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

Products of polymer human implants

The invention relates to a series of human body-absorbable polymer human body implants.

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. About the degree of degradation

(PLA) and (PGA) degrade faster than broken bone heals. Lost support and protection to a large extent.

2. About strength

(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. Easy to produce sinus tract

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) 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.

The technical purpose of polymer human implant product of the present invention to be achieved is:

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. Expand the application value and application scope of human implant products to better serve patients;

3. Greatly reduce the price of human implants.

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). The product made of the human implant, before being implanted in the human body,

Its flexural elastic modulus E bend = 4500MPa;

Compression elastic modulus E pressure = 5500MPa;

Bending strength σ bending = 150MPa;

Compressive strength σ pressure = 100MPa.

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.

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.

Figure 1 discloses a schematic diagram of the intramedullary nail provided by the present invention;

The components in the figure are: rod part 1, groove part 2, rib 3, groove 4 and positioning hole 5, the intramedullary needle is composed of rod part 1 and groove part 2, and rod part 1 is a solid garden cylinder , the symmetrical groove part 2 is processed into a four-sided groove shape, and a positioning 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.

Figure 4 discloses a schematic diagram of the spine provided by the present invention;

The components in the figure are: the main body of the spine 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.

Fig. 5 discloses the schematic diagram of the bone splint provided by the present invention;

The parts in the figure are: the bone splint is a concave strip plate, which has screw cap grooves 8 screw holes 9, can be used alone, or two or several pieces can be used in conjunction.

Figure 7 discloses a schematic diagram of a bone screw provided by the present invention;

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.

Fig. 9 discloses a schematic diagram of bone screw B provided by the present invention;

Figure 10 discloses a schematic diagram of the fixing rod provided by the present invention;

Each part among the figure is: facet 15, rod portion 16, and fixed rod is a multi-faceted solid cylinder.

Figure 12 discloses a schematic diagram of the bone sleeve provided by the present invention;

Each part among the figure is; Tube body 18, tube hole 17, and bone casing is a tubular thing.

Fig. 13 discloses a schematic diagram of a skull provided by the present invention.

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.

The present invention has following advantage:

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. The product of the polymer human implant disclosed in the present invention, after rigorous testing, before implantation, its

Bending elastic modulus E-bend = 4500MPa;

Compression elastic modulus E pressure = 5500MPa;

Bending strength σ bending = 150MPa;

Compressive strength σ pressure = 100MPa.

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. 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. 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. 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. The material of the present invention has good cutting performance and can be cut according to the needs of surgery.

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.

The present invention has following accompanying drawing:

Fig. 1 is a schematic diagram of the intramedullary nail provided by the present invention;

The components in the figure are: rod part 1, groove part 2, rib 3, groove 4 and positioning hole 5, the intramedullary needle is composed of rod part 1 and groove part 2, and rod part 1 is a solid garden cylinder , the symmetrical groove part 2 is processed into a four-sided groove shape, and a positioning 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.

Fig. 2 is the I-I sectional schematic diagram of intramedullary nail provided by the present invention;

Fig. 3 is a schematic diagram of the II-II section of the intramedullary nail provided by the present invention;

Fig. 4 is a schematic diagram of the spine provided by the present invention;

The components in the figure are: the main body of the spine 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.

Fig. 5 is a schematic diagram of a bone splint provided by the present invention;

The parts in the figure are: the bone splint is a concave strip plate, which has screw cap grooves 8 screw holes 9, can be used alone, or two or several pieces can be used in conjunction.

Fig. 6 is the III-III cross-sectional schematic view of the bone splint provided by the present invention;

Fig. 7 is a schematic diagram of a bone screw provided by the present invention;

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.

Fig. 8 is a schematic cross-sectional view of bone screw nail IV-IV of the present invention;

Fig. 9 is a schematic diagram of bone screw B of the present invention;

Fig. 10 is a schematic diagram of a fixed rod of the present invention;

Each part among the figure is: facet 15, rod portion 16, and fixed rod is a multi-faceted solid cylinder.

Fig. 11 is a schematic top view of the fixed rod of the wooden invention;

Fig. 12 is a schematic diagram of the bone sleeve of the present invention;

Each part among the figure is; Tube body 18, tube hole 17, and bone casing is a tubular thing.

Fig. 13 is a schematic diagram of the skull of the present invention.

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.

The present invention has following embodiment on product:

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.

The components in the figure are: rod part 1, groove part 2, rib 3, groove 4 and positioning hole 5, the intramedullary needle is composed of rod part 1 and groove part 2, and rod part 1 is a solid garden cylinder , the symmetrical groove part 2 is processed into a four-sided groove shape, and a positioning 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.

Fig. 4 is a schematic diagram of the spine of the present invention, which is the second product embodiment of the present invention.

The components in the figure are: the main body of the spine 6 and the end surface 7 of the fixed edge plate. The spine is a technical body with parallel ends.

Fig. 5 is a schematic diagram of the bone splint of the present invention, which is the third product embodiment of the present invention.

The parts in the figure are: the bone splint is a concave strip plate, which has screw cap grooves 8 screw holes 9, can be used alone, or two or several pieces can be used in conjunction.

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.

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. .

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.

Each part among the figure is; Shuttle face 15, bar portion 16, and fixed bar is a polygonal solid cylinder.

Fig. 12 is a schematic diagram of the bone sleeve of the present invention, which is the sixth product embodiment of the present invention.

Each part among the figure is: pipe body 18, pipe hole 17, and bone casing pipe is a tubular thing.

Fig. 13 is a schematic diagram of the skull of the present invention, which is the seventh product embodiment of the present invention.

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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