IMPLANT AND DELIVERY SYSTEM FOR NEURAL STIMULATOR

• US 20150133956A1
• Filed: 11/10/2014
• Published: 05/14/2015
• Est. Priority Date: 11/10/2013
• Status: Active Grant

• Current Assignee: BrainsGate Ltd.
• Original Assignee: BrainsGate Ltd.
• Inventors: Dayan, Avinoam, Dvorsky, Israel, Altman, Hernan
• Granted Patent: US 9,675,796 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/2065 Tracking using image or pattern recognition
• CPC Class Codes: A61B 2034/2068 using pointers, e.g. pointers having reference marks for determining coordinates of body points
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/16 Bite blocks
• CPC Class Codes: A61C 1/084 of implanting tools
• CPC Class Codes: A61C 8/0096 Implants for use in orthodontic treatment
• 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 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: Y10T 29/49 Method of mechanical manufacture

Abstract

Apparatus is described, the apparatus including an oral surgical guide. The oral surgical guide includes an arch portion configured to be placed on a dental arch of a subject; and an extension portion extending from the arch portion, and shaped to define a guide hole. Other applications are also described.

Claims

1. Apparatus, comprising:

an oral surgical guide comprising;

an arch portion configured to be placed on a dental arch of a subject; and

an extension portion extending from the arch portion, and shaped to define a guide hole.

2. The apparatus according to claim 1, wherein the extension portion extends from the arch portion in a superior and lingual direction with respect to the arch.

3. The apparatus according to claim 1, further comprising:

a steerable implantable neural stimulator configured to apply electrical stimulation to a sphenopalatine ganglion (SPG) of the subject,

wherein the guide hole is configured to guide the stimulator through a greater palatine foramen of a palate of an oral cavity of the subject and into a greater palatine canal of the subject.

4. The apparatus according to claim 3, wherein the guide hole is configured to guide the stimulator through the greater palatine foramen at an angle that is suitable for entering the greater palatine canal.

5. The apparatus according to claim 1, wherein the surgical guide is generated by using CT scan data of the subject and intra-oral scan data of the subject, and wherein the guide hole corresponds to a location of a greater palatine foramen of the subject.

6. The apparatus according to claim 5, wherein a portion of the surgical guide corresponding to a surface of gum tissue of the subject is shaped in a curved manner that matches curvature of the gum tissue.

7. The apparatus according to claim 1, wherein the surgical guide is generated by using CT scan data of the subject and not using intra-oral scan data of the subject, and wherein the guide hole corresponds to a location of a greater palatine foramen of the subject.

8. The apparatus according to claim 1, wherein the implant is shaped to define proximal and distal portions, and wherein the distal portion of the implant is configured to puncture oral mucosa of the subject.

9. The apparatus according to claim 1, wherein the implant is shaped to define proximal and distal portions, and wherein the distal portion of the implant comprises at least one electrode configured to apply electrical stimulation to a sphenopalatine ganglion (SPG) of the subject.

10. The apparatus according to claim 1, wherein the surgical guide is formed by a three-dimensional printing process.

11. The apparatus according to claim 1, wherein the surgical guide is shaped by shaping a pliable material on the dental arch of the subject.

12. The apparatus according to claim 11, wherein the pliable material comprises a thermoplastic material.

13-31. -31. (canceled)

32. A method comprising:

using an oral surgical guide generated using scan data selected from the group consisting of;

intra-oral scan data and CT scan data, to determine a location of a greater palatine foramen of a palate of an oral cavity of a subject;

inserting a steerable implantable neural stimulator into the greater palatine foramen of the subject, through a hole in the surgical guide; and

advancing the stimulator through a greater palatine canal of the subject to a sphenopalatine ganglion (SPG) of the subject.

33. The method according to claim 32, wherein using scan data selected from the group consisting of intra-oral scan data and CT scan data, comprises using CT scan data and not intra-oral scan data.

34. The method according to claim 32, wherein using scan data selected from the group consisting of intra-oral scan data and CT scan data, comprises using intra-oral scan data and not CT scan data.

35. The method according to claim 32, wherein using scan data selected from the group consisting of intra-oral scan data and CT scan data, comprises using intra-oral scan data and CT scan data.

36. The method according to claim 32, wherein using the oral surgical guide generated using the scan data comprises using the oral surgical guide generated using the CT scan data, wherein using the oral surgical guide generated using the CT scan data further comprises using the oral surgical guide to determine a suitable angle for entering the greater palatine canal, and wherein inserting the stimulator into the greater palatine foramen comprises inserting the stimulator at the suitable angle.

37. The method according to claim 32, further comprising creating an opening in mucosa of the subject using the stimulator, wherein inserting the stimulator comprises inserting the stimulator through the opening.

38. The method according to claim 32, further comprising coupling a tool, in which the stimulator is disposed, to the hole in the surgical guide, and wherein creating the opening comprises creating the opening while the tool is coupled to the hole in the surgical guide.

39. The method according to claim 32, wherein inserting the stimulator comprises inserting the stimulator using a tool, and wherein the method further comprises, following the advancing of the stimulator, allowing the tool to be withdrawn from the greater palatine canal without dislodging the stimulator by disengaging a locking element of the stimulator from the tool.

40. The method according to claim 39, wherein the locking element is shaped as a ball, and wherein disengaging the locking element comprises disengaging the ball-shaped locking element from the tool.

41. A method comprising:

receiving CT scan data and intra-oral scan data of a subject; and

using the CT and intra-oral scan data, generating an oral surgical guide shaped to define a hole, the hole being placeable against a location of a greater palatine foramen of the subject.

42. The method according to claim 41, wherein generating the oral surgical guide comprises:

generating the oral surgical guide without the hole, using the intra-oral scan data;

subsequently, performing the step of receiving the CT scan data; and

subsequently, generating the oral surgical guide with the hole by creating the hole using the CT scan data.

43-46. -46. (canceled)