RU2211010C2 - Implant for orbital reconstruction - Google Patents

Abstract

FIELD: medicine, ophthalmology, oral surgery. SUBSTANCE: the suggested implant is represented by titanium perforated plate (TPP) polymerized into hydrophilic polymeric composition consisting of hydroxyethylmethylacrylate, joining agent and water at the following ratio of components, weight%: hydroxyethylmethylacrylate 50-70, joining agent 0.5-0.7, water - the rest. Hydrophilic polymeric composition could additionally contain antiseptic, and/or antibiotic, and/or hemostatic preparation, and/or proteolytic enzymes, and/or local anesthetic, and/or antimicrobial preparations at the quantity of 0.01-1%. Implant in question is of high biocompatibility and possibility for intraoperational modeling. EFFECT: improved results of orbital reconstruction. 4 cl, 2 ex

Description

 The invention relates to medicine, namely to ophthalmology and maxillofacial surgery, and is intended for plastic and reconstructive operations on the tissues of the orbit.

 Traumatic injuries of the walls of the orbit are accompanied by a violation of the configuration of its bone skeleton, as well as the release of part of the soft tissues (mainly periorbital tissue) beyond the orbit. Enophthalmos develops, that is, the dropping of the eyeball into the orbit, with visual impairment in the form of diplopia, i.e. doubling.

 Currently, various materials are used to restore the walls of the orbit and to replace the deficit of soft tissues.

 The use of carbon felt is known (RF patent 2054911). However, a significant drawback is its resorption.

 Closest to the claimed is an implant, which is a combination of a titanium plate with a rib autograft fixed to the preserved walls of the orbit (Abstract of a doctoral dissertation, p. 35-39, Moscow, 2000, Davydov D.V.).

 However, the rib autograft undergoes partial resorption, and the metal plate can cause erosion of adjacent soft tissues.

 The technical result is a stable increase in the effectiveness of treatment by restoring the bone structures of the orbit, eliminating enophthalmos, preventing possible postoperative inflammatory and cicatricial complications, increasing the biocompatibility of the implant, as well as expanding the arsenal of plastic materials for reconstructive operations in the orbit.

 The technical result is achieved in that the implant for reconstruction of the orbit containing a titanium perforated plate (CCI) according to the invention further comprises a hydrophilic polymer composition (GPC) in the following ratio of components, wt. %: hydroxyethyl methacrylate 50-70, a crosslinking agent 0.5-0.7, the rest is water. One of the variants of the invention is one in which the CCI is at least on the one hand polymerized in the CCP. Another option is to attach at least one HPA plate to the titanium plate that has been polymerised into the hydrophilic polymer composition. The implant may additionally contain biologically active substances, such as antibiotics, antiseptics, hemostatic agents, proteolytic enzymes, local anesthetics, antimicrobial agents in an amount of 0.01-1%.

 The blank for the implant is a thin VT-100 titanium plate (GOST 19807-91), recommended for use in implantology, with a thickness of 0.3 and 0.4 cm, with jumpers between them 0.1 cm. Titanium has a number of positive properties: biological inertness, corrosion resistance, non-toxicity, high mechanical strength, ductility, non-magnetic, low specific gravity.

 In order to increase biocompatibility and reduce the mechanical pressure of the metal plate on the fabric, the CCI is polymerized in HPA. Owing to its hydrophilicity, ion and oxygen permeability, and the ability to form a thin connective tissue capsule, hydrogels have high biocompatibility, long-lasting high form stability and elasticity, and no toxic effects on tissues.

 Structural features of HPA allow introducing therapeutic doses of medicinal substances into the volume of polymer implants without reducing their activity with the possibility of a dosed prolonged release of biologically active substances into the surrounding tissues. Anesthetics and / or antibiotics and / or antimicrobial and / or hemostatic agents and / or proteolytic enzymes are used as such substances in order to prevent possible postoperative inflammatory, infectious, hemorrhagic complications, and to prevent cicatricial soft tissue contractures.

 The implant is sterilized by all available standard methods.

 Being durable, the implant at the same time has sufficient flexibility, which allows it to be modeled before or during surgery using scissors and a clamp, according to the nature of the defect being replaced. The implant is fixed with screws to the remaining bone edges. For the purpose of additional correction to the implant, it is possible to attach plates of HPA, location, shape, the number of which depends on the degree of soft tissue deficiency and the type of bone defect being replaced.

The implant is prepared as follows. A titanium plate is fixed in a special form and a polymerization solution is fed into this form. After the polymerization process is completed, the form is opened and the finished product is removed and placed in a washing solution, keeping for 100 hours at a temperature of 70-75 ^o C. The washed product is placed in bidistilled water, sterilized and used. Before sterilization, the implant is saturated with biologically active substances.

 Example 1

 Patient A., 35 years old. Diagnosis: Deformation of the bone orbit on the right, enophthalmos, diplopia. He had a car accident 1 year ago. Attempts to restore the integrity of the orbit have not been undertaken previously. Examination revealed fractures of the lower and lateral walls of the orbit with displacement of bone fragments and partially soft tissues in the maxillary sinus. There was a displacement of the eyeball down by 1.5 cm, enophthalmos 3 mm. The reconstruction of the orbit of the CCI, polymerized from all sides in the GCP, with a thickness of 3 mm, containing biologically active substances. The implant was placed in the orbit and was fixed with screws to the remaining bone edges. The position of the eyeball was evaluated in comparison with the paired eye. For additional correction, a hydrogel plate 1 mm thick was required, fixed by sutures (4/0 prolene) to the upper surface of the implant. The wound is sutured in layers. In the postoperative period, there was a slight swelling of the soft tissues in the lower part of the orbit for 1 week. Sutures were removed on day 8. When viewed after 2 weeks, 1 and 6 months, the patient's condition is stable, asymmetry and diplopia are eliminated.

 Example 2

 Patient S., 44 years old. Diagnosis: Deformation of the bone orbit on the right, enophthalmos. History of facial trauma. An examination revealed a fracture of the lower wall of the orbit, hypophthalmos 1 cm, enophthalmos 3 mm. The orbit was reconstructed with an implant, which is a TPP, polymerized in HRC, 3 mm thick, the postoperative period without complications. The eyeball is in the correct position, facial symmetry has been restored.

 From the above it follows that the described implant, along with high mechanical strength to create support for the soft tissues of the orbit, has high biocompatibility and the absence of mechanical and chemical damaging effects on the tissues. Due to its ability to intraoperative modeling, a bone defect and a deficit in the volume of soft tissues are replaced with greater accuracy.

 Thus, CCI in combination with HPA can be recognized as the optimal material for implantation in reconstructive orbit surgery.

Claims (4)

1. An implant for reconstruction of the orbit containing a titanium perforated plate (TPP), characterized in that the TPP is polymerized in a hydrophilic polymer composition consisting of hydroxyethylmethacrylate, a crosslinking agent and water in the following ratio, wt. %:
Hydroxyethylmethacrylate - 50 - 70
Crosslinking agent - 0.5 - 0.7
Water - Else
2. The implant according to claim 1, characterized in that the hydrophilic polymer composition further comprises an antiseptic and / or antibiotic in an amount of 0.01-1%.  3. The implant according to paragraphs. 1 and 2, characterized in that the hydrophilic polymer composition further comprises a hemostatic agent in an amount of 0.01-1%.  4. The implant according to paragraphs. 1 and 3, characterized in that the hydrophilic polymer composition further comprises proteolytic enzymes in an amount of 0.01-1%.  5. The implant according to paragraphs. 1 and 4, characterized in that the hydrophilic polymer composition further comprises a local anesthetic and / or antimicrobial agents in an amount of 0.01-1%.