Nasolacrimal duct biopsy kit

Abstract

FIELD: medical equipment.SUBSTANCE: kit for collecting biomaterial from the nasolacrimal duct. The kit for collecting biomaterial from the nasolacrimal duct contains a hollow probe and is equipped with a 100 mm long rod with a diameter of 0.7 mm and a tip for collecting biomaterial. The probe is 70 mm long, has a wall thickness of 0.1 mm, a diameter of 1.0 mm, and a funnel-shaped expansion at the entrance with a diameter of 10 mm. The probe is equipped with a graduated scale with a step of 1 mm. A mandrel with a length of 100 mm and a diameter of 0.8 mm is movably installed in the probe. The set is made of polylactide using a 3D printer.EFFECT: prevention of trauma to the lacrimal ducts, contamination of material during collection, possibility of obtaining contents for microbiological examination of the lacrimal ducts, and use in routine ophthalmological practice.1 cl, 1 dwg, 2 ex

Description

[0001] The invention relates to medicine, namely to ophthalmology and dacryotherapy, and can be used to obtain the contents of the lacrimal ducts for microbiological examination.

[0002] Among the pathological processes occurring within the lacrimal ducts, inflammatory processes represent a significant proportion. When treating these conditions conservatively or surgically, information about the nature of the inflammation within the lacrimal ducts, the presence and nature of microbial contamination, the presence of fungal infections, and other factors is important. To obtain this information, microbiological examination of the lacrimal duct contents is used. This involves obtaining microbiological samples of the lacrimal duct contents, which are then subjected to microscopic examination and other testing.

[0003] A method for the same purpose is known [patent RU 2348934, 10.03.2009], which consists of first removing mucus from the lower nasal passage using a sterile cotton swab, and then rinsing the lacrimal sac and nasolacrimal duct with a 15-colored solution through a cannula inserted through one of the lacrimal points, and after the solution appears in the lower nasal passage, the rinsing fluid is collected with a sterile swab applied to the mouth of the nasolacrimal duct.The disadvantages of this method include: 1) the need to sanitize the inferior nasal passage; 2) the risk of contamination of the removed swab with microbiological contents of the nasal cavity, which leads to inaccuracies in the result; 3) the need to introduce a 20 colored solution, which can also lead to artifacts during further examination of the collected material; 4) uneven distribution of material obtained from different parts of the lacrimal ducts on the swab; 5) the impossibility of separating the contents by localization; 6) the impossibility of obtaining the contents of the lacrimal canals, since only the lacrimal sac and nasolacrimal duct are washed; 7) the impossibility of regular sampling for research.

[0004] A known method for obtaining the contents of the lacrimal ducts involves performing dacryocystorhinostomy [Linberg JV, McCormick SA Primary acquired nasolacrimal duct obstruction. A clinicopathologic report and biopsy technique. Ophthalmology 30 1986;93:1055-63]. The method involves bluntly separating the nasolacrimal duct from the bone along its entire length during surgery, after which it is crossed and collected. This method allows for obtaining the entire contents of the lacrimal sac and nasolacrimal duct, but it is not without its drawbacks. In particular, the method is highly traumatic and is associated with the need for significant surgical intervention, and also does not allow for obtaining the contents of the lacrimal canals.

[0005] There is a known method in which dacryocystorhinostomy is performed without separating the nasolacrimal duct [Gupta N, Bansal S, Gandhi A. Endoscopic view of mascara laden lacrimal sac with canalicular involvement. Indian J Ophthalmol. 2019; 67(2):279]. This method is also highly traumatic and does not allow obtaining the contents of either the lacrimal canaliculi or the distal parts of the nasolacrimal duct.

[0006] The closest analogue of the proposed invention is an instrument for collecting biomaterial from the lacrimal ducts [AH MJ, Baig F, Lakshman M, Naik MN. Biofilms and Physical Deposits on Nasolacrimal Silastic Stents Following Dacryocystorhinostomy: Is There a Difference Between Ocular and Nasal Segments Ophthalmic Plast Reconstr Surg. 2015; 31(6):452-5], which is a silicone tube that is passed through the formed dacryostomy bicanalicularly. The tube is then removed. First, the loop located between the lacrimal puncta is pulled 5 mm and cut, thus obtaining the portion of the tube that was inserted into the lacrimal canaliculi. Then, the remaining portion is removed under endoscopic control through the nasal cavity, cutting off the distal portion of the tube, thus obtaining the portion that was located in the lacrimal sac. After removal of the tube fragments, the cytological contents of the lacrimal ducts remain on its surface.

[0007] However, the use of the prototype has a number of disadvantages, including: 1) the need to perform dacryocystorhinostomy; 2) the laboriousness and trauma of removing the silicone tube from the lacrimal ducts; 3) possible microbiological contamination of the removed tube when it is brought out through the nasal cavity; 4) the need to pass the tube bicanalicularly explains the injury to the lacrimal canaliculus during its probing; 5) the need to perform bicanalicular intubation explains the high consumption of disposable silicone material; 6) the impossibility of obtaining the contents of the nasolacrimal duct with this method.

[0008] The objective of the proposed invention is to develop a simple instrument for obtaining microbiological contents of the lacrimal ducts.

[0009] The technical result of the proposed invention is the prevention of trauma to the lacrimal ducts, contamination of material during collection, the possibility of obtaining contents for microbiological examination of the lacrimal ducts, and use in routine ophthalmologist practice.

[0010] The invention is illustrated by a figure, which shows the proposed kit, general view.

[0011] This kit for collecting biomaterial from the nasolacrimal duct contains a hollow probe 1, 70 mm long, with a wall thickness of 0.1 mm and a diameter of 1.0 mm. It has a funnel-shaped expansion 2 at the entrance, 10 mm in diameter, and a graduated scale 3 with 1 mm increments. For structural rigidity, a mandrel 4, 100 mm long and 0.8 mm in diameter, is movably mounted within the probe. It also contains a rod 5, 100 mm long and 0.7 mm in diameter, with a tip 6 for collecting biomaterial. This kit is made of polylactide (PLA) using a 3D printer. PLA-Poly[3,6-dimethyl-1,4-dioxane-2,5-dione], ((C3H4O2)n) is a linear, hydrophobic polymer belonging to the group of aliphatic polyesters, biocompatible, biodegradable.

[0012] The use of the invention ensures the prevention of trauma to the lacrimal ducts, a reduction in the risk of secondary infection during and after the procedure, contamination of the collected material with conjunctival flora, and the possibility of obtaining contents for microbiological examination at various levels of the lacrimal ducts.

[0013] The proposed kit is used as follows. After local anesthesia with 0.4% inocaine and dilation of the inferior lacrimal punctum with a sterile conical probe, probe 1 with stylet 4 is inserted into the lacrimal canaliculus to the desired level for biospecimen collection. The probe insertion depth is determined using the graduated scale 3. The stylet is removed. Rod 5 with tip 6 for biospecimen collection is passed along the probe to the desired level for biospecimen collection. Biospecimen collection is performed. The rod is removed from the probe, and the tip is broken off into a test tube containing nutrient medium. The probe is removed, and an antibacterial agent is instilled. The kit is sterile and single-use.

[0014] Thus, the proposed kit allows for the collection of lacrimal duct contents for further examination without labor-intensive and traumatic surgery. It allows for preoperative collection of material for necessary studies. It also eliminates the need to probe both lacrimal canaliculi, reducing the risk of potential complications and reducing trauma. The sample can be collected along the entire length of the lacrimal ducts at any point of interest.

[0015] The essence of the invention is explained by the following examples.

[0016] Case Study #1. Patient S / , 43, complains of lacrimation and purulent discharge from the left eye. The complaints have lasted for 2 months. The anamnesis includes a history of left lacrimal sac phlegmon, incised and drained 3 months ago. A lavage test is negative. The lacrimal sac area is unchanged. Purulent discharge from the inferior lacrimal punctum is observed during lacrimal sac massage. Elective surgical treatment is prescribed. To determine adequate preoperative and subsequent postoperative antibacterial therapy, a culture of the lacrimal duct contents for flora and antibiotic sensitivity is prescribed. To collect the biomaterial, a sterile disposable kit was used: the proposed kit for collecting biomaterial from the lacrimal ducts, which consists of a hollow probe 1 with a length of 70 mm, a wall thickness of 0.1 mm, a diameter of 1.0 mm, with a funnel-shaped expansion 2 at the entrance with a diameter of 10 mm, on which a graduated scale 3 is applied with a step of 1 mm.To ensure rigidity, a 100 mm long, 0.8 mm diameter mandrel (4) was movably inserted into the probe. To collect the biospecimen, a 100 mm long, 0.7 mm diameter rod (5) with a sampling tip was inserted to a depth of 11 mm, after which the biospecimen was collected from the lacrimal sac. The rod was removed from the probe, and the tip was broken off and placed in a test tube containing the nutrient medium. The probe was removed, and an antibacterial solution was instilled.

[0017] Case Study #2. Female patient M., 67, complains of lacrimation and intermittent purulent discharge from her right eye, which intensifies outdoors. The complaints have persisted for 2 years. A lavage test revealed partial patency. The lacrimal sac area is unchanged. To determine appropriate conservative therapy, lacrimal duct contents were cultured for flora and antibiotic sensitivity testing. A sterile, disposable kit was used to collect biomaterial: the proposed kit for collecting biomaterial from the lacrimal ducts, which consists of a hollow probe 1, 70 mm long, 0.1 mm thick, 1.0 mm in diameter, with a funnel-shaped expansion 2 at the entrance, 10 mm in diameter, on which a graduated scale 3 is applied with a 1 mm increment. To ensure the rigidity of the structure, a mandrel 4 with a length of 100 mm and a diameter of 0.8 mm was movably installed in the probe.A 5-gauge rod, 100 mm long and 0.7 mm in diameter, with a sampling tip was used to collect the biospecimen. The rod was inserted to a depth of 12 mm, after which the biospecimen was collected from the lacrimal sac. The rod was removed from the probe, and the tip was broken off and placed in a test tube containing the nutrient medium. The probe was removed, and an antibacterial solution was instilled.

Claims

A kit for collecting biomaterial from the nasolacrimal canal, comprising a hollow probe, characterized in that it is made of polylactide on a 3D printer and is equipped with a rod 100 mm long, 0.7 mm in diameter with a tip for collecting biomaterial, wherein the probe is 70 mm long, has a wall thickness of 0.1 mm, a diameter of 1.0 mm, with a funnel-shaped expansion at the entrance with a diameter of 10 mm, a graduated scale with a step of 1 mm is applied to the probe, a mandrel 100 mm long, 0.8 mm in diameter is movably installed in the probe.

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