Transluminal devices, systems and methods for enlarging interstitial penetration tracts

Abstract

Methods, apparatus and systems for enlarging interstitial penetration tracts which have been formed between blood vessels or elsewhere within the body of a mammalian patient. Included are debulking-type tract enlarging systems, dilation-type tract enlarging systems, tissue-slicing-type tract enlarging systems and two-catheter-type tract enlarging systems.

What is claimed is:  
     
         1 . An advanceable debulking system for enlarging an interstitial tract which extends outwardly from the lumen of an anatomical conduit, said system comprising: 
 a counter-traction member which is advanceable, in a first direction, at least partially through the interstitial tract, said counter-traction member having at least one tissue engagement surface formed thereon to engage tissue which is adjacent the interstitial tract, said counter-traction member being useable to apply a force which is directed in a second direction substantially opposite said first direction, upon the tissue which has been engaged by said tissue-engagement member; and,    a debulker which is advanceable out of the lumen of the sheath, in the first direction, to remove tissue which lies adjacent the interstitial tract, thereby enlarging the interstitial tract.    
     
     
         2 . The system of  claim 1  wherein the debulker is an elongate member having a lumen which extends longitudinally therethrough, and wherein said counter-traction member extends coaxially through the lumen of the debulker.  
     
     
         3 . The system of  claim 1  wherein the debulker has a distal end, and wherein a tissue-receiving chamber is formed in the distal end of the debulker such that tissue which has been removed by the debulker will enter said tissue-receiving chamber.  
     
     
         4 . The system of  claim 1  wherein a guidewire lumen extends through said counter-traction member such that said counter-traction member may be advanced over a guidewire which extends through the interstitial tract.  
     
     
         5 . The system of  claim 1  further comprising a sheath having a lumen extending longitudinally therethrough, the lumen of said sheath being sized to permit said debulker and said countertraction member to pass therethrough.  
     
     
         6 . The system of  claim 5  wherein said sheath has a distal end opening out of which said debulker and said countertraction member are passable.  
     
     
         7 . The system of  claim 6  wherein said sheath has a side opening out of which said debulker and said countertraction member are passable.  
     
     
         8 . The system of  claim 7  wherein the lumen of the sheath further comprises a deflector surface which is configured and located to deflect said debulker out of said side opening as said debulker is advanced in the distal direction therethrough.  
     
     
         9 . The system of  claim 1  wherein said debulker comprises an elongate member having a distal end whereupon an annular cutter is mounted, said annular cutter having a sharpened leading edge so as to sever tissue as it is advanced in the first direction.  
     
     
         10 . The system of  claim 9  wherein at least the annular cutter of said debulker is rotatable.  
     
     
         11 . The system of  claim 9  further comprising a motor for rotatably driving at least the annular cutter of said debulker.  
     
     
         12 . The system of  claim 1  wherein said countertraction member comprises an elongate shaft having a radially expandable tissue-engaging apparatus formed thereon, said radially expandable tissue-engaging apparatus having: 
 a) a radially collapsed configuration which is sufficiently small in diameter to pass at least partially through the interstitial tract; and,  
 b) a radially expanded configuration which is sufficiently large in diameter to engage tissue which surrounds the interstitial tract.  
 
     
     
         12 . The system of  claim 11  wherein said radially expandable apparatus is selected from the group of radially expandable apparatus consisting of: 
 i.) a balloon;  
 ii.) at least one barb;  
 iii.) at least one hook;  
 iv.) a plurality of outwardly curving tissue engagement members, each of said having proximal and distal ends which are attached to the shaft and outwardly curving mid-sections, the mid sections of said tissue engagement members being curved outwardly from said shaft when said  
 v.) a plurality of splayable tissue engagement members having distal ends which are unattached to the shaft of the counter-traction member and positioned at spaced apart locations thereabout, the distal ends of said tissue engagement members being splayable outwardly from the shaft when in their radially expanded configuration;  
 and,  
 vi.) a resilient tubular member which has a radially flared distal end, the flared distal end of said resilient tubular member being advanceable, in the first direction, from the distal end of the shaft of said counter-traction member.  
 
     
     
         13 . The system of  claim 1  wherein the debulker further comprises: at least one energy-transmitting member which may be connected to an energy source, said energy transmitting member being operative to transmit energy from an energy source connected thereto, to a location on the debulker at which said energy will enhance the ability of the debulker to remove tissue.  
     
     
         14 . The system of  claim 13  wherein the energy-transmitting member is a member which transmits radio-frequency energy.  
     
     
         15 . The system of  claim 14  further comprising: a radio-frequency generator attached to said energy-transmitting member.  
     
     
         16 . The system of  claim 14  wherein said debulker is an elongate member which has a tissue-severing surface formed on the distal end thereof, and wherein the energy-transmitting member is positioned and constructed to transmit radiofrequency energy to the tissue-severing surface of the debulker.  
     
     
         17 . The system of  claim 16  wherein the tissue-severing surface comprises a leading edge formed on an annular cutting member.  
     
     
         18 . The system of  claim 1  further comprising: A dilator formed on the distal end of said counter-traction member to dilate the interstitial tract as the counter-traction member is advanced therethrough.  
     
     
         19 . The system of  claim 18  wherein the dilator is a frusto-conical dilator member having a distal end of a first diameter and a proximal end of a second diameter larger than said first diameter.  
     
     
         20 . The system of  claim 18  wherein: the counter-traction member has a longitudinal axis; and, an annular tissue-abutment surface is formed on the proximal end of the frus which is generally perpendicular to the longitudinal axis of the counter-traction member.  
     
     
         21 . The system of  claim 20  wherein: an annular cutting member is formed on the distal end of the debulker; and, the annular tissue abutment surface comprises a cutting plate which is sized, configured and positioned such that when the debulker is advanced in the first direction, the annular cutting member will register with the cutting plate.  
     
     
         22 . A retractable debulking system for enlarging an interstitial tract which extends outwardly from the lumen of an anatomical conduit, said system comprising: 
 a tubular, proximal counter-force member which has at least one tissueengaging surface formed on the distal end thereof, said proximal counter-force member being advanceable into the lumen of the anatomical conduit from which said interstitial tract extends such that its tissue-engaging surface engages tissue adjacent the interstitial tract; and, a retractable debulker which is advanceable out of the distale end of the proximal counter-force member and through the interstitial tract in a first direction, said debulker being subsequently retractable in a second direction opposite said first direction, said debulker having a at least one tissue removing surface formed on the proximal end thereof to remove tissue located adjacent the interstitial tract as the debulker is retracted in the second direction through the interstitial tract; said proximal counter-traction member being operative to apply a counterforce in the first direction against the tissue adjacent the interstitial tract, as the debulker is being retracted in the second direction to remove said tissue.    
     
     
         23 . The system of  claim 22  wherein the retractable debulker has aproximal tissue cutting surface, and wherein a tissue-receiving chamber is formed with the debulker adjacent to said tissue cutting surface, such that tissue which has been removed by the debulker will enter said tissue-receiving chamber.  
     
     
         24 . The system of  claim 22  wherein a guidewire lumen extends through said retractable debulker such that said retractable debulker may be advanced over a guidewire which extends through the interstitial tract.  
     
     
         25 . The system of  claim 22  further comprising a sheath having a lumen extending longitudinally therethrough, the lumen of said sheath being sized to permit said debulker and said countertraction member to pass therethrough.  
     
     
         26 . The system of  claim 25  wherein said sheath has a distal end opening out of which said debulker and said countertraction member are passable.  
     
     
         27 . The system of  claim 25  wherein said sheath has a side opening out of which said debulker and said countertraction member are passable.  
     
     
         28 . The system of  claim 27  wherein the lumen of the sheath further comprises a deflector surface which is configured and located to deflect said debulker out of said side opening as said debulker is advanced in the distal direction therethrough.  
     
     
         29 . The system of  claim 22  wherein said retractable debulker comprises an elongate member having a proximal end whereupon an annular cutter is mounted, said annular cutter having a sharpened leading edge so as to sever tissue as it is retracted the proximal direction throught he penetration tract.  
     
     
         30 . The system of  claim 29  wherein at least the annular cutter of said retractable debulker is rotatable.  
     
     
         31 . The system of  claim 9  further comprising a motor for rotatably driving at least the annular cutter of said debulker.  
     
     
         32 . A laser debulking apparatus, useable for enlarging an interstitial penetration tract, said apparatus comprising: 
 an elongate flexible member having a guidewire lumen extending longitudinally therethorugh;    a plurality of laser transmitting members extending longitudinally through said flexible member, said laser transmitting members being disposed in a generally annular array,    each of said laser transmitting members having a distal end associated with a laser light transmitting surface whereby laser light from that laser transmitting member will be projected from said flexible member, such that when laser energy is concurrently passed through all of said laser transmitting members, a generally annular patern of laser light will be projected from said apparatus.    
     
     
         33 . The apparatus of  claim 32  further comprising a suction lumen extending through said flexible member to apply suction to the area into which said pattern of laser light is projected.  
     
     
         34 . A laser debulking apparatus, useable for enlarging an interstitial penetration tract, said apparatus comprising: 
 an elongate flexible member having a guidewire lumen extending longitudinally therethorugh;    a laser transmitting member extending longitudinally through said flexible member;    a prism having at least one light guide groove formed therein, said prism being rotatably positioned on the end of said laser transmitting member such that laser energy which passes through said laser transmitting member will pass into said prism and will be caused by said at least one light guide groove and the concurrent rotation of said prism, to be projected in a generally conical pattern from said apparatus.    
     
     
         35 . The apparatus of  claim 34  further comprising a suction lumen extending through said flexible member to apply suction to the area into which said pattern of laser light is projected.  
     
     
         36 . The apparatus of  claim 34  wherein said laser transmitting member is rotatable, and wherein said prism is mounted on the distal end of said laser transmitting member so as to rotate concurrently with said laser transmitting member.  
     
     
         37 . A laser debulking apparatus, useable for enlarging an interstitial penetration tract, said apparatus comprising: 
 an elongate flexible member having a guidewire lumen extending longitudinally therethorugh;    a laser transmitting member extending longitudinally through said flexible member;    a prism having a plurality of light guide grooves formed therein, said light guide grooves being disposed in a generally annular array, said prism being positioned on the end of said laser transmitting member such that laser energy which passes through said laser transmitting member will pass into said prism and will be caused by said plurality light guide grooves to be projected in a generally conical pattern, from said apparatus.    
     
     
         38 . The apparatus of  claim 37  further comprising a suction lumen extending through said flexible member to apply suction to the area into which said pattern of laser light is projected.