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US-12616548-B2 - Systems and methods for surgical field item detection

US12616548B2US 12616548 B2US12616548 B2US 12616548B2US-12616548-B2

Abstract

Systems and methods are provided for a surgical needle counting device for an operating room. An example system includes a collecting enclosure and a counting apparatus having a sensor configured for determining when a needle is dropped into the collecting enclosure. The counting apparatus is configured to maintain a count of needles introduced into a surgical field associated with the operating room and a count of needles accounted for in the counting apparatus.

Inventors

  • Jason Howe

Assignees

  • MAGVATION, LLC

Dates

Publication Date
20260505
Application Date
20240405

Claims (20)

  1. 1 . A surgical needle counting device for an operating room, comprising: a collecting enclosure; a counting apparatus having a sensor configured for determining when a needle is dropped into the collecting enclosure; the counting apparatus being configured to maintain a first count of needles introduced into a surgical field associated with the operating room and a second count of needles accounted for in the counting apparatus; wherein the second count of needles is associated with the collecting enclosure.
  2. 2 . The device of claim 1 , wherein the counting apparatus comprises a vision system trained to identify needles by type based on training images depicting different, pre-identified needle types.
  3. 3 . The device of claim 1 , wherein the counting apparatus is configured to increase the second count of needles and to emit a visible or audio signal upon determining that the needle has been dropped into the collecting enclosure.
  4. 4 . The device of claim 1 , wherein the second count of needles is transmitted to a mobile device in the operating room for display.
  5. 5 . The device of claim 1 , wherein the second count of needles is transmitted to a remote database for auditing of an operating room procedure.
  6. 6 . The device of claim 1 , wherein the collecting enclosure is removable from the device; wherein the counting apparatus is configured to detect attachment of a new removable collecting enclosure, wherein a new count of needles is stated based on said detecting attachment of the new removable collecting enclosure.
  7. 7 . The device of claim 1 , wherein the counting apparatus is configured to further maintain a total count of needles accounted for associated with an operating room procedure that spans multiple collecting enclosures.
  8. 8 . The device of claim 1 , wherein the counting apparatus is configured to issue an alert when the second count of needles reaches a threshold indicating that the collecting enclosure is full.
  9. 9 . The device of claim 1 , wherein the counting apparatus is configured to track counts of different types of needles introduced into the surgical field.
  10. 10 . The device of claim 1 , wherein the sensor is configured to discern a needle type when the needle is dropped into the collecting enclosure.
  11. 11 . The device of claim 1 , wherein the sensor is an infrared sensor, an electromagnetic sensor, an acoustic wave sensor, a visible light sensor, or a pressure sensor.
  12. 12 . The device of claim 1 , wherein the collecting enclosure includes a magnet for retaining a deposited needle at a desired location.
  13. 13 . The device of claim 12 , wherein the magnet is configured to hold a deposited needle at a sensing position in the collecting enclosure where a needle type is detected by the sensor; wherein the collecting enclosure is configured to allow the deposited needle to leave the sensing position following said needle type detecting.
  14. 14 . The device of claim 13 , wherein a visual image is made available on a display device for manual counting of needles in the collecting enclosure via physical touch of the image on the display device and an incremental counter.
  15. 15 . The device of claim 1 , further comprising a camera configured for viewing inside the collecting enclosure and capturing an image to validate the second count of needles.
  16. 16 . The device of claim 15 , further comprising image recognition software configured to identify a count of needles present in the image for comparison with the second count of needles.
  17. 17 . The device of claim 1 , wherein the collecting enclosure is collapsible, expandable, and self-sealing.
  18. 18 . The device of claim 1 , wherein the counting apparatus includes multiple sensors and software configured to prevent double counting of needles dropped into the collecting enclosure and sensed by more than one of the multiple sensors.
  19. 19 . The device of claim 1 , further comprising an intake funnel coated with a hydrophobic material configured to transit a deposited needle into the collecting enclosure.
  20. 20 . The device of claim 1 , wherein the counting apparatus comprises a vision system trained via machine learning, the vision system being configured to capture a color, a size, and a shape of succor, wherein the vision system is configured to identify both a succor and a needle type associated with the needle.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation application of U.S. patent application Ser. No. 17/829,471, filed Jun. 1, 2022, which claims priority to U.S. Provisional Application No. 63/195,924 filed Jun. 2, 2021, both of which are incorporated herein by reference in their entireties. FIELD Systems and methods herein relates to a medical counting device and software, suitable for the counting of the number of needles used in statistical operation on a sterile field on a patient in an operating room. BACKGROUND Accidental retention of foreign bodies, or Retained Surgical Items (RSI), occurs in approximately 1 of every 1000-1500 operations. Early identification and immediate remediation of such events are paramount to ensure patient safety and address the public's increased awareness of medical error prevention and avoidance. Although a large share of attention is directed toward retained surgical sponges and retained surgical instruments, retained suture-needles and suture-needlesticks are substantive problems that result in injury, morbidity, medicolegal impairments, and even mortality. The National Quality Foundation estimated in 2017, that there were 51 million operations/procedures performed at non-federal hospitals in the US, and in 2019 there were 67 million surgical outpatient procedures performed in ambulatory surgical centers. By a conservative estimate, suture-needle miscounts occur in 4% of operations, suture-needlesticks in 0.5%, and suture-needle retention in 0.06%. Assuming an even more conservative estimate that only 50% of the 134,000,000 operations/procedures utilize suture-needles, there are roughly 2,780,000 needle miscount incidents, 335,000 needlestick incidents, and 40,000 needle retention incidents per year, all with potentially tragic patient outcomes and potentially material financial consequences. SUMMARY Systems and methods are provided for a surgical needle counting device for an operating room. An example system includes a collecting enclosure and a counting apparatus having a sensor configured for determining when a needle is dropped into the collecting enclosure. The counting apparatus is configured to maintain a count of needles introduced into a surgical field associated with the operating room and a count of needles accounted for in the counting apparatus. As another example, a method of detecting a surgical needle in an operating room includes maintaining a count of needles introduced into a surgical field associated with the operating room. A needle is received in a collecting enclosure. A sensor is used to detect the presence of the needle in the collecting enclosure and to identify a type associated with the needle. An accounted-for-needle count associated with the detected needle type is updated based on said identifying. DESCRIPTION OF DRAWINGS FIG. 1 is a diagram depicting an example surgical counting device for an operating room. FIG. 2 is a diagram depicting a vision-system counting apparatus. FIG. 3 depicts an alternate form of a counting apparatus that utilizes an inductive sensor for detecting the presence of needles and characteristics of those needles. FIGS. 4A-4B depict another form of a counting apparatus including communication circuitry, rechargeable power supply and metal detecting sensors. FIG. 5 is a diagram depicting an example disposable collection enclosure 1. FIG. 6 displays a round, collapsible enclosure in component and assembled form, where the self-sealing interface is perforated in a star-shape configuration. FIG. 7 illustrates alternate self-sealing interface shapes including a point-shaped opening and a line-shaped opening. FIG. 8 is a flow diagram depicting an example process for counting objects in a operating room environment. FIG. 9 depicts user interfaces for setting up an operating room procedure and initiating counting of needles in a pack. FIG. 10 depicts user interfaces for viewing the counts and for manually adjusting a count. FIG. 11 depicts additional user interfaces in different orientations and arrangements, where per-enclosure counts are depicted for multiple enclosures used during the operation. FIG. 12 depicts example thread cutting devices. FIGS. 13-20 depict additional examples of counting apparatus shapes and physical arrangements. FIG. 21 is a flow diagram depicting a computer-implemented method of detecting a surgical needle in an operating room. DETAILED DESCRIPTION In the operating room, there are a variety of items, many of which are very small, that must be tracked. For example, almost every type of operation requires a variety of surgical succors and the associated succor needles which are sharp. There are medical risks to the patient if a needle is left in the patient, and there are risks to the medical staff if all needles are not accounted for. Sharps may also stick or injure the medical staff. Often at the conclusion of an operation, medical staff needs to accurately and statisticall