Thrombolysis and chronic anticoagulation therapy

• US 7,308,303 B2
• Filed: 11/01/2002
• Issued: 12/11/2007
• Est. Priority Date: 11/01/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Whitehurst, Todd K, McClure, Kelly H, Thacker, James R
• Primary Examiner(s): Mullen, Kristen D.
• Application Number:
  US10/285,803
• Publication Number:
  US 20030083698A1
• Time in Patent Office: 1,866 Days
• Field of Search: 607/3, 607/9, 604/890.1, 604/891.1, 604/892.2
• 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 directing flow of anticoagulation medication, the method comprising:

delivering at least one of a thrombolytic drug and an anticoagulation drug to a first tissue via an implanted treatment device that includes

a catheter having a discharge portion positioned to deliver the at least one drug to the first tissue, and

a lead having a stimulating electrode positioned to deliver an electrical pulse to a second tissue; and

limiting perfusion of the first tissue by delivering the electrical pulse to the second tissue via the stimulating electrode, wherein the electrical pulse is configured to constrict at least one arteriole supplying the first tissue.

2. The method of claim 1, wherein delivering the electrical pulse to the second tissue comprises delivering the electrical pulse to at least one of nerve tissue and/or smooth muscle tissue.

3. The method of claim 1, wherein the first 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.

4. The method of claim 1, wherein the electrical pulse is configured to constrict the at least one arteriole by causing contraction of smooth muscle surrounding at least one arteriole.

5. A method for providing at least one of thrombolytic or 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;

providing a lead connected to the stimulator, the lead including at least one electrode;

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

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

implanting the lead adjacent to at least a second one tissue;

delivering, via the catheter, pulses of at least one drug as at least one of thrombolytic or 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

limiting perfusion of the at least one tissue by delivering, via the lead, an electrical stimulating pulse to the at least one tissue, wherein said electrical pulse is configured to constrict at least one arteriole supplying the at least one tissue.

6. The method of claim 5 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.

7. A method for providing at least one of thrombolytic or anticoagulation therapy, comprising:

providing a stimulator that includes a lead having at least one electrode to generate 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;

chronically delivering via the catheter at least one drug as at least one of thrombolytic or anticoagulation treatment to at least one tissue;

increasing delivery via the catheter of at least one drug to the at least one tissue during an acute emergency, 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

limiting perfusion of the at least one tissue by delivering an electrical pulse to the at least one tissue, wherein said electrical pulse is configured to constrict at least one arteriole supplying the at least one tissue.

8. The method of claim 7 wherein the electrical pulse is configured to constrict the at least one arteriole by causing contraction of smooth muscle surrounding the at least one arteriole.

9. The method of claim 7 wherein the limiting of the perfusion of the at least one tissue is configured to increase an amount of time that the at least one drug remains in the at least one tissue.

10. The method of claim 7 wherein the at least one drug comprises at least one anticoagulant.

11. The method of claim 7 wherein the at least one drug delivered during the acute emergency comprises at least one thromboembolytic drug.

12. The method of claim 7 wherein the at least one 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.

13. The method according to claim 7 wherein the at least one drug that is chronically delivered 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.

14. The method according to claim 7 wherein the at least one drug delivered during the acute emergency comprises 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.

15. The method according to claim 7 further comprising providing both acute treatment and chronic treatment with a same at least one drug.

16. The method of claim 7 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.

17. The method of claim 16 wherein the at least one sensed condition is at least anticoagulation status.

18. The method of claim 16 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-l level, Troponin-T level, and level of antibodies that bind to Troponin-l.

19. The method of claim 16 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.

20. The method of claim 16 wherein the at least one sensor comprises at least one of an internal device and an external device.

21. An implantable system for providing at least one of thrombolytic or anticoagulation therapy, the system comprising:

a power storage device;

a stimulating electrode positionable to deliver an electrical pulse to a tissue;

a memory storing stimulation parameters that describe an electrical pulse operable to modulate an arteriole lumen area of an arteriole by exciting activity in a neural or a muscular cell;

an electrical signal generator to receive the stimulation parameters from the memory and to generate the electrical pulse deliverable by the stimulating electrode in accordance with the stimulation parameters, the electrical pulse generated using power drawn from the power storage device;

means for chronically delivering a first drug for the thrombolytic or anticoagulation therapy to at least one tissue in accordance with prescribed parameters, the at least one tissue comprising 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

means for acutely delivering a second drug for the thrombolytic or anticoagulation therapy to the at least one tissue.

22. The system of claim 21 further comprising means for providing the prescribed parameters to the drug discharge device.

23. The system of claim 22 wherein the means for providing the prescribed parameters comprises a physiological condition sensor.

24. The system of claim 22 wherein the system further comprises:

an implantable physiological condition sensor to sense at least one physiological condition indicative of an acute emergency and to generate a signal indicative of the acute emergency; and

a controller to increase the delivery of the second drug for the thrombolytic or anticoagulation therapy in response to a receipt of the signal indicative of the acute emergency.