Eclipse Surgical Technologies, Inc.

The Uab Research Foundation

Trimedyne, Inc.

Other

Jeffrey J Giba

Michael J Horzewski

Douglas R Murphy-Chutorian

James Edward Wilson

Samuel M Shaolian

Raymond E Ideker

Gregory P Walcott

Donald A Richardson

Richard L Mueller

Marvin P Loeb

To Van Pham

Stuart D Harman

Hung H Cao

Claudio I Zanelli

Fred G Kinley

Vahid Saadatmanesh

Randall J Blair

Vahid Saadat

Mark Roush

Michael A Davis

A conformable catheter comprising a catheter handle, an elongated catheter tube, and a distal tip portion of the catheter tube, capable of assuming a desired pre-programmed shape. A wire member is disposed within the core of the catheter's tip portion and is formed of a material, such as, for example, a shape-memory binary nickel-titanium alloy, that will assume a pre-programmed shape after pre-shaping, heat treatment, cooling and subsequent heating. To pre-program the shape of the wire member, prior to assembly of the catheter, the wire member is wound around a shaped, heat resistant fixture, heated until the temperature of the wire member exceeds the temperature at which the shape of the wire member on the fixture becomes programmed into the wire member, and cooled. Upon subsequent heating of the wire member above its activation temperature after inclusion of the wire member into the catheter tubing, such as by controllably connecting the wire member to an electrical power source, the wire member, and thus the catheter's tip portion, assumes the pre-programmed curved or bent shape from its normally straight generally linear disposition.

Method of making a catheter

An elongated steerable catheter for placement within a heart chamber, organ aperture or other body opening and having at least one center tube with hollow passageway for guiding a laser delivery means or other functional device to selected surfaces of a heart chamber, organ aperture or other body cavity for laser or other treatment thereon, particularly adapted for laser-assisted percutaneous transmyocardial revascularization (TMR), is disclosed herein. The steerable catheter has a handle portion at its proximal end and a controllably deflectable end portion at its distal end. The elongated center tube has a distal end, in the region where a curvature is to be formed, and a shim anchor sleeve is slidably disposed over the center tube. The shim anchor sleeve is attached to the inside wall of the outer jacket and coupled to the distal end of the center tube with a bendable shim member which extends between the distal tip of the steerable catheter and the sleeve over the center tube. Opposite the shim is a guide for a pull cable, the pull cable attached to the distal end of the steerable catheter and extending through the guide to the handle. Thus, the shim is maintained radially opposite the pull cable with the center tube in between. An outer jacket has, in a preferred embodiment, distinct sections of different stiffness or durometer. A distal, more flexible portion is coupled to a proximal, stiffer portion. The shim anchor sleeve is positioned at or near the junction of two portions of the outer jacket. Thus, the center tube moves freely through the shim anchor sleeve. Adjacent the handle, the outer jacket terminates at the catheter base. The pull cable extends past the catheter base, through a deflection housing tube, and terminates in a cable stop. Rotation of a deflection knob threadably mounted onto the deflection housing tube will cause the pull cable to be pulled backward, or the outer jacket to be pushed forward, relative to each other, thereby inducing deflection of the distal end of the steerable catheter.

Steerable catheter

Method of forming revascularization channels in myocardium using a

A treatment tool such as a catheter, MIS or other surgical tool apparatus for placement within a heart chamber, organ aperture or other body opening and axial ranging therein, the apparatus particularly adapted for laser-assisted percutaneous transmyocardial revascularization (MTR). At the distal end of the tool is an annular ultrasound transducer with associated structure, positioned to transmit ultrasound signals substantially axially aligned with the axis of the treatment tool to the cardiovascular tissue, the transducer further receiving returning signals from the cardiovascular tissue to be treated. In a preferred embodiment, the transducer comprises a piezoelectric crystal material. The transducer assembly is attached to the distal tip of the tool such that a laser delivery means or other functional device can be extended through the lumen of the tool and the annular ultrasound transducer. In a preferred embodiment, the invention is a modular ultrasound device capable of being detachably attached to a steerable catheter, MIS or other surgical tool apparatus. The system also comprises a signal interface extending from the ultrasound transducer and signal processing component operatively connected to the signal interface for real time determination of at least one boundary surface of cardiovascular tissue relative to one or more positions of the distal tip of the treatment tool. A method of delivering laser energy to tissue is disclosed, the method including the steps of positioning the firing tip of a laser delivery means adjacent the front surface of the tissue, delivering laser energy to the tissue, transmitting ultrasound energy to the tissue, receiving ultrasound signals reflected from at least the rear surface of the tissue, and determining the distance betwveen the firing tip of the laser delivery means and the rear surface of the tissue. In a preferred embodiment, the method includes quantitative determination of the contractility or motion of the beating heart, such that changes in the depth of tissue can be used to control the channel depth or other treatment parameters. Retrolasing can also be achieved by mechanically piercing the tissue to a determined depth based on axial ranging measurements, and retracting the treatment tool while simultaneously delivering laser energy therefrom.

Ultrasound device for axial ranging

A conformable catheter comprising a catheter handle, an elongated catheter tube, and a distal tip portion of the catheter tube, capable of assuming a desired pre-programmed shape. A wire member is disposed within the core of the catheter's tip portion and is formed of a material, such as, for example, a shape-memory binary nickel-titanium alloy, that will assume a pre-programmed shape after pre-shaping, heat treatment, cooling and subsequent heating. To pre-program the shape of the wire member, prior to assembly of the catheter, the wire member is wound around a shaped, heat resistant fixture, heated until the temperature of the wire member exceeds the temperature at which the shape of the wire member on the fixture becomes programmed into the wire member, and cooled. Upon subsequent heating of the wire member above its activation temperature after inclusion of the wire member into the catheter tubing, such as by controllably connecting the wire member to an electrical power source, the wire member, and thus the catheter's tip portion, assumes the pre-programmed curved or bent shape from its normally straight, generally linear disposition.

Shape memory catheter

Therapeutic appliance releasing device

A method of selecting laser parameters for performing laser-assisted myocardial revascularization to avoid inducing undesired cardiac arrhythmia without synchronization of delivery of laser energy and the patient's cardiac cycle, the method comprising the steps of minimizing the power level of laser energy used, thereby decreasing the overall trauma to the heart, selecting a pulse frequency as great as possible while avoiding adverse summation effects, selecting a pulse width as wide as possible to prevent excessively high peak powers per pulse and not so wide as to cause undesired thermal damage, selecting an energy flux rate, shaping the front end of each pulse of laser energy to provide efficient, non-explosive TMR channeling, and correcting the selected power level, pulse width, pulse frequency and energy flux rate for mechanical events, including method of access to the heart, position of selected portions of myocardium in the heart, temporal duration of the procedure, natural movement of the heart, specific heart geometry, pre-existing heart arrhythmia and other factors causing a predisposition to heart arrhythmia. A method for performing laser-assisted transmyocardial revascularization (TMR) and percutaneous transluminal myocardial revascularization (PTMR) using such laser energy with parameters selected to avoid inducing undesired cardiac arrhythmia, the method comprising the steps of generating laser energy having a predetermined non-square wave shape, a predetermined wavelength, a predetermined energy flux and a predetermined power level, and delivering the laser energy in a plurality of pulses, the plurality of pulses having a predetermined pulse frequency and a predetermined pulse width, to selected portions of myocardium to form TMR and PTMR channels without synchronizing delivery of the laser beam with the cardiac cycle.

Method for non-synchronous laser-assisted myocardial revascularization

A spiral catheter apparatus for access to, and laser or other treatment within, cavities and organs in the human body, the apparatus comprising a flexible, main catheter shaft defining a central axis of the apparatus, the catheter shaft having a proximal end, a distal end and a first hollow lumen region extending therethrough, the catheter shaft further having a spiral portion adjacent the distal end with a selected curvilinear shape, the curvilinear shape defining an inner arcuate sidewall and an outer arcuate sidewall, the catheter shaft flexible enough to assume a temporarily elongated shape such that the apparatus can be extended through at least a portion of the body in the temporarily elongated shape and will assume the selected curvilinear shape when extended into a body cavity or organ, the selected curvilinear shape serving to securely position the apparatus adjacent a selected surface within the body cavity or organ, at least the spiral portion of the catheter shaft having a plurality of guide holes thereon, the plurality of guide holes disposed at least on the outer arcuate sidewall in communication with the first lumen such that a distal end of a laser delivery means or other functional device can be controllably advanced through the plurality of guide holes for laser or other treatment on the selected surface.

Spiral catheter with multiple guide holes

A bow shaped, integrated wire catheter apparatus and method of use for access to, and laser or other treatment within, cavities and organs in the human body, the apparatus having a curvilinear shape but flexible enough to assume a generally elongated shape such that the apparatus can be extended through the vasculature in the generally elongated shape and can assume the curvilinear shape when extended into a body cavity or organ, the curvilinear shape serving to securely position the apparatus adjacent a selected surface within the body cavity or organ for laser or other treatment with a laser delivery device or other functional device thereon, the apparatus having a central axis, the apparatus comprising a main catheter shaft having a proximal end and an apex seeking and stabilizing distal end, the main catheter shaft having material of construction or other mechanism or means for causing a portion of the catheter shaft to have a bowed shape adjacent its distal end, the main catheter shaft having at least one hollow lumen extending axially and at least partially therethrough such that a bow shaped portion defines and distinguishes an outer arcuate sidewall for placement in contact with the selected area or areas for laser or other treatment thereon, and an inner arcuate sidewall, at least the outer arcuate sidewall having one or more guide holes disposed thereon for selectively providing laser or other treatment on the selected surface by controllably advancing a laser delivery device or other functional device selectively through the one or more guide holes to the selected surface. The catheter apparatus can be made at least partially of superelastic and/or shape memory materials of construction.

Bow shaped catheter

A spiral catheter apparatus and method of use for access to, and laser or other treatment within, cavities and organs in the human body, the apparatus having a spiral member with a selected curvilinear shape, but flexible enough to assume a temporarily elongated shape such that the spiral member can be extended through the vasculature in the temporarily elongated shape and will assume the selected curvilinear shape when extended into a body cavity or organ, the spiral member formed of a superelastic or other material, the selected curvilinear shape serving to securely position the spiral member adjacent a selected surface within the body cavity or organ for laser or other treatment with a laser delivery device or other functional device on a selected surface, the apparatus further having a main catheter shaft with at least two hollow lumens extending therethrough, the first lumen for slidably guiding the main catheter shaft over the spiral member into a first position adjacent the selected surface, and the second lumen having a guide hole adjacent the distal end of the main catheter shaft for advancing a laser delivery device or other functional device through the guide hole for laser or other treatment on the selected surface within the body cavity or organ.

Guided spiral catheter

A catheter suitable for the delivery of laser energy to an obstruction in a body lumen is provided, which has an expandable, elastic distal end portion containing optical fibers whose exposed distal end faces are arranged in two or more substantially concentric arrays that merge into a narrower band array of a larger diameter upon radial expansion of the elastic distal end portion. The distal end portion of the catheter is more elastomeric than the catheter body.

Growing community of inventors

Moreno Valley, CA, United States of America

Jeffrey J Giba