Electrotransport system with remote telemetry link

• US 5,551,953 A
• Filed: 10/31/1994
• Issued: 09/03/1996
• Est. Priority Date: 10/31/1994
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Lattin, Gary A., Riddle, Thomas A.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): HUANG, STEPHEN D
• Application Number:
  US08/332,322
• Time in Patent Office: 673 Days
• Field of Search: 604/19, 604/20, 604/30, 604/50, 604/4, 604/890.1, 604/891.1, 128/736, 128/782, 128/769, 128/903
• US Class Current: 604/20
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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

Abstract

An electrotransport system (20) for delivering a therapeutic agent (36) through a body surface (40) (eg, skin) of a patient includes a pair of electrodes (34, 38) for contacting the body surface, at least one of which contains the therapeutic agent (36). The system (20) is physically separated into a control unit (22) and a delivery unit (24) connected by a radiated energy signal-based telemetry link. The telemetry link may be radio frequency, ultrasonic, optical, infrared or inductively coupled. Signals from the control unit may be transmitted to the delivery unit by the telemetry link, or vice versa. The delivery unit may control electrotransport current on the signal transmitted. The radiated energy signal may be encoded to improve immunity to extrinsic interference. The delivery unit (24) may be configured with sensor means for detecting a condition such as a body or system parameter reaching some predetermined limit. The delivery unit (24) may also have an additional telemetry link connecting to the control unit (22) for transmitting the system or body status condition to the control unit. Visual or audio indicators may be provided on the control unit (22) for indication of system or body status conditions detected and transmitted by the delivery unit (24).

Claims

1. In an electrotransport system for delivering a therapeutic agent through a body surface of a patient, the system including a delivery unit having a pair of electrodes, at least one of the electrodes containing the therapeutic agent to be delivered, a source of electrical power electrically connectable to the electrodes, and a control unit for communicating with the delivery unit, the improvement comprising:

the delivery unit being physically remote from the control unit; and

a telemetry communication link between the delivery and control units whereby the units communicate through a radiated energy signal transmitter and a receiver.

2. The electrotransport system of claim 1, wherein the control unit comprises the transmitter and the delivery unit comprises the receiver.

3. The electrotransport system of claim 1, wherein the delivery unit comprises the transmitter and the control unit comprises the receiver.

4. The electrotransport system of claim 1, wherein the delivery unit comprises both a radiated energy signal transmitter and receiver and the control unit comprises both a radiated energy signal transmitter and receiver.

5. The electrotransport system of claim 1, wherein the control unit controls an electrotransport current applied to the patient.

6. The electrotransport system of claim 1, wherein the control unit is adapted to be mounted on a wrist of the patient.

7. The electrotransport system of claim 1, wherein the control unit operates and transmits the radiated energy signal to the receiver from a distance of several centimeters to thousands of kilometers.

8. The electrotransport system of claim 1, wherein the transmitter comprises a manually operated switch.

9. The electrotransport system of claim 1, wherein the control unit includes a microprocessor having an output connected to the transmitter, the microprocessor having a plurality of stored programs for providing a corresponding plurality of radiated energy signals;

and means for selecting one of said stored programs to provide a selected program;

whereby the delivery of the therapeutic agent is remotely controlled according to the radiated energy signal corresponding to the selected program.

10. The electrotransport system of claim 1, wherein the transmitter and receiver are adapted to communicate by radio frequency radiated energy.

11. The electrotransport system of claim 10, wherein the radio frequency radiated energy has a frequency of about 1 MHz to 1000 MHz.

12. The electrotransport system of claim 10, wherein the radio frequency radiated energy is modulated by a modulator selected from the group consisting of an amplitude modulator, a frequency modulator, a frequency shift key, and a phase shift key.

13. The electrotransport system of claim 1, wherein the radiated energy is selected from the group consisting of ultrasonic, optical, infrared and electromagnetic induction energies.

14. The electrotransport system of claim 1, wherein the transmitter includes a coder for coding the transmitted signals and the receiver includes a decoder for decoding the transmitted signals.

15. The electrotransport system of claim 1, wherein the delivery unit includes:

a sensor for sensing a predetermined patient body parameter condition, the sensor providing a sense signal; and

a radiated energy return transmitter responsive to the sense signal, for transmitting a return radiated energy signal;

wherein

the control unit includes a receiver and display for receiving the return radiated energy signal and providing a display of the body parameter condition.

16. The electrotransport system of claim 15, wherein the sensor is adapted to sense a body parameter selected from the group consisting of breathing rate, body temperature, muscle movement, blood glucose concentration, sweat response, skin resistance, heart rate, tissue oxygen content, tissue carbon dioxide content, patient emergency condition and body motion.

17. The electrotransport system of claim 15, wherein the display is selected from the group consisting of a light emitting diode, a liquid crystal display, an audio annunciator, a cathode ray tube display, a video screen and a printer.

18. The electrotransport system of claim 1, wherein the delivery unit includes:

a sensor for sensing a predetermined electrotransport system parameter condition, the sensor providing a sense signal; and

a radiated energy return transmitter responsive to the sense signal, for transmitting a return radiated energy signal;

wherein

the control unit includes a receiver and display for receiving the return radiated energy signal and providing a display of the system parameter condition.

19. The electrotransport system of claim 18, wherein the sensor senses a system parameter selected from the group consisting of therapeutic agent dosing history, amount of therapeutic agent remaining to be delivered, battery strength, geographic location of the delivery unit, whether the delivery unit is currently delivering therapeutic agent, and system malfunction.

20. The electrotransport system of claim 1, wherein the delivery unit comprises a receiver for receiving a radiated energy signal and providing a control signal responsive to the radiated energy signal and a current controller for controlling an electrotransport current applied by the delivery unit, the controller being responsive to the control signal;

and

the control unit comprises a transmitter means for transmitting the radiated energy signal, whereby the electrotransport current applied by the delivery unit is controlled by the radiated energy signal transmitted from the remote control unit.

21. The electrotransport system of claim 1, the control unit including a magnetically activated switch which when closed enables communication between the delivery and control units.