Ultrasound device for axial ranging

• US 6,024,703 A
• Filed: 05/07/1997
• Issued: 02/15/2000
• Est. Priority Date: 05/07/1997
• Status: Expired due to Fees

• Current Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Original Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Inventors: Davis, Michael A., Zanelli, Claudio I., Murphy-Chutorian, Douglas, Giba, Jeffrey J.
• Primary Examiner(s): Getzow, Scott M.
• Assistant Examiner(s): PATEL, MAULIN M
• Application Number:
  US08/852,977
• Time in Patent Office: 1,014 Days
• Field of Search: 600/466, 600/467, 600/443, 600/468
• US Class Current: 600/437
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22072 with an instrument channel, e.g. for replacing one instrument by the other in cannulas A61B17/3417
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00636 Sensing and controlling the application of energy

Abstract

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.

Claims

1. A device for treatment of cardiovascular tissue comprising:

a catheter having at least one lumen and a distal end;

a treatment tool mounted within the at least one lumen and egressible from the distal end of the catheter;

an ultrasound transducer located at the distal end of the catheter, the transducer positioned to transmit ultrasound signals into tissue in a forward direction substantially axially aligned with an axis of the treatment tool, the transducer further receiving returning signals from the tissue;

a signal interface extending from the ultrasound transducer; and

a signal processor connected to the signal interface, the signal processor performing real time determination of at least a first dynamic measurement of a distance between the transducer and at least one boundary surface of the tissue and a second dynamic measurement of an advancement distance of the treatment tool relative to the transducer.

2. The device of claim 1 further comprising a display device connected to the signal processor.

3. The device of claim 1 wherein the ultrasound transducer is an annular ring defining a generally central aperture therethrough.

4. The device of claim 1 wherein the treatment tool is a laser delivery device adapted for connection to a source of laser energy.

5. The device of claim 1 further comprising a source of laser energy connected to the treatment tool, the treatment tool comprising a laser delivery device.

6. The device of claim 4 wherein the laser delivery device is an optical fiber.

7. The device of claim 4 wherein the laser delivery device is a fiber optic bundle.

8. The device of claim 5 wherein the source of laser energy is a holmium laser.

9. The device of claim 5 wherein the source of laser energy is an excimer laser.

10. The device of claim 5 wherein the source of laser energy is a CO₂ laser.

11. The device of claim 1 wherein the treatment tool is a mechanical cutting device.

12. The device of claim 1 wherein the catheter is a pre-shaped tube having a lumen extending therethrough and the treatment tool is an optical fiber having a lens tip.

13. The device of claim 1 wherein the catheter has a proximal end attached to a handle and an inner tube within the lumen, the inner tube attached to the distal end of the catheter and slidable within the lumen, the handle having a deflection mechanism connected to deflection components extending between the deflection mechanism and the distal end.

14. The device of claim 1 wherein the ultrasound transducer comprises a piezoelectric crystal.

15. The device of claim 1 wherein the ultrasound transducer comprises a plurality of transducer elements.

16. The device of claim 1 wherein the signal interface is a coaxial cable.

17. The device of claim 1 wherein the signal processor performs real time determination of a third dynamic measurement of a distance between the advancing treatment tool and the at least one boundary surface.

18. The device of claim 1 wherein the signal processor performs real time determinations relative to two boundary surfaces of a tissue, the processor determining a substantially zero distance representing contact of the catheter with a first boundary surface, the processor further determining dynamic thickness between the first boundary surface and a second boundary surface, the processor further dynamically determining an advancement distance of the treatment tool from the first boundary surface and a remaining distance to the second boundary surface.

19. The device of claim 1 further comprising an alarm connected to the signal processor, the alarm activated when the signal processor detects a threshold distance between the treatment tool and the at least one boundary surface.

20. The device of claim 5 further comprising an interlock mechanism operatively attached to the source of laser energy and to the signal processor, the interlock mechanism deactivating delivery of laser energy to the laser delivery device upon determination of a threshold distance between the laser energy delivery device and the at least one tissue boundary.

21. The device of claim 1 further comprising an MIS tool having at least one lumen for guiding the catheter therethrough.

22. The device of claim 2 wherein the display generates an A-trace.

23. The device of claim 1 wherein the ultrasound transducer operates at a pulse repetition frequency of approximately 500 Hz to 10 kHz.

24. A method of monitoring tissue removal in tissue having a front boundary surface and a rear boundary surface, the method comprising the following steps:

(a) providing a device having a tissue removal tool with a treatment tip movably mounted within a catheter having a distal end, an ultrasound transducer mounted on the distal end, the device having a signal processing component operatively connected to the ultrasound transducer;

(b) positioning the catheter adjacent the front boundary surface of the tissue;

(c) moving the tissue removal tool within the catheter to position the treatment tip adjacent the tissue;

(d) transmitting ultrasound energy from the ultrasound transducer in a forward direction substantially aligned with an axis of the treatment tool into the tissue;

(e) receiving ultrasound signals reflected from at least the rear boundary surface of the tissue;

(f) determining the distance between the treatment tip of the tissue removal tool and the rear boundary surface of the tissue; and

(g) operating the tissue removal tool to remove tissue.

25. The method of claim 24 wherein step (g) further comprises controlling the removal of tissue based upon the distance determined in step (f).

26. The method of claim 24 in which the tissue removal tool is a laser delivery device adapted for connection to a source of laser energy, and step (b) positioning comprises introducing the catheter percutaneously into vasculature of a patient and advancing the catheter into a left ventricle of a beating heart until the catheter is positioned adjacent an endocardial surface.

27. The method of claim 24 in which the tissue removal tool is a laser delivery device adapted for connection to a source of laser energy, and step (b) positioning comprises introducing the catheter into the chest cavity and positioning the catheter adjacent an epicardial surface of a beating heart.

28. The method of claim 26 wherein step (f) further comprises determining the distance between the endocardial surface and the epicardial surface, the distance representing thickness of the myocardium.

29. The method of claim 28 wherein step (f) determines a dynamic thickness of the myocardium during contraction and expansion of the beating heart.

30. The method of claim 29 further comprising a display device connected to the signal processing component, the method further comprising the step of displaying the dynamic thickness determination to monitor a contraction phase and an expansion phase of the beating heart.

31. The method of claim 26 in which step (g) comprises mechanically piercing the tissue to a desired depth with the laser delivery device, the desired depth determined from the measurement in step (f);

and, retracting the laser delivery device while simultaneously delivering laser energy to the tissue.