RU2405587C1 - Bioactive-coated drainage system for treating abdominal diseases - Google Patents

Abstract

FIELD: medicine. ^ SUBSTANCE: invention refers to medicine, and can be used in oncology (oncogynaecology, oncoproctology), abdominal surgeries, urology, otolaryngology, proctology (hemorrhoids, proctitis, anal fissures), gynaecology (erosion, colpitis, vulvovaginitis), and also active drainage in surgery. A bioactive-coated drainage system for treating abdominal diseases represents a hollow shape element in the form of a cylinder made of silicon elastomers. A cylinder exterior comprises a bioactive coating tissue made of a hydrophilic textile material coated with at least one layer of a complex bioactive substance and biocompatible biodegradable polymer. The bioactive coating is attached to the shape element with a medical-grade polymer adhesive, and at least one end of the bioactive coating is sutured. ^ EFFECT: invention is easy-to-manufacture, practically feasible, exhibits prolonged medical action and less traumatic. ^ 11 cl, 6 dwg

Description

The invention relates to medicine, namely to devices and devices for treating cavity diseases in oncology (oncogynecology, oncoproctology), abdominal surgery, urology, otolaryngology, proctology (hemorrhoids, proctitis, anal fissures), gynecology (erosion, colpitis, vulvovaginitis) , as well as for active drainage in surgery.

A drainage device is known that contains a flexible polymer tube with a synthetic thread attached to its working part, threaded into the hole of the tube, and having two longitudinal parallel slots forming a flap (RU C1, 2065309, A61M, 08.20.96).

However, this device provides the flow of drugs only through its internal cavity, and when it is closed with pore decomposition products from the affected area, the flow of drugs stops.

A drainage device with a biologically active coating is known for drainage and prolonged local drug therapy for abdominal indications in surgery, proctology, gynecology, which is a hollow perforated shaping element in the form of a body of revolution, on the outside of which a napkin made of hydrophilic textile material is fixed, applied to it a complex based on a biologically active substance and a biocompatible biodegradable polymer, equipped with an input lock located on the opposite input end of the device, and the ends of the napkins on the input end of the device are fixed with a safety thread, and the ends of the napkins on the opposite side are fixed with a latch (patent RU, 2201258, MKI A61L 15/64, publ. 2003.03.27).

However, allowing for prolonged supply of drugs to the area of cavity diseases while ensuring the removal of decay products from the pathological focus, this device is laborious to manufacture, low-tech and has insufficient passability for gas removal and removal of the discharge end separated from the side.

A known drainage device with a biologically active coating adopted as a prototype is a hollow shaping element in the form of a body of revolution made of silicone elastomers, on the outside of which a biologically active coating in the form of a napkin made of hydrophilic textile material is fixed, with at least , with one layer of a complex based on a biologically active substance and a biocompatible biodegradable polymer, while the ends of the napkin are bent inside the forming element a and secured therein by means of rings made of elastomer (Patent RU, 2240839, IPC A61L 15/64, publ. 27.11.2004).

However, this device is also laborious to manufacture and low-tech, has increased rigidity, which creates a certain discomfort for the patient.

The present invention solves the problem of creating a more effective, easy to manufacture and technologically advanced drainage device with a prolonged therapeutic effect, which has a less traumatic effect when used.

This problem is solved in that in a drainage device with a biologically active coating for the treatment of cavity diseases, which is a hollow forming element in the form of a body of revolution, made of silicone elastomers, on the outside of which a biologically active coating is fixed in the form of a napkin made of hydrophilic textile material, with applied to it by at least one layer of a complex based on a biologically active substance and a biocompatible biodegradable polymer, new is that the biologically active coating was formed on the forming element using glue based on a polymer permitted in medicine, and at least one end of the biologically active coating was stitched with surgical suture material.

These adhesives provide gliding and, having stickiness, well envelop mucous surfaces (vagina, rectum, nasal mucosa), providing tight contact with surfaces and facilitating the transport of biologically active substances to the affected areas.

Currently, polyvinyl alcohol, sodium alginate, polyethylene glycols, methyl cellulose, carboxymethyl cellulose or mixtures thereof are most commonly used as adhesives.

To ensure sliding during insertion and removal of the device, it can be covered with an additional layer of glue.

To enhance the therapeutic effect, an additional layer of glue may contain one or more biologically active substances.

To improve fixation, the firmware at the output end of the forming element can be made passing to the output thread.

To ensure the softness of the device, which is especially important in otolaryngology, oncogynecology, proctology, biologically active coating can be performed at least two-layer.

The application of a complex based on biologically active substances, which is a pharmacopeiaic drug, stimulating the reparative processes of the mucosa, oils and biocompatible polymers onto a tissue, is performed in such a way that with a tissue thickness of 1-2 mm, the therapeutic effect of the introduced biologically active substances is carried out for 1-2 days ( proctology-hemorrhoectomy, oncogynecology - conservative treatment after sessions of radio / x-ray therapy), with a thickness of 3 mm - from 3 to 5 days (otolaryngology, abdomina te a surgery, general surgery). With a thickness of less than 1 mm, the therapeutic effect is insufficient, there is no prolongation of the action of the biologically active substance even for 1 day, a thickness of more than 3 mm is not advisable from the point of view of the consumption of the biologically active substance and possible side effects from their overdose - allergies, itching, swelling.

For abdominal surgery, the biologically active coating is located only on the middle part of the device.

To improve the fixing of the coating, both ends of it can be bent inside the forming element and fixed inside it with rings of elastomers.

For additional fixation of the coating, elastomeric rings are sewn together with the forming element.

To increase the strength of both the device itself and its attachment to the patient’s body, surgical dacron thread is used as a surgical suture material.

Currently, they are most commonly used as elastomers permitted in medicine, such as silicone rubber, polyvinyl chloride or medical rubber.

The inventive design of the device shown in the drawing, where figure 1 shows a General view of the device, a longitudinal section, and figure 2-6 - options.

The device is made in the form of a forming element in the form of a hollow cylinder 1. On the outer part of the hollow cylinder 1, a biologically active coating 3 is fixed by a layer of glue 2, consisting of a napkin of a textile material with hydrophilic properties and a complex based on a biologically active substance and a biocompatible biodegradable polymer . The output end of the forming element 1 is stitched with surgical suture material 4, passing into the lead thread 5. (Figure 1). To ensure sliding during insertion and removal, it can be covered with an additional layer of glue 2 (Figure 2). To enhance fixation, the drainage device can be additionally stitched at the input end of the device (Figure 3). To ensure the softness of the device biologically active coating can be performed at least two-layer (Figure 4). For abdominal surgery, a biologically active coating is located only on the middle part of the device (Figure 5). To improve fixation, both ends of the coating can be bent inside the forming element and fixed inside it using rings of elastomers 6 (Fig.6).

The proposed device operates as follows. Before use, the biologically active coating 3 is moistened, and the device is easily inserted into the inflamed cavity due to the sliding of the entire device until it touches the lesion site and is fixed by fixing the output thread 5 with a patch on the patient’s body. The prolonged therapeutic effect of the proposed drainage devices in gynecology is 2-3 days, in otolaryngology up to 5 days, in abdominal surgery and urology up to 7 days.

Thus, the maximum facilitated non-traumatic introduction of a drainage device is achieved, which ensures long-term contact of drugs with a pathological focus, which helps to reduce the time of its treatment.

The effectiveness is confirmed by the use of an experimental batch of the devices described above also for the treatment of hemorrhoids, anal fissures, active drainage of cavities in the postoperative period under stationary conditions.

Claims (11)

1. A drainage device with a biologically active coating for the treatment of cavity diseases, which is a hollow forming element in the form of a cylinder made of silicone elastomers, on the outside of which a biologically active coating is fixed in the form of a napkin made of hydrophilic textile material with at least , with one layer of a complex based on a biologically active substance and a biocompatible biodegradable polymer, characterized in that the fastening of the biologically active coating I on the forming element was made using glue based on a polymer permitted in medicine, and at least one end of the biologically active coating was stitched with surgical suture material. 2. The device according to claim 1, characterized in that the adhesive used is polyvinyl alcohol, sodium alginate, polyethylene glycols, methyl cellulose, carboxymethyl cellulose, or mixtures thereof. 3. The device according to claim 1, characterized in that to ensure sliding during insertion and removal, it is covered with an additional layer of glue. 4. The device according to claim 3, characterized in that the additional layer of glue contains one or more biologically active substances. 5. The device according to claim 1, characterized in that to improve fixation, the firmware on the output end of the forming element is made passing to the output thread. 6. The device according to claim 1, characterized in that to ensure the softness of the device biologically active coating can be performed at least two-layer. 7. The device according to claims 1 and 6, characterized in that the total thickness of the biologically active coating is 1-3 mm 8. The device according to claim 1, characterized in that for abdominal surgery, a biologically active coating is located only on the middle part of the device. 9. The device according to claim 1, characterized in that both ends of the coating are bent inside the forming element and secured inside it using rings of elastomers. 10. The device according to claim 9, characterized in that the rings of elastomers are stitched together with the forming element. 11. The device according to claim 1, characterized in that as a surgical suture material, a surgical mylar is used.

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