Insertion of medical devices through non-orthogonal and orthogonal trajectories within the cranium and methods of using

• US 9,820,668 B2
• Filed: 03/10/2014
• Issued: 11/21/2017
• Est. Priority Date: 12/21/2009
• Status: Active Grant

• Current Assignee: Sherwin Hua
• Original Assignee: Sherwin Hua
• Inventors: Hua, Sherwin
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US14/202,707
• Publication Number:
  US 20140194720A1
• Time in Patent Office: 1,352 Days
• Field of Search: 600300, 600378, 607 45
• CPC Class Codes: A61B 17/1695 Trepans or craniotomes, i.e. specially adapted for drilling thin bones such as the skull
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/375 using biofeedback
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6865 Access ports
• CPC Class Codes: A61B 5/6868 Brain
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

An elongated device adapted for insertion, including self-insertion, through the body, especially the skull is disclosed. The device has at least one effector or sensor and is configured to permit implantation of multiple functional components through a single entry site into the skull by directing the components at different angles. The device may be used to provide electrical, magnetic, and other stimulation therapy to a patient'"'"'s brain. The lengths of the effectors, sensors, and other components may completely traverse skull thickness (at a diagonal angle) to barely protrude through to the brain'"'"'s cortex. The components may directly contact the brain'"'"'s cortex, but from there their signals can be directed to targets deeper within the brain. Effector lengths are directly proportional to their battery size and ability to store charge. Therefore, longer angled electrode effectors not limited by skull thickness permit longer-lasting batteries which expand treatment options.

Claims

1. A method of effecting or collecting data about a target site in a brain, the method comprising:

creating an opening at an entry site in an outer surface of a patient'"'"'s skull, the skull having a thickness defined between the outer surface and an inner surface;

inserting a first shaft through the opening into the skull at the entry site along a first angle such that at least a portion of the first shaft extends within the skull between the outer and inner surfaces, the portion extending within the skull between the inner and outer surfaces diverging away from the opening of the outer surface as the first shaft extends from the outer surface to the inner surface, the first shaft having coupled thereto at least one component including an effector or a sensor, wherein the at least one component is inserted into the skull and extends inside the skull generally parallel to an inner surface of the skull, and extends between the skull and the brain; and

inserting a second shaft through the opening into the skull at the entry site along a second angle such that at least a portion of the second shaft extends within the skull between the outer and inner surfaces, the portion extending within the skull between the inner and outer surfaces diverging away from the opening of the outer surface as the second shaft extends from the outer surface to the inner surface, the second angle different from the first angle, the second shaft having coupled thereto at least one component including an effector or a sensor, wherein the at least one component is inserted into the skull and extends inside the skull generally parallel to the inner surface of the skull, and extends between the skull and the brain.

2. The method of claim 1, further comprising providing biofeedback to the patient based on data collected about the target site.

3. The method of claim 1, wherein effecting the target site comprises stimulating the target site in the brain.

4. The method of claim 1, wherein effecting the target site comprises stimulating the dura to stimulate the trigeminal nerve.

5. The method of claim 1, wherein upon insertion of the first shaft, an angle between the first shaft and skin is different from an angle between the first shaft and an inner cortex of the skull.

6. The method of claim 1, wherein upon insertion of the first shaft, an angle between the first shaft and an outer cortex of the skull is different from an angle between the first shaft and an inner cortex of the skull.

7. The method of claim 1, further comprising monitoring brainwaves to collect data, and using the collected data for biofeedback.

8. The method of claim 1, wherein the shafts are inserted percutaneously, and are removed after a duration of time.

9. The method of claim 1, further comprising inflating a balloon cuff disposed around the shafts to stabilize the components within the brain, and deflating the balloon cuff prior to removal of the shafts from the skull.

10. The method of claim 1, wherein the at least one component coupled to the first shaft and the at least one component coupled to the second shaft do not extend into the brain.

11. The method of claim 1, wherein one of the at least one component coupled to the first shaft or the at least one component coupled to the second shaft does not extend into the brain and is an implantable microstimulator.

12. The method of claim 1, wherein one of the at least one component coupled to the first shaft or the at least one component coupled to the second shaft is greater in size than the thickness of the skull.

13. The method of claim 1, wherein one of the at least one component coupled to the first shaft or the at least one component coupled to the second shaft is equal to or shorter than the thickness of the skull.