Neurostimulation and coronary artery disease treatment

• US 8,934,968 B2
• Filed: 07/18/2007
• Issued: 01/13/2015
• Est. Priority Date: 08/03/2001
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Whitehurst, Todd K., Thacker, James R., McClure, Kelly H., McGivern, James P.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US11/779,769
• Publication Number:
  US 20080021503A1
• Time in Patent Office: 2,736 Days
• Field of Search: 607/3
• US Class Current: 607/3
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

A method for treating a patient may include treating coronary artery disease in combination with angina pectoris and/or the control of angina pain by delivering chemical and/or electrical stimulation pulses to the cardiac and/or nervous tissue of the patient in a coordinated manner. A system for treating a patient suffering from coronary artery disease and angina may include a stimulator that generates at least one pulse in accordance with prescribed parameters, a catheter, a lead, and/or a sensor.

Claims

1. A method for treating coronary artery disease, comprising:

providing a stimulator system that generates a plurality of pulses in accordance with prescribed parameters to provide neural stimulation;

providing a catheter connected to the stimulator system, which catheter includes a discharge portion;

implanting the catheter discharge portion near cardiac tissue;

delivering via the stimulator system and the catheter infusion pulses of at least one drug as at least one treatment for coronary artery disease to the cardiac tissue;

providing a lead connected to the stimulator system, which lead includes an electrode;

implanting the electrode near at least one nervous tissue to be stimulated; and

delivering via the stimulator system and the lead electrical stimulation pulses as at least one treatment for angina to the at least one nervous tissue.

2. The method of claim 1 wherein delivering via the stimulator system and the lead electrical stimulation pulses as at least one treatment for angina to the at least one nervous tissue occurs immediately prior to and after delivering via the stimulator system and the catheter infusion pulses of at least one drug as at least one treatment for coronary artery disease to the at least one cardiac tissue.

3. The method of claim 1 wherein delivering via the stimulator system and the lead electrical stimulation pulses as at least one treatment for angina to the at least one nervous tissue occurs simultaneous with delivering via the stimulator system and the catheter infusion pulses of at least one drug as at least one treatment for coronary artery disease to the at least one cardiac tissue.

4. The method of claim 1 wherein delivering via the stimulator system and the lead electrical stimulation pulses as at least one treatment for angina to the at least one nervous tissue occurs on demand and at least once every eight hours.

5. The method of claim 1 further comprising delivering via the stimulator system and the lead electrical stimulation pulses to increase the blood circulation of the cardiac tissue.

6. The method of claim 5 wherein delivering via the stimulator system and the catheter infusion pulses of at least one drug as at least one treatment for coronary artery disease to the at least one cardiac tissue occurs during the increase of blood circulation of the cardiac tissue.

7. The method of claim 1 further comprising sensing an increase in blood circulation of the cardiac tissue, wherein delivering via the stimulator system and the catheter infusion pulses of at least one drug as at least one treatment for coronary artery disease to the at least one cardiac tissue occurs in response to the sensed increase in blood circulation.

8. The method of claim 1 further comprising using an electrocardiograph (ECG) sensor to detect an increase in anginal pain, wherein delivering via the stimulator system and the lead electrical stimulation pulses as at least one treatment for angina to the at least one nervous tissue occurs in response to the sensed increase in electrocardiograph.

9. The method of claim 1 wherein the at least one cardiac tissue comprises at least one of a coronary artery, a branch of a coronary artery, a coronary vein, a branch of a coronary vein, the aorta, a pulmonary vein, the coronary sinus, the inferior vena cava, the sino-atrial (SA) node, and the atrio-ventricular (AV) node.

10. The method of claim 1 wherein the at least one nervous tissue comprises at least one of an afferent nerve fiber;

a sympathetic nerve fiber;

tissue at the spinal levels of T1, T2, T3, or T4;

the white rams communicans;

the first, second, third, or fourth thoracic sympathetic ganglia;

the thoracic sympathetic trunk;

the cervical sympathetic trunk;

a thoracic sympathetic cardiac nerve;

a parasympathetic nerve fiber;

the vagus nerve;

the superior cervical (vagal) cardiac nerve;

the inferior cervical (vagal) cardiac nerve;

the cervical spinal cord; and

the thoracic cardiac branch of the vagus nerve.

11. The method of claim 1 wherein the drug comprises at least one of nitroglycerin, magnesium sulfate, adenosine, Atrial Natriuretic Peptide (ANP), Brain Natriuretic Peptide (BNP), isosorbide dinitrate, isosorbide mononitrate, amyl nitrite, nitric oxide, a nitric oxide donor, a calcium-channel blocker, a beta-blocker, a cholesterol-lowering agent, an anti-thrombotic agent, a kinin, prostacyclin, hypothalamic inhibitory factor (HIF), a medication used to promote angiogenesis, a gene that encodes a protein or other gene product that leads to angiogenesis, an AGE Crosslink Breaker, a gene that encodes a protein or other gene product that leads to removal of AGE Crosslinks, VEGF, phVEGF, FGF, and ALT-711.

21. The method of claim 1, wherein the stimulator system includes a first implanted device and a second implanted device, the method further comprising:

communicating between the first implanted device and the second implanted device to coordinate the delivery of the drug to the cardiac tissue to treat coronary artery disease and the delivery of the electrical stimulation pulses to treat angina, wherein the first implantable device delivers the drug to treat coronary artery disease and the second implantable device delivers the electrical stimulation pulses to treat angina.

12. A method for simultaneously treating coronary artery disease and angina, comprising:

implanting a fully implantable stimulator system for generating stimulating pulses of at least one drug and electrical neural stimulation pulses;

treating the coronary artery disease, wherein treating the coronary artery disease includes administering via the stimulator system stimulating pulses of at least one drug; and

treating the angina simultaneously with treating the coronary artery disease, wherein treating the angina includes administering via the stimulator system electrical neural stimulating pulses to treat the angina in concert with administering via the stimulator system stimulating pulses of at least one drug.

13. The method of claim 12 wherein administering via the stimulator system electrical stimulating pulses includes stimulating tissue to increase effectiveness of administration of the at least one drug.

14. The method of claim 12 wherein administering via the stimulator system electrical stimulating pulses occurs simultaneous with administering via the stimulator system stimulating pulses of at least one drug.

22. The method of claim 12, wherein implanting a fully implantable stimulator system includes implanting a first, frilly implantable device configured to deliver electrical neural stimulating pulses to treat angina, and a second, fully-implantable device configured to administer the drug to treat coronary artery disease, wherein the first and second fully implantable devices are configured to communicate with each other to coordinate delivery of the drug and delivery of the electrical neural stimulation pulses.

15. A system for treating coronary artery disease, comprising:

a stimulator system configured to deliver infusion pulses and to generate a plurality of electrical stimulation pulses in accordance with prescribed parameters to provide neural stimulation;

a power source configured to provide operating power to the stimulator system;

a catheter connected to the stimulator system, which catheter includes a discharge portion;

a lead connected to the stimulator system, which lead includes an electrode; and

a sensor in communication with the stimulator system, wherein the sensor is configured to measure a change in blood circulation,

wherein the infusion pulses include a drug to treat the coronary artery disease and the stimulator system, the lead and the electrode are configured to deliver the neural stimulation to appropriate sites to treat angina.

16. The system of claim 15 wherein the sensor includes an oxygen sensor.

17. The system of claim 15 wherein the sensor includes an electrocardiograph sensor.

18. The system of claim 17 wherein the sensor is further configured to measure a physiological condition associated with angina.

19. The system of claim 15 wherein the stimulator system is configured to coordinate delivery of the infusion pulses with delivery of the electrical stimulation pulses.

20. The system of claim 19 wherein the prescribed parameters are adjusted based on the change in blood circulation.

23. The system of claim 15, wherein the stimulator system includes a first fully implantable device configured to deliver infusion pulses to treat coronary artery disease and a second fully implantable device configured to generate a plurality of electrical stimulation pulses to provide neural stimulation to treat angina, and wherein the first and second fully implantable devices are configured to communicate with each to coordinate delivery of the infusion pulses and the electrical stimulation pulses.