AN EXTERNAL CATHETER FOR MALE URINARY INCONTINENCE EQUIPMENT, A METHOD OF MANUFACTURING SUCH A CATHETER AND AN APPARATUS FOR CARRYING OUT THE METHOD

Abstract: In an external catheter for a male urinary incontinence equipment, the inside of a soft, elastic, thin-walled body portion (1) is provided with a pressure sensitive adhesive layer (3). In order to make the catheter available for delivery with its body portion rolled up from the open end of the catheter towards the end (4) at a drainage tube the outer side of the body portion (1) is povided opposite the adhesive layer (3) with a cover layer (2) having an adhesive rejecting surface, preferably in the form of a foil. In the production of the catheter the pressure sensitive adhesive layer may be applied to a cylindrical mandrel by winding a strip-like material round it, following which the body portion is mounted in the form of a finished mantel on the adhesive layer, and the cover foil is applied to the outside of the body portion.

Description: An external catheter for male urinary incontinence equipment, a method of manufacturing such a catheter and an apparatus for carrying out the method. The invention relates to an external catheter for male urinary incontinence equipment comprising a soft, thin-walled, substantially cylindrical body portion which is open at one end and merges at the other end into a narrowed drainage tube portion to be connected with a collecting bag, said body portion being provided on its inside with an adhesive. Catheters of said kind are designed to be arranged as a condom on a penis in order to act as an aid against male incontinence in a safe manner free of leakage and with the fewest possible ' inconveniences to the users, who may be physically handicapped or elderly persons for whom greater openness concerning problems of incontinence has led to a growing demand for such aids. In order to securely fasten the catheter various accessories can be used in the form, inter alia, of se¬ parate adhesive tapes, as known from US patent No. 3,520,305, adhesive linings wound around or attached to the penis prior to arrangement of the catheter as known from US patent No. 4,187,851, or particular, compress¬ ible hydrophilic or hydrophobic lining members, as known from GB published patent specification No. 2,096,901. From US patent No. 3,788,324 a catheter of the above mentioned kind is known, having an adhesive on its inside, thereby eliminating the use of special fastening means. Due to the adhesive, this catheter is delivered in an unfolded condition, and in order to facilitate the arrangement it is slotted almost on the total length of the body portion. During the manufacture the catheter must be turned inside out in respect of the application of adhesive, and it must therefore be turned outside in, to the state of use, which may damage the catheter. Due to the slotting a gel-like adhesive is required capable of providing tightening against leakage of urine back¬ wards from the end at the drainage tube. From GB patent No. 2,106,784 another design is known in which a pressure sensitive adhesive layer is applied to the outside of the body portion on an ad¬ hesive releasing layer of silicone rubber so that the adhesive layer when rolling up the catheter to be deli¬ vered in a rolled-up condition will be transferred from the outside of the body portion to its inside. The anu- facture of said catheter is laborious in that subsequent to the forming of the body portion by immersing a mandrel into a latex solution, it is necessary to effect rinsing and drying prior to the application of the sili¬ cone rubber layer, following which this layer must further be hardened before the application of adhesive which may be troublesome due to bad adherence to the surface of the silicone rubber layer. In order to remedy these deficiencies and drawbacks of the said known products an external catheter of the kind concerned is according to the invention characterized in that the adhesive comprises a pressure sensitive adhesive and that with a view to deliver the catheter with the body portion rolled up from the open end towards the end at the drainage tube at least the part of the outside of the body portion which is opposite the adhesive is provided with a cover layer having an adhesive rejecting surface. As a result of the combination of an adhesive on the inside of the body portion and the said cover layer on the outside the catheter can be mounted safely and free of leakage when unrolling it from the rolled-up condition in which it is delivered. As no transfer of adhesive is taking place from one surface to another, difficulties are eliminated when unrolling and thus also the risk thereby involved of damaging due to too strong adhesion to the outside or to insufficien adhesive adherence to the inside, and the production of the catheter provides for a good adhesive adherence to the inside. In the rolled-up condition the cover layer on the outside ensures that neighbouring windings will not stick together throughout the length where the adhesive is applied. As a result of the improved security it is not necessary to apply the adhesive throughout the length of the body portion. A fully sufficient security for safe fastening is obtained by a preferred embodiment in which the adhesive layer and the cover layer extend across a strip-like zone on the inside and outside, respectively, of the body portion. As, contrary to the prior catheter according to the aforementioned GB patent, no different ability of adhesive adherence of the outside of the body portion is required, apart from the area provided with said cover layer, the body portion may be produced as a single- layer component of slight thickness, thereby increasing the convenience for the user. The invention further relates to a method of manufacturing a catheter of the kind concerned, which is characterized in that a prefabricated body portion is arranged on a substantially cylindrical mandrel and is provided with a pressure sensitive adhesive on its inside, following which a cover layer with an outwardly facing adhesive rejecting surface is applied to its out- side at least to the portion which during subsequent rolling-up will be opposite the adhesive. By this method the manufacture is facilitated and the production costs reduced due to the fact that the body portion may be available as a pre-fabricated sheath and that adhesive may be easily applied in a desired, accurately measured amount with certainty of uniform results. According to a preferred embodiment said method may be carried out in that the adhesive layer is applied to the mandrel prior to the arrangement of the body por- tion by winding an adhesive rejecting zone on the man¬ drel with a pre-fabricated adhesive tape provided with adhesive on both sides, the adhesive applied to the side of the tape opposite the mandrel being a pressure sen¬ sitive adhesive. It is thereby achieved that all components of the catheter, i.e. the body portion, the internal adhesive and the external cover layer may be available as pre¬ fabricated components so that the use of components in a liquid state in the production is avoided. The use of a pre-fabricated adhesive tape opens in an advantageous manner the possibility of a very accurate dosing of ad¬ hesive. As a second possibility of a simple and rational production the method may be carried out in that the ad- hesive is applied to a strip-like zone of the inside of the body portion mounted on the mandrel by applying the adhesive in a liquid state internally through the mandrel. The invention further relates to an apparatus adapted to carrying out said method which is charac¬ terized in that it comprises a rotatable, substantially cylindrical mandrel provided with an annular circum¬ ferential depression having a width adapted to applica¬ tion of adhesive to the inner side of a mounted catheter body portion. For carrying out the above mentioned preferred embodiment of the method a preferred embodiment of said apparatus is characterized in that an annular insert having an adhesive rejecting surface is disposed in the depression. The above mentioned alternative embodiment of the method may be correspondingly carried out by means of an embodiment of the apparatus adapted for that purpose which is characterized in that the mandrel is provided with adhesive supply ducts opening into the bottom of said depression. In the following the invention will now be explained in more detail with reference to the drawings, in which Fig. 1 is a longitudinal sectional view of an embodiment of a catheter according to the invention in its unrolled state of use, Fig. 2 is a longitudinal sectional view of the catheter in its rolled-up state of delivery, Fig. 3 is a detail of Fig. 2 on a larger scale, Fig. 4 is a schematical illustration of the design of an internal adhesive and an external cover layer in a preferred embodiment of the catheter, Fig. 5 the elements necessary to understand the invention of a first embodiment of an apparatus according to the invention, and Fig. 6 corresponding elements of another embodi¬ ment of the apparatus. In the embodiment of Fig. 1 the catheter compri- ses a substantially cylindrical body portion 1 having a diameter corresponding to a normal flaccid penis. The body portion 1 is manufactured as a soft, thin- walled single-layer component of an elastic material, preferably latex or synthetic rubber. At one end the body portion 1 merges into a narrowed drainage tube 4 for connecting the catheter with a urine collecting bag not shown through a hose that is likewise not shown. Such a collecting bag may in a manner known per se be adapted to be mounted for instance on one leg of the user. At some distance from its open end the body por¬ tion 1 is in the illustrated embodiment provided with a strip-like adhesive layer 3 of a pressure sensitive ad¬ hesive, which may for instance be of the hydrocolloid- -elastomeric type, so that the adhesive layer 3 is moi- sture-absorbing and will thus absorb perspiration moisture from the skin of the penis. The adhesive layer 3 may be applied in such a thickness that it forms an elastically resilient ring ensuring fastening with good tightness and without any inconvenience to the user. Opposite the adhesive layer 3 a likewise strip¬ like cover layer is applied to the outside of the body portion 1, • said cover layer having according to the invention an adhesive rejecting surface. In the illu- strated embodiment the cover layer 2 consists in a strip-like cover foil that may be applied to the body portion by means of an adhesive having a weaker adhesion so that the cover foil may possibly be detached after the catheter has been rolled on penis. The adhesive rejecting surface of the cover foil may be obtained, for instance, by means of a surface coating of silicone rubber. The described design entails that the catheter as illustrated in Figs 2 and 3 can be delivered in a rolled-up condition, thereby facilitating its arrange¬ ment. In the rolled-up condition the cover foil 2 will as shown in the enlarged sectional illustration in Fig. 3 engage the adhesive layer 3 so as to prevent neigh¬ bouring windings of the rolled-up catheter in the area of the adhesive layer 3 to stick to each other. In order to eliminate problems with cold-flowing of the adhesive the cover foil 2 has preferably a somewhat larger width than the adhesive layer 3. Instead of the illustrated cover foil the cover layer 2 may consist of a striplike covering of silicone rubber or other adhesive rejecting material applied by spraying, painting or the like. The adhesive layer 3 may have any desired exten- sion in the longitudinal direction of the catheter but, dependent on its thickness, the desired pliability and flexibility of the body portion 1 should be taken into consideration. There may possibly be more than one striplike adhesive zone with an associated cover layer. As schematically illustrated in Fig. 4 the ad¬ hesive layer on the inner surface of the body portion 1 is according to a preferred embodiment manufactured in that an adhesive tape 5 is applied to the inner surface. In the illustrated embodiment said adhesive tape con- sists of a basic layer 5a of a plastic film of substan¬ tially smaller thickness than the body portion 1, e.g. a polyurethane film having a thickness of 5 to 25 μm pro¬ vided with an adhesive layer 5b of an adhesive having a good adhesion ability, for instance an acrylic adhesive applied to that surface of the basic layer 5a which is adapted to be applied to the inner surface of the body portion 1 and a layer 5c of the above mentioned pressure sensitive liquid absorbing adhesive on the opposite sur¬ face which is adapted to fasten the catheter to the penis. Such an adhesive tape may be pre-fabricated as a finished component for use in the production of the catheter and in this form it may be provided with a paper cover 5d above the adhesive layer 5d, said paper cover being torn off prior to mounting the adhesive tape 5 and the body portion 1 in mutual contact. Correspondingly, a striplike cover foil έ to be : mounted on the external surface of the body portion 1 - may comprise a basic layer 6a of the same material and the same thickness as the basic layer 5a of the adhesive tape 5 and on the surface of said basic layer 6a which is adapted to be fastened to the body portion 1 there is provided an adhesive layer 6b of the same nature as the adhesive layer.5b, whereas a thin layer 6c of an ad¬ hesive rejecting material, for instance silicone rubber, is applied to the opposite surface of the basic layer 6a. Also the cover foil strip 6 may be pre-fabricated as a finished component and may in this condition be pro¬ vided with a paper cover 6b above the adhesive layer 6b. The composition illustrated in Fig. 4 of the ad¬ hesive tape 5 and the cover foil strip 6 opens the pos- sibility of a very rational production of said com¬ ponents from a common strip-like starting material com¬ prising the elements 5a, 5b and 5d, 6a, 6b and 6d, respectively, which may subsequently be joined with the adhesive layer 5c and the adhesive rejecting surface coating 6c, respectively. In Fig. 5 successive stages in a preferred method of manufacturing a catheter as illustrated in Fig. 4 are illustrated at A to D. With the body portion 1, the adhesive strip 5 and the cover foil strip 6 available as finished components the production is carried out on a rotatable, substan¬ tially cylindrical mandrel 7 whose free end is rounded substantially to a hemispherical shape. In a zone in which the adhesive strip 5 is to be fastened the mandrel 7 is formed with a depression 8 accommodating an annular insert 9 of an adhesive rejecting material, for instance silicone rubber. In the illustrated embodiment the 'mandrel 7 com¬ prises a longitudinal duct 10 positioned substantially in the axis of rotation, said duct comprising outside the area of mounting the body portion 1 of a catheter an attachment, not shown, for a hose or tube connection from a source of compressed air. Two inclined ducts 11 and 12 opening into a groove 13 at the upper surface of the hemispherical free end of the mandrel 7 are joined with the longitudinal duct 10. Further, two radial, diametrically opposite ducts 14, 15 likewise opening into annular grooves 16, 17 at the free surface of the mandrel are connected with the duct 10 on either side of the depression 8. In the production of the catheter the adhesive strip 5 is first wound round the mandrel 7 on the insert 8 during rotation as shown in Fig. 5A. The body portion 1 is then arranged by supplying pressurised air through the ducts 10 to 12 and 14, 15 as illustrated in Fig. 5B, thereby inflating the body portion which may then be mounted in a correct position on the mandrel 7 without contact with the coating 5b of the adhesive strip 5, the paper cover 5d having been removed prior to winding on the mandrel 7. By interruption of the supply of pressurised air the body portion 1 will be put into tight engagement against the surface of the mandrel 7 and the adhesive strip 5 wound thereon, thereby fastening the latter to the inside of the body portion 1. In this condition the cover foil strip 6 is mounted on the outside of the body portion 1 during rotation of the mandrel 7 and, as illustrated in Fig. 5c, at such a parallel displacement relative to the ad- hesive strip 5 that by the subsequent rolling-up of the body portion 1 to the condition shown in Fig. 3 it will become opposed to the adhesive strip 5. The rolling-up is effected as illustrated in Fig. 5D while the body portion 1 still remains on the mandrel 7, and the finished catheter is thus ready for packaging. The production of the catheter according to this " method is carried out on the basis of pre-fabricated components so that none of the components are applied in a liquid state. Thus, no drying and hardening operations are involved and the time of production is shortened. Fig. 6 shows a mandrel 18 to be used in an alter¬ native method. Also according to this embodiment the mandrel 18 is provided with a circumferential annular, depression 19 in an area corresponding to the internal adhesive layer in the finished catheter. The application of adhesive is, however, effected by spraying liquefied adhesive through ducts 20, 21 opening into the bottom of the depression 19. In order to control and locate the deposition of the sprayed adhesive the mandrel 18 is further provided with suction channels 22, 23 through which a partial vacuum is provided by means of a suction device not shown, said vacuum keeping the body portion in tight en¬ gagement with the surface of the mandrel 18 so as to prevent flowing of the adhesive outside the depression 19. In a similar manner the cover layer 24 is applied when liquefied which may be effected by spraying, painting or by means of a roller. According to this method of production the mandrel 18 is kept stationary during the period of the internal application of ad¬ hesive. This method implies that the production of the catheter requires a certain time of drying and of har- dening, respectively, before the rolling-up of the catheter can be effected.

Claims: PATENT CLAIMS 1. An external catheter for male urinary incon- ~ tinence equipment comprising a soft, thin-walled, substantially cylindrical body portion (1) which is open at one end and merges at the other end into a narrowed drainage tube portion (4) to be connected with a collecting bag, said body portion being provided on its inside with an adhesive (3), characterized in that the adhesive comprises a pressure sensitive adhesive and that with a view to deliver the catheter with the body portion (1) rolled up from the open end towards the end at the drainage tube (4) at least the part of the out¬ side of the body portion (1) which is opposite the ad¬ hesive (3) is provided with a cover layer (2) having an adhesive rejecting surface. 2. A catheter as claimed in claim 1, charac¬ terized in that the adhesive (1) and the cover layer (2) extend across a strip-like zone on the inside and out¬ side, respectively, of the body portion (1). 3. A catheter as claimed in claim 2, character- ized in that the cover layer (2) is constituted by a strip-like cover foil adhered to the outside of the body portion (1) . 4. A catheter as claimed in claim 1, 2 or 3, characterized in that the adhesive is constituted by an adhesive strip (5) provided with an adhesive coating on both sides. 5. A catheter as claimed in claim 3 or 4, charac¬ terized in that the strip-like cover foil (6) and/or the adhesive strip (5) comprise(s) a basic layer (6a, 5a) of a plastic film having a substantially smaller thickness than the body portion (1) and an adhesive layer (6b, 5b) on the surface of said film (6a, 5a) adapted to be mounted on the outside and inside, respectively, of the body portion (1) . 6. A method of manufacturing an external catheter as claimed in claim 1, characterized in that a prefabri- - cated body portion is arranged on a substantially cylin¬ drical mandrel and is provided with a pressure sensitive adhesive on its inside, following which a cover layer with an outwardly facing adhesive rejecting surface is applied to its outside at least to the portion which during the subsequent rolling-up will be opposite the adhesive. 7. A method as claimed in claim 6, characterized in that the adhesive layer is applied to the mandrel (7) prior to the arrangement of the body portion (1) by winding a pre-fabricated adhesive tape (5) provided with adhesive on both sides around an adhesiv rejecting zone (9) on the mandrel, the adhesive (5c) applied to the side of the tape opposite the mandrel (7) being a pressure sensitive adhesive. 8. A method as claimed in claim 7, characterized in that the body portion (1) is mounted on the mandrel (7) under inflation by controlled supply of pressurised air in the area around the applied adhesive strip (5). 9. A method as claimed in claim 6, characterized in that the adhesive is applied to a strip-like zone of the inside of the body portion mounted on the mandrel (18) by applying the adhesive in a liquid state inter¬ nally through the mandrel (18) . 10. A method as claimed in claim 4 or 5, charac¬ terized in that the body portion (1) is kept by suction to the mandrel during the application of adhesive. 11. A method as claimed in claim 4 or 5, charac¬ terized in that the cover layer is applied ' by winding a strip-like cover foil round the body portion positioned on the mandrel. 12. A method as claimed in claim 4 or 5, charac- terized in that the cover layer is applied in a liquid state. 13. An apparatus for carrying out the method as : claimed in claims 6 to 12, characterized in that it - comprises a rotatable, substantially cylindrical mandrel (7, 18) provided with an annular circumferential depres- sion (8, 19) having a width adapted to application of adhesive to the inner side of a mounted catheter body portion (1) . 14. An apparatus as claimed in claim 13 for- carrying out the method as claimed in claim 6, 7 or 8, characterized in that an annular insert (9) having an adhesive rejecting surface is disposed in the depression (8). 15. An apparatus as claimed in claim 14 for carrying out the method according to claim 8, charac- terized in that the mandrel (7) is provided with pressurised air ducts (11, 12, 14, 15) in connection with an attachment for a connection from a pressurised air source positioned outside the area for arrangement of a body portion (1) of a catheter, said ducts opening in the vicinity of the free end of the mandrel (7), on one hand, and in circumferential grooves (16, 17) on either side of said depression (8), respectively, on the other hand. 16. An apparatus as claimed in claim .13 for carrying out the method according to claim 9 or 10, characterized in that the mandrel (18) is provided with adhesive supply ducts (20, 21) opening into the bottom of said depression (19). 17. An apparatus as claimed in claim 16 for carrying out the method according to claim 10, charac¬ terized in that the mandrel (18) is provided with suc¬ tion ducts (22, 23) to be connected with a suction de¬ vice, said ducts opening into circumferential grooves (24, 25) on either side of said depression (19).

Inventors: JOHANNESSON NIELS OLAV, JOHANNESSON, NIELS, OLAV
Applicants: COLOPLAST AS, COLOPLAST A/S
Application year: 1985
Main classification: A61M25
IPC codes: A61F5