Method of forming revascularization channels in myocardium using a steerable catheter

• US 6,126,654 A
• Filed: 02/24/1999
• Issued: 10/03/2000
• Est. Priority Date: 04/04/1997
• Status: Expired due to Fees

• Current Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Original Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Inventors: Wilson, James Edward, Horzewski, Michael, Giba, Jeffrey
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US09/256,126
• Time in Patent Office: 587 Days
• Field of Search: 604/95, 604/264, 604/523, 604/530, 604/500, 604/511, 600/139, 600/146-151, 606/15, 606/16, 607/122
• US Class Current: 606/15
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0144 having flexible regions as a result of inner reinforcement means, e.g. struts or rods
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0158 with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials

Abstract

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.

Claims

1. A method of forming revascularization channels or stimulation sites in myocardium from an endocardial layer within a left ventricle of a heart comprising:

(a) providing a catheter having an outer jacket with a proximal end and a distal end with a deflection device therein coupled to a distal tip thereof, the catheter having an actuating assembly at the proximal end for activation of the deflection device and an inner tube movably mounted within the outer jacket, the inner tube having a proximal end and a distal end attached to the distal tip, the catheter further having a treatment tool slidably mounted within the inner tube and egressible from the distal tip of the jacket and a treatment tool advance mechanism attached to the handle and having an actuator;

(b) advancing the catheter through vasculature into the left ventricle;

(c) positioning the distal tip of the catheter at the endocardial layer;

(d) operating the treatment tool advance mechanism to advance the treatment tool from the distal tip; and

(e) operating the treatment tool to form a revascularization channel or stimulation site during advancement.

2. The method of claim 1 wherein the treatment tool is an optical fiber laser delivery device adapted for connection to a source of laser energy.

3. The method of claim 2 wherein step (c) further comprises activating the deflection device to deflect the distal tip.

4. The method of claim 2 wherein the catheter further comprises a piercing tool and the method further comprises the following step prior to step (d) piercing the endocardial layer with the piercing tool.

5. The method of claim 2 wherein the catheter further comprises a shape memory material and step (c) of the method further comprises activating the shape memory material to deflect the distal tip of the catheter during positioning.

6. The method of claim 2 further comprising, after step (e), the step of delivering a drug into the revascularization channel or stimulation site.

7. The method of claim 1 further comprising, prior to step (b), advancing a guide catheter through the vasculature into the left ventricle, and wherein step (b) further comprises advancing the catheter through the guide catheter into the left ventricle.

8. The method of claim 1 wherein the treatment tool is a drug delivery device.