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First In-Human Experience With Complete Integration of Neuromodulation Device Within a Customized Cranial Implant
Chad R Gordon1,2, Gabriel F Santiago1,2, Judy Huang2
1Department of Plastic and Reconstructive Surgery, Johns Hopkins University School of Medicine, The Johns Hopkins Hospital, Baltimore Maryland.
Operative Neurosurgery (Hagerstown, Md.)
|October 14, 2017
Summary
This study presents a novel method for integrating neuromodulation devices into custom cranial implants, improving outcomes for drug-resistant epilepsy patients. This approach enhances biocompatibility and eliminates visible deformities associated with traditional neurotechnology.
Area of Science:
- Neurosurgery
- Biomaterials Engineering
- Medical Device Design
Background:
- Neuromodulation devices offer promise for drug-resistant neurological conditions like epilepsy.
- Current device placement strategies lead to complications such as visible deformities, infection, and hardware explantation.
- Existing methods lack aesthetic integration and can compromise patient well-being.
Observation:
- A patient with drug-resistant focal epilepsy presented with significant cranial bone flap resorption and deformity.
- Responsive neurostimulation (RNS) device implantation was performed by integrating it within a custom-designed, clear cranial implant.
- This novel approach aimed to optimize biocompatibility and prevent visible cosmetic deformities.
Findings:
- The patient experienced a successful recovery with no complications over 180 days post-implantation.
- Wireless data transmission for device interrogation, including electrocorticographic data, was achieved through the clear implant material without interference.
- This demonstrates the feasibility of seamless communication with implanted devices through advanced biomaterials.
Implications:
- This integrated neuromodulation strategy offers a potential solution to adverse events like cranial contour irregularities and implant site infections.
- Computer-designed cranial implants can conceal neurotechnology, improving aesthetic outcomes and patient satisfaction.
- This approach paves the way for enhanced biocompatibility and optimized patient outcomes in implantable neurotechnology.