GB2516429A

GB2516429A - Waste management appliance & method

Info

Publication number: GB2516429A
Application number: GB1312937.4A
Authority: GB
Inventors: Graham Emery Steer
Original assignee: Prosys International Ltd
Current assignee: Prosys International Ltd
Priority date: 2013-07-19
Filing date: 2013-07-19
Publication date: 2015-01-28
Also published as: GB2518938A; GB201412348D0; GB201312937D0

Abstract

A waste management appliance 1 for insertion into a body cavity of a subject comprises a goblet-shaped first portion 7 in the vicinity of a distal end 5 of a tube 3 and which can be folded over at least part of a second portion 9, such as an inflatable balloon, which is adjacent to said first portion 7 and spaced from the distal end 5, to provide an externally accessible recess 13 between the first and second portions 7, 9, into which a finger can be inserted to facilitate insertion of at least part of the appliance into the body cavity, such as the rectum or a stoma. The device may be of silicone, the first portion may have a lubricious coating comprising parylene and the tube may include an irrigation lumen and a waste collection receptacle.

Description

WASTE MANAGEMENT APPLIANCE & METHOD

Field of the Invention

This invention relates to waste management appliances and methods, particularly but not exclusively to waste management appliances that can be inserted into the rectum or stoma of a subject.

Background to the Invention

It has long been understood that appliances that are to be inserted into a subject's body should preferably be soft and pliable in order to avoid discomfort for the subject. For example, the so-called Foley catheter was developed in 1937 and comprised a latex rubber catheter that was designed for insertion into the bladder via a subject's urethra. The catheter comprises a tube with an opening at the distal end (through which urine can flow when the catheter is in place), and a balloon that is inflated (via a lumen built into the tube) once the balloon is inside the bladder to hold the catheter in place.

More recent incarnations of the Foley catheter have been made from silicone, and in general terms it is fair to state that it is now well understood that subject comfort will be enhanced by increasing the softness and pliability of at least that part of the device that is inserted into the subject.

However, there is a limit to how soft and pliable such devices can be, as medical practitioners need the device to be sufficiently rigid to enable it to be inserted into the subject. Thus there is a happy medium to be struck between increasing softness to enhance subject comfort and ensuring the device is sufficiently rigid that it can easily be inserted into the subject.

One attempt to provide such a happy medium is disclosed in European Patent No. 1514572. This patent discloses a waste management system that comprises a rigid insertion tool, and a separate waste management appliance (for use with the tool) that has a distal end which is formed entirely of soft, compliant material. The intention with this device is that as the necessary rigidity (for insertion) is provided by the tool, the device itself can be extremely soft and compliant (presumably so much so that it cannot readily be inserted into the subject without the tool).

Whilst this arrangement would appear to provide the abovementioned "happy medium", there are significant drawbacks associated with it. It is never advisable to insert rigid tools into a subject, and in the context of fecal management, a rigid insertion tool in the hands of a careless or inexperienced practitioner could easily cause a perforation of the subject's bowel. It is also the case that as the tool is separate from the waste management device, there is always the potential for tools to be inadvertently (or deliberately) reused between patients. A further drawback is that as the system has a separate tool, use of the system is no longer intuitive, and users will need to be instructed in how to properly use the system. Lastly, a multi-part system will invariably be significantly more expensive than traditional waste management appliances, thereby increasing patient care costs (particularly as the catheter will need to be changed on a regular basis).

The present invention has been devised with the foregoing problems in mind.

Summary of the Invention

In accordance with a presently preferred embodiment of the teachings of the invention, there is provided a waste management appliance for a body cavity of a subject, the appliance comprising: a tubular element having a proximal end and a distal end, the tubular element including a first portion in the vicinity of said distal end, and a second portion adjacent to said first portion and spaced from said distal end, wherein said first portion can be folded over at least part of said second portion so as to provide an externally accessible recess between said first and second portions, the arrangement being such that a finger can be inserted into said recess to facilitate insertion of the tubular element into the body cavity of the subject.

In one implementation the appliance may further comprise an inflatable balloon surrounding at least part of said second portion. The balloon may surround at least part of said second portion in the vicinity of the interface between the first and second portions. The first portion may cover at least part of said balloon when folded over at least part of said second portion. The first portion may cover at least part of said balloon when the balloon is inflated.

The tubular element may include an externally accessible inflation lumen that is connected to said balloon and/or an externally accessible irrigation lumen that opens proximate said distal end of said tubular element.

The appliance may comprise a waste collection receptacle. Means for detachably mounting said receptacle to said proximal end of said tubular element may be provided. The receptacle mounting means may comprise a plate with an opening, and means for attaching said proximal end of said tubular element to said plate, in alignment with said plate opening.

In one implementation at least part of said first portion of said tubular element includes a lubricious coating. An internal and an external surface of at least part of said first portion may include a lubricious coating. The lubricious coating may comprise parylene.

The first portion may be integral with said second portion. In another implementation the first portion may comprise a separate component that has been attached to said second portion to form said tubular element.

Preferably the first portion is of a greater diameter than said second portion. The diameter of said first portion may increase towards the distal end of the tubular element.

The first portion may be generally goblet shaped.

The tubular element may be of silicone. The tubular element may have a shore A hardness of 70 to 100, preferably 80 to 90. The balloon may be of silicone. The balloon may have a shore A hardness of 70 to 100, preferably 80 to 90.

The body cavity with which the appliance is to be used may comprise the rectum or a stoma of said subject.

A further aspect of the invention relates to a method of preparing the appliance described herein for introduction into a body cavity of a subject, the method comprising folding the first portion towards the proximal end of said tubular element so that said first portion covers at least part of said second portion to thereby provide an externally accessible recess between said first and second portions.

Another arrangement embodying the teachings of the invention provides a waste management appliance for insertion into a subject's body cavity, the appliance comprising: a tubular element having a proximal end and a distal end, an inflatable balloon surrounding said tubular element at a location spaced from said distal end of the tubular element; wherein a portion of said tubular element between said balloon and said distal end is configured to be folded over the balloon, prior to insertion of said appliance into said body cavity, to at least partly cover the balloon and thereby provide an externally accessible recess into which a finger can be inserted.

Another arrangement embodying the teachings of the invention provides a waste management appliance for insertion into a subject's body cavity, the appliance comprising: an inflatable balloon surrounding a tubular element, the tubular element extending proximally from the balloon to a proximal end and distally from the balloon to a distal end; wherein that part of the tubular element that extends distally form the balloon can be folded in a proximal direction to at least partly cover said balloon and thereby provide an externally accessible recess into which a finger can be inserted.

Other features, advantages and embodiments of the invention are set out hereafter.

Brief Description of the Drawings

Various aspects of the teachings of the present invention, and arrangements embodying those teachings, will hereafter be described by way of illustrative example with reference to the accompanying drawings, in which: Fig. 1 is a schematic cross-sectional view of a distal part of a waste management appliance that embodies the teachings of the present invention; Fig. 2 is a schematic representation of the appliance in Fig. 1 configured for insertion into a subject's body cavity; Fig. 3 is a schematic representation of the manner in which the appliance can be inserted into the subject; and Fig. 4 is a schematic representation of the appliance in Fig. 2 following inflation of the balloon.

Detailed Description of Preferred Embodiments

Particular reference will be made hereafter to a preferred embodiment that is configured for insertion into the rectum of a subject. It should be noted, however, that this application is merely illustrative, and that the appliance disclosed herein could be inserted into any body cavity for waste management purposes.

Fig. 1 is a schematic representation of a distal pad of a waste management appliance 1 that embodies the teachings of the present invention. The appliance comprises a tubular element 3 that extends from a proximal end (not shown) to wards a distal end 5. The tubular element 3 includes a first portion 7 in the vicinity of the distal end 5, and a second portion 9 that is adjacent the first portion and spaced from said distal end S. An inflatable balloon 11 surrounds part of the second portion 9, and in this particular embodiment is located in close proximity to (preferably at) the interface between the first and second portions 7, 9. In common with all other appliances of this type, the balloon is inflatable by means of a lumen (not shown) that extends along the length of the tubular element. The lumen may be incorporated into the wall of the tubular element or attached (wholly or at spaced locations) thereto. If attached to the wall, it is preferred for the lumen to extend inside the tubular element.

In a preferred implementation, the diameter of the first portion 7 is greater than that of the second portion 9. In a particularly preferred implementation (as illustrated) the diameter of the first portion increases towards the distal end 5 of the tubular element 3, so that the first portion is generally goblet-shaped.

In a preferred implementation of the teachings of the invention, the first portion 7 is formed as a separate component and then attached to the inside of the second portion 9 (for example the first portion may be bonded to the second portion by means of a suitable adhesive) to form the tubular element 3. In another implementation, the first and second portions may be integral with one another.

At least part of the first portion 7 may be coated (inside, outside, or inside and outside) with a lubricious coating, such as parylene. Preferably the outside and inside of the first portion are coated with parylene as this aids flow of waste through the tubular element (when the appliance is installed in a subject) and withdrawal of the appliance from a subject). In a preferred implementation at least the first and second portions of the tubular element and the balloon are all formed of a soft, compliant material -for example, silicone with a shore A hardness of about 70 to 100, more preferably with a shore A hardness of about 80 to 90.

The proximal end (not shown) of the tubular element, as is commonplace with appliances of this type, is configured for attachment to a waste storage bag. For example, means may be provided to detachably couple the tubular element to the bag.

That means may comprise, in one implementation, a plate to which the proximal end of the tubular element can be attached, and the bag can be detachably coupled to the plate. In a particularly preferred implementation the coupling between the bag and plate may be configured to allow the bag to rotate relative to the plate so that the orientation of the bag relative to the plate can readily be adjusted.

The tubular element may also include (as is conventional with such appliances) an irrigation lumen (not shown), opening inside the tubular element proximate the distal end, by means of which a practitioner can irrigate the subject's body cavity, for example to attempt to remove any blockages that might occur.

Fig. 1 shows a distal pad of the tubular element in its out of the box" configuration prior to insertion into a subject's body cavity. To ready the appliance for insertion into a subject, as depicted schematically in Fig. 2, the first portion 7 is folded from the initial position shown in Fig. 1 (which position is indicated with dashed lines in Fig. 2) back over at least part of the balloon 11, to form an insertion recess 13 between the folded first portion 7 and the balloon 13. As shown in Fig. 3, the individual charged with inserting the device can then insert their index finger (for example) into the recess 13 and ease the appliance into the subject's body cavity, for example through the anus.

Once inserted, so that the balloon 11 lies inside the body cavity (in the anal example, behind the anal sphincter), the balloon 11 can be inflated, as shown in Fig. 4, by means of the aforementioned inflation lumen to retain the appliance in the subject's body cavity.

As shown, the recess is filled by the inflated balloon so that the first portion extends over part of the balloon and is held taut by the balloon. Inflation of the lumen is typically accomplished by injecting a known amount of fluid (such as warm water) into the inflation lumen, the amount being selected to be sufficient to inflate the balloon without exerting undue pressure on the tissue of the body cavity.

In the context of an appliance with a first portion that has been coated with a lubricious coating (for example, parylene) the coating provides a low-friction surface that reduces the degree to which waste evacuation is hindered. The partial overlap of the balloon by the first portion also allows the lubricious coating to come into contact with tissue inside the body cavity, thereby lessening the extent to which the first portion drags on that tissue if the appliance should move within the cavity!.

To withdraw the appliance from the subject's body cavity, the inflation lumen is opened and the fluid used to inflate the balloon is withdrawn until the appliance is as depicted in Fig. 2. The appliance can then be withdrawn from the body cavity by gently pulling on the tubular element, and as this is done the first portion will tend to move back to the position indicated in Fig. 1.

It will be appreciated that whilst various aspects and embodiments of the present invention have heretofore been described, the scope of the present invention is not limited to the particular arrangements set out herein and instead extends to encompass all arrangements, and modifications and alterations thereto, which fall within the scope of the appended claims.

For example, whilst the appliance will typically have a balloon, it is conceivable that a balloon may not be required for certain applications. In such applications the appliance disclosed herein will still be easier and safer to insert than previously proposed arrangements.

It should also be noted that whilst the accompanying claims set out particular combinations of features described herein, the scope of the present invention is not limited to the particular combinations hereafter claimed, but instead extends to encompass any combination of features herein disclosed.

Claims

CLAIMS1. A waste management appliance for a body cavity of a subject, the appliance comprising: a tubular element having a proximal end and a distal end, the tubular element including a first portion in the vicinity of said distal end, and a second portion adjacent to said first portion and spaced from said distal end, wherein said first portion can be folded over at least part of said second portion so as to provide an externally accessible recess between said first and second portions, the arrangement being such that a finger can be inserted into said recess to facilitate insertion of at least part of the tubular element into the body cavity of the subject.
2. An appliance according to Claim 1, further comprising an inflatable balloon surrounding at least part of said second portion.
3 An appliance according to Claim 2, wherein said balloon surrounds at least pad of said second porlion in the vicinity of the interface between the first and second portions.
4. An appliance according to Claim 2 or 3, wherein said first portion covers at least part of said balloon when folded over at least part of said second portion.
5. An appliance according to any of Claims 2 to 4, wherein said first portion covers at least part of said balloon when the balloon is inflated inside the subject.
6. An appliance according to any of Claims 2 to 5, wherein said tubular element includes an externally accessible inflation lumen that is connected to said balloon.
7. An appliance according to any of Claims 1 to 6, wherein said tubular element includes an externally accessible irrigation lumen that opens proximate said distal end of said tubular element.
8. An appliance according to any of Claims 1 to 7, further comprising a waste collection receptacle.
9. An appliance according to Claim 8, further comprising means for detachably mounting said receptacle to said proximal end of said tubular element.
10. An appliance according to Claim 9, wherein said receptacle mounting means comprises a plate with an opening, and means for attaching said proximal end of said tubular element to said plate, in alignment with said plate opening.
11. An appliance according to any preceding claim, wherein at least pad of said first portion of said tubular element includes a lubricious coating.
12. An appliance according to Claim 11, wherein an internal and an external surface of at least part of said first portion includes a lubricious coating.
13. An appliance according to Claim 11 or 12! wherein said lubricious coating comprises parylene.
14. An appliance according to any preceding claim, wherein said first portion is integral with said second portion.
15. An appliance according to any of Claims 1 to 13, wherein said first portion comprises a separate component that has been attached to said second portion to form said tubular element.
16. An appliance according to any preceding claim, wherein the first portion is of a greater diameter than said second portion.
17. An appliance according to any preceding claim, wherein the diameter of said first portion increases towards the distal end of the tubular element.
18. An appliance according to Claim 16 or 17, wherein said first portion is generally goblet shaped.
19. An appliance according to any preceding claim, wherein said tubular element is of silicone.
20. An appliance according to Claim 19, wherein said tubular element has a shore A hardness of 70 to 100, preferably 80 to 90.
21. An appliance according to any preceding claim, wherein said balloon is of silicone.
22. An appliance according to Claim 19, wherein said balloon has a shore A hardness of 70 to 100. preferably 80 to 90.
23. An appliance according to any preceding claim, wherein said body cavity comprises the rectum or a stoma ot said subject.
24. A method of preparing the appliance of Claim 1 for introduction into a body cavity of a subject, the method comprising folding the first portion towards the proximal end of said tubular element so that said first portion covers at least part of said second portion to thereby provide an externally accessible recess between said first and second portions.
25. A waste management appliance for insertion into a subject's body cavity, the appliance comprising: a tubular element having a proximal end and a distal end, an inflatable balloon surrounding said tubular element at a location spaced from said distal end of the tubular element; wherein a portion of said tubular element between said balloon and said distal end is configured to be folded over the balloon, prior to insertion of said appliance into said body cavity, to at least partly cover the balloon and thereby provide an externally accessible recess into which a finger can be inserted.
26. A waste management appliance for insertion into a subject's body cavity, the appliance comprising: an inflatable balloon surrounding a tubular element, the tubular element extending proximally from the balloon to a proximal end and distally from the balloon to a distal end; wherein that part of the tubular element that extends distally form the balloon can be folded in a proximal direction to at least partly cover said balloon and thereby provide an externally accessible recess into which a finger can be inserted.
27. A waste management appliance substantially as hereinbefore described and/or as shown in the accompanying drawings.