Gastro-electric stimulation for reducing the acidity of gastric secretions or reducing the amounts thereof

• US 7,620,454 B2
• Filed: 05/19/2003
• Issued: 11/17/2009
• Est. Priority Date: 05/19/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Starkebaum, Warren L., Dinsmoor, David A.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US10/441,785
• Publication Number:
  US 20040236381A1
• Time in Patent Office: 2,374 Days
• Field of Search: 607 40- 41, 607/133, 607129-131, 604/891.1, 600/361
• US Class Current: 607/40
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

A gastro-electric stimulation system includes an INS for producing an electrical stimulation signal, at least one medical electrical lead, and at least two electrical contacts. The medical electrical lead has a proximal end and a distal end, the proximal end being connected to the INS, the distal end being adapted for placement in or near a patient'"'"'s stomach or appropriate nerve or nerve portion. The electrodes are disposed near the distal end of the medical electrical lead, and are electrically connected through the medical electrical lead to the INS to receive the electrical stimulation signal and convey such signal to the selected electrode implant position. The electrical stimulation signal is provided in an amount and manner adapted to increase the pH of the gastric acid in the patient'"'"'s stomach and/or to decrease the amount of gastric acid produced thereby.

Claims

1. A method comprising:

generating electrical stimulation having one or more parameters selected to reduce acidity of gastric acid secretions in a patient; and

delivering the electrical stimulation to one or more portions of a gastrointestinal tract of the patient via an implantable electrical lead to reduce the acidity of the gastric acid secretions in the patient.

2. The method of claim 1, wherein the implantable electrical lead is selected from the group consisting of an intramuscular lead, a unipolar lead, a bipolar lead, a tri-polar lead, a quadrapolar lead, and a multi-polar lead.

3. The method of claim 1, wherein the implantable electrical lead is selected from the group consisting of a beam steering lead comprising multiple electrodes and a lead comprising multiple electrodes disposed in an areal pattern on a planar or curved surface.

4. The method of claim 1, wherein the implantable electrical lead is selected from the group consisting of a cuff lead, a paddle lead, a tined lead, and a lead having an active fixation device.

5. The method of claim 1, wherein the implantable electrical lead includes a fixation device selected from the group consisting of a suture sleeve, a barb, a helical screw, a hook and a tissue in-growth mechanism.

6. The method of claim 1, wherein the implantable electrical lead further comprises one or more electrodes configured to operate in conjunction with an electrically conductive portion of an implantable pulse generator acting as an indifferent electrode.

7. The method of claim 1, wherein the implantable electrical lead is a first implantable electrical lead, the method further comprising providing, implanting, operably connecting and delivering electrical stimuli from a second implantable medical electrical lead configured for implantation adjacent, around or in at least one of the stomach, the vagus nerve, the plexus on the anterior superior and/or the anterior inferior pancreaticoduodenal arteries, the plexus on the inferior pancreaticoduodenal artery, the plexus on the jejunal artery, the superior mesenteric artery and plexus, the plexus on the gastroepiploic arteries, the celiac ganglia and plexus, the splenic artery and plexus, the left lesser thoracic splanchic nerve, the left greater thoracic splanchic nerve, the principal anterior gastric branch of the anterior vagal trunk, the left gastric artery and plexus, the celiac branch of the anterior vagal trunk, the anterior vagal trunk, proximal, distal or portions between the proximal and distal portions of the vagus nerve, the hepatic branch of the anterior vagal trunk, the right and/or left inferior phrenic arteries and plexus, the anterior posterior layers of the lesser omenium, the branch from the hepatic plexus to the cardia via the lesser omentum, the right greater thoracic splanchic nerve, the vagal branch from the hepatic plexus to the pylorus, the right gastric artery, the plexus, and the intestine, or branches or portions thereof, wherein the second lead comprises proximal and distal ends and at least one electrode.

8. The method of claim 7, further comprising delivering the electrical stimulation through tissue disposed between the electrodes located on the first and second leads.

9. The method of claim 1, further comprising providing a lead extension, operably connecting the lead extension between a proximal end of the implantable electrical lead and an implantable pulse generator, and delivering the electrical stimulation pulses through the lead extension and the implantable electrical lead.

10. The method of claim 1, wherein the implantable electrical lead is selected from the group consisting of a lead comprising a lead body less than about 5 mm in diameter, and a lead comprising a lead body less than about 1.5 mm in diameter.

11. The method of claim 1, wherein the implantable electrical lead has at least two electrodes, wherein an inter-electrode distance of the implantable electrical lead is selected from the group consisting of about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm, about 20 mm, about 25 mm, and about 30 mm.

12. The method of claim 1, wherein the implantable electrical lead has at least one electrode, wherein the at least one electrode of the implantable electrical lead has an electrode surface area ranging between about 1.0 sq. mm and about 100 sq. mm, between about 2.0 sq. mm and about 50 sq. mm, or between about 4.0 sq. mm and about 25 sq. mm.

13. The method of claim 1, wherein the implantable electrical lead includes at least a proximal end and a distal end, wherein the distance between the proximal and distal ends of the implantable electrical lead is selected from the group consisting of less than about 4 inches, about 4 inches, about 6 inches, about 8 inches, about 10 inches, about 12 inches, about 14 inches, about 16 inches, about 18 inches, and about 20 inches.

14. The method of claim 1, wherein generating electrical stimulation comprises generating electrical stimulation pulses via an implantable pulse generator, and wherein the implantable pulse generator comprises an electronic circuitry architecture selected from the group consisting of a microprocessor-based architecture, a logic architecture and a state machine architecture.

15. The method of claim 1, wherein generating electrical stimulation comprises generating electrical stimulation pulses via an implantable pulse generator, the method further comprising providing an external programming unit and effecting telemetric communication between the programming unit and the implantable pulse generator.

16. The method of claim 1, wherein generating electrical stimulation comprises generating electrical stimulation pulses via an implantable pulse generator, and wherein the implantable pulse generator further comprises at least one of a primary battery power source and a secondary battery power source.

17. The method of claim 1, wherein generating electrical stimulation comprises generating electrical stimulation pulses via an implantable pulse generator, and wherein the implantable pulse generator is configurable so as to permit at least one of the frequency, rate, amplitude, phase, width and morphology of the pulses generated and delivered thereby to be varied programmably by a user.

18. The method of claim 1, wherein the implantable electrical lead is configured for percutaneous introduction and implantation within the patient and the implantable electrical lead is electrically coupled to a pulse generator outside of the patient configured for generating electrical stimulation.

19. The method of claim 1, wherein generating electrical stimulation comprises generating electrical stimulation pulses via an implantable pulse generator, and wherein the implantable pulse generator and the implantable electrical lead are capable of generating and delivering electrical pulses having frequencies ranging between about 50 Hz and about 100 Hz, between about 10 Hz and about 250 Hz, and between about 0.5 Hz and about 20,000 Hz.

20. The method of claim 1, wherein generating electrical stimulation comprises generating electrical stimulation pulses via an implantable pulse generator, and wherein the implantable pulse generator and the implantable electrical lead are capable of generating and delivering electrical pulses having amplitudes ranging between about 1 Volt and about 10 Volts, between about 0.5 Volts and about 20 Volts, and between about 0.1 Volts and about 50 Volts.

21. The method of claim 1, wherein generating electrical stimulation comprises generating electrical stimulation pulses via an implantable pulse generator, wherein the implantable pulse generator and the implantable electrical lead are capable of generating and delivering electrical pulses having pulse widths ranging between about 180 microseconds and about 450 microseconds, between about 100 microseconds and about 1000 microseconds, and between about 10 microseconds and about 5000 microseconds.

22. The method of claim 1, wherein generating electrical stimulation comprises generating electrical stimulation pulses via an implant able pulse generator, and wherein the implantable pulse generator and the implantable electrical lead and at least a second lead are capable of generating and delivering electrical pulses having varying spatial or temporal phases.

23. The method of claim 1, further comprising delivering a drug to the patient.

24. The method of claim 23, further comprising providing, implanting and activating an implantable drug pump for providing the drug to the patient.

25. The method of claim 1, further comprising providing at least one sensor to sense a physical condition, and adjusting the stimulation based on the sensed condition.

26. The method of claim 1, wherein the implantable electrical lead has a lead body selected from the group consisting of polyurethane and silicone.

27. The method of claim 1, wherein the implantable electrical lead comprises electrical conductors disposed within the body thereof and extending between the proximal and distal ends of the lead wherein the conductors are formed of coiled, braided or stranded wires.

28. The method of claim 1, wherein the implantable electrical lead comprises at least one of at least one ring electrode, at least one coiled electrode, at least one button electrode, at least one electrode formed from a portion of wire, a barb or a hook, a spherically-shaped electrode, or a helically-shaped electrode.

29. The method of claim 1, wherein generating electrical stimulation comprises generating electrical stimulation having one or more parameters selected to reduce acidity of gastric acid secretions in a patient and reduce an amount of the gastric acid secretions in the patient, and delivering the electrical stimulation comprises delivering the electrical stimulation to one of more portions of a gastrointestinal tract of the patient via an implantable electrical lead to reduce the acidity of the gastric acid secretions in the patient and reduce the amount of the gastric acid secretions in the patient.

30. The method of claim 1, wherein delivering the electrical stimulation to one or more portions of a gastrointestinal tract of the patient via an implantable electrical lead to reduce the acidity of the gastric acid secretions in the patient comprises delivering the electrical stimulation to one of the stomach, the plexus on the anterior superior and/or the anterior inferior pancreaticoduodenal arteries, the plexus on the inferior pancreaticoduodenal artery, the plexus on the jejunal artery, the superior mesenteric artery and plexus, the plexus on the gastroepiploic arteries, the celiac ganglia and plexus, the splenic artery and plexus, the left lesser thoracic splanchic nerve, the left greater thoracic splanchic nerve, the principal anterior gastric branch of the anterior vagal trunk, the left gastric artery and plexus, the celiac branch of the anterior vagal trunk, the anterior vagal trunk, proximal, distal or portions between the proximal and distal portions of the vagus nerve, the hepatic branch of the anterior vagal trunk, the right and/or left inferior phrenic arteries and plexus, the anterior posterior layers of the lesser omenium, the branch from the hepatic plexus to the cardia via the lesser omentum, the right greater thoracic splanchic nerve, the vagal branch from the hepatic plexus to the pylorus, the right gastric artery, the plexus, and the intestine, or branches or portions thereof wherein a second lead comprises proximal and distal ends and at least one electrode.

31. The method of claim 1, wherein delivering the electrical stimulation to one or more portions of a gastrointestinal tract of the patient via an implantable electrical lead to reduce the acidity of the gastric acid secretions in the patient comprises delivering the electrical stimulation to one of a stomach and an intestine of the patient.

32. The method of claim 1, wherein generating electrical stimulation comprises generating electrical stimulation via an implantable stimulation generator implanted within the patient and coupled to the implantable electrical lead.

33. The method of claim 32, further comprising modifying one or more parameters of the stimulation via a programming unit in telemetric communication with the implantable stimulation generator.