Device and Method to Control and Manipulate a Catheter

Abstract

In various embodiments of the invention, a manipulator attaches to and allows a sheath to be positioned inside the cervix and a catheter to thereby be inserted through the sheath and be positioned in a desired location in the uterus. In various embodiments of the invention, the manipulator may be attached or permanently connected to the sheath. In various embodiments of the invention, the sheath is fenestrated to allow the catheter to be detached from the sheath. In various embodiments of the invention, the manipulator allows the sheath to be positioned through the cervix canal to allow for catheter transmitted intrauterine pressure monitoring or balloon catheter assisted ripening of the cervix.

What is claimed is: 
     
         1 . A two clip manipulator for introducing and positioning a catheter toward a uterine amniotic cavity comprising:
 (a) a first clip, where the first clip comprises a first arm, a second arm and a first fenestration, where the first arm comprises a first width, a first thickness, a first length and a first curvature, where the second arm comprises the first width, the first thickness, the first length and the first curvature, where the first clip is adapted to surround a single finger while leaving a first gap corresponding to the first fenestration;   (b) a second clip, where the second clip comprises a third arm, a fourth arm and a second fenestration, where the third arm comprises the first width, the first thickness, a second length and a second curvature, where the fourth arm comprises the first width, the first thickness, the second length and the second curvature, where the first length is greater than the second length, where the second curvature is greater than the first curvature, where the second clip is adapted to surround a sheath while leaving a second gap corresponding to the second fenestration, where the sheath comprises a distal end, a proximal end and a third length;   (c) a common region, where the first clip and the second clip are joined at the common region, where the first fenestration is located on the first main axis of rotation and opposite the common region, where the second fenestration is located on the first main axis of rotation and opposite the common region;   (d) where the two clip manipulator has a first main axis of rotation passing through the first fenestration, the common region and the second fenestration, where the two clip manipulator has a second main axis of rotation, where the second main axis of rotation passes through the proximal end and the distal end, where the first main axis of rotation is perpendicular to the second main axis of rotation; and   (e) where the two clip manipulator is made of a flexible material, where the first clip is adapted to fit different size fingers, where the second clip is adapted to fit different size sheaths, where the first clip is adapted to release laterally from the single finger, where the second clip is adapted to release laterally from the sheath, where the two clip manipulator attached to the sheath is adapted to position a catheter toward a uterine amniotic cavity.   
     
     
         2 . The two clip manipulator of  claim 1 , where the two clip manipulator is made of one or more materials selected from the group consisting of plastic, metal, organic flexible material, and synthetic flexible material. 
     
     
         3 . The two clip manipulator of  claim 2 , where the plastic is selected from the group consisting of high impact polystyrene, polyphenylene ether and polystyrene impregnated with pentane, a blend of polyphenylene ether and polystyrene impregnated with pentane or polyethylene, polypropylene, polypropylene/polypropylene composites, polycarbonate, low density polyethylene, high density polyethylene, acrylonitrile butadiene styrene copolymers, polyphenoxy ether alloyed with high impact polystyrene, polyether, polyglycol, polyester, polyethylene, poly(halogen)ethylene, polypropylene, polyvinylidene halogen, polymethylmethacrylate, polyacrylonide, polycaprolactone, polylactide, poly butylene succinate, polybutylene succinate adipate, polybutylene succinate terephthalate, poly-hydroxypropionate, poly-hydroxybutyrate, poly-hydroxyvalerate, poly-hydroxyhexanoate, poly-3-hydroxyoctanoate, poly-3-hydroxyphenylvaleric acid and poly-3-hydroxyphenylhexanoic acid. 
     
     
         4 . The two clip manipulator of  claim 1 , where the two clip manipulator is adapted to be attached to a finger glove. 
     
     
         5 . The two clip manipulator of  claim 4 , where the two clip manipulator is detachable from the finger glove. 
     
     
         6 . The two clip manipulator of  claim 1 , adapted to allow the sheath to slide along the catheter to allow the sheath to be withdrawn from the vagina while the catheter remains in position. 
     
     
         7 . The two clip manipulator of  claim 1 , where the sheath further comprises a third fenestration which passes through the distal end and the proximal end, parallel with the second main axis of rotation for the third length. 
     
     
         8 . The two clip manipulator of  claim 7 , adapted to allow the second fenestration to be oriented relative to the third fenestration. 
     
     
         9 . The two clip manipulator of  claim 7 , adapted to allow the second fenestration to be aligned with the third fenestration to allow the sheath to peel from around the catheter to remove the sheath from the catheter while the catheter remains in the uterus. 
     
     
         10 . The two clip manipulator of  claim 1 , where the catheter is selected from the group consisting of an IUPC catheter and a Foley catheter. 
     
     
         11 . A two clip manipulator for introducing and positioning a catheter toward a uterine amniotic cavity comprising:
 (a) a first clip, where the first clip comprises a first arm, a second arm and a first fenestration, where the first arm comprises a first width, a first thickness, a first length and a first curvature, where the second arm comprises the first width, the first thickness, the first length and the first curvature, where the first clip is adapted to surround a single finger while leaving a first gap corresponding to the first fenestration;   (b) a second clip, where the second clip comprises a third arm, a fourth arm and a second fenestration, where the third arm comprises the first width, the first thickness, a second length and a second curvature, where the fourth arm comprises the first width, the first thickness, the second length and the second curvature, where the first length is greater than the second length, where the second curvature is greater than the first curvature, where the second clip is adapted to surround a catheter while leaving a second gap corresponding to the second fenestration, where the catheter comprises a distal end, a proximal end, a third length and a second main axis of rotation, where the second main axis of rotation passes through the proximal end and the distal end;   (c) a common region, where the first clip and the second clip are joined at the common region, where the first fenestration is located on the first main axis of rotation and opposite the common region, where the second fenestration is located on the first main axis of rotation and opposite the common region; and   (d) where the two clip manipulator is made of a flexible material, where the first clip is adapted to fit different size fingers, where the second clip is adapted to fit different size catheters, where the two clip manipulator has a first main axis of rotation passing through the first fenestration, the common region and the second fenestration, where the first main axis of rotation is perpendicular to the second main axis of rotation, where the first clip is adapted to release laterally from the single finger, where the second clip is adapted to release laterally from the catheter, where the two clip manipulator is adapted to position the catheter toward a uterine amniotic cavity.   
     
     
         12 . The two clip manipulator of  claim 11 , where the two clip manipulator is made of one or more materials selected from the group consisting of plastic, metal, organic flexible material, and synthetic flexible material. 
     
     
         13 . The two clip manipulator of  claim 12 , where the plastic is selected from the group consisting of high impact polystyrene, polyphenylene ether and polystyrene impregnated with pentane, a blend of polyphenylene ether and polystyrene impregnated with pentane or polyethylene, polypropylene, polypropylene/polypropylene composites, polycarbonate, low density polyethylene, high density polyethylene, acrylonitrile butadiene styrene copolymers, polyphenoxy ether alloyed with high impact polystyrene, polyether, polyglycol, polyester, polyethylene, poly(halogen)ethylene, polypropylene, polyvinylidene halogen, polymethylmethacrylate, polyacrylonide, polycaprolactone, polylactide, poly butylene succinate, polybutylene succinate adipate, polybutylene succinate terephthalate, poly-hydroxypropionate, poly-hydroxybutyrate, poly-hydroxyvalerate, poly-hydroxyhexanoate, poly-3-hydroxyoctanoate, poly-3-hydroxyphenylvaleric acid and poly-3-hydroxyphenylhexanoic acid. 
     
     
         14 . The two clip manipulator of  claim 11 , where the two clip manipulator is adapted to be attached to a glove. 
     
     
         15 . The two clip manipulator of  claim 14 , where the glove is a finger glove. 
     
     
         16 . The two clip manipulator of  claim 14 , where the two clip manipulator is detachable from the glove. 
     
     
         17 . A kit for positioning a catheter antepartum through a cervix comprising:
 (1) a two clip manipulator comprising:   (a) a first clip, where the first clip comprises a first arm, a second arm and a first fenestration, where the first arm comprises a first width, a first thickness, a first length and a first curvature, where the second arm comprises the first width, the first thickness, the first length and the first curvature, where the first clip is adapted to surround a single finger in a glove while leaving a first gap corresponding to the first fenestration;   (b) a second clip, where the second clip comprises a third arm, a fourth arm and a second fenestration, where the third arm comprises the first width, the first thickness, a second length and a second curvature, where the fourth arm comprises the first width, the first thickness, the second length and the second curvature, where the first length is greater than the second length, where the second curvature is greater than the first curvature, where the second clip is adapted to surround a sheath while leaving a second gap corresponding to the second fenestration, where the sheath comprises a distal end, a proximal end, a third length and a second main axis of rotation, where the second main axis of rotation passes through the proximal end and the distal end;   (c) a common region, where the first clip and the second clip are joined at the common region, where the first fenestration is located on the first main axis of rotation and opposite the common region, where the second fenestration is located on the first main axis of rotation and opposite the common region; and   (d) where the two clip manipulator is made of a flexible material, where the two clip manipulator has a first main axis of rotation passing through the first fenestration, the common region and the second fenestration, where the first main axis of rotation is perpendicular to the second main axis of rotation, where the first clip is adapted to release laterally from the single finger in the glove;   (2) a sheath, where the second clip is adapted to fit the sheath, where the second clip is adapted to release laterally from the sheath, where the two clip manipulator is contoured to allow the sheath to be steered antepartum toward the uterus cavity; and   (3) a catheter with a proximal end and a distal end sized to pass through the sheath with the two clip manipulator attached and thereby through the cervix.   
     
     
         18 . The kit of  claim 17 , where the two clip manipulator is made of one or more materials selected from the group consisting of plastic, metal, organic flexible material, and synthetic flexible material. 
     
     
         19 . The kit of  claim 18 , where the plastic is selected from the group consisting of high impact polystyrene, polyphenylene ether and polystyrene impregnated with pentane, a blend of polyphenylene ether and polystyrene impregnated with pentane or polyethylene, polypropylene, polypropylene/polypropylene composites, polycarbonate, low density polyethylene, high density polyethylene, acrylonitrile butadiene styrene copolymers, polyphenoxy ether alloyed with high impact polystyrene, polyether, polyglycol, polyester, polyethylene, poly(halogen)ethylene, polypropylene, polyvinylidene halogen, polymethylmethacrylate, polyacrylonide, polycaprolactone, polylactide, poly butylene succinate, polybutylene succinate adipate, polybutylene succinate terephthalate, poly-hydroxypropionate, poly-hydroxybutyrate, poly-hydroxyvalerate, poly-hydroxyhexanoate, poly-3-hydroxyoctanoate, poly-3-hydroxyphenylvaleric acid and poly-3-hydroxyphenylhexanoic acid. 
     
     
         20 . The kit of  claim 17 , where the catheter is selected from the group consisting of an IUPC catheter and a Foley catheter.