Implant and delivery system for neural stimulator

• US 10,271,907 B2
• Filed: 05/13/2016
• Issued: 04/30/2019
• Est. Priority Date: 05/13/2015
• Status: Active Grant

• Current Assignee: BrainsGate Ltd.
• Original Assignee: BrainsGate Ltd.
• Inventors: Dayan, Avinoam, Dvorsky, Israel, Hugeri, Malka
• Primary Examiner(s): Nguyen, Vi X
• Application Number:
  US15/153,878
• Publication Number:
  US 20160331472A1
• Time in Patent Office: 1,082 Days
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2034/2061 using shape-sensors, e.g. fiber shape sensors with Bragg gratings
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61N 1/0548 Oral electrodes
• CPC Class Codes: A61N 1/36103 Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

Apparatus is provided for use with an optical fiber shape-sensing system. The apparatus includes an optical fiber, optically couplable to the optical fiber shape-sensing system, and configured to change shape during advancement through a greater palatine canal of a subject. The apparatus additionally includes a delivery tool configured to be removably coupled to the optical fiber and to distally advance the optical fiber through the greater palatine canal. The apparatus further includes a neural stimulator implant, configured to apply electrical stimulation to a sphenopalatine ganglion (SPG) of the subject. The neural stimulator implant is not in contact with the optical fiber, and is shaped and sized to be delivered to the sphenopalatine ganglion (SPG) by the delivery tool. Other applications are also described.

Claims

1. Apparatus for use with an optical fiber shape-sensing system, the apparatus comprising:

an optical fiber, optically couplable to the optical fiber shape-sensing system, and configured to change shape during advancement through a greater palatine canal of a subject;

a delivery tool configured to be removably coupled to the optical fiber and to distally advance the optical fiber through the greater palatine canal; and

a neural stimulator implant, which is (a) shaped and sized to be delivered to a sphenopalatine ganglion (SPG) of the subject by the delivery tool, (b) configured to not be in contact with the optical fiber during delivery of the neural stimulator implant by the delivery tool, and (c) configured to apply electrical stimulation to the SPG.

2. The apparatus according to claim 1, wherein the neural stimulator implant is not disposed within the delivery tool.

3. The apparatus according to claim 1, wherein the optical fiber has a sensing length of 4-6 cm.

4. The apparatus according to claim 3, wherein the optical fiber has fiber Bragg gratings that are positioned 2-5 mm apart from each other.

5. The apparatus according to claim 1, wherein the optical fiber shape-sensing system includes optical fiber shape-sensing circuitry and wherein the optical fiber is optically couplable to the optical fiber shape-sensing circuitry.

6. The apparatus according to claim 1, wherein the neural stimulator has a proximal portion, a distal portion and a middle portion between the proximal and distal portions, and wherein the proximal portion is more rigid than the middle portion.

7. The apparatus according to claim 6, wherein the distal portion is more rigid than the middle portion.

8. The apparatus according to claim 1, wherein the optical fiber has fiber Bragg gratings.

9. A method comprising:

using a delivery tool, distally advancing, through a greater palatine canal of a subject, an optical fiber being configured to change shape during advancement through the greater palatine canal;

assessing a shape of the palatine canal using an optical fiber shape-sensing system, based on a shape of the optical fiber during advancement;

removing the optical fiber from the greater palatine canal; and

subsequently to removing the optical fiber, distally advancing through the greater palatine canal a neural stimulator that is configured to apply electrical stimulation to a sphenopalatine ganglion (SPG) of the subject.

10. The method according to claim 9, wherein distally advancing the neural stimulator comprises navigating the neural stimulator in the palatine canal based on the assessing of the shape of the palatine canal.

11. The method according to claim 9, wherein using the delivery tool comprises navigating the delivery tool in the palatine canal based on the assessing of the shape of the palatine canal.

12. The method according to claim 9, wherein assessing the shape of the palatine canal using the optical fiber shape-sensing system, comprises mapping the palatine canal based on a shape of the optical fiber during advancement.

13. The method according to claim 9, further comprising implanting the neural stimulator in a vicinity of the SPG.

14. The method according to claim 9, wherein the optical fiber shape-sensing system includes optical fiber shape-sensing circuitry and wherein assessing comprises assessing a shape of the palatine canal using the optical fiber shape-sensing circuitry.

15. The method according to claim 9, further comprising, using the delivery tool during the distal advancing thereof, widening the palatine canal in preparation for advancing of the neural stimulator.

16. Apparatus comprising:

an optical fiber shape-sensing system;

an optical fiber, optically couplable to the optical fiber shape-sensing system, and configured to change shape during advancement through a greater palatine canal of a subject;

a delivery tool configured to be removably coupled to the optical fiber and to distally advance the optical fiber through the greater palatine canal; and

a neural stimulator implant, which is (a) shaped and sized to be delivered to a sphenopalatine ganglion (SPG) of the subject by the delivery tool, (b) configured to not be in contact with the optical fiber during delivery of the neural stimulator implant by the delivery tool, and (c) configured to apply electrical stimulation to the SPG.

17. The apparatus according to claim 16, wherein the optical fiber has a sensing length of 4-6 cm.

18. The apparatus according to claim 17, wherein the optical fiber has fiber Bragg gratings that are positioned 2-5 mm apart from each other.

19. The apparatus according to claim 16, wherein the optical fiber shape-sensing system comprises optical fiber shape-sensing circuitry and wherein the optical fiber is optically couplable to the optical fiber shape-sensing circuitry.

20. The apparatus according to claim 16, wherein the neural stimulator has a proximal portion, a distal portion and a middle portion between the proximal and distal portions, and wherein the proximal portion is more rigid than the middle portion.