Method and apparatus for modulating cellular growth and regeneration using ventricular assist device

• US 7,828,711 B2
• Filed: 08/16/2004
• Issued: 11/09/2010
• Est. Priority Date: 08/16/2004
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Spinelli, Julio C., Ross, Jeffrey
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US10/919,016
• Publication Number:
  US 20060036126A1
• Time in Patent Office: 2,276 Days
• Field of Search: 6048901-8902, 604/891.1, 604/892.1, 604/6.11, 604 65- 67, 607/3, 607/120, 607/129, 623/1.42, 600 16- 18
• US Class Current: 600/17
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/247 Positive displacement blood pumps
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/554 of blood pressure

Abstract

A system delivers combined ventricular assist device (VAD) therapy and chemical and/or biological therapy to modulate myocardial tissue growth in a heart after myocardial infarction (MI). The system includes an agent delivery device to release one or more agents to an MI region to modulate myocardial tissue growth in that region, and a VAD to enhance the effects of the one or more agents by reducing myocardial wall stress and the overall cardiac workload. In one embodiment, the system is an implantable system including an implantable agent delivery device and an implantable VAD for long-term use in a patient.

Claims

1. A system adapted to be coupled to a heart having myocardial tissue and a myocardial infarct (MI) region, the system comprising:

an implantable agent delivery device containing one or more agents that promote myocardial tissue replacement and adapted to deliver the one or more agents to the MI region, wherein the one or more agents that promote myocardial tissue replacement enhance migration, implantation, or proliferation of stem cells in the MI region and reduce scar formation; and

an implantable ventricular-assist device (VAD) including;

a sensor to sense one or more signals indicative of one or more of a strain of the myocardial tissue and a size of the MI region;

a pump to assist the heart in blood pumping;

a VAD controller coupled to the pump, the VAD controller adapted to control the operation of the pump using the sensed one or more signals for enhancing one or more effects of the one or more agents; and

an agent delivery controller coupled to the implantable agent delivery device, the agent delivery controller adapted to control the delivery of the one or more agents using the sensed one or more signals in temporal coordination with the operation of the pump.

2. The system of claim 1, wherein the one or more agents comprise one or more agents that change one or more mechanical properties of tissue in the MI region.

3. The system of claim 1, wherein the one or more agents comprise one or more agents that promote vascularization in the MI region.

4. The system of claim 1, wherein the one or more agents comprise one or more agents that reduce adverse remodeling of tissue in the MI region.

5. The system of claim 1, wherein the one or more agents comprise one or more agents that modulate hypertrophic signaling in the MI region.

6. The system of claim 1, wherein the one or more agents comprise one or more agents that modulate fibrosis signaling in the MI region.

7. The system of claim 1, wherein the one or more agents comprise one or more of stem cell growth factor (SCF), granulocyte colony-stimulation factor (G-CSF), granulocyte macrophage colony-stimulating growth factor (GM-CSF), stem cell homing factor (SDF-1), bone morphogenetic protein 2 (BMP-2), Wnt protein, a gene encoding SCF, a gene encoding G-CSF, a gene encoding GM-CSF, a gene encoding SDF-1, a gene encoding BMP-2, and a gene encoding Wnt protein.

8. The system of claim 1, wherein the one or more agents comprise one or more agents that enhance myocardial tissue regeneration.

9. The system of claim 1, wherein the one or more agents comprise a cytokine.

10. The system of claim 1, the one or more agents comprise one or more of hepatocyte growth factor (HGF), insulin-like growth factor (IGF), fibroblast growth factor (FGF), transforming growth factor-beta (TGF-β

), a gene encoding HGF, a gene encoding IGF, a gene encoding FGF, and a gene encoding TGF-β

.

11. The system of claim 1, further comprising an agent eluting lead coupled to the agent delivery device.

12. The system of claim 11, further comprising an implantable device including the agent delivery device and the VAD.

13. The system of claim 1, wherein the agent delivery device comprises an agent eluting stent configured for placement in or near the MI region.

14. The system of claim 1, wherein the agent delivery device comprises an agent eluting epicardial patch configured for placement in or near the MI region.

15. The system of claim 1, wherein the sensor comprises an ischemia sensor to sense a signal indicative of an ischemic condition.

16. The system of claim 1, wherein the sensor comprises a cardiac sensing circuit to sense at least one electrogram indicative of arrhythmia.

17. The system of claim 1, wherein the sensor comprises a displacement sensor to sense a signal indicative of the strain of myocardial tissue.

18. The system of claim 1, wherein the sensor comprises a remodeling sensor to sense a signal indicative of the size of the MI region.

19. The system of claim 1, wherein the sensor comprises a sensor to sense hypertrophic signaling.

20. The system of claim 19, wherein the sensor comprises a sensor to sense the concentration of endothelin-1, brain natriuretic peptide (BNP) or p38MAPK.

21. The system of claim 1, wherein the sensor comprises a metabolic sensor to sense a signal indicative of a metabolic need of a body.

22. The system of claim 1, wherein the sensor comprises a temperature sensor to sense a signal indicative of a perfusion of thermal energy through myocardial tissue.

23. The system of claim 1, wherein the sensor comprises a metabolic sensor to sense one or more signals indicative of a cardiac metabolism level.

24. The system of claim 23, wherein the metabolic sensor includes at least one of a pH sensor, an oxygen pressure (PO₂) sensor, a carbon dioxide pressure (PCO₂) sensor, a glucose sensor, a creatine sensor, a C-creative protein sensor, a creatine kinase sensor, and a creatine kinase-MB sensor.

25. The system of claim 1, wherein the agent delivery device comprises an electrically controlled polymer containing the one or more agents, the polymer adapted to release the one or more agents at a rate controlled by an amplitude of the agent delivery control signal.

26. The system of claim 1, wherein the agent delivery controller comprises a command receiver to receive an external command, and wherein the agent delivery controller is adapted to produce the agent delivery control signal in response to the external command.

27. The system of claim 26, wherein the VAD is an implantable VAD, and the agent delivery device is an implantable agent delivery device, and further comprising an external system communicatively couple to the implantable VAD, the external system including a command transmitter to transmit the external command to the implantable VAD.

28. The system of claim 27, wherein the external system comprises a user input to receive a user command, and wherein the command transmitter transmits the external command in response to the user command.

29. The system of claim 28, wherein the external system comprises:

an external device communicatively coupled to the implantable VAD;

a network coupled to the external device; and

a remote device coupled to the network to provide for communication with the implantable VAD from a remote location.