Patent Application
20240342362
The present disclosure is related to infusion pumps and, more particularly, to infusion pump cassette identification using a detection system including sensors that detect presence/absence of holes in or markings on the cassette body and to set and/or limit parameters using the identified cassette type (e.g., intravascular, neural/neuraxial, enteral, etc.).
Infusion pumps deliver controlled doses of fluids such as medications, analgesics, and nutrition to patients. Infusion pumps are particularly well suited to delivering controlled doses of fluids over long periods of time, e.g., several hours or days. While many infusion pumps are designed for bedside use, there are ambulatory versions available. Ambulatory infusion pumps allow a patient to move around while the infusion pump is in use. These ambulatory pumps are also used in acute clinical settings to physically differentiate routes of therapy (e.g., intravascular, neural/neuraxial, enteral, etc.) so as to reduce possibility of wrong route medication errors.
Syringe pumps and peristaltic pumps are two conventional types of infusion pumps. A syringe pump depresses a cylinder within a syringe to deliver fluid from the syringe to a patient. A peristaltic pump acts on a tube to control the rate of fluid flow through the tube from a bottle or bag of fluid to a patient. Precise delivery of fluids is desirable to optimize treatment of a patient as there are many fluids where small variations can be critical.
Modular, multi-specialty fluid pumps have been described having a universal pump console that accepts removable pump cassettes (e.g., pump to infusion set interface element) with tube sets designed for various specialties that are attached to the universal pump console. The pump cassette that is attached to the pump console determines the categorical type of fluid pump mechanism. For example, U.S. 2021/0369940 describes a pump system including a pump console with a motor, a sensor, and a removable pump cassette attached to the pump console. The pump cassette includes a cassette identifier (e.g., a magnet or an RFID tag) that is detected by the sensor. The cassette identifier may dictate parameters such as motor operating parameters (e.g., default motor speed, timing, motor direction, etc.).
Alternative configurations for identifying an infusion cassette of an infusion pump are provided that are simple to implement yet sophisticated enough to convey pump parameter data to the infusion pump when inserted into a receptacle of the infusion pump. In sample configurations, the infusion pump includes a pump that acts on tubing to pump fluid through the tubing. The infusion pump has a receptacle configured to receive an infusion cassette. The tubing passes through the infusion cassette, which is inserted into the infusion pump such that the tubing engages the pump. The infusion pump implements a detection system to identify the type of infusion cassette and sets infusion pump parameters based on the detected type of infusion cassette. The detection system includes sensors within the pump that detect the presence/absence of holes or other types of markings (e.g., colored regions or textured areas) on the infusion cassette in order to determine the type of infusion cassette and associated pumping parameters.
In sample configurations, the detection system includes one or more sensors positioned within the receptacle of the infusion pump to detect holes, markings, or other properties of the infusion cassette to identify the type of infusion cassette. The sensors may be light sensors (e.g., optical, infrared (IR), etc.) that detect the presence/absence of holes or other markings or properties, a light sensor that detects the color of the cassette, mechanical sensors that detect indentations on the cassette, electrical sensors, electro-mechanical sensors, or other types of sensors that may be used to detect markings and properties so as to enable the infusion pump to distinguish one type of infusion cassette from another. The infusion sets thereby can be differentiated by including infusion cassettes specific to each infusion set's intended use and other features (e.g., inclusion of filters, access devices, tubing types, etc.). The ability to distinguish between infusion sets allows the pump to more safely infuse under a spectrum of intended uses by ensuring specific or limiting programmable infusion parameters.
The infusion cassette includes a cassette body having an indicator that can be sensed by the infusion pump detection system to determine the type of infusion cassette that has been inserted into the receptacle of the infusion pump. In one example, the infusion cassette has a wall with a detection surface area corresponding to sensors (e.g., IR sensors) within recesses of the infusion pump when the infusion cassette is fully inserted into the receptacle of the infusion pump. The detection surface area may include one or more through holes or other markings (e.g., colors) to convey data to the detection system.
The detection system includes an emitter/detector pair (with the detector adjacent or opposite the emitter) in the receptacle of the infusion pump corresponding to each through hole or marking and a controller configured to detect the presence/absence of through holes or markings at each of the through hole or marker positions and to determine the type of infusion cassette based on the detected presence/absence of through holes or markings. The marking on the detection surface of the infusion cassette may further include at least one colored region having a color representative of the code. The controller identifies the type of infusion cassette (e.g., intravascular, neural/neuraxial, enteral, etc.) by “reading” the through holes or markings of the infusion cassette. After identifying the type of infusion cassette, the infusion pump may set or limit pump parameters (e.g., delivery parameters, available drug options, etc.) other than the type of infusion cassette or infusion pump that is associated with that type of infusion cassette.
In sample configurations, an infusion pump is described that includes a housing having a pump and a receptacle, an infusion cassette that includes tubing for passage of an infusate, and an infusion cassette detection system. The infusion cassette fits into the receptacle such that the tubing is adjacent the pump when fully inserted. The infusion cassette further includes at least one hole or marking on a detection surface thereof that identifies at least the type of infusion cassette. The infusion cassette detection system detects a type of the infusion cassette when the infusion cassette is fully inserted in the receptacle of the housing. The detection system includes at least one emitter/detector pair including an emitter that emits light to the detection surface of the infusion cassette and a corresponding detector that receives reflected light, and a controller that determines a presence or absence of the at least one hole or marking on the detection surface from the reflected light and that determines the type of infusion cassette in accordance with the determination of the presence or absence of the at least one hole or marking. The controller, through engagement with on-board databases (e.g., drug delivery database), controls operation of the pump in accordance with the determined type of infusion cassette.
In the sample configurations, the controller determines the type of infusion cassette by determining a code represented by a presence or absence of the at least one hole or marking on the detection surface of the infusion cassette and uses the code as a search criterion into at least one of a drug library database or a library of available infusion cassettes. In addition to the type of infusion cassette, the code may represent at least one pumping parameter of the pump that the controller uses to control operation of the pump. The controller also may use the code to limit programming choices for the pump.
In addition, the controller may use the code to identify a mismatch between a selected drug and an installed infusion cassette and notify a user via a user interface of the infusion pump. For example, information provided to the user of the pump may serve as a safety measure (e.g., to prevent wrong-route medication errors, etc.). In the event this occurs, the pump controller may guide the user via the user interface to make informed pump parameter elections; those elections are then historically recorded.
The following description also describes a method of operating an infusion pump and a non-transitory controller-readable medium including instructions that when executed by one or more processors implement the steps of detecting the insertion of an infusion cassette into a receptacle of a housing of the infusion pump where the infusion cassette includes tubing adapted for passage of an infusate that is adjacent a pump of the housing when fully inserted in the receptacle; detecting at least one hole or marking on a detection surface of the infusion cassette that identifies at least the type of infusion cassette by using at least one emitter/detector pair to emit light to the detection surface of the infusion cassette and to receive reflected light indicative of a presence or absence of the at least one hole or marking on the detection surface; and determining a code represented by a presence or absence of the at least one hole or marking on the detection surface from the reflected light, the code representing the type of infusion cassette. The method also includes controlling operation of the pump in accordance with the determined type of infusion cassette.
In sample configurations, the method further includes using the code as a search criterion into at least one of a drug library database or a library of available infusion cassettes. Detecting the marking on the detection surface of the infusion cassette may further include detecting at least one colored region having a color representative of the code. Also, the code may represent at least one pumping parameter of the pump, and the method further includes controlling operation of the pump in accordance with the at least one pumping parameter. The code may represent at least one pumping parameter of the pump and may be used to control operation of the pump, limit programming choices for the pump, and/or to identify a mismatch between a selected drug and an installed infusion cassette and notify a user via a user interface.
The drawing figures depict multiple views of one or more implementations, by way of example only, not by way of limitations. In the figures, like reference numerals refer to the same or similar elements. The same numeral is used to represent the same or similar element across the multiple views. If multiple elements of the same or similar type are present, a letter may be used to distinguish between the multiple elements. When the multiple elements are referred to collectively or a non-specific one of the multiple elements is being referenced, the letter designation may be dropped.
In the following detailed description, numerous specific details are set forth by way of examples in order to provide a thorough understanding of the relevant teachings. However, it should be apparent to those skilled in the art that the present teachings may be practiced without such details. In other instances, well-known methods, procedures, components, and circuitry have been described at a relatively high-level, without detail, in order to avoid unnecessarily obscuring aspects of the present teachings. Moreover, while described with respect to an ambulatory peristaltic infusion pump for pain management, homecare, outpatient infusions, and the like, it will be appreciated by those skilled in the art that the pump cassette detection system described herein may be used with a variety of other pump types.
A peristaltic pump mechanism 106 within the receptacle 104 acts upon a tube 108 extending through a channel within the infusion cassette 102 to pump fluid from a fluid container (e.g., a bag or a bottle; not shown) into a patient. An example free flow prevention clamp 110 is positioned within the infusion cassette 102 to allow fluid flow through the tube 108 when the infusion cassette 102 is coupled to the ambulatory peristaltic infusion pump 100 within the receptacle 104 (during which time the peristaltic pump mechanism 106 controls fluid flow through the tube 108) and to selectively cut off fluid flow through the tube 108 when the infusion cassette 102 is not coupled to the ambulatory peristaltic infusion pump 100 in order to prevent unintentional fluid flow through the tube 108 (e.g., free flow).
The ambulatory peristaltic infusion pump 100 includes a user interface 122 for interacting with the ambulatory peristaltic infusion pump 100. The illustrated user interface 122 includes a display 124 (which may be a touchscreen) and buttons 126. A user controls the operation of the ambulatory peristaltic infusion pump 100 via the user interface 122. The ambulatory peristaltic infusion pump 100 additionally includes a housing 128 for containing and supporting the components of the ambulatory peristaltic infusion pump 100 such as the peristaltic pump mechanism 106, electronics, power supplies, and the like.
The free flow prevention clamp 110 includes a first elongate section 112a, a second elongate section 112b, and a clamping section 112c. The housing 130 of the infusion cassette 102 supports the free flow prevention clamp 110. The clamping section 112c is positioned within the cassette geometry such that, when the infusion cassette 102 is received within the receptacle 104 of the ambulatory peristaltic infusion pump 100, the clamping section 112c extends across the channel receiving the tube 108. The housing 130 of the infusion cassette 102 may be rigid plastic or other material capable of supporting the tube 108 and free flow prevention clamp 110.
The ambulatory peristaltic infusion pump 100 also includes a pair of arc cams 114a and 114b (
As shown in
The ambulatory infusion pump 100 further includes connector ports 136 that provide electronic access for control and for powering the ambulatory peristaltic infusion pump 100 when used in the configurations described below.
The controller 310 may include a main controller such as a dual core 32 bit processor from NXP of Eindhoven, Netherlands (e.g., model #MCIMX7S5EVM08SC), a microcontroller from NXP (e.g., model #MKV31F512VLH12), a pump motor driver from ST Microelectronics of Geneva, Switzerland (e.g., model #STSPIN250), and a magnetic encoder from Austriamicrosystems of Premstaetten, Austria (e.g., model number AS5601-ASOM). The microcontroller receives pump camshaft revolutions per minute (RPM) corresponding to the infusion flow rate from a system control core of the main processor. The microcontroller develops a pulse width modulation (PWM) motor drive parameter relating to the desired camshaft RPM. The PWM output of the microcontroller becomes the motor drive input to the pump motor driver, which contains motor drive transistors and protection circuitry. The rotation of the camshaft 306 of the pumping mechanism is measured by the magnetic encoder. At specified time intervals, the output of the encoder is read by the microcontroller, which uses the encoder value to compute the speed of the camshaft 306 and the position of the pump rotation. These values are then used to modify the PWM output to maintain the correct camshaft RPM.
An ambulatory peristaltic infusion pump 100 as described herein thus may include a linear peristaltic pump mechanism 106 that acts on tubing 108 to pump fluid through the tubing 108. The tubing 108 passes through the infusion cassette 102, which is inserted into the ambulatory peristaltic infusion pump 100 such that the tubing 108 engages the linear peristaltic pump mechanism 106. The ambulatory peristaltic infusion pump 100 may be configured based on the type of infusion cassette 102.
As noted above, the ambulatory peristaltic infusion pump 100 has a receptacle 104 configured to receive an infusion cassette 102. The emitter/detector pairs 610 of the detection system are positioned within the receptacle 104 as illustrated in
In sample configurations, the infusion cassette 102 includes a housing 130 having an indicator that can be sensed by the infusion pump detection system to determine pump type. In a first example shown in
In the configuration of
In the configuration of
In sample configurations, a code represented by the presence/absence of the holes and/or the unique markings is captured by the detection system to identify the type of infusion cassette 102 (e.g., intravascular, neural/neuraxial, enteral, etc.) by “reading” the indicator(s) (e.g., holes) or markings 710 or 810 on or associated with the infusion cassette 102. After identifying the type of infusion cassette 102, the ambulatory peristaltic infusion 100 pump may set pump parameters (e.g., delivery thresholds, available drug options, etc.) that are associated with that type of infusion cassette 102. Such parameters may be stored in a memory of the peristaltic infusion pump 100 and accessed based on the read holes or markings 710 or 810.
A code represented by the holes or markings 710 or 810 may further provide additional programming safety by constraining programming choices available through interaction and limitations of a drug or care area within a drug library database of the ambulatory peristaltic infusion pump 100. This feature assists in preventing wrong route medication errors (i.e., medications intended for a specific region of the body are prevented from being infused into the wrong region of the body). For example, a code represented by the holes or markings 710 or 810 would limit the programming choices for an Epidural Infusion Set to only specific epidural drugs within the drug library, or pop up a notice to a user in the event of a mismatch between the selected drug and the installed infusion cassette 102. In this example, the code read from the infusion cassette 102 does not directly influence, change, or set the pumping parameters (e.g., flow rate, pressure settings, etc.) but does warn the user when the user sets unexpected or incompatible pumping parameters.
To set up the ambulatory peristaltic infusion pump 100 for operation, an infusion cassette 102 is inserted into the receptacle 104. The detection system includes a series of emitter/detector pairs 610 positioned within the receptacle 104. The respective emitters 612 of the emitter/detector pairs 610 emit light towards the detection surface 700/800/900 of the fully inserted infusion cassette 102. As described above, the detection surface 700/800 includes holes 710 or 810 that extend through the detection surface 700/800 of the body of the infusion cassette 102. The emitted light is either reflected by the detection surface 700/800 in the absence of a hole 710/810 or passes through the hole 710/810 and is either not reflected back or is reflected back at a different timing and/or intensity. The light reflection characteristics detected by the detector(s) 614 differ between non-reflected light and light reflected at a different timing and/or intensity, and these light reflection characteristics are translated into values understood by the controller 620. The respective values are provided to the controller 620 for identification of the code represented by the hole(s) 710/810. Similarly, the respective emitters 612 may emit light toward the detection surface 900 including the colored markings 910 of the configuration of
In one example, a series of nine sensors consisting of 940 nm wavelength IR light emitter-detector pairs 610 are positioned within the receptacle 104 of the ambulatory peristaltic infusion pump 100. The presence/absence of corresponding holes 710/810 in the infusion cassette 102 effectively creates a code that can be used to identify the type of infusion cassette 102 inserted into the ambulatory peristaltic infusion pump 100.
In sample configurations, two of the nine sensors of the light emitter-detector pairs 610 may be used to calibrate the detection system. One of the sensors may take measurements that correspond to a hole 710/810 in the detection surface 700/800 of the infusion cassette 102 when the infusion cassette 102 is inserted and another sensor may take measurements that correspond to the absence of a hole 710/810 in the detection surface 700/800 of the infusion cassette 102 when the infusion cassette 102 is inserted. This calibration process is useful for detecting the presence/absence of holes by the other sensors even if the infusion cassettes 102 may have detection surfaces in different colors. After calibration, the remaining sensors may be used to determine properties of the infusion cassette 102 based on the presence/absence of holes (e.g., intravascular, neural/neuraxial, enteral, etc.).
It will be appreciated that fewer or more holes 710/810 and markings 910 may be used than are shown in the figures. For example, the holes 710/810 need not be cylindrical in shape but may be prismatic holes of any configuration such that the emitter 612 and the receiver 614 pairs can detect a difference in reflected light. The number of holes 710/810 and markings 910 is dependent upon the amount of data to be conveyed (e.g., the number of infusion cassette types and drug delivery configurations). It will also be appreciated that the holes 710/810 and markings 910 need not be used to adjust any direct pumping parameters such as flow rate, pressure settings, accuracy, etc. but instead may be limited to identification of the type of infusion cassette 102 and any unique characteristics of the infusion cassette 102. In such a configuration, the pumping parameters may be set during a programming process for programming the ambulatory peristaltic infusion pump 100.
Specifically,
Hardware of an example computer 1100 (
Hardware of a user terminal device 1200, such as a PC or tablet computer, similarly includes a data communication interface 1202, CPU 1204, main memory 1216 and 1218, one or more mass storage devices 1220 for storing user data and the various executable programs, an internal communication bus 1206, and an input/output device (I/O) 1208 (see
Aspects of the methods for pump control, as outlined above, may be embodied in programming in general purpose computer hardware platforms (such as described above with respect to
Hence, a machine-readable medium may take many forms, including but not limited to, a tangible storage medium, a carrier wave medium or physical transmission medium. Non-transitory storage media include, for example, optical or magnetic disks, such as any of the storage devices in any computer(s) or the like. It may also include storage media such as dynamic memory, for example, the main memory of a machine or computer platform. Tangible transmission media include coaxial cables; copper wire and fiber optics, including the wires that include a bus within a computer system. Carrier-wave transmission media can take the form of electric or electromagnetic signals, or acoustic or light waves such as those generated during radio frequency (RF) and light-based data communications. Common forms of computer-readable media therefore include for example: a floppy disk, a flexible disk, hard disk, magnetic tape, any other magnetic medium, a CD-ROM, DVD or DVD-ROM, any other optical medium, punch cards paper tape, any other physical storage medium with patterns of holes, a RAM, a PROM and EPROM, a FLASH-EPROM, any other memory chip or cartridge, a carrier wave transporting data or instructions, cables or links transporting such a carrier wave, or any other medium from which a computer can read programming code and/or data. Many of these forms of computer readable media may be involved in carrying one or more sequences of one or more instructions to a processor for execution.
Program instructions may include a software or firmware implementation encoded in any desired language. Programming instructions, when embodied in machine readable medium accessible to a processor of a computer system or device, render computer system or device into a special-purpose machine that is customized to perform the operations specified in the program performed by the controller 310 or 620 of the ambulatory peristaltic infusion pump 100.
While the foregoing has described what are considered to be the best mode and/or other examples, it is understood that various modifications may be made therein and that the subject matter disclosed herein may be implemented in various forms and examples, and that the teachings may be applied in numerous applications, only some of which have been described herein. It is intended by the following claims to claim any and all applications, modifications and variations that fall within the true scope of the present teachings.
Unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. They are intended to have a reasonable range that is consistent with the functions to which they relate and with what is ordinary in the art to which they pertain.
The scope of protection is limited solely by the claims that now follow. That scope is intended and should be interpreted to be as broad as is consistent with the ordinary meaning of the language that is used in the claims when interpreted in light of this specification and the prosecution history that follows and to encompass all structural and functional equivalents.
Notwithstanding, none of the claims are intended to embrace subject matter that fails to satisfy the requirement of Sections 101, 102, or 103 of the Patent Act, nor should they be interpreted in such a way. Any unintended embracement of such subject matter is hereby disclaimed.
Except as stated immediately above, nothing that has been stated or illustrated is intended or should be interpreted to cause a dedication of any component, step, feature, object, benefit, advantage, or equivalent to the public, regardless of whether it is or is not recited in the claims.
It will be understood that the terms and expressions used herein have the ordinary meaning as is accorded to such terms and expressions with respect to their corresponding respective areas of inquiry and study except where specific meanings have otherwise been set forth herein. Relational terms such as first and second and the like may be used solely to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms “comprises,” “comprising,” “includes,” “including,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element preceded by “a” or “an” does not, without further constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that includes the element.
The Abstract of the Disclosure is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, it can be seen that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter.
In addition, in the foregoing Detailed Description, it can be seen that various features are grouped together in various examples for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed examples require more features than are expressly recited in each claim. Rather, as the following claims reflect, the subject matter to be protected lies in less than all features of any single disclosed example. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter.
While the foregoing describes what is considered to be the best mode and other examples, it is understood that various modifications may be made and that the subject matter disclosed herein may be implemented in various forms and examples, and that they may be applied in numerous applications, only some of which have been described herein. It is intended by the following claims to claim any and all modifications and variations that fall within the true scope of the present concepts.
