Magnet control system for battery powered living tissue stimulators

• US 6,839,596 B2
• Filed: 02/21/2002
• Issued: 01/04/2005
• Est. Priority Date: 02/21/2002
• Status: Active Grant

• Current Assignee: Alfred E. Mann Foundation For Scientific Research
• Original Assignee: Alfred E. Mann Foundation For Scientific Research
• Inventors: Schulman, Joseph H., Nelson, Richard J.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US10/080,881
• Publication Number:
  US 20030171790A1
• Time in Patent Office: 1,048 Days
• Field of Search: 607 1-156
• US Class Current: 607/59
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• 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 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A programming system for controlling and/or altering an implantable device'"'"'s operation using externally applied magnetic means, e.g., a permanent magnet or the like. Typically, such devices stimulate a neural pathway or muscle and/or block pain or muscle stimulation according to programmable settings, e.g., the amplitude, duration, frequency/repetition rates, etc., of stimulation pulses applied to the neural pathways/muscles. Preferably, once programmed from an external programmer, such implantable devices can operate “independently” using the externally provided programmed information. However, external programmers may be unavailable due to cost, size, or other constraints. Accordingly, embodiments of the present invention include a magnetic sensor, preferably a magnetoresistive, Hall effect, saturated core reactors, or the like, to sense an externally provided magnetic field. By externally applying magnetic fields in sequences of controlled polarities, durations, intensities, etc., and sensing these sequences and transitions, the operation of the implantable device may be altered, i.e., programmed.

Claims

1. A system for programming one or more parameters in an implantable device, wherein said implantable device is configured for stimulating tissue within a patient'"'"'s body and said implantable device is contained within a sealed elongate housing having an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm, said system comprising:

a sensor within said implantable device sensitive to the presence of an externally applied magnetic field;

a controller within said implantable device coupled to said sensor for monitoring the presence of said externally applied magnetic field and determining a timing sequence for the application and removal of said externally provided magnetic field, wherein said controller is configured to alter at least one programmable parameter of said implantable device in response to detection of an identifiable timing sequence of the application and removal of said externally provided magnetic field;

a handheld programmer configured to be located external to the patient'"'"'s body and containing a permanent magnet within, wherein the patient can apply and remove a magnetic field according to an identifiable timing sequence by bringing said handheld programmer in proximity and removing it from proximity of the implantable device at one or more locations external to the patient'"'"'s body; and

wherein

said handheld programmer additionally comprises a selector for altering the position of said permanent magnet within the programmer to thereby correspondingly alter the strength of said externally applied magnetic field to which the implantable device is exposed when the handheld programmer is positioned in proximity to the implantable device.

2. The system of claim 1 wherein said selector for altering the position of said permanent magnet comprises:

a first handheld programmer portion having a cylindrical shape, an outer thread, and containing said permanent magnet; and

a second handheld programmer portion having an inner threaded cavity wherein said inner threaded cavity is formed to receive said outer thread of said first handheld programmer portion and whereby screwing said first handheld portion into said second handheld programmer portion alters the position of said permanent magnet relative to said second handheld programmer portion.

3. The system of claim 2 wherein said selector additionally comprises a ball detent mechanism cooperatively positioned on said first and second handheld programmer portions to fixedly position said permanent magnet relative to said second handheld programmer portion in one of a plurality of predefined positions.

4. The system of claim 1 wherein said selector for altering the position of said permanent magnet comprises:

a first handheld programmer portion having a square shape and containing said permanent magnet;

a second handheld programmer portion having an inner cavity wherein said inner cavity is formed to receive said first handheld programmer portion; and

a detent mechanism for altering the position of said permanent magnet relative to said second handheld programmer portion in one of a plurality of predefined positions.

5. A system for programming one or more parameters in an implantable device, wherein said implantable device is configured for stimulating tissue within a patient'"'"'s body and said implantable device is contained within a sealed elongate housing having an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm, said system comprising:

a sensor within said implantable device sensitive to the presence of an externally applied magnetic field;

a controller within said implantable device coupled to said sensor for monitoring the presence of said externally applied magnetic field and determining a timing sequence for the application and removal of said externally provided magnetic field, wherein said controller is configured to alter at least one programmable parameter of said implantable device in response to detection of an identifiable timing sequence of the application and removal of said externally provided magnetic field;

a handheld programmer configured to be located external to the patient'"'"'s body and containing a permanent magnet within, wherein the patient can apply and remove a magnetic field according to an identifiable timing sequence by bringing said handheld programmer in proximity and removing it from proximity of the implantable device at one or more locations external to the patient'"'"'s body; and

wherein

said handheld programmer has a first surface for presenting a magnetic field of a first polarity and a second surface for presenting a magnetic field of a second polarity, opposite of said first polarity.

6. A system for programming one or more parameters in an implantable device, wherein said implantable device is configured for stimulating tissue within a patient'"'"'s body and said implantable device is contained within a sealed elongate housing having an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm, said system comprising:

a sensor within said implantable device sensitive to the presence of an externally applied magnetic field;

a controller within said implantable device coupled to said sensor for monitoring the presence of said externally applied magnetic field and determining a timing sequence for the application and removal of said externally provided magnetic field, wherein said controller is configured to alter at least one programmable parameter of said implantable device in response to detection of an identifiable timing sequence of the application and removal of said externally provided magnetic field;

a handheld programmer configured to be located external to the patient'"'"'s body and containing a permanent magnet within; and

a mechanism, configured for activation by the patient, within said handheld programmer configured to provide an identifiable timing sequence of the application and removal of a magnetic field.

7. The system of claim 6 wherein said mechanism is spring powered.

8. The system of claim 6 wherein said mechanism is electro-mechanically powered.

9. A system for programming one or more parameters in an implantable device, wherein said implantable device is configured for stimulating tissue within a patient'"'"'s body and said implantable device is contained within a sealed elongate housing having an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm, said system comprising:

a sensor within said implantable device sensitive to the presence of an externally applied magnetic field;

a controller within said implantable device coupled to said sensor for monitoring the presence of said externally applied magnetic field and determining a timing sequence for the application and removal of said externally provided magnetic field, wherein said controller is configured to alter at least one programmable parameter of said implantable device in response to detection of an identifiable timing sequence of the application and removal of said externally provided magnetic field;

a handheld programmer configured to be located external to the patient'"'"'s body;

a coil within said handheld programmer suitable for generating a magnetic field when energized;

driver circuitry within said handheld programmer for energizing said coil;

a handheld programmer controller within said handheld programmer for generating a sequence of magnetic fields; and

a power source for powering said handheld programmer.

10. A system for programming one or more parameters in an implantable device, wherein said implantable device is configured for stimulating tissue within a patient'"'"'s body and said implantable device is contained within a sealed elongate housing having an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm, said system comprising:

a sensor within said implantable device sensitive to the presence of an externally applied magnetic field;

a controller within said implantable device coupled to said sensor for monitoring the presence of said externally applied magnetic field and determining a timing sequence for the application and removal of said externally provided magnetic field, wherein said controller is configured to alter at least one programmable parameter of said implantable device in response to detection of an identifiable timing sequence of the application and removal of said externally provided magnetic field; and

wherein

said sensor dissipates power when sensing a magnetic field and said implantable device additionally comprises circuitry for periodically applying and removing power from said sensor and sampling said sensor during time periods corresponding to when said power is applied.

11. A system for programming one or more parameters in an implantable device, wherein said implantable device is configured for modifying and/or sensing a patient'"'"'s body parameter, said system comprising:

a sensor within said implantable device sensitive to the presence of an externally applied magnetic field;

a controller within said implantable device coupled to said sensor for monitoring the presence of said externally applied magnetic field and determining a timing sequence for the application and removal of said externally provided magnetic field, wherein said controller is configured to alter at least one programmable parameter of said implantable device in response to detection of an identifiable timing sequence of the application and removal of said externally provided magnetic field;

a handheld programmer configured to be located external to the patient'"'"'s body and containing a permanent magnet within, wherein the patient can apply and remove a magnetic field according to an identifiable timing sequence by bringing said handheld programmer in proximity and removing it from proximity of the implantable device at one or more locations external to the patient'"'"'s body; and

wherein

said handheld programmer additionally comprises a selector for altering the position of said permanent magnet within the programmer to thereby correspondingly alter the strength of said externally applied magnetic field to which the implantable device is exposed when the handheld programmer is position in proximity to the implantable device.

12. The system of claim 11 wherein said selector for altering the position of said permanent magnet comprises:

a first handheld programmer portion having a cylindrical shape, an outer thread, and containing said permanent magnet; and

a second handheld programmer portion having an inner threaded cavity wherein said inner threaded cavity is formed to receive said outer thread of said first handheld programmer portion and whereby screwing said first handheld portion into said second handheld programmer portion alters the position of said permanent magnet relative to said second handheld programmer portion.

13. The system of claim 12 wherein said selector additionally comprises a ball detent mechanism cooperatively positioned on said first and second handheld programmer portions to fixedly position said permanent magnet relative to said second handheld programmer portion in one of a plurality of predefined positions.

14. The system of claim 11 wherein said selector for altering the position of said permanent magnet comprises:

a first handheld programmer portion having a square shape and containing said permanent magnet;

a second handheld programmer portion having an inner cavity wherein said inner cavity is formed to receive said first handheld programmer portion; and

a detent mechanism for altering the position of said permanent magnet relative to said second handheld programmer portion in one of a plurality of predefined positions.

15. A system for programming one or more parameters in an implantable device, wherein said implantable device is configured for modifying and/or sensing a patient'"'"'s body parameter, said system comprising:

a sensor within said implantable device sensitive to the presence of an externally applied magnetic field;

a controller within said implantable device coupled to said sensor for monitoring the presence of said externally applied magnetic field and determining a timing sequence for the application and removal of said externally provided magnetic field, wherein said controller is configured to alter at least one programmable parameter of said implantable device in response to detection of an identifiable timing sequence of the application and removal of said externally provided magnetic field;

a handheld programmer configured to be located external to the patient'"'"'s body and containing a permanent magnet within, wherein the patient can apply and remove a magnetic field according to an identifiable timing sequence by bringing said handheld programmer in proximity and removing it from proximity of the implantable device at one or more locations external to the patient'"'"'s body; and

wherein

said handheld programmer has a first surface for presenting a magnetic field of a first polarity and a second surface for presenting a magnetic field of a second polarity, opposite of said first polarity.

16. A system for programming one or more parameters in an implantable device, wherein said implantable device is configured for modifying and/or sensing a Patient'"'"'s body parameter, said system comprising:

a sensor within said implantable device sensitive to the presence of an externally applied magnetic field;

a controller within said implantable device coupled to said sensor for monitoring the presence of said externally applied magnetic field and determining a timing sequence for the application and removal of said externally provided magnetic field, wherein said controller is configured to alter at least one programmable parameter of said implantable device in response to detection of an identifiable timing sequence of the application and removal of said externally provided magnetic field;

a handheld programmer configured to be located external to the patient'"'"'s body and containing a permanent magnet within; and

a mechanism, configured for activation by the patient, within said handheld programmer configured to provide an identifiable timing sequence of the application and removal of a magnetic field.

17. The system of claim 16 wherein said mechanism is spring powered.

18. The system of claim 16 wherein said mechanism is electro-mechanically powered.

19. A system for programming one or more parameters in an implantable device, wherein said implantable device is configured for modifying and/or sensing a patient'"'"'s body parameter, said system comprising:

a sensor within said implantable device sensitive to the presence of an externally applied magnetic field;

a controller within said implantable device coupled to said sensor for monitoring the presence of said externally applied magnetic field and determining a timing sequence for the application and removal of said externally provided magnetic field, wherein said controller is configured to alter at least one programmable parameter of said implantable device in response to detection of an identifiable timing sequence of the application and removal of said externally provided magnetic field;

a handheld programmer configured to be located external to the patient'"'"'s body;

a coil within said handheld programmer suitable for generating a magnetic field when energized;

driver circuitry within said handheld programmer for energizing said coil;

a handheld programmer controller within said handheld programmer for generating a sequence of magnetic fields; and

a power source for powering said handheld programmer.

20. A system for programming one or more parameters in an implantable device, wherein said implantable device is configured for modifying and/or sensing a patient'"'"'s body parameter. said system comprising:

a sensor within said implantable device sensitive to the presence of an externally applied magnetic field;

a controller within said implantable device coupled to said sensor for monitoring the presence of said externally applied magnetic field and determining a timing sequence for the application and removal of said externally provided magnetic field, wherein said controller is configured to alter at least one programmable parameter of said implantable device in response to detection of an identifiable timing sequence of the application and removal of said externally provided magnetic field; and

wherein

said sensor dissipates power when sensing a magnetic field and said implantable device additionally comprises circuitry for periodically applying and removing power from said sensor and sampling said sensor during time periods corresponding to when said power is applied.

21. A system for programming one or more parameters in an implantable device, wherein said implantable device is configured for modifying and/or sensing a patient'"'"'s body parameter, said system comprising:

a sensor within said implantable device sensitive to the presence of an externally applied magnetic field;

a controller within said implantable device coupled to said sensor for monitoring the presence of said externally applied magnetic field and determining a timing sequence for the application and removal of said externally provided magnetic field, wherein said controller is configured to alter at least one programmable parameter of said implantable device in response to detection of an identifiable timing sequence of the application and removal of said externally provided magnetic field; and

wherein

said implantable device has at least one programmable parameter having an adjustment range prescribed according to settings provided from an external programmer and wherein said controller'"'"'s ability to alter said at least one programmable parameter is restricted to said prescribed adjustment range.

22. A system for programming one or more parameters in an implantable device, wherein said implantable device is configured for modifying and/or sensing a patient'"'"'s body parameter, said system comprising:

a sensor within said implantable device sensitive to the presence of an externally applied magnetic field;

a controller within said implantable device coupled to said sensor for monitoring the presence of said externally applied magnetic field and determining a timing sequence for the application and removal of said externally provided magnetic field, wherein said controller is configured to alter at least one programmable parameter of said implantable device in response to detection of an identifiable timing sequence of the application and removal of said externally provided magnetic field; and

wherein

said implantable device has a plurality of programmable parameters and wherein a set of said programmable parameters are selected according to settings provided from an external programmer and wherein said controller'"'"'s ability to alter said programmable parameters is restricted according to said selected set of programmable parameters.

23. A handheld programmer for programming one or more parameters in an implantable device, wherein the implantable device is configured for modifying and/or sensing a body parameter of a patient, said handheld programmer comprising:

a magnetic field source, wherein said magnetic field source is a permanent magnet;

a housing for holding said magnetic field source;

wherein said housing is configured for application to and removal from a portion of the patient'"'"'s body and to enabling presenting and removing a magnetic field from said magnetic field source to the implantable device and thereby alter at least one programmable parameter of the implantable device; and

at least one mechanism for altering the position of said permanent magnet relative to the patient'"'"'s body and thereby present altered intensities of the corresponding magnetic field to the implantable device and thus alter at least one programmable parameter of the implantable device accordingly.

24. The handheld programmer of claim 23 wherein said at least one mechanism for altering the position of said permanent magnet comprises:

a first handheld programmer portion having a cylindrical shape, an outer thread, and containing said permanent magnet; and

a second handheld programmer portion having an inner threaded cavity wherein said inner thread cavity is formed to receive said outer thread of said first handheld programmer portion and whereby screwing said first handheld portion into said second handheld programmer portion alters the position of said permanent magnet relative to said second handheld programmer portion.

25. The handheld programmer of claim 24 wherein said selector additionally comprises a ball detent mechanism cooperatively positioned on said first and second handheld programmer portions to fixedly position said permanent magnet relative to said second handheld programmer portion in one of a plurality of predefined positions.

26. The handheld programmer of claim 23 wherein said selector for altering the position of said permanent magnet comprises:

a first handheld programmer portion having a square shape and containing said permanent magnet;

a second handheld programmer portion having an inner cavity wherein said inner thread cavity is formed to receive said first handheld programmer portion; and

a detent mechanism for altering the position of said permanent magnet relative to said second handheld programmer portion in one of a plurality of predefined positions.