Method and device for locating guidewire and treating chronic total occlusions

Abstract

Devices, methods, kits, and methods remove obstructive material from the vasculature and other body lumens. Expansible baskets may be used as cooperating radially expansible shearing members. Helically oriented struts of each basket may wind in a uniform circumferential direction. The struts can be independently flexible, allowing the shearing members to flex axially together. The inner basket may be rotatably driven and may use an axial pump extending proximally from the shearing members and/or a distal penetrator for advancing into an occlusion which inhibits guidewire access. The struts may slide substantially continuously across each other, and may be sufficiently aggressive for highly effective thrombectomy. A rotationally static and axially flexible outer basket may provide a safe, limited atherectomy treatment.

What is claimed is:  
     
         1 . A vascular obstruction removal catheter comprising: 
 a flexible tubular body having a proximal end and a distal end;    an outer shearing member attached near the distal end, the outer member having a perforate inner surface;    an inner shearing member rotatably disposed within the outer member, the inner member having a proximal portion, a distal portion, and a circumferential series of struts extending therebetween, the struts sliding along the inner surface of the outer shearing member when the inner shearing member rotates.    
     
     
         2 . The vascular obstruction removal catheter of    claim 1   , wherein the inner member rotates about an axis, and wherein the inner and outer shearing bodies are sufficiently flexible to deflect the axis laterally when the outer shearing member engages a surrounding vessel and the inner member rotates therein.  
     
     
         3 . The vascular obstruction removal catheter of    claim 1   , wherein the struts comprise helical struts and uniformly coil distally toward a first circumferential orientation so that rotation of the inner shearing member toward the first circumferential orientation consistently urges sheared occlusive material proximally.  
     
     
         4 . The vascular obstruction removal catheter of    claim 1   , wherein the inner shearing member comprises tube material, the struts being separated by laser cut surfaces between adjacent tube material portions.  
     
     
         5 . The vascular obstruction removal catheter of    claim 4   , further comprising an expansible covering extending between adjacent struts of the outer basket to capture debris.  
     
     
         6 . The vascular obstruction removal catheter of    claim 4   , wherein the outer shearing member comprises outer tube material having a proximal outer portion, a distal outer portion and a circumferential series of outer struts extending helically therebetween, the struts being separated by laser cut outer surfaces between outer adjacent tube material portions.  
     
     
         7 . The vascular obstruction removal catheter of    claim 1   , wherein the struts are affixed together at the proximal portion and at the distal portion, and wherein the struts flex independently therebetween.  
     
     
         8 . The vascular obstruction removal catheter of    claim 1   , wherein the struts are helically oriented, and wherein a local pitch of the struts varies axially along the struts.  
     
     
         9 . The vascular obstruction removal catheter of    claim 8   , wherein the local pitch increases toward the proximal and distal portions sufficiently to inhibit excessive separation between adjacent struts when the outer shearing member flexes axially.  
     
     
         10 . The vascular obstruction removal catheter of    claim 9   , wherein the struts have protrusions which inhibit sliding of obstructive material axially between cooperating edges of the inner and outer shearing bodies.  
     
     
         11 . The vascular obstruction removal catheter of    claim 1   , wherein at least one expansion actuator extends proximally from the shearing members so that the inner and outer shearing members can be radially expanded in situ.  
     
     
         12 . The vascular obstruction removal catheter of    claim 11   , wherein axial translation of an expansion actuator selectively radially expands the inner and outer shearing members concurrently.  
     
     
         13 . The vascular obstruction removal catheter of    claim 1   , further comprising a distally oriented occlusion penetrator adjacent the distal end.  
     
     
         14 . The vascular obstruction removal catheter of    claim 13   , wherein the occlusion penetrator comprises at least one end cutter that rotates with the inner shearing member and is exposed distally of the outer shearing member to advance the shearing members within a body lumen distally through occlusive material.  
     
     
         15 . The vascular obstruction removal catheter of    claim 13   , wherein the occlusion penetrator comprises a shaft extendable distally of the shearing members, the shaft axially cycleable through occlusive material without penetrating through a vessel wall.  
     
     
         16 . The vascular obstruction removal catheter of    claim 1   , further comprising an intravascular ultrasound sensor to measure of vascular obstructions for removal.  
     
     
         17 . A vascular obstruction removal catheter comprising: 
 a flexible tubular body having a proximal end and a distal end;    a flexible drive shaft rotatably disposed within the tubular body;    an outer shearing member attached near the distal end of the tubular body, the outer member having a circumferential series of independent outer struts, the outer struts having inner surfaces;    an inner shearing member rotationally driven by the drive shaft within the outer member, the inner member having a circumferential series of independent inner struts, the inner struts having outer surfaces which slide across the inner surfaces of the outer struts when the inner shearing member rotates, at least one member of the group comprising the inner struts and the outer struts being helically oriented.    
     
     
         18 . The vascular obstruction removal catheter of    claim 17   , wherein the outer shearing member has an embolic debris capture coating.  
     
     
         19 . The vascular obstruction removal catheter of    claim 17   , wherein the inner and outer shearing members each have proximal portions and distal portions, the struts of each shearing member affixed together at the proximal and distal portions and extending independently therebetween so that the shearing members flex axially primarily along the struts.  
     
     
         20 . The vascular obstruction removal catheter of    claim 17   , further comprising a proximal housing coupled to the tubular body, the housing having a motor drivingly engaging the drive shaft.  
     
     
         21 . The vascular obstruction removal catheter of    claim 20   , wherein the drive shaft engages the distal portion of the inner shearing member, wherein the drive shaft is axially translatable relative to the outer tubular member from adjacent the proximal housing, and wherein an axial bearing surfaces of the outer and inner shearing members cooperate to effect concurrent radial expansion of the inner and outer shearing members when the drive shave translates axially.  
     
     
         22 . A method for forming a vascular obstruction removal catheter, the method comprising: 
 providing a first tube having a proximal end and a distal end with a central region therebetween, the tube comprising a tube material;    cutting axially along the central region of the first tube so as to define a circumferential series of independent struts, the struts comprising the tube material;    positioning the first cage coaxially with a second resiliently deformable cage; and    attaching a drive for rotating at least one of the cages within a blood vessel for shearing of obstructive material between the cages.    
     
     
         23 . A method for removing obstructive material from a blood vessel of a patient, the method comprising: 
 introducing a distal portion of a catheter into the blood vessel;    positioning the distal portion of the catheter adjacent the obstructive material from outside the patient by manipulating a flexible body of the catheter;    radially expanding inner and outer shearing members of the catheter within the blood vessel; and    rotating the inner shearing member within the outer shearing member to shear the occlusive material therebetween.    
     
     
         24 . A component for use in a catheter device for removal of obstructive material from the lumen of a body conduit, said component comprising: 
 first and second end portions having a longitudinal axis therebetween;    a middle portion having at least one second cross sectional diameter and further comprising one or more flexible struts around the circumference of said longitudinal axis and extending between, but not along, said first end portion and said second end portion; and    wherein said middle portion and said end portions are formed from a continuous tube.    
     
     
         25 . The component of    claim 24    wherein said struts comprise a helix about said longitudinal axis.  
     
     
         26 . The component of    claim 24   , wherein said struts are formed in a straight configuration along said longitudinal axis and between said first and second end portions.  
     
     
         27 . The component of    claim 24   , wherein the struts have a width and a radial thickness, wherein said width is greater than said thickness.  
     
     
         28 . The vascular obstruction removal catheter of    claim 24   , wherein the outer shearing member has a coating or covering which allows capture of embolic debris.  
     
     
         29 . The component of    claim 27    wherein said width of said strut is varied along the length of said strut.  
     
     
         30 . The component    claim 29    wherein said width is varied along the length of said strut so as to form at least one serration or pocket.  
     
     
         31 . The component of    claim 27    wherein the thickness of said strut is varied along the length of said strut.  
     
     
         32 . The component of    claim 27    wherein said thickness of said strut is varied along the length of said strut so as to form a cutting edge.  
     
     
         33 . The component of    claim 24    wherein cross sections of said first and said second end portions is less than a cross section of said middle section.  
     
     
         34 . The component of    claim 24   , wherein said component is formed by laser cutting, by photoetching, by EDM, or by water jet abrasion.  
     
     
         35 . The component of    claim 24   , wherein said first and second end portions are formed in a zigzag configuration.  
     
     
         36 . The component of    claim 24   , wherein said first and second end portions have a longitudinal length that is less than that of said middle portion.  
     
     
         37 . The component of    claim 24    wherein said component comprises a shape memory metal.  
     
     
         38 . The component of    claim 37    wherein said shape memory metal comprises a nickel titanium alloy.  
     
     
         39 . The component of    claim 37    wherein said shape memory metal comprises Elgiloy®.  
     
     
         40 . The component of    claim 24    wherein said component comprises stainless steel.  
     
     
         41 . The component of    claim 24    wherein said component comprises a formable polymer.  
     
     
         42 . The component of    claim 24    wherein said component comprises a composite material.  
     
     
         43 . A component for use in a catheter device for removal of obstructive material from the lumen of a body conduit, said component comprising: 
 first and second end portions having a longitudinal axis there between;    a middle portion having a plurality of struts forming a helix around the circumference of said longitudinal axis and extending between but not including, said first end portion and said second end portion,    wherein said middle portion and said end portions are formed from a continuous tube.    
     
     
         44 . A component of    claim 43   , wherein said plurality of struts are axially connected to adjacent struts by an expandable connector element.  
     
     
         45 . A component of    claim 44    wherein said expandable connector element has a serpentine configuration.  
     
     
         46 . A component of    claim 44    wherein said expandable connector element has a zigzag configuration.  
     
     
         47 . A device for treating a total occlusion in a vessel having a vessel wall, the device comprising: 
 a catheter body having a proximal end, a distal end and a lumen;    a radially expansible positioning cage near the distal end of the catheter body;    a shaft disposed in the catheter body lumen, the shaft advanceable into the total occlusion without penetrating through the vessel wall when the positioning cage is radially expanded.    
     
     
         48 . A device of    claim 47    wherein the shaft comprises a dottering member extendable beyond the catheter body distal end.  
     
     
         49 . A device of    claim 47    further comprising a mechanical pump received within the catheter body lumen.  
     
     
         50 . A device of    claim 47    wherein the radially expansible positioning cage has a coating or covering which allows capture of embolic debris.  
     
     
         51 . A device of    claim 47    further comprising a macerator extending at least partially along the length of said lumen adjacent the distal end.  
     
     
         52 . A method of removing a total occlusion from the vessel of a patient, the method comprising: 
 providing a positioning cage catheter system having a proximal end, a distal end and a lumen therethrough;    introducing said catheter system into a vessel of a patient and advancing it to the site of the occlusion to be treated;    radially expanding a positioning cage of the catheter system within the vessel to position a lumen of the catheter system;    advancing an occlusion penetrator of the catheter system within the positioned lumen and into the occlusion along a luminal length of the occlusion;    manipulating the catheter system to advance a guidewire or guide catheter distally of the occlusion.    
     
     
         53 . A method of removing a total occlusion from the vessel of a patient comprising the following steps: 
 providing a positioning cage catheter device having a proximal end, a distal end and a lumen therethrough;    introducing said positioning cage catheter device into a vessel of a patient and advancing it to the site of the occlusion to be treated;    further advancing said positioning cage catheter device to engage the occlusion to be treated such that a pilot hole is formed at a given point along the length of the occlusion to be treated;    advancing a guidewire device through the position cage catheter device lumen;    manipulating the positioning cage catheter device and said guidewire device such that the guidewire can be advanced through the pilot hole of the occlusion and positioned past the distal portion of the occlusion to be treated.