Infusion pump security system

Abstract

A system and method for securing a pump is disclosed. The system includes a pump including a medication delivery system, a processor operably coupled to the pump, a user interface in operative communication with the processor, a plurality of sensors in operative communication with the processor, and a housing. The housing includes a frame, a door, and a locking mechanism that can be selectively unlocked to allow the door to be partially removed from the frame. The security system includes a swivel door assembly that includes physical redundancy to selectively prevent access to an interior space of the swivel door assembly and a plurality of alarms. For example, in response to receiving input from the plurality of sensors, the processor initiates at least one of the plurality of alarms to provide an indication to a user that an event has occurred.

Description

[Background technology]

[0001] (background) Unauthorized tampering with medication delivery systems, such as patient-controlled analgesia ("PCA") pumps, to obtain pain medication creates inefficiencies in the health care system as well as risks to patient safety. Drug diversion by malicious individuals or clinicians can result in patients not receiving the required amount of medication, which can be detrimental to patient outcomes. Similarly, drug diversion can be costly and a strain on the finite resources of the health care system. Current security systems sound an alarm as soon as they detect possible unauthorized access to the pump. If the unauthorized user immediately turns off the alarm, it will disable the audible effect of the alarm. As a result, administrators of the system will be unaware of the alarm and possible diversion. More specifically, administrators of the system will be unaware that an unauthorized user may have gained access to a drug protected by the pump, and will not know what steps must be taken after an unauthorized user gains access to the pump. Thus, a system that provides an indication of unauthorized access, and that remains in an alarm state until an authorized user receives that indication, is desirable.

[0002] Furthermore, with current security systems, when unauthorized users are able to access the drug delivery system, drugs can be diverted using external tools. Therefore, a security system that redundantly blocks the drug delivery system from external tools is desirable. Additionally, a need exists for a system that provides instructions and details of unauthorized use to authorized users of the system. Summary of the Invention [Means for solving the problem]

[0003] Exemplary systems, methods, and devices are disclosed herein for systems and methods for securing a pump. The system includes a processor integrated and operably coupled to a pump including a medication delivery system, a user interface in operative communication with the processor, a plurality of sensors in operative communication with the processor, and a housing. The housing includes a frame, a door, and a locking mechanism that is selectively unlocked to allow partial removal of the door from the frame. The security system includes a swivel door assembly, the swivel door assembly including physical redundancy to selectively prevent access to an interior space of the swivel door and a plurality of alarms. For example, in response to receiving inputs from the plurality of sensors, the processor initiates at least one of the plurality of alarms to provide an indication to a user of the system that an event has occurred. The exemplary systems, methods, and devices are configured to provide an authorized user with instructions and details of unauthorized use on a screen of a user interface. Thus, the disclosed systems, methods, and devices improve effective infusion management by preventing diversion of medication.

[0004] In a first aspect of the present disclosure, which in view of the disclosure herein may be combined with any other aspect listed unless otherwise specified without limiting the scope of the invention in any way, a patient controlled analgesia pump includes an actuator, a syringe holder, a display screen, a security door assembly, a security frame assembly, a swivel assembly, a plurality of sensors including at least one occlusion sensor and at least one downstream in-line pressure sensor, a syringe flange, a syringe push button, a syringe barrel clamp, a syringe pump lever, a processor, and a memory storage device, which when executed by the processor, causes the processor to generate a syringe misloaded alarm when a syringe is misloaded in the PCA pump, generate a syringe loaded error alarm when there is a syringe loading error in the PCA pump, generate a door unlocked alarm when the security door assembly is unlocked from the security frame assembly, and generate a downstream occlusion alarm when there is a downstream occlusion in the PCA pump. Additionally, the alarm may be an audible, graphical, visual and / or tactile notification, or a combination thereof, and an authentication command entered by the user may allow the user to silence and / or stop the alarm.

[0005] In a second aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, a syringe misload alarm is issued when any of the following conditions are true: the syringe flange is removed; the syringe push button is not in contact with the occlusion sensor; the syringe barrel clamp is open; the syringe pump lever is activated; and / or the syringe push button detects a high pressure reading, except when the security door assembly is closed and confirmed to be locked by the user, the pump is in delivery mode, and the syringe misload alarm is active.

[0006] In a third aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, when the pump is in delivery mode and any of the following conditions are true: the syringe flange is removed; the syringe push button is not in contact with the occlusion sensor; the syringe barrel clamp is open; and / or the syringe pump lever is activated, a syringe misload alarm is issued and the pump stops delivery mode.

[0007] In a fourth aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, a syringe load error alarm is issued when the security door assembly is confirmed to be closed and locked by the user, the pump is not in delivery mode or is stopped, the syringe push button detects a high pressure reading, and the syringe load point is activated.

[0008] In a fifth aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, a door open alarm is issued when the security door assembly is opened and the pump is in delivery mode.

[0009] In a sixth aspect of the present disclosure, which may be combined with any other aspect listed unless otherwise specified, a downstream occlusion alarm is issued when the downstream in-line sensor detects a pressure outside of a pressure input by a user at about 1.0 meter downstream.

[0010] In a seventh aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, the security door assembly further comprises a mating portion, and the security frame assembly further comprises a mating portion.

[0011] In an eighth aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, a mating portion on the security door assembly selectively engages a mating portion on the security frame assembly to selectively couple the security door assembly and the security frame assembly.

[0012] In a ninth aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, the security door assembly further comprises ribs, grooves and / or contours on an interior surface of the security door assembly.

[0013] In a tenth aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, the security door assembly further comprises a receiving portion, and the security frame assembly further comprises a lock assembly.

[0014] In an eleventh aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, a lock assembly selectively mates with a receiver.

[0015] In a twelfth aspect of the present disclosure, which may be combined with any other aspect listed unless otherwise specified, a patient controlled analgesia pump includes an actuator, a syringe holder, a display screen, a security door assembly including a receiver, a security frame assembly including a lock assembly, a swivel door assembly including a syringe pump lever in an upright and downward orientation, and a plurality of sensors including at least one occlusion sensor and at least one downstream inline pressure sensor, The security door assembly couples with the security frame assembly, and the lock assembly mates with the receiver.

[0016] In a thirteenth aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, the swivel door assembly further comprises a main assembly body to which a lever door is pivotally coupled, a swivel door pivotally coupled to the assembly body and including a sidewall, and a sidewall planar surface coupled to the main assembly body, the sidewall planar surface completely covering the syringe pump lever, the lever stopper and the pull knob stopper.

[0017] In a fourteenth aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, the swivel door has an internal curvature that interfaces with the plunge lever and redirects a force applied to the syringe pump lever such that the plunge lever cannot be depressed when the swivel door is in a closed configuration relative to the main assembly body.

[0018] In a fifteenth aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, a lever stopper is pivotally mounted to the main assembly body and couples with a syringe pump lever to hold the syringe pump lever in an upright orientation, the pull knob stopper including a locking pin, the locking pin being engaged with the lever stopper and mated with a locking receptacle for selectively locking the lever stopper when the lever stopper couples with the syringe pump lever.

[0019] In a sixteenth aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, the pull knob lever includes a mechanism for orienting a locking pin into engagement with a locking receptacle, and a user can selectively deactivate the mechanism to selectively disengage the locking pin from the locking receptacle.

[0020] In a seventeenth aspect of the present disclosure, the security door assembly and the security frame assembly are interlocked such that when in a closed configuration, the syringe holder is inaccessible.

[0021] In an eighteenth aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, when the security door assembly and the security frame assembly are in an interlocking, closed configuration, the display screen is accessible.

[0022] In a nineteenth aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, when the security door assembly and the security frame assembly are interlocked and in a closed configuration, the swivel door assembly is inaccessible.

[0023] In a twentieth aspect of the present disclosure, which may be combined with any other aspects listed unless otherwise specified, when the security door assembly and the security frame assembly are in an interlocking, closed configuration, the actuator is inaccessible.

[0024] In a twenty-first aspect of the present disclosure, any of the structures, functionality, and alternatives disclosed in conjunction with any one or more of Figures 1 through 13 may be combined with any other structure, functionality, and alternatives disclosed in conjunction with any other one or more of Figures 1 through 13.

[0025] In view of the present disclosure and the above aspects, it is an advantage of the present disclosure to prevent physical access to pump components and to provide authorized users of the system with instructions and details of unauthorized use.

[0026] Additional properties and advantages will be described in and will be apparent from the following detailed description and drawings. The properties and advantages described herein are not all-inclusive, and in particular many additional properties and advantages will be apparent to those skilled in the art upon viewing the drawings and description. Also, any particular embodiment need not have all of the advantages listed herein, as it is expressly contemplated to separately claim each advantageous embodiment. Moreover, it should be noted that the language used in this specification has been chosen principally for readability and instructional purposes, and not to limit the scope of the inventive subject matter. [Brief description of the drawings]

[0027] Certain exemplary apparatus embodiments of the present invention, as well as exemplary procedures for making and using one or more exemplary embodiments, are described in detail herein, by way of example, with reference to the accompanying drawings (which are not necessarily drawn to scale with respect to any internal or external structures shown), in which like reference characters designate like elements throughout the several views.

[0028] [Figure 1A] FIG. 1A illustrates a perspective view of a security door assembly according to an example of the present disclosure.

[0029] [Figure 1B] FIG. 1B illustrates a detailed view of a striker assembly of a security door assembly according to an example of the present disclosure.

[0030] [Diagram 2] FIG. 2 illustrates a perspective view of a security frame assembly according to an example of the present disclosure.

[0031] [Diagram 3] 3A and 3B illustrate perspective views of an infusion pump utilizing a security system in an unlocked portion and a security door in a locked portion according to an example of the present disclosure.

[0032] [Figure 4] 4A and 4B illustrate exploded perspective views of a swivel door assembly according to an example of the present disclosure.

[0033] [Diagram 5] 5A and 5B illustrate exploded perspective views of the interior of a swivel door assembly according to an example of the present disclosure.

[0034] [Figure 6] 6A, 6B and 6C illustrate perspective views of plunger stoppers according to examples of the present disclosure.

[0035] [Figure 7] 7A, 7B and 7C illustrate perspective views of alternative plunger stoppers according to examples of the present disclosure.

[0036] [Figure 8] 8A, 8B and 8C illustrate perspective views of a pull knob stopper according to an example of the present disclosure.

[0037] [Figure 9] FIG. 9 illustrates a detailed view of a plunger stopper in a locked configuration with a pull knob stopper according to an example of the present disclosure.

[0038] [Figure 10] FIG. 10 illustrates a flow diagram of a syringe misloading alarm sequence of an infusion pump security system according to an example of the present disclosure.

[0039] [Figure 11] FIG. 11 illustrates a flow diagram of a syringe load error alarm sequence of an infusion pump security system according to an example of the present disclosure.

[0040] [Figure 12]FIG. 12 illustrates a flow diagram of a door unlock alarm sequence for an infusion pump security system according to an example of the present disclosure.

[0041] [Figure 13] FIG. 13 illustrates a flow diagram of a downstream occlusion alarm sequence of an infusion pump security system according to an example of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0042] DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS The present disclosure generally describes a pump security system and method of using the same that guards against unauthorized access to pump components. Physical components such as locks, enclosure assemblies and / or sensors may be used to physically prevent unauthorized access to pump components. In addition, virtual security measures such as alarms and passcodes may also be used to restrict access to pump components. Both physical and virtual security components may be used complementary. As an example, a sensor may detect tampering with a drug delivery, which may activate an alarm. In the event of unauthorized tampering, a passcode is required to silence the alarm, which can only be silenced by an authorized user. This alerts the user that a tampering event is actively occurring or has occurred. Unauthorized users will be deterred when they hear this alarm. In an additional example, a plunger stopper is disclosed that introduces a physical redundancy that requires the user to perform a dual simultaneous action to divert the drug, which makes it more difficult to divert the drug, thereby increasing the security of the pump.

[0043] Additionally, alarm sequences are disclosed that are triggered in response to various unauthorized events or pump anomalies. These alarms may assist in preventing tamper events and may provide a tamper event solution that instructs users of the system on steps to take when a tamper event occurs.

[0044] FIG. 1A illustrates a perspective view of a security door assembly 100 according to an example of the present disclosure. In an embodiment, the security door assembly 100 protects the syringe 132 (see FIG. 3A), the barrel clamp 137 (see FIG. 3A), and the plunger push button 135 (see FIG. 3A), thereby ensuring that the drugs are not accessible to unauthorized personnel while the door is locked. The security door assembly may include various ribs, grooves, and / or contours 147 on the inside and a mating portion 146 on one of its edges. The security door assembly 100 may be a component of a pump 125 (see FIG. 3A). In an embodiment, the security door assembly 100 may include a number of sensors 131 (see FIG. 3A) in operative communication with the processor 126 to communicate various inputs to the processor 126 (see FIG. 3A). In an embodiment, the security door assembly may be placed with a frame assembly 145 (see FIG. 2) to create an enclosure for the pump 125 (see FIG. 3A). In one embodiment, the security door assembly 100 may enclose the entire pump, thereby protecting the pump 125, the display screen 121 and the user interface 120 (see FIG. 3A).

[0045] FIG. 1B illustrates a detailed view of the striker assembly 105 of the security door assembly 100 according to an example of the present disclosure. In an embodiment, the security door assembly 100 may include a striker assembly 105 that can be reversibly locked when used in conjunction with a locking deadbolt assembly 115 (see FIG. 2). Specifically, the receiver 110 of the striker assembly 105 has a mating relationship with the deadbolt 130 (see FIG. 2) of the lock assembly 115 (see FIG. 2). The striker / deadbolt system 105, 115 ensures that the security door assembly 100 remains in a locked position unless opened with a proper key. As a result, an unauthorized user cannot access the plunger push button 135 (see FIG. 3A) and the plunger lever 170 (see FIG. 4A) for the purpose of unauthorized tampering, such as drug diversion. In one embodiment, the lock assembly 115 is selected to be a lock assembly of strong and robust materials to minimize the possibility that an unauthorized user will be able to destroy the lock deadbolt 115 .

[0046] FIG. 2 illustrates a perspective view of a security frame assembly 145 according to an example of the present disclosure. In an embodiment, the security frame assembly 145 ensures that the security door subassembly is locked during infusion. The security frame assembly may include a locking deadbolt assembly 115 that may be operatively disposed with the striker 105 of the security door assembly 100 to ensure that the security door 100 remains in a locked position unless opened with an appropriate key. Specifically, the locking assembly 115 includes a deadbolt 130 that mates with a receiver 110 on the striker 105. Thus, in an embodiment, the security frame assembly 145 may be disposed with the security door assembly 100 to create an enclosure immediately adjacent to the pump 125 (see FIG. 3A). To accomplish this, in one embodiment, both the security door assembly 100 and the security frame assembly 145 include a mating portion 146 that selectively couples the security door assembly 100 and the security frame assembly 145 while allowing the security door assembly 100 and the security frame assembly 145 to pivot about each other about the mating portion 146.

[0047] 3A illustrates a perspective view of a pump 125 utilizing a security system 150 in an unlocked position according to an example of the present disclosure. The pump 125 includes a memory 127, a processor 126, an actuator 128, a syringe holder 129, a display screen 121, a security door assembly 100, a security frame assembly 145, a swivel door assembly 160, a sensor 131, and a syringe 132 having a syringe flange 133, a syringe push button 134, a plunger push button 135, and a syringe barrel clamp 137. In an embodiment, when the security door assembly 100 is unlocked and partially disengaged from the security frame assembly 145, the pump user interface 120 and the plunger 155 are accessible to a user of the system 150. The security door assembly 100 and the security frame assembly 145 are integral with the pump 125 and are fastened to the pump 125 using fasteners (not shown) that are inaccessible to unauthorized use. When the security door is closed and locked, the fasteners become inaccessible to unauthorized users, preventing tampering with the door 100 to access the syringe 132 (and therefore drugs (not shown)). In an embodiment, the user interface 120 may be a graphical user interface and / or an audio user interface. In an embodiment, the user interface 120 receives user commands and then relays the commands to the processor 126, which may access the memory 127 to retrieve executable instructions that may be stored in the memory 127. The processor 126 may be capable of storing and executing machine-readable instructions and may coordinate inputs received from the multiple sensors 131. In one embodiment, multiple sensors are placed around the pump 125 at selected locations to detect various conditions of the pump 125 and / or security components. In response to the sensors 131 receiving particular inputs, the processor 126 may initiate various alarm sequences.

[0048] In an embodiment, the user interface 120 of the pump 125 may provide guidance to the user to check, verify and analyze a tampering event. In addition, various alarms suggest the user to check the pump for tampering (damage, vandalism, etc.). The pump 125 may be capable of receiving a programmed security code via the user interface 120. When the user enters the security code to access the pump 125, an alarm suggests the user to check for tampering to determine if any damage or vandalism has occurred. In an embodiment, the processor 126 of the pump 125 may provide the user with a post-tampering event solution, which may be an intuitive workflow for the user to follow to quickly unlock the pump after a tampering event. The intuitive workflow may be provided on the user interface 120 on the display screen 121 to assist the user in the appropriate steps to take when a tampering event occurs (i.e., when disarming the alarm).

[0049] In additional embodiments, the pump 125 may include an event history log that may include details of the tampering event, such as the amount of medication diverted, so that the user can make an informed decision on the next action to take. For example, based on the event history log, the user may decide to continue treatment, replace the syringe 132, or focus further attention on the user if excessive drug was diverted to the patient.

[0050] 3B illustrates a perspective view of an infusion pump 125 utilizing a security system 150 having a security door 100 in a locked portion according to an example of the present disclosure. In the locked portion, the security door 100 pivots about the mating portion 146. The user then engages the locking deadbolt assembly 115 such that the deadbolt 130 mates with the receiving portion 110. In one embodiment, when the security door assembly 100 is in the locked portion, the plunger push button 135 and other selected areas of the pump 125 are inaccessible.

[0051] In an embodiment, the locking deadbolt assembly 115 of the security door assembly 100 and security frame assembly 145 ensures that a physical key is required to lock and unlock the security system 150 after loading the syringe 132 to deliver the medicine. Additionally, ribs, grooves and / or contours 147 (see FIG. 1A) may be provided on the inside surface of the security door 100 to minimize the possibility of an unauthorized user inserting some object while the door 100 is already locked. This results in a more robust security system 150 that prevents unauthorized users from accessing the plunger push button 135 and plunger lever 170 (see FIG. 4A) for the purpose of drug diversion or other unauthorized tampering activities.

[0052] 4A and 4B illustrate exploded perspective views of a swivel door assembly 160 according to an example of the present disclosure. In an embodiment, the swivel door 161 is positioned to cover the plunger lever 170, which makes the plunger lever 170 inaccessible when the security door 100 is closed and locked. In an embodiment, the swivel door assembly 160 may include a swivel door 161, a hinge 162, a plunger lever 170, a sidewall planar 163, and a means 164 for reversibly attaching the sidewall planar 163 to the swivel door assembly 160. The sidewall 163 makes it more difficult for any outside tool to access the plunger lever 170. As a result, the plunger lever 170 can only be depressed when the door is open. In an embodiment, the components of the swivel door assembly 160 are easily disassembled to improve ease of cleaning and / or disinfection.

[0053] 5A and 5B illustrate exploded perspective views of the interior of a swivel door assembly 160 according to an example of the present disclosure. In an embodiment, the swivel door 161 rests on a flat surface 175, preferably having a curved surface 165, such that when a force is applied on the lever 170, the force is transferred through the door 161 to the flat surface 175, closing the door 161. In an embodiment, the lever 170 is fixed at end 1 177 to the swivel door assembly 160, and the force is applied to end 2 178 of the lever 170, opposite end 1 177. Closing the swivel door 161 prevents the plunger lever 170 from being depressed. As a result, the plunger lever 170 can only be depressed when the swivel door 161 is open.

[0054] 6A, 6B, and 6C illustrate perspective views of a plunger stopper 180 according to an example of the present disclosure. In an embodiment, the stopper 180 prevents the movement of the plunger lever 170 by an unauthorized user attempting to access the plunger lever 170 without authorization. In an embodiment, if the security door 100 is open, even if an unauthorized user is able to access the plunger lever by an external tool, the user will not be able to depress the plunger lever 170 to divert the drag by pressing the plunger head (not shown). The plunger stopper 180 will prevent the depression of the plunger lever 170. In addition, as seen in FIGS. 6B and 6C, the stopper 180 can only be rotated to its open position when the security door is unlocked and opened. Thus, the plunger lever 170 is protected with the plunger stopper 180, which prevents the plunger lever 170 from being depressed while tampering is occurring. Specifically, the shape of the plunger stopper 180 is such that, in one configuration, the plunger stopper 180 interlocks with the plunger lever 170 such that the plunger lever 170 cannot be depressed. In addition, the plunger stopper 180 includes a pull knob stopper 182 (see FIG. 8A). A rib 181 (see FIG. 9) is also provided on a surface of the pull knob stopper 182 to prevent full rotation of the plunger stopper 180. Specifically, the rib 181 engages with a mating end 183 (see FIG. 7B) on the plunger stopper 180 such that the plunger stopper 180 cannot rotate. In some embodiments, the enclosure of the plunger head of the pump 125 may need to be modified to spatially accommodate the pull knob stopper 182 .

[0055] 7A, 7B, and 7C illustrate perspective views of an alternative plunger stopper 180 according to an example of the present disclosure. In an embodiment, the stopper 180 prevents the movement of the plunger lever 170. The plunger lever 170 is protected with a rotatable plunger stopper 180, which prevents the plunger lever 170 from being depressed during tampering. In addition, the plunger stopper 180 includes a pull knob stopper 182 (see FIG. 8A). In addition, a rib 181 (see FIG. 9) is also provided on a surface of the pull knob stopper 182 to prevent the plunger stopper 180 from fully rotating. Specifically, the rib 181 engages with a mating end 183 on the plunger stopper 180 such that the plunger stopper 180 cannot rotate. In an embodiment, the enclosure of the plunger head of the pump 125 may need to be modified to spatially accommodate the pull knob stopper 182.

[0056] 8A, 8B, and 8C illustrate perspective views of a pull knob stopper 182 according to an example of the present disclosure. In an embodiment, the pull knob stopper 182 prevents the movement of the plunger lever 170. As a security mechanism, the pull knob stopper 182 creates physical redundancy by requiring the user to make a dual simultaneous action to depress the plunger lever 170 and press the plunger head (not shown) to divert the drag. When the security door 100 is closed and locked, the pull knob stopper 182 makes it extremely difficult for an unauthorized user to depress the plunger lever 170 because the pull knob stopper 182 requires two actions to depress the plunger lever 170. In an embodiment, the pull knob stopper 182 requires the user to first pull out the spring-loaded knob 185 (or a knob with any similar mechanical design) and then use a second tool to access and depress the plunger lever 170. The plunger lever 170 is further protected with a plunger stopper 180 that prevents the plunger lever 170 from being depressed during tampering. In addition, the plunger stopper 180 includes a pull knob stopper 182. As previously noted, a rib 181 (see FIG. 9 ) is provided on a surface of the pull knob stopper 182 to prevent full rotation of the plunger stopper 180. Specifically, the rib 181 engages with a mating end 183 on the plunger stopper 180 such that the plunger stopper 180 cannot rotate. In certain embodiments, the enclosure of the plunger head of the pump 125 may need to be modified to spatially accommodate the pull knob stopper 182.

[0057] FIG. 9 illustrates a detailed view of a cross section of a plunger stopper 180 in a locked configuration with a pull knob stopper 182 according to an example of the present disclosure. As seen in FIG. 9, a pull rib 181 on the pull knob stopper 182 engages with a mating end 183 of the plunger stopper 180. A spring 184 in a spring-loaded knob 185 keeps the pull rib 181 engaged with the mating end 183. To disengage the pull rib 181 from the mating end 183, a user must apply force in the opposite direction on the pull rib 181 to overcome the tension created by the spring 184. Thus, the plunger stopper 180 remains locked and cannot rotate until the user "pull" the pull knob stopper 182 to disengage the mating relationship between the two stoppers 180, 182.

[0058] 10 through 13 illustrate flow diagrams of an alarm sequence of the infusion pump security system 150 in response to various inputs received by the multiple sensors 131, which are received by the infusion pump security system 150, in accordance with examples of the present disclosure. In an embodiment, providing an additional layer of authentication before an alarm is heeded can improve the security of the infusion pump. An alarm indicating possible tampering can be silenced and cleared only when an authorized user enters a pre-programmed passcode to access the pump. In an embodiment, an alarm related to tampering can be one of a syringe load error, a syringe misload, a door unlock, and a downstream occlusion. These alarms may be generated as a result of an unauthorized user's drug diversion. However, *Some people think that "however" is a bad thing. These alarms may also be generated for any genuine reason other than tampering by an unauthorized user. Once an authorized user enters a pre-programmed passcode to access the pump, the alarm provides instructions to the user to check for tampering if any damage or vandalism is detected. The instructions provided by the pump security system may be one of visual, audio and / or tactile instructions via the user interface 120 of the pump 125. In an embodiment, the user may program the alarm sequences to be synchronized or function in an overlapping manner (dual / multiple alarm approach). The dual / multiple alarm approach reduces the complexity of adding many alarms, which can lead to alarm fatigue scenarios in hospitals for users.

[0059] 10 illustrates a flow diagram of a syringe misload alarm 200 sequence of an infusion pump security system 150 according to an example of the present disclosure. In an embodiment, the pump generates a high priority syringe load error alarm when any of the following conditions are true except when the security door 100 is confirmed to be closed and locked by the user, the delivery mode is running, and the syringe misload alarm is active: the syringe flange is removed; the syringe push button is not in contact with the occlusion sensor; the syringe barrel clamp is open; the syringe pump lever is activated; and / or the syringe push button detects a high pressure reading.

[0060] In an additional embodiment, when the delivery mode is running, the pump will stop the delivery mode and generate a high priority syringe misload alarm if the pump detects any of the following conditions: the syringe flange is removed; the syringe push button is not in contact with the occlusion sensor; the syringe barrel clamp is open; and / or the syringe pump lever is activated. In addition, a user of the security system 150 may lock the security door 100 with a physical key after loading the syringe. Furthermore, the security door 100 may have additional ribs, grooves and / or contours 147 (see FIG. 1A) on the inside of the security door 100 to minimize the possibility of an unauthorized user inserting an object into the housing while the door is already locked.

[0061] If the security door is locked with a loaded syringe, but an unauthorized user is still able to insert an object into the housing and activate the syringe loading point, then an additional alarm may be triggered as an added security measure.

[0062] 11 illustrates a flow diagram of a syringe load error alarm sequence 300 of an infusion pump security system 150 according to an example of the present disclosure. Similar to the syringe misload alarm 200, the syringe load error alarm 300 is triggered when there is an additional item missing from the syringe misload alarm. In one embodiment, the syringe load error alarm 300 is triggered when the syringe push button detects a high pressure reading. When the delivery mode is already running and the syringe push button detects a high pressure reading, then a downstream occlusion alarm is triggered instead of the syringe misload alarm.

[0063] While similar, the difference between the syringe misload alarm 200 and the syringe load error alarm 300 is that the syringe load error alarm 300 is generated when both of the following conditions are true: the delivery mode is not started or is stopped, and any syringe load point is activated, whereas the syringe misload alarm 200 is triggered when both of the following conditions occur: the delivery mode is running (regardless of whether or not a fluid infusion is occurring) and any syringe load point is activated.

[0064] 12 illustrates a flow diagram of a door unlock alarm 400 sequence of an infusion pump security system 150 according to an example of the present disclosure. In an embodiment, the pump stops delivery mode and generates a high priority door unlock alarm 400 when all of the following conditions occur: the security door is opened and delivery mode is running. For an unauthorized user to generate a door unlock alarm, one of the following must occur: an unauthorized user gains access to the physical key or an unauthorized user picks the lock and opens the door. If an unauthorized user gains access to the physical key, the LRS requirement is met and the system user manual provides an alarm to the user and hospital personnel to place the physical key in a safe location. If a user or hospital personnel misplaces the physical key and / or an unauthorized user obtains the key, this scenario is outside the scope of the security system's capabilities to prevent unauthorized access. In one embodiment, the lock is selected with a lock assembly of sturdy and robust materials to minimize the possibility that an unauthorized user will be able to force the lock. The door open alarm 400 is an additional measure in the event that an unauthorized user succeeds in opening the door due to either unauthorized possession of the key or physical damage being done to the lock.

[0065] 13 illustrates a flow diagram of a downstream occlusion alarm 500 sequence of an infusion pump security system 150 according to an example of the present disclosure. In an embodiment, the pump generates a high priority downstream occlusion alarm 500 when the occlusion pressure setting is achieved. In an embodiment, the downstream inline pressure (at 1.0 meter) is within (inclusive) the upper and lower limits for the pressure setting less than or equal to the following (0.1 to 250 ml / hr, at baseline / normal conditions). However, in additional embodiments, the system may be configured to trigger the downstream occlusion alarm sequence in response to other downstream inline pressure readings.

[0066] In one embodiment, when normal occlusion detection is activated by the user, the pump will stop the infusion and generate a high priority downstream occlusion alarm 500 when the downstream pressure approximately one meter from the pump exceeds a threshold pressure (psi) within the time shown for various syringe sizes. When rapid occlusion detection is activated by the user, either the set is occluded before the infusion begins or the set is occluded after the infusion has reached a steady state, the pump will stop the infusion and generate a high priority downstream occlusion alarm when the downstream pressure approximately one meter from the pump exceeds a threshold pressure (psi) within the time shown for various syringe sizes, flow rates and alarm settings. If an unauthorized user attempts to tamper with the administration set by applying pressure to the syringe barrel to administer a medication, the resulting increased pressure in the syringe will be detected and the pump will generate a downstream occlusion alarm accordingly. In addition, the flange holder creates a physical limit to the amount of medication that can be administered in this manner. In one embodiment, any attempts to twist or pull on the intravenous drip ("IV") may also be detected by a downstream occlusion alarm, depending on the extent to which the IV set becomes occluded during these attempts.

[0067] It should be understood that various changes and modifications to the exemplary embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended benefits. It is therefore intended that such changes and modifications be covered by the appended claims. Also, the nature of the dependent claims may be embodied in the respective systems, methods and apparatus of the independent claims.

[0068] Many modifications and other embodiments of the inventions described herein will come to mind to one skilled in the art to which these inventions pertain having the benefit of the teachings in the foregoing descriptions and the associated drawings. It is understood, therefore, that the invention is not limited to the specific embodiments disclosed, and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Claims

1. 1. A patient controlled analgesia pump, the pump comprising: Actuator, Syringe holder, Display screen, Security Door Assembly, Security Frame Assembly, Swivel Door Assembly, a plurality of sensors including at least one occlusion sensor and at least one downstream in-line pressure sensor; Syringe flange, Syringe push button, Syringe Barrel Clamp, Syringe pump lever, A processor, and A memory that stores instructions Equipped with The instructions, when executed by the processor, generating a syringe misloaded alarm when the syringe is misloaded into the PCA pump; generating a syringe load error alarm when there is a syringe load error in the PCA pump; generating a door unlock alarm when the security door assembly is unlocked from the security frame assembly; generating a downstream occlusion alarm when there is a downstream occlusion in the PCA pump; causing said processor to perform the alarm is an audible, graphical, visual, and / or tactile notification, or a combination thereof; A pump, wherein an authentication command entered by a user allows the user to mute and / or stop the alarm.

2. 2. The pump of claim 1, wherein the syringe misload alarm is issued when any of the following conditions are true except when the security door assembly is confirmed to be closed and locked by the user, the pump is in delivery mode, and the syringe misload alarm is active: the syringe flange is removed; the syringe push button is not in contact with the occlusion sensor; the syringe barrel clamp is open; the syringe pump lever is activated; and / or the syringe push button detects a high pressure reading.

3. 3. The pump of claim 2, wherein when the pump is in a delivery mode and any of the following conditions are true: the syringe flange is removed; the syringe push button is not in contact with the occlusion sensor; the syringe barrel clamp is open; and / or the syringe pump lever is activated, the syringe misloaded alarm is issued and the pump stops the delivery mode.

4. 2. The pump of claim 1, wherein the syringe load error alarm is issued when the security door assembly is confirmed to be closed and locked by the user, the pump is not in delivery mode or is stopped, the syringe push button detects a high pressure reading, and the syringe load point is activated.

5. 2. The pump of claim 1, wherein the door open alarm is activated when the security door assembly is opened and the pump is in a delivery mode.

6. 10. The pump of claim 1, wherein the downstream occlusion alarm is triggered when a downstream in-line sensor detects a pressure outside a pressure range entered by a user at approximately 1.0 meter downstream.

7. The pump of claim 1 , wherein the security door assembly further comprises a mating portion, and the security frame assembly further comprises a mating portion.

8. 8. The pump of claim 7, wherein the mating portion on the security door assembly selectively engages the mating portion on the security frame assembly to selectively couple the security door assembly and the security frame assembly.

9. The pump of claim 1 , wherein the security door assembly further comprises ribs, grooves and / or contours on an interior surface of the security door assembly.

10. The pump of claim 1 , wherein the security door assembly further comprises a receiving portion and the security frame assembly further comprises a lock assembly.

11. The pump of claim 10 , wherein the lock assembly selectively mates with the receiver.

12. 1. A patient controlled analgesia pump, the pump comprising: Actuator, Syringe holder, Display screen, A security door assembly including a receiving portion; a security frame assembly including a lock assembly; a swivel door assembly including a syringe pump lever in an upright and down position; and A plurality of sensors including at least one occlusion sensor and at least one downstream in-line pressure sensor. Equipped with The security door assembly couples with the security frame assembly, and the lock assembly mates with the receiver.

13. 13. The pump of claim 12, wherein the swivel door assembly further comprises a main assembly body to which a lever door is pivotally coupled, a swivel door pivotally coupled to the assembly body and including a sidewall, and a sidewall planar surface coupled to the main assembly body, the sidewall planar surface completely covering the syringe pump lever, lever stopper, and pull knob stopper.

14. 14. The pump of claim 13, wherein the swivel door has an internal curvature that interfaces with the plunge lever and redirects force applied to the syringe pump lever so that the plunge lever cannot be depressed when the swivel door is in a closed configuration relative to the main assembly body.

15. 13. The pump of claim 12, wherein the lever stopper is pivotally mounted to the main assembly body and engages the syringe pump lever to hold the syringe pump lever in an upright orientation, and the pull knob stopper includes a locking pin that engages the lever stopper with a locking receptacle for selectively locking the lever stopper when the lever stopper engages the syringe pump lever.

16. 16. The pump of claim 15, wherein the pull knob lever includes a mechanism for orienting the locking pin into engagement with the locking receptacle, the mechanism being selectively deactivatable by the user to selectively disengage the locking pin from the locking receptacle.

17. 13. The pump of claim 12, wherein the security door assembly and security frame assembly are interlocked and in a closed configuration such that the syringe holder is inaccessible.

18. 13. The pump of claim 12, wherein the display screen is accessible when the security door assembly and security frame assembly are in an interlocking, closed configuration.

19. 13. The pump of claim 12, wherein the swivel door assembly is inaccessible when the security door assembly and the security frame assembly are in an interlocking, closed configuration.

20. 13. The pump of claim 12, wherein the actuator is inaccessible when the security door assembly and the security frame assembly are in an interlocking, closed configuration.

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