Cone-shaped expander for maxillofacial surgery

Abstract

This utility model relates to medicine, specifically medical equipment, specifically soft tissue stretching devices used in maxillofacial and plastic surgery. There is a need for an expander specifically adapted for maxillofacial surgery that would provide localized and targeted soft tissue stretching, precise control of the volume and geometry of the stretch, minimal impact on surrounding healthy tissue, and conformity with facial anatomical features, specifically small volumes with thin, elastic walls.The technical result is achieved in that the expander for maxillofacial surgery contains an elastic shell, made with the possibility of filling with liquid for stretching soft tissues, the shell is made cone-shaped, wherein the volume of the expander ensures the possibility of filling it with liquid in the amount of 1.5 ml to 50 ml, and the thickness of the walls of the expander shell is from 0.4 mm to 0.5 mm, while the expander is characterized in that the volume of the filled liquid is from 1.5 ml to 50 ml with a height of the cone-shaped shape from 17 mm to 60 mm and a diameter of the base of the cone-shaped shape from 11 mm to 40 mm, wherein the elastic shell is made of medical silicone.

Description

[0001] Field of technology to which the utility model belongs

[0002] The utility model relates to medicine, in particular to medical equipment, namely to devices for stretching soft tissues used in maxillofacial plastic surgery.

[0003] Technology Level

[0004] The prior art includes various designs of expanders intended for stretching soft tissues for the purpose of subsequently replacing defects in the skin, including in the field of maxillofacial surgery.

[0005] Patent RU 2465861 C1, published November 10, 2012, patent holder: Federal State Budgetary Institution "Russian Scientific Center of Surgery named after Academician B.V. Petrovsky" of the Russian Academy of Medical Sciences, describes the use of tissue expanders to increase the area of ​​soft tissue for subsequent transplantation into the defect area. The known device consists of an elastic balloon, either round, rectangular, cylindrical, or crescent-shaped, from which extends a nipple tube consisting of two sections and having a device at the end for non-invasive balloon inflation. However, effective use of these expanders is not possible because the balloon surface is convex on all sides, which determines the specific stretching behavior: namely, stretching occurs in all planes except those requiring it.

[0006] Patent EP 1234545B1 (published December 28, 2005, patent holder GfE Medizintechnik GmbH) describes an expander with an asymmetrical balloon shape and a reinforced back wall to prevent excessive pressure on bone structures. However, this device is difficult to manufacture, and the shape of its working surface limits its use in areas with pronounced relief, such as the mandible or zygomatic arch.

[0007] Analysis of international commercial samples manufactured by Mentor Worldwide LLC, Nagor Ltd., and Polytech Health & Aesthetics GmbH reveals that commercially available expanders are predominantly spherical, crescent-shaped, rectangular, or anatomical, designed for breast or limb reconstruction. Devices for maxillofacial surgery are absent from these product lines, or they lack a specialized shape that provides targeted tissue expansion in the vertical plane.

[0008] Scientific publications (Plastic and Reconstructive Surgery, 2018-2021; Journal of Cranio-Maxillofacial Surgery, 2019-2022) confirm that existing expander designs are not optimized for use in the face and jaw area due to the lack of products with small balloon thickness for reconstructing small forms covering the skin, such as the mucous membrane during reconstruction in the oral cavity.

[0009] Therefore, there is a need to create an expander specifically adapted for maxillofacial surgery that would provide localized and targeted stretching of soft tissues, the ability to precisely control the volume and geometry of stretching, minimal impact on surrounding healthy tissues and compliance with the anatomical features of the face, namely small volumes with thin elastic walls.

[0010] The technical result is achieved in that the expander for maxillofacial surgery contains an elastic shell made with the possibility of filling with liquid for stretching soft tissues, the shell is made cone-shaped, while the volume of the expander provides the possibility of filling it with liquid in the amount of 1.5 ml to 50 ml, and the thickness of the walls of the expander shell is from 0.4 mm to 0.5 mm, while the expander is characterized by the fact that the volume of the filled liquid is from 1.5 ml to 50 ml with a height of the cone-shaped form from 17 mm to 60 mm and a diameter of the base of the cone-shaped form from 11 mm to 40 mm, and the elastic shell is made of medical silicone.

[0011] The expander may contain a nipple tube for injection filling with liquid.

[0012] The utility model is illustrated by a drawing, namely a particular case of implementation in Fig. 1.

[0013] Implementation of a utility model

[0014] The expander is made of medical-grade silicone approved for implantation. The expander's cone-shaped form is dipped 6 to 12 times in a mixture of silicone and heptane, followed by vulcanization in an oven to polymerize the shell located on the cone. After polymerization, the shell is stretched and removed from the cone, and the opening is sealed with a tube.

[0015] The thickness of the shell walls is 0.4-0.5 mm, which provides an optimal balance of elasticity and strength.

[0016] The nipple tube connects the shell to the injection port. A valve mechanism prevents backflow of liquid.

[0017] The expander is implanted through a 0.5 cm to 2 cm incision under the skin in the area of ​​the desired skin augmentation. After implantation, the expander is gradually filled with a sterile saline solution, such as furacilin. Filling is performed once every 3-5 days at a rate of 1-3 ml. The total filling volume is adjusted to a nominal 1.5-50 ml depending on the clinical need.

[0018] Due to the conical shape, tissue stretching occurs predominantly in the direction from the top of the shell to the base, which allows the formation of a flap of the required configuration and area.

[0019] After achieving the required stretch after 4-8 weeks, the expander is removed and the resulting excess tissue is used to close the defect.

Claims

1. An expander for maxillofacial surgery, comprising an elastic shell, capable of being filled with liquid for stretching soft tissues, characterized in that the shell is made cone-shaped, while the nominal volume of the expander allows it to be filled with liquid in the amount of 1.5 ml to 50 ml, and the thickness of the walls of the expander shell is from 0.4 mm to 0.5 mm.

2. An expander according to paragraph 1, characterized in that the volume of liquid being filled is from 1.5 ml to 50 ml with a height of the cone-shaped shell from 17 mm to 60 mm, with a diameter of the base of the cone-shaped shell from 11 mm to 40 mm.

3. The expander according to item 1, characterized in that the elastic shell is made of medical silicone.

4. An expander according to claim 1, characterized in that it additionally contains a nipple tube for injection filling with liquid.

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