CA1214086A - Female urinary incontinence device - Google Patents
Female urinary incontinence deviceInfo
- Publication number
- CA1214086A CA1214086A CA000435816A CA435816A CA1214086A CA 1214086 A CA1214086 A CA 1214086A CA 000435816 A CA000435816 A CA 000435816A CA 435816 A CA435816 A CA 435816A CA 1214086 A CA1214086 A CA 1214086A
- Authority
- CA
- Canada
- Prior art keywords
- cup
- periurethral
- pad
- opening
- wall portions
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
- 206010046543 Urinary incontinence Diseases 0.000 title claims abstract description 12
- 239000000463 material Substances 0.000 claims abstract description 43
- 210000002700 urine Anatomy 0.000 claims abstract description 12
- 241001313288 Labia Species 0.000 claims description 24
- 230000033001 locomotion Effects 0.000 claims description 13
- 239000003570 air Substances 0.000 claims description 11
- 239000006263 elastomeric foam Substances 0.000 claims description 8
- 229920002379 silicone rubber Polymers 0.000 claims description 8
- 239000004945 silicone rubber Substances 0.000 claims description 8
- 239000012530 fluid Substances 0.000 claims description 6
- 239000007789 gas Substances 0.000 claims description 6
- 230000002745 absorbent Effects 0.000 claims description 5
- 239000002250 absorbent Substances 0.000 claims description 5
- 239000007788 liquid Substances 0.000 claims description 5
- 230000000903 blocking effect Effects 0.000 claims description 4
- 239000012080 ambient air Substances 0.000 claims description 2
- 239000012858 resilient material Substances 0.000 claims 4
- 238000007789 sealing Methods 0.000 description 9
- 238000010276 construction Methods 0.000 description 6
- 230000008878 coupling Effects 0.000 description 6
- 238000010168 coupling process Methods 0.000 description 6
- 238000005859 coupling reaction Methods 0.000 description 6
- 238000004513 sizing Methods 0.000 description 5
- 238000013022 venting Methods 0.000 description 4
- 239000000853 adhesive Substances 0.000 description 3
- 230000001070 adhesive effect Effects 0.000 description 3
- 239000013536 elastomeric material Substances 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 230000002485 urinary effect Effects 0.000 description 3
- 239000004677 Nylon Substances 0.000 description 2
- 229920002323 Silicone foam Polymers 0.000 description 2
- 238000006073 displacement reaction Methods 0.000 description 2
- 229920001971 elastomer Polymers 0.000 description 2
- 239000000806 elastomer Substances 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 230000007794 irritation Effects 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 230000017074 necrotic cell death Effects 0.000 description 2
- 229920001778 nylon Polymers 0.000 description 2
- 229920001296 polysiloxane Polymers 0.000 description 2
- 239000013514 silicone foam Substances 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- 210000003708 urethra Anatomy 0.000 description 2
- 210000001215 vagina Anatomy 0.000 description 2
- 229920000742 Cotton Polymers 0.000 description 1
- 206010011985 Decubitus ulcer Diseases 0.000 description 1
- 101100536354 Drosophila melanogaster tant gene Proteins 0.000 description 1
- 206010021639 Incontinence Diseases 0.000 description 1
- MWCLLHOVUTZFKS-UHFFFAOYSA-N Methyl cyanoacrylate Chemical compound COC(=O)C(=C)C#N MWCLLHOVUTZFKS-UHFFFAOYSA-N 0.000 description 1
- 208000004210 Pressure Ulcer Diseases 0.000 description 1
- 238000012644 addition polymerization Methods 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 239000003054 catalyst Substances 0.000 description 1
- 239000013013 elastic material Substances 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- -1 for example Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 230000002452 interceptive effect Effects 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 229920000126 latex Polymers 0.000 description 1
- 239000004816 latex Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000012229 microporous material Substances 0.000 description 1
- 239000006082 mold release agent Substances 0.000 description 1
- GWUSZQUVEVMBPI-UHFFFAOYSA-N nimetazepam Chemical compound N=1CC(=O)N(C)C2=CC=C([N+]([O-])=O)C=C2C=1C1=CC=CC=C1 GWUSZQUVEVMBPI-UHFFFAOYSA-N 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 229920002635 polyurethane Polymers 0.000 description 1
- 239000004814 polyurethane Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 229920000260 silastic Polymers 0.000 description 1
- 208000020431 spinal cord injury Diseases 0.000 description 1
- 229920001169 thermoplastic Polymers 0.000 description 1
- 239000004416 thermosoftening plastic Substances 0.000 description 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B08—CLEANING
- B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
- B08B15/00—Preventing escape of dirt or fumes from the area where they are produced; Collecting or removing dirt or fumes from that area
- B08B15/02—Preventing escape of dirt or fumes from the area where they are produced; Collecting or removing dirt or fumes from that area using chambers or hoods covering the area
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/307—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the urinary organs, e.g. urethroscopes, cystoscopes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
- A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/451—Genital or anal receptacles
- A61F5/455—Genital or anal receptacles for collecting urine or discharge from female member
-
- E—FIXED CONSTRUCTIONS
- E04—BUILDING
- E04D—ROOF COVERINGS; SKY-LIGHTS; GUTTERS; ROOF-WORKING TOOLS
- E04D15/00—Apparatus or tools for roof working
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Surgery (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Pathology (AREA)
- Medical Informatics (AREA)
- Physics & Mathematics (AREA)
- Dentistry (AREA)
- Nursing (AREA)
- Optics & Photonics (AREA)
- Urology & Nephrology (AREA)
- Radiology & Medical Imaging (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Vascular Medicine (AREA)
- Architecture (AREA)
- Civil Engineering (AREA)
- Structural Engineering (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
Abstract
Abstract of the Disclosure A female urinary incontinence device including a periurethral cup, an external pad, and an elastic tubular bellows extending therebetween, as well as associated elements for holding the device in place and for collecting urine flowing therethrough. The periurethral cup is molded in one piece from soft compressible material and has walls of substantial thickness providing smoothly rounded surfaces for sealingly contacting surfaces of the periurethral floor and vaginal introitus. One wall portion of the cup curves upwardly to define a resilient urine-deflecting protuberance received within the vaginal introitus. The device also includes a conduit for directing urine to a collector, a valved port for allowing air to enter the system within the external pad to prevent the development of relative negative pressure within the system, and a vent for allowing gas to escape from the collector,
Description
1214081;
Background Various devices have been proposed in past years for directing and collecting urine from female patients suffering from urinary incontinence but, in general, such devices have been associated with problems of leakage, wearer discomfort, pressure sores, and even necrosis. An indication of the ineffectiveness of such prior devices lies in their lack of commercial success.
The problems associated with prior devices are particularly pronounced with ambulatory patients because of the varied and complex anatomical changes that occur in the periurethral area during locomotion and the failure of such devices to coapt to such changes. However, the need for an effective device is by no means limited to ambulatory patients. For example, non-ambulatory female patients with spinal cord injuries are not served well by existing devices ( indwelling catheters, intermittent catheters, diapers, etc.) despite only minimal body movement of such patients.
Prior patènts have disclosed female urinary collection devices equipped with locating elements intended to be inserted into the vagina for retaining the collection devices in operative positions. Reference may be had to U.S.
patents 2,483,079, 2,490,969, 3,116,734, 3,528,423, 3,512,185, 3,776,235, 3,611,155, and 4,246,901. Those constructions in which the locating elements are relatively rigid clearly fail to conform with the anatomical changes occurring during body movement. While prior devices with flexible or deformable vaginal locating elements may reduce tissue irritation and increase patient comfort, problems in providing an effective seal and avoiding lea~age along the lines or zones of con~act have nevertheless rQmain~d.
~r ~2~408~;
Other patents of interest are 4,270,539, 3,651,810, 4,198,979, and 3,194,238.
Summary One aspect of this invention lies in the discovery that effective sealing engagement with perimeatal tissues may be achieved if the female incontinence device is constructed so that the periurethral cup is compressible but generally form-retaining and is mounted so that it may move independently, at least to a limited exten~, with respect to those portions of the device that make external contact with the wearer. A further aspect lies in the recognition that if such a molded compressible element is cup-shaped in configuration and is operatively connected to an external pad (which is in turn held in place by a panty or supporting belts) by means of a tubular elastic bellows that exerts an upward force on the cup when the device is worn without, at the same time, interfering with limited independent movement of the cup with respect to the pad, such a combination will result in a device that eliminates or substantially reduces the aforementioned problems associated with prior devices. In another embodiment an air entry port, normally closed by a one-way valve, allows air to enter the system to prevent the development of relative negative pressure within that system, and a vent is provided in the collector to prevent expansion or deformation of the collector (normally an expandable plastic pouch) that might otherwise result ~rom entrapped air and the development of a relative positive pressure.
The periurethral cup of a device embodying this invention is molded in one piece of soft, compressikle but generally form-retaining material havin~ a durometer within the range o~ about 1 to 30 on the Shore A scal.e, ~X - 2 -the preferred range being approximately 5 to 20 on that scale. An elastomeric material, molded so that the outer surfaces of the cup are smooth and non-porous, has been found particularly effective.
The periurethral cup is preferably provided with front, rear, and lateral wall portions defining upper and lower openings, such wall portions having a substantial wall thickness (about 3 to 15 millimeters) and having smoothly rounded surfaces, for making substantial surface contact with the periurethral floor and vaginal introitus. The rear wall portion extends upwardly beyond the upper limits of the front and lateral portions to define a resilient, vaginally-insertable, urine-deflecting protuberance, a feature of importance for those patients whose urethral orifice is located in, or immediately adjacent to, the vaginal introitus.
The urine-deflecting protuberance is capable of flexing towards and away from the entrance opening of the cup without causing buckling or kinking of the smoothly-rounded contact surfaces engaging the periurethral floor and vaginal introitus because of the`compressibility and substantial wall thickness of the cup.
An external pad of soft, resilient and flexible material is dimensioned for externally contacting the labia majora of the wearer and has an opening extending therethrough.
Between that opening and the lower opening`of the periurethral cup is a tubular elastic bellows dimensioned for exerting an upward force on the cup, when the device is worn, to maintain an effective seal between the rounded contact surfaces of the cup and the surface of the periurethral floor and introitus despite the complex anatomical changes or displacements that occur during the dynamics of body movement. The length of the elas~ic bellows varies within certain predetermined limi~s ~ - 3 -~Z14086 according to the distance between the periurethral floor and the external surfaces of the labia majora for each wearer, and a sizing instrument, patterned after the construction of the urinary incontinence device, may be used to establish the proper bellows length for a given patient. Such sizing tool designed to allow endoscopic examination if deemed necessary or desirable.
The external pad may, if desired, be provided with a soft absorbent liner for directly contacting the labia majora of the patient. Flexible tubing extends from the outlet of the external pad to a leg bag or other suitable collection device. The external pad is preferably held in place by the wearer's undergarment (panty), but other supporting means in the form of straps or belts may be used.
Other features, advantages, and objects of the invention will become apparent from the drawings and specification.
Drawings Figure 1 is a perspective view of a female urinary incontinence dèvice embodying the invention.
Figure 2 is a vertical longitudinal sectional view of the device.
Figure 3 is an enlarged cross sectional view taken along line 3-3 of Figure 2.
Figure 4 is a saggital sectional view illustrating the device as it is worn.
Figure 5 is a saggital sectional view similar to Figure 4 but illustrating the relative displacements of the external pad and periurethral cup during weaxer movement~
Figure 6 is a lateral sectional view of the device as it is worn.
Figure 7 is a side elevational view, shown partly ~ - 4 -~214086 in section, of a sizing tool adapted to be used as part of the present invention.
Figure 8 is a fragmentary side view, taken partly in section, showing a modified device with ports or vents for preventing collapse of the bellows and conduit while at the same time allowing gas to escape from the pouch.
Figure 9 is an enlarged horizontal cross sectional view of the pouch's vent and filter, with certain elements of the pouch and associated coupling omitted for clarity of illustration.
Figure 10 is an enlarged vertical sectional view of certain portions of the device depicted in Figure 8.
Figure 11 is a horizontal sectional view taken along line ll-I1 of Figure 10.
Figure 12 is a still further enlarged sectional view of the inlet port and valve member taken along line 12-12 o~ Figure 11.
Figure 13 is a sectional view of the umbrella valve member showing details of construction thereof.
Figure 14`is an enlarged sectional view taken along line 14-14 of Figure 11.
Figure 15 is a perspective view of a fluid-deflecting element.
Figure 16 is an exploded perspective view of the valve member, fluid detector, and the portion of the device providing the valve passage or port.
Detailed Description of Preferred Embodiment Referring to the embodiment shown in Figures 1-6, the primary components of the female urinary incontinence device 10 are periurethral cup 11, external pad 12 f and tubular elastic bellows 13. A flexible tube 1~ carries ~2~4086 urine to a suitable collector or receptacle 15. For an ambulatory patient, collector 15 would ordinarily take the form of a leg bag. It is to be understood, however, that other types of collectors might be provided to suit the needs and physical condition of the user. Ordinarily, flexible tube 14 would include a suitable detachable coupling 16. The coupling illustrated in Figure 2 is similar to that shown and described in U.S. patent 4,280,498, but other types of couplings may be provided.
The periurethral cup 11 is molded in one piece from a soft, compressible, but generally form-retaining material.
A molded elastomeric silicone matexial having a smooth, substantially non-porous outer surface has been found particularly effective, but other molded compressible materials, such as elastomeric foam materials, might be used. Regardless of the material selected, it is believed critical that such material should have a durometer within the range of about 1 to 30 on the Shore A scale, preferably within the range of 5 to 20. Particularly effective results have been obtained with a material having a durometer of approximately 10.
It is also important that the side wall of the periurethral cup have substantial thickness and that the uppermost surfaces of the cup be smoothly curved or rounded as shown most clearly in Figures 2 and 3. More specifically, as depicted in the drawings, the cup has upper and lower openings 17 and 18, respectively. The integral side wall 19 is composed of front, rear, and lateral wall portions l9a, 19b, and l9c, respectively. In the region bordering top opening 17, each of those wall portions should have a thickness d (Figure 3) within the range of about 3 to 15 millimeters. The result is a cup which, as brought out ~ - 6 -~2~086 hereinafter, has upp~r surfaces making substantial contact with the periurethral ~loor and vaginal introitus and which, although soft and compressible, tends to be shape-retentive in use notwithstanding the upward force exerted by elastic bellows 13.
The rear wall portion l9b curves upwardly beyond the upper limits o~ the front and lateral wall portions to define a resilient, vaginally-insertable, urine-deflecting extension or protuberance 20. The essential purpose of the protuberance is to serve as a urine deflector for that portion of the female population, estimated at between 15 to 20%, whose urethral orifice is located within, or immediately adjacent to, the vaginal introitus. Any functions the protuberance performs in locating and retaining the cup in position are of secondary significance. As described more fully hereinafter, the wide-smoothly rounded contact surfaces of the compressible cup, in combination with the gentle upward force exerted by elastic bellows 13, serve primarily to maintain the cup in its operative position.
As shown in Figures 1-3, the rounded upper surfaces 20a of protuberance 20 merge smoothly and-gradually with the upper surfaces lla of the remaining side and front wall portions of the cup. Specifically, the upper front surfaces of the protuberance 20 merge with the upper surfaces of the side walls along a curved line represented in Figure 2 as having a substantial radius r. That radius would normally fall within the range of about 5 to 12 millimeters. Of particular significance is the fact that even when the protuberance is urged forwardly, as indicated by broken lines in Figure 2, no buckling or kinking of the wall occurs at radius r because of the compressibility of the material from which the cup i~ forme~. Consequently, an e~fective seal ~ ~ 7 -~Z140~36 between the curved upper surfaces of the cup (including the protuberance) and the contact surfaces of the patient tends to be maintained during normal body movement.
External pad 12 may be formed of the same soft, compressible material as periurethral cup 11 and, in any event, should be formed of a resilient, flexible polymeric material. The pad is generally oval in outline, substantially larger than cup 11, and has a passage or opening 21 extending therethrough (Figure 2). As shown in the drawings, the external pad has an upper surface 12a that is pre~erably concave or dish-shaped and, if desired, the upper surface may support an annular absorbent liner 22 (Figure 2) formed of non-woven cotton fibers or other suitable absorbent material.
Along its lower or external surface 12b, pad 12 may be provided with attachment means 23 in the form of fabric having nylon hooks or loops of the type commercially available under the Velcro* designation. If such retaining means is used, then the patient would also wear a panty having a brushed nylon crotch panel for engaging and interlocking with attachment means 23, thereby helping to maintain the external pad 12 against the outer surfaces of ~he labia majora.
Bellows 13 may be formed of any suitable elastomeric material and, in an uncompressed or extended state, assumes the appearance depicted in Figures 1-3. The number of corrugations or convolutions 13a of the bellows for any given urinary collection appliance will depend on the distance between the labia majora and the periurethral floor of the wearer to be fitted with the device so that, when worn, the corrugations will be compressed or axially reduced as indicated in Figures 4 and 6. Ordinarily, for adult wearers, the number of corrugations will range between 2 (Figure ~) to 6, and the undeormed length o ~h~ ~orrugated por~ion ~Trade M~rk ~Z140~36 will range from 10 to 50 millimeters, with 3 selected sizes within those ranges meeting the requirements for over 90%
of the adult female population. The tublar bellows may be formed of elastomers of polyurethane, silicone rubber, latex, or any of a variety of other materials having similar properties. A particularly effective material has been found to be a silicone rubber marketed by Dow Cornlng, Midland, Michigan, under the designation Q7-4840*; another, available from the same source, is MDX4-4210*.
In the embodiment shown, the bellows 13 and cup 11 are formed separately and the upper end of the bellows is then secured by adhesive or by any other suitable means to the cup about the lower opening 18; however, it is to ba understood that, if desired, the two elements may be formed integrally. The lower end of the bellows is connected to flexible tube or conduit 14 at the upper end of opening 21 of the external pad by means of an upwardly-flared extension 25 of conduit 14. Extension 25 of conduit 14 may be joined to the bellows 13, and to the wall of external pad 12, by adhesives, heat sealing, or any other suitable means.
Figures 4-6 depict the anatomical orientation of the urinary incontinence device 10 under normal conditions of use. External pad 12 bears upwardly against the external surfaces of the labia majora 30 and is held in that position by a panty or other support means (not shown) extending beneath the external pad and interlocked with the annular Velcro patch 23 (if provided). The periurethral cup 11 extends upwardly between the labia minora 31, and its soft rounded upper surfaces lla of front and side wall portions l9a and l9c engage the periurethral floor 32 about the meatus of the urethra 33. The urine-deflecting protuberance 20 e~tends * Trade Mark ~ _ 9 _ ~Z14086 upwardly a short distance into the introitus or vagina 34.
The gently-rounded upper surfaces 20a and lla of the peri-urethral cup therefore make resilient sealing contact with the periurethral meatal surfaces even in the minority of cases where the patient's urethra curves rearwardl~ and communicates directly with the introitus (as represented in broken lines 35 in Figure 4). The wide smoothly-rounded upper surfaces of the cup make substantial surface contact with the wearer and greatly reduce the possibility of localizing of forces that might result in discomfort and pressure necrosis. The thickness of the cup's walls yield a form-retaining construction despite the softness and compressibility of the material from which the cup is formed. Should limited deformation of the cup occur in use (as indicated, for example, by broken lines in Figure 2), such deformation can be accommodated by the compressibility of the material of the cup without accompanying buckling or kinking actions that might result in leakage, and without relative movement between body tissues and the cup surfaces that might produce irritation and discomfort.
It is to be emphasized that the form-retentive cup is urged upwardly into sealing contact with the periurethral floor and introitus because of the expansive force exerted by elastomeric bellows 13. When the urinary incontinence device is properly worn, the bellows is in a partially compressed state as shown most clearly in Figures 4 and 6.
External pad 12 is immobilized against labia ma~ora 30 and functions as a base against which the expansive force of the bellows is applied in a downward direction. The upward force exerted by cup 11 against the periurethral surfaces is therefore relatively con~tant in magnitude and direction.
)( - 10 -The bellows not only exexts a constant gentle upward force on the cup, to maintain the cup in the position illustrated, but also is capable of twisting, bending, and deflecting to accommodate changes in position of external pad 12 and internal cup 11 resulting from the dynamics of body movement. Figure S illustrates what is believed to be a typical condition where, because of wearer movement, the cup 11 and pad 12 have become laterally disposed but, nevertheless, the expansive force exerted by bellows 13 coupled with the substantial contact surfaces between the form-retentive but compressible cup and the periurethral surfaces still maintain the cup in sealing contact with the wearer.
Figure 7 illustrates a si~ing instrument 40 that may be conveniently used for establishing the bellows length required for properly fitting a wearer with urinary collection device 10. Periurethral cup 111 is of substantially the same size and shape as cup 11 previously described, the essential difference being that cup 111 is secured or formed at the upper end of a stiff calibrated tube 41 rather than extending from a resilient bellows 13. The external pad 112 may be similar to previously-described pad 12, being formed of a resilient elastomeric material (Dow Corning Q7-4840* has been found particularly effective) and having essentially the same dimensions. The primary difference is that instead of being secured to bellows 13 and flexible tube 14, external pad 112 may be provided with a sleeve 42 that slidably receives rigid calibrated tube 41. The external pad 112 may therefore be slid along the length of tube 41, and its position established by reference to calibration lines 43 and numerical indicia 44.
*Trade M~rk ~Z14086 The sizing instrument 40 may be disposable and is used by a doctor or other medically-trained personnel by inserting periurethral cup 111 into the position assumed by cup 11 in Figure 4, and then sliding the external pad 112 axially along the indexed tube 41 until the pad bears against the labia majora 30 in the same manner shown in Figure 4 for pad 12.
If inspection is deemed necessary or desirable to establish that the periurethral cup 111 is properly seated against the periurethral floor and vaginal introitus, or if inspection is required for any other reason, the doctor may insert the stem of a conventional endoscope through the passage 4~ of tube 41, so that the objective of the endoscope extends into the open cup 112. Once it is determined that both the periurethral cup 111 and the external pad 112 are properly positioned, the sizing instrument is removed and the determination of bellows length for the collection device 10 to be used by the patient is made from scale 43-44.
The following example details the preparation of a soft, compressible material, and the construction of a periurethral cup formed of such material, found to be particularly effective for use in practicing the invention:
Ten parts by weight of a first component and 7 parts by weight of a second component of a two-part silicone rubber addition polymerization system, type Q7-4840* from Dow Corning, Midland, Michigan, were mixed with 1.7 parts by weight of type 360 Dow Corning silicone fluid having a viscosity of about 350 centipoises, and then degassed and injected into molds for the periurethral cup 11, the external pad 12, and bellows 13. Curing was achieved by heating to a temperature of 200-400 F. for an interval of up to about 6 minutes. The silicone rubber of the inal parts was homogeneous, smooth and clear (semi-txanspa.rent), `
*Trade Mark ~ - 12 -12~40~
with a durometer of approximately 10 Shore A.
The parts may also be fabricated from an elastomeric foam as follows: Four parts by weight of a silicone foam base, type QU-4290* from Dow Corning, Midland, Michigan having a viscosity within the range of 1,000 to 6,000 centipoises, and 2.5 parts by weight of Silastic 382 elastomer from the same source, having a viscosity within the range of 35,000 to 65,000 cp, were mixed thoroughly and 0.045 part of a silicone foam catalyst, type Q7-4290*, was then added and mixed thoroughly for approximately 30 seconds. The mixture was allowed to degas for approximately 30 seconds and then stirred vigorously. The degasing and stirring procedures were repeated twice, and the mixture was then immediately poured into molds for the periurethral cup 11 and the external pad 12. The cup and pad were removed from their respective mold cavities from a curing interval of approximately 12 minutes. To facilitate removal, the cavities of the molds were pre-coated with a suitable mold release agent (HEM 41220*). The small cell size of the foàm parts were promoted by the degasing procedures and the vigorous stirring action. The final parts had smooth, substantially non-porous outer surfaces of skins and a durometer of approximately 10 Shore A.
The embodiment depicted in Figures 8-16 i9 essentially the same as the embodiment of Figures 1-6 except for air porting and gas venting means. The device includes an external pad 212 for contacting the labia majora of the wearer, a periurethral cup 211 having upper and lower openings 217 and 218, respectively, and a tubular elastic bellows 213 extending between the lower opening of the cup and the opening of the external pad for urging the cup into engagement with the periurethral floor and *Trade Mar~
~ - 13 -~2'140~6 vaginal introitus when the pad is held against the labia majora. The cup has an integral side wall 219 composed of front, rear, and lateral wall portions 219a, 219b, and ~19c, respectively. In the region bordering top opening 217, each of those wall portions has smoothly rounded surfaces and has a substantial thickness within the range of about 3 to 15 millimeters. The rear wall portion 219b curves upwardly beyond the upper limits of the front and lateral wall portions to define the resilient, vaginally-insertable, urine-deflecting extension or protuberance 2~0. All of the characteristics, compositions, dimensions, and functions of the cup, bellows, and pad of this embodiment are essentially the same as those described in connection with the first embodiment of Figures 1-6.
Whether bellows 213 and cup 211 are formed separately (and then joined by adhesive or-any other suitable means, as shown and previously described) or integrally, the upper end of the bellows 213 communicates directly with the periurethral cup 211 at lower opening 218. The lower end of the bellows is connected to the upper end of a flexible conduit or tube 214 by an extension 225 of that conduit.
As shown most clearly in Figures 8 and 10, the interfacial conduit extension 225 has a wall 225a that flares upwardly and outwardly to match the larger diameter of the bellows.
However, one portion 225b of that wall extends generally horizontally, that is, in a plane normal to the axis of the bellows in an undeformed state. One or more air entry ports 250 extend vertically (i.e., axially) through wall portion 225b; in the form shown, a pair of such ports are provided, each having an arcuate configuration when viewed in transverse section or plan (Figure 11). Valve means 251, which may take ~he ~orm of an umbrella valve ~214086 havin~ à conical canopy portion 252 and stem portion 253 is positioned to allow entry of ambient air while at the same time blocking the escape of fluids tgases and liquids) from the bellows 213 and upper end of the conduit 214. As shown most clearly in Figures 12-14, the elongated stem 253 o~ the valve member 251 is adapted to extend downwardly through an opening 254 in wall portion 225b, such opening being centered between arcuate ports 250. An intermediate enlargement 253a of the stem serves to limit upward movement of the stem with respect to wall portion 225b; downward movement is prevented by an upper enlargement 253b of the stem shrouded by the conical canopy portion 252.
The umbrella valve member 251 is composed of a soft, easily-deformable and readily-recoverable elastic material such as, for example, silicone rubber. Figure 13 depicts the valve member in an untensioned or undeformed state, but it will be noted from Figure 14 that when the valve member is secured to apertured wall 225b of the interfacial conduit extension 225 the valve member is in a pre-tensioned or pre-loaded condition with canopy portion 252 having a distinctive downward and outward curvature and with the peripheral edge of the canopy portion held in normal sealing engagement with the upper surface of wall 225b.
Because of its deformability, and notwithstanding the pre-tensioning, the canopy portion 252 of the valve member is capable of ~lexing upwardly to allow entry of air into the system when even a small pressure differential (for example, 0.5 inches H2O) exists. Such upward flexure is indica~ed in broken lines in Figure 12. On the other hand, should the pressure within the system be equal to or exceed ambient pressure, the highly flexible canopy 252 will eEectivel~ seal against tho upper surf~ce of wall portion 225b ~214086 and will block exit of fluids, at least within the range o~ pressure differentials encountered in normal use of the device. As shown in Figure 10, the external pad 212 has an inlet passage 255 communicating with opening 250 in wall portion 225b. Passage 255 extends upwardly through the wall of the pad from an entrance 256 at the pad's lower end.
The purpose of ports 250 and valve members 251 is to insure that the superior sealing action of the periurethral cup against the periurethral floor and vaginal introitus will not interfere with proper flow of urine through conduit 214 to pouch or collection device 257.
If it were not for the inlet ports, a column of liquid flowing downwardly through conduit 214 would generate a relative negative pressure that might even be sufficient to collapse bellows 213 and/or conduit 214, interfere with the fit of periurethral cup 211, and possibly result in leakage or wearer discomfort. Since ports 250 and one-way valve 251 permit the entry of air at the upper end of the conduit, pressure is equalized and such problems are thereby avoided.
While the umbrella valve construction shown in the drawings has been found highly effective, other types of air-inletting valves might be used. Furthermore, where an umbrella valve is utilized, it may or may not be used in conjunction with deflector means 253. The purpose of the deflector is simply to prevent the possibility that leakage might occur should canopy 252 of the valve member 251 be impacted by a stream of urine flowing rapidly through the bellows 213 and entering conduit 214. If the possibilities of leakage caused by urine impinging upon and deforming the valve member are considered so slight as to be ne~ ible or inconse~uentlal then deflector 25~ ~nay be elimin~ted.
~2~4086 As shown in Figures 12 and 14-16, the deflector 258 takes the form of a plate 259 havin~ a pair of spaced downwardly-extending legs 260. The cover plate 259 extends over the canopy 252 of valve member 251 and is held in place by upstanding spindles or lugs 261 that are formed integrally with interfacial conduit extension 225 and received within channels or holes 262 formed in the legs 260 of the deflector.
The deflector may be frictionally held in place by the lugs and, as shown, the free ends of the lugs may be flattened and whereby, laterally enlarged to lock the deflector in operative position. Alternatively, the parts may be permanently bonded or fused together by any suitable means.
To prevent air which enters the system through ports 250 from inflating pouch 257j a wall 257a of the pouch is provided at its upper end with air venting means 270. Any suitable means for venting air from the upper end of the pouch while at the same time blocking the outflow of liquid may be used. In the embodiment illustrated, the venting means takes the form of perforations 271 formed in wall 257a with the area of such perforations backed by a thermoplastic microporous strip 272 capable of allowing gases to escape from the pouch while at the same time blocking the passage of urine. The strip or patch 272 is perimetrically sealed to the wall of the pouch by heat sealing 273 or by any other suitable sealing means. While various types of hydrophobic microporous materials may be used for fabrication of the vent or filter patch 272, effective results have been achieved using 3-micron filter stock marketed under the designation "Versapor*" by Gelman Corporation, Ann Arbor, Michigan.
The lower or distal end of flexible conduit 214 is shown to be connected to pouch 257 b~ a detachable coupling 280 *Trade Mark ~12140~36 of the type shown and described in co-owned U.S. patent 4,280,498. Since any of a variety of couplings and connections between the conduit and the pouch might be provided, all within the knowledge of someone familiar with urine collection systems, a discussion of such structures in further detail is believed unnecessary herein.
While in the foregoing we have disclosed embodiments of the invention in considerable detail for purposes of illustration, it will be understood by those skilled in the art that many of these details may be varied without departing from the spirit and scope of the invention.
Background Various devices have been proposed in past years for directing and collecting urine from female patients suffering from urinary incontinence but, in general, such devices have been associated with problems of leakage, wearer discomfort, pressure sores, and even necrosis. An indication of the ineffectiveness of such prior devices lies in their lack of commercial success.
The problems associated with prior devices are particularly pronounced with ambulatory patients because of the varied and complex anatomical changes that occur in the periurethral area during locomotion and the failure of such devices to coapt to such changes. However, the need for an effective device is by no means limited to ambulatory patients. For example, non-ambulatory female patients with spinal cord injuries are not served well by existing devices ( indwelling catheters, intermittent catheters, diapers, etc.) despite only minimal body movement of such patients.
Prior patènts have disclosed female urinary collection devices equipped with locating elements intended to be inserted into the vagina for retaining the collection devices in operative positions. Reference may be had to U.S.
patents 2,483,079, 2,490,969, 3,116,734, 3,528,423, 3,512,185, 3,776,235, 3,611,155, and 4,246,901. Those constructions in which the locating elements are relatively rigid clearly fail to conform with the anatomical changes occurring during body movement. While prior devices with flexible or deformable vaginal locating elements may reduce tissue irritation and increase patient comfort, problems in providing an effective seal and avoiding lea~age along the lines or zones of con~act have nevertheless rQmain~d.
~r ~2~408~;
Other patents of interest are 4,270,539, 3,651,810, 4,198,979, and 3,194,238.
Summary One aspect of this invention lies in the discovery that effective sealing engagement with perimeatal tissues may be achieved if the female incontinence device is constructed so that the periurethral cup is compressible but generally form-retaining and is mounted so that it may move independently, at least to a limited exten~, with respect to those portions of the device that make external contact with the wearer. A further aspect lies in the recognition that if such a molded compressible element is cup-shaped in configuration and is operatively connected to an external pad (which is in turn held in place by a panty or supporting belts) by means of a tubular elastic bellows that exerts an upward force on the cup when the device is worn without, at the same time, interfering with limited independent movement of the cup with respect to the pad, such a combination will result in a device that eliminates or substantially reduces the aforementioned problems associated with prior devices. In another embodiment an air entry port, normally closed by a one-way valve, allows air to enter the system to prevent the development of relative negative pressure within that system, and a vent is provided in the collector to prevent expansion or deformation of the collector (normally an expandable plastic pouch) that might otherwise result ~rom entrapped air and the development of a relative positive pressure.
The periurethral cup of a device embodying this invention is molded in one piece of soft, compressikle but generally form-retaining material havin~ a durometer within the range o~ about 1 to 30 on the Shore A scal.e, ~X - 2 -the preferred range being approximately 5 to 20 on that scale. An elastomeric material, molded so that the outer surfaces of the cup are smooth and non-porous, has been found particularly effective.
The periurethral cup is preferably provided with front, rear, and lateral wall portions defining upper and lower openings, such wall portions having a substantial wall thickness (about 3 to 15 millimeters) and having smoothly rounded surfaces, for making substantial surface contact with the periurethral floor and vaginal introitus. The rear wall portion extends upwardly beyond the upper limits of the front and lateral portions to define a resilient, vaginally-insertable, urine-deflecting protuberance, a feature of importance for those patients whose urethral orifice is located in, or immediately adjacent to, the vaginal introitus.
The urine-deflecting protuberance is capable of flexing towards and away from the entrance opening of the cup without causing buckling or kinking of the smoothly-rounded contact surfaces engaging the periurethral floor and vaginal introitus because of the`compressibility and substantial wall thickness of the cup.
An external pad of soft, resilient and flexible material is dimensioned for externally contacting the labia majora of the wearer and has an opening extending therethrough.
Between that opening and the lower opening`of the periurethral cup is a tubular elastic bellows dimensioned for exerting an upward force on the cup, when the device is worn, to maintain an effective seal between the rounded contact surfaces of the cup and the surface of the periurethral floor and introitus despite the complex anatomical changes or displacements that occur during the dynamics of body movement. The length of the elas~ic bellows varies within certain predetermined limi~s ~ - 3 -~Z14086 according to the distance between the periurethral floor and the external surfaces of the labia majora for each wearer, and a sizing instrument, patterned after the construction of the urinary incontinence device, may be used to establish the proper bellows length for a given patient. Such sizing tool designed to allow endoscopic examination if deemed necessary or desirable.
The external pad may, if desired, be provided with a soft absorbent liner for directly contacting the labia majora of the patient. Flexible tubing extends from the outlet of the external pad to a leg bag or other suitable collection device. The external pad is preferably held in place by the wearer's undergarment (panty), but other supporting means in the form of straps or belts may be used.
Other features, advantages, and objects of the invention will become apparent from the drawings and specification.
Drawings Figure 1 is a perspective view of a female urinary incontinence dèvice embodying the invention.
Figure 2 is a vertical longitudinal sectional view of the device.
Figure 3 is an enlarged cross sectional view taken along line 3-3 of Figure 2.
Figure 4 is a saggital sectional view illustrating the device as it is worn.
Figure 5 is a saggital sectional view similar to Figure 4 but illustrating the relative displacements of the external pad and periurethral cup during weaxer movement~
Figure 6 is a lateral sectional view of the device as it is worn.
Figure 7 is a side elevational view, shown partly ~ - 4 -~214086 in section, of a sizing tool adapted to be used as part of the present invention.
Figure 8 is a fragmentary side view, taken partly in section, showing a modified device with ports or vents for preventing collapse of the bellows and conduit while at the same time allowing gas to escape from the pouch.
Figure 9 is an enlarged horizontal cross sectional view of the pouch's vent and filter, with certain elements of the pouch and associated coupling omitted for clarity of illustration.
Figure 10 is an enlarged vertical sectional view of certain portions of the device depicted in Figure 8.
Figure 11 is a horizontal sectional view taken along line ll-I1 of Figure 10.
Figure 12 is a still further enlarged sectional view of the inlet port and valve member taken along line 12-12 o~ Figure 11.
Figure 13 is a sectional view of the umbrella valve member showing details of construction thereof.
Figure 14`is an enlarged sectional view taken along line 14-14 of Figure 11.
Figure 15 is a perspective view of a fluid-deflecting element.
Figure 16 is an exploded perspective view of the valve member, fluid detector, and the portion of the device providing the valve passage or port.
Detailed Description of Preferred Embodiment Referring to the embodiment shown in Figures 1-6, the primary components of the female urinary incontinence device 10 are periurethral cup 11, external pad 12 f and tubular elastic bellows 13. A flexible tube 1~ carries ~2~4086 urine to a suitable collector or receptacle 15. For an ambulatory patient, collector 15 would ordinarily take the form of a leg bag. It is to be understood, however, that other types of collectors might be provided to suit the needs and physical condition of the user. Ordinarily, flexible tube 14 would include a suitable detachable coupling 16. The coupling illustrated in Figure 2 is similar to that shown and described in U.S. patent 4,280,498, but other types of couplings may be provided.
The periurethral cup 11 is molded in one piece from a soft, compressible, but generally form-retaining material.
A molded elastomeric silicone matexial having a smooth, substantially non-porous outer surface has been found particularly effective, but other molded compressible materials, such as elastomeric foam materials, might be used. Regardless of the material selected, it is believed critical that such material should have a durometer within the range of about 1 to 30 on the Shore A scale, preferably within the range of 5 to 20. Particularly effective results have been obtained with a material having a durometer of approximately 10.
It is also important that the side wall of the periurethral cup have substantial thickness and that the uppermost surfaces of the cup be smoothly curved or rounded as shown most clearly in Figures 2 and 3. More specifically, as depicted in the drawings, the cup has upper and lower openings 17 and 18, respectively. The integral side wall 19 is composed of front, rear, and lateral wall portions l9a, 19b, and l9c, respectively. In the region bordering top opening 17, each of those wall portions should have a thickness d (Figure 3) within the range of about 3 to 15 millimeters. The result is a cup which, as brought out ~ - 6 -~2~086 hereinafter, has upp~r surfaces making substantial contact with the periurethral ~loor and vaginal introitus and which, although soft and compressible, tends to be shape-retentive in use notwithstanding the upward force exerted by elastic bellows 13.
The rear wall portion l9b curves upwardly beyond the upper limits o~ the front and lateral wall portions to define a resilient, vaginally-insertable, urine-deflecting extension or protuberance 20. The essential purpose of the protuberance is to serve as a urine deflector for that portion of the female population, estimated at between 15 to 20%, whose urethral orifice is located within, or immediately adjacent to, the vaginal introitus. Any functions the protuberance performs in locating and retaining the cup in position are of secondary significance. As described more fully hereinafter, the wide-smoothly rounded contact surfaces of the compressible cup, in combination with the gentle upward force exerted by elastic bellows 13, serve primarily to maintain the cup in its operative position.
As shown in Figures 1-3, the rounded upper surfaces 20a of protuberance 20 merge smoothly and-gradually with the upper surfaces lla of the remaining side and front wall portions of the cup. Specifically, the upper front surfaces of the protuberance 20 merge with the upper surfaces of the side walls along a curved line represented in Figure 2 as having a substantial radius r. That radius would normally fall within the range of about 5 to 12 millimeters. Of particular significance is the fact that even when the protuberance is urged forwardly, as indicated by broken lines in Figure 2, no buckling or kinking of the wall occurs at radius r because of the compressibility of the material from which the cup i~ forme~. Consequently, an e~fective seal ~ ~ 7 -~Z140~36 between the curved upper surfaces of the cup (including the protuberance) and the contact surfaces of the patient tends to be maintained during normal body movement.
External pad 12 may be formed of the same soft, compressible material as periurethral cup 11 and, in any event, should be formed of a resilient, flexible polymeric material. The pad is generally oval in outline, substantially larger than cup 11, and has a passage or opening 21 extending therethrough (Figure 2). As shown in the drawings, the external pad has an upper surface 12a that is pre~erably concave or dish-shaped and, if desired, the upper surface may support an annular absorbent liner 22 (Figure 2) formed of non-woven cotton fibers or other suitable absorbent material.
Along its lower or external surface 12b, pad 12 may be provided with attachment means 23 in the form of fabric having nylon hooks or loops of the type commercially available under the Velcro* designation. If such retaining means is used, then the patient would also wear a panty having a brushed nylon crotch panel for engaging and interlocking with attachment means 23, thereby helping to maintain the external pad 12 against the outer surfaces of ~he labia majora.
Bellows 13 may be formed of any suitable elastomeric material and, in an uncompressed or extended state, assumes the appearance depicted in Figures 1-3. The number of corrugations or convolutions 13a of the bellows for any given urinary collection appliance will depend on the distance between the labia majora and the periurethral floor of the wearer to be fitted with the device so that, when worn, the corrugations will be compressed or axially reduced as indicated in Figures 4 and 6. Ordinarily, for adult wearers, the number of corrugations will range between 2 (Figure ~) to 6, and the undeormed length o ~h~ ~orrugated por~ion ~Trade M~rk ~Z140~36 will range from 10 to 50 millimeters, with 3 selected sizes within those ranges meeting the requirements for over 90%
of the adult female population. The tublar bellows may be formed of elastomers of polyurethane, silicone rubber, latex, or any of a variety of other materials having similar properties. A particularly effective material has been found to be a silicone rubber marketed by Dow Cornlng, Midland, Michigan, under the designation Q7-4840*; another, available from the same source, is MDX4-4210*.
In the embodiment shown, the bellows 13 and cup 11 are formed separately and the upper end of the bellows is then secured by adhesive or by any other suitable means to the cup about the lower opening 18; however, it is to ba understood that, if desired, the two elements may be formed integrally. The lower end of the bellows is connected to flexible tube or conduit 14 at the upper end of opening 21 of the external pad by means of an upwardly-flared extension 25 of conduit 14. Extension 25 of conduit 14 may be joined to the bellows 13, and to the wall of external pad 12, by adhesives, heat sealing, or any other suitable means.
Figures 4-6 depict the anatomical orientation of the urinary incontinence device 10 under normal conditions of use. External pad 12 bears upwardly against the external surfaces of the labia majora 30 and is held in that position by a panty or other support means (not shown) extending beneath the external pad and interlocked with the annular Velcro patch 23 (if provided). The periurethral cup 11 extends upwardly between the labia minora 31, and its soft rounded upper surfaces lla of front and side wall portions l9a and l9c engage the periurethral floor 32 about the meatus of the urethra 33. The urine-deflecting protuberance 20 e~tends * Trade Mark ~ _ 9 _ ~Z14086 upwardly a short distance into the introitus or vagina 34.
The gently-rounded upper surfaces 20a and lla of the peri-urethral cup therefore make resilient sealing contact with the periurethral meatal surfaces even in the minority of cases where the patient's urethra curves rearwardl~ and communicates directly with the introitus (as represented in broken lines 35 in Figure 4). The wide smoothly-rounded upper surfaces of the cup make substantial surface contact with the wearer and greatly reduce the possibility of localizing of forces that might result in discomfort and pressure necrosis. The thickness of the cup's walls yield a form-retaining construction despite the softness and compressibility of the material from which the cup is formed. Should limited deformation of the cup occur in use (as indicated, for example, by broken lines in Figure 2), such deformation can be accommodated by the compressibility of the material of the cup without accompanying buckling or kinking actions that might result in leakage, and without relative movement between body tissues and the cup surfaces that might produce irritation and discomfort.
It is to be emphasized that the form-retentive cup is urged upwardly into sealing contact with the periurethral floor and introitus because of the expansive force exerted by elastomeric bellows 13. When the urinary incontinence device is properly worn, the bellows is in a partially compressed state as shown most clearly in Figures 4 and 6.
External pad 12 is immobilized against labia ma~ora 30 and functions as a base against which the expansive force of the bellows is applied in a downward direction. The upward force exerted by cup 11 against the periurethral surfaces is therefore relatively con~tant in magnitude and direction.
)( - 10 -The bellows not only exexts a constant gentle upward force on the cup, to maintain the cup in the position illustrated, but also is capable of twisting, bending, and deflecting to accommodate changes in position of external pad 12 and internal cup 11 resulting from the dynamics of body movement. Figure S illustrates what is believed to be a typical condition where, because of wearer movement, the cup 11 and pad 12 have become laterally disposed but, nevertheless, the expansive force exerted by bellows 13 coupled with the substantial contact surfaces between the form-retentive but compressible cup and the periurethral surfaces still maintain the cup in sealing contact with the wearer.
Figure 7 illustrates a si~ing instrument 40 that may be conveniently used for establishing the bellows length required for properly fitting a wearer with urinary collection device 10. Periurethral cup 111 is of substantially the same size and shape as cup 11 previously described, the essential difference being that cup 111 is secured or formed at the upper end of a stiff calibrated tube 41 rather than extending from a resilient bellows 13. The external pad 112 may be similar to previously-described pad 12, being formed of a resilient elastomeric material (Dow Corning Q7-4840* has been found particularly effective) and having essentially the same dimensions. The primary difference is that instead of being secured to bellows 13 and flexible tube 14, external pad 112 may be provided with a sleeve 42 that slidably receives rigid calibrated tube 41. The external pad 112 may therefore be slid along the length of tube 41, and its position established by reference to calibration lines 43 and numerical indicia 44.
*Trade M~rk ~Z14086 The sizing instrument 40 may be disposable and is used by a doctor or other medically-trained personnel by inserting periurethral cup 111 into the position assumed by cup 11 in Figure 4, and then sliding the external pad 112 axially along the indexed tube 41 until the pad bears against the labia majora 30 in the same manner shown in Figure 4 for pad 12.
If inspection is deemed necessary or desirable to establish that the periurethral cup 111 is properly seated against the periurethral floor and vaginal introitus, or if inspection is required for any other reason, the doctor may insert the stem of a conventional endoscope through the passage 4~ of tube 41, so that the objective of the endoscope extends into the open cup 112. Once it is determined that both the periurethral cup 111 and the external pad 112 are properly positioned, the sizing instrument is removed and the determination of bellows length for the collection device 10 to be used by the patient is made from scale 43-44.
The following example details the preparation of a soft, compressible material, and the construction of a periurethral cup formed of such material, found to be particularly effective for use in practicing the invention:
Ten parts by weight of a first component and 7 parts by weight of a second component of a two-part silicone rubber addition polymerization system, type Q7-4840* from Dow Corning, Midland, Michigan, were mixed with 1.7 parts by weight of type 360 Dow Corning silicone fluid having a viscosity of about 350 centipoises, and then degassed and injected into molds for the periurethral cup 11, the external pad 12, and bellows 13. Curing was achieved by heating to a temperature of 200-400 F. for an interval of up to about 6 minutes. The silicone rubber of the inal parts was homogeneous, smooth and clear (semi-txanspa.rent), `
*Trade Mark ~ - 12 -12~40~
with a durometer of approximately 10 Shore A.
The parts may also be fabricated from an elastomeric foam as follows: Four parts by weight of a silicone foam base, type QU-4290* from Dow Corning, Midland, Michigan having a viscosity within the range of 1,000 to 6,000 centipoises, and 2.5 parts by weight of Silastic 382 elastomer from the same source, having a viscosity within the range of 35,000 to 65,000 cp, were mixed thoroughly and 0.045 part of a silicone foam catalyst, type Q7-4290*, was then added and mixed thoroughly for approximately 30 seconds. The mixture was allowed to degas for approximately 30 seconds and then stirred vigorously. The degasing and stirring procedures were repeated twice, and the mixture was then immediately poured into molds for the periurethral cup 11 and the external pad 12. The cup and pad were removed from their respective mold cavities from a curing interval of approximately 12 minutes. To facilitate removal, the cavities of the molds were pre-coated with a suitable mold release agent (HEM 41220*). The small cell size of the foàm parts were promoted by the degasing procedures and the vigorous stirring action. The final parts had smooth, substantially non-porous outer surfaces of skins and a durometer of approximately 10 Shore A.
The embodiment depicted in Figures 8-16 i9 essentially the same as the embodiment of Figures 1-6 except for air porting and gas venting means. The device includes an external pad 212 for contacting the labia majora of the wearer, a periurethral cup 211 having upper and lower openings 217 and 218, respectively, and a tubular elastic bellows 213 extending between the lower opening of the cup and the opening of the external pad for urging the cup into engagement with the periurethral floor and *Trade Mar~
~ - 13 -~2'140~6 vaginal introitus when the pad is held against the labia majora. The cup has an integral side wall 219 composed of front, rear, and lateral wall portions 219a, 219b, and ~19c, respectively. In the region bordering top opening 217, each of those wall portions has smoothly rounded surfaces and has a substantial thickness within the range of about 3 to 15 millimeters. The rear wall portion 219b curves upwardly beyond the upper limits of the front and lateral wall portions to define the resilient, vaginally-insertable, urine-deflecting extension or protuberance 2~0. All of the characteristics, compositions, dimensions, and functions of the cup, bellows, and pad of this embodiment are essentially the same as those described in connection with the first embodiment of Figures 1-6.
Whether bellows 213 and cup 211 are formed separately (and then joined by adhesive or-any other suitable means, as shown and previously described) or integrally, the upper end of the bellows 213 communicates directly with the periurethral cup 211 at lower opening 218. The lower end of the bellows is connected to the upper end of a flexible conduit or tube 214 by an extension 225 of that conduit.
As shown most clearly in Figures 8 and 10, the interfacial conduit extension 225 has a wall 225a that flares upwardly and outwardly to match the larger diameter of the bellows.
However, one portion 225b of that wall extends generally horizontally, that is, in a plane normal to the axis of the bellows in an undeformed state. One or more air entry ports 250 extend vertically (i.e., axially) through wall portion 225b; in the form shown, a pair of such ports are provided, each having an arcuate configuration when viewed in transverse section or plan (Figure 11). Valve means 251, which may take ~he ~orm of an umbrella valve ~214086 havin~ à conical canopy portion 252 and stem portion 253 is positioned to allow entry of ambient air while at the same time blocking the escape of fluids tgases and liquids) from the bellows 213 and upper end of the conduit 214. As shown most clearly in Figures 12-14, the elongated stem 253 o~ the valve member 251 is adapted to extend downwardly through an opening 254 in wall portion 225b, such opening being centered between arcuate ports 250. An intermediate enlargement 253a of the stem serves to limit upward movement of the stem with respect to wall portion 225b; downward movement is prevented by an upper enlargement 253b of the stem shrouded by the conical canopy portion 252.
The umbrella valve member 251 is composed of a soft, easily-deformable and readily-recoverable elastic material such as, for example, silicone rubber. Figure 13 depicts the valve member in an untensioned or undeformed state, but it will be noted from Figure 14 that when the valve member is secured to apertured wall 225b of the interfacial conduit extension 225 the valve member is in a pre-tensioned or pre-loaded condition with canopy portion 252 having a distinctive downward and outward curvature and with the peripheral edge of the canopy portion held in normal sealing engagement with the upper surface of wall 225b.
Because of its deformability, and notwithstanding the pre-tensioning, the canopy portion 252 of the valve member is capable of ~lexing upwardly to allow entry of air into the system when even a small pressure differential (for example, 0.5 inches H2O) exists. Such upward flexure is indica~ed in broken lines in Figure 12. On the other hand, should the pressure within the system be equal to or exceed ambient pressure, the highly flexible canopy 252 will eEectivel~ seal against tho upper surf~ce of wall portion 225b ~214086 and will block exit of fluids, at least within the range o~ pressure differentials encountered in normal use of the device. As shown in Figure 10, the external pad 212 has an inlet passage 255 communicating with opening 250 in wall portion 225b. Passage 255 extends upwardly through the wall of the pad from an entrance 256 at the pad's lower end.
The purpose of ports 250 and valve members 251 is to insure that the superior sealing action of the periurethral cup against the periurethral floor and vaginal introitus will not interfere with proper flow of urine through conduit 214 to pouch or collection device 257.
If it were not for the inlet ports, a column of liquid flowing downwardly through conduit 214 would generate a relative negative pressure that might even be sufficient to collapse bellows 213 and/or conduit 214, interfere with the fit of periurethral cup 211, and possibly result in leakage or wearer discomfort. Since ports 250 and one-way valve 251 permit the entry of air at the upper end of the conduit, pressure is equalized and such problems are thereby avoided.
While the umbrella valve construction shown in the drawings has been found highly effective, other types of air-inletting valves might be used. Furthermore, where an umbrella valve is utilized, it may or may not be used in conjunction with deflector means 253. The purpose of the deflector is simply to prevent the possibility that leakage might occur should canopy 252 of the valve member 251 be impacted by a stream of urine flowing rapidly through the bellows 213 and entering conduit 214. If the possibilities of leakage caused by urine impinging upon and deforming the valve member are considered so slight as to be ne~ ible or inconse~uentlal then deflector 25~ ~nay be elimin~ted.
~2~4086 As shown in Figures 12 and 14-16, the deflector 258 takes the form of a plate 259 havin~ a pair of spaced downwardly-extending legs 260. The cover plate 259 extends over the canopy 252 of valve member 251 and is held in place by upstanding spindles or lugs 261 that are formed integrally with interfacial conduit extension 225 and received within channels or holes 262 formed in the legs 260 of the deflector.
The deflector may be frictionally held in place by the lugs and, as shown, the free ends of the lugs may be flattened and whereby, laterally enlarged to lock the deflector in operative position. Alternatively, the parts may be permanently bonded or fused together by any suitable means.
To prevent air which enters the system through ports 250 from inflating pouch 257j a wall 257a of the pouch is provided at its upper end with air venting means 270. Any suitable means for venting air from the upper end of the pouch while at the same time blocking the outflow of liquid may be used. In the embodiment illustrated, the venting means takes the form of perforations 271 formed in wall 257a with the area of such perforations backed by a thermoplastic microporous strip 272 capable of allowing gases to escape from the pouch while at the same time blocking the passage of urine. The strip or patch 272 is perimetrically sealed to the wall of the pouch by heat sealing 273 or by any other suitable sealing means. While various types of hydrophobic microporous materials may be used for fabrication of the vent or filter patch 272, effective results have been achieved using 3-micron filter stock marketed under the designation "Versapor*" by Gelman Corporation, Ann Arbor, Michigan.
The lower or distal end of flexible conduit 214 is shown to be connected to pouch 257 b~ a detachable coupling 280 *Trade Mark ~12140~36 of the type shown and described in co-owned U.S. patent 4,280,498. Since any of a variety of couplings and connections between the conduit and the pouch might be provided, all within the knowledge of someone familiar with urine collection systems, a discussion of such structures in further detail is believed unnecessary herein.
While in the foregoing we have disclosed embodiments of the invention in considerable detail for purposes of illustration, it will be understood by those skilled in the art that many of these details may be varied without departing from the spirit and scope of the invention.
Claims (41)
PROPERTY OF PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A female urinary incontinence device comprising an external pad of flexible, resilient material for externally contacting the labia majora of a wearer, said pad having an opening therethrough; a periurethral cup molded of soft compressible material and having an upper opening defined by smoothly-rounded contact surfaces adapted to engage the periurethral floor and vaginal introitus of a wearer; said compressible material having a durometer within the range of about 1 to 30 on the Shore A scale; said cup also having a lower opening; and a tubular elastic bellows extending between said lower opening of said cup and said opening of said pad for urging said cup into engagement with said periurethral floor and vaginal introitus when said pad is held against the labia majora.
2. The device of Claim 1 in which retaining means are provided for holding said pad against the labia majora of a wearer.
3. The device of Claim 1 in which said cup includes front, rear, and side wall portions having upper surface merging smoothly with each other and being of rounded cross-sectional contour to provide wide gently-curved contact surfaces for sealingly engaging the periurethral floor and vaginal introitus of a wearer.
4. The device of Claim 3 in which said rear wall portion extends upwardly beyond said front and side wall portions to define a resilient vaginally-insertable urine-deflecting protuberance.
5. The device of Claim 4 in which said urine-deflecting protuberance is capable of flexing towards and away from said upper opening without causing buckling or kinking of the contact surfaces of said cup at the merger of said side and rear wall portions because of the compressibility and substantial wall thickness of the cup.
6. The device of Claims 3 and 4 in which said wall portions of said periurethral cup have thicknesses adjacent said upper opening within the range of about 3 to 15 millimeters.
7. The device of Claim 6 in which said material of said cup has a durometer within the range of about 5 to 20 on the Shore A scale.
8. The device of Claim 7 in which said material of said cup has a durometer of approximately 10.
9. The device of Claim 1 in which said material of said cup is silicone rubber.
10. The device of Claim 1 in which said material of said cup is an elastomeric foam.
11. The device of Claim 1 in which said pad includes soft, absorbent, removable liner for engaging the labia majora of a wearer.
12. A female urinary incontinence device comprising an external pad of flexible, resilient material having a concave upper surface for externally contacting the labia majora and having an opening extending therethrough, a periurethral cup molded of soft, compressible material having front, rear, and side wall portions with upper surfaces merging smoothly with each other and being of rounded cross-sectional contour to provide wide, curved contact surfaces for engaging the periurethral floor and vaginal introitus; said rear wall portion extending upwardly and beyond said front and side wall portions to define a resilient, vaginally-insertable, urine-deflecting protuberance; said compressible material of said periurethral cup having a durometer within the range of about 1 to 30 on the Shore A scale; said protuberance being capable of flexing towards and away from said upper opening without causing buckling or kinking of said contact surface of said cup at the merger of said side and rear wall portions; said cup also having a lower opening; and a tubular elastic bellows extending between said lower opening of said cup and said opening of said pad for urging said cup into engagement with the periurethral floor and vaginal introitus when said pad is supported against the labia majora.
13. The device of Claim 12 in which said material of said cup has a durometer within the range of about 5 to 20 on the Shore A scale.
14. The device of Claim 13 in which said material of said cup has a durometer of approximately 10 on the Shore A scale.
15. The device of Claim 12 in which said material of said cup is silicone rubber.
16. The device of Claim 12 in which said material of said cup is elastomeric foam.
17. The device of Claim 16 in which said elastomeric foam of said cup has a substantially non-porous outer skin.
18. The device of Claim 12 in which said wall portions of said periurethral cup have thicknesses within the range of about 3 to 15 millimeters.
19. The device of Claim 12 in which retaining means are provided for holding said external pad in position against the labia majora.
20. The device of Claim 19 in which said retaining means comprises a panty; and releasable interlocking means provided by said panty and the undersurface of said pad for securing said panty and pad against relative movement.
21. The device of Claim 12 in which a flexible tube has one end secured to said external pad at the opening thereof; and receptacle means communicating with the opposite end of said tube.
22. The device of Claim 12 in which said concave surface of said external pad supports an annular liner of soft, absorbent material for engaging the labia majora.
23. The device of Claim 12 in which said elastic bellows has from 2 to 6 corrugations and an undeformed length of from 10 to 50 millimeters.
24. A female urinary incontinence device comprising an external pad of flexible, resilient material for externally contacting the labia majora of a wearer, said pad having an opening therethrough; a periurethral cup molded of soft compressible material and having an upper opening defined by smoothly-rounded contact surfaces adapted to engage the periurethral floor and vaginal introitus of a wearer; said compressible material having a durometer within the range of about 1 to 30 on the Shore A scale;
said cup also having a lower opening; tubular elastic bellows extending between said lower opening of said cup and said opening of said pad for urging said cup into engagement with said periurethral floor and vaginal introitus when said pad is held against the labia majora; conduit means extending into said opening of said pad and joined to, and communicating with, the lower end of said bellows;
said conduit means including a wall having a port extending therethrough; and one-way valve means associated with said port for allowing air to enter said conduit means while at the same time preventing the escape of fluids therefrom.
said cup also having a lower opening; tubular elastic bellows extending between said lower opening of said cup and said opening of said pad for urging said cup into engagement with said periurethral floor and vaginal introitus when said pad is held against the labia majora; conduit means extending into said opening of said pad and joined to, and communicating with, the lower end of said bellows;
said conduit means including a wall having a port extending therethrough; and one-way valve means associated with said port for allowing air to enter said conduit means while at the same time preventing the escape of fluids therefrom.
25. The device of Claim 24 in which a urine collection pouch is connected to said conduit means; said pouch being provided with a wall having a gas vent extending therethrough;
and means for preventing the escape of liquids from said pouch through said vent.
and means for preventing the escape of liquids from said pouch through said vent.
26. The device of Claim 24 in which retaining means are provided for holding said pad against the labia majora of a wearer.
27. The device of Claim 24 in which said cup includes front, rear, and side wall portions having upper surfaces merging smoothly with each other and being of rounded cross-sectional contour to provide wide gently-curved contact surfaces for sealingly engaging the periurethral floor and vaginal introitus of a wearer.
28. The device of Claim 27 in which said rear wall portion extends upwardly beyond said front and side wall portions to define a resilient vaginally-insertable urine-deflecting protuberance.
29. The device of Claim 28 in which said urine-deflecting protuberance is capable of flexing towards and away from said upper opening without causing buckling or kinking of the contact surfaces of said cup at the merger of said side and rear wall portions because of the compressibility and substantial wall thickness of said cup.
30. The device of Claim 27 in which said wall portions of said periurethral cup have thicknesses adjacent said upper opening within the range of about 3 to 15 millimeters.
31. The device of Claim 30 in which said material of said cup has a durometer within the range of about 5 to 20 on the Shore A scale.
32. The device of Claim 31 in which said material of said cup has a durometer of approximately 10.
33. The device of Claim 24 in which said material of said cup is an elastomeric foam.
34. A female urinary incontinence device comprising an external pad of flexible, resilient material having a concave upper surface for externally contacting the labia majora and having an opening extending therethrough; a periurethral cup molded of soft, compressible material having front, rear, and side wall portions with upper surfaces merging smoothly with each other and being of rounded cross-sectional contour to provide wide, curved contact surfaces for engaging the periurethral floor and vaginal introitus; said rear wall portion extending upwardly beyond said front and side wall portions to define a resilient, vaginally-insertable, urine-deflecting protuberance; said compressible material of said periurethral cup having a durometer within the range of about 1 to 30 on the Shore A scale; said protuberance being capable of flexing towards and away from said upper opening without causing buckling or kinking of said contact surface of said cup at the merger of said side and rear wall portions;
said cup also having a lower opening; tubular elastic bellows extending between said lower opening of said cup and said opening of said pad for urging said cup into engagement with the periurethral floor and vaginal introitus when said pad is supported against the labia majora; conduit means extending into said opening of said pad and joined to, and communicating with, the lower end of said bellows; said conduit means including a wall having a port extending therethrough; and one-way valve means connected to said wall for allowing ambient air to enter said conduit means while at the same time preventing the escape of fluids therefrom.
said cup also having a lower opening; tubular elastic bellows extending between said lower opening of said cup and said opening of said pad for urging said cup into engagement with the periurethral floor and vaginal introitus when said pad is supported against the labia majora; conduit means extending into said opening of said pad and joined to, and communicating with, the lower end of said bellows; said conduit means including a wall having a port extending therethrough; and one-way valve means connected to said wall for allowing ambient air to enter said conduit means while at the same time preventing the escape of fluids therefrom.
35. The device of Claim 34 in which a urine collection pouch is connected to said conduit means; said pouch being provided with a wall having a gas vent extending therethrough;
and means for blocking the escape of liquids from said pouch while allowing gases to pass through said vent.
and means for blocking the escape of liquids from said pouch while allowing gases to pass through said vent.
36. The device of Claim 37 in which said material of said cup has a durometer within the range of about 5 to 20 on the Shore A scale.
37. The device of Claim 36 in which said material of said cup has a durometer of approximately 10 on the Shore A scale.
38. The device of Claim 36 in which said material of said cup is silicone rubber.
39. The device of Claim 36 in which said material of said cup is elastomeric foam.
40. The device of Claim 39 in which said elastomeric foam of said cup has a substantially non-porous outer skin.
41. The device of Claim 34 in which said wall portions of said periurethral cup have thicknesses within the range of about 3 to 15 millimeters.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA000505223A CA1229278A (en) | 1982-09-13 | 1986-03-26 | Female urinary incontinence device |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US41714082A | 1982-09-13 | 1982-09-13 | |
| US417,140 | 1982-09-13 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000505223A Division CA1229278A (en) | 1982-09-13 | 1986-03-26 | Female urinary incontinence device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1214086A true CA1214086A (en) | 1986-11-18 |
Family
ID=23652743
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000435816A Expired CA1214086A (en) | 1982-09-13 | 1983-08-31 | Female urinary incontinence device |
Country Status (14)
| Country | Link |
|---|---|
| JP (3) | JPS5964039A (en) |
| AU (2) | AU558872B2 (en) |
| BE (1) | BE897736A (en) |
| CA (1) | CA1214086A (en) |
| DE (1) | DE3331633A1 (en) |
| DK (1) | DK160855C (en) |
| ES (3) | ES282313Y (en) |
| FR (1) | FR2532837B1 (en) |
| GB (1) | GB2126902B (en) |
| HK (1) | HK19087A (en) |
| IE (1) | IE54485B1 (en) |
| IT (1) | IT1170480B (en) |
| NL (1) | NL184871B (en) |
| SE (2) | SE458662B (en) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IE54485B1 (en) * | 1982-09-13 | 1989-10-25 | Hollister Inc | Female urinary incontinence device |
| SE459469B (en) * | 1982-11-16 | 1989-07-10 | Illinois Tool Works | URIN COLLECTION FOR WOMEN |
| CH665556A5 (en) * | 1984-05-15 | 1988-05-31 | Max Nussbaumer | URINE COLLECTOR FOR INCONTINENT WOMEN. |
| GB2167304B (en) * | 1984-11-23 | 1988-11-30 | Graig Med Prod Ltd | Non-return valve assembly |
| US4889533A (en) * | 1986-05-28 | 1989-12-26 | Beecher William H | Female urinary collection devices having hollow-walled filled urine receptacles |
| US4795449A (en) * | 1986-08-04 | 1989-01-03 | Hollister Incorporated | Female urinary incontinence device |
| FR2622435B1 (en) * | 1987-10-30 | 1990-03-09 | Nigay Pierre | RECEPTACLE OF URINE AND SADDLE |
| US5147301A (en) * | 1991-12-11 | 1992-09-15 | Francesco Ruvio | Female incontinent device |
| DK112893A (en) * | 1993-10-08 | 1995-07-11 | Soeren Rahlff | urine collector |
| WO1996000096A1 (en) * | 1994-06-24 | 1996-01-04 | Joan Saltz | External urinary receptacle |
| US6183454B1 (en) * | 1998-05-08 | 2001-02-06 | Laurence Levine | Externally supported female urinary collector |
| WO2001054633A1 (en) * | 2000-01-25 | 2001-08-02 | Snyder And Associates | Urine retention and collection devices for incontinent women |
| US7931634B2 (en) * | 2003-12-18 | 2011-04-26 | Kimberly-Clark Worldwide, Inc. | Bodily exudate capturing article |
| GB2412587A (en) | 2004-03-31 | 2005-10-05 | Oumeima Ben Youssef | Urinary incontinence device |
| WO2006084405A1 (en) * | 2005-02-14 | 2006-08-17 | Fabian Stebler | Docking mouthpiece for leading away urine of a woman, comprising corresponding supplementary and additional parts |
| JP6446703B2 (en) * | 2013-05-02 | 2019-01-09 | 博人 中上 | Absorbent articles |
| CA2966849A1 (en) * | 2014-11-05 | 2016-05-12 | Gr Dome Medical Ltd. | A method and device for external urinary incontinence treatment for women |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3194238A (en) * | 1963-03-01 | 1965-07-13 | Resiflex Lab | Urinary device |
| GB1059680A (en) * | 1965-02-16 | 1967-02-22 | Francis Xavier Keane | Personal wear apparatus for use in incontinent and voluntary micturition |
| US3528423A (en) * | 1967-06-20 | 1970-09-15 | John W Lee | Female incontinence device |
| GB1522391A (en) * | 1975-02-12 | 1978-08-23 | Silvanov B | Method and apparatus for collecting human waste matter |
| US4246901A (en) * | 1978-05-30 | 1981-01-27 | Nasa | Urine collection device |
| GB2074875A (en) * | 1980-03-06 | 1981-11-11 | Craig Med Prod Ltd | Female incontinence Device |
| GB2090144A (en) * | 1980-12-31 | 1982-07-07 | Thames Valley Medical Ltd | Female incontinence device |
| IE54485B1 (en) * | 1982-09-13 | 1989-10-25 | Hollister Inc | Female urinary incontinence device |
-
1983
- 1983-08-24 IE IE1985/83A patent/IE54485B1/en not_active IP Right Cessation
- 1983-08-31 CA CA000435816A patent/CA1214086A/en not_active Expired
- 1983-09-01 DE DE19833331633 patent/DE3331633A1/en active Granted
- 1983-09-02 GB GB08323566A patent/GB2126902B/en not_active Expired
- 1983-09-06 JP JP58162721A patent/JPS5964039A/en active Pending
- 1983-09-08 SE SE8304822A patent/SE458662B/en not_active IP Right Cessation
- 1983-09-09 IT IT48954/83A patent/IT1170480B/en active
- 1983-09-09 NL NLAANVRAGE8303135,A patent/NL184871B/en not_active IP Right Cessation
- 1983-09-12 AU AU19031/83A patent/AU558872B2/en not_active Ceased
- 1983-09-12 BE BE0/211516A patent/BE897736A/en not_active IP Right Cessation
- 1983-09-12 ES ES1983282313U patent/ES282313Y/en not_active Expired
- 1983-09-12 FR FR8314490A patent/FR2532837B1/en not_active Expired
- 1983-09-13 DK DK416383A patent/DK160855C/en not_active IP Right Cessation
-
1984
- 1984-08-09 ES ES1984281040U patent/ES281040Y/en not_active Expired
- 1984-08-09 ES ES1984281039U patent/ES281039Y/en not_active Expired
-
1986
- 1986-01-04 JP JP61000139A patent/JPS61268250A/en active Granted
- 1986-08-25 JP JP1986128313U patent/JPH032263Y2/ja not_active Expired
- 1986-11-26 AU AU65728/86A patent/AU570862B2/en not_active Ceased
-
1987
- 1987-02-26 HK HK190/87A patent/HK19087A/en unknown
-
1988
- 1988-06-02 SE SE8802064A patent/SE464219B/en not_active IP Right Cessation
Also Published As
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US4681572A (en) | Female urinary incontinence device | |
| CA1214086A (en) | Female urinary incontinence device | |
| EP0348071B1 (en) | Female urinary incontinence device | |
| EP1827530B1 (en) | Urine collection assembly | |
| US6342049B1 (en) | Female urine collection device | |
| US4496355A (en) | External female urinary appliance | |
| CA1242124A (en) | Incontienence devices for women | |
| US4795449A (en) | Female urinary incontinence device | |
| US4889533A (en) | Female urinary collection devices having hollow-walled filled urine receptacles | |
| US6131575A (en) | Urinary incontinence device | |
| US6551292B1 (en) | Shaped flange for a urine collector | |
| US3742953A (en) | Disposable male urinary incontinence device | |
| US7476219B2 (en) | Urinary incontinence device | |
| WO1999058169A2 (en) | Externally supported female urinary collector | |
| WO2003020344A1 (en) | Female external catheter device | |
| GB2130097A (en) | Female urinary appliance | |
| CA1229278A (en) | Female urinary incontinence device | |
| EP0403101B1 (en) | Retractile penis device | |
| CN115279277B (en) | Urine collecting device | |
| GB2146901A (en) | Incontinence devices for women | |
| GB2147809A (en) | Urethral occlusion device | |
| WO1999018898A1 (en) | An external female urine collection device and a method for manufacturing such a device |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEX | Expiry |