Implantable systems and methods for acquisition and processing of electrical signals for therapeutic and/or functional restoration purposes

• US 20080132974A1
• Filed: 10/12/2007
• Published: 06/05/2008
• Est. Priority Date: 06/10/2004
• Status: Active Grant

• Current Assignee: Medtronic Urinary Solutions, Inc. (Medtronic Plc)
• Original Assignee: NDI Medical, Inc. (Medtronic Plc)
• Inventors: Strother, Robert B., Mrva, Joseph J., Thrope, Geoffrey B.
• Granted Patent: US 8,195,304 B2
• Time in Patent Office: Days
• US Class Current: 607/60
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Improved assemblies, systems, and methods provide an electrical signal processor for acquisition and processing of electric signals from tissue. The electrical signal processor is sized and configured to be implanted in subcutaneous tissue. The electrical signal processor includes an electrically conductive case of a laser welded titanium material. Control circuitry is located within the case, the control circuitry including a rechargeable power source, a receive coil for receiving a first radio frequency wireless telemetry to recharge the power source, and an antenna for receiving a second radio frequency wireless telemetry for communication with the electrical signal processor.

Claims

1. An electrical signal monitoring system comprising:

at least one electrically conductive surface adapted for implantation in a targeted tissue region,

a lead electrically coupled to the electrically conductive surface, the lead adapted to be implanted in subcutaneous tissue,

an electrical signal processor electrically coupled to the lead, the electrical signal processor adapted to be implanted in subcutaneous tissue remote from the electrically conductive surface, the electrical signal processor comprising

a housing, the housing comprising a header and an electrically conductive case,

electrical signal sensing circuitry positioned within the housing, the electrical signal sensing circuitry adapted to acquire and process electrical signals for therapeutic and/or functional restoration purposes,

a rechargeable power source positioned within the housing to power the electrical signal processor,

a receive coil positioned within the housing and adapted to receive a first radio frequency wireless telemetry, the first radio frequency wireless telemetry adapted to recharge the rechargeable power source,

an antenna positioned within the housing and adapted to transmit and/or receive a second radio frequency wireless telemetry, the second radio frequency wireless telemetry adapted for communication with the electrical signal processor, and

an electrical signal processor recharger, the electrical signal processor recharger adapted to transmit the first radio frequency wireless telemetry to the electrical signal processor to recharge the rechargeable power source, and the electrical signal processor recharger adapted to transmit and/or receive the second radio frequency wireless telemetry to and/or from the electrical signal processor for communication with the electrical signal processor.

2. A system according to claim 1

wherein the electrical signal processor recharger is adapted to transmit the first radio frequency wireless telemetry to the electrical signal processor to recharge the rechargeable power source, and the electrical signal processor recharger is adapted to simultaneously transmit and/or receive the second radio frequency wireless telemetry to and/or from the electrical signal processor for communication with the electrical signal processor.

3. A system according to claim 1

wherein the electrical signal processor is adapted to allow a patient to initiate electrical signal sensing to acquire and process electrical signals for therapeutic and/or functional restoration purposes.

4. A system according to claim 1

wherein the electrical signal processor recharger comprises a charging coil, the charging coil comprising between about 150 turns and about 250 turns of six strands of number 36 enameled magnetic wire.

5. A system according to claim 4

wherein the charging coil has a diameter of between about 40 mm and about 60 mm, and a thickness as measured perpendicular to the mounting plane of between about 2 mm and about 5 mm.

6. An electrical signal processing system comprising:

an electrical signal processor electrically coupled to a first lead,

the first lead electrically coupled to at least one sensing electrode, the first lead and the sensing electrode adapted to be implanted in subcutaneous tissue,

the electrical signal processor adapted to be implanted in subcutaneous tissue remote from the sensing electrode, the electrical signal processor comprising

a housing, the housing comprising a header and an electrically conductive case,

electrical signal sensing circuitry positioned within the housing, the electrical signal sensing circuitry adapted to acquire and process electrical signals for therapeutic and/or functional restoration purposes,

a rechargeable power source positioned completely within the housing to power the electrical signal processor,

a receive coil positioned completely within the housing and adapted for receiving a first radio frequency wireless telemetry, the first radio frequency wireless telemetry adapted for recharging the rechargeable power source,

a first antenna positioned completely within the housing and adapted to transmit and/or receive a second radio frequency wireless telemetry, the second radio frequency wireless telemetry adapted for communication with the electrical signal processor,

an external recharger, the recharger being adapted to transmit the first radio frequency wireless telemetry to the electrical signal processor to recharge the rechargeable power source, and the recharger being adapted to transmit and/or receive the second radio frequency wireless telemetry to and/or from the electrical signal processor for communication with the electrical signal processor,

an implantable pulse generator electrically coupled to a second lead,

the second lead electrically coupled to at least one stimulating electrode, the second lead and the stimulating electrode adapted to be implanted in subcutaneous tissue,

the implantable pulse generator adapted to be implanted in subcutaneous tissue remote from the stimulating electrode, the implantable pulse generator comprising

electrical signal generating circuitry positioned within a pulse generator housing, the electrical signal generating circuitry adapted to generate electrical signals for therapeutic and/or functional restoration purposes,

a second antenna positioned completely within the pulse generator housing and adapted to transmit and/or receive the second radio frequency wireless telemetry to and/or from the electrical signal processor and/or recharger for communication with the electrical signal processor and/or recharger.

7. A system according to claim 6

wherein the recharger is adapted to transmit the first radio frequency wireless telemetry to the electrical signal processor to recharge the rechargeable power source, and the recharger is adapted to simultaneously transmit and/or receive the second radio frequency wireless telemetry to and/or from the electrical signal processor for communication with the electrical signal processor.

8. A system according to claim 6

wherein the second radio frequency wireless telemetry is functional as far as about two meters away from the electrical signal processor.

9. A system according to claim 6 further including

a patient controller adapted to allow the patient to adjust only a predetermined range of characteristics of the electrical signals for therapeutic and/or functional restoration purposes.

10. A system according to claim 6

wherein the first radio frequency wireless telemetry is at a different frequency than the second radio frequency wireless telemetry.

11. An electrical signal processor comprising:

a housing adapted to be implanted in subcutaneous tissue, the housing comprising a header and a hermetically sealed case,

electrical signal sensing circuitry positioned within the housing, the electrical signal sensing circuitry including suppression, amplification, and filtering circuitry adapted to acquire and process electrical signals for therapeutic and/or functional restoration purposes,

a rechargeable power source positioned completely within the hermetically sealed case to power the electrical signal processor,

a receive coil positioned completely within the hermetically sealed case and adapted to receive a first radio frequency wireless telemetry, the first radio frequency wireless telemetry adapted to recharge the rechargeable power source,

an antenna positioned within the housing and adapted to transmit and/or receive a second radio frequency wireless telemetry while the receive coil is simultaneously receiving the first radio frequency wireless telemetry, and

a spacing nest positioned completely within the hermetically sealed case, the spacing nest adapted to hold the rechargeable power source, the receive coil, and the electrical signal sensing circuitry in a predetermined relationship within the hermetically sealed case.

12. A processor according to claim 11

wherein the first radio frequency wireless telemetry is at a lower frequency than the second radio frequency wireless telemetry.

13. A processor according to claim 11

wherein the receive coil comprises between about 250 turns and about 350 turns of four strands of number 40 enameled magnetic wire.

14. A processor according to claim 11

wherein the electrical signal sensing circuitry is adapted to provide stimulus pulses for the treatment of urinary incontinence, or fecal incontinence, or micturition/retention, or defecation/constipation, or restoration of sexual function, or pelvic floor muscle activity, or pelvic pain, or deep brain stimulation in the treatment of (i) Parkinson'"'"'s disease;

(ii) multiple sclerosis;

(iii) essential tremor;

(iv) depression;

(v) eating disorders;

(vi) epilepsy;

(vii) minimally conscious state, or pain management by interfering with or blocking pain signals from reaching the brain in the treatment of (i) peripheral neuropathy;

(ii) cancer, or obstructive sleep apnea.

15. A method of monitoring electrical signals comprising:

providing a lead including at least one electrically conductive surface, the lead adapted for implanting in subcutaneous tissue,

providing an electrical signal processor, the electrical signal processor adapted for implanting in subcutaneous tissue remote from the electrically conductive surface, the electrical signal processor comprising

a housing, the housing comprising a header and an electrically conductive case,

electrical signal sensing circuitry positioned within the housing and electrically coupled to the lead, the electrical signal sensing circuitry adapted for acquiring and processing electrical signals for therapeutic and/or functional restoration purposes,

a rechargeable power source positioned within the housing for powering the electrical signal processor,

a receive coil positioned within the housing and adapted for receiving a first radio frequency wireless telemetry, the first radio frequency wireless telemetry adapted for recharging the rechargeable power source, and

an antenna positioned completely within the housing and adapted for transmitting and/or receiving a second radio frequency wireless telemetry, the second radio frequency wireless telemetry adapted for communicating with the electrical signal processor,

providing an electrical signal processor recharger, the electrical signal processor recharger adapted for transmitting the first radio frequency wireless telemetry to the electrical signal processor for recharging the rechargeable power source, and the electrical signal processor recharger adapted for transmitting and/or receiving the second radio frequency wireless telemetry to and/or from the electrical signal processor for communicating with the electrical signal processor,

implanting the electrical signal processor in subcutaneous tissue,

implanting the lead and electrode in subcutaneous tissue, the electrode being implanted remote from the electrical signal processor,

coupling the lead to the electrical signal processor,

operating the electrical signal processor to acquire and process electrical signals,

operating the electrical signal processor recharger by transmitting the first radio frequency wireless telemetry to the electrical signal processor thereby recharging the rechargeable power source, and

operating the electrical signal processor recharger by transmitting and/or receiving the second radio frequency wireless telemetry to and/or from the electrical signal processor thereby communicating with the electrical signal processor.

16. A method according to claim 15 further comprising

operating the electrical signal processor recharger by transmitting the first radio frequency wireless telemetry to the electrical signal processor thereby recharging the rechargeable power source, and simultaneously transmitting and/or receiving the second radio frequency wireless telemetry to and/or from the electrical signal processor thereby communicating with the electrical signal processor.

17. A method according to claim 15 further comprising

a patient instructing the electrical signal processor to acquire and process electrical signals for therapeutic and/or functional restoration purposes.

18. A method according to claim 15

wherein the first radio frequency wireless telemetry is at a lower frequency than the second radio frequency wireless telemetry.

19. A method according to claim 15

wherein the first radio frequency wireless telemetry comprises a radio frequency wireless telemetry in the range of about 30 KHz to about 300 KHz and the second radio frequency wireless telemetry comprises a radio frequency wireless telemetry in the range of about 402 MHz to about 405 MHz.

20. A method according to claim 15

wherein communication includes programming and/or interrogating and/or transferring acquired electrical signal data.

21. A method according to claim 15

wherein the electrical signal sensing circuitry comprises a set of functional block circuitry including power management circuitry, wireless telemetry circuitry, a VCC power supply, a VHH power supply, a stimulus output stage, and an output multiplexer.

22. A method comprising:

providing a housing adapted for implanting in subcutaneous tissue, the housing comprising a header and a hermetically sealed case,

providing power management circuitry positioned completely within the housing, the power management circuitry comprising a rechargeable power source and a receive coil, the receive coil adapted for receiving a first radio frequency wireless telemetry from an external device, the first radio frequency wireless telemetry adapted for recharging the rechargeable power source,

providing wireless telemetry circuitry positioned completely within the housing, the wireless telemetry circuitry comprising an antenna, the wireless telemetry circuitry adapted for transmitting and/or receiving a second radio frequency wireless telemetry to and/or from the external device,

implanting the housing in subcutaneous tissue,

transmitting the first radio frequency wireless telemetry from the external device to the receive coil for recharging the rechargeable battery,

transmitting and/or receiving the second radio frequency wireless telemetry to and/or from the external device while the receive coil is receiving the first radio frequency wireless telemetry from the external device, and

instructing the external device using the second radio frequency wireless telemetry to adjust a magnitude of the first radio frequency wireless telemetry to affect the recharging of the rechargeable power source.

23. A method according to claim 22 further comprising

transmitting the second radio frequency wireless telemetry from the wireless telemetry circuitry for instructing a user of the external device to alter the position of the external device in relationship to the receive coil to affect the recharging of the rechargeable power source.

24. A method according to claim 22 further comprising

transmitting and/or receiving the second radio frequency wireless telemetry to and/or from the external device while the receive coil is simultaneously receiving the first radio frequency wireless telemetry from the external device.

25. A method according to claim 22

wherein the power management circuitry comprises at least three power management operating modes including an active and charging mode, an active mode, and a dormant mode.