Aspiration devices for treatment of thrombosis including expandable distal ends and systems and methods thereof

Abstract

Described herein are systems, devices, and methods for treating a thrombosis. In some embodiments, an apparatus may include a sleeve defining a first lumen, and an aspiration catheter defining a second lumen, the aspiration catheter slidably disposed within the first lumen. The aspiration catheter may include a proximal end coupleable to a vacuum source configured to apply a vacuum pressure within the second lumen to draw a thrombus into the second lumen, and an expandable tip configured to transition between a retracted configuration in which the expandable tip is constrained within the sleeve and an expanded configuration in which at least a portion of the expandable tip is disposed distal to the sleeve. The expandable tip in the expanded configuration can have a funnel-shaped profile that gradually increases in diameter from a proximal end of the expandable tip to a distal end of the expandable tip.

We Claim: 
     
         1 . An apparatus, comprising:
 a sleeve defining a first lumen; and   an aspiration catheter defining a second lumen, the aspiration catheter slidably disposed within the first lumen, the aspiration catheter including:
 a proximal end coupleable to a vacuum source configured to apply a vacuum pressure within the second lumen to draw a thrombus from a vessel into the second lumen; and 
 an expandable tip configured to transition between a retracted configuration in which the expandable tip is constrained within the sleeve and an expanded configuration in which at least a portion of the expandable tip is disposed distal to the sleeve, 
 the expandable tip in the expanded configuration having a funnel-shaped profile that gradually increases in diameter from a proximal end of the expandable tip to a distal end of the expandable tip, 
 the expandable tip in the expanded configuration having a pinch strength of between about 0.4 lb and about 3 lb when disposed within the vessel such that the expandable tip in the expanded configuration is configured to withstand collapse from pressure gradients being generated within the expandable tip as the vacuum pressure acts on the thrombus within the expandable tip, 
 the expandable tip in the expanded configuration further configured to be retractable into the sleeve in response to a retracting force of between about 0.5 lbs and about 4.0 lbs. 
   
     
     
         2 . The apparatus of  claim 1 , wherein the expandable distal tip includes a metallic frame and a coating that is disposed over the metallic frame. 
     
     
         3 . The apparatus of  claim 2 , wherein the metallic frame defines a plurality of open cells, and the coating as an inner layer and an outer layer that connect to one another at the plurality of open cells. 
     
     
         4 . The apparatus of  claim 3 , wherein each of the plurality of open cells has an area of at least about 0.5 mm 2  to enable the inner and outer layers of the coating to connect to one another at each open cell. 
     
     
         5 . The apparatus of  claim 1 , wherein the expandable distal tip includes a metallic frame that defines a plurality of open cells, the plurality of open cells increasing in size from the proximal end to the distal end of the expandable tip. 
     
     
         6 . The apparatus of  claim 5 , wherein the metallic frame further includes an atraumatic wave-shaped ring at the distal end of the expandable tip. 
     
     
         7 . The apparatus of  claim 5 , wherein open cells of the plurality of open cells disposed at the proximal end of the expandable tip have a length of at least about 2 mm and open cells of the plurality of open cells disposed at the distal end of the expandable tip have a length of less than about 5 mm, when the expandable tip is in the retracted configuration. 
     
     
         8 . The apparatus of  claim 5 , wherein open cells of the plurality of open cells disposed at the proximal end of the expandable tip have a proximal angle of at least about −10° and open cells of the plurality of open cells disposed at the distal end of the expandable tip have a proximal angle of less than about 40°, when the expandable tip is in the expanded configuration. 
     
     
         9 . The apparatus of  claim 1 , wherein the aspiration catheter defines at least one opening disposed near the proximal end of the expandable tip, the at least one opening configured to increase fluid available to mix with the thrombus to improve flow of the thrombus proximally through the second lumen. 
     
     
         10 . The apparatus of  claim 1 , further comprising:
 a flexible shaft having a distal end disposable within the expandable tip of the aspiration catheter,   the distal end of the flexible shaft configured to rotate within the expandable tip or within 1 cm of a proximal end of the expandable tip when the expandable tip is in the expanded configuration to engage and break portions of the thrombus disposed within the expandable tip.   
     
     
         11 . An apparatus, comprising:
 a sleeve defining a first lumen; and   an aspiration catheter defining a second lumen, the aspiration catheter including:
 a proximal end coupleable to a vacuum source configured to apply a vacuum pressure within the second lumen to draw a thrombus from a vessel into the second lumen; 
 an expandable tip disposable within the vessel, the expandable tip configured to transition between a retracted configuration in which the expandable tip is constrained within the sleeve and an expanded configuration in which at least a portion of the expandable tip is disposed distal to the sleeve, 
 the expandable tip in the expanded configuration having a funnel-shaped profile that gradually increases in diameter from a proximal end of the expandable tip to a distal end of the expandable tip; and 
 an elongate body extending between the proximal end of the aspiration catheter and a proximal end of the expandable tip, the elongate body having a linear proximal section and a flexible curved section disposed near the expandable tip, 
 at least one of the elongate body and the sleeve configured to translate relative to the other of the elongate body and the sleeve to selectively control a degree of exposure of the expandable tip and the memory-set curved section outside of the sleeve to change a degree of curvature of the memory-set curved section and a position of the expandable tip within the vessel. 
   
     
     
         12 . The apparatus of  claim 11 , wherein the elongate body is further configured to rotate within the first lumen to change the position of the expandable tip within the vessel. 
     
     
         13 . The apparatus of  claim 11 , wherein the memory-set curved section, when at least partially extended from the distal end of the sleeve, is configured to have a radius of curvature between about 10 mm and about 40 mm. 
     
     
         14 . The apparatus of  claim 11 , wherein the sleeve has a curved section. 
     
     
         15 . The apparatus of  claim 14 , wherein the elongate body is further configured to rotate within the first lumen to change a relative orientation of the memory-set curved section with respect to the curved section of the sleeve such that a total radius of curvature of the aspiration catheter can be adjusted. 
     
     
         16 . The apparatus of  claim 11 , wherein the expandable distal tip includes a metallic frame and a coating that is disposed over the metallic frame. 
     
     
         17 . The apparatus of  claim 11 , wherein the expandable distal tip includes a metallic frame that defines a plurality of open cells, the plurality of open cells increasing in size from the proximal end to the distal end of the expandable tip. 
     
     
         18 . The apparatus of  claim 17 , wherein the metallic frame further includes an atraumatic wave-shaped ring at the distal end of the expandable tip. 
     
     
         19 . The apparatus of  claim 17 , wherein open cells of the plurality of open cells disposed at the proximal end of the expandable tip have a length of between about 0.5 mm and about 3 mm and open cells of the plurality of open cells disposed at the distal end of the expandable tip have a length of between about 3 mm and about 10 mm, when the expandable tip is in the retracted configuration. 
     
     
         20 . The apparatus of  claim 17 , wherein open cells of the plurality of open cells disposed at the proximal end of the expandable tip have a proximal angle of between about −10° and about 0° and open cells of the plurality of open cells disposed at the distal end of the expandable tip have a proximal angle of between about 20° and about 40° when the expandable tip is in the expanded configuration. 
     
     
         21 . The apparatus of  claim 11 , further comprising:
 a flexible shaft having a distal end disposable within the expandable tip of the aspiration catheter,   the distal end of the flexible shaft configured to rotate within the expandable tip when the expandable tip is in the expanded configuration to engage and break portions of the thrombus disposed within the expandable tip.   
     
     
         22 . A system, comprising:
 an aspiration catheter defining a lumen, the aspiration catheter including:
 a proximal end coupleable to a vacuum source configured to apply a vacuum pressure within the lumen to draw a thrombus from a vessel into the lumen; 
 an expandable tip configured to transition between a retracted configuration in which the expandable tip is constrained within an outer sleeve and an expanded configuration in which at least a portion of the expandable tip is disposed distal to the outer sleeve, 
 the expandable tip in the expanded configuration having a funnel-shaped profile that gradually increases in diameter from a proximal end of the expandable tip to a distal end of the expandable tip; and 
   a flexible shaft disposable within the lumen of the aspiration catheter, the flexible shaft configured to extend from the proximal end of the aspiration catheter to the expandable tip such that a distal end of the flexible shaft is disposed within in the expandable tip or  1  cm from a proximal end of the distal tip,   the distal end of the flexible shaft having a non-linear configuration and being configured to rotate within the expandable tip when the expandable tip is in the expanded configuration to engage and break portions of the thrombus disposed within the expandable tip.   
     
     
         23 . The system of  claim 22 , further comprising:
 a handle assembly coupled to a proximal end of the aspiration catheter, the handle assembly including at least one actuator configured to rotate or translate the aspiration catheter.   
     
     
         24 . The system of  claim 23 , further comprising:
 a drive system coupled to a proximal end of the flexible shaft and configured to rotate the flexible shaft,   the drive system being releasably coupleable to the handle assembly.   
     
     
         25 . The system of  claim 24 , further comprising:
 an activation element configured to activate the vacuum pressure and to activate the drive system to rotate the flexible shaft.   
     
     
         26 . The system of  claim 25 , wherein the activation element is a button, the button configured to (1) activate the vacuum pressure in response to being depressed a first amount and (2) activate the drive system in response to being depressed a second amount greater than the first amount. 
     
     
         27 . The system of  claim 22 , further comprising the outer sleeve,
 the outer sleeve and the aspiration lumen defining an annular space configured to deliver a fluid into an area near the thrombus.   
     
     
         28 . The system of  claim 27 , further comprising a handle assembly coupled to a proximal end of the aspiration catheter and to a proximal end of the sleeve, the handle assembly including:
 a first actuator configured to rotate the aspiration catheter; and   a second actuator configured to translate at least one of the sleeve or the aspiration catheter relative to the other of the sleeve or the aspiration catheter.