Ultraportable system for intraoperative isolative and regulation of surgical site environments
Inventors
Teodorescu, Debbie Lin • Frey, Daniel D. • Miller, Sally A. • Smalley, Robert J.
Assignees
Publication Number
US-12201486-B2
Publication Date
2025-01-21
Expiration Date
2037-07-14
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Abstract
A portable surgical system including a transparent and flexible plastic enclosure (1) is disclosed. The enclosure is attached reversibly to the patient's body encompassing the surgical site such as to isolate and regulate the immediate environment of the surgical site, and to reduce bodily fluid splatters from the surgical site to the surgical providers. The enclosure is inflated with filtered air. Arm ports (8) are integrated into the enclosure to allow access to the inside of the enclosure by either provider arms or augmenting instrumentation taking the place of arms such as laparoscopes or robots. Material ports (10) maintain enclosure environmental integrity but allow the passing of anatomical specimens, instruments, and other materials into and out of the enclosure (1) during a procedure. The portable surgical system is lightweight and can be used in conventional operating rooms to improve sterility, or in other circumstances where no operating room is available, such as field hospitals.
Core Innovation
The invention is a portable surgical system comprising a transparent, flexible plastic enclosure that is reversibly attached to a patient's body encompassing the surgical site. This enclosure isolates and regulates the immediate environment around the surgical site to improve sterility and reduce bodily fluid splatters to surgical providers. The enclosure is inflated with filtered air supplied by an environmental control system, which may enact controls such as HEPA filtration, humidity modulation, temperature adjustment, or gas composition changes.
The enclosure integrates arm ports that allow access to the inside either by provider arms or augmenting instrumentation like laparoscopes or robots. Material ports enable the passing of anatomical specimens, instruments, and other materials in and out of the enclosure during a procedure while maintaining environmental integrity. The system is lightweight and can be used in conventional operating rooms or in settings without operating rooms, such as field hospitals.
The problem addressed is the lack of access to safe and sterile surgical environments for billions globally, especially in low-resource or remote settings. Current innovations focus on mobile operating rooms that are costly and difficult to rapidly deploy. Also, medical providers face risks from exposure to bodily fluids, with existing personal protective equipment having trade-offs between protection, cost, and user comfort affecting compliance. This invention aims to provide an ultraportable, self-contained barrier to reduce contaminant exchange between incisions and the surrounding surgical area, protecting both patient and provider.
Claims Coverage
The patent includes multiple independent claims covering the portable surgical system, focusing on the flexible enclosure design, airflow control via a perforated flexible tube, environmental control integration, and ports for access.
Flexible enclosure with drape and optical clarity
A flexible enclosure that includes a drape with releasable adhesive engaging patient skin to enclose the surgical site, and areas of high optical clarity for viewing inside the enclosure.
Flexible tube with perforations for uniform laminar airflow
A flexible tube attached inside the enclosure, extending longitudinally along the patient's body, connected to the environmental control system, featuring a plurality of perforations with equal diameters and non-uniform positional density, arranged so that airflow through each perforation is identical, providing uniform laminar airflow.
Environmental control system supplying sterile air
An environmental control system configured to supply air into the flexible tube to create essentially sterile conditions inside the enclosure.
Ports for surgical site access
One or more ports integrated into the enclosure for accessing the surgical site, including arm ports configured to permit user arms or operating instruments to access the site while preventing contamination, and material ports configured to allow passage of materials in and out without contamination.
Frame supporting the flexible enclosure
A frame disposed outside the enclosure to support the flexible enclosure structure.
Flexible tube acting as a valve to prevent backflow
The flexible tube operates as a valve system, collapsing closed when airflow is low to prevent air backflow from the enclosure, and expanding open when airflow from the environmental control system is present, with open or closed states serving as airflow indicators.
Mathematically determined perforation distribution
Positions and density of perforations along the flexible tube are determined using iterative computations and mathematical expressions based on airflow velocity, tube and perforation dimensions, and air density, resulting in a stable distribution of exit velocities to achieve uniform airflow.
The independent claims collectively cover a portable surgical system featuring a flexible enclosure with a sterile drape, an internally attached flexible tube with strategically positioned perforations to ensure uniform laminar airflow supplied by an environmental control system, ports that enable sterile access to the surgical site, and an external supporting frame. The flexible tube also functions as a valve to prevent airflow reversal, with all perforation positions determined by iterative mathematical modeling to achieve uniform airflow within the enclosure.
Stated Advantages
Improves sterility of the surgical site by isolating and regulating the immediate environment.
Reduces exposure of surgical providers to bodily fluid splatters and infectious agents.
Lightweight and ultraportable, enabling use in conventional operating rooms and settings without operating rooms such as field hospitals.
Enables uniform laminar airflow through precise perforation design, enhancing environmental control effectiveness.
Facilitates ergonomic and sterile access to the surgical site via integrated arm and material ports.
Includes features that maintain environmental integrity during material passage and access.
Valve function of the flexible tube prevents backflow, enhancing system safety and performance.
Documented Applications
Use in conventional operating rooms to improve sterility of surgical procedures.
Use in field hospitals or in circumstances where no operating room is available, enabling safe surgery in austere or low-resource settings.
Protection of medical providers from exposure to patient bodily fluids during surgery.
Interested in licensing this patent?