Abstract:
An intraluminal molding device in accordance with the disclosed invention has an elongated body member having a series of independent inflatable sections along its length. As lest one inflating/deflating line extends from each inflatable section to a distal end of the body member. The device may be used for positioning, isolating or identifying a lumen by giving shape to a collapsed viscus. The device may also be sued to visualize intraluminal structure or control pressure within a hollow viscus.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     The present application is a continuation-in-part of U.S. patent application Ser. No. 10/825,544 filed on Apr. 15, 2004, which was a continuation of U.S. patent application Ser. No. 09/245,788 filed on Feb. 5, 1999, which claimed the benefit of the filing date of U.S. 60/073,902 filed on Feb. 6, 1998. Each of these aforementioned applications is hereby incorporated by reference in its entirety. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT  
       [0002]     Not applicable.  
       FIELD OF THE INVENTION  
       [0003]     The present invention relates to the field of intraluminal medical treatment, and more specifically, to an intraluminal molding device for positioning, isolating and/or identifying relevant segments of a hollow viscus during surgical, diagnostic or other procedures.  
       BACKGROUND OF THE INVENTION  
       [0004]     During operations on any hollow viscus, such as colorectal surgery, gastrointestinal surgery, urological or biliary surgery, it is often necessary to position, isolate and/or identify relevant segments of the hollow viscus being operated upon. It would be advantageous during such surgery, or during any procedure (surgical, diagnostic, theraputical or otherwise) to perform the positioning, isolation and/or identifying procedure from the interior of the hollow viscus.  
       SUMMARY OF THE INVENTION  
       [0005]     The present invention provides an inflatable intraluminal device for positioning, isolating, identifying, and/or treating a hollow viscus for use internally of the hollow viscus to give shape to the collapsed viscus by acquiring its distended form. The present invention further provides an intraluminal surgical and diagnostic device independently operable at several locations within a hollow viscus. The present invention further provides a device to maintain the lumen of the hollow viscus clear of fluid and/or air. The present invention further provides a device which can assist in visualizing intraluminal structure and control pressure within an internal viscus. The present invention further provides an intraluminal surgical, theraputical and diagnostic device which is easy to manufacture and simple to use and operate.  
         [0006]     The present invention comprises an elongated body member with a plurality of independent inflatable balloon sections extending along the length of the body member, and a mechanism for independently inflating each individual balloon section along the length of the body member.  
         [0007]     The elongated body member may be in the form of a sleeve which is adapted to fit over an existing scope and/or suction tube. The mechanisms for individually inflating the specific balloon sctions may be formed as individual air/fluid lines extending from each balloon section along the body member to a distal end of the body member. The individual balloon sections may be formed such that they conform to the specific anatomical structure when inflated. One or more suction tubes and/or optical scopes may be positioned at various locations along the body member between adjacent balloon sections. Leads from the individual scopes and suction tubes will extend along the body member to the distal end of the device for appropriate connection to a suction source or video display equipment as known in the art. The suction tubes may also be used to supply medicine or irrigation fluid to selected portions of the hollow viscus.  
         [0008]     Still other aspects, features, and advantages of the present invention are readily apparent from the following detailed description, simply by illustrating a preferable embodiments and implementations. The present invention is also capable of other and different embodiments and its several details can be modified in various obvious respects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. Additional objects and advantages of the invention will be set forth in part in the description which follows and in part will be obvious from the description, or may be learned by practice of the invention. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]     The invention of the present application will now be described in more detail with reference to preferred embodiments of the architecture and method, given only by way of example, and with reference to the accompanying drawings, in which:  
         [0010]      FIG. 1  schematically illustrates an inflatable intraluminal surgical device according to a first embodiment of the present invention.  
         [0011]      FIG. 2  schematically illustrates an inflatable intraluminal surgical device according to a second embodiment of the present invention.  
         [0012]      FIG. 3  schematically illustrates an inflatable intraluminal surgical device according to a third embodiment of the present invention. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0013]      FIG. 1  schematically illustrates an inflatable intraluminal surgical and diagnostic device  10  according to the present invention. The surgical device  10  includes an elongated body member formed as a sleeve  12 . along the length of the sleeve  12  are a plurality of independent balloon sections  14 . Individual air lines  16  extend from each balloon section  14  along the sleeve  12  to the distal control end of the device  10 . the individual air lines  16  may be color coded, numbered or include other appropriate indicia to indicate which specific balloon section  14  along the length of sleeve  12  the specific air line  16  is associated with.  
         [0014]     The sleeve  12  is adapted to fit around an existing suction tube and scope member  20 . the leading end of the sleeve  12  may include appropriate conventional connecting mechanisms to attach the leading end of the sleeve  12  to the leading end of the suction tube and scope member  20  in the position generally shown in  FIG. 1 .  
         [0015]     In operation, the surgical device  10  is positioned on the suction tube and scope member  20  by sliding sleeve  12  along the suction tube and scope member  20  and attaching the leading end of the sleeve  12  to a leading end of the suction tube and scope member  20  through a connecting mechanism. The surgical device  10 , along with the existing suction tube and scope member  20 , can be inserted into the specific hollow viscus, such as the colon or esophagus. With the surgical device inserted into the colon, for example, a desired segment of the colon can be isolated by inflating the specific balloon section  14  associated with that segment. The balloon section  14  can be inflated with air, fluid, and/or plasma injected through the appropriate air line  16 . The injection may be through the use of a syringe or any appropriate inflation device. The balloon sections  14  may also be deflated through use of air lines  16 . the inflated balloon section  14  will expand the colon section serving to isolate and identify the specific section. The segment associated with the inflated balloon section  14  (one of which is shown in phantom in  FIG. 1 ) can be easily identified and positioned from the exterior for appropriate operations. The surgical device  10  may be utilized for isolating a section of a hollow viscus to be operated upon, such as a section of colon to be resected, which is between a pair of inflated, spaced balloon sections  14  along the surgical device  10 . The surgical device  10  may also be used to control bleeding along the length of a hollow viscus. There are many independent applications for the surgical device  10  of the present invention.  
         [0016]      FIG. 2  schematically illustrates a surgical device  30  according to a second embodiment of the present invention. The surgical device  30  is similar to the surgical device  10  and includes a body member  32  with a plurality of independently inflatable/deflatable balloon sections  34  along the length of body member  32 . Individual air lines  36  extend from each balloon section  34  along the body member  32 . the surgical device  30  additionally includes suction tubes  38  extending from the leading end of the body member  32  and also positioned between adjacent balloon sections  34 . the surgical device  30  further includes optical fibers  40  extending from the leading end of the body member  32  and also positioned between adjacent balloon sections  34 . The optical fibers  40  between adjacent balloon sections are illustrated extending in opposite directions relative to the body member  32  to provide a comprehensive view to the surgeon or other operator. The air lines  36 , suction tubes  38  and optical fibers  40  extend along the body member  32  to an external control panel  42 . The control panel  42  allows the specific air lines  36 , suction tubes  38  or optical fibers  40  to be accessed as desired.  
         [0017]     In operation, the surgical device  30  operates similar to the surgical device  10  above with the surgical device  30  inserted into an appropriate hollow viscus, such as a colon, gastrointestinal track, or the like. The specific balloon sections  34  can be independently inflated and deflated by accessing the associated air line  36  on the control panel  42 . As discussed above, the balloon section  34  can be filled with air through air line  36  or fluid, such as saline or the like, through air line  36 . Additionally, suction tubes  38  allow for specific sections along the length of the surgical device  30  to be suctioned or for medication or other fluid to be introduced to specific sections along the length of the surgical device  30 .  
         [0018]     For example, a pair of spaced balloon sections  34  may be inflated to isolate a colon section therebetween which is to be filled with a specific liquid applied through appropriate suction tube  38 . This may for example be used to treat a specific isolated section of the colon with chemotherapy. The surgeon can view the desired location along the surgical device  30  by connecting the appropriate optical fibers  40  to visual equipment through connections to control panel  42  in a known manner. As discussed above in connection with surgical device  10 , there are many applications, surgical, diagnostical and theraputical for the surgical device  30  of the present invention.  
         [0019]     Similarly, the invention may be used to treat specific sections or segments of the hollow viscus. Such a treatment may be performed, for example, by injecting a radiotheraputical compound into a specific balloon section. Other examples that would be apparent to those of skill in the art would be the injection of radiotheraputical, chemotherapeutical or diagnostic materials in between balloon sections, on the outside of balloon section or in balloon section. Consider three adjacent balloon sections. If the two outer balloon sections are inflated and the middle section is not, a theraputical fluid may be injected between the two inflated balloon sections such that it coats the outer surface of the middle balloon section. If the middle balloon section is then inflated, the theraputical fluid will be applied to the section of the colon surrounding that middle balloon section.  
         [0020]      FIG. 3  schematically illustrates a surgical device  50  according to a third embodiment of the present invention. Surgical device  50  is substantially similar to surgical devices  10  and  30  described above and includes an elongated body member  52  with a plurality of spaced balloon sections  54  along the length thereof. Individual air lines  56  extend to these individual balloon sections  54  along the body member  52  in substantially the same manner discussed above in connection with surgical devices  10  and  30 . the surgical device  50  is illustrated with a suction tube  58  and an optical fiber  60  extending to the end of the surgical device  50  and may further include suction tubes and optical fibers with the air lines  56  and suction tubes and optical fibers attached to a control panel similar to that discussed above in connection with surgical device  30 . the surgical device  50  is designed for a gastrointestinal operation and illustrates that the specific balloon sections  54 , when inflated, are designed to conform to the specific anatomical structure. As discussed above, the surgical device  50  of the present invention can be utilized in a wide variety of procedures, both surgical and diagnostic. The device  50  can maintain the desired size and intraluminal pressure on the esophagus eliminating other tubes and dilators currently used.  
         [0021]     Any of the devices  10 ,  30  and  50  of the present invention can be used to help identify lumen perforations, isolate lumen segments, control lumen pressure, control and prevent bleeding into the lumen, medicate and/or suction selected portions of the lumen, visualize inner lumen structure and a variety of other applications. Further, it would be apparent to those of ordinary skill in the art that various modifications may be made to the present invention without departing from the spirit and scope thereof. For example, the devices  10 ,  30  and  50  may be used with a reusable light source to assist the operation.  
         [0022]     The foregoing description of the preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. The embodiment was chosen and described in order to explain the principles of the invention and its practical application to enable one skilled in the art to utilize the invention in various embodiments as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims appended hereto, and their equivalents. The entirety of each of the aforementioned documents is incorporated by reference herein.