Abstract:
A device and method for treating female urinary incontinence is provided. A device in accordance with the invention includes a sheath having a distal portion, a proximal portion, and a lumen extending therebetween. A distal member is elastically hinged to the distal portion of the sheath. A flow control valve unit is disposed within a lumen of the sheath. The distal member may be urged into axial alignment with the sheath, and the device may be inserted into a female urethra. Once the device is inserted sufficiently distally into the female urethra, the distal member will return to a position which is not in axial alignment with the sheath.

Description:
[0001]     This application is a continuation application of U.S. Ser. No. 10/699,989 filed Nov. 2, 2003, which is a continuation of U.S. Ser. No. 09/908,467 filed Jul. 18, 2001, now U.S. Pat. No. 6,676,593, which is a continuation of U.S. Ser. No. 09/302,856 filed Apr. 30, 1999. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates generally to devices and methods for treating female urinary incontinence. More particularly, the present invention relates to intraurethral devices and methods for controlling urine flow.  
       BACKGROUND OF THE INVENTION  
       [0003]     Female urinary incontinence is a common medical condition, having widespread economic and social ramifications. The difficulty and embarrassment associated with urinary incontinence often causes the affected person to limit her social activities. In some cases, pads or diapers are used to absorb the uncontrolled seepage of urine. These absorbent items must be changed frequently, creating an ongoing economic burden. The wearing of absorbent undergarments may also restrict the type or style of clothing which the patient may wear. More seriously, skin irritation and other hygienic difficulties often result from the lingering presence of captured urine against tender urogenital tissues.  
         [0004]     An additional method of treating urinary incontinence is the use of bladder flow control devices, sometimes referred to as artificial sphincters or prosthetic urethral valves. A bladder flow control device may be positioned in the urethra of a patient to control the flow of urine out of the bladder. It is desirable for the placement of the bladder flow control apparatus in the urethra to be performed easily and non-surgically. Once the bladder flow control device is placed, it is desirable that it be safely and securely retained in the urethra. Optimally, the device surfaces which contact the human body will be formed of biocompatible materials, to lessen chances of inflammation in patients.  
       SUMMARY OF THE INVENTION  
       [0005]     The present invention relates generally to devices and methods for treating female urinary incontinence. More particularly, the present invention relates to an intraurethral device including a sheath having a distal portion and a proximal portion. The sheath includes a proximal retainer disposed proximate its proximal end. The proximal retainer serves to prevent distal motion of the sheath into the patient by lying against the urethral labia. The sheath further includes a sheath wall defining a central lumen. A flow control valve unit is disposed in the lumen of the sheath.  
         [0006]     An intraurethral device in accordance with the present invention, further includes a distal member having a distal tip and a proximal portion. The proximal portion of the distal member is fixed to the distal portion of the sheath by a linking means. In one embodiment of the present invention, the linking means includes an elastomer hinge. When the elastomer hinge is in a natural, undeformed state, the central axis of the distal member of the intraurethral device is positioned at an angle to the central axis of the sheath. The distal member of the intraurethral device may be urged into axial alignment with the sheath by deforming the elastomer hinge.  
         [0007]     In a presently preferred method in accordance with the present invention, the distal member is urged into axial alignment with the sheath during insertion of the intraurethral device into the urethra of a patient. In this presently preferred method, the intraurethral device is inserted into the urethra of the patient until the distal member is free to assume a misaligned position. In this misaligned position, the elastomer hinge assumes its natural, undeformed state. When the distal member of the intraurethal device assumes this misaligned position, the distal member serves to prevent proximal motion of the sheath out of the patient by contacting the bladder Door. Distal motion of the sheath into the patient is prohibited by the proximal retainer disposed at the proximal end of the sheath. In this manner, the intraurethral device is held within the urethra by the distal member and the proximal retainer acting at opposite ends of the urethra.  
         [0008]     An insertion tool is also provided. The insertion tool includes a shaft having a distal end and a proximal end. The distal end of the shaft is adapted to selectively form a connection with a proximal end of the flow control valve unit disposed in the lumen of the sheath. The shaft of the insertion tool provides a convenient location to grasp the assembly. The use of an insertion tool minimizes the risk of infection by minimizing human contact with the intraurethral device. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]      FIG. 1  is a perspective view of an intraurethral device in accordance with an exemplary embodiment of the present invention;  
         [0010]      FIG. 2  is a side view of an intraurethral device in accordance with an exemplary embodiment of the present invention;  
         [0011]      FIG. 3  is a perspective view of an intraurethral device in accordance with an exemplary embodiment of the present invention;  
         [0012]      FIG. 4  is a perspective view of an assembly including an insertion tool and an intraurethral device in accordance with an exemplary embodiment of the present invention;  
         [0013]      FIG. 5  is a perspective view of an additional embodiment of an intraurethral device in accordance with the exemplary embodiment of the present invention; and  
         [0014]      FIG. 6  is a side view of an intraurethral device disposed in the urethra of a patient.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0015]     The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered identically. The drawings which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention.  
         [0016]     Examples of constructions, materials, dimensions, and manufacturing processes are provided for selected elements. All other elements employ that which is known to those of skill in the field of the invention. Those skilled in the art will recognize that many of the examples provided have suitable alternatives which may be utilized.  
         [0017]      FIG. 1  is a perspective view of an intraurethral device  20  in accordance with the present invention. Intraurethral device  20  includes a sheath  22  having a distal portion  26  and a proximal portion  24 . Sheath  22  also includes a proximal retainer  28  disposed proximate it&#39;s proximal portion  24 . Proximal retainer  28  serves to prevent distal motion of sheath  22  into the patient by lying against the urethral labia. Sheath  22  includes a sheath wall  32  defining a central lumen  30 .  
         [0018]     A flow control valve unit  40  is disposed in lumen  30  of sheath  22 . Two examples of flow control valve assemblies which are suitable for inclusion in valve housing  40  are described by Kulisz et al. in U.S. Pat. No. 5,437,604 entitled NONSURGICAL INTRAURETHRAL BLADDER CONTROL DEVICE, and U.S. patent application Ser. No. 09/207,821 by Migachyov and entitled VALVE FOR BLADDER CONTROL DEVICE, the disclosure of each being hereby incorporated by reference. Those of skill in the art will appreciate that other flow control valves may be used in conjunction with intraurethral device  20  without departing from the spirit or scope of the present invention.  
         [0019]     Proximal region  24  of sheath  22  includes a proximal lock  42  having recesses or cavities  44 . Recesses  44  are adapted to receive a flange portion  48  of flow control valve unit  40 . A distal stop  46  lies in distal region  26  of sheath  22  for arresting the distal movement of flow control valve unit  40 . Sheath walls  32  are preferably formed of an elastomeric material such that a tubular flow control valve unit inserted within lumen  30  is partially held in position by a friction fit between the elastically stretched sheath walls  32  and the outside walls of the inserted flow control valve and/or by a medical grade adhesive.  
         [0020]     Intraurethral device  20  also includes a distal member  50  having a distal tip  52  and a proximal portion  54 . Proximal portion  54  of distal member  50  is fixed to distal portion  26  of sheath  22  by a linking means  60 . In the embodiment of  FIG. 1 , linking means  60  includes an elastomer hinge  62 .  
         [0021]     When no external force is applied to elastomer hinge  62 , intraurethral device  20  assumes the position illustrated in  FIG. 1 . Intraurethral device  20  may be selectively placed in other positions by deforming elastomer hinge  62 . For example, distal member  50  may be urged into axial alignment with sheath  22 . When intraurethral device  20  is in the position shown in  FIG. 1 , distal member  50  serves to prevent proximal motion of sheath  22  out of the patient by contacting the bladder floor. Two exemplary positions of distal member  50  are best illustrated in  FIG. 2 .  
         [0022]      FIG. 2  is a plan view of intraurethral device  20  with an axially aligned position of distal member  50  shown with phantom lines. The axially aligned position of distal member  50  is generally designated by the number  100 . In a presently preferred method in accordance with the present invention, intraurethral device  20  is urged into position  100  to aid in inserting intraurethral device  20  into a urethra. When no external forces are applied, intraurethral device  20  assumes a second position  200  as shown in  FIG. 2 . When intraurethral device  20  assumes second position  200 , distal member  50  serves to prevent proximal motion of sheath  22  out of the patient by contacting the bladder floor. In this presently preferred method, intraurethral device  20  is inserted into the urethra of a patient until distal member  50  is free to assume a second position similar to position  200 . Those of skill in the art will appreciate that elastomer hinge  62  may be deformed in varying degrees to achieve any number of second positions of distal member  50 .  
         [0023]     In a presently preferred embodiment, sheath  22 , distal member  50 , and elastomer hinge  62  are all comprised of the same material. A presently prefer-red method of manufacturing this preferred embodiment is injection molding. Materials which may he suitable for this preferred embodiment include implantable grade silicone rubber, and thermoplastic rubber. Single piece construction simplifies assembly and reduces the possibility of any device components separating during residence in the patient.  
         [0024]     Embodiments of intraurethral device  20  have also been envisioned which include a surface layer  90 . Surface layer  90  may include an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. Surface layer  90  may also include materials such as hyaluronic acid, a hydrogel, or other materials to mimic mucous. Surface layer  90  may also include a lubricious material such as a hydrophilic hydrogel or a hydrophobic silicone to facilitate insertion and removal. It is envisioned that one or more of the above described surface layer materials can be used. Embodiments of intraurethral device  20  have also been envisioned having a distal member  50  and a sheath  22  which are comprised of a material which includes the materials described above.  
         [0025]      FIG. 3  is a perspective view of intraurethral device  20  with distal member  50  in axial alignment with sheath  22 . In a presently preferred embodiment, distal member  50  preferably has a rounded shape to ease insertion through the urethra. Also in a presently preferred embodiment, the outer diameter of distal member  50  is substantially equal to the outer diameter of sheath  22 .  
         [0026]     In a presently preferred method distal member  50  is urged into position  100  when inserting sheath  22  into the urethra. This method may now be described with reference to  FIGS. 1, 2 , and  3 . It should be understood that steps may be omitted from this process and/or, the sequence of the steps may be changed without deviating from the spirit or scope of the invention.  
         [0027]     A presently preferred method in accordance with the present invention begins with the step of inserting distal member  50  into a female urethra. Intraurethral device  20  is then urged into position  100  as shown in  FIGS. 2 and 3 . The remainder of intraurethral device  20  including sheath  22  may then be urged into the female urethra. In many cases it is desirable to apply a lubricant to the exterior surfaces of distal member  50  and sheath  22  prior to insertion. During this insertion step, the urethra will hold intraurethral device  20  in position  100  until distal portion  50  enters the bladder. After distal portion  50  of intraurethral device  20  enters the bladder, it will be free to assume position  200 . When intraurethral device  20  assumes first position  200 , distal member  50  serves to prevent proximal motion of sheath  22  out of the patient by contacting the bladder floor. As mentioned previously, elastomer hinge  62  is biased to place distal portion  50  in first position  200 .  
         [0028]      FIG. 4  is a perspective view of an assembly including an intraurethral device  20  and an insertion tool  400 . Insertion tool  400  includes a shaft  402  having a distal end  404  and a proximal end  406 . In the embodiment of  FIG. 4 a  distal portion  408  of insertion tool  400  is disposed in lumen  30  of sheath  22 . A lumen  30  (shown in  FIG. 1 ) extends into proximal portion  54  of tip  52 .  
         [0029]     Proximal portion  54  of distal member  50  is fixed to distal portion  26  of sheath  22  by a linking means  60 . In the embodiment of  FIG. 4 , linking means  60  includes an elastomer hinge  62 . A distal end  404  of insertion tool  400  is disposed in lumen  30  of distal member  50 . As shown in  FIG. 4 , distal member  50  is held in axial alignment with sheath  22  by the presence of distal end  404  of shaft  402  in lumen  30  of distal member  50 .  
         [0030]     A method of positioning an intraurethral device  20  into a urethra using insertion tool  400  may now be described with reference to  FIG. 4 . A first step desirable in some applications is to pre-lubricate and pre-dilate the urethra of the patient. The use of insertion tool  400  begins with the step of inserting distal end  404  of shaft  402  into lumen  30  of sheath  22 . Distal portion  50  of intraurethral device  20  is then urged into axial alignment with sheath  22 . As a result, lumen  30  of distal portion  50  is disposed in axial alignment with lumen  30  of sheath  22 . Insertion tool  400  may then be urged forward so that distal end  404  enters lumen  430  of distal portion  50 . The entire assembly may now be held be grasping shaft  402  of insertion tool  400 . When insertion tool  400  is disposed within lumen  30  of sheath  22  and distal portion  50  it provides structural support. The structural support provided by insertion tool  400  improves the pushability of sheath  22  and distal member  50 . Distal member  50  and sheath  22  may now be inserted into the urethra. In many cases it is desirable to apply a lubricant to the exterior surfaces of distal member  50  and sheath  22  prior to insertion.  
         [0031]     Having placed intraurethral device  20  into the urethra, insertion tool  400  may now be removed from lumen  30  of sheath  22 . This may be accomplished by applying a pulling force on shaft  402  of insertion tool  400  while applying a pushing force on proximal retainer  28  of intraurethral device  20 . When insertion tool  400  is removed, distal portion  50  of intraurethral device  20  will be free to assume position  200  as shown in  FIG. 2 . When intraurethral device  20  assumes position  200 , distal member  50  serves to prevent proximal motion of sheath  22  out of the patient by contacting the bladder floor. Distal motion of sheath  22  into the patient is prohibited by proximal retainer  28 .  
         [0032]     With sheath  22  and distal member  50  now in the desired position, flow control Valve unit  40  may now be inserted into lumen  30  of sheath  22 . One method suitable for inserting a flow control valve unit into a sheath is described by Pham in U.S. Pat. No. 5,871,016 entitled BLADDER CONTROL DEVICE RETAINER AND METHOD, the disclosure of which is hereby incorporated by reference. This U.S. patent is commonly assigned with the present application.  
         [0033]     In the foregoing method, shaft  402  of insertion tool  400  provides a convenient location to grasp with the fingers. The use of insertion tool  400  minimizes the risk of infection by minimizing human contact with intraurethral device  20 .  
         [0034]     Other embodiments of insertion tool  400  are possible without deviating from the spirit or scope of the present invention. Specifically, in a presently preferred embodiment, distal end  404  of shaft  402  is adapted to releasably mate with the proximal end of flow control valve unit  40 . A method of inserting an intraurethral device  20  in a urethra utilizing this presently preferred embodiment of insertion tool  400  may now be described with reference to  FIGS. 1 and 4 . This method typically begins with the step of inserting flow control valve  40  into lumen  30  of sheath  22 . An additional step in this method is releasably mating the distal end  404  of shaft  402  with the proximal end of flow control valve unit  40 . In some instances, it may be desirable to reverse the order of these steps since insertion tool  400  may aid in inserting flow control valve unit  40  into lumen  30  of sheath  22 .  
         [0035]     When flow control valve  40  is inserted completely into lumen  30  of sheath  22 , flange  48  may be inserted into recesses  44 . With the distal end of insertion tool  400  mated to the proximal end of flow control valve unit  40 , shaft  402  of insertion tool  400  provides a convenient location to grasp the assembly. The use of insertion tool  400  minimizes the risk of infection by minimizing human contact with intraurethral device  20 .  
         [0036]     Shaft  402  of insertion tool  400  may be grasped with the physicians fingers to begin insertion of intraurethral device  20  is inserted into the urethra. Distal member  50  of intraurethral device  20  may then be inserted into the urethra of the patient. Having positioned distal member  50  in the urethra, intraurethral device  20  is then urged into position  100  as shown in  FIGS. 2 and 3 . The remainder of intraurethral device  20  including sheath  22  may then be urged into the female urethra. During this insertion step, the urethra will hold intraurethral device  20  in position  100  until distal portion  50  enters the bladder. After distal portion  50  of intraurethral device  20  enters the bladder, it will be free to assume position  200 . When intraurethral device  20  assumes first position  200 , distal member  50  serves to prevent proximal motion of sheath  22  out of the patient by contacting the bladder floor. As mentioned previously, elastomer hinge  62  is biased to place distal portion  50  in first position  200 .  
         [0037]     Once intraurethral device  20  is located in the desired position, the distal end of insertion tool  400  may be disengaged from the proximal end of flow control valve unit  40 . Those of skill in the art will appreciate that a number of methods may be used to releasably mate distal end  404  of shaft  402  to the proximal end of the flow control valve unit  40 . Examples of methods suitable for some applications include screw threads, a bayonet connection, and an interference fit.  
         [0038]      FIG. 5  is a perspective view of an additional embodiment of an intraurethral device  120  in accordance with the present invention. Intraurethral device  120  includes a sheath  122  having a distal portion  126  and a proximal portion  124 . Sheath  122  also includes a proximal retainer  128  disposed proximate it&#39;s proximal portion  124 . Sheath  122  includes a sheath wall  132  defining a central lumen  130 , providing a fluid flow channel from a distal orifice  136  to a proximal orifice  134  in proximal region  124 .  
         [0039]     A flow control valve unit  140  is disposed in lumen  130  of sheath  122 . Proximal region  124  includes a proximal lock  142  having recesses or cavities  144 . Recesses  144  are adapted to receive a flange portion  148  of flow control valve unit  140 . A distal stop  146  ties in distal region  126  for arresting the distal movement of flow control valve unit  140 . Sheath walls  132  are preferably formed of an elastomeric material such that a tubular flow control valve unit inserted within lumen  130  is partially held in position by a friction fit between the elastically stretched sheath walls  132  and the outside walls of the inserted flow control valve.  
         [0040]     Intraurethral device  120  also includes a distal member  150  having a distal tip  152  and a proximal portion  154 . Proximal portion  154  of distal member  150  is fixed to distal portion  126  of sheath  122  by a linking means  160 . In the embodiment of  FIG. 5 , linking means  160  includes a leaf spring  500 . In a presently preferred embodiment, leaf spring  500  is comprised of stainless steel. Those of skill in the art will appreciate that leaf spring  500  may be comprised of other materials without deviating from the spirit and scope of the present invention.  
         [0041]     Intraurethral device  120  assumes the position illustrated in  FIG. 5 , whenever no outside forces are acting upon leaf spring  500 . Intraurethral device  120  may be selectively placed in other positions by applying force to deform leaf spring  500 . For example, distal member  150  may be urged into axial alignment with sheath  122 . When intraurethral device  120  is in the position shown in  FIG. 5 , distal member  150  serves to prevent proximal motion of sheath  122  out of the patient by contacting the bladder floor. Distal member  150  may be selectively positioned in axial alignment with sheath  122 .  
         [0042]     In a presently preferred embodiment, distal member  150  and leaf spring  500  are fixed together using an over molding process. In the is manufacturing process, a distal portion of leaf spring  500  is positioned in a mold cavity. The material of distal member  150  is then injected into the mold cavity. The material of distal member  150  surrounds distal portion of leaf spring  500 . When the material solidifies, it forms a bond with distal portion of leaf spring  500 . Materials which may be suitable for this preferred embodiment include thermoset materials such as implantable grade silicone rubber. Materials which may be suitable for this preferred embodiment also include thermoplastic materials such as thermoplastic rubber. Those of skill in the art will appreciate that other methods of attaching distal portion  502  of leaf spring  500  to distal member  150  may be used without deviating from the spirit or scope of the present invention. For example, the mechanical attachment or the use of adhesives may be suitable for some applications.  
         [0043]     In the embodiment of  FIG. 5 , a proximal portion of leaf spring  500  is fixed to sheath  122 . A number of methods may be used to attach proximal portion  504  to sheath  122 , including over-molding, adhesive bonding, and mechanical attachment. Additional embodiments have been envisioned in which proximal portion of leaf spring  500  is fixed to flow control valve unit  140 .  
         [0044]     When insertion tool  400  is removed, distal portion  150  of intraurethral device  120  will be free to assume position  200  as shown in  FIG. 2 . When intraurethral device  120  assumes position  200 , distal member  150  serves to prevent proximal motion of sheath  122  out of the patient by contacting the bladder floor. Distal motion of sheath  122  into the patient is prohibited by proximal retainer  128 .  
         [0045]     Referring now to  FIG. 6  there is shown a partial cross-sectional view representative of a urethra  600  and a bladder  602  of a patient. In  FIG. 6  intraurethral device  20  is shown after placement in the urethra of the patient and after whatever placement devices which were used have been removed and the urethra has undilated to closely hold and form to the outer surface of intraurethral device  20 . It can be appreciated that after intraurethral device  20  is placed in the desired position distal portion  50  of intraurethral device  20  assumes a position which is not in axial alignment with sheath  22 . When intraurethral device  20  assumes such a position, distal member  50  serves to prevent proximal motion of sheath  22  out of the patient by contacting the bladder floor. Distal motion of sheath  22  into the patient is prohibited by proximal retainer  28  which contacts the labia of the urethra. In this manner, intraurethral device  20  is held within the urethra by distal member  50  and proximal retainer  28  acting at opposite ends of the urethra.  
         [0046]     Having thus described the preferred embodiments of the present invention, those of skill in the art will readily appreciate that yet other embodiments may be made and used within the scope of the claims hereto attached.  
         [0047]     Numerous advantages of the invention covered by this document have been set forth in the foregoing description. It will be understood, however, that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of parts without exceeding the scope of the invention. The invention&#39;s scope is, of course, defined in the language in which the appended claims are expressed.