RU2359640C1 - Prosthesis of fronto-nasal fistula - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: prosthesis of fronto-nasal fistula is made in form of tube with oval section supplied with rectangular modellable wing for fixation under soft tissues of nasal clivus and is produced from poly-[bis(trifluoretoxy)phosphazene].

EFFECT: ensuring biocompatibility, aeration, natural epithelisation and drainage of frontal sinus and does not require prosthesis removal in nearest and distant post-operation period.

1 dwg

Description

The invention relates to medicine, in particular to otorhinolaryngology, and for the surgical treatment of acute complicated and chronic frontal sinusitis.

The number of ENT patients requiring reconstructive surgical treatment of patients with frontitis remains significant for many years and has a tendency to increase. This is due to both the deterioration of the environmental situation, especially in large cities, and the large number and constant increase in the number of chronic patients due to many, especially social, reasons.

Currently, two methods of treating chronic frontal sinusitis are used: the imposition of the fronto-nasal anastomosis and obliteration of the frontal sinuses after their surgical opening. The numerous methods used for obliteration of the frontal sinuses cannot be considered progressive, since they contradict the organ-preserving tendency of modern ENT surgery.

One of the ways to solve this problem is to develop new materials for prosthetics of the nasolabial anastomosis.

A device for prosthetic frontal-nasal anastomosis, consisting of a polymer tube made of Teflon. This device is used for the temporary (up to 3 months) formation of fronto-nasal anastomosis during frontotomy (Pogosov BC, Phrikyan S.Zh., Akopyan R.G. Use of a Teflon tube for the formation of fronto-nasal anastomosis during frontotomy. Abstract 11, International Conference . "Modern approaches to the development of effective dressings", M., 1995, S. 242-243).

A device is known as an allograft for an endoprosthesis-dilator made of titanium nickelide in combination with a lyophilized artery for temporary prosthetics of the fronto-nasal anastomosis (Shager Jarar. Surgical formation of the fronto-nasal anastomosis by using a combined allograft. Otolaryngology Bulletin, 1990, No. 2, p. 45-46). The drainage dilator was removed on day 30.

The disadvantages of the known endoprostheses of the fronto-nasal anastomosis are the difficulty of manufacturing, the absence of a stable and persistent effect that allows long-term use, and the absence of affinity for prostheses in a living organism, in particular, in soft tissues of the nose.

As a prototype, the device of the frontal-nasal anastomosis prosthesis was selected, which is an oval-shaped tube with a uniform narrowing to one end. The tube is made of hydroxyapatite. The prosthesis is implanted in the formed stock of the anastomosis immediately after radical surgery on the frontal sinus (Palchun V.T., Lapchenko A.S., Lantsov I.I. Prosthesis of the fronto-nasal anastomosis. RF patent №2082354).

Immediately after a radical operation on the frontal sinus, the prosthesis described above is implanted without additional fixation without additional fixation, and the prosthesis described above is 2.5 mm long with maximum dimensions: 6 mm wide, 9 mm high, and minimum dimensions: 6 mm wide, 7 mm high. The wall thickness of the prosthesis, constant throughout, is 1.5 mm. A thin polyethylene drainage is introduced into the lumen of the prosthesis to rinse the frontal sinus for 10 days.

The disadvantage of this solution is the lack of reliable fixation of the prosthesis. In addition, other disadvantages are the increased rigidity and brittleness of the material - hydroxyapatite - and the associated complexity of manufacturing prostheses from it. A significant drawback is the roughness and hydrophilicity of the surface of the prosthesis, which leads to drying in the form of a hard-to-remove peel of the secretion that appears on the graft, and is often accompanied by a putrid odor.

The objective of the present invention is to provide a new device for the prosthesis of the fronto-nasal anastomosis, which is more reliable, high deformation-strength characteristics, does not adsorb postoperative transudate and other secretion components and is easy to manufacture.

The essence of the invention lies in the fact that the prosthesis is made of a synthetic polymer poly- [bis- (trifluoroethoxy) phosphazene] and is an oval tube with a rectangular modeling wing for fixation under the soft tissue of the nose.

The drawing shows a prosthesis of the fronto-nasal anastomosis, where A is the width of the prosthesis tube, B is the height of the prosthesis tube, C is the thickness of the tube and fixing wing (constant throughout), D is the length of the prosthesis (modeled depending on the size of the nose), E - the width of the fixing wing (can be modeled depending on the size of the outer nose). The clearance of the prosthesis is determined by the size and thickness of its walls.

Immediately at the time of the radical debridement operation on the frontal sinus, the prosthesis described above is implanted with the dimensions A 7 mm, B 10 mm, C 0.5 mm, D 50 mm (randomly), E 20 mm (randomly) and fixed using the wing under the soft tissues of the nose slope. A thin polyvinyl chloride vinyl drainage (catheter for puncture of the subclavian vein) is inserted into the lumen of the prosthesis to rinse the frontal sinus in the early postoperative period, which is removed for 5-7 days.

This prosthesis has the following advantages over the prototype. The tube, fixed under the soft tissues of the nose, forms a stable fistula due to its properties, providing aeration, natural epithelization and drainage of the frontal sinus, and does not require removal in the near and remote postoperative period.

The material poly- [bis- (trifluoroethoxy) phosphazene] lacks cytotoxicity and antigenic properties. It has good biocompatibility, permanent antiseptic properties and anti-inflammatory effect due to the peculiarities of its chemical structure. The prosthesis made of poly- [bis- (trifluoroethoxy) phosphazene] has a hydrophobic and smooth surface, does not adsorb secret components, has high deformation-strength characteristics and is significantly simpler to manufacture compared to the prostheses described above.

Claims (1)

The frontal-nasal anastomosis prosthesis made in the form of a tube with an oval cross-section, characterized in that the tube is equipped with a rectangular simulated wing for fixation under the soft tissues of the nose and is made of poly- [bis- (trifluoroethoxy) phosphazene].