Laser device for transmyocardial revascularization procedures

• US 6,019,756 A
• Filed: 01/30/1997
• Issued: 02/01/2000
• Est. Priority Date: 04/05/1996
• Status: Expired due to Term

• Current Assignee: Cryolife Incorporated
• Original Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Inventors: Mueller, Richard L., Harman, Stuart D., Phipps, Richard D.
• Primary Examiner(s): Smith, Ruth S.
• Application Number:
  US08/790,193
• Time in Patent Office: 1,097 Days
• Field of Search: 606/7, 606/13-16, 606/11, 606/10, 606/167, 606/170, 607/89
• US Class Current: 606/7
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• 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 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 18/20 using laser
• 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 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints

Abstract

A laser surgery device for performing laser myocardial revascularization procedures on a human heart comprises a hand-held body portion with a forwardly extending probe member with an enlarged head end assembly including a piercing tip. A movable fiber bundle connected to a laser source extends through the body portion and the probe member with its distal tip at the head end assembly. A control button on the body portion enables the device to move the distal tip forwardly from the head end, and selectable stop members are provided on the body portion to provide different travel distances for the optical fiber bundle during a procedure. The body portion has a rotatable nose-piece with an internal ratchet mechanism which enables the device user to rotate the probe member and its head end to a selected optimum position before commencing a procedure. The head end assembly includes an easily replaceable piercing member in combination with a concave disk having a yieldable liner for cushioning the head assembly contact with the patient'"'"'s heart. The device is used with a TMR procedure wherein the epicardium is initially pierced to provide access to the myocardium for the distal tip of the fiber bundle which then emits laser pulses as it is moved through the myocardium.

Claims

1. A hand-held device for use in performing transmyocardial revascularization comprising:

a housing having a ratcheting means therein and a distal rotatable nose piece, the nose piece attached to the ratcheting means;

a probe member having proximal and distal ends, the proximal end attached to the housing and operatively connected to the rotatable nose piece, the ratcheting means thereby enabling incremental rotation of the nose piece to selected positions to change orientation of the probe member;

a head member having a connector attached to the distal end of the probe member;

at least one optical fiber having proximal and distal ends, the proximal end adapted for attachment to a source of laser energy, the optical fiber extending through the housing, the probe member and the head member; and

an adjustment mechanism on the housing and connected to the optical fiber for moving the optical fiber.

2. The hand-held device of claim 1 wherein the head member further includes a generally disc shaped tip attached to the connector, the disc shaped tip forming a tissue contact surface.

3. The hand-held device of claim 2 wherein at least a selected portion of the disc shaped tip is removed to enable visualization of tissue.

4. The hand-held device of claim 2 wherein at least a portion of the disc shaped tip is transparent to enable visualization of tissue.

5. The hand-held device of claim 2 wherein the head rnember further comprises a tubular piercing member extending therefrom to enable epicardial piercing and anchoring of the head member during a transmyocardial revascularization procedure.

6. The hand-held device of claim 5 further comprising a cushioning member attached to the disc shaped tip and surrounding the tubular piercing member, the cushioning member compressible to enable the tubular piercing member to pierce tissue.

7. The hand-held device of claim 6 wherein the cushioning member comprises a medical-grade plastic foam capable of absorbing fluids.

8. The hand-held device of claim 2 further comprising a cushioning member attached to the disc shaped tip thereby providing a yieldable tissue contact surface.

9. The hand-held device of claim 8 wherein the cushioning member comprises a inedical-grade plastic foam capable of absorbing fluids.

10. The hand-held device of claim 1 wherein the ratcheting means comprises a detent member having a generally circular flange comprising teeth separated by spaces, a projection attached within the housing, and a spring means for urging the detent member against the projection so that the projection seats in one space while allowing the detent member to retract and the projection to seat in another space when rotating the nose piece.

11. The hand-held device of claim 1 wherein the nose piece has an outwardly extending projection thereby enabling rotational ease of the nose piece.

12. The hand-held device of claim 1 wherein the housing includes a slot and the adjustment mechanism comprises:

a movable control button mounted within the slot, a shuttle within the housing and attached to the at least one optical fiber, and a web mechanism extending through the slot for connecting the shuttle to the control button such that movement of the control button within the slot moves the distal end of the at least one optical fiber into and out of the head member.

13. The hand-held device of claim 12 wherein the housing includes a stop assembly for limiting movement of the control button within the slot thereby controlling displacement of the at least one optical fiber out of the head member.

14. The hand-held device of claim 12 wherein the stop assembly, the control button and the rotatable nose piece are positioned on the housing to enable a user single-handed motion control of both the at least one optical fiber and the rotatable nose piece to change orientation of the probe member.

15. The hand-held device of claim 12 wherein the stop assembly comprises projections extending outwardly from the housing and a cross member attached to the control button and having mating projections, the cross member slidable within the control button to select a travel distance for the control button prior to engagement of a housing projection by a mating projection of the cross member.

16. The hand-held device of claim 15 wherein the cross member has a central position within the control button, the central position enabling the control button unrestricted movement within the slot without engagement of the projections of the housing with the cross member mating projections, the cross member further having left and right positions within the control button, movement of the control button with the cross member in the left position limiting travel of the control button to a first preselected distance when a first projection of the housing engages a cross member projection, the right position limiting travel of the control button to a second preselected distance when a second projection of the housing engages an opposite cross member projection.

17. The hand-held device of claim 1 further comprising a tubular support member within at least the distal rotatable nose piece and surrounding at least the distal end of the at least one optical fiber.

18. The hand-held device of claim 1 wherein the connector is a Luer taper and lock mechanism for providing quick interchangeability of the head member.

19. The hand-held device of claim 1 further comprising at least one fluid passage extending through the housing, the probe member and the head member, the at least one fluid passage having a proximal end adapted for connection to a fluid source and a vacuum source.

20. The hand-held device of claim 19 wherein the proximal end of the fluid passage is attached to a fitting enabling selection of an irrigation mode to allow passage of fluid from the fluid source to the head member and selection of a suction mode.

21. The hand-held device of claim 1 wherein the at least one optical fiber is a bundle of fibers.

22. The hand-held device of claim 1 wherein the at least one optical fiber is a single fiber.

23. A surgical hand piece for use in performing laser transmyocardial revascularization comprising:

a housing having proximal and distal ends, the distal end having a rotatable nose piece;

a tubular probe member having proximal and distal ends, the proximal end attached to the distal end of the housing and the distal end of the tubular probe member extending outwardly through the rotatable nose piece, the tubular probe member connected to and rotatable by the rotatable nose piece;

a head member having a connector and a distal tip, the connector attached to the distal end of the tubular probe member, the distal tip forming a disc with a tissue contacting surface;

at least one fluid passage extending through the housing, the nose piece, the probe member and the head member, the fluid passage adapted for connection to a fluid source at the proximal end of the housing;

at least one optical fiber having proximal and distal ends, the proximal end adapted for connection to a source of laser energy, the distal end extending through the housing, the nose piece, the probe member and the bead member; and

an adjustment mechanism disposed on the housing for moving the at least one optical fiber.

24. A surgical device for performing transmyocardial revascularization on a patient'"'"'s heart comprising:

a body portion having a ratchet means therein and a rotatable nose piece attached to the ratchet means, the ratchet means for enabling the nose piece to be rotated in increments and to be retained in any selected position;

a tubular probe member connected to the body portion and rotatable by the nose piece on the body portion, the probe member defining proximal and distal ends;

a head assembly attached to the distal end of the probe member and including a quick disconnect connector adapted for attaching thereto a tip member;

an optical fiber means having a proximal end adapted for connection to a source of laser energy, the fiber means extending through the body portion and into the probe member, the fiber means having a distal end extending through the head assembly; and

control means on the body portion for moving the fiber means axially therein thereby moving the distal end of the fiber means forwardly from the head assembly to emit laser pulses when connected to the source to form revascularization channels in a myocardial layer of the heart.