Apparatus for performing transmyocardial revascularization

• US 6,010,476 A
• Filed: 10/17/1997
• Issued: 01/04/2000
• Est. Priority Date: 12/02/1996
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Angiotrax, Inc.
• Inventors: Saadat, Vahid
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US08/953,769
• Time in Patent Office: 809 Days
• Field of Search: 606/187, 606/170, 606/173, 606/184, 606/171, 606/180, 604/22, 600/566, 600/567, 600/568
• US Class Current: 604/22
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00208 actively driven, e.g. by a motor
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00916 with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1437 whereby the windings of the spiral touch each other such as to create a continuous surface
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation

Abstract

Apparatus and methods for intraoperatively performing surgery to create transmural channels in tissue, for example, as in transmyocardial revascularization, are provided using a device including a mechanical end effector and means for stabilizing the end effector in contact with the tissue. The end effector is adapted to cooperate with a source of suction to evacuate tissue severed during the channel forming process, and may optionally include an electrode for cauterizing the tissue surrounding the channel.

Claims

1. Apparatus for use for performing transmyocardial revascularization by cutting a channel in cardiac tissue, the apparatus comprising:

a housing,

a shaft coupled to the housing, the shaft including a lumen and a distal endface;

an end effector disposed within the shaft for cutting a channel in the cardiac tissue, the end effector selectively movable from a first position disposed within the shaft to a second position wherein the end effector is extended beyond the distal endface,

a stabilizing element disposed on the shaft that stabilizes the cardiac tissue against the end effector to counteract wall motion of the cardiac tissue;

means for drawing a level of suction through the end effector to aspirate cardiac tissue severed by the end effector;

control circuitry for monitoring the level of suction and generating a signal; and

a linear actuator mechanism that controls movement of the end effector between the first and second positions responsive to the signal.

2. The apparatus as defined in claim 1 further comprising means for cauterizing the cardiac tissue surrounding the channel.

3. The apparatus as defined in claim 2 wherein the means for cauterizing comprises an RF energy source and at least one electrode disposed on the shaft for applying RF energy to the cardiac tissue surrounding the channel.

4. The apparatus as defined in claim 2 wherein the means for cauterizing comprises an exterior surface of the end effector, the end effector moved in relation to the cardiac tissue surrounding the channel so as to frictionally generate heat that cauterizes the cardiac tissue.

5. The apparatus as defined in claim 4 wherein motion of the end effector is selected from the group consisting of reciprocatory motion, angular motion or vibrational motion.

6. The apparatus as defined in claim 1 wherein the end effector includes a cutting head, the apparatus further comprising a motor disposed within the housing and coupled to the cutting head to rotate the cutting head.

7. The apparatus as defined in claim 1 wherein the linear actuator mechanism comprises a handle assembly and a motion switch, the motion switch configured to activate the motor when the handle assembly is actuated.

8. The apparatus as defined in claim 1 wherein the linear actuator mechanism comprises:

a motor;

a lead screw coupled to the motor; and

means for coupling the lead screw to the end effector.

9. The apparatus as defined in claim 1 wherein the stabilizing element comprises a suction cup disposed on the shaft near the end effector and means for inducing suction through the suction cup.

10. The apparatus as defined in claim 9 wherein the means for drawing suction through the end effector provides a first level of suction to the end effector and the means for inducing suction through the suction cup provides a second level of suction, the second level lower than the first level.

11. The apparatus as defined in claim 1 wherein the stabilizing element comprises:

a tubular member defining a passageway;

a shaft disposed within the passageway, the shaft having a distal end and a plurality of resilient outwardly directed fingers disposed on the distal end, the shaft biased in the passageway so that the outwardly directed fingers are disposed adjacent one another,

wherein, when the shaft is displaced in a distal direction, the outwardly directed fingers move apart to grip the cardiac tissue.

12. The apparatus as defined in claim 1 wherein the stabilizing element comprises:

a corkscrew element; and

means for rotating the corkscrew element to pierce and engage the cardiac tissue.

13. The apparatus as defined in claim 1 wherein the stabilizing element comprises:

a tubular member defining a passageway;

a wire having a sharpened tip, the wire disposed for movement through the passageway from a first position wherein the wire is retracted within the passageway to a second position wherein the wire is extended from the passageway, the wire having a curved form in the second position that retains the end effector in contact with the cardiac tissue.

14. The apparatus as defined in claim 1 wherein the end effector comprises:

a cutting head and

the apparatus further comprises means for rotating the cutting head.

15. The apparatus as defined in claim 14 further comprising a drive tube having a distal end coupled to the cutting head and a proximal end coupled to the means for drawing suction through the end effector.

16. The apparatus as defined in claim 15 wherein the drive tube and cutting head are disposable.

17. The apparatus as defined in claim 15 wherein the drive tube comprises:

a rigid proximal portion;

a rigid distal portion; and

a flexible drive coupling disposed between the rigid proximal portion and the rigid distal portion.

18. The apparatus as defined in claim 15 wherein the means for drawing suction induces suction through the drive tube and the drive tube comprises a portion formed of a coil spring having closely spaced adjacent turns, the apparatus further comprising an angled sleeve having a portion defining a lumen, the coil spring being disposed within the lumen so that the drive tube passes through the angled sleeve without substantial loss of suction.

19. The apparatus as defined in claim 14 wherein the cutting head comprises:

a tubular member having an interior passage in communication with the lumen.

20. The apparatus as defined in claim 19 wherein the cutting head further comprises a helical blade disposed within the tubular member.

21. The apparatus as defined in claim 19 wherein the cutting head has a distal end and a proximal end, and the interior passage of the cutting head has a diameter that increases from the distal end to the proximal end.

22. The apparatus as defined in claim 19 wherein the tubular member further comprises a raised thread disposed in the interior passage, the raised thread oriented so that the raised thread pushes severed cardiac tissue in a proximal direction as the cutting head rotates.

23. The apparatus as defined in claim 19 wherein the tubular member includes a distal end, and the cutting head further comprises a sharpened band projecting from the distal end.

24. The apparatus as defined in claim 19 wherein the cutting head comprises:

a tubular portion having a proximal end, an interior passage and an interior surface;

a plurality of teeth disposed from the interior surface;

a frustoconical portion coupled to the proximal end of the tubular portion, the frustoconical portion including portions defining windows the enable cardiac tissue collected in the interior passage to pass into the lumen; and

a hub for coupling the cutting head to the means for rotating.

25. The apparatus as defined in claim 19 wherein the means for rotating comprises:

a motor; and

a drive shaft coupled between the motor and the hub, the drive cable disposed within the lumen.

26. The apparatus as defined in claim 1 wherein the end effector comprises a sharpened tube, the apparatus further comprising means for advancing the sharpened tube at high speed in a distal direction.

27. The apparatus as defined in claim 1 wherein the end effector comprises a tubular member and means for ejecting a fluid stream from the tubular member at high speed.

28. Apparatus for use for performing transmyocardial revascularization by cutting a channel in cardiac tissue, the apparatus comprising:

a housing,

a shaft coupled to the housing, the shaft including a lumen and a distal endface;

an end effector disposed within the shaft for cutting a channel in the cardiac tissue, the end effector selectively movable from a first position disposed within the shaft to a second position wherein the end effector is extended beyond the distal endface;

a stabilizing element disposed on the shaft that stabilizes the cardiac tissue against the end effector to counteract wall motion of the cardiac tissue;

means for drawing suction through the end effector to aspirate cardiac tissue severed by the end effector;

control circuitry for monitoring a displacement of the end effector and generating a signal; and

a linear actuator mechanism that controls movement of the end effector between the first and second positions responsive to the signal.

29. The apparatus as defined in claim 28 further comprising means for cauterizing the cardiac tissue surrounding the channel.

30. The apparatus as defined in claim 28 wherein the end effector includes a cutting head, the apparatus further comprising a motor disposed within the housing and coupled to the cutting head to rotate the cutting head.

31. The apparatus as defined in claim 28 wherein motion of the end effector is selected from the group consisting of reciprocatory motion, angular motion or vibrational motion.

32. The apparatus as defined in claim 28 wherein the end effector comprises:

a cutting head and

the apparatus further comprises means for rotating the cutting head.

33. The apparatus as defined in claim 32 further comprising a drive tube having a distal end coupled to the cutting head.

34. The apparatus as defined in claim 33 wherein the drive tube and cutting head are disposable.

35. The apparatus as defined in claim 33 wherein the drive tube comprises:

a rigid proximal portion;

a rigid distal portion; and

a flexible drive coupling disposed between the rigid proximal portion and the rigid distal portion.

36. The apparatus as defined in claim 33 wherein the means for drawing suction induces suction through the drive tube and the drive tube comprises a portion formed of a coil spring having closely spaced adjacent turns, the apparatus further comprising an angled sleeve having a portion defining a lumen, the coil spring being disposed within the lumen so that the drive tube passes through the angled sleeve.