Thrombolysis and chronic anticoagulation therapy

• US 20030083698A1
• Filed: 11/01/2002
• Published: 05/01/2003
• Est. Priority Date: 11/01/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Whitehurst, Todd K., Thacker, James R., McClure, Kelly H.
• Granted Patent: US 7,308,303 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61M 2205/3507 with implanted devices, e.g. external control
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/8243 by induction
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy

Abstract

Thrombolytic and/or anticoagulation therapy of the present invention includes implantation of the discharge portion(s) of a catheter and, optionally, one or more electrodes on a lead, adjacent tissue(s) to be stimulated. Stimulation pulses, i.e., drug infusion pulses and optional electrical pulses, are supplied by a stimulator implanted remotely, and through the catheter or lead, which is tunneled subcutaneously between the stimulator and stimulation site. Stimulation sites include the coronary arteries, coronary veins, cerebral arteries, other blood vessels, chambers of the heart, mesenteric vessels, deep vessels of the leg, and other locations. Disclosed treatments include drugs used for chronic treatment and/or prevention of thromboembolic disease, for acute treatment of thromboembolic disease, for acute treatment of thrombosis, and combinations of these. The invention reduces or eliminates the incidence of thromboembolic disease and related morbidities, improve symptoms resulting from thromboembolic disease, and improve patient quality of life.

Claims

1. A method for providing thrombolytic and anticoagulation therapy, comprising:

providing a stimulator that generates a pulse in accordance with prescribed parameters;

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

implanting the catheter discharge portion adjacent to at least one tissue to be stimulated;

implanting the stimulator at a location remote from the at least one tissue to be stimulated;

tunneling the catheter subcutaneously to the stimulator location; and

delivering via the stimulator and catheter infusion pulses of at least one drug as thrombolytic and anticoagulation treatment to at least one tissue, which tissue comprises at least one of a coronary artery, a coronary vein, the coronary sinus, the left ventricle, the left atrium, the surface of the myocardium, a pulmonary vein, a carotid artery, the anterior cerebral artery, the middle cerebral artery, the posterior cerebral artery, the circle of Willis, a meningeal artery, the basilar artery, a pulmonary artery, the superior vena cava, the inferior vena cava, the right ventricle, the right atrium, the aorta, a common iliac vessel, an internal iliac vessel, an external iliac vessel, a femoral vessel, a renal vessel, the celiac trunk, the middle colic artery, a superior mesenteric vessel, an inferior mesenteric vessel, a deep vein of the leg, a vessel that influences coronary circulation, a vessel that influences cerebral circulation, a vessel that influences pulmonary circulation, a vessel that influences circulation of the lower limbs, and a vessel that influences visceral circulation.

2. The method of claim 1 further comprising causing constriction of arterioles to limit perfusion and treatment delivery via the arterioles.

3. The method of claim 1 further comprising causing dilation of arterioles to increase perfusion and treatment delivery via the arterioles.

4. The method of claim 1 further comprising:

providing a lead connected to the stimulator, which lead includes at least one electrode, and

delivering an electrical stimulating pulse to tissue surrounding the at least one electrode.

5. The method of claim 4 further comprising causing constriction of arterioles to limit perfusion and treatment delivery via the arterioles.

6. The method of claim 4 further comprising causing dilation of arterioles to increase perfusion and treatment delivery via the arterioles.

7. The method of claim 1 further comprising:

chronically infusing at least one anticoagulant; and

increasing delivery of the at least one anticoagulant during an acute emergency.

8. The method of claim 1 further comprising infusing at least one thromboembolytic drug during an acute emergency.

9. The method of claim 1 wherein the drug comprises at least one of heparin, low molecular weight heparin, warfarin, aspirin, a platelet aggregation inhibitor, streptokinase, a streptokinase derivative, a tissue plasminogen activator (tPA), a plasminogen activator derivative, anistreplase, urokinase, and a urokinase derivative.

10. The method according to claim 1 wherein the at least one drug provides chronic treatment delivered at a basal rate or via periodic bolus of at least one of heparin, low molecular weight heparin, warfarin, aspirin, and a platelet aggregation inhibitor.

11. The method according to claim 1 wherein the at least one drug provides acute treatment with at least one of streptokinase, a streptokinase derivative, a tissue plasminogen activator (tPA), a plasminogen activator derivative, urokinase, a urokinase derivative, anistreplase, heparin, and low molecular weight heparin.

12. The method according to claim 1 further comprising providing both acute treatment and chronic treatment.

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

14. The method of claim 13 wherein the at least one sensed condition is at least anticoagulation status.

15. The method of claim 13 wherein the at least on sensed condition is at least one of an abnormal ECG event, an abnormal EEG event, an abnormal ultrasound echocardiogram event, oxygen level, flow level, change in perfusion, coagulation state, left ventricular end diastolic pressure, pulmonary capillary wedge pressure, systemic blood pressure, cardiac output, Prothrombin Time (PT), International Normalized Ratio (INR), Partial Thromboplastin Time (PTT), Activated Partial Thromboplastin Time (APTT), Native Prothrombin Antigen Assay, Specific Prothrombin Assay, Anti-Xa Assay, medication level, hormone level, D-dimer level, lupus anticoagulant antibody level, anti-cardiolipin antibody level, Troponin-I level, Troponin-T level, and level of antibodies that bind to Troponin-I.

16. The method of claim 13 wherein the at least one sensed condition is an indicator of at least one of myocardial infarction, stroke, cardiomyopathy, pulmonary embolism, paradoxical embolism, venous thrombosis, deep vein thrombosis, clotted arteriovenous fistula or shunt, atrial fibrillation, thrombus, thromboembolic disease, cardiac ischemia, cerebral ischemia, pulmonary ischemia, limb ischemia, and mesenteric ischemia.

17. The method of claim 13 wherein the at least one sensor comprises at least one of an internal device and an external device.

18. A method for providing thrombolytic and anticoagulation therapy, comprising:

providing a stimulator that generates a pulse in accordance with prescribed parameters;

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

implanting the catheter discharge portion adjacent to at least one tissue to be stimulated;

implanting the stimulator at a location remote from the at least one tissue to be stimulated;

tunneling the catheter subcutaneously to the stimulator location;

delivering via the stimulator and catheter infusion pulses of at least one drug as thrombolytic and anticoagulation treatment to at least one tissue, which tissue comprises at least one of a coronary artery, a coronary vein, the coronary sinus, the left ventricle, the left atrium, the surface of the myocardium, a pulmonary vein, a carotid artery, the anterior cerebral artery, the middle cerebral artery, the posterior cerebral artery, the circle of Willis, a meningeal artery, the basilar artery, a pulmonary artery, the superior vena cava, the inferior vena cava, the right ventricle, the right atrium, the aorta, a common iliac vessel, an internal iliac vessel, an external iliac vessel, a femoral vessel, a renal vessel, the celiac trunk, the middle colic artery, a superior mesenteric vessel, an inferior mesenteric vessel, a deep vein of the leg, a vessel that influences coronary circulation, a vessel that influences cerebral circulation, a vessel that influences pulmonary circulation, a vessel that influences circulation of the lower limbs, and a vessel that influences visceral circulation; and

causing modulation of arteriole lumen area to modulate perfusion and treatment delivery via the arterioles.

19. The method of claim 18 further comprising providing at least one sensor to sense at least one physical condition, and adjusting the parameters based on the at least one sensed condition.

20. A system for providing thrombolytic and anticoagulation therapy, comprising:

means for generating infusion pulses of at least one drug in accordance with prescribed parameters, which at least one drug provides thrombolytic and anticoagulation treatment;

means for providing the prescribed parameters;

means for delivering the infusion pulses to at least one tissue, which tissue comprises at least one of a coronary artery, a coronary vein, the coronary sinus, the left ventricle, the left atrium, the surface of the myocardium, a pulmonary vein, a carotid artery, the anterior cerebral artery, the middle cerebral artery, the posterior cerebral artery, the circle of Willis, a meningeal artery, the basilar artery, a pulmonary artery, the superior vena cava, the inferior vena cava, the right ventricle, the right atrium, the aorta, a common iliac vessel, an internal iliac vessel, an external iliac vessel, a femoral vessel, a renal vessel, the celiac trunk, the middle colic artery, a superior mesenteric vessel, an inferior mesenteric vessel, a deep vein of the leg, a vessel that influences coronary circulation, a vessel that influences cerebral circulation, a vessel that influences pulmonary circulation, a vessel that influences circulation of the lower limbs, and a vessel that influences visceral circulation.

21. The system of claim 20 wherein the means for providing prescribed parameters includes at least one means for sensing at least one physical condition and means for adjusting the parameters based on the at least one sensed condition.

22. The system of claim 20 further comprising means for modulating arteriole lumen area to modulate perfusion and treatment delivery via the arteriole.