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

• US 20040236382A1
• Filed: 05/19/2003
• Published: 11/25/2004
• 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.
• Granted Patent: US 7,742,818 B2
• Time in Patent Office: Days
• 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 comprises a INS for producing a 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 The electrodes 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 increase the amount of gastric acid produced thereby.

Claims

1. A gastro-electric stimulation system for at least one of increasing the pH of gastric acid in a stomach of a patient and increasing an amount of gastric acid produced in the stomach of the patient, comprising:

an INS for producing at least one electrical stimulation signal;

at least one medical electrical lead having a proximal end and a distal end, the proximal end being connected to the INS, the distal end being adapted for positioning the lead in a lead position comprising at least one of near the patient'"'"'s stomach, near a selected nerve and near a nerve portion; and

,

at least two electrodes disposed near the medical electrical lead distal end, the electrodes being electrically connected through the medical electrical lead to the INS to receive the at least one electrical stimulation signal and convey such signal to the electrode position;

wherein the electrical stimulation signal is provided in an amount and manner effective to at least one of increase the pH of the gastric acid in the patient and increase the amount of gastric acid produced in the stomach of a patient.

2. The gastro-electric stimulation system of claim 1, wherein the electrode position is selected from the group consisting 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 omenium, 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, and branches or portions thereof.

3. The gastro-electric stimulation system of claim 1, wherein the electrical stimulation signal frequency ranges between about 0.1 pulses per minute and about 18,000 pulses per minute.

4. The gastro-electric stimulation system of claim 1, wherein the electrical stimulation signal pulse width ranges between about 0.01 mS and about 500 mS.

5. The gastro-electric stimulation system of claim 1, wherein the electrical stimulation signal has a peak amplitude ranging between about 0.01 mA and about 100.0 mA.

6. The gastro-electric stimulation system of claim 1, wherein the electrical stimulation signal is provided in an amount and manner sufficient to influence 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 omenium, 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.

7. The gastro-electric stimulation system of claim 1, wherein the electrical stimulation signal is adapted to substantially influence efferent nerves.

8. The gastro-electric stimulation system of claim 1, wherein the electrical stimulation signal is adapted to substantially influence afferent nerves.

9. The gastro-electric stimulation system of claim 1, further comprising a sensor electrically connected to the INS, the sensor generating a sensor signal indicative of a patient condition wherein the INS receives the sensor signal and controls the delivered electrical stimulation signal in response to the sensor signal.

10. A system for at least one of increasing the pH of gastric acid in a stomach of a patient and increasing an amount of gastric acid produced in the stomach of the patient, comprising:

a pulse generator for generating stimulus pulses; and

a medical electrical lead adapted to deliver the stimulus pulses to a portion of a patient'"'"'s body;

wherein the stimulus pulses and medical electrical lead cooperate to provide electrical stimulation, to a selected stimulation site in the patient, in an amount and manner effective to at least one of increase the pH of the gastric acid in the patient and increase the amount of gastric acid produced in the stomach of the patient.

11. The system of claim 10, wherein the pulse generator is an implantable neurological stimulator.

12. A gastro-electric stimulator for at least one of increasing the pH of gastric acid in a stomach of a patient and increasing an amount of gastric acid produced in the stomach of the patient, comprising:

a neuro-electrical stimulator for producing a stimulation signal;

at least one electrical lead having a proximal end and a distal end, the proximal end being connected to the neuro-electrical stimulator, the distal end being positionable in a selected lead position comprising at least one of near the patient'"'"'s stomach, near a selected nerve and near a nerve portion; and

,

at least two electrodes disposed near the distal end of the electrical lead, the electrodes being electrically connected through the electrical lead to the neuro-electrical stimulator to receive the stimulation signal and convey such signal to the selected electrode position

13. The gastro-electric stimulator of claim 12, wherein the electrode position is selected from the group consisting 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 omenium, 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, and branches or portions thereof.

14. The gastro-electric stimulator of any of claims 12 and 13, wherein the stimulation signal frequency ranges between about 0.10 pulses per minute and about 18,000 pulses per minute.

15. The gastro-electric stimulator of any of claims 12 and 13, wherein the stimulation signal pulse width ranges between about 0.01 mS and about 500 mS.

16. The gastro-electric stimulator of any of claims 12 and 13, wherein the stimulation signal has a peak amplitude ranging between about 0.01 mA and about 500.0 mA.

17. A method for at least one of increasing the pH of gastric acid in a stomach of a patient and increasing an amount of gastric acid produced in the patient'"'"'s stomach, comprising:

diagnosing gastric acid in a patient'"'"'s stomach comprising at least one of having a low pH and being produced in insufficient quantities;

generating electrical stimulus pulses; and

delivering the stimulus pulses to at least one electrode stimulation site within the patient in an amount and manner effective to at least one of increase the pH of the gastric acid the patient'"'"'s stomach and increase the amount of gastric acid produced in patient'"'"'s stomach.

18. The method of claim 17, wherein the step of delivering stimulus pulses further comprises providing at least two electrodes across the at least one electrode stimulation site.

19. The method of claim 18, wherein the step of providing at least two electrodes across the at least one electrode stimulation site further comprises selecting at least one of a selected portion of the patient'"'"'s stomach, a nerve and a nerve portion as the electrode stimulation site.

20. The method of claim 18, wherein the step of providing at least two electrodes across the at least one electrode stimulation site further comprises selecting 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 omenium, 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 as the electrode stimulation site.

21. The method of any of claims 17-20, wherein the stimulation signal frequency ranges between about 0.10 pulses per minute and about 18,000 pulses per minute.

22. The method of any of claims 17-20, wherein the stimulation signal pulse width ranges between about 0.01 mS and about 500 mS.

23. The method of any of claims 17-20, wherein the stimulation signal has a peak amplitude ranging between about 0.01 mA and about 500.0 mA.

24. A method for at least one of increasing the pH of gastric acid in a stomach of a patient and increasing an amount of gastric acid produced in the patient'"'"'s stomach, comprising:

providing an hermetically sealed implantable electrical pulse generator configured to provide at least one electrical stimulation pulse regime effective to at least one of increase the pH of gastric acid and increase the amount of gastric acid produced in the patient'"'"'s stomach;

providing at least a first implantable medical electrical lead configured for implantation adjacent, around or in a selected electrode stimulation site, the electrode stimulation site comprising 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 omenium, 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, and branches or portions thereof, the first lead comprising proximal and distal ends and at least one electrode;

implanting the first lead in tissue of the patient adjacent, around or in the selected electrode stimulation site;

operably connecting the proximal end of the at least first lead to the implantable pulse generator;

implanting the implantable pulse generator within the patient; and

delivering electrical stimulation pulses from the implantable pulse generator to the selected electrode stimulation site through the at least first lead and electrode, the pulses being provided in accordance with the electrical stimulation pulse regime to at least one of increase the pH of the gastric acid and increase the amount of gastric acid produced by the patient'"'"'s stomach.

25. The method of claim 24, wherein the at least first 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.

26. The method of claim 24, wherein the at least first lead is selected from the group consisting of a beam steering lead comprising multiple electrodes and a lead comprising multiple electrodes disposed in an a real pattern on a planar or curved surface.

27. The method of claim 24, wherein the at least first lead is selected from the group consisting of a cuff lead, a paddle lead, a tined lead, a lead having an active fixation device or member disposed thereon, attached thereto or forming a portion thereof.

28. The method of claim 24, wherein the at least first lead is selected from the group consisting of a suture sleeve, a barb, a helical screw, a hook and a tissue in-growth mechanism.

29. The method of claim 24, wherein the at least first lead further comprises one or more electrodes configured to operate in conjunction with an electrically conductive portion of the implantable pulse generator acting as an indifferent electrode.

30. The method of claim 24, 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 omenium, 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.

31. The method of claim 30, further comprising delivering the electrical pulses through tissue disposed between the electrodes located on the first and second leads.

32. The method of claim 24, further comprising providing a lead extension, operably connecting same between the proximal end of the at least first lead and the implantable pulse generator, and delivering the electrical stimulation pulses through the lead extension.

33. The method of claim 24, wherein the first lead is selected from the group consisting of a lead comprising a lead body less than about 5 mm in diameter, a lead comprising a lead body less than about 1.5 mm in diameter, a lead having a lead body comprising polyurethane or silicone, a lead comprising 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, and a lead comprising 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, and a helically-shaped electrode.

34. The method of claim 24, wherein an inter-electrode distance of the first 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.

35. The method of claim 24, wherein the at least one electrode of the first 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.

36. The method of claim 24, wherein the distance between the proximal and distal ends of the at least first 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, about 20 inches and more than about 20 inches.

37. The method of claim 24, 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.

38. The method of claim 24, further comprising providing an external programming unit and effecting telemetric communication between the programming unit and the implantable pulse generator.

39. The method of claim 24, wherein the implantable pulse generator further comprises at least one of a primary battery power source and a secondary battery power source.

40. The method of claim 24, 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.

41. The method of claim 24, wherein the at least first lead is configured for percutaneous introduction and implantation within the patient.

42. The method of claim 24, wherein the implantable pulse generator and the at least first 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.

43. The method of claim 24, wherein the implantable pulse generator and the at least first 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.

44. The method of claim 24, wherein the implantable pulse generator and the at least first 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.

45. The method of claim 24, wherein the implantable pulse generator and the at least first lead and at least a second lead are capable of generating and delivering electrical pulses having varying spatial or temporal phases.

46. The method of claim 24, further comprising delivering a drug to the patient.

47. The method of claim 46, further comprising providing, implanting and activating an implantable drug pump for providing the drug to the patient.

48. The method of claim 24, further comprising providing at least one sensor to sense a physical condition, and adjusting the stimulation regime or parameters based on the sensed condition.