Functional neuromuscular stimulation system

• US 20010000187A1
• Filed: 11/29/2000
• Published: 04/05/2001
• Est. Priority Date: 10/23/2000
• Status: Abandoned Application

• Current Assignee: Case Western Reserve University
• Original Assignee: Case Western Reserve University
• Inventors: Smith, Brian, Peckham, Paul Hunter, Letechipia, Jorge Ernesto, Buckett, James Robert, Thrope, Geoffrey Bart
• Application Number:
  US09/726,146
• Publication Number:
  US 20010000187A1
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance

Abstract

An input command controller (A) provides logic function selection signals and proportional signals. The signals are generated by movement of a ball member (12) and socket member (14) relative to two orthogonal axes. When the joystick is implanted, a transmitter (50) transmits the signals to a patient carried unit (B). The patient carried unit includes an amplitude modulation algorithm such as a look-up table (124), a pulse width modulation algorithm (132), and an interpulse interval modulation algorithm (128). The algorithms derive corresponding stimulus pulse train parameters from the proportional signal which parameters are transmitted to an implanted unit (D). The implanted unit has a power supply (302) that is powered by the carrier frequency of the transmitted signal and stimulation pulse train parameter decoders (314, 316, 318). An output unit (320) assembles pulse trains with the decoded parameters for application to implanted electrodes (E). A laboratory system (C) is periodically connected with the patient carried unit to measure for changes in patient performance and response and reprogram the algorithm accordingly. The laboratory system also performs initial examination, set up, and other functions.

Claims

1. A functional nueromuscular stimulation system comprising:

an input command control means for providing electrical command signals indicative of a selected muscular response;

at least a first parameter selecting means for selecting properties of an electrical stimulation pulse train in accordance with the input command signal, the first channel including an amplitude means for selecting an amplitude of each stimulation pulse, an interval means for selecting an interpulse interval, and a pulse width means for selecting a width of each pulse;

a pulse train generator means for generating a train of stimulation pulses with the selected amplitude, interpulse interval, and pulse width, the pulse train generator means being operatively connected with the first parameter selecting means; and

,

at least a first electrode operatively connected with the pulse train generator.

2. The system as set forth in

claim 1

wherein the input command control means provides a proportional signal which is proportional to a selected degree of muscular response, the input command means being operatively connected with the amplitude means, the interval means, and the pulse width means such that the amplitude, interpulse interval, and pulse width are selected in accordance with the proportional signal.

3. The system as set forth in

claim 2

wherein the amplitude means, the interval means, and the pulse width means each include a preprogrammable memory for storing an algorithm which represents a selected relationship between the proportional signal and one of the amplitude, interpulse interval, and pulse width.

4. The system as set forth in

claim 3

wherein each memory includes a look-up table.

5. The system as set forth in

claim 3

further including a central reprogramming means which is selectively connectable with the programmable memories for selectively different algorithms therein.

6. The system as set forth in

claim 2

further including:

a physical parameter transducer for monitoring a parameter of the muscular response;

a look-up table for storing a plurality of values corresponding to the monitored parameter at a plurality of points along the selected muscular response;

a comparing means for comparing the monitored parameter and the stored value from the look-up table, the comparing means being operatively connected with at least one of the amplitude means, the interval means, and the pulse width means for adjusting the stimulation pulse train until a relationship between the monitored parameter and the stored value is optimized.

7. The system as set forth in

claim 1

wherein the input command control means includes a relative position sensor for sensing the relative position of a joint of a patient'"'"'s body, the electrical command signals being proportional to the sensed joint position.

8. The system as set forth in

claim 7

wherein the position sensor is implanted in the patient'"'"'s body and further including an implantable telemetry system for transmitting the command signals, the telemetry system includes an encoding means which applies the command signals to a gate means which selectively applies a load across a power signal receiving antenna to modify a characterisitic thereof, such that a monitorable characterisitic of the power signal is modulated by the command signals.

9. The system as set forth in

claim 1

wherein the input command control means includes:

a permanent magnet mounted within a ball joint;

at least three Hall-effect plates mounted in a socket in which the ball member is movably received;

a means for applying electrical potential across each of the Hall-effect plates in a first direction;

a means for monitoring a potential difference across each Hall-effect plate in a direction generally transverse to the first direction, the potential difference monitoring means each providing an output signal which varies in proportion to the monitored potential difference, such that as the ball member and socket move relative to each other, the physical proximity of the magnet relative to the Hall-effect plates changes as does the magnetic flux through each Hall-effect plate and the potential thereacross, whereby the output signals are indicative of the relative position of the ball member and socket.

10. The system as set forth in

claim 1

wherein the input command control means includes a socket member which defines a ball receiving cavity therein;

a ball member which has a ferrite core received within the socket member cavity;

a driver coil disposed around the socket member adjacent the ferrite core; and

,

a plurality of sensing coils mounted to the socket member in a geometric array adjacent the ferrite core such that as the ball member rotates relative to the socket the driving coil and the sensing coils, the relative transfer of signal from the driving coil to each of the sensing coils varies in accordance with the relative position of the ball and socket members.

11. The system as set forth in

claim 1

wherein the pulse train generator is implanted in a patient and further including a transmitter means for transmitting the selected amplitude, interpulse interval, and pulse width to the pulse train generator.

12. The system as set forth in

claim 11

further including:

a capsule for encasing the pulse train generator and being implanted therewith;

a receiving coil being mounted exteriorally with the capsule and being potted in an electrically transmissive medium, the receiving coil being operatively connected with the pulse train generator for receiving signals transmitted by the transmitting means; and

,

a flexible electrical lead mechanically connected at one end through the capsule into electrical contact with the pulse train generator and being electrically connected with one of the electrodes at another end.

13. The system as set forth in

claim 11

wherein the transmitter encodes the selected channel, amplitude, interpulse interval, and pulse width in a carrier signal and wherein the pulse train generator includes:

a power supply means for converting energy from the carrier signal into electrical potential for operating the pulse train generator and for providing electrical currents to the electrodes;

a decoding means for decoding at least the encoded amplitude and pulse width from the encoded carrier signal, the decoding means including a channel decoder for decoding which electrode is to apply the selected stimulus current pulse train, a pulse width decoder for determining the pulse width of pulses of the stimulus current pulse train, and an amplitude decoder for determining an amplitude of pulses of the stimulus pulse train;

an energy storage means for storing a source of electrical potential for each electrode channel;

a channel selection means for selectively passing electrical current from the energy storage means to the electrode of the selected channel with the selected pulse width; and

,

a current regulator means for regulating the amplitude of the stimulus current pulses in accordance with the amplitude decoded by the amplitude decoding means.

14. The system as set forth in

claim 1

wherein the signal generator is carried external to a patient and the electrode is implanted in muscle tissue of the patient and connected to the signal generator by an electrical lead, and further including a percutaneous interface shield member for protecting the electrical lead at a site at which the lead passes through the patient'"'"'s skin, the shield member including:

a peripheral lip region extending peripherally therearound;

a low profile central portion disposed within the peripheral lip, the central portion defining an aperture to be disposed over a site at which the lead passes through the patient'"'"'s skin, the central region being configured of an elastomeric material;

a first electrical connector portion connected with the central region, a portion of the lead which passes through the patient'"'"'s skin being operatively connected with the shield mounted on the first electrical connector portion;

a second electrical connector portion which is selectively interconnectable with the first connector portion, the second connector portion being connected with the pulse train generator; and

,

an adhesive means for adhering the shield member with the patient'"'"'s skin.

15. The system as set forth in

claim 1

further including a flexible, electrical cable interconnected with the first electrode, the electrical cable comprising at least one spiral of multi-strand wire encased in a resilient non-conductive sheath.

16. The system as set forth in

claim 1

further including a first electrical lead operatively connected with the pulse train generator, a second electrical lead operatively connected with the first electrode, and an interconnection means for electrically interconnecting the first and second leads, the interconnection means including:

a first electrically conductive pin electrically connected with the first lead;

a second electrically conductive pin electrically connected with the second lead;

an electrically conductive coil spring member frictionally connected with the first and second pins in a secure frictional and electrical interconnection such that tension caused by moving the pins apart causes the coil spring member to contract and adhere more strongly to the pins; and

,

a flexible, insulating sheath surrounding the first and second pins and the coil spring member.

17. A method of functional neuromuscular stimulation comprising:

deriving an electrode command signal which is indicative of a preselected muscular response;

deriving pulse amplitude, interpulse interval, and pulse width characteristics of an electrical stimulation pulse train from the command signal for each of a plurality of channels;

for each channel generating a stimulus pulse train with the selected amplitude, interpulse interval, and pulse width parameters; and

,

applying each pulse train to muscle tissue of a patient with an implanted electrode.

18. A position monitoring system for providing output signals which vary in proportion to monitored movement relative to two axes, the system comprising:

a permanent magnet mounted within a ball member;

at least three Hall-effect plates mounted in a socket in which the ball member is movably received;

a means for applying electrical potential across each of the Hall-effect plates in a first direction;

a means for monitoring a potential difference across each Hall-effect plate in a direction generally transverse to the first direction, the potential difference monitoring means each providing a monitor signal which varies in proportion to the potential difference such that as the ball member and socket move relative to each other, the physical proximity of the magnet relative to the Hall-effect plates changes as does the magnetic flux through each Hall-effect plate and the potential thereacross; and

,

a means for deriving from the monitor signals first and second output signals which are indicative of the relative position of the ball member and socket along first and second axes, respectively.

19. The system as set forth in

claim 18

wherein the ball member is a clavical bone of a patient and the socket is connected with a sternum of the patient.

20. The system as set forth in

claim 18

wherein the at least three Hall-effect plates includes a first pair of plates mounted in the socket along the first axis and a second pair of plates mounted in the socket along a second axis and wherein the deriving means includes a first differential combining means for differentially combining the monitor signals from the first pair of Hall-effect plates and a second differential combining means for differentially combining the monitor signals of the second pair of Hall-effect plates.

21. The system as set forth in

claim 20

further including an implantable telemetry system for digitally encoding the first and second output signals, the telemetry system includes an encoding means which applies the command signals to a gate means which selectively applies a load across a power signal receiving coil to modify a characteristic thereof, such that a monitorable characteristic of the power signal is modulated by the command signals.

22. A position monitoring system for providing output signals which vary in proportion to monitored movement relative to two axes, the system comprising:

a ferrite core mounted within a ball member;

a socket member within which the ball member is rotatably mounted;

a driving coil operatively connected with the socket member;

a plurality of sensing coils mounted to the socket member and disposed adjacent the ferrite core such that transfer of an input signal from the driving coil to each of the sensing coils is controlled by the relative proximity of the ferrite core to each sensing coil, whereby the relative position of the socket and ball members is indicated by the relative signal transfer to the sensing coils.

23. A method of monitoring movement relative to two axes, the method comprising:

mounting permanent magnetic within a ball member;

mounting at least three Hall-effect plates in a socket in which the ball member is movably received, the plates being mounted such that at least two axes are defined therethrough;

applying an electrical potential across each of the Hall-effect plates in a first direction;

moving the ball member relative to the socket such that the permanent magnet is moved relative to the Hall-effect plates such that the magnetic flux through each Hall-effect plate changes with the relative movement between the ball member and socket, the change in magnetic flux causing a change in a path of current flow generally along the first direction of each plate which alters the potential across the Hall-effect plate, whereby the change in potential across each Hall-effect plate is indicative of the relative proximity between the permanent magnet and the Hall-effect plate and the potential across the Hall-effect plates is indicative of the relative position of the ball member and the socket;

monitoring the potential difference across each Hall-effect plate in the direction generally transverse to the first direction; and

,

deriving at least two output signals indicative of the relative ball member and socket position from the monitored potential differences.

24. An implantable telemetry system for transmitting encoded signals, the telemetry system comprising:

an antenna for receiving a radio frequency signal;

a power supply operatively connected with the antenna to convert the received radio frequency signal into electromotive power;

an encoding means for encoding at least a first signal to produce an encoded signal, the encoding means being operatively connected with the power supply to receive electromotive power therefrom;

a gate means for selectively gating a load across the antenna to modulate a characteristic thereof such that a monitorable characteristic of the radio frequency signal is modulated by the applied load, the gate means being operatively connected with the encoding means to be controlled by the encoded signal.

25. The system as set forth in

claim 24

wherein the encoding means encodes first and second signals into the encoded signal.

26. The system as set forth in

claim 25

wherein the encoding means digitally encodes the first and second signals such that the gate means selectively connects and disconnects the load across the antenna.

27. The system as set forth in

claim 25

further including an input signal means for generating a first axis signal indicative of relative movement along a first axis and a second axis signal indicative of movement along a second axis, the input signal means being operatively connected with the encoding means to supply the first and second axis signals to be encoded as the first and second signals.

28. The system as set forth in

claim 27

further including:

a receiving means for receiving the modulated characteristic of the radio frequency signal;

a demodulating means for recovering the first and second axis signals from the received modulated signal;

at least one pulse width algorithm means for applying a preselected pulse width algorithm to the first axis signal to derive a first pulse width;

an amplitude algorithm means for applying an amplitude algorithm to the first axis signal to derive a first amplitude therefrom;

a stimulation pulse train generator for generating a stimulus pulse train which has the selected pulse width and pulse amplitude; and

,

at least one electrode for applying the pulse train to muscle tissue.

29. The system as set forth in

claim 27

wherein the input signal means includes:

a permanent magnet mounted within a ball member;

at least three Hall-effect plates mounted in a socket in which the ball member is movably received, the Hall effect plates being operatively connected with the power supply such that an electrical potential is applied across each of the Hall-effect plates in a first direction;

a means for monitoring a potential difference across each Hall-effect plate in a direction generally transverse to the first direction, the potential difference monitoring means each providing a monitor signal which varies in proportion to the potential difference such that as the ball member and socket move relative to each other, the physical proximity of the magnet relative to the Hall-effect plates changes as does the magnetic flux through each Hall-effect plate and the potential thereacross; and

,

a means for deriving the first and second axis signals from the monitored signal.

30. The system as set forth in

claim 27

wherein the input signal means includes:

a ferrite core mounted within a ball member;

a socket member within which the ball member is rotatably mounted;

a driving coil operatively connected with the socket member;

a plurality of sensing coils mounted to the socket member and disposed adjacent the ferrite core such that transfer of an input signal from the driving coil to each of the sensing coils is controlled by the relative proximity of the ferrite core to each sensing coil, whereby the relative position of the socket and ball members is indicated by the relative signal transfer to the sensing coils.

31. A method of transmitting encoding information on radio frequency signals, the method comprising:

transmitting a radio frequency signal from exterior to a patient;

receiving the radio frequency signal on an antenna within a patient;

converting the radio frequency signal received by the antenna into electromotive power;

within the patient, generating a signal indicative of a physiological parameter of the patient with the electromotive power;

gating a load across the antenna in accordance with the physiological parameter signal to modulate a characteristic of the antenna and a monitorable characteristic of the radio frequency signal; and

,

monitoring the monitorable characteristic of the radio frequency signal exterior of the patient to recover the physiological parameter signal.

32. A functional, neuromuscular stimulation system comprising:

a command processing means for deriving command control parameters from joystick positions;

a movement planning means for deriving movement parameters from the control parameters;

a coordination and regulation means for deriving electrical stimulus signal parameters from the movement parameters; and

,

a stimulus generator for generating electrical stimulus signals with the derived parameters for application to implanted electrodes.

33. The system as set forth in

claim 32

further including:

a motion monitoring means for monitoring movement parameters of a limb which is caused to move by the electrical stimulus signals;

a comparing means for comparing the monitored motion parameters with the movement parameters to determine a difference therebetween, the comparing means being operatively connected with the movement planning means and the motion monitoring means, and,

the coordination and regulation means being operatively connected with the comparing means to adjust the stimulus signal parameters to optimize correspondence between the monitored motion parameters and the movement parameters.

34. The system as set forth in

claim 32

further including:

a motion monitoring means for monitoring motion parameters of a patient;

a comparing means for comparing the movement parameters with the monitored motion parameters;

a storage means for periodically storing the differences;

and an improvement means for determining from the stored differences whether the monitored motion parameters and the movement parameters are becoming more consistent, whereby measurement of the patient'"'"'s adaptation to the system is monitored.

35. The system as set forth in

claim 32

wherein the command processing means includes:

an axis resolving means operatively connected with a patient joystick which has at least two degrees of freedom, the axis resolving means monitoring patient movement of the joystick to determine first and second generally orthogonal axes of movement, the patient having smooth and coordinated movement over a significant range of motion along the first axis and having rapid movement over a significant range of motion along the second axis, the joystick generating a first axis signal which varies with movement along the first axis and a second axis signal that varies with movement along the second axis;

a range of motion measuring means for measuring the range of movement of the patient along the first axis from the first axis signal;

an amplification selection means for matching the first axis signal with a range of input signals processable by the command processing means;

a velocity measuring means for measuring velocity along the second axis from the second axis signal; and

,

a second amplification selection means for adjusting amplification of the second axis signal in accordance with the measured velocity.

36. The system as set forth in

claim 35

further including:

a first filter selecting means for selecting a filter function for the first axis signal in accordance with the smoothness of the patient'"'"'s movement along the first axis to select the first filter function such that the first axis signal is substantially unaffected by involuntary movements relative to the first axis; and

,

a second filter selecting means for measuring voluntary movement velocities along the second axis to select a second filter for the second axis signal such that the second axis signal is substantially unaffected by involuntary movements along the second axis.

37. A method of functional neuromuscular stimulation comprising:

deriving command control parameters from positions of a joystick;

deriving movement parameters from the command control parameters;

deriving electrical stimulus signal parameters from the movement parameters; and

,

generating electrical stimulus signals with the derived parameters and applying the electrical stimulus signals to implanted electrodes.

38. An implantable electrical stimulus system for providing electrical stimulation pulse trains of selectable parameters to stimulus electrodes implanted in muscle tissue, the stimulus system comprising:

a power supply means for converting energy from a carrier frequency of a received modulated input signal into electrical potential for operating components of the implanted stimulus system and for providing electrical currents to the electrodes;

a decoding means for decoding encoded stimulus pulse train parameters from the received modulated input signal, the decoding means including a channel decoder for decoding which electrode is to apply a stimulus pulse train with the decoded parameters, a pulse width decoder for determining the pulse width of pulses of the stimulus pulse train, and an amplitude decoder for determining an amplitude of the pulses of the stimulus pulse train;

an energy storage means for separately storing a source of electrical potential for each stimulus electrode;

a channel selection means for selectively passing pulses of electrical current from the energy storage means between the selected stimulus electrode and a reference electrode with the selected pulse width; and

,

a stimulus current regulating means for regulating the amplitude of the stimulus pulses in accordance with the amplitude decoded by the amplitude decoding means.

39. The system as set forth in

claim 38

further including a titanium capsule in which the power supply means, the decoding means, the energy storage means, the channel selection means, and the stimulus current regulating means are mounted in a hermetically sealed inert gas filled chamber thereof;

and,

an antenna mechanically interconnected through the titanium capsule in electrical connection with the power supply means.

40. The system as set forth in

claim 38

wherein the energy storage means includes an output capacitor connected in series with each stimulus electrode and further including:

a transistor connected in series with the stimulus current regulating means, the transistor and stimulus current regulating means being connected in parallel with the output capacitor, the stimulus electrode, and a reference electrode such that a current loop including muscle tissue between the stimulus and reference electrodes is formed thereby.

41. The system as set forth in

claim 40

further including a recharge current regulating means connected between the output capacitor and the power supply means for regulating a capacitor recharging current.

42. The system as set forth in

claim 38

wherein the stimulus current regulating means includes a plurality of reference current transistors and mirror transistors connected in a current mirroring relationship with each reference current transistor for providing a regulated mirror current therethrough, which regulated mirror current is a multiple of the regulated current, the amplitude decoder being operatively connected with the reference current transistors for selectively selecting reference current transistors with different numbers of the mirror current transistors connected therewith in the current mirroring relationship such that the amplitude of the stimulus current pulse is selected by the amplitude decoder means.

43. The system as set forth in

claim 42

further including a zener diode connected with the base of the reference transistor for preventing the reference transistor from switching conductive when power is first applied to the implanted stimulus system and as power is disconnected whereby the regulated current is held to zero during power up and power down situations which the integrity of the logic circuit cannot be guaranteed.

44. The system as set forth in

claim 38

further including a voltage monitor for monitoring the voltage level supplied by the power supply, the voltage monitor enabling the decoding means and the channel selection means when the monitored voltage exceeds a preselected minimum and disabling the decoding means and the channel selection means when the monitored voltage fails to exceed the preselected minimum voltage.

45. The system as set forth in

claim 38

further including:

an input command control means for providing a proportional signal which is proportional to a selected degree of muscular response;

for each electrode, a pulse width algorithm means and an amplitude algorithm means, the pulse width algorithm means being operatively connected with the input command control means for receiving the proportional signal therefrom and deriving an appropriate pulse width in accordance with an algorithm stored therein, the amplitude means being operatively connected with the input command control means to receive the proportional signal therefrom and derive a pulse amplitude in accordance with an algorithm stored therein; and

,

a carrier signal modulating means for modulating a carrier signal to encode the pulse width and amplitude therein.

46. The system as set forth in

claim 45

wherein the input command control means includes a joystick which is implanted in the patient.

47. The system as set forth in

claim 38

further including an electrical lead operatively connected with the stimulus current regulating means for conveying the stimulus current to one of the stimulus electrodes, the lead including:

a color coded strand of flexible insulative material extending longitudinally along the lead;

at least one multi-strand wire wrapped helically around the central strand;

a non-conductive, elastomeric material disposed in interstices between the multi-strand wire and surrounding the multi-strand wire to provide an electrically insulative cover therearound to provide protection for the multistrand wire.

48. The system as set forth in

claim 47

further including a second electrical lead operatively connected with the stimulus electrode and a connector for interconnecting the first and second leads, the interconnection means including:

an electrically conductive pin electrically connected with the first lead;

an electrically conductive pin electrically connected with the second lead; and

,

a spring helix frictionally and electrically connected with the first and second pins to provide electrical and flexible mechanical interconnection therebetween.

49. A method of providing electrical stimulation pulse trains of selectable parameters to electrodes which are implanted in muscle tissue, the method comprising:

receiving an input signal which includes a carrier frequency modulated with encoded stimulus pulse train parameters;

converting energy from the carrier frequency into an electrical operating potential;

decoding the encoded stimulus pulse train parameters from the received modulated input signal, the decoding including decoding at least an indication of which electrode is to apply the stimulus pulse train, a pulse width of the pulses of the pulse train, and an amplitude of the pulses of the pulse train;

for each electrode, separately storing a source of electrical potential with energy from the electrical operating potential;

selectively passing pulses of electrical current from the separately stored electrical potential between the selected stimulus electrode and a reference electrode with the selected pulse width; and

,

regulating the amplitude of the stimulus pulses in accordance with the decoded amplitude.

50. A percutaneous interface shield system for protecting electrical leads which pass through a patient'"'"'s skin, the shield system comprising:

a shield member having a peripheral lip portion extending peripherally around a low profile central portion, the central portion defining an aperture to be disposed over a site at which the leads pass through the patient'"'"'s skin, the central portion being configured of an elastomeric material;

an electrical connector connected with the central region, the leads which pass through the patient'"'"'s skin being operatively connected with the shield mounted electrical connector; and

,

an adhesive means for adhering the shield member with the patient'"'"'s skin.

51. The system as set forth in

claim 50

wherein the adhesive means includes an overlay member having an aperture therethough which corresponds generally in size to the shield member central portion, the overlay member having an adhesive surface which adheres to the shield member lip portion and to the patient'"'"'s skin therearound.

52. The system as set forth in

claim 51

wherein the adhesive means further includes an adhesive layer disposed between the shield member central and lip portions and the patient'"'"'s skin.

53. The system as set forth in

claim 50

further including a second electrical connector operatively connected with a source of electrical signals, the second connector being selectively connectable and disconnectable with the shield member mounted connector.

54. The system as set forth in

claim 53

wherein the first and second electrical connectors include a plug and socket assembly which are frictionally interconnected, the frictional interconnection between the plug and socket members being sufficiently small that the plug and socket members disconnect at a lower force than required to shift the shield member relative to the patient'"'"'s skin.

55. The system as set forth in

claim 53

wherein the shield member central portion defines a passage extending from the shield member mounted connector for frictionally receiving the second connector therethrough.

56. The system as set forth in

claim 54

wherein the plug and socket members are mechanically connectable with either of two polarities such that if the attendant should attempt to interconnect the plug and socket member backwards, the plug and socket members interconnect before the attendant applies sufficient pressure to dislodge the shield member from the patient'"'"'s skin.

57. The system as set forth in

claim 50

wherein the electrical leads are connected with electrodes which are implanted in muscle tissue of the patient and further including a second electrical connector which is connectable with the first electrical connector, the second electrical connector being operatively connected with a stimulus generator for generating electrical stimulus signals to be applied to the electrodes.

58. The system as set forth in

claim 57

further including a joystick for providing at least a proportional command signal which varies in proportion to joystick motion and algorithm means for deriving stimulus signal parameters from the proportional signal, the algorithm means being operatively connected with the joystick to receive the proportional signal therefrom and with the signal generator for controlling the parameters of the generated stimulus signal.

59. The system as set forth in

claim 58

wherein the joystick further generates logic control signals indicative of a selected function to be performed by the system and further including a logic signal decoding means for decoding the logic signal and causing alterations in the functioning of the algorithm means in accordance therewith.

60. The system as set forth in

claim 50

wherein each of the leads includes:

a strand of flexible insulative material extending longitudinally along the lead;

at least one multi-strand wire wrapped helically around the central strand;

a non-conductive, elastomeric material disposed in interstices between the multi-strand wire and surrounding the multi-strand wire to provide an electrically insulative cover therearound to provide protection for the multistrand wire.

61. A method of of providing a percutaneous interface comprising:

passing at least one electrical lead through a site in a patient'"'"'s skin;

connecting the electrical lead with a first electrical connector which is mounted in a shield member, which shield member has a peripheral lip portion surrounding a low profile central portion, the central portion defining an aperture therethrough in communication with the first electrical connector which is mounted to the central portion;

adhering the central and peripheral portions to the patient'"'"'s skin with a layer of adhesive;

adhesively applying an overlay member having an aperture therethrough which corresponds generally in size to the sheild member central portion over the peripheral lip portion and the patient'"'"'s skin therearound such that the shield member is securely adhered to the patient'"'"'s skin around the lead penetration site; and

,

connecting a second electrical connector with the first connector.

62. An implantable electrical stimulus system including:

a receiving antenna for receiving radio frequency signals indicative of stimuli to be applied to electrodes;

a metal capsule defining a hermetically sealed chamber therein, the antenna being mechanically interconnected with the capsule;

electrical circuitry mounted within the capsule cavity in electrical communication with the antenna for converting received radio frequency signals into stimulus pulses for each of a plurality of electrodes; and

,

a plurality of electrical leads, each electrical lead being electrically connected with the electrical circuitry and being mechanically interconnected with the metal capsule.

63. The system as set forth in

claim 62

wherein the capsule defines a first recessed axis adjacent the mechanical interconnection with the aerial and a second recessed axis adjacent the mechanical interconnection with the electrical leads such that the recessed areas provide protection to the mechanical interconnections and wherein the antenna is potted in a polymeric material, which polymeric material mechanically mounts the potted antenna with the first capsule recessed area;

a polymeric potting material filling the second capsule recessed area to improve the mechanical interconnection between the leads and the capsule.

64. The system as set forth in

claim 63

further including an elastomeric material substantially surrounding the capsule and the polymeric potting material, a portion of the capsule remaining exposed to function as a reference electrode with a patient in whom the capsule is implanted.

65. The system as set forth in

claim 62

wherein the leads each include at least one helix of multi-strand wire encased in a polymeric insulator.

66. An electrical lead for providing electrical stimulation signals to an implanted electrode, the lead comprising:

first and second lengths of multi-strand wire wrapped into a helix extending along a longitudinal axis of the lead such that the wires and the lead may be readily flexed about the axis with minimal fatigue to the wires;

a flexible polymeric insulator material encapsulating the wires.

67. The lead as set forth in

claim 66

wherein the polymeric encapsulating material includes a first polymeric material filling interstices between the helically wound wires and a sleeve of elastomeric material therearound.

68. The lead as set forth in

claim 67

wherein each of the first and second lengths of multi-strand wire are coated with a flexible polymeric insulating material.

69. The lead as set forth in

claim 66

further including an interconnecting means for interconnecting the lead with means for supplying electrical stimulating current, the interconnecting means including:

a first pin electrically connected with the multi-strand wires;

a second pin electrically connected with an electric stimulation current supplying means; and

,

a helical metal spring frictionally and electrically connected with the first and second pins to provide a flexible electrical interconnection therebetween.