Method and device for neurocryo analgesia and anesthesia

• US 6,761,715 B2
• Filed: 02/05/2002
• Issued: 07/13/2004
• Est. Priority Date: 04/26/2001
• Status: Active Grant

• Current Assignee: Access Point Technologies, Inc., Applied Cryoneurologics, LLC
• Original Assignee: Applied Cryoneurologics, LLC
• Inventors: Carroll, Ronald J.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): Vrettakos, Peter J
• Application Number:
  US10/071,574
• Publication Number:
  US 20020161360A1
• Time in Patent Office: 889 Days
• Field of Search: 606/20-26, 128/898
• US Class Current: 606/21
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

A catheter system and method for selectively cooling or freezing target neuronal tissue to induce lesions along the neuroaxis and produce cryoanalgesia by impairing nerve conduction of the targeted neuronal tissue. The system includes a catheter that has cryogenic capability for variable cooling or freezing of neuronal tissue. The catheter also includes temperature sensing and electrodiagnostic capabilities. A pressurized fluid source is included for inflating a portion of the catheter body. The system includes electrodiagnostic equipment for stimulating and monitoring sensory evoked potentials in the patient. The method involves placement of the catheter tip in the subarachnoid space of the spinal canal and location of the tip on the neuronal target using imaging and electrodiagnostic techniques.

Claims

1. A method of freezing neuroaxis structure targets with a cryocatheter having a distal end and a proximate end, said method comprising:

inserting said distal end of said cryocatheter into the subarachnoid space of a patient; and

delivering a coolant fluid into said cryocatheter so as to effect freezing of a neuronal tissue target.

2. The method of claim 1 further comprising positioning said distal end adjacent to said neuronal tissue target and wherein said coolant fluid is delivered to said distal end such that the temperature of said distal end is reduced.

3. The method of claim 2 further comprising using imaging guidance when positioning said distal end.

4. The method of claim 2 further comprising expanding at least a portion of said cryocatheter once said distal end is positioned adjacent to said neuronal tissue target.

5. The method of claim 2 further comprising measuring the temperature of said distal end and controlling delivery of said coolant fluid in response to distal end temperature.

6. The method of claim 2 further comprising applying an electrical stimulus to a dermatome on said patient that corresponds to said neuronal tissue target and using an electrode disposed on said cryocatheter to measure resultant sensory evoked potentials.

7. The method of claim 6 wherein measurement of sensory evoked potentials is used to verify that said distal end is properly positioned relative to said neuronal tissue target.

8. The method of claim 1 wherein said neuronal tissue target is selected from the group consisting of dorsal root filaments, dorsal root ganglia, dorsal horns, and Lissauer'"'"'s tract.

9. A method of cooling or freezing neuroaxis structure targets with a cryocatheter having a distal end and a proximate end, said method comprising:

inserting said distal end of said cryocatheter into the subarachnoid space of a patient;

placing said distal end in contact with selected dorsal root filaments of said patient; and

delivering a coolant fluid into said cryocatheter so as to effect cooling or freezing of said selected dorsal root filaments.

10. The method of claim 9 wherein placing said distal end in contact with selected dorsal root filaments includes positioning said distal end adjacent to said selected dorsal root filaments and expanding at least a portion of said cryocatheter.

11. The method of claim 10 further comprising using imaging guidance when positioning said distal end.

12. The method of claim 9 further comprising measuring the temperature of said distal end and controlling delivery of said coolant fluid in response to distal end temperature.

13. The method of claim 9 further comprising applying an electrical stimulus to a dermatome on said patient that corresponds to said selected dorsal root filaments and using an electrode disposed on said cryocatheter to measure resultant sensory evoked potentials.

14. The method of claim 13 wherein measurement of sensory evoked potentials is used to verify that said distal end is properly positioned relative to said selected dorsal root filaments.

15. A method of providing pain relief comprising:

providing a cryocatheter having an electrically conductive tip member and means for cooling said tip member;

introducing said tip member into the subarachnoid space of a patient by percutaneous spinal canal puncture;

placing said tip member in contact with selected dorsal root filaments of said patient;

applying a repetitive electrical stimulus to a dermatome on said patient that corresponds to said selected dorsal root filaments;

using said electrically conductive tip member as an electrode to measure sensory evoked potentials that may result from applying said electrical stimulus, wherein detection of sensory evoked potentials provides confirmation that said tip member is properly positioned in contact with said selected dorsal root filaments;

operating said means for cooling to cool said selected dorsal root filaments without freezing said selected dorsal root filaments subsequent to confirming that said tip member is properly positioned in contact with said selected dorsal root filaments;

continuing to use said electrically conductive tip member as an electrode to measure sensory evoked potentials that may result from applying said electrical stimulus, wherein cessation of detected sensory evoked potentials subsequent to cooling said selected dorsal root filaments provides further confirmation that said tip member is properly positioned in contact with said selected dorsal root filaments;

operating said cryocatheter to freeze said selected dorsal root filaments subsequent to further confirming that said tip member is properly positioned in contact with said selected dorsal root filaments; and

withdrawing said tip member from said subarachnoid space subsequent to freezing said selected dorsal root filaments.

16. The method of claim 15 wherein said cryocatheter includes an expandable portion and the step of placing said tip member in contact with selected dorsal root filaments of said patient comprises:

positioning said tip member adjacent to said selected dorsal root filaments; and

expanding said expandable portion once said tip member is positioned adjacent to said selected dorsal root filaments so that said tip member is pressed into contact with said selected dorsal root filaments.

17. The method of claim 16 further comprising using imaging guidance when positioning said tip member.

18. The method of claim 15 further comprising monitoring temperature of said tip member to control cooling and freezing of said selected dorsal root filaments.