ELECTRODES, ELECTRODE SYSTEMS, AND METHODS OF MANUFACTURE

• US 20130023816A1
• Filed: 04/13/2012
• Published: 01/24/2013
• Est. Priority Date: 07/18/2011
• Status: Active Grant

• Current Assignee: DJO LLC (Enovis Corp.)
• Original Assignee: EMPI Incorporated (Enovis Corp.)
• Inventors: Bachinski, Thomas Jerome, Moore, Michael, Dave, Jay, Winn, Joseph
• Granted Patent: US 9,211,400 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 2562/227 Sensors with electrical connectors
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/251 Means for maintaining electrode contact with the body
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/263 characterised by the electrode materials
• CPC Class Codes: A61B 5/268 containing conductive polymers, e.g. PEDOT:PSS polymers
• CPC Class Codes: A61B 5/274 using snap or button fasteners
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/048 Electrodes characterised by a specific connection between lead and electrode
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: H01R 11/30 End pieces held in contact by a magnet
• CPC Class Codes: H01R 2201/12 for medicine and surgery
• CPC Class Codes: Y10T 29/49155 Manufacturing circuit on or in base

Abstract

Multilayer electrodes, electrode systems, and stimulation systems are disclosed. An electrode may include a conductive layer with a unitary tail, a connector disposed on a distal end of the tail, and a nonconductive top layer disposed along a top portion of the conductive layer. An electrode may include a magnetic lead connector socket, or a receptacle formed by a depression in the conductive layer configured to receive a male connector. An electrode system may include a plurality of conductive zones and a plurality of connectors. A stimulation system may include an electronics layer in electrical contact with a conductive layer via a puncture connection, and may provide an iontophoretic treatment followed by a TENS treatment. Other electrodes, systems and methods are also disclosed.

Claims

1-43. -43. (canceled)

44. A stimulation system comprising:

a nonconductive top layer;

an electronics layer, disposed beneath the nonconductive top layer, comprising pulse generation circuitry in electrical communication with a first conductive contact point in the electronics layer; and

a conductive layer, disposed beneath the electronics layer, having a second conductive contact point in electrical contact and alignment with the first conductive contact point via a puncture connection between the electronics layer and the conductive layer.

45. The stimulation system of claim 44, further comprising:

a second conductive layer, disposed beneath the electronics layer, having a third conductive contact point in electrical contact and alignment with a fourth conductive contact point in the electronics layer via a puncture connection between the electronics layer and the second conductive layer.

65. The stimulation system of claim 44, wherein the conductive layer comprises a conductive polyvinylchloride or polyurethane impregnated with carbon.

66. The stimulation system of claim 44, wherein the conductive layer comprises a plurality of conductive zones spaced apart from each other.

67. The stimulation system of claim 44, wherein the conductive layer comprises a ring-shaped conductive zone and a second conductive zone within an interior of the ring-shaped conductive zone.

68. The stimulation system of claim 66, wherein the second conductive zone is ring-shaped.

46-54. -54. (canceled)

55. A method of assembling a stimulation system, comprising:

providing an electronics layer comprising pulse generation circuitry in electrical communication with a first conductive contact point in the electronics layer;

disposing a conductive layer beneath the electronics layer;

puncturing the electronics layer and the conductive layer at the first conductive contact point to form an electrical connection between the conductive contact point of the electronics layer and the conductive layer.

56. The method of claim 55, further comprising:

disposing a gel layer beneath the conductive layer; and

disposing a nonconductive top layer above the electronics layer;

57. The method of claim 55, wherein the electronics layer comprises one or more switches configured to control the pulse generation circuitry, and further comprising:

disposing one or more buttons in alignment with the one or more switches such that pressing the one or more buttons activates the corresponding one or more switches.

58. The method of claim 57, wherein the one or more switches comprises a power-on switch and pressing the button associated with the power-on switch initiates delivery of electrical pulses from the pulse generation circuitry to the conductive layer.

59. An iontophoresis delivery system comprising:

a conductive layer;

a drug delivery layer comprising a therapeutic compound, the drug delivery layer arranged to deliver the therapeutic compound into a patient'"'"'s tissue when a DC current is driven into the patient'"'"'s tissue from the conductive layer; and

an electronics layer, having a conductive contact point in electrical contact and alignment with a conductive contact point in the conductive layer via a puncture connection, further comprising pulse generation circuitry configured to;

deliver the DC current to the conductive layer for a predetermined period of time to drive the therapeutic compound into the patient'"'"'s tissue;

after delivering the DC current for the predetermined period of time, deliver an AC TENS current to the conductive layer.

60. The iontophoresis delivery system of claim 59, further comprising a battery, wherein the pulse generation circuitry is configured to use the battery to power the delivery of the DC current and the delivery of the AC TENS current.

61. The iontophoresis delivery system of claim 59, further comprising a chemical switch configured to indicate that the predetermined period of time has elapsed when a predetermined amount of therapeutic compound has been driven into the patient'"'"'s tissue.

69. The iontophoresis delivery system of claim 59, wherein the conductive layer comprises a conductive polyvinylchloride or polyurethane impregnated with carbon.

70. The iontophoresis delivery system of claim 59, wherein the conductive layer comprises a plurality of conductive zones spaced apart from each other.

71. The iontophoresis delivery system of claim 59, wherein the conductive layer comprises a ring-shaped conductive zone and a second conductive zone within an interior of the ring-shaped conductive zone.

72. The iontophoresis delivery system of claim 71, wherein the second conductive zone is ring-shaped.

62. A method of configuring a single device for the delivery of iontophoretic and TENS treatments, comprising:

providing an electrical stimulation system comprising a conductive layer, a drug delivery layer comprising a therapeutic compound, and pulse generation circuitry, the pulse generation circuitry in electrical contact with the conductive layer via a puncture connection;

configuring the pulse generation circuitry to, upon activation when positioned on a patient'"'"'s tissue;

deliver a DC current to the conductive layer for a predetermined period of time to drive the therapeutic compound from the drug delivery layer into the patient'"'"'s tissue;

after delivering the DC current for the predetermined period of time, deliver an AC TENS current to the conductive layer.

63. The method of claim 62, wherein the pulse generation circuitry comprises a battery and the method further comprises:

configuring the pulse generation circuitry to use the battery to power the delivery of the DC current and the delivery of the AC TENS current.

64. The method of claim 63, further comprising:

configuring the pulse generation circuitry to deliver the AC TENS current until the battery is depleted.