GB2191095A - Device for facilitating the attachment of appliances to the penis - Google Patents

Abstract

A device for facilitating the attachment of medical appliances to the penis, such as a male incontinence device or a device for attaching a bladder catheter to the penis, includes a split ring of closed cell compressible foam material of substantial radial thickness and whose inside diameter is such that the ring when applied to encircle the penis immediately behind the corona of the glans is a snug fit on the penis but does not apply any significant compression thereto, and a tubular member dimensioned to encircle and fit over the external surface of the ring to hold it closed on the penis. The ring may be held closed by a simple clip-on encircling member. <IMAGE>

Description

SPECIFICATION Device for facilitating the attachment of appliances to the penis This invention relates to a device for facilitating the attachment of medical appliances to the penis. One example of the invention is embodied in a male incontinence device. Another example is a device for attaching a bladder catheter to the penis.

According to the invention, a device for facilitating attachment of a medical appliance to the penis includes a split ring of closed cell compressible foam material of substantial radial thickness and whose inside diameter is such that the ring when applied to encircle the penis immediately behind the corona of the glans is a snug fit on the penis but does not apply any significant compression thereto, and a tubular member dimensioned to encircle and fit over the external surface of the ring to hold it closed on the penis.

An important application of this invention is in a male incontinence device.

Many different types of male incontinence device are known. The most common type currently in use is based on the condom, that is to say a thin walled latex sheath which has a urine drainage outlet at one end.

There have been many problems in attaching male urinary drainage devices to the penis. The penis is protusile, loose skinned, highly evascular, sometimes flacid, sometimes erectile, and these characteristics make it difficult to provide a leak-proof securing method which is comfortable and does not give rise to medical difficulties such as irritative or allergic reactions, or compressive effects such as penetrating or non-penetrating lesions. These problems are particularly acute in paraplegic patients, and reference may be made to a learned paper "Complications of External Condom Drainage" by Hossein Golji, M.D., published in the journal "Paraplegia" 19 (1981) by the International Medical Society of Paraplegia. The paper is found at pages 189197.

Frequently condom-type urinary drainage devices have been secured using adhesive tape. Devices of this kind are described in the following U.K. published patents and applications:- 1 459486 (Rogers Ind.), 2094632 (Bullen), 2096901 (Bard Inc.) and 2099706 and 7 (Hollister).

Another approach is to provide a condom with an adhesive on its interior surface so that when the condom is unrolled onto the penis, the inner surface of the condom is bonded to the outer skin of the penis. While this arrangement has some advantages, see for example U.K. Patent Application No. 2 106784 (Mentor Corp), it suffers from serious disadvantages. Firstly, for removal one must break the bonding between the condom and the skin of the penis and this is often difficult and painful for the patient. Secondly, when applying it, if it should be mis-positioned or mis-applied or a fold of skin should be trapped, no correction can be made without unsticking the device, which is either difficult or painful or both. In other words, in applying this kind of device one has one chance, and one chance only, to get it right.

It would be desirable to have a male incontinence device which allowed visual inspection of the penis without removing the device. It would be desirable to have a device which is virtually leak-proof under all conditions of wear, but at the same time is readily removed. In view of the reluctance of some nursing personnel to handle the male genital organ, it would be desirable if a male incontinence device was such that it could be applied to the patient with a minimum of handling of the organ. Many male incontinence devices now on the market do not cope adequately with spontaneous erections.It can be said that the currently used methods of attachment of male incontinence devices do not take adequate account of the physiological requirements for urogenital vitality and may give rise to one or more of the following pathalogical conditions: penile irritation, soreness, allergic reaction, impaired vascular function, odoema, maceration, tissue erosion, and infection.

It is an aim of the present invention as embodied in a male incontinence device to greatly alleviate or totally overcome these problems.

According to one aspect of the invention, there is provided a male incontinence device comprising firstly a urine conducting member, e.g. a substantially rigid cup or a condom, having in either case an outlet orifice, and secondly a means for attaching the member to a penis, characterised in that said means includes a split ring of closed cell compressible foam material of substantial radial thickness and whose inside diameter is such that the ring when applied to encircle the penis immediately behind the corona of the glans is a snug fit on the penis but does not apply any significant compression thereto, the ring being held closed and in that position on the penis by location of part of the urine conducting member to encircle the external surface of the ring.

While it is possible for extra security of attachment to wind adhesive tape around the device and the penis, in the great majority of cases this will be entirely unnecessary and the location of the part of tubular (or urine conducting) member externally of the ring holds the ring closed, applying only minimal pressure to the penis.

That is, the ring and the member together are usually the sole means whereby the device is held on the penis.

Use of an adhesive between the skin of the penis and part of the incontinence device is accordingly completely unnecessary, this being a departure from, and an important advantage over, the recent trend of development in this art, as exemplified by U.K. Patent Application Nos. 2099706 and 2 106 784.

According to the presently-preferred male incontinence embodiment of the invention, the urine conducting member approximates to a cylindrical-mouthed funnel and the diameter of its larger end is chosen to be complementary to the O.D. of the split ring. That is, the end of the funnel is a gentle push fit over the ring when it encircles the penis just behind the corona of the glans. A portion of the inner surface of the funnel mouth may be, but need not be, roughened to enhance the frictional grip between it and the external surface of split ring.

The split ring is preferably of a closed cell polyethylene which has been foamed with a gas of an inert nature such as that known as "FREON" (R.T.M.) and the ring cross-section is preferably rectangular. The ring thickness may be from about 4 mm to about 16 mm, preferably from about 5 to about 12 mm, and more preferably from about 6 to about 10 mm. The ring l.D. may be 15 to 25 mm, and the axial length of the ring may be 10 to 30 mm, preferably 15to 25 mm, and more preferably 17 to 23 mm. The split in the ring may be made by a cut in an axial plane, and one or both of the facing ring surfaces exposed by the cut may be provided with a low bond strength adhesive. This lightly holds the split ring closed around the penis shaft during application, exerting only minimal pressure on the penis.Hence no obstruction or pinching of blood vessels within the penis occurs and the device is highly comfortable to wear. It is believed that the surprisingly high degree of comfort arises because the soft compressible nature of the foamed ring facilitates even load spreading over the whole of the inner surface of the ring. The surprising security of attachment is believed to occur (according to the Applicants' present best knowledge and belief) because any force tending to pull the device off the end of the penis first results in the device together with the penis skin thereunder sliding towards the end of the penis. Some of this skin "piles up" behind the corona of the glans.The head of the penis would in most cases prevent passage past it of the closed split ring, but this build up of skin makes it even more unlikely that the split ring can be pulled off, the ring at this time being held closed since it is encircled by the tubular member, e.g. the cylindrical mouthed funnel. To remove the device from the penis, a tab attached to the split ring is gripped while the member is removed. Holding the tab prevents longitudinal movement of the ring relative to the penis shaft and enables the cylindrical mouthed funnel to be easily pulled off the ring, after which the ring is opened and removed from the penis.

According to another embodiment of the invention, a split ring of the kind described is utilised in the way previously described but it is held onto the penis by a condom-type urine conducting member instead of by a cylindrical mouthed funnel. A condom having a urine drain tube such as is conventional in male incontinence is employed and its free end is stretched over the closed split ring disposed on the penis immediately to the rear of the corona of the glans. The stretched condom due to its own elasticity applies some inward force to the ring but due to the foamed closed cell nature and load spreading property of the ring, the pressure on the surface of the penis is only increased by a very small amount; no discomfort and no blood vessel constriction is caused.When it is desired to remove the device from the wearer the condom outer end is stretched and removed from the split ring, and the split ring is opened and removed from the penis. While the condom end is over the split ring, the ring cannot be opened and any pulling force tending to pull the device off the penis is resisted by a piling up of mobile skin behind the corona in the manner already described.

Use of a split-ring and tubular member to retain a bladder catheter in position has numerous advantages as will appear from the following description.

Embodiments of the invention will now be particularly described, by way of explanation and not of limitation, with reference to the accompanying drawings in which :- Figures 14 illustrate a first embodiment of male incontinence device according to the invention; and Figure 5 illustrates a second embodiment of incontinence device according to the invention.

Figure 1 is a side elevation partly in section showing the first embodiment of the invention applied to a penis, Figure 2 is a plan view of a split ring forming part of the device shown in Figure 1, and Figures 3 and 4 are respectively cross-sections on the line 3-3 and 4-4 looking in the indicated directions.

Figure 5 is a view similar to Figure 1 but illustrating a device having a condom type urine conducting member.

Figure 6 illustrates an alternative embodiment of tubular urine conducting member; Figures 7 and 8 illustrate one form of applicator employed for applying a male incontinence device of the kind shown in Figure 5; and Figures 9 and 10 illustrate respective embodiments of the invention in the form of a catheter-retaining device.

Referring firstly to Figures 1-4, the illustrated male urinary drainage device includes a urine conducting member 10 having a drainage pipe 12 and a means 14for attaching the member 10 to the penis 16. The said means 14 is a split ring of closed cell compressible foam material which has a substantial, i.e. non negligible, radial thickness. As illustrated, the ring 14 is applied to encircle the penis immediately behind the corona 18 of the glans 20 of the penis. The ring 14 being flexible can be opened at the split 22 and wrapped around the penis. When in position immediately behind the corona it is a snug fit on the penis but does not apply any significant compression thereto, this being achieved by choice of a suitable internal diameter d (Figure 2) for the ring. Normally it will be sufficient to provide the ring in three different sizes.

For example, the split ring could be provided in pediatric, adolescent and adult sizes, which may be tabulated as follows, all dimensions being quoted in millimetres: TABLE A Ring wall Axial Internal Thickness Length Diameter Pediatric 6 to 9 10 to 15 10 to 20 Adolescent 6 to 9 14 to 18 15 to 22 Adult 9 to 13 15 to 20 22 to 30 If desired, adhesive may be applied to one or other of the confronting surfaces exposed by the cut 22.

The ring 14 is held on the penis by sliding thereover the open end of the urine conducting member 10 which in this embodiment of the invention is constituted by a cylindrical mouthed funnel having a generally cylindrical wall portion 24 and a tapering portion 26 leading to the outlet pipe 12. A portion 28 of the internal wall of the funnel portion 24 may be roughened or abraded or otherwise have its frictional properties increased if desired although this is not normally necessary. There is no adhesive or other form of attachment between the surface 28 and the split ring 14. Despite this, the security of attachment of the device to the penis 16 is found to be fully adequate.A pull tab 30 is attached to the split ring 14 (for simplicity the tab 30 is not shown in Figure 2) and it is found that by grasping the tab 30 and gently withdrawing the cylindrical funnel 10 in an axial direction the two parts of the device are readily separated. However, if a similar axial force is applied to the member 10 without the pull tab 30 being held it is found that the device cannot be removed from the penis. The cylindrical mouthed funnel is preferably made of a transparent plastics material as this allows the penis to be inspected without removing the device. A urine drainage system of any desired kind may be fitted to the drainage outlet 12. For example, a tube coupling of the kind described and illustrated in U.K. Patent Number 2092690 may advantageously be employed to fix a drainage tube to the outlet 12.

This method of attaching an incontinence device to the penis imposes no constraints upon the vascularity, tumescence or detumescence of the penis and the device has a minimal contact area with the penile tissue.

Moreover, compression or constriction of the penis is kept to an absolute minimum and, in practice, is found not to be noticeable by a wearer. The device as illustrated is lightweight, may be made odour-free, is aseptic, disposable, inexpensive and easy to apply and remove, even by non-dexterous persons. It can be applied to males whether circumsised or not and if not circumsised with the prepuce (foreskin) either retracted or non-retracted. It is advantageous in the case of obese, elderly patients who suffer from penile retraction as it prevents retraction of the penis. The device, unlike many adhesively secured devices, does away with the problems of cleaning the penis before and after use and in particular totally avoids any elastic sheath-induced constriction of the blood vessels within the penis.

While the many advantages of the slide-on, slide-off cylindrical mouth funnel urine conducting member make this the preferred embodiment of the invention, some of the advantages of the split ring arrangement described can be obtained without utilizing such a funnel. A second embodiment of the invention is accordingly described.

In Figure 5, a male incontinence device is shown consisting of a split ring 50 of the kind previously described which encircles a penis 52 and is held thereon by stretching the open end 54 of a condom 56 so that it encircles the outer peripheral surface of the split ring 50. The lower end of the condom 56 is provided, in conventional manner, with an outlet pipe 58. This is connected in any known manner to a urine drainage tube leading to a leg bag or other urine receptacle. The ring 50 has a pull tab 60 as illustrated but this is not essential and may be dispensed with. As seen in Figure 5, the rolled end 62 of the condom is located just to the rear of the split ring 50.

This embodiment of the invention avoids any constriction of blood vessels within the penis and has the advantage that it is somewhat less bulky than the first embodiment of the invention.

The preferred dimensions of split ring usable in the Figure 5 embodiment of the invention are substantially the same as those described above with reference to Figures 1-4.

Figure 6 illustrates, in central vertical cross-section through a penis 70 having a head or glans 72, a urine-conducting member 74 of a particular shape intended to prevent the head of the penis becoming splashed or imersed in urine if the wearer is either supine in bed or is liable to make erratic uncontrolled releases or "spurts" of urine. The member 74 is made of a soft stretchable material, preferably transparent or translucent, e.g. latex rubber or synthetic rubber. It is shaped so that a first or outer portion 76 has an unstretched diameter which is slightly smaller than the outside diameter of the split ring 78. When stretched over the split ring it holds the split ring closed in the same manner as already described with reference to Figure 5. The split ring 78 may take the form particularly described with reference to Figures 1-4.The urine conducting member 74 has a second or intermediate portion 80 which is formed to closely engage the head of the penis, and a third or drain outlet portion 82 which can be connected to a drain tube (not shown) in a known manner. The snug engagement of the portion 80 with the head 72 and the location of the portion 82 substantially opposite to the outlet 84 of the urethra is intended to ensure minimal or no contact of expelled urine with the outer skin of head 72. This arrangement also has an advantage that the stretchable nature of the portion 76 allows some radial expansion movement of the split ring 78 if this should be necessary, e.g. if a "spurting" of urine was accompanied by an erection. Techiques for shaping or forming the member 74 in the manner described are known to those skilled in the relevant art and are therefore not described here.

Figure 7 illustrates an applicator 90 by a short length 92 of a substantially rigid plastics tube having a flange 94. This is employed to apply a male incontinence device of the kind shown in Figure 5 or Figure 6, the illustrated device 96 shown in Figure 7 being the Figure 5 type. In use, one starts with the male incontinence device 96 with its open end stretched over the tube 92, and the applicator is brought near to the head 98 of the penis by the nurse, to the position substantially as shown in Figure 8, but with the right hand end of the applicator 90 almost in contact with the face 102 of the split ring 104. Then the free end portion 100 of the male incontinence device 96 is "rolled" off the applicator by the nurse using a finger and thumb pushing action and it takes up the position seen at 1 00A in dotted line.In this position it holds the split ring 104 on the penis in the manner described above with reference to Figures 14. The applicator has the advantage that allows nurses and other persons who wish to avoid handling the male organ to make effective use of an incontinence device according to the invention.

Catheter retainers according to the invention are illustrated in Figures 9 and 10.

Referring now to Figure 9, this shows a penis 110, a split ring 112, and a funnel-shaped rigid tubular member 114. The funnel narrows to a tube 116 whose inner diameter is chosen to comfortably accommodate a bladder catheter 118. Any suitable form of bladder catheter may be used and in particular catheters without retention balloons may be used, which is a considerable advantage since these are more expensive than simple catheters. A more important point is that sometimes balloon catheters give rise to acute difficulties in removal if the balloon cannot be deflated/retracted when desired. The catheter 118 is retained in position by a short rubber tube 120, of high elasticity and preferably with a relatively high-friction inner surface, which is placed as illustrated so as to overlap a short length of the catheter 118 and the outer portion of the tube 116.In use, the tube 120 tightly grips both the catheter 118 and the tubular member 114, so holding the catheter securely in position.

An alternative catheter retention arrangement is shown in Figure 10. In this, a tubular member 124 of latex orrubberorthermoplastics moulding of the shape illustrated has first portion 126 which is a stretch fit over a split ring 128, a second portion 130 which snugly conforms to the head 132 of the penis, and a relatively thin tubular portion 134 which is dimensioned to snugly engage a tubular bladder catheter 136. At least the portion 134 is of high elasticity so that in use it firmly grips the catheter 136. In this case also, it is possible to use a catheter not having a retention balloon. The employment of a split-ring of closed-cell compressible foam material of substantial radial thickness and a tubular member to hold it in position on the penis gives a catheter retainer which is comfortable to wear and which has reliable security of retention over prolonged periods.

It will be appreciated that modifications can be made without departing from the invention, the essential concept of the invention involving the employment of a split ring which snugly surrounds the penis immediately behind the corona of the glans and is held thereon by a tubular member.

Claims (14)

1. Adeviceforfacilitating attachment of a medical appliance to the penis including a split ring of closed cell compressible foam material of substantial radial thickness and whose inside diameter is such that the ring when applied to encircle the penis immediately behind the corona of the glans is a snug fit on the penis but does not apply any significant compression thereto, and a tubular member dimensioned to encircle and fit over the external surface of the ring to hold it closed on the penis.

2. A male incontinence device comprising firstly a urine conducting member, e.g. a substantially rigid cup or a condom, having in either case an outlet orifice, and secondly a means for attaching the member to a penis, characterised in that said means includes a split ring of a closed cell compressible foam material of substantial radial thickness and whose inside diameter is such that the ring when applied to encircle the penis immediately behind the corona of the glans is a snug fit on the penis but does not apply any significant compression thereto, the ring being held closed and in that position on the penis by location of part of the urine conducting member to encircle the external surface of the ring.

3. A male incontinence device according to claim 2 in which the urine conducting member approximates to a cylindrical-mouthed funnel and the diameter of its larger end is chosen to be complementary to the O.D.

of the split ring, that is to say, the end of the funnel is a gentle push fit over the ring when it encircles the penis just behind the corona of the glans.

4. A male incontinence device according to claim 3 in which a portion of the inner surface of the funnel mouth is roughened to enhance the frictional grip between it and the external surface of the split ring.

5. A male incontinence device according to claim 2,3 or 4 in which the split ring is preferably of a closed cell polyethylene which has been foamed with a gas of an inert nature (such as that known as "FREON" R.T.M.) and the ring cross-section is substantially rectangular.

6. A device according to any of claims 2-4 including a condom-type urine conducting member whose open end is stretched over the split ring to hold it closed.

7. A device according to claim 1 including an encircling member constructed to hold the split ring closed and to hold a bladder catheter in position.

8. A device according to any one of claims 1-7 including a pull-tab attached to the split ring.

9. A device according to any one of claims 1-8 in which the ring thickness is from 4 to 16 mm.

10. A device according to any one of claims 1-9 in which the ring l.D. is from 15 to 25 mm.

11. A device according to any one of claims 1-10 in which the axial length of the ring is from 10 to 30 mm.

12. A male incontinence device substantially as herein described with reference to and as illustrated in Figures 1-5.

13. A male incontinence device substantially as herein described with reference to and as illustrated in Figures 68.

14. A bladder catheter retaining device substantially as herein described with reference to and as illustrated in Figure 9 or Figure 10.