WO2006045851A1

WO2006045851A1 - Surgical material which has an inductive, conductive and osseointegrational influence and which is made from hydrocarbons and cellulose

Info

Publication number: WO2006045851A1
Application number: PCT/ES2004/000431
Authority: WO
Inventors: Jose Bouza Barrera
Original assignee: Jose Bouza Barrera
Priority date: 2004-10-04
Filing date: 2004-10-04
Publication date: 2006-05-04

Abstract

The invention relates to a surgical material which has an inductive, conductive and osseointegrational influence and which is made from hydrocarbons and cellulose, particularly polymethacrylate and ethyl cellulose. The inventive material is biocompatible, of cartilaginous consistency and can harden progressively or rapidly. Said material can be fixed to tissues using surgical suture and can be modified by a surgeon during a surgical procedure by cutting same with a surgical knife or scissors. The material is intended for use in specialised fields, such as neurosurgery, ophthalmology, maxillo-facial surgery, orthopaedics, stomatological practice and, more generally, for bone filling in reconstructive and aesthetic surgery, in traumatic lesions with significant bone tissue loss, cardiovascular surgery, orthopaedic traumatology and similar.

Description

Surgical material with inductive, conductive and osseointegration influence, consisting of hydrocarbons and cellulose.

DESCRIPTION

"Surgical material with inductive conductive influence and osseointegration". The present invention falls within the state of the art relating to medicine, surgery and implantology and more specifically relates to a new surgical material intended for application in bone filling, restoration of anatomical surfaces and general trauma of human structure and animal.

The object of this patent is to provide a biocompatible surgical material, of great inductive, conductive and bone integration influence by means of which

10 notable improvements are achieved in relation to other surgical materials known up to now, speeding up and simplifying the surgical act, shortening the operative time as well as the postoperative recovery. This product can be used as surgical material in specialties such as neurosurgery, ophthalmology, orthopedic, facial, and masilo surgeries.

15 stomatological and other similar ones.

In the state of the art, an infinity of materials for restorative surgery are known, which nevertheless have certain drawbacks such as; Hardness, non-cartilaginous character, reversibility, lack of highly dispersed surfaces. In general, these are negatively charged elements

20 that do not contribute to the neoformation of surrounding tissues in a short period of time, other drawbacks of the products used so far are, for example, their low receptivity for exchange with tissue fluid, lack of malleability, lack of flexibility and elasticity, thus such as its difficult adaptation to surfaces with concave or convex characteristics, its detachment from

25 heat energy (exothermic) harmful to living tissues. Neither do they allow them to be cut or beveled with scissors or a scalpel and they do not achieve a degree of consistency or hardness greater than that of autogenous bone, nor are they capable of restoring extensive bone surfaces. The compounds currently used are not feasible to be placed in

The septic tissue neither allow the introduction of drugs and antibiotics in its infrastructure, they do not contain bactericidal, antimicrobial or anti-infective elements in their molecular structure. They are unable to restore large portions of flat bones and require sterilization prior to surgery. For its part, the biocompatible surgical material object of the present invention has the following most relevant advantages, which we quote below with a merely illustrative and never limiting character;

-Cartilaginous consistency material. -Adaptable to each patient, use and specific case.

-It can be fixed to tissues by surgical suture.

-Modifiable during the surgical act by the surgeon through cuts with scalpel or scissors.

-Manufacture in blocks of various dimensions and sheets of different thicknesses and rolls of different lengths and diameters.

-It does not require sterilization, its preservation in the ester liquid provides this sterility.

-Tightening capacity that can be carried out in two variants;

Progressive and fast. Progressive, through direct placement in living tissues, reaching its maximum hardness in 72 hours and a resistance of 80 ATM / cm2 and fast, by introducing, spraying and / or applying a CS09T solution on the implant surface. This hardening is carried out by means of a natural endothermic chemical reaction without the need for catalysts or plasticizers. -Allows the incorporation of antibiotics in its preparation.

-It presents a fibrovascular integration demonstrated by radiographic gamrnagraphic studies.

-Possible elaboration of the material with variable characteristics in its morphology (smooth, grainy, rough, intra and extra porous). -Atoxic, bactericidal, fungicidal and anti-infective qualities in its nature.

These are, among others, some of the most outstanding advantages and characteristics of the product object of this invention consisting of an implant material that is used as bone filler in reconstructive and aesthetic surgery, for application or use in traumatic injuries with great loss of bone tissue of the flat bones, as well as in tumor-like lesions, trephine holes, osteomilitis, restorations of supra and infra-orbital arches, vertical laminae, orbital floor, zygomatic arch, molar bones and other similar ones, their use It is indicated as an immediate implant in stornatological surgical traumatologies attributable to extractions of teeth whose roots are They are in communication with the maxillary sinuses, as well as in the loss of conjunctival grooves, traumatic injuries with bone loss in dissimilar fractures and vertebral shims. The uses in cardiovascular surgery with a view to restoring the loss of bone substance caused by the sternum bone being divided into two parts by means of a surgical saw, as well as in orthopedic traumatology, being able to restore any type of injury to long bones, are thus very outstanding. like bones in dissimilar frictions and shapes. In the state of the art, a material that meets the cartilaginous characteristics of the surgical material object of this invention is not known, nor is its endothermic morphology of change in its molecular infrastructure from soft to hard that occurs through the union of crystalline networks, endothermic hardening that can obtain a consistency and hardness in 24 hours that allows a pressure of 80 to 100 ATM / cm2. The surgical material object of the present invention consists of a hybrid of hydrocarbons and celluloses (hybrid of plastic substances) that has a semi-crystalline structure that is not completely transparent, slightly opaque, whose coloring defect varies as the material achieves the consistency of the bone, changing at that time the microcrystallinity to a bone white color with shades of pale yellow corpuscles and faint very similar to human cortical bone.

Regarding the thermal dynamics of this product, it allows an oscillation of temperatures in a range of between + 40 and - 5 degrees centigrade without producing significant changes in its molecular structure. As other very significant characteristics of this new surgical material, it is worth mentioning its flexibility and elasticity. All cartilaginous consistency materials allow adaptation to dissimilar surfaces, whether concave or convex, semi-elliptical or marginal edges with a view to being applied for the restoration of arches, crevices, interposition between bloody surfaces, replacement of lost or modified spaces, hole filling and the like. All these possibilities can be used in its transition stage from soft to hard until reaching the final phase in which the consistency or solidity of human bone is reached.

More specifically, the stress tests demonstrate a remarkable elasticity of the product in its cartilage stage, demonstrating the ability to duplicate the size of a piece of this material measures 4 cm long by 1 cm in diameter.

The flexural tests of the product prove that, in its cartilaginous stage, it allows flexing from 0 to 45 degrees in a column 4 cm long by 1 cm2 in a dynamometer under tension at 50 grams.

The surgical material object of the present invention consists of a formula of the following structural elements in the percentages detailed below;

-Poly methacrylate CH2CCH3CCOR 56%, Ethyl cellulose C2H5-O-R 36%, Colloid CH

7%, excipient 1%.

The active elements of the compound are as follows and in the proportions detailed below;

Calcium CA 0.367% Chlorine CL 0.040% Magnesium Mg 0.026% Fluorine F 0.005% Sodium NA 0.018% Carbacrol (Serpol) 0.347% Potassium K 0.017% Excipients 0.020%. PO4 Phosphate 0.160%

Claims

1.- Surgical material with inductive conductive influence and osseointegration intended for application in bone filling, restoration of anatomical surfaces and general trauma of human and animal structure characterized by consisting of a hybrid of hydrocarbons and celluloses (hybrid of plastic substances) that It has a semi-crystalline structure that is not totally transparent, which varies as the material achieves the consistency of the bone.

2.- Surgical material with inductive conductive influence and osseointegration intended for application in bone filling, restoration of anatomical surfaces and general trauma of human and animal structure according to the preceding claim, characterized by its capacity for progressive hardening, through its direct placement in living tissues, reaching its maximum hardness in 72 hours and a resistance of 80 ATM / cm2.

3. Surgical material with inductive conductive influence and osseointegration intended for application in bone filling, restoration of anatomical surfaces and general trauma of human and animal structure according to the first claim characterized by its ability to rapidly harden, by means of the introduction, spray and / or application of a CS09T solution on the implant surface.

4.- Surgical material with inductive conductive influence and osseointegration intended for application in bone filling, restoration of anatomical surfaces and general trauma of human and animal structure according to the preceding claims, characterized by its endothermic morphology of change in its molecular infrastructure of soft to hard through the union of the crystalline networks, endothermic hardening by means of an endothermic natural chemical reaction.

5. Surgical material with inductive conductive influence and osseointegration intended for application in bone filling, restoration of anatomical surfaces and general trauma of human and animal structure according to the first claim, characterized in that its thermal dynamics allow an oscillation of temperatures in a range between + 40 and - 5 degrees centigrade without producing significant changes in its molecular structure.

6.- Surgical material with inductive conductive influence and osseointegration intended for application in bone filling, surface restoration anatomical and general trauma of human and animal structure according to the preceding claims characterized by demonstrating a remarkable elasticity of the product in its cartilaginous stage, being able to double the size of a piece of this material measuring 4 cm long by 1 cm in diameter .

7.- Surgical material with inductive conductive influence and osseointegration intended for application in bone filling, restoration of anatomical surfaces and general trauma of human and animal structure according to the preceding claims, characterized by allowing flexion from 0 to 45 degrees in one column 4 cm long by 1 cm2 on a dynamometer under tension at 50 grams.

8. Surgical material with inductive conductive influence and osseointegration intended for application in bone filling, restoration of anatomical surfaces and general trauma of human and animal structure according to the preceding claims, characterized by consisting of a mixture in proportion of; Poly methacrylate CH2CCH3CCOR 56%, Ethyl cellulose C2H5-OR 36%, Colloid CH 7 ^« %, excipient 1%.

9.- Surgical material with inductive conductive influence and osseointegration intended for application in bone filling, restoration of anatomical surfaces and general trauma of human and animal structure according to the preceding claims, characterized by having as active elements the following in the determined proportions ; Calcium CA 0.367% Chlorine CL 0.040%

Magnesium Mg 0.02S% Fluorine F 0.005% Sodium NA 0.018% Carbacrol (Serpol) 0.347%

Potassium K 0.017% Excipients 0.020%.

PO4 Phosphate 0.16O%

10. -Use of the composition described in claims numbers 8 and 9 to obtain a surgical material with inductive conductive influence and osseointegration intended for application as bone filler in reconstructive and aesthetic surgery, for application or use in injuries traumatic type with great loss of bone tissue of the flat bones, as well as in tumor type lesions, trephine holes, osteomilitis, restorations of supra and infra orbital arches, vertical laminae, orbital floor, zygomatic arch, molar bones, trauma stomatological surgery, loss of grooves conjunctival, traumatic injuries with bone loss in dissimilar fractures and vertebral shims, cardiovascular surgery as well as orthopedic trauma.