GB2268882A - Urostomy pouch & system - Google Patents

Abstract

The pouch comprises front and rear walls 10, 12 joined by a weld 14 and has an intervening wall 20 which is fluid-impermeable and extends downwardly from the top of the bag (where it is held in place by said weld) to 20-40 mm below the lowest part of the stomal orifice 16. At its lower edge, the wall 20 is welded via V-shaped bar welds 24, 26 to the rear wall so as to define a "non-return valve" 22 of width "X" at least one fifth of the width of the bag. The pouch may be supplied with an applicator having a barrel 40 and a plunger 48 for introduction into the pouch of a rolled-up sheet 50 of superabsorbent material. The latter material may alternatively be in pill form. <IMAGE>

Description

UROSTOMY POUCH & SYSTEM This invention relates to a urostomy pouch and to a system for introducing a superabsorbent into the pouch in a quick, easy and hygienic manner.

There have been a large number of prior proposals to use an absorbent material to facilitate collection of urine. For example, in U.K. Patent Specification 1,161,015, C.R. Bard Inc.

propose an appliance including wicking materials for absorbing urine from an ileostomy stoma. Other patents relating to absorption of urine and appliances to achieve such absorption include German Patent Application 3,037,797; U.K. Patent Application 2,168,899; U.K. Patent Application 2,124,072; U.K.

Patent 1,411,087; German Patent Application 3,422,748; EP-A264,238; and U.K. Patent 1,283,616. In U.S. Patent No. 4,820,291 Terauchi et al disclose a genital receiving bag connected to a storage bag. A highly water-absorbent resin is placed inside the storage bag to absorb and gel the urine. Lennard in PCT International Application W085/03428 shows a bag for male incontinents. The bag receives the genitalia and has an insert attached to the inside of its wall consisting of material with great water-absorbing capacity capable of swelling to form a gellike mass. U.S. Patent Specification No. 4,886,509 of Mattsson describes a urine collector having an arrangement of layers which include at least one super-absorbent laminate, which on absorption forms a gel. The same inventor made similar proposals in EP-A-228353.In EP-186209-A of Kimberly Clark Corporation, a male incontinence pouch is shown, intended for attachment to underwear, and containing a superabsorbent. Other patents which suggest the inclusion of a super-absorbent material in appliances for collecting urine are EP-A-228353 and EP-A-174756. A substance useful for thickening urinary and intestinal tract excrement is disclosed by Barthell et al in U.S. Patent No.

4,179,367. The use of a superabsorbent in various environments, including colostomy and urinary bags, is disclosed in European Application No. EP-A-138427. Other patents on superabsorbents are discussed in the preamble of EP-A-138427.

To the best of Applicant's knowledge and belief, however, despite a wealth of suggestions in the prior art, there has been no proposal which successfully addresses the problems of a typical urostomate. Such a person may have to empty or change his or her urostomy pouch several times per day and between changes, the pouch will often contain a quantity of liquid which sloshes about when the person moves. This is embarrassing and raises doubts in the wearer's mind as to the security of attachment of the pouch to the body, even though the attachment may be quite secure. In order to effectively use the valuable qualities of superabsorbents now available, it would be desirable if there were available a urostomy pouch and system which would overcome or at least mitigate these problems.

In this specification (including the claims) references to "upwardly" and "downwardly11 are used in relation to a pouch which is hanging in a normal position on a wearer standing upright.

These words are used in this sense to facilatate brevity and clarity of description but of course are not intended to limit the scope of the invention only to pouches which are vertical.

Clearly when a wearer is sitting or in a relaxed posture the pouch may well not have its axis of lon#itudinal symmetry vertical.

According to one aspect of the present invention, there is provided a urostomy pouch having a rear wall of synthetic plastics material joined by a suitable plastics weld substantially around its periphery to a front wall, the rear wall having a stomal orifice which is surrounded by a first coupling member by which the pouch can be releasably fixed to a counterpart coupling member attached to the body of the wearer, the pouch further having an intervening wall non-permeable to liquids and gases which extends downwardly from the top of the pouch to a distance not less than 20 and not more than 40 mms.

from the lowermost part of the stomal orifice, the intervening wall being held in position by the plastics weld and at its lower edge being welded to the rear wall so as to define therewith a non-return valve having a width at least a fifth of the width of the pouch at that level and which is located substantially centrally of the pouch and beneath the stomal orifice.

According to another aspect of the invention, there is provided a kit for use by an ostomate which includes a pouch as defined in the preceding paragraph and an applicator which comprises an open-ended tubular barrel which contains a rolled-up sheet of superabsorbent material, the applicator also including a plunger for causing the said material to be expelled from the barrel and injected into the lower part of the pouch via its stomal orifice and the non-return valve.

The width of the non-return valve referred to is preferably from about 26 to about 34 mms. and most preferably about 30 mms.

These particular dimensions have been found to give surprisingly good performance in meeting the conflicting requirements of permitting passage of excreted material to pass downwardly thrugh the valve while substantially preventing any reflux reaching the tender stomal area when the lower part of the pouch is subjected to pressure (such as may occur when the wearer moves about).

According 'o a further aspect of the invention, there is provided an applicator for use with a urostomy pouch, comprising an open-ended barrel, a plunger slidable within said barrel, the plunger having a head end external to the barrel, and superabsorbent material within the barrel, whereby in use upon moving the plunger axially towards the open end of the barrel, the superabsorbent material is expelled from the said open end.

In a preferred embodiment of the invention, a urostomy pouch would be sold or delivered to the user in a package which also contains one or more applicators already filled with superabsorbent. While in a preferred embodiment of the invention, the superabsorbent is dispensed from a plunger-type applicator, it may of course be dispensed into the urostomy pouch in other ways. For example, superabsorbent could be formed in the shape of a pill or block, and could be fed into the pouch using a pill-dispenser of conventional kind. The pouch could then be packaged together with the pill-dispenser and an additional supply of pills. While it is preferred that the superabsorbent should take the form of a rolled up strip of laminate of suitable material, other forms of superabsorbent may equally well be employed.Other methods of delivering superabsorbent material into a urostomy pouch via the stomal orifice and a non-return valve located below the stomal orifice will occur to a man of average skill in the art, and are considered to be within the scope of the invention.

The invention will be better understood from the following description of particular embodiments of the invention, given with reference to the accompanying drawings, in which: Figure 1 is an elevation view of the rear side of a urostomy pouch according to one example of the invention. In this specification (including its claims), the words "rear" and "front" are used in the sense that the side of the pouch which faces towards the body of the wearer is called the rear side, and the side of the pouch which faces outwardly of the wearer is called the front side.

Figure 2 is a diagrammatic cross section in a vertical plane, taken on the line II-II of Figure 1; Figure 3 is a diagrammatic cross sectional view, taken in the same plane as Figure 2, but illustrating use of an applicator to introduce a roll of superabsorbent material into the interior of the lower part of the pouch; Figure 4 is an illustration of one form of applicator used to eject a roll of superabsorbent material from a covering sleeve; and Figure 5 illustrates how the applicator and sleeve components shown in Figure 4 are employed to introduce the roll of superabsorbent to the interior of a pouch, the upper part of the left hand drawing showing the introduction procedure and the lower part of that drawing showing the roll of superabsorbent located in the bottom region of the pouch.

Referring firstly to Figures 1 and 2, the illustrated urostomy pouch 8 has front and rear walls 10, 12 of synthetic plastics film material joined at their periphery by a plastics seam weld 14. The rear wall 12 has a stomal orifice 16, surrounded by a coupling member 18 by which the pouch can be releasably fixed to a counterpart coupling member (not shown) on a medical grade adhesive pad which is attachable to the skin of the wearer in the peristomal area. A variety of ostomy couplings are known, having first and second mutually engaging coupling members, one of the best known being that described and claimed in British Patent No. 1,571,657. Other couplings, however, could be employed to join the pouch to a pad adhesively attached to the peristomal area.

An intervening wall of synthetic plastics film 20 (see Fig.

2) is located in the top region of the bag. This wall is sandwiched between the walls 10 and 12 and extends down to a short distance below the stomal orifice. The peripheral seam weld 14 holds the peripheral region of the wall 20 between the walls 10 and 12. In Figure 1, the bottom edge of the wall is seen at 20A. The purpose of the intervening wall 20 is to faciliate the provision of a non-return valve 22. Two V-shaped bar welds 24 and 26, each joining up at their outer ends with the seam weld 14, are provided and join together the intervening wall 20 and the rear wall 12. Thus there is a flap valve 22 defined between the walls 12 and 20 and between inner ends of these welds 24, 26, whose width is the distance indicated x on Figure 1.The value of x may be in the range about 23 to 37 mms., preferably about 26 to 34 mms., and most preferably about 30 mms. for a urostomy pouch of height (excluding outlet 32f of about 250 mms.

and having a stomal orifice of diameter about 45 mms. It is desirable that the valve should not be too narrow. For best results, the value will have a width of at least one fifth of the width of the pouch at that level. The non-return valve 22 is symmetrically placed on the vertical centre line 28 of the pouch and is preferably located so that its horizontal centre line 30 is located a specified distance y below the lowermost point of the stomal orifice 14. The arrow 34 indicates the entry path of excreted material. The value of y may be from 20 to 40 mms., more preferably from 25 to 35, and most preferably about 30 mms., in the case of a pouch having an overall height (excluding the outlet 32) of approximately 245 mms. and having a stomal orifice of 45 mms. diameter. Pouches of different larger or smaller sizes would have proportionately larger or smaller values of y.

The urostomy pouch is shaped to have an outlet 32, of fixed width. This is provided so that a suitable closure clip (known per se, see for example UK Patent No. 2188085) can be employed to close off the bottom of the pouch. The wearer is then able to release the clip and expel the contents as will be later described.

Referring now to Figure 3, this illustrates an applicator whereby a roll of absorbent material can be delivered into the lower part of a urostomy pouch. The pouch concerned is essentially that described with reference to Figures 1 and 2.

The applicator essentially comprises a plunger having a body or barrel 40, the barrel being open at one end 42 and having the other end closed. Through the closed end passes the shaft 46 of a plunger 48, the arrangement being generally similar to the well known syringe as used for medical injections. With the plunger retracted, a rolled up sheet 50 of superabsorbent material or laminate is placed within the barrel. This may be done as a separate assembly operation in a factory which produces already-loaded applicators. To introduce the superabsorbent into the urostomy pouch, the open end of the barrel is then passed through the stomal orifice 14 downwardly at an angle so that the barrel can then be pushed partly through the flap valve 22. To achieve this some bending of the urostomy pouch is of course needed but since the pouch is flexible, this raises no difficulty.Once the open end of the barrel has fully entered the non-return valve 22, the plunger 48 is pushed home so discharging the superabsorbent material from the barrel 40 into the lower part of the urostomy pouch. The applicator is then withdrawn upwardly. When it is withdrawn the flap valve closes automatically due to the tendency of the plastics films 20 and 12 to return into face-to-face contact.

An advantage of this system is that the superabsorbent material is effectively kept away from liquid until it is in its proper working position within the pouch.

Referring now to Figure 4, a modified apparatus is shown.

This comprises a sleeve 60 of cardboard or kraft paper of the like in the form of a hollow tube open at both ends. The tube may be circular in cross section. Within this tube is located a rolled up sheet, that is, a sheet rolled generally into the shape of a cylinder, of superabsorbent material 62. Alternatively, superabsorbent material in the form of a rod or a number of strips or rods may be loaded into the tube.

A simple plastics plunger, seen best at 64 in Figure 5, and having a head 66 and a shaft 68 is used as a tool to push out the superabsorbent 62 when desired.

As seen in best in Figure 5, this illustrates a urostomy pouch 70 with the applicator inserted through the stomal orifice with the sleeve 60 extending between the pouch walls 12 and 20 through the non-return valve 22. The applicator is held betwen the thumb and one finger as seen in Figure 4 and by pressing the plunger with the index finger the rolled up superabsorbent is ejected from the sleeve and falls into the bottom portion of the pouch (as seen at 62A) having passed through the non-return valve 22. while a superabsorbent consisting of a rolled up laminate such as is illustrated at 62A in Figure 5 is preferred, other forms or shapes of superabsorbent material can be employed.

The superabsorbent, when urine is discharged into the pouch, becomes converted to a gel-like, soft mass which can be squeezed out of the pouch outlet 32 into a suitable container when the wearer has a suitable opportunity. The non-return valve acts to prevent any substantial reflux (upward flow) of the gellike mass during this squeezing out process.

A preferred method of manufacture of the applicator as shown in Figure 3 is to form a series of syringe barrels in a multi-cavity injection mould. The plungers would be made in the manner conventional in manufacturing syringes.

Referring to Figures 1-3, it has been found desirable to shape the v-shaped welds 24, 26 so that the angle of the limbs of each v is in the range 13-17 and preferably 150. Moreover, it is desirable to provide welds of a shape in which the apex of the v is rounded, the preferred rounding being that of a radius of about 3.9 to 4.2 mm. This has been found to give a good "leadin" to the applicator and also to be satisfactory from the conflicting requirements of (i) permitting a ready and unobstructed flow of discharge from the stoma to the lower part of the pouch and (ii) preventing undesired reflux of urine and other material in the lower part of the pouch.

It will be seen that there has been disclosed a simple, yet practical and effective, urostomy pouch and system.

Claims (15)

1. A urostomy pouch having a rear wall of synthetic plastics material joined by a suitable plastics weld substantially around its periphery to a front wall, the rear wall having a stomal orifice which is surrounded by a first coupling member by which the pouch can be releasably fixed to a counterpart coupling member attached to the body of the wearer, the pouch further having an intervening wall non-permeable to liquids and gases which extends downwardly from the top of the pouch to a distance not less than 20 and not more than 40 mms. from the lowermost part of the stomal orifice, the intervening wall being held in position by the plastics weld and at its lower edge being welded to the rear wall so as to define therewith a non-return valve having a width at least a fifth of the width of the pouch at that level and which is located substantially centrally of the pouch and beneath the stomal orifice.

2. A urostomy pouch according to claim 1 in which the nonreturn valve is defined in part by weld seams joining the rear and intervening walls and which are rounded at lateral extremities of the valve.

3. A urostomy pouch according to claim 1 or 2 in which the non-return valve is in part defined by a pair of V-shaped weld seams whose apices point towards each other and each of whose pair of limbs are located to enclose an angle of from 13 to 17 degrees.

4. A urostomy pouch according to claim 3 in which the said angles are substantially 15 degrees.

5. A urostomy pouch according to any one of claims 1-4 in which the width of the non-return valve is from 23 to 37 mms., and its vertical spacing from the lowermost part of the stomal orifice is from 25 to 35 mms.

6. A urostomy pouch according to claim 5 in which the width of the said valve is about 30 mms.

7. A kit of parts for use by an ostomate which includes a pouch as defined in any of claims 1-6 and an applicator which comprises an open-ended tubular barrel which contains a rolled-up sheet of superabsorbent material, the applicator also including a plunger for causing the said material to be expelled from the barrel and injected into the lower part of the pouch via its stomal orifice and the non-return valve.

8. An applicator for use with a urostomy pouch comprising an open-ended barrel, a plunger slidable within said barrel, the plunger having a head end external to the barrel, and superabsorbent material within the barrel, whereby in use upon moving the plunger axially towards the open end of the barrel, the superabsorbent material is expelled from the said open end.

9. A packaged kit for use by an ostomate which comprises, within a single package, a urostomy pouch, an applicator for dispensing a superabsorbent into the pouch, and, optionally, a stock of items of superabsorbent each designed for insertion into the applicator.

10. A kit according to claim 9 in which the superabsorbent is in pill form.

11. A kit according to claim 9 in which the superabsorbent is in the form of a rolled-up sheet.

12. A kit according to claim 9 in which the applicator is a pill-dispenser.

13. The combination of an applicator according to claim 8 and a urostomy pouch according to claim 1.

14. A urostomy pouch substantially as herein described with reference to and as illustrated in Figures 1-3, or Figures 4 and 5 of the accompanying drawings.

15. All novel combinations disclosed and/or illustrated herein.