Integrated Delivery and Visualization Tool for a Neuromodulation System

• US 20100168513A1
• Filed: 12/29/2009
• Published: 07/01/2010
• Est. Priority Date: 12/29/2008
• Status: Active Grant

• Current Assignee: Realeve LLC
• Original Assignee: Autonomic Technologies, Inc. (Ford Motor Company)
• Inventors: Boling, Carl Lance, Caparso, Anthony, Pless, Benjamin David
• Granted Patent: US 8,412,336 B2
• Time in Patent Office: Days
• US Class Current: 600/106
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 1/00154 using guiding arrangements for insertion
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/042 characterised by a proximal camera, e.g. a CCD camera
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• CPC Class Codes: A61B 1/313 for introducing through surgical openings, e.g. laparoscopes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

Methods and apparatus for delivering a neurostimulator to a target tissue are provided which may include any number of features. One feature is a delivery tool comprising a handle portion, an elongate shaft comprising a contoured distal portion, a visualization system embedded in the elongate shaft, and an insertion groove on the elongate shaft configured to deploy the neurostimulator. The contoured distal portion can be shaped and configured to maintain contact with a posterior maxilla and elevate a periosteum off of the posterior maxilla to avoid soft tissue dissection. In some embodiments, the neurostimulator is implanted in close proximity to or touching the sphenopalatine ganglion.

Claims

1. A method of delivering a neurostimulator to within close proximity of a sphenopalatine ganglion, comprising:

making an incision over an anterior maxilla;

inserting a delivery tool having an integrated visualization system into the incision;

visualizing tissue near a distal portion of the delivery tool with the visualization system;

advancing the delivery tool sub-periosteally at a lateral edge of a zygomaticomaxillary buttress region towards a pterygopalatine fossa; and

delivering the neurostimulator in close proximity to the sphenopalatine ganglion.

2. The method of claim 1 further comprising the step of elevating a periosteum away from the anterior maxilla with the delivery tool to expose a zygomaticomaxillary buttress region prior to the advancing step.

3. The method of claim 1 wherein the advancing step further comprises advancing the delivery tool posteriorly, medially, and superiorly towards the pterygopalatine fossa.

4. The method of claim 1 wherein the delivery tool includes a contoured distal portion that is shaped and configured to maintain contact with a posterior maxilla and elevate a periosteum off of the posterior maxilla to avoid soft tissue dissection.

5. The method of claim 4 wherein the contoured distal portion has a thickness of between 2-5 mm.

6. The method of claim 4 wherein the contoured distal portion has an elliptical cross-section.

7. The method of claim 1 wherein the visualization system comprises a fiberscope.

8. The method of claim 1 further comprising the step of illuminating the delivery tool with a light source placed within a nasal cavity and positioned close to or within a sphenopalatine foramen.

9. A delivery tool configured to deliver a neurostimulator into a patient, comprising:

a handle portion;

an elongate shaft comprising a contoured distal portion, the contoured distal portion shaped and configured to maintain contact with a posterior maxilla and elevate a periosteum off of the posterior maxilla to avoid soft tissue dissection;

a visualization system embedded in the elongate shaft; and

an insertion groove on the elongate shaft configured to deploy the neurostimulator.

10. The delivery tool of claim 9, wherein the insertion groove is recessed into the elongate shaft.

11. The delivery tool of claim 9 wherein the insertion groove is located on an opposing edge of the delivery tool from the visualization system, allowing for visualization of the deployment of the neurostimulator.

12. The delivery tool of claim 9 wherein the visualization system is a fiberscope.

13. The delivery tool of claim 9 wherein the visualization system comprises a light source contained in the handle portion.

14. The delivery tool of claim 9 further comprising a lens embedded at the distal portion, the lens constructed to allow for a focal length of between 2-15 mm.

15. The delivery tool of claim 9 wherein the visualization system is configured to highlight differences between soft tissue and bone.

16. The delivery tool of claim 9 wherein the visualization system comprises an electronic chip positioned within the distal portion and configured to provide video and/or still images to be sent to a viewing system.

17. The delivery tool of claim 9 further comprising an external light source configured to provide illumination of the delivery tool.

18. The delivery tool of claim 9 further comprising an aperture configured to dispense a fluid to a distal end of the delivery tool.

19. The delivery tool of claim 18 further comprising a touch sensitive button coupled to the aperture, wherein a quick press of the button releases a bolus of fluid from the aperture and a long press of the button releases a continuous stream of fluid from the aperture.

20. The delivery tool of claim 9 further comprising a bifurcated distal dissecting tip having a lens positioned between the dissecting tips.

21. The delivery tool of claim 9 further comprising a tissue clearance tip around the visualization system configured to provide increased tissue clearance around the visualization system.

22. The delivery tool of claim 9 wherein the contoured distal portion has a thickness of between 2-5 mm.

23. The delivery tool of claim 9 wherein the contoured distal portion has an elliptical cross-section.

24. A method of treating a neurological disorder, comprising:

making an incision over an anterior maxilla;

inserting a delivery tool having an integrated visualization system into the incision;

visualizing tissue near a distal portion of the delivery tool with the visualization system;

advancing the delivery tool sub-periosteally at a lateral edge of the zygomaticomaxillary buttress region towards the pterygopalatine fossa;

delivering the neurostimulator in close proximity to the sphenopalatine ganglion; and

applying an electrical current from the neurostimulator to the sphenopalatine ganglion to treat the neurological disorder.

25. The method of claim 24 further comprising the step of elevating a periosteum away from the anterior maxilla with the delivery tool to expose a zygomaticomaxillary buttress region prior to the advancing step.

26. The method of claim 24 wherein the delivery tool includes a contoured distal portion that is shaped and configured to maintain contact with a posterior maxilla and elevate a periosteum off of the posterior maxilla to avoid soft tissue dissection.

27. The method of claim 24 wherein the neurological disorder is headache.