Implantable cell/tissue-based biosensing device

• US 7,519,409 B2
• Filed: 12/29/2005
• Issued: 04/14/2009
• Est. Priority Date: 12/29/2005
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Reinke, James D., Yang, Zhongping
• Primary Examiner(s): Nasser; Robert L
• Assistant Examiner(s): Toth; Karen E
• Application Number:
  US11/322,117
• Publication Number:
  US 20070154893A1
• Time in Patent Office: 1,202 Days
• Field of Search: 600/345, 600/347, 600/365, 600/372
• US Class Current: 600/347
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

An implantable cell/tissue-based biosensor device detects and/or monitors the amount of one or more specific analytes within a patient. Stimulation circuitry stimulates the cells/tissue of the biosensor device causing the cells/tissue to evoke a response that is altered by the presence of a specific analyte. Sensing circuitry detects the evoked response and the amount of analyte is determined based on the detected response.

Claims

1. A biosensor device for sensing an analyte in a patient, the biosensor device comprising:

a biosensing recognition element capable of interacting with the analyte and carrying out a response to electrical stimulation that is alterable upon interaction with the analyte;

an electrical interface contacting the biosensing recognition element;

stimulation circuitry, associated with the electrical interface, for delivering the electrical stimulation to the biosensing recognition element; and

sensing circuitry, associated with the electrical interface, for sensing the response of the biosensing recognition element to the electrical stimulation.

2. The biosensor device of claim 1 wherein the biosensing recognition element composes:

a biologic agent; and

a permeable membrane encapsulating the biologic agent.

3. The biosensor device of claim 2 wherein the biologic agent is molecularly, genetically or cellularly modified.

4. The biosensor device of claim 1 wherein the response sensed by the sensing circuitry is cellular action potential, impedance or both.

5. The biosensor device of claim 1 operably connected to a therapy delivery device.

6. The biosensor device of claim 5 wherein the therapy delivery device is one of a pacemaker, defibrillator, cardiac resynchronization therapy system and drug pump.

7. The biosensor device of claim 1 wherein stimulation circuitry provides one of monophasic voltage, biphasic voltage, multiphasic voltage and current pulses.

8. The biosensor device of claim 1 and further comprising:

telemetry circuitry in communication with the sensing circuitry.

9. The biosensor device of claim 1 wherein the biosensing recognition element further comprises a biologic agent and the sensing circuitry monitors viability of the biologic agent.

10. An implantable biosensor device for sensing a plurality of analytes, the implantable biosensor device comprising:

a plurality of biosensing recognition elements, each biosensing recognition element capable of interacting with at least one of the plurality of analytes and carrying out a response to electrical stimulation that is alterable upon interaction with at least one of the plurality of analytes;

a plurality of electrical interfaces contacting the plurality of biosensing recognition elements;

stimulation circuitry, associated with the plurality of electrical interfaces, for delivering the electrical stimulation to the plurality of biosensing recognition elements; and

sensing circuitry, associated with the plurality of electrical interfaces, for sensing the response of the plurality of biosensing recognition elements to the electrical stimulation.

11. The implantable biosensor device of claim 10 wherein each biosensing recognition element includes a biologic agent that is specific for at least one of the plurality of analytes.

12. The implantable biosensor device of claim 11 wherein the biologic agent is derived from stem cells.

13. The implantable biosensor device of claim 11 wherein the biologic agent is molecularly, genetically or cellularly modified.

14. The implantable biosensor device of claim 11 wherein the biologic agent is encapsulated in a permeable membrane.

15. The implantable biosensor device of claim 10 and further comprising:

a lead switch operably connected to the plurality of electrical interfaces.

16. A method of sensing an analyte in a patient, the method comprising:

implanting a biosensing recognition element in the patient, the biosensing recognition element being capable of interacting with the analyte and carrying out a response to electrical stimulation that is alterable upon interaction with the analyte;

electrically stimulating the biosensing recognition element;

detecting the response of the biosensing recognition element to the electrical stimulation; and

relating the detected response with an amount or presence of the analyte.

17. The method of claim 16 wherein the response includes a cellular action potential or impedance.

18. The method of claim 16 and further comprising:

altering or initiating treatment of the patient based on the detected amount or presence of the analyte.

19. The method of claim 16 and further comprising:

monitoring viability of the biosensing recognition element.

20. The method of claim 16 wherein the response is implemented as a diagnostic, monitoring or both tools.