Implantable system and methods for acquisition and processing of electrical signals from muscles and/or nerves and/or central nervous system tissue

• US 7,283,867 B2
• Filed: 06/10/2005
• Issued: 10/16/2007
• Est. Priority Date: 06/10/2004
• Status: Active Grant

• Current Assignee: Medtronic Urinary Solutions, Inc. (Medtronic Plc)
• Original Assignee: NDI Medical, LLC
• Inventors: Strother, Robert B., Mrva, Joseph J., Thrope, Geoffrey B.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US11/150,734
• Publication Number:
  US 20050277844A1
• Time in Patent Office: 858 Days
• Field of Search: 600372-375, 600/377, 600/394, 600/546, 600/554, 600587-595, 600/38, 600/41, 600/508, 600/518, 606/34, 606/41, 607/2, 607 39- 52, 607/60, 607/62, 607116-118, 607/138, 607/143, 607/5, 607 32- 34, 607/9, 607/27, 128/903, 320/163
• US Class Current: 600/546
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: Y10S 128/903 Radio telemetry
• CPC Class Codes: Y10S 128/904 Telephone telemetry

Abstract

Improved assemblies, systems, and methods provide an MES processor for acquisition and processing of myoelectric signals from muscles, nerves, or central nervous system tissue, or any combination. The MES processor is sized and configured to be implanted subcutaneous a tissue region. The MES 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 an RF magnetic field to recharge the power source, and a microcontroller for control of the MES processor. Improved assemblies, systems, and methods also provide an acquisition and processing system for sensing myoelectric signals from muscles, nerves, or central nervous system tissue, or any combination. The acquisition and processing system provides at least one electrically conductive surface, a lead connected to the electrically conductive surface, and an MES processor electrically connected to the lead.

Claims

1. A system for acquiring and processing myoelectric signals (MES) comprising:

at least one electrically conductive surface sized and configured for implantation in a targeted neural or muscular tissue region to acquire MES,

a lead electrically coupled to the electrically conductive surface, the lead sized and configured to be positioned in subcutaneous tissue,

an MES processor sized and configured to be coupled to the lead and positioned in subcutaneous tissue remote from the at least one electrically conductive surface, the MES processor comprising a housing having a size between about 5 mm and about 10 mm thick, between about 30 mm and about 40 mm wide, and between about 50 mm and about 60 mm long,

circuitry carried entirely within the housing operable to process the MES,

a rechargeable battery coupled to the circuitry and carried entirely within the housing, and

the MES processor including non-inductive wireless telemetry circuitry using VHF/UHF signals, the non-inductive wireless telemetry circuitry being functional at a distance as far as arm'"'"'s reach away from the patient, and being adapted for programming and interrogation of the MES processor.

2. A system according to claim 1

wherein the MES processor includes an antenna coupled to the non-inductive wireless telemetry circuitry and carried entirely within the housing to enable transmission and reception of wireless telemetry signals.

3. A system according to claim 1 further including:

a clinician programmer adapted to download signal processing algorithms and/or detection algorithms into the MES processor using wireless telemetry, and an external device adapted to receive processed MES data using wireless telemetry, the processed MES data being used to control prosthetic or orthotic or other devices.

4. A system according to claim 3

wherein the clinician programmer employs a network connection to transfer patient data to a host computer or server for electronic processing and archiving.

5. A system according to claim 1

wherein the MES processor housing includes a lead connection header coupled to the MES processor circuitry for electrically coupling the lead to the MES processor, the lead connection header enabling reliable replacement of the MES processor.

6. A system according to claim 1

wherein the MES processor provides stimulus pulses for the treatment of indications selected from the group consisting of urinary incontinence, fecal incontinence, micturition/retention, defecation/constipation, restoration of sexual function, pelvic floor muscle activity, pelvic pain, 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, pain management by interfering with or blocking pain signals from reaching the brain in the treatment of (i) peripheral neuropathy;

(ii) cancer;

gastric function;

restoration of motor control; and

obstructive sleep apnea.

7. A system according to claim 1

wherein the rechargeable includes a battery capacity of at least 30 mA-hr.

8. A method comprising:

providing a system as defined in claim 1,

implanting the MES processor in subcutaneous tissue,

implanting the lead and electrically conductive surface in subcutaneous tissue, with the electrically conductive surface positioned remote from the MES processor,

coupling the MES processor to the lead, and

operating the MES processor to acquire and process the MES.

10. A system according to claim 1 or 9

wherein the MES processor is sized and configured for implanting in subcutaneous tissue at an implant depth of between about five millimeters and about fifteen millimeters.

11. A system according to claim 1 or 9

wherein recharging of the rechargeable battery is required less than weekly.

17. A system according to claim 1 or 9 or 12 or 15

wherein the housing includes a smaller end and a larger end to facilitate placement within a subcutaneous pocket small end first.

9. A system for acquiring and processing myoelectric signals (MES) comprising

at least one electrically conductive surface sized and configured for implantation in a targeted neural or muscular tissue region to acquire MES,

a lead electrically coupled to the electrically conductive surface, and the lead sized and configured to be positioned in subcutaneous tissue,

an MES processor sized and configured to be coupled to the lead and positioned in subcutaneous tissue remote from the at least one electrically conductive surface to process the MES, the MES processor comprising a housing having a size between about 5 mm and about 10 mm thick, between about 30 mm and about 40 mm wide, and between about 50 mm and about 60 mm long,

circuitry carried entirely within the housing operable to process the MES,

the MES processor including non-inductive wireless telemetry circuitry using VHF/UHF signals, the non-inductive wireless telemetry circuitry being functional at a distance as far as arm'"'"'s reach away from the patient, and being adapted for programming and interrogation of the MES processor,

a rechargeable battery coupled to the circuitry and carried entirely within the housing, the rechargeable battery having a capacity as small as 30 mA-hr, and

a power receiving coil coupled to the rechargeable battery and carried entirely within the housing, the power receiving coil and circuitry being configured, when the housing is implanted in subcutaneous tissue, to transfer received power from a transcutaneously applied radio frequency magnetic field to the rechargeable battery and recharge the battery in a time period of not more than six hours.

12. A method for acquiring and processing myoelectric signals (MES) comprising

providing at least one electrically conductive surface sized and configured for implantation in a targeted neural or muscular tissue region to acquire MES, and a lead electrically coupled to the electrically conductive surface, wherein the lead is sized and configured to be positioned in subcutaneous tissue,

providing an MES processor sized and configured to be coupled to the lead and positioned in subcutaneous tissue remote from the at least one electrically conductive surface, the MES processor comprising a housing having a size between about 5 mm and about 10 mm thick, between about 30 mm and about 40 mm wide, and between about 50 mm and about 60 mm long, circuitry carried entirely within the housing operable to process the MES and to provide non-inductive wireless telemetry using VHF/UHF signals, the non-inductive wireless telemetry circuitry being functional at a distance as far as arm'"'"'s reach away from the patient and being adapted for programming and interrogation of the MES processor, and a rechargeable battery coupled to the circuitry and carried entirely within the housing, the rechargeable battery having a capacity as small as 30 mA-hr,

implanting the lead and electrically conductive surface in subcutaneous tissue, with the electrically conductive surface positioned remote from the MES processor,

coupling the MES processor to the lead,

operating the MES processor to acquire the MES, and

processing the MES by performing an operation selected from the group consisting of implementing a control algorithm and telemetering out a final result or command for a prosthesis, neuroprosthesis, or therapeutic application;

partially processing the MES and telemetering out the intermediate result; and

performing data compression and telemetering out the compressed MES data for processing by other devices.

13. A method according to claim 12

wherein recharging of the rechargeable battery is required less than weekly.

14. A method according to claim 12

further including implanting the MES processor in subcutaneous tissue at an implant depth of between about five millimeters and about fifteen millimeters.

15. A system for acquiring and processing myoelectric signals (MES) comprising:

at least one electrically conductive surface sized and configured for implantation in a targeted neural or muscular tissue region to acquire MES,

a lead electrically coupled to the electrically conductive surface, the lead sized and configured to be positioned in subcutaneous tissue,

an MES processor sized and configured to be coupled to the lead and positioned in subcutaneous tissue surface remote from the at least one electrically conductive surface, the MES processor being sized and configured for implanting in subcutaneous tissue at an implant depth of between about 0.5 cm and about 1.5 cm,

circuitry carried entirely within the housing operable to process the MES,

a rechargeable battery coupled to the circuitry and carried entirely within the housing, the rechargeable battery having a capacity as small as 30 mA-hr, and

the MES processor including non-inductive wireless telemetry circuitry using VHF/UHF signals, the non-inductive wireless telemetry circuitry being functional at a distance as far as arm'"'"'s reach away from the patient, and being adapted for programming and interrogation of the MES processor.

16. A system according to claim 15

wherein the MES processor comprising a housing having a size between about 5 mm and about 10 mm thick, between about 30 mm and about 40 mm wide, and between about 50 mm and about 60 mm long.