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EP-3545882-B1 - APPARATUS TO ACCOUNT FOR TRANSPONDER TAGGED OBJECTS USED DURING CLINICAL PROCEDURES, EMPLOYING A TROCAR

EP3545882B1EP 3545882 B1EP3545882 B1EP 3545882B1EP-3545882-B1

Inventors

  • AQUINO, Allan
  • BRANDT, KIM
  • BUERSMEYER, Andy

Dates

Publication Date
20260506
Application Date
20190326

Claims (14)

  1. An apparatus for use in clinical environments, the apparatus comprising: a trocar (100), the trocar having a cannula (104) with a proximal end (106a) and a distal end (106b), the cannula which delineates a lumen (108) therethrough that extends from the proximal end to the distal end, with a proximal port (110a) at the proximal end which provides access to an interior of the lumen from an exterior of the cannula and with a distal port (110b) at the distal end which provides access to the interior of the lumen from the exterior of the cannula; and at least one trocar antenna (102a, 102b, 102c, 102d), the at least one trocar antenna physically coupled to the trocar and positioned and oriented to provide wireless communications coverage of at least a portion of an interior of the lumen and any wireless communications transponders that pass through the lumen of the cannula; and at least one indicator (124) communicatively coupleable to receive signals that are representative of wireless communications transponders that pass through the lumen of the cannula, if any; wherein the at least one indicator is physically coupled to the trocar and positioned and oriented to provide at least one human-perceptible indication (126) and configured to display: a) a count of a number (130) of the wireless communications transponders that have entered the lumen of the cannula, and b) a count of a number (132) of the wireless communications transponders that have exited the lumen of the cannula; wherein the at least one human-perceptible indication is generated to indicate a discrepancy in a number of the wireless communications transponders that have entered the lumen of the cannula and a number of the wireless communications transponders that have exited the lumen of the cannula.
  2. The apparatus of claim 1, further comprising: at least one processor (136), the at least one processor communicatively coupled to at least one interrogator (114) and to the at least one indicator (124); and at least one non-transitory processor-readable medium (408) that stores at least one of processor-executable instructions or data, execution of which causes the at least one processor to: itemize each of the wireless communications identification transponders that enters the lumen (108) of the trocar (100); itemize each of the wireless communications identification transponders that exits the lumen of the trocar; compare the itemization of each of the wireless communications identification transponders that exits the lumen of the trocar with the itemization of each of the wireless communications identification transponders that enters the lumen of the trocar; and transmit a signal to the indicator based at least in part on the comparison of the itemizations, the signal which causes the at least one indicator to provide an alert.
  3. The apparatus of claim 2 wherein the at least one of processor-executable instructions or data, when executed, further cause the at least one processor (136) to transmit the signal to the at least one indicator (124) based on a discrepancy between the identities of the wireless transponders identified entering and exiting the cannula (104).
  4. The apparatus of claim 3 wherein the at least one of processor-executable instructions or data, when executed, further cause the at least one processor (136) to transmit the signal to the at least one indicator (124) based on the identities of the wireless transponders identified entering the cannula (104) matches the identities of the wireless transponders identified exiting the cannula; preferably wherein the signal is comprised of a first signal and a second signal, the first signal which is transmitted based upon discrepancy between the identities of the wireless transponders identified entering and exiting the cannula, the first signal which causes the at least one indicator to emit a light of a first wavelength, and the second signal which is transmitted based upon the identities of the wireless transponders identified entering the cannula matching the identities of the wireless transponders identified exiting the cannula, the second signal which causes the at least one indicator to emit a light of a second wavelength.
  5. The apparatus of claim 4 wherein the identities of the wireless transponders identified entering the cannula (104) includes a number of wireless transponders entering the cannula, and the identities of the wireless transponders identified exiting the cannula includes a number of items exiting the cannula; preferably wherein the signal transmitted to the at least one indicator (124) includes an indicator of a difference between the number of items entering the cannula and the number of items exiting the cannula.
  6. The apparatus of any of claims 2-5, wherein the at least one trocar antenna (102a, 102b, 102c, 102d) is communicatively coupled to the at least one interrogator (114) via at least one electrical cable; preferably wherein the at least one trocar antenna is communicatively detachably coupled to the at least one interrogator via at least one electrical cable and a plug.
  7. The apparatus of any preceding claim wherein the cannula (104) of the trocar (100) shields the at least one trocar antenna (102a, 102b, 102c, 102d) from response signals emitted by any wireless communications transponders in the exterior of the cannula; and/or wherein the trocar antenna comprises at least one electrically conductive coil that is concentric with at least one of the proximate or the distal ports (110b) of the lumen (108).
  8. The apparatus of any preceding claim wherein the at least one trocar antenna (102a, 102b, 102c, 102d) is positioned and oriented to provide coverage of an entirety of the interior of the lumen (108) of the cannula (104) and all wireless communications transponders in the interior of the lumen of the cannula.
  9. The apparatus of any preceding claim wherein the at least one trocar antenna (102a, 102b, 102c, 102d) is positioned and oriented to provide coverage of the proximal port (110a) and all wireless communications transponders passing through the proximal port.
  10. The apparatus of any preceding claim wherein the at least one trocar antenna (102a, 102b, 102c, 102d) is positioned and oriented to provide coverage of the distal port (110b) and all wireless communications transponders passing through the distal port.
  11. The apparatus of any preceding claim wherein the at least one trocar antenna (102a, 102b, 102c, 102d) includes a first trocar antenna (102a) positioned and oriented to provide coverage of the proximal port (110a) and all wireless communications transponders passing through the proximal port, and at least a second trocar antenna (102b) positioned and oriented to provide coverage of the distal port (110b) and all wireless communications transponders passing through the distal port.
  12. The apparatus of any of claims 2-6, wherein processor-executable instructions or data, when executed, cause the at least one processor (136) to: itemize each of the wireless communications identification transponders that exits the lumen (108) of the trocar (100) via at least one of the distal port (110b) and the proximal port (110a); and itemize each of the wireless communications identification transponders that enters the lumen of the trocar via at least the distal port and the proximal port.
  13. The apparatus of any preceding claim wherein the trocar (100) further includes a seal (112) located at least proximate the proximal end (106a) and an obturator that movingly extends through the cannula (104) with a piercing tip located proximate the distal end (106b).
  14. The apparatus of any preceding claim wherein the proximal port (110a) is sized and dimensioned to receive pieces of disposable gauze (202), each piece of disposable gauze tagged with a respective dumb wireless communications transponder (230) that does not store any unique identifier nor provide any unique identifier; and/or wherein each piece of disposable gauze is tagged with a respective radio frequency identification (RFID) wireless communications identification transponder (228).

Description

Technical Field The present disclosure generally relates to accounting for transponder tagged medical or clinical procedure objects or items, for instance disposable gauze or sponges, and/or medical or clinical instruments typically employed in a medical or clinical environment in which medical or clinical procedures are performed. BACKGROUND Description of the Related Art It is important to determine whether objects or items associated with a medical or clinical procedure are present or unintentionally retained in a patient's body before completion of a medical or clinical procedure. The medical or clinical procedure may, for example, take the form of a surgery or childbirth delivery. Such objects or items may take a variety of forms used in medical or clinical procedures. For example, the objects or items may take the form of instruments, for instance scalpels, scissors, forceps, hemostats, and/or clamps, which may be reusable after sterilization or alternatively may be single-use disposable objects or items. Also for example, the objects or items may take the form of related accessories and/or disposable objects, for instance disposable surgical sponges, gauzes, and/or absorbent pads. When used in surgery, failure to locate an object or item before closing the patient may require additional surgery, and in some instances may have serious adverse medical consequences. In other medical procedures, such as vaginal childbirth deliveries, failure to remove objects, for instance gauze or absorbent pads, can lead to infections and undesired complications. Some hospitals have instituted procedures that include checklists or requiring multiple manual counts to be performed to track the use and return of objects or items during surgery. Such a manual approach is inefficient, requiring the time of highly trained personnel, and is prone to error. Another approach employs wireless transponders that are attached to various objects or items used during surgery, and a wireless interrogation and detection system. Such an approach can employ "dumb" wireless transponders, i.e., wireless communications transponders that do not store and/or transmit any unique identifying information. Dumb wireless transponders have traditionally been employed for electronic article surveillance (EAS) to prevent loss of merchandise at retail locations. Alternatively, such an approach can employ radio frequency identification (RFID) wireless transponders, i.e., wireless communications transponders which do store and return a unique identifier in response to an interrogation signal emitted by an RFID interrogator or RFID reader. In the approach that employs dumb wireless transponders, an interrogation and detection system includes a transmitter that emits pulsed wireless interrogation signals (e.g., radio or microwave frequency) and a detector for detecting wireless response signals returned by the dumb wireless transponders in response to the emitted interrogation signals. Such an automated system detects the presence or absence of dumb wireless transponders, but typically does not detect any unique identifying information. Since no power is required to operate the dumb wireless transponder, such an approach may have better range or better ability to detect objects or items retained within bodily tissue as compared to RFID wireless transponders communicating in similar ranges of wavelength and levels of power, but cannot uniquely identify the dumb wireless transponders. In the approach that employs RFID wireless transponders, an interrogator or reader includes a transmitter that emits wireless interrogation signals (e.g., radio or microwave frequency) and a detector for detecting wireless response signals returned by the RFID wireless transponders in response to the emitted interrogation signals. Such an automated system advantageously detects the unique identifiers of the RFID wireless transponders; however since some of the power in the interrogation signal is required to operate the RFID wireless transponder such an approach may have shorter range or less ability to detect objects or items retained within bodily tissue as compared to dumb wireless transponders communicating in similar ranges of wavelength and levels of power. Commercial implementation of such an automated system requires that the overall system be cost competitive, highly accurate, and easy to use. In particular, false negatives must be avoided to ensure that objects are not mistakenly left in the patient and false positives avoided to ensure valuable time and resources are not spent looking for objects which were not actually retained in the patient. Consequently, a new approach to prevention of foreign object retention in medical procedure environments is highly desirable. WO2018013417 discloses objects related to medical procedures, such as instruments, supplies. These objects may be tagged with transponders, e.g. RFID transponders, dumb transponders, and are accounted