Medical implant device for electrostimulation using discrete micro-electrodes

• US 7,096,070 B1
• Filed: 02/06/2001
• Issued: 08/22/2006
• Est. Priority Date: 02/09/2000
• Status: Expired due to Term

• Current Assignee: Transneuronix Inc. (Medtronic Plc)
• Original Assignee: Transneuronix Inc. (Medtronic Plc)
• Inventors: Gordon, Pat, Jenkins, David
• Primary Examiner(s): Nicolas, Frederick C.
• Application Number:
  US09/777,979
• Time in Patent Office: 2,023 Days
• Field of Search: 607116-117, 607/119, 607/122, 607/9, 607/148, 600373-374, 600/377, 600/393, 128/898
• US Class Current: 607/116
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

An improved medical implant device is provided which has a plurality of micro-electrodes. The use of a plurality of micro-electrodes allows a clinically effective electrical stimulation pathway to be selected once the implant is positioned within or adjacent to the tissue to be treated even if the implant is not optimally placed or located. Thus, in cases where the implant is not optimally placed, it is not necessary to remove the implant and then reposition it within or adjacent to the tissue to be treated, thereby reducing stress to the patient caused by additional surgery. Moreover, using the micro-electrodes of this invention, directional electrostimulation can be provided to the tissue to be treated. Implant devices with a plurality of micro-electrodes are provided which are especially adapted for use in reducing the frequency and/or severity of neurological tremors. Other implant devices having micro-electrodes are provided which are especially adapted for electrostimulation and/or electrical monitoring of endo-abdominal tissue or viscera.

Claims

1. An implant device adapted for treatment of neuroglial or neuro-muscular tissue, said implant device comprising (1) an elongated body with a distal end and a proximal end;

(2) a plurality of micro-electrodes at the distal end;

(3) an electric connection terminal at the proximal end for connection to a power source;

(4) a plurality of electrical conductors extending through the elongated body from the distal end to the proximal end, wherein each electrical conductor is attached to a single micro-electrode at the distal end, whereby any selected pair of the plurality of micro-electrodes can be electrically connected to the electric connection terminal to form an electrical pathway between the electric connection terminal, the selected pair of the plurality of micro-electrodes, and the neuroglial or neuro-muscular tissue to be treated; and

(5) a multiplexer or switching device to measure impedance between the selected pair of the plurality of micro-electrodes in order to determine a satisfactory pair of the plurality of micro-electrodes to form the electrical pathway.

2. The implant device as in claim 1, wherein the plurality of micro-electrodes is greater than about 3 micro-electrodes.

3. The implant device as in claim 2, wherein the plurality of micro-electrodes is about 4 to about 20 micro-electrodes.

4. The implant device as in claim 1, wherein the multiplexer or switching device comprises a computer chip.

5. The implant device as in claim 4, wherein the power source is a pacemaker.

6. The implant device as in claim 5, wherein the multiplexer or switching device is incorporated into the power source.

7. The implant device as in claim 4, wherein the plurality of micro-electrodes allows the electrical pathway to be directional.

8. A method for clinically effective electrostimulation of neuroglial or neuro-muscular tissue, said method comprising

(a) positioning an implant device having a distal end and a proximal end such that the distal end can provide electrical stimulation of the neuroglial or neuro-muscular tissue, wherein the distal end of the implant device has a plurality of micro-electrodes and the proximal end of the implant device has an electrical connection terminal for connection to an electrical pulse generator, and wherein various pairs of the micro-electrodes can be electrically connected to the electrical connection terminal,

(b) positioning the distal end of the implant device sufficiently close to the neuroglial or neuro-muscular tissue to be electrostimulated,

(c) attaching the electrical pulse generator to the electrical connection terminal of the implant device,

(d) delivering electrical impulses to the implant device whereby various pairs of the plurality of micro-electrodes can be tested for electrostimulation of the neuroglial or neuro-muscular tissue, and

(e) selecting a pulsing micro-electrode and a receiving micro-electrode from the various pairs of the plurality of micro-electrodes tested in step (d) to provide clinical effective electrostimulation of the neuroglial or neuro-muscular tissue.

9. The method as in claim 8, wherein the plurality of micro-electrodes is greater than about 3 micro-electrodes.

10. The method as in claim 9, wherein the plurality of micro-electrodes is about 4 to about 20 micro-electrodes.

11. The method as in claim 8, wherein a multiplexer or switching device comprising a computer chip is used to select the pulsing micro-electrode and the receiving micro-electrode in step (e).

12. The method as in claim 11, wherein the power source is a pacemaker.

13. The method as in claim 12, wherein the multiplexer or switching device is incorporated into the power source.

14. The method as in claim 8, wherein the plurality of micro-electrodes allows the electrical pathway to be directional.

15. The method as in claim 8, wherein the clinical effectiveness of the electrostimulation is a clinically significant reduction in the frequency or severity of neurological tremors in the neuroglial or neuro-muscular tissue.

16. A method for clinically effective electrostimulation of gastrointestinal tissue within a patient'"'"'s endo-abdominal cavity, said method comprising

(a) inserting an implant device through a trocar into the endo-abdominal cavity, wherein the implant device has a plurality of micro-electrodes and an electrical connection terminal for connection to an electrical pulse generator, wherein various pairs of the micro-electrodes can be electrically connected to the electrical connection terminal,

(b) positioning the plurality of micro-electrodes within an area of gastrointestinal track to provide electrical stimulation to the gastrointestinal tissue to be electrostimulated,

(c) immobilizing the implant device so as to maintain good electrical stimulation of the gastrointestinal tissue to be electrostimulated during a treatment regime,

(d) attaching the electrical pulse generator to the electrical connection terminal of the implant device,

(e) delivering electrical impulses to the implant device whereby various pairs of the plurality of micro-electrodes can be tested for electrical stimulation of the gastrointestinal tissue to be electrostimulated,

(f) selecting a pulsing micro-electrode and a receiving micro-electrode from the various pairs of the plurality of micro-electrodes tested in step (e) to provide clinically effective electrical stimulation of the of the gastrointestinal tissue to be electrostimulated, and

(g) using the selected pulsing micro-electrode and received micro-electrode to electrostimulate the gastrointestinal tissue.

17. The method as in claim 16, wherein the plurality of micro-electrodes is greater than about 3 micro-electrodes.

18. The method as in claim 17, wherein the plurality of micro-electrodes is about 4 to about 20 micro-electrodes.

19. The method as in claim 17, wherein a multiplexer or switching device comprising a computer chip is used to select the pulsing micro-electrode and the receiving micro-electrode in step (f).

20. The method as in claim 19, wherein the power source is a pacemaker.

21. The method as in claim 20, wherein the multiplexer or switching device is incorporated into the power source.

22. The method as in claim 16, wherein the first and second immobilizing mechanisms are tines, clamps, or a flexible attachment member which can be folded back on the elongated body and attached to the elongated body thereby forming a closed loop around the tissue to be treated.

23. The method as in claim 16, wherein the plurality of micro-electrodes allows the electrical pathway to be directional.

24. The method as in claim 16, wherein the gastrointestinal tissue subjected to electrostimulation is associated with the Auerbach plexus or the Meissner plexus.

25. The method as in claim 16, wherein the clinically effective electrical stimulation is designed to effect weight reduction.

26. The method as in claim 24, wherein the clinically effective electrical stimulation is designed to effect weight reduction.

27. A method for clinically effective electrostimulation of gastrointestinal tissue within a patient'"'"'s endo-abdominal cavity, said method comprising

(a) implanting an implant device in the endo-abdominal cavity, wherein the implant device has a plurality of micro-electrodes and an electrical connection terminal for connection to an electrical pulse generator, wherein various pairs of the micro-electrodes can be electrically connected to the electrical connection terminal,

(b) positioning the plurality of micro-electrodes within an area of gastrointestinal track to provide electrical stimulation to the gastrointestinal tissue to be electrostimulated,

(c) immobilizing the implant device so as to maintain good electrical stimulation of the gastrointestinal tissue to be electrostimulated during a treatment regime,

(d) attaching the electrical pulse generator to the electrical connection terminal of the implant device,

(e) delivering electrical impulses to the implant device whereby various pairs of the plurality of micro-electrodes can be tested,

(f) measuring impedance between the various pairs of the plurality of micro-electrodes,

(g) selecting a pulsing micro-electrode and a receiving micro-electrode from the various pairs of the plurality of micro-electrodes tested in step (e), wherein the selected pulsing micro-electrode and the selected receiving micro-electrode pair has the lowest, or close to the lowest, impedance measured in step (f), and

(h) providing electrostimulation of the gastrointestinal tissue using the selected pulsing micro-electrode and the selected receiving micro-electrode pair.

28. The method as in claim 27, wherein the impedance between the various pairs of the plurality of micro-electrodes is periodically remeasured and the pulsing micro-electrode and the selected receiving micro-electrode pair is reflected based on the remeasured impedance between the various pairs of the plurality of micro-electrodes.

29. The method as in claim 27, wherein the clinically effective electrical stimulation is designed to effect weight reduction.

30. The method as in claim 28, wherein the clinically effective electrical stimulation is designed to effect weight reduction.

31. The method as in claim 28, wherein impedance between the various pairs of the plurality of micro-electrodes is periodically remeasured at least once a day.

32. The method as in claim 28, wherein impedance between the various pairs of the plurality of micro-electrodes is periodically remeasured at least every 12 hours.

33. A method for clinically effective electrostimulation of neuroglial or neuro-muscular tissue, said method comprising

(a) positioning an implant device having a distal end and a proximal end such that the distal end can provide electrical stimulation of the neuroglial or neuro-muscular tissue, wherein the distal end of the implant device has a plurality of micro-electrodes and the proximal end of the implant device has an electrical connection terminal for connection to an electrical pulse generator, and wherein various pairs of the micro-electrodes can be electrically connected to the electrical connection terminal,

(b) positioning the distal end of the implant device sufficiently close to the neuroglial or neuro-muscular tissue to be electrostimulated,

(c) attaching the electrical pulse generator to the electrical connection terminal of the implant device,

(d) delivering electrical impulses to the implant device whereby various pairs of the plurality of micro-electrodes can be tested for electrostimulation of the neuroglial or neuro-muscular tissue, and

(e) measuring impedance between the various pairs of the plurality of micro-electrodes;

(f) selecting a pulsing micro-electrode and a receiving micro-electrode from the various pairs of the plurality of micro-electrodes tested in step (d), wherein the selected pulsing micro-electrode and the selected receiving micro-electrode pair has the lowest, or close to the lowest, impedance measured in step (e); and

(g) providing electrostimulation of the neuroglial or neuro-muscular tissue using the selected pulsing micro-electrode and the selected receiving micro-electrode pair.

34. The method as in claim 33, wherein the impedance between the various pairs of the plurality of micro-electrodes is periodically remeasured and the pulsing micro-electrode and the selected receiving micro-electrode pair is reflected based on the remeasured impedance between the various pairs of the plurality of micro-electrodes.

35. The method as in claim 34, wherein impedance between the various pairs of the plurality of micro-electrodes is periodically remeasured at least once a day.

36. The method as in claim 34, wherein impedance between the various pairs of the plurality of micro-electrodes is periodically remeasured at least every 12 hours.