Laser device with auto-piercing tip for myocardial revascularization procedures

• US 6,152,918 A
• Filed: 04/09/1998
• Issued: 11/28/2000
• Est. Priority Date: 04/05/1996
• Status: Expired due to Fees

• Current Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Original Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Inventors: Padilla, Henry N., Mueller, Richard L., Harman, Stuart D.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): YARNELL, BRYAN KEITH
• Application Number:
  US09/058,387
• Time in Patent Office: 964 Days
• Field of Search: 606/2, 606/7, 606/10, 606/11, 606/13-16, 606/167, 606/181, 606/182, 606/184, 606/185, 606/186, 606/41, 606/45, 606/48, 606/49, 606/50
• 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 18/22 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 2017/00172 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 2017/22075 with motorized advancing or retracting means
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2018/00291 using suction
• 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
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation

Abstract

The apparatus for combined mechanical/laser myocardial revascularization of a human heart includes: inserting a mechanical piercing device and an elongated flexible lasing apparatus into the chest cavity of a patient; mechanically auto-piercing, micro-tearing or spreading the epicardium of the heart; and then lasing from beneath the epicardium through the myocardium. The apparatus is guided to an area exterior to a ventricle of the patient'"'"'s heart, and the distal end of the energy delivery device such as an optical fiber apparatus is placed internal to the exterior wall of the heart through an opening which has been created by mechanically piercing, micro-tearing or spreading the epicardium, so that the myocardium and not the epicardium is irradiated with laser energy to allow passage of said energy delivery device such as an optical fiber distal end or said laser energy into the left ventricular cavity without causing a laser irradiation of the epicardium which might be a cause of operative bleeding and for better allowing the sealing of the epicardium after the apparatus is removed. The apparatus includes a hand-held device controllable by the physician having a removable distal head portion with an auto-piercing mechanism and can use a vacuum source to provide a suction force at the head portion. The auto-piercing mechanism is implemented by various ways such as a spring-biased actuating member in the TMR hand-held device and an electro-mechanical operated piercing mechanism. The hand-held TMR device with handle assembly can also be controlled by a computer to provide auto- sequencing of the auto-piercing needle mechanism and the laser firing with auto-fiber advancement.

Claims

1. A hand held auto-piercing mechanism comprising:

a handle assembly having a head portion whose distal end is configured to engage tissue;

a channel forming device extending through the handle assembly and head portion, the channel forming device comprising an optical fiber;

a piercing means surrounding the channel forming device for making an initial opening in tissue, the piercing means includes a piercing tubular member which is retractable into the head portion, the piercing tubular member has a tapered tip portion and an internal bore for allowing slidable displacement of the optical fiber, a distal section of the piercing tubular member includes a means for axially bending of the piercing tubular member, and the optical fiber therein; and

a movement means operatively attached to the piercing means and the channel forming device for independently controlling the movement of the piercing means and the channel forming device, the movement means comprises an adjustment means for moving the optical fiber within the handle assembly and head portion, the adjustment means forms part of the handle assembly, whereby the optical fiber'"'"'s distal end can move beyond the head portion, and a means for presetting displacement of the optical fiber, thereby limiting the optical fiber'"'"'s displacements.

wherein the piercing means is wholly responsive to the movement means for making an initial opening in tissue.

2. The device of claim 1 wherein the handle assembly further includes rotational adjusting means for orienting the tapered tip portion, the rotational adjusting means attaches to the piercing tubular member and the handle assembly, the piercing means further includes a means for offsetting an angle of the optical fiber from the piercing means.

3. The device of claim 1 wherein the adjustment means includes a movable shuttle which connects to the optical fiber and moves independently and inter-lockingly with the movement of the piercing means.

4. The device of claim 1 wherein the adjustment means for moving the optical fiber includes a means for operably advancing the optical fiber at a rate coordinated with a configurable laser energy source.

5. A hand held auto-piercing mechanism comprising:

a handle assembly having a head portion whose distal end is configured to engage tissue;

a channel forming device extending through the handle assembly and head portion;

a piercing means surrounding the channel forming device for making an initial opening in tissue; and

a movement means operatively attached to the piercing means and the channel forming device for independently controlling the movement of the piercing means and the channel forming device, the movement means comprising a controlling means for controllably advancing the channel forming device at a rate coordinated with a laser energy source,

wherein the piercing means is wholly responsive to the movement means for making an initial opening in tissue.

6. A surgical device for treating myocardium comprising:

a handle assembly with a distal end configured to engage epicardium including at least one distal opening communicating through the hand assembly;

a piercing mechanism within the distal end of the handle assembly, movement of said piercing mechanism relative to and translatable through said opening;

a substance delivery conduit distally connected to the handle assembly through to the opening and proximally connected to a source; and

an acceleration mechanism operatively coupled to the handle assembly for controllably advancing the piercing mechanism through the opening and epicardium to myocardium;

wherein the piercing mechanism is wholly responsive to the acceleration mechanism.

7. A hand held auto-piercing mechanism comprising:

a handle assembly having a head portion whose distal end is configured to engage tissue;

a channel forming device extending through the handle assembly and head portion;

a piercing means surrounding the channel forming device for making an initial opening in tissue; and

a movement means operatively attached to the piercing means and the channel forming device for independently controlling the movement of the piercing means and the channel forming device, the movement means further comprising an actuating means,

wherein the piercing means is wholly responsive to the movement means for making an initial opening in tissue and operation of the actuating means triggers a spontaneous advancement of the piercing means.

8. The device of claim 7 wherein the actuating means comprises an actuator, a trigger, and a biasing member, the actuator operatively attached to the trigger and holding the trigger in place, the biasing member operatively attached to the trigger and initially having potential energy prior to operation of actuator,

wherein operation of the actuator results in a trigger event, the trigger event initially resulting in the disengagement of the actuator from the trigger, whereby the biasing member causes the spontaneous advancement of the piercing means.

9. The device of claim 7 wherein the handle assembly further comprises a depth stop, wherein, during displacement, the depth of the channel forming device in tissue can be controlled.

10. A hand held auto-piercing mechanism comprising:

a handle assembly having a head portion whose distal end is configured to engage tissue;

a channel forming device extending through the handle assembly and head portion;

a piercing means surrounding the channel forming device for making an initial opening in tissue; and

a movement means operatively attached to the piercing means and the channel forming device for independently controlling the movement of the piercing means and the channel forming device, the movement means further comprising an actuating means,

wherein the piercing means is wholly responsive to the movement means for making an initial opening in tissue and operation of the actuating means results in a first event followed by a second event, the first event resulting in a spontaneous advancement of the piercing means, the channel forming device remaining at least in the piercing means, the second event resulting in the continued displacement of the channel forming device.

11. The device of claim 10 wherein the movement means further comprises a control knob operatively attached to the piercing means,

wherein the piercing means can rotate, rotation of the piercing means being independently controlled with respect to the displacement of the piercing means and channel forming device.

12. The device of claim 11 wherein the piercing means comprises a guiding member, whereby the guiding member guides the channel forming device to facilitate formation of branched revascularization channels in tissue.

13. A hand held auto-piercing mechanism comprising:

a handle assembly having a head portion whose distal end is configured to engage tissue;

a channel forming device extending through the handle assembly and head portion;

a piercing means surrounding the channel forming device for making an initial opening in tissue; and

a movement means operatively attached to the piercing means and the channel forming device for independently controlling the movement of the piercing means and the channel forming device, the movement means comprising a first displacement mechanism which advances and retracts the piercing means, and a second displacement mechanism which advances and retracts the channel forming device;

wherein the piercing means is wholly responsive to the movement means for making an initial opening in tissue.

14. The device of claim 13 wherein the first displacement mechanism comprises a thumbwheel and the second displacement mechanism comprises a side knob,

wherein movement of the thumbwheel results in displacement of the piercing means, movement of the side knob results in displacement of the channel forming device.

15. The device of claim 14 wherein the first displacement mechanism further comprises a motor, and a first and second switching means operatively attached to the thumbwheel and the motor,

wherein operation of the thumbwheel defines at least three operational modes, during a first of the at least three operational modes the first switching means is activated whereby the motor operates and the piercing means advances, during a second of the at least three operational modes the first and second switching means are deactivated and the piercing means is stationary, and during a third of the at least three operational modes the second switching means is activated whereby the motor operates and the piercing means retracts.

16. The device of claim 14 wherein the first displacement mechanism further comprises a motor, and a switching means operatively attached to the thumbwheel and the motor,

wherein operation of the thumbwheel defines at least two operational modes, during a first of the at least two operational modes the switching means is activated whereby the motor operates and the piercing means advances and retracts in a reciprocating fashion, during a second of the at least two operational modes the switching means is deactivated and the piercing means neither advances nor retracts.

17. The device of claim 16 wherein the second displacement mechanism further comprises a depth stop control whereby the depth of the channel forming device in tissue can be set to preselect values.

18. The device of claim 16 further comprising a control knob operatively attached to the piercing means and the channel forming device therein,

wherein the piercing means can rotate, rotation of the piercing means being independently controlled with respect to the first and second displacement mechanisms.

19. The device of claim 13 wherein the handle assembly further comprises at least one lumen, the at least one lumen having an opening at the distal end of the head portion and another opening which communicates with a vacuum source, whereby operation of the vacuum source results in secure engagement of the head portion with the tissue, assisted removal of ablated tissue, and increased blood flow into a channel formed by the channel forming device.

20. A handheld myocardial revascularization device comprising:

a handle assembly with a head portion whose distal end is configured to engage the heart;

a channel forming device extending through the handle assembly and head portion;

a piercing means surrounding the channel forming device for making an initial opening in tissue, the piercing means moves relative to the head portion and is translatable through the head portion; and

an advancing means for controllably advancing the piercing means, the advancing means comprising an actuator means for advancing the piercing means, the actuator means comprising a thumbwheel attached to the handle assembly, a belt drive that rides on a pair of gear members, and a rotatably mounted needle piercing element that translates within one of the gear members bore with internal threads, whereby the advancing means enables initial tissue piercing.

21. A handheld myocardial revascularization device comprising:

a handle assembly with a head portion whose distal end is configured to engage the heart;

a channel forming device extending through the handle assembly and head portion;

a piercing means surrounding the channel forming device for making an initial opening in tissue, the piercing means moves relative to the head portion and is translatable through the head portion, the piercing means and the channel forming device moving independently with respect to one another; and

an advancing means for controllably advancing the piercing means, the advancing means comprising an actuator means for advancing the piercing means, the actuator means comprising a motor operatively attached to the piercing means, whereby the advancing means enables initial tissue piercing.

22. The device of claim 21 wherein the actuator means further comprises a shaft operatively attached to the motor, the distal end of the shaft having a gear which engages and rotatably drives a rotatably mounted needle element.

23. The device of claim 22 wherein the gear is a worm gear.

24. The device of claim 22 wherein the gear is a bevel gear.

25. The device of claim 21 wherein the actuator means further comprises a shaft having a bladed end portion operatively attached to a spring-biased reciprocating needle element, whereby shaft rotations cause displacements of the needle element.

26. The device of claim 21 wherein the actuator means further comprises a translating shaft operatively attached to the motor, the translating shaft having a surface which engages a leaf-spring biased reciprocation needle element, whereby translating movements of the shaft cause displacements of the needle element.

27. The device of claim 21 wherein the actuator means further comprises a pivotal shaft, the distal end of the pivotal shaft engages a reciprocating needle element, whereby pivoting of the shaft cause displacements of the needle element.

28. The device of claim 27 wherein the pivotal shaft comprises a rack and pinion mechanism operatively attached to the needle, whereby the needle can be rotated and branched myocardial revascularization channels can be created.