WO1988000816A1

WO1988000816A1 - Valve for control of discharge from a stoma

Info

Publication number: WO1988000816A1
Application number: PCT/AU1987/000232
Authority: WO
Inventors: Roy Edward Mcdonnell
Original assignee: Roy Edward Mcdonnell
Priority date: 1986-07-25
Filing date: 1987-07-23
Publication date: 1988-02-11

Abstract

A valve for a prosthetic device for ileostomates, colostomates and the like has a tubular body (10) which is open at one end (11) thereof. The other end of the body is closed by a generally wedge-shaped extension (12) which terminates in a pair of openable lips (13). The valve is made of a resilient material, such as silicone rubber, and the lips (13) are biased into contact with each other to form a sealed opening for the valve. Preferably the lips comprise a pair of flat flaps of the resilient material. The valve may be included within a drainage tube (21, 31) of a continence device for ileostomates.

Description

TITLE: "VALVE FOR CONTROL OF DISCHARGE FROM A STOMA"

Technical Field

This invention concerns valves. More particularly it concerns valves for use in prosthetic devices which provide continence for ileostomates, colostomates and the like.

Background

Persons who have had an ileostomy, a colostomy or an ileal conduit operation, or the like have a continence problem. Such persons have had the whole or part of their bowel removed, or they have had their bladder by-passed. Consequently they have no anus or they have no bladder outlet. The ileu (in the case of an ileostomy), or the colon (in the case of a colostomy), or a conduit pouch constructed from the ileum, is brought to the surface of the abdomen to form what is known as a stoma. Waste products from the body pass through the opening of the stoma and, because there is no muscular control of this opening, form a continuous or periodic discharge. Thus such persons are incontinent.

Hitherto, this type of incontinence has been overcome by collecting the waste products from the body in a bag. This bag is held in a position to receive the effluent from the stoma by an adhesive disc surrounding the stoma. However, the disposal of the products from the bag can be difficult and embarrassing for a person who has undergone an ileostomy, a colostomy or an ileal conduit operation. In addition, the presence of the bag is often uncomfortable - especially in hot weather - and the possibility of the collection bag being detectable by another person is usually a cause for anxiety by the person with the stoma. Also, leakage at the adhesive disc or from the bag can cause skin excoriation around the stoma, as well as being embarrassing.

These disadvantages of the commonly used collection bag have been recognised for many years, and a number of alternative collection methods have been proposed. Included in those alternative techniques is the collection of wastes within the ileum, colon or conduit of the person who has a stoma, instead of in an external bag. In such techniques, a plug is formed at the stoma and waste products (which are essentially liquid) collect in the end of the ileum, colon or conduit that is adjacent to the stoma.

Of those techniques, the most likely to succeed was the ileostomy applicance developed by William G Robertson, which is the subject of US patent No 4,344,434 (the disclosure in the specification of US patent No 4,344,434 is incorporated herein by this reference thereto). Robertson's device relies upon a preshaped, collapsible but resilient cavity formed around a drainage tube to secure the device in position in a stoma. After inserting the device through the aperture of the stoma with the cavity collapsed, the cavity is allowed to expand to form a seal with the wall of the ileum (or colon, or conduit). A mitre valve, located within the drainage tube, is designed to prevent the passage of waste matter through the stoma opening until the mitre valve is opened with a catheter. Unfortunately, the mitre valve cannot be closed properly, and the absence of a proper seal has led to the Robertson device being rejected as unsuitable.

The problems with sealing such devices against leakage were tackled in a different manner by Thomas A Burton. In the specification of his US patent No 4,381,765, Burton describes an internal collection device for ileostomy and colostomy patients -having a tubular drainage tube which extends into the ileum through the stoma. The device is held in position by a balloon, which is formed around the internal portion of the drainage tube and is inflated using a hypodermic syringe when the device has been inserted into the ileum. The closure of the drainage tube is effected by folding and clamping the end of the tube which projects beyond the external valve body of the device. It is understood that the complex folding and clamping arrangement to seal the drainage tube has not been v/ell received by users of this device so it, too, has been considered as unsuitable by most patients . Disclosure of the Present Invention

It is an object of the present invention to provide a valve for use in the drainage tube of ileostomy and colostomy continence devices and the like which provides a positive seal against the passage of fluids but which is easily and safely openable to permit fluids held back by the seal to be removed or allowed to pass through the valve.

To achieve this objective, the present invention provides a valve made from a resilient material such as the silicone rubber compound known as SILASTIC (trade mark) . The valve has a tubular body portion that is tapered at one end to form a closure for-the tubular body. The closure is effected by a pair of lips which are formed at the end of the tapered part of the valve. The resilience of the material from which the valve is made ensures that the lips are biased into contact with each other. However, the lips may be opened by a catheter, a narrow bore tube or the like inserted through the body portion of the valve and into the tapered part, where it meets the material of the valve and separates the closed lips of the valve.

Thus, according to the present invention, there is provided a valve comprising a tubular body moulded from a resilient material, characterised in that (a) the tubular body is open at one en .thereof; and

(b) the tubular body is closed at the other end thereof by a generally wedge-shaped extension of the body member which terminates in a pair of openable lips that are biased, by the resilience of said material, into contact with each other to form a sealed opening for the valve.

Preferably the lips each comprise a flat flap of the resilient material, at the end of the wedge-shaped extension of the body member. The adjacent surfaces of the flaps make contact with each other over substantially the whole of the area of the flaps.

The present invention also includes an ileostomy or colostomy continence device or the like which incorporates such a valve.

Embodiments of the present invention will now be described with reference to the accompanying drawings .

Brief Description of the Drawings

Figure 1 is a perspective sketch of a valve constructed in accordance with the present invention.

Figure 2 is a partly sectional view (which is also partly schematic) of an ileostomy continence device which includes the valve of the present invention. Figure 3 is a partly sectional, partly schematic view of another ileostomy continence device which includes the valve of the present invention.

Figure 4 is a sectional view of part of the continence device of Figure 3.

Detailed Description of the Illustrated Embodiments

The valve illustrated in Figure 1 comprises a tubular body 10 which is open at one end 11 thereof. The other end of the tubular body is closed by a generally wedge-shaped extension 12 of the body 10 which terminates in a pair of lips 13. The lips 13 are each generally rectangular, overlapping, planar regions joined at their edges 14. An opening slit 15 between the lips is normally closed.

If the valve of Figure 1 is made from a resilient material, the resiliency of the material will bias the lips 13 into contact with each other, thus ensuring that the opening slit 13 is normally closed. In the illustrated embodiment of Figure 1, the lip-closing bias extends over the entire area of each lip 13 , so that the closure of the valve is an areal closure, not a line closure.

To open the slit 15, a tubular implement (for example, a catheter or a pipette) may be inserted into the open end 11 of the valve until it comes into contact with the inner surface of the tapering wedge-shaped extension 12. Further insertion of the tubular implement will cause the lips 13 to separate to allow the implement to break the seal established by the resiliency of the material of the valve, and to project through the slit 15.

Valves constructed in accordance with Figure 1 have been made using a die with a thin shim (approximately 0.14 mm or 0.005 inches thick) to form the slot 15. Each valve was made from a silicone rubber material marketed under the trade mark "SILASTIC 732", which was dissolved in toluene and sprayed on to the die. After a reasonable thickness of material had built up on the die, it was allowed to cure in air. The valve so formed was hen peeled off the die and the sealed end of the lips 13 (the seal was established by material sprayed on to the outer edge of the shim) was cut off to expose the slit 15. Such dies have been found to provide good seals across lips 13 measuring approximately 12 mm by 12 mm. For mass production of the valves, an injection moulding technique will be used.

It will be appreciated that any increase in the pressure over the outer surface of the lips 13 relative to the pressure within the tubular body 10 will enhance and reinforce the seal established by the valve of the present invention. The ileostomy continence device illustrated in Figure 2 shows a valve 20 of the type shown in Figure 1 located at one end of a drainage tube 21. The other end of the drainage tube 21 is formed into an annular flange 22 which is ridged and is adapted to be held in contact with the skin covering the abdomen of a user of the device, around a stoma. An inflatable collar 23 is attached to the tube 21 a distance d from the flange 22. The distance d corresponds to the thickness of the abdominal wall of the patient that is to use the device. As in the case of the ileostomy device of US patent No 3,381,765, the collar 23 is inflated using a syringe which is inserted into the outer end of a tube 24 which extends from alongside the flange 22 to the interior of ^"the collar 23. A non-return valve 27 of known construction will normally be located in the tube 24 at its outer end. An optional sheath 25 extends from the end of the drainage tube 21 which is remote from the flange 22 and surrounds the valve 20, to facilitate insertion of the continence device into the ileum through a stoma. An aperture 26 is provided at the end of the sheath 25.

After the device of Figure 2 has been placed in position within a patient and the collar 23 has been inflated to provide a seal between the device and the wall of the ileum, liquid waste collected within the ileum builds up against the outer surface of the valve 20. This build-up of liquid waste puts a small additional pressure on the outside of the valve 20 - Q —

which enhances or reinforces the sealing of the lips of the valve 20. Removal of body waste from the reservoir in the ileum formed by the continence device may be effected simply by inserting a catheter into the drainage tube 21 until it opens the lips of the valve 20 (the lips tend to encircle the catheter) and reaches the liquid which surrounds the lips of the valve. When the catheter is removed from the device, after draining the collected body wastes, the lips of the valve 20 re-seal the valve, thus preventing leakage of the liquid waste into the drainage tube 21.

The ileostomy continence device of Figure 3 is essentially the same as the device of US patent No 4,344,434, but with the mitre valve of that device replaced with the "lip" valve 30 of the present invention. The collapsible member 33 which surrounds the drainage tube 31 in which the valve 30 is located, and the partial evacuation of the collapsible member 33 through a tube 34, have been described in the specification of US patent No 4,344,434. Thus a repeated explanation now of this known procedure would be superfluous . The operation of the valve 30 has been fully described above. The flange 32 of the device illustrated in Figures 3 and 4 is provided with circular corrugations to improve the adhesion of the flange to the skin of the abdomen which surrounds the stoma of a patient. Figure 4 has been included because in the presently-adopted procedure for assembling an ileostomy continence device of the type shown in Figure 3, the components of the device are formed separately. The valve 30 is moulded integrally with the flange 32. This component is bonded to the other components of the device by conventional techniques.

All the valves of the present invention that have been made by the present inventor have been manufactured from the aforementioned "SILASTIC" material. However, other resilient materials having a suitable stif ness may be. used for the manufacture of the valve. If required, continence devices incorporating the valve of the present invention may include a metal indicator thread moulded into the wall of the drainage tube, or barium sulphate (or other x-ray opaque material) may be sealed into at least one component of the device, to enable the position of the device within a patient to be monitored by x-ray techniqes.

It will be apparent that when continence devices incorporating a valve constructed in accordance with the present invention are used to provide an internal collection region or reservoir for liquid body wastes, instead of the conventional bag,

(a) removal of the waste products from the body becomes a relatively simple matter; (b) the need for an unsightly and possibly embarrassing external collection bag is avoided;

(c) skin excoriation is prevented as the closure of the stoma is sealed against liquids;

(d) the problem of odour is avoided as the end of the ileum (or colon, or conduit pouch) is sealed;

(e) the user of the device may participate in sports (including swimming);

(f) the user of the device may travel, work and mix socially with other persons without fear of causing offence; and

(g) a user of the device can experience a period of four or more hours before the collection chamber or reservoir established in the ileum needs to be drained.

Claims

1. A valve comprising a tubular body (10) moulded from a resilient material, characterised in that:

(a) the tubular body (10) is open at one end (11) thereof; and

(b) the tubular body (10) is closed at the other end thereof by a generally wedge-shaped extension (12) of the body which terminates in a pair of openable lips (13) that are biased, by the resilience of said material, into contact with each other to form a sealed opening for the valve.

2. A valve as defined in claim 1, in which said lips (13) each comprise a flat flap of resilient material at the end of the wedge-shaped extension of the body member, the adjacent surfaces of said flaps normally being in contact with each other over substantially the entire area of the flaps.

3. A valve as defined in claim 1 or claim 2, in which the resilient material is a silicone rubber compound.

4. A valve as defined in claim 1, claim 2 or claim 3, inserted into a drainage tube (21, 31) of a continence device.

5. A valve substantially as hereinbefore described with reference to Figure 1 of the accompanying drawings.

6. A valve as defined in claim 4, substantially as hereinbefore described with reference to Figure 2 or Figure 3 of the accompanying drawings .