Systems and methods for modulation of pancreatic endocrine secretion and treatment of diabetes

• US 7,477,944 B1
• Filed: 12/09/2004
• Issued: 01/13/2009
• Est. Priority Date: 11/21/2000
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed Incorporated
• Inventors: Whitehurst, Todd K, McGivern, James P
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US11/007,906
• Time in Patent Office: 1,496 Days
• Field of Search: 607/40, 607/133, 600/300, 600/301, 600/554, 128897-899, 128/920, 604/890.1, 604/891.1, 604 65- 67
• US Class Current: 607/40
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells

Abstract

Systems and methods for introducing one or more stimulating drugs and/or applying electrical stimulation to the pancreas and/or nerve fibers innervating the pancreas to treat or prevent diabetes and/or to modulate pancreatic endocrine secretions uses at least one system control unit (SCU) producing electrical pulses delivered via electrodes and/or producing drug infusion pulses, wherein the stimulating drug(s) are delivered via one or more pumps and infusion outlets.

Claims

1. A system for modulating pancreatic endocrine secretions of a patient, comprising:

an implantable control unit adapted to be implanted in the body of a patient, wherein the control unit includes means for controlling the delivery of at least one stimulus to at least one type of pancreatic cell affecting pancreatic endocrine secretions; and

means for applying the at least one stimulus to the at least one type of pancreatic cell in order to hyperpolarize the at least one type of pancreatic cell and thereby modulate at least one pancreatic endocrine secretion;

wherein the at least one type of pancreatic cell is selected from the group comprising;

an alpha cell wherein the hyperpolarization inhibits secretion of glucagon, and a delta cell wherein the hyperpolarization inhibits secretion of somatostatin.

2. A system for modulating pancreatic endocrine secretions of a patient, comprising:

an implantable control unit adapted to be implanted in the body of a patient, wherein the control unit includes means for controlling the delivery of at least one stimulus to at least one type of pancreatic cell affecting pancreatic endocrine secretions; and

means for applying the at least one stimulus to the at least one type of pancreatic cell in order to depolarize the at least one type of pancreatic cell to thereby increase secretion of a substance that inhibits insulin secretion;

wherein the at least one type of pancreatic cell is selected from the group comprising;

an alpha cell wherein the depolarization increases secretion of glucagon, and a delta cell wherein the depolarization increases secretion of somatostatin.

3. A system of modulating pancreatic endocrine secretions of a patient, comprising:

an implantable control unit adapted to be implanted in the body of a patient, wherein the control unit includes means for controlling the delivery of stimulation to at least one parasympathetic tissue innervating the pancreas; and

means for applying the stimulation to the at least one parasympathetic tissue in order to minimize stimulation of gastrointestinal structures and the heart while maximizing stimulation of pancreatic beta cells, whereby insulin secretion is increased;

wherein the system control unit is connected to at least two implantable electrodes, and wherein the means for applying the stimulation comprises means for applying electrical stimulation via the at least two implantable electrodes at a frequency that ranges between about 3 to 12 Hz.

4. The system of claim 3 wherein the means for applying the stimulation to the at least one parasympathetic tissue comprises means for applying the stimulation to at least one of the posterior gastric, anterior gastric, celiac, and hepatic branches of the vagus nerve.

5. The system of claim 3 wherein the system control unit includes means for providing drug stimulation and wherein the means for applying the stimulation comprises means for providing at least one of a cholinoceptor-blocking medication and an autonomic ganglion-blocking medication to the parasympathetic tissue.

6. The system of claim 3 further comprising means for sensing a condition and means for using the sensed condition to automatically determine the stimulation to be applied.

7. A system of modulating pancreatic endocrine secretions of a patient, comprising:

an implantable control unit adapted to be implanted in the body of a patient, wherein the control unit includes means for controlling the delivery of stimulation to at least one parasympathetic tissue innervating the pancreas; and

means for applying the stimulation to the at least one parasympathetic tissue in order to minimize stimulation of gastrointestinal structures and the heart while maximizing stimulation of pancreatic beta cells, whereby insulin secretion is decreased;

wherein the system control unit is connected to at least two implantable electrodes, and wherein the means for applying the stimulation comprises means for applying electrical stimulation via the at least two implantable electrodes at a frequency that is greater than about 50 Hz.

8. The system of claim 7 wherein the means for applying the stimulation to the at least one parasympathetic tissue comprises means for applying the stimulation to at least one of the posterior gastric, anterior gastric, celiac, and hepatic branches of the vagus nerve.

9. The system of claim 7 wherein the system control unit includes means for providing drug stimulation and wherein the means for applying the stimulation comprises means for providing at least one of a cholinoceptor-blocking medication and an autonomic ganglion-blocking medication to the parasympathetic tissue.

10. The system of claim 7 further comprising means for sensing a condition and means for using the sensed condition to automatically determine the stimulation to be applied.

11. A system of modulating pancreatic endocrine secretions of a patient, comprising:

an implantable system control unit adapted to be implanted in the body of a patient, wherein the system control unit includes means for delivering stimulation to at least one sympathetic tissue innervating the pancreas; and

means for controlling the stimulation delivered to the at least one sympathetic tissue in order to modulate at least one pancreatic endocrine secretion;

wherein the at least one sympathetic tissue to which the stimulation is delivered is selected from the group comprising;

the ganglia of the paraspinal sympathetic trunks, celiac ganglia, aorticorenal ganglia, super mesenteric ganglion, inferior mesenteric ganglion, phrenic ganglion, left greater splanchnic nerve, left lesser splanchnic nerve, left least splanchnic nerve, right greater splanchnic nerve, right lesser splanchnic nerve, and right least splanchnic nerve;

wherein the stimulation delivered to the at least one sympathetic tissue is adapted to inhibit sympathetic input to the pancreas, whereby glucagon secretion is reduced; and

wherein the means for delivering stimulation includes at least two implantable electrodes, and wherein the means for controlling the stimulation comprises means for applying electrical stimulation to the at least two implantable electrodes at a frequency of greater than about 50 Hz.

12. The system of claim 11 further comprising means for sensing a condition and means for using the sensed condition to automatically determine the stimulation to be applied.

13. The system of claim 11 wherein the means for delivering stimulation comprises means for delivering drug stimulation, and wherein the means for controlling the stimulation comprises means for delivering an adrenoceptor antagonist medication or an autonomic ganglion-blocking medication to the sympathetic tissue.

14. A system of modulating pancreatic endocrine secretions of a patient, comprising:

an implantable system control unit adapted to be implanted in the body of a patient, wherein the system control unit includes means for delivering stimulation to at least one sympathetic tissue innervating the pancreas; and

means for controlling the stimulation delivered to the at least one sympathetic tissue in order to modulate at least one pancreatic endocrine secretion;

wherein the at least one sympathetic tissue to which the stimulation is delivered is selected from the group comprising;

the ganglia of the paraspinal sympathetic trunks, celiac ganglia, aorticorenal ganglia, super mesenteric ganglion, inferior mesenteric ganglion, phrenic ganglion, left greater splanchnic nerve, left lesser splanchnic nerve, left least splanchnic nerve, right greater splanchnic nerve, right lesser splanchnic nerve, and right least splanchnic nerve;

wherein the means for controlling the stimulation is adapted to excite sympathetic input to the pancreas, whereby glucagon secretion is increased; and

wherein the implantable control unit is connected to at least two implantable electrodes, and wherein the means for delivering stimulation comprises means for delivering electrical stimulation via the at least two electrodes and wherein the means for controlling the stimulation comprises means for controlling the frequency of the electrical stimulation to be less than about 100 Hz.

15. The system of claim 14 wherein the means for delivering stimulation comprises means for delivering an adrenoceptor-activating medication or a sympathomimetic medication to the sympathetic tissue.

16. The system of claim 14 further comprising means for sensing a condition and means for using the sensed condition to automatically determine the stimulation to be applied.