Apparatus for percutaneously performing myocardial revascularization having controlled cutting depth and methods of use

• US 6,165,188 A
• Filed: 03/23/1999
• Issued: 12/26/2000
• Est. Priority Date: 12/02/1996
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Angiotrax, Inc.
• Inventors: Saadat, Vahid, Leopold, Eric W., Tartaglia, Joseph M., Park, Peter K., Philip, Susan
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US09/274,569
• Time in Patent Office: 644 Days
• Field of Search: 606/45-49, 606/1, 606/159, 606/170, 606/171, 606/180, 604/22
• US Class Current: 606/159
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• 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 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00208 actively driven, e.g. by a motor
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00279 deployable
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00738 : Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00839 : Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00916 : with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/1435 : Spiral
• CPC Class Codes: A61B 2018/1437 : whereby the windings of the spiral touch each other such as to create a continuous surface
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/034 : abutting on parts of the device itself
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2217/005 : with suction drainage system
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation

Abstract

Apparatus and methods for percutaneously performing myocardial revascularization are provided using a catheter having an end region that is directable to contact a patient'"'"'s endocardium at a plurality of positions. A cutting head is disposed within a lumen of the catheter and coupled to a drive tube that rotates and reciprocates the drive shaft. One or more stabilizing elements are disposed on the distal end to retain the catheter in position when the cutting head is actuated. The cutting head and drive tube include a lumen through which severed tissue is aspirated. Mechanisms are provided for controlling the maximum extension of the cutting head beyond a distal endface of the catheter, independent of the degree of tortuosity imposed on the catheter. Mechanisms and methods also are provided for providing the operator with information to assess the desirability of treating a proposed site.

Claims

1. Apparatus for percutaneously performing myocardial revascularization comprising:

a first catheter adapted for insertion into the left ventricle, the first catheter having a lumen and a distal endface movable to a plurality of sites on an endocardial surface;

a stabilizer element disposed on the first catheter, the stabilizer element contacting the endocardial surface to stabilize the first catheter against the endocardial surface;

a cutting head movable from a retracted position within the lumen of the first catheter to an extended position wherein the cutting head extends beyond the distal endface of the first catheter to form a channel in cardiac tissue; and

means for limiting extension of the cutting head in the extended position.

2. The apparatus of claim 1 wherein a distal region of the first catheter further comprises a preformed bend.

3. The apparatus of claim 1 wherein the first catheter further comprises a pull wire for directing the distal endface of the first catheter.

4. The apparatus of claim 1 further comprising a second catheter adapted for insertion into the left ventricle, the second catheter having a preformed bend and a lumen for accepting the first catheter therethrough.

5. The apparatus of claim 1 further comprising means for adjusting a maximum cutting depth of the cutting head.

6. The apparatus of claim 1 wherein the means for limiting extension comprises an electrical circuit that senses when the cutting head is disposed a predetermined distance from the distal endface of the first catheter.

7. The apparatus of claim 6 wherein the electrical circuit further comprises one of:

a fiber optic element, a resilient contact member, a strain gauge, a Hall effect sensor or an electrically conductive fluid.

8. The apparatus of claim 7 wherein the electrical circuit further comprises a light source coupled to the fiber optic element and monitoring circuitry for sensing when light emitted from the fiber optic element is reflected back to the fiber optic element.

9. The apparatus of claim 1 wherein the cutting head is affixed to a drive tube, the means for limiting extension further comprising a first bearing surface disposed on the drive tube and a second bearing surface disposed in the lumen of the first catheter.

10. The apparatus of claim 9 wherein the drive tube is driven by a motor, the means for limiting extension further comprising monitoring circuitry for monitoring a motor parameter and generating a signal that causes movement of the cutting head towards the extended position to cease when the motor parameter exceeds a predetermined threshold.

11. The apparatus of claim 10 wherein the motor parameter is selected from the group consisting of winding current, stall torque, displacement and linear force.

12. The apparatus of claim 1 wherein the stabilizer element comprises a first retractable needle.

13. The apparatus of claim 12 wherein the first retractable needle is curved towards or away from a longitudinal axis of the cutting head.

14. The apparatus of claim 12 wherein the first retractable needle includes a lumen having one or more ports adapted for injecting a therapeutic agent into the cardiac tissue.

15. The apparatus of claim 12 wherein the distal end of the first catheter comprises an electrically conductive end cap, the apparatus further comprising sensing circuitry for measuring an electrical impedance between the end cap and a reference electrode located at a remote site.

16. The apparatus of claim 12 wherein the distal end of the first catheter comprises an electrically conductive end cap, the apparatus further comprising sensing circuitry for measuring an electrical impedance of cardiac tissue disposed between the end cap and the first retractable needle.

17. The apparatus of claim 12 wherein the stabilizer element further comprises a second retractable needle, the apparatus further comprising sensing circuitry for measuring a physiologic state of cardiac tissue disposed between the first and second retractable needles.

18. The apparatus of claim 17 wherein the physiologic state comprises one of:

a degree of electrical activity within the cardiac tissue or an electrical impedance of the cardiac tissue.

19. The apparatus of claim 1 wherein the stabilizer element comprises one of:

a plurality of stabilizing members adapted to be adjusted between a contracted state and an expanded state, an inflatable member, and a plurality of sections of the first catheter that fold back on themselves when the distal endface is urged against an endocardial surface.

20. The apparatus of claim 1 further comprising drive means for rotating the cutting head and a linear actuator that translates the cutting head from the retracted position to the extended position, the cutting head further comprising a tubular member having a lumen through which cardiac tissue severed by the cutting head is aspirated.

21. The apparatus of claim 20 wherein the cutting head further comprises one of:

a stepped portion disposed between the lumen and a distal endface of the cutting head, a plurality of flutes or grooves disposed along an interior surface of the lumen, a plurality of pins projecting within the lumen, a sharpened element disposed within and spanning the lumen, and a sharpened element extending from a distal endface of the cutting element.

22. A method of percutaneously performing revascularization of a patient'"'"'s cardiac tissue, the method comprising:

providing a first catheter adapted for insertion into the left ventricle comprising a stabilizer element and a cutting head movable from a retracted position to an extended position;

advancing a distal region of the first catheter transluminally to a position within a patient'"'"'s left ventricle;

deploying the stabilizer element to stabilize the distal region of the first catheter in contact with an endocardial surface;

rotating the cutting head; and

advancing the cutting head from the retracted to the extended position to bore a channel into the patient'"'"'s cardiac tissue, the channel having a predetermined maximum depth substantially independent of a degree of bending imposed on the first catheter.

23. The method of claim 22 further comprising adjusting the location of the cutting head relative to a distal endface of the first catheter to account for the degree of bending imposed on the first catheter.

24. The method of claim 22 further comprising:

inserting a second catheter transluminally into the patient'"'"'s left ventricle; and

advancing the first catheter through a lumen of the second catheter.

25. The method of claim 22 further comprising adjusting the predetermined maximum depth of the channel.

26. The method of claim 25 further comprising sensing when the cutting head is disposed a predetermined distance from the distal endface of the first catheter.

27. The method of claim 22 wherein the cutting head is disposed on a drive tube, and wherein advancing the cutting head further comprises advancing the cutting head the cutting head until a first bearing surface disposed on the drive tube engages a second bearing surface disposed in a lumen of the first catheter.

28. The method of claim 22 wherein the drive tube is driven by a motor, the method further comprising:

monitoring a motor parameter; and

generating a signal that causes movement of the cutting head towards the extended position to cease when the motor parameter exceeds a predetermined threshold.

29. The method of claim 22 wherein the stabilizer element comprises a first retractable needle and deploying the stabilizer element comprises advancing the first retractable needle to penetrate into the patient'"'"'s cardiac tissue.

30. The method of claim 29 wherein the first retractable needle includes a lumen having one or more ports, the method further comprising injecting a therapeutic agent into the cardiac tissue through the lumen via the one or more ports.

31. The method of claim 30 further comprising injecting the therapeutic agent into the channel formed by the cutting head.

32. The method of claim 30 wherein the first retractable needle includes a lumen having one or more ports, the method further comprising:

aspirating cardiac tissue severed by the cutting head; and

injecting an irrigant into the channel to assist aspiration of cardiac tissue severed by the cutting head.

33. The method of claim 22 further comprising aspirating cardiac tissue severed by the cutting head.

34. The method of claim 33 further comprising engaging and shredding a core of cardiac tissue.

35. The method of claim 29 wherein the distal end of the first catheter comprises an electrically conductive end cap, the method further comprising measuring an electrical impedance of cardiac tissue between the end cap and a reference electrode.

36. The method of claim 29 wherein the distal end of the first catheter comprises an electrically conductive end cap, the method further comprising measuring an electrical impedance of cardiac tissue disposed between the end cap and the first retractable needle.

37. The method of claim 36 further comprising comparing a measured value of electrical impedance of the cardiac tissue to a predetermined threshold to decide whether to advance the cutting head or re-position the first catheter.

38. The method of claim 29 wherein the stabilizer element further comprises a second retractable needle, the method further comprising measuring a physiologic state of cardiac tissue disposed between the first and second retractable needles.

39. The method of claim 38 wherein measuring a physiologic state comprises measuring one of:

a degree of electrical activity within the cardiac tissue or an electrical impedance of the cardiac tissue.

40. The method of claim 39 further comprising determining a degree of infarction based on the measured value of the physiologic state of the cardiac tissue.