Intraoperative myocardial device and stimulation procedure

• US 20030073985A1
• Filed: 05/11/2001
• Published: 04/17/2003
• Est. Priority Date: 06/13/1996
• Status: Active Grant

• Current Assignee: Douglas Murphy-Chutorian, Richard L. Mueller, Stuart D. Harman
• Original Assignee: Douglas Murphy-Chutorian, Richard L. Mueller, Stuart D. Harman
• Inventors: Harman, Stuart D., Mueller, Richard L., Murphy-Chutorian, Douglas
• Granted Patent: US 6,620,153 B2
• Time in Patent Office: Days
• US Class Current: 606/7
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00172 Pulse trains, bursts, intermittent continuous operation
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22074 the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/208 with multiple treatment beams not sharing a common path, e.g. non-axial or parallel

Abstract

A method and device for causing angiogenesis in the heart including the formation of a pattern of stimulus pockets or zones and channels. Laser energy is deliverable through one or more fiber optic elements at a controlled penetration depth and direction. The fiber element of the device is advanced incrementally within the myocardium. Laser bursts are triggered at intervals to create stimulus zones and/or channels.

Claims

1. A method for stimulating revascularization of myocardium tissue in the ventricular wall of a human heart comprising the steps of:

providing optical fiber means having at least one distal end and at least one proximal end connected to a source of laser energy;

moving the optical fiber means forwardly through the epicardium of the heart and into the myocardium;

emitting laser energy from said distal end to form at least one stimulus injury within the myocardium of the heart to promote capillary growth and revascularization therein.

2. The method of claim 1 wherein the step of providing optical fiber means includes providing a single optical fiber having a distal end shaped to emit laser energy in at least one radial direction relative to an axis of the optical fiber means.

3. The method of claim 2 wherein the step of moving the optical fiber means forwardly includes the step of incrementally advancing the fiber means.

4. The method of claim 3 wherein the step of emitting laser energy includes the step of emitting laser energy when the fiber means is stationary.

5. The method of claim 1 wherein the step of emitting laser energy includes formation of one or more pockets in the myocardium connected by temporary channels.

6. The method of claim 1 wherein the step of emitting laser energy includes emitting laser energy at a first energy level to create at least one temporary channel and emitting laser energy at a second energy level to create at least one pocket.

7. The method of claim 1 wherein the step of providing optical fiber means includes providing a plurality of parallel, spaced apart fiber probes each having a distal tip shaped to emit laser energy radially or in a generally axial direction.

8. The method of claim 1 wherein the step of providing optical fiber means includes providing a central optical fiber surrounded by a plurality of parallel optical fibers each having a diameter smaller than said central fiber.

9. The method of claim 1 wherein the step of providing optical fiber means including the step of emitting laser energy from said central optical fiber as said fiber means is moved forwardly in the myocardium to form a temporary channel therein and then emitting laser energy from said plurality of outer fibers to form an ablated pocket in the myocardium.

10. The method of claim 1 wherein said central optical fiber is connected to a Holmium HO:

YAG laser source and said outer fibers are connected to an Argon Nd;

YAG laser source.

11. The method of claim 1 including the step of mechanically piercing the epicardium to provide an opening for the optical fiber means to pass through into the myocardium.

12. A method for stimulating revascularization of myocardium tissue in the ventricle wall of a human heart comprising the steps of:

providing an optical fiber means having a distal end and a proximal end connected to a source of laser energy;

moving said fiber means forwardly through the epicardium of the heart and positioning said distal end at a first position within the myocardium;

emitting a burst of relatively low level of laser energy from said distal end in a radial direction from the longitudinal axis of the fiber means and for a limited distance to form at least one zone of partially ablated tissue within the myocardium which stimulates capillary growth and revascularization therein;

moving said fiber means from said first position to a second position and emitting another burst of relatively low level laser energy to form an additional zone of ablated tissue within the tissue; and

withdrawing said optical fiber means from the heart and moving it laterally to another location to facilitate a repetition of the method steps.

13. The method of claim 12 wherein said optical fiber means is a single strand with a tapered distal tip.

14. The method of claim 12 wherein said optical fiber means comprises a plurality of optical fiber strands that are bundled together including a central strand surrounded by two or more additional strands.

15. The method of claim 12 wherein said optical fiber means comprises a plurality of optical fiber strands which are axially parallel and spaced apart and extend a preselected fixed distance from a stop member.

16. The method of claim 12 wherein said fiber means is moved forwardly in small increments and stopped at each increment of movement as laser energy is simultaneously emitted from its distal tip to form a pattern of stimulus pockets within the myocardium.

17. The method of claim 12 wherein said fiber means is first moved forwardly a preselected distance into the myocardium, then is moved rearwardly in small increments and stopped at each increment of movement as laser energy is emitted from its distal tip to form a pattern of stimulus pockets within the myocardium.

18. The method of claim 12 wherein the laser power is derived from a Holmium:

YAG laser having a wavelength range of approximately 1.8 to 2.2 um and power level range of approximately 0.6 J to 1.65 J.

19. The method of claim 18 wherein the laser power level is varied from around 0.6 J to 1.65 J at increments of axial movement of said fiber means to create stimulation pockets in the myocardium.

20. The method of claim 12 wherein said first position of said optical fiber means is axially aligned with said second position and laser energy is reflected radially from the distal end of said optical fiber means.

21. The method of claim 12 wherein said first position of said optical fiber means is angularly displaced from said second position of said optical fiber means.

22. A device for revascularization of the myocardium tissue in the ventricle wall of a human heart, comprising:

a body member;

a neck member connected to said body member;

a flared stop member on the distal end of said neck member;

an optical fiber means having a distal tip and a proximal end connectable to a source of laser energy, said fiber means extending through said body member, said neck member and said stop member;

means on said body member for moving said fiber means axially by increments to stop and position said distal tip at preselected positions relative to said stop member; and

means for triggering the source of laser energy at each said position of said distal tip to thereby create a zone of partially ablated tissue in the myocardium that stimulates revascularization of the tissue.

23. The device as described in claim 22 wherein said distal tip of the fiber means is tapered and pointed.

24. The device as described in claim 23 wherein said distal tip of the fiber means has at least one outer surface that lies in a plane that forms an oblique angle with the axis of said fiber means, for deflecting the laser beam transmitted with said fiber means radially outwardly from its axis.

25. The device as described in claim 23 wherein said distal tip of said fiber means has a plurality of outer surfaces, each surface being in a plane forming a oblique angle with the axis of said fiber means, whereby multiple laser beams are deflected radially outwardly from the axis of said fiber beams.

26. The device as described in claim 22 wherein said distal tip of said fiber means comprises a plurality of parallel, spaced apart optical fiber prongs.

27. The device as described in claim 24 wherein said optical fiber prongs each have a diameter of around 0.1 to 0.5 mm and a length of around 1.5 to 3.0 cm.

28. The device as described in claim 22 wherein said optical fiber means comprises a central optical fiber surrounding by a plurality of outer optical fibers having a smaller diameter than said central optical fiber.

29. The device as described in claim 28 wherein said central optical fiber has a diameter of around 0.6 mm and said outer fibers have a diameter of around 0.2 mm.

30. The device as described in claim 28 wherein said central optical fiber has a proximal end connected to an Argon Nd:

YAG laser and said outer optical fibers are connected to a Holmium HO;

YAG laser.

31. The device as described in claim 28 wherein said central and outer optical fibers all have flat, non-tapered end faces which are perpendicular to the fiber axis.

32. The device as described in claim 22 including a hollow piercing means connected to said stop member, said optical fiber means being movable axially through said piercing means.

33. The device as described in claim 32 wherein said optical fiber means has its proximal end connected to a laser energy source which is operable at different, selectable power levels.

34. The device as described in claim 22 including means for adjusting the extension of said neck member from said body member.

35. The device as described in claim 22 wherein said neck member has a proximal end portion slidably connected within a frontal aperture of said body member, said proximal end portion having a series of spaced apart circular grooves, and neck adjustment means attached to said body member having a locking means adapted to fit within a selected said groove to thereby retain said stop member at a preselected initial distance from the distal end of said optical fiber means.

36. The device as described in claim 35 wherein said neck adjustment means comprises a latch member pivotally attached to said body member said latch member having a locking end projection at its outer end that fits in a selected groove, and a thumb actuated inner end portion connected to spring means for urging said end projection into engagement within the selected groove.

37. The device as described in claim 22 wherein said means for moving said fiber means axially comprises a shuttle having first a second spaced apart internal gear racks, a driving gear between said gear racks and connected to an operating handle, and means for urging said driving gear into engagement with said first gear rack to move said fiber means forwardly, and control means for alternatively moving said driving gear into engagement with said second gear rack for moving said fiber means rearwardly.

38. The device as descried in claim 37 wherein said means for urging includes a series of springs extending between an interior portion of said body member and said shuttle.

39. The device as described in claim 37 wherein said control means includes a pivotal member having a cam portion adapted to bear against and move said shuttle against said springs so that said driving gear engages said second gear rack.

40. The device as described in claim 22 including electrical power means for moving said fiber means axially, either forwardly or rearwardly.

41. The device as described in claim 40 including shuttle means fixed to said optical fiber means within said body member;

helical drive means extending through said shuttle means and rotatably supported within said body means;

motor means for driving said helical drive means to move said shuttle axially; and

means for controlling said motor means so that said fiber means can be moved in increments backwardly or forwardly.