Abstract:
An artificial urinary sphincter operable as a single, uncomplicated component, not prone to failure, and easily repaired. Being preassembled, installation is easy through a single incision in one site. It incorporates an outer cuff having an inner cuff of interconnecting flexible fluid-containing portions. The outer cuff overlaps itself where a spring loaded push button device is installed. The device acts like a retractable ball point pen, pushing on the overlapped portion to compress the fluid-containing portions, to compress and shut the urethra when the push button is first pushed, and then alternately relaxing pressure on the overlapped portion so as to release pressure on the urethra upon additional pushing. Circumferential wires on pulleys mounted on an inner portion of the button alternately contract and relax radially inward pressure on the inner cuff, coordinated with inward pressure and relaxation of overlapped outer cuff portion.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    1. Field of the Invention  
           [0002]    The present invention relates to medical devices. More particularly, the present invention relates to mechanical implants acting as urinary sphincters in human beings having urinary incontinence.  
           [0003]    2. Description of the Related Art  
           [0004]    Currently available urinary sphincter devices are multi-component and cumbersome to place surgically in the human body. Multiple components need to be installed in different locations, and this is a time consuming and difficult process. Malfunctions in these devices are generally very difficult to detect and correct. They have very complicated components, making assembly difficult and prone to complications. Those devices which use an inflatable ring to close off the urethra are prone to non-uniform inflation and resultant injury to the urethra. Others may not be effective for severe incontinence, or require access through the skin to operate. Some employ a magnetically operated valve requiring an external magnetic key to operate, the key being subject to loss or misplacement. Devices inserted directly into the urethra increase the likelihood of infection. Likely failure modes in many devices leave the urethra closed, which would result in the need of timely surgery to avoid bladder damage.  
           [0005]    U.S. Pat. No. 3,810,259, issued May 14, 1974, to Summers is complicated and intrusive, and requires the use of magnetic keys which are subject to loss, or may be otherwise unavailable.  
           [0006]    U.S. Pat. No. 5,643,194, issued Jul. 1, 1997, to Negre is similarly subject to loss of the very specialized magnetic key, and is primarily directed toward relief and drainage of fluid for treatment of hydrocephalus. This device could not be used to control urinary incontinence where a urethra remains intact.  
           [0007]    U.S. Pat. No. 4,571,749, issued Feb. 25, 1986, and U.S. Pat. No. 4,784,660, issued Nov. 15, 1988, both to Fischell, describe inflatable cuffs located around the urethra. These devices are not uniformly inflated, resulting in likely damage to the urethra.  
           [0008]    U.S. Pat. No. 4,118,805, issued Oct. 10, 1978, to Reimelds describes an artificial sphincter. It is a very complicated device, and thus can be subject to failure or maladjustment.  
           [0009]    U.S. Pat. No. 6,074,341, issued Jun. 13, 2000, to Anderson et al. describes mechanically complicated embodiments of an artificial urethra sphincter. The mechanical operation of the occlusive apparatus appears to be difficult to operate through the skin. Other means of operation are complicated and subject to failure.  
           [0010]    U.S. Pat. No. 6,095,969, issued Aug. 1, 2000, to Karram et al. describes an implantable device for controlling stress incontinence in female patients. This device is intended to control incontinence when a patient is coughing, etc. It would not be effective in more severe cases of incontinence.  
           [0011]    U.S. Pat. No. 6,063,119, issued May 16, 2000, to Pintauro et al. describes a device for maintaining urinary incontinence. The device is inserted into the urethra and partially into the bladder. Such a device enhances the likelihood of infections and may potentially cause damage to the urethra inner wall or bladder.  
           [0012]    None of the above inventions and patents, taken either singularly or in combination, is seen to describe the instant invention as claimed. Thus, an artificial urinary sphincter solving the aforementioned problems is desired.  
         SUMMARY OF THE INVENTION  
         [0013]    The present invention provides a device for treatment of urinary incontinence in males and females which is a single component, mechanically uncomplicated, and hence less prone to failure. Malfunctions are easily fixed. Since it will be preassembled, it is easy to install through a single incision in one site.  
           [0014]    The device incorporates an outer cuff having an inner cuff of interconnecting flexible fluid-containing portions. The outer cuff overlaps itself at a point where a spring loaded push button device is installed. The device acts much as that of a retractable ball point pen, pushing on the overlapped portion to compress the fluid-containing portions so as to compress and shut the urethra when the button is first pushed, and then alternately relaxing pressure on the overlapped portion so as to release pressure on the urethra upon pushing the button the second time.  
           [0015]    The fluid-containing portions are so designed that they will expand concentrically toward the urethra. Wires are wrapped around pulleys mounted on an inner portion of the push button base and one end of each wire anchored to the outer cuff in the vicinity of its overlapping outer portion, so as to move inward when the push button of the push button assembly is pushed. The wires wrap around the inner cuff of the artificial sphincter and are mounted at their other end to the outer cuff near its fixation opening so as to alternately contract and relax circumferential pressure on the inner cuff. This contracting action is coordinated with the inward pressure and relaxation of the overlapped outer cuff portion.  
           [0016]    Accordingly, it is a principal object of the invention to provide an artificial urinary sphincter which is simple in design, easily used, and requires only one incision to implant.  
           [0017]    It is another object of the invention to provide an artificial urinary sphincter as above providing uniform pressure around the urethra in a closed position.  
           [0018]    It is a further object of the invention to provide an artificial urinary sphincter as above having an outer cuff surrounding an inner cuff, the inner cuff having interconnecting fluid filled compartments for providing uniform pressure around the urethra.  
           [0019]    Still another object of the invention is to provide an artificial urinary sphincter having an assembly operable by a push button operated through the skin which alternately opens and closes the urinary sphincter.  
           [0020]    It is an object of the invention to provide improved elements and arrangements thereof for the purposes described which is inexpensive, dependable and fully effective in accomplishing its intended purposes.  
           [0021]    These and other objects of the present invention will become readily apparent upon further review of the following specification and drawings. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0022]    [0022]FIG. 1 is a diagrammatical perspective view of one embodiment of the artificial urinary sphincter of the present invention.  
         [0023]    [0023]FIG. 2 is diagrammatical elevational view of another embodiment of the artificial urinary sphincter of the present invention illustrating the outer casing in an open position for installation on the urethra.  
         [0024]    [0024]FIG. 3 is diagrammatical plan view of the urinary sphincter of FIG. 2, as it surrounds a section of a urethra in an open position.  
         [0025]    [0025]FIG. 4 is a diagrammatical plan view of the urinary sphincter of FIG. 2, as it surrounds a section of a urethra in a closed position.  
         [0026]    [0026]FIG. 5 is a diagrammatical exploded view in perspective of the closure assembly of FIGS. 3 and 4.  
         [0027]    [0027]FIG. 6 is a diagrammatical perspective view of the closure assembly of FIG. 5 as assembled in the open position.  
         [0028]    [0028]FIG. 7 is a diagrammatical perspective view of the closure assembly of FIG. 6 in the closed position.  
         [0029]    [0029]FIG. 8 is a diagrammatical detail view of the closure assembly of the outer casing of FIG. 6 in the open position.  
         [0030]    [0030]FIG. 9 is a diagrammatical detail view of the closure assembly of the outer casing of FIG. 7 in the closed position.  
         [0031]    [0031]FIG. 10 is a diagrammatical detail view of the inner push rod of FIG. 6 and  7  with its associated spring.  
         [0032]    [0032]FIG. 11 is a diagrammatical detail view of the outer push rod, with its associated spring, of FIGS. 6 and 7.  
         [0033]    [0033]FIG. 12 is a diagrammatical detail view of the rotating locker for the inner push rod of FIGS. 6 and 7.  
         [0034]    [0034]FIG. 13 is an environmental, perspective view of an artificial urinary sphincter inserted in the human body according to the present invention. 
     
    
       [0035]    Similar reference characters denote corresponding features consistently throughout the attached drawings.  
       DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0036]    Referring to FIG. 1, the artificial urinary sphincter system  10  comprises artificial sphincter  12  having outer cuff  14 . Circumferential wires  16  run over pulleys  18  and are attached at push button assembly  20 . Push button assembly  20 , having push button  42 , is located and attached to the outer overlap portion  24  of outer cuff  14 . Inner overlap portion  22  is slidingly engaged with outer overlap portion  24 .  
         [0037]    Outer cuff  14  surrounds inner cuff  26  having interconnecting fluid-containing cuff chambers  32  partially separated from each other by inner cuff walls  28 , and the fluid therein is free to flow through the clearance between inner cuff walls  28  and inner cuff outer wall  30 .  
         [0038]    Inner cuff chambers  32  begin with inner cuff inner chamber wall  36  and end with inner cuff outer chamber wall  34 , thereby defining inner cuff void space  37  which allows the inner cuff to slide around the urethra upon implant. Inner cuff chambers  32  extend radially inward toward urethra  38  to a closed position when contracting pressure is placed on outer cuff  14  by placing tension on wires  16  by pushing push button  42  of assembly  20 .  
         [0039]    Push button assembly  20  contains a retractable device similar to that of a retractable ball point pen.(not shown) Upon pushing push button  42  again, tension on wires  16  is relaxed, allowing the inner cuff chambers to radially retract to the open position.  
         [0040]    Referring to FIG. 2, there is shown a diagrammatical side view in elevation of artificial sphincter  12  without inner cuff  26 (see FIG. 3) before it is installed around the urethra. The overlapping outer portion of outer cuff  14  defines a fixation opening  44  which is drawn around inner overlap portion  22  and placed over push button  42 , and push button base  56  of push button assembly  20  (see FIG. 3). to be fixed in groove  55  of push button base  56 . Wire cavities  40  are provided for wires  16  to anchor to outer casing overlap portion near fixation opening  44 . The push button  42  may be rectangular and normal to the outer cuff as shown in FIG. 1, above, with base  56  conforming thereto, or push button  42  may be circular as shown in FIG. 2 with base  56  conforming thereto.  
         [0041]    Referring to FIG. 3, there is shown a diagrammatical plan view of the artificial sphincter  12  in an open position as it surrounds a section of a urethra  38 . Outer sphincter cuff  14  extends from an outer end  50  through outer overlap portion  24 , around interconnecting fluid-containing inner cuff  26 , through inner overlap portion  22 , and ends at inner end  54 . The portion of outer overlap portion  24  which surrounds push button assembly  20  is broken away for illustration purposes.  
         [0042]    Push button base to outer cuff connector  48  attaches push button assembly  20  to outer cuff  14  to maintain connection during installation of the artificial sphincter, and may be made of an extensible material such as rubber to allow relative motion between outer cuff  14  and push button base  56 . Fluid-containing inner cuff  26  features inner cuff walls  28  extending radially outward from urethra  38  and ending near inner cuff outer wall  30 , forming inner cuff chambers  32 . Inner cuff walls  28  allow fluid to travel around between the partial walls  28  and inner cuff outer wall  30 , forming interconnected inner cuff chambers  32 . A gap  37  in interconnecting fluid-containing inner cuff  26  is formed between inner cuff outer chamber wall  34  and inner cuff inner chamber wall  36  so as to allow outer cuff outer overlap portion  24  and outer cuff inner overlap portion  22  to overlap.  
         [0043]    Outer cuff  14  has no inner cuff chambers  32  in the outer overlap portion  24  ending in outer cuff outer end  50 . Push button assembly  20  bears radially inward upon outer cuff  14  at its inner overlap portion  22  near inner end  54 . Pulleys  18  are located in and attached to the inner wall of push button base  56  and direct circumferential wires  16  to push button assembly  20 , they being secured at circumferential wire attachment points  52  within push button assembly  20 . The wires then run around the inner cuff  26  and the opposite ends of wires  16  are threaded through cavities  40 (see FIG. 2) and anchored to outer cuff  14  near push button base  56  at remote attachment points  60 .  
         [0044]    Referring to FIG. 4, there is shown a diagrammatical plan view of the artificial sphincter  12  similar to that of FIG. 3, but in the open position. In practice, outer overlap portion  24  overlays portions of push button assembly  20  and wires  16 , shown here for illustrative purposes. Push button assembly  20  has engaged the inner overlap portion  22  of the outer cuff  14 , moving it inward relative to the outer overlap portion  24  of outer cuff  14 . Also, circumferential wires  16  are tightened around outer cuff  14  by running over pulleys  18  as the inner push rod  62  of closure assembly  48  (see FIG. 5) is pushed inward as push button  42  is pushed inward. Pulleys  18  remain fixed within push button base  56  relative to the inward movement of the inner end portion of push button assembly  20 . These two operations act to distribute inward radial force on interconnecting fluid-containing cuff chambers  32 , resulting in an inward pressure causing the centrally located urethra  38  to close.  
         [0045]    Referring to FIG. 5, there is shown a diagrammatical exploded view in perspective of closure assembly  48  of push button assembly  20  (see FIG. 4). Assembly  48  is a combination of elements which cooperate to simulate the spring-loaded action of a ball point pen that alternately extends and retracts the refill portion of the pen. The major components of push button assembly  20  are solid cylindrical inner push rod  62 , generally cylindrical rotating locker  66 , hollow cylindrical push button assembly casing  78 , and hollow cylindrical outer push rod  84 . Rotating locker  66  is generally cylindrical in shape, having an inner portion  68  having inner end  67 . Rotating locker inner portion  68  is of such diameter that spaced rotating locker teeth  70 , directed outward, lengthwise and distributed around the circumference of inner portion  68 , interact with outer wall  79  of push button casing  78 . Spaced rotating locker teeth  70  each have angled end portions ending in a sharp point. Rotating locker outer portion  72  has a second diameter smaller than the diameter of inner portion  68 , forming an intermediate wall  69 , normal to the central axis of rotating locker  66 .  
         [0046]    Outer rotating locker coil spring  74  is located along rotating locker outer portion  72  and bears against intermediate wall  69  at its inner end, and outer push rod  84  at its outer end. Push button casing  78  is cylindrical in conformation, its outer wall  79  featuring generally crosswise, spaced, locking ridges  76  and lengthwise grooves  80 , defined thereby, which alternately interact with spaced rotating locker teeth  70  as artificial sphincter  12  (see FIG. 1) is opened and closed by actuation of push button assembly  20  (see FIG. 4). Inner push rod  62  bears against rotating locker  66  at locker inner end  67  and against outer cuff  14  (see FIG. 3) at a point in its inner overlap portion  22 . Inner push rod coil spring  64  surrounds inner push rod  62  and bears against rotating locker inner end  67  and inner overlap portion  22  of outer cuff  14 . Wire attachment points  52  are located near the inner end of inner push rod  62 . Outer push rod  84  has a solid outer end  87  and features teeth  88  disposed around hollow core  85  at its inner end, and outer push rod collar  88  to seal outer push rod  84  within casing  78 .  
         [0047]    Referring to FIGS. 6 and 7, there are shown the assembled closure assembly  48  of FIG. 5 in its respective open and closed position. A portion of outer cuff  14  is shown spaced from the closure assembly  48  for illustrative purposes, but bears against the closure assembly in use. As diagrammatically illustrated in FIG. 6, closure assembly outer push rod  84  hangs loosely within closure assembly casing  78 , and is held therein by outer push rod teeth  86  resting on outer push rod cuff  88  (see FIG. 5). Inner push rod  62  does not exert force on outer cuff  14  in the open position. Rotating locker teeth  70  are aligned with casing grooves  80  and inserted therein by the action of inner push rod spring  64 .  
         [0048]    As diagrammatically illustrated in FIG. 7, push button closure assembly inner push rod  62  bears against the inner overlap portion  22  of outer cuff  14  (see FIG. 3) at inner end  61  and against inner end  67  of rotating locker  67  at inner push rod outer end  63 , while the outer end portion  72 (see FIG. 5) of rotating locker  66  is held within the hollow core  85  of outer push rod  84 . Rotating locker spaced teeth  70  rest on casing locking ridges  76 , and inner push rod  62  is forced inward by rotating locker  66  at inner end  67 , transferring force to outer cuff  14 , thus, closing the sphincter.  
         [0049]    Referring to FIGS. 8 and 9, there is diagrammatically illustrated closure assembly outer casing  78  as it relates to spaced rotating locker teeth  70  when closure assembly  48 (see FIG. 5) of push button assembly  20  is in the closed position and in the open position, respectively. When spaced rotating locker teeth  70  bear against outer casing locking ridges  76 , the assembly is in the closed position as seen in FIG. 9. When spaced rotating locker teeth  70  rest in grooves  80 , the assembly is in the open position as seen in FIG. 8. Locking ridges  76  and grooves  80  alternate along the circumference of outer wall  79  of casing  78 .  
         [0050]    Referring to FIG. 10, there is shown inner push rod  62  surrounded by inner push rod coil spring  64 . Circumferential wires  16  wrap around pulleys  18  (not shown) and are attached diametrically opposed to each other at attachment points  60 (see FIG. 3).  
         [0051]    Referring to FIG. 11, there is shown hollow cylindrical outer push rod  84  of closure assembly  48 , having outer push rod teeth  83  (diagrammatically illustrated) located around its inner end. Outer push rod  84  has a solid outer end wall  87  and an open inner end  89  defining hollow portion  85  configured for receiving the outer end portion  72  of rotating locker  66 (see FIG. 5).  
         [0052]    Referring to FIG. 12, there is shown generally cylindrical rotating locker  66  of closure assembly  48 , having an inner end portion  68  of a diameter such that spaced rotating locker teeth  70 , mounted thereon, physically interact with closure assembly casing outer wall  79  of push button casing  78 (see FIGS. 8 and 9). An outer portion  72  of rotating locker  66  is of a lesser diameter than the inner portion  68 , thereof. Rotating locker outer coil spring  74  is located around the outer portion  72  of rotating locker  66 . Rotating locker intermediate wall  69  divides inner portion  68  and outer portion  72 . Rotating locker intermediate wall  69  has teeth (not shown) disposed on rotating locker  66  around the perimeter of intermediate wall  69 .  
         [0053]    Referring to FIG. 13, there is shown a diagrammatical, environmental, perspective view of the artificial urinary sphincter  12  inserted in the human body according to the present invention.  
         [0054]    In operation, the artificial sphincter  12  is implanted surgically by sliding the urethra between outer cuff outer end  50  and outer cuff inner end  54  and through inner cuff void space  37  so that the inner cuff  26  surrounds the urethra at its center loosely without putting any pressure on the urethra  38 . The outer cuff fixation opening is then snapped over push button base  56  and held in fixation opening groove  55 . This is the installed open position of sphincter  12 (See FIG. 3). Its push button assembly is on the skin side interiorly and operable through the skin between an open position and a closed position. Fluid-containing inner cuff walls  28  are on the side of the urethra  38 .  
         [0055]    When push button  42  is activated by pushing it, the closure assembly  48  will advance and become locked in the closed position. The mechanism is similar to ball point pen refill locking in an open position. It will push the outer cuff inner end  54  and adjacent overlap portion  22  toward the center and will displace the fluid through the chambers  32  concentrically and toward the closed end thereof. This will compress the urethra  38  and close it.  
         [0056]    To aid the closure further, as push button  42  is pushed to the closed position, the attached end of wires  16  are pulled over the pulleys  18 , respectively, and thus will add radially inward pressure to the inner cuff toward the center of the artificial sphincter. When the sphincter is closed, it will compress the urethra and prevent urine from leaking (See FIG. 4). When the individual desires to urinate, he presses on the push button  42  and thereby the closure assembly  48 , and, like a refill of a ball point pen, the closure assembly will retract into the base  56 , allowing the fluid in inner cuff  22  to move away from the center as outer cuff  14  moves away from the center. This movement of closure assembly  48  will also release the tension on the wires  16  and allow the inner cuff to move away from the urethra. This will open the urethra and allow urine to flow. The sphincter is closed again by depressing the push button  42 .  
         [0057]    When outer push rod  84  is pushed, it pushes rotating locker  66  up and its spaced teeth  70  move through grooves  80  on outer wall  79  of push button casing  78 . Once spaced teeth  70  have reached above grooves  80 , the teeth  70  will lock into spaced locking ridges  76  and will hold inner push rod  62  up, compressing the outer cuff. Spaced locking ridges  76  define grooves  80 . This is the closed position of sphincter  12 . When outer push rod  52  is pushed again, it pushes the rotating locker  66 , and rotates it, so that the grooves  80  and spaced rotating locker teeth  70  align, and the spaced locker teeth  70  slide outward in the grooves  80  under spring pressure, and the rotating locker  66  moves down. Downward movement is aided by inner push rod coil spring  64  and rotating locker coil spring  74 . The pressure from inner push rod  62  on the outer cuff  14  is released, opening up the sphincter (See FIG. 6).  
         [0058]    The teeth  83  on outer push rod  84 , and the teeth on rotating locker intermediate wall  69  engage in such a way that when they are engaged as a result of each push of push button  42  and outer push rod  84 , the rotating locker  66  is turned counter clockwise a discrete distance, thereby at one turn aligning spaced locker teeth  70  and grooves  80  between ridges  76 , and on the next turn placing spaced locker teeth  70  on ridges  76 , thereby alternately locking and unlocking the sphincter. This type of ratcheting and turning mechanism is well known is the retractable pen art as illustrated, for example, in U.S. Pat. No. 3,679,317, issued Jul. 25, 1972 to Ivar G. Larson, hereby incorporated by reference.  
         [0059]    Any appropriate materials may be used in the construction of the inventive sphincter, such as titanium and appropriate plastic materials. The outer cuff is of relatively inflexible material, while the inner cuff is of readily flexible material. Nylon or similar cord may be substituted for metal wire in the inventive artificial sphincter.  
         [0060]    It is to be understood that the present invention is not limited to the embodiments described above, but encompasses any and all embodiments within the scope of the following claims.