System of implantable devices for monitoring and/or affecting body parameters

• US 6,164,284 A
• Filed: 03/25/1998
• Issued: 12/26/2000
• Est. Priority Date: 02/26/1997
• Status: Expired due to Term

• Current Assignee: Alfred E. Mann Foundation For Scientific Research
• Original Assignee: Alfred E. Mann Foundation For Scientific Research
• Inventors: Schulman, Joseph H., Gord, John C., Dell, Robert Dan
• Primary Examiner(s): Gilbert, Samuel G.
• Application Number:
  US09/048,827
• Time in Patent Office: 1,007 Days
• Field of Search: 600/300, 128/899, 128/897, 128/898, 128/903, 128/904
• US Class Current: 128/899
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/07 Endoradiosondes
• 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 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61F 2/72 Bioelectric control, e.g. myoelectric
• CPC Class Codes: A61F 2002/5058 having means for restoring the perception of senses
• CPC Class Codes: A61F 2002/704 computer-controlled, e.g. robotic control
• CPC Class Codes: A61F 2002/705 Electromagnetic data transfer
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A system for monitoring and/or affecting parameters of a patient'"'"'s body and more particularly to such a system comprised of a system control unit (SCU) and one or more other devices, preferably battery-powered, implanted in the patient'"'"'s body, i.e., within the envelope defined by the patient'"'"'s skin. Each such implanted device is configured to be monitored and/or controlled by the SCU via a wireless communication channel. In accordance with the invention, the SCU comprises a programmable unit capable of (1) transmitting commands to at least some of a plurality of implanted devices and (2) receiving data signal from at least some of those implanted devices. In accordance with a preferred embodiment, the system operates in closed loop fashion whereby the commands transmitted by the SCU are dependent, in part, on the content of the data signals received by the SCU. In accordance with the invention, a preferred SCU is similarly implemented as a device capable of being implanted beneath a patient'"'"'s skin, preferably having an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm. Wireless communication between the SCU and the implanted devices is preferably implemented via a modulated sound signal, AC magnetic field, RF signal, or electric conduction.

Claims

1. A system for monitoring and/or affecting at least one parameter of a patient'"'"'s body, said system comprising:

at least one implantable device operable to sense and/or stimulate a patient'"'"'s body parameter in accordance with one or more controllable operating parameters; and

a system control unit for controlling said controllable operating parameters, said system control unit comprising;

a sealed elongate housing configured for implantation in a patient'"'"'s body, said sealed housing having an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm suitable for injection into the patient'"'"'s body;

a signal transmitter in said housing for transmitting command signals;

a signal receiver in said housing for receiving status signals; and

a programmable controller in said housing responsive to received status signals for producing command signals for transmission by said signal transmitter to said implantable devices.

2. The system of claim 1 comprising at least one said implantable device operable as a sensor and at least one said implantable device operable as a stimulator and wherein said controller is responsive to status data signals received from said sensor for generating said addressable command data signals to said stimulator to perform closed loop control of the operation of said stimulator.

3. The system of claim 1 wherein said system control unit additionally comprises a power source contained within said sealed housing for providing operating power to said data signal transmitter, said data signal receiver, and said programmable controller.

4. The system of claim 1 wherein said signal receiver includes a coil responsive to status signals defined by a modulated magnetic field.

5. The system of claim 1 wherein said signal receiver includes a transducer responsive to status signals defined by a modulated ultrasonic signal.

6. The system of claim 1 wherein said signal transmitter includes means for transmitting command signals in the form of a modulated magnetic field.

7. The system of claim 1 wherein said signal transmitter includes means for transmitting command signals in the form of a modulated ultrasonic signal.

8. The system of claim 1 wherein said system control unit additionally includes:

at least one electrode;

sensor/stimulator circuitry; and

wherein

said sensor stimulator circuitry is configurable to generate a data signal representative of an electrical signal conducted by said electrode and/or supply a sequence of drive pulses to said electrode.

9. The system of claim 1 wherein each of said implantable devices includes a power source having a capacity of at least 1 microwatt-hour.

10. The system of claim 9 wherein each said implantable device includes means for monitoring status of its power source and said system control unit is configured to transmit command signals to each said implantable device and to responsively receive status signals corresponding to said power source status.

11. The system of claim 1 further including:

program storage means in said housing for specifying the operation of said programmable controller; and

means to modify said program storage means in response to signals received by said signal receiver.

12. The system of claim 11 wherein said program storage means includes means to cause said system control unit to transmit a programmable list of command signals to said implantable devices.

13. The system of claim 12 wherein said means to cause said system control unit to transmit a programmable list of command signals includes:

a magnetic sensor for generating a signal responsive to a DC magnetic field; and

wherein

said programmable list of command signals is transmitted in response to said magnetic sensor signal.

14. A system for monitoring and/or affecting at least one parameter of a patient'"'"'s body, said system comprising:

a system control unit including;

a sealed elongate housing having an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm suitable for injection into said patient'"'"'s body;

a data signal transmitter for wireless transmission of command data signals;

a data signal receiver for wireless reception of status data signals; and

means responsive to status data signals received by said data signal receiver for causing said data signal transmitter to transmit addressable command data signals to control and/or monitor the operation of one or more implantable devices; and

a plurality of addressable implantable devices configured for implanting in a patient'"'"'s body, said implantable devices including;

(1) stimulators responsive to command data signals for producing an electrical current for stimulating body tissue to affect a parameter of the patient'"'"'s body; and

/or

(2) sensors configured to produce a data signal representative of a parameter of the patient'"'"'s body; and

wherein

each of said implantable devices includes a rechargeable power source having a rechargeable power capacity of at least 1 microwatt-hour.

15. The system of claim 14 wherein said implantable devices include:

at least one stimulator and at least one sensor; and

wherein said system control unit is responsive to status data signals received from

said sensor for transmitting addressable command data signals to said stimulator to exercise closed loop control of the operation of said stimulator.

16. The system of claim 14 wherein said implantable devices further includes at least one transponder for transmitting a data signal in response to a command signal received by said transponder.

17. The system of claim 16 wherein:

said system control unit is responsive to status data signals received from a sensor for transmitting addressable command data signals to a stimulator to exercise closed loop control of the operation of said stimulator.

18. The system of claim 14 wherein said data signal receiver includes a coil responsive to a status data signal defined by a modulated magnetic field.

19. The system of claim 14 wherein said data signal receiver includes a transducer responsive to a status data signal defined by a modulated ultrasonic signal.

20. The system of claim 14 wherein said data signal transmitter includes means for transmitting a command data signal in the form of a modulated magnetic field.

21. The system of claim 14 wherein said data signal transmitter includes means for transmitting a command data signal in the form of a modulated ultrasonic signal.