GB1601735A

GB1601735A - Surgical draining appliance

Info

Publication number: GB1601735A
Application number: GB2512078A
Authority: GB
Original assignee: Individual
Current assignee: Individual
Priority date: 1978-05-31
Filing date: 1978-05-31
Publication date: 1981-11-04

Description

(54) SURGICAL DRAINAGE APPLIANCE (71) I, THOMAS GEORGE EAKIN, a British subject of 18 Ballyrogen Road, Greengraves, Newtownards, County Down, Northern Ireland, do hereby declare the invention, for which I pray that a patent may be granted to me, and the method by which it is to be performed, to be particularly described in and by the following statement:- The present invention relates to improved surgical drainage appliances particularly adapted for use for collecting urine or urine and faeces from patients who have undergone ureterostomy or ileostomy or colostomy operations respectively. A consequence of these operations is that the relevant normal body tract is diverted from its usual outlet from the body and is brought out of the body on either side of the stomach area via a piece of bowel, or isolated bowel in the case of ureterostomy, the stoma, or other suitable duct means. The urine or urine and faeces or faeces are then discharged out of the body involuntarily since the outlet of the stoma is not under the control of a sphincter muscle and means have to be provided for continuous collection of this waste matter and intermittent disposal with the minimum of effort on the part of the patient and the minimum of inconvenience.

Conventional appliances of this type comprise a flexible, desirably disposable, bag, for example of thin translucent polymer or plasticized polyvinyl chloride or rubber sheet, provided with an inlet aperture for fitting over the stoma, so that the stoma is in communication with the inside of the bag, and desirably outlet means from the bag and means for securing the bag to the patient in fixed relationship to the stoma.

A device of this type is described in my earlier granted British Patent Specification Serial No. 1 445092.

The present invention is concerned with an improved inlet aperture for such devices but whilst it is ideally applicable to the device shown in the above specification it is not restricted in its application to that device alone.

Conventional devices have a single circular aperture and have to be made in at least 6 separate sizes. The aperture must always be slightly larger than the stoma so as to avoid constricting it. This introduces the problem that the edge of the karaya gum or other pliable washer, which is located around the stoma and which seals the edges of the aperture of the bag to the patients skin, is exposed to urine and faeces. The washer is thus eroded more rapidly than is desirable.

According to my earlier granted British Patent Specification Serial No. 1570181, surgical drainage appliance comprising a flexible bag provided with an inlet aperture for fitting over the stoma so that the stoma is in communication with the interior of the bag and means for securing the bag to the patient in fixed relationship to the stoma is characterised in that the aperture is afforded by a wall of the bag and a plurality of slits extend out from the edge of the aperture, preferably radially, so that the aperture is defined by a series of adjacent flaps located around the aperture.

There are preferable at least 3, 4, 5, or more e.g. up to 12 or more such flaps, 6 to 10 being a preferred range.

In a preferred embodiment the wall of the bag at least in the vicinity of the aperture is made at least double walled and each wall is provided with a plurality of slits so as to afford flaps.

Preferably the slits are offset from one another so that the flaps in one wall overlie the slits in the other wall or the adjacent walls if more than two walls are used.

The multi walled structure can be formed by welding one or more superimposed patches to the back wall to either its outer or preferably its inner face.

According to the present invention there is provided a surgical drainage appliance comprising a flexible bag provided with an inlet aperture for fitting over the stoma so that the stoma is in communication with the interior of the bag and means for securing the bag to the patient in fixed relationship to the stoma, the surface adapted to contact the patients skin being provided by the fibrous surface of a laminated material, which comprises a flexible liquid permeable plastics sheet material, for example of plasticized polyvinyl chloride or polyolefin e.g. polyethylene and a fibrous, preferably cellulose, sheet material adhered thereto in such a way that the fibrous sheet material remains absorbent and is effective to prevent the laminate adhering to the patients skin when the fibrous face of the laminate is applied to the patients skin.

The fibrous face of the laminated material preferably has free fibre ends issuing therefrom and preferably retains a substantial percentage of its thickness or area or both in unimpregnated form.

The laminate is thus effective to prevent a film of sweat from forming between the patients skin and the laminate.

In one preferred form of the invention the fibrous sheet which is used to make the laminated material is a sheet of tissue paper such as is used for towelling; it weighs about 50 grams I sq metre e.g. 20 or 30 or 40 to 50, 60 or 70 grams/m2 and is about 0.1 mms thick e.g. 0.020 to 0.060 inches thick before being adhered to the plastic film which is about 0.005 to 0.020 inches thick. The laminated material is preferably made by adhering the fibrous sheet to the plastics sheet material by a light application of adhesive which may be a discontinuous or preferably a continuous coating. The adhesive is preferably a contart of pressure adhesive and is preferably applied from a liquid vehicle to the plastics film, ideally an aqueous emulsion, allowed to dry or nearly dry and laminated to the fibrous sheet under pressure preferably light pressure.

The laminated material is preferably made by laminating the fibrous sheet to the plastic sheet under pressure using 1 to 20 g/m2 of an aqueous acrylic emulsion as the adhesive and a pressure of 5 to 35 lbs/ sq in.

About 10 g/m2 of an aqueous acrylic emulsion has been found satisfactory using a pressure of 5 to 25 lbs/sq in.

The invention may be put into practice in various ways and one specific embodiment as applied to a bag in accordance with British patent specification Serial No.

1 445092 will be described by way of example with reference to the drawings accompanying the application in which: Figure 1 is a diagrammatic cross sectional view of part of a surgical drainage appliance in accordance with the present invention located on a patient; Figure 2 is a plan view of the aperture structure shown in Figure 1 viewed along the arrow A in Figure 1; Figure 3 is a diagrammatic vertical cross section of the bag in use; Figure 4 is a horizontal cross section on the line IV-IV of Figure 3; and Figure 5 shows a further form of the bag incorporating three modifications.

Figure 1 shows the appliance with its rear wall 151 secured to the patients skin 61 by a Karaya gum washer 152.

The stoma 153 extends through the aperture 154 in the bag. A circular patch 155 is attached to the inside face of the wall 150 by a circular weld 156. The wall 150 has eight flaps 157 formed by radial slits 158 disposed around the aperture 154.

The patch 155 similarly has eight flaps 159 formed by radial slits 160 disposed around the aperture 154 but the flaps 159 overlie the slits 158.

It will be appreciated that the flaps are shown flat in Figure 2. In use they will be partly spread apart in most cases leaving triangular gaps between adjacent flaps 159 and adjacent flaps 157, since as shown in Figure 1 it is preferred to use a size of aperture slightly smaller than the stoma so that the flaps extend some way up the sides of the stoma.

This arrangement permits a single aperture size to accomodate a range of stoma sizes without exposing the washer and without constricting the stoma.

Thus three sizes of aperture namely 1+ inches diameter with the slits being + inches long, 14 inches diameter with the slits being + inches long, and 2+ inches diameter with the slits being i inches long can be used to accommodate stomas having diameters in the range i to 1+ inches, 1+ to 1+ inches and 1+ to 2+ inches respectively.

The drainage bag can be used for any surgical drainage purpose e.g. ureterostomy where only fluids are being drained and the bag acts as an external bladder or ileostomy where both fluids and solids are being drained and the bag acts as an external bladder and bowel combined.

The drainage bag shown in Figure 3 has a front wall 10 which has a generally oval upper half 11 with its long axis vertical in use and leading down into a tail 12 about the same length as the oval upper half 11.

The oval upper half 11 has pleats or folds formed in it to allow it to expand in use e.g. the pleats 13 may be arranged vertically e.g. parallel to each other or diverging apart from each other towards the tail 12.

Behind the front wall 10 is a one way valve wall 20 which extends about half way down the oval upper half 11 of the front wall.

Behind the wall 20 is an intermediate or flushing wall 30 of the same shape as the front wall 10 but having a hole 31 for the stoma in the centre of the upper half of the oval upper half 11 and no pleats.

This wall 30 also has an arcuate arrangement of small flushing holes 32 located above the hole 31 and spaced about one radius of the hole 31 from its edge.

Behind the wall 30 is a back wall 40 of the same shape as the wall 30 except that it does not have the flushing holes 32 above its hole 41 for the stoma. Also the bottom of its tail 42 is chamfered at 43 rather than being square. wall 40 is an attachment wall Behind the wall 40 is an attachment wall 50 which is circular but could be of any desired shape. It has a central stoma hole 51 of the same size as the holes 31 and 41.

Also behind the wall 40 there is a pouch or bag 45 into which the tails 12, 33 and 42 can be folded. This feature is subject matter of my British patent specification No.

1 370 622.

The wall 20 carries a pair of vertically disposed air bubble cushions 24. The air bubble cushion arrangement has been found surprisingly not only to separate the valve wall from the intermediate wall and thus prevent pressure being applied to the stoma but also to preserve an air space around the stoma during use. This air space seems to reduce the tendency for faeces (when used in ileostomy to be pressed around the stoma.

This has the advantage that sincefaeces tend to digenst the stoma, avoiding such digestion enables the bag to be used for longer periods of time.

The description of the assembly of the bag is given in my British patent specification Serial No. 1 445 092 and it is not thought necessary to repeat it.

The bag is made from plastics sheet material and conveniently is made from a soft plasticised polyvinyl chloride or polyethylene or polypropylene film and the components can be attached together by any suitable method but heat and pressure welding is the most convenient method. Any suitable thickness of film can be used and preferably a transparent or translucent film is used. However an opaque film could be used if desired.

With polyethylene film thicknesses in the range 0.005 inches to 0.020 inches are satisfactory but thick film e.g. up to 0.050 inches or more could be used. The film should however by such that the appliance is flexible and thus takes up the minimum of space and is cheap thus being disposable if necessary.

Ultra violet light degradable plastics could be used as could biodegradable plastics.

The appliance is used as follows: A double sided adhesive plaster 65 has a hole cut in it to surround the stoma and is applied to the stomach wall 61 surrounding the stoma. The stomach wall has been cleaned and suitably prepared. A load bearing supporting arrangement is slipped between the wall 50 and the wall 40. This arrangement is usually a disc 66 of strong plastic with a central hole for the stoma and lugs at opposite sides for attachment to a sling or belt which passes round the patients body.

The Karaya washer 152 is located in the pouch 53 and the bag slipped over the stoma and pressed against the adhesive plastic and the sling or belt secured around the patients body.

Instead of a Karaya washer other plastics gum ring washers can be used e.g. of other polysaccharide natural gum or an equivalent synthetic gum which may be blended with a non volatile carrier e.g. an oil such as glycerine to render the composition softer and preferably such as to melt slightly under body heat so as to conform very accurately to the stoma 60 and stomach wall 61 and form a good seal.

AIternatively a soft plastics flange or compressible foam ring could be used.

The bag 10 has the same general shape and internal structure as described above but the flushing channel 42 is replaced by a flushing channel 170 formed between the front and back walls at the top end of the bag. This simplifies the structure and enables the flushing to be carried out more easily and also under gravity. A loop 175 is attached to flushing channel so that when the channel is not in use it can be closed by being rolled up and inserted into the loop.

In the second modification the patch 155 is made to extend beyond the circular weld 156 to form a further annular pocket 171 and a rigid polymer ring 172 is located in this pocket and secured in place by a further circular weld 173. The ring 172 may be of PVC and can be about 0.5 to 1.5 e.g.

1 mm thick and about 3 to 5 mms wide e.g. 4 mms wide and preferably has rounded edges. It has an external diameter appropriate to the aperture size and the size of the slits.

The third modification is to provide integral attachment means for the belt.

These are formed at the top corners of the bag by weld lines 176 and 177 closing off the corner of the bag and by securing a rigid or flexible reinforcing element 178 defining an eyelet 179 either between the front or back wall or on either wall e.g.

by glueing of welding.

The reinforcing element could be of rigid PVC e.g. 0.5 to 1.5 mms thick or other tough weldable polymer or of flexible PVC sheet e.g. thicker than the rest of the bag e.g. 0.010 to 0.030 inches, (0.25-0.75 mms) thick.

An example of the laminate material in accordance with the present invention will now be given.

Example A sheet of flexible PVC material 0.010 inches thick was coated with an aqueous acrylic adhesive emulsion and allowed to almost dry. The coating weight was 10 g/m2 (solids).

A sheet of porous tissue paper weighing 47 g/m2 was then laminated to the adhesive coating using a rubber backed roll beneath the PVC sheet and a steel roll against the tissue paper. The nip was 5 feet across and the nip pressure was 200 lbs. The backing roll distorted only slightly so that the nip length was in the range +" to i" long, i.e.

the laminating pressure was in the range 30 to 10 p.s.i.

The product was evenly adhered and presented a porous open surface.

A translucent plastic tube of 2 mm inter- nal diameter was filled to a depth of 1 cm and the drop at the end of the tube wiped off. A drop of water was placed on the tissue side of the laminate, the level in the tube dropping to 6.5 mms. i.e. the droplet volume was 7r x 4 x 3.5 cubic mms. The droplet was about 4 mms across when first placed on the tissue. It slowly spread outwards and had become flat in 2.5 minutes reaching a radius of 0.9 cms and was completely absorbed in 3 minutes. When a drop was placed on the unlaminated PVC surface it had still retained its unspread drop shape after 5 minutes.

The fibrous surface of the laminate is highly fibrous having fibres up to 2 mm long extending out from its surface.

In accordance with the invention the walls 40 and 45 and 150 of the device shown in Figures 1 to 5 are provided by the material described above. If desired all the outside surfaces can be provided by material in accordance with the invention.

The fibrous surface is absorbent and de sirably has an absorption time of not more than 10 minutes. The absorption time is defined herein as the time taken for the sheet to absorb a drop of water of 4.4 cubic millimetres volume applied from a tube of 2 mm internal diameter applied at one point on its surface. The absorption time may be in the range 1, 2 or 3 to 10 minutes and preferably less than 5 minutes. The term absorbent is used herein in the general sense of meaning that the fabric picks up moisture; the fabric will perform its desired function whether the liquids which are picked up are held within the fibres or between the fibres or in both these ways.

WHAT I CLAIM IS: 1. A surgical drainage appliance comprising a flexible bag provided with an inlet aperture for fitting over the stoma so that the stoma is in communication with the interior of the bag and means for securing the bag to the patient in fixed relationship to the stoma, the surface adapted to contact the patients skin being provided by the fibrous surface of a laminated material, which comprises a flexible liquid impermeable plastics sheet material, and a fibrous sheet material adhered thereto in such a way that the fibrous sheet material remains absorbent and is effective to prevent the laminate adhering to the patients skin when the fibrous face of the laminate is applied to the patients skin.

2. A surgical drainage appliance as claimed in Claim 1 in which the fibrous face of the laminated material has free fibre ends issuing therefrom and retains a substantial percentage of its thickness or area or both in unimpregnated form.

3. A surgical drainage appliance as claimed in Claim 1 or Claim 2 in which the fibrous sheet which is used to make the laminated material is a sheet of tissue paper weighing 20 to 70 grams/m2 before being adhered to the plastic sheet material.

4. A surgical drainage appliance as claimed in Claim 1, 2 or 3 in which the laminated material is made by adhering the fibrous sheet to the plastics sheet material by a light application of adhesive which is a continuous coating.

5. A surgical drainage appliance as claimed in Claim 4 in which the laminated material is made by laminating the fibrous sheet to the plastics sheet under pressure using 1 to 20 g/m2 of an aqueous acrylic emulsion as the adhesive and a pressure of 5 to 35 lbs/sq in.

6. A surgical drainage appliance as claimed in any one of Claims 1 to 5 in which the fibrous surface of the laminated material has an absorption time as defined herein of not more than 10 minutes.

7. A surgical drainage appliance as claimed in any one of Claims 1 to 6 in which the aperture is afforded by a wall of the bag and a plurality of slits extend out from the edge of the aperture so that the aperture is defined by a series of adjacent flaps located around the aperture.

8. A bag as claimed in Claim 7 in which the slits extend radially from the aperture.

9. A bag as claimed in Claim 7 or Claim 8 in which there are three to twelve such flaps.

10. A bag as claimed in any of Claims 1 to 9 in which the wall at least in the vicinity of the aperture is made at least double walled and each wall is provided with a plurality of slits so as to afford flaps.

11. A bag as claimed in Claim 10 in which the slits are offset from one another so that the flaps in one wall overlie the slits in the other wall or the adjacent walls if

**WARNING** end of DESC field may overlap start of CLMS **.

Claims

**WARNING** start of CLMS field may overlap end of DESC **. An example of the laminate material in accordance with the present invention will now be given. Example A sheet of flexible PVC material 0.010 inches thick was coated with an aqueous acrylic adhesive emulsion and allowed to almost dry. The coating weight was 10 g/m2 (solids). A sheet of porous tissue paper weighing 47 g/m2 was then laminated to the adhesive coating using a rubber backed roll beneath the PVC sheet and a steel roll against the tissue paper. The nip was 5 feet across and the nip pressure was 200 lbs. The backing roll distorted only slightly so that the nip length was in the range +" to i" long, i.e. the laminating pressure was in the range 30 to 10 p.s.i. The product was evenly adhered and presented a porous open surface. A translucent plastic tube of 2 mm inter- nal diameter was filled to a depth of 1 cm and the drop at the end of the tube wiped off. A drop of water was placed on the tissue side of the laminate, the level in the tube dropping to 6.5 mms. i.e. the droplet volume was 7r x 4 x 3.5 cubic mms. The droplet was about 4 mms across when first placed on the tissue. It slowly spread outwards and had become flat in 2.5 minutes reaching a radius of 0.9 cms and was completely absorbed in 3 minutes. When a drop was placed on the unlaminated PVC surface it had still retained its unspread drop shape after 5 minutes. The fibrous surface of the laminate is highly fibrous having fibres up to 2 mm long extending out from its surface. In accordance with the invention the walls 40 and 45 and 150 of the device shown in Figures 1 to 5 are provided by the material described above. If desired all the outside surfaces can be provided by material in accordance with the invention. The fibrous surface is absorbent and de sirably has an absorption time of not more than 10 minutes. The absorption time is defined herein as the time taken for the sheet to absorb a drop of water of 4.4 cubic millimetres volume applied from a tube of 2 mm internal diameter applied at one point on its surface. The absorption time may be in the range 1, 2 or 3 to 10 minutes and preferably less than 5 minutes. The term absorbent is used herein in the general sense of meaning that the fabric picks up moisture; the fabric will perform its desired function whether the liquids which are picked up are held within the fibres or between the fibres or in both these ways. WHAT I CLAIM IS:

1. A surgical drainage appliance comprising a flexible bag provided with an inlet aperture for fitting over the stoma so that the stoma is in communication with the interior of the bag and means for securing the bag to the patient in fixed relationship to the stoma, the surface adapted to contact the patients skin being provided by the fibrous surface of a laminated material, which comprises a flexible liquid impermeable plastics sheet material, and a fibrous sheet material adhered thereto in such a way that the fibrous sheet material remains absorbent and is effective to prevent the laminate adhering to the patients skin when the fibrous face of the laminate is applied to the patients skin.

more than two walls are used.

12, A bag as claimed in Claim 10 or Claim 11 in which the multi-walled structure is formed by welding one or more superimposed patches to the back wall to either its outer or its inner face.

13. A bag as claimed in Claim 1 substantially as specifically described herein with reference to the accompanying drawings.