Monitoring, preventing, and treating rejection of transplanted organs

• US 20060036286A1
• Filed: 10/07/2005
• Published: 02/16/2006
• Est. Priority Date: 09/18/2001
• 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., McGivern, James P., McClure, Kelly H., Marnfeldt, Goran N.
• Granted Patent: US 7,904,162 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/41 Detecting, measuring or recording for evaluating the immune or lymphatic systems
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/416 the spleen
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• CPC Class Codes: A61B 5/4244 liver
• 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: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02

Abstract

An implantable system control unit (SCU) includes means for measuring tissue impedance or other condition to determine allograft health, in order to predict or detect allograft rejection. The SCU also includes at least two electrodes coupled to means for delivering electrical stimulation to a patient within whom the device is implanted, and may also include a reservoir for holding one or more drugs and a driver means for delivering the drug(s) to the patient. In certain embodiments, the system is capable of open- and closed-loop operation. In closed-loop operation, at least one SCU includes a sensor, and the sensed condition is used to adjust stimulation parameters. Alternatively, this sensory “SCU” sounds an alarm, communicates an alarm to an external device, and/or is responsive to queries regarding sensed information, such as tissue impedance.

Claims

1. A method for treating a patient with an allograft, comprising:

providing at least one system control unit (SCU) having a pump coupled to an infusion outlet, the SCU being housed within a case;

implanting the at least one SCU such that a portion of the case is disposed within an allograft;

containing as a substance in the at least one pump at least one of a drug used to promote angiogenesis, a gene that encodes a protein that leads to angiogenesis, and a gene product that leads to angiogenesis;

providing operating power to the at least one SCU;

providing stimulation parameters to the at least one SCU; and

delivering the substance via the at least one outlet to allograft tissue adjacent to the at least one SCU in accordance with the stimulation parameters.

2. The method of claim 1, wherein the at least one drug includes at least one of VEGF, FGF, and phVEGF.

3. The method of claim 1, wherein the at least one SCU has a size and shape suitable for placement entirely within the allograft and implantation via a cannula.

4. The method of claim 1, wherein the substance further comprises at least one of a corticosteroid, cyclosporine, FK506, azathioprine, mycophenolate mofetil, daclizumab, basiliximab, nicotine receptor agonist, a gene that leads to suppression of allograft rejection, and a gene product that leads to suppression of allograft rejection.

5. The method of claim 1, further comprising:

providing at least one sensor;

using the at least one sensor to sense a physical condition; and

adjusting the stimulation parameters based at least in part upon the sensed condition.

6. The method of claim 5, wherein the at least one sensor is a part of the SCU.

7. A method for treating a patient with an allograft, comprising:

providing a microstimulator;

implanting the microstimulator in or near an allograft;

providing operating power to the microstimulator;

providing stimulation parameters to the microstimulator; and

delivering stimulation with the microstimulator to allograft tissue adjacent to the microstimulator according to the stimulation parameters;

wherein the stimulation comprises both electrical stimulation and stimulation via at least one drug.

8. The method of claim 7, wherein the microstimulator has a size and shape suitable for placement entirely within the allograft and for implantation via a cannula.

9. The method of claim 7, wherein the at least one drug delivered to the allograft is at least one of a corticosteroid, cyclosporine, FK506, azathioprine, mycophenolate mofetil, daclizumab, basiliximab, nicotine receptor agonist, a gene that leads to suppression of allograft rejection, a gene product that leads to suppression of allograft rejection, a medication used to promote angiogenesis, a gene that encodes a protein, a gene product that leads to angiogenesis, VEGF, FGF, and phVEGF.

10. The method of claim 7, further comprising:

providing at least one sensor;

using the sensor to sense a physical condition;

determining the stimulation parameters based at least in part upon the sensed condition.

11. The method of claim 10, wherein the at least one sensor is a part of the microstimulator.

12. The method of claim 10, wherein the sensed physical condition includes level or change in level of at least one of impedance, inflammation, necrosis, volume, pressure, oxygen, pH, EMG, ECG, a neurotransmitter, a neurotransmitter breakdown product, a medication, a hormone, an enzyme, an interleukin, a cytokine, a lymphokine, a chemokine, a growth factor, a medication, a blood plasma substance, and a body fluid.

13. The method of claim 7, further comprising using at least one external appliance to determine the stimulation parameters.

14. The method of claim 7, wherein the stimulation parameters are determined by the at least one microstimulator.

15. The method of claim 7, further comprising providing and implanting more than one microstimulator.

16. A method for monitoring the health of an allograft prior to transplant, comprising:

providing at least one system control unit (SCU) housed within a case and coupled to at least two electrodes;

placing the case of the at least one SCU in or on an allograft prior to transplant;

providing operating power to the at least one SCU;

providing monitoring parameters to the at least one SCU; and

measuring electrical impedance of allograft tissue adjacent to the at least two electrodes in accordance with the monitoring parameters.

17. The method of claim 16, wherein the at least one SCU is placed entirely within the allograft.

18. A method of monitoring the health of an allograft, said method comprising:

providing at least one system control unit (SCU) having at least two electrodes;

placing the at least one SCU in or on said allograft prior to a transplant of said allograft into a patient;

measuring an electrical impedance of said allograft with said SCU in accordance with one or more monitoring parameters prior to said transplant; and

stimulating said allograft with said SCU in accordance with one or more stimulation parameters after said transplant.

19. The method of claim 18, wherein said at least one SCU is placed entirely within said allograft.