CN1089009C - Polymer human implant and its preparation method, product and use - Google Patents

Abstract

The invention discloses a series of products of human body polymer implants. The product is made by high molecular material through resin fiber hot pressing, which are used as intramedullary needle, spine, bone sleeve, skull and fixing rod of the fixing piece; bone splints, fixation rods, bone cannulas and cranium for use as shaping blocks; bone screws and surgical sutures used as fasteners. The strength and the toughness of the implanted bone are high in the healing period; the degradation begins in the twenty-fourth week, and the materials are completely absorbed in one year, a half year or two years; no effusion and sinus tract are generated, the cost is greatly reduced, and the polymer implant is an ideal polymer implant for human bodies.

Description

Translated fromChinese

高分子人体植入物的产品Products of polymer human implants

本发明涉及到一种人体可吸收的高分子人体植入物的系列产品。The invention relates to a series of human body-absorbable polymer human body implants.

目前芬兰及欧洲一些国家，已经在医学上，为固定断骨使用了一种，人体可吸收的高分子人体植入物材料，并用此材料制成了用于固定断骨的固定棒和骨螺钉。这种材料是以聚乙胶脂(简称PGA)和聚丙胶指(简称PLA)为原料经高分子聚合加工制成。(PLA)和(PGA)所制成的固定棒和骨螺钉在医学应用中存在有以下缺点；At present, Finland and some European countries have used a kind of polymer human body implant material that can be absorbed by the human body to fix broken bones in medicine, and use this material to make fixation rods and bone screws for fixing broken bones. . This material is made of polyethylene glue (PGA for short) and polypropylene glue (PLA for short) as raw materials through polymer polymerization. (PLA) and (PGA) fixed rods and bone screws have the following disadvantages in medical applications;

1、关于降解度1. About the degree of degradation

(PLA)和(PGA)降解的速度快于断骨的愈合速度。很大程度上失去了支撑和保护的作佣。(PLA) and (PGA) degrade faster than broken bone heals. Lost support and protection to a large extent.

2、关于强度2. About strength

(PLA)和(PGA)制成的固定棒和小负荷的骨螺钉，只能用于受力负荷小的人体断骨的再接中，如掌关节、跺关节等。(PLA) and (PGA) fixation rods and small-load bone screws can only be used for the reconnection of human body broken bones with little stress load, such as palmar joints and stomp joints.

3、容易产生窦道3. Easy to produce sinus tract

由于易产生液体积聚和窦道，给病人带来很大的痛苦，也给医疗护理带来不便。Because it is easy to produce fluid accumulation and sinus tract, it brings great pain to the patient and also brings inconvenience to medical care.

4、(PLA)和(PGA)材料价格昂贵，一个4.5mm的骨螺钉要1500-2000元(长度不同)，一个3mm的固定棒要500-1000元。4. (PLA) and (PGA) materials are expensive. A 4.5mm bone screw costs 1500-2000 yuan (with different lengths), and a 3mm fixation rod costs 500-1000 yuan.

本发明的高分子人体植入物产品在技术上要达到的目的是：The technical purpose of polymer human implant product of the present invention to be achieved is:

1.用新的人体植入物，能恰当地降低其降解度，在应用中不产生液体积聚和窦道；从而加快断骨、伤骨的愈合；1. With the new human implant, its degradation degree can be appropriately reduced, and no fluid accumulation and sinus tract will be generated during application; thus, the healing of broken and injured bones can be accelerated;

2.扩大人体植入物产品的应用价值和应用范围，更好地为病人服务；2. Expand the application value and application scope of human implant products to better serve patients;

3.大大降低人体植入物的价格。3. Greatly reduce the price of human implants.

本发明是通过如下方案实现的，所说的人体高分子植入物体的产品，其产品是由高分子材料经树脂纤维热压而形成，具有如下特性：The present invention is achieved through the following schemes, the product of said polymer implanted into the human body is formed by thermal pressing of polymer materials through resin fibers, and has the following characteristics:

1).该人体植入物所制成的产品，在植入人体前，1). The product made of the human implant, before being implanted in the human body,

其弯曲弹性模量E弯＝4500MPa；Its flexural elastic modulus E bend = 4500MPa;

压缩弹性模量E压＝5500MPa；Compression elastic modulus E pressure = 5500MPa;

抗弯强度σ弯＝150MPa；Bending strength σ bending = 150MPa;

抗压强度σ压＝100MPa。Compressive strength σ pressure = 100MPa.

2).该人体植入物所制成的产品，在植入人体后的第二十四周开始降解，一年半至两年才被完全吸收。2). The product made of the human implant begins to degrade at the 24th week after being implanted in the human body, and is completely absorbed in one and a half to two years.

以上材料，由于所需要的产品不同，产品使用的部位不同，可以生产出人体骨骼各种不同的植入物产品，如用于大腿的股骨及胫骨、手臂的肱骨和桡骨断骨再接的髓内针；制造成肩骨断裂的接骨物——骨夹板；制成人体手术时用的高强度骨螺钉、骨套管等接骨植入物。还可以制成医用手术缝合线。以上这些产品满足了由于使用中植入人体的部位不同，在具体的部位上生物化学、生物电学、运动状态和所需机械强度不同所提出的要求，大大提高了应用范围和使用价值。The above materials, due to the different products required and the parts used in the products, can produce various implant products of human bones, such as the marrow used for femur and tibia of the thigh, humerus and radius of the arm for rejoining broken bones Inner needles; bone splints, bone splints for shoulder bone fractures; high-strength bone screws, bone sleeves and other bone implants used in human surgery. It can also be made into medical surgical sutures. The above products meet the requirements of biochemistry, bioelectricity, motion state and required mechanical strength due to the different parts of the implanted body in use, greatly improving the application range and use value.

图1公开了本发明所提供的髓内针示意图；Figure 1 discloses a schematic diagram of the intramedullary nail provided by the present invention;

图中各部件是：杆部1、槽形部2、肋条3、凹槽4和定位孔5，髓内针是由杆部1和槽形部2构成，杆部1是实心的园柱体，对称的槽形部2加工成四面槽形，在凹槽中开有定位孔5，髓内针的直径可以根据伤骨骨骼内径的粗细加工，嵌在断骨的髓内，由骨螺钉等和断骨固接。The components in the figure are: rod part 1,groove part 2,rib 3,groove 4 andpositioning hole 5, the intramedullary needle is composed of rod part 1 andgroove part 2, and rod part 1 is a solid garden cylinder , thesymmetrical groove part 2 is processed into a four-sided groove shape, and apositioning hole 5 is opened in the groove. The diameter of the intramedullary nail can be processed according to the thickness of the inner diameter of the injured bone, embedded in the marrow of the broken bone, and fixed by bone screws, etc. Bonded to the broken bone.

图4公开了本发明所提供的脊椎示意图；Figure 4 discloses a schematic diagram of the spine provided by the present invention;

图中各部件是：脊柱主体6和固定缘板端面7，脊柱是两端面平行的柱体，其高度、粗细由手术需要决定，用来支垫被固定的骨路。The components in the figure are: the main body of thespine 6 and the end surface 7 of the fixed edge plate. The spine is a column with parallel ends. Its height and thickness are determined by the needs of the operation and used to support the fixed bone road.

图5公开了本发明所提供的骨夹板示意图；Fig. 5 discloses the schematic diagram of the bone splint provided by the present invention;

图中各部件是：骨夹板是凹型条板，其上开有带有螺钉帽槽8螺钉孔9，可以单独使用，也可以两块或者数块配合使用。The parts in the figure are: the bone splint is a concave strip plate, which has screw cap grooves 8screw holes 9, can be used alone, or two or several pieces can be used in conjunction.

图7公开了本发明所提供的骨螺钉甲示意图；Figure 7 discloses a schematic diagram of a bone screw provided by the present invention;

图中各部件是：骨螺钉是伤骨和人体植入物之间的紧固物，是平顶螺钉13、螺杆11，其螺帽有对称的扳扭平面12，部分螺纹14的螺钉称为骨螺钉甲，全螺纹螺钉称为螺钉乙。The parts in the figure are: the bone screw is the fastening thing between the injured bone and the human body implant, it is a flat top screw 13, a screw rod 11, its nut has a symmetrical wrenching plane 12, and the screw with part thread 14 is called Bone screw A, fully threaded screw is called screw B.

图9公开了本发明所提供的骨螺钉乙示意图；Fig. 9 discloses a schematic diagram of bone screw B provided by the present invention;

图10公开了本发明所提供的固定杆示意图；Figure 10 discloses a schematic diagram of the fixing rod provided by the present invention;

图中各部件是：棱面15、杆部16，固定杆是一个多棱面实心柱体。Each part among the figure is:facet 15,rod portion 16, and fixed rod is a multi-faceted solid cylinder.

图12公开了本发明所提供的骨套管示意图；Figure 12 discloses a schematic diagram of the bone sleeve provided by the present invention;

图中各部件是；管体18、管孔17，骨套管是个管形物。Each part among the figure is;Tube body 18, tube hole 17, and bone casing is a tubular thing.

图13公开了本发明所提供的颅骨示意图。Fig. 13 discloses a schematic diagram of a skull provided by the present invention.

图中各部件是：凹面19、凸面20，颅骨是一环形的断开物，断开的角度、凹、凸面的弧度，由手术的实际需要决定。Each part among the figure is: concave surface 19, convex surface 20, and skull is a ring-shaped disconnection thing, and the angle of disconnection, the curvature of concave and convex surfaces are determined by the actual needs of the operation.

本发明有如下优点：The present invention has following advantage:

1.本发明所公开的高分子人体植入物产品的性能，95年已通过国家医药管理局医用高分子产品质量检测中心的检测。1. The performance of the polymer human body implant product disclosed by the present invention has passed the detection of the Medical Macromolecule Product Quality Inspection Center of the State Pharmaceutical Administration in 1995.

2.本发明所公开的高分子人体植入物的产品，经严格测试，在植入前，其2. The product of the polymer human implant disclosed in the present invention, after rigorous testing, before implantation, its

弯曲弹性模量E弯＝4500MPa；Bending elastic modulus E-bend = 4500MPa;

压缩弹性模量E压＝5500MPa；Compression elastic modulus E pressure = 5500MPa;

抗弯强度σ弯＝150MPa；Bending strength σ bending = 150MPa;

抗压强度σ压＝100MPa。Compressive strength σ pressure = 100MPa.

该植入物所制成的产品，其植入后第二十四周开始降解，一年半至两年才被完全吸收。Products made from the implant begin to degrade twenty-four weeks after implantation and are fully absorbed in one and a half to two years.

3.本发明所公开的高分子人体植入物产品，在医学应用中不产生液体积聚，不造成窦道，3. The polymer human body implant product disclosed by the present invention does not produce fluid accumulation in medical applications, does not cause sinus tracts,

4.本发明所公开的高分子人体植入物产品，扩大了人体植入物的应用范围，其系列产品可以满足制成各种断骨再接人体植入物，如用于大腿的股骨及胫骨、手臂的肱骨和桡骨断骨再接的髓内针；制造成肩骨断裂的接骨物一一骨夹板；制成人体手术时用的高强度骨螺钉、骨套管等接骨植入物。也可以制成医用手术缝合线，更好地为病人服务。4. The polymer human body implant product disclosed by the present invention expands the application range of human body implants, and its series of products can meet the requirements of making various broken bones and then connecting human body implants, such as femurs and Intramedullary nails for tibial, arm humerus, and radius fractures; bone splints for shoulder bone fractures; high-strength bone screws, bone sleeves, and other bone implants for human surgery. It can also be made into medical surgical sutures to better serve patients.

5.本发明的产品所需要的原材料，完全取自于国内，其产品的价格只有(PLA)和(PGA)的1/5-1/10，大大降低了产品的价格，降低了成本。5. The raw materials needed by the product of the present invention are completely taken from home, and the price of its product is only 1/5-1/10 of that of (PLA) and (PGA), which greatly reduces the price of the product and reduces the cost.

6.本发明的材料有良好地切削性能，可以根据手术的需要进行切削。6. The material of the present invention has good cutting performance and can be cut according to the needs of surgery.

7.本发明的材料无磁性，植入后不影响X光检查、B超检查和核磁共振检查，可以实现直观监视下的手术，明显地提高了手术的成功率。7. The material of the present invention is non-magnetic, does not affect X-ray examination, B-ultrasound examination and nuclear magnetic resonance examination after implantation, and can realize surgery under visual monitoring, significantly improving the success rate of surgery.

本发明有如下附图：The present invention has following accompanying drawing:

图1是本发明提供的髓内针示意图；Fig. 1 is a schematic diagram of the intramedullary nail provided by the present invention;

图中各部件是：杆部1、槽形部2、肋条3、凹槽4和定位孔5，髓内针是由杆部1和槽形部2构成，杆部1是实心的园柱体，对称的槽形部2加工成四面槽形，在凹槽中开有定位孔5，髓内针的直径可以根据伤骨骨骼内径的粗细加工，嵌在断骨的髓内，由骨螺钉等和断骨固接。The components in the figure are: rod part 1,groove part 2,rib 3,groove 4 andpositioning hole 5, the intramedullary needle is composed of rod part 1 and groovepart 2, and rod part 1 is a solid garden cylinder , thesymmetrical groove part 2 is processed into a four-sided groove shape, and apositioning hole 5 is opened in the groove. The diameter of the intramedullary nail can be processed according to the thickness of the inner diameter of the injured bone, embedded in the marrow of the broken bone, and fixed by bone screws, etc. Bonded to the broken bone.

图2是本发明提供的髓内针的I-I剖面示意图；Fig. 2 is the I-I sectional schematic diagram of intramedullary nail provided by the present invention;

图3是本发明提供的髓内针的II-II剖面示意图；Fig. 3 is a schematic diagram of the II-II section of the intramedullary nail provided by the present invention;

图4是本发明提供的脊椎示意图；Fig. 4 is a schematic diagram of the spine provided by the present invention;

图中各部件是：脊柱主体6和固定缘板端面7，脊柱是两端面平行的柱体，其高度、粗细由手术需要决定，用来支垫被固定的骨路。The components in the figure are: the main body of thespine 6 and the end surface 7 of the fixed edge plate. The spine is a column with parallel ends. Its height and thickness are determined by the needs of the operation and used to support the fixed bone road.

图5是本发明提供的骨夹板示意图；Fig. 5 is a schematic diagram of a bone splint provided by the present invention;

图中各部件是：骨夹板是凹型条板，其上开有带有螺钉帽槽8螺钉孔9，可以单独使用，也可以两块或者数块配合使用。The parts in the figure are: the bone splint is a concave strip plate, which has screw cap grooves 8screw holes 9, can be used alone, or two or several pieces can be used in conjunction.

图6是本发明提供的骨夹板的III-III剖面示意图；Fig. 6 is the III-III cross-sectional schematic view of the bone splint provided by the present invention;

图7是本发明提供的骨螺钉甲示意图；Fig. 7 is a schematic diagram of a bone screw provided by the present invention;

图中各部件是：骨螺钉是伤骨和人体植入物之间的紧固物，是平顶螺钉13、螺杆11，其螺帽有对称的扳扭平面12，部分螺纹14的螺钉称为骨螺钉甲，全螺纹螺钉称为螺钉乙。The parts in the figure are: the bone screw is the fastening thing between the injured bone and the human body implant, it is a flat top screw 13, a screw rod 11, its nut has a symmetrical wrenching plane 12, and the screw with part thread 14 is called Bone screw A, fully threaded screw is called screw B.

图8是本发明的骨螺钉甲IV-IV剖面示意图；Fig. 8 is a schematic cross-sectional view of bone screw nail IV-IV of the present invention;

图9是本发明的骨螺钉乙示意图；Fig. 9 is a schematic diagram of bone screw B of the present invention;

图10是本发明的固定杆示意图；Fig. 10 is a schematic diagram of a fixed rod of the present invention;

图中各部件是：棱面15、杆部16，固定杆是一个多棱面实心柱体。Each part among the figure is:facet 15,rod portion 16, and fixed rod is a multi-faceted solid cylinder.

图11是木发明的固定杆顶视示意图；Fig. 11 is a schematic top view of the fixed rod of the wooden invention;

图12是本发明的骨套管示意图；Fig. 12 is a schematic diagram of the bone sleeve of the present invention;

图中各部件是；管体18、管孔17，骨套管是个管形物。Each part among the figure is;Tube body 18, tube hole 17, and bone casing is a tubular thing.

图13是本发明的颅骨示意图。Fig. 13 is a schematic diagram of the skull of the present invention.

图中各部件是：凹面19、凸面20，颅骨是一环形的断开物，断开的角度、凹、凸丽的弧度，由于手术的实际的需要决定。Each part among the figure is: concave surface 19, convex surface 20, and skull is an annular disconnection thing, and the angle of disconnection, the curvature of concave and convex are determined due to the actual needs of the operation.

本发明在产品上有如下实施例：The present invention has following embodiment on product:

图1是本发明的髓内针示意图，是本发明的产品实施例之一。Fig. 1 is a schematic diagram of the intramedullary nail of the present invention, which is one of the product embodiments of the present invention.

图中各部件是：杆部1、槽形部2、肋条3、凹槽4和定位孔5，髓内针是由杆部1和槽形部2构成，杆部1是实心的园柱体，对称的槽形部2加工成四面槽形，在凹槽中开有定位孔5，髓内针的直径可以根据骨伤骨路的内径的粗细而加工，嵌在断骨的髓内，由骨螺钉和断骨连接。The components in the figure are: rod part 1,groove part 2,rib 3,groove 4 andpositioning hole 5, the intramedullary needle is composed of rod part 1 and groovepart 2, and rod part 1 is a solid garden cylinder , thesymmetrical groove part 2 is processed into a four-sided groove shape, and apositioning hole 5 is opened in the groove. The diameter of the intramedullary nail can be processed according to the thickness of the inner diameter of the bone wound bone road, and embedded in the marrow of the broken bone. Bone screw and broken bone connection.

图4是本发明的脊椎示意图，是本发明的产品实施例之二。Fig. 4 is a schematic diagram of the spine of the present invention, which is the second product embodiment of the present invention.

图中各部件是：脊柱主体6和固定缘板端面7，脊柱是两端面平行的技体，其高度、粗细由手术需要决定，用来支垫被固定的骨骸。The components in the figure are: the main body of thespine 6 and the end surface 7 of the fixed edge plate. The spine is a technical body with parallel ends.

图5是本发明的骨夹板示意图，是本发明的产品实施例之三。Fig. 5 is a schematic diagram of the bone splint of the present invention, which is the third product embodiment of the present invention.

图中各部件是：骨夹板是凹型条板，其上开有带有螺钉帽槽8螺钉孔9，可以单独使用，也可以两块或者数块配合使用。The parts in the figure are: the bone splint is a concave strip plate, which has screw cap grooves 8screw holes 9, can be used alone, or two or several pieces can be used in conjunction.

图7是本发明的骨螺钉甲示意图，是本发明的产品实施例之四。Fig. 7 is a schematic diagram of the bone screw nail of the present invention, which is the fourth embodiment of the product of the present invention.

图中各部件是：骨螺钉是骨路和伤骨的紧固物，是平顶螺钉，其螺帽有对称的扳扭平面，部分螺纹14的螺钉称骨螺钉甲，全螺纹螺钉称螺钉乙。The components in the figure are: the bone screw is the fastening object of the bone road and the injured bone, it is a flat-top screw, and its nut has a symmetrical torsion plane. The screw with part thread 14 is called bone screw A, and the screw with full thread is called screw B. .

图10是本发明的固定杆示意图，是本发明的产品实施例之五。Fig. 10 is a schematic diagram of the fixing rod of the present invention, which is the fifth embodiment of the product of the present invention.

图中各部件是；梭面15、杆部16，固定杆是一个多棱面实心柱体。Each part among the figure is;Shuttle face 15,bar portion 16, and fixed bar is a polygonal solid cylinder.

图12是本发明的骨套管示意图，是本发明的产品实施例之六。Fig. 12 is a schematic diagram of the bone sleeve of the present invention, which is the sixth product embodiment of the present invention.

图中各部件是：管体18、管孔17，骨套管是个管形物。Each part among the figure is:pipe body 18, pipe hole 17, and bone casing pipe is a tubular thing.

图13是本发明的颅骨示意图，是本发明的产品实施例之七。Fig. 13 is a schematic diagram of the skull of the present invention, which is the seventh product embodiment of the present invention.

图中各部件是：凹面19、凸面20，颅骨是一环形的断开物，断开的角度、凹、凸面的弧度，由手术的实际的需要决定。Each part among the figure is: concave surface 19, convex surface 20, and skull is a ring-shaped broken thing, and the angle of breaking, the radian of concave, convex surface are decided by the actual needs of operation.

Claims (2)

1. the product of a human body macromolecule implanted object, the made product of this implant can be made the fixed block of fixing bone in the human body operation, such as intramedullary needle, spinal column, bone sleeve pipe, skull and fixed bar; The dressing stick that can make adjustment bone position is such as bone clamping plate, fixed bar, bone sleeve pipe and skull; Make firm that implant and skeleton or linked groups are tightened up, such as bone screw with make operation suture thread; It is characterized in that:

1). its intramedullary needle is to be made of bar portion (1), channel-shaped portion (2), rib (3), groove (4) and locating hole (5), its bar portion (1) is solid Cylinder, symmetric channel-shaped portion (2) is processed into the four sides flute profile, in groove, have locating hole (5), the diameter of intramedullary needle can be according to the thickness processing of injury of the bone bone road internal diameter, be embedded in the marrow of wound, knochenbruch, affixed by bone screw etc. and wound, knochenbruch.

2). its vertebra be by spinal column main body (6) and fixedly listrium end face (7) constitute, vertebra is the parallel cylinders of both ends of the surface, its height, thickness need decision by operation, are used for a skeleton that pad is fixed.

3). its bone clamping plate are matrix battens, have the screw hole (9) that has screw clevis (8) on it, can use separately, also can two or several piece be used, its radian, length are decided by the needs of operation.

4). its bone screw is the fastener between wound, knochenbruch and the body implant, is flat-top screw (13), screw rod (11), and its nut has symmetric pulling to turn round plane (12), and the screw of part screw thread (14) is called the bone screw first, and the full thread screw is called screw second.

5). its fixed bar is to be made of faceted pebble (15), bar portion (16), and fixed bar is a faceted pebble solid cylinder more than.

6). its bone sleeve pipe is to be made of body (18), pore (17), is a pipe

7). skull is to be made of concave surface (19), convex surface (20), and skull is an annular disconnection thing, and the radian of the angle of disconnection, concave, convex face is by the actual needs decision of operation.

2. according to the product of the said human body macromolecule of claim 1 implanted object, it is characterized in that its product is to be formed through resin fibre hot pressing by macromolecular material,

1). the product that this body implant is made, before implant into body, its

Modulus of elasticity in static bending E bends=4500MPa;

Modulus of elasticity in comperssion E pressure=5500MPa;

Bending strength σ bends=150MPa;

Comprcssive strength σ pressure=100MPa.

2) the made product product of this body implant, behind implant into body the 20 around begin degraded, a year and a half to two year is just absorbed fully.

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