Abstract:
Apparatus and method for adjustably restricting a selected body lumen such as an anal canal of a patient to passively treat fecal incontinence. The apparatus in various examples comprises a plurality of expandable elements. Each of the elements is comprised of a membrane of biocompatible material enclosing a volume. The elements expand upon introduction of fluid into the elements and contract upon withdrawal of fluid from the elements. The expandable elements are adjustable in size by adjusting an amount of fluid in the elements. Fluid communication to the expandable elements is provided by a plurality of flexible conduits of biocompatible material coupled to both the expandable elements and a fill port block comprising a plurality of fill ports.

Description:
RELATED APPLICATIONS  
       [0001]     This application claims the benefit under 35 U.S.C. 119(e) of Provisional Patent Application Ser. No. 60/546,769 filed Feb. 23, 2004, the entire specification of which is hereby incorporated by reference. 
     
    
     TECHNICAL FIELD  
       [0002]     This document relates generally to implantable devices, and in particular to method and apparatus for adjustably restricting a selected body lumen, such as an anal canal of a patient to passively treat fecal incontinence.  
       BACKGROUND  
       [0003]     Various implantable devices are known in which distensible medical devices are implanted into the tissue of a human to treat fecal incontinence. These devices have typically relied upon a pump activated by a patient to restrict or constrict the anal canal of the patient to maintain continence. However, patients have been known to have difficulty activating such devices and properly controlling them.  
         [0004]     There is a need in the art for a continence device that does not require patient activation and which assists in restoring natural anatomical function. Such a device should be adjustable by a physician after implantation.  
       SUMMARY  
       [0005]     This document discusses implantable medical apparatus and method for providing fecal continence. The embodiments of the present subject matter include a plurality of expandable elements. Each of the elements includes a membrane of biocompatible material enclosing a volume. The elements expand upon introduction of fluid into the elements and contract upon withdrawal of fluid from the elements. The expandable elements are adjustable in size by adjusting an amount of fluid in the elements. Fluid communication to the expandable elements is provided by a plurality of flexible conduits of biocompatible material coupled to both the expandable elements and a fill port block comprising a plurality of fill ports.  
         [0006]     Some embodiments of the present subject matter are adapted to provide control of a body lumen by, among other things, locating a plurality of expandable elements in a cluster around the body lumen of a patient, establishing fluid communication with the expandable elements, and adjusting volume of the elements to restrict the body lumen. In applications where the body lumen is the anal canal, it is possible to restore fecal continence to patients where the expandable elements are properly adjusted.  
         [0007]     This summary is intended to provide an overview of the subject matter of the present application and is not intended to be an exclusive or exhaustive explanation of the present subject matter. The reader is directed to the detailed description to provide further information about the subject matter of the present patent application. 
     
    
     BRIEF DESCRIPTIONS OF THE DRAWINGS  
       [0008]     In the drawings like numerals refer to like components throughout the several views.  
         [0009]      FIG. 1  is a drawing of an apparatus according to one embodiment of the present subject matter.  
         [0010]      FIG. 2  is a drawing of an apparatus according to one embodiment of the present subject matter.  
         [0011]      FIGS. 3A, 3B , and  3 C are illustrations of one embodiment of the apparatus as implanted in one example of an application of the present subject matter.  
         [0012]      FIG. 4  is a drawing of an apparatus according to one embodiment of the present subject matter.  
         [0013]      FIG. 5  is a drawing of an apparatus according to one embodiment of the present subject matter.  
         [0014]      FIG. 6  is a drawing of an apparatus according to one embodiment of the present subject matter.  
         [0015]      FIG. 7  is a drawing of an apparatus according to one embodiment of the present subject matter.  
         [0016]      FIG. 8  is a flowchart of a method for providing fecal continence according to one embodiment of the present subject matter. 
     
    
     DETAILED DESCRIPTION  
       [0017]     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. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention.  
         [0018]     This document discusses an implantable apparatus to provide a controllable restriction about a body lumen. One application of the present subject matter is for restoring control fecal continence. The present apparatus offers a passive system in that intervention by the user is not necessary for its use. However, the system is adapted to be postoperatively adjustable. In so doing, the system can be adjusted to restore natural function to a body lumen. In applications involving fecal incontinence, placement of the system about the anal canal and proper adjustment may provide substantially normal anatomical function to a patient.  
         [0019]      FIG. 1  is a drawing of an apparatus according to one embodiment of the present subject matter. Such a device may be implanted and adjusted to controllably restrict flow through a body lumen. In applications involving restoration of fecal continence, the apparatus  100  includes a plurality of expandable elements or balloons  110 . The balloons  110  include an outer wall constructed of a biocompatible resiliently elastomeric polymer or polymer blend of polyurethane, silicone, or the like. Some examples of the construction of implantable expandable elements are provided in U.S. Pat. No. 5,964,806, to Cook et al., which is incorporated herein by reference in its entirety. The balloons  110  expand when filled with fluid and contract when fluid is withdrawn. In one embodiment, each balloon encloses a volume of about 12 cubic centimeters. The embodiment shown includes three balloons  110 . A lumen segment  115  within the elements  110  contains holes  112  to introduce the fluid into the elements  110 . Conduit  120  couples the distal ends of the balloons  110  to a fill port block  140 . In one embodiment conduit  120  is comprised of silicone tubing. In this embodiment the cavity of the fill port block  140  has a tube shape and the ports  150  are disposed serially along the tube. Sealing plugs  170  are positioned along the tube to isolate the ports  150 . The third sealing plug  175  has a mushroom shape to cap the fill port block  140 . The sealing plugs  170 ,  175  are self-sealing to allow a fill needle to be inserted through a plug  170 ,  175  to adjust the level of fluid in each balloon  110 . The plugs  170 ,  175  re-seal when the needle is withdrawn. By isolating each port  150 , each balloon  110  is independently adjustable. Conduit sleeve  130  provides strain relief for the conduit/port junctions  180 . The conduit sleeve is comprised of a biocompatible material such as molded silicone. Conduit segment  160  is a three lumen segment. In one embodiment, segment  160  is a bundle of three of the single conduit segments  120  passed through the conduit sleeve  130 . In another embodiment, the single conduit segments  120  and the three conduit segment  160  terminate at the conduit sleeve  130 . Other embodiments with various different arrangements are possible without departing from the scope of the present subject matter.  
         [0020]     In one embodiment of the apparatus  100 , the balloons include a lumen segment  115  comprising two lumen tubing. A first lumen is attached to the conduit  120  and contains holes  112  to introduce fluid into the balloons  110 . A second lumen  116  is shaped to receive a push-wire to facilitate placement and/or tunneling of the balloons  110  into position.  
         [0021]     The fill port block  140  is implanted in a manner to allow access to the fill ports  150 . In some applications, fill port block  140  is implanted subcutaneously to provide ready adjustment of the device using a syringe and needle. In applications involving restriction of the anal canal, filling the balloons  110  with fluid provides pressure to support and restrict the anal canal wall.  
         [0022]      FIG. 2  shows one embodiment of the present subject matter including an apparatus  200  with the fill port block  140  oriented at a different angle to the tubing than the fill port block  140  in  FIG. 1 . The example in  FIG. 2  may be advantageous in implantation to match contours of a patient&#39;s body. Other angles and configurations are possible without departing from the scope of the present subject matter.  
         [0023]      FIGS. 3A, 3B  and  3 C are illustrations of one embodiment of the apparatus as implanted in one example of an application of the present subject matter. To implant the device in a male patient, the patient is placed in a modified lithotomy position with the perineal area  310  exposed. An incision is made in a midline of the perineal area  310  equidistant between the posterior side of the scrotum  330  and anterior side of the rectum. A delivery tool is then used to tunnel interiorly towards the scrotal area to place the fill port block  140  just under the skin in the patient&#39;s scrotum  330 . A delivery tool is used to capture a balloon  110  and tunnel in a posterior manner towards the rectal and sphincter area. If the embodiment of the apparatus used contains a second lumen  116 , the delivery tool could be a push-wire inserted into the lumen  116 . Three balloons  110  are placed outside of the external sphincter tissue in a cluster somewhat resembling a tulip shape as is shown in  FIGS. 3B and 3C . Because the external sphincter tissue is striated and wraps the anal canal  320 , expanding the balloon cluster will provide support to allow the anal canal  320  to close in; thereby passively providing fecal continence. Access to the fill port block  140  allows the volume of the balloons to be adjusted post-operatively.  
         [0024]     To implant the device in a female patient, the patient is also placed in a modified lithotomy position with the perineal area exposed. An incision is made in the midline of the perineal area and equidistant from the most posterior portion of the introitus and the anterior side of the rectum. Using a dilator tool a balloon  110  is pushed through the dilator to the external sphincter tissue. Three balloons  110  are again placed in a cluster outside the external sphincter tissue. The fill port is placed at the perineal incision, just under the skin.  
         [0025]      FIG. 4  shows an apparatus according to one embodiment of the present subject matter. In the demonstrated embodiment of apparatus  400 , fill ports  150  are disposed in parallel along the fill port block  140 . The single lumen conduit  120  is attached substantially perpendicular to the fill port block  140  and the block  140  provides strain relief to the tube/port junctions  180 . Each fill port  150  has a mushroom shaped self-sealing plug  175  to isolate the port. In one embodiment of fill port block  140 , the block  140  comprises machined titanium or tantalum. In another embodiment, the block  140  comprises drawn titanium or tantalum. In a further embodiment of block  140 , the fill ports  150  contain a fill port can  155 . The fill port can 155 lines the fill port and is comprised of a metal such as titanium or tantalum, for example, and provides protection against a fill needle going beyond a fill port  150 .  
         [0026]      FIG. 5  is a drawing of an apparatus according to one embodiment of the present subject matter. In this embodiment, the orientation of the fill port block  140  of apparatus  500  is achieved by rotating the fill port block  140  in  FIG. 4  ninety degrees. The conduit  120  is attached substantially parallel to a length of the fill port block.  FIG. 6  is a drawing of an apparatus according to one embodiment of the present subject matter. The apparatus  600  shown is a combination of the parallel and perpendicular orientations. Some conduit/port junctions  180  are parallel to the fill port block  140  and some junctions  180  are perpendicular.  FIG. 7  is a drawing of an apparatus according to one embodiment of the present subject matter. The demonstrated embodiment includes an apparatus  700  including fill ports  150  staggered instead of aligned. Thus, the present subject matter contemplates different positions of the fill ports  150 . Which of the fill port  150  orientations is most advantageous will depend on contours of a patient&#39;s body. Some embodiments of the fill port block  150  are bendable to allow further matching of the contours of the patient&#39;s body.  
         [0027]     One of ordinary skill in the art would understand, upon reading and comprehending this disclosure, that various embodiments of the apparatus include various combinations of the illustrated fill port blocks  140 , fill port  150  orientations, seal plugs  170 ,  175 , conduit segments  115 ,  120 ,  160 , sleeve  130  and balloons  110 .  
         [0028]      FIG. 8  is a flowchart of a method of providing controllable restriction to a body lumen. In the case where the body lumen is an anal canal, the method  800  provides implantation of a device for fecal continence. At  810 , a plurality of expandable elements are located in a cluster around a body lumen, such as the anal canal, of a patient. At  820 , fluid communication is established with the expandable elements. In one embodiment, establishing fluid communication includes inserting a hollow needle through a seal plug into a fill port and passing fluid through the hollow needle to adjustably contract or expand a volume of the expandable elements by introducing or removing fluid from the expandable elements. In another embodiment, each element is individually adjustable through a dedicated fill port for each element. At  830 , the fluid communication adjusts the volume of the elements to restrict the body lumen. At  840 , sealing the expandable elements maintains the volume. In one embodiment the sealing is achieved by using self sealing plugs that re-seal when the hollow needle is withdrawn from the plug.  
         [0029]     Although specific examples have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that any arrangement calculated to achieve the same purpose could be substituted for the specific example shown. This application is intended to cover adaptations or variations of the present subject matter. Therefore, it is intended that the invention be defined by the attached claims and their legal equivalents.