Devices and methods for disruption and removal of luminal occlusions

Abstract

The subject invention pertains to an elastic sheath, device, and methods for disrupting and/or removing occlusive material from lumens, particularly biological lumens, such as the vasculature, ureter, urethra, fallopian tubes, bile duct, intestines, and the like. The subject invention provides for effective disruption and removal of occlusive material, such as a thrombus, from the body lumen with minimal risk of injury to the lumen wall. Advantageously, the invention can be used to achieve a high degree of removal while minimizing the amount of occlusive material that is released into the body lumen. The subject invention further pertains to methods for disrupting and removing occlusive material from a biological lumen. In another aspect, the present invention concerns a device useful as an in vitro model of luminal occlusion and methods for using the device to test the efficacy of devices and methods for treating luminal occlusions.

1 . A device for occlusion removal and/or disruption comprising:
 a rod;   an elastic sheath that ensheaths a segment of said rod, wherein said sheath has a plurality of slits; and   means for expanding said elastic sheath, and wherein said elastic sheath is displaced from said segment of said rod when said expansion means is activated, and wherein said rod and said elastic sheath cooperate to form a compartment when said expansion means is activated.   
     
     
         2 . The device of  claim 1 , wherein said expansion means comprises an expandable balloon, wherein at least a portion of said expandable balloon is covered by said elastic sheath. 
     
     
         3 . The device of  claim 1 , wherein said plurality of slits are longitudinally arranged around at least a portion of the circumference of said elastic sheath, and wherein each slit is separated from adjacent slits by a longitudinal band of elastic material. 
     
     
         4 . The device of  claim 3 , wherein said longitudinal bands are cross-linked with a plurality of lateral bands that bridge said longitudinal slits, thereby forming a mesh. 
     
     
         5 . The device of  claim 2 , wherein said expandable balloon comprises at least one radially constrained portion and at least one radially unconstrained portion. 
     
     
         6 . The device of  claim 5 , wherein when pressure is applied to said expandable balloon, said at least one radially unconstrained portion expands to form at least one sphere or spheroid shape. 
     
     
         7 . The device of  claim 6 , wherein said at least one radially constrained portion is constrained with a fiber that is wrapped around said at least one radially constrained portion. 
     
     
         8 . The device of  claim 6 , wherein the compartment is substantially conical in shape. 
     
     
         9 . The device of  claim 1 , wherein the elastic sheath comprises a flexible polymer tube. 
     
     
         10 . The device of  claim 1 , wherein the elastic sheath comprises a thermoplastic elastomer. 
     
     
         11 . The device of  claim 1 , wherein the elastic sheath comprises a flexible polymer selected from the group consisting of silicone, polyurethane, silicone-polyurethane copolymer, and styrene-ethylene-butylene-styrene (copolymer). 
     
     
         12 . The device of  claim 1 , wherein said device is at least partially composed of an imageable material.