Hemostasis-enhancing device and method for its use

Abstract

The present invention advantageously provides devices, systems, and methods for percutaneous access and closure of vascular puncture sites. In an embodiment, the device for enhancing the hemostasis of a puncture site in a body lumen or tract comprises a catheter having one tubular member having a proximal end and a distal end with one inner lumen extending between at least a longitudinal portion of the catheter tubular member. The one tubular member includes external and internal tubular bodies each having proximal and distal ends. At least one of the external and the internal tubular bodies is longitudinally movable with respect to the other. An expansible member with proximal and distal ends is disposed on the distal end of the one tubular member. The distal end of the expansible member is connected to the distal end of internal tubular body and with its proximal end connected to the distal end of external tubular body.

1 . A device for enhancing the hemostasis of a puncture site in a body lumen or tract, the device comprising one catheter comprising:
 one tubular member having a proximal end and a distal end with one inner lumen extending between at least a longitudinal portion thereof, the one tubular member comprising external and internal tubular bodies each having proximal and distal ends with at least one of the external and the internal tubular bodies being longitudinally movable with respect to the other; and   one expansible member having proximal and distal ends and disposed on the distal end of the one tubular member with the one expansible member distal end connected to the distal end of internal tubular body and the one expansible member proximal end connected to the distal end of external tubular body.   
     
     
         2 . A device as in  claim 1 , wherein, the one expansible member is configured for expansion in response to the longitudinal movement of at least one of the external or internal tubular bodies with respect to the other. 
     
     
         3 . A device as in  claim 2 , wherein, the external and internal tubular bodies are longitudinally spaced at a predetermined distance from one another. 
     
     
         4 . A device as in  claim 3 , wherein the degree of expansion of the one expansible member is based on a longitudinal displacement between the external and the internal tubular bodies. 
     
     
         5 . A device as in  claim 2 , wherein, the one expansible member comprises a braided filament, mesh layer, spring, coil, slotted tube, or coiled string. 
     
     
         6 . A device as in  claim 5 , wherein the one expansible member comprises a braided filament having small pores. 
     
     
         7 . A device as in  claim 2 , further comprising a distal spacer having a distal spacer thickness attaching the distal end of the one expansible member to an exterior surface of the internal tubular body at a distal end thereof. 
     
     
         8 . A device as in  claim 2 , further comprising a proximal spacer having a proximal spacer thickness attaching the proximal end of the one expansible member to an exterior surface of the external tubular body at a distal end thereof. 
     
     
         9 . A device as in  claim 7 , further comprising a proximal spacer having a proximal spacer thickness attaching the proximal end of the one expansible member to an exterior surface of the external tubular body at a distal end thereof. 
     
     
         10 . A device as in  claim 7 , wherein the one expansible member has an expanded and an unexpanded configuration. 
     
     
         11 . A device as in  claim 10 , wherein in the unexpanded configuration the internal diameter of the one expansible member at the one expansible member distal end is smaller than an internal diameter of the one expansible member at the one expansible member proximal end. 
     
     
         12 . A device as in  claim 10 , wherein in the unexpanded configuration the internal diameter of the one expansible member at the one expansible member distal end is greater than an internal diameter of the one expansible member at the one expansible member proximal end. 
     
     
         13 . A device as in  claim 10 , wherein in the unexpanded configuration the internal diameter of the one expansible member at the one expansible member distal end and proximal end are equal. 
     
     
         14 . A device as in  claim 11 , wherein the one expansible member is configured to fold forward in the expanded configuration. 
     
     
         15 . A device as in  claim 2 , wherein the internal tubular body is configured for fluid communication with a mechanism for removal of bodily fluids from the body lumen. 
     
     
         16 . A device as in  claim 15 , further comprising a hemostatic valve at a proximal end of the one tubular member configured for fluid communication with the blood removal mechanism. 
     
     
         17 . A device as in  claim 1 , wherein the one expansible member is configured for expansion intraluminally within the body lumen at the puncture site. 
     
     
         18 . A device as in  claim 1 , wherein the one expansible member is configured for expansion extraluminally within a fascia along a tissue tract of the puncture site. 
     
     
         19 . A device as in  claim 17 , wherein the one expansible member is at least partially covered with a membrane. 
     
     
         20 . A device as in  claim 2 , wherein the external tubular body is longitudinally movable. 
     
     
         21 . A device as in  claim 2 , wherein the one expansible member is configured for expansion in response to the longitudinal movement of the external tubular body in the distal direction. 
     
     
         22 . A device as in  claim 1 , wherein the one catheter is configured for being slidably disposed over another catheter having another tubular member with proximal and distal ends and another expansible member with proximal and distal ends disposed on the distal end of the another tubular member. 
     
     
         23 . A device as in  claim 22 , wherein at least one of the expansible members is configured for intraluminal expansion within the lumen at the puncture site. 
     
     
         24 . A device as in  claim 22 , wherein the one expansible member is configured for intraluminal expansion within the lumen at the puncture site. 
     
     
         25 . A device as in  claim 22 , wherein the another expansible member is configured for intraluminal expansion within the lumen at the puncture site. 
     
     
         26 . A device as in  claim 22 , wherein both expansible members are configured for intraluminal expansion within the lumen at the puncture site. 
     
     
         27 . A device as in  claim 22 , wherein the one and the another catheters are integrally formed with one another. 
     
     
         28 . A device as in  claim 22 , wherein the one expansible member is configured for extraluminal expansion within a fascia along a tissue tract of the puncture site. 
     
     
         29 . A device as in  claim 28 , wherein the one expansible member is configured to provide compression within the fascia along a tissue tract of the puncture site. 
     
     
         30 . A device as in  claim 22 , wherein hemostasis is achieved, at least in part, by way of extraluminal compression provided by the one expansible member within a fascia along a tissue tract of the puncture site. 
     
     
         31 . A device as in  claim 22 , wherein both the one and the another expansible members are configured for sequential or simultaneous expansion. 
     
     
         32 . A method for enhancing the hemostasis of a puncture site in a body lumen or tract, comprising:
 advancing a hemostatsis enhancing device through the tissue tract; the hemostasis enhancing device including one catheter comprising:   one tubular member having a proximal end and a distal end with one inner lumen extending between at least a longitudinal portion thereof, the one tubular member comprising external and internal tubular bodies each having proximal and distal ends with at least one of the external and the internal tubular bodies being longitudinally movable with respect to the other; and   one expansible member having proximal and distal ends and disposed on the distal end of the one tubular member with the one expansible member distal end connected to the distal end of internal tubular body and the one expansible member proximal end connected to the distal end of external tubular body;   positioning the one catheter distal end at a target location; and   expanding the one expansible member at the target location.   
     
     
         33 . A method according to  claim 32 , wherein the expanding step comprises longitudinally moving at least one of the external or internal tubular bodies of the one catheter with respect to the other. 
     
     
         34 . A method according to  claim 32 , wherein the expanding step comprises distally moving the external tubular body of the one catheter. 
     
     
         35 . A method according to  claim 32 , wherein the hemostasis is achieved at least in part by compression of the one expansible member against at least a portion of the target site. 
     
     
         36 . A method according to  claim 32 , wherein the target site is a fascia along a tissue tract of the puncture site. 
     
     
         37 . A method according to  claim 32 , wherein the target site is a lumen within the body. 
     
     
         38 . A method according to  claim 33 , wherein the expansible member folds forward upon expansion at the target site. 
     
     
         39 . A method according to  claim 32 , further comprising removing bodily fluids from the target site through the one inner lumen. 
     
     
         40 . A method according to  claim 32 , further comprising advancing the one catheter over another catheter having another tubular member with proximal and distal ends and another expansible member with proximal and distal ends disposed on the distal end of the another tubular member. 
     
     
         41 . A method according to  claim 40 , wherein the target site comprises a lumen within the body. 
     
     
         42 . A method according to  claim 40 , wherein the target site comprises a fascia along a tissue tract of the puncture site. 
     
     
         43 . A method according to  claim 40 , wherein the target site comprises a lumen within the body and a fascia along a tissue tract of the puncture site. 
     
     
         44 . A method according to  claim 40 , wherein the another catheter is advanced to the target site prior to advancing of the one catheter to the target site. 
     
     
         45 . A method according to  claim 40 , wherein the one and the another catheter are advanced to the target site simultaneously. 
     
     
         46 . A method according to  claim 32 , wherein the hemostasis enhancing device further includes another catheter having another tubular member with proximal and distal ends and another expansible member with proximal and distal ends disposed on the distal end of the another tubular member. 
     
     
         47 . A method according to  claim 46 , wherein the one and the another catheters are formed integral with one another. 
     
     
         48 . A method according to  claim 46 , wherein the one and the another catheters are advanced to the target site simultaneously. 
     
     
         49 . A method according to  claim 40 , wherein the one expansible member and the another expansible member are both expanded in a lumen of the body. 
     
     
         50 . A method according to  claim 40 , wherein the one expansible member is expanded in the fascia along a tissue tract of the puncture site and the another expansible member is expanded in a lumen of the body. 
     
     
         51 . A method according to  claim 40 , further comprising withdrawing the another catheter proximally out of the body. 
     
     
         52 . A method according to  claim 51 , further comprising withdrawing the one catheter proximally out of the body. 
     
     
         53 . A method according to  claim 46 , further comprising simultaneously withdrawing the one and the another catheter proximally out of the body.