医院 Absorbable rib intramedullary nail
CN204500924U (en) * 2015-01-13 2015-07-29 上海市同济医院 The degradable shape memory rib internal fixation body

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