# US 12,594,166 B2 · Method for manufacturing a low-profile intercranial device and the low-profile intercranial device manufactured thereby

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- Number: US 12,594,166 B2
- Document ID: US12594166B2
- Status: Granted
- Kind: B2
- Application number: 17/344,518
- Filed: 2021-06-10
- Published: 2021-09-30
- Granted: 2026-04-07
- Earliest claimed: 2016-08-30
- Assignees: Longeviti Neuro Solutions LLC
- Applicants: Longeviti Neuro Solutions, Inc.; The Johns Hopkins University
- Inventors: Chad R. Gordon; Jesse Christopher
- Web page: https://patentgrep.com/patent/US12594166B2

## CPC

- A61F 2/2875: {Skull or cranium (A61F2/2803 takes precedence; joints for temporo-mandibular [TM] joints [TMJ] A61F2/3099)}
- A61N 1/0526: {Head electrodes (A61N1/0551 takes precedence)}
- B33Y 10/00: Processes of additive manufacturing
- B33Y 50/00: Data acquisition or data processing for additive manufacturing
- B33Y 80/00: Products made by additive manufacturing
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2034/102: {Modelling of surgical devices, implants or prosthesis}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- A61F 2/30942: {for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques}
- A61F 2002/30948: {using computerized tomography, i.e. CT scans}
- A61F 2002/30952: {using CAD-CAM techniques or NC-techniques}
- A61F 2002/30985: {using three dimensional printing [3DP]}
- A61N 1/0529: {Electrodes for brain stimulation}
- A61N 1/37514: {Brain implants}
- A61N 1/37518: {Anchoring of the implants, e.g. fixation}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A low-profile intercranial device including a low-profile static cranial implant and a functional neurosurgical implant. The low-profile static cranial implant and the functional neurosurgical implant are virtually designed and interdigitated prior to physical assembly of the low-profile intercranial device.

## Claims

### Claim 1

A cranial device, comprising:
a cranial implant shaped and dimensioned for placement at least partially within a resected portion of a patient's skull during performance of a cranioplasty, wherein the cranial implant is clear and allows for ultrasound transmission through the cranial implant for transmission of vital imaging with minimal distortion and wireless signal communication; and
the cranial implant including an outer first surface, an inner second surface, and a peripheral edge extending between the outer first surface and the inner second surface, the cranial implant further including a cavity formed in the cranial implant, the cavity being shaped and dimensioned to receive a functional neurosurgical implant;
the cranial implant comprises a base cranial implant member and a cover cranial implant member, the base cranial implant member including an outer convex first surface, an inner second surface, and a peripheral edge extending between the outer convex first surface and the inner second surface, the base cranial implant member including a recess formed in the outer convex first surface thereof, the recess having side walls and a bottom, the recess being shaped and dimensioned to receive the functional neurosurgical implant; and the cover cranial implant member fits over the recess along the outer convex first surface of the base cranial implant member and is shaped and dimensioned for selective placement over the recess to define the cavity in which the functional neurosurgical implant may be positioned, the cover cranial implant member including an outer convex first surface, an inner second surface, and a peripheral edge shaped and dimensioned for engagement with the outer convex first surface of the base member along an entirety of a periphery of the recess of the base member such that the outer first surface of the cranial implant consists essentially of the outer convex first surface of the cover cranial implant member and that portion of the outer convex first surface of the base cranial implant member not covered by the cover cranial implant member, wherein the inner second surface of the cover cranial implant member and the outer first surface of the base cranial implant member along the center recess define the cavity configured to conform to requirements of the functional neurosurgical implant, and that portion of the outer convex first surface of the base cranial implant member not covered by the cover cranial implant member extends to the peripheral edge of the base cranial implant member exhibiting a shape conforming to the resected portion of the skull; and
a functional neurosurgical implant positioned in the cavity.

### Claim 2 (depends on 1)

The cranial device according to claim 1, wherein the cranial implant is made of clear polymethyl methacrylate (PMMA).

### Claim 3 (depends on 2)

The cranial device according to claim 2, wherein the cranial implant allows for wireless optical links between the functional neurosurgical implant and remote devices or for power transmission and/or receipt between the functional neurosurgical implant and devices outside of the cranial implant.

### Claim 4 (depends on 2)

The cranial device according to claim 2, wherein the cranial implant allows for radio-frequency (RF) transmission through the cranial implant.

### Claim 5 (depends on 1)

The cranial device according to claim 1, wherein the cranial implant is a custom cranial implant.

### Claim 6

A cranial device, comprising:
a cranial implant shaped and dimensioned for placement at least partially within a resected portion of a patient's skull during performance of a cranioplasty, the cranial implant allowing for transmission of ultrasound waves therethrough;
the cranial implant including an outer first surface, an inner second surface, and a peripheral edge extending between the outer first surface and the inner second surface, the cranial implant further including a cavity formed in the cranial implant, the cavity being shaped and dimensioned to receive a functional neurosurgical implant providing for ultrasound functionality; and
the cranial implant comprises a base cranial implant member and a cover cranial implant member, the base cranial implant member including an outer convex first surface, an inner second surface, and a peripheral edge extending between the outer convex first surface and the inner second surface, the base cranial implant member including a recess formed in the outer convex first surface thereof, the recess having side walls and a bottom, the recess being shaped and dimensioned to receive the functional neurosurgical implant; and the cover cranial implant member fits over the recess along the outer convex first surface of the base cranial implant member and is shaped and dimensioned for selective placement over the recess to define the cavity in which the functional neurosurgical implant may be positioned, the cover cranial implant member including an outer convex first surface, an inner second surface, and an entirety of a peripheral edge shaped and dimensioned for engagement with the outer convex first surface of the base member along a periphery of the recess of the base member such that the outer first surface of the cranial implant consists essentially of the outer convex first surface of the cover cranial implant member and that portion of the outer convex first surface of the base cranial implant member not covered by the cover cranial implant member, wherein the inner second surface of the cover cranial implant member and the outer first surface of the base cranial implant member along the center recess define the cavity configured to conform to requirements of the functional neurosurgical implant, and that portion of the outer convex first surface of the base cranial implant member not covered by the cover cranial implant member extends to the peripheral edge of the base cranial implant member exhibiting a shape conforming to the resected portion of the skull; and
a functional neurosurgical implant with ultrasound functionality positioned in the cavity.

### Claim 7 (depends on 6)

The cranial device according to claim 6, wherein the cranial implant is a custom cranial implant.

### Claim 8 (depends on 6)

The cranial device according to claim 6, wherein the cranial implant is made of clear polymethyl methacrylate (PMMA).

### Claim 9 (depends on 6)

The cranial device according to claim 6, wherein the cover cranial implant member is removably securable to the base cranial implant member.

### Claim 10

A cranial device, comprising:
a radiolucent cranial implant shaped and dimensioned for placement at least partially within a resected portion of a patient's skull;
the cranial implant including an outer first surface, an inner second surface, and a peripheral edge extending between the outer first surface and the inner second surface, the cranial implant further including a cavity formed in the cranial implant, the cavity being shaped and dimensioned to receive a functional neurosurgical implant; and
the cranial implant comprises a base cranial implant member and a cover cranial implant member, the base cranial implant member including an outer convex first surface, an inner second surface, and a peripheral edge extending between the outer convex first surface and the inner second surface, the base cranial implant member including a recess formed in the outer convex first surface thereof, the recess having side walls and a bottom, the recess being shaped and dimensioned to receive the functional neurosurgical implant; and the cover cranial implant member fits over the recess along the outer convex first surface of the base cranial implant member and is shaped and dimensioned for selective placement over the recess to define the cavity in which the functional neurosurgical implant may be positioned, the cover cranial implant member including an outer convex first surface, an inner second surface, and an entirety of a peripheral edge shaped and dimensioned for engagement with the outer convex first surface of the base member along a periphery of the recess of the base member, such that the outer first surface of the cranial implant consists essentially of the outer convex first surface of the cover cranial implant member and that portion of the outer convex first surface of the base cranial implant member not covered by the cover cranial implant member, wherein the inner second surface of the cover cranial implant member and the outer first surface of the base cranial implant member along the center recess define the cavity configured to conform to requirements of the functional neurosurgical implant, and that portion of the outer convex first surface of the base cranial implant member not covered by the cover cranial implant member extends to the peripheral edge of the base cranial implant member exhibiting a shape conforming to the resected portion of the skull; and
a functional neurosurgical implant with radio-frequency (RF) functionality positioned in the cavity.

### Claim 11 (depends on 10)

The cranial device according to claim 10, wherein the cranial implant is a custom cranial implant.

### Claim 12 (depends on 10)

The cranial device according to claim 10, wherein the cranial implant is made of clear polymethyl methacrylate (PMMA).