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

• US 7,742,818 B2
• Filed: 05/19/2003
• Issued: 06/22/2010
• Est. Priority Date: 05/19/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Dinsmoor, David A., Starkebaum, Warren L.
• Primary Examiner(s): Schaetzle; Kennedy J
• Assistant Examiner(s): SARCIONE, JESSICA LYNN
• Application Number:
  US10/441,786
• Publication Number:
  US 20040236382A1
• Time in Patent Office: 2,591 Days
• Field of Search: 607 1- 3, 607 40- 41, 607129-131, 607/133, 604/891.1, 600/361, 606/41
• 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 and 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 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 decrease 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 method for at least one of increasing the acidity of gastric acid secretion in a stomach of a human patient and increasing an amount of the gastric acid secretion produced in the human patient'"'"'s stomach, comprising:

providing a hermetically sealed implantable electrical pulse generator configured to provide at least one electrical stimulation pulse regime effective to at least one of decrease the pH of gastric acid secretion and increase the amount of the gastric acid secretion produced in the human 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 a stomach, a plexus on an anterior superior and/or anterior inferior pancreaticoduodenal arteries, a plexus on a inferior pancreaticoduodenal artery, a plexus on a jejunal artery, a superior mesenteric artery and plexus, a plexus on a gastroepiploic arteries, a celiac ganglia and plexus, a splenic artery and plexus, a left lesser thoracic splanchic nerve, a left greater thoracic splanchic nerve, a principal anterior gastric branch of an anterior vagal trunk, a left gastric artery and plexus, a celiac branch of the anterior vagal trunk, a hepatic branch of the anterior vagal trunk, a right and/or left inferior phrenic arteries and plexus, an anterior posterior layers of a lesser omenium, a branch from a hepatic plexus to a cardia via the lesser omenium, the right greater thoracic splanchic nerve, a vagal branch from the hepatic plexus to a pylorus, and a right gastric artery and plexus, and the first lead comprising proximal and distal ends and at least one electrode;

implanting the first lead in tissue of the human 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 human 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, wherein the human patient suffers from at least one of gastric hypoacidity and inadequate gastric acid production and the pulses are provided in accordance with the electrical stimulation pulse regime to at least one of increase the acidity of the gastric acid secretion and increase the amount of the gastric acid secretion produced by the human patient'"'"'s stomach.

2. The method of claim 1, 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.

3. The method of claim 1, 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 a real pattern on a planar or curved surface.

4. The method of claim 1, wherein the at least first 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 or member disposed thereon, attached thereto or forming a portion thereof.

5. The method of claim 1, 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.

6. The method of claim 1, 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.

7. The method of claim 1, 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 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 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, and the right gastric artery and plexus, 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 pulses 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 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.

10. The method of claim 1, wherein the first lead is selected from a 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 a 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 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, and a helically-shaped electrode.

11. The method of claim 1, 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.

12. The method of claim 1, 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.

13. The method of claim 1, 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.

14. The method of claim 1, 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, 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 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 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 at least first lead is configured for percutaneous introduction and implantation within the human patient.

19. The method of claim 1, wherein the implantable pulse generator and the at least first lead are capable of generating and delivering electrical pulses having a frequency range of one of 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 the implantable pulse generator and the at least first lead are capable of generating and delivering electrical pulses having an amplitude range of one of 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 the implantable pulse generator and the at least first lead are capable of generating and delivering electrical pulses having a pulse width range of one of 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 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.

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

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

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

26. The method of claim 1, wherein the at least one electrical stimulation pulse regime is effective to decrease the pH of the gastric acid secretion in the stomach of the human patient.

27. A method comprising:

generating electrical stimulation having one or more parameters selected to produce at least one of increased acidity of gastric acid secretion in a stomach of a human patient and an increased amount of the gastric acid secretion in the stomach of the human patient; and

delivering the electrical stimulation to a portion of the human patient via an implantable electrical lead, the portion of the human patient comprising at least one of the stomach, a plexus on an anterior superior and/or anterior inferior pancreaticoduodenal arteries, a plexus on a inferior pancreaticoduodenal artery, a plexus on a jejunal artery, a superior mesenteric artery and plexus, a plexus on a gastroepiploic arteries, a celiac ganglia and plexus, a splenic artery and plexus, a left lesser thoracic splanchic nerve, a left greater thoracic splanchic nerve, a principal anterior gastric branch of an anterior vagal trunk, a left gastric artery and plexus, a celiac branch of the anterior vagal trunk, a hepatic branch of the anterior vagal trunk, a right and/or left inferior phrenic arteries and plexus, an anterior posterior layers of a lesser omenium, a branch from a hepatic plexus to a cardia via the lesser omenium, the right greater thoracic splanchic nerve, a vagal branch from the hepatic plexus to a pylorus, and a right gastric artery and plexus vagal branch from the hepatic plexus to a pylorus, and a right gastric artery and plexus, wherein the human patient suffers from at least one of gastric hypoacidity and inadequate gastric acid production.

28. The method of claim 27, 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.

29. The method of claim 27, 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 a real pattern on a planar or curved surface.

30. The method of claim 27, 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 or member disposed thereon, attached thereto or forming a portion thereof.

31. The method of claim 27, wherein the implantable electrical lead is selected from the group consisting of a suture sleeve, a barb, a helical screw, a hook and a tissue in-growth mechanism.

32. The method of claim 27, 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.

33. The method of claim 27, further comprising delivering the electrical stimulation through tissue disposed between electrodes of the implantable electrical lead and electrodes of a second implantable electrical lead.

34. The method of claim 27, wherein the implantable electrical lead is selected from a 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 a 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 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, and a helically-shaped electrode.

35. The method of claim 27, wherein the implantable electrical lead comprises a plurality of electrodes, and wherein an inter-electrode distance 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.

36. The method of claim 27, wherein the implantable electrical lead comprises at least one electrode that 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.

37. The method of claim 27, wherein a distance between a proximal and a distal end 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, about 20 inches and more than about 20 inches.

38. The method of claim 27, further comprising providing an external programming unit and effecting telemetric communication between the programming unit and an implantable stimulator that generates the electrical stimulation.

39. The method of claim 27, wherein an implantable stimulator that generates the electrical stimulation 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.

40. The method of claim 27, wherein the implantable electrical lead is configured for percutaneous introduction and implantation within the human patient.

41. The method of claim 27, wherein an implantable stimulator that generates the electrical stimulation and the implantable electrical lead are capable of generating and delivering electrical pulses having a frequency range of one of 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.

42. The method of claim 27, wherein an implantable stimulator that generates the electrical stimulation and the implantable electrical lead are capable of generating and delivering electrical pulses having an amplitudes range of one of 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.

43. The method of claim 27, wherein an implantable stimulator that generates the electrical stimulation and the implantable electrical lead are capable of generating and delivering electrical pulses having a pulse widths range of one of 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.

44. The method of claim 27, wherein an implantable stimulator that generates the electrical stimulation and the implantable electrical lead are capable of generating and delivering electrical pulses having varying spatial or temporal phases.

45. The method of claim 27, further comprising delivering a drug to the human patient.

46. The method of claim 45, further comprising providing, implanting and activating an implantable drug pump for providing the drug to the human patient.

47. The method of claim 27, further comprising providing at least one sensor to sense a physical condition, and adjusting the one or more parameters based on the sensed condition.

48. The method of claim 27, wherein the electrical stimulation has one or more parameters selected to produce an increased acidity of the gastric acid secretion in the stomach of the human patient.

49. A method comprising:

generating, via an electrical stimulator implanted in a human patient, electrical stimulation selected to produce increased acidity of gastric acid secretion in a stomach of the human patient and an increased amount of the gastric acid secretion in the stomach of the human patient;

delivering the electrical stimulation from the implanted electrical stimulator to a portion of the human patient via one or more implantable electrical leads, the portion of the human patient comprising at least one of a stomach, a plexus on an anterior superior and/or anterior inferior pancreaticoduodenal arteries, a plexus on a inferior pancreaticoduodenal artery, a plexus on a jejunal artery, a superior mesenteric artery and plexus, a plexus on a gastroepiploic arteries, a celiac ganglia and plexus, a splenic artery and plexus, a left lesser thoracic splanchic nerve, a left greater thoracic splanchic nerve, a principal anterior gastric branch of an anterior vagal trunk, a left gastric artery and plexus, a celiac branch of the anterior vagal trunk, a hepatic branch of the anterior vagal trunk, a right and/or left inferior phrenic arteries and plexus, an anterior posterior layers of a lesser omenium, a branch from a hepatic plexus to a cardia via the lesser omenium, the right greater thoracic splanchic nerve, a vagal branch from the hepatic plexus to a pylorus, and a right gastric artery and plexus; and

controlling the electrical stimulation delivered by the implanted electrical stimulator based at least in part on a sensed physical condition of the human patient, wherein the human patient suffers from at least one of gastric hypoacidity and inadequate gastric acid production.

50. A method comprising:

generating, via an electrical stimulator implanted in a human patient, electrical stimulation selected to produce increased acidity of gastric acid secretion in a stomach of the human patient and an increased amount of the gastric acid secretion in the stomach of the human patient; and

delivering the electrical stimulation from the implanted electrical stimulator to a portion of the human patient via one or more implantable electrical leads, the portion of the human patient comprising at least one of the stomach, a plexus on an anterior superior and/or anterior inferior pancreaticoduodenal arteries, a plexus on a inferior pancreaticoduodenal artery, a plexus on a jejunal artery, a superior mesenteric artery and plexus, a plexus on a gastroepiploic arteries, a celiac ganglia and plexus, a splenic artery and plexus, a left lesser thoracic splanchic nerve, a left greater thoracic splanchic nerve, a left gastric artery and plexus, a right and/or left inferior phrenic arteries and plexus, an anterior posterior layers of a lesser omenium, a branch from a hepatic plexus to a cardia via the lesser omenium, the right greater thoracic splanchic nerve, and a right gastric artery and plexus, wherein the human patient suffers from at least one of gastric hypoacidity and inadequate gastric acid production.