Method for wirelessly monitoring implanted medical device

• US 8,403,907 B2
• Filed: 10/29/2007
• Issued: 03/26/2013
• Est. Priority Date: 10/10/2000
• Status: Active Grant

• Current Assignee: DARE MB Incorporated
• Original Assignee: MicroCHIPS Inc.
• Inventors: Sheppard, Norman F. Jr., Santini, John T. Jr., Cima, Michael J., Langer, Robert S., Ausiello, Dennis
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): GRAY, PHILLIP A
• Application Number:
  US11/926,458
• Publication Number:
  US 20080221555A1
• Time in Patent Office: 1,975 Days
• Field of Search: 6048901-8921, 604 65- 67, 604/131, 604151-155, 604500-522
• US Class Current: 604/502
• CPC Class Codes: A61B 1/041 Capsule endoscopes for imaging
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 2210/1042 Alimentary tract A61M2210/0618 takes precedence
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

A method is provided for monitoring the status of a medical device implanted in a patient. The method includes the steps of implanting in a patient a medical device which comprises (i) a substrate in which two or more reservoirs are located, with each covered by a reservoir cap, (ii) a drug or sensor located in the reservoir, (iii) a power source and actuation electronics for disintegrating or permeabilizing the reservoir cap, and (iv) a telemetry system; and then using said telemetry system to wirelessly transmit to a remote controller data about the condition of the power source and/or data about which reservoirs have been or have yet to be activated to release the drug therefrom or to expose the sensor therein.

Claims

1. A method for monitoring the status of a medical device implanted in a patient, the method comprising:

implanting in a patient a medical device which comprises (i) a substrate in which two or more reservoirs are located, with each covered by a reservoir cap, (ii) a drug or sensor located in the reservoir, (iii) a power source and actuation electronics operable to melt each reservoir cap and thereby expose the drug or sensor to an environment at the site of implantation in the patient, and (iv) a telemetry system; and

using said telemetry system to wirelessly transmit to a remote controller data about the condition of the power source and/or data about which reservoirs have been or have yet to be activated to release the drug therefrom or to expose the sensor therein.

2. The method of claim 1, further comprising using a microprocessor to compare the data transmitted to the remote controller with safety protocols stored in a memory.

3. The method of claim 2, wherein the reservoirs comprise at least one drug for release and the safety protocols prohibit (i) the release of an unsafe quantity of the drug to the patient over a particular time interval, and/or (ii) the unsafe release of two or more incompatible drugs.

4. The method of claim 1, further comprising transmitting the data received by the remote controller to the patient'"'"'s physician or to a central monitoring system on a real-time basis.

5. The method of claim 1, wherein the data is transmitted in the form of electromagnetic energy selected from radio frequency signals, microwave signals, infrared signals, ultraviolet signals, and combinations thereof.

6. The method of claim 1, wherein the actuation electronics comprises components selected from the group consisting of multiplexers, demultiplexers, signal generators, signal oscillators, amplifiers, switches, potentiostats, and combinations thereof.

7. A method for monitoring the status of a medical device implanted in a patient, the method comprising:

implanting at a site in a patient a medical device which comprises (i) a substrate in which two or more reservoirs are located, with each covered by a reservoir cap, (ii) a drug formulation disposed in the two or more reservoirs, (iii) a power source and actuation electronics operable to melt each reservoir cap, thereby permitting the drug to be released from the medical device to the patient, and (iv) a telemetry system; and

using said telemetry system to wirelessly transmit to a remote controller data about the condition of the power source and/or data about which reservoirs caps have been or have yet to be disintegrated, melted, or otherwise ruptured.

8. The method of claim 7, wherein the drug formulation comprises a hormone, steroid, or chemotherapeutic agent.

9. A method for monitoring a medical device implanted in a patient, the method comprising:

implanting in a patient a medical device which comprises (i) a silicon substrate in which two or more reservoirs are located, with each covered by a reservoir cap comprising a metal film, (ii) a drug or sensor located in the reservoir, (iii) a power source and actuation electronics operable to cause a rise in temperature of each reservoir cap to disintegrate or melt each reservoir cap and thereby expose the drug or sensor to an environment at the site of implantation in the patient, and (iv) a telemetry system; and

using said telemetry system to wirelessly transmit to a remote controller data about the condition of the power source and/or data about which reservoirs have been or have yet to be activated to release the drug therefrom or to expose the sensor therein.