Device for protecting nasal mucosa during transcanalicular laser endoscopic dacryocystorhinostomy

Abstract

FIELD: medical equipment.SUBSTANCE: device for protecting the mucous membrane of the nasal cavity during transcanalicular laser endoscopic dacryocystorhinostomy. The device for protecting the mucous membrane of the nasal cavity during transcanalicular laser endoscopic dacryocystorhinostomy is made of polylactide using 3D printing and contains a housing with a smooth surface, an elongated shape, tapered at both edges. The outer side of the device is made flat to fit the mucous membrane of the nasal cavity. The side facing the nasal cavity has a groove at the lower base of the body, made for passing a guiding thread through it and pulling the stent out of the dacryostomy.EFFECT: protection of the nasal mucosa from mechanical and thermal damage, reduction in trauma during surgical interventions, ease of use in work, expansion of the range of technical means for the specified purpose, and possibility of sterilizing and using the device repeatedly.2 cl, 3 dwg

Description

[0001] The invention relates to the field of medicine, namely to ophthalmology, and can be used for the surgical treatment of chronic dacryocystitis.

[0002] Today, the "gold standard" for the treatment of chronic dacryocystitis is transcanalicular dacryocystorhinostomy using laser and endoscopic methods, which create a new pathway for the outflow of lacrimal fluid from the lacrimal sac into the nasal cavity [Tsirbas A., Davis G., Wormald PJ Revision Dacryocystorhinostomy: A Comparison of Endoscopic and External Techniques / / Am J Rhinol. 2005. - Vol. 19 (3). - P. 322-325.]. However, with the transcanalicular method of performing dacryocystorhinostomy, there is a high probability of damage to the nasal mucosa, including the nasal septum, by laser radiation. As a result, in the postoperative period, excessive scarring is possible in the area of ​​the formed dacryostomy with the formation of a connective tissue scar, which contributes to the recurrence of dacryocystitis, which will subsequently require repeated surgical treatment.

[0003] A method is known for protecting the mucous membrane of the nasal cavity during transcanalicular laser dacryocystorhinostomy by filling the nasal cavity with hydrogel and using a cannula tip with a laser light guide placed in it [patent for invention of the Russian Federation No. 2289353, published in Bulletin No. 35 of 20.12.2006].

[0004] This method has its drawbacks. The cannula tip can injure the lacrimal canal during insertion, and the hydrogel can leak into the patient's nasopharynx and airways. Furthermore, the wide range of laser parameters and dacryostomy formation times does not eliminate the risk of nasal mucosal burns.

[0005] The prototype of the invention is a method of transcanalicular laser endoscopic dacryocystorhinostomy (TLED) [Patent for Invention of the Russian Federation No. 2408334, published in Bulletin No. 1 of January 10, 2011]. The method consists of the following: after the working end of a light laser is brought to the site of action, a plate of preserved costal cartilage is placed in the nasal cavity of the affected side. The plate prevents the passage of laser radiation to the protected structures, thereby protecting the mucosa from thermal damage. The plate is cut out immediately before use and individually modeled for each patient. The dimensions of the cut plate are determined by the topography of the surgical area and are: thickness from 2 to 5 mm, length from 0.8 to 15 mm, width from 4 to 6 mm, oval shape.To form a junction between the lacrimal sac and the nasal cavity, pulsed laser radiation with a wavelength of 2.08 μm, pulse energy of 800-1200 mJ, pulse repetition frequency of 6-10 Hz, pulse duration of 250 μsec, and power of 4-12 W is used.

[0006] A disadvantage of the prototype is the limited application of the plate and its small size. The protective plate is single-use, requiring a new, individual plate to be cut for each patient. The small size of the plate poses a risk of ingestion and entry into the patient's respiratory tract and nasopharynx if not securely secured during surgery. Furthermore, when "trying on" or subluxating the plate, there is a risk of accidental mechanical damage to the mucosa, which can cause bleeding and subsequently complicate the surgery.

[0007] The objective of the invention is to develop a device for protecting the mucous membrane of the nasal cavity during transcanalicular laser endoscopic dacryocystorhinostomy in the surgical treatment of chronic dacryocystitis.

[0008] The technical result of the invention is: protection of the mucous membrane of the nasal cavity from mechanical and thermal damage; reduction of trauma during surgical intervention; ease of use in work; expansion of the range of technical means for the specified purpose; the ability to sterilize and use the device repeatedly.

[0009] To achieve the specified technical result, a device for protecting the mucous membrane of the nasal cavity was developed that meets the following requirements: smooth, streamlined, durable, lightweight, biocompatible.

[0010] The proposed protection device is explained by the image of its three-dimensional model in Fig. 1-3.

[0011] Fig. 1 shows the body 1 of the device from the side adjacent to the surface of the mucous membrane of the nasal cavity.

[0012] Fig. 2 shows a general view of the device from the side of the groove 2, facing the nasal cavity.

[0013] Fig. 3 shows a three-dimensional model of the device, side view.

[0014] The nasal mucosal protection device is made of polylactide (PLA) by 3D printing.

[0015] The device body (Fig. 1) has a smooth surface, a narrow, elongated shape, tapered at both edges. The outer side of the device 1 (Fig. 1), adjacent to the mucous membrane of the nasal cavity, is flat. The side of the device facing the nasal cavity (Fig. 2) has a groove 2 at the lower base of the body, through which the guiding thread is passed and the stent is pulled out of the dacryostomy.

[0016] Dimensions of device body 1 (Fig. 1): length of lower base - 100 mm, length of upper base - 50 mm, thickness - 2 mm, height - 7 mm and total width - 5 mm. Dimensions of groove 2 (Fig. 2): length - 100 mm, width - 2 mm and outer wall height - 3 mm.

[0017] When performing TLED, the nasal mucosa is protected using the proposed device as follows: a sterile lubricant (tetracycline ointment, viscoelastic, etc.) is applied to the outer surface of the sterile protective device in contact with the nasal mucosa to facilitate insertion. The device, lubricated with lubricant, is inserted, positioned, and held in the nasal cavity opposite the dacryostomy being formed. The correct position of the device is determined and adjusted under endoscopic control. The working tip of the diode laser is inserted through the pre-dilated inferior lacrimal punctum and lacrimal canaliculus to the medial wall of the lacrimal sac, resting against the lacrimal bone. Laser coagulation is then performed on the medial wall of the lacrimal sac, lacrimal bone, and nasal mucosa in the area of ​​the middle turbinate until the working tip of the laser appears in the nasal cavity. After which the dacryostomy is expanded to the required size.A Lakhta-Milon diode laser is used to create a dacryostomy. The laser has a wavelength of 920 nm and a power of 8 W. The lacrimal sac and dacryostomy are then rinsed. A guidewire is inserted into the nasal cavity through the formed dacryostomy, resting its tip against the protective device. A guiding thread is passed through the guidewire, which exits the nasal cavity through a groove in the device. Using the guiding thread, a silicone stent is pulled through the groove and then secured. After the TLED procedure, the protective device is removed from the nasal cavity, disinfected, and sent for sterilization. All stages of the surgical procedure are performed under endoscopic guidance from the nasal cavity.

[0018] The advantage of the claimed invention is the use of a universal device for protecting the nasal mucosa, which prevents thermal and mechanical damage during TLED. The use of this protective device prevents the risk of excessive scarring and helps reduce the occurrence of adhesions in the area of ​​the formed dacryostomy and the recurrence of dacryocystitis.

[0019] The device body has a streamlined, elongated shape, with both edges symmetrically tapered. The outer side of the device, adjacent to the nasal mucosa, has a flat, smooth surface. The side of the device facing the nasal cavity has a groove at the lower base through which a guiding thread is passed and the stent is pulled out of the formed dacryostomy. The unique shape and universal dimensions of the device are designed with anatomical considerations in mind, allowing it to be used in both the right and left nasal cavities. The device is easy to use and allows the assistant to hold it securely in the nasal cavity during surgery, minimizing the risk of swallowing.

[0020] Using a lubricant improves glide and helps reduce trauma when inserting the device into the nasal cavity.

[0021] The protective device is made of polylactide using additive manufacturing via 3D printing. Polylactide is poly[3,6-dimethyl-1,4-dioxane-2,5-dione], chemical formula: (C3H4O2)n. PLA is a non-toxic and relatively inexpensive biopolymer obtained from natural raw materials. The advantages of PLA biopolymer over other materials are: biocompatibility, environmental friendliness, and biodegradability. Polylactide is widely available, easily 3D printed, and produces a streamlined device with clear details and a smooth surface. Polylactide is resistant to laser radiation, repeated disinfection and sterilization treatments, allowing the device to be reused. This makes the device easier to use and allows for its repeated use.

[0022] The essence of the invention is explained by the following clinical examples.

[0023] Example No. 1. Patient B., 58 years old, was admitted with a diagnosis of right-sided chronic dacryocystitis for surgical treatment.

[0024] After preparing the surgical site, the patient was anesthetized with 0.4% inocaine drop anesthesia and infiltration anesthesia of the skin in the lacrimal sac area with 1 ml of 2% lidocaine solution. A turunda soaked in 2% lidocaine solution and 1:10,000 adrenaline solution was inserted into the right nasal cavity. The inferior lacrimal canaliculus was then probed and dilated using a set of conical Sichel probes of increasing diameter. The turunda with lidocaine and adrenaline was removed from the right nasal cavity. The working end of a diode laser was inserted through the inferior lacrimal punctum along the lacrimal canaliculus to the medial wall of the lacrimal sac, resting on the lacrimal bone at a 45-degree angle. Simultaneously, an endoscope was inserted into the right nasal cavity, and the glow of the working end of the laser was observed in the area of ​​the middle turbinate. A lubricant consisting of sterile tetracycline ointment was applied to the outer surface of the sterile device for protection.The protective device was then carefully inserted into the right nasal cavity and pressed against the septum. The device was held against the dacryostomy being formed so that it adhered to and protected the surface of the nasal septum. The correct position of the device was determined and adjusted under endoscopic guidance. A Lakhta-Milon diode laser with a wavelength of 920 nm and a power of 8 W was used to form the dacryostomy. Laser coagulation of the medial wall of the lacrimal sac, lacrimal bone, and nasal mucosa was performed in the area of ​​the middle turbinate until the working tip of the laser appeared in the nasal cavity. Using a cylindrical probe, the bony septa were destroyed and the bony "window" was rounded to a diameter of 3x3 mm. The lacrimal sac and the formed dacryostomy were rinsed with saline. A guidewire was then advanced through the dacryostomy into the nasal cavity until its tip rested against the device.A guide wire was brought out through the device's groove, and a silicone stent was pulled out. The tip of the stent protruding from the nasal cavity was adjusted to length and cut off. The distal end of the silicone stent was fixed in the inferior lacrimal punctum by the stent itself. The protective device was carefully removed from the nasal cavity, disinfected, and sent for sterilization. All manipulations were monitored endonasally with an endoscope via a monitor. At the end of the surgery, the nasal cavity was packed with gauze.

[0025] On the first postoperative day, the nasal cavity was inspected using an endoscope. A dacryostomy with a silicone stent was observed, with isolated petechial hemorrhages around it. The nasal septum surface showed no signs of burns, and there were no hemorrhages.

[0026] Postoperatively, the patient reported a positive result, and the irrigation test was positive. She was discharged for outpatient follow-up with a local ophthalmologist. At a follow-up examination six months later, she had no complaints or lacrimation, and the irrigation test was positive.

[0027] Example No. 2. Patient Sh., 37 years old, was admitted with a diagnosis of left-sided chronic dacryocystitis for surgical treatment.

[0028] After preparing the surgical site, the patient was anesthetized with 0.4% inocaine drop anesthesia and infiltration anesthesia of the skin in the lacrimal sac area with 1 ml of 2% lidocaine solution. A turunda soaked in 2% lidocaine solution and 1:10,000 adrenaline solution was inserted into the left nasal cavity. The inferior lacrimal canaliculus was probed and dilated using a set of conical Sichel probes of increasing diameter. The turunda with lidocaine and adrenaline was removed from the left nasal cavity. The working end of a diode laser was inserted through the inferior lacrimal punctum along the lacrimal canaliculus to the medial wall of the lacrimal sac, resting on the lacrimal bone at a 45-degree angle. Simultaneously, an endoscope was inserted into the left nasal cavity, and the glow of the working end of the laser was observed in the area of ​​the middle turbinate. A sterile lubricant, tetracycline ointment, was applied to the outer surface of the sterile device for protection.The protective device was then carefully inserted into the left nasal cavity and pressed against the septum. The device was held against the dacryostomy being formed so that it adhered to and protected the surface of the nasal septum. The correct position of the device was determined and adjusted under endoscopic guidance. A Lakhta-Milon diode laser with a wavelength of 920 nm and a power of 8 W was used to form the dacryostomy. Laser coagulation of the medial wall of the lacrimal sac, lacrimal bone, and nasal mucosa was performed in the area of ​​the middle turbinate until the working tip of the laser appeared in the nasal cavity. Using a cylindrical probe, the bony septa were destroyed and the bony "window" was rounded to a diameter of 3x3 mm. The lacrimal sac and the formed dacryostomy were rinsed with saline. A guidewire was then advanced through the dacryostomy into the nasal cavity until its tip rested against the device.A guide wire was brought out through the device's groove, and a silicone stent was pulled out. The tip of the stent protruding from the nasal cavity was adjusted to length and cut off. The distal end of the silicone stent was fixed in the inferior lacrimal punctum by the stent itself. The protective device was carefully removed from the nasal cavity, disinfected, and sent for sterilization. All manipulations were monitored endonasally with an endoscope via a monitor. At the end of the surgery, the nasal cavity was packed with gauze.

[0029] On the first postoperative day, the nasal cavity was inspected using an endoscope. A dacryostomy with a silicone stent was observed, with isolated petechial hemorrhages around it. The nasal septum surface showed no signs of burns, and there were no hemorrhages.

[0030] Postoperatively, the patient reported a positive result, and the irrigation test was positive. She was discharged for outpatient follow-up with a local ophthalmologist. At a follow-up examination six months later, she had no complaints or lacrimation, and the irrigation test was positive.

[0031] The use of the proposed protective device reliably protects the nasal mucosa from damage during TLED, and is convenient and safe for repeated use.

Claims

1. A device for protecting the mucous membrane of the nasal cavity during transcanalicular laser endoscopic dacryocystorhinostomy, made from polylactide using 3D printing, comprising a housing having a smooth surface, an elongated shape, tapered at both edges, wherein the outer side of the device is made flat for adhering to the mucous membrane of the nasal cavity, and the side facing the nasal cavity has a groove in the lower base of the housing made for passing a guide thread through it and pulling a stent out of the dacryostomy.

2. A device for protecting the mucous membrane of the nasal cavity according to paragraph 1, characterized in that the body of the device has a lower base length of 100 mm, an upper base length of 50 mm, a thickness of 2 mm, a height of 7 mm and a total width of 5 mm, the groove has a length of 100 mm and a width of 2 mm, the height of the outer wall is 3 mm.

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