Monitoring, preventing, and treating rejection of transplanted organs

• US 7,904,162 B2
• Filed: 10/07/2005
• Issued: 03/08/2011
• Est. Priority Date: 09/18/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Marnfeldt, Goran N, McClure, Kelly H, Whitehurst, Todd K, Thacker, James R, McGivern, James P
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): Heller; Tammie K
• Application Number:
  US11/246,719
• Publication Number:
  US 20060036286A1
• Time in Patent Office: 1,978 Days
• Field of Search: 607 50- 52, 607/120
• US Class Current: 607/50
• 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 a system control unit, wherein the system control unit comprises a power source disposed within a housing;

implanting the system control unit in or near an allograft, wherein the allograft is an organ from another person that is transplanted into the patient;

providing operating power to the system control unit;

providing stimulation parameters to the system control unit; and

delivering stimulation with the system control unit to allograft tissue adjacent to the system control unit according to the stimulation parameters thereby preventing or reducing rejection of the transplanted organ by the patient'"'"'s body;

wherein the stimulation comprises both electrical stimulation and stimulation via at least one drug, and wherein the drug and the electrical stimulation are delivered by the system control unit.

2. The method of claim 1, wherein the system control unit has a size and shape suitable for placement entirely within the allograft and wherein implanting the system control unit comprises implanting the system control unit via a cannula.

3. The method of claim 1, wherein the at least one drug delivered to the allograft is at least one of a corticosteroid, cyclosporine, FK506, azathioprine, mycophenolate mofetil, daclizumab, and basiliximab.

4. The method of claim 1, 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 physical condition.

5. The method of claim 4, wherein the at least one sensor is a part of the system control unit.

6. The method of claim 4, wherein the sensed physical condition includes level or change in level of at least one of an electric impedance of the transplanted organ, inflammation of the transplanted organ, and necrosis of the transplanted organ.

7. The method of claim 4, wherein the sensed physical condition includes level or change in level of at least one of tissue volume, pressure, oxygen, or pH or change in an EMG, or ECG.

8. The method of claim 1, further comprising using at least one external appliance to determine the stimulation parameters.

9. The method of claim 1, wherein the stimulation parameters are determined by the at least one system control unit.

10. The method of claim 1, further comprising providing and implanting more than one system control unit.

11. The method of claim 1, further comprising opening an implantation site before implanting the system control unit and closing the implantation site after implanting the system control unit, wherein the system control unit remains implanted in or near the allograft after closing the implantation site.

12. The method of claim 1, wherein the at least one drug delivered to the allograft is at least one of a 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 that leads to angiogenesis, a gene product that leads to angiogenesis, VEGF, FGF, and phVEGF.

13. The method of claim 1, wherein implanting the system control unit in or near an allograft comprises implanting the system control unit during an organ transplantation procedure.

14. The method of claim 1, wherein the organ from another person that is transplanted into the patient comprises a liver, a kidney, a lung, an intestine or a pancreas.