Abstract:
An implantable device for controlling a body conduit including a cuff portion adapted to substantially encircle a body conduit. An inlet tube is operatively connected for delivering fluid to the cuff portion. The inlet tube has a one-way valve. An outlet tube is operatively connected to the cuff portion for releasing fluid therefrom and includes a normally closed valve. A pumping reservoir is in communication with the inlet tube and the outlet tube, wherein manipulation of the pumping reservoir inflates the cuff portion and manipulation of the normally closed valve deflates the cuff portion. An inflatable lumen surrounds the pumping reservoir and the cuff portion to provide rigidity and balance pressure between the cuff portion and the pumping reservoir.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]    This application claims priority to U.S. Provisional Patent Application No. 60/178,349 filed Jan. 25, 2000, which is incorporated herein by reference. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    1. Field of the Invention  
           [0003]    The subject disclosure relates to systems for artificially constricting body conduits, and more particularly to an improved artificial sphincter for preventing fecal incontinence.  
           [0004]    2. Background of the Related Art  
           [0005]    In the medical field, colostomies, Krohn&#39;s disease, short-gut syndrome in children, bowel resections for colorectal carcinoma and a variety of other circumstances can cause an individual to become incontinent. To accommodate such conditions, it is desirable to artificially constrict a body conduit or otherwise stop the flow of biological material therethrough.  
           [0006]    Several devices have been developed to perform this function. For example, U.S. Pat. No. 3,750,194 to Summers discloses an apparatus for reversibly closing a body passage which includes a pump activated by an external switch to fill or empty a band, which acts as an artificial internal sphincter. U.S. Pat. No. 4,428,365 to Hakky discloses an anti-incontinent prosthesis which includes a strip of silicone rubber which has three bladders which are connected to tubing. The tubing connects the bladders to a flexible bulb. A non-return valve, between the bulb and the tubing, can be deformed to open the valve allowing the bladders to deflate. Pinching the flexible bulb fills the bladders with fluid.  
           [0007]    Further examples include U.S. Pat. No. 4,634,443 to Haber, which discloses an elastofluidic sphincter having an occlusion cuff surrounding an expandable chamber. Primary and secondary fluid paths communicate with inlets and outlets of the expansible chamber. The fluid paths consist of several tube connectors and manually manipulatable one way check valves communicating with patient controlled hemispheric fluid reservoir-actuators. Depression of the fluid reservoirs increases pressure in the expansible chamber and manual manipulation of the check valves relieves pressure within the expansible chamber. A physician control port connected to the primary path facilitates adding more fluid to the system at any time.  
           [0008]    Still further, U.S. Pat. No. 4,222,377 to Burton discloses a pressure regulated artificial sphincter having cuff member which encircles an affected vessel. A variable volume chamber, communicating with the cuff member, regulates system pressure. The cuff member receives fluid from hoses attached to a pump. Squeezing the pump introduces fluid into the cuff and chamber. A check valve prevents backflow when the pump is not being squeezed. To release the pressure within the cuff member, a tip portion of stem is depressed to overcome a spring tension against a blocking plug to unblock the check valve. U.S. Pat. No. 4,351,322 to Prager discloses a stoma control device having a ring for surgical implantation around an emerging bowel. The ring can be a gel filled skin containing a balloon which inflates to block the stoma.  
           [0009]    Also, U.S. Pat. No. 4,994,020 to Polyak discloses an artificial sphincter which includes a cuff having a non-elastic backing and an inflatable inner cushion. The cuff is in fluid communication with a pump bulb by means of a tube. The tube has a one way check valve and a deactivation valve. U.S. Pat. No. 5,893,826 to Salama discloses an artificial sphincter. The artificial sphincter includes an inflatable balloon cuff which receives fluid through a tube from a syringe-type bulb pump connected to a one-way valve. The patient squeezing the valve with their fingers opens the valve and allows the cuff to deflate. The bulb pump is constructed of rubber or plastic with sufficient memory to allow it to maintain shape.  
           [0010]    In light of the foregoing, a need exists for an artificial sphincter which is simple, reliable, cost-effective and which will not fail or damage the adjoining tissue.  
         SUMMARY OF THE INVENTION  
         [0011]    The present disclosure provides an device for controlling the flow of matter through a body including a cuff portion configured to substantially encircle a section of a body conduit. An inlet conduit is operatively connected to the cuff portion for delivering fluid. The inlet conduit has a first flow control device operatively associated therewith. An outlet conduit is operatively connected to the cuff portion for releasing fluid therefrom. The outlet conduit has a second flow control device. A pumping reservoir is in fluid communication with the inlet conduit and the outlet conduit, wherein actuation of the pumping reservoir causes fluid to ingress into the cuff portion such that the cuff portion radially contracts and actuation of the second flow control device causes fluid to egress from the cuff portion such that the cuff portion radially expands. A lumen surrounds the cuff portion for admitting a fluid to provide rigidity and balance the pressure between the cuff portion and the pumping reservoir.  
           [0012]    Another embodiment of the present disclosure is an artificial sphincter having an inflatable cuff for occluding a body passageway. The inflatable cuff has an interior wall portion and an exterior wall portion, wherein a first lumen is defined between the exterior wall portion and the interior wall portion, and a second lumen is defined by the interior wall portion. A pumping reservoir is in fluid communication with the inflatable cuff for controlling the ingress and egress of fluid to and from the second lumen to cause the inflatable cuff to radially contract and expand relative to the body passageway.  
           [0013]    Still another embodiment of the present disclosure includes an implantable device for reversibly closing a body passageway. The device includes a coil having an elastic radially inner portion configured to be positioned about a body passageway such that when pressure within the coil increases, the elastic radially inner portion expands radially inward to block the body passageway. When pressure decreases, the elastic radially inner portion contracts and the body passageway opens. An outer housing provides structural support to the coil and a port is provided to inject fluid into the outer housing to adjust the rigidity of the outer housing. A reservoir stores fluid to reversibly inflate the coil by way of the at least one tube operatively connecting the coil to the reservoir. The tube has a valve to prevent backflow of fluid from the at least one coil into the reservoir and allow opening to allow fluid to flow from the coil into the reservoir.  
           [0014]    Yet another embodiment of the present disclosure includes an artificial sphincter for controlling incontinence which has a cuff in the form of at least part of a turn of a coil. The cuff has an outer wall, an intermediate wall and an elastic inner wall. The outer wall and intermediate wall define a first lumen therebetween and the intermediate wall and the elastic inner wall define a second lumen therebetween. An injection port is provided to allow a surgeon to inflate the first lumen to set shape and rigidity but not to occlude the bowel and a pumping reservoir allows the patient to reversibly inflate and deflate the second lumen.  
           [0015]    These and other unique features of the system disclosed herein will become more readily apparent from the following description, the accompanying drawings and the appended claims. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]    So that those having ordinary skill in the art to which the disclosed system appertains will more readily understand how to make and use the same, reference may be had to the drawings wherein:  
         [0017]    [0017]FIG. 1 illustrates a device for preventing fecal incontinence constructed in accordance with subject disclosure, and in particular a sectional view of the abdominal region of a patient having the artificial sphincter fully disposed in an operational position;  
         [0018]    [0018]FIG. 2 is a perspective view of an artificial sphincter constructed in accordance with a preferred embodiment of the subject disclosure;  
         [0019]    [0019]FIG. 3 is a perspective view of the artificial sphincter of FIG. 1 disposed in an operational position occluding a body conduit;  
         [0020]    [0020]FIG. 4 is an exploded perspective view of an artificial sphincter constructed in accordance with the subject disclosure, the components including a pumping reservoir, a normally closed valve and tubing;  
         [0021]    [0021]FIG. 5 is an assembled cross-sectional view of the pumping reservoir, normally closed valve and tubing of FIG. 4;  
         [0022]    [0022]FIG. 6 is a cross-sectional view of a normally closed spring-loaded release valve of FIG. 4 in a closed position and in an open position in phantom lines;  
         [0023]    [0023]FIG. 7 is a partial cross-sectional view of an artificial sphincter constructed in accordance with the subject disclosure in a deflated state during surgical implantation;  
         [0024]    [0024]FIG. 8 is a partial cross-sectional view of the artificial sphincter of FIG. 7 illustrated with a first injection port being used to fill the outer lumen of the device during surgical implantation of the artificial sphincter;  
         [0025]    [0025]FIG. 9 is an enlarged localized cross-sectional view of the upper portion of the pumping reservoir as shown in FIG. 8;  
         [0026]    [0026]FIG. 10 is another enlarged localized cross-sectional view of the tubing connection to the cuff portion as shown in FIG. 8;  
         [0027]    [0027]FIG. 11 is a partial cross-sectional view of the artificial sphincter of FIG. 7 illustrated with a second injection port being used to fill the inner lumen of the device during surgical implantation of the artificial sphincter;  
         [0028]    [0028]FIG. 12 is an enlarged localized cross-sectional view of the upper portion of the pumping reservoir as shown in FIG. 11;  
         [0029]    [0029]FIG. 13 is another enlarged localized cross-sectional view of the tubing connection to the cuff portion as shown in FIG. 11;  
         [0030]    [0030]FIG. 14 is a partial cross-sectional view of an artificial sphincter constructed in accordance with the subject disclosure fully disposed in an operational position on a patient who is actuating the normally closed valve to evacuate the bowel;  
         [0031]    [0031]FIG. 15 is a localized cross-sectional view of FIG. 14 with the normally closed valve in the open position;  
         [0032]    [0032]FIG. 16 a partial cross-sectional view of an artificial sphincter constructed in accordance with the subject disclosure fully disposed in an operational position on a patient who is actuating the pumping reservoir to occlude the bowel; and  
         [0033]    [0033]FIG. 17 is a localized cross-sectional view of the pumping reservoir as shown in FIG. 16 with the pumping reservoir being manually actuated to occlude the bowel. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0034]    The subject disclosure relates to an improved device for occluding a body conduit. The device is particularly applicable to serving as an artificial sphincter, although the device may be utilized in many applications, such as to treat urinary dysfunction, as would be readily appreciated by those skilled in the art.  
         [0035]    The advantages and other features of the device disclosed herein will become more readily apparent to those having ordinary skill in the art from the following detailed description of certain preferred embodiments of the invention taken in conjunction with the drawings which set forth representative embodiments of the present disclosure and wherein like reference numeral identify similar structures.  
         [0036]    Referring to FIG. 1, an artificial sphincter, designated generally by reference numeral  10 , includes a cuff portion  16  configured to occlude a body passageway. It is envisioned that the body passageway is the large bowel or descending colon  1 . A pumping reservoir  14  extends from and is in fluid communication with the cuff portion  16 . A first injection port  18  and a second injection port  20  in pumping reservoir  14  are adapted to allow a surgeon to inject hydraulic fluid with a syringe device  57  into the artificial sphincter  10 . Flange  52  around pumping reservoir  14  secures the pumping reservoir  14  in place, and engages tubing  60 . Preferably, a surgeon anchors flange  52  by using suture sites  55 . Tubing  60  connects the pumping reservoir  14  to the cuff portion  16 . In operation, the pumping reservoir  14  controls the ingress and egress of fluid to and from the cuff portion  16 . The ingress and egress of fluid radially contracts and expands, respectively, the cuff portion  16 .  
         [0037]    When deployed, the cuff portion  16  surrounds the internal anal sphincter at the level of the superior rectum below the descending sigmoid colon. The tubing  60  is routed toward the body wall and the pumping reservoir  14  is secured to the internal peritoneum of the lower abdomen  2 . It is envisioned that the pumping reservoir  14  could be mounted to the body wall of the flank superior to the iliac crest to avoid invading the peritoneal space or to such other location as may be indicated by the patient&#39;s anatomy or the surgeon&#39;s preference.  
         [0038]    I. The Artificial Sphincter  
         [0039]    Referring to FIGS. 2 and 3, there are shown perspective views of an artificial sphincter  10  unassembled and assembled in an occluded condition on a body conduit  3 , respectively. The cuff portion  16  has an elastic inner radial portion  32  and, as hydraulic pressure increases through the introduction of fluid, the elastic inner radial portion  32  radially contracts to occlude the patient&#39;s body conduit  3 . It is envisioned that the cuff portion  16  may include a split sleeve as illustrated, a partial occlusion coil, or any shape as appropriate for the specific patient and application.  
         [0040]    In another embodiment, the cuff portion  16  may include a plurality of arcuate portions which are selectively engaged to form a desired length. The plurality of arcuate portions serve to effectively spread the pressure required to occlude the bowel over a greater area thereby reducing risk of local tissue damage. Further, the selection of an appropriate length by the surgeon enhances performance of the subject device. It is envisioned that the connectors which couple the plurality of arcuate portions may be needleless connectors which support bi-directional flow (as are available from Becton Dickinson and Company, 1 Becton Drive, Franklin Lakes, N.J. USA 07417), ¼ turn Luer locks, snap fit friction couplings with o-rings or any suitable leak-proof fitting as is known to those skilled in the art.  
         [0041]    To prevent migration of cuff portion  16 , suture sites  34  are provided along the inner radius  32  of the cuff portion  16 . Grommets  36  are provided along the outer radius  30 . Multiple filaments  38  lace through the grommets  36  to allow fine tuning of the fit of the cuff portion  16 . Preferably, a surgeon secures the cuff portion  16  to an individual&#39;s body conduit by the combination of lacing and suturing. However, it is also envisioned that the laces and the suture sites  34  separately are sufficient to secure the artificial sphincter  10  in a location as selected by a surgeon. It is envisioned that the length of the tubing  60  may be extended by connecting multiple tube sections with couplings to create the tubing  60 . Such extending tube sections will accommodate various anatomical attachment positions.  
         [0042]    Referring to FIG. 4, tubing  60  defines an outlet passageway  24 , an inlet passageway  22  and a portion of the inflatable lumen  17 . The outlet passageway  24  partially houses a normally closed spring-loaded release valve  28 . Pumping reservoir  14  houses the remaining portion of normally closed valve  28 . Pumping reservoir  14  preferably includes a dome  50  of generally hemispheric configuration. The dome  50  defines a first aperture  51  and a second aperture  53  for sealingly receiving the first injection port  18  and the second injection port  20 , respectively. An annular rim  58  provides structural support to the dome  50 . The flange  52  couples to the annular rim  58  of the dome  50 . Suture sites  55  are provided in the flange  52  to enable a surgeon to secure the pumping reservoir  14  in a sub-dermal location.  
         [0043]    Normally closed valve  28  has a valve housing  54  in the form of a fenestrated baffle conduit. A plunger  56  extends axially from a proximal end of the normally closed valve  28  into the dome  50 . A shoulder  59  mounts normally closed valve  28  to the flange  52 . Further, the shoulder  59  defines a bore for receiving a fluid conducting lead  62  from the second injection port  20 . The fluid conducting lead  62  is in fluid communication with inflatable lumen  17 . The tubing  60  is divided into the inlet passageway  22  and the outlet passageway  24  by an internal wall  64 . The distal end of the normally closed valve  28  extends into the outlet passageway  24 .  
         [0044]    Now referring to FIG. 5, shoulder  59  locks the normally closed valve  28  in relation to the flange  52 . Further, shoulder  59  receives tubing  60  in a fluid tight seal. Preferably, plunger  56  and a portion of the proximal end of valve  28  extend partially into the dome  50 . The valve housing  54  extends into the outlet passageway  24  such that fluid cannot pass through the outlet passageway  24  without passing through valve  28 . The distal end of valve  28  terminates within outlet passageway  24 . The first injection port  18  is in fluid communication with the inlet passageway  22  and the second injection port  20  is in fluid communication with the inflatable lumen  17 .  
         [0045]    Referring to FIG. 6, the plunger  56  is located within the valve housing  54  and is biased in a closed position by a spring  68 . The proximal end of the plunger  56  has a head  66  to enable location and manual depression of the plunger  56  within the pumping reservoir  14 . In another embodiment, the proximal end of the plunger  56  is bulbous in shape. The distal end of the plunger  56  has a “T” shaped configuration to normally prevent flow through the opening of the valve housing  54 . Thus, when the valve  28  is closed, fluid cannot pass through the outlet passageway  24 . Depression in the direction indicated by arrow  65  of the head  66  enables overcoming the force of spring  58  to displace the T-shaped distal end as shown in phantom line. As a result of the plunger  56  being displaced, fluid can pass through the outlet passageway  24  from the cuff portion  16  into pumping reservoir  14 .  
         [0046]    Referring to FIG. 7, the outer radius  30  of cuff portion  16  is defined by an exterior wall portion  15  and an interior wall portion  13 . An inflatable lumen  17  is defined between the exterior wall portion  15  and the interior wall portion  13  for providing structural rigidity to the artificial sphincter  10  during use. Inflatable lumen  17  preferably extends throughout the circumference of artificial sphincter  10 . Therefore, a surgeon can control the hydraulic pressure within the inflatable lumen  17  to provide the desired rigidity and hydraulic balance between the cuff portion  16  and the pumping reservoir  14 . Proper inflation of the inflatable lumen  17  protects the underlying tissue from damage which can be caused by an overly rigid or improperly balanced system. The even distribution of pressure by inflatable lumen  17  is of particular importance where delicate tissue is concerned.  
         [0047]    Interior wall portion  13  and exterior wall portion  15  each contain an elastic inner radial portion  32 . The interior wall portion  13  of cuff portion  16  forms a lumen  19  for occluding a body passageway. Preferably, occluding lumen  19  extends throughout the tubing  60  and into the pumping reservoir  14  such that the occluding lumen  19  is in fluid communication with the pumping reservoir  14 . The second injection port  20  of pumping reservoir  14  allows a surgeon to insert hydraulic fluid into the pumping reservoir  14 . The injection ports  18  and  20  may be selected from many types known to those skilled in the art such as needle valves as shown or sealed Luer lock-injection ports. The hydraulic fluid may be selected from a variety of well known biocompatible sterile fluids, such as saline, sterile water and the like.  
         [0048]    II. Surgical Implantation of the Artificial Sphincter  
         [0049]    Still referring to FIG. 7, to secure the cuff portion  16  in place a surgeon sutures the cuff portion  16  to the bowel or the annular ring musculature of the distal bowel. The inflatable lumen  17  and the occluding lumen  19  are deflated. Thus, the cuff portion  16 , the tubing  60  and the pumping reservoir  14  are in a non-rigid contracted state.  
         [0050]    Referring now to FIGS. 8, 9 and  10 , after suturing the cuff portion  16  in place, a surgeon uses a syringe device  57  to pierce the second injection port  20  to inject fluid into the inflatable lumen  17 . The fluid will flow generally in the direction indicated by arrows  78  until the inflatable lumen  17  is inflated. As the pressure within the inflatable lumen  17  increases, the pumping reservoir  14 , the tubing  60  and the cuff portion  16  gain structural integrity. Using the syringe device  57 , the surgeon can inflate and deflate the inflatable lumen  17  until the pumping reservoir  14 , the tubing  60  and the cuff portion  16  have the desired rigidity. In another embodiment, the inflatable lumen  17  extends substantially throughout the dome  50  of the pumping reservoir  14 .  
         [0051]    The inlet passageway  22  and the outlet passageway  24  comprise tubing  60 . The inlet passageway  22  has a one-way check valve  26  disposed within occluding lumen  19  to allow fluid to pass only from the pumping reservoir  14  into the cuff portion  16 . Tubing  60  also allows fluid to flow within inflatable lumen  17  as indicated by arrows  78 .  
         [0052]    The surgeon insures that the inflatable lumen  17  is sufficiently cushioned to mitigate any potential tissue damage. Further, the surgeon insures that the fluid balance between the cuff portion  16  and the pumping reservoir  14  is optimized. As required in the judgement of the surgeon, fluid is added through the second injection port  20  to the inflatable lumen  17  in the direction indicated by arrows  78  using a syringe device  57 . When filled properly with fluid, the inflatable lumen  17  provides cushion to prevent unnecessary tissue damage.  
         [0053]    Now referring to FIGS. 11, 12 and  13 , prior to completing the surgical implantation procedure, the surgeon adds fluid to the occluding lumen  19  in the direction indicated by arrows  84  using a syringe device  57 . The normally closed valve  28  disposed within the outlet passageway  24  and one-way check valve  26  disposed within the inlet passageway  22  prevent flow out of the cuff portion  16 . Thus, once the surgeon increases pressure with the cuff portion  16 , it is maintained therein even though the pumping reservoir is at a lower pressure. Upon completion of radial contraction of the elastic inner radial portion  32  of the cuff portion  16  in the direction indicated by arrows  86 , the bowel is occluded with a minimal potential for tissue damage. Further, the patient will be ambulatory without fear of unwanted bowel evacuation and undue discomfort. To complete the surgical implementation, the surgeon sutures the pumping reservoir  14  in a suitable location beneath the skin of the patient.  
         [0054]    In another embodiment, a single tube may be in fluid communication between pumping reservoir  14  and cuff portion  16 . Preferably, the single tube contains a non-return valve which can be manually deformed to allow cuff portion  16  to drain into pumping reservoir  14 . In another embodiment, the occluding lumen  19  and the inflatable lumen  17  can be inflated with a gas such as air. In still another embodiment, the first injection port  18  and second injection port  20  are ¼ turn female Luer locks to allow a surgeon to reversibly inflate the occluding lumen  19  and the inflatable lumen  17 .  
         [0055]    III. Utilization By a Patient  
         [0056]    Referring to FIGS. 14 and 15, when a patient desires to evacuate their bowel, the patient manually actuates the normally closed valve  28 . The patient needs to locate the pumping reservoir  14 . As noted above, the plunger  56  is located within the dome  50  of pumping reservoir  14 . The plunger  56  of the valve  28  is depressed in the direction indicated by arrow  90  to open the normally closed valve  28 . When the normally closed valve  28  is in the open position, fluid flows in the direction as indicated by arrows  96  from the higher pressure cuff portion  16  into the relatively lower pressure area within the pumping reservoir  14  and the normally closed valve  28 . The fluid flow out of the cuff portion  16  reduces the hydraulic pressure within the cuff portion  16 . As a result, the elastic inner radial portion  32  contracts in the direction indicated by arrows  92  and the cuff portion  16  relaxes the rectal constriction to allow the bowel to evacuate. At such time the patient can release the plunger  56  and the valve  28  springs closed.  
         [0057]    Referring to FIGS. 16 and 17, after evacuation of the bowel, the patient manually initiates occlusion of the bowel. To actuate the artificial sphincter  10  to occlude the bowel, the patient depresses the sub-dermal pumping reservoir  14  while coincidentally avoiding depression of the plunger  56 . Depression of the dome  50  increases the hydraulic pressure within the inlet passageway  22  until the bias of the one-way check valve  26  is overcome. When the bias force of the check valve  26  is overcome, fluid passes in the direction indicated by arrows  94  through the one-way check valve  26  to increase hydraulic pressure within the cuff portion  16 . The normally closed valve  28  prevents fluid flow through the outlet passageway  24  and maintains pressure within the occluding lumen  19  of the cuff portion  16 . As a result of the increased pressure within the cuff portion  16 , the inner elastic radial portion  32  of the cuff  16  expands as described above with reference to FIG. 13. The expansion of the inner elastic radial portion  32  restricts the bowel at the level of the superior rectum. Thus, cuff portion  16  serves the function of the internal anal sphincter muscle. Once evacuation of the bowel is desired again, the individual again depresses the plunger  56  of the valve  28  within the pumping reservoir  14  as described with respect to FIGS. 14 and 15.  
         [0058]    In another embodiment, the inflatable lumen  17  does not extend throughout the artificial sphincter  10 , but only extends over a section of the cuff portion  16 . Notwithstanding the operative reliability of the preferred embodiments, it is envisioned that a radio-opaque dye within the fluid may be utilized. In the rare event that problems later develop, the dye enables investigation with conventional X-ray techniques. In another embodiment, the cuff portion  16  is implanted to press against the corpus spongiosum so as to constrict the urethra when expanded to act as a urinary incontinence device. The pumping reservoir  14  can be mounted in the patient&#39;s dartos pouch or other suitable location as decided by the surgeon.  
         [0059]    While the subject invention has been described with respect to preferred embodiments, it will be appreciated by those skilled in the art that the principles and inventive concepts could be applied in various application obvious to those skilled in the art of occluding real and artificial body passageways. Further, those skilled in the art will readily appreciate that various changes and/or modifications can be made thereto without departing from the spirit or scope as defined by the appended claims.