Abstract:
A method of treating urinary incontinence in a person includes fabricating a device having a rod connected between a proximal portion that is insertable into a urinary bladder and a distal portion that is circular in lateral cross-section, and inserting the proximal portion into the urinary bladder and the rod in a urethra extending away from the urinary bladder. The method includes instructing the person to pass urine by pushing the distal portion in a proximal direction inward, thus lifting the proximal portion out of engagement with an exit region of the urinary bladder, and allowing the flow of urine to exit the urinary bladder through the urethra.

Description:
BACKGROUND 
       [0001]    Devices for treating urinary incontinence include slings, supports, and other scaffold-like devices that are implanted in a patient&#39;s body to support the urethra. 
         [0002]    A sub-urethral sling is a urinary incontinence treatment device that is surgically implanted under the urethra to support the urethra and inhibit urine from leaking out of the urethra during a provocative event such as coughing or sneezing. Such an incontinence treatment device is typically implanted through one or more incisions and is anatomically secured to supporting tissue(s). 
         [0003]    Other urinary incontinence treatment devices, such as injected bulking liquids, are applied to coaptate the urethra. Injected bulking agents have proven effective. However, most injected bulking agents are associated with reduced efficacy over time, the solution of which is to re-inject more bulking agent. 
         [0004]    Improved incontinence treatment methods and devices would be welcomed by both the patient and the surgical staff. 
       SUMMARY  
       [0005]    One aspect provides an incontinence treatment device having a solid rod connected between a proximal portion and a distal portion. The proximal portion is insertable into a urinary bladder. The solid rod is configured for placement in the urethra. The solid rod has a length that adapts the distal portion to be positioned outside and distal to the urethra with the proximal portion positioned in the urinary bladder. The proximal portion has a lateral dimension that is at least a factor of 3 greater than a lateral dimension of the solid rod and is so configured to block an exit of the urinary bladder and impede flow of urine out of the urinary bladder. A force applied to the distal portion displaces the proximal portion away from the exit of the urinary bladder to allow urine to exit the urinary bladder. 
         [0006]    One aspect provides an incontinence treatment device including an inflatable proximal portion that is insertable into a urinary bladder, a pump, and a tube connected between the proximal portion and the pump. The pump is positionable distal to an exit of the urethra. The pump is operable to inflate the proximal portion to an expanded dimension that blocks an exit of the urinary bladder to impede flow of urine out of the urinary bladder. The pump is operable to deflate the proximal portion to a contracted dimension that allows urine to flow from the urinary bladder through the urethra. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]    The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts. 
           [0008]      FIG. 1A  is a perspective view and  FIG. 1B  is a cross-sectional view of one embodiment of an incontinence treatment system including an incontinence treatment device and an insertion tool. 
           [0009]      FIG. 2  is a side cross-sectional view of the device illustrated in  FIG. 1 . 
           [0010]      FIG. 3  is a top view of the device illustrated in  FIG. 1 . 
           [0011]      FIGS. 4A-4C  are schematic views of the system illustrated in  FIG. 1  being placed in a female. 
           [0012]      FIG. 5A  is a schematic view of the device illustrated in  FIG. 1  blocking a neck of a urinary bladder to impede flow of urine out of the urinary bladder. 
           [0013]      FIG. 5B  is a schematic view of the device illustrated in  FIG. 1  adjusted to position a proximal portion away from the neck of the urinary bladder to allow urine to exit the urinary bladder. 
           [0014]      FIG. 6  is a perspective view of one embodiment of an incontinence treatment device. 
           [0015]      FIG. 7A  is a side view of one embodiment of an incontinence treatment device including a proximal portion attached to a rod at a pivot point. 
           [0016]      FIG. 7B  is a side view and  FIG. 7C  is a front view of the device illustrated in  FIG. 7A  with the proximal portion rotated into a substantial longitudinal alignment with the rod. 
           [0017]      FIG. 8  is a side cross-sectional view of one embodiment of an incontinence treatment device including an inflatable proximal portion in a deflated state. 
           [0018]      FIG. 9  is a side cross-sectional view of the incontinence treatment device illustrated in  FIG. 8  with the inflatable proximal portion in an inflated state. 
           [0019]      FIG. 10  is a schematic view of the device illustrated in  FIG. 9  when implanted in a female. 
       
    
    
     DETAILED DESCRIPTION 
       [0020]    In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims. 
         [0021]    It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise. 
         [0022]    Tissue includes soft tissue, which includes dermal tissue, sub-dermal tissue, ligaments, tendons, or membranes. As employed in this specification, the term “tissue” does not include bone. 
         [0023]    The urethra is normally supported by connective and other tissues. Over time, and particularly with parous women, the support of the urethra erodes, which can give rise to hyper-mobility of the urethra. Hyper-mobile urethras are susceptible to the undesirable leaking of urine during provocative events such as sneezing, laughing, or coughing (the persistence of which is sometimes referred to as stress urinary incontinence). 
         [0024]    Embodiments provide an incontinence treatment device configured for urethral placement into the bladder. The device includes a proximal portion that is inserted into the urinary bladder and a distal portion that is accessible by the user. The proximal portion is configured to block the exit of the urinary bladder to impede the flow of urine out of the bladder. The distal portion is operable to displace the proximal portion and allow urine to flow out of the urinary bladder. The device is initially placed through the urethra into the bladder, preferably by a surgeon, a gynecologist, or a urologist, without creating an incision. In one embodiment the device is removable by the user (for example for cleaning) and replaceable by the user. 
         [0025]      FIG. 1A  is a perspective view and  FIG. 1B  is a cross-sectional view of one embodiment of an incontinence treatment system  10  including an insertion tool  12  and a device  20 . The insertion tool  12  is sized for placement into the urethra, and in one embodiment is a rigid tubular cylinder provided with an interior annular space sized to retain the device  20 . The device  20  is flexible and compressible to fit inside of the insertion tool  12 . The insertion tool  12  is operable to deliver the device  20  through the urethra into the urinary bladder. The insertion tool  12  is removed from the urethra after the device  20  is ejected or pushed out of the insertion tool  12  and placed in the urethra and partway into the bladder of the user. 
         [0026]    The device  20  includes a rod  22  connected between a proximal portion  24  and a distal portion  26 . The rod  22  is provided with a length L that adapts the distal portion  26  to be positioned outside and distal to the urethra when the proximal portion  24  is positioned in the urinary bladder. The proximal portion  24  is insertable into the urinary bladder and has a lateral dimension W that is at least a factor of 3 greater than a lateral dimension D of the rod  22  and is so configured to block a neck of the urinary bladder to impede flow of urine out of the urinary bladder. 
         [0027]    In one embodiment, the length L of the rod  22  is between 2-10 cm, with one acceptable length L of the rod  22  being about 3 cm. In one embodiment, the lateral dimension D of the rod  22  is between 0.5-6 mm, with one acceptable lateral dimension D of the rod  22  being about 1 mm. In one embodiment, the lateral dimension W of the proximal portion  24  is at least a factor of 3 times the lateral dimension D of the rod  22  and has a width ranging from about 1.5-20 mm. 
         [0028]    The device  20  is sized according to user anatomy. In one embodiment, the device  20  is provided in sizes of small, medium, and large. The small device  20 , in one example, is provided with a length L of the rod  22  of about 3 cm, a lateral dimension D of the rod  22  of about 1.5 mm, and a lateral dimension W of the proximal portion  24  of about 10 mm. The large device  20 , in one example, is provided with a length L of the rod  22  of about 5 cm, a lateral dimension D of the rod  22  of about 4 mm, and a lateral dimension W of the proximal portion  24  of about 16 mm. 
         [0029]      FIG. 2  is a side cross-sectional view and  FIG. 3  is a top view of the device  20 . 
         [0030]    The device  20  is adapted to be inserted through the urethra with the proximal portion  24  inserted into the bladder while permitting the user to manually displace the proximal portion to allow urine to flow of the bladder. In one embodiment, the rod  22  is oriented along a longitudinal direction such as the longitudinal axis A, and the proximal portion  24  has a substantially triangular shape in longitudinal cross-section that is configured to block the neck to the urinary bladder and prevent urine from exiting the bladder until desired by the user. In one embodiment, the proximal portion  24  is substantially circular in lateral cross-section. The distal portion  26  is configured to be comfortable and identifiable by the user, and in one embodiment is provided in a spherical shape. 
         [0031]    The rod  22  provides a connection between the distal portion  26  and the proximal portion  24  and is not provided as a urine conduit or other form of tubular urinary catheter. To this end, in one embodiment the rod  22  is a solid rod having sufficient column strength to rigidly attach the proximal portion  24  and the distal portion  26 . 
         [0032]    To accommodate insertion of the proximal portion  24  into the bladder through the urethra, in one embodiment the proximal portion  24  is fabricated from a compressible, flexible material that can be compacted for insertion into and removal from the bladder through the urethra. 
         [0033]      FIGS. 4A-4C  are schematic views of the system  10  illustrated in  FIG. 1  being placed in a female. The urethra extends from a distal location that forms an exit from the body to a proximal location connected with the bladder. The portion of the urethra that connects to the bladder is called a trigone, or that triangular region in cross-section that expands from the diameter of the urethra into the larger diameter of the bladder. 
         [0034]      FIG. 4A  is a schematic representation of the device  20  placed in the insertion tool  12  prior to delivery of the device  20  through the urethra into the bladder. The diameter of the insertion tool  12  is modeled after the diameter of cystoscopes, which are employed to visualize the interior of the urethra. The diameter of the insertion tool  12  is selected to be from 12 French to 20 French (or 4 mm to 6.7 mm), which configures the insertion tool  12  for passage through the urethra. 
         [0035]      FIG. 4B  illustrates one example of the system  10  initially inserted into a urethra of the user by a urologist. The urologist guides the insertion tool  12  through the urethra and ejects or otherwise pushes the device  20  out of the insertion tool  12  until the proximal portion  24  of the device  20  is engaged with the trigone region of the bladder. 
         [0036]      FIG. 4C  illustrates the insertion tool  12  removed from the urethra leaving the device  20  inserted into urethra with the proximal portion  24  engaged with the trigone of the bladder and the distal portion  26  located exterior and distal to the urethra. 
         [0037]    One typical lifecycle envisioned for the system  10  is for a potential user to be evaluated in a clinic or other setting by a healthcare provider such as a uro-gynecologist; fitted for one of many available sizes of the device  20 ; tested/observed by the uro-gynecologist for continence with the device  20  in place; instructed in the use of the device  20 ; and discharged from the clinic, after which the user may remove the device  20  for cleaning or other reasons before self-replacing the device  20 . 
         [0038]      FIG. 5A  is a side schematic view of the device  20  after insertion into the urethra. The proximal portion  24  of the device  20  is seated within the trigone region of the bladder and operates to occlude the exit of bladder. The rod extends from the proximal portion  24  to the distal portion  26 . The distal portion  26  is located outside and distal to the urethra. In this position, the user has access to the distal portion  26  and is able to manipulate a position of the proximal  24  relative to the exit of the bladder. 
         [0039]    In one embodiment, the proximal portion  24  is flexible and the lateral dimension W is selected to prevent the proximal portion from passing distal the exit of the urinary bladder in the trigone region; the lateral dimension D of the solid rod  22  is sized to allow urine to pass by the solid rod and exit the urethra; and a distal end of the distal portion  26  is sized to prevent the distal end from passing proximal to an exterior exit of the urethra. 
         [0040]      FIG. 5B  is a side schematic view of the device  20  manipulated to allow urine to pass from the bladder through the urethra. In the illustration, the proximal portion  24  has been displaced in a proximal direction to allow urine to escape the bladder through the urethra. The user voids urine by manually manipulating a location of the distal portion  24  in a proximal direction that lifts and separates the proximal portion  24  off of the seal formed at the trigone region of the bladder. In this position, the device  20  allows allow urine to flow around the proximal portion  24 , alongside the rod  22 , and out of the urethra. For example, the user may be instructed to provide an axial force against the distal portion  26  with a finger or other object. The force against the distal portion  26  moves the device  20  in a proximal direction and displaces the proximal portion  24  off of the trigone region of the bladder to form an opening for the escape of urine from the bladder. Removal of the force from the distal portion  26  of the device  20  operates to return the device to its initial position in which the proximal portion  24  blocks the exit of the bladder. The device  20  beneficially will return to its initial position under the force of gravity after the axial force applied to the distal portion  26  is removed. However, the accumulation of urine in the bladder also creates a force on the surface of the proximal portion  24  within the bladder to further assist in sealing the exit of the bladder. 
         [0041]    The urinary sphincter is generally located at the upper one third proximal portion of the urethra. The urinary sphincter is a muscle that operates to contract against the urethra to impede the flow of urine out of the bladder. Generally, the tissue of the urethra is soft and pliable and has been described as having a nearly gelatinous consistency. Some people experience stress urinary incontinence or the sphincter muscle is deficient in fails to fully coapt the urethra to fully impede the flow of urine out of the bladder. The device  20  provides the beneficial advantage in that the rod  22  occupies some amount of space within the urethra that combines with the thickness of the wall of the urethra to allow the sphincter muscle to compress against the urethra and a portion of the rod, thus providing an improved seal in the area of the sphincter that impedes the flow of urine out of the bladder. 
         [0042]    Embodiments of the device  20  provide a convenient and minimally invasive approach to providing urinary incontinence. The device  20  is configured to be biologically inert and functionally usable for months or years. With this in mind, in one embodiment the device  20  is fabricated as a single monolithic unit that is adapted for insertion through the urethra until the proximal portion  24  is inserted into the urinary bladder. In one embodiment, the device  20  is fabricated from plastic such as a thermoplastic elastomer, or polyethylene, or a silicone that is configured to allow the device  20  to move within the urethra and the bladder as the patient moves. That is, the device  20  is flexible and moves with the user. 
         [0043]    The proximal portion  24  is desirably flexible and compressible to allow the proximal portion  24  to be inserted within the insertion tool  12  ( FIG. 1A ). The rod  22  is selected to have a sufficient column strength to allow an axial force against the distal portion  26  to transfer the force to the proximal portion  24 . With this in mind, the rigidity or column strength of the rod  22  is preferably greater than the rigidity of the proximal portion  24 . 
         [0044]    In one embodiment, the device  20  is fabricated as a single integral or monolithic piece from a thermoplastic polymer in which the rod  22  has a first higher durometer than a durometer of the proximal portion  24 . As an example, in one embodiment the durometer of the proximal portion  24  is less than approximately 25 on the durometer A scale and the durometer of the rod  22  is greater than approximately 25 on the durometer A scale. Exemplary values for the durometer of the device  20  include a durometer A scale of approximately 20 for the proximal portion  24  and a durometer A scale of approximately 40 for the durometer of the rod  22 . In one embodiment, the durometer of the proximal portion  24  is low and configures the proximal portion  24  to be pliable enough to allow the user to remove the device  20  from her body by passing the proximal portion  24  out of the urinary bladder and out of the urethra. 
         [0045]    In one embodiment, at least a portion of the device  20  is fabricated from metal such as stainless steel or a shape memory alloy such as the nickel-titanium alloy referred to as NiTiNOL. However, when the device  20  is formed of metal it can be expected to be less flexible and not move with the patient at the patient moves. Although fabrication of the device  20  from metal is acceptable from an engineering standpoint it may not be acceptable from a medical or end-user patient standpoint. 
         [0046]      FIG. 6  is a side cross-sectional view of one embodiment of incontinence treatment device  40 . The device  40  includes a rod  42  connected between a proximal portion  44  and a distal portion  46 . In one embodiment, the shape of the proximal portion  44  in longitudinal cross-section is kidney shaped and so configured to block an exit of the bladder to the urethra and the trigone region. The rod  42  and the distal end  46  are configured in a manner similar to that described above for the rod  22  and the distal portion  26 . It is desirable that the device  40  is fabricated from material that allows the proximal portion  44  to be flexible and compressible at least to the extent that allows the proximal portion  44  to be inserted through the urethra into the bladder. 
         [0047]      FIG. 7A-7C  are side views of one embodiment of incontinence treatment device  60 . Incontinence treatment device  60  includes a rod  62  connected by a pivot point  63  to a proximal portion  64 , where the rod  62  terminates at a distal portion  66 . In one embodiment, the proximal portion  64  includes a recess  68  that is sized to accommodate a section of the rod  62  when the proximal portion  64  is moved in to axial alignment with the rod  62  about pivot point  63 . In one embodiment, the proximal portion  64  has a substantially rectangular shape in longitudinal cross-section and is substantially circular in lateral cross-section. 
         [0048]    In one embodiment, the proximal portion  64  is configured to fold or otherwise align with the rod  62  to reduce a cross-sectional area of the device  60 , which is useful when passing the device  60  through the urethra into the bladder. 
         [0049]      FIG. 8  is a side cross-sectional view of one embodiment of an incontinence treatment device  100 . The device  100  includes a tube  102  extending between an inflatable proximal portion  104  and a pump  106 . In general terms, a liquid Q is retained within the pump  106  and a portion of the tube  102 . Compression of the pump  106  moves the fluid along the tube  102  into the inflatable proximal portion  104 . In one embodiment, a check valve  108  is provided in the pump  106  to selectively maintain the liquid Q within the inflatable proximal portion  104 . The check valve  108  is operable to allow the user to selectively move between a continent state in which the flow of urine from the bladder is blocked to a voiding state that allows the urine to the flow from the bladder through the urethra. 
         [0050]    The tube  102  is preferably a kink resistant tube. Inflatable proximal portion  104  is configured to be collapsed when empty of liquid to assist in the placement through the urethra and the bladder. The proximal portion  104  is inflatable to provide a large area stopper that is configured to fit within the trigone region of the bladder to impede the flow of urine from the bladder through the urethra. The inflatable proximal portion  104  and the tube  102  are both flexible and so configured to move as the user moves. Suitable material for fabricating the inflatable proximal portion  104  and the tube  102  include plastic material, such as silicone or polyethylene or thermoplastic elastomers. 
         [0051]    The pump  106  is sized for implantation, for example, subcutaneously within the labia majora of the user. It may become desirable to eventually replace the tube  102  or the inflatable proximal portion  104 , and with this in mind one embodiment provides a connector  110  that allows the tube  102  and the proximal portion  104  to be replaced and reconnected with the pump  106 . 
         [0052]      FIG. 9  is a side cross-sectional view of the device  100 . The pump  106  has been compressed to drive the liquid Q from the pump  106  and the tube  102  into the proximal portion  104 . The proximal portion  104  has become inflated and the liquid Q is prevented from flowing back into the pump  106  by the check valve  108 . In this configuration, the inflated proximal portion  104  provides a substantially greater lateral area than the tube  102 , and thus functions as a seal to prevent the flow of urine from the bladder through the urethra. 
         [0053]    In one embodiment, the device  100  is a closed system containing the liquid Q and the pump is configured to move the liquid Q out of the tube  102  into the inflatable proximal portion  104 . For example, in one embodiment the check valve  108  is configured to retain the liquid Q in the inflatable proximal portion  104  after operation of the pump  106  to provide the user with a state of continence. The proximal portion  104  will cover the trigone region of the bladder and impede the exit of urine from the bladder after inflation of the proximal portion  104 . In one embodiment, the check valve  108  is conveniently located within the pump  106  to allow the user to selectively displace a valve off of a valve seat to allow the liquid Q to drain from the proximal portion  104  back into the pump  106 . With this in mind, the check valve  108  is suitably provided as a ball valve that is biased by a spring or other such suitable valve arrangements. 
         [0054]      FIG. 10  is a schematic view of the device  100  placed within a female user. In one embodiment, the pump  106  is subcutaneously implanted into the labia majora and the tube  102  extends through the urethra. The proximal portion  104  is placed within the bladder and is inflated to provide the user with a continent state and is deflated to allow the user to void urine. In this manner, the user has access to the distal portion (the pump  106 ), which facilitates inflating and deflating the proximal portion  104 . 
         [0055]    In one embodiment, the tube  102  is inserted into the urethra and a lateral dimension of the tube is less than approximately 4 mm and so configured to allow urine to pass an exterior of the tube  102  and exit the urethra. 
         [0056]    In one embodiment, the inflatable proximal portion  104  is insertable through the urethra into the urinary bladder and the pump  106  is placed alongside or even attached to the labia majora, for example with adhesive. When inflated, the inflatable proximal portion  104  is substantially circular in lateral cross-section and so configured to block the exit of the urinary bladder to the urethra. 
         [0057]    Embodiments provide for placement of the device  100  in a male user in which the proximal portion  104  is placed within the bladder and the pump  106  is implanted in the scrotum. The pump  106  is operable to inflate the proximal portion  104  to prevent urine from exiting the bladder and is also operable to deflate the proximal portion  104  to allow urine to exit the bladder alongside the tube  102 . 
         [0058]    Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of medical devices as discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.