Techniques for selective activation of neurons in the brain, spinal cord parenchyma or peripheral nerve

• US 6,353,762 B1
• Filed: 04/30/1999
• Issued: 03/05/2002
• Est. Priority Date: 04/30/1999
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Baudino, Michael, Rise, Mark T.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US09/302,519
• Time in Patent Office: 1,040 Days
• Field of Search: 607/45, 607/46, 607/116, 607/117, 607/139, 600/378
• US Class Current: 607/45
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain

Abstract

Disclosed are techniques for therapeutically treating peripheral vascular disease. A sensor is implemented for sensing the extent of blood flow in a patient'"'"'s limb or ischemic pain and generating a corresponding sensor signal. The signal is processed to determine the level of spinal cord stimulation or peripheral nerve stimulation to be applied. This information is provided to a signal generator which thereby provides electrical stimulation energy to one or more stimulation leads. Stimulation of the spinal cord, peripheral nerve or neural tissue ganglia thereby improves blood flow, helps restore tissue health and reduces the extent of ischemic pain in the limbs of a PVD patient or organs of other patients. Stimulation may be adjusted automatically to account for changing conditions of the patient throughout the day.

Claims

1. A system for providing treatment therapy to a volume of neural tissue comprising in combination:

(a) a cannula having a lumen distal end, the lumen distal end having at least one opening, each opening capable of directing a lead outwardly along a predetermined non-colinear trajectory;

(b) at least two leads insertable within the cannula, each lead having a lead distal end;

(c) at least one therapy delivery element at the lead distal end of each lead; and

(d) a therapy delivery device coupled to each therapy deliver element and capable of selectively providing treatment therapy via at least one therapy delivery element,

whereby the therapy delivery elements are positionable in a non-linear configuration to affect a volume of neural tissue.

2. A system as claimed in claim 1, wherein the therapy delivery device is a signal generator and the therapy delivery element is an electrode.

3. A system as claimed in claim 2 further comprising:

(e) means for selectively adjusting the electrical field created by the signal generator.

4. A system as claimed in claim 1, wherein the therapy delivery device is a pump and the therapy delivery element is a catheter.

5. A system as claimed in claim 4, further comprising:

(e) means for selectively adjusting the relative drug delivery by the pump to each catheter.

6. A system for providing treatment therapy to a volume of neural tissue comprising in combination:

(a) a cannula having a lumen distal end, the lumen distal end having at least one opening, each opening capable of directing a lead outwardly along a predetermined non-colinear trajectory;

(b) at least two leads insertable within the cannula, each lead having a lead distal end;

(c) at least one therapy delivery element at the lead distal end of each lead;

(d) a therapy delivery device coupled to each therapy deliver element and capable of selectively providing treatment therapy via at least one therapy delivery element;

(e) a sensor for generating a signal related to the extent of a condition to be treated; and

(f) a processor responsive to the sensor for adjusting at least one parameter of the treatment therapy provided to the therapy delivery device,

whereby the therapy delivery elements are positionable in a non-linear configuration to affect a volume of neural tissue.

7. A system for providing treatment therapy to a volume of neural tissue comprising in combination:

(a) a cannula having a lumen distal end, the lumen distal end having at least one opening, each opening capable of directing a lead outwardly along a predetermined non-colinear trajectory;

(b) at least two leads insertable within the cannula, each lead having a lead distal end;

(c) at least one therapy delivery element at the lead distal end of each lead;

(d) a therapy delivery device coupled to each therapy deliver element and capable of selectively providing treatment therapy via at least one therapy delivery element;

(e) a sensor for generating a signal related to the extent of a condition to be treated; and

(f) a processor responsive to the sensor for selectively altering the relative treatment therapy delivery delivered through each of the therapy delivery elements,

whereby the therapy delivery elements are positionable in a non-linear configuration to affect a volume of neural tissue.

8. A method for providing treatment therapy to a volume of neural tissue comprising the steps of:

(a) positioning a cannula within a brain of a patient, the cannula having at least one opening near a distal end capable of directing a lead outwardly along a predetermined non-colinear trajectory;

(b) inserting at least two leads into the cannula, wherein each lead has at least one therapy delivery element on a lead end of the lead; and

(c) directing the lead ends outwardly through at least one of the openings of the cannula and positioning the therapy delivery elements in a non-linear configuration.

9. A method as claimed in claim 8, further comprising the step of:

(d) coupling the therapy delivery element to a therapy delivery device.

10. A method as claimed in claim 9, further comprising the step of:

(e) adjusting the treatment therapy by selectively altering the relative treatment therapy delivered through each of the therapy delivery elements.

11. A method as claimed in claim 8, wherein the step of directing includes the step of positioning the therapy delivery elements to affect a predetermined treatment site is of a volume of a the brain.

12. A method as claim in claim 11, wherein the predetermined treatment site is selected from the group consisting of subthalamic nucleus (STN), peduncular pontine nucleus (PPN), caudate, putamen, internal palladium, external palladium, cingulum, anterior limb of an internal capsule, anterior nucleus (AN), centremedian (CM), dorsal medial nucleus, a nucleus of a thalamus hippocampus, a structure in a temporal lobe, hypothalamus, a structure of a diencephalon, pons, medulla corext, cerebellum, lateral geniculate body, and medial geniculate body.

13. A method as claimed in claim 8, wherein the therapy delivery device is a signal generator and the therapy delivery element is an electrode.

14. A method as claimed in claim 13, further comprising the steps of:

(d) establishing an anode/cathode relationship between at least one electrode of the lead and at least one electrode of the second lead; and

(e) presenting electrical pulses to the established anode/cathode relationships of the electrodes of the lead and second lead, whereby a volume of neural tissue is activated.

15. A method as claimed in claim 8, wherein the therapy delivery device is a pump and the therapy delivery element is a catheter.

16. A method for providing treatment therapy to a volume of neural tissue comprising the steps of:

(a) positioning a cannula within a brain of a patient, the cannula having at least one opening near a distal end capable of directing a lead outwardly along a predetermined non-colinear trajectory;

(b) inserting at least two leads into the cannula, wherein each lead has at least one therapy delivery element on a lead end of the lead; and

(c) directing the lead ends outwardly through at least one of the openings of the cannula and positioning the therapy delivery elements in a non-linear configuration;

(d) sensing the extent of a condition to be treated and generating a sensor signal; and

(e) adjusting at least one parameter of the treatment therapy provided to the therapy delivery device in response to the sensor signal.

17. A method for providing treatment therapy to a volume of neural tissue comprising the steps of:

(a) positioning a cannula within a brain of a patient, the cannula having at least one opening near a distal end capable of directing a lead outwardly along a predetermined non-colinear trajectory;

(b) inserting at least two leads into the cannula, wherein each lead has at least one therapy delivery element on a lead end of the lead; and

(c) directing the lead ends outwardly through at least one of the openings of the cannula and positioning the therapy delivery elements in a non-linear configuration;

(d) sensing the extent of a condition to be treated and generating a sensor signal; and

(e) adjusting the treatment therapy in response to the sensor signal by selectively altering the relative treatment therapy delivered through each of the therapy delivery elements.

18. A method of affecting a volume of neural tissue comprising the steps of:

(a) inserting at least a first, second, and third therapy delivery elements through a cannula and into neural tissue, wherein at least one therapy delivery element is directed into the neural tissue in a predetermined non-colinear trajectory;

(b) positioning the first, second, and third therapy delivery elements near a predetermined portion of the neural tissue in a nonlinear configuration; and

(c) selectively providing treatment therapy to first, second, and third party delivery elements to affect a predetermined volume of neural tissue.

19. A method as claimed in claim 18, wherein the therapy delivery elements are electrodes and the treatment therapy is electrical stimulation.

20. A method as claimed in claim 19, further comprising the steps of:

(d) establishing at least one anode/cathode relationship between at least two of the electrodes; and

(e) selectively adjusting the electrical field created by the electrodes.

21. A method as claimed in claim 19, wherein the electrical stimulation includes pulses that are independently variable in amplitude.

22. A method as claimed in claim 19, wherein the electrical stimulation includes pulses that are variable in pulse width.

23. A method as claimed in claim 18, wherein the therapy delivery elements are catheters and the treatment therapy is drug infusion.

24. A method as claimed in claim 23, further comprising the step of:

(d) selectively adjusting the relative drug delivery through each catheter.

25. A method as claimed in claim 18, wherein said first, second, and third therapy delivery elements define a volume of space.

26. A method as claimed in claim 18, further comprising the step of:

(d) adjusting said treatment therapy to cause a steerable locus of excitation of a volume of neural tissue.

27. A method as claimed in claim 18, wherein the predetermined volume of neural tissue is a volume of a brain parenchyma.

28. A method as claimed in claim 27, wherein the predetermined volume of neural tissue is selected from the group consisting of subthalamic nucleus (STN), peduncular pontine nucleus (PPN), caudate, putamen, internal palladium, external palladium, cingulum, anterior limb of an internal capsule, anterior nucleus (AN), centremedian (CM), dorsal medial nucleus, a nucleus of a thalamus, hippocampus, a structure in a temporal lobe, hypothalamus, a structure of a diencephalons, pons, medulla, corext, cerebellum, lateral geniculate body, and medial geniculate body.

29. A method as claimed in claim 18, wherein the predetermined volume of neural tissue is a volume of a spinal cord parenchyma.

30. A method as claimed in claim 18, wherein the predetermined volume of neural tissue is a volume of a peripheral nerve.

31. A system for altering the locus of treatment therapy delivered to a volume of neural tissue comprising in combination:

(a) a cannula having a lumen distal end, the lumen distal end;

(b) at least two leads insertable within the cannula, each lead having a lead distal end, at least one of the leads having a predetermined curvature at a distal end;

(c) at least one therapy delivery element at the lead distal end of each lead;

(d) a therapy delivery device coupled to each therapy delivery element and capable of selectively providing treatment therapy to at least one therapy delivery element;

(e) a sensor for generating a signal related to the extent of a physical condition; and

(f) a processor responsive to the sensor for adjusting at least one parameter of treatment therapy provided by the therapy delivery device,

whereby the therapy delivery elements are positionable in a non-linear configuration to affect a volume of neutral tissue.

32. A system as claimed in claim 31, wherein the therapy delivery device is a signal generator and the therapy delivery element is an electrode.

33. A system as claimed in claim 31, wherein the therapy delivery device is a pump and the therapy delivery element is a catheter.

34. A system as claimed in claim 31, further comprising:

(e) means for selectively altering the relative treatment therapy delivered through each of the therapy delivery elements.

35. A method of controlling a volume of neural tissue treatment comprising the steps of:

(a) positioning a cannula within a predetermined site, the cannula having an opening at a distal end;

(b) inserting at least two leads into the cannula and directing a lead end of each lead outwardly through the opening of the cannula, wherein the lead is a predetermined curvature at a distal end;

(c) positioning each therapy delivery element on the lead in a non-linear configuration to provide treatment therapy to the predetermined treatment site;

(d) sensing the extent of a physical condition and generating a sensor signal; and

adjusting in response to the sensor signal at least one parameter of treatment therapy provided by the therapy delivery device.

36. A method as claimed in claim 35, wherein the predetermined treatment is a volume of a brain.

37. A method as claimed in claim 36, wherein the predetermined treatment site is selected from the group consisting of subthalamic nucleus (STN), peduncular pontine nucleus (PPN), caudate, putamen, internal palladium, external palladium, cingulum, anterior limb of an internal capsule, anterior nucleus (AN), centremedian (CM), dorsal medial nucleus, a nucleus of a thalamus, hippocampus, a structure in a temporal lobe, hypothalamus, a structure of a diencephalon, pons, medulla, corext, cerebellum, lateral geniculate body, and medial geniculate body.

38. A method as claimed in claim 35, wherein the predetermined treatment site is a volume of a spinal cord parenchyma.

39. A method as claimed in claim 35, wherein the predetermined treatment site is a volume of a peripheral nerve.

40. A method as claimed in claim 35, wherein the therapy delivery element is an electrode.

41. A method as claimed in claim 40, further comprising the steps of:

(f) establishing an anode/cathode relationship between at least two electrodes of the lead; and

(g) presenting electrical pulses to the established anode/cathode relationships of the electrodes of the lead, whereby neural tissue are activated in the in the predetermined treatment site.

42. A method as claimed in claim 35, wherein the therapy delivery element is a catheter.

43. A method for providing treatment therapy to a volume of neural tissue comprising the steps of:

(a) positioning a cannula to affect a predetermined treatment site of a patient, the cannula having at least one opening near a distal end capable of directing a lead outwardly along a predetermined non-colinear trajectory, the predetermined treatment site being selected from the group consisting of a spinal cord parenchyma and a peripheral nerve;

(b) inserting at least two leads into the cannula, wherein each lead has at least one therapy delivery element on a lead end of the lead; and

(c) directing the lead ends outwardly through at least one of the openings of the cannula and positioning the therapy delivery elements in a non-linear configuration.