IE50389B1 - Valved drain assembly for urostomy pouch - Google Patents

Description

This application is derived from Patent Specification No. 5038S .

A urostomy pouch or bag of the type exemplified by co-owned patents 3,523,534 and 3,622,704 is capable of being worn continuously by a patient for several days or more before being removed and replaced by a fresh pouch. During the period of continuous wear, such a pouch must be periodically drained of its fluid contents by manipulating a drain valve at the pouch's lower end. Vhile periodic draining is a necessary and acceptable inconvenience during hours while the wearer is awake, it ie an objectionable inconvenience during hours of rest.

Drainage pouches are currently available which are designed to be coupled to drainage tubes leading to relatively large volume bedside containers, thereby permitting exudate to drain continuously through the pouches into the containers so that the user's sleep need not be interrupted by 2o the necessity of periodically emptying the contents of the pouches. Vhile sound in principle, such arrangements have not been entirely successful In practice because of a variety of problems, including difficulties in manipulating the valves and couplings, and tendencies to wear rapidly and leak in use, or to obstruct flow and cause distension and possible rupture of the pouches. There is also the risk that excessive force applied during manipulation of a valve, or in coupling or uncoupling a drainage 3o tube, may impose undue^strain on the walls of the drainage pouch, resulting in tearing of the pouch and leakage of its contents. Such risks may be increased if the fittings of the pouch are blocked from direct view by the veer, or where the UBer suffers from some condition or disease,' such as arthritis, which makes manipulation of the valve and coupling more 50388 difficult.

More specifically, current drainage pouches are sometimes equipped with eoft plastic drainage nozzles equipped with removable caps of the same material. Vhen a drainage tube ie to be connected, the cap is simply removed, a separate connector is attached to the nozzle, and the tube of the drainage set is then coupled tc the connector. Although such a nozzle construction has the advantages of softness and flexibility, thereby reducing the possibilities of pouch rupture, manipulative difficulties exist and are increased by the need for an additional part (connector). Also experience indicates that such constructions are more prone to leakage over periods of extended use.

In another type of comaercially-available construction the drainage pouch is equipped with a sleeve valve designed to be operated by sliding one telescoping part with respect to another part. While such a valve is advantageous in terms of ease of operation, the act of coupling the valve to a drainage tube is more difficult. Also, because such a construction involves the provision of relatively small flow passages through the valve, such passages have a tendency to be clogged by the more viscous components (e.g., mucus) of the exudate. Where such problems are likely to arise, users are instructed to disassemble the valves prior to attachment of the drainage tubes, such disassembly thereby increasing the complexities and likelihood of user problems, including lose of parts, in performing the manipulative steps.

Accordingly, it is an objective of the present invention to provide a drain assembly for a urostomy pouch which overcomes the defects and 50388 difficult.

More specifically, current drainage pouches are sometimes equipped with eoft plastic drainage nozzles equipped with removable caps of the same material. When a drainage tube ie to be connected, the cap is simply removed, a separate connector is attached to the nozzle, and the tube of the drainage set is then coupled tc the connector. Although such a nozzle construction has the advantages of softness and flexibility, thereby reducing the possibilities of pouch rupture, manipulative difficulties exist and are increased by the need for an additional part (connector). Also experience indicates that such constructions are more prone to leakage over periods of extended use.

In another type of commercially-available construction the drainage pouch is equipped with a sleeve valve designed to be operated by sliding one telescoping part with respect to another part. While such a valve is advantageous in terms of ease of operation, the act of coupling the valve to a drainage tube is more difficult. Also, because such a construction involves the provision of relatively small flow passages through the valve, such passages have a tendency to be clogged by the more viscous components (e.g., mucus) of the exudate. Where such problems are likely to arise, users are instructed to disassemble the valves prior to attachment of the drainage tubes, such disassembly thereby increasing the complexities and likelihood of user problems, including loss of parts, in performing the manipulative steps.

Accordingly, it is an objective of the present invention to provide a drain assembly for a urostomy pouch which overcomes the defects and 38 8 pouch at the lower end thereof, a tubular valve member rotatably connected to the body aesber, and a drainage tube equipped at one end with a coupler for releasably engaging the tubular stem of the valve member. The body member has walls defining a generally cylindrical discharge chamber, such chamber having a side opening and a lower end opening. The valve member includes a sleeve portion which is rotatably received within the chamber of the body 'C member through the lower end thereof, such valve member also having an open-endec tubular etem which projects downwardly below the body member. The sleeve portion cf the valve member has a lateral port which is registrable with the side opening of the tody member when the valve member is rotated |nto an open position, such lateral port being out-ofregister with such side opening when the valve member is rotated into a closed position, locking Beans secures the body and valve members against axial displacement without at the same time preventing relative rotation of the parts.

Each of the body and valve aeabers is formed of a semi-rigid plasticsmaterial, the plastics of the valve member being more rigid (or lees flexible) than that of the body member. An integral bead ia formed about the lateral port of the valve member and forceably engages the more yieldable material of the body member to produce a highly effective primary or internal seal. A secondary or 'external seal is formed between an annular flange at the lower end of the body member and the sore rigid material of the valve member, such contact occurring Within an annular upwardly-facing channel formed in the valve member about the sleeve portion thereof.

The body member also includes a pair of 50388 diametrically-disposed lateral extensions, such extensions having side surfaces which extend along converging planes and which terminate in lateral edges substantially parallel with the axis of the body member. In addition, the body member includes a top wall which merges with such lateral edges to form corners, and a pair of thin flexible stress-relieving tabs which are formed integrally with the body member and which project radially and upwardly from such corners.

The tubular stem of the valve member is provided with an annular shoulder spaced above the stem's open lower end, such shoulder having an upwardly-facing latching surface and a downwardly and inwardly inclined camming surface. The coupling meane of the drainage tube takes the form of a flexible tubular connector which is secured to the drainage tube and dimensioned to sealingly receive the lower portion of the valve Btem. Such coupling means also includes latching means in the form of a flexible oval latching ring extending along a plane normal to the axis of the tubular connector and joined thereto by a pair of flexible aras. Bormally the flexible ring assumes an oval configuration in which its minimum inside diameter approximates the outside diameter of the stem and is less than the greater diameter of the latching shoulder, however, when finger pressure is applied to opposite ends of the oval latching ring, such ring may be temporarily reformed or distorted into a generally circular configuration in which its inside diameter exceeds the diameter of the shoulder, thereby permitting the coupler to be removed frcm the stem of the valve member.

Thus, the present invention provides a drainage tube assembly adapted to be coupled to a tubular drain stem of a drainage pouch, euch stem having an annular latching shoulder disposed intermediate the length of such stem, said assembly comprising a flexible drainage tube provided at one end thereof with a coupler; said coupler including a flexible tubular connector secured to said tube, a flexible oval latching ring coaxial with said connector and spaced axially therefrom, and a pair of flexible arms joining said ring and connector; said ring in an unflexed state having a minimum inside diameter approximating the outeide diameter of a drain stem and less than the maximum diameter of a latching shoulder extending about euch stem; said ring being capable of assuming a generally circular configuration vhen a squeezing force is applied thereto.

Other advantages, objectives, and features sectional view showing the formation of the seal between the coupler and the valve stem.

Figure 12 is an enlarged cross-sectional view taken along line 12-12 of Figure 10.

Referring to the drawings (Figures 1 and 2), the numeral 10 generally designates an ostomy pouch or hag having front and rear walls 11 and 12 formed of flexible fluid-impermeable thermoplastic sheet material. The front wall 11 and rear wall 12 are sealed around their peripheries by a heat-sealed bond 13 or by any other suitable means. The flexible walls may be formed of any effective gas and liquid impervious theremoplastic material such as, for example, a polyolefin film laminated with an appropriate barrier material. A particularly suitable commercial material comprises low density polyethylene coextruded with a coextensive layer or core of polyvinylidene chloride. Such material is commercially available under the designation Saranex Registered Trade Mark from Dow Chemical Company, Midland, Michigan.

The rear panel of the ostomy pouch, in accordance with standard practice, is provided with a stoma-receiving opening surrounded by a patch coated with a conventional pressure-sensitive medical adhesive. Neither the opening nor the patch are depicted in the drawings since they would be located near the upper end of the pouch; however, such elements are well known and are disclosed, for example, in cc-owned patents 3,804,091, 3.759i260, 3,622,704, and 3,523,534. Details of the stomareceiving opening, the adhesive attachment patch, the gasket which may be used to form an effective seal about the stoma, and the attachment means which may take the form of a belt, are all shewn and described sectional view showing the formation of the seal between the coupler and the valve stem.

Figure 12 is an enlarged cross-sectional view taken along line 12-12 of Figure 10.

Referring to the drawings (Figures 1 and 2), the numeral 10 generally designates an ostomy pouch or hag having front and rear walls 11 and 12 formed of flexible fluid-impermeable thermoplastic sheet material. The front wall 11 and rear wall 12 are sealed around their peripheries by a heat-sealed bond 13 or hy any other suitable means. The flexible walls may be formed of any effective gas and liquid impervious theremoplastic material such as, for example, a polyolefin film laminated with an appropriate barrier material. A particularly suitable commercial material comprises low density polyethylene coextruded with a coextensive layer or core of polyvinylidene chloride. Such material is commercially available under the designation Saranex Registered Trade Mark from Dow Chemical Company, Midland, Michigan.

The rear panel of the ostomy pouch, in accordance with standard practice, is provided with a stoma-receiving opening surrounded by a patch coated with a conventional pressure-sensitive medical adhesive. Neither the opening nor the patch are depicted in the drawings since they would be located near the upper end of the pouch; however, such elements are well known and are disclosed, for example, in co-owned patents 3,804,091, 3,759,260, 3,822,704, and 3,523,534· Details of the stomareceiving opening, the adhesive attachment patch, the gasket which may be used to form an effective seal about the stoma, and the attachment means which may take the form of a belt, are all shewn and described in such patents, the disclosures of which are incorporated hy reference herein.

The drain assembly is generally designated by the numeral 15 and comprises a body member 16, a valve member 17, and a drainage tube assembly 18.

The drainage tube assembly includes a standard flexible drainage tube 19 formed of polyvinyl chloride or other suitable material and a coupler 20. The coupler is adapted tc make sealing engagement with the stem of the valve member 17 in the manner hereinafter described, such parts being shown in separated condition in Figure 1 for clarity of illustration. It is to be understood that during waking hours the wearer of the ostomy appliance would normally maintain the parts uncoupled with the valve member in closed condition and that the parts would ordinarily be coupled, with the valve member in open condition (shown in dashed lines in Figure 1), when the user is at rest, or is bedridden or otherwise incapacitated. Under the latter conditions, the opposite end of the flexible drainage tube would be connected to, or inserted into, a suitable bedside receptacle 21 positioned on the floor or in any case at a level sufficiently below the user to insure proper gravity flow.

The body member 16 and valve member 17 together constitute a valve assembly for controlling drainage from pouch 11. The body member includes a generally cylindrical wall 22 defining a cylindrical discharge chamber 23 having a side opening 24 and a lower end opening 25, all as shown most clearly in Figure 3· The member also includes a top wall 26 having a central aperture 27.

A pair of extensions 28 and 29 project laterally from the cylindrical core of the body υ. member, such extensions being diametrically disposed with one extension 28 having a greater radial dimension than the other extension 29. Extension 28 is defined hy side vails 28a, bottom vail 28b, and top vail 28c (Figures 2 and 3). The side vails extend outwardly along converging planes, terminating in a lateral edge 30 which extends vertically, that is, in a direction parallel with the axis of the cylindrical chanter 23· The bottom and side *0 walls 28b and 2oa, along with ar. interior wall 28d, combine to define a cavity 31 which is disposed adjacent to and communicates directly with chamber 23 through lateral opening 24. As illustrated in Figures 2-5, the top wall (or upper end wall) 28c has an aperture 32 which exposes cavity 31. To increase the rigidity and strength of the part, the body member may also include a partition cr septum 33 which divides cavity 31, but it is to be understood that such partition may be omitted where the reinforcing action is deemed unnecessary.

Like extension 26, extension 29 includes a pair of converging side walls 29b and a top wall 29c. The side walls 29a project outwardly and converge along a lateral edge 34 which is parallel with edge 30 and with the central axis of cylindrical chamber 23· Lateral edges 34 and 30 may be slightly rounded in section so that they do not constitute cutting edges. Similarly, the side and top surfaces of the body member intersect along edges which are smoothly rounded so that they do not constitute sharpened edges capable of cutting the thermoplastic film of the drainage pouch 11.

At the upper corners of the body where lateral edges 3C and 34 merge with top walls 28c 3: and 29c, respectively, ar/e a pair of flexible planar S0389 tabs 35, such tabs projecting radially and upwardly from the corners and being coplanar with the lateral edges and with each other. As depicted, the tabs are laterally elongated and smoothly curved in outline; that is, they have no corners which might tend to pierce or cut into the film of the pouch. Since the entire body member is molded from a semi-rigid but flexible or yieldable plastics material such as, for example, medium cr low density polyethylene, tabs 35 vill flex and thereby function as strain relievers- to protect the material of the pouch from damaging contact with the upper corners of the body member and the lateral edges of that member.

The valve member 17 is similarly molded of a semi-rigid plastics material although such material should be more rigid, or less flexible and yieldable, than the material of body member 16. High density polyethylene has been found particularly effective as the fabricating material for the valve member, but other polymeric materials such as polypropylene might be used.

The valve member 17 includes a tubular sleeve portion 36 which is rotatably received within the chamber 23 of the body member. Referring in particular to Figure 3, it will be seen that the tubular sleeve portion is provided with a lateral port which, upon rotation of the valve member, may be moved into and out of register with side opening 24 of the body member. When the valve member is rotated 'into its closed position, a smoothly-rounded bead 38 which extends about port 37 forceably engages the flexible wall defining the cylindrical chamber 23 to fore a primary seal between the parts. Figures 7 and 6 reveal that such contact between the more rigid materiel of valve member 17 and the more flexible 50388 material of the body member 22 results in a slight but perceptable deformation of the body member, thereby producing tight contact that insures an effective seal.

The valve member also includes a tubular stem portion 39 which is coaxial with sleeve portion 36 and which projects downwardly therefrom as a continuation or extension of the sleeve. The stem is open at its lower end and defines a generally ‘.0 cylindrical flow passage 40·. When the valve member is rotated into its open position (Figure 6), the lateral port 37 of the sleeve is in direct register with the side opening 24 of the body member and communicates with the upvardiy-cper.ing cavity 31 of 15 that member. liquid may therefore flow from the interior of the ostomy pouch into the open topped cavity 31 end then into flow passage 40 through ' aligned openings 24 and 37. It is significant that the area of port 37 approximates, and is at least as large, as the cross-sectional area of flow passage 40 and, hence, is at least as large as the internal cross-sectional area of flexible drainage tube 19Since the side opening 24 of the body member, and also the top opening 32 of that member, each has an area greater than the area of lateral port 37, the valve assembly imposes no appreciable restriction on the drainage cf fluid from the pouch or bag 10. Furthermore, because cf the relatively large Bize of such openings ar.d port, the possibilities of the drain assembly becoming clogged by mucus or other viscous constituents cf the exudate are remote.

Referring to Figures 7 and 9, the cylindrical wall 22 of the body member includes a depending annular flange 41 having a downwardly and irtwardly sloping inner surface 4Ja. Valve member 17 50388 material of the body member 22 results in a slight but perceptable deformation of the body member, thereby producing tight contact that insures an effective seal.

The valve member also includes a tubular stem portion 39 which is coaxial with sleeve portion 36 and which projects downwardly therefrom as a continuation or extension of the sleeve. The stem is open at its lower end and defines a generally ‘.Z cylindrical flow passage 40·. When the valve member is rotated into its open position (Figure 6), the lateral port 37 of the sleeve is in direct register with the side opening 24 of the body member and communicates with the upwardly-opening cavity 31 of 15 that member, liquid may therefore flow from the interior of the ostomy pouch into the open topped cavity 31 end then into flow passage 40 through ' aligned openings 24 and 37. It is significant that the area of port 37 approximates, and is at least as large, as the cross-sectional area of flow passage 40 and, hence, is at least as large as the internal cross-sectional area of flexible drainage tube 19Since the side opening 24 of the body member, and also the top opening 32 of that member, each has an area greater than the area of lateral port 37, the valve assembly imposes no appreciable restriction on the drainage cf fluid from the pouch or bag 10. Furthermore, because cf the relatively large Bize of such openings ar.d port, the possibilities of the drain assembly becoming clogged by mucus or other viscous constituents cf the exudate are remote.

Referring to Figures 7 and 9, the cylindrical wall 22 of the body member includes a depending annular flange 41 having a downwardly and irtwardly sloping inner surface 4Ja. Valve member 17 is virtually no danger that in use the two members of the valve assembly might become separated and cause accidental release of the contents of the pouch.

The valve member is provided with 5 diametrically-disposed lateral extensions or wings which correspond generally to the lateral extensions 28 and 29 of the tody member.

Extension 47 projects radially outwardly a distance greater than extension 48. The two extensions 47,48 iC are coplanar with their common plane extending through the axis of the valve body. As shown in Figure 5, the lateral dimension cf extension 48 approximates the corresponding dimension of extension 26; similarly, the lateral dimension of extension 48 generally matches the corresponding dimension of extension 29· Therefore, a user can readily determine by touch and without visual inspection when the valve member 17 is in its closed position. In that condition, the valve assembly 2C assumes its most compact configuration with the lateral extensions of the respective members being in register as shown.

The valve assembly is opened by rotating valve member 17 through 180* into the offset position depicted in Figure 6. Since the extensions of the valve member are then out of register with the corresponding extensions of the valve body, a user may again readily determine by sense of touch that the valve member 17 is in its fully open position.

Stop elements are provided by the respective members 16 and 17 tc assist a user in positioning the valve member 17 in either its fully opened or fully closed position. As revealed in Figures 3, 5 and 6, the extensions 47 and 48 of the velve member have upstanding stop elements 49 and 50 respectively, whereas the body member 16 has a single depending step element 51· When the valve member is closed, stops 49 and 51 engage each other as indicated in Figure 5, whereas when the valve is fully opened such engagement occurs between stops 50 and 51 (Figure 6).

The valve assembly is secured to the lower end of the drainage pouch 11 as shovn in Figure 1, with body member 16 disposed between walls 11 and 12 '0 et the extreme lower end of the pouch and with valve member 17 projecting downwardly below the pouch.

While various means might be utilized to secure the body member to the walls of the pouch so that the pouch's fluid contents may escape only through the passages of the valve assembly, a particularly effective manner of attachment is believed to consist of heat sealing lower edge portions of the pouch's walls directly to the side surfaces of the thermoplastic body member 1 6 as a continuation of the same heat seal zones 13 which join the walls of the pouch to each other.

The tubular stem 39 of the valve member 17 is provided with an annular shoulder 55 spaced above the stem's lower end and below lateral extensions 47 and 48. The configuration of the shoulder ie clearly revealed in Figure 7 where it will be seen that the shoulder has an upwardly facing latching surface 55a which extends in a plane normal to the axis of the stem and a downwardly and inwardly inclined camming surface 55b. Such shoulder cooperates with the coupler 20 of the drainage tube assembly for detachably securing the parts together in the manner described below.

The coupler 20 is formed integrally of a tough flexible plastics material having substantial 50388 elastic memory. While any cf a variety of materials might he used, particularly effective results have been obtained when the ooupler is fabricated of an acetal resin marketed under the designation Delrin Tirade Mark by El duPont deNemours, Wilmington, Delaware. The coupler includes a tubular connector 60, a latching ring 61, and a pair of arms or straps 62 which join the connector and latching ring together. As clearly illustrated in figures 1, 2, JO and 12, the latching '0 ring 61 is coaxial with the tubular connector 60 and is non-circular or oval in configuration. When the flexible spring-like latching ring 61 is in a normal or untensioned state, its minimum inside diameter (i.e., its inside diameter measured across the shorter axis) approximates the outside diameter of stem 39 and is less than the outside diameter of shoulder 55 (Figure 12). Therefore, with the parts in the assembled condition indicated in Figures 10 and 12, the latching ring 61 is restrained by the upwardly-facing latching surface 55s of the shoulder from being separated or pulled from the stem.

However, if finger pressure is applied in the direction of arrows 63 in Figure 12, the oval latching ring may be easily reformed into a generally circular configuration (represented by dashed lines) in which the ring will have a generally uniform inside diameter greater than latching shoulder 55· Therefore, by simply squeezing the ring into a generally circular configuration, a user may easily detach the coupler from stem 29· Ideally, the flexible arms or straps 62 join the oval latching ring £1 at the zones of sharpest curvature of that ring. Such locations facilitate operation of the coupler since the user may Readily locate the arms by touch and, simply by are fully latched together.

The tapered lower end portion 60b of the connector (Figure 10) may be permanently secured to the flexible drainage tubes 19 by any suitable seans.

Heat sealing, solvent bonding, or mechanical engagement, or combinations thereof, may be utilized. Where a mechanical functional ir.terengagement is relied upon, the outer surface of portion 60b may be provided with annular ridges or projections to C prevent accidental separation of the drainage tube from the connector· ϋΰΐϊά = 12 with or snappish sound that infar?B« the user that the parts are fully latched together.

The tapered lower end portion 60b of the connector (Figure 10) may be permanently secured to the flexible drainage tubes 19 by any suitable Beans.

Heat sealing, solvent bonding, or mechanical engagement, or combinations thereof, may he utilized. Where a mechanical functional interengagement is relied upon, the outer surface of portion 60b may be provided with annular ridges or projections to prevent accidental separation of the drainage tube from the connector.

Claims (6)

1. CLAIMS;1. A drainage tube assembly adapted to be coupled to a tubular drain stew of a drainage pouch, such stem having ar. annular latching shoulder disposed intermediate the length of such stem, said assembly comprising a flexible drainage tube provided at one end thereof with a coupler; said coupler including a flexible tubular connector secured to said tube, a flexible oval latching ring coaxial with said connector and spaced axially therefrom, and a pair cf flexible arms joining said ring and connector; said ring in an unflexed state having a minimum inside diameter approximating the outside diameter of a drain stem and less than the maximum diameter of a latching shoulder extending about such stem; said ring being capable of assuming a generally circular configuration when a squeezing force is applied thereto.

2. The assembly of Claim 1 in which said connector, ring, and arms are formed integrally of flexible plastics material.

3. The assembly of Claim 1 or 2 in which said arms are diametrically disposed and join said oval ring along portions of sharpest curvature thereof.

4. - The assembly of Claim 1, 2 or 3 in which said tubular connector is provided with an inner surface having a portion of reduced diameter.

5. - The assembly of Claim 4 in which said inner surface portion of reduced diameter is disposed intermediate the length of said connector and has inwardly-sloping frusto-conical inner surface portions leading thereto and disposed axially cn opposite Bides thereof.

6. 'A drainage tube assembly according to any or.e cf the Claims 1 to 5, substantially as hereinbefore described with reference to, and as illustrated by the accompanying drawings.