FES stimulator

• US 20030139782A1
• Filed: 01/17/2003
• Published: 07/24/2003
• Est. Priority Date: 01/21/2002
• Status: Active Grant

• Current Assignee: Neopraxis Pty., Ltd. (Cochlear Limited)
• Original Assignee: Neopraxis Pty., Ltd. (Cochlear Limited)
• Inventors: Milijasevic, Zoran, Duncan, Michael, Bruinsma, Ian, Barriskill, Andrew
• Granted Patent: US 7,231,252 B2
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

A multi-purpose, implantable stimulator for use in an FES system includes a housing, implantable into a patient'"'"'s body. The housing contains a receiving device and a control unit, the control unit receiving signals from the receiving device which, in turn, receives signals transcutaneously from a controller arranged externally of the patient'"'"'s body. A plurality of leads extend from the housing, the leads being arranged in separate bundles of discrete leads, each bundle being associated with a particular site of the patient'"'"'s body.

Claims

1. A multi-purpose, implantable stimulator for use in an FES system, the stimulator including:

a housing, implantable into a patient'"'"'s body, the housing containing a receiving device and a control unit, the control unit receiving signals from the receiving device which, in turn, receives signals transcutaneously from a controller arranged externally of the patient'"'"'s body; and

a plurality of leads extending from the housing, the leads being arranged in separate bundles of discrete leads, each bundle being associated with a particular site of the patient'"'"'s body.

2. The stimulator of claim 1 in which the housing is of a bio-compatible material.

3. The stimulator of claim 1 in which the housing comprises a base and cover which engage each other to form an interior cavity containing the receiving device and the control unit.

4. The stimulator of claim 3 in which the cover supports a first electrode thereon and the base of the housing carries a second electrode.

5. The stimulator of claim 1 in which the control unit is in the form of an electronics package containing pulse generating circuitry.

6. The stimulator of claim 1 in which the receiving device is in the form of an antenna.

7. The stimulator of claim 6 in which the antenna is implemented in the form of a coil for receiving signals from the controller via a transmitter.

8. The stimulator of claim 7 which includes a retaining means for removably retaining the transmitter in position relative to the housing.

9. The stimulator of claim 8 in which the retaining means is retained in position by a cover member which is removably secured to the housing, the cover member forming the first electrode.

10. The stimulator of claim 1 in which the housing is sutured in position within the patient'"'"'s body, in use, the housing defining at least one suturing opening.

11. The stimulator of claim 1 in which the leads are arranged in at least three bundles, each bundle exiting the housing through an opening in the housing and each opening communicating with a tube arranged on an external surface of the housing and extending radially outwardly from the housing.

12. The stimulator of claim 1 in which each lead is constituted by a number of conductors arranged in an insulating sleeve and terminating in one of a connector and an electrode.

13. A multi-purpose, implantable stimulator for an FES system, the stimulator including:

a housing implantable into a patient'"'"'s body;

a control unit contained within the housing; and

a receiving device contained within the housing, the receiving device providing signals to the control unit and the receiving device receiving signals, transcutaneously, from a controller arranged externally of the patient'"'"'s body, in use, the receiving device being in the form of a coil which lies in a plane spaced from a plane containing the control unit.

14. A multi-purpose, implantable stimulator for an FES system, the stimulator including:

a housing implantable into a patient'"'"'s body;

a control unit contained within the housing;

a receiving device contained within the housing, the receiving device feeding signals to the control unit and, in turn, receiving signals, transcutaneously, from a transmitter arranged externally of the patient'"'"'s body; and

a retaining means carried by the housing for retaining the transmitter in position relative to the housing, in use, the retaining means being removably mounted relative to the housing.

15. A controller for an FES system, the controller including

a patient-operable, clinician-programmable control device for controlling an implantable, multi-purpose stimulator for stimulating one of a plurality of sites in a patient'"'"'s body;

and

a controller interface unit in communication with the control device for communicating signals to a transmitter attached externally of the patient'"'"'s body, the transmitter, in turn, transmitting commands transcutaneously to the stimulator.

16. The controller of claim 15 in which tailoring of the stimulator is effected via the control device under the action of the clinician.

17. The controller of claim 15 in which the control device communicates, via the interface unit, with a central site so that data relating to unique stimulation characteristics for the patient and contained within the control device can be downloaded, via the interface unit, to the central site.

18. The controller of claim 17 in which the control device is in the form of a handheld programmable device.

19. The controller of claim 18 in which the hand-held programmable device includes a display for use by the patient for providing operating instructions to the stimulator and for use by the clinician for programming the device to incorporate the unique stimulation characteristics for the patient.

20. The controller of claim 15 in which the control device communicates with the transmitter via an implant interface of the interface unit using a dedicated, embedded RF transmission protocol.

21. The controller of claim 20 in which the protocol incorporates reception telemetry for receiving data from the stimulator.

22. The controller of claim 15 in which the control device includes a receiving means for a memory element.

23. The controller of claim 15 in which the interface unit includes a peripherals interface for enabling the control device to communicate with peripheral devices.

24. The controller of claim 15 in which the interface unit includes a microphone interface for enabling a microphone to communicate with the control device.

25. The controller of claim 15 in which the interface unit includes a remote control interface.

26. The controller of claim 25 in which the remote control interface is a bidirectional communications interface to permit bidirectional communication between a remote control unit and the control device.

27. The controller of claim 15 in which the interface unit includes an I/O interface.

28. The controller of claim 15 in which the interface unit includes a peripherals interface to facilitate communication between the control device and at least one sensor pack connected to the control device, in use.

29. The controller of claim 28 in which an external stimulating device is connectable to the control device via the peripherals interface of the interface unit.

30. An FES transmission device for use in an FES system assisting in restoration of multiple bodily functions in a neurologically impaired patient, the transmission device including:

a carrier of a resiliently flexible material;

a transmitting means arranged on the carrier for transmitting data transcutaneously to an implanted FES stimulator; and

an attachment means mounted on the carrier for attaching the carrier on the patient'"'"'s body in a desired position relative to the stimulator.

31. The device of claim 30 in which the carrier is of a resiliently flexible construction.

32. The device of claim 30 in which the carrier is covered by a coating of a plastics material.

33. The device of claim 30 in which the transmitting means is in the form of a coil.

34. The device of claim 33 in which the coil is a spiral coil.

35. The device of claim 34 in which the carrier is in the form of a flexible printed circuit board with the coil being implemented as a spiral track on one surface of the carrier.

36. The device of claim 35 in which the coil is tunable and, therefore, forms part of a LCR tuning circuit.

37. The device of claim 36 in which, to facilitate tuning of the LCR circuit, a variable capacitor is connected in the circuit with at least one other tuning capacitor.

38. The device of claim 37 in which the variable capacitor is accessible for fine tuning.

39. The device of claim 33 in which the coil has a connecting means for connection to a transmitter cable.

40. The device of claim 30 in which the attachment means is a magnetic attachment device.

41. The device of claim 30 in which the carrier is disc-shaped with the magnetic attachment device being substantially centrally located.

42. An accessory for an FES system which includes a multi-purpose, implantable stimulator for stimulating various sites in a neurologically impaired patient'"'"'s body and a controller for controlling the stimulator, the accessory including:

a carrier;

a remote control unit carried by the carrier;

a transmitting means in communication with the remote control unit for transmitting data from the remote control unit to the controller of the system; and

a non-visual annunciator for alerting the patient to receipt of command-carrying data by the controller.

43. The accessory of claim 42 in which bi-directional communication occurs between the remote control unit, and the controller the remote control unit including a transceiver incorporating the transmitting means.

44. The accessory of claim 43 in which the transceiver is switch-operable under the action of the patient to transmit command-carrying signals to the controller.

45. The accessory of claim 44 in which the remote control unit includes at least one patient-operable switch.

46. The accessory of claim 43 in which the remote control unit communicates in a wireless manner with the controller.

47. The accessory of claim 46 in which the remote control unit carries its own power supply.

48. The accessory of claim 47 in which the remote control unit is self-diagnostic to send data to the controller on the status of the unit.

49. The accessory of claim 47 in which the remote control unit is able to be interrogated by the controller, via the transmitting means, for enabling the controller to monitor the operational status of the remote control unit.

50. The accessory of claim 43 in which data transmitted by the remote control unit includes an identification key or code which is embedded in the data which is transmitted so that the remote control unit only activates its own controller thereby inhibiting one remote control unit communicating with the controller of another, different system.

51. The accessory of claim 50 in which the data transmitted by the remote control unit includes authentication data to inhibit spurious transmissions activating the controller.

52. The accessory of claim 42 in which the annunciator is one of an audible device, a vibratory device, and a combination of the aforegoing.

53. The accessory of claim 42 in which the remote control unit is mountable on an item of equipment used by the patient.

54. A remote control system for use with an FES system which includes a multipurpose, implantable stimulator for stimulating various sites in a neurologically impaired patient'"'"'s body and a controller for controlling the stimulator, the remote control system including a plurality of remote control units as claimed in claim 42.