Method for detecting and revascularizing ischemic myocardial tissue

• US 6,024,739 A
• Filed: 09/05/1997
• Issued: 02/15/2000
• Est. Priority Date: 09/05/1997
• Status: Expired due to Fees

• Current Assignee: Cordis Webster, Inc. (Johnson & Johnson)
• Original Assignee: Cordis Webster, Inc. (Johnson & Johnson)
• Inventors: Moaddeb, Shahram, Ponzi, Dean M.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): YARNELL, BRYAN KEITH
• Application Number:
  US08/924,612
• Time in Patent Office: 893 Days
• Field of Search: 606/2, 606/7, 606/10, 606/11, 606/13-17, 600/409, 600/373, 600/374, 604/95, 604/93, 604/523, 604/528, 604/19, 604/20
• 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 2017/003 Steerable
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems

Abstract

A method for direct myocardial revascularization by providing a catheter with a catheter body having proximal and distal ends and at least one lumen extending therethrough, a control handle at the proximal end of the catheter body, and a tip section having proximal and distal ends. The tip section is fixedly attached to the distal end of the catheter body. The catheter also comprises an electromagnetic sensor in the distal portion tip section for producing electrical signals indicative of the location of the electromagnetic sensor. The catheter further comprises at least one electrode carried by the tip section for mapping electrical activity of the heart tissue and at least one electrode lead wire electrically connected to the electrode. An optic fiber is provided within the catheter with its distal end being substantially flush with the distal end of the tip section. Manipulation of the control handle results in deflection of the tip section. The method further comprises inserting the catheter through a blood vessel into a heart chamber, monitoring the location of the distal end of the catheter tip section within the heart on a visual display, contacting the heart wall with at least one electrode to measure the electrical activity of the heart at the points of contact to locate ischemic areas of the heart tissue, deflecting the tip section so that the distal ends of the tip section and optic fiber are generally normal to an ischemic area of heart tissue, and transmitting sufficient laser energy through the optic fiber to create a channel in the heart tissue.

Claims

1. A method for direct myocardial revascularization comprising:

providing a catheter comprising;

a unitary catheter body having proximal and distal ends, inner and outer surfaces and at least one lumen extending therethrough;

a control handle at the proximal end of the catheter body;

a tip section comprising a tubing more flexible than the catheter body having proximal and distal ends and at least one lumen therethrough, the proximal end of the tip section being fixedly attached to the distal end of the catheter body;

an electromagnetic sensor in the distal portion of the tip section for producing electrical signals indicative of the location of the electromagnetic sensor;

an electromagnetic sensor cable electrically connected to the electromagnetic sensor and extending through the tip section, body and control handle for carrying electrical signals from the electromagnetic sensor to a computer;

at least one electrode carried by the tip section for mapping electrical activity of the heart tissue and at least one electrode lead wire electrically connected to the electrode, said lead wire extending through the tip section, catheter body and control handle;

an optic fiber having a distal end and a proximal end, said optic fiber extending through a lumen in the catheter body and tip section, said distal end of the optic fiber being substantially flush with the distal end of the tip section; and

means for deflecting the distal end of the tip section by manipulation of the control handle;

inserting the catheter through a blood vessel into a heart chamber;

monitoring the location of the distal end of the catheter tip section within the heart on a visual display;

contacting the heart wall with at least one electrode to measure the electrode to measure the electrical activity of the heart at the points of contact to locate ischemic areas of the heart tissue;

deflecting the distal end of the tip section so that the distal end of the tip section and the distal end of the optic fiber are generally normal to an ischemic area of heart tissue; and

transmitting sufficient laser energy through the optic fiber to create a channel in the heart tissue.

2. A method according to claim 1, further comprising moving the tip section and transmitting laser energy through the optical fiber to create a second channel in the ischemic area.

3. A method according to claim 2, further comprising repeatedly moving the tip section and transmitting laser energy through the optical fiber to create a plurality of channels in the ischemic area of the heart.

4. A method according to claim 1 wherein the tip section of the catheter carries a tip electrode.

5. A method according to claim 1 further comprising a circuit board in the control handle, wherein the electromagnetic sensor cable is electrically connected to the circuit board and the circuit board is electrically connected by means of a cable to a computer.

6. A method according to claim 1 wherein the control handle comprises a first member fixedly attached to the proximal end of the catheter body and a second member that is movable relative to the first member.

7. A method according to claim 6 wherein the deflecting means comprises a puller wire having a proximal end and a distal end, the puller wire extending from the control handle, through the catheter body and into the a lumen in the tip section, wherein the distal end of the puller wire is fixedly secured within the tip section and the proximal end of the puller wire is fixedly secured to the second member of the control handle, whereby manipulation of the first member of the control handle relative to the second member of the control handle moves the puller wire relative to the catheter body, resulting in deflection of the tip section.

8. The method of claim 7 wherein the deflecting means further comprises a compression coil situated in the catheter body in surrounding relation to the puller wire and extending into the off-axis lumen in the tip section into which the puller wire extends.

9. A method according to claim 1 wherein the catheter further comprises an infusion tube having distal and proximal ends, said infusion tube extending through a lumen in the catheter body and a lumen in the tip section, wherein the distal end of the infusion tube is anchored in the tip section and wherein the proximal end of the infusion tube extends outside the catheter for receiving fluids.

10. A method according to claim 9, further comprising the step of administering a drug through the infusion tube to the channel.

11. A method according to claim 10, wherein the drug is selected from the group consisting of fibroblast growth factor, vascular endothelial growth factor, thromboxane-A2, and protein kinase-C.

12. A method according to claim 1 wherein the catheter further comprises a temperature sensing means.

13. A method according to claim 12 wherein the temperature sensing means comprises a thermocouple formed by an enameled wire pair comprising a copper wire and a construction wire, wherein the enameled wire pair extends through a lumen in the catheter body and a lumen in the tip section and is fixedly attached in the distal end of the tip section.

14. A method for direct myocardial revascularization comprising:

providing a catheter comprising;

a unitary catheter body having proximal and distal ends, inner and outer surfaces and at least one lumen extending therethrough;

a control handle at the proximal end of the catheter body comprising a first member fixedly attached to the proximal end of the catheter body and a second member that is movable relative to the first member;

a tip section comprising a tubing more flexible than the catheter body having proximal and distal ends and at least one lumen therethrough, the proximal end of the tip section being fixedly attached to the distal end of the catheter body;

an electromagnetic sensor in the distal portion of the tip section for producing electrical signals indicative of the location of the electromagnetic sensor;

an electromagnetic sensor cable electrically connected to the electromagnetic sensor and extending through the tip section, body and control handle for carrying electrical signals from the electromagnetic sensor to a computer;

at least one electrode carried by the tip section for mapping electrical activity of the heart tissue and at least one electrode lead wire electrically connected to the electrode, said lead wire extending through the tip section, catheter body and control handle;

an optic fiber having a distal end and a proximal end, said optic fiber extending through a lumen in the catheter body and tip section, said distal end of the optic fiber being substantially flush with the distal end of the tip section; and

a puller wire having proximal and distal ends, the puller wire extending from the control handle, through the catheter body and into an off-axis lumen in the tip section, wherein the distal end of the puller wire is fixedly secured within the tip section and the proximal end of the puller wire is fixedly secured to the second member of the control handle, whereby manipulation of the first member of the control handle relative to the second member of the control handle moves the puller wire relative to the catheter body;

inserting the catheter through a blood vessel into a heart chamber;

monitoring the location of the distal end of the catheter tip section within the heart on a visual display;

contacting the heart wall with at least one electrode to measure the electrode to measure the electrical activity of the heart at the points of contact to locate ischemic areas of the heart tissue;

deflecting the tip section so that the distal end of the tip section and distal end of the optic fiber are generally normal to an ischemic area of heart tissue; and

transmitting sufficient laser energy through the optic fiber to create a channel in the heart tissue.

15. The method of claim 14 wherein the deflecting means further comprises a compression coil situated in the catheter body in surrounding relation to the puller wire and extending into the off-axis lumen in the tip section into which the puller wire extends.

16. A method for direct myocardial revascularization comprising:

providing a catheter comprising;

a catheter body having proximal and distal ends and at least one lumen extending therethrough;

a control handle at the proximal end of the catheter body comprising a first member fixedly attached to the proximal end of the catheter body and a second member that is movable relative to the first member;

a tip section having proximal and distal ends and at least one lumen therethrough, the proximal end of the tip section being fixedly attached to the distal end of the catheter body;

an electromagnetic sensor in the distal portion of the tip section for producing electrical signals indicative of the location of the electromagnetic sensor;

an electromagnetic sensor cable electrically connected to the electromagnetic sensor and extending through the tip section, body and control handle for carrying electrical signals from the electromagnetic sensor to a computer;

at least one electrode carried by the tip section for mapping electrical activity of the heart tissue and at least one electrode lead wire electrically connected to the electrode, said lead wire extending through the tip section, catheter body and control handle;

an optic fiber having a distal end and a proximal end, said optic fiber extending through a lumen in the catheter body and tip section, said distal end of the optic fiber being substantially flush with the distal end of the tip section;

an infusion tube having proximal end distal ends, said infusion tube extending through a lumen in the catheter body and a lumen in the tip section, wherein the distal end of the infusion tube is anchored in the tip section and wherein the proximal end of the infusion tube extends outside the catheter for receiving fluids; and

a puller wire having proximal and distal ends, the puller wire extending from the control handle, through the catheter body and into an off-axis lumen in the tip section, wherein the distal end of the puller wire is fixedly secured within the tip section and the proximal end of the puller wire is fixedly secured to the second member of the control handle, whereby manipulation of the first member of the control handle relative to the second member of the control handle moves the puller wire relative to the catheter body;

inserting the catheter through a blood vessel into a heart chamber;

monitoring the location of the distal end of the catheter tip section within the heart on a visual display;

contacting the heart wall with at least one electrode to measure the electrode to measure the electrical activity of the heart at the points of contact to locate ischemic areas of the heart tissue;

deflecting the tip section so that the distal end of the optic fiber is generally normal to an ischemic area of heart tissue;

transmitting sufficient laser energy through the optic fiber to create a channel in the heart tissue; and

administering a drug through the infusion tube to the channel, wherein the drug is selected from the group consisting of fibroblast growth factor, vascular endothelial growth factor, thromboxane-A2 and protein kinase-C.