Abstract:
A duel lumen catheter is provided for use in minimally invasive surgery. The catheter generally includes a first tube defining an operative lumen and a second tube terminating proximally of the first tube and defining an inflation lumen. In one embodiment, the first and second tubes are concentric. In an alternative embodiment, the first and second tubes are separate and extend parallel to each other. The first and second tubes are provided with inflation ports adjacent their respective distal ends. There is also provided a method for performing minimally invasive surgery by inserting the catheter through the esophagus of a patient, insufflating the stomach and performing a surgical operation through the catheter and external to the stomach.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of and priority to U.S. Provisional Patent Application No. 60/987,444, filed Nov. 13, 2007, the entire disclosure of which is incorporated by reference herein. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present disclosure relates to a dual lumen catheter having an operative passageway for use in minimally invasive endoluminal surgery. More particularly, the present disclosure relates to a duel lumen catheter and method of performing minimally invasive endoluminal surgery through the stomach of a patient. 
     2. Background of Related Art 
     Surgeons are constantly searching for ways of performing surgical procedures within the body of a patient in a minimally invasive manner. This is desirable in order to reduce scarring, as well as, to shorten the healing or recuperation time of a patient from the surgery. As an example, one way to accomplish this is through the use of trans-luminal or trans-gastric surgery. In these methods, the surgeon inserts various instruments through the esophagus of the patient to gain access to the stomach. Once the stomach has been reached, and opening in the gastric wall is accomplished to gain access to the peritoneal cavity and perform various surgeries, such as, for example, hernia repair, etc. 
     In these surgical procedures the peritoneal cavity is typically insufflated to provide a visualization area and\or working room for the surgical instruments. However, a potential problem exists when the peritoneal cavity is pressurized in that the pressure created within the peritoneal cavity pushes down on the stomach thereby flattening the stomach and making it difficult to manipulate surgical and/or visualization instruments through the interior of the stomach. 
     Thus, it would be desirable to provide a catheter and method of performing a trans-gastric surgery without the attendant problem of stomach collapse due to pressurization of the adjacent peritoneal cavity. 
     SUMMARY 
     There is disclosed a dual lumen catheter for use in minimally invasive surgery. The catheter generally includes a hub, a first tube extending through the hub and defining an operative lumen from the hub to a distal end of the first tube. A second tube extends parallel to the first tube and sealed at its distal end. The distal end of the second tube is positioned proximally of the distal end of the first tube, wherein the second tube defines an inflation lumen. 
     In one embodiment the second tube is positioned concentrically about the first tube. The second tube includes inflation ports positioned adjacent the distal end of the second tube. A seal is positioned between the first and second tubes to seal the distal end of the second tube. A valve system is in fluid communication with the inflation lumen such that the valve system applies a source of fluid through the inflation lumen. 
     The first tube includes ports positioned adjacent the distal end of the first tube and includes a cutting edge at the distal end thereof. 
     In an alternative embodiment, the first and second tubes extend through and distally of a support tube associated with the hub. A seal is positioned within the support tube and about the first and second tubes to seal interior of the support tube. The second tube includes inflation ports positioned adjacent the distal end of the second tube. 
     There is also disclosed a method of performing a minimally invasive procedure utilizing a dual lumen catheter. A catheter is provided having a first tube defining an operative lumen and a second tube, parallel to the first tube, defining an inflation lumen and terminating proximally of the distal end of the first tube. The catheter is inserted through the esophagus of a patient so as to position a distal end of the second tube within the stomach of a patient. The catheter is further advanced through the esophagus of a patient so as to position the distal end of the first tube outside of the stomach of the patient and a surgical operation is performed through the first tube and outside the stomach of the patient. The method further includes pressurizing the interior of the stomach by forcing a fluid through the inflation lumen and pressurizing an area outside of the stomach by forcing a fluid through the operative lumen. 
     In one use of the disclosed method the wall of the stomach is punctured with the distal end of the first tube. 
    
    
     
       DESCRIPTION OF THE DRAWINGS 
       Various embodiments of the presently disclosed dual lumen surgical catheter are disclosed herein with reference to the drawings, wherein: 
         FIG. 1  is a perspective view of one embodiment of a duel lumen catheter for use in minimally invasive endoluminal surgery; 
         FIG. 2  is a cross-sectional view taken along the line  2 - 2  of  FIG. 1 ; 
         FIG. 3  is a cross-sectional view taken at the junction of the outer tubular member and the inner tubular member; 
         FIG. 4  is a perspective view, partially shown in section, illustrating the embodiment of  FIG. 1  initially inserted into a patient; 
         FIG. 5  is a perspective view, similar to  FIG. 4 , illustrating the operating end of the catheter positioned within the peritoneal cavity of the patient; 
         FIG. 6  is a perspective view of an alternative embodiment of a duel lumen catheter for use in minimally invasive endoluminal surgery; 
         FIG. 7  is a cross-sectional view taken along lines  7 - 7  of  FIG. 6 ; 
         FIG. 8  is a cross-sectional view taken at the junction of an outer sheath with the inner lumens; 
         FIG. 9  is a perspective view, partially shown in section, illustrating the embodiment of  FIG. 6  initially inserted into a patient; and 
         FIG. 10  is a perspective view, similar to  FIG. 9 , illustrating the operating end of the catheter positioned within the peritoneal cavity of a patient. 
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
     Embodiments of the presently disclosed dual lumen catheter and methods of endoluminal surgery 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 further away from the user. 
     Referring to  FIG. 1 , there is disclosed a dual lumen catheter  10  particularly suitable for use in endoluminal surgery to support the stomach against collapse during surgical procedures. Catheter  10  generally includes a hub  12  having an outer sheath  14  extending distally from hub  12 . An operative or inner tube  16  extends through hub  12  and sheath  14  and defines an operative lumen  18  extending from a proximal end  20  of inner tube  16  to a distal end  22  of inner tube  16 . Operative lumen  18  in inner tube  16  provides an access passageway for surgical instruments as well as a fluid flow path for insufflation fluids to insufflate the peritoneal cavity. A plurality of insufflation ports  24  are provided adjacent distal end  22  of inner tube  16 . Insufflations ports  24  are provided in case the instruments inserted through inner tube  16  block or seal the distal end of operative lumen  18  and thus prevent the flow of insufflation fluid out of the open end of operative lumen  18 . Distal end  22  of inner tube  16  may additionally be provided with a cutting edge  26  to facilitate advancement of distal end  22  through a stomach wall and a peritoneal lining. In order to steer or direct catheter  10  through the body of a patient, hub  12  may be provided with a pair of wings  28 . It should be noted that, however, other methods of steering catheter  10  to the body of a patient are contemplated here in such as, for example, various steerable guide wires etc. Additionally, other means or instruments known in the art may be provided to penetrate the stomach wall and peritoneal lining to provide access to the peritoneal cavity. 
     Catheter  10  is additionally provided with an outer tube  30  which extends partially over inner tube  16  to define a common longitudinal axis A-A. Outer tube  30  is sealed at a distal end  32  to inner tube  16 . A plurality of inflation ports  34  are provided adjacent distal end  32  of outer tube  30  and are spaced proximally from insufflation ports  24  at a distal end  22  of inner tube  16 . A T-collar  36  surrounds sheath  14  and is in fluid communication with inflation ports  34  at distal end  32  of outer tube  30 . A valve system  38  is in fluid communication with T-collar  36  through a fluid tube  40 . The inner tube  16  extends to a position  50  distal from the distal end  32  of the outer or insufflation tube  30  to define the common longitudinal axis A-A, the common longitudinal axis A-A extending at least to the position  50 . The distal end  22  of the inner tube  16  defines a portion  16 ′ of the inner tube  16  that extends at least from the position  50  to define an offset axis B-B with respect to the common longitudinal axis A-A. The offset axis B-B defines an offset angle θ with respect to the common longitudinal axis A-A of the inner tube  16 . Consequently, the radially oriented insufflation ports  24  in proximity to the distal end  22  of the operative or inner tube  16  are positioned at a position that is offset from the radially oriented insufflation ports  34  at the distal end  32  of the outer or insufflation tube  30 . 
     Referring for the moment to  FIG. 2 , an inflation lumen  42  is defined between outer tube  30  and inner tube  16 . As shown, inner tube  16  and outer tube  30 , and thus operative lumen  18  and inflation lumen  42 , are concentric. Inflation lumen  42  carries inflation fluid from valve system  38  to inflation ports  34  at a distal end of outer tube  30 . 
     Referring to  FIG. 3 , and as noted hereinabove, distal end  32  of outer tube  30  terminates proximally of distal end  22  of inner tube  16  and is sealed to inner tube  16 . Specifically, distal end  32  of outer tubes  30  is sealed to inner tube  16  by a circumferential seal  44 . Seal  44  may be formed by gluing distal end  32  to inner tube  16  or may be provided as a separate member which is glued, welded, or otherwise affixed to distal end  32  and inner tube  16 . Thus, fluid flowing from valve system  38  through inflation lumen  42  can only exit inflation ports  34  formed in distal end  32  of outer tube  30 . 
     Referring to  FIGS. 4 and 5 , and initially with regard to  FIG. 4 , the use of catheter  10  in endoluminal surgery to access the peritoneal cavity through the stomach will now be described. Initially, catheter  10  is inserted through the mouth M of a patient P and advanced through the esophagus E so as to position distal end  22  of inner tube  16 , as well as distal end  32  of outer tube  30 , within the stomach S of the patient. Once catheter  10  has been so positioned, a first source of insufflation fluid (not shown) may be attached to a valve system  38  and actuated to force a first inflation fluid F 1  through inflation lumen  42  and out inflation ports  34  in outer tube  30  in order to insufflate stomach S. The first source of inflation fluid may provide various auxiliary functions such as, for example, providing for pressure measurement so as to maintain constant pressure within the stomach, etc. While the present procedure is being described as insufflating stomach S prior to penetration of the stomach and the peritoneal cavity and insufflation of the peritoneal cavity, insufflation of stomach S may be delayed until after one or more of these steps have been accomplished. 
     With continued reference to  FIG. 4 , catheter  10  is then further advanced through the esophagus E to cause cutting edge  26  at distal end  22  of inner tube  16  to engage and puncture stomach S. 
     Referring now to  FIG. 5 , continued advancement of catheter  10  through esophagus E causes cutting edge  26  to form a hole  46  through stomach S and a hole  48  in peritoneal cavity PC to position distal end  22  of inner tube  16  within peritoneal cavity PC. Thereafter, a second source of inflation fluid (not shown) is connected to hub  12  and actuated to force a second inflation fluid F 2  through operative lumen  18  so as to insufflate peritoneal cavity PC. Once peritoneal cavity PC has been insufflated, operative lumen  18  is used as the access passageway for the insertion of instruments into peritoneal cavity PC to perform any of various surgical procedures. It should be noted that, during the performance of the surgical procedures, the fluid pressure within stomach S due to inflation fluid F 1  prevents the flattening or collapse of stomach S due to the inflation pressure in the peritoneal cavity PC and the activities of the surgical procedures being conducted therein. As with the first source of inflation fluid described hereinabove, the second source of inflation fluid might also be provided with auxiliary functions such as, for example, pressure measurement, pressure monitors and control devices, etc. in order to manage and adjust any losses in inflation pressure within peritoneal cavity PC during the surgical procedure. 
     It should be further noted that the disclosed catheter  10  and disclosed surgical method allows the surgeon to precisely control the pressures within peritoneal cavity PC and stomach S concurrently. 
     While not specifically shown, it is also contemplated that catheter  10  may be provided with the various anchoring and or sealing structures, such as, for example anchoring or sealing balloons adjacent distal ends  22  and  32  of inner tube  16  and outer tubes  30 , respectively. This will assist in preventing movement of catheter  10  during the surgical procedures as well as preventing leakage and/or transfer of inflation fluids between stomach S and peritoneal cavity PC. 
     Referring now to  FIG. 6 , there is disclosed in alternative embodiment of a dual lumen catheter  50 . In contrast to dual lumen catheter  10  described hereinabove, the operative and inflation lumens of catheter  50  are parallel but not concentric as was the case with dual lumen catheter  10 . Catheter  50  generally includes a hub  52  having an outer sheath  54  extending distally therefrom. A support tube  56  extends through hub  52  and outer sheath  54  and encases the operative and inflation lumens of catheter  50  as described in more detail hereinbelow. Hub  52  is provided with a pair of wings  58  to facilitate manipulation of catheter  50  through the body of a patient. 
     A distal tube  60  extends through hub  52 , outer sheath  54  and support tube  56  to define a longitudinal axis N-A′. A proximal end  62  of distal tube  60  is positioned adjacent hub  52  while a distal end  64  of distal tube  60  is provided with a plurality of ports  66 . A cutting edge  68  may be provided on distal end  64  to facilitate puncturing of the stomach and the peritoneal cavity. 
     A proximal tube  70  extends partially through sheath  54  and through support tube  56 . Proximal tube  70  has a sealed distal end  72  and a plurality of ports  74  adjacent sealed distal end  72 . A T-collar  76  surrounds sheath  54  and is in fluid communication with ports  74  in proximal tube  70 . A valve system  78  is provided to receive of source of fluid and is connected to T-collar  76  by a fluid tube  80 . 
     Distal tube  60  defines an operative lumen  82  extending from proximal end  62  to distal end  64 . As best shown in  FIG. 7 , inner tube  70  defines an inflation lumen  84 . Distal tube  60  and proximal tube  70 , and thus operative lumen  82  and inflation lumen  84 , extend through support tube  56  in parallel, but not concentric, fashion. The distal tube  60  extends at least to a position  92  that is distal from the sealed end  72  of the proximal tube  70  to define the longitudinal axis A′-A′. The distal end  64  of the distal tube  60  defines a portion  60 ′ of the distal tube  60  that extends at least from position  92  to define an offset axis B′-B′ with respect to the longitudinal axis A′-A′. Additionally, the sealed distal end  72  of proximal tube  70  extends through hub  52 , outer sheath  54  and support tube  56  to define a longitudinal axis A″-A″ along the proximal tube  70 . Since the distal tube  60  and proximal tube  70 , and thus operative lumen  82  and inflation lumen  84 , extend through support tube  56  in parallel fashion, the longitudinal axes A′-A′ and A″-A″ are also parallel to each other. 
     The offset axis B′-B′ of the portion  60 ′ of the distal tube  60  defines an offset angle θ 1  with respect to the longitudinal axis A′-A′ of the distal tube  60 . The offset axis B′-B′ also defines an offset angle θ 2  with respect to the longitudinal axis A″-A″ of the proximal tube  70 . When the two longitudinal axes A′-A′ and A″-A″ are precisely parallel, the offset angles θ 1  and θ 2  are equal. Consequently, the radially oriented insufflation ports  66  in proximity to the distal end  64  of the distal tube  60  are positioned at a position that is offset from the radially oriented insufflation ports  74  at the sealed distal end  72  of the proximal tube  70 . 
     Referring for the moment to  FIG. 8 , both distal tube  60  and proximal tube  70  extend beyond support tube  56 . A seal  86  is provided within support tube  56  and about distal tube  60  and proximal tube  70  to prevent the influx of any fluids or other matter within support tube  56  during a surgical procedure. 
     Referring to  FIGS. 9 and 10 , and initially with regard to  FIG. 9 , the use of catheter  50  in endoluminal surgery to access the peritoneal cavity through the stomach will now be described. The following procedure is substantially identical to that described hereinabove with respect to catheter  10 . Initially, catheter  50  is inserted through the mouth M of a patient P and advanced through the esophagus E so as to position in distal end  64  of distal tube  60  as well as distal end  72  of proximal tube  70  within stomach S of the patient. Once catheter  50  has been so positioned, a first source of insufflation fluid (not shown) may be attached to a valve system  78  and actuated to force a first inflation fluid F 1  through inflation lumen  84  and out inflation ports  74  in proximal tube  70  in order to insufflated stomach S. As above, the first source of inflation fluid may provide various auxiliary functions such as, for example, providing for pressure measurement so as to maintain constant pressure within the stomach, etc. While the present procedure is being described as insufflated stomach S prior to penetration of the stomach and the peritoneal cavity and insufflation of the peritoneal cavity, insufflation of stomach S may be delayed until after one or more of these steps have been accomplished. 
     With continued reference to  FIG. 9 , catheter  50  is then further advanced through the esophagus E to cause cutting edge  68  at distal end  64  of distal tube  60  to engage and puncture stomach S. 
     Referring now to  FIG. 10 , continued advancement of catheter  50  through esophagus E causes cutting edge  68  to form a hole  88  through stomach S and a hole  90  in peritoneal cavity PC to position distal end  64  of distal tube  60  within peritoneal cavity PC. Thereafter, a second source of inflation fluid (not shown) may be connected to hub  12  and actuated to force a second inflation fluid F 2  through operative lumen  82  so as to insufflate peritoneal cavity PC. Once peritoneal cavity PC has been insufflated, operative lumen  82  is used as the access passageway for the insertion of instruments into peritoneal cavity PC to perform any of various surgical procedures. As noted hereinabove, the fluid pressure within stomach S due to inflation fluid F 1  prevents the flattening or collapse of stomach S due to the inflation the peritoneal cavity PC and the activities of the surgical procedures being conducted therein. As with the first source of inflation fluid described hereinabove the second source of inflation fluid might also be provided with auxiliary functions such as, for example, pressure measurement, pressure monitors and control devices, etc. in order to manage and adjust any losses in inflation pressure within peritoneal cavity PC during the surgical procedure. 
     It should be further noted that the disclosed catheter  50  and the disclosed surgical method allow the surgeon to precisely control the pressures within peritoneal cavity PC and stomach S concurrently. 
     While not specifically shown, it is also contemplated that catheter  50 , similar to catheter  10  described hereinabove, may be provided with the various anchoring and or ceiling structures, such as, for example anchoring or sealing balloons adjacent distal ends  64  and  72  of distal tube  60  and proximal tube  70 , respectively. This will assist in preventing movement of catheter  50  during the surgical procedures as well as preventing leakage and/or transfer of inflation fluids between stomach S and peritoneal cavity PC. 
     It will be understood that various modifications may be made to the embodiments disclosed herein. For example, additional lumens may be provided through the disclosed catheters to provide for auxiliary instruments such as, for example, endoscopes, etc. Further, as noted hereinabove, various anchoring and/or sealing structures may be provided on the disclosed tubes to prevent leakage as well as movement of the catheter within the body of the patient. Additionally, various known types of fluid sources and auxiliary devices for maintaining and monitoring pressure through the various lumens and within the various cavities in the body of the patient may be provided. 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.