RU47672U1 - ANTI-MICROBIAL POLYMERIC IMPLANT FOR REPLACING BODIES AND CALLBOARDS - Google Patents

Abstract

The utility model relates to the neurosurgical field of medicine and can be used in the treatment of destroyed vertebral bodies and discs ..

The utility model is a rod with four stiffeners having the following dimensions:

diameter described

circumference mm from 7 to 16 length mm from 5 to 90

and made from a copolymer of vinylpyrrolidone with methyl methacrylate, capron fiber and calcium gluconate and having on the surface from 1 to 4 inserts with geometric dimensions:

length from 5 to 90 mm width from 1 to 3 mm thickness from 0.5 to 2 mm,

made from a copolymer of vinylpyrrolidone with methyl methacrylate and an antimicrobial agent.

Description

The utility model relates to medical devices, namely to products used in neurosurgery.

Known metal and ceramic implants to replace the bodies and discs of the vertebrae (Ramikh EA, Atomanenko MG "Surgical methods in the complex treatment of fractures of the thoracic and lumbar spine." Traumatology and Orthopedics named after N.N. Priorov, 2003 , No. 3, pp. 43-48). However, the use of such implants has a number of disadvantages:

- implants are made of non-destructible material and are constantly inside the body, which causes a prolonged reaction to a foreign body;

- implants have high rigidity, significantly greater than the bone tissue of the vertebrae, which causes the resorption of adjacent areas of the bone;

- the dimensions of the implant cannot be changed during surgery in accordance with the individual dimensions of the patient;

- Implantant does not have antimicrobial activity.

The technical task of the proposed utility model is the possibility of gradual replacement of the implant with its own bone tissue and providing conditions that exclude the resorption of adjacent bone tissue under the influence of the implant and providing the possibility of changing the implant size during the operation in accordance with the individual size of the patient, ensuring antimicrobial activity.

The technical result is achieved by the fact that the implant is made in the form of a rod with four stiffeners, with a diameter of the circumscribed circle of 7 to 16 mm and a length of 5 to 90 mm, which is made of a copolymer of vinyl pyrrolidone with methyl methacrylate grade PPM-1, modified nylon fiber and calcium gluconate in the following ratio of constituent parts (% wt.):

PPM-1 copolymer 30.0-50.0

Modified

nylon fiber 45.0-60.0 Calcium gluconate 5.0-10.0,

and from 1 to 4 inserts with the following dimensions are formed on the surface:

length from 5 to 90 mm width from 1 to 3 mm thickness from 0.5 to 2 mm,

consisting of a copolymer of vinylpyrrolidone with methyl methacrylate and an antimicrobial substance in the following ratio of components (% wt.):

vinylpyrrolidone copolymer with

methyl methacrylate 50.0-90.0 antimicrobial substance 10.0-50.0

The implant section is shown in Fig. 1

The essence of the utility model is expressed in the fact that an implant made of incompatible polymer materials is able to gradually biodegrade in the body, is easily processed with surgical instruments, and has antimicrobial activity.

The use of a polymer implant provides reliable fixation of the vertebrae, provides bone tissue regeneration throughout the intervertebral space, allows you to accurately simulate the size of the implant in accordance with the individual size of the patient, eliminates the complications associated with resorption of bone tissue in contact with the implant and eliminates the occurrence of postoperative suppuration.

The proposed utility model operates as follows. After removal of the damaged body or disc of the vertebra, the dimensions of the implant are changed by treatment with a surgical instrument in exact accordance with the distance between the intact vertebrae and the implant is implanted between them. The wound is sutured in layers. If necessary, the strength of fixation of the implant in the intervertebral space can be increased through the use of medical adhesives, for example, grades MK-7, MK-9.

Utility Model Manufacturing Examples

Example No. 1

0.7 g of a prepreg, consisting of 0.42 g (60%) of a modified capron fiber with 0.21 g (30%) of GSHM-1 copolymer containing 0.07 g (10%) of calcium gluconate, is placed in a mold and, at a temperature of 180 ° C, form a core with a diameter of the described circle of 7 mm and a length of 20 mm

The method of watering from a suspension of cefamesin in an alcoholic solution of the PPM-1 copolymer on 3 faces of the implant forms inserts 0.5 mm thick, 1 mm wide and 20 mm long, containing 50% cefamezin and 50% PPM-1 copolymer.

Example No. 2

5.4 g of a prepreg consisting of 2.97 g (55%) of a modified nylon fiber with 1.94 g (36%) of a PPM-1 copolymer deposited on it containing 0.49 g (9%) of calcium gluconate, placed in the mold and, at a temperature of 185 ° C, form a core with a diameter of the circumference of 10 mm and a length of 90 mm.

By watering from a suspension of dioxidine in an alcoholic solution of the PPM-1 copolymer, an insert 1 mm thick, 2 mm wide and 90 mm long containing 25% dioxidine and 75% PPM-1 copolymer is formed on 1 face of the implant.

Example No. 3

0.8 g of prepreg, consisting of 0.36 g (45%) of a modified nylon fiber with 0.4 g (50%) of a PPM-1 copolymer deposited on it containing 0.04 g (5%) of calcium gluconate, placed in the mold and, at a temperature of 190 ° C, form a rod with a diameter of the described circle of 16 mm and a length of 5 mm

The method of watering from a suspension of gentamicin sulfate in an alcoholic solution of the PPM-1 copolymer on 4 faces of the implant forms 2 mm thick inserts, 3 mm wide and 5 mm long, containing 10% gentamicin sulfate and 90% PPM-1 copolymer.

Claims (1)

Polymer implant for replacing vertebral bodies and discs in the form of a rod of synthetic material, characterized in that it is made in the form of a rod with four stiffeners with geometric dimensions: Diameter described circumference mm from 7 to 16 length mm from 5 to 90 which is made from a copolymer of vinylpyrrolidone with methyl methacrylate grade PPM-1, modified nylon fiber and calcium gluconate in the following ratio of components, wt.%: PPM-1 copolymer 30.0-50.0 Modified nylon fiber 45.0-60.0 Calcium gluconate 5.0-10.0 and having on the surface of the faces from one to four inserts with geometric dimensions length from 5 to 90 mm width from 1 to 3 mm thickness from 0.5 to 2 mm which are made of a copolymer of vinylpyrrolidone with methyl methacrylate grade PPM-1 and antimicrobial substance in the following ratio of constituent parts, wt.%: Vinylpyrrolidone copolymer with methyl methacrylate 50.0-90.0 antimicrobial substance 10.0-50.0