Methods and apparatus for defibrillating a heart refractory to electrical stimuli

• US 6,224,617 B1
• Filed: 12/17/1998
• Issued: 05/01/2001
• Est. Priority Date: 10/17/1997
• Status: Expired due to Fees

• Current Assignee: Angiotrax, Inc.
• Original Assignee: Angiotrax, Inc.
• Inventors: Saadat, Vahid, Macoviak, John A.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/213,740
• Time in Patent Office: 866 Days
• Field of Search: 607/5, 606/167, 606/159, 606/170
• US Class Current: 606/170
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• 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 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• 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 2017/00247 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 2017/00703 correcting for movement of heart, e.g. ECG-triggered
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2017/320028 with reciprocating movements
• CPC Class Codes: A61B 2017/320084 Irrigation sleeves
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00916 with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/1437 whereby the windings of the spiral touch each other such as to create a continuous surface
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/3784 : both receiver and transmitter being in the instrument or receiver being also transmitter

Abstract

Apparatus and methods for defibrillating a heart in fibrillation are provided using apparatus that forms a plurality of transmural channels in a wall of the heart. The apparatus includes a single-use handpiece having a mechanical cutting head and means for stabilizing the cutting head in contact with the tissue. The handpiece is coupled by a disposable cable to a controller that houses a vacuum pump and mechanisms for driving the cutting head. The cutting head is adapted to cooperate with the vacuum pump to evacuate tissue severed during the channel forming process.

Claims

1. A method of defibrillating a heart in fibrillation comprising steps of:

providing apparatus having a cutting head for boring a channel in a wall of the heart and means for aspirating tissue severed by the cutting head; and

repeating, until the heart ceases fibrillating, steps of;

positioning the cutting head against a wall of the heart;

actuating the cutting head to form a transmural channel in the wall of the heart; and

evacuating tissue cut by the cutting head.

2. The method as defined in claim 1 wherein the step of actuating the cutting head comprises a step of rotating the cutting head.

3. The method as defined in claim 2 wherein the step of evacuating tissue is performed simultaneously with the step of rotating the cutting head.

4. The method as defined in claim 2 wherein the step of actuating the cutting head further comprises a step of varying a speed of penetration of the cutting head into the wall of the heart responsive to a distance that the cutting head has penetrated into the wall.

5. The method as defined in claim 1 wherein the step of evacuating tissue cut by the cutting head comprises aspirating tissue cut by the cutting head by drawing a level of suction through the cutting head, the method further comprising a step of monitoring the level of suction to determine when the channel is fully formed.

6. The method as defined in claim 1 wherein the apparatus comprises a suction cup that stabilizes the cutting head in contact with the wall of the heart, the method further comprising, after the step of positioning the cutting head, a step of inducing suction through the suction cup to engage the suction cup to the wall.

7. The method as defined in claim 6 further comprising, after the step of evacuating tissue cut by the cutting head, a step of ceasing suction through the suction cup to disengage the wall of the heart.

8. The method as defined in claim 1 further comprising a step of measuring a thickness of the wall of the heart, the step of actuating the cutting head further comprising a step of adjusting a stroke length of the cutting head responsive to the measured thickness.

9. The method as defined in claim 1 further comprising a step of detecting a heart rhythm, the step of actuating the cutting head further comprising a step of triggering formation of the transmural channel responsive to the detected heart rhythm.

10. Apparatus for defibrillating a heart in fibrillation, the apparatus comprising:

a first vacuum source; and

a handpiece having;

a body, a shaft coupled to the body, the shaft including a lumen;

a cutting head having a bore coupled to the first vacuum source, a first position wherein the cutting head extends from within the lumen to form a channel in the tissue, tissue severed by the cutting head being aspirated through the bore by the first vacuum source, and a second position wherein the cutting head is retracted within the lumen; and

a stabilizer surface that contacts the heart and the cutting head in contact with the tissue.

11. The apparatus as defined in claim 10 wherein the apparatus further comprises:

a controller housing a linear motor; and

a cable coupling the linear motor to the cutting head to move the cutting head between the first and second positions.

12. The apparatus as defined in claim 11 wherein the first vacuum source is housed within the controller.

13. The apparatus as defined in claim 11 further comprising a rotary motor disposed within the controller and coupled by the cable to the cutting head to rotate the cutting head.

14. The apparatus as defined in claim 13 wherein the handpiece further comprises a control panel having buttons that cause activation of the linear and rotary motors.

15. The apparatus as defined in claim 13 wherein the cable comprises a drive cable and the apparatus further comprises a coupling that transmits rotary motion and longitudinal motion from the rotary and linear motors, respectively, to the drive cable.

16. The apparatus as defined in claim 15 wherein the handpiece further comprises a spool coupled between the drive cable and the cutting head, the spool including struts defining apertures that permit tissue aspirated through the bore of the cutting head to pass to a tissue filter.

17. The apparatus as defined in claim 10 wherein the shaft comprises a portion capable of articulating the cutting head to a position forming an angle relative to a longitudinal axis of the shaft.

18. The apparatus as defined in claim 10 wherein the cutting head, in the first position, also experiences motion selected from the group consisting of reciprocatory motion, angular motion, vibrational motion and high speed longitudinal motion.

19. The apparatus as defined in claim 10 wherein the stabilizer surface comprises a suction opening disposed near the cutting head and means for inducing suction through the suction opening.

20. The apparatus as defined in claim 19 wherein the first vacuum source provides a first level of suction to the cutting head and the means for inducing suction through the suction cup comprises a second vacuum source that provides a second level of suction, the second level of suction lower than the first level of suction.

21. The apparatus as defined in claim 10 wherein the handpiece is discarded after a single use.

22. The apparatus as defined in claim 10 wherein the handpiece further comprises a drive tube coupled between the drive cable and the cutting head, the drive tube comprising:

a rigid proximal portion;

a rigid distal portion; and

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