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

• US 20010001125A1
• Filed: 01/03/2001
• Published: 05/10/2001
• Est. Priority Date: 02/26/1997
• Status: Active Grant

• Current Assignee: Alfred E. Mann Foundation For Scientific Research, Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Alfred E. Mann Foundation For Scientific Research, Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Schulman, Joseph H., Mann, Carla M.
• Granted Patent: US 6,315,721 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• 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: 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 for implantable prostheses A61F2250/0002
• 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
• CPC Class Codes: Y10S 128/903 Radio telemetry

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 housing configured for implantation in a patient'"'"'s body;

a signal transmitter in said housing for transmitting command signals;

a signal receiver in said housing for receiving status signals;

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;

a power supply contained within said housing for providing operating power to said signal transmitter, said signal receiver and said programmable controller; and

wherein

said power supply has a capacity of at least 1 watt-hour.

2. The system of

claim 1

wherein said sealed housing has at least one dimension greater than 1 inch suitable for implantation within a patient'"'"'s body.

3. The system of

claim 1

comprising at least one said implantable device operable as a sensor and at least one said implantable 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.

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

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.

9. 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.

10. The system of

claim 1

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

11. The system of

claim 10

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.