WO2017035474A1 - Système de confinement d'objets pointus ou tranchants et procédé pour le stockage et le suivi automatisé d'instruments médicaux pointus ou tranchants - Google Patents

Système de confinement d'objets pointus ou tranchants et procédé pour le stockage et le suivi automatisé d'instruments médicaux pointus ou tranchants Download PDF

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Publication number
WO2017035474A1
WO2017035474A1 PCT/US2016/049000 US2016049000W WO2017035474A1 WO 2017035474 A1 WO2017035474 A1 WO 2017035474A1 US 2016049000 W US2016049000 W US 2016049000W WO 2017035474 A1 WO2017035474 A1 WO 2017035474A1
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WO
WIPO (PCT)
Prior art keywords
sharps
medical instruments
sensor
sharp medical
interior cavity
Prior art date
Application number
PCT/US2016/049000
Other languages
English (en)
Inventor
James J. JABER
Johnny NUNEZ
Neena AGARWAL-WILL
Kevin C. WELCH
Original Assignee
Tribar Medical Technology, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tribar Medical Technology, Llc filed Critical Tribar Medical Technology, Llc
Publication of WO2017035474A1 publication Critical patent/WO2017035474A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B50/36—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for collecting or disposing of used articles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B50/36—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for collecting or disposing of used articles
    • A61B50/362—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for collecting or disposing of used articles for sharps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00221—Electrical control of surgical instruments with wireless transmission of data, e.g. by infrared radiation or radiowaves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00734—Aspects not otherwise provided for battery operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/20—Holders specially adapted for surgical or diagnostic appliances or instruments
    • A61B2050/21—Magnetic holders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0804—Counting number of instruments used; Instrument detectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0804—Counting number of instruments used; Instrument detectors
    • A61B2090/0805—Counting number of instruments used; Instrument detectors automatically, e.g. by means of magnetic, optical or photoelectric detectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/20—Holders specially adapted for surgical or diagnostic appliances or instruments

Definitions

  • the present disclosure relates generally to a sharps containment system and method for the storing and tracking of sharp medical instruments including sharp surgical instruments, and an automated system and method for the storing and tracking of sharp medical instruments.
  • HBV Human Immunodeficiency Virus
  • HBV Hepatitis B Virus
  • HCV Hepatitis C Virus
  • CDC Centers for Disease Control and Prevention
  • Any worker handling sharp devices or equipment such as scalpels, sutures, hypodermic needles, blood collection devices, or phlebotomy devices are at risk.
  • EPINET Exposure Prevention Information Network
  • Suture needles are the main source of needlesticks to operating room (OR) personnel, causing 51% of all sharps injuries in surgical settings. Scalpel blades rank at second, with 12% of injuries giving a combined 63% of all injuries in the OR related to the surgical field. Of an estimated 384,000 percutaneous injuries (Pis) occurring in U.S. hospitals each year, handling of sharp-tip suture needles account for approximately 14% of such Pis.
  • FIG. 1 An open disposable container 101 that is puncture-resistant with marked numbers slots 27, 29 (FIG. 1) is used for counting and disposing needles and sharps, including suture needles 33, syringe needles 35, scalpel blades 31, and the like. Used needles 33, 35 should be put in these needle counting boxes 101 by placing one needle 33, 35 per marked slot 29 in the container 101.
  • injuries to surgical personnel from sharps 31, 33, 35 can occur for a number of reasons, other than from the actual suturing technique. This other reasons may include:
  • the sharps container 101 includes a first box portion 13 having a locking tab 21, and a second box portion 15, having a locking slot 23.
  • the first and second box portions 13, 15 are brought together in a closed position to form a shell 11 that encases the sharps 31, 33, 35, as the locking tab 21 releasably engages the locking slot 23 to form a closure lock 19 that retains the shell 11 in the closed position.
  • the sharps container 101 includes elongated strips 25 disposed in a grid on the inside of the first box portion 13. Consecutive number slots 27 are presented on each elongated strip 25.
  • Slots 29 are defined between the adjacent elongated strips 25 to receive the sharps 31, 33, 35 therebetween.
  • the needles 31, 33, 35 are pressed into the elongated strips 25.
  • the second box portion 15 further allows surgical instruments, such as syringes 41 and scalpels 39 to rest along an edge thereof.
  • the sharps container 101 utilized in the operating suite may not only cause the occurrence of percutaneous injuries, due to the sharps container 101 only being able to receive used sutures 33 and other sharps 31, 33, 35 when in the open position, but counting of the sharps 31, 33, 35 by virtue of the individual placements on the elongated strips 25 heavily relies on the accuracy of such placements. Thus, such a counting system is prone to human error.
  • a sharps containment system includes a container, a sensor, and a counter.
  • the container defines an interior cavity and is configured for storing sharp medical instruments therein.
  • the container includes a wall defining an aperture that opens to the interior cavity to allow the sharp medical instruments to be inserted into the interior cavity therethrough.
  • the aperture and the container are configured to retain the sharp medical instruments within the interior cavity.
  • the sensor is disposed relative to the aperture and is configured to sense an insertion of each of the sharp medical instruments into the interior cavity, as each of the sharp medical instruments passes through the aperture.
  • Each sensor is configured to transmit a signal corresponding to the sensed insertion of each of the sharp medical instrument into the interior cavity.
  • the counter is configured to receive the signal from the sensor and index a counted quantity of the sharp medical instruments stored in the interior cavity by an integer of one for each of the sensed sharp medical instruments.
  • a method for counting and storing sharp medical instruments in a container of a sharps containment system includes sensing, with a sensor, the insertion of one of the sharp medical instruments into the container. The sensor then transmits a signal to the counter to indicate the insertion of one of the sharp medical instruments has been sensed. The counter receives the signal and then indexes a counted quantity of the sharp medical instruments stored in the interior cavity by an integer of one to provide an updated quantity of sharp medical instruments stored in the interior cavity.
  • FIG. 1 is a schematic view of a prior art example of an open disposable container for receiving, counting and disposing of needles and sharps via an aperture in the container;
  • FIG. 2 is a schematic perspective view of a sharps tracking apparatus including a container for receiving and automatically counting sharp objects disposed therein;
  • FIG. 3 is a schematic side view of the sharps tracking apparatus of FIG. 3;
  • FIG. 4A is a schematic cross-sectional view of section 4A-4A of FIG. 3, showing an interior view of the top portion of the container;
  • FIG. 4B is a schematic cross-sectional view of section 4B-4B of FIG. 3, showing an interior view of the bottom portion of the container;
  • FIG. 5 is a schematic view of a sharps tracking system including the container of FIG. 2;
  • FIG. 6 is a schematic perspective view of the sharps tracking apparatus of FIG. 2, further including a sharps holding pad;
  • FIG. 7 is a schematic view of a method for using the sharps tracking apparatus.
  • FIG. 8 is a schematic perspective view of another example configuration of the sharps tracking apparatus of FIG. 2.
  • FIGS. 2 and 5 show a sharps containment system 100 for the storing and the automatic tracking of sharp medical instruments ("sharps"), such as sharp surgical instruments in a sealed container 45 that includes a counting system 47.
  • the sharps containment system 100 is designed to store sharps in an interior cavity 43 (shown in FIG. 4B) of the sealed container 45 to decrease the risk of percutaneous injury, as well as provide a quantification of the sharps used in a surgical procedure by utilizing the counting system 47, as explained in more detail below. Counting of the sharps is used to ensure that no sharp objects are left exposed that could cause injury to the patient or the operating room staff.
  • the containment system 100 is configured to allow or require the users hands to remain behind sharp portions of the sharps at all times, even after disposal of the sharps and the containment system 100, such that users, trash handlers, patients, and the surrounding environment are insulated from the sharps. Further, the containment system 100 is configured to require little to no training, while being simple to use effectively.
  • the sharps containment system 100 is configured to be inexpensive and reliable, while providing the counting system 47 that provides a hands-free, automated counting of the sharps inserted in the sealed container 45.
  • the sharps containment system 100 is also configured to conceal the sharps, once the sharps are inserted into the container 45, thereby minimizing the biohazard exposure risk.
  • the sharps containment system 100 is configured to perform two tasks: (1) count the sharps via the counting system 47, and (2) conceal sharps to eliminate the biohazard presented by the sharps.
  • the sharps BBx may include any device or object that is used to puncture or lacerate the skin.
  • the sharps BBx may include needles Bi, scalpels B2, blades B3, sutures B4, injection devices B5, and the like.
  • the category of blades B3 may include razors, scalpels, X-acto® surgical knives, scissors, and any other medical items used for cutting in the medical setting.
  • anything connectable to the device or object used to puncture or lacerate the skin may also be considered sharps waste. Examples may include, but should not be limited to, a tube, a Vacutainer®, and the like. The entire combination may be considered as one unit of sharps waste BBx, even though the attached item cannot puncture or lacerate the skin.
  • biohazardous material will be treated with the same concern as needles and blades, even if unbroken. If not contaminated, broken glass and plastic is still a sharp waste, but does not pose the same public health risk. Therefore, broken glass and plastic that has not been contaminated is not handled as delicately.
  • Some common medical items of this category may be test tubes, microscope slides, culture dishes, pipettes, vials, and the like.
  • the sharps containment system includes the container 45 and the counting system 47, operatively attached to the container 45.
  • the container 45 includes a top portion 12 and a bottom portion 14, with the top portion 12 secured to the bottom portion 14 along the perimeter to form a joint 16 therebetween (FIG. 2).
  • the top portion 12 may be secured to the bottom portion 14 using any suitable method to ensure the top portion 12 and the bottom portion 14 are not detachable from one another during or after the surgical procedure, thus ensuring the sharps BBx remain contained within the interior cavity 43 after insertion.
  • Suitable attachment methods may include, but should not be limited to, adhesive bonding, welding, and the like.
  • the top and bottom portions 12, 14 cooperate to define an interior cavity 43 configured for holding a quantity of sharps BBx therein.
  • the top portion 12 may include a top wall 18, defining an aperture 24.
  • the aperture 24 is an elongated slot having an aperture width Z and an aperture length X that is configured to allow the sharps BBx to pass therethrough, into the interior cavity 43.
  • sharps are inserted into the aperture 24, and enter into the interior cavity 43.
  • the length X and the width Z are configured to only allow small sharps BBx, such as needles Bi, blades B4, and sutures B4 therethrough.
  • the aperture 24 is configured to provide one-way access to the interior cavity 43 to retain biohazard therein, while preventing the removal of the sharps BBx.
  • a diverter 38 may extend from the top portion 12, within the interior cavity 43, to provide a barrier to prevent the sharps BBx from exiting the interior cavity 43, should the container 45 be turned over.
  • Such as diverter 38 may be configured to prevent any sized sharps BBx from exiting the interior cavity 43, should the container 45 be turned over.
  • the aperture 24 may be sized with the length X and width Z of sufficient size to allow larger sharps BBx, such as scalpels B2 and injection syringes B5, and the like to also be inserted therethrough.
  • a trap door may be provided to also assist in facilitating one-way access to the interior cavity 43.
  • the trapdoor may be spring-loaded, such that insertion of the sharps BBx causes the trapdoor to open and allow the sharps BBx to pass into the container 45, and automatically closes once the sharps BBx has been inserted. Therefore, not only is the container 45 sealed to prevent being opened by the user and to prevent subsequent access to the sharps BBx stored therein, but the aperture 24 is also configured to prevent the removal of the sharps BBx from the container 45.
  • the counting system 47 is configured to automatically count each sharps BBx, there is no longer a need to re-count the sharps contained within the container 45 at the end of the surgical procedure if the count of the sharps BBx indicates there are missing sharps BBx that need to be accounted for.
  • a needle driver that is already loaded with a previously used suture may be passed over the aperture 24, and then released into the container 45. After release of the used suture, the used suture may come to rest on a collection area 36 of the bottom wall 60 of the bottom portion 14 of the container 45, while the container 45 provides a oneway, sealed biohazard container.
  • the collection area 36 may include a retainer 34, e.g., an adhesive, foam pad, and the like), configured for retaining the sharps BBx thereto, so as to prevent the sharps BBx rattling or otherwise moving around in the interior cavity 43 of the container 45.
  • the container 45 may be configured for one-time use, such that the top portion 12 may not be separated from the bottom portion 14. As such, at the completion of the surgical procedure, the entire containment system 100, including the sharps disposed in the container 45, may be disposed with other biohazard waste, without disassembly.
  • the counting system 47 is in operative communication with the aperture 24 to detect and count the sharps BBx inserted in the aperture 24. Therefore, the counting system 47 automatically counts, or otherwise keeps track of, a quantity of the sharps BBx that have been inserted through the aperture 24 and are stored in the container 45.
  • the top portion 12 includes the top wall 18, which may extend in spaced and facing relationship to the bottom wall 60 of the bottom portion 14, to extend over a bottom portion 14, such that the top and bottom portions 12, 14 cooperate to define the interior cavity 43.
  • the top portion 12 may define the aperture 24, as illustrated in FIGS. 2, 4A, 6, and 8.
  • the aperture 24 is configured to provide a one-way passage for the sharps to be stored the container 45.
  • the bottom portion 14 may include a bottom wall 60 and four side walls 22.
  • the bottom wall 60 may be rectangular in shape, with each of the four side walls 22 extending generally perpendicularly from the perimeter of the bottom wall 60, such that the side walls 22 and the bottom wall 60 define a collection receptacle 32 for receiving the sharps BBx.
  • the interior volume of the collection receptacle 32 defines at least a portion the volume of the interior cavity 43.
  • the counting system 47 may include at least one sensor 62 and a counter C in operative communication with the sensor 62.
  • the sensor 62 is disposed relative to the aperture 24 and is configured to sense the passage of each sharps BBx that passes through the aperture 24.
  • the sensor 62 may be operatively attached to the top wall 18, relative to the aperture 24.
  • the sensor 62 outputs a sensor signal S62 to the counter C.
  • the counter C indexes a counted quantity of sharps BBx stored within the interior cavity 43 by an integer of one.
  • the counted quantity of sharps may be displayed as display characters 42 on a visual display 40 (FIG. 2).
  • the visual display 40 may be operatively disposed on an exterior of the container 45. With reference to FIG. 2, the visual display 40 may be operatively disposed on the top wall 18 of the top portion 12. The visual display 40 is in operative communication with the controller, such that the visual display 40 may display one or more display characters pertaining to a quantity of sharps stored in the interior cavity 43 of the container 45.
  • the visual display 40 may be a light-emitting diode (LED) display, a liquid-crystal display (LCD), a plasma display, and the like.
  • the LCD display may be used in a well-lit installation, such as the case in most operating room setting. Alternatively, the LED display may be used in dark or dimly lit environments such as surgical cases in which microscopic, endoscopic, laparoscopic or robotic surgery is performed.
  • the visual display 40 may be operatively disposed on an exterior of the container 45. With reference to FIG. 2, the visual display 40 may be operatively disposed on the top wall 18 of the top portion 12.
  • the visual display 40
  • the time delay may be a five second delay.
  • the counting system 47 may include a controller 68 including the counter C.
  • the controller 68 is configured to function as a logic circuit, such that the controller 68 is configured to perform logical operations based on data.
  • the controller 68 of the present disclosure is depicted as a single device for illustrative clarity. When so configured, the controller 68 may be embodied as a central processing unit (CPU), integrated circuit, or any other suitable device controller. In one embodiment, the controller 68 may be a micro controller, such as an Arm Cortex M3, that provides a desired connectivity, sensor interface, and data management.
  • controller 68 may be decentralized into multiple control chips, microprocessors, or control modules to provide the functionality detailed below. Embodiments of the controller 68 may therefore also include a processor P and sufficient amounts of memory M, at least some of which is tangible and non-transitory to include the instructions needed for implementing a method 200 (FIG. 7).
  • the memory M may include sufficient read only memory (ROM), random access memory (RAM), electrically- programmable read-only memory (EPROM), flash memory, etc., and any required circuitry including but not limited to a high-speed clock (not shown), analog-to-digital (A/D) circuitry in addition to A/D converter(s), digital-to-analog (D/A) circuitry, a digital signal processor (DSP), and the necessary input/output (I/O) devices and other signal conditioning and/or buffer circuitry.
  • the controller 68 is specifically programmed to execute instructions embodying the method 200 by performing basic arithmetic, logical, control, and input/output (I/O) operations specified by the instructions, as explained below with reference to FIG 7.
  • the containment system 100 may be configurable as either a single- function or a multi-function system that can store the number of used sharps and/or unused sharps during the surgical procedure in the memory M.
  • the counter C may be configured to count the number of sharps BBx by registering each sharps BBx insertion, and subsequently updating a count stored in the memory M.
  • the visual display 40 may then be updated to display the count stored in the memory M.
  • the counter C may be powered by a battery, by a rechargeable power source 50, or by any other source of power.
  • the number of unused sharps may be determined when a total number of sharps to be used for a given surgical procedure is entered into the controller 68.
  • the total number of sharps to be used for a given surgical procedure may be entered using a data connection 46, i.e., a communication port, or via an input 44, such as a switch or button.
  • a data connection 46 i.e., a communication port
  • an input 44 such as a switch or button.
  • the sensor 62 transmits a sensor signal S62 to the controller 68, such that the counter C decrements the total number of sharps by an integer of one.
  • the total number is then stored in the memory M location, and subsequently displayed on the visual display 40 as the unused number of sharps remaining.
  • the controller 68 may be programmed to perform more than one function.
  • the controller 68 may be uploaded with the number of sharps BBx to be used (or brought into the surgical procedure) at the beginning of the surgical case, and, as the sharps BBx begin to be inserted into the container 45 through the aperture 24, the counter C will decrement each used sharp BBx from the total input number. Then, at the end of the surgical procedure, the total number of sharps BBx displayed on the visual display 40, or stored in memory M, would represent the total number of unused sharps. The surgical team may count the total number of unused sharps BBx at the end of the surgical procedure, and compare to the number of unused sharps displayed on the visual display 40 to confirm that all sharps BBx have been accounted for.
  • the surgical team may also count and input the total number of unused sharps BBx into the containment system 100. If the quantities do not match, an indication or alert may be displayed on the visual display 40. Additionally, the total number of used sharps BBx, i.e., those sharps BBx inserted into the container 45 during the surgical procedure, may be displayed on the visual display 40. The surgical team may then immediately initiate a search or investigation as to the count discrepancy. This would therefore increase the reliability of the sharps count at the end of the surgical procedure.
  • Data such as information pertaining to the surgical case, may be downloaded and archived into an electronic medical record.
  • the controller 68 may be programmed to initiate a "surgery complete" switch that verifies that the number of sharps BBx used during the surgical procedure, plus the number of unused sharps, are equal to the expected number of needles. An alert may be displayed on the visual display 40 if the numbers are not equal. The controller 68 may then download this numerical information across a network 66, as well as a sharps count verification, into an electronic medical record database system 78, for audited sharps tracking information. [0048] In another embodiment, the controller 68 may be configured with a preprogrammed number of sharps BBx stored in the memory M location.
  • the containment system 100 may be prepackaged and standardized with a typically desired number of sharps, in order to provide a standardized ease of tracking and/or germ minimization.
  • a code or switch identifying the module may be entered into or received as data by the controller 68.
  • the controller 68 may then interpret the code through a lookup table of module codes that includes one or more of a maximum number of sharps BBx for the specific container 45 and/or a number of sharps BBx in the module.
  • a maximum sharp number is stored in the memory M location inside the controller 68.
  • the counter C indexes by an integer of one, and the indexed value is recorded in the memory M.
  • the controller 68 may then retrieve the value of the maximum number of sharps to be placed within the container 45 from the memory M location, along with the value of the counted quantity of sharps BBx received through the aperture 24.
  • the controller 68 may then compare the retrieved values to determine whether the quantity of sharps BBx received through the aperture 24 is equal to the preset number of sharps BBx. If the preset value has been achieved, the container 45 may be configured to decline to accept additional sharps BBx.
  • the containment system 100 may include an overfill protection system49, configured to inhibit or otherwise prevent additional sharps BBx from being inserted through the aperture 24, when a maximum quantity of sharps BBx in the interior cavity 43 of the container 45 is reached.
  • an overfill protection system49 configured to inhibit or otherwise prevent additional sharps BBx from being inserted through the aperture 24, when a maximum quantity of sharps BBx in the interior cavity 43 of the container 45 is reached.
  • the overfill protection system 49 may be in operative communication with the controller 68, where the controller 68 transmits a filled signal SSx to the overfill protection system49 when the maximum quantity of sharps in the container 45 has been reached.
  • the overfill protection system49 may include a blocking mechanism 70 and/or an alert system 51.
  • the overfill protection system49 may include the blocking mechanism 70.
  • the blocking mechanism 70 includes a blocking actuator 72 and a blocking member 74.
  • the blocking member 74 is disposed relative to the aperture 24.
  • the blocking actuator 72 is in operative communication with the controller 68 and is movably connected to the blocking member 74.
  • the blocking actuator 72 is configured to be in one of two states, i.e., a non-actuated state and an actuated state, as a function of the counted quantity of sharps BBx stored in the container 45.
  • the blocking actuator 72 may be a linear actuator, a rotary actuator, and the like.
  • the blocking actuator 72 When the blocking actuator 72 is in the non-actuated state, the blocking mechanism 70 is operatively disposed in an unblocked position, such that the blocking member 74 does not block the aperture 24. Thus, when the blocking member 74 is in the unblocked position, sharps BBx are allowed to be inserted through the aperture 24. However, as the user continues to insert sharps BBx through the aperture 24, when the counter C reaches the maximum quantity of sharps BBx, the controller 68 transmits a full signal S70 to the blocking actuator 72. In response, the blocking actuator 72 actuates and causes the blocking member 74 to move to a blocked position.
  • the blocking member 74 blocks the aperture 24 to prevent additional sharps from being inserted through the aperture 24.
  • This embodiment may be ideal for long surgical cases in which the number of sharps BBx exceeds a threshold for the container to hold, while still providing an external check for surgical staff to ensure the number of sharps have been accurately counted.
  • the overfill protection system 49 may include the alert system 51 in operative communication with the controller 68.
  • the alert system 51 may be configured to emit an alert, such as an audio alert and/or a visual alert, indicating that the container 45 has received the maximum number of sharps BBx.
  • the alert system 51 may include an audio output 64 and/or a display 40.
  • the audio output 64 e.g., a speaker, may emit an audio alert, such as a chime, beep, verbal information, and the like, in response to receiving a full signal S70 from the controller 68 that indicates the counted quantity of sharps BBx disposed in the container 45 being the maximum quantity.
  • the display 40 may present text 42 (FIG. 2), a blinking light, blinking display characters, and the like, in response to receiving a full signal S70 from the controller 68.
  • the containment system 100 may include at least one sensor 62.
  • the sensors 62 may be configured with a three-wire connection, and based on a digital input/output (I/O) interface, meaning that the sensor 62 will provide a false (0 volts direct current (VDC)) or true (4.5 VDC) signal to a pin on the controller 68.
  • a detection event may refer to action taken by either the sensor 62 or the controller 68, when a sharps BBx is detected by the sensor 62 as being present in a field detection area 92. As such, the sensor 62 will react by producing a voltage change on an output signal terminal.
  • the algorithm 200 within the controller will manage the detection event in a way that may provide a "true count", and prevent a "false count” from occurring.
  • the senor 62 may be a Hall effect sensor, a transformer, a current clamp meter, a resistor, a fiber optic current sensor, an induction sensor, a capacitance sensor, a piezoelectric sensor, a laser sensor, a light intensity sensor, an infrared sensor, an ultrasonic sensor, and a contact sensor.
  • a Hall effect sensor a transformer, a current clamp meter, a resistor, a fiber optic current sensor, an induction sensor, a capacitance sensor, a piezoelectric sensor, a laser sensor, a light intensity sensor, an infrared sensor, an ultrasonic sensor, and a contact sensor.
  • a field detection area 92 that each sharps BBx passes through.
  • the Hall effect sensor may be especially suited for sharps BBx formed from metallic material, which create a magnetic field that can be easily recognized and counted by the counter C.
  • the Hall effect is the production of a voltage difference, i.e., the "Hall voltage", across an electrical conductor, transverse to an electric current in the conductor and a magnetic field perpendicular to the current.
  • Hall effect sensors are immune these contaminations. These characteristics make Hall effect sensors useful for position sensing, as opposed to other types of sensing, such as electromechanical sensing.
  • the induction sensor may be suitable for detecting ferrous materials, when the ferrous materials are placed near the sensor field detection area 92.
  • the sensor 62 may be powered by 4.5 VDC, and output a high (4.5 VDC) signal to the controller 68 when the ferrous material is detected.
  • the induction sensor is a three-wire sensor.
  • the capacitance sensor is configured to detect the presences of non-ferrous material, when the non-ferrous material is placed near the field detection area 92.
  • the internal capacitor capacitances in the capacitance sensor change when the non-ferrous sharps enters the field detection area 92, thus, triggering a detection event.
  • the capacitance sensor is power by 4.5 VDC and outputs a high 4.5 volts signal to the controller 68 when the non-ferrous sharps is detected. This is a three-wire sensor.
  • the transformer when used as a sensor, may be a split core current transformer that detects the electrical current, and, generates a voltage signal proportional to the electrical current.
  • the voltage signal is transmitted to the controller 68.
  • the controller 68 detects a voltage that is outside of a preset range, the controller 68 determines that a sharps has been detected, and indexes, i.e., increments or decrements, the counter C by an integer of one.
  • the piezoelectric sensor is configured to detect when the sharps contacts and deflects the sensor.
  • a frequency generated by the piezoelectric sensor is transferred to a controller 68 pin.
  • a small 1 microfarad (uF) capacitor, together with a 1 mega-ohm ( ⁇ ) will average an output of the piezoelectric sensor, thus shaping the signal to a more DC-like form. This shaping may provide an output that is easier and more accurate for the controller 68 to read.
  • the laser sensor includes a beam generator and a receiving unit that is configured to detect the presence of the laser beam.
  • the receiving unit When the sharps to be counted is placed in front of the transmitted laser beam, the receiving unit will see a reduction on the amount of light. This reduction of light is what triggers a detection signal. Each interruption may equal a count of one sharps.
  • the sensor may be powered by 4.5 VDC and outputs a high (4.5 VDC) signal to the controller 68 upon the detection of the sharps.
  • the laser sensor may be a three wire sensor.
  • the LED sensor includes an LED light generator and a photo resistor.
  • the LED light may be placed inside a round tube, and aimed at the photo resistor.
  • the detection field is located between the LED light generator and the photo resistor.
  • the photo resistor is monitored by an analog input on the controller 68.
  • the photo resistor is connected in series with a resistor, creating a voltage divider network. Voltage is sampled at the intersection of the photo resistor and the resistor.
  • a voltage drop is detected by the controller 68, triggering a detection event.
  • a high and a low threshold parameter may be preprogrammed into the controller 68.
  • the infrared (IR) sensor operated similarly to the LED sensor, with the only difference being that the light emitted is on the infrared spectrum.
  • the IR sensor may be powered by 4.5 VDC, and output a high (4.5 VDC) signal to the controller 68 when the sharps is detected.
  • the IR sensor may be a three-wire sensor.
  • the ultrasonic sensor is a transducer that converts ultrasound waves to electrical signals.
  • the ultrasound sensor includes a transmitter and a receiver that may be configured to operate with the same principles of a bat, in that the ultrasound sensor sends an ultrasonic wave, and then pauses and listens for an echo. The amount of time it takes for the echo to be received by the ultrasound sensor is used to determine the distance of the sharps placed in the detection field. The ultrasound sensor will output a 0 to 5 volts signal, proportional to the echo receiving time. The output of the ultrasound sensor is then communicated to an analog input pin on the controller 68. When the containment system 100 is first powered on, the controller 68 is configured to sample a voltage at the input pin. This voltage is recorded in the memory M for future use.
  • Ultrasonic sensor may be a three-wire sensor.
  • the contact sensor otherwise known as a mechanical sensor, includes a normally open switch that includes a contact. When the sharps contacts the contact, the contact sensor is configured to close, which triggers a detection event.
  • the contact sensor may be connected to a digital input/output (I/O) pin on the controller 68.
  • the containment system 100 may include at least one communication port 46 and/or antenna 53 in operative communication with the controller 68.
  • the communication port 46 and/or the antenna 53 may be configured to facilitate data transfer with the controller 68 to track the number of sharps BBx from the beginning of the surgical procedure and ensure the tracked number is consistent with the count at the end of surgical case.
  • Counts may be specific to the types of sharps BBx, such as the quantity of surgical sutures B4, injectable needles Bi, surgical blades B3, and the like.
  • the containment system 100 may be configured to separate the different types of sharps BBx by time stamping the data transmitted from the containment system 100 to the electronic record on the database 78.
  • This information may be used from a quality control and risk management perspective to help stratify which surgical cases cause a bigger financial risk to a healthcare entity.
  • the collected data may indicate there is an increase in sharps BBx counting errors occurs with cardiac surgical processes, as opposed to oncology procedures, the cardiac procedures may be identified as causing a bigger financial risk. Less opportunity for human counting error at each stage of the case improves safety of patients.
  • the containment system 100 may be configured to act as a human interface device (HID) for data transfer. In doing so, a mini USB connection through the communication port 46 may provide a physical layer needed for receiving devices.
  • the containment system 100 will emulate a keyboard, where the command to the containment system 100 stems from pressing an input switch 44 located on the container 45 (FIG. 2).
  • the receiving devices places a cursor in the correct place, where the data will be delivered.
  • the controller 68 delivers the data.
  • the controller 68 functions as a virtual keyboard, after the receiving agrees to pair with the containment system 100, such that the controller 68 of the containment system 100 becomes a virtual keyboard to the receiving device.
  • the controller 68 may initialize a series of four keystrokes, each corresponding to values presented as display characters 42 on the LED counter 40.
  • Data that may be received using the HID may include the maximum sharps input into the memory M for the container 45 or the remaining sharps BBx, each of which may then be stored in an internal container memory.
  • the HID may also receive a command from the controller 68 of the containment system 100 that the surgery has ended and the sharps count should be formally conducted and the results downloaded to the database 78 or an alert emitted if the count does not match.
  • the controller 68 may be configured to constantly monitor an internal register, and, if any data arrives, a buffer is read and analyzed by the controller 68. All commands received by the controller 68 may return an "OK" or acknowledge response. All commands may be two bytes long. If the command received by the controller 68 expects data from the controller 68, then data may be delivered in a format such as: "CC” + "DDDD” +"OK", where CC is the two byte command received, where DDDD is a 4 byte long data requested, and the frame is close with the two byte long acknowledge "OK".
  • Commands received, and data output using, the communication port 46, along with other data and/or interface connections described herein, may include data pertaining to the HID that has been described above.
  • remote communication interfaces such as RS232 or TCP/IP may allow sharps count information to be communicated or updated from, or to, a remote system, and may allow the initiation of a sharps verification procedure from a remote system.
  • an Ethernet cable connection such as an RJ45 Ethernet cable connection using a TCP/IP open socket
  • raw data by using any terminal console, such as Telnet, program data is requested by the use of predefined commands.
  • web page format a web site inside the controller 68 may be accessed by the receiving devices by the use of any web browser.
  • a default IP address for the containment system 100 may be 198,198.0.1, with a network Mask 255.255.255, 0.
  • the containment system 100 may maintain an open socket and constantly scan the incoming traffic for any node request.
  • the controller 68 of the containment system 100 may respond by sending a preformatted HTML file containing the current sharps count, the sensor condition, and a single button to reset the current count to zero.
  • the Web browser on the receiving machine may subsequently display the HTML file as a web page.
  • a WiFi TCP/IP open socket can be obtained by accessing a WiFi module.
  • the controller 68 of the containment system 100 will connect to a wireless router. Such a connection may be accomplished with the antenna 53 in communication with the controller 68.
  • Connectivity parameters may need to be transferred to the controller 68, such as by using a regular USB keyboard that connect to the communication port 46.
  • Parameters, such as an SSI ID, a pass-code, and the like may be input and saved on the memory M of the controller 68 for future use. Data may be obtained in the same way as previously describe.
  • the containment system 100 may be configured to provide communication using a Bluetooth® connection.
  • the sharps verification information may be used for a variety of purposes.
  • the sharps-used count in the sharps verification information may be provided to an inventory management, tracking, and/or replenishment system.
  • the system may compare the number of sharps BBx used to a pre-stored current inventory number, as well as to a pre-stored desired inventory number. Ordering of additional sharps BBx may be initiated when the pre- stored current inventory number that has been decremented by the sharps BBx used number results in a number that is less than the desired inventory number.
  • the inventory may be tracked for individual locations, such as individual operating rooms in a hospital, and re-stock instructions may be electronically transmitted to a restocking system.
  • the sharps verification information such as the total number of sharps BBx used, may be passed to an electronic billing system for use in calculating a bill for the surgical procedure.
  • a magnetic pocket 26, having a generally concave shape is installed in, or otherwise formed in, the top wall 18 of the top portion 12 on the container 45.
  • the magnetic pocket 26 presents a magnetic surface 28 for the placement, retention, and temporary storage of reusable sharps BBx during a surgical case.
  • Such a magnetic pocket 26, or magnetic holder provides a location for a surgical technician to place sutures BB4, or other reusable sharps BBx, during the surgical procedure. By providing such location for the placement of reusable sharps BBx, at least two purposes are served. First, blunting of a suture tip of the reusable sharps BBx is prevented.
  • a holding pad 80 may be provided that includes a pad member 82 disposed over a magnetic region 94. The holding pad 80 is configured to support reusable sharps BBx.
  • the pad member 82 may be formed form any material configured to support the reusable sharps BBx, while preventing blunting or dulling.
  • the holding pad 80 may be formed as any desirable shape, such as a rectilinear, pyramidal, hemicylindrical, or hemispherical shape.
  • the magnetic area may instead be a magnetic region 94 that may be flush with the top wall 18 of the top portion 12, or, with specific reference to FIG. 8, the holding pads 80 may extend from the top wall 18 of the top portion 12 of the container 45, or follow surface contours of the top portion 12.
  • the magnetic pocket 26 may be positioned on a side wall 22 of the container 45, or proximal to the aperture 24 and/or the counter display output 40.
  • a region with an adhesive and/or a fabric may be employed instead of a holding pad 80.
  • the magnetic region 94 may be established using several magnetic systems, including a permanent magnet, and/or a de-activatable magnet, such as an electro magnet, that may be turned on or off using a control positioned on the holder.
  • the adhesive and/or fabric regions may be replaceable.
  • the holding pad 80 may be positioned as part of a removable structure 95 that may include a first attachment member 84 configured to be interlocked and de-interlocked with a second attachment member 88, e.g., a peg, as desired.
  • the second attachment member 88 may extend from the top wall 18 of the top portion 12.
  • the second attachment member 88 interlocks with the first attachment member to retain the removable structure to the container 45.
  • the holding pad 80 may include the magnetic pad base 94 and the pad member 82.
  • the pad member 94 may include an adhesive and/or a fabric region.
  • the method 200 may be encoded as computer- readable instructions residing in the memory M of the controller 68 shown in FIGS. 4A and 5.
  • An example embodiment of the method 200 begins with step 103, where a containment system 100 is obtained for use.
  • step 105 the containment system 100 is activated. Activation may occur by toggling a switch 44 or by merely supplying electrical power to the controller 68 from a power source 50, such as by inserting at least one battery in a power compartment 54. It should be appreciated that electrical power may also be supplied via connecting the controller 68 to any other power source 50.
  • step 110 the containment system 100 is set up.
  • the display on the display output 40 may blink to indicate the containment system 100 is ready to receive sharps BBx.
  • the counter C may be set to zero (if the count is to be incremented) or may be set to a preset number (if the count is decremented).
  • patient identifying information may be place on the container 45, such as on an identification region 90. Such patient identifying information may be in the form of a printed label, handwritten, a barcode, a microchip, and the like. Alternatively, patient identifying information may be input directly to the memory M of the controller 68.
  • step 115 the containment system 100 is connected to a network or other device or system via the communication port 46, a USB connection, the Bluetooth connection, WiFi, and the like.
  • step 120 a sharps BBx is passed through the aperture 24.
  • step 125 the sensor 62 is actuated by virtue of the sensor 62 sensing the sharps BBx is passing through the aperture 24. As the sensor 62 is activated, the sensor 62 outputs an sensor signal S62 to the controller 68. It should be appreciated that steps 120 and 125 may be accomplished
  • the method 200 may optionally proceed to step 130, where the controller 68 may transmit a signal to the audio output 64, such as a "beep", to indicate a sharps BBx has been sensed by the sensor 62.
  • a signal to the audio output 64 such as a "beep"
  • step 135 a debounce may be activated, such that the display characters 42 on the display output 40 toggle between blinking and non-blinking.
  • the display characters 42 may start blinking when it becomes okay to insert another sharps BBx in the container 45 and the display characters 42 may stop blinking when it is not yet acceptable to insert another sharps BBx into the container 45.
  • Such a visual indicator may be used to allow enough time for the individual sharps BBx to have cleared the sensor 62 and be counted only one time by the counter C, such that double-counting of the sharps BBx is prevented.
  • step 140 the single sharps BBx is recorded in the memory M.
  • the count of the sharps BBx received in the container 45 is adjusted by an integer of one.
  • the adjusted count of the sharps BBx is displayed on the display output 40.
  • the count of the sharps BBx may correspond to the total number of sharps BBx actually contained in the container 45 and/or the number of sharps BBx the container 45 has room to receive before the container 45 is considered to be at maximum capacity, as previously recorded in the memory M as a preset value.
  • step 150 the count C recorded in the memory M is compared to the preset value to determine if the container is at maximum capacity.
  • step 155 a determination is made by the controller 68 as to whether the container is at maximum capacity. If the container 45 is not at maximum capacity, the method proceeds to 160. However, if the container 45 is at maximum capacity, the method may proceed to step 170, where the alert signal S70 may be transmitted to the blocking mechanism 70 to actuate the blocking actuator 72 to move the blocking member 74 and block the aperture 24.
  • step 175 the alert signals S40, S64 may be transmitted to the display output 40 and/or the audio output 64 of the alert system 51 to emit a visual and/or an audio signal to alert the user. It should be appreciated that one or both of steps 170 and 175 are optional, and may also occur
  • the method may simultaneously retum to step 103 and proceed to step 160.
  • step 103 another containment system 100 is obtained for use, and the method proceeds as described above.
  • step 160 a determination is made as to whether the surgical procedure is complete. If the determination is made that the surgical procedure is not complete, method proceeds to step 165, where the controller 68 sends a signal to activate blinking of the display characters 42 to indicate to the user that it is okay to insert another sharps BBx in the container 45. After step 165, the method returns to step 120, where the container 45 receives another sharps BBx.
  • step 180 the controller 45 may transmit a signal to indicate the procedure is complete.
  • the controller 68 may request a count of unused BBx sharps be input, such that the counted unused sharps BBx are compared by the controller 68 to the total used sharps BBx, in order to determine if all of the sharps BBx brought into surgery have been accounted for.
  • step 190 a determination is made as to whether the sharps BBx count has been reconciled, i.e., whether all sharps BBx brought into surgery been accounted for. If all of the sharps BBx have been accounted for, the method proceeds to step 205, where data from the controller 68 may be downloaded to another device, such as a database 78 that is remote to the containment system 100.
  • step 210 the containment system 100 may be disposed of.
  • the entire containment system 100 including all of the sharps BBx contained therein, may be disposed of by autoclaving or any other suitable method of disposal.
  • step 215 there data is transferred to the database/server 78 to record information pertaining to the patient (i.e., recorded as part of the patient's medical record).
  • step 190 the method proceeds to step 195, where reconciliatory action is taken by the staff. In doing so, the staff may search for missing sharps BBx, recount unused sharps BBx, and the like. Once the reconciliatory action is completed, the method returns to step 190, where the determination is made as to whether all of the sharps BBx have been accounted for.

Abstract

La présente invention concerne un système de confinement d'objets pointus ou tranchants comprenant un récipient, un capteur, et un compteur. Le récipient délimite une cavité intérieure qui stocke et retient en son sein des instruments médicaux pointus ou tranchants (objets pointus ou tranchants). Le récipient délimite une ouverture qui s'ouvre sur la cavité intérieure. Le capteur détecte l'insertion de chacun des objets pointus ou tranchants dans la cavité intérieure, à mesure que chacun des objets pointus ou tranchants passe par l'ouverture, et transmet un signal au compteur. À son tour, le compteur reçoit le signal et indexe une quantité comptée des objets pointus ou tranchants stockés dans la cavité intérieure par un nombre entier unitaire afin de fournir une quantité mise à jour d'objets pointus ou tranchants. Des informations relatives à la quantité mise à jour d'objets pointus ou tranchants stockés dans le récipient sont affichées sur un écran d'affichage, de sorte que le récipient ne doit jamais être ouvert pour déterminer si tous les objets pointus ou tranchants ont été pris en compte.
PCT/US2016/049000 2015-08-26 2016-08-26 Système de confinement d'objets pointus ou tranchants et procédé pour le stockage et le suivi automatisé d'instruments médicaux pointus ou tranchants WO2017035474A1 (fr)

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US201562265146P 2015-12-09 2015-12-09
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WO2020263245A1 (fr) * 2019-06-26 2020-12-30 Healthbeacon Système et procédé favorisant l'observance thérapeutique
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