Enhanced cross stream mechanical thrombectomy catheter with backloading manifold

Abstract

An enhanced cross stream mechanical thrombectomy catheter with backloading manifold having a distal end with outflow and inflow orifices at one side for producing concentrated cross stream jet flow for selective and concentrated thrombus ablation during thrombectomy procedures. The invention provides for suitable distancing of high powered ablation or suction forces from the near walls of the vasculature. Cross stream flow emanating from the one side of the distal end of the catheter resultantly urges the distal end of the catheter and thus the opposing non-orificed side of the distal end of the catheter toward and against the vascular wall to inhibit contact of the inflow orifice with the vascular wall. Features of the invention include a geometrically configured insert to facilitate the backloading or exchange of guidewires.

1 . A cross stream fluid jet catheter for removal of unwanted material from a body vessel or cavity comprising: 
 a. a catheter tube having a proximal end and a distal end and a lumen and a wall, said catheter tube having an inflow orifice and an outflow orifice through said wall;    b. a high pressure tube having a proximal end and a distal end and located at least in part within said lumen of said catheter tube and aligned with at least one of said inflow orifice and said outflow orifice;    c. a fluid jet emanator in fluid communication with said distal end of said high pressure tube, said fluid jet emanator having at least one jet orifice for directing at least one high velocity fluid jet in a generally proximal direction from said fluid jet emanator;    d. means for retaining said high pressure tube in alignment with said catheter tube; and,    e. a manifold affixed to said proximal end of said catheter tube, said manifold having surfaces configured to pass a guidewire in either forward or backward direction through said manifold and having a seal configured to pass a guidewire in fluid-tight relation in either forward or backward direction through said manifold, said manifold also providing fluid-tight connection for passage of high pressure fluid and for passage of exhaust fluid and debris.    
     
     
         2 . The cross stream fluid jet catheter of  claim 1 , wherein at least one of said inflow orifice and said outflow orifice is configured in a shape selected from the group of shapes consisting of round, oval, elliptical, obround, tapered, slotted, rectangular, triangular, rounded corner, protruding, and multiple-radius.  
     
     
         3 . The cross stream fluid jet catheter of  claim 1 , wherein at least one of said inflow orifice and said outflow orifice is configured to direct flow in a preferred direction.  
     
     
         4 . The cross stream fluid jet catheter of  claim 1 , further comprising a shaped external surface for mechanical abrasion of unwanted material in a body vessel or cavity.  
     
     
         5 . The cross stream fluid jet catheter of  claim 1 , further comprising a deflector to direct flow through said outflow orifice.  
     
     
         6 . The cross stream fluid jet catheter of  claim 1 , further comprising: 
 a. at least one jet orifice in said fluid jet emanator for directing at least one high velocity fluid jet in a generally distal direction from said fluid jet emanator; and,    b. a deflector for redirecting distal high velocity fluid jet flow out of said catheter tube.    
     
     
         7 . The cross stream fluid jet catheter of  claim 1 , wherein said high pressure tube is aligned to partially block said outflow orifice.  
     
     
         8 . The cross stream fluid jet catheter of  claim 1 , wherein said outflow orifice is configured to create a cross stream jet and a reaction force which tends to deflect the distal portion of said catheter tube.  
     
     
         9 . The cross stream fluid jet catheter of  claim 1 , wherein at least a portion of said catheter tube comprises a reinforcing component selected from the group of reinforcing components consisting of fibers, wound strands, rings, braids, wraps, or combinations thereof.  
     
     
         10 . The cross stream fluid jet catheter of  claim 1 , wherein said catheter tube comprises polyimide.  
     
     
         11 . The cross stream fluid jet catheter of  claim 1 , wherein said means for retaining includes a support ring forming part of said fluid jet emanator, said support ring having a central passageway with a beveled annular surface for directing a guidewire into said central passage.  
     
     
         12 . The cross stream fluid jet catheter of  claim 1 , wherein said means for retaining comprises: 
 a. at least one support ring affixed to said high pressure tube; and,    b. at least one radiopaque marker band configured to fit to said at least one support ring for providing a mechanical bond to said catheter tube at the location of said at least one support ring.    
     
     
         13 . A fluid jet catheter for removal of unwanted material from a body vessel or cavity comprising: 
 a. a catheter tube having a proximal end and a distal end and a lumen and a wall, said catheter tube having an inflow orifice and an outflow orifice through said wall;    b. a high pressure tube having a proximal end and a distal end and located at least in part within said lumen of said catheter tube;    c. a fluid jet emanator in fluid communication with said distal end of said high pressure tube, said fluid jet emanator having at least one jet orifice for directing at least one high velocity fluid jet from said fluid jet emanator;    d. means for retaining said high pressure tube in alignment with said catheter tube; and,    e. a manifold affixed to said proximal end of said catheter tube, said manifold having surfaces configured to pass a guidewire in either forward or backward direction through said manifold and having a seal configured to pass a guidewire in fluid-tight relation in either forward or backward direction through said manifold, said manifold also providing fluid-tight connection for passage of high pressure fluid and for passage of exhaust fluid and debris.    
     
     
         14 . The fluid jet catheter of  claim 13 , further comprising a manifold insert having a central passageway and a slot intersecting with said central passageway.  
     
     
         15 . A thrombectomy system comprising: 
 a. a fluid jet thrombectomy catheter comprising: 
 (1) a catheter tube having a proximal end and a distal end and a lumen and a wall, said catheter tube having an inflow orifice and an outflow orifice through said wall;  
 (2) a high pressure tube having a proximal end and a distal end and located at least in part within said lumen of said catheter tube;  
 (3) a fluid jet emanator in fluid communication with said distal end of said high pressure tube, said fluid jet emanator having at least one jet orifice for directing at least one high velocity fluid jet from said fluid jet emanator;  
 (4) means for retaining said high pressure tube in alignment with said catheter tube; and,  
 (5) a manifold affixed to said proximal end of said catheter tube, said manifold having surfaces configured to pass a guidewire in either forward or backward direction through said manifold and having a seal configured to pass a guidewire in fluid-tight relation in either forward or backward direction through said manifold, said manifold also providing fluid-tight connection for passage of high pressure fluid and for passage of exhaust fluid and debris; and,  
   b. a high pressure fluid source means.    
     
     
         16 . The thrombectomy system of  claim 15 , further comprising suction means to draw fluid and debris from the proximal end of said catheter tube, said suction means being connectible to said fluid-tight connection for passage of exhaust fluid and debris.  
     
     
         17 . The thrombectomy system of  claim 15 , further comprising an insert having a central passageway with a beveled surface entrance and fitting a guidewire passage of said manifold to facilitate passage of a guidewire within said guidewire passage of said manifold.  
     
     
         18 . The thrombectomy system of  claim 15 , wherein the high pressure fluid source means provides fluid in the range of 100 psi to 20,000 psi.  
     
     
         19 . A method for fabricating a fluid jet catheter comprising the steps of: 
 a. providing a catheter tube having an outflow orifice and an inflow orifice;    b. providing a high pressure tube and a fluid jet emanator in fluid communication with and attached to the high pressure tube;    c. providing at least one support ring and at least one band;    d. attaching the at least one support ring to the high pressure tube;    e. inserting the high pressure tube and attached fluid jet emanator and at least one support ring into the catheter tube;    f. aligning the high pressure tube and attached fluid jet emanator and at least one support ring in the catheter tube so that the high pressure tube is at least partially blocking at least one of the outflow orifice and inflow orifice; and,    g. applying the at least one band external to the catheter tube to align with the at least one support ring, thereby affixing the high pressure tube, the fluid jet emanator, the at least one support ring, and the catheter tube to maintain these components in a desired configuration.    
     
     
         20 . A method for treating unwanted material in a body vessel or cavity comprising the steps of: 
 a. providing a fluid jet catheter having a catheter tube with an inflow orifice and an outflow orifice, a high pressure tube aligned to at least one of the inflow orifice and outflow orifice, a fluid jet emanator in fluid communication with the high pressure tube, the fluid jet emanator being constructed to enable a guidewire to be directed in either direction past the fluid jet emanator, and a manifold affixed to and fluidly coupled to the catheter tube and high pressure tube and having surfaces which are configured to direct a guidewire in either forward or backward direction through the manifold and having a seal which is configured to pass a guidewire in fluid-tight relation in either forward or backward direction through said manifold;    b. introducing the fluid jet catheter into the body vessel or cavity by passage over a guidewire in the body vessel or cavity;    c. providing a source of high pressure fluid to the high pressure tube thereby causing at least one high velocity fluid jet to emanate from the fluid jet emanator and create entrainment through the inflow orifice and a recirculation flow out the outflow orifice and back in through the inflow orifice;    d. positioning the guidewire at a desired location with respect to the fluid jet emanator and inflow orifice and outflow orifice; and,    e. using the at least one high velocity fluid jet to remove unwanted material from a location in the body vessel or cavity.    
     
     
         21 . The method of  claim 20 , further comprising the step of removing unwanted material from the body vessel or cavity by passage along the catheter tube.  
     
     
         22 . The method of  claim 20 , further comprising the steps of: 
 a. providing a guidewire introducer having a central passageway with a beveled surface entrance; and,    b. inserting the guidewire introducer into the manifold to aid in backloading a guidewire into the manifold.    
     
     
         23 . A cross stream fluid jet catheter for removal of unwanted material from a body vessel or cavity comprising: 
 a. a catheter tube having a proximal end and a distal end and a lumen and a wall, said catheter tube having, in longitudinal alignment, an inflow orifice, an outflow orifice, and an evacuation orifice through said wall, said inflow orifice located distally of said outflow orifice and said evacuation orifice located proximally of said outflow orifice;    b. a high pressure tube having a proximal end and a distal end and located at least in part within said lumen of said catheter tube and aligned with at least one of said inflow orifice and said outflow orifice;    c. a fluid jet emanator in fluid communication with said distal end of said high pressure tube, said fluid jet emanator having at least one jet orifice for directing at least one high velocity fluid jet in a generally proximal direction from said fluid jet emanator;    d. a deflector in the lumen, the deflector having a distally located deflector face longitudinally angled with respect to the catheter and aligned with and oriented to the outflow orifice, the deflector blocking the lumen between the outflow orifice and the evacuation orifice; and,    e. a manifold affixed to said proximal end of said catheter tube, said manifold having surfaces configured to pass a guidewire in either forward or backward direction through said manifold and having a seal configured to pass a guidewire in fluid-tight relation in either forward or backward direction through said manifold, said manifold also providing fluid-tight connection for passage of high pressure fluid and for passage of exhaust fluid and debris.    
     
     
         24 . A fluid jet catheter for removal of unwanted material from a body vessel or cavity comprising: 
 a. a catheter tube having a proximal end and a distal end and a lumen and a wall, said catheter tube having an outflow orifice and an inflow orifice and an evacuation orifice in ordered longitudinal alignment from distal to proximal and through said wall;    b. a high pressure tube having a proximal end and a distal end and located at least in part within said lumen of said catheter tube;    c. a multidirectional fluid jet emanator in fluid communication with said distal end of said high pressure tube, said fluid jet emanator having at least one jet orifice for directing at least one high velocity fluid jet from said fluid jet emanator in one direction and at least one jet orifice for directing at least one high velocity fluid jet from said fluid jet emanator in another direction;    d. a deflector having a proximal angled deflector face in alignment with the outflow orifice for directing flow out of said outflow orifice; and,    e. a manifold affixed to said proximal end of said catheter tube, said manifold having surfaces configured to pass a guidewire in either forward or backward direction through said manifold and having a seal configured to pass a guidewire in fluid-tight relation in either forward or backward direction through said manifold, said manifold also providing fluid-tight connection for passage of high pressure fluid and for passage of exhaust fluid and debris.    
     
     
         25 . A cross stream fluid jet catheter for removal of unwanted material from a body vessel or cavity comprising: 
 a. a catheter tube having a proximal end and a distal end and a lumen and a wall, said catheter tube having, adjacent the distal end, a curved section and a reversed section, defining an inwardly facing aspect and an outwardly facing aspect, the inwardly facing aspect of the reversed section having an inflow orifice and an outflow orifice through said wall and being in ordered longitudinal alignment thereon;    b. a high pressure tube having a proximal end and a distal end and located at least in part within said lumen of said catheter tube and aligned with at least one of said inflow orifice and said outflow orifice;    c. a fluid jet emanator in fluid communication with said distal end of said high pressure tube, said fluid jet emanator having at least one jet orifice for directing at least one high velocity fluid jet in a generally proximal direction from said fluid jet emanator, said fluid jet emanator situated distal of the outflow orifice; and,    d. a manifold affixed to said proximal end of said catheter tube, said manifold having surfaces configured to pass a guidewire in either forward or backward direction through said manifold and having a seal configured to pass a guidewire in fluid-tight relation in either forward or backward direction through said manifold, said manifold also providing fluid-tight connection for passage of high pressure fluid and for passage of exhaust fluid and debris.    
     
     
         26 . A cross stream fluid jet catheter for removal of unwanted material from a body vessel or cavity comprising: 
 a. a catheter tube having a proximal end and a distal end and a lumen and a wall, said catheter tube having a major paired inflow orifice and outflow orifice through said wall, the major paired inflow orifice and outflow orifice having ordered longitudinal alignment from distal to proximal, and at least one additional minor paired inflow orifice and outflow orifice having ordered longitudinal alignment and additionally having symmetrical angular opposition relative to the major paired inflow orifice and outflow orifice;    b. a high pressure tube having a proximal end and a distal end and located at least in part within said lumen of said catheter tube and aligned with at least one of said major paired inflow orifice and outflow orifice;    c. a fluid jet emanator in fluid communication with said distal end of said high pressure tube, said fluid jet emanator having at least one jet orifice for directing at least one high velocity fluid jet in a generally proximal direction from said fluid jet emanator;    d. means for retaining said high pressure tube in alignment with said catheter tube;    e. a manifold affixed to said proximal end of said catheter tube, said manifold having surfaces configured to pass a guidewire in either forward or backward direction through said manifold and having a seal configured to pass a guidewire in fluid-tight relation in either forward or backward direction through said manifold, said manifold also providing fluid-tight connection for passage of high pressure fluid and for passage of exhaust fluid and debris; and,    f. wherein the at least one minor paired inflow orifice and outflow orifice produce an additional cross stream jet flow less than provided by the major paired inflow orifice and outflow orifice.