Abstract:
The instant application relates to a device, and a method for extending a distal end of an anatomic tube. This device includes an accordion pleated bladder, which includes a proximal end and a distal end. The method includes the steps of (1) providing a device for extending a distal end of an anatomic tube including an accordion pleated bladder, wherein said bladder has a proximal end and a distal end; (2) placing the device for extending a distal end of an anatomic tube in the anatomic tube; (3) connecting the device to a pressure generator; (4) increasing the internal pressure of the device thereby extending the bladder along its longitudinal axis; and (5) thereby extending the anatomic tube along its longitudinal axis.

Description:
FIELD OF INVENTION  
       [0001]     The instant application relates to a device, and a method for extending a distal end of an anatomic tube.  
       BACKGROUND OF THE INVENTION  
       [0002]     Congenital abnormalities may cause serious threats to the well-being of individuals with such abnormalities. Congenital abnormalities, i.e. birth defects, include a wide range of malformations that occur during the fetal development. For example, esophageal atersia is a congenital abnormality where the esophagus fails to connect to the stomach. As a result, the esophagus ends in a pouch, and nothing the baby swallows gets into the stomach.  
         [0003]     In the case of a baby with esophageal atersia, a surgery is generally required to connect the esophagus to the stomach. In general, a residual esophagus is expanded via a bladder thereby facilitating the connection between the esophagus and the stomach via surgery. Residual esophagus, as used herein, may be a tubular extension of the stomach; or in the alternative, it may be an incomplete esophagus that fails to connect to the stomach. However, the expansion of the residual esophagus via the current methods causes expansion of the residual esophagus both circumferentially and longitudinally. Although the longitudinal expansion of the residual esophagus facilitates the connection to the stomach and the esophagus; thus a desired outcome, the circumferential expansion of the residual esophagus is an undesired by-product, which must be corrected via surgery.  
         [0004]     Accordingly, there is a need for a device to facilitate the extension of the distal end of an anatomic tube, e.g. a residual esophagus, along its longitudinal axis while minimizing any circumferential expansion.  
       SUMMARY OF THE INVENTION  
       [0005]     The instant application relates to a device, and a method for extending a distal end of an anatomic tube. This device includes an accordion pleated bladder, which includes a proximal end and a distal end. The method includes the steps of (1) providing a device for extending a distal end of an anatomic tube including an accordion pleated bladder, wherein said bladder has a proximal end and a distal end; (2) placing the device for extending a distal end of an anatomic tube in the anatomic tube; (3) connecting the device to a pressure generator; (4) increasing the internal pressure of the device thereby extending the bladder along its longitudinal axis; and (5) thereby extending the anatomic tube along its longitudinal axis. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0006]     For the purpose of illustrating the invention, there is shown in the drawings a form that is presently preferred; it being understood, however, that this invention is not limited to the precise arrangements and instrumentalities shown.  
         [0007]      FIG. 1  is a first embodiment of the instant invention in a compressed state; and  
         [0008]      FIG. 2  is the first embodiment of the instant invention in an extended state. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0009]     Referring to the drawings wherein like numerals indicate like elements, there is shown, in  FIGS. 1-2 , a first embodiment of device  10  for extending a distal end of an anatomic tube such as a residual esophagus. Device  10  includes an accordion pleated bladder  12 . The bladder  12  has a proximal end  14  and a distal end  16 .  
         [0010]     The instant invention, for convenience, has been described in terms of a device for extending the distal end of a residual esophagus; however, the instant invention is not so limited, and it may be employed to extend the distal end of any anatomic tube, e.g. the distal end of an intestine in the case of bowl removal. Residual esophagus, as used herein, may be a tubular extension of the stomach; or in the alternative, it may be an incomplete esophagus that fails to connect to the stomach.  
         [0011]     Bladder  12  may be made of any biocompatible elastomeric material. For example, bladder  12  may be made of a biocompatible elastomeric material selected from the group consisting of silicone rubber, natural rubber, styrene-butadiene copolymer, polychloroprene, nitrile rubber, butyl rubber, polysulfide rubbercis-i,4-polyisoprene, ethylene-propylene terpolymers (EPDM rubber), certain metallocene grades of elasticated polyolefins such as elasticated polypropylene or elasticated polyethylene, and polyurethane rubber. Bladder  12  may have any shape adapted to facilitate the longitudinal extension of any anatomic tube such as a residual esophagus. Bladder  12  may, for example, have a tubular shape. Bladder  12  may further include different physical configurations; for example, bladder  12  may have a compressed state or an extended state, as shown in  FIGS. 1 and 2  respectively.  
         [0012]     Bladder  12  is pleated. Bladder  12  may have any number of pleats  18 . For example, bladder  12  may have a single pleat  18 ; or it may have a plurality of pleats  18 . Pleats  18  may be any type of pleats; for example, pleats  18  may be annular pleats. Pleats  18  may have any shape; for example, pleats  18  may have a discoid shape.  
         [0013]     Bladder  12  may further include a small diameter rib  24  or a large diameter rib  26 . Bladder  12  may include any number of small diameter ribs  24  or any number of large diameter ribs  26 . Bladder  12  may, for example, include one or a plurality of either of small diameter ribs  24  or large diameter ribs  26 .  
         [0014]     Small diameter rib  24  may have any shape adapted to minimize the uncontrolled circumferential expansion of bladder  18 ; for example, small diameter rib  24  may have an annular shape. Small diameter rib  24  may be made of any biocompatible elastomeric material. Small diameter rib  24 , for example, may be a biocompatible elastomeric material selected from the group consisting of silicone rubber, natural rubber, styrene-butadiene copolymer, polychloroprene, nitrile rubber, butyl rubber, polysulfide rubbercis-i,4-polyisoprene, ethylene-propylene terpolymers (EPDM rubber), certain metallocene grades of elasticated polyolefins such as elasticated polypropylene or elasticated polyethylene, and polyurethane rubber. Small diameter rib  24  may be an integrated component of bladder  12 , or in the alternative, it may be a separate component secured thereto bladder  12 .  
         [0015]     Large diameter rib  26  may have any adapted to minimize the uncontrolled circumferential expansion of bladder  12 ; for example, large diameter rib  26  may have an annular shape. Large diameter rib  26  may be made of any biocompatible elastomeric material. Large diameter rib  26  may, for example, may be a biocompatible elastomeric material selected from the group consisting of silicone rubber, natural rubber, styrene-butadiene copolymer, polychloroprene, nitrile rubber, butyl rubber, polysulfide rubbercis-i,4-polyisoprene, ethylene-propylene terpolymers (EPDM rubber), certain metallocene grades of elasticated polyolefins such as elasticated polypropylene or elasticated polyethylene, and polyurethane rubber. Large diameter rib  26  may be an integrated component of bladder  12 , or in the alternative, it may be a separate component secured thereto bladder  12 .  
         [0016]     Proximal end  14  is a non-pleated proximal portion of bladder  12 , and it may have a sealable opening  32 . Proximal end  14  may include alternative means for securing bladder  12  to the proximal end of an anatomic tube such as a residual esophagus. Proximal end  14  may have any shape adapted to facilitate the extension of the distal end of an anatomic tube such a residual esophagus. For example, proximal end  14  may have a cylindrical shape adapted for securing bladder  12  to the proximal end of an anatomic tube such as a residual esophagus. Proximal end  14  may be adapted to expand circumferentially in a range of about 1% to about 30% thereby securing bladder  12  to the proximal end of an anatomic tube such as a residual esophagus. Proximal end  14  may further include first anchors (not shown) to secure the bladder  12  to the proximal end of an anatomic tube such as a residual esophagus. Proximal end  14  may further include the means for connecting bladder  12  to a pressure generator (not shown). Means for connecting bladder  12  to a pressure generator includes, but is not limited to, quick-connect fittings, threads, or other detachable coupling means such as clamps or fasteners.  
         [0017]     Distal end  16  is a non-pleated distal portion of bladder  12 , and it is sealed. Distal end  16  may include alternative means for securing bladder  12  to the distal end of an anatomic tube such as a residual esophagus. Distal end  16  may have any shape adapted to facilitate the extension of the distal end of an anatomic tube such a residual esophagus. For example, distal end  16  may have a cylindrical shape adapted for securing bladder  12  to the distal end of an anatomic tube such as a residual esophagus. Distal end  16  may be adapted to expand circumferentially in a range of about 1% to about 30% thereby securing bladder  12  to the distal end of an anatomic tube such as a residual esophagus. Distal end  16  may further include second anchors (not shown) to secure the bladder  12  to the distal end of an anatomic tube such as a residual esophagus.  
         [0018]     In operation, device  10  is disposed in a residual esophagus, employing conventional methods known in the medical field. Device  10  is connected to a pressure generator (not shown) via a pressure pipe coupled with the proximal end  14 . Pressure generator, for example, may generate pressure by pumping a fluid into device  10  thereby facilitating the expansion of bladder  12 . Fluid, as used herein, refers to any liquid, e.g. saline solution, or any gas, e.g. CO 2 . As the fluid is pumped into device  10 , the internal pressure of device  10  increases thereby inducing bladder  12  to expand both circumferentially and longitudinally. However, the small diameter ribs  24  and the large diameter ribs  26  prevent the uncontrolled circumferential expansion of bladder  12  thereby facilitating the extension of the bladder  12  along its longitudinal axis. The controlled circumferential expansion of bladder  12  facilitates securing the proximal end  14  of the bladder  12  to the proximal end of the residual esophagus; and, it further facilitates securing the distal end  16  of bladder  18  to the distal end of the residual esophagus. The longitudinal extension of bladder  12  facilitates the extension of the distal end of the residual esophagus along its longitudinal axis. The extended residual esophagus may be maintained in an extended state until its extension along its longitudinal axis becomes permanent. For example, the extended residual esophagus may be maintained in an extended state for a period of about 1 month to about 6 months. During this period of extended state, as the residual esophagus gradually extends further, the internal pressure of device  10  declines; therefore, supplemental fluid is pumped into device  10  in order to increase the internal pressure of device  10  thereby inducing bladder  12  to further extend along its longitudinal axis. The longitudinal extension of bladder  12  facilitates further extension of the distal end of the previously extended residual esophagus. The addition of the supplemental fluid to facilitate further extension of the distal end of residual esophagus may be repeated as many times as necessary until an optimum extension of the distal end of the residual esophagus is achieved. In the alternative, the residual esophagus may be extended along its longitudinal axis as many times as necessary to induce a permanent extension along its longitudinal axis. For example the internal pressure of device  10  may, repeatedly, be reduced, and then, increased in order to induce a permanent extension along the longitudinal axis of the residual esophagus.  
         [0019]     In an alternative operation, device  10  is disposed in residual esophagus, employing conventional methods known in the medical field. Device  10  is connected to a pressure generator (not Shown) via a pressure pipe coupled with the proximal end  14 . Pressure generator, for example, may generate pressure by pumping a fluid into device  10  thereby facilitating the expansion of bladder  12 . Fluid, as used herein, refers to any liquid, e.g. saline solution, or any gas, e.g. CO 2 . The proximal end  14  of the bladder  12  is secured to the proximal end of the residual esophagus via first anchors, and the distal end  16  of the bladder  12  is secured to the distal end of the residual esophagus via second anchors. As the fluid is pumped into device  10 , the internal pressure of device  10  increases, and the bladder  12  begins to expand both circumferentially and longitudinally. However, the small diameter ribs  24  and the large diameter ribs  26  prevent the uncontrolled circumferential expansion of bladder  12  thereby facilitating the extension of the bladder  12  along its longitudinal axis. The longitudinal extension of bladder  12  facilitates the extension of the distal end of the residual esophagus along its longitudinal axis. The extended residual esophagus may be maintained in an extended state until its extension along its longitudinal axis becomes permanent. For example, the extended residual esophagus may be maintained in an extended state for a period of about 1 month to about 6 months. During this period of extended state, as the residual esophagus gradually extends further, the internal pressure of device  10  declines; therefore, supplemental fluid is pumped into device  10  in order to increase the internal pressure of device  10  thereby inducing bladder  12  to further extend along its longitudinal axis. The longitudinal extension of bladder  12  facilitates further extension of the distal end of the previously extended residual esophagus. The addition of the supplemental fluid to facilitate further extension of the distal end of residual esophagus may be repeated as many times as necessary until an optimum extension of the distal end of the residual esophagus is achieved. In the alternative, the residual esophagus may be extended along its longitudinal axis as many times as necessary to induce a permanent extension along its longitudinal axis. For example the internal pressure of device  10  may, repeatedly, be reduced, and then, increased in order to induce a permanent extension along the longitudinal axis of the residual esophagus.  
         [0020]     The present invention may be embodied in other forms without departing from the spirit and the essential attributes thereof, and, accordingly, reference should be made to the appended claims, rather than to the foregoing specification, as indicated the scope of the invention.