Abstract:
An apparatus ( 50 ) is adapted for insertion in a body lumen ( 140 ) having a surgical connection ( 58 ). The apparatus ( 50 ) includes a first conduit ( 80 ) insertable in the lumen ( 140 ) and having a distal end portion spaced distally beyond the surgical connection ( 58 ). The first conduit ( 80 ) directs fluid through the lumen ( 140 ) and isolates the fluid from the surgical connection ( 58 ). The apparatus ( 50 ) also includes a second conduit ( 84 ) insertable in the lumen ( 140 ). The second conduit ( 84 ) has a distal end portion positioned adjacent the surgical connection ( 58 ). The second conduit ( 84 ) is adapted to control the pressure in a space ( 90 ) in which the surgical connection ( 58 ) is exposed.

Description:
RELATED APPLICATIONS  
       [0001]     This application claims the benefit of U.S. Provisional Application No. U.S. 60/634,693, filed Dec. 9, 2004. 
     
    
     TECHNICAL FIELD  
       [0002]     The present invention is related to systems, methods, and apparatus for reducing leakage through connections, such as sutured connections, in lumens in the body and drawing the connections together to promote quick and complete healing. More particularly, it is directed to catheters that facilitate healing of sutured connections such as those between the urethra and the bladder neck following radical prostatectomy.  
       BACKGROUND  
       [0003]     Many types of surgery require connections or repairs in body lumens that must carry fluid during the healing process. A catheter is often inserted in the lumen to reduce pressure on the connection and provide mechanical support during the healing process. When using a catheter in this manner, however, the fluid pressure balance is typically such that fluid may leak through the annular area between the catheter and the lumen. The fluid may then contact the connection, leak through the connection into the surrounding tissue, and retard healing of the connection. Radical prostatectomy is an example of such surgery. In this procedure, the prostate gland is removed together with the section of the urethra that passes through the gland. The remaining urethra is sutured to the bladder to provide a urine passage.  
         [0004]     Typically, a catheter, such as one commonly referred to in the art as a “Foley” catheter, is inserted during surgery to provide urine drainage and promote healing. Also, one or more drains may be placed in the abdominal cavity to remove urine that may leak from the urethra through the sutured connection between the urethra and bladder. This method is shown in  FIGS. 1-3 . As shown in  FIG. 1 , a catheter  1  (e.g., a Foley catheter) is inserted into the body  2  through the penis and urethra  3 , beyond the sutured connection  4 , and into the bladder  5 . Typically, the catheter  1  is constructed of flexible materials, such as latex or silicone rubber, and is supplied sterilized. The catheter  1  may be coated with hydrogel to reduce friction and improve comfort, and antibacterial agents may be added to reduce the risk of infection.  
         [0005]     An elastic balloon or bulb  6  at the bladder or distal end of the catheter  1  is inflated or filled with saline solution to anchor it in the bladder  5 . As best shown in  FIGS. 2 and 3 , the catheter  1  has a central urine conduit  7  that drains to an external collection bag (not shown) and a concentric saline tube or second conduit  8  that is used to inflate or fill the elastic bulb  6 . Once the bulb  6  is filled, the second conduit  8  is capped off. An annular region  9  ( FIG. 3 ) is defined between the catheter  1  and the sutured connection  4 . Initially, the sutured connection  4  between the bladder  5  and the urethra  3  is not fluid-tight. As a result, urine may seep or leak between the bulb  6  and the bladder  5  into the annular region  9 , through the sutured connection  4 , and into the abdominal cavity  12  ( FIG. 1 ) of the body  2 . A drain tube  10 , such as one commonly referred to in the art as a “Jackson-Pratt” drain, is passed through the abdominal wall  11 . A compressed elastic squeeze bulb (not shown) is used as a suction pump to apply a slight vacuum P ab  to the abdominal cavity  12  and collect urine leakage through drain tube  10 . Fluid in the squeeze bulb is periodically emptied and the bulb is re-compressed to maintain the vacuum. After healing of the sutured connection  4  has progressed to the point that the urine leakage flow stops, the drain tube  10  is removed.  
         [0006]     The catheter  1  is left in place after surgery for a period that may, for example, last from 10 days to 4 weeks. This serves several purposes in the healing process. The catheter  1  continuously drains urine from the bladder  5  to assure complete voiding and reduce pressure stress and leakage at the sutured connection  4 . Also, the catheter  1  provides a mechanical support to reduce shrinkage of the urine passage caused by scar tissue contraction as the sutured connection  4  between the bladder  5  and the urethra  3  heals. Further, the catheter  1  allows for the application of a traction force  14  that presses the bladder  5  against the urethra  3  to promote healing of the sutured connection  4 .  
         [0007]     In the catheterization shown in  FIGS. 1-3 , the bladder  5  is maintained at atmospheric pressure P at  by the open urine conduit  7  while the abdominal cavity  12  is maintained at a pressure P ab  below atmospheric pressure due to the vacuum. The pressure differential between P at  and P ab  can lead to the leakage described above, i.e., urine leakage or seepage around the elastic bulb  6 , into the annular region  9 , and through the sutured connection  4  into the abdominal cavity  12 . Also, since fluid pressure forces  13  ( FIG. 3 ) may tend to open gaps in the sutured connection  4 , urine leakage through the sutured connection  4  may retard healing, thereby lengthening recovery. Mechanical traction forces  14  on the catheter  1  and elastic bulb  6  are helpful since they tend to close these gaps and at least partially counter the pressure forces  13 . Traction is, however, difficult to maintain over extended periods, such as days to weeks, and can be uncomfortable.  
       SUMMARY  
       [0008]     The present invention is related to systems, methods, and apparatus for creating a favorable pressure balance across a sutured connection of a body lumen to promote healing. According to one embodiment, a concentric tube surrounds the catheter and provides an annular conduit extending from the vicinity of the sutured connection to a position outside of the body. A distal end of the concentric tube has an opening that provides fluid communication between the annular conduit and an annular region defined generally between the sutured connection and the catheter. A proximal end of the concentric tube communicates with a service connection. A partial vacuum can be applied via the service connection, creating a reduced pressure P an  in the annular region. P an  is set lower than atm ospheric pressure P at  and an abdominal cavity pressure P ab  to create a pressure differential across the sutured connection that creates pressure forces that tend to close the sutured connection to speed healing without mechanical traction and to intercept and remove fluid seepage or leakage into the annular region, thus preventing seepage or leakage through the healing sutured connection.  
         [0009]     According to one aspect, the present invention relates to an apparatus adapted for insertion in a body lumen having a surgical connection. The apparatus includes a first conduit insertable in the lumen. The first conduit has a distal end portion for being positioned spaced distally beyond the surgical connection. The first conduit directs fluid through the lumen and isolates the fluid from the surgical connection. The apparatus also includes a second conduit insertable in the lumen. The second conduit has a distal end portion positioned adjacent the surgical connection. The second conduit is adapted to control the pressure in a space in which the surgical connection is exposed.  
         [0010]     According to another aspect, the present invention relates to a catheter system that includes a Foley catheter insertable through a urethra into a bladder. The Foley catheter has a proximal end portion for being positioned outside the urethra and an opposite distal end portion for being disposed in the bladder. The Foley catheter includes a first conduit for emptying the bladder, an elastic bulb disposed on the distal end portion in the bladder, and a second conduit for delivering inflation fluid to the elastic bulb. The elastic bulb is inflatable to help retain the Foley catheter inserted in the bladder. The system also includes a concentric tubular member that encircles the Foley catheter. The tubular member has a proximal end portion positioned outside urethra and an opposite distal end portion that terminates before a proximal end of the elastic bulb. The tubular member defines a third conduit for controlling the pressure in a space defined between the tubular member and the bladder and urethra. A surgical connection between the bladder and urethra are exposed in the space.  
         [0011]     According to a further aspect, the present invention relates to a method for facilitating the healing of a surgical connection in a body lumen. The method includes the step of providing a first conduit in the lumen. The method also includes the step of positioning a distal end portion of the first conduit distally beyond the surgical connection. The first conduit directs fluid through the lumen and isolates the fluid from the surgical connection. The method also includes the step of providing a second conduit in the lumen and positioning a distal end portion of the second conduit adjacent the surgical connection. The method further includes the step of regulating the pressure in a space in which the surgical connection is positioned via the second conduit. 
     
    
     DRAWINGS  
       [0012]     The foregoing and other features of the present invention will become apparent to those skilled in the art to which the present invention relates upon reading the following description with reference to the accompanying drawings, in which:  
         [0013]      FIG. 1  illustrates a prior art urethra catheterization;  
         [0014]      FIG. 2  is a sectional view taken generally along line  2 - 2  in  FIG. 1 ;  
         [0015]      FIG. 3  is a magnified view of a portion of  FIG. 1 ;  
         [0016]      FIG. 4  illustrates a catheterization system, method, and apparatus according to the present invention;  
         [0017]      FIG. 5  is a sectional view taken generally along line  5 - 5  in  FIG. 4 ; and  
         [0018]      FIG. 6  is a magnified view of a portion of  FIG. 4 . 
     
    
     DESCRIPTION  
       [0019]     The present invention is related to systems, methods, and apparatus for helping to reduce leakage through sutured connections in lumens in the body and drawing the connections together to promote quick and complete healing. The invention is described herein with respect to urinary catheters to facilitate healing of a sutured connection between the urethra and the bladder following radical prostate prostatectomy surgery. It will, however be apparent to those skilled in the art that the following detailed description is similarly applicable to sutured connections of other body lumens and other types of surgery.  
         [0020]      FIG. 4  is illustrative of a system or apparatus  50  for helping to reduce leakage through connections, such as sutured connections, in lumens in the body and drawing the connections together to facilitate and promote quick and complete healing.  FIG. 4  illustrates a body  52  in which the prostate gland (not shown) together with the section of the urethra that passes through the gland is removed surgically. The remaining urethra  54  is attached to the bladder  56  via a surgical, e.g., sutured, connection  58  to provide a urine passage. The catheter  60  is inserted into the body  52  through the penis and urethra  54 , beyond the sutured connection  58  and into the bladder  56 .  
         [0021]     Referring to  FIGS. 5 and 6 , the catheter  60  includes an inner, first tube or tubular member  70 , a middle, second tube or tubular member  72 , and an outer, third tube or tubular member  74 . The tubes  70 ,  72 , and  74  are generally elongate and flexible and are constructed of materials, such as latex or silicone rubber, that are suitable for the medical uses described herein. The tubes  70 ,  72 , and  74  are arranged generally concentric with each other and extend along a longitudinal axis  100 .  
         [0022]     The first tube  70  defines a first passage or conduit  80  that, in the embodiment illustrated and described herein, serves as a urine passage, which is described in further detail below. An annular second passage or conduit  82  is defined between an outer surface of the first tube  70  and an inner surface of the second tube  72 . In the embodiment illustrated and described herein, the second conduit  82  serves as an inflation passage for inflating or filling an elastic bulb  62 , which is described in further detail below. A third passage or conduit  84  is defined between an outer surface of the second tube  72  and an inner surface of the third tube  74 . In the embodiment illustrated and described herein, the third tube  74  may include ribs  76  on its inner surface that help support and maintain the position of the third tube on the second tube  72 . The third conduit  84  thus may comprise a series of axial grooves defined by the ribs  76  and spaced about the circumference of the second tube  72 . Alternatively, the third conduit  84  could have an annular configuration similar to that of the second conduit  82 . In the embodiment illustrated and described herein, the third conduit  84  serves as a vacuum passage for helping to control pressure differentials between an annular pressure P an , an abdominal pressure P ab , and atmospheric pressure P at , which is described in further detail below.  
         [0023]     When the catheter  60  is inserted as shown in  FIGS. 4 and 6 , the urine conduit  80  drains urine from the bladder to an external collection bag (not shown). The elastic bulb  62  at the bladder or distal end  64  of the catheter  60  is inflated or filled with saline solution delivered via the second conduit  82  to anchor it in the bladder  56 . Once the bulb  62  is filled, the second conduit  72  is capped off.  
         [0024]     An annular region  90  is defined between the catheter  60  and the region of the urethra  54  and bladder  56  at or adjacent the sutured connection  58 . The third tube  74  has a distal end portion  102  that terminates adjacent or just behind the elastic bulb  62  (i.e., before a proximal end of the bulb) at or in the vicinity of the annular region  90 . This places the third conduit  84  in fluid communication with the annular region  90 .  
         [0025]     Referring to  FIG. 4 , an outside or proximal end portion  104  of the third tube  74  is fitted with a service connection  110  that communicates with the third conduit  84 . The service connection  110  includes an annular collar  112  that encircles the first and second conduits  70  and  72  and engages the third conduit  74  to establish fluid communication with the third conduit  84 . The service connection  110  also includes a service tube or tap  114  that is connected to the collar  112  and is in fluid communication with the third conduit  84  via the collar  112 .  
         [0026]     In use, a partial vacuum is applied to the service connection  110 . Any suitable vacuum source may be used, such as an elastic squeeze bulb  116  secured to the service tube  114 . This reduces the pressure P an  in the annular region  90  (see  FIG. 5 ). The vacuum is applied such that P an  is lower than atmospheric pressure P at  and the abdominal pressure P ab . As a result, the pressure differential across the sutured connection  58  is reversed compared to that illustrated in  FIG. 3 . This is indicated generally in  FIG. 6  by the pressure forces  122 . As shown in  FIG. 6 , the pressure forces  122  would tend to close the sutured connection  58 , which would help speed healing. This would also help reduce or eliminate the need for the application of mechanical traction forces (indicated generally at  124  in  FIG. 4 ).  
         [0027]     Also, the reversed pressure differential would allow urine seeping around the bulb  62  into the annular region  90  to be intercepted and removed via the third conduit  84 , which helps prevent the seepage from flowing through the healing sutured connection  58  and into the abdominal cavity  130 . This may help eliminate or reduce the need for Jackson-Pratt drains  132  for urine removal from the abdominal cavity  130 , although drains may still be needed for removal of other fluids. If a Jackson-Pratt drain  132  is used, the vacuum is adjusted such that P an  is less than P ab . The vacuum may thus be applied to the annular region  90  throughout substantial portion of the duration of use of the system  50 . For example, the vacuum may be removed for periodic maintenance of the system  50 .  
         [0028]     In other respects, the catheter  60  of the present invention provides similar or identical functions as the Foley catheters described above. The catheter  60  It is left in place during the healing process to drain urine from the bladder  56  in order to assure complete voiding and reduce pressure stress at the sutured connection  58 . The catheter  60  also maintains the bladder  56  at atmospheric pressure P at  by the open urine conduit  80 . The catheter  60  also provides mechanical support to reduce shrinkage of the urine passage caused by scar tissue contraction as the sutured connection  58  heals. Optionally, traction forces  124  may be applied to press the bladder  56  more tightly against the urethra  54  to supplement the pressure forces  122 . The catheter  60  may thus comprise a Foley catheter and a concentric sleeve in which the Foley catheter is disposed.  
         [0029]     From the above description of the invention, those skilled in the art will perceive improvements, changes and modifications. Such improvements, changes and modifications within the skill of the art are intended to be covered by the appended claims.