Contiguous, branched transmyocardial revascularization (TMR) channel, method and device

• US 6,066,131 A
• Filed: 06/05/1998
• Issued: 05/23/2000
• Est. Priority Date: 07/03/1996
• Status: Expired due to Fees

• Current Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Original Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Inventors: Richardson, Bruce J., Lathrop, Robert L. Jr., Mueller, Richard L., Harman, Stuart D.
• Primary Examiner(s): Jaworski, Francis J.
• Application Number:
  US09/092,798
• Time in Patent Office: 718 Days
• Field of Search: 606/7, 606/9, 606/12, 606/10, 606/14-17, 606/19, 607/89
• US Class Current: 606/15
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 18/201 with beam delivery through a hollow tube, e.g. forming an articulated arm through a flexible conduit A61B18/22; Hand-pieces therefor
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22075 with motorized advancing or retracting means
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/2005 with beam delivery through an interstitially insertable device, e.g. needle
• CPC Class Codes: A61B 2018/2288 the optical fibre cable having a curved distal end

Abstract

Improved methods and devices related to laser-assisted transmyocardial revascularization (TMR), and more particularly, to improved methods and devices for creating branched TMR channels through myocardium in which a single opening is made in an epicardial surface with a plurality of channel branches, having predetermined geometries extending into and through myocardium, depending therefrom. A method of creating branched TMR channels comprises piercing an epicardial surface mechanically or with laser energy, directing laser energy through the opening in a first predetermined angular orientation with respect to the epicardial surface to create a first channel and delivering laser energy in a second predetermined angular orientation to create a second branch. A plurality of branches can thus be created in a single channel structure. A guide block device allows an opening to be made in an epicardial surface mechanically or with laser energy and provides a structure for directing laser energy into myocardium in a plurality of channels depending from the opening. Rotating guide devices and finger held devices with rotating head means include a hand held device with an elongated wand-like handle portion, a rotating head portion and a hollow guide needle means. Preferred embodiments further comprise a laser delivery means advancing mechanism and guide needle rotating means.

Claims

1. A method for creating contiguous branched transmyocardial revascularization channels comprising:

a) positioning a guide device having a rotating distal head in combination with a hollow piercing element having a curvature at a distal end, on an epicardial surface adjacent myocardium;

b) piercing the epicardial surface with the piercing element to create an entry point;

c) deflecting a laser energy delivery device through the curvature of the piercing element into myocardium at a predetermined angle with respect to the epicardial layer; and

d) creating a first angled channel in myocardium.

2. The method of claim 1 further comprising:

e) retracting the laser energy delivery device into the hollow piercing element;

f) rotating the piercing element;

g) advancing the laser energy delivery device into myocardium from the entry point to create a second channel.

3. The method of claim 2 wherein the rotating distal head is indexed with a predetermined number of angular positions and further comprising step h) repeating steps e) through g) and angling the distal end of the piercing element to a number of angular positions to allow the laser energy delivery device to deliver laser energy into myocardium at predetermined angles.

4. A method for forming angled myocardial revascularization channels comprising:

a) positioning a distal tip of an apparatus having a distal rotating orientation member in combination with a curved hollow needle on a heart surface adjacent a preselected location of myocardium;

b) perforating the surface to create an access opening;

c) curving a distal end of a laser energy delivery device through the needle through the perforated surface into myocardium at a predetermined angle with respect to the surface; and

d) transmitting laser energy from the distal end of the laser energy delivery device into myocardium.

5. The method of claim 4 further comprising step e) rotating the orientation member to form a multi-ended channel with the access opening.

6. The method of claim 4 further comprising step e) rotating the orientation member to form a plurality of channel branches from the access opening, having predetermined geometries extending into and through myocardium.

7. The method of claim 6 further comprising step f) directing laser energy into a junction of the plurality of channel branches to create a cavity.

8. The method of claim 4 further comprising a laser energy delivery device housed in and translatable through the apparatus and step b) perforating the surface with laser energy.

9. The method of claim 4 step b) perforating the surface mechanically with the curved hollow needle.

10. The method of claim 9 the apparatus further comprising a heating mechanism operatively coupled to the needle and further during step b) cauterizing the perforated surface opening.

11. The method of claim 4 the apparatus further comprising an automated advancing mechanism operatively coupled to the laser energy delivery device and during step c) advancing the laser energy delivery device automatically to a predetermined depth in the myocardium.

12. The method of claim 4 the apparatus further comprising a manual advancing mechanism operatively coupled to the laser energy delivery device and during step c) advancing the laser energy delivery device manually to a predetermined depth in the myocardium.

13. A method for forming multiple transmyocardial channels with a single entry point comprising:

a) tilting a hollow piercing element and laser energy delivery device combination against a first surface of a guide device having a plurality of frustoconical internal bearing surfaces, said guide device placed on a heart surface adjacent myocardium;

b) piercing the surface with the piercing element;

c) advancing the laser energy delivery device through the piercing element to create a first channel in myocardium;

d) retracting the laser energy delivery device into the hollow piercing element;

e) orienting the piercing element against a second surface of the guide device;

creating a second channel at an angle to the first channel in myocardium.

14. A method for creating contiguous branched transmyocardial revascularization channels comprising:

a) positioning a guide device having a distal head in combination with a hollow piercing element having a curvature at a distal end, on a heart surface adjacent myocardium;

b) inserting the piercing element through the surface and into myocardium;

c) advancing and deflecting a laser energy delivery device through the curvature of the piercing element into myocardium at a predetermined angle with respect to the surface; and

d) creating a first angled channel in myocardium.