Apparatus and methods for intraoperatively performing surgery

• US 6,251,121 B1
• Filed: 02/25/2000
• Issued: 06/26/2001
• Est. Priority Date: 12/02/1996
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Angiotrax, Inc.
• Inventors: Saadat, Vahid
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US09/513,493
• Time in Patent Office: 487 Days
• Field of Search: 606/1, 606/107, 606/159, 606/167, 606/170, 606/180, 606/185, 128/898, 604/19, 604/22, 604/35, 604/118-120, 604/264, 600/562-566
• US Class Current: 606/180
• 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 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• 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 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/00991 Telescopic means
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/306 holding by means of suction
• 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 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00279 deployable
• 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 2018/00839 : Bioelectrical parameters, e.g. ECG, EEG
• 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 2018/1435 : Spiral
• 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 2090/034 : abutting on parts of the device itself
• CPC Class Codes: A61B 2090/0811 : for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2217/005 : with suction drainage system
• 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
• CPC Class Codes: A61M 25/0084 : being one or more injection needles

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. A method of intraoperatively forming a channel in tissue comprising:

providing apparatus having an end effector for boring a channel in the tissue and a stabilizing element that stabilizes the tissue against the end effector;

contacting the stabilizing element against a selected region of tissue;

actuating the end effector to cut a channel in the tissue;

evacuating the tissue cut by the end effector by drawing a level of suction through the end effector; and

monitoring the level of suction to determine when the channel is fully formed.

2. The method as defined in claim 1 further comprising:

applying a burst of RF energy to cauterize the tissue defining the channel.

3. The method as defined in claim 1 wherein the end effector includes a cutting head, and actuating the end effector comprises rotating the cutting head.

4. The method as defined in claim 3 wherein evacuating the tissue is performed simultaneously with rotating the cutting head.

5. The method as defined in claim 3 wherein rotating the cutting head further comprises varying a speed of penetration of the cutting head into the tissue responsive to a distance that the cutting head has penetrated into the tissue.

6. The method as defined in claim 3 wherein rotating the cutting head deposits frictional heat into the tissue that cauterizes the tissue defining the channel.

7. The method as defined in claim 1 wherein the stabilizing element comprises a suction cup and evacuating the tissue comprises aspirating the tissue from the end effector at a first level of suction, and contacting the stabilizing element against the tissue comprises inducing a second level of suction through the suction cup which is lower than the first level of suction.

8. The method as defined in claim 7 further comprising, after actuating the end effector, de-actuating the stabilizing element to disengage the selected region of tissue.

9. The method as defined in claim 1 wherein the apparatus further comprises means for monitoring cardiac activity, the method further comprising:

monitoring the cardiac activity to detect the onset of diastole; and

actuating the end effector responsive to the detection of the onset of diastole.

10. A method of intraoperatively performing transmyocardial revascularization comprising:

providing apparatus comprising an end effector for boring a transmural channel in cardiac tissue, a lumen disposed through the end effector, and a stabilizing element that stabilizes the cardiac tissue against the end effector;

drawing a level of suction through the lumen;

contacting the stabilizing element against an epicardial surface to counteract wall motion of the cardiac tissue;

determining a displacement of the end effector with a control circuit that generates a signal;

actuating the end effector, responsive to the signal, to cut a transmural channel in the tissue; and

evacuating the cardiac tissue cut by the end effector.

11. The method as defined in claim 10 further comprising:

applying a burst of RF energy to cauterize the cardiac tissue defining the transmural channel.

12. The method as defined in claim 10 wherein the end effector includes a cutting head, and actuating the end effector comprises rotating the cutting head.

13. The method as defined in claim 12 wherein evacuating the tissue is performed simultaneously with rotating the cutting head.

14. The method as defined in claim 12 wherein rotating the cutting head comprises varying a speed of penetration of the cutting head into the cardiac tissue responsive to the signal.

15. The method as defined in claim 12 wherein rotating the cutting head deposits frictional heat into the cardiac tissue that cauterizes the cardiac tissue defining the transmural channel.

16. The method as defined in claim 10 wherein evacuating the cardiac tissue cut by the end effector further comprises monitoring the level of suction to determine when the transmural channel is fully formed.

17. The method as defined in claim 10 wherein the stabilizing element comprises a suction cup, evacuating the tissue comprises aspirating the cardiac tissue from the end effector at a first level of suction, and contacting the stabilizing element against the epicardial surface comprises inducing a second level of suction through the suction cup which is lower than the first level of suction.

18. The method as defined in claim 10 wherein the apparatus further comprises means for monitoring cardiac activity, the method further comprising:

monitoring the cardiac activity to detect the onset of diastole; and

actuating the end effector responsive to the detection of the onset of diastole.

19. A method of intraoperatively performing transmyocardial revascularization comprising:

providing apparatus comprising an end effector for boring a transmural channel in cardiac tissue, a lumen disposed through the end effector, and a stabilizing element that stabilizes the cardiac tissue against the end effector;

drawing a level of suction through the lumen;

contacting the stabilizing element against an epicardial surface to counteract wall motion of the cardiac tissue;

actuating the end effector, responsive to the level of suction exceeding a predetermined level, to cut a transmural channel in the cardiac tissue, the transmural channel extending between the epicardial surface and an endocardial surface; and

evacuating the cardiac tissue cut by the end effector through the lumen.

20. The method as defined in claim 19 further comprising:

applying a burst of RF energy to cauterize the cardiac tissue defining the transmural channel.

21. The method as defined in claim 19 wherein the end effector includes a cutting head, and actuating the end effector comprises rotating the cutting head.

22. The method as defined in claim 21 wherein evacuating the tissue is performed simultaneously with rotating the cutting head.

23. The method as defined in claim 21 wherein rotating the cutting head further comprises varying a speed of penetration of the cutting head into the cardiac tissue responsive to a distance that the cutting head has penetrated into the cardiac tissue.

24. The method as defined in claim 21 wherein rotating the cutting head deposits frictional heat into the cardiac tissue that cauterizes the cardiac tissue defining the transmural channel.

25. The method as defined in claim 19 wherein evacuating the cardiac tissue cut by the end effector further comprises monitoring the level of suction to determine when the transmural channel is fully formed.

26. The method as defined in claim 19 wherein the stabilizing element comprises a suction cup, evacuating the tissue comprises aspirating the cardiac tissue from the end effector at a first level of suction, and contacting the stabilizing element comprises inducing a second level of suction through the suction cup which is lower than the first level of suction.

27. The method as defined in claim 19 wherein the apparatus further comprises means for monitoring cardiac activity, the method further comprising:

monitoring the cardiac activity to detect the onset of diastole; and

actuating the end effector responsive to the detection of the onset of diastole.