Device for prevention of stenosis of external auditory canal

Abstract

FIELD: medical equipment.SUBSTANCE: device for preventing stenosis of the external auditory canal includes a prefabricated metal funnel with two screws and a power source. The funnel consists of two identical halves. Each half includes a conical and working nose section, as well as a uniformly applied outer silicone coating 2–3 mm thick. Each half is equipped with two threaded ears for fastening screws, located longitudinally near the edge of the conical part of the half, as well as the first piezoelectric elements. The first piezoelectric element is located under a silicone coating near the outer edge of the working nose section and is configured to be connected to the second piezoelectric element using a spirally wound wire with a silicone coating applied to it. The wire from the first piezoelectric element is located under the outer silicone coating and is designed to be connected through an opening to a load cell. The sensor is fixed to the inner surface of the conical part of one of the funnel halves and is equipped with a power source. The ratio of the dimensions of the outer diameter of the working nose of the funnel, the diameter at the transition to the conical part, the maximum diameter of the conical part and the length of the funnel is 1.2:1:5:6.EFFECT: safe and effective expansion of the external auditory canal is achieved without the need for repeated surgical intervention.5 cl, 3 dwg

Description

[0001] The invention relates to medicine, namely to otolaryngology (otosurgery), and is intended for the prevention of stenosis of the external auditory canal in patients with fibrous dysplasia of the temporal bone, congenital atresia / stricture of the external auditory canal (EAC), and post-traumatic stenosis of the EAC.

[0002] Acquired stenosis of the external auditory canal can be caused by various injuries, all of which share a common pathogenesis: a cascade of inflammatory changes leading to fibrosis of the medial canal. Previous surgeries (canaloplasty or meatoplasty) and radiation therapy are considered possible causes, especially if they are associated with a history of parotid gland surgery extending into the external auditory canal.

[0003] Thus, the prior art discloses the insertion of sterile soft elastic tubes into the lumen of the external auditory canal (EAC) to restore its lumen in patients with injuries to the membranous-cartilaginous portion of the external auditory canal (Egorov V.I. et al., Diagnosis and Treatment of Combat Ear Injuries, Almanac of Clinical Medicine, 2016, Vol. 44, No. 7, pp. 841-849). A disadvantage of using such tubes is the lack of sufficient support to prevent EAC stenosis.

[0004] Several types of stents have been developed. One of them is a Foley catheter, which is inserted 5 weeks after surgery and modified by connecting the distal and proximal ends. The catheter size was determined based on the diameter of the patient's EAC. The distal end of the catheter was designed to enter the bony portion of the canal, and the proximal end into the cartilaginous portion. The patient independently removed the stent for cleaning and reinserted it 1 month after placement. The duration of catheter placement was 6 months or more (Chao-Yin Kuo et al., A Composite Foley Catheter Stent Used to Successfully Manage Recurrent Canal Stenosis Caused by Fibrous Dysplasia of the Temporal Bone, J Int Adv Otol 2014; 10 (2), p. 194-196). Disadvantages of using a Foley catheter also include the lack of sufficient framework to prevent stenosis of the cerebrovascular insufficiency and the lack of pressure control on the cerebrovascular insufficiency wall when inflating the catheter.

[0005] The development of an acrylic stent with a hollow tube for ventilation and drainage is reported. First, a plaster cast of the NSP was made using putty. The impression was obtained as a single piece, and a stone cast was made. Given the skin color, acrylic of the same shade was used. After creating a wax structure, the model was soaked and dewaxed. The putty material was molded around a 3 mm diameter stainless steel wire to create a hole in the stent. After dewaxing, the casting mold was packed with thermosetting acrylic, and the putty was inserted into the center of the canal. The putty and wire were removed, creating the stent opening. The acrylic stent was shaped according to the anatomy of the auricle. The patient removed the stent independently for cleaning (Adhershitha AR et al, Prosthetic management of posttraumatic external auditory canal atresia: A rare cause of conductive hearing loss, J Indian Prosthodont Soc, 2016; 16 (4), p. 390-394).The disadvantages of using such a technical solution also include the lack of sufficient framework to prevent stenosis of the cerebrospinal fluid, as well as the likelihood of soft tissue injury and the development of pressure ulcers.

[0006] Also known in the art is a method for preventing stenosis of the external auditory canal after surgery, radiation therapy, and other causes (Tirelli G et al, Stretching stenoses of the external auditory canal: a report of four cases and a brief review of the literature, Acta Otorhinolaryngol Ital., 2015 Feb, 35(1), p. 34-38). This technique involves the use of a series of surgical steel tubes of increasing diameter, usually used to expand tissue in piercings and known as ear stretching tunnels or ear stretchers. However, as the authors themselves note, further research is needed to increase the number of clinical cases in order to confirm how long such an ear stretcher should be left in place to prevent stenosis, and to establish whether surgery is always necessary after installing an ear stretcher, and if so, what is the optimal timing for the surgery.The authors also noted the following disadvantages: the tunnels are not approved medical devices; the steel tunnel may cause some discomfort at night due to its rigidity and pressure on the tragus; its small size may make it difficult to use in elderly patients; and the expected results are worse in the case of radiation therapy, as radiation therapy aggravates stenosis of the tragus.

[0007] Silicone-based products have become the most widely used in the prevention and treatment of hypertrophic scars due to their wide availability and ease of use. Their effect is explained as being based on the temperature under the dressing, oxygen tension, and hydration regulation (Berman B et al., A review of the biologic effects, clinical efficacy, and safety of silicone elastomer sheeting for hypertrophic and keloid scar treatment and management, Dermatol Surg 2007; 33, p. 1291-1303). Silicone is widely used for stenting of the endoscopic stenosis. As research shows, despite the development of otosurgery, recurrent atresia remains a common complication of these procedures. This process can significantly reduce the effectiveness of surgical treatment, primarily the patient’s hearing (Rex S. et al, Middle ear and mastoid surgery, New York: Thieme, 2004; p. 177-188; Astashchenko S.V., Method for eliminating neotympanic membrane lateralization in patients who have undergone tympanoplasty, Ross. Otolaryngology. 2012, No. 2, Vol. 57, pp. 19-23). ​​Therefore, postoperative care, including regular toilet of the neotympanic membrane, topical antibiotic therapy and procedures aimed at the rapid suppression of inflammatory and reparative reactions, are necessary conditions for maintaining a positive result of the operation (Rex S. et al., Middle ear and mastoid surgery, New York: Thieme, 2004; p. 177-188; Dhooge I et al., Acquired atresia of the external auditory canal: long-term clinical and audiometric results aftersurgery, Otol Neurotol, 2014, 35 (7), p. 1196-1200).It is important to understand that the use of silicone cannot reduce an already formed scar and only affects "immature" tissues in which the inflammatory process has not yet ended. Therefore, these methods can only be used as a preventative measure or to correct minor defects that arise in the early and late postoperative periods (Anikin I.A. et al., Cicatricial processes in the external auditory canal and methods of their correction, Consilium Medicum. 2018, Vol. 20, No. 3, pp. 61-66).

[0008] The exact mechanism of action of silicone elastomer sheets has not been established, but clinical trials show that this product is safe and effective for the treatment and prevention of hypertrophic and keloid scars when worn on the scar 12 to 24 hours a day for at least 2-3 months. Some silicone elastomer sheets currently on the market are durable and adhere well to the skin.

[0009] An example of stenosis prevention during the formation of postoperative NSP can be a method for temporary auricular prosthesis during the postoperative formation period (patent RU 2714119 C1, published February 11, 2020). A CT scan of the patient's head with an absent (anotia) or underdeveloped (microtia) auricle is performed. The external and internal auditory canals "from the healthy side" are isolated from the CT scan of the auricle. The missing auricle and the parameters of the external auditory canal are modeled by mirroring the image of the structures on the opposite side. A postoperative forming ear prosthesis is 3D printed from a medical polymer. The resulting polymer composition of the ear prosthesis with the formed ear canal is coated with a 1-2 mm thick layer of medical silicone using a layer-by-layer application.A transmastoid approach to the external auditory canal is created, with a diameter corresponding to the diameter of the ear canal of the fabricated prosthesis, with skin flaps placed against the bony edges of the trephination cavity. The temporary auricular prosthesis is secured into the surgical canal by inserting the portion of the prosthesis corresponding to the patient's ear canal into the formed surgical canal using silicone adhesive applied to the cuff, ensuring a good marginal fit of the temporary auricular prosthesis to the skin. The postoperative temporary auricular prosthesis is used for 6 months during the postoperative ear canal formation period, with daily fixation and hygienic treatment with antiseptic agents. This method certainly has its advantages, but for the simple prevention of stenosis, the creation of such a complex, customized technical solution is not advisable.

[0010] Therefore, there is a need for a device for the prevention of stenosis of the external auditory canal, free from all the above-mentioned disadvantages.

[0011] The technical result of the present invention is the creation of a device for the prevention of stenosis of the external auditory canal, which allows for safe and effective expansion of the external auditory canal without the need for repeated surgical intervention.

[0012] This technical result is achieved by the fact that in a device for preventing stenosis of the external auditory canal, which includes a prefabricated metal funnel equipped with two screws and a power source, and consisting of two identical halves;wherein each half includes a conical part and a working nose part, it is proposed to apply an external silicone coating of 2-3 mm thickness uniformly to each half, wherein each half is equipped with two ears with threads for fastening screws, located longitudinally near the edge of the conical part of the half, as well as a first piezoelectric element located under the silicone coating of one of the halves near the outer edge of the working nose part, and made with the possibility of connecting with a second piezoelectric element located under the silicone coating of the second half, using a spirally wound wire with a silicone coating applied to it, and located in a transverse groove (8) applied to the external silicone coating of both halves of the funnel between the first and second piezoelectric elements;the wire from the first piezoelectric element is located under the outer silicone coating and is designed with the possibility of connection through an opening to a dynamometric sensor fixed on the inner surface of the conical part of one of the halves of the funnel and equipped with a power element, while the ratio of the dimensions of the outer diameter of the working nose of the funnel, the diameter at the transition to the conical part, the maximum diameter of the conical part and the length of the funnel is 1.2:1:5:6.

[0013] The prefabricated metal funnel can be equipped with a holder for fixing to the auricle.

[0014] The power element may be configured to be connected via a wire to the power button of the device; may be a battery configured to be connected to a charging port located on the outer surface of the conical portion of the same half of the funnel on which the battery is located; may be a replaceable galvanic power element.

[0015] Fig. 1 shows the general appearance of the device.

[0016] Fig. 2 schematically shows the working nose part of the device with open halves.

[0017] Fig. 3 schematically shows a spirally wound wire coated with silicone and connecting both piezoelectric elements of the device.

[0018] The device for preventing stenosis of the external auditory canal (Fig. 1) is represented by a prefabricated metal funnel equipped with two screws (not shown in the figures) and a power source, and consists of two identical halves. Each half includes a conical part (1) and a working nose part (2), as well as a uniformly applied outer silicone coating (3) with a thickness of 2-3 mm, and is equipped with two ears (4) with threads for fastening screws, located longitudinally near the edge of the conical part (1) of the half, as well as a first piezoelectric element (5) located under the silicone coating (3) near the outer edge of the working nose part (2). The piezoelectric element (5) is configured to be connected to the second piezoelectric element (6) using a spirally wound wire (7). A silicone coating (7') is applied to the spiral wire (7) for its sliding / stretching when the halves of the funnel are separated (Fig. 3).The wire (7) is located in the transverse groove (8) applied (cut) on the outer silicone coating (3) between the first (5) and second (6) piezoelectric elements on the nose working parts of both halves of the funnel, and, thus, is recessed into the outer silicone coating (3) (Fig. 2). The wire (9) from the first piezoelectric element (5) is located under the outer silicone coating (3) and is designed with the possibility of connection through an opening (10) with a dynamometric sensor (11) fixed on the inner surface of the conical part (1) of one of the halves of the funnel and provided with a power supply element (12). The ratio of the dimensions of the outer diameter of the working nose part of the funnel, the diameter at the transition to the conical part, the maximum diameter of the conical part and the length of the funnel is 1.2:1:5:6. Thus, the working nose part (2) is made slightly widened at the end for better fixation in the external auditory canal. The ratio of the length of the working nose part and the length of the conical part is 1:5-1:4.

[0019] The prefabricated metal funnel can be equipped with a holder for fixing to the auricle.

[0020] The power element (12) can be configured to be connected through the hole (13) using a wire (14) to the power button (15) (Fig. 1).

[0021] The power element (12) can be represented as a miniature battery, designed with the possibility of connection to a port for a charger located on the outer surface of the conical part of the same half of the funnel on which the battery is located; or it can be represented as a replaceable galvanic power element.

[0022] The device operates as follows.

[0023] When performing prophylaxis of stenosis of the external auditory canal, the working nose part of the funnel with closed halves fixed with screws through loops (4) is inserted into the external auditory canal. Then, turn on the device and begin to slowly rotate the screws, monitoring the parameters of the pressure exerted on the external auditory canal through the dynamometric sensor (11). When the screws are rotated and the halves of the funnel are opened, a signal is sent to the sensor (11) through piezoelectric elements (5) and (6), connected to each other by a spirally coiled wire (7), located in the groove (8).When opening / closing the funnel halves, the wire (7) slides / stretches without hindrance due to the thin silicone coating (7') applied to the wire spirals (7), since the wire (7) is located in the transverse groove (8) applied (cut) on the outer silicone coating (3) between the first (5) and second (6) piezoelectric elements on the nasal working parts of both funnel halves, and, thus, is recessed into the outer silicone coating (3). The optimal pressure mode exerted by the halves of the device on the external auditory canal is selected, the device is switched off and fixed to the head for the required period, including using a holder for fixation to the auricle. At the end of the prophylactic session, the device is removed and, if necessary, the effect on the external auditory canal is repeated until the desired restenotic effect is achieved.Thus, firstly, controlled pressure on the tissues using the proposed device prevents the formation of stenosis of the ear canal after injuries and surgeries; secondly, controlled pressotherapy and the use of silicone in the design of the proposed device significantly reduce the risk of keloid scarring, which allows for safe and effective expansion of the external auditory canal without the need for repeated surgery.

[0024] A study of the obtained prototypes of the proposed device was conducted. The study included 28 patients, including 8 with fibrous dysplasia of the temporal bone, 2 with congenital atresia / stricture of the anterior ventricular stenosis, and 20 with post-traumatic and post-operative stenosis of the anterior ventricular stenosis. A significant restenotic effect was observed in the entire group of patients, and no further surgical interventions were required.

[0025] The proposed device for the prevention of stenosis of the external auditory canal can be used in otolaryngology to obtain adequate measures to prevent the formation of stenosis of the EAC.

[0026] Use of the proposed device for 3-6 months during the postoperative / post-traumatic formation of the external auditory canal, with daily fixation and hygienic treatment with antiseptic preparations recommended for the use of medical silicone, allows for safe and effective expansion of the external auditory canal without the need for repeated surgery.

Claims

1. A device for preventing stenosis of the external auditory canal, comprising a prefabricated metal funnel equipped with two screws and a power source, and consisting of two identical halves, each half including a conical part and a working nose part, as well as a uniformly applied outer silicone coating with a thickness of 2-3 mm, and equipped with two threaded ears for fastening screws, located longitudinally near the edge of the conical part of the half, as well as a first piezoelectric element located under the silicone coating near the outer edge of the working nose part and configured to be connected to the second piezoelectric element using a spirally wound wire with a silicone coating applied to it, located in a transverse groove applied to the outer silicone coating between the first and second piezoelectric elements;the wire from the first piezoelectric element is located under the outer silicone coating and is designed with the possibility of connection through an opening to a dynamometric sensor fixed on the inner surface of the conical part of one of the halves of the funnel and equipped with a power element, while the ratio of the dimensions of the outer diameter of the working nose of the funnel, the diameter at the transition to the conical part, the maximum diameter of the conical part and the length of the funnel is 1.2:1:5:

6.

2. The device according to paragraph 1, characterized in that the prefabricated metal funnel is equipped with a holder for fixing to the auricle.

3. The device according to paragraph 1, characterized in that the power element is designed with the possibility of connection to the power button.

4. The device according to paragraph 1, characterized in that the power element is a battery designed with the possibility of connection to a port for a charger located on the outer surface of the conical part of the same half of the funnel on which the battery is located.

5. The device according to paragraph 1, characterized in that the power element is a replaceable galvanic power element.

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