Apparatus for percutaneously performing myocardial revascularization having means for sensing tissue parameters and method of use

• US RE45,638 E1
• Filed: 08/14/2002
• Issued: 08/04/2015
• Est. Priority Date: 12/02/1996
• Status: Expired due to Term

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Tartaglia, Joseph M., Saadat, Vahid, Leopold, Eric W., Park, Peter K., Philip, Susan
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US10/219,785
• Time in Patent Office: 4,738 Days
• Field of Search: 604523-528, 604/264, 604272-274, 606/170, 606/159, 600/564
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• 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 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 2017/00199 with a console, e.g. a control panel with a display
• 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 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/066 : for measuring torque
• CPC Class Codes: A61B 2090/0811 : for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2217/005 : with suction drainage system
• 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
• CPC Class Codes: A61M 25/0084 : being one or more injection needles

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 and methods are provided for providing the operator with information to assess the desirability of treating a proposed site. Mechanisms also 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.

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 disposed 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 sensing a physiologic state of cardiac tissue in a region adjacent to the distal endface of the first catheter.

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 stabilizer element comprises a first retractable needle.

7. The apparatus of claim 6 wherein the distal end of the first catheter comprises an electrically conductive end cap, the means for sensing comprising circuitry for measuring an electrical impedance of cardiac tissue between the end cap and a reference electrode located at a remote position.

8. The apparatus of claim 6 wherein the distal end of the first catheter comprises an electrically conductive end cap, and the means for sensing comprises circuitry for measuring an electrical impedance of cardiac tissue disposed between the end cap and the first retractable needle.

9. The apparatus of claim 6 wherein the stabilizer element further comprises a second retractable needle, the means for sensing comprising circuitry for measuring a physiologic state of cardiac tissue disposed between the first and second retractable needles.

10. The apparatus of claim 9 wherein the physiologic state comprises one of:

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

11. The apparatus of claim 6 wherein the first retractable needle is curved towards or away from a longitudinal axis of the cutting head.

12. The apparatus of claim 6 wherein the first retractable needle includes a lumen having one or more ports adapted for injecting a therapeutic agent into the cardiac tissue.

13. The apparatus of claim 1 further comprising means for limiting extension of the cutting head in the extended position.

14. The apparatus of claim 13 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.

15. The apparatus of claim 14 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

16. The apparatus of claim 13 wherein the means for limiting extension further comprises 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.

17. 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.

18. 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.

19. The apparatus of claim 1 wherein the cutting head comprises a tubular member having a lumen through which cardiac tissue severed by the cutting head is aspirated, the cutting head further comprising 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 member that projects within the lumen, and a sharpened element extending from a distal endface of the cutting element.

20. Apparatus for percutaneously performing myocardial revascularization comprising.

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

a first needle disposed on the first catheter movable from a retracted position within the needle lumen to an extended position extending beyond a distal endface of the first catheter, the first needle contacting and penetrating the endocardial surface to stabilize the first catheter against the endocardial surface; and

a cutting head disposed 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.

21. The apparatus of claim 20 wherein the first needle includes a lumen having one or more ports adapted for injecting a therapeutic agent into the cardiac tissue.

22. The apparatus of claim 20 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 between the end cap and a reference electrode at a remote location.

23. The apparatus of claim 20 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 needle.

24. The apparatus of claim 20 wherein further comprising a second needle mounted for extension and retraction from the distal endface of the first catheter, the apparatus further comprising sensing circuitry for measuring a physiologic state of cardiac tissue disposed between the first and second needles.

25. The apparatus of claim 24 wherein the physiologic state comprises one of:

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

26. The apparatus of claim 20 wherein a distal region of the first catheter further comprises a preformed bend, the apparatus of 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.

27. The apparatus of claim 20 further comprising means for adjusting a maximum cutting depth of the cutting head

28. The apparatus of claim 20 further comprising means for limiting extension of the cutting head in the extended position.

29. The apparatus of claim 20 wherein the cutting head comprises a tubular member having a lumen through which cardiac tissue severed by the cutting head is aspirated, the cutting head further comprising 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 band disposed within and spanning the lumen, and a sharpened element extending from a distal endface of the cutting element.

30. 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;

sensing a physiologic state of cardiac tissue in a portion of the cardiac tissue adjacent to the distal endface of the first catheter; and

if it is determined that myocardial revascularization in the portion of cardiac tissue adjacent to the distal endface would have a beneficial effect, advancing the cutting head from the retracted to the extended position to bore a channel into the patient'"'"'s cardiac tissue.

31. The method of claim 30 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.

32. The method of claim 31 wherein the distal end of the first catheter comprises an electrically conductive end cap, and sensing a physiologic state further comprises measuring an electrical impedance of cardiac tissue between the end cap and a reference electrode located at a remote location.

33. The method of claim 32 wherein the distal end of the first catheter comprises an electrically conductive end cap, and sensing a physiologic state further comprises measuring an electrical impedance of cardiac tissue disposed between the end cap and the first retractable needle.

34. The method of claim 33 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.

35. The method of claim 31 wherein the stabilizer element further comprises a second retractable needle, and sensing a physiologic state further comprises measuring a physiologic state of cardiac tissue disposed between the first and second retractable needles.

36. The method of claim 35 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.

37. The method of claim 36 further comprising determining a degree of infarction based on the measured value of the physiologic state of the cardiac tissue.

38. The method of claim 31 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.

39. The method of claim 31 further comprising aspirating cardiac tissue severed by the cutting head.

40. 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 first needle movable from a retracted position to an extended position 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;

advancing the first needle to the extended position to penetrate and 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.

41. The method of claim 40 wherein the first 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.

42. The method of claim 40 wherein the first catheter further comprises a second needle movable from a retracted position to an extended position, the method further comprising measuring a physiologic state of cardiac tissue disposed between the first and second needles.

43. The method of claim 42 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.

44. The method of claim 42 further comprising determining a degree of infarction based on the measured value of the physiologic state of the cardiac tissue.

45. The method of claim 40 further comprising aspirating cardiac tissue severed by the cutting head.

46. An apparatus comprising:

a first catheter adapted for percutaneous insertion into a cardiac tissue, the first catheter having a needle lumen with a longitudinal axis, a stabilizer lumen radially offset from the needle lumen, and a distal endface steerable to a plurality of sites on the cardiac tissue relative to another portion of the first catheter proximal to the distal endface;

a needle disposed within the needle lumen while in a retracted position, the needle moveable from the retracted position, through the distal endface, to an external position beyond the distal endface in which the needle extends in alignment with the longitudinal axis of the needle lumen from the distal endface to a distal tip of the needle, the needle having at least one lumen to inject a therapeutic agent into the cardiac tissue;

a stabilizer element to stabilize the first catheter against the cardiac tissue, the stabilizer element moveable through the stabilizer lumen from an unextended position to an extended position, wherein the stabilizer element is disposed within the stabilizer lumen while in the unextended position, and wherein the stabilizer element angles in a distal direction while in the extended position; and

a second catheter adapted for insertion into a left ventricle, the second catheter having a preformed bend and an inner lumen for receiving movement of the first catheter therethrough.

47. The apparatus of claim 46, wherein the stabilizer element comprises at least one wire.

48. The apparatus of claim 47 wherein the at least one wire is responsible for stabilizing the distal endface against the cardiac tissue.

49. The apparatus of claim 46, wherein the cardiac tissue is an intraventricular wall.

50. The apparatus of claim 46, wherein a distal region of the first catheter further comprises a preformed bend.

51. The apparatus of claim 46, wherein the stabilizer element is configured to retain the distal endface of the first catheter against a surface of the cardiac tissue and includes a surface parallel to the first catheter.

52. The apparatus of claim 46 wherein the stabilizer element is configured to retain the distal endface of the first catheter against a surface of the cardiac tissue to ensure that the needle is stable relative to the cardiac tissue when injecting a therapeutic agent into the cardiac tissue.

53. The apparatus of claim 46 wherein the needle can advance to different depths into the cardiac tissue.

54. An apparatus comprising:

a first catheter adapted for percutaneous insertion into a cardiac tissue, the first catheter having a preformed bend, a needle lumen with a longitudinal axis, a stabilizer lumen radially offset from the needle lumen, and a distal endface steerable to a plurality of sites on the cardiac tissue relative to another portion of the first catheter proximal to the distal endface;

a needle disposed within the needle lumen while in a retracted position, the needle moveable from the retracted position, through the distal endface, to an external position beyond the distal endface in which the needle extends in alignment with the longitudinal axis of the needle lumen from the distal endface to a distal tip of the needle, the needle having at least one lumen to inject a therapeutic agent into the cardiac tissue;

a stabilizer element to stabilize the first catheter against the cardiac tissue, the stabilizer element moveable through the stabilizer lumen from an unextended position to an extended position, wherein the stabilizer element is disposed within the stabilizer lumen while in the unextended position, and wherein the stabilizer element angles in a distal direction while in the extended position; and

a second catheter adapted for insertion into a left ventricle, the second catheter having a preformed bend and an inner lumen for receiving movement of the first catheter therethrough.

55. The apparatus of claim 54 wherein the stabilizer element is configured to retain the distal endface of the first catheter against a surface of the cardiac tissue and includes a surface parallel to the first catheter.

56. An apparatus comprising:

a first catheter adapted for percutaneous insertion into a cardiac tissue, the first catheter having a needle lumen with a longitudinal axis, a stabilizer lumen radially offset from the needle lumen, and a distal endface steerable to a plurality of sites on the cardiac tissue relative to another portion of the first catheter proximal to the distal endface;

a needle disposed within the needle lumen while in a retracted position, the needle moveable from the retracted position, through the distal endface, to an external position beyond the distal endface in which the needle extends in alignment with the longitudinal axis of the needle lumen from the distal endface to a distal tip of the needle, the needle having at least one lumen to inject a therapeutic agent into the cardiac tissue; and

a stabilizer element to stabilize the first catheter against the cardiac tissue, the stabilizer element moveable through the stabilizer lumen from an unextended position to an extended position, wherein the stabilizer element is disposed within the stabilizer lumen while in the unextended position, and wherein the stabilizer element angles in a distal direction while in the extended position.

57. The apparatus of claim 56 wherein the stabilizer element is configured to retain the distal endface of the first catheter against a surface of the cardiac tissue and includes a surface parallel to the first catheter.