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US-20260124037-A1 - CRANIAL IMPLANT DEVICES, SYSTEMS, AND RELATED METHODS

US20260124037A1US 20260124037 A1US20260124037 A1US 20260124037A1US-20260124037-A1

Abstract

Provided herein are cranial implant devices that include at least one acoustic, optical, and/or photoacoustic lens element comprising one or more electromagnetically translucent, electromagnetically transparent, sonolucent, and/or acoustically active materials. The cranial implant devices are structured for subgaleal scalp implantation within, beneath, and/or over at least one cranial opening of a subject and typically includes a substantially anatomically-compatible shape. In addition, the cranial implant devices permit transcranial therapeutic ultrasound, transcranial diagnostic ultrasound, photoacoustic imaging, electromagnetic wave diagnostic imaging, and/or electromagnetic wave therapeutic intervention of intracranial matter of the subject via the acoustic, optical, and/or photoacoustic lens element when the cranial implant device is subgalealy implanted within, beneath, and/or over the cranial opening of the subject. Other aspects are directed to various related systems and methods of obtaining diagnostic information from, and/or administering therapy to, a subject.

Inventors

  • Chad Gordon
  • Micah Belzberg
  • Amir Manbachi

Assignees

  • THE JOHNS HOPKINS UNIVERSITY

Dates

Publication Date
20260507
Application Date
20251229

Claims (20)

  1. 1 . A cranial implant device, comprising: at least one acoustic, optical, and/or photoacoustic lens element comprising one or more electromagnetically translucent, electromagnetically transparent, sonolucent, and/or acoustically active materials; one or more transparent, sonolucent, and/or acoustically inert materials disposed at least proximal to a first and/or a second side of the acoustic, optical, and/or photoacoustic lens element; wherein the cranial implant device is structured for subgaleal scalp implantation within, beneath, and/or over at least one cranial opening of a subject; wherein the cranial implant device comprises a substantially anatomically-compatible shape; and wherein the cranial implant device permits transcranial therapeutic ultrasound, transcranial diagnostic ultrasound, photoacoustic imaging, electromagnetic wave diagnostic imaging, and/or electromagnetic wave therapeutic intervention of intracranial matter of the subject via the acoustic, optical, and/or photoacoustic lens element when the cranial implant device is subgalealy implanted within, beneath, and/or over the at least one cranial opening of the subject.
  2. 2 . The device of claim 1 , wherein the cranial implant device comprises a standardized form.
  3. 3 . The device of claim 1 , wherein the cranial implant device is structured for subgaleal scalp implantation within, beneath, and/or over at least one burr hole in a skull or in at least one skull bone flap of the subject.
  4. 4 . The device of claim 1 , wherein an autologous skull bone flap comprises at least a portion of the cranial implant device.
  5. 5 . The device of claim 1 , wherein an alloplastic cranial implant comprises at least a portion of the cranial implant device.
  6. 6 . The device of claim 1 , wherein the cranial implant device comprises one or more transparent, sonolucent, and/or acoustically inert materials disposed at least proximal to a first and/or a second side of the acoustic, optical, and/or photoacoustic lens element.
  7. 7 . The device of claim 1 , wherein the acoustic, optical, and/or photoacoustic lens element comprises a plano-convex lens, a biconvex lens, a plano-concave lens, a biconcave lens, a positive meniscus lens, a negative meniscus lens, a converging Fresnel lens, and/or a diverging Fresnel lens.
  8. 8 . The device of claim 1 , wherein the acoustic, optical, and/or photoacoustic lens element comprises a curved or rectilinear cross-sectional shape.
  9. 9 . The device of claim 1 , comprising 2, 3, 4, 5, 6, 7, 8, 9, 10 or more acoustic, optical, and/or photoacoustic lens elements.
  10. 10 . The device of claim 1 , wherein the acoustic, optical, and/or photoacoustic lens element comprises one or more diverging and/or converging lenses.
  11. 11 . The device of claim 1 , wherein a position of the acoustic, optical, and/or photoacoustic lens element in the cranial implant device is adjustable.
  12. 12 . The device of claim 1 , wherein the acoustic, optical, and/or photoacoustic lens element is structured to extend into an epidural space and/or beneath a scalp of the subject when the cranial implant device is subgalealy implanted within, beneath, and/or over the at least one cranial opening of the subject.
  13. 13 . The device of claim 1 , wherein the acoustic, optical, and/or photoacoustic lens element comprises polymethylmethacrylate (PMMA), room-temperature-vulcanizing (RTV) silicone, polydimethylsiloxane (PDMS), epoxy, polyetheretherketone (PEEK), and/or metamaterials.
  14. 14 . The device of claim 1 , wherein the acoustic, optical, and/or photoacoustic lens element comprises one or more acoustic metamaterials and/or one or more phononic crystals.
  15. 15 . The device of claim 1 , wherein the acoustic, optical, and/or photoacoustic lens element comprises a three-dimensional structure configured to reduce a speed of sound transmitted through the acoustic, optical, and/or photoacoustic lens element.
  16. 16 . The device of claim 1 , wherein the acoustic, optical, and/or photoacoustic lens element comprises one or more wave-guides.
  17. 17 . The device of claim 1 , wherein the acoustic, optical, and/or photoacoustic lens element comprises at least one material that is modified to increase or decrease a speed of sound or a speed of light transmitted through the material.
  18. 18 . The device of claim 1 , wherein the cranial implant device is configured to allow sound and acoustics to be used for both transmission (Tx) and reception (Rx).
  19. 19 . The device of claim 1 , wherein the cranial implant device is configured to allow sound and acoustics to be used for either transmission (Tx) or reception (Rx).
  20. 20 . The device of claim 1 , wherein the acoustic, optical, and/or photoacoustic lens element comprises at least one diverging lens that transmits sound at a higher speed than a tissue of the subject.

Description

CROSS REFERENCE TO RELATED APPLICATION This application is a continuation of U.S. patent application Ser. No. 17/642,408, filed Mar. 11, 2022, which is a 371 of international PCT/US2020/050358, filed Sep. 11, 2020, which claims the benefit of U.S. Provisional Application No. 62/899,926, filed Sep. 13, 2019, the disclosures of each of which are hereby incorporated by reference in their entirety. FIELD The present disclosure relates generally to cranial implants and, more particularly, to cranial implants that include optical and/or acoustic lenses to provide enhanced functionality. BACKGROUND Surgical access to the intracranial space frequently involves a craniectomy or a craniotomy. To perform a craniectomy, for example, a series of burr holes or key holes are typically created in the skull. Following surgery, these burr holes may be repaired with a variety of biocompatible materials, such as autologous bone, mineralized collagen, titanium alloys, polyethylene, polymethyl methacrylate (PMMA), polyetheretherketone (PEEK), and calcium phosphate bioceramics, among others. Although custom sizes may be utilized, 14 mm is the standard diameter for burr holes used in these neurosurgical procedures. The size of burr holes generally limits their usefulness as synthetic apertures for diagnostic and therapeutic applications, including transcranial therapeutic ultrasound, diagnostic ultrasound, photoacoustic imaging, optical coherence tomography (OCT), electromagnetic wave intervention, and the like. Thus, there remains a need for approaches that enable the use of “synthetic windows” into the intracranial space through burr holes or other cranial openings when performing such diagnostic and therapeutic applications. SUMMARY This application discloses a variety of cranial implant devices that include optical and/or acoustic lenses that permit and enhance a wide array of transcranial mechanical and/or electromagnetic wave-based diagnostic and/or therapeutic applications. Once implanted in subjects, the devices may remain in place for indefinite durations with minimal risk of infection. The devices have substantially anatomically-compatible shapes such that they are essentially non-detectable upon implantation in subjects. In addition to cranial implant devices, related systems and methods are also provided. In one aspect, this disclosure provides a cranial implant device that includes at least one acoustic, optical, and/or photoacoustic lens element comprising one or more electromagnetically translucent, electromagnetically transparent, sonolucent, and/or acoustically active materials. The cranial implant device is structured for subgaleal scalp implantation within, beneath, and/or over at least one cranial opening of a subject. The cranial implant device also comprises a substantially anatomically-compatible shape. In addition, the cranial implant device permits transcranial therapeutic ultrasound, transcranial diagnostic ultrasound, photoacoustic imaging, electromagnetic wave diagnostic imaging, and/or electromagnetic wave therapeutic intervention of intracranial matter of the subject via the acoustic, optical, and/or photoacoustic lens element when the cranial implant device is subgalealy implanted within, beneath, and/or over the at least one cranial opening of the subject. In some embodiments, the cranial implant device comprises a standardized form, whereas in others, the cranial implant device comprises a form that is customized for the subject. In certain embodiments, a kit comprising the cranial implant device. In some embodiments, the cranial implant device is structured for subgaleal scalp implantation within, beneath, and/or over at least one burr hole in a skull or in at least one skull bone flap of the subject. In certain embodiments, an autologous skull bone flap comprises at least a portion of the cranial implant device. In some embodiments, an alloplastic cranial implant comprises at least a portion of the cranial implant device. In another aspect, the present disclosure provides a system that includes at least one cranial implant device. The cranial implant device includes at least one acoustic, optical, and/or photoacoustic lens element comprising one or more electromagnetically translucent, electromagnetically transparent, sonolucent, and/or acoustically active materials. The cranial implant device is structured for subgaleal implantation within, beneath, and/or over at least one cranial opening of a subject. The cranial implant device also comprises a substantially anatomically-compatible shape. In addition, the cranial implant device permits transcranial therapeutic ultrasound, transcranial diagnostic ultrasound, photoacoustic imaging, electromagnetic wave diagnostic imaging, and/or electromagnetic wave therapeutic intervention of intracranial matter of the subject via the acoustic, optical, and/or photoacoustic lens element when the at least one cranial implant device is subgalealy implanted within