Intraoperative myocardial device and stimulation procedure

• US 6,620,153 B2
• Filed: 05/11/2001
• Issued: 09/16/2003
• Est. Priority Date: 06/13/1996
• Status: Expired due to Fees

• Current Assignee: Douglas Murphy-Chutorian, Richard L. Mueller, Stuart D. Harman
• Original Assignee: Douglas Murphy-Chutorian, Richard L. Mueller, Stuart D. Harman
• Inventors: Murphy-Chutorian, Douglas, Mueller, Richard L., Harman, Stuart D.
• Primary Examiner(s): Shay, David M.
• Application Number:
  US09/854,072
• Publication Number:
  US 20030073985A1
• Time in Patent Office: 858 Days
• Field of Search: 606/3, 606/7, 606/10-17
• US Class Current: 606/15
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00172 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

An apparatus for stimulating revascularization of myocardium tissue in the ventricular wall of a human heart is disclosed. The apparatus includes means for moving the distal end of an optical fiber element forwardly through the epicardium of the heart and into the myocardium and emitting relatively low power bursts of laser energy from the distal end to form stimulus injury zones that promote capillary growth and tissue revascularization. Each penetration of the optical fiber element may produce multiple stimulus zones spaced radially from or in line with the axis of the optical fiber element. Apparatus for moving the optical fiber element and controlling the laser emissions in a predetermined manner is also disclosed.

Claims

1. An apparatus for stimulating angiogenesis in myocardium, the apparatus comprising:

a body member;

a neck member connected to said body member;

a neck adjustment mechanism for adjusting said neck member relative to said body member having a distal section slidably connected within said body member, wherein a proximal section of said neck adjustment mechanism has a series of grooves;

a head member connected to a proximal end of said neck member, said head member defining a stop member adapted for engaging a heart;

a laser energy delivery device for ablating tissue to form stimulating zones having a distal end and a proximal end configured to optically connect to a laser energy source, and translatable through and egressible from said head member;

a laser energy delivery device advancement mechanism attached to said body member for controlling by discrete and incremental movement said distal end of said laser energy delivery device to pre-selected positions relative to said head member, whereby firing said laser energy delivery device reproducibly creates said stimulating zones at said pre-selected positions; and

a locking member pivotally attached to said body member having a distal end with a projection configured to fit within one of said series of grooves and a proximal end having a thumb actuated portion connected to a spring bias member for urging engagement of said projection into one of said series of grooves, whereby when said locking member is disengaged said neck member can be adjusted thereby adjusting a length of exposure of said distal end of said laser energy delivery device from said stop member.

2. The apparatus of claim 1 wherein said laser energy delivery device comprises an optical fiber element having a tapered distal end and at least one outer surface lying in a plane forming an oblique angle with respect to a longitudinal axis of said optical fiber element,

whereby laser energy transmissions from said distal end of said optical fiber element form at least one outwardly directed a beam from said longitudinal axis of said optical fiber element.

3. The apparatus of claim 1 wherein said laser energy delivery device comprises an optical fiber element having a tapered distal end with a plurality of outer surfaces, each of said plurality of outer surfaces being in a plane forming an oblique angle with respect to a longitudinal axis of said optical fiber element, whereby laser energy transmissions from said distal end of said optical fiber element form outwardly directed beams from said longitudinal axis of said optical fiber element.

4. The apparatus of claim 1 further including a how piercing element for tissue penetration connected to said head member, said distal end of said laser energy delivery device translatable through said hollow piercing element.

5. The apparatus of claim 1 wherein said laser energy delivery device further includes an adaptive control mechanism for operating said laser source at variable power levels.

6. The apparatus of claim 1 wherein said laser energy delivery device advancement mechanism includes a shuttle having first and second spaced apart internal gear racks, a driving gear between said gear racks and connected to an operating handle, and further comprising a directional control mechanism fixed to said laser energy delivery device for controlling directional movement of said laser energy delivery a device.

7. The apparatus of claim 6 wherein said directional control mechanism includes:

at least one spring extending between an interior portion of said body member and said shuttle such that when said driving gear is urged into engagement with said first gear rack, said laser energy delivery device is advanced and when said driving gear is urged into engagement with said second gear rack, said a laser energy delivery device is retracted; and

a pivotal member having a cam portion adapted to bear against and move said shuttle against said at least one spring so that said driving gear engages said second gear rack.

8. The apparatus of claim 1 wherein said laser energy delivery device comprises a plurality of spaced apart parallel optical fiber strands having distal tips.

9. The apparatus of claim 8 wherein said distal tips of said optical fiber strands have a diameter of about 0.1 to 0.5 mm and can extend about 1.5 to 3.0 cm beyond said head member.

10. The apparatus of claim 1 wherein said laser energy delivery device comprises a central optical fiber strand surrounded by a plurality of outer optical fiber strands having a smaller diameter than said central optical fiber.

11. The apparatus of claim 10 wherein said central optical fiber strand has a diameter of around 0.6 mm and said outer fiber optical strands have a diameter of around 0.2 mm.

12. The apparatus of claim 10 wherein said central optical fiber has a proximal end configured to connect to an argon or Nd:

YAG laser and said outer optical fiber strands have proximal ends configured to connect to a holmium (Ho;

YAG) laser.

13. The apparatus of claim 10 wherein said central and outer optical fiber strands have flat, non-tapered end faces it are perpendicular to a longitudinal axis of said central and outer optical fiber strands.