System and methods for a cranial lead fixation device

1 . A device, comprising:

a body including:

a burr hole aperture defining a central axis;

a first portion of a fixation channel, the first portion of the fixation channel being in communication with the burr hole aperture; and

an insertion channel in communication with the burr hole aperture for insertion of a medical device through the insertion channel and into the burr hole aperture; and

a fixation mechanism pivotably coupled to the body by a connector mechanism defining a pivot axis that is substantially parallel to the central axis of the burr hole aperture, the fixation mechanism being rotatable about the pivot axis between a first open configuration and a second closed configuration, and the fixation mechanism having an inner face and a protrusion projecting from the inner face;

wherein rotation of the fixation mechanism about the pivot axis from the first open configuration into the second closed configuration positions the protrusion within the insertion channel to occlude the insertion channel, completes the fixation channel, and occludes the burr hole aperture.

2 . The device of claim 1 , wherein the body defines an inner face and an outer face, the inner face being configured for engagement with a cranium of a patient.

3 . The device of claim 2 , wherein the inner face of the body further comprises a burr hole lip defined circumferentially around the burr hole aperture.

4 . The device of claim 2 , the inner face of the fixation mechanism being configured for engagement along the outer face of the body, the inner face of the fixation mechanism defining a second portion of the fixation channel that aligns with the first portion of the fixation channel to complete the fixation channel when in the second closed configuration.

5 . The device of claim 2 , wherein the inner face of the body is a concave surface that corresponds to a curvature of the cranium of the patient.

6 . The device of claim 1 , wherein the body defines at least one cranial screw aperture configured for engagement with at least one cranial screw, wherein the at least one cranial screw is configured and arranged to secure the device to a cranium of a patient.

7 . The device of claim 6 , wherein the at least one cranial screw aperture includes a first cranial screw aperture and a second cranial screw aperture and the at least one cranial screw includes a first cranial screw and a second cranial screw, and wherein the fixation mechanism includes a second cranial screw seat that aligns with the second cranial screw aperture when the device is in the second closed configuration, wherein the first cranial screw aperture is configured to receive the first cranial screw to secure the body to a cranium of a patient and wherein the second cranial screw aperture and the second cranial screw seat are collectively configured to receive the second cranial screw configured and arranged to secure the body and the fixation mechanism to a cranium of a patient.

8 . The device of claim 1 , wherein the connector mechanism includes a cranial screw configured for insertion into a cranial screw seat of the fixation mechanism and a cranial screw aperture of the body, wherein the cranial screw is configured and arranged to secure the device to a cranium of a patient.

9 . The device of claim 1 , wherein the fixation channel and the burr hole aperture are collectively configured to capture the medical device therein.

10 . The device of claim 9 , wherein the fixation mechanism is configured and arranged to apply a force to the medical device captured at the fixation channel.

11 . The device of claim 1 , wherein the fixation mechanism defines a plate shape for rotatable and/or removeable engagement along an outer face of the body.

12 . A method, comprising:

a body defining an inner face, an outer face, and a burr hole aperture defining a central axis, the inner face being configured for engagement with a cranium of a patient;

forming a first portion of a fixation channel along the outer face of the body and in communication with the burr hole aperture;

forming an insertion channel in communication with the burr hole aperture for insertion of a medical device through the insertion channel and into the burr hole aperture;

providing a fixation mechanism having an inner face;

forming a first hinge aperture in the body and a second hinge aperture in the fixation mechanism, the first hinge aperture and the second hinge aperture being coaxially positionable to receive a pivot hinge of a connector mechanism that defines a pivot axis substantially parallel to the central axis of the burr hole aperture, such that, when the fixation mechanism is coupled to the body by the connector mechanism, the fixation mechanism is rotatable about the pivot axis between a first open configuration and a second closed configuration; and

forming a protrusion projecting from the inner face of the fixation mechanism such that rotation of the fixation mechanism into the second closed configuration positions the protrusion within the insertion channel to occlude the insertion channel, completes the fixation channel, and occludes the burr hole aperture.

13 . The method of claim 12 , further comprising:

positioning an inner face of the body against a cranium of a patient such that the burr hole aperture of the body is positioned over a burr hole of the cranium; and

inserting a cranial screw into the body and the cranium to fix the body to the cranium.

14 . The method of claim 12 , further comprising:

inserting the medical device through the insertion channel of the body and into the burr hole aperture.

15 . The method of claim 12 , further comprising:

rotating the fixation mechanism about the connector mechanism from the first open configuration to the second closed configuration.

16 . The method of claim 15 , further comprising:

inserting a cranial screw through the fixation mechanism, the body, and into the cranium to fix the fixation mechanism and the body to the cranium.

17 . The method of claim 12 , further comprising:

coupling the connector mechanism to at least one of the body and the fixation mechanism.