Classifications

• • 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

Definitions

• the present invention relates to a novel plug which is in ⁇ serted into the urethra to control urinary incontinence.
• Urinary stress incontinence is defined as the involuntary loss of urine when the pressure within the urethra exceeds the maximum urethral pressure required for maintaining closure. While the problem of urinary incontinence occurs in men and women, it is an affliction especially common in women of child bearing age and beyond.
• non-manipulable devices for controlling urinary incontinence. Many of these devices require surgery for implantation, and of these surgically implanted devices, there are two distinct types: 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 the urethra to exert an occluding force thereon.
• a similar, non-manipulable capsule implant is described in United States Patent No. 3,789,828.
• this device has ties extending therefrom to aid in fiber ingrowth, thus providing mechanical stability to the capsule.
• One problem associated with this device is the risk of fluid leakage. In ad- dition to problems with leakage, severe tissue damage may result from the unnatural method in which such devices regulate incon ⁇ tinence.
• indwelling devices that do not require surgical implantation. These devices are in ⁇ serted by a physician through the urethral orifice and allow 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 material through the urethra and into the bladder. The bolus rests at the juncture of the bladder and urethra and is moved for bladder evacuation, by the relative positioning of a magnet across the body of the wearer. However, the bolus may become lodged in an area beyond the reaches of the magnetic force exhibited by the magnet, making the device inoperative.
• indwelling device is the prestressed capsule disclosed in United States Patent No. 4,457,299.
• the capsule is inserted by a physician within the lower interior of the urethra and is set at a prestressed pressure slightly above involuntary pressure.
• the capsule deforms allowing urine to flow around the device.
• This device has no feature to prevent migration of the device into the bladder.
• United States Patent No. 4,553,533 there is shown a prosthetic urethral sphincter valve which is placed in the urethra and anchored in the bladder. The patient increases his bladder pressure by means 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 complicated, expensive, difficult to manufacture and uncomfortable.
• Another physician-inserted device is disclosed in United States Patent No. 3,797,478.
• This device has an expandable collar which is inflated after insertion, by an injection of fluid therein. When it is desired to remove the device, the inflated collar is ruptured or serrated, thus expelling the fluid into the wearer's body. Notwithstanding the cumbrous use of this device, there is a risk of infection associated with the release of injection fluid upon removal.
• United States Patent No. 3,841,304 discloses a plug which is inserted by a physician into the urethra and subsequently inflated to block the flow of urine.
• This device may be left in the body for extended periods. After insertion, the device merely requires repositioning in the urethra to permit 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 complications can occur upon removal, when a separate wire must be inserted therein. These devices being indwelling, are often cumbersome to the wearer and often cause numerous complications such as encrustation, irritation and infection.
• An example of such a device is the solid-type urethral plug, described by Neilsen, Kurt K. et al., in "The Urethral Plug: A New Treatment Modality for Genuine Uri ⁇ nary Stress Incontinence in Women" J. Urology, vol. 44, p. 1100 (1990) .
• This device consists of one or two solid spheres located along a soft shaft, and a thin, soft plate located at the end of the shaft.
• One sphere is located upstream of the maximum urethral closing pressure point, corresponding to the location of the sphincter.
• the second sphere 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.
• the plug is removed, evacuation occurs, and a fresh plug is inserted.
• One problem associated with this device is that the patient must have three urethral closure pressure profiles performed as well as other examinations, before the device is made for the wearer. Additional problems associated with this device include placement difficulties, lack of sealing capabilities associated therewith, inadequate retention thereby allowing expelling and inadequate anchoring by the plate at the meatus.
• One object of the invention is to provide a urethral plug which is easily manipulated by the wearer.
• Another object of the invention is to improve the degree of comfort associated with insertion and removal of a urethral plug.
• a further object of the invention is to enhance the sealing ability of a urethral plug with the urethra, bladder neck or bladder wall.
• Another object of the invention is to stabilize the place ⁇ ment of a urethral plug at the urethral meatus, such that migra ⁇ tion into the bladder will not occur.
• Still another object of the invention is to reduce the risk of infection to the wearer of a urethral plug .
• Still another object of the invention is to provide a method of using a manually deployable urethral plug by patients suffer ⁇ ing from urinary incontinence.
• an expandable urethral plug having a contracted diameter for in ⁇ sertion and removal through the orifice of the urethra, and a larger, expanded diameter for blocking the flow of urine in the urethra, bladder neck and bladder.
• the plug comprises a cooperating housing and inner member lying in coaxial engagement. A larger diameter is achieved by mechanical deployment of the inner member, resulting in the changing of the shape of the housing, or in another embodiment, the changing of the shape of the inner member.
• the urethral plug comprises a member comprised of material which un ⁇ dergoes automatic expansion when exposed to temperature or li ⁇ quid.
• the urethral plug assumes a non-expanded first condition when exposed to a temperature approximately less than that of a mammalian body, and assumes an expanded second condition when ex ⁇ posed to a transition temperature of approximately the body tem ⁇ perature of a mammal.
• the expanded second condition is achieved when the urethral plug is exposed to natural bodily conditions such as, but not limited to, body moisture.
• the expansion of the plug causes a bal ⁇ loon to expand, which seals the plug to the urethral, bladder neck and bladder wall.
• the plug further has a meatal plate for anchoring the plug in the urethra, which prevents migration of both the plug and the cord into the bladder. Removal of the plug for bladder evacuation, may be easily accomplished by pull ⁇ ing a cord.
• Figure 1A shows a first embodiment of the urethral plug which has an expansible outer tube, in its contracted configura ⁇ tion.
• Figure IB shows the first embodiment of the urethral plug in its expanded configuration.
• Figure 2A shows a second embodiment of the urethral plug which has a braided mesh, in its contracted configuration.
• Figure 2B shows the second embodiment of the urethral plug in its expanded configuration.
• Figure 3A shows a third embodiment of the urethral plug in its contracted configuration.
• Figure 3B shows the third embodiment of the urethral plug in its expanded configuration.
• Figure 4A shows a fourth embodiment of the urethral plug, which is thermally expandable, in its contracted configuration.
• Figure 4B shows a fourth embodiment of the urethral plug, which is thermally expandable, in its expanded configuration.
• Figure 5A shows a fifth embodiment of the urethral plug, comprising a hydrophillic material, in its contracted configuration.
• Figure 5B shows a fifth embodiment of the urethral plug, comprising a hydrophillic material, in its expanded configuration.
• Figure 6 shows an end view of the meatal plate of the urethral plug of each of the above embodiments.
• Figure 7A shows an cross sectional view of the urethral plug.
• Figure 7B shows a cross sectional view of an alternate em ⁇ bodiment of the urethral plug.
• FIG. 1A shows the urethral plug of the first embodiment 10, in its contracted configuration.
• the plug housing comprises a hollow, cylindrical tube 2 which is sized to be easily inserted through the orifice of the urethra.
• the tube 2 is made from a biocompatible material having characteristics of compressibility. Attached on the periphery thereof either by thermal bonding, laminating or other means, is a sealing membrane, or balloon, 4 which is adapted to rest against the outer tube 2.
• a meatal plate 6 is adapted to anchor the urethral plug 10 at the meatus urinarius.
• the meatal plate 6 is of a thickness sufficient to withstand bodily compression during wear, preferably on the order of 1 millimeter or greater.
• the meatal plate 6 prevents the plug 10 from passing through the orifice in the urethra ultimately leading into the bladder neck or bladder.
• Figure 6 shows an end view of the meatal plate 6, which is the same as the meatal plates to be shown in future embodiments.
• a portion of the meatal plate 6 is extended so as to form a tab 8 which may be grasped by the wearer for ease of removal.
• the meatal plate may further aid in maintaining the plug's expanded configuration during wear, by providing means for securing, such as a ball retention socket (not shown) .
• the meatal plate 6 also has an opening 11 therein, lying within the plane of the opening of the outer tube 2.
• a support rod 12 which may be a hollow or a solid member.
• the support rod 12 has a bulb 14 at one end thereof, abutting the proximal end of the tube 2.
• the bulb 14 functions to hold the support rod 12 within the tube 2.
• the support rod 12 has a cord 16 attached at its end opposite the bulb 14, which extends through the tube 2 and beyond the meatal plate 6, thus ensuring that a wearer will always be able to reach the cord 16.
• the support rod 12 is preferably stainless steel
• the outer tube 2 is preferably formed of a biocompatible thermoplastic material
• the balloon 4 is preferably a biocompatible thermoplastic elas ⁇ tomer, such as that sold under the trademark KRATON.
• any biocompatible material may be used for each of the aforemen ⁇ tioned elements, as the invention is not to be limited to those named above.
• Lines A-A' represents the cross sectional view of the tube 2, which will be discussed further with reference to Figures 7A and 7B.
• the plug 10 may be deployed by the wearer, upon which it achieves an expanded configuration, as set forth in Figure IB.
• the wearer pulls on the cord 16 depending from the support rod 12.
• a downward force is exerted on the cord 16 in the vertical direction, forcing the support rod 12 to slide downwardly in the tube 2 and exert a compressive force against the proximal end of the outer tube 2.
• the tube 2 thus expands outwardly in the horizontal direction, causing the balloon 4 to expand until the balloon forms a seal with the wall of the urethra, bladder neck or bladder.
• the wearer then secures the cord by sliding it through a slit (not shown) in the ball retention socket 7 located on the meatal plate 6. This causes the knot 18 to act as a stop, as the knot 18 rests within the socket 7, thereby preventing the tube 2 from returning to its contracted state ( Figure 1A) .
• the plug 10 in an expanded form as shown in Figure IB, functions to retain and block the flow of urine.
• a simple tug on the cord 16 in a direction away from the socket 7 will cause the knot 18 to be released therefrom, thus causing the tube 2 to retract to its contracted state of Figure 1A.
• the tube 2 thereby returns to its original diameter prior to insertion, making plug removal a comfortable task.
• the tube 2 and balloon 4 cooperatively provide an expandable housing and the plug includes means for mechanically expanding the housing and selectively returning the housing to its non-expanded condition.
• Figure 2A shows a second embodiment of the urethral plug 110 in its contracted configuration.
• Tube 102 is formed by a flexible braided mesh 103. Attached on the periphery thereof either by thermal bonding, laminating or other means, is a seal ⁇ ing membrane, or balloon, 104 which is adapted to rest against the tube 102.
• a support rod 112 Enclosed within the tube 102 is a support rod 112, which may be a hollow or a solid member.
• the support rod has a bulb 114 at one end thereof, fixed to the proximal end of the tube 102.
• the bulb 114 functions to secure the support rod 112 within the tube 102.
• the support rod 112 has a cord 116 attached at its end opposite the bulb 114, which extends through the tube 102 and beyond the meatal plate 106, thus ensuring that a wearer will always be able to reach the cord 116.
• the cord 116 preferably has formed therein a knot 118. Although a knot 118 has been used, the attachment of any member having a diameter greater than ball retention socket 107 would suffice.
• the sup ⁇ port rod 112 is preferably stainless steel
• the outer tube 102 is preferably formed of a biocompatible thermoplastic material
• the balloon 104 is preferably a biocompatible thermoplastic elastomer, such as that sold under the trademark KRATON.
• Lines A-A' represent the cross sectional view of the tube 102, which will be discussed further with reference to Figures 7A and 7B.
• the user inserts the plug 110 while it is in the configuration shown in Figure 2A.
• the plug is deployed by the wearer, upon which it achieves the expanded configuration as set forth in Figure 2B.
• the wearer pulls down on the cord 116, in a direction opposite the direction of initial insertion of the device.
• a compressive force is exerted in the vertical direction by the cord 116 on the bulb 114, which is transmitted from the bulb 114 to the tube 102.
• This force causes the braided mesh 103 to expand outwardly in the horizontal direction.
• the expansion of the braided mesh forms an oval projection, which projection causes the balloon 104 to expand therewith.
• the wearer then secures the cord 116 by sliding it through the slit (not shown) in the ball retention socket 107 in the meatal plate 106. This causes the knot 118 to act as a stop, as the knot is brought to rest within the socket 107, thereby preventing the braided mesh 103 from returning to its contracted state as shown in Figure 2A) .
• the balloon thus retains its seal with the urethral, bladder neck or bladder wall and functions to block the flow of urine.
• Figure 3A shows the plug 210 of the third embodiment of the present invention in its contracted state.
• An outer tube 202 has a plurality of elongated apertures 201 formed therein.
• Line A-A' represents the cross sectional view of the outer tube 202 which will be discussed further with reference to Figures 7A and 7B.
• Attached to the periphery of the outer tube 202 is a sealing membrane, or balloon 204 which is its pre-insertion configuration ( Figure 3A) , is adapted to rest against the outer tube 202.
• an end cap 214 At the proximal end of the outer tube 202 is an end cap 214.
• a meatal plate 206 which has a thickness sufficient to prevent compression thereof while the plug is worn.
• the meatal plate 206 further has a tab 208 and a a groove 207 within its upper portion, which acts as a retaining means, to be described in further detail below.
• the meatal plate 206 also has an opening 211 therein, lying within the plane of the opening of the outer tube 202, through which an inner tube 212 passes.
• inner tube 212 fits within the outer tube 202, and is preferably longer than the outer tube 202.
• the inner tube 212 has a plurality of cuts 213 defining a plurality of elongated segments 215 therein.
• the inner tube 212 is made from a biocompatible material having a property of com ⁇ pressibility.
• the inner tube 212 further has a flange 218 at its distal end which aids in securing the inner tube 212 within the outer tube 202 after deployment.
• the inner tube 212 has a cord 216 attached to its bottom end, which aids in the removal of the plug 210.
• the user inserts the plug 210 while it is in the configura ⁇ tion shown in Figure 3A.
• the plug 210 may be deployed by the wearer, whereupon it achieves the expanded con ⁇ figuration set forth in Figure 3B.
• the wearer pushes the inner tube 212 into the outer tube 202, thus causing the proximal end of the inner tube 212 to abut the end cap 214 of the outer tube 202.
• the wearer continues to push in the vertical direction until the elongated segments 215 of the inner tube 212 expand in the horizontal direction.
• each elongated segment 215 pops through one of the elongated apertures 201 in the outer tube.
• the elongated segments 215 cause the balloon 204 to expand.
• the wearer continues to push until the flange 218 of the inner tube 212 is received in the groove 207 of the outer tube 202, whereupon the two members form a snap-fit thereby locking the elongated segments 215 in a flared configura ⁇ tion.
• the balloon 204 having expanded with the flaring of the elongated segments 215, thus forms a seal with the urethral, bladder neck or bladder wall, and thus functions to retain the device and block the flow of urine.
• a simple tug on the cord 216 breaks the snap fit connection between the flange 218 and the groove 207, thereby releasing the flange.
• This releasing action will cause the elon ⁇ gated segments 215 of the inner tube 212 to retract as the distal end of the inner tube 212 is pulled down and away from abutment with the end cap 214-
• the elongated segments 215 will again lie flush within the outer tube, as shown in Figure 3A, making removal of the plug a comfortable and easy procedure.
• the urethral plug assemblies of Figures 4A, 4B are com ⁇ prised of a temperature sensitive compound, more particularly a plastic polymer compound, even more particularly, a polyurethane- based polymer compound.
• the compound is selected for its expan ⁇ sion properties when subjected to temperatures of up to about and including 37 * C, which temperatures encompass the range of temperature of a mammalian body, more particularly, a human body.
• the compound further exhibits properties of shape memory.
• the plug of this embodiment is formed from a mold having a hollow center.
• the shape memory polymer material is blow molded into the maximum expanded shape desired for the plug.
• the plug in this maximum expanded shape is then drawn through a tubular shaped die heated beyond the transition temperature of the shape memory polymer material, thereby reducing the diameter of the to form a smaller diameter tubular shape, hereinafter referred to as the 'pre-insertion'.
• the plug is cooled to a temperature below the transition temperature of the shape memory polymer material to maintain its pre-insertion shape. This process produces a plug suitable for insertion into a subject's urethra.
• Packaging means includes encasing the plug in a suitable plastic molded tray designed to maintain the pre-insertion diameter during shipping, as handling and temperature fluctua ⁇ tions above the transition temperature of the shape memory polymer material may follow. Encasing the plug in a gelatin material will also maintain the pre-insertion diameter while the plug is in storage or transit. For those plugs packaged in gelatin, the gelatin simply dissolves when exposed to moisture in the body when inserted by the subject.
• the plug Upon insertion of the plug into the urethra of a mammal, the plug is exposed to a temperature gradient which triggers automatic expansion of the device.
• the plug begins to expand from its pre-insertion shape to its mold shape. As it expands toward this end, the plug conforms to the shape and size of the urethra, especially upstream of the sphincter toward the bladder neck.
• the plug continues to expand diametrically as it continues to realize its mold shape, with the outer limits of expansion defined by the walls of the urethra. Under no circumstances, however, can the plug expand beyond the dimensions of its original mold shape.
• the shape memory polymer comprising the plug is only capable of expanding and conforming to the environ ⁇ ment into which it is placed; it is incapable of exerting a resistive force by itself.
• the plug may be manufactured in several lengths and sizes in order to ac ⁇ commodate males and females, adults and children. In its active and operational state, after having been properly sized and used, the plug forms a secure seal with the urethral, bladder neck or bladder wall. The flow of urine through the urethra is thus blocked.
• FIG. 4A shows the urethral plug 410 in its contracted con ⁇ figuration.
• Tube 420 is a hollow, thin-walled cylindrical tube which is sized to be easily inserted through the orifice of the urethra.
• the tube 420 is made from a biocompatible material having characteristics of expansion and compressibility.
• a meatal plate 406 is a flanged-type member which is adapted to anchor the urethral plug at the meatus urinarius. To carry out this func ⁇ tion of anchoring, the meatal plate 406 is of a thickness suffi ⁇ cient to withstand bodily compression during wear, preferably on the order of 1 millimeter or greater. The meatal plate 406 will prevent the plug from passing through the orifice of the urethra and into the proximal urethra, bladder neck or bladder.
• the tube 420 is preferably formed of a biocompatible ther ⁇ moplastic material.
• the tube 420 is made of a known polyurethane-based polymer which provides the plug with shape memory.
• the unique characteristic of the plas- tic polymer is its thermally triggered shape memory, which allows the tube 420 constructed of the shape memory polymer to be in ⁇ serted into the urethra in a relatively compressed and elongated state, and regain a useful shape at a selected temperature, such as human body temperature.
• the two interchangeable shapes are possible because the shape memory polymer has "elastic memory", that is, a large reversible change in elastic modulus across the glass transition temperature (Tg) .
• the shape memory polymer offers the unique characteristic of changing from a glassy, more rigid condition to a softer, rubbery condition across the Tg temperature.
• Such a large change in elastic modulus around the Tg temperature allows for significant deforma ⁇ tion in response to temperature changes.
• An increase in tempera ⁇ ture allows the shape memory polymer to become more flexible and, therefore, easily deformable into a new shape.
• the glass transi ⁇ tion of a polymer, such as the shape memory polymer of the preferred embodiment is depicted below. The diagram demonstrates a first transition from a glassy state to a rubbery state as the temperature increases, and a second transition from a rubbery state to a fluid state as the temperature is allowed to further increase. It is the first transition from the glassy state to the rubbery state that is exploited in the present invention.
• Any compound with thermally-triggered shape memory and having a glass transition temperature approximately that of mam ⁇ malian body temperature can be used in the device of the present invention.
• a preferred compound is the polyurethane-based shape memory polymer as described above, developed by Mitsubishi Heavy Industries, Ltd. and available from Memry Technologies in Brook- field, CT.
• the relatively rigid plug changes to a second condition in which it is flexible and easily deformable.
• the plug is now pliable and, remembering its " mold shape plug” , able to expand significantly in diameter to conform to the shape of the wearer's urethra.
• a tight seal with the urethra, bladder neck or bladder wall is formed and the plug is retained in the wearer's urethra to block the flow of urine.
• the user inserts the urethral plug of the present invention into the urethra while it is in the configuration of Figure 4A.
• the plug is exposed to the heightened tempera ⁇ ture of the human body.
• the temperature increase causes the shape memory polymer comprising the tube 420 to automatically ex ⁇ pand outwardly and achieve a protrusion 422 to conform to the size and shape of the wearer's urethra.
• the shape memory polymer is able to freely adapt and conform to its environment - here, the urethra - because, as already discussed, it is only capable of expanding and conforming to the environment into which it is placed; it is incapable of exerting a resistive force by itself. This important characteristic of the shape memory polymer prevents displacement of the urethra, bladder neck or bladder by the shape memory polymer material.
• the plug is now in its expanded configuration 422 as set forth in Figure 4B.
• the downward .force in turn bears down on the proximal portion of the expanded member of the plug, furthering the 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 retain the plug in the wearer's body.
• Figure 5A shows a second embodiment of the automatically ex- pandable urethral plug 510 of the present invention in its con ⁇ tracted configuration.
• tube 502 comprises a hollow, thin-walled cylindrical shaft which is sized to be easily inserted through the orifice of the urethra.
• the tube 502 may comprise a solid cylindrical shaft.
• the tube 502 may be made of any inert material suitable for insertion into a mammalian body.
• the tube 502 is made from a biocompatible material, preferably from a biocompatible thermoplastic elastomer, more preferably from a biocompatible polyurethane-based polymer.
• a biocompatible material preferably from a biocompatible thermoplastic elastomer, more preferably from a biocompatible polyurethane-based polymer.
• the most preferred tube is injection molded Kraton G, a non-toxic, biocom ⁇ patible thermoplastic elastomer.
• Other suitable materials in ⁇ clude polyethylene and nylon polymers, and other copolymers similar thereto.
• an expandable, deformable member 507 which, upon insertion into a mammalian body, is exposed to normal bodily conditions. Exposure to the normal bodily conditions in turn causes the member 507 to expand and achieve its expanded configuration, as shown in Figure 5B.
• the member 507 may be sponge or any suitable absorbent hydrophillic material.
• the expandable, deformable member 507 may be attached to the tube 502 by an adhesive, a collar, thermal bonding, or any attaching means suitable for the materials selected for the member 507.
• the bodily conditions which affect the member 507 are temperature (as in the shape memory material device); moisture; pH gradations; and/or other such conditions that act on and expand the member 507.
• a meatal plate 506 which, as in the aforementioned embodiment, is a flanged-type member with a thickness sufficient to prevent compression by the urethra during insertion and wear, preferably on the order of 1 millimeter or greater.
• a tab 508 for ease of removal.
• Tab 508 is instructive only and can be substituted by other removal means such as, but not limited to, a cord 510 attached to the inside of the tube 502 and extending downwardly through the opening 509 in the meatal plate. Any other such adaptation sufficient to allow removal of the device by a simple, continuous pulling by the subject, without tools or undue force, is equally contemplated.
• the expandable, deformable member 507 has a pre-insertion shape which is sufficiently sized to allow easy insertion into the urethra of a mammalian body, more particularly, a human body. Once inserted, natural conditions in the body cause expansion, preferably diametrical expansion, of the member 507. In one em ⁇ bodiment, the member would be a sponge secured to the tube 502 by any of, but not limited to, the aforementioned attaching means. Upon insertion of the plug into the body, the sponge is exposed to and absorbs moisture naturally present in the body and expands diametrically, thereby forming a secure seal with the urethral, bladder neck or bladder wall of the body.
• the urethral plug of this embodiment also expands diametrically until it meets with resistance from the walls of the urethra, bladder neck or bladder.
• the member 507 maintains its expanded state until acted upon by the wearer, for instance, when voiding is desired.
• the diametrically expanded member is sufficiently soft and deformable so as to respond to the downward pressure exerted by the wearer's pulling on the tab 508 or other pulling means. A continuous tug on tab 508 of the meatal plate 506, or on cord 510, will cause the expanded member 507 to elongate, as it meets tissue resistance. The plug is then returned to a smaller diameter and is simply withdrawn from the body.
• Figure 7A shows a cross sectional view of the urethral plug along line A-A of the preferred embodiments set forth above.
• Tube 300 represents the diameter of outer tubes 2, 202 of Figures 1A and 3B, and as applicable to the embodiments of Figures 2A, 4A, 5A the diameter of the tubes 102, 420, and 502, respectively.
• Figure 7B shows an alternate embodiment, along line A-A, of the above mentioned tubes, in cross section.
• the diameter of tube 700 is not constant but variant as shown by the curved indentations 702 on the periphery.
• the indentations 702 provide enhanced surface area by which the plug may more readily adapt to the urethral wall. Such enhanced sealing ability of the plug, means a better fit for the wearer.

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• Health & Medical Sciences (AREA)
• Urology & Nephrology (AREA)
• Cardiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Prostheses (AREA)
• External Artificial Organs (AREA)
• Orthopedics, Nursing, And Contraception (AREA)

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• 1994
  • 1994-05-17 EP EP94917427A patent/EP0699060A4/de not_active Withdrawn
  • 1994-05-17 CA CA 2163131 patent/CA2163131A1/en not_active Abandoned
  • 1994-05-17 WO PCT/US1994/005536 patent/WO1994026215A1/en not_active Application Discontinuation
  • 1994-05-17 AU AU69160/94A patent/AU6916094A/en not_active Abandoned

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