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

• US 10,736,533 B2
• Filed: 10/13/2017
• Issued: 08/11/2020
• Est. Priority Date: 12/21/2009
• Status: Active Grant

• Current Assignee: Sherwin Hua
• Original Assignee: Sherwin Hua
• Inventors: Hua, Sherwin
• Primary Examiner(s): Piateski, Erin M
• Application Number:
  US15/783,954
• Publication Number:
  US 20180153429A1
• Time in Patent Office: 1,033 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

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 brain stimulation of a patient, the method comprising:

inserting a first device having a first housing into a skull at an entry site along a first angle that is orthogonal or non-orthogonal with an outer surface of the skull such that at least a substantial portion of the first housing remains inserted within a thickness of the skull, wherein the first housing of the first device has a length longer than a thickness of the skull and is inserted into the skull without penetrating into the brain, wherein the first device carries a first component;

inserting a second device having a second housing into the skull at the entry site along a second angle that is orthogonal or non-orthogonal with the outer surface of the skull such that at least a substantial portion of the second housing remains inserted within the thickness of the skull, wherein the second housing of the second device has a length longer than the thickness of the skull and is inserted into the skull without penetrating into the brain, the second angle different from the first angle, wherein the second device carries a second component, and wherein at least one of the first and second components comprises a stimulation electrode; and

stimulating the brain using at least one of the first and second components.

2. The method of claim 1, wherein the first device and the second device are inserted into the skull at non-orthogonal angles to the outer surface of the skull.

3. The method of claim 1, wherein the first device and the second device are inserted into the skull through the entry site and extend inside the skull generally parallel to an inner surface of the skull.

4. The method of claim 1, wherein the second device is inserted into the skull at the entry site with the first device inserted into the skull through the entry site.

5. The method of claim 1, wherein both the first and second components comprise stimulation electrodes.

6. The method of claim 1, wherein at least one of the first and second components is selected from the group consisting of a battery, a transmitter, a receiver, a radio transceiver, a heat generator, a cooling device, a magnetic coil, a capacitor, a transformer, an ultrasonic transducer, a hypersonic emitters/receiver, electrophysiological recording means, a sensors, iontophoresis means, an optical stimulator, a laser, a camera, and an address/positioning unit.

7. The method of claim 1, wherein at least one of the first and second components comprises a sensor, wherein the sensor receives and records data.

8. The method of claim 1, wherein stimulating the brain comprises stimulating a temporal lobe using at least one of the first and second components.

9. The method of claim 8, wherein the first device and the second device are inserted into a temporal bone of the skull superior to a zygomatic process to traverse a petrous temporal bone parallel to an inferior surface of the temporal lobe.

10. The method of claim 1, wherein stimulating the brain comprises stimulating a cerebral cortex using at least one of the first and second components.

11. The method of claim 1, wherein the first and second devices are positioned with respect to the brain to treat memory loss.

12. The method of claim 1, wherein the first and second devices are positioned with respect to the brain to treat epilepsy.

13. The method of claim 1, wherein stimulating the brain comprises using waves of energy transmitted through at least one of the first and second components.

14. The method of claim 1, wherein the first and second devices are inserted into the skull through the same, single entry site.

15. The method of claim 14, wherein the entry site comprises a minimally invasive entry site, wherein the entry site is no larger than a 2-10 mm incision.

16. The method of claim 1, wherein stimulating the brain using at least one of the first and second components comprises generating an electric field to treat a tumor.

17. The method of claim 1, wherein stimulating the brain comprises inserting nine different shafts each carrying an electrode through a single entry site such that eight electrodes surround a central electrode, wherein the shafts are configured for epilepsy stimulation with the central electrode configured to sense seizure activity at a seizure focus and be activated to abort a seizure and the surrounding electrodes configured to trap and cancel a spreading waive of seizure activity from the seizure focus.

18. The method of claim 1, comprising inserting the first device having the first housing into a skull and inserting the second device having the second housing into a skull such that at least one of the first housing and the second housing remains inserted entirely within the skull.

19. A method of brain stimulation of a patient, the method comprising:

making a first hole in the skull at an entry site, wherein the first hole is made along a first angle that is non-orthogonal with an outer surface of the skull;

inserting a first device having a first housing into the first hole such that the first housing remains implanted at least substantially within a thickness of the skull, wherein the first housing of the first device has a length longer than a thickness of the skull and is inserted into the skull without penetrating into the brain, and wherein the first device carries a first component in the first housing;

making a second hole in the skull at the entry site, wherein the second hole is made along a second angle that is non-orthogonal with an outer surface of the skull, wherein the second angle is different than the first angle;

inserting a second device having a second housing into the second hole such that the second housing remains implanted at least substantially within a thickness of the skull, wherein the second housing of the second device has a length longer than the thickness of the skull and is inserted into the skull without penetrating into the brain, and wherein the second device carries a second component in the second housing; and

stimulating the brain using at least one of the first and second components.