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

• US 9,642,552 B2
• Filed: 03/11/2015
• Issued: 05/09/2017
• 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:
  US14/645,167
• Publication Number:
  US 20150245781A1
• Time in Patent Office: 790 Days
• Field of Search: 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

The invention comprises an elongated device adapted for insertion, including self-insertion, through the body, especially the skull. 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 gathering data about or providing electrical stimulation therapy to a patient'"'"'s brain, the method comprising:

creating an incision at an entry site in the patient'"'"'s scalp;

drilling a partial burrhole in the patient'"'"'s skull through the incision at the entry site;

implanting a first shaft comprising a first sensor or effector in the patient'"'"'s skull by passing the first shaft through the incision and partial burrhole and into the skull, wherein when the first shaft is fully inserted along a first trajectory, a proximal end of the shaft passes through the incision and burrhole, thereby allowing for another shaft to be inserted at a different trajectory; and

implanting a second shaft comprising a second sensor or effector in, the patient'"'"'s skull by passing the second shaft through the incision and partial burrhole and into the skull, wherein the second shaft is implanted along a second trajectory that is different than the first trajectory, and wherein when the second shaft is fully inserted along the second trajectory, a proximal end of the shaft passes through the incision and burrhole, thereby allowing for another shaft to be inserted at a different trajectory;

wherein each of the first and second shafts is configured to be inserted at an angle between and inclusive of parallel to a tangent of a surface at the incision and perpendicular to a tangent of a surface at the incision; and

wherein a length of the second shaft is independent of the first shaft and the lengths of the first and second shafts are not limited to the thickness of the skin, muscle, tissue, bone, or skull at the entry site.

2. The method of claim 1, wherein the lengths of the first and second shafts are selected such that the first and second shafts do not pass into the patient'"'"'s brain.

3. The method of claim 1, further comprising identifying at least first and second targets in the patient'"'"'s brain.

4. The method of claim 1, wherein the incision has a length of about 5-10 mm.

5. The method of claim 1, wherein the burrhole has a depth of about 2-4 mm.