The tablet stays out of the sterile field. The screen stays in view.
A sterile surgical drape with a pocket built into it. A standard tablet goes in from the patient side, so it never crosses into the sterile field. Its display faces the physician side through a transparent wall that is designed for viewing and touch input from the sterile side.
U.S. Patent 10,265,133, issued April 2019. Working prototypes built in 2026. FDA 510(k) submission in preparation. The patent, prototypes, and design history are available to license or acquire.
How it is built
Reference numbers match the figure. Hover or tap a row to find it.
- Drape body 18
- A sterile surgical drape with a patient side and a physician side, placed following standard draping technique. The fenestration (36) sits on the drape's line of symmetry (42), and the pocket is aligned with it.
- Pocket 40
- An enclosed pocket attached to the drape body. The patent describes it sized for a tablet, roughly 6 to 10 inches by 8 to 12 inches, with smaller and larger variants contemplated.
- Transparent wall 44
- The physician-side wall of the pocket is a clear film. The display is viewed through it, and the film is designed for touch input from the sterile side.
- Patient-side opening 48
- The pocket opens only on the patient side. Non-scrubbed staff load the tablet, and it is never accessible from the sterile side, so the device itself stays outside the sterile field.
- Tablet 20
- A standard consumer tablet, unmodified, running whatever the room already uses. The patent also contemplates a phone-sized or laptop-sized pocket.
- Supply
- Intended to be supplied sterile and single-use, in place of a standard drape for the procedure.
Why put the pocket in the drape
Once scrubbed in, a clinician can't touch anything that isn't sterile. Meanwhile, more of what a procedure depends on lives on a screen: imaging, the patient record, checklists, equipment and room settings, and sometimes a call to someone outside the room.
The usual answers are a wall display, a circulating nurse relaying instructions, a separately draped device that someone has to hold and position, or breaking scrub.
This design puts the screen where the sterile team already is, without adding a device to the sterile field. Because the pocket is part of the drape, there is nothing extra to drape, position, or manage.
What the patent contemplates reaching through the window
The patent describes a scrubbed user pressing on-screen controls through the transparent wall to reach:
Information
- Imaging and diagrams
- The patient record and anesthesia information
- Vital signs
- Procedural instructions and checklists
- Web access and live audio or video calls
Room and equipment controls
- Music and lighting
- Patient positioning and room temperature
- Cautery and tourniquet settings
Where it stands
A sequenced plan toward a Traditional 510(k). Each step is documented in a design history file built to transfer to a partner.
- U.S. Patent 10,265,133 issued April 23, 2019. Sterile Drape Having Transparent Pocket, 18 claims.
- Working prototypes built 2026, with a U.S. contract manufacturer.
- Design review and risk analysis In progress: failure mode and effects analysis, design review records, and materials documentation.
- FDA Pre-Submission (Q-Sub) Planned, to confirm predicate devices and the test plan before testing begins.
- Verification testing and sterilization validation Planned: barrier, biocompatibility, packaging, and sterilization, per the standards named below.
- 510(k) submission Planned.
Regulatory status
This device is in development. It has not been cleared or approved by the U.S. Food and Drug Administration, and it is not available for sale or clinical use in the United States or elsewhere. Nothing on this page is an offer to sell, and no orders are accepted.
Descriptions of function on this page reflect design intent and engineering prototypes, not verified performance.
Planned pathway: Traditional 510(k) premarket notification as a Class II surgical drape under 21 CFR 878.4370, with a Pre-Submission to FDA to confirm predicates and testing. Planned testing references AAMI PB70, ASTM F1670 and F1671, ISO 10993, ISO 11607, and sterilization validation to ISO 11135 or ISO 11137, depending on the method selected.
Partnering
The patent, the prototypes, and the design history built so far are available to license or acquire. Structures open for discussion: an exclusive license with royalties and milestones, an option period for evaluation while the 510(k) work continues, or outright assignment.
The best fit is a manufacturer of surgical drapes or procedure packs, or of sterile equipment covers, doing business in the United States. Clinicians who would like to weigh in on the design are welcome too.
Shared under NDA
- Patent prosecution history
- Risk analysis (FMEA) and design review records
- Prototype bill of materials and process documentation
- Regulatory plan and test protocols
- FDA Pre-Submission correspondence, once available
Only non-confidential information is shared before a mutual NDA is in place. Everything on this page is in the public record.
Prototypes
Engineering prototypes, built in 2026 with a U.S. contract manufacturer, shown in simulated use.
Photographs show engineering prototypes in simulated use, not clinical use.
Get in touch
Aaron McClellan
Inventor and patent holder
Email: inquiries@example.com
LinkedIn: Profile
Email is the fastest way to reach me. A mutual NDA can be sent the same day.