Telemetry system for use with microstimulator

• US 9,242,106 B2
• Filed: 02/17/2014
• Issued: 01/26/2016
• Est. Priority Date: 06/28/2002
• Status: Expired due to Term

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Klosterman, Daniel J., Haller, Matthew I., Parramon, Jordi, McClure, Kelly H., Marnfeldt, Goran N., Park, Rudolph V.
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US14/182,064
• Publication Number:
  US 20140236263A1
• Time in Patent Office: 708 Days
• Field of Search: 607 32- 33, 607 60- 61
• US Class Current: 1/1
• 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 1/37205 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 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/3727 characterised by the modulation technique
• CPC Class Codes: A61N 1/37276 characterised by means for reducing power consumption during telemetry
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: H01L 2224/45144 Gold (Au) as principal constituent
• CPC Class Codes: H01L 2224/45147 Copper (Cu) as principal constituent
• CPC Class Codes: H01L 2224/48465 the other connecting portion not on the bonding area being a wedge bond, i.e. ball-to-wedge, regular stitch
• CPC Class Codes: H01L 2224/49175 Parallel arrangements
• CPC Class Codes: H01L 2924/00 Indexing scheme for arrangements or methods for connecting or disconnecting semiconductor or solid-state bodies as covered by H01L24/00
• CPC Class Codes: H01L 2924/00011 Not relevant to the scope of the group, the symbol of which is combined with the symbol of this group
• CPC Class Codes: H01L 2924/01005 Boron [B]
• CPC Class Codes: H01L 2924/01033 Arsenic [As]
• CPC Class Codes: H01L 2924/1461 : MEMS
• CPC Class Codes: H01L 2924/19105 : in a side-by-side arrangement on a common die mounting substrate
• CPC Class Codes: H01L 2924/19107 : off-chip wires
• CPC Class Codes: H01L 2924/3011 : Impedance
• CPC Class Codes: H01L 2924/30111 : matching
• CPC Class Codes: H02J 2310/23 : The load being a medical device, a medical implant, or a life supporting device
• CPC Class Codes: H02J 50/10 : using inductive coupling
• CPC Class Codes: H02J 7/345 : using capacitors as storage or buffering devices
• CPC Class Codes: H04B 5/26 : using coils
• CPC Class Codes: H04B 5/79 : for data transfer in combination with power transfer
• CPC Class Codes: H04L 27/02 : Amplitude-modulated carrier systems, e.g. using on-off keying; Single sideband or vestigial sideband modulation H04L27/32 takes precedence
• CPC Class Codes: H04L 27/10 : Frequency-modulated carrier systems, i.e. using frequency-shift keying H04L27/32 takes precedence
• CPC Class Codes: Y10T 29/4902 : Electromagnet, transformer or inductor
• CPC Class Codes: Y10T 29/49071 : by winding or coiling
• CPC Class Codes: Y10T 29/49073 : by assembling coil and core
• CPC Class Codes: Y10T 29/49128 : Assembling formed circuit to base
• CPC Class Codes: Y10T 29/4913 : Assembling to base an electrical component, e.g., capacitor, etc.
• CPC Class Codes: Y10T 29/49155 : Manufacturing circuit on or in base
• CPC Class Codes: Y10T 29/49169 : Assembling electrical component directly to terminal or elongated conductor
• CPC Class Codes: Y10T 29/49826 : Assembling or joining
• CPC Class Codes: Y10T 29/49945 : by driven force fit
• CPC Class Codes: Y10T 29/49968 : Metal fusion joining
• CPC Class Codes: Y10T 428/12264 : having outward flange, gripping means or interlocking feature
• CPC Class Codes: Y10T 428/12271 : having discrete fastener, marginal fastening, taper, or end structure
• CPC Class Codes: Y10T 428/12347 : Plural layers discontinuously bonded [e.g., spot-weld, mechanical fastener, etc.]
• CPC Class Codes: Y10T 428/12375 : having member which crosses the plane of another member [e.g., T or X cross section, etc.]
• CPC Class Codes: Y10T 428/12396 : Discontinuous surface component
• CPC Class Codes: Y10T 428/12535 : with additional, spatially distinct nonmetal component
• CPC Class Codes: Y10T 428/12806 : Refractory [Group IVB, VB, or VIB] metal-base component

Abstract

An implantable microstimulator configured to be implanted beneath a patient'"'"'s skin for tissue stimulation employs a bi-directional RF telemetry link for allowing data-containing signals to be sent to and from the implantable microstimulator from at least two external devices. Further, a separate electromagnetic inductive telemetry link allows data containing signals to be sent to the implantable microstimulator from at least one of the two external devices. The RF bidirectional telemetry link allows the microstimulator to inform the patient or clinician regarding the status of the microstimulator device, including the charge level of a power source, and stimulation parameter states. The microstimulator has a cylindrical hermetically sealed case having a length no greater than about 27 mm and a diameter no greater than about 3.3 mm. A reference electrode is located on one end of the case and an active electrode is located on the other end of the case.

Claims

1. An external device configured to communicate with an implantable medical device, the device comprising:

an antenna; and

circuitry coupled to the antenna and configured to utilize the antenna to communicate with the implantable medical device in accordance with a first modulation scheme via a first bi-directional wireless link and in accordance with a second modulation scheme via a second wireless link, wherein the first modulation scheme is a frequency modulation scheme.

2. The device of claim 1, wherein the first modulation scheme comprises a frequency shift keying (FSK) modulation scheme.

3. The device of claim 1, wherein the second modulation scheme comprises a pulse width modulation (PWM) scheme.

4. The device of claim 1, wherein the second modulation scheme comprises an on-off keying (OOK) modulation scheme.

5. The device of claim 1, wherein in the second modulation scheme, a logic ‘

0’

bit is represented by a first pulse width and a logic ‘

1’

bit is represented by a second pulse width, wherein a transition between adjacent bits is marked by a change in the transmitted signal from an ON to an OFF state or from the OFF state to the ON state, wherein the ON state is characterized by the transmitted signal having a frequency, and wherein the OFF state is characterized by the transmitted signal having no frequency.

6. The device of claim 1, wherein the second modulation scheme is frequency independent.

7. The device of claim 1, wherein the circuitry is configured to receive data from the implantable medical device modulated in accordance with the first modulation scheme.

8. The device of claim 7, wherein the received data comprises an acknowledgment from the implantable medical device following transmission of a command and/or data to the implantable medical device.

9. The device of claim 7, wherein the circuitry is not configured to receive data from the implantable medical device modulated in accordance with the second modulation scheme.

10. The device of claim 9, wherein the circuitry comprises first transmitter and receiver circuitry coupled to the antenna operable in accordance with the first modulation scheme, and second transmitter circuitry coupled to the antenna operable in accordance with the second modulation scheme.

11. The device of claim 1, wherein the first wireless link comprises a Radio Frequency (RF) wireless link, and wherein the second wireless link comprises an inductive wireless link.

12. The device of claim 1, wherein the antenna comprises a coil.

13. The device of claim 12, wherein the coil is further configured to provide power to the implantable medical device via the second wireless link.

14. The device of claim 1, wherein the second wireless link is used upon indication that the implantable medical device is not listening for commands and/or data transmitted from the external device via the first wireless link.

15. The device of claim 14, wherein the second wireless link is used when a voltage of a battery in the implantable medical device is below a threshold.

16. The device of claim 1, wherein the second wireless link is used to transmit instructions to perform an emergency shut down of the implantable medical device.

17. The device of claim 1, further comprising a base station, wherein the antenna is coupled to the base station by an extension.

18. An external device configured to communicate with an implantable medical device, the device comprising:

an antenna;

first circuitry coupled to the antenna and configured to use the antenna to send and receive commands and/or data to and from the implantable medical device in accordance with a first frequency modulation scheme; and

second circuitry coupled to the antenna and configured to use the antenna to send commands and/or data and power to the implantable medical device in accordance with a second modulation scheme.

19. The device of claim 18, wherein the first modulation scheme comprises a frequency shift keying (FSK) modulation scheme.

20. The device of claim 18, wherein the second modulation scheme comprises a pulse width modulation (PWM) scheme.

21. The device of claim 18, wherein the second modulation scheme comprises an on-off keying (OOK) modulation scheme.

22. The device of claim 18, wherein in the second modulation scheme, a logic ‘

0’

bit is represented by a first pulse width and a logic ‘

1’

bit is represented by a second pulse width, wherein a transition between adjacent bits is marked by a change in the transmitted signal from an ON to an OFF state or from the OFF state to the ON state, wherein the ON state is characterized by the transmitted signal having a frequency, and wherein the OFF state is characterized by the transmitted signal having no frequency.

23. The device of claim 18, wherein the second modulation scheme is frequency independent.

24. The device of claim 18, wherein the first circuitry is further configured to receive data from the implantable medical device modulated in accordance with the first modulation scheme.

25. The device of claim 24, wherein the received data comprises an acknowledgment from the implantable medical device following transmission of a command and/or data to the implantable medical device.

26. The device of claim 24, wherein the second circuitry is not configured to receive data from the implantable medical device modulated in accordance with the second modulation scheme.

27. The device of claim 26, wherein the first circuitry comprises first transmitter and receiver circuitry and wherein the second circuitry comprises second transmitter circuitry.

28. The device of claim 18, wherein commands and/or data transmitted to the implantable medical device in accordance with the first modulation scheme are transmitted via a first wireless link, and wherein commands and/or data transmitted to the implantable medical device in accordance with the second modulation scheme are transmitted via a second wireless link.

29. The device of claim 28, wherein the second wireless link further carries the power for the implantable medical device.

30. The device of claim 28, wherein the first wireless link comprises a Radio Frequency (RF) wireless link, and wherein the second wireless link comprises an inductive wireless link.

31. The device of claim 18, wherein the antenna comprises a coil.

32. The device of claim 18, wherein the second modulation scheme is used to send commands and/or data when the implantable medical device is not listening for commands and/or data transmitted from the external device via the first modulation scheme.

33. The device of claim 32, wherein the second modulation scheme is used when a voltage of a battery in the implantable medical device is below a threshold.

34. The device of claim 18, wherein the second modulation scheme is used to transmit instructions to perform an emergency shut down of the implantable medical device.

35. The device of claim 18, further comprising a base station, wherein the antenna is coupled to the base station by an extension.