# US 10,478,265 B2 · Cranial fixation device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,478,265 B2 - Document ID: US10478265B2 - Status: Granted - Kind: B2 - Application number: 15/476,088 - Filed: 2017-03-31 - Published: 2018-10-04 - Granted: 2019-11-19 - Earliest claimed: 2017-03-31 - Assignees: Integra LifeSciences Corporation - Applicants: Integra LifeSciences Corporation - Inventors: Michael A. DeFusco; Gregory M. Schorn - Web page: https://patentgrep.com/patent/US10478265B2 ## CPC - A61B 90/14: Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins - A61M 25/02: Holding devices, e.g. on the body - A61B 2017/347: {Locking means, e.g. for locking instrument in cannula} - A61B 2017/349: {Trocar with thread on outside} - A61B 2090/031: {torque limiting} - A61B 2090/035: {preventing further rotation} - A61B 2090/0808: {for indicating correct assembly of components, e.g. of the surgical apparatus} - A61B 2090/0812: {indicating loosening or shifting of parts of an instrument, signaling maladjustment of parts} - A61B 2090/103: {Cranial plugs for access to brain} - A61M 2025/024: {having a clip or clamp system} - A61M 2025/028: {having a mainly rigid support structure} - A61M 2025/0286: {anchored in the skin by suture or other skin penetrating devices} - A61M 2210/0687: Skull, cranium - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract Cranial fixation devices are provided. For example, a cranial fixation device may include positive stops that provide visual and tactical feedback when a predetermined compression is applied once a medical device is inserted therein and placed in position. ## Claims ### Claim 1 A cranial fixation device comprising: a cap comprising: a central body having a mating connector with a threaded portion projecting from a distal end of the central body; a pair of wings extending radially out from the central body; and a first opening extending from a proximal end of the central body to the distal end of the central body and through the threaded portion of the mating connector, a base comprising: a threaded central opening corresponding to the threaded portion of the mating connector, the threaded central opening being positioned on a proximal end of the base; a distal threaded portion configured to engage with an opening in a skull; a pair of wings extending radially out from the threaded central opening; and a second opening extending through the threaded central opening and the distal threaded portion; and a compression grommet configured to be placed into the threaded central opening of the base, the compression grommet having a third opening extending from a proximal end of the compression grommet to a distal end of the compression grommet, the first opening, the second opening and the third opening being aligned when the cap mates with the base and forms an instrument lumen configured to accept a portion of an instrument cable, the threaded portion of the cap being configured to mate with the threaded central opening of the base, and at least one wing of the pair of wings of the cap having a projection protruding in a direction towards the base, and each wing of the pair of wings of the base having a seat, wherein, when the instrument cable extends through the instrument lumen, the projection from at least one wing of the pair of wings of the cap and at least one of the seats in the pair of wings of the base are configured to create a torque stop when a predetermined compression of the compression grommet is applied by tightening the cap on the base, and when the predetermined compression of the compression grommet is applied, the compression grommet compresses against the instrument cable fixing the instrument cable in place at a determined depth. ### Claim 2 (depends on 1) The cranial fixation device of claim 1, wherein when the predetermined compression of the compression grommet is applied, the pair of wings of the cap are aligned with the pair of wings of the base. ### Claim 3 (depends on 1) The cranial fixation device of claim 1, wherein the threaded portion of the mating connector, the projection from at least one wing of the pair of wings of the cap and at least one of the seats in the pair of wings of the base are configured such that when the predetermined compression of the compression grommet is applied, a distal end of the threaded portion mates with the threaded central opening, the pair of wings of the cap are aligned with the pair of wings of the base and the projection from at least one of the pair of wings of the cap and at least one of the seats in the pair of wings of the base creates the torque stop. ### Claim 4 (depends on 1) The cranial fixation device of claim 1, wherein each wing of the pair of wings of the base further comprises a notch configured to receive a portion of the instrument cable. ### Claim 5 (depends on 4) The cranial fixation device of claim 4, wherein each notch is located on a distal portion of each wing, respectively. ### Claim 6 (depends on 5) The cranial fixation device of claim 5, wherein when a portion of the instrument cable is received in the respective notches, a portion of the instrument cable extends between the respective notches. ### Claim 7 (depends on 1) The cranial fixation device of claim 1, wherein each wing of the pair of wings of the cap comprises a projection towards the direction of the base, and each wing of pair of wings of the base comprises a corresponding seat, each projection and the corresponding seat forming a torque stop when the predetermined compression of the compression grommet is applied by tightening the cap on the base. ### Claim 8 (depends on 1) The cranial fixation device of claim 1, wherein the instrument lumen has a diameter dimensioned for slidably accepting the instrument cable. ### Claim 9 (depends on 1) The cranial fixation device of claim 1, wherein the determined depth is adjustable. ### Claim 10 (depends on 1) The cranial fixation device of claim 1, wherein the pair of wings of the cap extends symmetrically in opposite directions with respect to the central body and wherein the pair of wings of the base extend symmetrically in opposite directions with respect to the threaded central opening. ### Claim 11 (depends on 1) The cranial fixation device of claim 1, wherein the first opening has a larger diameter at the proximal end of the central body than the distal end of the central body. ### Claim 12 (depends on 1) The cranial fixation device of claim 1, wherein the threaded portion has a male threading. ### Claim 13 (depends on 1) The cranial fixation device of claim 1, the projection being located on a distal end of at least one wing of the pair of wings of the cap. ### Claim 14 (depends on 1) The cranial fixation device of claim 1, wherein the pair of wings of the cap are configured to facilitate mating the cap to the base. ### Claim 15 A cranial fixation device comprising: a base comprising: a threaded central opening positioned on a proximal end of the base, the threaded central opening configured to mate with a mating connector of a cap; a distal threaded portion configured to engage with an opening in a skull; an opening extending through the threaded central opening and the distal threaded portion, the opening configured to receive a portion of an instrument cable; and a pair of wings extending radially out from the threaded central opening, each wing having a notch configured to receive another portion of the instrument cable; wherein each notch is located on a distal portion of each wing, respectively. ### Claim 16 (depends on 15) The cranial fixation device of claim 15, wherein when a portion of the instrument cable is received in the respective notches, a portion of the instrument cable extends between the respective notches. ### Claim 17 (depends on 16) The cranial fixation device of claim 16, wherein the threaded central opening is further configured to receive a compression grommet, each wing of the pair of wings has a seat, each seat configured to form a torque stop by engaging with a corresponding projection in a cap when a predetermined compression of the compression grommet is applied responsive to the cap mating with the base. ### Claim 18 A cranial fixation device comprising: a cap comprising: a central body having a mating connector with a threaded portion projecting from a distal end of the central body; a first opening extending from a proximal end of the central body to the distal end of the central body and through the threaded portion of the mating connector, a base comprising: a threaded central opening corresponding to the threaded portion of the mating connector, the threaded central opening being positioned on a proximal end of the base; a distal threaded portion configured to engage with an opening in a skull; a pair of wings extending radially out from the threaded central opening; and a second opening extending through the threaded central opening and the distal threaded portion; and a compression grommet configured to be placed into the threaded central opening of the base, the compression grommet having a third opening extending from a proximal end of the compression grommet to a distal end of the compression grommet, the first opening, the second opening and the third opening being aligned when the cap mates with the base and forms an instrument lumen configured to accept a portion of an instrument cable, the threaded portion of the cap being configured to mate with the threaded central opening of the base, wherein, when the instrument cable extends through the instrument lumen, the dimensions of the threaded central opening and the threaded portion are configured to create a torque stop when a predetermined compression of the compression grommet is applied by tightening the cap on the base, and when the predetermined compression of the compression grommet is applied, the compression grommet compresses against the instrument cable fixing the instrument cable in place at a determined depth.