CA2172136A1 - Urethral plug having adhesive sealing capabilities - Google Patents
Urethral plug having adhesive sealing capabilitiesInfo
- Publication number
- CA2172136A1 CA2172136A1 CA002172136A CA2172136A CA2172136A1 CA 2172136 A1 CA2172136 A1 CA 2172136A1 CA 002172136 A CA002172136 A CA 002172136A CA 2172136 A CA2172136 A CA 2172136A CA 2172136 A1 CA2172136 A1 CA 2172136A1
- Authority
- CA
- Canada
- Prior art keywords
- plug
- urethral
- adhesive
- urethra
- bladder
- 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.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
-
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0009—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body
-
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0009—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body
- A61F2/0013—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body inflatable
-
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
-
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
- A61F2/005—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra with pressure applied to urethra by an element placed in the vagina
-
- 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
- A61F5/48—Devices for preventing wetting or pollution of the bed
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S128/00—Surgery
- Y10S128/25—Artificial sphincters and devices for controlling urinary incontinence
Abstract
A novel urethral plug assembly (1) having adhesive (6) which seals the plug assembly (1) against an internal wall thereby arresting movement of the plug assembly (1). The plug assembly (1) may comprise a solid body (2) which is of a sufficient diameter to occlude the urethra. Alternatively, the plug assembly (1) may comprise a body which has the ability to change its shape from a compressed to an elongated condition. In one embodiment of the invention, the adhesive (6) lies on the meatal plate (4) so as to secure the plug assembly (1) against the meatus urinarius. In a second embodiment, the adhesive (106) is on the body (102) of the plug assembly (100) so as to seal the plug assembly (100) against the urethra bladder neck or bladder wall. In a third embodiment, the adhesive (206) is on a portion of the meatal plate (204) so as to seal the plug assembly (200) at the tissue surrounding the meatus urinarius. The adhesive (206) seals the plug assembly (200) in place until the wearer wishes to void, at which point, the seal may be broken by the exertion of a downward pulling force on the plug assembly.
Description
2 1 7 2 1 3 6 PCT~S94/10606 URETHRAL PLUG HAVING ADHESIVE SEALING CAPABILITIES
. The present application is a continuation-in-part application of pending application U.S. Serial No. 08/062,592, 6 filed May 15, 1993 and pending application U.S. Serial No .
7 08/088,469 filed July 7, 1993, both of which are a continuation-in-part application of pending application U.S.
Serial No. 811,571, filed December 20, 1991, which is a 9 continuation-in-part application of pending application U.S.
Serial No. 746,364, filed August 16, 1991, which is a continuation-in-part application of U.S. Serial No. 636,285, 11 filed December 31, 1990, ~ow U.S. Patent No. 5,090,424.
13 R~R~ROUND OF THE lNvL.. LlON
Technical Field of the ~nvention This invention relates to a urethral plug assembly having an 16 adhesive coating thereon, enabling it to maintain stability in the urethra.
18 Description of the Prior Art Urinary stress incontinence is defined as the involuntary 20 loss of urine when the pressure within the urethra exceeds the 21 maximum urethral pressure required for maintaining closure.
22 While the problem of urinary incontinence occurs in men and women, it is an affliction especially common in women of child 23 bearing age and beyond.
There are in existence many methods used to address the problem of incontinence. Bladder neck suspension surgery, 26 wherein the neck of the bladder is reduced by suspending the 27 bladder, is perhaps the most desirable way to treat incontinence, 28 especially in younger patients. However, there are numerous W095/08968 ~ l 7 2 1 3 6 PCT~S94/1~606 1 risks associated with such surgery, notwithstanding the expense.
2 For some patients, surgery is not recommended for medical or other reasons, and for those with mild incontinence surgery is 3 not an appropriate solution.
As an alternative to surgical correction, devices have been developed to address the problem of urinary incontinence. Many 6 of these devices require surgery for implantation, and of these 7 surgically implanted devices, there are two distinct types:
8 non-manipulable devices and manipulable devices. One such non-manipulable device, described in United States Patent No.
7 08/088,469 filed July 7, 1993, both of which are a continuation-in-part application of pending application U.S.
Serial No. 811,571, filed December 20, 1991, which is a 9 continuation-in-part application of pending application U.S.
Serial No. 746,364, filed August 16, 1991, which is a continuation-in-part application of U.S. Serial No. 636,285, 11 filed December 31, 1990, ~ow U.S. Patent No. 5,090,424.
13 R~R~ROUND OF THE lNvL.. LlON
Technical Field of the ~nvention This invention relates to a urethral plug assembly having an 16 adhesive coating thereon, enabling it to maintain stability in the urethra.
18 Description of the Prior Art Urinary stress incontinence is defined as the involuntary 20 loss of urine when the pressure within the urethra exceeds the 21 maximum urethral pressure required for maintaining closure.
22 While the problem of urinary incontinence occurs in men and women, it is an affliction especially common in women of child 23 bearing age and beyond.
There are in existence many methods used to address the problem of incontinence. Bladder neck suspension surgery, 26 wherein the neck of the bladder is reduced by suspending the 27 bladder, is perhaps the most desirable way to treat incontinence, 28 especially in younger patients. However, there are numerous W095/08968 ~ l 7 2 1 3 6 PCT~S94/1~606 1 risks associated with such surgery, notwithstanding the expense.
2 For some patients, surgery is not recommended for medical or other reasons, and for those with mild incontinence surgery is 3 not an appropriate solution.
As an alternative to surgical correction, devices have been developed to address the problem of urinary incontinence. Many 6 of these devices require surgery for implantation, and of these 7 surgically implanted devices, there are two distinct types:
8 non-manipulable devices and manipulable devices. One such non-manipulable device, described in United States Patent No.
4,019,499, is a capsule filled with a variable amount of fluid.
The capsule is surgically implanted between supporting tissue and 11 the urethra to exert an occluding force thereon. A similar, non-manipulable capsule implant is described in United States 12 Patent No. 3,789,828. However, this device has ties extending 13 therefrom to aid in fiber ingrowth, thus providing mechanical 14 stability to the capsule. One problem associated with this device is the risk of fluid leakage. In addition to problems with leakage, severe tissue damage may result from the unnatural 16 method in which such devices regulate incontinence.
Other surgically implanted devices exist which are 18 manipulable. These devices provide the wearer with the ability 19 to selectively control the operation of the device via manually operable elements implanted in the tissue surrounding the urethra. United States Patent No. 4,428,365, and United States 21 Patent No. 4,846,784 each disclose an indwelling device having an 22 inflatable chamber with an attached tubing and an inflation bulb.
23 The wearer may manually adjust the pressure exhiblted by the inflatable member on the urethra, simply by squeezing the tissue 24 encasing the bulb. These devices, however, often produce thickening and scarring of surrounding tissue, making their 26 usefulness questionable. Additional adverse effects associated with surgically implanted indwelling devices, whether 27 non-manipulable or manipulable in nature, are encrustation, 28 irritation and infection.
wo9S~ 8 2 1 72 1 36 PCT~S94/10606 2 There are also known in the art certain indwelling devices that do not require surgical implantation. These devices are 3 inserted by a physician through the urethral orifice and allow 4 the wearer to void either past or through the device. An example of such a device is disclosed in United States Patent No.
4,850,963 in which a physician inserts a bolus of ferromagnetic 6 material through the urethra and into the bladder. The bolus 7 rests at the juncture of the bladder and urethra and is moved for 8 bladder evacuation, by the relative positioning of a magnet across the body of the wearer. However, the bolus may become 9 lodged in an area beyond the reaches of the magnetic force exhibited by the magnet, making the device inoperative. Another 11 example of this type of indwelling device is the prestressed capsule disclosed in United States Patent No. 4,457,299. The 12 capsule is inserted by a physician within the lower interior of 13 the urethra and is set at a prestressed pressure slightly above 14 involuntary pressure. When the urine pressure exceeds the preset pressure of the capsule, the capsule deforms allowing urine to flow around the device. This device, however, has no feature to 16 prevent migration of the device into the bladder. In United 17 States Patent No. 4,553,533 there is shown a prosthetic urethral sphincter valve which is placed in the urethra and anchored in 18 the bladder. The patient increases his bladder pressure by means 19 of a valsalva maneuver, and holds this pressure while the valve activates. Urine may then pass through the valve with the valve later returning to its closed position. This device is very 21 complicated, expensive, difficult to manufacture and 22 uncomfortable. Another physician-inserted device is disclosed 23 in United States Patent No. 3,797,478. This device has an expandable collar which is inflated after insertion, by an 24 injection of fluid therein; When it is desired to remove the device, the inflated collar is ruptured or serrated, thus 26 expelling the fluid into the wearer's body. Notwithstanding the cumbrous use of this device, there is a risk of infection 27 associated with the release of injection fluid upon removal.
28 Similarly, United States Patent No. 3,841,304 discloses a plug WosS/08968 2 1 7 2 1 3 6 PCT~S94/10606 1 which is inserted by a physician into the urethra and 2 subsequently inflated to block the flow of urine. This device may be left in the body for extended periods. After insertion, 3 the device merely requires repositioning in the urethra to permit 4 bladder evacuation. Such a device leaves the wearer susceptible to infection, as bacteria may be introduced into the urethra during repositioning, or during indwelling time. Also, serious 6 complications can occur upon removal, when a separate wire must 7 be inserted therein. These devices being indwelling, are often 8 cumbersome to the wearer and often cause numerous complications such as encrustation, irritation and infection.
Also known in the art are devices capable of being inserted 11 by the wearer into the urethra. Such devices are removed for voiding, and then reintroduced into the urethra upon completion 12 of bladder evacuation. An example of such a device is the 13 solid-type urethral plug, described by Neilsen, Kurt K. et al., 14 in "The Urethral Plug: A New Treatment Modality for Genuine Urinary Stress Incontinence in Women~ J. Urology, vol. 44, p.
1100 (1990). This device consists of one or two solid spheres 16 located along a soft shaft, and a thin, soft plate located at the 17 end of the shaft. One sphere is located upstream of the maximum urethral closing pressure point, corresponding to the location of 18 the sphincter. In the two sphere embodiment, the second sphere 19 is located with its midpoint at the bladder neck, and is used to assist in reducing urinary flow and pressure transmission to the urethra so that the sphincter can operate. When the patient 21 wants to evacuate the bladder, the plug is removed, evacuation 22 occurs, and a fresh plug is inserted. One problem associated 23 with this device is that the patient must have three urethral closure pressure profiles performed as well as other 24 examinations, before the device is made for the wearer.
Additional problems associated with this device include placement 26 difficulties, lack of sealing capabilities associated therewith, inadequate retention thereby allowing expelling and inadequate 27 anchoring by the plate at the meatus. In addition, such problems 28 is the discomfort associated with insertion and removal, due to W095/08968 2 1 7 2 1 3 6 PCT~Sg4/l0606 1 the size profile and rigidity of the spheres, which maintain a 2 constant diameter during insertion, and removal. Another ~remove-to-void" device is disclosed in United States Patent No.
The capsule is surgically implanted between supporting tissue and 11 the urethra to exert an occluding force thereon. A similar, non-manipulable capsule implant is described in United States 12 Patent No. 3,789,828. However, this device has ties extending 13 therefrom to aid in fiber ingrowth, thus providing mechanical 14 stability to the capsule. One problem associated with this device is the risk of fluid leakage. In addition to problems with leakage, severe tissue damage may result from the unnatural 16 method in which such devices regulate incontinence.
Other surgically implanted devices exist which are 18 manipulable. These devices provide the wearer with the ability 19 to selectively control the operation of the device via manually operable elements implanted in the tissue surrounding the urethra. United States Patent No. 4,428,365, and United States 21 Patent No. 4,846,784 each disclose an indwelling device having an 22 inflatable chamber with an attached tubing and an inflation bulb.
23 The wearer may manually adjust the pressure exhiblted by the inflatable member on the urethra, simply by squeezing the tissue 24 encasing the bulb. These devices, however, often produce thickening and scarring of surrounding tissue, making their 26 usefulness questionable. Additional adverse effects associated with surgically implanted indwelling devices, whether 27 non-manipulable or manipulable in nature, are encrustation, 28 irritation and infection.
wo9S~ 8 2 1 72 1 36 PCT~S94/10606 2 There are also known in the art certain indwelling devices that do not require surgical implantation. These devices are 3 inserted by a physician through the urethral orifice and allow 4 the wearer to void either past or through the device. An example of such a device is disclosed in United States Patent No.
4,850,963 in which a physician inserts a bolus of ferromagnetic 6 material through the urethra and into the bladder. The bolus 7 rests at the juncture of the bladder and urethra and is moved for 8 bladder evacuation, by the relative positioning of a magnet across the body of the wearer. However, the bolus may become 9 lodged in an area beyond the reaches of the magnetic force exhibited by the magnet, making the device inoperative. Another 11 example of this type of indwelling device is the prestressed capsule disclosed in United States Patent No. 4,457,299. The 12 capsule is inserted by a physician within the lower interior of 13 the urethra and is set at a prestressed pressure slightly above 14 involuntary pressure. When the urine pressure exceeds the preset pressure of the capsule, the capsule deforms allowing urine to flow around the device. This device, however, has no feature to 16 prevent migration of the device into the bladder. In United 17 States Patent No. 4,553,533 there is shown a prosthetic urethral sphincter valve which is placed in the urethra and anchored in 18 the bladder. The patient increases his bladder pressure by means 19 of a valsalva maneuver, and holds this pressure while the valve activates. Urine may then pass through the valve with the valve later returning to its closed position. This device is very 21 complicated, expensive, difficult to manufacture and 22 uncomfortable. Another physician-inserted device is disclosed 23 in United States Patent No. 3,797,478. This device has an expandable collar which is inflated after insertion, by an 24 injection of fluid therein; When it is desired to remove the device, the inflated collar is ruptured or serrated, thus 26 expelling the fluid into the wearer's body. Notwithstanding the cumbrous use of this device, there is a risk of infection 27 associated with the release of injection fluid upon removal.
28 Similarly, United States Patent No. 3,841,304 discloses a plug WosS/08968 2 1 7 2 1 3 6 PCT~S94/10606 1 which is inserted by a physician into the urethra and 2 subsequently inflated to block the flow of urine. This device may be left in the body for extended periods. After insertion, 3 the device merely requires repositioning in the urethra to permit 4 bladder evacuation. Such a device leaves the wearer susceptible to infection, as bacteria may be introduced into the urethra during repositioning, or during indwelling time. Also, serious 6 complications can occur upon removal, when a separate wire must 7 be inserted therein. These devices being indwelling, are often 8 cumbersome to the wearer and often cause numerous complications such as encrustation, irritation and infection.
Also known in the art are devices capable of being inserted 11 by the wearer into the urethra. Such devices are removed for voiding, and then reintroduced into the urethra upon completion 12 of bladder evacuation. An example of such a device is the 13 solid-type urethral plug, described by Neilsen, Kurt K. et al., 14 in "The Urethral Plug: A New Treatment Modality for Genuine Urinary Stress Incontinence in Women~ J. Urology, vol. 44, p.
1100 (1990). This device consists of one or two solid spheres 16 located along a soft shaft, and a thin, soft plate located at the 17 end of the shaft. One sphere is located upstream of the maximum urethral closing pressure point, corresponding to the location of 18 the sphincter. In the two sphere embodiment, the second sphere 19 is located with its midpoint at the bladder neck, and is used to assist in reducing urinary flow and pressure transmission to the urethra so that the sphincter can operate. When the patient 21 wants to evacuate the bladder, the plug is removed, evacuation 22 occurs, and a fresh plug is inserted. One problem associated 23 with this device is that the patient must have three urethral closure pressure profiles performed as well as other 24 examinations, before the device is made for the wearer.
Additional problems associated with this device include placement 26 difficulties, lack of sealing capabilities associated therewith, inadequate retention thereby allowing expelling and inadequate 27 anchoring by the plate at the meatus. In addition, such problems 28 is the discomfort associated with insertion and removal, due to W095/08968 2 1 7 2 1 3 6 PCT~Sg4/l0606 1 the size profile and rigidity of the spheres, which maintain a 2 constant diameter during insertion, and removal. Another ~remove-to-void" device is disclosed in United States Patent No.
5,090,424, which comprises a conformable urethral plug. The body 4 of the plug forms a cavity which is in fluid communication with another cavity via a check-valve. Thus, fluid may be pumped into the cavity within the urethra to provide a custom fit. This 6 device, like many others relying on liquids or gels for 7 expansion, relies heavily on a fluid-tight valve in order to 8 maintain retention. Should valve failure occur, evacuation would immediately follow. There is also a chance of fluid leakage into 9 the body of the wearer should rupture of the plug occur.
11 There are also known in the art certain external devices that do not require insertion into the urethra. Urine absorbing 12 pads have been developed to collect and absorb urine as it flows 13 out of the body. Such pads have difficulty retaining a 14 stationary position and often lack effectiveness in preventing leakage. An example of an external device in which such problems have been addressed is the urine absorbing pad disclosed in U.S.
16 Patent No. 5,074,855. This device employs adhesive to secure a 17 pad to the vestibule such that urine is absorbed as it is expelled from the body. However, there are many disadvantages 18 associated with such a device. Urine buildup in the urethra 19 creating an uncomfortable sensation for the wearer is one such disadvantage. Additionally, due to the structure and function of such a device, there is nothing to increase urethral resistance 21 to urine flow. Moreover, as such a pad is designed only to be 22 worn externally, it is subject to migration in the course of 23 one's daily movement and activities, even with the use of adhesive given the friction associated with undergarments 24 contacting the pad. Migration as such, increases the likelihood of accidents and leakage. Although this pad attempts to seal and 26 absorb urine at the meatus, the meatus is not physiologically blocked thus the wearer is susceptible to discomfort and leakage.
27 This device, given its structure and composition, would not be 28 effective internally due to the differing physiological WO95/08968 2 1 7 2 1 3 6 PCT~S94/10606 1 conditions present in the urethra, bladder neck or bladder, where 2 internal conditions such as high temperature and moisture levels exist.
4 As evidenced by the above discussion, problems associated with the stability of urinary incontinence devices have not been adequately addressed in the prior art. Prior art devices have 6 focused solely on sizing a device such that the urethra is 7 occluded, without addressing the need for enhancing the retention 8 and sealing capabilities of such devices.
9 In view of the above problems associated with the prior art, an easily manipulable, "remove-to-void", indwelling urethral plug 11 assembly having enhanced retention and sealing capabilities }2 would be desirable to those afflicted with urinary incontinence.
13 SUMMARY OF THE lNv~NLlON
One object of the invention is to improve the degree of retention of a urethral plug assembly in the urethra.
16 A further object of the invention is to enhance the sealing 17 ability of a urethral plug assembly with the urethral, bladder neck, or bladder wall.
18 Another object of the invention is to enhance the sealing 19 ability of a urethral plug assembly at the urethral meatus, such that migration into the bladder will not occur.
Another object of the invention is to prevent slippage of 21 the urethral plug assembly while disposed in the urethra.
22 Another object of the invention is to continuously block the 23 flow of urine in the event of malfunction of the plug assembly.
Another object of the invention is to reduce the risk of 24 contamination to the wearer of a urethral plug assembly.
Yet another object of the invention is to provide a device 26 which is easily used by the wearer.
Another object of the invention is to increase the urethral 27 resistance to urine flow through the urethra.
*rB
W O 95/08968 PCTrUS94/10606 1 Still another object of the invention is to provide a method 2 for controlling urinary incontinence.
3 These and other objects of the invention are carried out by 4 a novel urethral plug assembly having adhesive thereon, wherein the adhesive seals the plug against the meatus urinarius, or alternatively, the urethral, bladder neck or bladder wall. The 6 plug may comprise a solid body which is of a sufficient diameter 7 to allow occlusion of the urethra to prevent incontinence.
8 Alternatively, the plug may comprise a body which has the ability to change its shape. One such plug assembly may comprise a member comprising a body having a lumen for accepting fluid from an external syringe, and delivering such to a fluidly inflatable 11 balloon. The fluid may be a liquid or gel, or air. Such a plug is to be inserted while the balloon is in a non-inflated 12 position. After insertion, fluid can be introduced into the 13 lumen via a syringe, from where it travels through a valve to 14 inflate and distend the balloon thereby occluding the urethra, bladder neck or bladder. Another type of plug assembly may comprise a mechanically expandable housing and cooperating inner 16 member, lying in coaxial engagement and possessing a contracted 17 diameter for insertion and removal through the orifice of the urethra, and a larger, expanded diameter for blocking the flow of 18 urine in the urethra, bladder neck and bladder. A larger 19 diameter is achieved by mechanical deployment of the inner member Z0 resulting in a change in the shape of the housing. This change in shape causes the external surface to expand, which seals the 21 plug assembly to the urethral, bladder neck or bladder wall.
22 Alternatively, the plug may comprise a condition-responsive 23 expandable member having the ability to possess an expanded condition when exposed to a physiological condition such as body 24 temperature, moisture, or pH. The adaptation of the condition responsive plug to the expanded condition occurs automatically 26 without actuation of the plug by the wearer.
WO 9'~g~8 PCT/US94110606 1 In each of the above plug assemblies, the portion of the 2 plug that functions to block the flow of urine is the body, and the portion of the plug that serves to anchor the plug at the 3 meatus urinarius, is the meatal plate. Removal of the plug 4 assembly for bladder evacuation, is easily accomplished by either pulling a cord causing the contraction of the plug assembly and/or grasping a tab associated with said meatal plate. The 6 meatal plate serves to prevent migration of the plug assembly 7 into the bladder.
In one embodiment of the invention, an adhesive layer lies on the meatal plate so as to secure the plug against the meatus urinarius. In a second embodiment of the invention, an adhesive 11 layer lies on the body of the plug so as to seal the plug against the urethra, bladder neck or bladder wall. In a third embodiment 12 of the invention, an adhesive layer lies on the outer 13 circumference of the meatal plate so as to seal the plug against 14 the tissue surrounding the meatus urinarius. These and other advantages will be better appreciated from the detailed description that follows.
BRIEF DESCRIPTION OF THE DRAWINGS
19 Figure 1 shows a solid urethral plug having adhesive on the meatal plate.
21 Figure 2A shows a fluidly expandable urethral plug assembly 22 having adhesive on its meatal plate, in a deflated state.
Figure 2B shows a fluidly expandable urethral plug assembly 24 having adhesive on its meatal plate, in an inflated state.
26 Figure 3A shows a mechanically expandable urethral plug assembly having adhesive on its meatal plate, in a contracted 27 state.
2 l 72 1 36 W095/08968 PCT~S94/l0606 1 Figure 3B shows a mechanically expandable urethral plug 2 assembly having adhesive on its meatal plate, in an expanded state.
4 Figure 4A shows a condition-responsive, expandable urethral plug assembly having adhesive on its meatal plate in an elongated state.
7 Figure 4B shows a condition-responsive, expandable urethral 8 plug assembly having adhesive on its meatal plate in an expanded state.
Figure 5 shows a urethral plug assembly having adhesive on a 11 portion of its body.
12 Figure 6 shows a urethral plug assembly having adhesive on a 13 portion of the meatal plate.
Figure 7A shows an cross section along line A-A of the body of each of the urethral plug assemblies.
17 Figure 7B shows an alternative cross section along line A-A
of the body of each of the urethral plug assemblies.
19 Figure 8 shows a perspective view of the meatal plate of each of the urethral plug assemblies.
21 DET~TT-~n DESCRIPTION OF T~E PREFERRED EMBODl_I~NLS
23 Referring first to Figure 1, shown is a solid plug assembly 1, having a body 2 sized to allow occlusion of the urethra 24 following insertion. A meatal plate 4 is disposed at the distal end of the body which prevents migration of the plug assembly 1 26 into the bladder. The meatal plate 4 is a flanged type member, having a tab 5 which prevents migration of the plug assembly 1 27 into the bladder and aids in removal of the plug assembly 1 when 28 the wearer wishes to void. The meatal plate 4 anchors the plug WO95/0~968 PCT~S94/10606 1 assembly 1 at the meatus urinarius. To carry out this function 2 of anchoring, the meatal plate 4 is of a thickness sufficient to withstand bodily compression during wear, preferably on the order 3 of one millimeter or greater. On the meatal plate 4, is a layer 4 of adhesive 6, preferably a hydrogel adhesive. This layer 6 seals the meatal plate 4 at the meatus urinarius after insertion of the plug into the urethra, thereby ensuring a firm and secure 6 placement of the plug assembly 1. A string 8 extends from the 7 body for removal of the plug assembly 1 after insertion.
8 Alternatively, removal may be carried out by the tab 5, a ring (not shown), or another removal member may be adapted to extend from the body 2. Line A-A represents the cross sectional view of the body 2, which will be discussed further with reference to 11 Figures 7A and 7B.
12 The operation of the plug assembly 1 is such that upon 13 insertion, the urethral wall conforms thereto, via an automatic 14 reflex motion. The meatal plate 4, anchoring the plug assembly 1 at the meatus urinarius further provides a seal therewith, via the adhesive layer 6. This seal prevents slippage of the 16 assembly 1 from its position in the urethra, thereby ensuring 17 continuous blockage of urine. Note that the adhesive layer 6, although shown to be continuous, may be discontinuous depending 18 on the degree of adhesion desired.
Figure 2A shows a fluidly expandable urethral plug assembly 100 in a deflated state. The plug assembly 100 has a body 102 21 with a meatal plate 104 on its distal end, and an expandable 22 balloon 116 at its proximal end. The body 102 wall is relatively 23 constant in outer diameter allowing the device to be easily inserted. The meatal plate 104, as in the embodiment of Figure 1 24 has a layer of adhesive 106 thereon. The internal portion of the body 102 of the plug assembly defines a lumen 108, a first cavity 26 111, and a valve seat 113. The fluid responsible for inflating balloon 116 is introduced from an external syringe 110 adapted to 27 be inserted in the first cavity lll. The fluid can be any fluid 28 capable of being pumped from the syringe 110 with sufficient W095/08968 2 1 7 2 1 3 6 PCT~S94/10606 1 force to displace a ball 115 resting against valve seat 113. The 2 meatal plate 104 and tab 105, like the meatal plate 104 as previously discussed in the above embodiment, is adapted to 3 anchor the urethral plug assembly 100 at the meatus urinarius.
4 The layer of adhesive 106 lies on the meatal plate 104 so as to form a seal with the meatus after insertion.
6 Figure 2B shows the urethral plug assembly 100 after the 7 fluid has been pumped into the balloon 116, such that the plug 8 assembly 100 is in an inflated state. Inflation is carried out by inserting syringe 110 into the plug assembly 100 so that it 9 lies within the first cavity 111. Fluid is then expelled from the syringe 110 for travel through the first cavity 111 to the 11 valve seat 113, whereby the force of the fluid pushes the ball 115 off the valve seat 113 thereby providing a continuous flow 12 path from the first cavity 111 to the lumen 108. The fluid thus 13 travels freely from syringe 110 through the valve seat opening 14 112 and into lumen 108. The fluid then continues to travel out of the opening 114 of lumen 108, whereupon it inflates the balloon 116. When the balloon 116 is inflated, the expulsion of 16 fluid from syringe 110 may be terminated and the syringe 110 17 removed. At this point, the ball 115 falls back against valve seat 113 to occlude valve seat opening 112, thus closing such 18 opening 112 off from external fluid entry or exit. Thus the 19 fluid contained in the balloon 116 functions to-maintain the plug assembly in its inflated state for urine blockage. When it is desired to remove the plug assembly, the wearer deflates the 21 balloon 116 by simply pulling on the cord 117 attached to the 22 ball 115, causing the ball 115 to dislodge and pass from the 23 valve seat opening 112 toward the distal end of the plug assembly 100. Although such action results in the expulsion of fluid from 24 the balloon 116, the seal between the plug assembly 100 and the meatus remains intact due to the adhesive 106 on the plate 104, 26 which continues to block the flow of urine. ~he wearer may then comfortably remove the plug assembly 100 as the diameter thereof ~t72136 WO95t08968 PCT~S94/10606 1 is reduced. Removal is accomplished by a continuous tug on the 2 tab 105, which serves to break the seal and disengage the meatal plate 104 from the meatus.
4 Figure 3A like Figure 2A, shows an expandable plug assembly 200 also having a layer of adhesive 206 on its meatal plate 204.
Plug assembly 200, has a body 202 comprised of a hollow, 6 cylindrical tube which is sized to be easily inserted through the 7 orifice of the urethra. The tube 202 is made from a 8 biocompatible material having characteristics of compressibility.
Attached on the periphery thereof either by thermal bonding, laminating or other means, is a balloon 208 which is adapted to rest against the tube 202. At the distal end of the tube is a 11 meatal plate 204 having a tab 205. The meatal plate 204, like the meatal plates previously discussed, is adapted to anchor the 12 urethral plug assembly 200 at the meatus urinarius. A layer of 13 adhesive 206 lies on the meatal plate 204 so as to form a seal 14 with the meatus after insertion. Referring again to Figure 1, enclosed within the tube is a support rod 210, which may be a hollow or a solid member. The support rod 210 has a bulb 212 at 16 one end thereof, abutting the proximal end of the tube. The bulb 17 212 functions to hold the support rod within the tube. The support rod 212 has a cord 214 attached at its end opposite the 18 bulb 212, which extends through the tube 202 and beyond the 19 meatal plate 204, thus ensuring that a wearer will always be able to reach the cord 214. On the cord 214 there is preferably formed a knot 216. Although the knot 216 has been used, the 21 attachment of any member having a diameter greater than ball 22 retention socket 218 in meatal plate 206 would suffice. The 23 support rod 210 is formed of a biocompatible material, the tube 202 is preferably formed of a biocompatible thermoplastic 24 material and the balloon 208 is preferably a biocompatible thermoplastic elastomer, such as that sold under the trademark 26 KRATON. However, any biocompatible material may be used for each 27 of the aforementioned elements, as the invention is not to be W09s/08968 PCT~S94/10606 1 limited to those named above. Line A-A represents the cross 2 sectional view of the tube, which will be discussed further with reference to Figures 7A and 7B.
4 The operation of the plug assembly 200 iS described in connection with Figure 3B. A user inserts the plug assembly 200 while it is in a contracted configuration. Once the plug 6 assembly 200 has been inserted, the meatal plate 204 abuts the 7 meatus urinarius and the adhesive layer 206 forms a seal with the 8 meatus. At this point, the plug assembly 200 may be deployed by the wearer, whereupon it achieves an expanded configuration. To deploy, the wearer pulls on the cord 214 depending from the support rod 210. By pulling on cord 214, a downward force is 11 exerted on the cord 214 in the vertical direction, forcing the support rod 210 to slide downwardly in the tube 202 and exert a 12 compressive force against the proximal end of the outer tube 202.
13 The tube 202 thus expands outwardly in the horizontal direction, 14 causing the balloon 208 to expand until the balloon 208 forms a seal with the wall of the urethra, bladder neck or bladder. The wearer then secures the cord 216 by sliding it through a slit in 16 the ball retention socket 218 located on the meatal plate 204.
17 This causes the knot 216 to act as a stop, as the knot 216 rests within the socket 218, thereby preventing the tube 202 from 18 returning to its contracted state. The expansion of the tube 202 19 serves to block the flow of urine as the balloon 208 forms a seal 20 with the urethral, bladder neck or bladder wall. The placement of the plug assembly 200 is further retained in this position by 21 the seal formed by the adhesive layer 206 on the meatal plate 204 22 with the meatus.
The plug assembly 200 in an expanded form, functions to 24 block the flow of urine from the body. When the wearer wishes to remove the plug assembly 200, a simple tug on the cord 214 in a 26 direction away from the socket 218 Will cause the knot 216 to be released therefrom, thus causing the tube 202 to retract. The 27 tube 202 thereby returns to its original diameter prior to 28 insertion, making plug removal a comfortable task. Thus, the 2 t 72 1 36 WO95/08968 PCT~S94/10606 1 tube 202 and balloon 208 cooperatively provide an expandable 2 housing and the plug includes means for mechanically expanding the housing and selectively returning the housing to its 3 non-expanded condition. The seal between the adhesive layer 206 4 on the meatal plate 204 and the meatus, is then broken by the continuous downward pulling of the cord 214. At this point, the plug assembly may be removed and bladder evacuation may occur.
7 Referring now to Figure 4A, a plug assembly 300 is shown, 8 which is preferably formed of a biocompatible thermoplastic material. In a preferred embodiment, the plug 300 is made of a tube 302 of known polyurethane-based polymer which provides the plug 300 with shape memory. The unique characteristic of the 11 plastic polymer is its automatically triggered shape memory, which allows the tube constructed of the shape memory polymer to 12 be inserted into the urethra in a relatively compressed and 13 elongated state, and regain a useful shape in response to a 14 selected transition temperature, that being body temperature.
The shape memory material however, may alternatively comprise a hydrophillic material (not shown) capable of expanding in 16 response to moisture or pH gradations. Like the above 17 embodiments, the tube 302 terminates in a meatal plate 304 which has a layer of adhesive 306 thereon. For purposes of 18 illustration only, the ability of plug assembly 300 to expand due 19 to changes in temperature, will be discussed.
When the urethral plug shown in Figure 4A is subjected to a 21 transition temperature, the relatively rigid plug 300 changes to 22 a second condition in which it is flexible and easily deformable.
23 The plug 300 is now pliable and, remembering its "mold shape plug", able to expand significantly in diameter to conform to the 24 shape of the wearer~s urethra. The expansion results in the formation of a tight seal between the urethra, bladder neck or 26 bladder wall and the plug 300. The adhesive layer 306 also forms a seal between the plug 300 and the meatus. Thus the plug 300 is 27 retained in the urethra to block the flow of urine.
Wo95/08968 PCT~S94/10606 l In accordance with the above discussion, the operation of 2 the plug is discussed in reference to Figure 4B. The user inserts the urethral plug 300 of the present invention into the 3 urethra while it is in its compressed and elongated state. The 4 plug 300 is inserted until the meatal plate 304 abuts the meatus urinarius. At this point the layer of adhesive 306 on the meatal plate 304 forms a seal with the meatus urinarius. The plug 300, 6 now lying in the urethra, is exposed to the heightened 7 temperature of the human body. The temperature increase causes 8 the shape memory polymer comprising the tube 302 to automatically expand outwardly and achieve a protrusion to conform to the size 9 and shape of the wearer's urethra. The shape memory polymer is able to freely adapt and conform to its environment, the urethra, ll as it is only capable of expanding and conforming to the environment into which it is placed; it is incapable of exerting 12 a resistive force by itself. This important characteristic of 13 the shape memory polymer prevents displacement of the urethra, 14 bladder neck or bladder by the shape memory polymer material.
As urine accumulates in the bladder, pressure from the 16 accumulating urine builds until the bladder is sufficiently full 17 to exert a downward force on the urine in the bladder neck and urethra. The downward force in turn bears down on the proximal 18 portion of the expanded member of the plug 300, furthering the 19 diametrical expansion of the proximal portion of the member. The expansion of the plug, in its expanded form, provides a tight seal with the wall of the urethra, bladder neck or bladder to 21 retain the plug in the wearer~s body. When the wearer wishes to 22 remove the plug to void, a continuous tug on tab 305 of the 23 meatal plate 304 will cause the rubbery, diametrically expanded member to elongate, and will break the seal formed between the 24 adhesive layer 306 on the meatal plate 304 and the meatus. The tube 302 is then returned to a smaller diameter and is simply 26 withdrawn from the body. Other means for removal of the plug is contemplated, such as but not limited to, a pulling means, such 27 as a cord or ring (not shown), whereby the plug is simply removed W O 95/08968 PCTnUS94110606 by pulling on a cord attached to the plug. The ease with which 2 the shape memory polymer plug allows removal prevents discomfort potentially associated with plug removal.
4 Figure 5 shows an alternative embodiment of the invention with a urethral plug assembly 400 havin~ an adhesive layer 406 on a portion of its body 402. For purposes of example only, the 6 solid plug of Figure 1 will be employed to illustrate this 7 embodiment. Note, however, that the use of an adhesive layer as 8 shown in this figure is to be applied to all of the aforementioned plug assemblies. In contrast with the plug assembly of figure 1, this plug assembly may or may not have an adhesive layer on the meatal plate 404. Instead, an adhesive 11 layer 406 is found on a portion of the body 402 of the plug assembly 400, or, alternatively, with reference to Figures 3 A and 12 3B, may be found on a balloon attached to the body. The adhesive 13 layer located in such position, secures the placement of the plug 14 assembly 400 in the urethra. Upon insertion of the plug assembly 400 into the urethra, the adhesive layer 406 bonds with the 15 urethral, bladder neck or bladder wall, such that the walls 16 conform to the plug assembly 400. This results in a tight 17 sealing effect, such that the plug assembly 400 is prevented from moving in any direction. Moreover, with respect to the 18 embodiments of Figures 2 B and 3B, should the expansion of balloon 19 116 or tube 202, respectively, no longer function in the expanded 20 state while placed in the urethra, due to valve or mechanical failure, the seal provided between a portion of the plug assembly 21 and the urethra, bladder or bladder neck remains intact. If the 22 wearer wishes to void, removal is carried out in much the same 23 manner as in the above embodiments. The tab 405 of the meatal plate 404, and/or the string 408 associated with the plug is 24 grasped and pulled downward, which serves to break the seal formed between the portion of the body and the urethral, bladder 26 neck or bladder wall. Note that although this figure shows a continuous layer of adhesive 406, such a layer may be 27 discontinuous, spotty or uneven, depending upon the degree of 28 adhesion desired.
W095/08968 PCT~S94/10606 2 Figure 6 shows an alternative embodiment of the invention, and for purposes of illustration only, the solid plug of Figure l 3 is shown for this embodiment of the invention. In this 4 embodiment a urethral plug assembly 500 has a meatal plate 504 with a layer of adhesive 506 thereon. The adhesive layer 506 is positioned on the meatal plate 504 so as to seal the plug 6 assembly 500 with the tissue surrounding the meatus. As shown, 7 the adhesive layer 506 lies on a the outer circumferential 8 portion of the meatal plate 504, such that a space 510 exists between the adhesive layer 506 and the body 502 of the plug 9 assembly 500, the space 510 being free of adhesive. The plug assembly 500 with the adhesive layer 506 so positioned, functions ll to seal the plug at a distance from the meatus urinarius. When the wearer wishes to void, removal is carried out in much the 12 same manner as in the above embodiments. The tab 505 of the 13 meatal plate 504, and/or the string 508 is grasped and pulled 14 downward, which serves to break the seal formed between a portion of the meatal plate 504 and the tissue surrounding the meatus 15 urinarius. As with the aforementioned embodiments, note that 16 although this figure shows a continuous layer of adhesive 506, 17 such a layer may be discontinuous, spotty or uneven, depending upon the degree of adhesion desired. Moreover, this embodiment 18 may optionally include a layer of adhesive on the body 502 of the l9 p~ug assembly 500.
Figure 7A shows a cross sectional view of the urethral plug 21 assembly along line A-A of the preferred embodiments set forth 22 above. Body 602 is representative of elements 2, 102, 202, 302, 23 402 and 502 of the aforementioned plug assemblies, and as shown, is of a constant diameter. Figure 7B shows an alternative 24 embodiment of the urethral plug assembly, along line A-A. ~s shown, the diameter of body 702 is not constant but variant as 26 shown by the curved indentations 704 on the periphery. The indentations 704 provide enhanced surface area by which the plug 2~ 72 1 36 W095/08968 PCT~S94/10606 1 assembly may more readily adapt to the urethral, bladder neck or 2 bladder wall. Such enhanced sealing ability of the plug assembly, provides a better fit for the wearer.
4 Figure 8 shows a bottom perspective view of the meatal plate 804, which is the same as meatal plates 4, 104, 204, 304, 404, and 504, respectively discussed in the aforementioned 6 embodiments. A portion of the meatal plate 804 iS extended so as 7 to form a tab 805 which may be grasped by the wearer for ease of 8 removal. The meatal plate 804 may additionally have a ball retention socket 809 and slit 811 formed therein, particularly 9 with respect to Figure 3B so as to aid in maintaining the plug's expanded configuration.
While the invention has been particularly shown and 12 described with reference to the aforementioned embodiments, it 13 will be understood by those skilled in the art that various 14 changes in form, composition and detail may be made therein without departing from the spirit and scope of the invention.
Thus, any modification to the shape, configuration and/or 16 composition of the elements comprising the invention is within 17 the scope of the present invention.
11 There are also known in the art certain external devices that do not require insertion into the urethra. Urine absorbing 12 pads have been developed to collect and absorb urine as it flows 13 out of the body. Such pads have difficulty retaining a 14 stationary position and often lack effectiveness in preventing leakage. An example of an external device in which such problems have been addressed is the urine absorbing pad disclosed in U.S.
16 Patent No. 5,074,855. This device employs adhesive to secure a 17 pad to the vestibule such that urine is absorbed as it is expelled from the body. However, there are many disadvantages 18 associated with such a device. Urine buildup in the urethra 19 creating an uncomfortable sensation for the wearer is one such disadvantage. Additionally, due to the structure and function of such a device, there is nothing to increase urethral resistance 21 to urine flow. Moreover, as such a pad is designed only to be 22 worn externally, it is subject to migration in the course of 23 one's daily movement and activities, even with the use of adhesive given the friction associated with undergarments 24 contacting the pad. Migration as such, increases the likelihood of accidents and leakage. Although this pad attempts to seal and 26 absorb urine at the meatus, the meatus is not physiologically blocked thus the wearer is susceptible to discomfort and leakage.
27 This device, given its structure and composition, would not be 28 effective internally due to the differing physiological WO95/08968 2 1 7 2 1 3 6 PCT~S94/10606 1 conditions present in the urethra, bladder neck or bladder, where 2 internal conditions such as high temperature and moisture levels exist.
4 As evidenced by the above discussion, problems associated with the stability of urinary incontinence devices have not been adequately addressed in the prior art. Prior art devices have 6 focused solely on sizing a device such that the urethra is 7 occluded, without addressing the need for enhancing the retention 8 and sealing capabilities of such devices.
9 In view of the above problems associated with the prior art, an easily manipulable, "remove-to-void", indwelling urethral plug 11 assembly having enhanced retention and sealing capabilities }2 would be desirable to those afflicted with urinary incontinence.
13 SUMMARY OF THE lNv~NLlON
One object of the invention is to improve the degree of retention of a urethral plug assembly in the urethra.
16 A further object of the invention is to enhance the sealing 17 ability of a urethral plug assembly with the urethral, bladder neck, or bladder wall.
18 Another object of the invention is to enhance the sealing 19 ability of a urethral plug assembly at the urethral meatus, such that migration into the bladder will not occur.
Another object of the invention is to prevent slippage of 21 the urethral plug assembly while disposed in the urethra.
22 Another object of the invention is to continuously block the 23 flow of urine in the event of malfunction of the plug assembly.
Another object of the invention is to reduce the risk of 24 contamination to the wearer of a urethral plug assembly.
Yet another object of the invention is to provide a device 26 which is easily used by the wearer.
Another object of the invention is to increase the urethral 27 resistance to urine flow through the urethra.
*rB
W O 95/08968 PCTrUS94/10606 1 Still another object of the invention is to provide a method 2 for controlling urinary incontinence.
3 These and other objects of the invention are carried out by 4 a novel urethral plug assembly having adhesive thereon, wherein the adhesive seals the plug against the meatus urinarius, or alternatively, the urethral, bladder neck or bladder wall. The 6 plug may comprise a solid body which is of a sufficient diameter 7 to allow occlusion of the urethra to prevent incontinence.
8 Alternatively, the plug may comprise a body which has the ability to change its shape. One such plug assembly may comprise a member comprising a body having a lumen for accepting fluid from an external syringe, and delivering such to a fluidly inflatable 11 balloon. The fluid may be a liquid or gel, or air. Such a plug is to be inserted while the balloon is in a non-inflated 12 position. After insertion, fluid can be introduced into the 13 lumen via a syringe, from where it travels through a valve to 14 inflate and distend the balloon thereby occluding the urethra, bladder neck or bladder. Another type of plug assembly may comprise a mechanically expandable housing and cooperating inner 16 member, lying in coaxial engagement and possessing a contracted 17 diameter for insertion and removal through the orifice of the urethra, and a larger, expanded diameter for blocking the flow of 18 urine in the urethra, bladder neck and bladder. A larger 19 diameter is achieved by mechanical deployment of the inner member Z0 resulting in a change in the shape of the housing. This change in shape causes the external surface to expand, which seals the 21 plug assembly to the urethral, bladder neck or bladder wall.
22 Alternatively, the plug may comprise a condition-responsive 23 expandable member having the ability to possess an expanded condition when exposed to a physiological condition such as body 24 temperature, moisture, or pH. The adaptation of the condition responsive plug to the expanded condition occurs automatically 26 without actuation of the plug by the wearer.
WO 9'~g~8 PCT/US94110606 1 In each of the above plug assemblies, the portion of the 2 plug that functions to block the flow of urine is the body, and the portion of the plug that serves to anchor the plug at the 3 meatus urinarius, is the meatal plate. Removal of the plug 4 assembly for bladder evacuation, is easily accomplished by either pulling a cord causing the contraction of the plug assembly and/or grasping a tab associated with said meatal plate. The 6 meatal plate serves to prevent migration of the plug assembly 7 into the bladder.
In one embodiment of the invention, an adhesive layer lies on the meatal plate so as to secure the plug against the meatus urinarius. In a second embodiment of the invention, an adhesive 11 layer lies on the body of the plug so as to seal the plug against the urethra, bladder neck or bladder wall. In a third embodiment 12 of the invention, an adhesive layer lies on the outer 13 circumference of the meatal plate so as to seal the plug against 14 the tissue surrounding the meatus urinarius. These and other advantages will be better appreciated from the detailed description that follows.
BRIEF DESCRIPTION OF THE DRAWINGS
19 Figure 1 shows a solid urethral plug having adhesive on the meatal plate.
21 Figure 2A shows a fluidly expandable urethral plug assembly 22 having adhesive on its meatal plate, in a deflated state.
Figure 2B shows a fluidly expandable urethral plug assembly 24 having adhesive on its meatal plate, in an inflated state.
26 Figure 3A shows a mechanically expandable urethral plug assembly having adhesive on its meatal plate, in a contracted 27 state.
2 l 72 1 36 W095/08968 PCT~S94/l0606 1 Figure 3B shows a mechanically expandable urethral plug 2 assembly having adhesive on its meatal plate, in an expanded state.
4 Figure 4A shows a condition-responsive, expandable urethral plug assembly having adhesive on its meatal plate in an elongated state.
7 Figure 4B shows a condition-responsive, expandable urethral 8 plug assembly having adhesive on its meatal plate in an expanded state.
Figure 5 shows a urethral plug assembly having adhesive on a 11 portion of its body.
12 Figure 6 shows a urethral plug assembly having adhesive on a 13 portion of the meatal plate.
Figure 7A shows an cross section along line A-A of the body of each of the urethral plug assemblies.
17 Figure 7B shows an alternative cross section along line A-A
of the body of each of the urethral plug assemblies.
19 Figure 8 shows a perspective view of the meatal plate of each of the urethral plug assemblies.
21 DET~TT-~n DESCRIPTION OF T~E PREFERRED EMBODl_I~NLS
23 Referring first to Figure 1, shown is a solid plug assembly 1, having a body 2 sized to allow occlusion of the urethra 24 following insertion. A meatal plate 4 is disposed at the distal end of the body which prevents migration of the plug assembly 1 26 into the bladder. The meatal plate 4 is a flanged type member, having a tab 5 which prevents migration of the plug assembly 1 27 into the bladder and aids in removal of the plug assembly 1 when 28 the wearer wishes to void. The meatal plate 4 anchors the plug WO95/0~968 PCT~S94/10606 1 assembly 1 at the meatus urinarius. To carry out this function 2 of anchoring, the meatal plate 4 is of a thickness sufficient to withstand bodily compression during wear, preferably on the order 3 of one millimeter or greater. On the meatal plate 4, is a layer 4 of adhesive 6, preferably a hydrogel adhesive. This layer 6 seals the meatal plate 4 at the meatus urinarius after insertion of the plug into the urethra, thereby ensuring a firm and secure 6 placement of the plug assembly 1. A string 8 extends from the 7 body for removal of the plug assembly 1 after insertion.
8 Alternatively, removal may be carried out by the tab 5, a ring (not shown), or another removal member may be adapted to extend from the body 2. Line A-A represents the cross sectional view of the body 2, which will be discussed further with reference to 11 Figures 7A and 7B.
12 The operation of the plug assembly 1 is such that upon 13 insertion, the urethral wall conforms thereto, via an automatic 14 reflex motion. The meatal plate 4, anchoring the plug assembly 1 at the meatus urinarius further provides a seal therewith, via the adhesive layer 6. This seal prevents slippage of the 16 assembly 1 from its position in the urethra, thereby ensuring 17 continuous blockage of urine. Note that the adhesive layer 6, although shown to be continuous, may be discontinuous depending 18 on the degree of adhesion desired.
Figure 2A shows a fluidly expandable urethral plug assembly 100 in a deflated state. The plug assembly 100 has a body 102 21 with a meatal plate 104 on its distal end, and an expandable 22 balloon 116 at its proximal end. The body 102 wall is relatively 23 constant in outer diameter allowing the device to be easily inserted. The meatal plate 104, as in the embodiment of Figure 1 24 has a layer of adhesive 106 thereon. The internal portion of the body 102 of the plug assembly defines a lumen 108, a first cavity 26 111, and a valve seat 113. The fluid responsible for inflating balloon 116 is introduced from an external syringe 110 adapted to 27 be inserted in the first cavity lll. The fluid can be any fluid 28 capable of being pumped from the syringe 110 with sufficient W095/08968 2 1 7 2 1 3 6 PCT~S94/10606 1 force to displace a ball 115 resting against valve seat 113. The 2 meatal plate 104 and tab 105, like the meatal plate 104 as previously discussed in the above embodiment, is adapted to 3 anchor the urethral plug assembly 100 at the meatus urinarius.
4 The layer of adhesive 106 lies on the meatal plate 104 so as to form a seal with the meatus after insertion.
6 Figure 2B shows the urethral plug assembly 100 after the 7 fluid has been pumped into the balloon 116, such that the plug 8 assembly 100 is in an inflated state. Inflation is carried out by inserting syringe 110 into the plug assembly 100 so that it 9 lies within the first cavity 111. Fluid is then expelled from the syringe 110 for travel through the first cavity 111 to the 11 valve seat 113, whereby the force of the fluid pushes the ball 115 off the valve seat 113 thereby providing a continuous flow 12 path from the first cavity 111 to the lumen 108. The fluid thus 13 travels freely from syringe 110 through the valve seat opening 14 112 and into lumen 108. The fluid then continues to travel out of the opening 114 of lumen 108, whereupon it inflates the balloon 116. When the balloon 116 is inflated, the expulsion of 16 fluid from syringe 110 may be terminated and the syringe 110 17 removed. At this point, the ball 115 falls back against valve seat 113 to occlude valve seat opening 112, thus closing such 18 opening 112 off from external fluid entry or exit. Thus the 19 fluid contained in the balloon 116 functions to-maintain the plug assembly in its inflated state for urine blockage. When it is desired to remove the plug assembly, the wearer deflates the 21 balloon 116 by simply pulling on the cord 117 attached to the 22 ball 115, causing the ball 115 to dislodge and pass from the 23 valve seat opening 112 toward the distal end of the plug assembly 100. Although such action results in the expulsion of fluid from 24 the balloon 116, the seal between the plug assembly 100 and the meatus remains intact due to the adhesive 106 on the plate 104, 26 which continues to block the flow of urine. ~he wearer may then comfortably remove the plug assembly 100 as the diameter thereof ~t72136 WO95t08968 PCT~S94/10606 1 is reduced. Removal is accomplished by a continuous tug on the 2 tab 105, which serves to break the seal and disengage the meatal plate 104 from the meatus.
4 Figure 3A like Figure 2A, shows an expandable plug assembly 200 also having a layer of adhesive 206 on its meatal plate 204.
Plug assembly 200, has a body 202 comprised of a hollow, 6 cylindrical tube which is sized to be easily inserted through the 7 orifice of the urethra. The tube 202 is made from a 8 biocompatible material having characteristics of compressibility.
Attached on the periphery thereof either by thermal bonding, laminating or other means, is a balloon 208 which is adapted to rest against the tube 202. At the distal end of the tube is a 11 meatal plate 204 having a tab 205. The meatal plate 204, like the meatal plates previously discussed, is adapted to anchor the 12 urethral plug assembly 200 at the meatus urinarius. A layer of 13 adhesive 206 lies on the meatal plate 204 so as to form a seal 14 with the meatus after insertion. Referring again to Figure 1, enclosed within the tube is a support rod 210, which may be a hollow or a solid member. The support rod 210 has a bulb 212 at 16 one end thereof, abutting the proximal end of the tube. The bulb 17 212 functions to hold the support rod within the tube. The support rod 212 has a cord 214 attached at its end opposite the 18 bulb 212, which extends through the tube 202 and beyond the 19 meatal plate 204, thus ensuring that a wearer will always be able to reach the cord 214. On the cord 214 there is preferably formed a knot 216. Although the knot 216 has been used, the 21 attachment of any member having a diameter greater than ball 22 retention socket 218 in meatal plate 206 would suffice. The 23 support rod 210 is formed of a biocompatible material, the tube 202 is preferably formed of a biocompatible thermoplastic 24 material and the balloon 208 is preferably a biocompatible thermoplastic elastomer, such as that sold under the trademark 26 KRATON. However, any biocompatible material may be used for each 27 of the aforementioned elements, as the invention is not to be W09s/08968 PCT~S94/10606 1 limited to those named above. Line A-A represents the cross 2 sectional view of the tube, which will be discussed further with reference to Figures 7A and 7B.
4 The operation of the plug assembly 200 iS described in connection with Figure 3B. A user inserts the plug assembly 200 while it is in a contracted configuration. Once the plug 6 assembly 200 has been inserted, the meatal plate 204 abuts the 7 meatus urinarius and the adhesive layer 206 forms a seal with the 8 meatus. At this point, the plug assembly 200 may be deployed by the wearer, whereupon it achieves an expanded configuration. To deploy, the wearer pulls on the cord 214 depending from the support rod 210. By pulling on cord 214, a downward force is 11 exerted on the cord 214 in the vertical direction, forcing the support rod 210 to slide downwardly in the tube 202 and exert a 12 compressive force against the proximal end of the outer tube 202.
13 The tube 202 thus expands outwardly in the horizontal direction, 14 causing the balloon 208 to expand until the balloon 208 forms a seal with the wall of the urethra, bladder neck or bladder. The wearer then secures the cord 216 by sliding it through a slit in 16 the ball retention socket 218 located on the meatal plate 204.
17 This causes the knot 216 to act as a stop, as the knot 216 rests within the socket 218, thereby preventing the tube 202 from 18 returning to its contracted state. The expansion of the tube 202 19 serves to block the flow of urine as the balloon 208 forms a seal 20 with the urethral, bladder neck or bladder wall. The placement of the plug assembly 200 is further retained in this position by 21 the seal formed by the adhesive layer 206 on the meatal plate 204 22 with the meatus.
The plug assembly 200 in an expanded form, functions to 24 block the flow of urine from the body. When the wearer wishes to remove the plug assembly 200, a simple tug on the cord 214 in a 26 direction away from the socket 218 Will cause the knot 216 to be released therefrom, thus causing the tube 202 to retract. The 27 tube 202 thereby returns to its original diameter prior to 28 insertion, making plug removal a comfortable task. Thus, the 2 t 72 1 36 WO95/08968 PCT~S94/10606 1 tube 202 and balloon 208 cooperatively provide an expandable 2 housing and the plug includes means for mechanically expanding the housing and selectively returning the housing to its 3 non-expanded condition. The seal between the adhesive layer 206 4 on the meatal plate 204 and the meatus, is then broken by the continuous downward pulling of the cord 214. At this point, the plug assembly may be removed and bladder evacuation may occur.
7 Referring now to Figure 4A, a plug assembly 300 is shown, 8 which is preferably formed of a biocompatible thermoplastic material. In a preferred embodiment, the plug 300 is made of a tube 302 of known polyurethane-based polymer which provides the plug 300 with shape memory. The unique characteristic of the 11 plastic polymer is its automatically triggered shape memory, which allows the tube constructed of the shape memory polymer to 12 be inserted into the urethra in a relatively compressed and 13 elongated state, and regain a useful shape in response to a 14 selected transition temperature, that being body temperature.
The shape memory material however, may alternatively comprise a hydrophillic material (not shown) capable of expanding in 16 response to moisture or pH gradations. Like the above 17 embodiments, the tube 302 terminates in a meatal plate 304 which has a layer of adhesive 306 thereon. For purposes of 18 illustration only, the ability of plug assembly 300 to expand due 19 to changes in temperature, will be discussed.
When the urethral plug shown in Figure 4A is subjected to a 21 transition temperature, the relatively rigid plug 300 changes to 22 a second condition in which it is flexible and easily deformable.
23 The plug 300 is now pliable and, remembering its "mold shape plug", able to expand significantly in diameter to conform to the 24 shape of the wearer~s urethra. The expansion results in the formation of a tight seal between the urethra, bladder neck or 26 bladder wall and the plug 300. The adhesive layer 306 also forms a seal between the plug 300 and the meatus. Thus the plug 300 is 27 retained in the urethra to block the flow of urine.
Wo95/08968 PCT~S94/10606 l In accordance with the above discussion, the operation of 2 the plug is discussed in reference to Figure 4B. The user inserts the urethral plug 300 of the present invention into the 3 urethra while it is in its compressed and elongated state. The 4 plug 300 is inserted until the meatal plate 304 abuts the meatus urinarius. At this point the layer of adhesive 306 on the meatal plate 304 forms a seal with the meatus urinarius. The plug 300, 6 now lying in the urethra, is exposed to the heightened 7 temperature of the human body. The temperature increase causes 8 the shape memory polymer comprising the tube 302 to automatically expand outwardly and achieve a protrusion to conform to the size 9 and shape of the wearer's urethra. The shape memory polymer is able to freely adapt and conform to its environment, the urethra, ll as it is only capable of expanding and conforming to the environment into which it is placed; it is incapable of exerting 12 a resistive force by itself. This important characteristic of 13 the shape memory polymer prevents displacement of the urethra, 14 bladder neck or bladder by the shape memory polymer material.
As urine accumulates in the bladder, pressure from the 16 accumulating urine builds until the bladder is sufficiently full 17 to exert a downward force on the urine in the bladder neck and urethra. The downward force in turn bears down on the proximal 18 portion of the expanded member of the plug 300, furthering the 19 diametrical expansion of the proximal portion of the member. The expansion of the plug, in its expanded form, provides a tight seal with the wall of the urethra, bladder neck or bladder to 21 retain the plug in the wearer~s body. When the wearer wishes to 22 remove the plug to void, a continuous tug on tab 305 of the 23 meatal plate 304 will cause the rubbery, diametrically expanded member to elongate, and will break the seal formed between the 24 adhesive layer 306 on the meatal plate 304 and the meatus. The tube 302 is then returned to a smaller diameter and is simply 26 withdrawn from the body. Other means for removal of the plug is contemplated, such as but not limited to, a pulling means, such 27 as a cord or ring (not shown), whereby the plug is simply removed W O 95/08968 PCTnUS94110606 by pulling on a cord attached to the plug. The ease with which 2 the shape memory polymer plug allows removal prevents discomfort potentially associated with plug removal.
4 Figure 5 shows an alternative embodiment of the invention with a urethral plug assembly 400 havin~ an adhesive layer 406 on a portion of its body 402. For purposes of example only, the 6 solid plug of Figure 1 will be employed to illustrate this 7 embodiment. Note, however, that the use of an adhesive layer as 8 shown in this figure is to be applied to all of the aforementioned plug assemblies. In contrast with the plug assembly of figure 1, this plug assembly may or may not have an adhesive layer on the meatal plate 404. Instead, an adhesive 11 layer 406 is found on a portion of the body 402 of the plug assembly 400, or, alternatively, with reference to Figures 3 A and 12 3B, may be found on a balloon attached to the body. The adhesive 13 layer located in such position, secures the placement of the plug 14 assembly 400 in the urethra. Upon insertion of the plug assembly 400 into the urethra, the adhesive layer 406 bonds with the 15 urethral, bladder neck or bladder wall, such that the walls 16 conform to the plug assembly 400. This results in a tight 17 sealing effect, such that the plug assembly 400 is prevented from moving in any direction. Moreover, with respect to the 18 embodiments of Figures 2 B and 3B, should the expansion of balloon 19 116 or tube 202, respectively, no longer function in the expanded 20 state while placed in the urethra, due to valve or mechanical failure, the seal provided between a portion of the plug assembly 21 and the urethra, bladder or bladder neck remains intact. If the 22 wearer wishes to void, removal is carried out in much the same 23 manner as in the above embodiments. The tab 405 of the meatal plate 404, and/or the string 408 associated with the plug is 24 grasped and pulled downward, which serves to break the seal formed between the portion of the body and the urethral, bladder 26 neck or bladder wall. Note that although this figure shows a continuous layer of adhesive 406, such a layer may be 27 discontinuous, spotty or uneven, depending upon the degree of 28 adhesion desired.
W095/08968 PCT~S94/10606 2 Figure 6 shows an alternative embodiment of the invention, and for purposes of illustration only, the solid plug of Figure l 3 is shown for this embodiment of the invention. In this 4 embodiment a urethral plug assembly 500 has a meatal plate 504 with a layer of adhesive 506 thereon. The adhesive layer 506 is positioned on the meatal plate 504 so as to seal the plug 6 assembly 500 with the tissue surrounding the meatus. As shown, 7 the adhesive layer 506 lies on a the outer circumferential 8 portion of the meatal plate 504, such that a space 510 exists between the adhesive layer 506 and the body 502 of the plug 9 assembly 500, the space 510 being free of adhesive. The plug assembly 500 with the adhesive layer 506 so positioned, functions ll to seal the plug at a distance from the meatus urinarius. When the wearer wishes to void, removal is carried out in much the 12 same manner as in the above embodiments. The tab 505 of the 13 meatal plate 504, and/or the string 508 is grasped and pulled 14 downward, which serves to break the seal formed between a portion of the meatal plate 504 and the tissue surrounding the meatus 15 urinarius. As with the aforementioned embodiments, note that 16 although this figure shows a continuous layer of adhesive 506, 17 such a layer may be discontinuous, spotty or uneven, depending upon the degree of adhesion desired. Moreover, this embodiment 18 may optionally include a layer of adhesive on the body 502 of the l9 p~ug assembly 500.
Figure 7A shows a cross sectional view of the urethral plug 21 assembly along line A-A of the preferred embodiments set forth 22 above. Body 602 is representative of elements 2, 102, 202, 302, 23 402 and 502 of the aforementioned plug assemblies, and as shown, is of a constant diameter. Figure 7B shows an alternative 24 embodiment of the urethral plug assembly, along line A-A. ~s shown, the diameter of body 702 is not constant but variant as 26 shown by the curved indentations 704 on the periphery. The indentations 704 provide enhanced surface area by which the plug 2~ 72 1 36 W095/08968 PCT~S94/10606 1 assembly may more readily adapt to the urethral, bladder neck or 2 bladder wall. Such enhanced sealing ability of the plug assembly, provides a better fit for the wearer.
4 Figure 8 shows a bottom perspective view of the meatal plate 804, which is the same as meatal plates 4, 104, 204, 304, 404, and 504, respectively discussed in the aforementioned 6 embodiments. A portion of the meatal plate 804 iS extended so as 7 to form a tab 805 which may be grasped by the wearer for ease of 8 removal. The meatal plate 804 may additionally have a ball retention socket 809 and slit 811 formed therein, particularly 9 with respect to Figure 3B so as to aid in maintaining the plug's expanded configuration.
While the invention has been particularly shown and 12 described with reference to the aforementioned embodiments, it 13 will be understood by those skilled in the art that various 14 changes in form, composition and detail may be made therein without departing from the spirit and scope of the invention.
Thus, any modification to the shape, configuration and/or 16 composition of the elements comprising the invention is within 17 the scope of the present invention.
Claims
What is claimed is:
20. A remove-to-void urethral plug having enhanced sealing capabilities comprising:
a non-expandable body for internally occluding the urethra, said body having a substantially constant cross section, a meatal plate attached to said body, having a layer of adhesive thereon for anchoring said meatal plate to the urethral meatus, whereby said anchoring by said adhesive, enhances a seal of said body to the urethral wall such that movement of the plug is arrested.
21. A method of using a urethral plug having enhanced sealing capabilities;
providing a urethral plug comprising a body having an expandable portion adapted to expand in response to a stimulus external to said plug, said body having a layer of adhesive thereon, inserting said urethral plug into the urethra of a wearer, in a position such that it blocks the flow of urine, introducing a stimulus to said urethral plug, causing said expandable portion to expand in response thereto, sealing said body against the meatus urinarius, urethra, bladder neck, or bladder wall via said adhesive, retaining said expandable portion in place through said layer of adhesive, without the movement or slippage thereof from said position until the wearer wishes to void.
24. A method of using a urethral plug according to claim 21, further comprising anchoring said urethral plug at the urethral meatus.
25. A method of using a urethral plug according to claim 21, further comprising removing said urethral plug to void the bladder.
26. A remove-to-void device for controlling urinary incontinence comprising:
a body having an expandable portion at one end, which is capable of expanding upon introduction of fluid, to form a plug, which when placed in a urethra through the natural opening thereof, and expanded, provides a urine-impermeable barrier to the flow of urine, which can only permit the passage of urine from the bladder by removal of the device, said body further having adhesive disposed thereon to anchor the body against a wall of the urethra, bladder neck or bladder, means for transmitting fluid into the interior of said expandable portion of said device, from a source external to said device, to enable said expandable portion to expand upon the introduction of fluid from the source, said expandable portion having a hollow interior, which hollow interior is in fluid communication with an opening in said body, on the end of the body opposite the end which has said expandable portion, said body defining a lumen fluidly coupling the opening and the hollow interior, a valve in the lumen preventing flow of the fluid from the expandable portion until flow of the fluid from the expandable portion is desired by the user, means for exerting a force on said valve to open said valve to allow deflation of the expandable portion when desired, and to enable the device to be removed in order to void.
27. The remove-to-void urethral plug according to claim 26, said adhesive comprising hydrogel adhesive.
28. The remove-to-void urethral plug according to claim 26, further comprising a means for anchoring at an end of the body opposite the end which has said expandable portion, whereby when the body is placed in the urethra, bladder neck or bladder, said means for anchoring abuts the urethral meatus.
29. The remove-to-void urethral plug according to claim 28, whereby said adhesive is disposed on said means for anchoring to seal said means for anchoring at the urethral meatus.
30. The remove-to-void urethral plug for controlling urinary incontinence according to claim 26, said adhesive being disposed on said expandable portion.
31. The remove-to-void urethral plug for controlling urinary incontinence according to claim 26, said body further having curved indentations on the periphery thereof.
32. A remove-to-void device for blocking unwanted flow of urine comprising an expandable member, said member comprising a plastic polymer possessing a first shape prior to insertion into a human body, said first shape being insufficient in size and volume to form a plug to block the flow of urine, and a second shape following insertion into a human body, said second shape being in response to the environment of the urethra, bladder neck or bladder, said second shape forming a urine-impermeable plug, said urine-impermeable plug being of sufficient size and volume so as to remain in place against the walls of the urethra, bladder neck, or bladder while blocking the flow of urine, such that in said first shape said member is adapted to be configured in its non-expanded disposition and in said second shape said member is adapted to be configured in its expanded disposition, said member further having adhesive disposed thereon so as to seal said member against a wall of the urethral meatus, urethra, bladder neck or bladder.
33. The remove-to-void device according to claim 32, said adhesive further comprising hydrogel adhesive.
34. The remove-to-void device according to claim 32, said member further comprising a means for anchoring disposed at one end of said member, whereby when the member is placed in the urethra, bladder neck or bladder, said means for anchoring abuts the urethral meatus.
35. The remove-to-void device according to claim 34, whereby said adhesive is disposed on said means for anchoring so as to seal said means for anchoring at the meatus urinarius.
36. The remove-to-void device according to claim 32, said member further having curved indentations on the periphery thereof.
37. A plug assembly for use in the urethra to control urinary incontinence comprising:
a housing adapted to be inserted into the natural opening of a wearer, said housing having adhesive disposed thereon to anchor said housing to the urethral meatus, urethra, bladder neck or bladder wall, means for mechanically changing the shape of said housing upon insertion into the natural opening, means for reversing the changing of the shape of said housing, so that the wearer may remove said housing from the natural urethral opening and effect bladder evacuation.
22a 38. A plug assembly for use in the urethra to control urinary incontinence according to claim 37, said adhesive further comprising hydrogel adhesive.
39. The plug assembly for use in the urethra to control urinary incontinence according to claim 37, said housing further comprising a means for anchoring at one end thereof, such that when the housing is placed in the urethra, bladder neck or bladder, said means for anchoring abuts the urethral meatus.
40. The plug assembly for use in the urethra to control urinary incontinence according to claim 39, said means for anchoring having adhesive disposed thereon to seal said means for anchoring at the urethral meatus.
41. The plug assembly for use in the urethra to control urinary incontinence according to claim 37, said housing further having curved indentations on the periphery thereof.
42. The method of using a urethral plug having enhanced sealing capabilities according to claim 21 further comprising, providing a meatal plate at an end of said body opposite the end having the expandable portion, said meatal plate adapted to anchor the plug to the meatus urinarius.
43. The method of using a urethral plug having enhanced sealing capabilities according to claim 42 further comprising, 22b providing adhesive on said meatal plate so as to seal said meatal plate to the meatus urinarius.
44. The method of using a urethral plug having enhanced sealing capabilities according to claim 21, wherein said stimulus comprises the introduction of fluid through said body to expand said expandable portion.
45. The method of using a urethral plug having enhanced sealing capabilities according to claim 21, wherein said stimulus comprises the introduction of a mechanical force on said body to expand said expandable portion.
46. A method of using a urethral plug having enhanced sealing capabilities comprising;
providing a urethral plug comprising a body having an expandable portion adapted to expand in response to a stimulus, said body having a layer of adhesive thereon, inserting said urethral plug into the urethra of a wearer, in a position such that it blocks the flow of urine, introducing a stimulus to said urethral plug, causing said expandable portion to expand in response thereto, sealing said body against the meatus urinarius, urethra, bladder neck or bladder wall via said adhesive, retaining said expandable portion in place through said layer of adhesive, without the movement or slippage of said expandable portion from said position until the wearer wishes to void.
22c 47. The method of using a urethral plug according to claim 46, whereby said stimulus is the introduction of a temperature greater than the temperature of said urethral plug causing the expansion of said expandable portion.
48. A urethral plug having enhanced sealing capabilities comprising:
a body adapted to expand for internally occluding the urethra having a layer of adhesive disposed thereon, a meatal plate for anchoring said body to the urethral meatus, whereby said adhesive retains said body against the wall of the urethra, bladder neck or bladder, such that movement of the plug is arrested.
49. A urethral plug having enhanced sealing capabilities comprising:
a body adapted to expand after insertion into a urethra for internally occluding the urethra, a meatal plate for anchoring said body to the urethral meatus, said meatal plate having a discontinuous layer of adhesive thereon, whereby said adhesive anchors said meatal plate at the meatus such that movement of the plug is arrested.
50. A method of using a urethral plug having enhanced sealing capabilities comprising:
22d providing a non-expandable body having a substantially constant cross section adapted to internally occlude the urethra, providing a meatal plate attached to said body, having a layer of adhesive thereon for anchoring said meatal plate to the urethral meatus, whereby said anchoring by said adhesive, enhances a seal of said body to the urethral wall such that movement of the plug is arrested.
51. A urethral plug having enhanced sealing capabilities comprising:
a non-expandable body adapted to internally occlude the urethra having a layer of adhesive disposed thereon, a meatal plate for anchoring said body to the urethral meatus, whereby said adhesive retains said body against the wall of the urethra, bladder neck or bladder, such that movement of the plug is arrested.
52. A method of using a urethral plug having enhanced sealing capabilities comprising:
providing a non-expandable body adapted to internally occlude the urethra having a layer of adhesive disposed thereon, providing a meatal plate attached to said body, for anchoring said meatal plate to the urethral meatus, 22e whereby said adhesive retains said body against the wall of the urethra, bladder neck or bladder, such that movement of the plug is arrested.
22f
20. A remove-to-void urethral plug having enhanced sealing capabilities comprising:
a non-expandable body for internally occluding the urethra, said body having a substantially constant cross section, a meatal plate attached to said body, having a layer of adhesive thereon for anchoring said meatal plate to the urethral meatus, whereby said anchoring by said adhesive, enhances a seal of said body to the urethral wall such that movement of the plug is arrested.
21. A method of using a urethral plug having enhanced sealing capabilities;
providing a urethral plug comprising a body having an expandable portion adapted to expand in response to a stimulus external to said plug, said body having a layer of adhesive thereon, inserting said urethral plug into the urethra of a wearer, in a position such that it blocks the flow of urine, introducing a stimulus to said urethral plug, causing said expandable portion to expand in response thereto, sealing said body against the meatus urinarius, urethra, bladder neck, or bladder wall via said adhesive, retaining said expandable portion in place through said layer of adhesive, without the movement or slippage thereof from said position until the wearer wishes to void.
24. A method of using a urethral plug according to claim 21, further comprising anchoring said urethral plug at the urethral meatus.
25. A method of using a urethral plug according to claim 21, further comprising removing said urethral plug to void the bladder.
26. A remove-to-void device for controlling urinary incontinence comprising:
a body having an expandable portion at one end, which is capable of expanding upon introduction of fluid, to form a plug, which when placed in a urethra through the natural opening thereof, and expanded, provides a urine-impermeable barrier to the flow of urine, which can only permit the passage of urine from the bladder by removal of the device, said body further having adhesive disposed thereon to anchor the body against a wall of the urethra, bladder neck or bladder, means for transmitting fluid into the interior of said expandable portion of said device, from a source external to said device, to enable said expandable portion to expand upon the introduction of fluid from the source, said expandable portion having a hollow interior, which hollow interior is in fluid communication with an opening in said body, on the end of the body opposite the end which has said expandable portion, said body defining a lumen fluidly coupling the opening and the hollow interior, a valve in the lumen preventing flow of the fluid from the expandable portion until flow of the fluid from the expandable portion is desired by the user, means for exerting a force on said valve to open said valve to allow deflation of the expandable portion when desired, and to enable the device to be removed in order to void.
27. The remove-to-void urethral plug according to claim 26, said adhesive comprising hydrogel adhesive.
28. The remove-to-void urethral plug according to claim 26, further comprising a means for anchoring at an end of the body opposite the end which has said expandable portion, whereby when the body is placed in the urethra, bladder neck or bladder, said means for anchoring abuts the urethral meatus.
29. The remove-to-void urethral plug according to claim 28, whereby said adhesive is disposed on said means for anchoring to seal said means for anchoring at the urethral meatus.
30. The remove-to-void urethral plug for controlling urinary incontinence according to claim 26, said adhesive being disposed on said expandable portion.
31. The remove-to-void urethral plug for controlling urinary incontinence according to claim 26, said body further having curved indentations on the periphery thereof.
32. A remove-to-void device for blocking unwanted flow of urine comprising an expandable member, said member comprising a plastic polymer possessing a first shape prior to insertion into a human body, said first shape being insufficient in size and volume to form a plug to block the flow of urine, and a second shape following insertion into a human body, said second shape being in response to the environment of the urethra, bladder neck or bladder, said second shape forming a urine-impermeable plug, said urine-impermeable plug being of sufficient size and volume so as to remain in place against the walls of the urethra, bladder neck, or bladder while blocking the flow of urine, such that in said first shape said member is adapted to be configured in its non-expanded disposition and in said second shape said member is adapted to be configured in its expanded disposition, said member further having adhesive disposed thereon so as to seal said member against a wall of the urethral meatus, urethra, bladder neck or bladder.
33. The remove-to-void device according to claim 32, said adhesive further comprising hydrogel adhesive.
34. The remove-to-void device according to claim 32, said member further comprising a means for anchoring disposed at one end of said member, whereby when the member is placed in the urethra, bladder neck or bladder, said means for anchoring abuts the urethral meatus.
35. The remove-to-void device according to claim 34, whereby said adhesive is disposed on said means for anchoring so as to seal said means for anchoring at the meatus urinarius.
36. The remove-to-void device according to claim 32, said member further having curved indentations on the periphery thereof.
37. A plug assembly for use in the urethra to control urinary incontinence comprising:
a housing adapted to be inserted into the natural opening of a wearer, said housing having adhesive disposed thereon to anchor said housing to the urethral meatus, urethra, bladder neck or bladder wall, means for mechanically changing the shape of said housing upon insertion into the natural opening, means for reversing the changing of the shape of said housing, so that the wearer may remove said housing from the natural urethral opening and effect bladder evacuation.
22a 38. A plug assembly for use in the urethra to control urinary incontinence according to claim 37, said adhesive further comprising hydrogel adhesive.
39. The plug assembly for use in the urethra to control urinary incontinence according to claim 37, said housing further comprising a means for anchoring at one end thereof, such that when the housing is placed in the urethra, bladder neck or bladder, said means for anchoring abuts the urethral meatus.
40. The plug assembly for use in the urethra to control urinary incontinence according to claim 39, said means for anchoring having adhesive disposed thereon to seal said means for anchoring at the urethral meatus.
41. The plug assembly for use in the urethra to control urinary incontinence according to claim 37, said housing further having curved indentations on the periphery thereof.
42. The method of using a urethral plug having enhanced sealing capabilities according to claim 21 further comprising, providing a meatal plate at an end of said body opposite the end having the expandable portion, said meatal plate adapted to anchor the plug to the meatus urinarius.
43. The method of using a urethral plug having enhanced sealing capabilities according to claim 42 further comprising, 22b providing adhesive on said meatal plate so as to seal said meatal plate to the meatus urinarius.
44. The method of using a urethral plug having enhanced sealing capabilities according to claim 21, wherein said stimulus comprises the introduction of fluid through said body to expand said expandable portion.
45. The method of using a urethral plug having enhanced sealing capabilities according to claim 21, wherein said stimulus comprises the introduction of a mechanical force on said body to expand said expandable portion.
46. A method of using a urethral plug having enhanced sealing capabilities comprising;
providing a urethral plug comprising a body having an expandable portion adapted to expand in response to a stimulus, said body having a layer of adhesive thereon, inserting said urethral plug into the urethra of a wearer, in a position such that it blocks the flow of urine, introducing a stimulus to said urethral plug, causing said expandable portion to expand in response thereto, sealing said body against the meatus urinarius, urethra, bladder neck or bladder wall via said adhesive, retaining said expandable portion in place through said layer of adhesive, without the movement or slippage of said expandable portion from said position until the wearer wishes to void.
22c 47. The method of using a urethral plug according to claim 46, whereby said stimulus is the introduction of a temperature greater than the temperature of said urethral plug causing the expansion of said expandable portion.
48. A urethral plug having enhanced sealing capabilities comprising:
a body adapted to expand for internally occluding the urethra having a layer of adhesive disposed thereon, a meatal plate for anchoring said body to the urethral meatus, whereby said adhesive retains said body against the wall of the urethra, bladder neck or bladder, such that movement of the plug is arrested.
49. A urethral plug having enhanced sealing capabilities comprising:
a body adapted to expand after insertion into a urethra for internally occluding the urethra, a meatal plate for anchoring said body to the urethral meatus, said meatal plate having a discontinuous layer of adhesive thereon, whereby said adhesive anchors said meatal plate at the meatus such that movement of the plug is arrested.
50. A method of using a urethral plug having enhanced sealing capabilities comprising:
22d providing a non-expandable body having a substantially constant cross section adapted to internally occlude the urethra, providing a meatal plate attached to said body, having a layer of adhesive thereon for anchoring said meatal plate to the urethral meatus, whereby said anchoring by said adhesive, enhances a seal of said body to the urethral wall such that movement of the plug is arrested.
51. A urethral plug having enhanced sealing capabilities comprising:
a non-expandable body adapted to internally occlude the urethra having a layer of adhesive disposed thereon, a meatal plate for anchoring said body to the urethral meatus, whereby said adhesive retains said body against the wall of the urethra, bladder neck or bladder, such that movement of the plug is arrested.
52. A method of using a urethral plug having enhanced sealing capabilities comprising:
providing a non-expandable body adapted to internally occlude the urethra having a layer of adhesive disposed thereon, providing a meatal plate attached to said body, for anchoring said meatal plate to the urethral meatus, 22e whereby said adhesive retains said body against the wall of the urethra, bladder neck or bladder, such that movement of the plug is arrested.
22f
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/124,264 US5509427A (en) | 1990-12-31 | 1993-09-20 | Urethral plug assembly having adhesive for enhanced sealing capabilities and method of using said plug assembly |
| US08/124,264 | 1993-09-20 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2172136A1 true CA2172136A1 (en) | 1995-04-06 |
Family
ID=22413810
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002172136A Abandoned CA2172136A1 (en) | 1993-09-20 | 1994-09-20 | Urethral plug having adhesive sealing capabilities |
Country Status (11)
| Country | Link |
|---|---|
| US (2) | US5509427A (en) |
| EP (1) | EP0720460A4 (en) |
| JP (1) | JPH09502908A (en) |
| KR (1) | KR960704498A (en) |
| CN (1) | CN1131385A (en) |
| AU (1) | AU7731294A (en) |
| BR (1) | BR9407593A (en) |
| CA (1) | CA2172136A1 (en) |
| FI (1) | FI961253A (en) |
| NO (1) | NO961118L (en) |
| WO (1) | WO1995008968A1 (en) |
Families Citing this family (58)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5509427A (en) * | 1990-12-31 | 1996-04-23 | Uromed Corporation | Urethral plug assembly having adhesive for enhanced sealing capabilities and method of using said plug assembly |
| US6131575A (en) * | 1991-01-10 | 2000-10-17 | The Procter & Gamble Company | Urinary incontinence device |
| US5769091A (en) * | 1993-09-20 | 1998-06-23 | Uromed Corporation | Urethral plug having adhesive for enhanced sealing capabilities and method of using said plug |
| SE504276C2 (en) * | 1993-12-30 | 1996-12-23 | Siko Medical Ab | Valve intended to be placed in the urethra |
| DK171585B1 (en) * | 1994-04-18 | 1997-02-10 | Coloplast As | Tampon or closure device for body channels in animals or humans |
| US5640976A (en) * | 1995-06-06 | 1997-06-24 | Iotek, Inc. | Incontinence plug anchor |
| US5722931A (en) * | 1996-03-05 | 1998-03-03 | Urohealth Systems, Inc. | Female incontinence device |
| US5906575A (en) | 1996-04-25 | 1999-05-25 | Rochester Medical Corporation | Urethral urine retention device |
| WO1997045066A1 (en) * | 1996-05-31 | 1997-12-04 | Uromed Corporation | Urinary medical devices |
| US5755236A (en) * | 1996-12-12 | 1998-05-26 | Dann; Jeffrey A. | Female incontinence device |
| US5887593A (en) | 1997-01-28 | 1999-03-30 | Levius; Dezso K. | Urinary incontinence device |
| US5924423A (en) * | 1997-04-22 | 1999-07-20 | Heshmat Majlessi | Device for reducing symptoms of prolapsed hemorrhoids |
| US6056687A (en) * | 1997-12-04 | 2000-05-02 | American Medical Systems, Inc. | Device for alleviating urinary incontinence |
| US6030337A (en) * | 1998-07-30 | 2000-02-29 | American Medical Systems, Inc. | Continence augmentor and methods for urinary control |
| US6048306A (en) * | 1998-08-14 | 2000-04-11 | Theodore E. Spielberg | Non-invasive dual acting urological press for the prevention of female incontinence |
| US6090038A (en) * | 1998-12-21 | 2000-07-18 | Kimberly-Clark Worldwide, Inc. | Expandable dome-shaped urinary incontinence device and a method of making the same |
| US6090098A (en) * | 1998-12-21 | 2000-07-18 | Kimberly-Clark Worldwide, Inc. | Method for alleviating female urinary incontinence |
| US6142928A (en) * | 1998-12-21 | 2000-11-07 | Kimberly-Clark Worldwide, Inc. | Urinary incontinence device and a method of making the same |
| US6527702B2 (en) | 2000-02-01 | 2003-03-04 | Abbeymoor Medical, Inc. | Urinary flow control device and method |
| AU770465B2 (en) * | 2000-04-07 | 2004-02-19 | Mdsa Pty Ltd | Dental device |
| US7141038B2 (en) * | 2000-08-07 | 2006-11-28 | Abbeymoor Medical, Inc. | Endourethral device and method |
| WO2002058541A2 (en) * | 2001-01-23 | 2002-08-01 | Abbeymoor Medical, Inc. | Endourethral device & method |
| US20020166560A1 (en) * | 2001-05-11 | 2002-11-14 | Wolak Ruth A. | Feminine urinary incontinence inhibitor interlabial device |
| US6558370B2 (en) | 2001-06-05 | 2003-05-06 | Kimberly-Clark Worldwide, Inc. | Urinary incontinence device |
| DE60235757D1 (en) | 2001-06-22 | 2010-05-06 | Abbeymoor Medical Inc | URETHRA PROFILING DEVICE |
| US6627673B2 (en) | 2001-07-24 | 2003-09-30 | Kimberly-Clark Worldwide, Inc. | Methods of making humidity activated materials having shape-memory |
| US6933421B2 (en) * | 2001-07-24 | 2005-08-23 | Kimberly-Clark Worldwide Inc. | Methods of making disposable products having humidity activated materials with shape-memory |
| US6664436B2 (en) | 2001-07-24 | 2003-12-16 | Kimberly-Clark Worldwide, Inc. | Disposable products having humidity activated materials with shape-memory |
| AUPR790901A0 (en) * | 2001-09-25 | 2001-10-18 | Mccloskey, Jenny Colleen | Inactivation of papillomavirus |
| ATE536198T1 (en) * | 2001-10-18 | 2011-12-15 | Abbeymoor Medical Inc | ENDOURETHRAL DEVICE |
| KR20030069757A (en) * | 2002-02-21 | 2003-08-27 | 김철준 | Indwelling Urinary Catheter |
| US6676594B1 (en) | 2002-09-18 | 2004-01-13 | Kimberly-Clark Worldwide, Inc. | C-shaped vaginal incontinence insert |
| US6770025B2 (en) | 2002-09-18 | 2004-08-03 | Kimberly-Clark Worldwide, Inc. | Molar shaped vaginal incontinence insert |
| US6808485B2 (en) | 2002-12-23 | 2004-10-26 | Kimberly-Clark Worldwide, Inc. | Compressible resilient incontinence insert |
| US20050109442A1 (en) * | 2003-11-24 | 2005-05-26 | Kimberly-Clark Worldwide, Inc. | Quick change gender specific forming surface and method of using same |
| US8147472B2 (en) * | 2003-11-24 | 2012-04-03 | Kimberly-Clark Worldwide, Inc. | Folded absorbent product |
| US7931634B2 (en) * | 2003-12-18 | 2011-04-26 | Kimberly-Clark Worldwide, Inc. | Bodily exudate capturing article |
| US8864730B2 (en) | 2005-04-12 | 2014-10-21 | Rochester Medical Corporation | Silicone rubber male external catheter with absorbent and adhesive |
| EP2083902B1 (en) * | 2006-10-18 | 2017-08-30 | Inspiremd Ltd. | Filter assemblies |
| DE502007001069D1 (en) | 2007-01-24 | 2009-08-27 | Delphi Tech Inc | Modular system |
| US9408683B2 (en) | 2009-05-27 | 2016-08-09 | Parapatch, Inc. | Method and device for treating female pelvic nerve dysfunction |
| CA2762066A1 (en) | 2009-05-27 | 2010-12-02 | Cora St. Anne | Method and device for female urinary incontinence |
| DK2459118T3 (en) * | 2009-07-29 | 2022-06-27 | Life360 Innovations Llc | URINE CONTINENT FACILITY |
| AU2010331820B2 (en) * | 2009-12-18 | 2015-03-05 | Vysera Biomedical Limited | A urological device |
| EP2343026B1 (en) * | 2010-01-11 | 2021-12-01 | ForConti Medical Ltd. | Device for controlling fecal incontinence |
| US9707375B2 (en) | 2011-03-14 | 2017-07-18 | Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. | Catheter grip and method |
| US10092728B2 (en) | 2012-11-20 | 2018-10-09 | Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. | Sheath for securing urinary catheter |
| US9872969B2 (en) | 2012-11-20 | 2018-01-23 | Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. | Catheter in bag without additional packaging |
| FR3024652A1 (en) * | 2014-08-06 | 2016-02-12 | Eurl Cornier | DEVICE FOR THE VISUALIZATION OF THE FEMININE URETRE IN IMAGING |
| MX2017002457A (en) | 2014-08-26 | 2017-05-19 | Bard Inc C R | Urinary catheter. |
| USD798462S1 (en) | 2016-04-01 | 2017-09-26 | Parapatch, Inc. | Clitoral adhesive device |
| USD835273S1 (en) | 2017-07-25 | 2018-12-04 | Life360 Innovations Inc. | Urethral plug inserter |
| USD835784S1 (en) | 2017-07-25 | 2018-12-11 | Life360 Innovations Inc. | Urethral plug |
| US10485644B2 (en) | 2017-08-22 | 2019-11-26 | Life360 Innovations Inc. | Inserter for urethral plug |
| US10441396B2 (en) * | 2017-08-22 | 2019-10-15 | Life360 Innovations Inc. | Urethral plug and system for addressing urinary incontinence |
| CA3070865A1 (en) | 2017-09-19 | 2019-03-28 | C.R. Bard, Inc. | Urinary catheter bridging device, systems and methods thereof |
| CA3086554A1 (en) | 2017-12-05 | 2019-06-13 | Jenny Colleen Mccloskey | Device for treatment of a body canal and adjacent surfaces |
| CN110279488A (en) * | 2019-08-05 | 2019-09-27 | 安徽医科大学第一附属医院 | A kind of aid urination device of orthotopic bladder and its artificial bladder |
Family Cites Families (39)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2324520A (en) * | 1941-04-07 | 1943-07-20 | Otis F Lamson | Apparatus and method for closing abnormal openings in wall-like members of the anatomy |
| US2494393A (en) * | 1949-02-05 | 1950-01-10 | Otis F Lamson | Removable appliance for use as an artificial dam in cases of rectal incontinence |
| US2638093A (en) * | 1949-12-20 | 1953-05-12 | Kulick George | Vaginal insert |
| US3503400A (en) * | 1967-07-12 | 1970-03-31 | Sven M Osthagen | Urethral valve |
| GB1289107A (en) * | 1968-12-10 | 1972-09-13 | ||
| US3726277A (en) * | 1970-08-31 | 1973-04-10 | S Hirschman | Feminine hygienic pad |
| BE788910A (en) * | 1971-09-17 | 1973-03-15 | Alemany R | GYNECOLOGICAL MEANS |
| US3797478A (en) * | 1972-07-11 | 1974-03-19 | M Walsh | Multi-functional valve for use in the urethra |
| US3789828A (en) * | 1972-09-01 | 1974-02-05 | Heyer Schulte Corp | Urethral prosthesis |
| US3841304A (en) * | 1972-10-16 | 1974-10-15 | A Jones | Inflatable leakage inhibitor |
| US4019499A (en) * | 1976-04-22 | 1977-04-26 | Heyer-Schulte Corporation | Compression implant for urinary incontinence |
| FR2417291A1 (en) * | 1978-02-21 | 1979-09-14 | Biotrol Sa Lab | ARTIFICIAL ANUS BLOCKING DEVICE |
| US4258704A (en) * | 1978-08-30 | 1981-03-31 | Johnson & Johnson | Body orifice accessory |
| GB2090741B (en) * | 1981-01-14 | 1985-11-20 | Craig Med Prod Ltd | Female incontinence device |
| GB2099304B (en) * | 1981-02-06 | 1985-01-30 | Cornwell George Herbert Ivan | Incontinence control devices |
| US4428365A (en) * | 1982-03-01 | 1984-01-31 | Hakky Said I | Anti-incontinent prostheses |
| US4563183A (en) * | 1983-04-06 | 1986-01-07 | Barrodale Patricia M | Female external catheter |
| US4553533A (en) * | 1983-11-08 | 1985-11-19 | Leighton Stephen B | Intra-urethral prosthetic sphincter valve |
| DK153122C (en) * | 1985-01-15 | 1988-11-14 | Coloplast As | CLOSURE FOR SINGLE USE FOR AN ARTIFICIAL OR INCONTINENT NATURAL TREATMENT |
| US4682592A (en) * | 1985-01-28 | 1987-07-28 | Thorsgard Knute E | Method and device for achieving reversible male sterilization |
| US4850963A (en) * | 1986-06-11 | 1989-07-25 | Utah Bioresearch, Inc. | Apparatus and methods for achieving urinary continence |
| US4938759A (en) * | 1986-09-02 | 1990-07-03 | Alza Corporation | Transdermal delivery device having a rate controlling adhesive |
| US4946449A (en) * | 1986-12-18 | 1990-08-07 | Davis Jr Richard C | Indwelling urethral catheter system and method |
| GB8713938D0 (en) * | 1987-06-15 | 1987-07-22 | West H R | Female urinary incontinence devices |
| US4846784A (en) * | 1987-07-01 | 1989-07-11 | C. R. Bard, Inc. | Manually adjustable sphincteric system |
| US5097848A (en) * | 1988-10-11 | 1992-03-24 | Schwarz Gerald R | Incontinence bladder control method and apparatus |
| US5012822A (en) * | 1988-10-11 | 1991-05-07 | Schwarz Gerald R | Method for controlling urinary incontinence |
| AU4492989A (en) * | 1988-10-20 | 1990-05-14 | Fusen H. Chen | Incontinence device |
| US5116387A (en) * | 1989-06-09 | 1992-05-26 | American Medical Systems, Inc. | Preparation of injectable polymeric bodies |
| US5234409A (en) * | 1989-07-07 | 1993-08-10 | Cabot Technology Corporation | Female incontinence control device and method |
| DK484689A (en) * | 1989-09-29 | 1991-03-30 | Slagteriernes Forskningsinst | PROCEDURE FOR SELECTION OR TREATMENT OF INSERT FROM PIG BODY |
| US5114398A (en) * | 1990-02-27 | 1992-05-19 | Medical Engineering Corporation | Female incontinence control device with mechanically operable valve |
| JP3179480B2 (en) * | 1990-06-22 | 2001-06-25 | コクラン、ウイリアム・エイチ | Composite |
| US5479945A (en) * | 1990-12-31 | 1996-01-02 | Uromed Corporation | Method and a removable device which can be used for the self-administered treatment of urinary tract infections or other disorders |
| US5090424A (en) * | 1990-12-31 | 1992-02-25 | Uromed Corporation | Conformable urethral plug |
| US5509427A (en) * | 1990-12-31 | 1996-04-23 | Uromed Corporation | Urethral plug assembly having adhesive for enhanced sealing capabilities and method of using said plug assembly |
| US5074855A (en) * | 1991-01-10 | 1991-12-24 | Advanced Surgical Intervention, Inc. | Urinary incontinence pad |
| US5336208A (en) * | 1991-01-10 | 1994-08-09 | Advanced Surgical Intervention, Inc. | Urinary incontinence pad |
| DK77491A (en) * | 1991-04-25 | 1992-10-26 | Tage Wenzel Debess | SELF-ADJUSTING PRESSURE-COMPENSATING DEVICE WITH THE PURPOSE OF PREVENTING THE IMPROPER DISPOSAL OF URINE, INCLUDING INCONTINENCE, PRIOR TO WOMEN |
-
1993
- 1993-09-20 US US08/124,264 patent/US5509427A/en not_active Expired - Fee Related
-
1994
- 1994-09-20 BR BR9407593A patent/BR9407593A/en not_active Application Discontinuation
- 1994-09-20 KR KR1019960701420A patent/KR960704498A/en not_active Application Discontinuation
- 1994-09-20 CN CN94193446A patent/CN1131385A/en active Pending
- 1994-09-20 EP EP94928161A patent/EP0720460A4/en not_active Withdrawn
- 1994-09-20 CA CA002172136A patent/CA2172136A1/en not_active Abandoned
- 1994-09-20 AU AU77312/94A patent/AU7731294A/en not_active Abandoned
- 1994-09-20 WO PCT/US1994/010606 patent/WO1995008968A1/en not_active Application Discontinuation
- 1994-09-20 JP JP7510362A patent/JPH09502908A/en active Pending
-
1995
- 1995-12-04 US US08/566,732 patent/US5752525A/en not_active Expired - Fee Related
-
1996
- 1996-03-18 FI FI961253A patent/FI961253A/en not_active Application Discontinuation
- 1996-03-19 NO NO961118A patent/NO961118L/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| FI961253A0 (en) | 1996-03-18 |
| EP0720460A1 (en) | 1996-07-10 |
| NO961118D0 (en) | 1996-03-19 |
| US5509427A (en) | 1996-04-23 |
| US5752525A (en) | 1998-05-19 |
| NO961118L (en) | 1996-05-13 |
| CN1131385A (en) | 1996-09-18 |
| FI961253A (en) | 1996-05-09 |
| EP0720460A4 (en) | 1997-03-26 |
| BR9407593A (en) | 1997-01-07 |
| JPH09502908A (en) | 1997-03-25 |
| WO1995008968A1 (en) | 1995-04-06 |
| AU7731294A (en) | 1995-04-18 |
| KR960704498A (en) | 1996-10-09 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US5509427A (en) | Urethral plug assembly having adhesive for enhanced sealing capabilities and method of using said plug assembly | |
| US5483976A (en) | Mechanically actuated urethral plug assembly and method for controlling urinary incontinence | |
| US5513660A (en) | Expandable urethral plug | |
| US5724994A (en) | Fluidly expandable urethral plug assembly which receives fluid from an external source and method for controlling urinary incontinence | |
| US5090424A (en) | Conformable urethral plug | |
| US8506537B2 (en) | Sealing device | |
| AU577823B2 (en) | Elastomeric prosthetic sphincter | |
| US4909785A (en) | Method for valving body fluids | |
| US5112306A (en) | Method and apparatus for valving body fluids | |
| US5593443A (en) | Prosthetic anal sphincter | |
| US5520606A (en) | Mechanical urinary sphincter device | |
| US5887593A (en) | Urinary incontinence device | |
| US20070213661A1 (en) | Closure system for managing rectal or anal incontinence | |
| JPH0624550B2 (en) | Implantable sphincter device | |
| WO1990004431A1 (en) | Incontinence device | |
| EP0699060A4 (en) | Expandable urethral plug | |
| JP2003531645A (en) | Self-control ostomy opening | |
| JPH0691890B2 (en) | Gastrointestinal prosthesis sphincter | |
| EP0553075A1 (en) | Incontinence bladder control method and apparatus. | |
| US5769091A (en) | Urethral plug having adhesive for enhanced sealing capabilities and method of using said plug | |
| US5806527A (en) | Urethral plug with means for protection against infection | |
| EP0769931A1 (en) | An assembly and method for prevention of urinary incontinence in humans | |
| WO2001024843A2 (en) | Female urinary incontinence catheter | |
| NZ210804A (en) | Elastomeric prosthetic sphincter |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |