# US 12,226,626 B2 · Electrode and percutaneous lead and method of use

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- Number: US 12,226,626 B2
- Document ID: US12226626B2
- Status: Granted
- Kind: B2
- Application number: 16/946,714
- Filed: 2020-07-01
- Published: 2021-01-07
- Granted: 2025-02-18
- Earliest claimed: 2019-07-01
- Assignees: Wavegate Corporation
- Applicants: Wavegate Corporation
- Inventors: Erich W. Wolf, II
- Web page: https://patentgrep.com/patent/US12226626B2

## CPC

- A61N 1/0553: {Paddle shaped electrodes, e.g. for laminotomy}
- H02J 7/42: with electronic devices having internal batteries, e.g. mobile phones
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/0558: {Anchoring or fixation means therefor}
- A61N 1/36071: {Pain}
- A61N 1/36139: {with automatic adjustment}
- A61N 1/37518: {Anchoring of the implants, e.g. fixation}
- A61N 1/3752: {Details of casing-lead connections}
- A61N 1/3787: {from an external energy source}
- G02B 6/02033: {Core or cladding made from organic material, e.g. polymeric material (G02B1/04 takes precedence)}
- G02B 6/3624: {Fibre head, e.g. fibre probe termination (optical details of light guide terminations G02B6/241; reshaping of light guides G02B6/2552; optical details of coupling light into or out of fibre end G02B6/262)}
- G02B 6/4212: {the intermediate optical element being a coupling medium interposed therebetween, e.g. epoxy resin, refractive index matching material, index grease, matching liquid or gel}
- G02B 6/4234: {Passive alignment along the optical axis and active alignment perpendicular to the optical axis}
- G02B 6/4246: {Bidirectionally operating package structures}
- H02J 7/02: for charging batteries from AC mains by converters
- H02J 50/10: using inductive coupling
- H02J 50/80: involving the exchange of data, concerning supply or distribution of electric power, between transmitting devices and receiving devices
- A61N 1/37223: {Circuits for electromagnetic coupling}
- A61N 1/378: Electrical supply
- G02B 6/4293: {hybrid electrical and optical connections for transmitting electrical and optical signals}
- H01R 4/30: utilising a screw or nut clamping member (H01R4/50 takes precedence; utilising a clamping member acted on by screw or nut H01R4/38; {for coaxial cables H01R9/0521})
- H01R 13/08: Resiliently-mounted rigid pins or blades
- H02J 2105/46: Medical devices, medical implants or life supporting devices
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- H02J: ELECTRIC POWER NETWORKS; CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
- G02B: OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
- H01R: ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS

## Abstract

A surgical lead is provided which includes a generally flexible polymeric panel incorporating a set of electrode arrays embedded in one side. The electrode arrays are connected to integrally formed leads which house conductors that connect the electrodes to a set of contacts. The contacts engage an IPG header. The leads incorporate an optical fiber which extends from the IPG header to a set of window portals in the flexible panel. Each of the fibers includes a side firing section adjacent the optical windows for transmission or reception of light. Optimally placed reflectors and heat shields are also provided.

## Claims

### Claim 1

A percutaneous lead for a pulse generator, the pulse generator having an external casing with a hermetically sealed optical window, between an interior of the external casing and an exterior of the external casing, and a header, the header having an alignment cylinder for the percutaneous lead, the alignment cylinder terminating in a concave oriented frustoconical centering surface adjacent the hermetically sealed optical window, the percutaneous lead further comprising:
a flexible lead body, incorporating a stylet channel and a set of axially extending lumens, and having an internal surface and an external surface, and having a first distal end and a first proximal end, and wherein the set of axially extending lumens is radially distributed around the stylet channel;
an optical transmission section, having a cap and an optical fiber diffuser cavity, at the first distal end;
wherein the cap is internally reflective;
a set of electrodes, positioned adjacent the optical transmission section, fixed to the external surface;
an anchor ring, connected to a ground line for providing electrical shielding, positioned at the first proximal end and fixed to the external surface;
the ground line, positioned in a lumen of the set of axially extending lumens, parallel and adjacent to a set of conductors;
the ground line connected to the external casing, and not connected to any electrode of the set of electrodes and not connected to any conductor of the set of conductors;
a set of contacts, adjacent to the anchor ring;
the set of conductors positioned in the set of axially extending lumens;
wherein at least one contact, of the set of contacts, is electrically connected to at least one electrode of the set of electrodes by a conductor of the set of conductors;
an optical fiber, having a second distal end and a second proximal end, the second distal end terminated in a radial light dispersion section, positioned in the stylet channel;
wherein the radial light dispersion section is positioned in the optical fiber diffuser cavity; and,
a cylindrical ferrule, having a convex oriented frustoconical alignment tip, positioned around the optical fiber, coterminous with the second proximal end, preventing the optical fiber from exerting pressure on the hermetically sealed optical window, by the convex oriented frustoconical alignment tip impinging on the concave oriented frustoconical centering surface.

### Claim 2 (depends on 1)

The percutaneous lead of claim 1 wherein the anchor ring is positioned proximal to the set of contacts.

### Claim 3 (depends on 1)

The percutaneous lead of claim 1 further comprising:
a low friction surface adjacent the internal surface.

### Claim 4 (depends on 3)

The percutaneous lead of claim 3 wherein the low friction surface is a polytetrafluoroethylene material.

### Claim 5 (depends on 1)

The percutaneous lead of claim 1 further comprising:
a low friction surface adjacent the external surface.

### Claim 6 (depends on 1)

The percutaneous lead of claim 1 wherein the optical fiber further comprises a low friction exterior surface.

### Claim 7 (depends on 1)

The percutaneous lead of claim 1 wherein the optical fiber is removable from the stylet channel.

### Claim 8 (depends on 1)

The percutaneous lead of claim 1 wherein the optical fiber further comprises a polymethylmethacrylate material.

### Claim 9 (depends on 1)

The percutaneous lead of claim 1 wherein the optical fiber includes an internally reflective tip, adjacent the radial light dispersion section.

### Claim 10 (depends on 9)

The percutaneous lead of claim 9 wherein the internally reflective tip is further comprised of a non-metallic reflective coating.

### Claim 11 (depends on 1)

The percutaneous lead of claim 1 wherein the set of conductors is radially positioned in the flexible lead body, between the internal surface and the external surface.

### Claim 12 (depends on 1)

The percutaneous lead of claim 1 wherein:
the flexible lead body has a lead external diameter and a stylet channel diameter;
the cylindrical ferrule has a ferrule exterior diameter; and,
wherein the ferrule exterior diameter is greater than the stylet channel diameter and lesser than the lead external diameter.

### Claim 13 (depends on 1)

The percutaneous lead of claim 1 further comprising:
a ground shielding layer, connected to the ground line, positioned on the external surface of the flexible lead body between the optical transmission section and the anchor ring.

### Claim 14 (depends on 13)

The percutaneous lead of claim 13 wherein the ground shielding layer is a carbon fiber infusion into the external surface of the flexible lead body.

### Claim 15

A pulse generator system comprising:
a housing;
a header, adjacent the housing, having a lead channel terminating in a concave oriented frustoconical centering surface;
an optical window, positioned in the housing, adjacent the concave oriented frustoconical centering surface;
the housing supporting a set of optical components adjacent the optical window;
the lead channel further having an optical axis;
a flexible lead body, incorporating a stylet channel and a set of axially extending lumens, and having an internal surface and an external surface, and having a first distal end and a first proximal end, and wherein the set of axially extending lumens is radially distributed around the stylet channel;
an optical transmission section, having a cap and an optical fiber diffuser cavity, at the first distal end;
wherein the cap is internally reflective;
a set of electrodes, positioned adjacent the optical transmission section, fixed to the external surface;
an anchor ring, positioned at the first proximal end, fixed to the external surface;
a set of contacts, adjacent to the anchor ring;
a set of conductors positioned in the set of axially extending lumens;
wherein at least one contact, of the set of contacts, is electrically connected to at least one electrode of the set of electrodes by a conductor of the set of conductors;
an optical fiber, having a second distal end and a second proximal end, the second distal end terminated in a radial light dispersion section, positioned in the stylet channel;
wherein the radial light dispersion section is positioned in the optical fiber diffuser cavity; and,
a cylindrical ferrule, having a convex oriented frustoconical alignment tip, fixed on the optical fiber, polished flush with the second proximal end;
wherein the convex oriented frustoconical alignment tip impinges on the concave oriented frustoconical centering surface thereby preventing the optical fiber from exerting longitudinal pressure on the optical window.

### Claim 16 (depends on 15)

The pulse generator system of claim 15 wherein:
the lead channel further comprises a plurality of toroidal header connections; and,
the at least one contact, of the set of contacts, is in electrical contact with at least one toroidal header connection of the plurality of toroidal header connections.