Patent Application
20240408370
Vascular access treatment includes drug Infusion into a human body that is often achieved through catheters that are either inserted into a peripheral vein (PIVC) or central vein (PICC/CVC). A catheter may be connected to a fluid source, such as a pump, and/or the like, via a needleless connector.
A clinician providing a vascular access treatment may be affected by various factors, such as a high cognitive load due to a large variety of products used for vascular access treatment and a learning curve required for their usage, a large variety of patient profiles, a busy schedule, a lack of experience and/or expertise, and/or the like. These factors can lead to non-standardized practices and/or not using the correct device at the correct time during a vascular access treatment, which may lead to patients being exposed to various complications, such as phlebitis, occlusion, infiltration, Catheter Related Blood Stream Infection (CRBSI), Central Line-associated Bloodstream Infection (CLABSI), and/or the like. These complications may result in additional complications and/or increased costs through additional treatment, an incorrect choice of medical devices and insertion locations for vascular access treatment, an incorrect impression about the medical devices, additional pressure on more experienced staff, patient dissatisfaction impact hospital reputation, and/or the like.
Hospitals and homecare patient environments (e.g., in which nurses, caregivers, patient maintenance activities, etc. can be monitored) have adopted protocols that are aimed at ensuring proper catheter maintenance. However, multiple studies have shown poor adherence to these existing protocols, leading to sub-optimal patient outcomes. Moreover, these existing protocols do not support vascular access management due to different causes that create complications requiring different solutions.
Accordingly, provided are improved systems, devices, products, apparatus, and/or methods for vascular access management that obtain vascular access management (VAM) data associated with a vascular access treatment associated with a patient; determine an insight associated with the vascular access treatment associated with the patient; and provide the insight associated with the vascular access treatment.
In accordance with an embodiment of the present invention, a system includes at least one processor programmed and/or configured to obtain vascular access management (VAM) data associated with a vascular access treatment associated with a patient, determine an insight associated with the vascular access treatment associated with the patient, and provide the insight associated with the vascular access treatment.
In accordance with an embodiment of the present invention, the at least one processor is programmed and/or configured to determine the insight associated with the vascular access treatment associated with the patient by determining, based on the VAM data, an initial risk prediction for the vascular access treatment associated with the patient, wherein the initial risk prediction includes a probability that the patient experiences at least one complication in response to the vascular access treatment. The system also determines, based on the VAM data and the initial risk prediction, a recommendation associated with the vascular access treatment associated with the patient, wherein the recommendation includes at least one of a recommended process and a recommend product to be used for the vascular access treatment. The system also determines, based on the VAM data and the recommendation, an updated risk prediction for the vascular access treatment associated with the patient. The system also determines, based on the VAM data, the initial risk predication, the recommendation, and the updated risk prediction, a cost prediction associated with the vascular access treatment associated with the patient, wherein the cost prediction includes a predicted savings in terms of a reduced cost of complication from adoption of the at least one of the recommended process and the recommend product.
In accordance with an embodiment of the present invention, the at least one processor provides the insight by providing, to a user device, at least one of the following: the initial risk predication, the recommendation, and the updated risk prediction, the cost prediction, or any combination thereof.
In accordance with an embodiment of the present invention, the at least one processor provides the insight by automatically controlling, based on the insight, at least one medical device to adjust a flow of a fluid to the patient during the vascular access treatment.
In accordance with an embodiment of the present invention, the at least one processor is programmed and/or configured to obtain the VAM data by collecting, from a plurality of different data sources, source data, associating the source data with at least one clinical protocol, and aggregating the source data associated with the at least one clinical protocol as the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, the VAM data includes one or more of the following parameters: a patient identifier; a hospital identifier; a patient name; a patient gender; a patient age, a co-morbidity associated with a patient; a medication associated with a patient, a symptom associated with a patient; a reason for admission associated with a patient; an infusion type associated with a patient; an admission date associated with a patient; a readmission indicator associated with a patient; a discharge date associated with a patient; a length of stay associated with a patient; a number of lines used associated with a patient; a type of accessories used associated with a patient; a date of use associated with a medical device; an average dwell time associated with a medical device, an average number of stick attempts associated with a patient, a complication associated with a patient; a department of a hospital; a user or nurse identifier; a user or nurse experience indicator; a question associated with a vascular access treatment; a question identifier associated with a question; an answer associated with a question; a time stamp associated with a usage of a medical device; a device identifier associated with a medical device, a type of a medical device, a device signal associated with a medical device; a number of occlusion cases in a period of time, a number of CRBSI and/or CLABSI cases in a time period; a predicted vascular signal (e.g., CRBSI, phlebitis, etc.); or any combination thereof.
In accordance with an embodiment of the present invention, the system of further includes a plurality of local systems, wherein each local system includes a central computing system, a sensor system including at least one sensor, and a user device, and a management system configured as a central unit or command center for remotely monitoring line maintenance activities at each local system of the plurality of local systems.
In accordance with an embodiment of the present invention, the system further includes one or more image capture devices configured to capture, over a period of time, a plurality of images of an environment surrounding the one or more image capture devices. The at least one processor is further programmed and/or configured to determine, based on the plurality of images, a plurality of locations of a plurality of medical devices within the environment over the period of time and a plurality of types of the plurality of medical devices. The processor is further programmed and/or configured to determine, based on the plurality of locations of the plurality of medical devices within the environment over the period of time and the plurality of types of the plurality of medical devices, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, further including a plurality of identifier elements associated with a plurality of medical devices, wherein the plurality of identifier elements encapsulates a plurality of identifiers associated a plurality of types of the plurality of medical devices. The system further includes one or more image capture devices configured to capture, over a period of time, a plurality of images of an environment surrounding the one or more image capture devices. The at least one processor is further programmed and/or configured to determine, based on the plurality of images, the plurality of identifier elements within the environment over the period of time, and determine, based on the plurality of identifier elements determined in the plurality of images, the plurality of types of the plurality of medical devices and a plurality of locations of the plurality of medical devices within the environment over the period of time. The processor is further programmed and/or configured to determine, based on the plurality of types of the plurality of medical devices and the plurality of locations of the plurality of medical devices within the environment over the period of time, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, the plurality of identifier elements includes at least one identifier element including at least one of the following types of identifier elements: a colored pattern, a reflective pattern, a fluorescent pattern, a predetermined shape and color, a LED pattern, a barcode, or any combination thereof.
In accordance with an embodiment of the present invention, the system further includes one or more image capture devices configured to capture, over a period of time, a plurality of images of an environment surrounding the one or more image capture devices. The at least one processor is further programmed and/or configured to determine, based on the plurality of images, a plurality of locations of a plurality of medical devices within the environment over the period of time and a plurality of types of the plurality of medical devices, and determine, based on the plurality of locations of the plurality of medical devices within the environment over the period of time, a plurality of distances between the plurality of medical devices over the period of time. The at least one processor is programmed and/or configured to determine, based on the plurality of distances between the plurality of medical devices over the period of time and the plurality of types of the plurality of medical devices, at least one event of the following events: (i) a connection of a first medical device of the plurality of medical devices to a second medical device of the plurality of medical devices and (ii) a disconnection of the first medical device of the plurality of medical devices from the second medical device of the plurality of medical devices, and to determine, based on the at least one determined event, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, the system further includes a first identifier element associated with a medical device, wherein the first identifier element encapsulates a first identifier associated with the medical device, a second identifier element associated with a glove of a caregiver, wherein the second identifier element encapsulates a second identifier associated with the glove of the caregiver, one or more image capture devices configured to capture, over a period of time, a plurality of images of an environment surrounding the one or more image capture devices. The at least one processor is further programmed and/or configured to determine, based on the plurality of images, the first identifier element associated with the medical device and the second identifier element associated with the glove of a caregiver, determine, based on the first identifier element in the plurality of images, the medical device and a location of the medical device within the environment over the period of time, determine, based on the second identifier element in the plurality of images, the glove of the caregiver and a location of the glove of the caregiver within the environment over the period of time, determine, based on the location of the medical device within the environment over the period of time and the location of the glove of the caregiver within the environment over the period of time, at least one event associated with the medical device, and determine, based on the at least one determined event, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, the system further includes one or more image capture devices configured to capture, over a period of time, a plurality of images of an environment surrounding the one or more image capture devices, wherein the at least one processor is further programmed and/or configured to determine, based on the plurality of images, a location of a plunger of a syringe relative to a barrel of the syringe in the environment over the period of time, determine, based on the location of the plunger of the syringe relative to the barrel of the syringe over the period of time, at least one fluid delivery from the syringe, and determine, based on the at least one determined fluid delivery, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, the system further includes a package containing a medical device, one or more image capture devices configured to capture, over a period of time, a plurality of images of an environment surrounding the one or more image capture devices, and wherein the at least one processor is further programmed and/or configured to determine, based on the plurality of images, a state of the package over the period of time, determine, based on the state of the package over the period of time, whether the medical device is removed from the package, and determine, based on a determination that the medical device is removed from the package, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, further including a needleless connector including a fluid flow path, and a force sensor connected to the needleless connector. The at least one processor is further programmed and/or configured to receive, from the force sensor, a force signal, and determine, based on the force signal, at least one of: a scrubbing event in which the needleless connector is scrubbed with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof. The at least one processor is further programmed and/or configured to determine, based on the at least one of: a scrubbing event in which the needleless connector is scrubbed with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, wherein the force sensor is positioned between an outer surface of an inner wall of the needleless connector defining the fluid flow path of the needleless connector and an inner surface of an outer wall of the needleless connector surrounding the inner wall of the needleless connector.
In accordance with an embodiment of the present invention, a first end of the needleless connector includes a septum including a surface facing in a first direction, wherein at least one of the force sensors is configured to detect a force in a second direction perpendicular to the surface of the septum facing in the first direction, and wherein the at least one processor are further programmed and/or configured to determine, based on the force signal indicating periodic forces in the second direction perpendicular to the surface of the septum facing in the first direction, the flushing event, wherein the flushing event includes a pulsatile flushing event.
In accordance with an embodiment of the present invention, the system further includes a needleless connector including a fluid flow path, a force sensor configured to measure a force signal, and a visual indicator, wherein the at least one processor is further programmed and/or configured to receive, from the force sensor, a force signal. The at least one processor further programmed and/or configured to determine, based on the force signal, at least one of: a scrubbing event in which the needleless connector is scrubbed with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof, and control the visual indicator to provide a visual indication associated with the at least one of: the scrubbing event in which the needleless connector is scrubbed with the disinfectant, the flushing event in which the needleless connector is flushed with the solution, the connection event in which the needleless connector is connected to the medical device, the disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof.
In accordance with an embodiment of the present invention, further including a needleless connector including a fluid flow path, an acoustic sensor connected to the needleless connector, wherein the at least one processor is further programmed and/or configured to receive, from the acoustic sensor, a signal including a sound signature, determine, based on the signal, an event associated with the needleless connector, and determine, based on the determined event associated with the needleless connector, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, the system further includes a needleless connector including a fluid flow path and a septum, an optical sensor connected to the needleless connector, wherein the optical sensor is configured to detect a movement of the septum, wherein the at least one processor is further programmed and/or configured to receive, from the optical sensor, a signal associated with the movement of the septum, determine, based on the signal, an event associated with the needleless connector, and determine, based on the determined event associated with the needleless connector, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, a method includes obtaining, with at least one processor, vascular access management (VAM) data associated with a vascular access treatment associated with a patient, determining, with the at least one processor, an insight associated with the vascular access treatment associated with the patient, and providing, with the at least one processor, the insight associated with the vascular access treatment.
In accordance with an embodiment of the present invention, the method includes that the insight associated with the vascular access treatment associated with the patient is determined by determining, based on the VAM data, an initial risk prediction for the vascular access treatment associated with the patient, wherein the initial risk prediction includes a probability that the patient experiences at least one complication in response to the vascular access treatment, determining, based on the VAM data and the initial risk prediction, a recommendation associated with the vascular access treatment associated with the patient, wherein the recommendation includes at least one of a recommended process and a recommend product to be used for the vascular access treatment, determining, based on the VAM data and the recommendation, an updated risk prediction for the vascular access treatment associated with the patient, and determining, based on the VAM data, the initial risk predication, the recommendation, and the updated risk prediction, a cost prediction associated with the vascular access treatment associated with the patient, wherein the cost prediction includes a predicted savings in terms of a reduced cost of complication from adoption of the at least one of the recommended process and the recommend product.
In accordance with an embodiment of the present invention, the at least one processor provides the insight by providing, to a user device, at least one of the following: the initial risk predication, the recommendation, and the updated risk prediction, the cost prediction, or any combination thereof.
In accordance with an embodiment of the present invention, the at least one processor provides the insight by automatically controlling, based on the insight, at least one medical device to adjust a flow of a fluid to the patient during the vascular access treatment.
In accordance with an embodiment of the present invention, the at least one processor obtains the VAM data by collecting, from a plurality of different data sources, source data, associating the source data with at least one clinical protocol, and aggregating the source data associated with the at least one clinical protocol as the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, the VAM data includes one or more of the following parameters: a patient identifier; a hospital identifier; a patient name; a patient gender; a patient age, a co-morbidity associated with a patient; a medication associated with a patient, a symptom associated with a patient; a reason for admission associated with a patient; an infusion type associated with a patient; an admission date associated with a patient; a readmission indicator associated with a patient; a discharge date associated with a patient; a length of stay associated with a patient; a number of lines used associated with a patient; a type of accessories used associated with a patient; a date of use associated with a medical device; an average dwell time associated with a medical device, an average number of stick attempts associated with a patient, a complication associated with a patient; a department of a hospital; a user or nurse identifier; a user or nurse experience indicator; a question associated with a vascular access treatment; a question identifier associated with a question; an answer associated with a question; a time stamp associated with a usage of a medical device; a device identifier associated with a medical device, a type of a medical device, a device signal associated with a medical device; a number of occlusion cases in a period of time, a number of CRBSI and/or CLABSI cases in a time period; a predicted vascular signal (e.g., CRBSI, phlebitis, etc.); or any combination thereof.
In accordance with an embodiment of the present invention, the method further includes remotely monitoring, with a management system configured as a central unit or command center, line maintenance activities at a plurality of local systems, wherein each local system includes a central computing system, a sensor system including at least one sensor, and a user device.
In accordance with an embodiment of the present invention, the method further includes capturing, with one or more image capture devices, over a period of time, a plurality of images of an environment surrounding the one or more image capture devices. The method further includes determining, with the at least one processor, based on the plurality of images, a plurality of locations of a plurality of medical devices within the environment over the period of time and a plurality of types of the plurality of medical devices, and determining, with the at least one processor, based on the plurality of locations of the plurality of medical devices within the environment over the period of time and the plurality of types of the plurality of medical devices, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, the method further includes a plurality of identifier elements associated with a plurality of medical devices, wherein the plurality of identifier elements encapsulates a plurality of identifiers associated a plurality of types of the plurality of medical devices. The method also includes capturing, with one or more image capture devices, over a period of time, a plurality of images of an environment surrounding the one or more image capture devices, determining, with the at least one processor, based on the plurality of images, a plurality of identifier elements within the environment over the period of time, wherein the plurality of identifier elements is associated with a plurality of medical devices, and wherein the plurality of identifier elements encapsulates a plurality of identifiers associated a plurality of types of the plurality of medical devices, and determining, with the at least one processor, based on the plurality of identifier elements determined in the plurality of images, the plurality of types of the plurality of medical devices and a plurality of locations of the plurality of medical devices within the environment over the period of time.
In accordance with an embodiment of the present invention, the plurality of identifier elements includes at least one identifier element including at least one of the following types of identifier elements: a colored pattern, a reflective pattern, a fluorescent pattern, a predetermined shape and color, a LED pattern, a barcode, or any combination thereof.
In accordance with an embodiment of the present invention, the method further includes capturing, with one or more image capture devices, over a period of time, a plurality of images of an environment surrounding the one or more image capture devices, determining, with the at least one processor, based on the plurality of images, a plurality of locations of a plurality of medical devices within the environment over the period of time and a plurality of types of the plurality of medical devices, determining, with the at least one processor, based on the plurality of locations of the plurality of medical devices within the environment over the period of time, a plurality of distances between the plurality of medical devices over the period of time, determining, with the at least one processor, based on the plurality of distances between the plurality of medical devices over the period of time and the plurality of types of the plurality of medical devices, at least one event of the following events: (i) a connection of a first medical device of the plurality of medical devices to a second medical device of the plurality of medical devices and (ii) a disconnection of the first medical device of the plurality of medical devices from the second medical device of the plurality of medical devices, and determining, with the at least one processor, based on the at least one determined event, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, the method further includes capturing, with one or more image capture devices, over a period of time, a plurality of images of an environment surrounding the one or more image capture devices, determining, with the at least one processor, based on the plurality of images, a first identifier element associated with a medical device and a second identifier element associated with a glove of a caregiver, wherein the first identifier element encapsulates a first identifier associated with the medical device, and wherein the second identifier element encapsulates a second identifier associated with the glove of the caregiver, determining, with the at least one processor, based on the first identifier element in the plurality of images, the medical device and a location of the medical device within the environment over the period of time, determining, with the at least one processor, based on the second identifier element in the plurality of images, the glove of the caregiver and a location of the glove of the caregiver within the environment over the period of time, determining, with the at least one processor, based on the location of the medical device within the environment over the period of time and the location of the glove of the caregiver within the environment over the period of time, at least one event associated with the medical device, and determining, with the at least one processor, based on the at least one determined event, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, the method further includes capturing, with one or more image capture devices, over a period of time, a plurality of images of an environment surrounding the one or more image capture devices, determining, with the at least one processor, based on the plurality of images, a location of a plunger of a syringe relative to a barrel of the syringe in the environment over the period of time, determining, with the at least one processor, based on the location of the plunger of the syringe relative to the barrel of the syringe over the period of time, at least one fluid delivery from the syringe, and determining, with the at least one processor, based on the at least one determined fluid delivery, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, the method further includes a package containing a medical device, one or more image capture devices configured to capturing, with one or more image capture devices, over a period of time, a plurality of images of an environment surrounding the one or more image capture devices, determining, with the at least one processor, based on the plurality of images, a state of a package containing a medical device over the period of time, determining, with the at least one processor, based on the state of the package over the period of time, whether the medical device is removed from the package, and determining, with the at least one processor, based on a determination that the medical device is removed from the package, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, the method further includes measuring, with a force sensor connected to a needleless connector including a fluid flow path, a force signal, receiving, with at least one processor, from the force sensor, the force signal, and determining, with the at least one processor, based on the force signal, at least one of: a scrubbing event in which the needleless connector is scrubbed with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof, and determining, with the at least one processor, based on the at least one of: a scrubbing event in which the needleless connector is scrubbed with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, the force sensor is positioned between an outer surface of an inner wall of the needleless connector defining the fluid flow path of the needleless connector and an inner surface of an outer wall of the needleless connector surrounding the inner wall of the needleless connector.
In accordance with an embodiment of the present invention, wherein a first end of the needleless connector includes a septum including a surface facing in a first direction, wherein at least one of the force sensors is configured to detect a force in a second direction perpendicular to the surface of the septum facing in the first direction, and wherein the method further includes determining, with the at least one processor, based on the force signal indicating periodic forces in the second direction perpendicular to the surface of the septum facing in the first direction, the flushing event, wherein the flushing event includes a pulsatile flushing event.
In accordance with an embodiment of the present invention, the method further includes measuring, with a force sensor of a needleless connector including a fluid flow path, the force sensor, and a visual indicator, a force signal, receiving, with the at least one processor, from the force sensor, a force signal, determining, with the at least one processor, based on the force signal, at least one of: a scrubbing event in which the needleless connector is scrubbed with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof, and controlling, with the at least one processor, the visual indicator to provide a visual indication associated with the at least one of: the scrubbing event in which the needleless connector is scrubbed with the disinfectant, the flushing event in which the needleless connector is flushed with the solution, the connection event in which the needleless connector is connected to the medical device, the disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof.
In accordance with an embodiment of the present invention, the method further includes measuring, with an acoustic sensor connected to a needleless connector including a fluid flow path, a signal including a sound signature, receiving, with the at least one processor, from the acoustic sensor, a signal including a sound signature, determining, with the at least one processor, based on the signal, an event associated with the needleless connector, and determining, with the at least one processor, based on the determined event associated with the needleless connector, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
In accordance with an embodiment of the present invention, the method further includes measuring, with an optical sensor connected to a needleless connector including a fluid flow path and a septum, a movement of the septum, receiving, with the at least one processor, from the optical sensor, a signal associated with the movement of the septum, determining, with the at least one processor, based on the signal, an event associated with the needleless connector, and determining, with the at least one processor, based on the determined event associated with the needleless connector, at least a portion of the VAM data associated with the vascular access treatment associated with the patient.
It is to be understood that the present disclosure may assume various alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary and non-limiting embodiments or aspects. Hence, specific dimensions and other physical characteristics related to the embodiments or aspects disclosed herein are not to be considered as limiting.
For purposes of the description hereinafter, the terms “end,” “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and derivatives thereof shall relate to embodiments or aspects as they are oriented in the drawing figures. However, it is to be understood that embodiments or aspects may assume various alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply non-limiting exemplary embodiments or aspects. Hence, specific dimensions and other physical characteristics related to the embodiments or aspects of the embodiments or aspects disclosed herein are not to be considered as limiting unless otherwise indicated.
No aspect, component, element, structure, act, step, function, instruction, and/or the like used herein should be construed as critical or essential unless explicitly described as such. Also, as used herein, the articles “a” and “an” are intended to include one or more items, and may be used interchangeably with “one or more” and “at least one.” Furthermore, as used herein, the term “set” is intended to include one or more items (e.g., related items, unrelated items, a combination of related and unrelated items, etc.) and may be used interchangeably with “one or more” or “at least one.” Where only one item is intended, the term “one” or similar language is used. Also, as used herein, the terms “has,” “have,” “having,” or the like are intended to be open-ended terms. Further, the phrase “based on” is intended to mean “based at least partially on” unless explicitly stated otherwise.
As used herein, the terms “communication” and “communicate” may refer to the reception, receipt, transmission, transfer, provision, and/or the like of information (e.g., data, signals, messages, instructions, commands, and/or the like). For one unit (e.g., a device, a system, a component of a device or system, combinations thereof, and/or the like) to be in communication with another unit means that the one unit is able to directly or indirectly receive information from and/or transmit information to the other unit. This may refer to a direct or indirect connection that is wired and/or wireless in nature. Additionally, two units may be in communication with each other even though the information transmitted may be modified, processed, relayed, and/or routed between the first and second unit. For example, a first unit may be in communication with a second unit even though the first unit passively receives information and does not actively transmit information to the second unit. As another example, a first unit may be in communication with a second unit if at least one intermediary unit (e.g., a third unit located between the first unit and the second unit) processes information received from the first unit and communicates the processed information to the second unit. In some non-limiting embodiments or aspects, a message may refer to a network packet (e.g., a data packet and/or the like) that includes data. It will be appreciated that numerous other arrangements are possible.
As used herein, the term “computing device” may refer to one or more electronic devices that are configured to directly or indirectly communicate with or over one or more networks. A computing device may be a mobile or portable computing device, a desktop computer, a server, and/or the like. Furthermore, the term “computer” may refer to any computing device that includes the necessary components to receive, process, and output data, and normally includes a display, a processor, a memory, an input device, and a network interface. A “computing system” may include one or more computing devices or computers. An “application” or “application program interface” (API) refers to computer code or other data sorted on a computer-readable medium that may be executed by a processor to facilitate the interaction between software components, such as a client-side front-end and/or server-side back-end for receiving data from the client. An “interface” refers to a generated display, such as one or more graphical user interfaces (GUIs) with which a user may interact, either directly or indirectly (e.g., through a keyboard, mouse, touchscreen, etc.). Further, multiple computers, e.g., servers, or other computerized devices directly or indirectly communicating in the network environment may constitute a “system” or a “computing system”.
It will be apparent that systems and/or methods, described herein, can be implemented in different forms of hardware, software, or a combination of hardware and software. The actual specialized control hardware or software code used to implement these systems and/or methods is not limiting of the implementations. Thus, the operation and behavior of the systems and/or methods are described herein without reference to specific software code, it being understood that software and hardware can be designed to implement the systems and/or methods based on the description herein.
Some non-limiting embodiments or aspects are described herein in connection with thresholds. As used herein, satisfying a threshold may refer to a value being greater than the threshold, more than the threshold, higher than the threshold, greater than or equal to the threshold, less than the threshold, fewer than the threshold, lower than the threshold, less than or equal to the threshold, equal to the threshold, etc. In some non-limiting embodiments or aspects, satisfying a threshold may refer to recognition of a pattern in a signal as a result of a pattern recognition technique, a data mining technique, a slope of signal analysis, an Xbar R chart analysis, and/or the like being applied to the signal. For example, satisfying a threshold may be based on a dynamic time based analysis of a signal.
Referring now to
Management system 102 may include one or more devices capable of receiving information and/or data from the plurality of local systems 104a, 104b, . . . 104n (e.g., via communication network 106, etc.) and/or communicating information and/or data to the plurality of local systems 104a, 104b, . . . 104n (e.g., via communication network 106, etc.). For example, management system 102 may include one or more computing systems including one or more processors (e.g., one or more computing devices, one or more server computers, one or more mobile computing devices, etc.).
Management system 102 may be configured to access and/or update a standardized clinical protocol database located within management system 102 or external (e.g., remote from) management system 102. The standardized clinical protocol database may include clinical protocol data associated with standardized clinical protocols for vascular access management. In some non-limiting embodiments or aspects, a standardized clinical protocol may be customized according to a disease state of the patient, a type of local system (e.g., a care location, etc.) at which the patient is located, etc.
Local system 102 may include one or more devices capable of receiving information and/or data from management system 102 (e.g., via communication network 106, etc.) and/or communicating information and/or data to management system 102 (e.g., via communication network 106, etc.). For example, local system 102 may include one or more computing systems including one or more processors (e.g., one or more computing devices, one or more server computers, one or more mobile computing devices, etc.). In some non-limiting embodiments or aspects, local system 104 may include a home care system, an acute care system, a hospital care system, and/or the like. In such an example, local system 104 may include one or more signal extenders configured to extend wireless communication between components of local system 104, such as to extend wireless communication to cover an entire floor of a hospital enterprise, and/or the like.
Communication network 106 may include one or more wired and/or wireless networks. For example, communication network 106 may include a cellular network (e.g., a long-term evolution (LTE) network, a third generation (3G) network, a fourth generation (4G) network, a fifth generation (5G) network, a code division multiple access (CDMA) network, etc.), a short range wireless communication network (e.g., a Bluetooth network, etc.), a public land mobile network (PLMN), a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a telephone network (e.g., the public switched telephone network (PSTN)), a private network, an ad hoc network, an intranet, the Internet, a fiber optic-based network, a cloud computing network, and/or the like, and/or a combination of these or other types of networks.
Central computing system 202 may include one or more devices capable of receiving information and/or data from management system 102, medication source system 204, sensor system 206, and/or user device 208 (e.g., via communication network 106, etc.) and/or communicating information and/or data to management system 102, medication source system 204, sensor system 206, and/or user device 208 (e.g., via communication network 106, etc.). For example, central computing system 202 may include one or more computing systems including one or more processors (e.g., one or more computing devices, one or more server computers, one or more mobile computing devices, etc.). In some non-limiting embodiments or aspects, central computing system 202 may be implemented within management system 102 medication source system 204, sensor system 206, and/or user device 208.
Medication source system 204 may include one or more devices capable of delivering one or more fluids to one or more lumens (e.g., fluid lines, IV lines, etc.). For example, medication source system 204 may include one or more manual fluid delivery systems (e.g., one or more IV bags, one or more syringes, etc.) and/or an infusion pump system including one or more infusion pumps.
Medication source system 204 may include one or more devices capable of receiving information and/or data from management system 102, central computing system 202, sensor system 206, and/or user device 208 (e.g., via communication network 106, etc.) and/or communicating information and/or data to management system 102, central computing system 202, sensor system 206, and/or user device 208 (e.g., via communication network 106, etc.). For example, medication source system 204 may include one or more computing systems including one or more processors (e.g., one or more computing devices, one or more server computers, one or more mobile computing devices, etc.).
Sensor system 106 may include one or more sensors configured to determine (e.g., determine, collect, acquire, capture, measure, sense, etc.) sensor data associated with a patient and/or a medical device. For example, sensor system 106 may include image capture system 702, one or more smart devices 804, and/or user device(s) 208.
Sensor system 206 may include one or more devices capable of receiving information and/or data from management system 102, central computing system 202, medication source system 204, and/or user device 208 (e.g., via communication network 106, etc.) and/or communicating information and/or data to management system 102, central computing system 202, medication source system 204, and/or user device 208 (e.g., via communication network 106, etc.). For example, sensor system 206 may include one or more computing systems including one or more processors (e.g., one or more computing devices, one or more server computers, one or more mobile computing devices, etc.).
User device 208 may include one or more devices capable of receiving information and/or data from management system 102, central computing system 202, medication source system 204, and/or sensor system 206 (e.g., via communication network 106, etc.) and/or communicating information and/or data to management system 102, central computing system 202, medication source system 204, and/or sensor system 206 (e.g., via communication network 106, etc.). For example, user device 208 may include one or more computing systems including one or more processors (e.g., one or more computing devices, one or more server computers, one or more mobile computing devices, etc.).
In some non-limiting embodiments or aspects, user device 208 includes a nurse station or terminal in a hospital. For example, user device 208 may provide bedside nurse support (e.g., recordation of events in real-time by a nurse and feedback to a nurse if events, such as scrubbing or flushing, are determined to be due or needed, etc.), nursing station manager support (e.g., optimization of flushing procedures to reduce workflow and improve timed targets for flushing, etc.), retrospective reporting for nursing administration (e.g., a scrub duration, a flushing technique, a time between flushes, improper medical device reuse, proper medical device replacement, etc.), and/or the like.
The number and arrangement of systems and devices shown in
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Bus 202 may include a component that permits communication among the components of device 200. In some non-limiting embodiments or aspects, processor 204 may be implemented in hardware, software, or a combination of hardware and software. For example, processor 204 may include a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and/or any processing component (e.g., a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), etc.) that can be programmed to perform a function. Memory 206 may include random access memory (RAM), read-only memory (ROM), and/or another type of dynamic or static storage device (e.g., flash memory, magnetic memory, optical memory, etc.) that stores information and/or instructions for use by processor 204.
Storage component 208 may store information and/or software related to the operation and use of device 200. For example, storage component 208 may include a hard disk (e.g., a magnetic disk, an optical disk, a magneto-optic disk, a solid state disk, etc.), a compact disc (CD), a digital versatile disc (DVD), a floppy disk, a cartridge, a magnetic tape, and/or another type of computer-readable medium, along with a corresponding drive.
Input component 210 may include a component that permits device 200 to receive information, such as via user input (e.g., a touch screen display, a keyboard, a keypad, a mouse, a button, a switch, a microphone, etc.). Additionally or alternatively, input component 210 may include a sensor for sensing information (e.g., a global positioning system (GPS) component, an accelerometer, a gyroscope, an actuator, a force sensor a camera, and/or any of the sensors described herein, etc.). Output component 212 may include a component that provides output information from device 200 (e.g., a display, a speaker, a tactile or haptic output, one or more light-emitting diodes (LEDs), etc.).
Communication interface 214 may include a transceiver-like component (e.g., a transceiver, a separate receiver and transmitter, etc.) that enables device 200 to communicate with other devices, such as via a wired connection, a wireless connection, or a combination of wired and wireless connections. Communication interface 214 may permit device 200 to receive information from another device and/or provide information to another device. For example, communication interface 214 may include an Ethernet interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, a Wi-Fi® interface, a cellular network interface, and/or the like.
Device 200 may perform one or more processes described herein. Device 200 may perform these processes based on processor 204 executing software instructions stored by a computer-readable medium, such as memory 206 and/or storage component 208. A computer-readable medium (e.g., a non-transitory computer-readable medium) is defined herein as a non-transitory memory device. A memory device includes memory space located inside of a single physical storage device or memory space spread across multiple physical storage devices.
Software instructions may be read into memory 206 and/or storage component 208 from another computer-readable medium or from another device via communication interface 214. When executed, software instructions stored in memory 206 and/or storage component 208 may cause processor 204 to perform one or more processes described herein. Additionally or alternatively, hardware circuitry may be used in place of or in combination with software instructions to perform one or more processes described herein. Thus, embodiments or aspects described herein are not limited to any specific combination of hardware circuitry and software.
Memory 206 and/or storage component 208 may include data storage or one or more data structures (e.g., a database, etc.). Device 200 may be capable of receiving information from, storing information in, communicating information to, or searching information stored in the data storage or one or more data structures in memory 206 and/or storage component 208.
The number and arrangement of components shown in
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Communication between management system 102 and local system 104 may be based on a clinical protocol data unit (CPDU). A CPDU may include a block of VAM data and/or clinical information that can be transferred over communication network 106. For example, a CPDU may include clinical protocol-specific information and/or a payload of VAM data. As an example, management system 102 may be configured to associate, aggregate, and/or transmit VAM data (e.g. meaningful and clinically relevant insights with a time stamp, etc.) as CPDUs over communication network 106 to local system 104 (e.g., to central computing system 202, etc.) and receive VAM data (e.g., sensor data or signals, patient data, user input data, etc.) as CPDUs over communication network 106 from local system 104.
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Association unit 302 may be programmed and/or configured to use one or more algorithms to associate VAM data and/or patient data with clinical standards data to determine one or more clinical insights and/or to associate the one or more clinical insights with VAM data to determine one or more clinical protocols. In some non-limiting embodiments or aspects, association unit 302 may generate hospital and/or patient specific custom clinical protocols from standard clinical protocols using VAM data and/or clinical insights. In some non-limiting embodiments or aspects, association unit 302 may use standard clinical protocols as is (e.g., without modifying the standard clinical protocols, etc.) depending upon a clinical condition.
Aggregation unit 304 may be programmed and/or configured to aggregate VAM data from a plurality of different data sources (e.g., from various smart devices, from a nursing table, from an EMR, etc.). Aggregation unit 304 may be programmed and/or configured to aggregate data from different association units 302. For example, aggregation unit 304 may aggregate VAM data from the plurality of different sources after the data is collected by data collection unit 308 and associated with clinical standards data by association unit 302.
Transceiver unit 306 may be programmed and/or configured to transmit and/or receive CPDUs over communication network 106, packetize VAM data, clinical protocols, and/or insights into CPDUs, and/or de-packetize CPDUs into VAM data, clinical protocols and/or insights. For example, transceiver unit 306 may transmit the data after the data has been aggregate by aggregation unit 304.
Data collection unit 308 may include raw data aggregator 310, raw data source(s) 312, VAM data pre-processor 314, VAM data source(s) 316, VAM data integrator 318, and/or VAM data input 320. Data collection unit 308 may be programmed and/or configured to collect source data (e.g., VAM data, patient data, etc.) from a plurality of different data sources (e.g., from various smart devices, from a nursing table, from an EMR, etc.). For example, a sequence of operation or data processing in data collection unit 308 may be from raw data source(s) 312 to raw data aggregator 310 to VAM data pre-processor 310 to VAM data source(s) 316 to VAM data integrator 318 to VAM data input 320. For example, a sequence of operation or data processing in data collection unit 308 may be from data collection unit 308 to association unit 302, to aggregation unit 304, to transceiver unit 306.
Raw data aggregator (RDA) 310 may be programmed and/or configured to interface with all available data sources, such as an EHR, a smart device system, treatment checklists, physician and nursing notes, assessment charts, product information, the clinical protocol database, and/or the like.
Raw data source(s) (RDS) 312 may include at least one of the following data sources: an EHR, a smart device system, treatment checklists, physician and nursing notes, assessment charts, product information, the clinical protocol database, or any combination thereof.
VAM data pre-processor (VDP) 314 may be programmed and/or configured to transform raw data and filter the data for vascular access treatment relevant information. For example, VAM data pre-processor 314 may be programmed and/or configured to filter vascular access treatment relevant data from each data source, normalize attributes in the filtered data, provide treatment of missing values, and/or perform feature engineering for better understanding by signal models.
VAM data source(s) (VDS) 316 may include data sources that include only vascular access treatment specific information. For example VAM data source(s) 316 may include vascular Access data derived from an EHR, vascular access product/practice data from a smart device system, physician and nursing notes converted to structured format using NLP, charts from VAM assessments, vascular signal data, vascular relevant data from treatment checklists, or any combination thereof.
VAM data integrator (VDI) 318 may be programmed and/or configured to combine preprocessed data from various sources into a single data source.
VAM data input (DIN) 320 may include a consolidated input or data structure with VAM data in which each row represent a single historical instance of a patient.
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VAM data may include sensor data, user input data, patient data, medical device data, medication data, event data, compatibility data, location data, insight data, and/or clinical protocol data. For example, VAM data may include data associated with one or more vascular access treatments, such as EMR data, product data, caretaker notes, treatment checklist, sensor data, event data, VAM assessment, clinical protocols, and/or the like, associated with one or more patients. As an example, VAM data may include one or more of the following parameters: a patient identifier; a hospital identifier; a patient name; a patient gender; a patient age, a co-morbidity/problem associated with a patient (e.g., poor venous condition, etc.); a medication associated with a patient, a symptom associated with a patient; a reason for admission associated with a patient (e.g., surgery, etc.); an infusion type associated with a patient (e.g., non-vesicant, vesicant, etc.); an admission date associated with a patient; a readmission indicator (e.g., yes, no, etc.); a discharge date associated with a patient; a length of stay associated with a patient; a number of lines used associated with a patient; a type of accessories used associated with a patient (e.g., extension set with connector, etc.); a date of use associated with a medical device; an average dwell time, an average number of stick attempts, a complication (e.g., occlusion, no complication, etc.); a department; a nurse identifier; a nurse experience indicator (e.g., competent, expert, etc.); a question associated with a vascular access treatment (e.g., was the skin dried as per IFU, was the flush clamped before disconnecting, etc.); a question identifier associated with a question; an answer associated with a question (e.g., yes, no, etc.); a time stamp associated with a usage of a medical device; a device identifier associated with a medical device, a type of a medical device, a device signal associated with a medical device (e.g., scrubbed, vesicant infused, etc.); a section (e.g., a status, an observation, etc.); metadata and/or other keywords associated with a vascular access treatment entered by a user; a department (e.g., cardiology, radiology, etc.); a number of occlusion cases in a period of time, a number of CRBSI and/or CLABSI cases in a time period; a predicted vascular signal (e.g., CRBSI, phlebitis, etc.); an insight; an initial risk prediction; a recommendation; an updated risk prediction; a cost prediction; or any combination thereof.
Sensor data may include one or more parameters determined (e.g., determined, collected, acquired, captured, measured, sensed, etc.) by one or more sensors of sensor system 106 (e.g., an image capture system 702, smart device 804, user device 208, etc.). For example sensor data may include at least one of the following parameters: images and/or image data, determined events and/or event data, an identifier of a particular sensor, information, data, and/or a signal sensed, measured, and/or detected by one or more sensor in one or more smart devices and/or peripheral devices (e.g., a piezoelectric signal or data, a force signal or data, a flow, or any combination thereof. Sensor data may include patient data, medical device data, medication data, image data, and/or clinical protocol data.
User input data may include one or more parameters input via user interaction with a user interface of local system 104, central computing system 202, medication source system 204, sensor system 206, and/or user device 208. For example, user input data may include at least one of the following parameters: a number of stick attempts, a location of a stick attempt on a patient (e.g., left arm, right, arm, left leg, right leg, etc.), a location of an insertion site on a patient (e.g., left arm, right arm, left leg, right leg, etc.), a developmental venous anomaly (DVA), or any combination thereof. User input data may include patient data, medical device data, medication data, and/or clinical protocol data.
Patient data may include at least one of the following parameters associated with a patient: one or more patient demographics (e.g., age, weight, etc.), a treatment history, a patient identifier, or any combination thereof.
Medical device data may include at least one of the following parameters associated with a medical device: a device identifier, a type of a device, or any combination thereof.
A medical device may include a disposable medical device or a reusable medical device. For example, a medical device may include at least one of the following types of medical devices: a peripheral IV catheter (PIVC), a peripherally inserted central catheter (PICC), a midline catheter, a needleless connector, a catheter dressing, a catheter stabilization device, a disinfectant cap, a disinfectant swab or wipe, an IV tubing set, an infusion pump, a flush syringe, a medication delivery syringe, a caregiver glove, an IV fluid bag, a medication dispensing cabinet, an ultrasound device, a sharps collector, a smart device, or any combination thereof.
Medication data may include at least one of the following parameters associated with a medication: a type of the medication, a scheduled delivery of the medication via a particular medication source device and/or lumen, a previous delivery of the medication via a particular medication source device and/or lumen, an amount of the medication, a patient to which the medication is scheduled to be delivered (or delivered), one or more different types of medication that are incompatible for delivery via a same lumen with the medication, or any combination thereof.
Clinical protocol data may include at least one of the following parameters associated with a clinical protocol (e.g., standardized nursing care, practices, processes, and/or the like associated with a vascular access treatment, etc.): a catheter dwell time, a scrub time associated with a medical device, a scrub time, a flush time, a flush duration, a lock time, a lock duration, a disinfecting time, a disinfecting duration, an order of a plurality of clinical actions, or any combination thereof. For example, an example clinical protocol may include the following ordered instructions: 1. Scrub a hub to provide disinfection, 2. Flush to assess catheter functionality, 3. Scrub the hub to provide disinfection before delivering IV medication, 4. After delivering IV medication, scrub the hub to provide disinfection, 5. Flush to clear the medication, 6. Scrub the hub to provide disinfection, 7. Lock the catheter to maintain catheter patency, 8. Attach a disinfecting cap to disinfect between line accesses.
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An insight may include a data dashboard (e.g., graphs, trends, comparisons, etc.), a digitized audit, support and training information, a recommendation (including reasoning therefor), predictive analytics, and/or the like. For example, an insight may include patient's underlying condition and complication history at an early stage of treatment, associated risk of complications continuously updating during the entire course of patient treatment (e.g. an initial risk prediction, a reduced risk prediction, etc.), best practices and product recommendations (e.g., a recommendation, etc.), cost analysis based on adopted practices and products (e.g. a cost prediction, etc.), or any combination thereof. An insight may include metrics associated with a hospital or care location, such as a CRBSI and/or CLABSI Rate (outcome), an average dwell time length (outcome), a pull-through revenue, a number of recommendations adopted (adoption), a number and/or a type of products used for prepping an insertion site, a location of an insertion site on a patient, a number and/or a type of risk associated with an insertion site, and/or the like. Risk
Management system 102 may apply an algorithm or aspects of one or more algorithms, which may be an adaptation or implementation of a standardized clinical protocol, a professional society guideline, and/or a hospital procedure into computer code, to VAM data associated with one or more vascular access treatments associated with one or more patients to determine one or more insights associated with the one or more vascular access treatments. In such an example, different hospitals, locations, and/or providers may have different algorithms or aspects of one or more algorithms based on a local preference, a practice, a country, and/or other factors associated with the different hospitals.
Further details regarding non-limiting embodiments or aspects of step 404 of process 400 are now provided with regard to
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A complication may include at least one of the following complications: a phlebitis, an occlusion, an infiltration, a Catheter Related Blood Stream Infection (CRBSI), a Central Line-associated Bloodstream Infection (CLABSI), a first stick failure in a right arm of a patient, a first stick failure in a left arm of a patient, a dislodgement of a catheter, an extravasation, an infiltration, or any combination thereof.
In some non-limiting embodiments or aspects, management system 102 may process VAM data associated with a vascular access treatment associated with a patient with a machine learning model to determine an initial risk prediction for the vascular access treatment associated with the patient. For example, management system 102 may generate a risk prediction model (e.g., an estimator, a classifier, a prediction model, a detector model, etc.) using machine learning techniques including, for example, supervised and/or unsupervised techniques, such as decision trees (e.g., gradient boosted decision trees, random forests, etc.), logistic regressions, artificial neural networks (e.g., convolutional neural networks, etc.), Bayesian statistics, learning automata, Hidden Markov Modeling, linear classifiers, quadratic classifiers, association rule learning, and/or the like. The risk prediction machine learning model may be trained to provide an output including a probability that a patient, in response to the vascular access treatment, experiences at least one complication in response to an input including the VAM data. In such an example, the risk prediction may include a probability score associated with a prediction that the patient experiences the at least one complication in response to the vascular access treatment.
Management system 102 may generate and/or update the risk prediction model based on VAM data (e.g., training data, etc.). In some implementations, the risk prediction model is designed to receive, as an input, VAM data (e.g., one or more parameters of the VAM data, EHR data, diagnostics, sensor data, real-time treatment checklists, a complication history associated with a patient, etc.) and provide, as an output, a prediction (e.g., a probability, a binary output, a yes-no output, a score, a prediction score, a classification, etc.) as to whether a patient experiences at least one complication in response to a vascular access treatment. In some non-limiting embodiments or aspects, management system 102 stores the risk prediction model (e.g., stores the model for later use). In some non-limiting embodiments or aspects, management system 102 stores the risk prediction model in a data structure (e.g., a database, a linked list, a tree, etc.). In some non-limiting embodiments, the data structure is located within management system 102 or external (e.g., remote from) management system 102 (e.g., within auxiliary system 112, etc.).
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A recommended process may include at least one of the following recommended processes: a recommendation to use a specific arm of a patient for a vascular access treatment (e.g., a specific arm for a first stick, etc.), a recommendation to use a specific type of medical device for a vascular access treatment (e.g., a specific type of catheter, such as an ultrasound guided catheter, a specific type of syringe, such as a pre-filled saline syringe, etc.), a recommendation to disinfect a medical device (e.g., a recommendation to scrub a catheter hub for a period of time, etc.), a recommendation to flush and/or a type of flush to perform (e.g., a recommendation to use a pulsatile flush, etc.), a recommendation to lock a catheter, a recommendation to attach a disinfection cap, or any combination thereof.
A recommended product may include a recommendation to use a specific type of a medical device for a vascular access treatment. For example, recommended product may include a specific type of catheter (e.g., an ultrasound guided catheter, et.), a specific type of syringe (e.g., a pre-filled saline syringe, etc.), or any combination thereof. As an example, a recommended product may include one or more of the following: Peripheral IV Catheters: 1. Conventional straight and ported catheters, 2. Safety straight and ported catheters, 3. Conventional closed catheter systems, 4. Safety closed catheter systems, 5. Guidewire-assisted intravascular catheters; Catheter Care Syringes: 1. Saline sterile fluid path and externally sterile prefilled syringes, 2. Heparin prefilled syringes, 3. Citrate prefilled syringes, 4. Flush syringes with alcohol disinfectant pad; Medication Delivery Needles and Syringes: 1. Conventional hypodermic needles and syringes Blunt Fill/Filter Needles, Fluid Dispensing Syringes), 2. Safety hypodermic needles and syringes, 3. Reuse prevention syringes, 4. Enteral/Oral syringes, 5. Spinal and epidural needles; Advanced Access Devices: 1. Peripherally inserted central catheters, 2. Acute dialysis catheters, 3. Acute central venous catheters, 4. Midline catheters, 5. Port access devices, 6. Intraosseous devices; Other Catheter Care Devices: 1. Disinfecting caps, 2. Single-use skin preparation antiseptics, 3. Dressings and dressing change kits (Antimicrobial Hemostatic IV Dressing), 4. Stabilization devices; Other Medication Delivery Devices: 1. Regional anesthesia kits and trays, 2. Sharps collectors; or any combination thereof.
In some non-limiting embodiments or aspects, management system 102 may process VAM data and/or an initial risk prediction associated with a vascular access treatment associated with a patient with a k-nearest neighbors algorithm (k-NN) to determine a recommendation associated with the vascular access treatment associated with the patient. For example, management system 102 may identify the most similar patient characteristics and practices and/or products associated with the patients based on a distance metric and recommend products and/or processes for new patients based thereon.
In some non-limiting embodiments or aspects, management system 102 may process VAM data and/or an initial risk prediction associated with a vascular access treatment associated with a patient with a machine learning model to determine a recommendation associated with the vascular access treatment associated with the patient. For example, management system 102 may generate a recommendation model (e.g., an estimator, a classifier, a prediction model, a detector model, etc.) using machine learning techniques including, for example, supervised and/or unsupervised techniques, such as decision trees (e.g., gradient boosted decision trees, random forests, etc.), logistic regressions, artificial neural networks (e.g., convolutional neural networks, etc.), Bayesian statistics, learning automata, Hidden Markov Modeling, linear classifiers, quadratic classifiers, association rule learning, and/or the like. The recommendation machine learning model may be trained to provide an output including a recommendation that a recommended best practice and/or a recommended product be used for the vascular access treatment.
Management system 102 may generate and/or update the recommendation model based on VAM data and/or one or more previous initial risk predications (e.g., training data, etc.). In some implementations, the recommendation model is designed to receive, as an input, VAM data (e.g., one or more parameters of the VAM data, EHR data, diagnostics, sensor data, real-time treatment checklist, etc.) and an initial risk predication (e.g., a complication predicted for the patient, etc.) associated with a vascular access treatment and provide, as an output, a recommendation that a recommended best practice and/or a recommended product be used for the vascular access treatment. In some non-limiting embodiments or aspects, management system 102 stores the recommendation model (e.g., stores the model for later use). In some non-limiting embodiments or aspects, management system 102 stores the recommendation model in a data structure (e.g., a database, a linked list, a tree, etc.). In some non-limiting embodiments, the data structure is located within management system 102 or external (e.g., remote from) management system 102 (e.g., within auxiliary system 112, etc.).
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In some non-limiting embodiments or aspects, management system 102 may process VAM data associated with a vascular access treatment associated with a patient, an initial risk prediction associated with the vascular access treatment, and/or a recommendation associated with the vascular access treatment (e.g., an adopted recommendation, etc.) with a machine learning model to determine a cost prediction for the vascular access treatment associated with the patient. For example, management system 102 may generate a cost prediction model (e.g., an estimator, a classifier, a prediction model, a detector model, etc.) using machine learning techniques including, for example, supervised and/or unsupervised techniques, such as decision trees (e.g., gradient boosted decision trees, random forests, etc.), logistic regressions, artificial neural networks (e.g., convolutional neural networks, etc.), Bayesian statistics, learning automata, Hidden Markov Modeling, linear classifiers, quadratic classifiers, association rule learning, and/or the like. The cost prediction machine learning model may be trained to provide an output including a cost prediction associated with the vascular access treatment. In such an example, the cost prediction may include a probability score associated with a prediction of a cost associated with the vascular access treatment.
Management system 102 may generate and/or update the cost prediction model based on VAM data associated with a vascular access treatment associated with a patient, an initial risk prediction associated with the vascular access treatment, and/or a recommendation associated with the vascular access treatment (e.g., training data, etc.). In some implementations, the cost prediction model is designed to receive, as an input, VAM data associated with a vascular access treatment associated with a patient (e.g., one or more parameters of the VAM data, EHR data, diagnostics, sensor data, real-time treatment checklists), an initial risk prediction associated with the vascular access treatment (e.g., a predicted complication associated with the patient, etc.), and/or a recommendation associated with the vascular access treatment (e.g., an adopted recommendation, a process used for a vascular access treatment, a product used for a vascular access treatment, etc.) and provide, as an output, a prediction (e.g., a probability, a binary output, a yes-no output, a score, a prediction score, a classification, etc.) of a cost associated with the vascular access treatment (e.g., an overhead cost associated with each process and/or product associated with the vascular access treatment and/or a predicted savings in terms of reduced cost of complication from adoption of a recommended process and/or a recommend product, etc.). In some non-limiting embodiments or aspects, management system 102 stores the cost prediction model (e.g., stores the model for later use). In some non-limiting embodiments or aspects, management system 102 stores the cost prediction model in a data structure (e.g., a database, a linked list, a tree, etc.). In some non-limiting embodiments, the data structure is located within management system 102 or external (e.g., remote from) management system 102 (e.g., within auxiliary system 112, etc.).
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In some non-limiting embodiments or aspects, providing an insight associated with a vascular access treatment associated with a patient may include automatically controlling a medical device associated with the vascular access treatment. For example, management system 102 may automatically control, based on VAM data associated with a vascular access treatment associated with a patient, an initial risk prediction associated with the vascular access treatment, a recommendation associated with the vascular access treatment, an updated risk prediction associated with the vascular access treatment, and/or an insight associated with the vascular access treatment, a medical device during the vascular access treatment provided to the patient. As an example, management system 102 may automatically control, based on VAM data associated with a vascular access treatment associated with a patient, an initial risk prediction associated with the vascular access treatment, a recommendation associated with the vascular access treatment, an updated risk prediction associated with the vascular access treatment, and/or an insight associated with the vascular access treatment, a valve and/or an infusion pump associated with the vascular access treatment to stop a flow of fluid in a fluid flow path including the valve and/or the infusion pump.
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Another example of model inputs may include an indication that a patient has no vascular access history (e.g., a new patient, etc.), a scrubbing event for a catheter hub associated with an insufficient duration of scrubbing (e.g., 3 seconds, etc.), an indication that pulsatile flushing is not detected, and a cost of treatment for patients with a similar patient profile of $1500. The risk prediction model may provide, based on these model inputs, an initial risk prediction including a probability of CRBSI of 1% and a probability of occlusion of 15%. The recommendation model may provide, based on these model inputs and/or the initial risk prediction, a recommendation to scrub the catheter hub for at least 10 seconds, a recommendation to use a pulsatile flush, and a recommendation to use a pre-filled saline syringe. The risk prediction model may provide, based on these model inputs, the initial risk prediction, and/or the recommendations, an updated risk prediction including a probability of CRBSI of 0.001% and a probability of occlusion of 0.2%. The cost prediction engine may provide, based on these model inputs, the initial risk prediction, the recommendations, and/or the updated risk prediction, an overhead cost of the recommended processes and/or products of $1 and a cost savings in terms of reduced risk of $8000.
Accordingly, non-limiting embodiments or aspects of the present disclosure may help a medical practitioner to select a correct medical device (e.g., a correct catheter, etc.) for a vascular access treatment, properly prepare the skin of a patient for the vascular access treatment, properly place the medical device for the vascular access treatment, properly maintain the device for the vascular access treatment, properly use the device for the vascular access treatment, and/or properly secure the device for the vascular access treatment. In this way, non-limiting embodiments or aspects of the present disclosure may reduce vascular catheter colonization and catheter-related bloodstream infections (CRBSI) in patients with central venous or arterial catheters, assist hospitals in improving dwell times of peripheral IV catheters and in reducing vascular access complications in patients, reduce overall cost associated with vascular access complications, and/or the like.
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A medical device 712 may enter environment 700 (e.g., via the caretaker, etc.), remain in environment 700 for a period of time (or indefinitely) during which the medical device 712 may move within environment 700 and/or interact with (e.g., connect to, disconnect from, etc.) one or more other medical devices 712, the patient, and/or the caretaker, and/or exit environment 700 at a subsequent time after entering environment 700 (e.g., via the caretaker, etc.). A medical device 712 may include a disposable medical device and/or a reusable medical device. For example, a medical device 712 may include at least one of the following types of medical devices a peripheral IV catheter (PIVC), a peripherally inserted central catheter (PICC), a midline catheter, a needleless connector, a catheter dressing, a catheter stabilization device, a disinfectant cap, a disinfectant swab or wipe, an IV tubing set, an infusion pump, a flush syringe, a medication delivery syringe, a caregiver glove, an IV fluid bag, a medication dispensing cabinet, an ultrasound device, a sharps collector, or any combination thereof.
Detection of a shape, a size, a movement or trajectory, a location, an orientation, and/or the like of an object may be computationally expensive and/or error-prone. For example, a camera based object detection system may make a mistake in identifying similar objects and/or miss (e.g., fail to detect, etc.) an object in a noisy environment. Accordingly, in some non-limiting embodiments or aspects, an identifier element 714 (e.g., a tag, a label, a code, etc.) may be associated with (e.g., removably attached to, permanently attached to, integrated with, implemented on, etc.) a medical device 712. In some non-limiting embodiments or aspects, each medical device 712 in environment 700 may be associated with an identifier element 714. In some non-limiting embodiments or aspects, only a portion the medical devices 712 in environment 700 may be associated with identifier elements 714. In some non-limiting embodiments or aspects, none of the medical devices 712 in environment 700 may be associated with identifier elements 714. As described in more detail herein below, in some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may detect and use a shape, a size, a movement or trajectory, a location, and/or an orientation of an identifier element to identify a type of medical device 712 associated with the identifier element 714 and/or to uniquely identify medical device 712 associated with the identifier element 714 from other medical devices in environment 700, as well as to track locations of the medical device 712 associated with the identifier element 714 in environment 700 and/or determine events associated with the medical device 712 associated with the identifier element 714.
An identifier element 714 may encapsulate an identifier associated with a type of a medical device 712 associated with the identifier element 714 and/or uniquely identify the medical device 712 associated with the identifier element 714 from other medical devices and/or indicate an orientation of the medical device 712 within environment 700 and/or with respect to another medical device 712 (e.g., a fluid flow path direction through a medical device 712, an input or inlet position and an output or outlet position of a medical device, etc.). For example, an identifier element 714 may encapsulate an identifier associated with at least one of the following types of medical devices: a peripheral IV catheter (PIVC), a peripherally inserted central catheter (PICC), a midline catheter, a needleless connector, a disinfectant cap, a disinfectant swab or wipe, an IV tubing set, an infusion pump, a flush syringe, a medication delivery syringe, a caregiver glove, an IV fluid bag, a medication dispensing cabinet, an ultrasound device, a sharps collector, or any combination thereof, and/or uniquely identify a medical device 712 from other medical devices including identifiers associated with a same type of medical device. In such an example, an identifier element 714 may include at least one of the following: a colored pattern, a reflective pattern, a fluorescent pattern, a predetermined shape and color, a LED pattern, a barcode, or any combination thereof, which may encapsulate the identifier.
In some non-limiting embodiments or aspects, an identifier element 714 may include one or more colored areas, one or more reflective areas, one or more fluorescent areas, or any combination thereof that encapsulate an identifier. For example, an identifier element 714 may include one or more high-reflection areas such as, mirror surface particles, corner or edge reflectors, and/or the like, that encapsulate an identifier and render the identifier element 714 brighter than ambient illumination in environment 700. In such an example, an identifier element 714 may include a fluorescent coating or pattern on a medical device 712 that encapsulates an identifier by emitting light of a predetermined wavelength detectable in infrared by an image capture device including a filter configured to filter non-infrared light. In such an example, an identifier element 714 may include a tag or label having a predetermined shape and/or a predetermined color and/or color pattern that encapsulates an identifier (e.g., a green tag in a shape of a star, a red tag in a shape of a square, etc.). For example, an identifier element 714 may include a unique geometry and/or shape to differentiate itself from other identifier elements 714, and/or bars that wrap around cylindrical objects, grids, and/or patterns of shapes may be included in identifier element 714 for further identification and differentiation from other identifier elements 714.
In some non-limiting embodiments or aspects, an identifier element 714 may include colors selected (e.g., optimized, etc.) to be detected by image capture system 702. For example, for image capture system 702 may include an RGB camera, and an identifier element 714 may include variable color regions to create unique tag identities. As an example, an individual color used in a variable color region may be created from a percentage (e.g., 0%, 50% or 100%) of one of R, G, and B, and R, G, and B can be used to create 33 or 27 color combinations of variable color regions for reliable differentiation of color. In such an example, multiple variable colors can be placed adjacent to one another to create even more combinations, such as a 2×2 grid of colors, 3 parallel bars of color, and/or the like.
In some non-limiting embodiments or aspects, an identifier element 714 may include color calibration areas positioned adjacent to variable color regions to calibrate color in a wider range of lighting conditions. For example, for a 2×2 grid, a cell (1,1) in an upper-left corner of the gird may include a predetermined and/or standard calibration color region (e.g., neutral gray, etc.), and image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may use the predetermined and/or standard calibration color region to calibrate colors in images used to detect or determine the identifier element 714 in those images. In such an example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202_may use the predetermined and/or standard calibration color region to orient identifier element 714 to determine how to properly rotate and decode the colors in identifier element 714 to decode the identifier encapsulated by the identifier element 714 and/or track the identifier element 714 within environment 700.
Accordingly, non-limiting embodiments or aspects of the present disclosure may use unique tags that identify medical devices individually and/or as a category or type of medical device for more robust image segmentation input, which may avoid the use of more standard bar code technology that may be more difficult to resolve without higher-cost cameras by instead using lower spatial resolution images, and lower cost cameras and processing. Further, in some non-limiting embodiments or aspects, additionally or alternatively to variable identifier elements 714 that identify product categories (e.g., by SKU, etc.), identifier elements 714 may include a hyper-variable region in which random hyper-variable tags may be applied during manufacturing. For example, if there are a predetermined number of unique identifiers (e.g., one hundred unique random identifiers, etc.), for any given patient, medical devices 712 may be uniquely identified, even if the medical devices 712 have the same SKU.
In some non-limiting embodiments or aspects, an identifier element 714 may include at least one light emitting diode (LED) (e.g., an RGB LED, an IR LED, etc.) configured to emit light of at least one predetermined wavelength in at least one predetermined pattern (e.g., a color code, a dynamic pattern, etc.) and/or at least one predetermined intensity, which encapsulates an identifier. For example, an identifier element 714 may include a battery (e.g., a rechargeable battery, a single use battery, a replaceable battery, etc.), an energy harvester (e.g., a thermoelectric energy harvester, a photovoltaic energy harvester, a piezoelectric energy harvester, etc.), a wireless power receiver (e.g., an RFID device, etc.), or any combination thereof that is configured to power the at least one LED and/or a controller configured to control the at least one LED to emit the light encapsulating the identifier, and image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may analyze the light captured in images to decode the identifier encapsulated by the identifier element 714 and/or track the identifier element 714 within environment 700.
In some non-limiting embodiments or aspects, an identifier element 714 may include a 1D barcode and/or a 2D barcode (e.g., a QR code, an Aztec code, a Data Matrix code, an ArUco marker, etc.) that encapsulates an identifier. For example, as described in more detail herein below, in some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may detect and/or track an identifier element 714 within environment 700 by detecting three square boxes on QR codes to reposition or orient an image and read a pattern in the QR code to identify a type of medical device 712 associated with the identifier element 714. For example,
In some non-limiting embodiments or aspects, an identifier element 714 may include at least one color changing dye configured to change color over a period of time. For example, as described in more detail herein below, in some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine, based on a change in the color of the color changing dye in a plurality of images, an amount of time associated with a use of a medical device 712 associated with the identifier element 714 (e.g., an amount of time since the medical device 712 is removed from a package, an amount of time medical device 712 is in environment 700, etc.).
Image capture system 702 (e.g., a camera system, a sensor system, sensor system 206, etc.) may include one or more image capture devices (e.g., one or more cameras, one or more sensors, etc.) configured to capture, over a period of time, a plurality of images (e.g., image data, etc.) of an environment (e.g., environment 700, an environment of a local system 104, etc.) surrounding the one or more image capture devices. For example, an image capture device may include at least one of the following: a plurality of image capture devices, an infrared (IR) camera, a pan, tilt, and zoom (PTZ) camera including a variable field-of-view (FOV) and an automatic zoom function, a master and slave camera system including a static camera and a dynamic camera, a camera including a filter configured to filter a predetermined wavelength of light, a LiDAR sensor, or any combination thereof.
In some non-limiting embodiments or aspects, image capture system 702 may include a single camera configured to detect or capture only identifier elements 714 (e.g., from background, from other objects in environment 700, etc.). In some non-limiting embodiments or aspects, image capture system 702 may include a plurality of cameras configured to generate images with depth and/or to capture images from multiple different angles or fields-of-view to resolve occlusion of an object in a field of view of a single camera. In some non-limiting embodiments or aspects, image capture system 702 may include an IR camera configured to capture and/or read identifier elements 714 including infrared and/or near-infrared fluorescent tags or markings. In some non-limiting embodiments or aspects, image capture system 702 may include a PTZ camera configured to use variable FOV and automatic zoom functions to automatically zoom in on and capture zoomed images of medical devices 712 and/or identifier elements 714 that are identified by image capture system 702 as objects for which a more detailed image is to be captured by the PTZ camera (e.g., identified as objects likely to be a medical device 712 and/or an identifier element 714, etc.). In some non-limiting embodiments or aspects, image capture system 702 may include a master and slave camera system including a static camera configured to capture an initial image(s) and a dynamic camera configured to zoom in on and capture zoomed images of medical devices 712 and/or identifier elements 714 that are identified by image capture system 702, based on the images from the static camera, as objects for which a more detailed image is to be captured (e.g., identified as objects likely to be a medical device 712 and/or an identifier element 714, etc.). In some non-limiting embodiments or aspects, image capture system 702 may include a color camera configured to capture and/or detect one or more predetermined wavelengths of light. In some non-limiting embodiments or aspects, image capture system 702 may include a camera including a filter configured to filter a predetermined wavelength of light to distinguish medical devices 712 and/or identifier elements 714 from a background or scene based on a color of the medical devices 712 and/or identifier elements 714 in the captured images.
Image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may be configured to obtain image data and process the image data to determine object data associated with objects detected and/or determined from the image data. For example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may obtain image data from image capture system 702. As an example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may obtain a plurality of images, captured over a period of time, of an environment (e.g., environment 700, an environment of a local system 104, etc.) surrounding one or more image capture devices of image capture system 702. In such an example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may be configured to detect and/or determine, based on the images captured by image capture system 702 (e.g., based on image data, etc.), object data associated with at least one of the following: objects in the images (e.g., medical devices 712, identifier elements 714, medical devices 712 associated with identifier elements 714, etc.), types of the objects in the images, locations of the objects within environment 700 and/or with respect to other objects (e.g., other medical devices 712, other identifier elements 714, a patient, a caretaker, an image capture device, etc.), orientations (e.g., fluid flow path orientations through medical devices 712, inputs and outputs of medical devices 712, etc.) of the objects within environment 700 and/or with respect to the other objects, movements and/or trajectories of motion of the objects within environment 700 and/or with respect to the other objects, or any combination thereof. For example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine, based on the detected and/or determined objects in the images, object data associated with at least one of the following: the types of the objects in the images, the locations of the objects within environment 700 and/or with respect to other objects, the orientations of the objects within environment 700 and/or with respect to the other objects, and/or the movements and/or trajectories of motion of the objects within environment 700 and/or with respect to the other objects, or any combination thereof.
In some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may differentiate medical devices 712 and/or identifier elements 714 from background and/or other objects in captured images based on object features detected and/or determined in the images, such as geometries of the medical devices 712 and/or the identifier elements 714, orientations in camera field-of-view of the medical devices 712 and/or the identifier elements 714, colors of the medical devices 712 and/or the identifier elements 714, proximities of the medical devices 712 and/or the identifier elements 714 to other medical devices 712 and/or other identifier elements 714, a patient, a caretaker, an image capture device, and/or the like, and/or interactive associations with the other medical devices 712 and/or the other identifier elements 714, the patient, the caretaker, the image capture device, and/or the like. For example, management system 102 may automatically document usage of medical devices 712 as the medical devices 712 and/or identifier elements 714 associated with the medical devices 712 are tracked within a field of view of the one or more image capture devices of image capture system 702 to provide event and/or usage-based guidance and alerts to caretakers, which may reduce complications during vascular access management assessment by continuously monitoring and updating usage information associated with the medical devices 712 and reducing errors associated with manual documentation.
In some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may process the image data using one or more object detection techniques (e.g., a deep learning technique, an image processing technique, an image segmentation technique, etc.) to identify or determine medical devices 712 and/or identifier elements 714 in the images of the image data and/or in the object data associated with the medical devices 712 and/or the identifier elements 714. For example, a deep learning technique may include a bounding box technique that generates a box label for objects (e.g., medical devices 712, identifier elements 714, etc.) of interest in images, an image masking technique (e.g., masked FRCNN (RCNN or CNN) that captures specific shapes of objects (e.g., medical devices 712, identifier elements 714, etc.) in images, a trained neural network that identifies objects (e.g., medical devices 712, identifier elements 714, etc.) in images, and/or the like. As an example, an image processing technique may include a cross correlation image processing technique, an image contrasting technique, a binary or colored filtering technique, and/or the like.
In some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may process the image data using a stereoscopic imaging technique and/or a shadow distance technique to determine object data including a distance from image capture system 702 to detected objects and/or distances between detected objects, and/or image capture system 702 may obtain the image data using multiple cameras, a laser focus technology, LiDAR sensors, and/or a camera physical zoom-in function to determine object data including a distance from image capture system 702 to detected objects and/or distances between detected objects. In some non-limiting embodiments or aspects, image capture system 702 may obtain image data and/or object data including a 3D profile of an object using a 3D optical profiler.
In some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine, based on image data and/or object data, event data associated with events and/or activities (e.g., vascular access management events, connections between medical devices 712, disconnections of medical devices 712, uses of medical devices, such as scrubbing events, disinfecting events, reuses of medical devices 712, replacements of medical devices 712, and/or the like, etc.) associated with the detected objects and/or an amount of time associated with the determined events and/or activities (e.g., an amount of time medical devices 712 are connected, a scrubbing time associated with a medical device 712, a drying time associated with a medical device after the scrubbing time, etc.).
In some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may generate, based on image data and/or object data (e.g., based on locations of detected medical devices 712 and/or identifier elements 714, types of the detected medical devices 712 and/or identifier elements 714, orientations of the detected medical devices 712 and/or identifier elements 714 relative to one another, movements and/or trajectories of the detected medical devices 712 and/or identifier elements 714 relative to one another, etc.), event data including a relational model of which medical devices 712 are connected to one another, as well as determine when these medical devices 712 are connected to each other and/or a duration of connection, disconnected from each other and/or a duration of disconnection, are involved in one or more other events or caretaker activities, and/or times associated therewith. For example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may use one or more criteria, such as a threshold distance between points of medical devices 712, relative orientations and/or direction vectors of the medical devices 712, threshold times associated therewith, and/or the like, to determine event data associated with whether medical devices 712 are connected and/or disconnected from each other (e.g., whether a fluid path connection is established between medical devices 712, etc.), whether another event involving one or more of the medical devices 712 has occurred (e.g., a scrubbing or disinfecting event, etc.), and/or times associated therewith. In such an example, as medical devices 712 are moved in environment 700, continuing connections of the same medical devices 712 at or over different points in time (and/or in different images) may increase a probability that those medical devices are connected in a fluid pathway.
In some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may generate one or more models (e.g., an estimator, a classifier, a prediction model, a detector model, etc.) using one or more machine learning techniques including, for example, supervised and/or unsupervised techniques, such as decision trees (e.g., gradient boosted decision trees, random forests, etc.), logistic regressions, artificial neural networks (e.g., convolutional neural networks, etc.), Bayesian statistics, learning automata, Hidden Markov Modeling, linear classifiers, quadratic classifiers, association rule learning, and/or the like. Management system 104 may generate the model based on image data and/or object data (e.g., training data, etc.) associated with one or more environments. In some implementations, the model is designed to receive, as an input, image data and/or object data and provide, as an output, a prediction (e.g., a probability, a binary output, a yes-no output, a score, a prediction score, a classification, event data, etc.) as to whether one or more events have occurred. In some non-limiting embodiments, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 stores the model (e.g., stores the model for later use). In some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may store the model in a data structure (e.g., a database, a linked list, a tree, etc.). In some non-limiting embodiments, the data structure is located within image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 or external (e.g., remote from) image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202. The one or more machine learning models may be trained to provide an output including event data associated with a prediction or classification of an event or activity associated with one or more medical devices 712 in response to input including image data and/or object data. In such an example, the prediction or classification of an event may include at least one of the following predictions or classifications: (i) a reuse of a medical device including a disconnection of the medical device from at least one of a patient and another medical device a reconnection of the medical device to the at least one of the patient and the another medical device, (ii) a replacement of a medical device with a new medical device of a same type as the medical device (e.g., a catheter dressing change, etc.) (iii) a connection of a first medical device to a second medical device, (iv) a disconnection of a first medical device from a second medical device, (v) a scrubbing or disinfecting event including scrubbing or disinfecting a medical device with another medical device, (vi) a drying event including an amount of time a medical device remains disconnected from other medical devices after a scrubbing or disinfecting event, or any combination thereof. In some non-limiting embodiments or aspects, a prediction or classification may include a probability score associated with a class prediction for an event. For example, the prediction or classification of the event may include a probability that the event occurred. As an example, the prediction or classification of the event may include at least one of the following: (i) a probability that a reuse of a medical device occurred (e.g., a reuse of a disinfectant swab or wipe, etc.), (ii) a probability that a replacement of a medical device occurred (e.g., a catheter dressing change, etc.) (iii) a probability that a connection of a first medical device to a second medical device occurred, (iv) a probability that a disconnection of a first medical device from a second medical device occurred, (v) a probability that a scrubbing or disinfecting event occurred, (vi) a probability that a drying event occurred, or any combination thereof.
In some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may generate and/or update, based on the image data, the object data, and/or the event data, a database including locations of detected medical devices 712 and/or identifier elements 714, types of the detected medical devices 712 and/or identifier elements 714, orientations of the detected medical devices 712 and/or identifier elements 714 relative to one another, movements and/or trajectories of the detected medical devices 712 and/or identifier elements 714 relative to one another, which medical devices 712 are connected to one another, when medical devices 712 are connected to each other and/or a duration of connection, which medical devices 712 are disconnected from each other and/or a duration of disconnection, which medical devices 712 are involved in one or more other events or activities and/or a duration thereof, and/or times associated therewith. For example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may maintain and update a database that includes spatial relationships of medical devices 712 and/or identifier elements 714 (e.g., distances between medical devices 712 and/or identifier elements 714, etc.) at a gross level (e.g., where an object is represented as a point, etc.) and orientations of the objects (e.g., fluid path vectors associated with a fluid path direction through a medical device, etc.), 3-space data that includes point locations of input-connectors and output connectors of medical devices 712, as well as intermediate points for larger devices, and/or the like, and/or determined events or activities therebetween. As an example, the database may include at least one of the following: a list of the plurality of medical devices currently in the environment, spatial relationships between the plurality of medical devices, current connections between the plurality of medical devices, current trajectories of the plurality of medical devices, orientations of the plurality of medical devices, events associated with the plurality of medical devices, or any combination thereof. In such an example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may control a display (e.g., a display of user device 208, etc.) to display a visual representation of the information stored and/or maintained in the database. For example,
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In some non-limiting embodiments or aspects, the at least one event may include a connection between two or more medical devices of the plurality of medical devices 712. For example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine, based on the plurality of locations of the plurality of medical devices 712 within the environment over the period of time, the plurality of types of the plurality of medical devices 712, the plurality of trajectories of the plurality of medical devices 712 within the environment over the period of time, and/or the plurality of orientations of the plurality of medical devices 712 within the environment over the period of time, at least one connection between two or more medical devices of the plurality of medical devices 712.
In some non-limiting embodiments or aspects, at least one connection between two or more medical devices forms a fluid flow path through the two or more medical devices. For example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine, based on the plurality of locations of the plurality of medical devices 712 within the environment over the period of time, the plurality of types of the plurality of medical devices 712, the plurality of trajectories of the plurality of medical devices 712 within the environment over the period of time, and/or the plurality of orientations of the plurality of medical devices 712 within the environment over the period of time, at least one event including at least one connection between two or more medical devices of the plurality of medical devices 712 that forms a fluid flow path through the two or more medical devices and a direction of a fluid flow in the fluid flow path through the two or more medical devices.
In some non-limiting embodiments or aspects, the at least one event may include at least one event of the following events: (i) a reuse of a medical device including a disconnection of the medical device from at least one of a patient and another medical device in the environment and a reconnection of the medical device to the at least one of the patient and the another medical device in the environment and (ii) a replacement of the medical device with a new medical device of a same type as the medical device in the environment. For example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine, based on the plurality of locations of the plurality of medical devices 712 within the environment over the period of time, the plurality of types of the plurality of medical devices 712, the plurality of trajectories of the plurality of medical devices 712 within the environment over the period of time, and/or the plurality of orientations of the plurality of medical devices 712 within the environment over the period of time, at least one event of the following events: (i) a reuse of a medical device including a disconnection of the medical device from at least one of a patient and another medical device in the environment and a reconnection of the medical device to the at least one of the patient and the another medical device in the environment and (ii) a replacement of the medical device with a new medical device of a same type as the medical device in the environment.
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In some non-limiting embodiments or aspects, in response to the at least one event including a reuse of a medical device, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may at least one of: provide to user device 208, an alert associated with the use of the medical device 712; and automatically control at least one medical device (e.g., a valve, an infusion pump, etc.) to stop a flow of fluid in a fluid flow path including the medical device.
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In some non-limiting embodiments or aspects, the plurality of identifier elements 714 may include at least one identifier element including a fluorescent coating configured to emit light of a predetermined wavelength, and image capture system 702 may capture only the light of the predetermined wavelength in the plurality of images.
In some non-limiting embodiments or aspects, the plurality of identifier elements 714 includes at least one identifier element including at least one LED configured to emit light of at least one predetermined wavelength in at least one pattern and/or at least one intensity, and image capture system 702 may capture only the light of the predetermined wavelength in the plurality of images. For example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine, based on the at least one pattern and/or the at least one intensity of the emitted light of the at least one predetermined wavelength captured in the plurality of images, a type of a medical device associated with the at least one identifier element.
In some non-limiting embodiments or aspects, the plurality of identifier elements 714 includes at least one identifier element including at least one color changing dye configured to change color over the period of time. For example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine, based on a change in the color of the color changing dye in the plurality of images, an amount of time associated with a use of a medical device associated with the at least one identifier element.
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In some non-limiting embodiments or aspects, in response to the at least one event including a reuse of a medical device, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may at least one of: provide to user device 208, an alert associated with the use of the medical device 712; and automatically control at least one medical device (e.g., a valve, an infusion pump, etc.) to stop a flow of fluid in a fluid flow path including the medical device.
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In some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may delay determining the plurality of distances between the plurality of medical devices 712 over the period of time and determining the at least one event until a location of at least one of the first medical device and the second medical device changes in the plurality of images over the period of time. Accordingly, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may save processing power and/or other computer resources until they are needed to detect a change in environment 700.
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In some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine based on the plurality of distances between the plurality of medical devices 712 over the period of time and the plurality of types of the plurality of medical devices 712, one of the following further events: (i) a reuse of the first medical device including a disconnection of the first medical device from the second medical device in the environment and a reconnection of the first medical device to the second medical device in the environment and (ii) a replacement of the first medical device with a new medical device of a same type as the first medical device.
In some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine, based on an orientation of the first medical device and an orientation of the second medical device, a direction of a fluid flow in a fluid flow path through the first medical device and the second medical device and/or update, based on the direction of the fluid flow in the fluid flow path through the first medical device and the second medical device, a database.
In some non-limiting embodiments or aspects, the first medical device includes at least one of a disinfectant cap and a disinfectant swab such that the connection of the first medical device of the plurality of medical devices 712 to the second medical device of the plurality of medical devices 712 does not form a fluid flow path through the first medical device and the second medical device. For example, the connection of the first medical device of the plurality of medical devices 712 to the second medical device of the plurality of medical devices 712 may be associated with a scrubbing event including scrubbing of the second medical device (e.g., a needleless connector, etc.) with the disinfectant cap and/or the disinfectant swab.
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In some non-limiting embodiments or aspects, in response to the at least one event including a reuse of a medical device, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may at least one of: provide to user device 208, an alert associated with the use of the medical device 712; and automatically control at least one medical device (e.g., a valve, an infusion pump, etc.) to stop a flow of fluid in a fluid flow path including the medical device.
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In some non-limiting embodiments or aspects, in response to the at least one event, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may at least one of: provide to user device 208, an alert associated with the at least one event; and automatically control at least one medical device (e.g., a valve, an infusion pump, etc.) to stop a flow of fluid in a fluid flow path including the medical device associated with the at least one event.
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In some non-limiting embodiments or aspects, in response to the at fluid delivery, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may at least one of: provide, to user device 208, an alert associated with the fluid delivery; and automatically control at least one medical device (e.g., a valve, an infusion pump, etc.) to stop a flow of fluid in a fluid flow path including the medical device associated with the at least one event.
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In some non-limiting embodiments or aspects, the package includes a removable first layer covering a second layer, wherein the first layer including a first color, wherein the second layer includes a second color different than the first color, and wherein removal of the first layer from the package reveals the second layer. In some non-limiting embodiments or aspects, a color of the package is configured to change when exposed to air. For example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine, based on a detected or determined color or layer of the package, whether the package has been opened and the medical device removed from the package. In such an example, the first layer may be at least partially transparent.
In some non-limiting embodiments or aspects, a portion of the package is transparent such that the medical device contained within the package is visible through the transparent portion of the package. For example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine, based on whether the medical device is detected or determined within the package, whether the package has been opened and the medical device removed from the package.
In some non-limiting embodiments or aspects, the package is associated with a first identifier element, the medical device is associated with a second identifier element different than the first identifier element, and the state of the package is determined based on a location of the first identifier element with respect to a location of the second identifier element. For example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine, based on a distance between the first identifier element and the second identifier element satisfying a threshold distance, whether the package has been opened and the medical device removed from the package.
In some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine, based on the plurality of images, a location of a glove of a caregiver within the environment over the period of time with respect to a location of the package, and determine the state of the package based on the location of the glove of the caregiver within the environment over the period of time with respect to the location of the package.
In some non-limiting embodiments or aspects, the package includes a removable first layer covering a second layer, the removable first layer includes a first identifier element, the second layer includes a second identifier element, and the removable first layer is at least partially transparent. For example, management system 102 may determine the state of the package by: determining, based on the plurality of images, a distance between the first identifier element and the second identifier element; determining, based on the distance between the first identifier element and the second identifier element, whether the package is faulty; and in response to determining that the package is faulty, provide, to a user device, an alert associated with the faulty package.
In some non-limiting embodiments or aspects, management system 102 may determine, based on the plurality of images, a plurality of locations of a plurality of medical devices 712 within the environment over the period of time and a plurality of types of the plurality of medical devices 712; and determine, based on the plurality of locations of the plurality of medical devices 712 within the environment over the period of time, the plurality of types of the plurality of medical devices 712, and the state of the package over the period of time, at least one event of the following events: (i) a reuse of the medical device including a connection of the medical device to two or more medical devices in the environment over the period of time and (ii) a replacement of the medical device with a new medical device of a same type as the medical device in the environment.
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In some non-limiting embodiments or aspects, the medical device includes a catheter, and the auxiliary data includes at least one of: a tubing type of the catheter, a size of the catheter, a shape of the catheter, and a location of a catheter insertion site of the catheter on a patient.
In some non-limiting embodiments or aspects, the auxiliary data is associated with the audio recorded in the environment during the period of time. For example, the audio may include a predetermined signal associated with the medical device. As an example, the medical device may include an infusion pump, and the predetermined signal may include an audible signal emitted by the infusion pump (e.g., a power on sound, an indicator sound, etc.).
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In some non-limiting embodiments or aspects, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine a plurality of locations of a plurality of medical devices 712 within the environment over the period of time and a plurality of types of the plurality of medical devices 712. For example, the plurality of medical devices 712 may include the medical device and the at least one other medical device, and the medical device and the at least one other medical device may be configured to emit a predetermined audible signal when connected (and/or disconnected). As an example, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may determine, based on the plurality of locations of the plurality of medical devices 712 within the environment over the period of time and the plurality of types of the plurality of medical devices 712, at least one connection (and/or disconnection) between two or more medical devices of the plurality of medical devices 712 and/or update, based on the at least one connection determined between the two or more medical devices, a database. In such an example, the audio included in the auxiliary data may include the predetermined audible signal emitted when the medical device and the at least one other medical are connected (and/or disconnected).
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In some non-limiting embodiments or aspects, in response to the at fluid delivery, image capture system 702 (e.g., sensor system 206, etc.), management system 102, and/or central computing system 202 may at least one of: provide, to user device 208, an alert associated with the fluid delivery; and automatically control at least one medical device (e.g., a valve, an infusion pump, etc.) to stop a flow of fluid in a fluid flow path including the medical device associated with the at least one event.
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In some non-limiting embodiments or aspects, medication source system 802 includes one or more devices capable of delivering one or more fluids to one or more lumens (e.g., fluid lines, IV lines, etc.). For example, medication source system 802 may include one or more manual fluid delivery systems (e.g., one or more IV bags, one or more syringes, etc.) and/or an infusion pump system including one or more infusion pumps. In some non-limiting embodiments, smart device 804 may include a plurality of smart devices 804 (e.g., one or more other and/or differ types of smart devices 804, etc.).
In some non-limiting embodiments or aspects, smart device 804 includes one or more devices capable of receiving information and/or data from medication source system 802, one or more other smart devices 804, communication network 806, central computing system 808, and/or terminal/mobile computing system 810 and/or communicating information and/or data to medication source system 802, one or more other smart devices 804, communication network 806, central computing system 808, and/or terminal/mobile computing system 810. For example, smart device 804 may include one or more computing systems including one or more processors (e.g., one or more computing devices, one or more mobile computing devices, etc.). In some non-limiting embodiments or aspects, smart device 804 may be capable of receiving information (e.g., from medication source system 802 (e.g., from medication source controller 904 and/or from medication source device 906, etc.), from terminal/mobile computing system 810, from one or more other smart devices 804, etc.) via a short range wireless communication connection (e.g., an NFC or proprietary communication connection, an RFID communication connection, a Bluetooth® communication connection, and/or the like), and/or communicating information (e.g., to medication source system 802 (e.g., to medication source controller 904 and/or to medication source device 906, etc.), to terminal/mobile computing system 810, to one or more other smart devices 804, etc.) via a short range wireless communication connection.
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In some non-limiting embodiments or aspects, terminal/mobile computing system 810 includes a nurse station in a hospital. For example, as shown in an implementation 2600A in
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In some non-limiting embodiments or aspects, smart device 804 is configured to be removably connected to needleless connector 914 and/or a portion of lumen 912 proximate needleless connector 914, such as an IV lumen (e.g., a peripherally inserted central catheter (PICC), a peripheral intravenous catheter (PIVC), a central venous catheter (CVC), etc.), and/or the like. For example, smart device 804 may include a clamp, an adhesive, a frictional fit, and/or other attachment means configured to removably connect smart device 804 to needleless connector 914 and/or lumen 912 proximate needleless connector 914. As an example, as shown in
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In some non-limiting embodiments or aspects, smart device 804 may include a label (e.g., a human readable label, etc.) that characterizes visual indicator 952 of smart device 804. For example, as shown in implementation 2400C in
In some non-limiting embodiments or aspects, communication circuitry (e.g., communication interface 214, etc.) of medication source device 906 is configured to establish communication with communication circuitry (e.g., communication interface 214, etc.) of smart device 804 based on user input to pairing input 908 of medication source device 906 and user input to pairing input 956 of smart device 804. For example, medication source device 906 may establish a short range wireless communication connection (e.g., an NFC communication connection, an RFID communication connection, a Bluetooth® communication connection, etc.) with smart device 804. As an example, visual indicator 910 may be configured to emit a predetermined light pattern (e.g., to blink rapidly to indicate that medication source device 906 is in a pairing mode, etc.) in response to a predetermined user input to pairing input 908 (e.g., in response to a user pressing and holding a button of pairing input 908, etc.) of medication source device 906. In such an example, smart device 804 may be configured to establish communication with medication source device 906 (e.g., pair and/or activate a pairing sequence for pairing smart device 804 with medication source device 906, etc.) in response to a predetermined user input to paring input 956 (e.g., in response to a user pressing and holding a button of pairing input 956, etc.) of smart device 804 at a same time that medication source device 906 is in the pairing mode.
In some non-limiting embodiments or aspects, when medication source device 906 is paired with smart device 804, visual indicator 910 of medication source device 906 and visual indicator 952 of smart device 804 are configured to provide a same type of visual output (e.g., a same color of light from a multi-colored LED, a same pattern of light, etc.). For example, and referring again to
In some non-limiting embodiments or aspects, sensor 954 includes at least one of: one or more force sensors (e.g., one or more piezoelectric elements or transducers, one or more force sensitive resistive (FSR) sensors, one or more strain gauges, etc.); one or more accelerometers; one or more gyroscopes; one or more pressure sensors; one or more acoustic sensors (e.g., an acoustic sensor configured to detect a sound signature associated with a type, a state, and/or an operation of a medical device, etc.); one or more optical sensors (e.g., an optical sensor configured to detect at least one of a movement of a septum, a color signature and a reflectance of a medical device connected to smart device 804, etc.), one or more identification sensors (e.g., an identification sensor configured to detect an identification tag on a medical device connected to or being connected to the needleless connector 914, such as a magnetometer configured to detect a magnetic material, a barcode scanner configured to read a bar code, etc.); one or more position sensors (e.g., a position sensor configured to detect movement of smart device 804, etc.); one or more RBG color sensors; one or more mechanical switches; one or more flow sensors (e.g., an ultrasonic flow sensor, a thermal flow sensor, etc.); or any combination thereof.
In some non-limiting embodiment or aspects, smart device may 804 may include communication circuitry configured to transmit the force signal to a remote computing system. For example, medication source system 802, central computing system 808, and/or terminal/mobile computing system 810 may obtain the force signal from smart device 804 and/or needleless connector 914 and process the force signal to determine at least one of: a scrubbing event in which the needleless connector is scrubbed with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof.
In some non-limiting embodiments or aspects, force sensor 1202 includes at least one of: a piezoelectric element, a force sensitive resistive (FSR) sensor, a strain gauge, or any combination thereof. In some non-limiting embodiments or aspects, force sensor 1202 is positioned between an outer surface of inner wall 1210 (e.g., an inner harder plastic wall) of needleless connector 914 defining the fluid flow path of needleless connector 914 and an inner surface of an outer wall 1212 (e.g., a softer, a more flexible, a more pliable, a rubber, etc. wall) of needleless connector 914 surrounding the inner wall 1210 of needleless connector 914. In some non-limiting embodiments or aspects, an area between an outer surface of inner wall 1210 (e.g., an inner harder plastic wall) of needleless connector 914 defining the fluid flow path of needleless connector 914 and an inner surface of an outer wall 1212 (e.g., a softer, a more flexible, more, a more pliable, a rubber, etc. wall) of needleless connector 914 surrounding the inner wall 1210 of needleless connector 914, which may be held by a user during cleaning and/or connection to another medical device, may be filled with a rubber or other pliable type material 1214 including force sensors 1202 as force sensing films within the material 1214 between the inner wall 1210 and the outer wall 1212. In some non-limiting embodiments or aspects, force sensors 1202 may be located between inner wall 1210 and outer wall 1212 below threading on and/or proximal to inlet 1104 of needleless connector 914.
In some non-limiting embodiments or aspects, force sensor 1202 includes a plurality of force sensors 1202 positioned around the fluid flow path of needleless connector 914 between the outer surface of inner wall 1210 of needleless connector 914 defining the fluid flow path of needleless connector 914 and the inner surface of outer wall 1212 of needleless connector 914 surrounding inner wall 1210 of needleless connector 914. For example, inlet 1104 of needleless connector 914 may include septum 1108 including a surface facing in a first direction, and force sensor 1202 may be configured to detect a force in a second direction perpendicular to the surface of the septum facing in the first direction. As an example, the flushing event, which may include a pulsatile flushing event, may be determined based on the force signal indicating periodic forces in the second direction perpendicular to the surface of the septum facing in the first direction.
In some non-limiting embodiments or aspects, sensor 954 includes a pressure sensor, and the pressure sensor is one of: in direct contact with a fluid in the fluid flow path of the needleless connector; located within an inner wall of the needleless connector defining the fluid flow path of the needleless connector, and located within a wall of a lumen connected to the needleless connector. For example, smart device 804 may determine or detect pulsatile flush, a flush, and or a med-administration by the pressure sensor in contact with the fluid path in the needleless connector 914 and/or a lumen thereof.
In some non-limiting embodiments or aspects, sensor 954 includes an optical sensor configured to detect at least one of a color signature and a reflectance of a medical device connected to and/or being connected to needleless connector 914, and smart device 804 may determine a type of the medical device based on the at least one of the color signature and the reflectance of the medical device. For example, a color signature and/or the reflectance of the medical device may be indicative of a syringe, an IV bag, an infusion pump, and/or a particular type thereof.
In some non-limiting embodiments or aspects, sensor 954 includes an identification sensor configured to detect an identification tag on a medical device connected to or being connected to the needleless connector. For example, the identification sensor may include a magnetometer, and the identification tag may include a magnetic material on and/or integrated with needleless connector 914.
In some non-limiting embodiments or aspects, sensor 954 includes a position sensor configured to detect movement of the needleless connector. For example, a movement of the patient, a fall event of the patient, a movement of a bed of the patient may be determined (e.g., by smart device 804, etc.) based on the detected movement of the needleless connector.
In some non-limiting embodiments or aspects, sensor 954 includes an RGB color sensor configured to detect a color of a fluid in the fluid flow path of the needleless connector. For example, at least one of a blood-draw in the needleless connector and a retention of blood in the needleless connector may be determined (e.g., by smart device 804, etc.) based on the color of the fluid detected in the fluid flow path of the needleless connector.
In some non-limiting embodiments or aspects, smart device 804 including needleless connector 914 may include visual indicator 952, and visual indicator 952 may be configured to provide a visual indication associated with the at least one of: the scrubbing event in which the needleless connector is scrubbed with the disinfectant, the flushing event in which the needleless connector is flushed with the solution, the connection event in which the needleless connector is connected to the medical device, the disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof. For example, as shown in an implementation 2600B in
In some non-limiting embodiments or aspects, smart device 804 may include sensor 954 located outside a body of the patient (e.g., at needleless connector 914 at the hub of catheter 1402 located outside of a body of the patient, and sensor 954 may be connected to the hub of catheter 1402 outside the body of the patient, etc.). For example, sensor 954 may include at least one of a pressure sensor and an acoustic sensor (e.g., a piezoelectric transducer, etc.). As an example, sensor 954 including the pressure sensor and/or the acoustic sensor may be connected to catheter 1402 at needleless connector 914 at the hub of catheter 1402. For example, the hub of catheter 1402 may include needleless connector 914 and/or smart device 804, and sensor 954 may be included in needleless connector 914. In such an example, sensor 954 may be configured to sense, detect, and/or measure a pressure signal, an acoustic signal, and/or temporal variations in the pressure signal and/or the acoustic signal with the catheter needle in the body of the patient. For example, the pressure signal and/or the acoustic signal sensed by sensor 954 may be transmitted through a fluid in the catheter and/or through material of the catheter (e.g., via needle tip 1406, catheter lumen 1404, the needleless connector 914, etc.) for sensing by sensor 954. As an example, the pressure signal and/or the acoustic signal sensed by sensor 954 may decrease or drop if needle tip 1406 punctures a wall of a blood vessel or urinary tract of the patient. In such an example, a decrease and/or lack in the pressure signal (e.g., a decreased amplitude of a heart rate and/or a drop in blood pressure, etc.) may indicate a lack of a pressure signal associated with an absence of a blood pressure signal, thereby indicating an infiltration event.
In some non-limiting embodiments or aspects, smart device 804 may be programmed and/or configured to compare a relatively slower change or variation in a pressure signal over time (e.g., a relatively slower decrease in an amplitude of a heart rate and/or a drop in blood pressure, etc.) to a threshold level to determine an occlusion event rather than an infiltration event or an extravasation event. For example, an occlusion in a lumen may be at a relatively slow rate over time (e.g., as compared to an infiltration event, an extravasation even, a disconnection event, etc.), which slowly changes in the pressure signal sensed by sensor 954. As an example, smart device 804 may determine an occlusion event and provide an alert and/or automatically flush a lumen associated with the occlusion in response to detection of the occlusion event. In some non-limiting embodiments or aspects, smart device 804 may detect a disconnection event in response to detecting a pressure signal substantially equal to an atmospheric pressure by sensor 954, which indicates that a connection of catheter 1402, e.g., needleless connector 914 is disconnected therefrom and provide an alert to a user to address the connection. In some non-limiting embodiments or aspects, smart device 804 may detect a kink in the catheter lumen 1404 in response to detecting a pressure signal associated with an amplitude of a heart rate that suddenly or immediately drops to zero, as opposed to an occlusion in a lumen that may cause the amplitude of the heart rate to drop a relatively slower rate over time.
In some non-limiting embodiments or aspects, smart device 804 can provide, according to the pressure signal and/or the acoustic signal, a location of the tip of the needle with respect to a blood vessel or a urinary tract of the patient in real-time, thereby providing real-time feedback to a user as a catheter is being installed in a blood vessel or a urinary tract of patient to indicate whether the catheter is properly placed within the blood vessel or the urinary tract or if with one of a potential or existing infiltration of the fluid and a potential or existing extravasation of the fluid. For example, smart device 804 can determine, according to the pressure signal and/or the acoustic signal (e.g., based on a fluid pressure due to fluid entering a catheter path of smart device 804, etc.) a heart rate of a patient, a respiration rate of the patient, a blood pressure of the patient, a penetration force of a needle of the catheter, and/or the like. As an example, smart device 804 can provide, according to the pressure signal and/or the acoustic signal, an indication of entry of the tip of the needle into a blood vessel or a urinary tract of the patient in real-time.
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In some non-limiting embodiments or aspects, when smart device 804 is paired with medication source device 906, medication source device 906 may illuminate visual indicator 910 to a color that has not been previously used in medication source system 802 (e.g., that is not associated with another medication source device 906 and another smart device 804 that are paired in medication source system 802, that is different than each other color of light produced by each other smart device 804 of the plurality of smart devices 804a, 804b, . . . 804n and each other medication source device 906 of the plurality of medication source devices 906a, 906b, . . . 906n in medication source system 802, etc.), and smart device 804 may illuminate visual indicator 952 to the same color as visual indicator 910 (e.g., medication source system 802, medication source device 906, smart device 804, etc. may control visual indicator 952 to illuminate to the same color as visual indictor 910). In some non-limiting embodiments or aspects, smart device 804 may illuminate visual indicator 952 to the same color as visual indicator 910 in response to smart device 804 being connected to a lumen and/or during a period of time at which smart device 804 is connected to the lumen. For example, smart device 804 may automatically stop illumination of visual indicator 952 to the same color as visual indicator 910 (e.g., turn off an LED, set the LED to a default color indicating a non-paired smart device 804, etc.) in response to smart device 804 being disconnected from the lumen. As an example, smart device 804 may include a switch connected to visual indicator 952 that is configured to be activated/deactivated in response to a clamp or other connection means being connected/disconnected to a lumen and/or a needleless connector 914 thereof.
In some non-limiting embodiments or aspects, medication source system 802 determines a color of the same color of light for visual indicator 952 of smart device 804 and visual indicator 910 of medication source device 906 to produce based on at least one of the user input received by pairing input 908 of medication source device 906 and the user input received by pairing input 956 of smart device 804. For example, after smart device 804 is paired with medication source device 906, a user may actuate pairing input 908 and/or pairing input 956 to cycle through colors of light available for the pairing to select a desired (and/or available or previously unused) color of light for the pairing.
As shown in
In some non-limiting embodiments or aspects, medication source system 802 may obtain user input received by a user input component of another medication source device, obtain user input received by a user input component of another smart device, establish a communication between the another medication source device and the another smart device based on the user input received by the user input component of the another medication source device and the user input received by the user input component of the another smart device, control the visual indicator of the another smart device and the visual indicator of the another medication source device to produce another same type of visual output based on the communication established between the another medication source device and the another smart device, wherein the another same type of visual output is different than the same type of visual output, and/or associate the another same type of visual output with another same lumen of the plurality of lumens, wherein the another medication source device is connected to the another same lumen. For example, and referring again to
As shown in
In some non-limiting embodiments or aspects, medication source system 802 identifies a lumen by automatically associating and/or providing medical data or VAM data with the same type of visual output associated with the lumen and/or an identifier of the lumen. For example, medical data or VAM data may include at least one of the following: patient data (e.g., an identifier of a particular patient, information and/or data associated with a patient, etc.); medication source data (e.g., an identifier of a particular medication source device 906, etc.); medication data (e.g., an identifier of a type of a medication, a scheduled delivery of a particular medication, a previous delivery of a particular medication, a lumen associated with a medication, etc.); lumen data (e.g., an identifier of a particular lumen, such as the identifier of the same lumen associated with the same type of visual output, etc.); sensor data (e.g., an identifier of a particular sensor 954, information, data, and/or a signal sensed, measured, and/or detected by one or more sensors 954 in one or more smart devices 804, etc.); compliance data (e.g., information or data associated with a scrubbing event in which a needleless connector 914 and/or a lumen is scrubbed with a disinfectant, information or data associated with a flushing event in which a needleless connector 914 and/or a lumen is flushed with a solution, information or data associated with a connection or capping event in which a needleless connector 914 or a lumen is connected to a medical device, etc.); location data (e.g., a location of a patient, a location a previous or scheduled fluid delivery procedure, a location a lumen, a location of a medication source device, etc.); time data (e.g., a time associated with a previous or scheduled fluid delivery procedure, a time of connection of a lumen to medication source device 906, a time of connection of smart device 804 to a lumen, a time of pairing of medication source device 906 and smart device 804, etc.); a location of a tip of a needle of a catheter of a lumen with respect to a blood vessel or urinary tract of the patient; or any combination thereof. As an example, medication source system 802 may obtain medical data from smart device 804, central computing system 808, terminal/mobile computing system 810, one or more databases connected thereto, and/or one or more sensors (e.g., a barcode sensor for scanning a patient identifier, a fluid flow sensor for sensing a flow a fluid, a medication type sensor for sensing a type of a medication, etc.) connected thereto. In such an example, medication source system 802 may identify lumens with information and/or data associated therewith, as well as provide a visual indication of which lumens of a plurality of lumens 912a, 912b, . . . 912n are connected to which medication source devices of a plurality of medication source devices 906a, 906b, . . . 906n, which can enable a user to more easily trace a lumen from a patient to a particular medication source device to which the lumen is connected; connections between lumens and medication source devices to be removed if the patient is moved (e.g., to a new room, to a new floor, to surgery, to the bathroom, etc.) with the same type of visual indicator on a lumen/medication source device pair used to more easily reattach the correct medication source device channel to the correct (e.g., the same as before) lumen; tracking compliance to best practice protocols, for example, by determining if hub scrubbing has occurred and if hub scrubbing occurred effectively (e.g., sufficient pressure, sufficient time scrubbing, etc.) and/or if a device has been flushed, maintained, and/or the like; providing reminders and prescriptive help for protocol adherence, and/or the like.
In some non-limiting embodiments or aspects, medication source system 802 identifies a lumen by determining and providing, based on the medical data, one or more alerts or reminders associated with the lumen and/or the same type of visual output associated with the lumen, such as a reminder to flush the lumen and/or a needleless connector 914 thereof, a reminder to remove or replace a lumen, BD MedMined™ infection prevention guidance (e.g., identification and reporting healthcare-associated infections (HAIs) and using customized alerts and reports to facilitate timely patient intervention, etc.), an alert to use a different lumen for delivery of a particular medication to reduce a chance of a chemical occlusion forming, an alert indicating whether to treat a lumen for thrombus occlusion or chemical occlusion, an alert that an occlusion is detected in a lumen, an alert that a location of a tip of a needle connected to the lumen is associated with one of a potential or existing infiltration of the fluid and a potential or existing extravasation of the fluid, and/or the like.
In some non-limiting embodiments or aspects, medication source system 802 identifies a lumen by controlling a medication source device 906 or another medical device (e.g., an electronic valve, etc.), based on the medical data, to inhibit or prevent delivery of a fluid (e.g., a particular medication, a type of medication, etc.) via the lumen.
Further details regarding non-limiting embodiments or aspects of step 2812 of process 2800 are provided below with regard to
Referring now to
As shown in
In some non-limiting embodiments or aspects, medication data is associated with at least one of the following: an identifier of a type of a medication, a scheduled delivery of the medication via a particular medication source device, and/or lumen, a previous delivery of the medication via a particular medication source device and/or lumen, an amount of the medication, an identifier of a patient to which the medication is scheduled to be delivered (or delivered), one or more identifiers of one or more different types of medication that are incompatible for delivery via a same lumen with the medication, and/or the like.
As shown in
In some non-limiting embodiments or aspects, medication source system 802 may use an identifier of the first type of medication and/or an identifier of the second type of medication to access a look-up table that indicates whether the first type of medication and the second type of medication are compatible or incompatible (e.g., compatible or incompatible for delivery via a same lumen, etc.). In some non-limiting embodiments or aspects, the look-up table maybe be stored in and/or associated with the identifier of the first type of medication and/or the identifier of the second type of medication.
In some non-limiting embodiments or aspects, medication source system 802 may obtain medication data associated with a third type of medication delivered or scheduled to be delivered via another same lumen (e.g., different than the same lumen, etc.) to the patient, and determine, based on the medication data, a compatibility of the second type of medication for delivery via the another same lumen as the third type of medication, wherein the indication further indicates whether the second type of medication is compatible for delivery via the another same lumen associated with the another same type of visual output. For example, and referring again to
As shown in
In some non-limiting embodiment or aspects, medication source system 802 may provide the indication of the compatibility by controlling medication source device 906 to inhibit or prevent delivery of the second medication via the same lumen associated with the same type of visual output. For example, the first type of medication may be delivered to the patient with the same lumen associated with the same type of visual output, and the second type of medication may be scheduled to be delivered via the same lumen to the patient. As an example, and referring again to
In some non-limiting embodiments or aspects, the first type of medication and the second type of medication may be delivered to the patient via the same lumen associated with the same type of visual output, and medication source system 802 may provide a prompt to the user to treat the same lumen associated with the same type of visual output for one of a thrombus occlusion and a chemical occlusion. For example, when an occlusion occurs, which may be detected by medication source system 802 as described herein, a user (e.g., a nurse, etc.) may need to determine if the occlusion is thrombotic or chemical due to drug interactions, and medication source system 802 can determine which medications were delivered via which lumens to inform the user of the lumen history and/or provide an indication of a potential cause of the occlusion, which enables a correct decision of whether the lumen should be treated for thrombus or chemical occlusion. In some non-limiting embodiments or aspects, medication source system 802 may control medication source device 906 to automatically perform a flushing operation to deliver a flushing fluid to a lumen connected to the medication source device 906 in response to a determination that an occlusion of the lumen is a chemical occlusion.
Referring now to
As shown in
In some non-limiting embodiments or aspects, sensor 954 measures at least one signal including at least one of a pressure signal and an acoustic signal. For example, sensor 954 may measure the at least one signal including at least one of a pressure signal and an acoustic signal, and smart device 804 (and/or medication source system 802, central computing system 808, and/or terminal/mobile computing system 810) may obtain the at least one signal including at least one of a pressure signal and an acoustic signal from sensor 954. For example, smart device 804 may include communication circuitry (e.g., communication interface 214, etc.) that wirelessly transmits the at least one signal to a remote computing system. As an example, smart device 804 may process the pressure signal and/or the acoustic signal on a microprocessor within a housing of smart device 804 including sensor 954 and the microprocessor, and/or smart device 804 may wirelessly transmit (and/or transmit via wired connection) the pressure signal and/or the acoustic signal to a remote computer that perform digital signal processing on the pressure signal and/or the acoustic signal, to identify and classify events of interest (e.g., infiltration, extravasation, catheter occlusion, etc.).
As shown in
In some non-limiting embodiments or aspects, the location of tip 1406 of the needle is determined as one of: within the blood vessel or the urinary tract; within a wall of the blood vessel or a wall of the urinary tract; and outside the blood vessel or the urinary tract and the wall of the blood vessel or the wall of the urinary tract. In some non-limiting embodiments or aspects, smart device 804 and/or one or more components thereof may be connected to or included in (e.g., be integrated with, etc.) a needleless connector 914 at a catheter hub of catheter 1402 located outside the body of the patient. For example, sensor 954 of smart device 804 (e.g., a pressure sensor, an acoustic sensor, etc.) may measure at least one signal including at least one of a pressure signal and an acoustic signal, wherein the catheter includes a needle having a tip for delivering a fluid to a patient.
In some non-limiting embodiments or aspects, smart device 804 determines that the location of tip 1406 of the needle is associated with one of a potential or existing infiltration of the fluid and a potential or existing extravasation of the fluid. For example, sensor 954 (e.g., one or more pressure sensors, one or more acoustic sensors, etc.) may detect temporal variations in a pressure signal and/or an acoustic signal resulting from tip 1406 of the needle of the catheter 1402 being properly inserted in a blood vessel or urinary tract, being located in a wall of the blood vessel or urinary tract, being located outside the blood vessel or urinary tract, and/or the like. As an example, smart device 804 may compare the variation in the at least one signal over the period of time to a threshold variation associated with a heartbeat of the patient. For example, the variations in a pressure signal and/or an acoustic signal may be associated with variations in pressure and/or acoustics in a blood vessel or urinary tract as a result of a heartbeat of the patient. As an example, smart device 804 may compare the variations in the detected pressure signal and/or the detected acoustic signal to variations in a pressure signal and/or an acoustic associated with a heartbeat of the patient to determine if tip 1406 of the needle of catheter 1402 is properly located within the blood vessel (e.g., artery, vein, etc.) of the patient. In such an example, if tip 1406 of the needle of catheter 1402 overshoots the vessel or urinary tract (e.g., punctures a wall of the blood vessel or urinary tract, is not properly within the blood vessel or urinary tract, etc.) the pressure and/or acoustic signature of the at least one signal measured by sensor 954 changes. In some non-limiting embodiments or aspects, infiltration or extravasation of medication into tissues surrounding the blood vessel or urinary tract (rather than into the blood vessel or urinary tract) may result in distinctive pressure or acoustic signals being detected by sensor 954 depending upon the impact of the infiltration or extravasation on surrounding tissues (e.g., if the extravasating medication is a strong vesicant agent such impacts may be severe, etc.).
In some non-limiting embodiments or aspects, smart device 804 determines, based on the variation in the at least one signal over the period of time, at least one of an occlusion of the catheter and a disconnection of the catheter from a needleless connector. For example, smart device 804 may compare the variation in the at least one signal over the period of time to a threshold period of time associated with formation of an occlusion in a catheter. As an example, smart device 804 may compare a relatively slower change or variation in a pressure signal over time (e.g., a relatively slower decrease in an amplitude of a heart rate and/or a drop in blood pressure as compared to an infiltration or extravasation, etc.) to a threshold level to determine an occlusion event rather than an infiltration event or an extravasation event. For example, an occlusion in a lumen may develop at a relatively slow rate over time (e.g., as compared to an infiltration event, an extravasation even, a disconnection event, etc.), which slowly changes the pressure signal sensed may sensor 954. As an example, smart device 804 may determine an occlusion event and provide an alert and/or automatically flush a lumen associated with the occlusion in response to detection of the occlusion event. In some non-limiting embodiments, smart device 804 may detect a disconnection event in response to detecting a pressure signal substantially equal to an atmospheric pressure by sensor 954, which indicates that a connection of catheter 1402, e.g., needleless connector 914 is disconnected therefrom and provide an alert to a user to address the connection.
As shown in
In some non-limiting embodiments or aspects, smart device 804 controls a warning device to issue a warning associated with the one of the potential or existing infiltration of the fluid and the potential or existing extravasation of the fluid. For example, smart device 804 controls visual indicator 952 of smart device 804 to output a color and/or a pattern of light associated with the one of the potential or existing infiltration of the fluid and the potential or existing extravasation of the fluid. As an example, in response to determining an event as infiltration, extravasation, or catheter occlusion, smart device 804 may flash a warning light to a user (e.g., a clinician, a caregiver, a family member, another patient in a homecare or assisted living environment, etc.) and/or transmit a signal to a remote computing system (e.g., medication source system 802, central computing system 808, terminal/mobile computing system 810, etc.) to control (e.g., trigger) output of an audio and/or visual alarm at the remote computing system to alert appropriate individuals of the determined event.
In some non-limiting embodiments or aspects, smart device 804 controls medication source device 906 or a valve (e.g., a valve controlling fluid delivery to/from catheter 902, etc.) to stop (e.g., inhibit, prevent, etc.) delivery of the fluid to the catheter and/or from the catheter. As an example, in response to determining an event as infiltration, extravasation, catheter occlusion, or catheter disconnection smart device 804 may send a signal to an infusion device to immediately stop medication infusion or send a signal to a valve or mechanical clamp to block further medication from infusing into the catheter and/or the patient.
In some non-limiting embodiments or aspects, smart device 804 and/or needleless connector may include communication circuitry (e.g., communication interface 214, etc.) that wirelessly transmits the at least one signal to a remote computing system. As an example, smart device 804 and/or needleless connector 914 may process the pressure signal and/or the acoustic signal on a microprocessor within housing 950 of smart device 804 and/or within housing 1102 of needleless connector 914 including sensor 954 and the microprocessor, and/or smart device 804 and/or needleless connector 914 may wirelessly transmit (and/or transmit via a wired connection) the pressure signal and/or the acoustic signal to a remote computer that performs digital signal processing on the pressure signal and/or the acoustic signal, to identify and classify events of interest (e.g., infiltration, extravasation, catheter occlusion, catheter disconnection, etc.).
In some non-limiting embodiments or aspects, smart device 804 may provide real-time feedback during catheter insertion (e.g., via visual indicator 952, output component 212, medication source system 802, etc.) such that a clinician or other person may be alerted as to whether catheter 1402 is being properly inserted and/or as to whether tip 1406 of the needle of catheter 1402 has pierced or is in the process of piercing a blood vessel or a urinary tract and/or has been accidentally disconnected or occluded.
Referring now to
As shown in
In some non-limiting embodiments or aspects, a signal obtained by smart device 804 may include a measurement of a value at an instantaneous, static, or single point in time (e.g., a force, a pressure, a sound, a vibration, a reflectance, and/or the like, at a single point in time, etc.). In some non-limiting embodiments or aspects, a signal obtained by smart device 804 may include a dynamic or time-varying signal (e.g., a measurement of a value over a period of time, etc.). For example, a time varying force, pressure, stress, strain, and/or the like may include low frequency signal, such as a signal that changes in sub-audible frequencies (e.g., below 20 Hz, etc.), and/or the like, and/or may include a signal in the acoustic range that travels as sound waves propagating through solids, liquids, and/or air. As described in more detail herein with respect to sensor 954, a time-varying signal may be measured with a force sensor, a seismograph, a pressure sensor, an optical sensor, a microphone, an acoustic sensor for air waves in the audible range, a hydrophone, an acoustic sensor for liquid waves, a pickup or a transducer that captures or senses mechanical vibrations, or any combination thereof.
As shown in
In some non-limiting embodiments or aspects, sensor 954 may include force sensor 1202. In some non-limiting embodiments or aspects, force sensor 1202 includes at least one of: a piezoelectric element, a force sensitive resistive (FSR) sensor, a strain gauge, or any combination thereof. In some non-limiting embodiments or aspects, force sensor 1202 is positioned between an outer surface of inner wall 1210 (e.g., an inner harder plastic wall) of needleless connector 914 defining the fluid flow path of needleless connector 914 and an inner surface of an outer wall 1212 (e.g., a softer, a more flexible, a more pliable, a rubber, etc. wall) of needleless connector 914 surrounding the inner wall 1210 of needleless connector 914. In some non-limiting embodiments or aspects, an area between an outer surface of inner wall 1210 (e.g., an inner harder plastic wall) of needleless connector 914 defining the fluid flow path of needleless connector 914 and an inner surface of an outer wall 1212 (e.g., a softer, a more flexible, more, a more pliable, a rubber, etc. wall) of needleless connector 914 surrounding the inner wall 1210 of needleless connector 914, which may be held by a user during cleaning and/or connection to another medical device, may be filled with a rubber or other pliable type material 1214 including force sensors 1202 as force sensing films within the material 1214 between the inner wall 1210 and the outer wall 1212. In some non-limiting embodiments or aspects, force sensors 1202 may be located between inner wall 1210 and outer wall 1212 below threading on and/or proximal to inlet 1104 of needleless connector 914.
In some non-limiting embodiments or aspects, force sensor 1202 includes a plurality of force sensors 1202 positioned around the fluid flow path of needleless connector 914 between the outer surface of inner wall 1210 of needleless connector 914 defining the fluid flow path of needleless connector 914 and the inner surface of outer wall 1212 of needleless connector 914 surrounding inner wall 1210 of needleless connector 914. For example, inlet 1104 of needleless connector 914 may include septum 1108 including a surface facing in a first direction, and force sensor 1202 may be configured to detect a force in a second direction perpendicular to the surface of the septum facing in the first direction. As an example, the flushing event, which may include a pulsatile flushing event, may be determined based on the force signal indicating periodic forces in the second direction perpendicular to the surface of the septum facing in the first direction.
In some non-limiting embodiments or aspects, sensor 954 includes a pressure sensor, and the pressure sensor is one of: in direct contact with a fluid in the fluid flow path of the needleless connector; located within an inner wall of the needleless connector defining the fluid flow path of the needleless connector, and located within a wall of a lumen connected to the needleless connector. For example, smart device 804 may determine or detect pulsatile flush, a flush, and or a med-administration by the pressure sensor in contact with the fluid path in the needleless connector 914 and/or a lumen thereof.
In some non-limiting embodiments or aspects, the pressure sensor may be configured to sense a pressure transmitted through at least one of a fluid in a catheter and a material of the catheter. For example, and referring again to
In some non-limiting embodiments or aspects, the event associated with the catheter 1402 includes a time at which the needle tip 1406 of the catheter 1402 enters a blood vessel of the patient. For example, smart device 804 may determine the time at which the needle tip 1406 of the catheter 1402 enters the blood vessel based on at least one: of a heart rate, a respiration rate, a blood pressure, a penetration force of the needle tip 1406, or any combination thereof, determined from the signal associated with the sensed pressure.
In some non-limiting embodiments or aspects, the event associated with the catheter 1402 includes a clamping sequence, and smart device 804 may determine the clamping sequence based on one or more changes over time in the signal associated with the sensed pressure. In such an example, smart device 804 may determine, based on the determined clamping sequence and a type of the needleless connector 914 (e.g., a neutral displacement connector, a positive displacement connector, a negative displacement connector, etc.), whether the determined clamping sequence satisfies a clamping protocol associated with the type of the needleless connector 914. For example, different types of needleless connector 914 (e.g., neutral displacement connectors, positive displacement connectors, negative displacement connectors, etc.) may be associated with different clamping protocols recommended to be performed during connection events and/or disconnection events to reduce or prevent backflow into catheter 1402. As an example, not following a claiming protocol associated with the type of needleless connector 914 connected to the catheter 1402 may result in an occlusion in the catheter 1402 or an infection of the patient due to a backflow into the catheter 1402. Accordingly, smart device 804 may reduce or prevent such occlusions and/or infections by monitoring whether a user performs the recommended clamping protocol associated with the particular type of needleless connector 914 connected to catheter 1402.
In some non-limiting embodiments or aspects, the event associated with the catheter 1402 includes an occlusion of the catheter lumen 1404, and smart device 804 may determine the occlusion of the catheter lumen 1404 based on a rate of change in the sensed pressure included in the signal from the pressure sensor. For example, smart device 804 may be programmed and/or configured to compare a relatively slower change or variation in a pressure signal over time (e.g., a relatively slower decrease in an amplitude of a heart rate and/or a drop in blood pressure, etc.) to a threshold level to determine an occlusion event rather than an infiltration event or an extravasation event. For example, an occlusion in a lumen may be at a relatively slow rate over time (e.g., as compared to an infiltration event, an extravasation even, a disconnection event, etc.), which slowly changes in the pressure signal sensed by sensor 954. As an example, smart device 804 may determine an occlusion event and provide an alert and/or automatically flush a lumen associated with the occlusion in response to detection of the occlusion event. In such an example, smart device 804 may detect a kink in the catheter lumen 1404 in response to detecting a pressure signal associated with an amplitude of a heart rate that suddenly or immediately drops to zero, as opposed to an occlusion in a lumen that may cause the amplitude of the heart rate to drop at relatively slower rate over time.
In some non-limiting embodiments or aspects, sensor 954 includes an optical sensor configured to detect a movement of a septum 1108 of needleless connector 914. For example, the optical sensor may be connected to the needleless connector including septum 1108 to detect a movement of the septum 1108. As an example, smart device 804 may receive, from the optical sensor, a signal associated with the movement of the septum and determine, based on the signal, an event associated with the needleless connector 914. For example, the event associated with the needleless connector may include at least one of: a connection event in which the needleless connector 914 is connected to a medical device (e.g., a syringe, a male luer connection, etc.) causing the movement (e.g., a depression, etc.) of septum 1108, a disconnection event in which the needleless connector is disconnected from the medical device cause the movement (e.g., release, etc.) of septum 1108, or any combination thereof. As an example, septum 1108 may include one or more markings, and the optical sensor may be configured to detect a movement of the one or more markings to detect the movement of the septum 1108.
In some non-limiting embodiments or aspects, sensor 954 includes an optical sensor configured to detect at least one of a color signature and a reflectance of a medical device connected to and/or being connected to needleless connector 914, and smart device 804 may determine a type of the medical device based on the at least one of the color signature and the reflectance of the medical device. For example, a color signature and/or the reflectance of the medical device may be indicative of a syringe, an IV bag, an infusion pump, and/or a particular type thereof.
In some non-limiting embodiments or aspects, sensor 954 includes an acoustic sensor. For example, the acoustic sensor may be connected to needleless connector 914 and configured to measure one or more sounds, vibrations, and/or the like (e.g., a sound signature, etc.). As an example, smart device 804 may receive, from the acoustic sensor, a signal including a sound signature, and determine, based on the signal, an event associated with needleless connector 914.
In some non-limiting embodiments or aspects, the event associated with the needleless connector 914 includes (i) a connection event in which the needleless connector 914 is connected to a medical device (e.g., a syringe, a cap, etc.) and/or (ii) an operation of a medical device connected to the needleless connector 914. In such an example, smart device 804 may determine, based on the sound signature (e.g., a sound signature generated from connecting the needleless connector 914 to the medical device, a sound signature generated from operation of the medical device connected to needleless connector 914, one or more ticking sounds, etc.), a type of the medical device connected to the needleless connector 914 from a plurality of types of medical devices and/or a state of the medical device connected to the needleless connector 914. For example, the plurality of types of medical devices may include two or more of the following: a cap, a syringe, a tubing, a medical device connector, or any combination thereof. In some non-limiting embodiments or aspects, smart device 804 may determine, based on the sound signature, a subtype of the determined type of the medical device connected to the needleless connector from a plurality of subtypes of that type of medical device, such as a subtype of a syringe (e.g., a syringe size, a flush syringe, a medication administration syringe, etc.), a subtype of a cap (e.g., a disinfectant cap, etc.), and/or the like. In some non-limiting embodiments or aspects, a state of a medical device includes an unused state or a used state.
In some non-limiting embodiments or aspects, and referring also to
In some non-limiting embodiments or aspects, and referring also to
In some non-limiting embodiments or aspects, sensor 954 includes an identification sensor configured to detect an identification tag on a medical device connected to or being connected to the needleless connector. For example, the identification sensor may include a magnetometer, and the identification tag may include a magnetic material on and/or integrated with needleless connector 914.
In some non-limiting embodiments or aspects, sensor 954 includes a position sensor configured to detect movement of the needleless connector. For example, a movement of the patient, a fall event of the patient, a movement of a bed of the patient may be determined (e.g., by smart device 804, etc.) based on the detected movement of the needleless connector.
In some non-limiting embodiments or aspects, sensor 954 includes an RGB color sensor configured to detect a color of a fluid in the fluid flow path of the needleless connector. For example, at least one of a blood-draw in the needleless connector and a retention of blood in the needleless connector may be determined (e.g., by smart device 804, etc.) based on the color of the fluid detected in the fluid flow path of the needleless connector.
As shown in
In some non-limiting embodiments or aspects, smart device 804 including needleless connector 914 may include visual indicator 952, and visual indicator 952 may be configured to provide a visual indication associated with the at least one of: the scrubbing event in which the needleless connector is scrubbed with the disinfectant, the flushing event in which the needleless connector is flushed with the solution, the connection event in which the needleless connector is connected to the medical device, the disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof. For example, as shown in an implementation 2600B in
In some non-limiting embodiments or aspects, smart device 804 may include communication circuitry (e.g., communication interface 214, etc.) that wirelessly transmits the signal (e.g., the force signal, the signal other than the force signal, etc.) and/or an event determined based thereon to a remote computing system. As an example, smart device 804 may process the signal on a microprocessor within a housing of smart device 804 including sensor 954 and the microprocessor, and/or smart device 804 may wirelessly transmit (and/or transmit via wired connection) the signal to a remote computer that performs digital signal processing on the signal, to identify and classify events of interest (e.g., a scrubbing event, a flushing event, a connection event, a disconnection event, a dwell or connection time, etc.).
In some non-limiting embodiments or aspects, a pattern of events including a plurality of the least one of: the scrubbing event in which needleless connector 914 is scrubbed with the disinfectant, the flushing event in which needleless connector 914 is flushed with the solution, connection or capping event in which needleless connector 914 is connected to the medical device, or any combination thereof, may be determined based on the signal (e.g., the force signal, the signal other than a force signal, etc.), and, based on the pattern of events, a medication administration event in which a medication is administered to a patient via needleless connector 914 may be determined.
In some non-limiting embodiments or aspects, smart device 804 may use sensor 954 to detect an identification tag on a medical device connected to or being connected to the needleless connector, movement of the needleless connector, a color of a fluid in the fluid flow path of the needleless connector, or any combination thereof, and provide, with visual indicator 952 visual indication associated with the any information or data sensed and/or measured by sensor 954, such as, a type of the medical device, a medication administration event in which a medication is administered to a patient via the needleless connector, an identification of a medical device, a movement of the patient, a patient fall event, a movement of a bed of the patient, a color of a fluid in the fluid flow path of needleless connector 914, a blood-draw in the needleless connector, a retention of blood in the needleless connector, a scrubbing event in which the needleless connector is scrubbed with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection or capping event in which the needleless connector is connected to a medical device, or any combination thereof.
Although embodiments or aspects have been described in detail for the purpose of illustration and description, it is to be understood that such detail is solely for that purpose and that embodiments or aspects are not limited to the disclosed embodiments or aspects, but, on the contrary, are intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment or aspect can be combined with one or more features of any other embodiment or aspect. In fact, many of these features can be combined in ways not specifically recited in the claims and/or disclosed in the specification. Although each dependent claim listed below may directly depend on only one claim, the disclosure of possible implementations includes each dependent claim in combination with every other claim in the claim set.
This application is the United States national phase of International Application No. PCT/US2022/044693 filed Sep. 26, 2022, and claims priority to U.S. Provisional Application Ser. No. 63/248,818, entitled “System, Method, and Computer Program Product for Vascular Access Management”, filed Sep. 27, 2021, the entire disclosures of which are hereby incorporated by reference in their entireties.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2022/044693 | 9/26/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63248818 | Sep 2021 | US |
