Deflectable variable radius catheters

Abstract

The invention provides a deflectable catheter capable of forming many variable radius spiral forms from a single, flexible, distal end section. In one aspect, the catheter employs a variable radius control wire to extend or deform a pre-formed loop structure into a three dimensional spiral-like form or geometry. The ability of a single catheter to create the multitude of shapes and sizes possible allows users to access a greater number of anatomical areas without changing the catheter during a procedure or treatment. In another aspect, the invention encompasses methods of producing deflectable variable radius catheters, where two or more regions of the catheter having common control wires are fused or formed onto one another.

1 . A catheter comprising 
 a proximal section comprising a shaft and a control section at a proximal end, the control section operably connected to two or more bidirectional control wires and a variable radius control wire; and    a distal section comprising at desired points along its length at least one electrode, a connection point for the variable radius control wire, and a connection point for the at least two bidirectional control wires,    wherein engaging one or more of the bidirectional control causes a left to right motion in the distal section, and wherein engaging the variable radius control wire modifies the radius of the loop.    
     
     
         2 . The catheter of  claim 1 , wherein there are two or more connection points in the distal section for the at least two bidirectional control wires.  
     
     
         3 . The catheter of  claim 2 , wherein the two or more connection points are pull rings around the circumference of the catheter.  
     
     
         4 . The catheter of  claim 1 , further comprising a shape wire at the distal section.  
     
     
         5 . The catheter of  claim 4 , wherein the shape wire is a Nitinol composition.  
     
     
         6 . The catheter of  claim 4 , wherein the radius control wire is connected to a distal end and the distal end comprises a tip electrode.  
     
     
         7 . The catheter of  claim 1 , wherein the distal section comprises an exterior polymer cover.  
     
     
         8 . The catheter of  claim 7 , wherein the polymer is a flexible polyether block amide.  
     
     
         9 . The catheter of  claim 8 , wherein more than one polymer composition is used along the length of the distal section and at least two polymer compositions have different hardness properties.  
     
     
         10 . The catheter of  claim 1 , wherein there are two bidirectional control wires contained in at least a first compression coil and the variable radius control wire is contained within at least a second compression coil.  
     
     
         11 . The catheter of  claim 10 , wherein the second compression coil is inside the lumen of the first compression coil.  
     
     
         12 . The catheter of  claim 10 , wherein a portion of the bidirectional control wires are flattened wires.  
     
     
         13 . The catheter of  claim 11 , wherein a portion of the control wires are flattened, and wherein the flattened sections are connected at one end to a first pull ring.  
     
     
         14 . The catheter of  claim 13 , wherein a second pull ring is positioned at a different point along the length of the distal section than the first pull ring.  
     
     
         15 . The catheter of  claim 7 , wherein the external surface of the distal section comprises at least one sensing electrode.  
     
     
         16 . The catheter of  claim 8 , wherein the external surface of the distal section comprises at least one sensing electrode.  
     
     
         17 . The catheter of  claim 15 , wherein the external surface comprises at least 5 sensing electrodes and a tip electrode.  
     
     
         18 . The catheter of  claim 16 , wherein the external surface comprises at least 5 sensing electrodes and a tip electrode.  
     
     
         19 . A method of forming a desired three dimensional loop form in a catheter distal section, for positioning the catheter in an intracardial or epicardial area, comprising 
 providing a catheter having at least one control wire and at least one variable radius control wire;    inserting the catheter into a patient and advancing the catheter end to an epicardial or intracardial position;    engaging at least one control wire; and    engaging the variable radius control wire to modify the radius of a loop form.    
     
     
         20 . The method of  claim 19 , wherein the catheter comprises two bidirectional control wires and a variable radius control wire.  
     
     
         21 . The method of  claim 19 , wherein the control wire is housed in a first compression coil along the length of the catheter, and the variable radius control wire is housed in a second compression coil along the length of the catheter.  
     
     
         22 . A deflectable catheter comprising 
 a flexible distal end section having a tip or tip electrode and a proximal end having two or more actuators for controlling the shape of the distal end section;    a first control wire connected to a desired point in a central catheter shaft;    a variable radius control wire connected at or near the tip or tip electrode of the distal end section;    a central catheter shaft connecting the distal end section to the proximal end;    an actuator at the proximal end that engages the first control wire to produce a desired deflection in the distal end section; and    an actuator at the proximal end that engages the variable radius control wire to modify a loop form at the distal end.    
     
     
         23 . The deflectable catheter of  claim 22 , wherein the distal end section is covered by one or more flexible polymer compositions  
     
     
         24 . The deflectable catheter of  claim 23 , wherein the polymer composition is selected from polyether block amide (PEBA); polyethylene; polyetherimide; polypropylene; polyetheretherketone (PEEK); polytetrafluoroethylene (PTFE); Ultra High Molecular Weight (UHMW) polyethylene; high density polyethylene (HDPE); polyimide; polyaryletherketones; polyetheretherketones; polyurethane; polypropylene; oriented polypropylene; polyethylene; crystallized polyethylene terephthalate; polyethylene terephthalate; polyester; polyoxymethylene; polyamide-imide (PAI); polyoxymethylene (POM), acetal resin; and polyvinylidene fluoride.  
     
     
         25 . The deflectable catheter of  claim 24 , wherein two or more polymer compositions having different hardness properties on a durometer scale are selected.  
     
     
         26 . The deflectable catheter of  claim 22 , wherein the first control wire is housed in the first compression coil and the variable radius control wire is housed in the second compression coil.  
     
     
         27 . The deflectable catheter of  claim 22 , wherein the distal end section further comprises a shape wire.  
     
     
         28 . The deflectable catheter of  claim 27 , wherein the shape wire and first control wire are connected or bonded to each other.  
     
     
         29 . The deflectable catheter of  claim 27 , wherein the first control wire is the shape wire.  
     
     
         30 . The deflectable catheter of  claim 22 , wherein the first control wire has a distal section with a flattened shape.  
     
     
         31 . The deflectable catheter of  claim 30 , wherein the first control wire has a transition point from a flattened shape to a round shape.  
     
     
         32 . The deflectable catheter of  claim 30 , wherein the flattened shape is connected to a pull ring.  
     
     
         33 . The deflectable catheter of  claim 32 , wherein the pull ring comprises two separated circumferential sections.  
     
     
         34 . The deflectable catheter of  claim 22 , further comprising a second control wire.  
     
     
         35 . The deflectable catheter of  claim 34 , the first and second control wires are housed in a first compression coil.  
     
     
         36 . The deflectable catheter of  claim 35 , wherein the variable radius control wire is housed in a second compression coil.  
     
     
         37 . The deflectable catheter of  claim 36 , further comprising a braided reinforcing member along a desired length of the catheter, the braided reinforcing and positioned internal to an external polymer covering.  
     
     
         38 . The deflectable catheter of  claim 34 , further comprising a shape wire in the distal end section.  
     
     
         39 . The deflectable catheter of  claim 34 , further comprising a third control wire connected to a desired point at or near the tip or tip electrode of the distal end section.  
     
     
         40 . The deflectable catheter of  claim 34 , further comprising a fourth control wire connected to a desired point at or near the tip or tip electrode of the distal end section.  
     
     
         41 . The deflectable catheter of  claim 39 , wherein at least one of the first, second or third control wires is covered in PTFE tubing.  
     
     
         42 . The deflectable catheter of  claim 40 , wherein at least one of the first, second, third, or fourth control wires has a distal section with a flattened shape.  
     
     
         43 . The deflectable catheter of  claim 42 , wherein the flattened shape is connected to a pull ring.  
     
     
         44 . The deflectable catheter of  claim 42 , wherein the at least two control wires has a distal section with a flattened shape and both flattened control wires are connected to at least one pull ring.  
     
     
         45 . The deflectable catheter of  claim 27 , where the two compression coils extend from the proximal end and terminate at different points along the length of the catheter.  
     
     
         46 . The deflectable catheter of  claim 27 , where the two compression coils extend from the proximal end and terminate at the same point along the length of the catheter.