RU128102U1 - DEVICE FOR COLLECTING DISCHARGES FROM STOMA - Google Patents

Abstract

1. A device for collecting discharge from the stoma, consisting of a bag-collector and a fixing element, in which the bag-collector is made in the form of a polymer bag, if necessary, with the possibility of emptying it, on one of the surfaces of which around the inlet is fixed a locking element with a sealing a ring of adhesive hydrocolloid material, characterized in that the adhesive hydrocolloid material contains a fluorine-containing polymer. 2. The device according to claim 1, characterized in that the adhesive composition as a polymer base contains a mixture of polyisobutylene and acrylate copolymer in the following ratio of components, wt.%: Provided that the sum of the percentages of all components is 100% .3. The device according to claim 1, characterized in that the adhesive composition as a polymer base contains a copolymer of butyl methacrylate with methacrylic acid in the following ratio of components, wt.%: Provided that the sum of the percentages of all components is 100%.

Description

The technical field to which the utility model relates.

The utility model relates to the field of medical devices. More specifically, it relates to devices for collecting secretions, in particular feces and urine, from an ostomy and can be used in medical institutions and in everyday life according to relevant indications.

State of the art

From the publication SU 1109156 (publ. 23.08.1984), a receiver is known comprising a housing with a flange, a removable bag-collector and elastic fastening elements, characterized in that the body has a cone shape, and a removable bag-collector is placed inside the housing and fixed on the flange. The kalopriemnik fixation elements are fixed, covering the artificial passage. After filling the collection bag, the kalopriemnik is pulled away from the body, with the open end of the collection bag, the remains of the secretions are removed from the body and the collection bag is removed. The main disadvantage is the fixed size of the body, which does not provide the best fit of the cone to the position, shape and size of the stoma, thereby allowing prolonged contamination of the peristomal region with secretions, leading to allergies and / or inflammation of the skin. In addition, the elastic fasteners do not guarantee the required position of the device on the body, they can create areas of increased pressure and / or friction, thereby causing pain and damage to the skin.

Known single-component drained stoma care systems (colo-and urinal), including a bag-collector, fixing and locking elements, in which the bag-collector is made in the form of a polymer bag, on one of the surfaces of which around the inlet there is a fixing element made in the form rings and containing an adhesive composition comprising a hydrocolloid. The device is optionally provided with an outlet element, such as a tap. Products of this design are commercially available under the trademarks Stomadress® and Esteem Synergy® (holder - ConvaTec Inc., US). A disadvantage of the known product is the fragmentation of the fixing element for a short time (about a day), which leads to clogging of the outlet element (in the case of the urinal), as well as to irritation by secretions of that part of the peristomal region in which fragmentation occurred. Further use of such a product becomes impossible also due to a decrease in the strength of attachment to the skin up to the appearance of leaks and separation from the place of attachment.

Thus, there is a need to expand the arsenal of funds devoid of these shortcomings.

Utility Model Disclosure

As a result of the development, the authors proposed a device for collecting secretions from the stoma, with which it is possible to overcome the disadvantages of the solutions of the prior art. In particular, fragmentation of the fixing element can be delayed by introducing a hydrophobic fluorine-containing polymer into the adhesive composition, which allows to achieve the following technical results:

1) to ensure the purity of the peristomal region during the entire time of wearing the colostomy bag and

2) increase the application time by several times. Thus, a device consisting of a bag-collector and a fixing element is proposed, in which the bag-collector is made in the form of a polymer bag, if necessary with the possibility of emptying it, on one of the surfaces of which around the inlet a fixing element is fixed, with a sealing ring made of adhesive hydrocolloid material, characterized in that the adhesive hydrocolloid material contains a fluorine-containing polymer.

Preferably, the adhesive composition as a polymer base contains a mixture of polyisobutylene and acrylate copolymer in the following ratio of components (in wt.%):

Acrylate copolymer 10-20

Polyisobutylene 15-35

Castor Oil 10-20

Hydrocolloids 20-30

Fluorine-containing polymer 0.1-30

provided that the sum of the percentages of all components is 100%.

Alternatively, the preferred adhesive composition as a polymer base comprises polyisobutylene and hydrocarbon resins in the following ratio of components (wt.%):

Polymer base 30.0-60.0

Hydrocolloid 25.0-40.0

Softener up to 15.0

Filler Up to 10.0

Fluorine-containing polymer 0.2-10.0,

provided that the sum of the percentages of all components is 100%.

Also, the preferred adhesive composition as a polymer base contains a copolymer of butyl methacrylate with methacrylic acid in the following ratio of components (in wt.%):

Butyl methacrylate copolymer with methacrylic acid 20.0-30.0

Hydrocolloid 21.0-46.0

Plasticizer 20.0-35.0

Fluorine-containing polymer 0.1-5.0,

provided that the sum of the percentages of all components is 100%.

Brief Description of the Drawings

The figure 1 presents the receiver with the outlet element.

The figure 2 presents the receiver without the exhaust element.

The figure 3 presents the urinal with an outlet element in the form of a tap. Utility Model Implementation

The discharge receiver must be made of materials and products approved for medical use that are resistant to the effects of climatic factors and the vibrations to which they can be exposed during storage, transportation and operation.

For the manufacture of the front and rear walls of sheets of the corresponding polymeric materials, parts 1 of the same size are cut, having angular roundings. In the front wall along the long axial line, an inlet is made corresponding to the minimum size of the stoma (about 20 mm). For the manufacture of a bag-collector, its walls are connected by welding, avoiding extraneous inclusions and burn-throughs in welds, punctures and cuts of the walls.

The fixing element 2, which is a ring with an inner hole corresponding in diameter to the inlet of the collection bag, is provided with a protective coating 3 on the working side and is thermally pressed in one piece to the collection bag in the region of the inlet. To ensure proper tightness, the fixing element must have an adhesive characteristic of at least 70 N / m, while its material must have a moisture absorption of at least 180%. Preferably, the moisture absorption is 300%, more preferably 500%.

In a preferred embodiment, the inlet and the fixing element of the collecting bag are round and the diameter of the fixing element is approximately 90% of the maximum width of the collecting bag. Also preferably, the product has an exhaust element 4. In the case of a kalopriemnik, the width of the outlet is approximately half the maximum width of the collection bag, and the locking is carried out by a clamp consisting of a U-shaped profile, thickened at the edges, and the counter plate. In the case of the urinal, locking is carried out by a tap.

The receiver may have a size of the locking element, allowing mounting around the stoma size from 20 to 80 mm To reduce irritation, a gasket of porous hypoallergenic material can be installed in the area of contact between the receiver and the skin integrally with the upper part.

When using a receiver to collect secretions, the following actions are performed: if necessary, an incision is made on the fixing element that is configured according to the configuration of the stoma, if necessary, the previously installed receiver is removed, the peristomal region and the stoma are cleaned using appropriate hygiene and / or medical devices and devices ( lotions, creams, gels, ointments, wipes, tampons, etc.), remove the protective coating of the fixing element, press the receiver to the peristomal region with the required short-term one-time effort and Check the strength of the mount. In the case of a secretion receiver equipped with an outlet element, it is sealed by locking the outlet element of the receiver with a clip or by closing the tap of the urinal.

The purity of the peristomal region of the receiver is ensured by the absence of fragmentation of the locking element. The time to reach the maximum moisture absorption before fragmentation can be estimated in the following experiment. The precipitation receiver is glued onto the surface of a transparent sheet of polymethylmethacrylate with an opening with a diameter of 57 mm imitating the stoma, and filled with water at room temperature (300-500 ml depending on the model). The hole is closed with a plug, placed on a horizontal surface with the sheet down and observe the swelling and fragmentation of the fixing element, evaluating the thickness of the swollen layer (D, mm) and its integrity (C, + or -) over time. The results of comparative studies for receivers with an outer diameter of the fixing element of 80 mm are shown in table 1.

Table 1 Device Indicator The time of the experiment, h 6 h 12 h 24 h 48 h 72 h Receiver (utility model) D mm 58 60 63 67 75 C, +/- + + + + + One-component conduit collector “ConvaTech” (Bristol-Myers Squibb Company) D mm 65 73 78 C, +/- + + -

The increase in the wearing time of the ileostomy receiver in accordance with the utility model and ConvaTek products were evaluated by 14 volunteers aged 45-73 years, divided into groups of 7 people. In the group of people who used the receivers in accordance with the utility model, the average wearing time of the product was 5.0 days with a spread of 3.0 to 7.0 days. In the group of ConvaTek products, the average wearing time of the ileostomy receiver was 2.5 days with a spread of 1.5 to 4.0 days.

The data presented confirm the achievement of technical results when using a utility model.

Claims (3)

1. A device for collecting discharge from the stoma, consisting of a bag-collector and a fixing element, in which the bag-collector is made in the form of a polymer bag, if necessary, with the possibility of emptying it, on one of the surfaces of which around the inlet is fixed a locking element with a sealing a ring of adhesive hydrocolloid material, characterized in that the adhesive hydrocolloid material contains a fluorine-containing polymer. 2. The device according to claim 1, characterized in that the adhesive composition as a polymer base contains a mixture of polyisobutylene and acrylate copolymer in the following ratio, wt.%: Acrylate copolymer 10-20 Polyisobutylene 15-35 Castor oil 10-20 Hydrocolloids 20-30 Fluorine-containing polymer 0.1-30, provided that the sum of the percentages of all components is 100%. 3. The device according to claim 1, characterized in that the adhesive composition as a polymer base contains a copolymer of butyl methacrylate with methacrylic acid in the following ratio, wt.%: Butyl methacrylate copolymer with methacrylic acid 20.0-30.0 Hydrocolloid 21.0-46.0 Plasticizer 20.0-35.0 Fluorine-containing polymer 0.1-5.0 provided that the sum of the percentages of all components is 100%.

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