Systems and methods for increased operating room efficiency

Inventors

Gorek, Josef E. • Trauner, Kenneth B. • Rimer, Douglas G.

Assignees

Sharp Fluidics Inc

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Publication Number

US-10603033-B2

Patent

Publication Date

2020-03-31

Expiration Date


Abstract

Systems, devices and methods to improve safety and efficiency in an operating room comprise providing a suture package that holds new suture needles and needle receptacles for storing used needles. The devices can be safely worn for the surgeon to self-dispense new suture needles in the near surgical field and to secure the used needles into a needle trap or a needle retainer located on his extremity, on his operative instruments or on the surgical drapes. The device may provide automated and/or simplified needle counting both during use and after removal from the surgical field. The device may be configured for ergonomic and efficient use so as to minimize the actions and motions of the surgeon to dispense and secure the needle.

Core Innovation

This disclosure relates to needle receptacles and needle traps that provide controlled placement and secure retention of one or more needles. The needle receptacle includes an upper structure and a lower structure coupled to the upper structure, a needle driver slot extending through the upper structure, and a needle slot located between the upper structure and the lower structure that extends from an opening to a secure zone. A needle receiver sized and shaped to receive one or more needles slides along the needle slot with advancement of the needle driver along the needle driver slot, placing the one or more needles in the secure zone.

The disclosure further describes needle identification and closed-loop tracking for needle receptacles and needle traps. Needle identification is performed using visual markings on needle bodies readable via optical sensors through a needle driver slot, and via an embedded RFID/radio frequency transmitter interrogated by a needle sensor. Active suture-pack tracking signals and a processor support monitoring, reconciliation, and error signaling.

The document further describes systems for improved used-needle receptacle safety and handling, including forearm-mounted barriers, transparent domes, magnetic or foam needle retention, and needle counting. The disclosed apparatus links secure-zone placement and tracking to display or audio output and reconciliation logic to reduce the likelihood of missing a retained needle.

Claims Coverage

The claim coverage centers on one independent needle receptacle claim with three core inventive features, plus dependent refinements directed to retention, spacing, depth control, and passage arrangements.

Needle receptacle with upper and lower structure and secure-zone needle slot

A needle receptacle comprising an upper structure and a lower structure coupled to the upper structure, with a needle slot located between the upper structure and the lower structure that extends from an opening to a secure zone.

Needle driver slot through upper structure to advance placement

A needle driver slot extending through the upper structure.

Needle receiver sliding along needle slot with needle driver advancement

A needle receiver sized and shaped to receive one or more needles and slide along the needle slot with advancement of the needle driver along the needle driver slot to place the one or more needles in the secure zone.

Needle receiver configured to ratchet into the needle slot

The needle receiver is configured to ratchet into the needle slot.

Needle receiver permits entry and resists exit

The needle receiver permits movement into the needle slot and resists movement out of the needle slot.

Needle receiving tabs holding needles in a spaced array

One or more needle receiving tabs hold the one or more needles within the needle slot in a spaced apart array.

Needle slot and needle receiver constrain needles to a single needle depth

The needle slot and needle receiver constrain the one or more needles to a single needle depth in the secure zone.

Aperture through lower structure for needle receiver passage

The needle receptacle further comprises an aperture through the lower structure in an entry zone or a transition zone, wherein the needle receiver passes from underneath the lower structure through the aperture into the needle slot.

Overall, the claim set covers a needle receptacle with an upper structure, a lower structure, a needle driver slot, and a needle slot extending to a secure zone, together with a needle receiver that slides with needle driver advancement to place needles in the secure zone. Dependent features further specify ratcheting retention, resistance to exit, spaced-array retention, single-needle-depth constraints, and aperture-based passage into the needle slot.

Stated Advantages

Improves operating-room efficiency and safety by keeping needle dispensing and used-needle storage within a surgeon’s near surgical field.

Provides secure needle handling by aligning, retaining, and preventing needle removal.

Uses needle counting approaches including visual clarity, mechanical, electrical, optical/electronic sensing, pressure sensing, and wireless remote display.

Protects proximal needle ends in used needle storage using channels/barriers and provides used-needle repositories with antimicrobial/disinfectant contained within receptacles.

Improved used-needle receptacle safety and handling.

Improved needle identification and closed-loop tracking for needle receptacles and needle traps.

Support for needle reconciliation with processor error signaling, including potential procedure stop when a needle is lost.

Needle counting with visual display and audio output to support reconciliation.

Increasing operating room efficiency.

Reducing needle passes.

Improving micro-ergonomics.

Enabling real-time needle reconciliation/counting in the near surgical field.

Needle-stick injury reduction

Documented Applications

Forearm-mounted surgical workflow intended to keep needle dispensing and used-needle storage within a surgeon’s near surgical field during an operating-room surgical workflow.

Used needle handling and storage using a needle receptacle, needle trap, or sharps container with secure zones and needle counting approaches.

Used-needle receptacle safety and handling in suturing contexts associated with a sterile suturing kit and suture packs.

Needle receptacle or needle trap needle identification and closed-loop tracking during needle placement and reconciliation.

Mounting a suture package and a used-needle receptacle in a near surgical field on the surgeon’s non-dominant limb/forearm/hand during suturing.

Mounting a suture package and a used-needle receptacle in a near surgical field on operative instruments/drapes.

Using the near surgical field configuration to support surgeon self-dispensing of new needles and immediate securing of used needles.

Needle counting/reconciliation supported by slots, gaps, and indicator/light concepts

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