Method and device for vascular therapy

Abstract

Medical devices, as well as methods of treatment and manufacturing such devices, are provided for applying vascular therapy locally within the body vessel. The medical devices include an expandable tubular frame and a sleeve. The medical devices can be used for local delivery of a therapeutic agent within a body vessel or a tamponade for a lacerated body vessel, while simultaneously allowing perfusion of fluid or blood flow distal of the implanted medical device. The tubular frame of the medical device can have a middle region with a plurality of members. The members can expand radially outward away from a longitudinal axis of the tubular frame, which can urge the sleeve to contact the wall of the body vessel. In the expanded configuration, a portion of the device allows fluid flow to continue while the sleeve is against the body vessel wall.

1 . A method of preventing hemorrhaging from within a body vessel, while maintaining fluid perfusion through the body vessel, the method comprising:
 introducing a system through the body vessel, the system comprising a catheter shaft and a medical device, the medical device being introduced in a compressed configuration, wherein the catheter shaft is fixedly attached to a proximal end of the medical device, and the medical device comprises a tubular frame defining a lumen about a longitudinal axis, the tubular frame comprising an expandable region capable of expanding from the compressed configuration to an expanded configuration, the tubular frame comprising a plurality of members extending along a length from the proximal end to the expandable region, and along the length the members being generally equally spaced from each other, wherein when the tubular frame is in the expanded configuration, the members extend outward from the proximal end to the expandable region, the members thereby forming unobstructed arc-shaped interstices between each of the members and between the proximal end and the expandable region, and a sleeve attached to the expandable region of the tubular frame;   radially expanding the expandable region of the tubular frame from the compressed configuration to the expanded configuration so that the expandable region is placed in close proximity to the body vessel wall and the sleeve is urged to contact the wall of the body vessel; and   maintaining the sleeve in contact with the wall of the body vessel to apply vascular therapy within the body vessel, where the vascular therapy comprises treating a lacerated hole extending laterally through an entire vessel wall of the body, the sleeve preventing hemorrhaging from the body, while the interstices permit fluid flow to areas distal from the medical device, the catheter remaining attached to the medical device while the fluid flows through the interstices.   
     
     
         2 . The method of  claim 1 , wherein the sleeve further comprises a therapeutic agent, where the therapeutic agent is configured to be delivered to the wall of the body vessel. 
     
     
         3 . The method of  claim 2 , wherein the therapeutic agent comprises a pro-coagulant. 
     
     
         4 . The method of  claim 1 , further comprising injecting a therapeutic agent at said lacerated hole. 
     
     
         5 . The method of  claim 1 , wherein the sleeve further comprises a remodelable material. 
     
     
         6 . The method of  claim 5 , wherein the remodelable material comprises a foamed extracellular matrix. 
     
     
         7 . The method of  claim 1 , wherein the system further comprises a sheath disposed around the catheter, the sheath positionable around the medical device to maintain the medical device in the compressed configuration during the introducing step, where the sheath is slidably removed from the medical device during the expanding step. 
     
     
         8 . The method of  claim 7 , further comprising the step of re-compressing the expandable region of the medical device to the compressed configuration by sliding the sheath over the medical device after the maintaining step. 
     
     
         9 . The method of  claim 1 , wherein the expandable region of the tubular frame has a first diameter in the compressed configuration and a second diameter in the expanded configuration that is greater than the first diameter, where the first diameter is substantially identical to the diameter of the proximal end of the medical device in the compressed configuration. 
     
     
         10 . The method of  claim 1 , wherein the expandable region is self-expanding. 
     
     
         11 . The method of  claim 1 , wherein the expandable region mechanically expands by translating one of a distal end of the tubular frame and the proximal end toward each other. 
     
     
         12 . The method of  claim 11 , wherein a pull member is attached to the distal end, the expandable region thereby mechanically expanding when the pull member is pulled to translate the distal end toward the proximal end. 
     
     
         13 . The method of  claim 1 , wherein along the length from the proximal end to the expandable region the members are generally straight along a longitudinal direction of the longitudinal axis. 
     
     
         14 . The method of  claim 1 , wherein the members extend along an entire length of the expandable region. 
     
     
         15 . The method of  claim 14 , wherein along the expandable region the members are generally equally spaced from each other and generally straight along a longitudinal direction of the longitudinal axis. 
     
     
         16 . The method of  claim 1 , wherein the tubular frame comprises a non-expandable distal end, the expandable region being a middle region between the proximal end and the distal end. 
     
     
         17 . The method of  claim 16 , wherein the members extend along a length from the expandable region to the distal end and along the length the members are generally equally spaced from each other and generally straight along the longitudinal direction of the longitudinal axis, wherein when the tubular frame is in the expanded configuration, the members extend inward from the expandable region to the distal end, the members thereby forming unobstructed arc-shaped interstices between each of the members and between the expandable region and the distal end. 
     
     
         18 . The method of  claim 16 , further comprising a dilator at the distal end of the tubular frame. 
     
     
         19 . The method of  claim 1 , wherein the members extend along an entire length of the expandable region, a series of open slots being disposed between each of the members along the expandable region, the members thereby lying in immediate contiguous proximity to each other in the compressed configuration. 
     
     
         20 . The method of  claim 1 , wherein the expandable region is self-expanding, the system further comprises a sheath disposed around the catheter, the sheath positionable around the medical device to maintain the medical device in the compressed configuration during the introducing step, where the sheath is slidably removed from the medical device during the expanding step, further comprising the step of re-compressing the expandable region of the medical device to the compressed configuration by sliding the sheath over the medical device after the maintaining step, wherein the members extend along an entire length of the expandable region, and along the expandable region the members are generally equally spaced from each other.