CN1089009C - High molecular human body embedding article and its preparing process product and use - Google Patents

High molecular human body embedding article and its preparing process product and use Download PDF

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Publication number
CN1089009C
CN1089009C CN97119073A CN97119073A CN1089009C CN 1089009 C CN1089009 C CN 1089009C CN 97119073 A CN97119073 A CN 97119073A CN 97119073 A CN97119073 A CN 97119073A CN 1089009 C CN1089009 C CN 1089009C
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bone
product
screw
implant
present
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CN1214939A (en
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刘建宇
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Shenzhen Changhua Biomedical Engineering Co Ltd
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Abstract

The present invention discloses a high molecular implant for human bodies, a preparation process thereof, a product made of the implant and an application thereof. The product provided by the present invention is prepared by a formula provided by the present invention through resin fiber hot pressing. After being implanted, within the period of bone healing, the product has high strength and good toughness, and the shape of the product can be processed as required; after being implanted, the product starts degrading after the twenty-fourth week, and can be safely absorbed within one year to two years. The product can not generate any dropsy and sinus tract and can be made into fixing blocks, normal blocks, fastening pieces and sewing threads for the connection of injured and broken bones. The cost of the product is greatly reduced, and the product is an ideal high molecular implant for human bodies.

Description

The product of high molecular human body embedding article
The present invention relates to a kind of series of products of human body absorbable polymer body implant.
At present Finland and some countries of Europe, medically, for fixation of bone fragments used a kind of, human body absorbable polymer body implant material, and made hold-down bars and the bone screw that is used for fixing knochenbruch with this material.This material is to refer to that with poly-second glue fat (being called for short PGA) and poly-third glue (being called for short PLA) is that raw material is processed into through high molecular polymerization.(PLA) and (PGA) made hold-down bars and bone screw have following shortcoming in medical application;
1, about degree of degradation
(PLA) and (PGA) speed of degraded is faster than the healing rate of knochenbruch.Lost hiring of supporting and protect to a great extent.
2, about intensity
(PLA) and the bone screw of hold-down bars of (PGA) making and little load, can only be used for connecing again of the little human body knochenbruch of stressed load, as metacarpal joint, stamp joint etc.
3, be easy to generate sinus tract
Owing to easily produce fluid accumulation and sinus tract, bring very big misery to patient, also make troubles to medical treatment and nursing.
4, (PLA) and (PGA) material price costliness, the bone screw of a 4.5mm is wanted 1500-2000 unit (length difference), and the hold-down bars of a 3mm is wanted 500-1000 unit.
The purpose that high molecular human body embedding article product of the present invention will reach technically is:
1. with new body implant, its degree of degradation be can reduce rightly, fluid accumulation and sinus tract in application, do not produced; Thereby accelerate the healing of knochenbruch, the injury of the bone;
2. enlarging the using value and the range of application of body implant product, is service for patients better;
3. reduce the price of body implant greatly.
The present invention is achieved by the following scheme, and the product of said human body macromolecule implanted object, its product are to be formed through resin fibre hot pressing by macromolecular material, have following characteristic:
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 product that this body implant is made, behind implant into body the 20 around begin degraded, a year and a half to two year is just absorbed fully.
Above material, because needed product difference, the position difference that product uses can be produced the various implant product of skeleton, as be used for femur and tibia, the humerus of arm and the intramedullary needle that the radius knochenbruch connects again of thigh; Manufacture synthetism thing---the bone clamping plate of shoulder bone fracture; Synthetism implants such as the high-strength bone screw of using when making the human body operation, bone sleeve pipe.Can also make medical operation suture thread.More than these products satisfied because the position difference of implant into body in using, biochemistry, electrobiology, the different institute with required mechanical strength of kinestate requirement have improved range of application and use value greatly on concrete position.
Fig. 1 discloses intramedullary needle sketch map provided by the present invention;
Each parts is among the figure: bar portion 1, channel-shaped portion 2, rib 3, groove 4 and locating hole 5, intramedullary needle is to be made of bar portion 1 and channel-shaped portion 2, 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 embedded in the marrow of knochenbruch according to the processing of the thickness of injury of the bone skeleton internal diameter, and is affixed with knochenbruch by bone screw etc.
Fig. 4 discloses vertebra sketch map provided by the present invention;
Each parts is among the figure: spinal column main body 6 and fixing listrium end face 7, and spinal column is the parallel cylinders of both ends of the surface, its height, thickness need decision by operation, are used for a bone road that pad is fixed.
Fig. 5 discloses bone clamping plate sketch map provided by the present invention;
Each parts is among the figure: the bone clamping plate are matrix battens, have on it to have screw clevis 8 screw holes 9, can use separately, also can two or several piece be used.
Fig. 7 discloses bone screw first sketch map provided by the present invention;
Each parts is among the figure: bone screw is the fastener between the injury of the bone 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.
Fig. 9 discloses bone screw second sketch map provided by the present invention;
Figure 10 discloses fixed bar sketch map provided by the present invention;
Each parts is among the figure: faceted pebble 15, bar portion 16, fixed bar is a faceted pebble solid cylinder more than.
Figure 12 discloses bone sleeve pipe sketch map provided by the present invention;
Each parts is among the figure; Body 18, pore 17, bone sleeve pipe are pipes.
Figure 13 discloses skull sketch map provided by the present invention.
Each parts is among the figure: concave surface 19, convex surface 20, skull are annular disconnection things, and the radian of the angle of disconnection, concave, convex face is by the actual needs decision of operation.
The present invention has following advantage:
1. the performance of high molecular human body embedding article product disclosed in this invention, the detection by medical high polymer product quality inspection center of State Pharmaceutical Administration in 95 years.
2. the product of high molecular human body embedding article disclosed in this invention is tested through strictness, before implantation, 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.
The product that this implant is made, it begins degraded around implanting back the 20, and a year and a half to two year is just absorbed fully.
3. high molecular human body embedding article product disclosed in this invention does not produce fluid accumulation in medical application, do not cause sinus tract,
4. high molecular human body embedding article product disclosed in this invention, enlarged the range of application of body implant, its series of products can satisfy to be made various knochenbruch and connects body implant again, as is used for femur and tibia, the humerus of arm and the intramedullary needle that the radius knochenbruch connects again of thigh; The synthetism thing that manufactures shoulder bone fracture is the bone clamping plate one by one; Synthetism implants such as the high-strength bone screw of using when making the human body operation, bone sleeve pipe.Also can make medical operation suture thread, be service for patients better.
5. the needed raw material of product of the present invention is taken from domesticly fully, and the price of its product has only (PLA) and 1/5-1/10 (PGA), greatly reduces the price of product, has reduced cost.
6. material of the present invention has cutting ability well, can cut according to the needs of operation.
7. material of the present invention is nonmagnetic, does not influence X-ray examination, ultrasound diagnosis and nuclear magnetic resonance check after the implantation, can realize the operation under the intuitive monitoring, has improved the success rate of operation significantly.
The present invention has following accompanying drawing:
Fig. 1 is an intramedullary needle sketch map provided by the invention;
Each parts is among the figure: bar portion 1, channel-shaped portion 2, rib 3, groove 4 and locating hole 5, intramedullary needle is to be made of bar portion 1 and channel-shaped portion 2, 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 embedded in the marrow of knochenbruch according to the processing of the thickness of injury of the bone skeleton internal diameter, and is affixed with knochenbruch by bone screw etc.
Fig. 2 is the I-I generalized section of intramedullary needle provided by the invention;
Fig. 3 is the II-II generalized section of intramedullary needle provided by the invention;
Fig. 4 is a vertebra sketch map provided by the invention;
Each parts is among the figure: spinal column main body 6 and fixing listrium end face 7, and spinal column is the parallel cylinders of both ends of the surface, its height, thickness need decision by operation, are used for a bone road that pad is fixed.
Fig. 5 is a bone clamping plate sketch map provided by the invention;
Each parts is among the figure: the bone clamping plate are matrix battens, have on it to have screw clevis 8 screw holes 9, can use separately, also can two or several piece be used.
Fig. 6 is the III-III generalized section of bone clamping plate provided by the invention;
Fig. 7 is a bone screw first sketch map provided by the invention;
Each parts is among the figure: bone screw is the fastener between the injury of the bone 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.
Fig. 8 is a bone screw first IV-IV generalized section of the present invention;
Fig. 9 is a bone screw second sketch map of the present invention;
Figure 10 is a fixed bar sketch map of the present invention;
Each parts is among the figure: faceted pebble 15, bar portion 16, fixed bar is a faceted pebble solid cylinder more than.
Figure 11 is the fixed bar schematic top view of wood invention;
Figure 12 is a bone sleeve pipe sketch map of the present invention;
Each parts is among the figure; Body 18, pore 17, bone sleeve pipe are pipes.
Figure 13 is a skull sketch map of the present invention.
Each parts is among the figure: concave surface 19, convex surface 20, skull are annular disconnection things, and the angle of disconnection, the beautiful radian of concave, convex are owing to the decision that needs of the reality of performing the operation.
The present invention has following embodiment on product:
Fig. 1 is an intramedullary needle sketch map of the present invention, is one of product embodiments of the present invention.
Each parts is among the figure: bar portion 1, channel-shaped portion 2, rib 3, groove 4 and locating hole 5, intramedullary needle is to be made of bar portion 1 and channel-shaped portion 2, 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 processed according to the thickness of the internal diameter on bone injury bone road, is embedded in the marrow of knochenbruch, is connected with knochenbruch by bone screw.
Fig. 4 is a vertebra sketch map of the present invention, is two of product embodiments of the present invention.
Each parts is among the figure: spinal column main body 6 and fixing listrium end face 7, and spinal column is the parallel skill bodies of both ends of the surface, its height, thickness need decision by operation, are used for an anatomy that pad is fixed.
Fig. 5 is a bone clamping plate sketch map of the present invention, is three of product embodiments of the present invention.
Each parts is among the figure: the bone clamping plate are matrix battens, have on it to have screw clevis 8 screw holes 9, can use separately, also can two or several piece be used.
Fig. 7 is a bone screw first sketch map of the present invention, is four of product embodiments of the present invention.
Each parts is among the figure: bone screw is the fastener of the bone road and the injury of the bone, is the flat-top screw, and its nut has symmetric pulling to turn round the plane, and the screw of part screw thread 14 claims the bone screw first, and the full thread screw claims screw second.
Figure 10 is a fixed bar sketch map of the present invention, is five of product embodiments of the present invention.
Each parts is among the figure; Shuttle face 15, bar portion 16, fixed bar is a faceted pebble solid cylinder more than.
Figure 12 is a bone sleeve pipe sketch map of the present invention, is six of product embodiments of the present invention.
Each parts is among the figure: body 18, pore 17, bone sleeve pipe are pipes.
Figure 13 is a skull sketch map of the present invention, is seven of product embodiments of the present invention.
Each parts is among the figure: concave surface 19, convex surface 20, skull are annular disconnection things, and the radian of the angle of disconnection, concave, convex face is by the decision that needs of the reality of performing the 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.
CN97119073A 1997-10-22 1997-10-22 High molecular human body embedding article and its preparing process product and use Expired - Lifetime CN1089009C (en)

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Application Number Priority Date Filing Date Title
CN97119073A CN1089009C (en) 1997-10-22 1997-10-22 High molecular human body embedding article and its preparing process product and use

Related Child Applications (1)

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CN 00132607 Division CN1210070C (en) 2000-11-16 2000-11-16 High molecular human body implant and its preparing method and use

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CN1089009C true CN1089009C (en) 2002-08-14

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Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2955392C (en) 2014-09-07 2024-01-30 Ossio Ltd. Anisotropic biocomposite material, medical implants comprising same and methods of treatment thereof
MX2017008530A (en) 2014-12-26 2017-10-26 Ossio Ltd Continuous-fiber reinforced biocomposite medical implants.
US10117647B2 (en) * 2015-09-03 2018-11-06 Biomedical Enterprises, Inc Elastic orthopedic implant and method of manufacturing thereof
US10869954B2 (en) 2016-03-07 2020-12-22 Ossio, Ltd. Surface treated biocomposite material, medical implants comprising same and methods of treatment thereof
EP3474913B1 (en) 2016-06-27 2024-05-08 Ossio Ltd Fiber reinforced biocomposite medical implants with high mineral content
CN113425398B (en) * 2021-08-04 2022-12-27 华科精准(北京)医疗科技有限公司 Skull lock
CN113440234B (en) * 2021-08-04 2022-12-27 华科精准(北京)医疗科技有限公司 Skull lock with osteogenesis piece

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1128944A (en) * 1988-06-13 1996-08-14 卡林技术公司 Apparatus and method of inserting spinal implants

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1128944A (en) * 1988-06-13 1996-08-14 卡林技术公司 Apparatus and method of inserting spinal implants

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Owner name: SHENZHEN CITY CHANGHUA BIOLOGY ENGINEERING CO., L

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Address after: Longgang District of Shenzhen City, Guangdong province 517182 city Tefalongfei Industrial Park building C

Patentee after: Shenzhen Changhua Bioengineering Co., Ltd.

Address before: 518111 Pinghu village, Pinghu Town, Longgang District, Guangdong, Shenzhen

Patentee before: Liu Jianyu

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Owner name: SHENZHEN CHANGHUA BIOMEDICAL ENGINEERING CO., LTD.

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Address after: Longgang District of Shenzhen City, Guangdong province 517182 city Tefalongfei Industrial Park building C

Patentee after: SHENZHEN CHANGHUA BIOMEDICAL ENGINEERING CO., LTD.

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Patentee before: Shenzhen Changhua Bioengineering Co., Ltd.

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Address after: 517182 Guangdong Province, Shenzhen city Longgang District Center City Tefalongfei City Industrial Park A building two floor

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