102
D. L. Teodorescu et al.
enclosure. Material ports were kept closed; armports were kept in neutral position.
Particle counts were then benchmarked against Wagner et al. (2014) data correlating
particle counts and colony-forming units in operating rooms.
9.3 Results
9.3.1 Device Design
SurgiBox is an ultraportable, modular system to provide sterile intraoperative environments over surgical sites. This product went through extensive evolution. Initially,
the design comprised a reusable box-like system with hinged clear panels of polycarbonate that could be collapsed into a flat package. Based on stakeholder feedback
regarding sterilization capabilities, bulk, ergonomics, and modularity potential, the
design was iterated upon and became a disposable, patient-contacting plastic enclosure with a minimal frame, and reusable environmental controls. The arm ports
were redesigned several times to ensure that the system was ergonomic for the users
and minimized the chances of contamination. By contrast, whereas we had originally planned for material ports to be hermetic airlock-inspired systems, feedback
on impact to workflow prompted redesign to quick-opening ports with a single layer
of sealing, and this design was shown to not compromise sterility through environmental testing. Throughout the design process, each iteration was tested with local
surgeons, ensuring that each new design improved upon the previous.
The final design comprises a low-density polyethylene enclosure with a highvisibility vinyl window. The enclosure adheres to the patient’s surgical site with
an adhesive iodine-infused antimicrobial drape and is inflated with HEPA-filtered
air. There is an optional minimal frame that can be used with the enclosure, but
the enclosure can also be used alone and the positive pressure within provides its
structure. In the case that a port needs to be opened to move materials in or out, the
airflow can simply be increased to accommodate the extra outflow. The inflow system
is designed such that the filtered air enters the enclosure directly over the surgical site,
in the same way that air is introduced to state-of-the-art hospital operating rooms.
There are four sets of arm ports to accommodate up to four users at any given
time. The arm ports were designed so the users can perform the same motions that
they would use in a standard operation, and can pass tools back and forth easily.
There are also four material ports so materials (such as tools or even an infant in the
case of a cesarean section) can quickly be passed in or out of the surgical field.
Based on serial testing of workflow, it was found that the time of patient being
positioned on the operating table to time of first incision was consistently less than
85 s for users naïve to the system. Per qualitative report from the medical members
of the team, this timing compares favorably to that of existing patient and provider
preparation. We note that system does not preclude users from donning additional
D. L. Teodorescu et al.
enclosure. Material ports were kept closed; armports were kept in neutral position.
Particle counts were then benchmarked against Wagner et al. (2014) data correlating
particle counts and colony-forming units in operating rooms.
9.3 Results
9.3.1 Device Design
SurgiBox is an ultraportable, modular system to provide sterile intraoperative environments over surgical sites. This product went through extensive evolution. Initially,
the design comprised a reusable box-like system with hinged clear panels of polycarbonate that could be collapsed into a flat package. Based on stakeholder feedback
regarding sterilization capabilities, bulk, ergonomics, and modularity potential, the
design was iterated upon and became a disposable, patient-contacting plastic enclosure with a minimal frame, and reusable environmental controls. The arm ports
were redesigned several times to ensure that the system was ergonomic for the users
and minimized the chances of contamination. By contrast, whereas we had originally planned for material ports to be hermetic airlock-inspired systems, feedback
on impact to workflow prompted redesign to quick-opening ports with a single layer
of sealing, and this design was shown to not compromise sterility through environmental testing. Throughout the design process, each iteration was tested with local
surgeons, ensuring that each new design improved upon the previous.
The final design comprises a low-density polyethylene enclosure with a highvisibility vinyl window. The enclosure adheres to the patient’s surgical site with
an adhesive iodine-infused antimicrobial drape and is inflated with HEPA-filtered
air. There is an optional minimal frame that can be used with the enclosure, but
the enclosure can also be used alone and the positive pressure within provides its
structure. In the case that a port needs to be opened to move materials in or out, the
airflow can simply be increased to accommodate the extra outflow. The inflow system
is designed such that the filtered air enters the enclosure directly over the surgical site,
in the same way that air is introduced to state-of-the-art hospital operating rooms.
There are four sets of arm ports to accommodate up to four users at any given
time. The arm ports were designed so the users can perform the same motions that
they would use in a standard operation, and can pass tools back and forth easily.
There are also four material ports so materials (such as tools or even an infant in the
case of a cesarean section) can quickly be passed in or out of the surgical field.
Based on serial testing of workflow, it was found that the time of patient being
positioned on the operating table to time of first incision was consistently less than
85 s for users naïve to the system. Per qualitative report from the medical members
of the team, this timing compares favorably to that of existing patient and provider
preparation. We note that system does not preclude users from donning additional