# US 12,213,884 B2 · Low-profile intercranial device

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- Number: US 12,213,884 B2
- Document ID: US12213884B2
- Status: Granted
- Kind: B2
- Application number: 17/357,249
- Filed: 2021-06-24
- Published: 2021-10-14
- Granted: 2025-02-04
- Earliest claimed: 2015-09-04
- Assignees: The Johns Hopkins University
- Applicants: The Johns Hopkins University
- Inventors: Chad Gordon
- Web page: https://patentgrep.com/patent/US12213884B2

## CPC

- A61F 2/2875: {Skull or cranium (A61F2/2803 takes precedence; joints for temporo-mandibular [TM] joints [TMJ] A61F2/3099)}
- A61B 5/0006: {ECG or EEG signals}
- A61B 5/0013: {Medical image data (A61B1/00011, A61B6/56, A61B8/56 take precedence)}
- A61B 5/0036: {including treatment, e.g., using an implantable medical device, ablating, ventilating}
- A61B 5/0066: {Optical coherence imaging}
- A61B 5/0071: {by measuring fluorescence emission}
- A61B 5/031: {Intracranial pressure}
- A61B 5/37: Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61B 5/6868: {Brain}
- A61F 2/30942: {for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques}
- A61N 1/00: Electrotherapy; Circuits therefor (A61N2/00 takes precedence; irradiation apparatus A61N5/00)
- A61N 1/0531: {Brain cortex electrodes}
- A61N 1/3605: {Implantable neurostimulators for stimulating central or peripheral nerve system}
- A61B 5/0084: {for introduction into the body, e.g. by catheters (A61B5/1459 takes precedence)}
- A61B 5/4839: {combined with drug delivery}
- A61F 2/482: {Electrical means}
- A61F 2002/3067: {for data transfer}
- A61F 2002/3068: {the pharmaceutical product being in a reservoir}
- A61F 2002/30948: {using computerized tomography, i.e. CT scans}
- A61M 5/14276: {specially adapted for implantation}
- A61M 2210/0687: Skull, cranium
- G06T 2207/20128: Atlas-based segmentation
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- 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)}
- G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL

## Abstract

Provided is a functional, low-profile intercranial device (LID). The LID includes a base portion; at least one cavity associated with the base portion and configured to accept at least one functional component; and at least one conduit having a first end in communication with the at least one cavity. The at least one functional component includes a medicinal, electronic, or optic therapeutic. The at least one conduit is configured to accept the medicinal therapeutic and a second end configured to dispense the therapeutic.

## Claims

### Claim 1

A cranial device, comprising:
a cranial or craniofacial implant made of polymethylmethacrylate (PMMA), polyether ether ketone (PEEK), or polyethylene, the cranial or craniofacial implant being shaped and dimensioned for placement at least partially within a resected portion of a patient's skull during a surgical procedure, wherein the cranial or craniofacial implant includes a curvature specific to that of the skull to ensure a fit with absence of gaps along a periphery of the cranial or craniofacial implant, and being shaped and dimensioned to address a patient clinical care algorithm both from a skull bone perspective and from an underlying regional brain perspective such that the cranial or craniofacial implant corrects deformities and/or defects by placement at least partially within the resected portion of the skull during a surgical procedure replacing missing bone and providing cerebral protection from injury;
at least one functional component providing for ultrasound functionalities; and
at least one cavity formed in the cranial or craniofacial implant, the at least one cavity being shaped and dimensioned to house the at least one functional component, such that the at least one functional component is encased within a void-space defined by the at least one cavity, and the at least one functional component and the cavity are customized to be patient-specific.

### Claim 2 (depends on 1)

The cranial device of claim 1, wherein the cranial or craniofacial implant is radiolucent.

### Claim 3 (depends on 1)

The cranial device of claim 1, wherein the at least one functional component is configured to monitor a physiological condition.

### Claim 4 (depends on 1)

The cranial device of claim 1, wherein the at least one functional component is configured to perform imaging.

### Claim 5 (depends on 4)

The cranial device of claim 4, wherein the imaging comprises optical coherence tomography (OCT).

### Claim 6 (depends on 1)

The cranial device of claim 1, wherein the at least one functional component is configured to perform intracranial pressure (ICP) monitoring or vital sign monitoring.

### Claim 7 (depends on 1)

The cranial device of claim 1, wherein the cranial or craniofacial implant is made of the PMMA.

### Claim 8 (depends on 1)

The cranial device of claim 1, wherein the cranial or craniofacial implant is made of PEEK.

### Claim 9 (depends on 1)

The cranial device of claim 1, wherein the cranial or craniofacial implant is made of the polyethylene.

### Claim 10

A cranial device, comprising:
a cranial or craniofacial implant shaped and dimensioned for placement at least partially within a resected portion of a patient's skull during a surgical procedure, wherein the cranial or craniofacial implant includes a curvature specific to that of the skull to ensure a fit with absence of gaps along a periphery of the cranial or craniofacial implant, and being shaped and dimensioned to address a patient clinical care algorithm both from a skull bone perspective and from an underlying regional brain perspective such that the cranial or craniofacial implant corrects deformities and/or defects by placement at least partially within the resected portion of the skull during a surgical procedure replacing missing bone and providing cerebral protection from injury;
at least one functional component providing for ultrasound functionalities; and
at least one cavity formed in the cranial or craniofacial implant, the at least one cavity being shaped and dimensioned to house the at least one functional component, such that the at least one functional component is encased within a void-space defined by the at least one cavity, and the at least one functional component and the cavity are customized to be patient-specific.

### Claim 11 (depends on 10)

The cranial device of claim 10, wherein the cranial or craniofacial implant is made of polymethylmethacrylate (PMMA).

### Claim 12 (depends on 10)

The cranial device of claim 10, wherein the cranial or craniofacial implant is made of polyether ether ketone (PEEK).

### Claim 13 (depends on 10)

The cranial device of claim 10, wherein the cranial or craniofacial implant is made of polyethylene.

### Claim 14

A cranial device, comprising:
a cranial or craniofacial implant that is radiolucent, the cranial or craniofacial implant being shaped and dimensioned for placement at least partially within a resected portion of a patient's skull during a surgical procedure, wherein the cranial or craniofacial implant includes a curvature specific to that of the skull to ensure a fit with absence of gaps along a periphery of the cranial or craniofacial implant, and being shaped and dimensioned to address a patient clinical care algorithm both from a skull bone perspective and from an underlying regional brain perspective such that the cranial or craniofacial implant corrects deformities and/or defects by placement at least partially within the resected portion of the skull during a surgical procedure replacing missing bone and providing cerebral protection from injury;
at least one functional component providing for ultrasound functionalities; and
at least one cavity formed in the cranial or craniofacial implant, the at least one cavity being shaped and dimensioned to house the at least one functional component, such that the at least one functional component is encased within a void-space defined by the at least one cavity, wherein an orientation of at least one of the at least one functional component or the cavity are customizable.

### Claim 15 (depends on 14)

The cranial device of claim 14, wherein the cranial or craniofacial implant is made of polymethylmethacrylate (PMMA).

### Claim 16 (depends on 14)

The cranial device of claim 14, wherein the cranial or craniofacial implant is made of polyether ether ketone (PEEK).

### Claim 17 (depends on 14)

The cranial device of claim 14, wherein the cranial or craniofacial implant is made of polyethylene.

### Claim 18 (depends on 14)

The cranial device of claim 14, wherein the at least one functional component is configured to monitor a physiological condition.

### Claim 19 (depends on 14)

The cranial device of claim 14, wherein the at least one functional component is configured to perform imaging.

### Claim 20 (depends on 14)

The cranial device of claim 14, wherein the at least one functional component is configured to perform duplex ultrasound.
