FR2502489A1 - Homo:transplant material, esp. for conjunctiva - comprising retro:peritoneal fascia tissue - Google Patents

Abstract

Novel homotransplant material, esp. for repairing damaged conjunctiva, comprises retroperitoneal fascia tissue (I). (I) gives better results than known materials (e.g. labial, oesophagal, vaginal or conjunctival tissue); it is not subject to immune rejection, promotes rapid epithelisation (e.g. within 3-5 days) without significant scarring, and can be readily obtained in relatively large amts.

Description

HOMOTRANSPLANT FOR CONJUNCTIVE PLASTY
The present invention relates to medicine, more specifically, to ophthalmology, and more particularly, to transplants for plasty or repair of the conjunctiva.

The invention relates to a homotransplant for the plasty of the conjunctiva of the eyeball in the after-effects of trachoma, the after-effects of burns and recent burns, Stevens-Johnson syndrome, tumor affections, pterygium and injuries.

One of the topical problems in ophthalmology is ocular conjunctiva plasty. The conjunctiva is frequently affected by burns, the frequency of which is equal to 20.3X compared to all traumas of the eye (NA Puchkovskaya et al., Pathogenesis and therapy for burns of the eye and its sequelae M., 1973, pages 123-127). The conjunctiva is the site of various tumor pathologies (Aftab M., Pergival
SPB Basal cell Carcinoma of the Conjunctiva. Brit. J. Ophtal., 1973, 57, 11, 836-837), she is affected during pemphigus, lupus, Dürhing's disease, Stevens-Johnson disease (NA Puchkovskaya.

Corneal transplant in complicated pillow cases. Kiev, 1960, pages 21 and 127). Pterygium is a widespread disease, and in the steppe regions its frequency reaches 21% compared to the whole population (BI Ismallov. Some data concerning the pterygium and its spread among the inhabitants of the regions of the Autonomous Soviet Socialist Republic of Kara-Kalpakie. Oftalmologichesky journal, 1978, 6, pages 471-472).

Until now, there are a huge number of patients with trachoma in the world (Chronicle of the World Health Organization, 1979, No. 11).

 Most patients, suffering from the above-mentioned pathologies, require plastic surgery on the conjunctiva. At present, autotransplants of the labial mucosa are most often used for conjunctival plasty (NA Puchkovskaya et al. Pathogenesis and and therapy for burns of the eye and its sequelae. M., 1973, pages 123127 ). The removal of the labial mucosa from patients, however, represents a very traumatic manipulation, as a result of which we can observe in some cases a labial retraction, and the effettosmetic of the intervention remains unsatisfactory, taking into account that the grafted labial mucosa is distinguished by a bright red color (OD Morozova. The corneo-conjontival plasty in the surgical treatment of symblepharon and recurrent pterygium. Vestnik oftalmologii. 1971, 2, pages 24-26).

The use of homotransplants of the conjunctiva of the eyeball is well known (Byerly Holt L. Eye Tissue Transplantation in children. Eye,
Ear, Nose, Thr Monthly, 1970, 49, 1, 172-174; Jarplid B., Schantz B. Rejection of Skin and Conjunctival Allograft in the Dog after prolonged Graft Survival.

Acta chir. Scand., 1973, 139, 6, 517-521), but the results of these interventions are not always satisfactory. In addition, there are quite a few difficulties in obtaining the eyeballs from corpses (Paton R.T. Keratoplasty. New York, 1955). The same disadvantage exists for the plasty of the conjunctiva by means of corneal graft coming from human corpse (V.P.

Filatov. Surgical procedures in the pterygium. In the book "Manual of eye pathology". 1960, t.5, pages 33-34). Homotransplants of the labial mucosa (G.V. Legeza. Homotransplantation of the mucosa in the surgical treatment of sequelae of burns of the eye. Doctoral thesis. Odessa, 1970) and of the esophageal mucosa (N.A. Ushakov, P.T.

Chesnokov. Ophthalmic plastic surgery problems. Leningrad, 1972, t. 191, pages 73-74) have proven effective only for the repair of small defects of the ocular conjunctiva.

 We know the use in experimental conditions of homologous venous wall for conjunctival plasty (François J. Gdal-On M.

The venous wall for Korrogreffe of the conjunctiva. Ann. Oculist. Paris, 1972, 205, 4, 447-458).

 There are also data concerning the use of homotransplants of the vaginal mucosa (AA Colin. On the use of the vaginal mucosa for the plastic restoration of the conjunctival sac. Collection of professor NI Gorizontov. Novosibirsk, 1935), of placenta Barkhash. The placenta as graft material. Vestnik oftalmologii, 1940, 6, page 758), of the membrane of the egg (BI Tikhvinsky. The use of the membrane of the egg in plastic operations on the eyeball. Vestnik oftalmologii, 1938, 13, page 397).

 Known homotransplants cannot satisfy ophthalmic surgeons: some of said homotransplants are not very effective from the clinical point of view, the others are difficult to prepare in large quantities (conjunctive, vaginal mucosa, labial), while the third are difficult to fix by sutures (placenta).

 The object of the present invention is to obtain a widely accessible homotransplant for conjunctival plasty, which would give the possibility of creating large stocks of said homotransplant, and which would improve the clinical and cosmetic results of said intervention.

 This problem is solved by the fact that, according to the invention, the retroperitoneal fascia is used as a homotransplanter for conjunctival plasty.

 Retroperitoneal fascia, for example, transverse fascia, retroperitoneal fascia, is removed from human cadavers at the time of autopsy, under non-sterile conditions, separating them from adjacent anatomical formations. The removal of these fascias in no way precludes national and religious traditions and other problems, since it is carried out at the time of the autopsy and it does not in any way alter the external aspect of the 'dead man. The collected fascias are cleaned and immersed in 70% ethyl alcohol, where the said material is stored until it is completely sterilized. Subsequently, the material is placed in an extended or flat state in cellophane packages or in sterile laboratory capsules.

70% ethyl alcohol is used as the storage medium. Said material is stored at a temperature of 0 to 30 C. Transplants are then used, the storage period of which ranges from 7 days to 4 years and more. You can easily transport the stored material. From a single human corpse one can obtain grafting material, sufficient for carrying out 80 plastic interventions and more on the conjunctiva. The retroperitoneal fascias have an optimal thickness for conjunctival plasty.

 Experimental research on conjunctival homoplasty using retroperitoneal fascia has involved 60 rabbits. Two series of experiments were carried out: in the first of these series the defect of the conjunctiva was repaired by a homotransplant of retroperitoneal fascia, and in the second by a conjunctival homotransplant. The transplants were subjected to a biomicroscopic and morphological study on 3,7,14,21,30,60,90, 120 and 180th days. These studies established that homotransplants of retroperitoneal fascia produce a less pronounced tissue reaction than homotransplants of the conjunctiva, and that their surface becomes covered with conjunctival epithelium at earlier times (around the 3rd, 7th day). the restitution of the fascial homotransplant by a tissue, identical to that of the conjunctiva, while the conjunctival homotransplant, as a rule, is subject to a more or less pronounced scar deformation.

 The operative technique when using the proposed homotransplant is as follows.

 The defect of the conjunctiva of the eyeball, which is formed, for example, as a result of the separation of flanges between the eyelid and the eyeball, from the scar tissue is identified. The retroperitoneal fascia homotransplanter is removed from the preservation liquid and modeled according to the shape of the defect, after which the transplant is applied to the defect, for example, in the conjunctiva of the eyeball. The edges of the homo-transplant are fixed by sutures on the episclerotic so that said homotransplant can be placed regularly on. the surface of the sclera while in a tense state. In the post-operative period, drops of antiseptic are instilled into the conjunctival sac, and no immunosuppression is used. Patients leave the hospital after the operation at the deadline of 5.15 days after the epithelization of the surface of the transplant.

 Homotransplants of retroperitoneal fascia can be used to restore conjunctiva defects of the eyeball of any size, including complete conjunctiva defects, as well as defects of the palpebral conjunctiva. Conjunctival honioplasty by retroperitoneal fascia can be associated with lamellar keratoplasty.

 Using the fascial homotransplant, according to the invention, a plastic operation was performed on 308 patients (326 eyeballs) for sequelae of burns, trachoma, wounds, primary and secondary pterygium, benign and malignant tumors, burns recent. The long-term results of these interventions relate to a period of up to 6 years. In all cases, the homotransplants of the retroperitoneal fascia were grafted well and restored the defect of the conjunctiva in a stable manner.

At distant times the color and character of the surface of the transplant differed little from the normal conjunctiva. A good cosmetic effect was obtained in 96.4% of the cases. A stable clinical effect of the intervention was recorded in 90.8% of the cases (absence of relapses, sufficient depth of conjunctival folds) -.

 The transplant according to the invention has the following advantages over the other known graft materials.

 The removal of graft material is made easier, and it does not cause alteration of the external integuments of the corpse; it is performed during the ordinary autopsy. The possibility of obtaining a large quantity of transplant material immediately and the simplicity of its conservation for long periods represent good conditions for creating large stocks of transplants. The supply of graft material according to the invention does not require the training of highly qualified specialists and the use of expensive preservatives, and for this reason is profitable from an economic point of view.

 Compared to other known autotransplants (labial mucosa of the patient) retroperitoneal fascia homoplasty reduces the operative trauma, as well as the duration of the surgical intervention. The cosmetic effect of the operation is clearly improved, while not giving way to the clinical results obtained by autograft techniques. The comparative study carried out on identical type of clinical material with long-term results of up to 5 years shows that following the use of the homotransplant of retroperitoneal fascia a good cosmetic result was obtained in 59 cases out of 62 (95.2%), while following the use of autotransplants of the labial mucosa in 8 cases out of 48 (16.6%). A good clinical effect was noted in 90.3 and 87.4% of the cases, respectively.

Compared to known homotransplants (labial, esophageal, vaginal, conjunctival mucosa) the use of the fascial homotransplant according to the invention, clearly improves the clinical results of the intervention, gives the possibility of performing the plastic operation even in the presence large, extensive conjunctival defects. It is no longer necessary to have recourse in the post-operative period to expensive immunosuppressive means and the duration of said post-operative period is reduced by almost two times. Comparative experimental studies show that following conjunctival homoplasty using the retroperitoneal fascia, scar deformities (at day 120) occur in 7.2% of cases, while following conjunctival homograft they The absence of an epithelial layer in homotransplants of retroperitoneal fascia occurs in 63% of cases, this epithelial layer existing in almost all
known homotransplants, plays a positive role. The epithelium of said trans
known plants will inevitably come off, thereby increasing the reaction
immunological tion. Homotransplantation of retroperitoneal fascia creates
optimal conditions for its epithelization, and for this reason at
early delays (3, 5th day) we observe at the site of the transplant the restitution of the own epithelial layer of the conjunctiva. The immunological reaction is negligible, and for this reason the restoration of the transplant takes place without significant scar modifications.

 The operative technique is made simpler, since the retroperitoneal fascia is fixed securely by suture, which is explained by the peculiarities of its fibrous structure.

 Of course, the present invention is not limited to the embodiments described and shown; it is susceptible of numerous variants accessible to those skilled in the art without departing from the spirit of the invention.

Claims (2)

R E V E N D I C A T I O N S  1. As a new industrial product, a homotransplant intended in particular for conjunctival plasty, consisting of retroperitoneal fascia.  2. As a new industrial product, a homotransplant for conjunctival plasty consisting of retroperitoneal fascia, contained flat in a sterile packaging and immersed in a sterile liquid medium consisting of an alcoholic solution.