RU2133598C1 - Method for creating supporting stump with enucleation - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: method involves introducing implant into Tennon's capsule. Spongious pear-shaped collagen pretreated with 1% β-(5-nitrofuryl-2)-acrolein solution during 36-48 h. Musculus rectus is sutured to conjunctiva 4-6 mm distant from its boundary. Purse-string suture is applied at the place of attachment and tightened until it touches the implant 4-6 mm distant from the top of the implant. EFFECT: reduced risk of postoperative complications. 1 dwg

Description

 The invention relates to medicine, namely to ophthalmology, and may find application in plastic ophthalmosurgery.

 Removing the eyeball without implanting any bulk material into the stump creates unfavorable conditions for cosmetic prosthetics, as a result of which complications arise in the form of a prosthesis retraction, a decrease in its mobility, and a sharp deepening of the upper eyelid orbitopalpebral groove.

 There are many ways to form a supporting stump of an ocular prosthesis by introducing into the stump submersible solid, elastic, porous and spongy implants made of synthetic polymeric materials - foam rubber / 1 /, lavsan / 2 /, silicone rubber / 3 /, rubber with mylar mesh / 4,5 /, AKR-E / 6 / plastic, Teflon / 7.8 /, silicone sponge / 9 /.

 The main disadvantage of these materials is the frequent rejection of implants in the early and long term, exposure of implants, the occurrence of toxic, inflammatory or allergic reactions of surrounding tissues, which makes it difficult to obtain the necessary cosmetic effect.

 In addition, for muscle fixation, such an implant should be equipped with special devices and devices that significantly complicate both the implant device and its manufacturing method.

 For the manufacture of most of these implants require special expensive devices. All this limits the possibility of using implants made of synthetic materials in wide clinical practice.

 There is another method of forming a supporting stump during enucleation by introducing into the tenon capsule an expandable polymer composition / 10 /. The use of such an implant in the formation of the supporting stump reduces the possibility of its rejection and is easy to perform.

 However, the disadvantage of this method is the possibility of developing a toxic reaction of the surrounding tissues to the implant, which leads to excessive scarring of the orbital tissue, prosthesis retraction and an unsatisfactory cosmetic effect.

 Known methods for the formation of a supporting stump of an ocular prosthesis by introducing into a tenon capsule biological materials - bioplastics / 11 /, autogyros / 12 /, costal cartilage / 13,14,15 /, embryonic and cadaverous bones / 16,17 / and subcutaneous fat of the sole /18/.

 The use of biological tissues provides the physiological conditions for the implants to stay in the orbital tissue and thereby eliminates the possibility of their rejection.

 Due to the implantation of implants into the surrounding tissue, strong fixation and mobility of the supporting stump is ensured.

 In addition, for fixing the rectus muscles to biological implants, special devices and devices are not required.

 However, the suture fixation of the rectus muscles used in these methods is extremely unreliable and often leads to complications in the form of limiting the mobility of the formed supporting stump.

 Other disadvantages of these methods include the relatively rapid resorption of biological implants and their replacement with coarse connective tissue, which leads to a decrease in the volume of orbital tissue and retraction of the prosthesis.

 In addition, the disadvantages of these methods of forming a supporting stump include the difficulty of collecting cadaver material, the difficulty of its conservation, storage, disinfection, as well as the risk of infection.

 Closest to the proposed one is a method of forming a supporting stump during enucleation by introducing a synthetic polymer foamable composition into a tenon capsule and fixing the rectus muscles to the conjunctiva according to the copyright certificate N 1005786 dated 03.23.83 / 10 /, which we took as a prototype.

 This method due to the stitching of the rectus muscles to the conjunctiva 4-6 mm from its edge allows to exclude the procedure of stitching the rectus muscles directly to the implant, while ensuring the full volume of mobility of the supporting stump, and the foam-spongy structure of the hardening composition itself, as shown by clinical experience with it, provides strong fixation of the implant and eliminates its rejection.

 However, this method does not exclude the toxic effect of the implant on the orbital tissues, which is accompanied by their inflammatory edema, infiltration and can lead to excessive scarring, a decrease in their volume and subsequent lowering of the prosthesis.

 At the same time, strong fixation of the synthetic implant described in the prototype does not preclude its exposure, the consequence of which are the development of purulent complications and the need for either repeated conjunctival closure of the implant or its removal, which is very difficult and can lead to severe cosmetic defect of the entire orbital cavity and the impossibility repeated prosthetics.

 The technical result of the present invention consists in increasing the reliability of the method of forming a supporting stump and reducing the number of complications due to our use of a biological implant previously treated with tanning agents that was not previously used for these purposes.

 This result is achieved by the fact that in the known method of forming a supporting stump during enucleation by inserting an implant into a tenon capsule and suturing the rectus muscles to the conjunctiva 4-6 mm from its edge, according to the invention, pear-shaped spongy collagen pre-treated with 1% is used as an implant solution of β - / 5-nitrofuryl-2 / -acrolein for 36-48 hours, and in the place of suturing the muscles on the conjunctiva, a purse string suture is applied and tightened until it comes into contact with the implant 4-6 mm from the top of the implant.

 The use of sponge collagen, which is a biopolymer obtained by alkaline-salt hydrolysis of collagen-containing animal tissue, as an implant, significantly reduces toxic and allergic reactions, and also eliminates the development of inflammatory complications in orbital tissues.

 Preliminary treatment of collagen with tanning agents / 1% solution of β - / 5-nitrofuryl-2 / -acrolein / makes it resistant to the action of tissue enzymes and able to not absorb for a long time in the tissues, while maintaining its biological properties. Moreover, as shown by our experimental studies, to give the implant biological stability, providing for its gradual resorption over 1 - 1.5 years with the gradual replacement of its elements with connective tissue, preserving its native shape and volume, thereby eliminating further retention the prosthesis, necessary and sufficient is the treatment of the implant with a 1% solution of β - / 5-nitrofuryl-2 / -acrolein for 36 to 48 hours

 The tanning of the collagen implant with β - / 5-nitrofuryl-2- / acrolein - a nitrofuran-type drug - not only stabilizes collagen, but also gives it antimicrobial properties, which provides reliable protection against infection.

 The spongy structure increases the surface of the implant, and the porosity of this structure creates the necessary conditions for strong and reliable fixation of the implant in the tenon capsule due to the incorporation of elements of surrounding tissues into its structure.

 The manufacture of a pear-shaped implant makes it possible, by applying a purse string suture to the neck of the implant, to provide a firm fixation of the rectus muscles along with the conjunctiva.

 This method of fixing the rectus muscles to the implant eliminates the complications associated with limiting the mobility of the implant and provides high mobility of the formed supporting stump and, consequently, the ocular prosthesis.

 In addition, this form of the implant, due to the greater part immersed in the tenon capsule, provides the volumetric function of the implant, and the smaller part, separated by the neck and covered by the conjunctiva, plays the role of a lever for the prosthesis, also providing it with high mobility.

 For a better understanding of the proposed method for the formation of a supporting stump during enucleation, it is shown in the drawing, where 1 is the majority of the pear-shaped collagen implant immersed in the tenon capsule, 2 is the smaller part of the pear-shaped implant, separated by the neck and covered by the conjunctiva, 3 is a purse string suture on the conjunctiva, extended to contact of the conjunctiva with the implant 4-6 mm from the top of the implant, 4 - places of hemming of the rectus muscles / on the line of application of the purse string suture on the conjunctiva /.

 The method is as follows.

 Under local anesthesia / 2% novocaine solution / the conjunctiva and tenon capsule are cut off near the limbus, they are separated from the limbus and enucleated with neurectomy. Then, a pear-shaped individually made collagen implant is immersed in a tenon capsule, which is pretreated for 36-48 hours with a 1% solution of β - / 5-nitrofuryl-2 - / - acrolein. The rectus muscles are sutured to the conjunctiva, departing 4-6 mm from its edge. A purse string suture is placed on the conjunctiva at the site of the stitching of the rectus muscles and is tightened until it comes into contact with the implant 4-6 mm from the top of the implant.

 The essence of the method is illustrated by example.

 Example 1

 Patient K., 37 years old, and / b N3419, was admitted to the city eye hospital N 7 of Leningrad on 12.11.87 g for a sluggish traumatic iridocyclitis of the left eye. The patient received a penetrating complex corneal-scleral wound of the left eye in 1987 IY. Visual acuity of the right eye - 1.0 eyes are healthy. Visual acuity of the left eye is 0, there are clinical signs of traumatic iridocyclitis, hypotension. Given the combination of anamnestic and clinical data, the patient underwent enucleation of the damaged left eyeball with the formation of a supporting stump by the proposed method. 11.16.87, the operation was performed.

 After local anesthesia with a 2% solution of novocaine in a volume of 3.0 ml, the conjunctiva and tenon capsule were cut off near the limbus and separated from the eyeball. The rectus muscles were flashed with catgut threads and cut off. The optic nerve was cut 2.0 mm from the sclera. A thorough hemostasis was performed. The ends of the catgut sutures were passed through the conjunctiva to its anterior surface at 5.0 mm from its edge in sectors corresponding to the location of each rectus muscle and fixed by the application of nodal sutures. A purse string suture was placed on the conjunctiva at the site of the hemming of the muscles. A pear-shaped collagen implant and a purse string suture, which was prepared in advance and processed for 40 hours with a 1% solution of β - / 5-nitrofuryl-2 / -acrolein and the purse string suture, were immersed into the tenon capsule until it came into contact with the implant 5.0 mm from its top. A purse string suture was placed on the tenon capsule and pulled into a knot. A continuous supramid suture was placed on the conjunctival incision. On the 5th day after the operation, staged prosthetics began.

The proposed method has currently operated on 12 patients aged 15 to 60 years. With follow-up periods of up to 1.5 years, in no case was implant rejection observed. Mobility of the stump was determined by a tour of the prosthesis along the perimeter of Ferster in four meridians with a candle. The total range of movements was 80 - 115 ^o .

The proposed method of forming a supporting stump during enucleation in comparison with the known has the following advantages:
1. Eliminates the possibility of developing toxic, inflammatory, allergic reactions in orbital tissues through the use of a biopolymer - collagen - for the manufacture of an implant devoid of toxic, antigenic properties, while these reactions of orbit tissues are characteristic for the use of synthetic polymeric materials, as well as foaming polymer composition.

 2. The method provides a solid and reliable fixation of the implant in the tenon capsule due to the incorporation into the spongy and porous collagen structure of elements of surrounding tissues, which does not distinguish methods involving the use of synthetic and biological implants.

 3. The method eliminates the complications associated with limiting the mobility of the implant, and provides high mobility of the formed supporting stump, and hence the ocular prosthesis, which is the main disadvantage of the previously used methods.

 4. The method ensures the stability of the obtained cosmetic effect and eliminates complications in the form of a prosthesis retraction, which is often noted when using previously proposed methods.

 5. The method does not require the use of expensive and complex technical devices for the manufacture and fixation of the implant.

 6. The method eliminates the difficulties associated with the fence, preservation, storage of cadaverous tissue for the manufacture of the implant, and the development of purulent infection.

 The method was developed at the Department of Ophthalmology of the St. Petersburg Medical Academy of Postgraduate Education and passed clinical trials in the city eye hospital No. 7.

Sources of information
1. Shif L.V. Improving the cosmetic results of prosthetics after enucleation / imitation of some polymers /, // Avtoref.diss ... cand.med.nauk. M., 1968.

 2. Shkromid M.I., Mosyak M.A. The creation of a supporting stump after enucleation of the eyeball, // Vestn.Oftalm., N 1, 1978, p. 57.

 3. Rubinchik L. Z. The results of implantation of silicone balls into orbit, // Vestn.ophthalmos., 1973, N 4, p.40.

 4. Druyanov Yu.S. Improving the method of stump formation and prosthetics of the conjunctival cavity after enucleation, // Avtoref.diss..kand. Medical Science, 1977.

 5. Shif L.V., Kovalevsky E.I., Druyanov Yu.S., Moiseeva A.N., Massin B.M. An implant for the formation of a stump after enucleation, // Vestn.Oftalm., 1976, N 1, p. 61.

 6. Rubinchik L.Z. The use of certain polymers as implants to create a cosmetic prosthesis after enucleation and evisceration, Vestn. Ophthalmos, 1970, N 5, p. 49.

 7. Tukhvotullina Sh. G. Formation by a teflon insert of a volume-motor stump after enucleation, // Materials of the All-Russian Congress of Ophthalm., M., 1968, p. 418 - 429.

 8. Rubinchik L.Z. Creating a volumetric stump after enucleation and evisceration and restoring the cavity of enucleation and evisceration and restoring the cavity of the conjunctival sac to wear the prosthesis, // Abstract. Diss ... Candidate of Medical Sciences, Kazan, 1971.

 9. Kataev M. G. The possibility of correction of anophthalmic syndrome, // Vestn.ofthalm., 1986, N 3, p. 48 - 51.

 10. Kasparov A. A., Gryaznova II, Vahedi Abdul Sami, Davydov AB, Khromov G. L. The method of formation of the supporting stump during enucleation / auth. N 1005786 dated 03/23/1983 /.

 11. Krylova L. D. Comparative evaluation of some methods for the formation of post-enucleation stump / experimental-clinical observation /, // Abstract. diss ... Candidate of Medical Science, 1969, LenGIDUV.

 12. Shif L.V., Druyanov Yu.S. Some issues of medical cosmetics for prosthetics, // In the book. "Prosthetics and prosthetics", 1972, no. XXIX.

 13. Kalachev I.I. Cosmetic results of prosthetics after simple enucleation of the eyeball and after enucleation with plastic surgery of the stump by various methods, // Avtoref.diss ... cand.med.nauk, 1970.

 14. Zaykova M.V., Pankin V.I. The use of hetero cartilage in ophthalmic surgery, // Vestn.Oftalm, 1965, N 2, p. 67.

 15. Gundorova R.A., Morozov V.I., Grechushkina G.A., Morozova O.L. The formation of the stump with various materials after enucleation, // Vestn.Oftalm., 1974, N 6, p.66.

 16. Mazuryak A.V. On the use of the embryonic bone for the formation of the musculoskeletal stump after enucleation, // Vestn.Oftalm., 1985, N 1, p.25.

 17. Cadaveric bone as an orbit implant. Bansal R.K. "Cadaver Bone as Orbital Implant" // British I.Ophthalm., 1976, 60, No. 6, p. 486 - 488 (English).

 18. Muldashev E.R. et al. (Aut. St. N 513692 dated 04/18/1973.).

Claims (1)

 A method of forming a supporting stump during enucleation by introducing an implant into a tenon capsule and suturing the rectus muscles to the conjunctiva 4-6 mm from its edge, characterized in that pear-shaped spongy collagen pretreated with 1% β- / solution is used as an implant 5-nitrofuryl-2 / -acrolein for 36-48 hours, and at the site of the hemming of the muscles, a purse string suture is applied to the conjunctiva and tightened until it comes into contact with the implant 4-6 mm from the top of the implant.