Patent Publication Number: US-2007123781-A1

Title: Surgical anastomosis leak detection system

Description:
BACKGROUND  
      1. Technical Field  
      The present disclosure relates to methods and apparatii for verifying the integrity of an anastomosis resulting from various surgical procedures. More particularly, the present disclosure relates to a system and method for pressurizing an area inside tissue at an anastomosis site and measuring the rate of pressure change adjacent the anastomosis site.  
      2. Background Of Related Art  
      During various surgical procedures, it may become necessary to connect one tubular tissue section to another tubular tissue section. This type of surgical procedure is termed a surgical “anastomosis procedure”. An anastomosis procedure can be performed in one of two ways. The first is termed an “end to end” anastomosis procedure while the second is termed an “end to side” anastomosis procedure. An end to end anastomosis is typically performed during such surgeries as colorectal surgery and gastric bypass surgery. For example, during a colorectal surgery, it is necessary to remove a diseased section of the colon and reconnect the two healthy end sections of the colon. In gastric bypass surgery, a section of the stomach is bypassed to minimize the volume of the stomach and the intestine is shortened. The ends of the tissue sections are then reconnected.  
      An end to side anastomosis may be performed in conjunction with a heart bypass surgery. In this instance, it is necessary to connect one open end of a tubular tissue section to the side of another tubular tissue section.  
      Various methods and devices are provided for connecting sides or ends of tubular tissue sections. For example, one prior art method employs applying suture or staple lines to connect various tubular tissue sections. More complex devices include the use of single or multipart fasteners to secure the tubular tissue sections.  
      In most anastomosis procedures, it is often necessary to check for leaks, i.e., to verify the integrity of the anastomosis site, in order to ensure proper sealing of the tissue sections. Various methods are known to check the integrity of an anastomosis site and typically include the step of directly visualizing the anastomosis site. For example, in one method, a methylene blue dye is injected near the site and the anastomosis joint is visualized to monitor the escape of the dye, which would indicate the presence of leaks. However, in addition to the difficulty and inaccuracies resulting from attempting to verify the integrity by direct visualization, certain patients may be allergic to the dye. Further, direct visualization methods either with the naked eye or through the use of a laparoscope or an endoscope adds substantial time to the surgical procedure.  
      The presence of minor leaks at an anastomosis site is generally not considered serious as they will close during the normal healing process. However, more significant leaks may require additional surgical intervention involving extra time, effort and inconvenience to the patient. Therefore, it would be desirable to have a more efficient and accurate method of determining the integrity of an anastomosis site.  
     SUMMARY  
      Accordingly, the present disclosure is directed to a system, apparatus and method for evaluating the integrity of an anastomosis site. In one preferred embodiment, a system for monitoring the integrity of an anastomosis of first and second tubular organ sections is disclosed. The system includes a pressure source for supplying fluids under pressure, first and second occluding members dimensioned for sealing a tubular organ section at first and second tissue sites adjacent respective opposed sides of an anastomosis site, a fluid conduit connectable to the pressure source and being adapted to deliver the fluids to the tubular organ sections between the first and second tissue sites, and a pressure sensor adapted to detect fluid pressure change adjacent the anastomosis site. At least one of the first and second occluding members includes a clamp which is positionable about the tubular organ section. Preferably, each of the first and second occluding members includes a clamp. The clamps are adapted for positioning about the tubular organ section adjacent the first and second tissue sites.  
      In one embodiment, the fluid conduit is adapted for passage through a lumen of the tubular organ section. The fluid conduit may include an insertion end portion adapted to form a substantial seal within the lumen of the tubular organ section adjacent one of the first and second tissue sites. Preferably, an expandable member, e.g., a balloon member, is mounted adjacent the insertion end portion thereof. The expandable member is expandable to form a substantial seal within the lumen of the tubular organ section. First and second expandable members may be provided to substantially seal the lumen adjacent the first and second tissue sites.  
      The fluid conduit may include an insertion needle associated therewith adapted to penetrate the tubular organ section to access the internal lumen thereof. The pressure sensor may be mounted to the fluid conduit. A controller may be associated with the pressure sensor. The controller includes logic to measure a rate of pressure loss adjacent the anastomosis site. Means for adjusting the sensitivity of the pressure sensor is also contemplated.  
      In another aspect of the disclosure, a method for monitoring the integrity of an anastomosis procedure is disclosed. The method includes the steps of sealing a tubular organ section at first and second tissue sites adjacent respective opposed sides of an anastomosis site, introducing fluids adjacent the anastomosis site between the first and second tissue sites and monitoring pressure change adjacent the anastomosis site with a pressure sensor. The step of monitoring may include introducing the pressure sensor within the tubular organ section between the first and second tissue sites. The step of monitoring may include monitoring pressure loss or a rate of pressure loss.  
      In one embodiment, the step of sealing includes applying a clamp adjacent at least one of the first and second tissue sites, preferably, adjacent each of the first and second tissue sites.  
      The step of introducing fluids includes positioning a fluid conduit into a lumen at the tubular organ section between the first and second tissue sites. The fluid conduit is in fluid communication with a pressure source and is adapted to deliver fluids under pressure to the tubular organ section.  
      The step of sealing may include positioning an end portion of the fluid conduit within the lumen of the tubular organ section and forming a substantial seal within the lumen of the tubular organ section with the end portion. The end portion of the fluid conduit may have an expandable member coaxially mounted thereabout. The expandable member is expanded to form a substantial seal within the lumen of the tubular organ section. The expandable member may include a balloon member. The fluid conduit may include a pressure sensor which is positioned within the tubular organ section between the first and second tissue sites. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
      Various embodiments of the presently disclosed system, apparatus and method for monitoring the integrity of an anastomosis site are disclosed herein with reference to the drawings, wherein:  
       FIG. 1  is a perspective view of a prior art apparatus and method for monitoring the integrity of an anastomosis site;  
       FIG. 2  is a perspective view, partially shown in section, of the system and method for monitoring the integrity of an end to end anastomosis site in accordance with the principles of the present disclosure;  
       FIG. 2A  is a side view, shown in section, of the distal end of the fluid conduit of the system of  FIG. 2 ;  
       FIG. 3  is perspective view of an alternate embodiment of the system and method of the present disclosure;  
       FIG. 4  is a perspective view illustrating use of the system of  FIG. 3  in monitoring the integrity of an end to side anastomosis site; and  
       FIG. 5  is perspective view of another alternate embodiment of the system and method of the present disclosure. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S)  
      Embodiments of the presently disclosed system and method for evaluating the integrity of an anastomosis site will now be described in detail with reference to the drawings wherein like numerals designate identical or corresponding elements in each of the several views. As is common in the art, the term proximal refers to that part or component closer to the user or operator, i.e. surgeon or physician, while the term distal refers to that part or component more remote from the user.  
       FIG. 1  illustrates a prior art method and apparatus for monitoring the integrity of an anastomosis site. Prior art device  10  includes pressure source  12  and pressure line  14 . Pressure line  14  includes proximal end  16  which is connected to pressure source  12 . In using this prior art device, distal end  18  of pressure line  14  is inserted intraorally and advanced within the esophageal tract to a location adjacent anastomosis site  20 . For illustrative purposes, anastomosis site  20  is an end to end anastomosis performed during a gastric bypass procedure as discussed hereinabove. Clamp  22  is inserted through port  24  to clamp a distal tissue section DT distal of anastomosis site  20 . Distal end  18  of pressure line  14  disposed within esophagus E forms an internal airtight seal with a proximal tissue section PT located proximal to anastomosis site  20 .  
      The method further includes filling the abdominal cavity AC with saline S and activating the pressure source  12  such that the area of anastomosis site  20  between clamp  22  in distal tubular tissue DT and distal end  18  of pressure line  14  located within proximal tissue PT is pressurized. Once anastomosis site  20  has been pressurized, a laparoscope may be inserted through a second port (not shown) and the air bubbles BB escaping through the anastomosis site  20  and into saline S are visualized through the laparoscope. This known method is fairly invasive due to the insertion of the endoscope, and cumbersome due to the time required to evaluate the degree of bubbles BB escaping from anastomosis site  20 . Additionally, due to the inconsistencies in the quantity of bubbles escaping through anastomosis site  20 , it is difficult to obtain a precise determination of the degree of actual leakage through anastomosis site  20 . As noted above, the presence of minor leaks would not be problematic, while the presence of a larger degree of leaks would require further surgical intervention. Thus, the prior art methods, which rely on visualization of air bubbles to evaluate the integrity of anastomosis site  20 , are imprecise at best.  
      Referring now to  FIG. 2 , there is disclosed a first embodiment of a novel system, apparatus and method for accurately and instantaneously verifying the integrity of an anastomosis site. Integrity monitoring system  30  generally includes fluid source  32  and fluid conduit  34 . Fluid source  32  is adapted to supply fluids under pressure (e.g., negative or positive pressure) to a tissue site. Fluid source  32  may be a conventional insufflation apparatus adapted to deliver CO2 gas at a predetermined pressure to the tissue site. Preferably, fluid source  32  includes pressure adjustment knob  36  to enable the user to selectively control and/or vary the fluid pressure being supplied to fluid conduit  34 . Fluid source  32  further includes circuitry or computer logic to control, monitor and/or modify the various operating parameters of system  30 . For example, fluid source  32  may incorporate pressure sensor means shown schematically as dashed lines  38  in  FIG. 2  to permit the operator to monitor the fluid pressure adjacent the anastomosis site  20 . Pressure sensor means  38  may incorporate circuitry or logic to calculate various parameters, including, e.g., the rate of pressure change, e.g., loss or decay or increase, at the anastomosis site, or simply detect and display real time pressure readings. Pressure sensor means  38  preferably incorporates a pressure transducer which is mounted to or extends within fluid conduit  34  as will be discussed hereinbelow. Pressure sensor means  38  may further include sensor adjustment knob  40  which provides a degree of control over the sensitivity of the pressure sensor means  38 , i.e., to control the ability of the pressure sensor means  38  to detect gross or fine leaks. Pressure sensor means  38  is also provided with video display  42  which provides a visual indication in the form of a digital readout or gauge of an operating parameter of the system  30 . Such parameters are inclusive of a real time pressure reading adjacent the anastomosis site  20 , or, more preferably, a digital reading of the rate of loss or decay of the pressure adjacent the site. Pressure sensor means  38  may be a component of fluid source  32  or provided as a separate apparatus.  
      Fluid conduit  34  is in fluid communication with the pressure source  32  and incorporates proximal end  44  which is connected to the fluid source  32  and insertion end or distal end  46 . As best depicted in  FIG. 2A , fluid conduit  34  further includes occluding member  48  coaxially mounted about distal end  46 . In the preferred embodiment, occluding member  48  is in the form of a balloon member adapted for expansion from a contracted state to an expanded state to substantially close off the esophageal tract. In the alternative, occluding member  48  may be a gel filled membrane or incorporate a septum or frusto-conical seal mounted about the outer surface of the fluid conduit  34 . As a further alternative, distal end  46  of fluid conduit  34  may be sized to approximate the internal dimension of the tubular organ to substantially seal the lumen upon introduction therein. Fluid conduit  34  is preferably dimensioned for passage through the esophageal tract. Fluid conduit  34  may be provided with a filter to reduce the amount of impurities flowing through the fluid conduit  34 .  
      With continued reference to  FIG. 2A , fluid conduit  34  includes central lumen  50  and first and second supplemental lumens  52 ,  54 . Central lumen  50  permits passage of pressurized fluid to the anastomosis site. First supplemental lumen  52  delivers the fluids used to expand occluding member or balloon member  48 . First supplemental lumen  52  may be in fluid communication with fluid source  32  or in communication with an alternative fluid source. First supplemental lumen  52  may be a separate tube as shown or may be formed in the wall of fluid conduit  34 . In the former arrangement, pressure source  32  may incorporate adjustment knob  56  ( FIG. 2 ) to control fluid flow through first supplemental lumen  52  and exit port  52 a to selectively expand occluding member  48 . Second supplemental lumen  54  accommodates pressure detector lead  58  extending to pressure detector or transducer  60  mounted adjacent the distal end of fluid conduit  34 . In the alternative, lumen  54  may be a pressure lumen with the pressure transducer  60  being within the external control unit. Second supplemental lumen  54  may include a separate tube or be defined in the wall of fluid conduit  54 . Detector lead  58  is in electrical communication with the controller of pressure source  32 .  
      In use, a gastric bypass surgery is performed resulting in an anastomosis site  20  located between a distal tubular section DT and proximal tubular section PT. Thereafter, a clamp, such as, for example, clamp  22  is inserted through a laparoscopic port  24  and used to clamp distal tubular section DT at a first tissue site disposed distal of anastomosis site  20 . Thereafter, distal end  48  of fluid conduit  34  is introduced into the patient through esophagus E and into an area within proximal tubular section PT. Occluding member  48  is pressurized to expand the member  48  to substantially occlude the internal lumen of the proximal tubular section PT at a second tissue site on the opposed side of anastomosis site  20 . Preferably, occluding member  48  provides a substantial seal to prevent escape of gases from the anastomosis site  20  through the occluding member  48  and through the lumen of the tubular organ.  
      Fluid source  32  is thereafter activated and adjusted by, e.g., means of pressure adjustment knob  42 , to provide a predetermined level of pressure in the area adjacent anastomosis site  20  between the proximal and distal occluded tissue sites provided by occluding member  48  and clamp  22 . Typically, a pressure level of approximately up to 200 mmHg is supplied during the evaluation of an anastomosis site  20  in a gastric bypass procedure. This pressure level is initially supplied to anastomosis site  20 . No further amount of pressure needs to be applied to maintain the initial amount. Thereafter, sensor  42  is adjusted utilizing sensor adjustment knob  44  to achieve the desired sensitivity of the sensor  42 . As noted above, pressure sensor means  38  evaluates the rate of pressure decay of the pressure provided to anastomosis site  20 . This can be visually evaluated using visual display  42 . A high or rapid rate of pressure decay indicates significant leakage at anastomosis site  20 , which as noted above may require further surgical intervention. Conversely, a slow, or low, rate of pressure decay indicated by pressure sensor means  38  indicates an acceptable anastomosis  20 . Thus, integrity monitoring system  30  provides a novel and accurate instrument for monitoring an anastomosis site  20  constructed during a gastric bypass surgical procedure.  
      Referring now to  FIGS. 3 and 4 , there is disclosed an alternative integrity monitoring system  100  for use in monitoring an anastomosis site. Integrity monitoring system  100  includes fluid conduit  102  and hollow insertion needle  104  mounted to an end portion of the fluid conduit  102 . Fluid conduit  102  is connected to pressure source  106  associated with integrity monitoring system  100 . Insertion needle  104  is dimensioned to penetrate, pierce and/or puncture tissue. Preferably, insertion needle  104  includes a non-coring tip configured to penetrate tissue such that the resulting puncture wound can be readily healed. As with the previous embodiment, pressure source  106  is adapted to supply a predetermined amount of CO 2  through fluid conduit  102  and hollow insertion needle  104 , and may be controlled via pressure adjustment knob  108 .  
      Integrity monitoring system  100  further includes pressure sensor means indicated schematically by dashed lines  110 . Pressure sensor means  110  is substantially similar to the pressure sensing means  38  described in connection with the embodiment of  FIG. 2  and performs in similar manner to monitor the rate of pressure loss or, alternatively, real time pressure at the anastomosis site  20 . Pressure sensor means  110  includes adjustment knob  112  and visual display  114 . Pressure detector lead (not shown) and detector or transducer  116  are mounted to fluid conduit  102  and insertion needle  104  in the manner described hereinabove or by any other suitable conventional means. Preferably, pressure transducer or detector  116  extends to at least the distal end of insertion needle  104  as schematically shown in  FIG. 3 .  
      In use, an end to end anastomosis procedure is performed resulting in an anastomosis site  120  between a distal tubular section DT and a proximal tubular section PT. As with the previously disclosed end to end anastomosis procedure, a distal clamp  122  is inserted through a first port  124  in a body wall BW to substantially seal distal tubular section DT at a first site distal of anastomosis site  120 . Similarly, a proximal clamp  126  is provided through a second port  128  in body wall BW to seal proximal tubular tissue section PT at a second tissue site proximal of anastomosis site  120 . Third port  130  is provided through body wall BW and fluid conduit  102  and insertion needle  104  are introduced therethrough. Insertion needle  104  mounted to fluid conduit  102  is advanced through the tissue adjacent anastomosis site  120  such that non-coring tip of insertion needle  104  penetrates the tubular organ tissue. A sealant  132  may be provided about insertion needle  104  to seal the puncture site against any inadvertent leakage of CO 2 . Once insertion needle  104  accesses the internal area of the anastomosis site, pressure source  106  is activated and the fluid pressure is adjusted using pressure adjustment knob  108 . The pressure within the clamped tubular organ is detected with pressure detector  116 , and the internal pressure is monitored by pressure sensor means  110  and viewed with visual display  114 .  
      Referring now to  FIG. 4 , the use of integrity monitoring system  100  to verify the integrity of an end to side anastomosis will now be described. An end to side surgical procedure is performed such that a puncture is located in a side wall SW between distal tissue section DT and proximal tissue section PT in a first tubular tissue section TTS. An end E 1  of a second tubular tissue section STS is connected through an anastomosis procedure to the side wall W. This particular procedure functions similar to that described above, however it is desirable to provide a third clamp  140  through a third port  142 . Clamp  140  is configured to seal second tissue section STS proximally of anastomosis  144 . Insertion needle  104  is inserted into second tissue section STS such that the non-coring tip penetrates second tissue section STS. Alternatively, insertion needle  104  may be inserted in to tubular tissue section TTS. Once insertion needle  104  has been properly positioned, the pressure source  106  can be activated and adjusted via adjustment knob  108  to provide an initial predetermined level of pressure to the anastomosis site  144 . The pressure is monitored by sensor  116  after initial adjustments have been made with adjustment knob  112 . The rate of pressure decay can be calculated via the circuitry or logic of pressure sensor means  110  and visually displayed on display  114 .  
       FIG. 5  illustrates an alternate embodiment of the present disclosure. In accordance with this embodiment, fluid conduit  200  includes first and second spaced expandable members  202 ,  204  at the insertion end of the fluid conduit  200 . Fluid conduit  200  defines central lumen  206  for supplying fluid under pressure to the anastomosis site. Fluid conduit  200  further includes first and second supplemental lumens  208 ,  210 . First lumen  208  delivers fluids to first and second expandable members  202 ,  204  to expand the members  202 ,  204 . Second supplemental lumen  210  serves as the pressure lumen for detecting pressure loss. Second supplemental lumen  210  terminates in opening  212  defined in an intermediate wall portion of fluid conduit  200  between first and second expandable members  202 , 204 . Second supplemental lumen  210  may be a pressure tube or incorporate a transducer as discussed hereinabove.  
      In use, fluid conduit  200  is introduced through the esophagus and advanced to position second expandable member  204  distal of the anastomosis site  20  and first expandable member  202  proximal of the anastomosis site. Expandable members  202 ,  204  are pressurized to substantially occlude the internal lumen at locations proximal and distal of the anastomosis site  20 . Fluids are supplied under pressure through central lumen  206  to exit opening  214  disposed between first and second expandable members  202 ,  204 . The pressure loss or rate of pressure loss adjacent the site and between expandable members  202 ,  204  is monitored with the pressure sensor means as discussed hereinabove. Expandable members  202 ,  204  may be balloon membranes filled with fluid or air.  
      It will be understood that various modifications may be made to the embodiments disclosed herein. For example, structure other than a sealing balloon may be provided at a distal end of the fluid conduit to facilitate sealing within the esophagus. Additionally, as noted above, the pressure source and sensors of the integrity checking device may be provided as a single unit or maybe provided separately. Further in the particular embodiment utilizing an insertion needle various other relatively a traumatic tips may be provided to facilitate puncturing the tubular tissue sections while allowing for relatively ease of healing and little loss of backflow air pressure. Still further, the sensor may be connected to other peripheral devices such as, for example, computers databases etc. to record and evaluate the pressure lost data. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.