Implantable nerve stimulation device

• US 5,094,242 A
• Filed: 12/09/1988
• Issued: 03/10/1992
• Est. Priority Date: 11/07/1988
• Status: Expired due to Term

• Current Assignee: Uroplasty Incorporated (2941881 Canada, Inc.)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Lue, Tom F., Schmidt, Richard A., Stoller, Marshall L., Tanagho, Emil A., Gleason, Curtis A.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): Reichle, K.
• Application Number:
  US07/282,002
• Time in Patent Office: 1,187 Days
• Field of Search: 128/419 R, 128/419 E, 128/421, 128/422, 128/303.18, 128/804 A, 128/329 A, 128/784, 128/642, 128/903, 128/907, 128/420.5, 128/419 G, 128/419 C, 600/30, 600/26, 600/640, 606/32, 606/41, 606/189, 604/20
• US Class Current: 600/377
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: Y10S 128/907 Acupuncture

Abstract

An electro-acupuncture system comprises a transmitter for emitting high frequency magnetic energy pulses and a receiver, sealed within an implantable "thumb-tack" shaped device, for receiving and converting such pulses into stimulating pulses of current. The device comprises a head having an exposed ring-electrode (anode) secured therein and a needle-like electrode (cathode) having a proximal end secured in the head and a distal end adapted to pierce body tissue. The latter electrode comprises a metallic tube secured in the head and a metallic wire inserted through the tube to position and fix an exposed tip of the wire at a preselected location and depth in the body tissue, in accordance with method steps taught herein.

Claims

1. An implantable nerve stimulation device adapted to receive pulses from a transmitter for stimulating body tissue comprising

a head having a top side and an opposite bottom side and defining a cavity at the top side thereof, said head disposed on a central longitudinal axis,

receiver means mounted in said head for selectively receiving and converting high frequency magnetic energy pulses into stimulating pulses,

first electrode means having a proximal end positioned in the cavity defined in said head and a distal end extending outwardly from the bottom side of said head and connected to said receiver means for transmitting said stimulating pulses to the distal end thereof when the distal end of said first electrode means is placed in said body tissue,

dielectric and bio-compatible adhesive means in the form of plug for filling said cavity and to aid in securing the proximal end of said first electrode means in said head to fix the distal end thereof at a pre-selected location and depth in said body tissue, and

second electrode means secured and confined entirely within said head and connected to said receiver means, to define an exposed outer surface positioned to extend across the bottom side of said head and exposed exteriorly thereof, for receiving said stimulating pulses directly from the distal end of said first electrode means after they pass through said body tissue.

2. The device of claim 1 further comprising dielectric insulating material substantially encapsulating said receiver means and a dielectric and bio-compatible cover on the exterior of said head, except for sole external exposure of said adhesive means, the distal end of said first electrode means, and the outer surface of said second electrode means, and for electrically insulating said first electrode means from said second electrode means.

3. The device of claim 1 wherein said first electrode means comprises a needle-like metallic wire, having distal and proximal ends, inserted through a metallic tube, having distal and proximal ends, and wherein the proximal ends of said wire and said tube are electrically connected together within said plug of adhesive means.

4. The device of claim 3 wherein said tube is crimped to electrically connect it to said wire.

5. The device of claim 3 wherein said wire is covered with a dielectric and bio-compatible insulation, except for its connection to said tube and except at an exposed tip at the distal end of said wire.

6. The device of claim 5 wherein said second electrode means comprises a metallic ring and said receiver means comprises a generally annular inductive coil circumventing the central longitudinal axis of said head and wherein the exposed outer surface of said ring constitutes the sole portion of said second electrode means that is exposed exteriorly of said device and is further exposed to the exposed tip of said wire.

7. The device of claim 6 wherein said first electrode means is disposed on the central longitudinal axis of said head.

8. The device of claim 1 combined with a transmitter means for transmitting said pulsed high frequency magnetic energy to said receiver means.

9. An implantable nerve stimulation device adapted to receive pulses from a transmitter for stimulating body tissue, said device having the general shape of a "thumb-tack" and comprising

a head disposed on a central longitudinal axis thereof and having top and bottom sides,

receiver means mounted in said head for selectively receiving and converting pulsed magnetic energy into stimulating pulses,

a first electrode comprising a metallic tube, having distal and proximal ends, disposed on said axis and connected to said receiver means for receiving said stimulating pulses therefrom and a metallic needle-like wire, having distal and proximal ends, slidably mounted in said tube to have the distal end thereof extend from the bottom side of said head to form an exposed tip adapted to pierce said body tissue, and

a second electrode connected to said receiver means and secured entirely within said head to solely expose an outer side thereof, positioned at the bottom side of said head, to the exposed tip of said wire whereby said stimulating pulses will be sequentially emitted from the exposed tip of said wire, passed through said body tissue and received by said second electrode.

10. The device of claim 9 wherein said head is disc-shaped and is centered on said axis and the proximal end of said wire is electrically connected to the proximal end of said tube.

11. The device of claim 10 wherein the proximal end of said tube is crimped to the proximal end of said wire.

12. The device of claim 9 wherein said second electrode comprises a metallic ring circumventing said axis and having an underside constituting the outer side of said second electrode.

13. The device of claim 10 further comprising a cavity defined around the proximal ends of said tube and said wire and a solidified, dielectric and biocompatible adhesive material forming a plug filling said cavity to secure said tube and said wire in said head.

14. The device of claim 13 further comprising a body of dielectric insulating material encapsulating said receiver means and a coating of dielectric and biocompatible material covering said dielectric insulating material to expose the plug of adhesive material filling said cavity, the underside of said ring, and the exposed tip of said wire, exteriorly of said device.

15. The device of claim 14 wherein said ring defines an annular cavity therein adjacent to the bottom side of said head and the distal end of said tube extends into said annular cavity and further comprising a solidified, dielectric and bio-compatible second plug of adhesive material filling said annular cavity to electrically insulate said first and second electrodes from each other.