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US 2013/0096545 A1Published application
Small flexible liquid core catheter for laser ablation in body lumens and methods for use
AssigneeRa Medical Systems, Inc.
InventorsJames B. LAUDENSLAGER, Dean S. Irwin, Cesar M. Diaz
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Abstract
Embodiments relate to the design and use of a low profile ablation catheter with a liquid core for use in laser ablation removal of arterial plaque blockages to restore blood flow.
Claims85
A laser catheter system to ablate blockages in body lumens using high energy and high power short duration laser pulses, comprising:
- a high energy, high power short duration ultraviolet pulsed laser source;
- and
- a low profile, kink resistant, torqueable liquid core ablation catheter operatively coupled to the laser source, comprising:
- an elongate multi-layer catheter tube, comprising:
- a base tubular layer including fluorinated or mostly fluorinated material,
- a braided layer disposed over an outside surface of the base tubular layer,
- a over-jacket layer coated over the braided layer and base tubular layer to encapsulate the braided layer, and
- a thin inner luminal layer of a low IR, U.V. transparent, amorphous fluoropolymer having an index of refraction of less than or equal to about 1.33 disposed on an inside surface of the base tubular layer;
- an ultraviolet grade output optical window or window assembly sealed to a surface of the catheter tube;
- a ultraviolet grade input optical window sealed to a surface of the catheter tube at a proximal end of the catheter tube to create a fluid tight core liquid volume;
- and
- a biocompatible U.V. transparent fluid disposed within and completely filling the core liquid volume formed between an inner surface of the thin inner luminal layer, a proximal surface of the output optical window and a distal surface of the input optical window.
9 more elements
A support catheter for use supporting a liquid core ablation catheter, comprising:
- a thin inner tubular layer that comprises an inner lumen with an inner diameter which is configured to accommodate passage of a liquid core ablation catheter and space therebetween sufficient for saline injection to flush blood and contrast fluid in front of the liquid core ablation catheter distal end and that comprises a low friction material to ease passage of the ablation catheter;
- an over layer of high durometer material disposed over the thin inner tubular layer;
- a braided layer disposed over an outer surface of the over layer;
- an outer layer covering the braided layer;
- a wall thickness of less than about 0.006 inches;
- and
- wherein the support catheter has the required torque, pushability and kink resistance to guide the liquid core ablation catheter with a low enough profile to advance through an opening generated by laser ablation of tissue with the liquid core ablation catheter.
4 more elements
The support catheter of claim 29 wherein the angled distal section has a length of about 5 mm to about 50 mm.
The support catheter of claim 29 wherein a discharge axis of the angled distal section forms an angle of about 3 degrees to about 10 degrees with respect to a longitudinal axis of the support catheter.
A multi-lumen support catheter, comprising at least two guidewire lumens and a working lumen configured for passage of an ablation catheter.
A method of ablation of blockages in a lumen of a human vessel, comprising:
- positioning a support catheter at a target site of a blockage of the vessel;
- inserting a liquid core ablation catheter adjacent the blockage;
- injecting saline through an inner lumen of the support catheter to flush contrast fluid and blood from a distal tip of the liquid core ablation catheter;
- advancing the liquid core ablation catheter while lasing and emitting ablation energy from a distal end of the liquid core ablation catheter up to about 5 mm from a distal end of the support catheter;
- repositioning the support catheter and continuing this process until the blockage is traversed.
2 more elements
A method of making a multi-layer catheter tube for a liquid core ablation catheter, comprising:
- extruding a thin inner luminal layer of amorphous fluoropolymer onto a metal mandrel;
- etching an outer surface of the extruded inner luminal layer;
- applying a base layer tube over the etched outer surface of the inner luminal layer;
- applying a braided layer of thin metal filaments onto an outer surface of the baser layer tube with the metal mandrel in place;
- applying an outer jacket layer over an outer surface and braided layer and an outer surface of the base layer tube;
- and
- removing the metal mandrel from the inner luminal layer by stretching the metal mandrel to reduce an outer diameter thereof and withdrawing the metal mandrel from an inner lumen of the inner luminal layer.
4 more elements
A method of making an inner luminal layer of a multi-layer catheter tube of a liquid core ablation catheter, comprising:
- coating a metal mandrel with an inner coat of an amorphous fluoropolymer solution;
- processing the coated mandrel at temperatures above a boiling point of a solvent of the amorphous fluoropolymer solution and above a glass transition temperature (Tg) of an amorphous fluoropolymer material of the amorphous fluoropolymer solution to drive off the solvent and anneal the amorphous fluoropolymer material and form an inner layer;
- coating the processed inner layer of amorphous fluoropolymer with a second coat of amorphous fluoropolymer solution;
- processing the second coat at temperatures above the boiling point of the solvent of the fluoropolymer solution and above the glass transition temperature (Tg) of the fluoropolymer material of the fluoropolymer solution to drive off the solvent and anneal the fluoropolymer material to form a multi-layer inner luminal layer;
- etching an outer surface of the inner luminal layer;
- applying a base layer tube configured as a water barrier over the etched outer surface of the inner luminal layer;
- applying a braided layer of thin metal filaments onto the etched outer surface of the inner luminal layer with the metal mandrel in place;
- applying an outer jacket layer over the etched outer surface and braided layer;
- and
- removing the metal mandrel from the inner luminal layer by stretching the metal mandrel to reduce an outer diameter thereof and withdrawing the metal mandrel from an inner lumen of the inner luminal layer.
7 more elements
A method of making a multi-layer catheter tube for a liquid core ablation catheter, comprising:
- applying a base layer tube configured as a water barrier onto a metal mandrel;
- applying a braided layer of thin metal filaments onto an outer surface of the baser layer tube with the metal mandrel in place;
- applying an outer jacket layer over an outer surface and braided layer and an outer surface of the base layer tube;
- removing the metal mandrel from the inner luminal layer by stretching the metal mandrel to reduce an outer diameter thereof and withdrawing the metal mandrel from an inner lumen of the inner luminal layer;
- drip coating a solution of amorphous fluoropolymer(s) onto an inside surface of the base layer;
- and
- removing a solvent of the solution of amorphous fluoropolymer(s) to form an inner luminal layer of amorphous fluoropolymer(s).
4 more elements
A laser catheter system to ablate blockages in body lumens using high energy and high power short duration laser pulses, comprising:
- a high energy, high power short duration ultraviolet pulsed laser source;
- and
- a low profile, kink resistant, torqueable liquid core ablation catheter operatively coupled to the laser source, comprising:
- an elongate multi-layer catheter tube including a thin inner luminal layer of a low IR, U.V. transparent, amorphous fluoropolymer having an index of refraction of less than or equal to about 1.33 disposed on an inside surface of the base tubular layer;
- an ultraviolet grade output optical window or window assembly sealed to a distal end of the catheter tube;
- an ultraviolet grade input optical window sealed to a proximal end of the catheter tube to create a fluid tight core liquid volume;
- and
- a biocompatible U.V. transparent fluid disposed within and completely filling the core liquid volume formed between an inner surface of the thin inner luminal layer, the output optical window and the input optical window.
5 more elements
A high energy laser coupler, comprising:
- a coupler body including a proximal section with a cylindrical outer surface, an inner bore disposed concentrically within the cylindrical outer surface and extending distally from a proximal end of the coupler body, a window connector bore disposed at a distal end of the inner bore, and a distal section extending distally from the window connector bore;
- a window connector body having a proximal section with a cylindrical outer surface configured to fit closely with an inside surface of the window connector bore of the coupler body, a flange portion disposed at a distal end of the proximal section, a stepped portion extending distally of the flange portion and an inner bore extending the length of the window connector body from a proximal end to a distal end thereof;
- an optical input window disposed within and secured to the inner bore of the window connector body such that a proximal end of the optical input window extends proximally from a proximal end of the proximal section of the window connector body;
- a flexible waveguide catheter tube including a proximal portion thereof disposed over the stepped portion of the window connector body;
- and
- a cylindrical metal sleeve disposed over the proximal portion of the flexible waveguide catheter tube so at to secure the catheter tube to the stepped portion of the window connector body.
3 more elements
A liquid core ablation catheter package assembly, comprising:
- a thin walled hermetically sealed enclosure including an interior volume and comprising a material suitable for gamma sterilization;
- a liquid core ablation catheter disposed within the interior volume of the hermetically sealed enclosure;
- and
- a liquid disposed within the interior volume which is configured to maintain a vapor pressure within the interior volume sufficient to prevent loss of a liquid of a liquid core of the liquid core ablation catheter due to diffusion of the liquid core into the interior volume.
1 more element
An ablation catheter, comprising:
- an elongate catheter body;
- a transmissive core which is configured to transmit high energy laser light and which extends longitudinally from a proximal end to a distal end of the elongate catheter body;
- an input surface in optical communication with the transmissive core at a proximal end of the elongate catheter body;
- an output surface in optical communication with the transmissive core at a distal end of the elongate catheter body;
- and
- a tapered metal housing which includes a distal end having an inner bore that is disposed about the output surface, which includes a distal end that is longitudinally coextensive with a distal end of the output surface, which includes a tapered distal section that terminates distally with a thin wall that facilitates passage of a distal end of the ablation catheter through a lumen within a patient's body and which is configured to be sufficiently radiopaque in such as to be viewable by fluoroscopic imaging during a medical procedure.
3 more elements
Dependencies are inferred from the claim text.