HK1104165B - Medical device configuration based on recognition of identification information - Google Patents

Description

Medical device configured according to identification information

Technical Field

The present invention relates generally to medical delivery systems and, more particularly, to an administration line set for use with a medical delivery device and an identification system for identifying information associated with the line set.

Background

The delivery of medical fluids to a patient is well known in the medical arts. There are many types of medical delivery devices in the field that deliver various medical fluids to a patient, examples of such medical fluids include: parenteral fluids, medicaments or other drugs, electrolytes, blood and blood products, and the like. One particular type of medical delivery device is an infusion pump (infusion pump) that can deliver one or more therapeutic fluids to a patient in a variety of forms, examples of which include applications such as Intravenous (IV), arterial (IA), subcutaneous, epidural, irrigation of fluid spaces, and the like. Many medical delivery devices that operate in these administration forms typically employ an administration line set and a container associated therewith containing one or more medical fluids. In infusion pump applications, the tubing set is typically incorporated into the delivery mechanism of the pump for delivering fluid to a patient.

US 2001/0040127 discloses a dialysis device with a detector arrangement that detects an identifier located on a connector of a container of a dialysis solution component. The detector device identifies the type and amount of the dialysis solution component.

US 5980501 discloses a medicament container having electrically and/or mechanically embedded operating means for carrying data such as the identity and/or concentration of a medicament. A separate reader device, which may be clipped on a clip, attached to the infusion set is capable of reading the data on the carrier.

US 2003/0139701 discloses a medical infusion pump with an attached reader to scan bar codes on drug containers or on badges of prescribed healthcare personnel and patients.

US 2001/0020148 discloses a medical device that reads bar code identification information on an accessory between uses of the accessory. If the identification information is recognized, the device is activated to be used.

US 5647854 discloses a pump having a control module and an attachable reservoir with an identification tag. The control module includes a cassette flag identification structure.

US 6285285 discloses an assembly comprising a container and means for computer monitoring of the contents of the container, the means comprising a printed circuit, an antenna and an electronic chip or memory card. The device is attached to a removable compartment containing an example of the contents of the container.

US 5925014 discloses a computerized mixing controller device for preparing and administering pharmaceutical solutions. The barcode reader monitors the type of drug and expiration date of drug vials inserted into the device.

US 66626862 discloses an angiographic injector system using a relief or rim as a keying member to ensure that the appropriate injector body and accessory are used.

US 2C02/0038392 discloses a method and apparatus for controlling IV medical infusions by utilizing identification tags on the IV bag for specifying infusion parameters.

US 2003/0135388 discloses a medical infusion system comprising a hand-held device for reading a label on a medical container or patient label. After the drug is verified to match the patient, the device transmits instructions to the infusion device.

Each form of administration, and each therapeutic fluid, typically includes several operating parameters, variables, constraints, and other relevant information, such as medical and pharmaceutical relevant information. To ensure proper, effective and safe delivery of therapeutic fluids to and effective treatment of a patient, these operating parameters, variables, constraints, and other relevant information must be detected and tracked. A difficult task of medical delivery devices is to keep the attributes and values of these operational parameters, variables, constraints, and other relevant information within allowable human error. While most of the known infusion devices are microprocessor controlled and software driven devices with associated memory and thus the ability to customize and control the infusion device by user-specific features (user-typically) by downloading specific data or software from another source, there is still a risk of improperly matching data and software to the appropriate treatment, drug or fluid, or administration set, particularly from a logistical standpoint. In addition, prior art infusion devices, such as infusion pumps, operate in a fixed manner and have only one set of fixed functions, regardless of the particular condition of the treatment, the medication or fluid, or the administration set, which can be another source of error. The potential for error in the fluid delivered to the patient is numerous and minimizing this potential is an important goal.

The present invention addresses these and other problems, and generally provides a new and improved system, device and method relating to a therapeutic fluid in an administration line set and medical delivery device for delivering the therapeutic fluid to a patient.

Disclosure of Invention

The present invention provides a medical delivery system for delivering a drug or fluid to a patient. In accordance with a particular aspect of the present invention, a disposable element is provided having an identifier that is recognizable by a medical device associated with the system. In a particular embodiment, the system includes a line set associated with a container containing a fluid, the line set carrying an identifier, and identification information associated with the identifier. The system also includes an infusion set configured to couple with the line set and deliver the fluid to the patient. The delivery device includes a recognition system capable of obtaining identification information associated with the identifier.

According to another aspect of the present invention, the device obtains the identification information in a state of being coupled to the piping apparatus. The identification information includes the type of administration associated with the line set and may also include information regarding the identification of the fluid, the type of line set.

According to another aspect of the invention, the identifier may be a bar code, a passive RF device, a magnetic device, a non-volatile memory device, or the like,

the identifier is integrated with a slide clamp associated with the line set.

The infusion set includes a slide clamp receptacle for receiving the slide clamp associated with the line set.

The identification system is integrated with the slide clamp receptacle.

According to another aspect of the invention, the device can be configured according to the identification information.

According to another aspect of the invention, the device is automatically configured upon obtaining the identification information from the identifier.

According to another aspect of the invention, the device, when configured, is capable of being configured for operation in particular relation to the obtained identification information.

According to another aspect of the invention, a disposable element such as a MEMS pump may be used in the system of the invention.

These and other aspects of the invention will be apparent from the following drawings, specification and appended claims.

Drawings

FIG. 1 is a general schematic view of a medical delivery system according to the principles of the present invention;

FIG. 2 is a schematic view of one embodiment of the medical fluid delivery system of FIG. 1 including a medical fluid delivery pump;

FIG. 3 is a perspective view of a slide clamp for use with an administration line set in accordance with the principles of the present invention;

FIG. 4 is a screen shot of the medical pump display of FIG. 2 showing the various zones that may be configured based on the identification information obtained from the pump;

FIG. 5 is a schematic view of a medical delivery system according to another embodiment of the present invention;

fig. 6 is a schematic diagram of a comparative medical delivery system.

Detailed Description

The invention may be embodied in many different forms. It is to be understood that the preferred embodiments shown in the drawings and described in detail below are merely a few examples that have been set forth to illustrate the principles of the invention, and that the broad scope of the invention is not limited by these embodiments.

Referring to fig. 1, a medication delivery system or medical infusion system 10 is generally depicted. The system 10 includes a medical delivery device 12, the device 12 including a controller (C) with associated memory (M), a processor (P), and an input device (I). While the controller (C) is preferably integrated with the device 12, it should be understood that the controller (C) may be separate from the device 12 and/or distinct from the device 12. For example, the controller (C) may be associated with a Personal Digital Assistant (PDA) or other external computing device distinct from the device 12.

Referring again to fig. 1, the system 10 also includes at least one administration line set 14, and the line set 14 is considered a single use component or disposable element. The line set 14 may be in communication with a container 16 containing a drug 17 or fluid 17 to be delivered to the patient. The assembly of line set 14 and container containing fluid 17 is sometimes referred to as a unit administration set. The container 16 can take many different forms and in a preferred embodiment is a flexible bag. The line set 14 typically comprises a tube having one end in communication with the container 16 and the other end having a conduit or other device for communicating with the patient. The device 12 acts on a portion of the line set 14 to deliver the fluid 17 to the patient. The device 12 may be any form of device capable of delivering a variety of different fluids to a patient, examples of which include fluids such as parenterally delivered fluids, medicaments or other medicaments, electrolytes, blood and blood products, and the like. Fluid 17 may include any flowable substance that may be delivered to a patient. The device 12 may deliver one or more types of fluids to a patient via different types of administration, examples of which include, for example, Intravenous (IV), arterial (IA), subcutaneous, epidural, irrigation of fluid spaces, and the like. One preferred embodiment of the device 12 is an infusion pump such as those disclosed in U.S. Pat. Nos. 5,782,805 and 5,842,841.

As shown in fig. 1, the administration line set 14 carries an identifier 18. the identifier 18 may also be referred to as a label 18. The identifier 18 may be physically attached or loosely coupled to the line set 14 or in proximity to the line set 14. The identifier 18 may also be integral with the line set 14 or attached as two separate elements. The identifier 18 has identification information associated therewith. The identification information may comprise an identification code or may comprise a set of one or more data portions, which may be any form of information that may be utilized by the device 12 in operation and during the course of treatment of the patient. The identification information includes the type of administration associated with the line set and, in a preferred embodiment, the identification information also includes information regarding the patient, the drug or fluid 17, the type of line set 14, the material forming the line set 14 (e.g., PVC, non-PVC), and/or other operating parameters. The identification information may also include information regarding the stiffness, the dimensions (e.g., inner diameter, outer diameter of the tubing), micro-pores, etc. of the tubing set 14 and/or other parameters necessary for accurate delivery of the drug through the tubing set. With respect to the medication, the identifier 18 may include identification information such as a medication identification number as is well known in the art. The identifier 18 may also include information about the patient such as name, age, sex, weight, allergy history, disease, health status, etc.; information such as the type (whether pharmaceutical or non-pharmaceutical), name, concentration, etc. of the fluid 17 that is part of the line set 14 (i.e., contained within the container 16); and all or necessary process parameters of the medication therapy to be performed with the line set 14. The process parameters may include at least drug type, drug concentration, drug quantity, volume of an individual bolus, total bolus volume, bolus rate (bolus rate), dose, time interval between bolus doses (time bolus deliveries), maximum bolus number per unit time, loading dose volume (loading dose volume), loading dose rate (loading dose rate), loading dose time (loading dose time), maintenance rate (maintenance rate), maintenance volume (maintenance volume), maintenance time (maintenance time), maintenance dose (maintenance volume), diluent volume, and patient weight. Finally, the identifier 18 may also include pertinent profile data (profile data) which may include, but is not limited to, patient profile data such as the patient's state of suffering, chronologic age, age group, gestational age; and health profile data of the patient, such as a medical health or medical disease state, including (but not limited to) kidney disease, congenital heart disease, and liver disorders. In addition to including specific medication therapy information, the identifier 18 may also include information for the same type of medication therapy. For example, the identifier 18 may include process parameters and data that are applicable to a plurality of medications, a category of medications, or a category of patient and/or health profiles.

The information or code for the identifier 18 may be provided by a programming device and loaded onto the identifier 18. As described in detail below, the identifier 18 may be associated with a medical device that is to be acted upon by recognition of the identifier 18 (activated). The identifier 18 may also include an additional portion or additional identification number bit for programming by the programming device, the identification information or data encoding in the additional portion or identification number bit allowing the programmed device to be reused in a subsequent system. This will be described in connection with other embodiments described below.

The identifier 18 may be attached to the line set 14 by the manufacturer of the line set 14, or by a hospital pharmacy, or some other organization. When the identifier 18 is attached to the line set 14 by the manufacturer, the line set typically does not yet include the container 16. At this point, the line set 14 with the identifier 18 may be pre-manufactured for use with a class or group of medications and provided with that information. The line set 14 with the identifier 18 may then be connected to the container 16 containing the type of medication. Alternatively, the line set 14 may be highly customized (high throughput) to include many of the patient and/or therapy specific process parameters identified by the above cables. Such customization is typically performed by a pharmacy, wherein specialized instructions and treatment instructions are added to the identifier 18.

The identifier 18 may take any form, such as a bar code or other IR technology, an RFID technology such as an RFID tag, any other accessible passive RF device, magnetic storage device, non-volatile memory, or any other device or technology capable of representing information to and being retrieved by another device or system. The device 12 includes a recognition system 20 that is capable of recognizing the identifier 18 and/or obtaining or retrieving identification information from the identifier 18 for use by the device 12. In a preferred embodiment, the recognition system 20 is part of the controller (C). The form of the recognition system 20 will depend on the particular form of the identifier 18 and associated technology. For example, if the identifier 18 is a bar code, the recognition system would be an IR or other light emitting device capable of reading the bar code. When the form of an identifier 18 is determined, those skilled in the art will readily recognize the appropriate form of the recognition system, which will include all known forms capable of obtaining or retrieving identification information from the particular form of the identifier 18. It should be understood that the identifier 18 and the recognition system 20 may be used in situations where the identifier 18 is located in a predetermined area near the recognition system 20 without any physical connection or contact therebetween, in which case the recognition system 20 is able to recognize and identify the identification information on the identifier 18.

Fig. 2 shows a preferred embodiment in the form of a medical delivery system 30. The system 30 includes an infusion pump 32 and at least one line set 34 connected to a container 35 containing a fluid 36 to be delivered. It should be noted that the infusion pump 32 herein may be any form of infusion pump including, for example, a positive displacement infusion pump, a peristaltic pump, a cassette pump, a syringe pump, or a MEMS pump (micro-electromechanical pump). The infusion pump 32 is preferably a microprocessor-based pump that is programmable and capable of utilizing software and/or firmware to enhance the operability and functionality of the pump 32. The software is preferably stored on a computer readable storage medium, such as memory (M), located in the controller (C) of the pump 32. The line set 34 includes a fluid line 38, which fluid line 38 communicates with the pump 32 to facilitate the flow of the fluid 36 to the pump 32. The system 30 of fig. 2 is shown with three administration line sets 34, although a single line set, single channel pump, may be used. The pump 32 may deliver one or more fluids to the patient via a variety of administration modalities, such as, for example, Intravenous (IV), arterial (IA), subcutaneous, epidural, irrigation of fluid spaces, etc. The types of fluids may include, for example, parenteral fluids, medicaments or other drugs, electrolytes, blood and blood products, and the like. In this particular embodiment, the pump 32 includes three passages 40, each of which passages 40 is configured to be coupled to the fluid tube 38 of one of the line sets 34. As is well known in the art, the pump passageway 40, when operated, delivers the fluid 36 from the container 35 to the patient through the fluid tube 38 of the line set 34. Each administration line set 34 includes a slide clamp 42 as described in detail in fig. 3. The slide clamp 42 is designed to engage the fluid tube 38 on the line set to prevent fluid from running through the fluid tube 38 before the fluid tube 38 is installed in the tube receptacle 43 on the pump channel 40. The pump includes a slide clamp socket 44 on each channel 40.

The slide clamp 42 includes an identifier 18 as described above. The slide clamp 42 and the identifier 18 are also contemplated to be disposable. The identifier 18 on the slide clamp 42 can be in any form, such as, for example, a bar code (including, but not limited to, one-dimensional or two-dimensional bar codes) or other form of IR technology, an RFID technology such as an RFID tag, any other passive RF device or transponder that can be interrogated, a magnetic storage device, a non-volatile memory, or any other form of device or technology that can represent information to and be retrieved by the pump 32. The pump 32 includes a recognition system 20 as described above, the recognition system 20 being capable of recognizing the identifier 18 and/or obtaining or retrieving identification information from the identifier 18 for use by the pump 32. In a preferred embodiment, the identifier 18 is a bar code 50 located on the slide clamp 42 shown in FIG. 3, and the recognition system 20 is a bar code reader (which in a preferred embodiment is integrated into the clamp receptacle 44) that can interrogate the bar code 50 and obtain identification information for use by the pump 32. The identification information includes the type of administration associated with the line set, and in a preferred embodiment, the identification information also includes identification information regarding the type of medication or fluid 36, the line set 34, and/or other desired information such as, for example, the age and other data of the patient, the type of treatment, the type of illness, and the type of health condition of the patient. It should also be understood that the identifier 18 can be located at several different locations on the slide clamp 42, with the recognition system 20 corresponding to the location of the identifier 18 or the slide clamp 42.

When the pump 32 obtains the identification information from the identifier 18, the pump 32 may utilize this information in several ways, including changing the operating conditions of the pump. For example, once the pump 32 obtains the identification information, the pump 32 may be configured according to the identification information. In a preferred embodiment, the pump 32 is configured automatically upon obtaining the identification information from the identifier 18, or in response to the obtained information. The configuration may include setting and/or executing any number of operating parameters and/or user interface parameters of the pump 32. For example, the pump operating system may be configured to modify the effectiveness of certain functions, such as by adding or activating certain functions that are specifically associated with the identification information. For example, configuration may include initiating a function that should only be active for one particular type of administration, fluid, or line set. Conversely, the pump operating system may modify the effectiveness of certain functions by disabling certain functions that are specific to a particular type of administration, fluid, or line set. For example, the identifier 18 may include information indicating that the line set 34 used is of the epidural type, for example, and that subsequent operation of the pump 32 and treatment of the patient will depend on the initial information. The pump 32 may also be configured to operate based on the identified type of material forming the line set 34.

The arrangement of the present invention may have many uses in the field of medical delivery systems. Although a few specific examples of configuration operations are described in this specification, it should be understood that many possible configuration operations, either alone or in combination, may be implemented on the basis of the principles of the present invention. Although not specifically illustrated, such implementation-specific decisions should be interpreted as causing a departure from the scope of the present invention.

In accordance with the principles of the present invention, the controller (C) of the pump 32 may be configured to configure the pump based on a set of configuration information associated with predetermined identification information, which is preloaded in the memory (M). In this case, the identification system receives identification information regarding the administration line set from the identifier 18, and the processor retrieves configuration information associated with the received identification information based on comparing the received identification information to predetermined identification information. Once the received identification information matches the predetermined identification information, the processor configures the controller according to the set of configuration information. The matching criteria may be specified in a number of ways, such as, for example, according to the type of line set or the type of administration being performed with the line set. The matching criteria may also be specified based on the identification of certain parameters or certain values in the identification information, such as, for example, based on whether the parameters or values fall within a predetermined range. It is also contemplated that the health care facility may customize the pump controller by specifying predetermined identification information, matching criteria, and/or pre-loaded sets or profiles of configuration information.

In some cases, it may be necessary to modify the performance of the pump 32 and the effectiveness of the function based on the identification information, such as to add or enable the function of the pump 32 based on certain identification information or other criteria. For example, the added functionality may include providing a user with a message specifically associated with the identification information, such as a message providing the patient with unique characteristics regarding a particular type of fluid or administration of the line set. The added functionality may also include allowing the user to see a set of guidelines for the administration of a particular fluid, such as guidelines for a recommended administration method for a particular medicament. The added functionality may also include allowing the user to view a set of guidelines regarding a predetermined policy, such as a policy set by the hospital regarding line set replacement. The function may include certain notifications, such as a notification to a user of a particular type of administration of a particular fluid. In some cases, it may be necessary to provide functionality that includes connecting the user to certain types of information, such as information regarding the drug protocol of the drug to which the identification information corresponds. In this example, the protocol may include information on the dosage of a particular agent and the method of administration. In other cases, it may also be desirable to add functionality including a warning system that may include an alarm for alerting of non-compatibility of the medication when a particular medication is identified. In some cases, it may also be desirable to add a function that includes an alarm escalation function that provides an alarm escalation signal when a specific event occurs in which the caregiver is not responding to a previous alarm. In some cases, it may be possible to remove a function from the pump 32 or disable the pump 32 from performing a function based on the identification information. For example, certain specific functions of the pump 32 may be disabled based on identification information such as the identified type of administration. As a more specific example, the pump 32 may be disabled from functioning as an automatic piggybacking function based on the identification that the administration is of the epidural type.

The configuration work may include making adjustments or changes to the system. For example, adjustments may be made to the sensing system in the pump 32 based on the identification information.

It is also contemplated that the configuration may include functional configuration based on identification information of a treatment system, such as a particular combination of container, fluid, line set, and/or type of administration, such as an administration line set kit. In this case, some functionality may be added that is specific to the therapy system, such as adding an announcement or guide for that particular combination. For example, certain guidelines may be provided that are specific to a particular fluid container and line set combination, such as those included in a particular administration line set kit.

The configuration operation may also include modification of the user interface 46 (see FIG. 2) of the pump 32 depending on the configuration. For example, as shown in FIG. 4, the added functionality may require the addition of one or more soft keys 60 on the display 48 of the pump 32. Certain symbols, messages or other information may also be displayed within the display area 62 of the display 48 depending on the added functionality. Conversely, if certain functions are disabled, the corresponding soft keys 60 may be "faded-out" or removed, while certain symbols or information within the display area 62 may be removed. The display area 62 may be further divided into several small areas, which may also be customizable. It should be noted that the soft keys 60 may alternatively be labels for hard keys (not shown) of the user interface 46 of the pump 32. It should be appreciated that where the user interface of pump 32 is customized based on the identification information, many potential sources of error may be eliminated.

The identification information associated with the identifier 18 may also be used in device diagnostics. For example, the information may instruct the pump 32 to perform certain tests or device diagnostic procedures. It is also contemplated that the identifier 18 may be associated with a line set for use in device diagnostics. In such instances, when the diagnostic line set is installed on the pump 32, the pump 32 recognizes the identification information and signals that a diagnostic line set has been installed, and the specific operating parameters, mechanisms (mechanisms), and alarm functions of the pump 32 may be identified for proper operation. For example, the identifier 18 associated with a diagnostic line set may instruct the pump 32 to perform a check and verification as to whether the alarm device is functioning at the proper operating level of the apparatus. An instrument diagnostic administration set kit may include a container containing a particular fluid for testing. In such a case, once the pump 32 recognizes the identifier 18 associated with the diagnostic kit, the pump 32 performs a series of checks in which the expected value of the operating parameter of the pump 32 based on the particular fluid can be used as a diagnostic reference for the device.

Fig. 5 illustrates another embodiment of the system of the present invention, generally designated by the reference numeral 100. Similar to the previously illustrated embodiments, the system 100 utilizes a disposable element and an identifier. In a preferred embodiment, a disposable element such as a disposable pump is used. The disposable pump may be a micro-pump or a MEMS pump (micro-electromechanical pump), or other type of disposable pump. As shown in FIG. 5, the system 100 generally includes a medical device 112 (preferably a MEMS pump), an administration line set 114 and a container 116. The system 100 may also take the form of any system such as that disclosed in commonly owned U.S. patent application US 2003/0130625 (application No.10/040,887) entitled "infusion System".

The container 116 is similar to the container 16 described above. In a preferred embodiment, the container 116 is a flexible bag adapted to contain a medication or medicament, such as a medical fluid. The administration line set 114 is similar to the line set 14 described above. Line set 114 includes a tube having one end connected to or in communication with container 116 and the other end having a catheter or other device for communicating with a patient.

As shown in FIG. 5, the MEMS pump 112 and the line set 114 are operatively associated (operatively associated). The MEMS pump 112 may be connected to the line set 114 in different configurations. For example, the MEMS pump 112 may have an inlet 120 and an outlet 122, wherein the MEMS pump 112 is connected in a middle section of the line set 114. Thus, a portion of the line set 114 is connected to the inlet 120, and another portion of the line set 114 is connected to the outlet 122, wherein the MEMS pump 112 and the line set 114 are operably associated. Once properly connected, the MEMS pump 112 can force fluid from the container 116 through the line set 114 and onto the patient. The disposable pump 112 may further be incorporated within the line set 114 or may be integrated with the line set 114 in some manner.

As previously discussed, the pump 112 may be a MEMS pump 112. MEMS devices are typically etched (etched) in silicon. It is further understood that the MEMS pump may also be described as other forms of micro electromechanical systems devices, such as micro molded in plastic devices. Thus, MEMS devices may include devices etched in silicon, molded in plastic, or otherwise fabricated on a small scale.

An identifier 118 may also be used in the system 100. In a preferred embodiment, the identifier 118 is associated with or connected to the MEMS pump 112. It should be understood, however, that the identifier 118 may be associated with other elements and connected at other locations, such as the disposable line set 114, as shown in FIG. 5. The identifier 118 is similar to the identifier 18 previously described and may contain any information or identifying indicia or data as described above.

A controller 130 may also be used in the system 100. The controller 130 is operatively associated with the MEMS pump 112. The controller 130 may communicate with the MEMS pump 112 via a wireless connection. Alternatively, a hard-wired approach may be taken, wherein the MEMS pump 112 may be plugged into the controller 130. It should also be understood that the controller 130 may be an integral part of the MEMS pump 112. It should also be understood that the controller 130 may be a stand-alone handheld computer or a stand-alone network controller that controls the pump 112 via a network communication link. Similar to the foregoing, the controller 130 has a recognition system 132, and the recognition system 132 is capable of recognizing the data contained in the identifier 118.

The recognition system 132 may operate in conjunction with the identifier 118 to operate the system 100. For example, the identifier 118 may contain information identifying the type of line set 114 to which the MEMS pump 112 is connected. The identifier 118 may also contain any type of other information as previously described. The information contained on the identifier 118 may also include data regarding the function that directs the controller 130 in controlling operation of the MEMS pump 112. It should also be understood that the disposable elements, such as the MEMS pump 112, may be activated by a separate patient care system.

It will be appreciated that the disposable element may take many different forms. The disposable element may be referred to as the MEMS pump 112, or as the line set 114, or a combination of both. In addition, other types of MEMS components may also be used in the system 100.

Fig. 6 shows a comparative embodiment, the system being generally designated by the reference numeral 200. Similar to the embodiments described above, the system 200 uses a disposable element and an identifier. Similar to the system 100 shown in FIG. 5, a MEMS component, such as a MEMS pump, is used. As shown in FIG. 6, the system 200 generally includes a medical device 212 (preferably a MEMS pump 212), an administration line set 214, and a container 216. The system 200 also includes a programming device 220 and a controller 230.

Similar to the previously described systems, an identifier 218 is associated with the disposable element. In the preferred configuration shown in FIG. 6, the identifier 218 is associated with the MEMS pump 212 and may contain any of the data described above. As further shown in FIG. 6, a programming device 220 is used to program the identifier 218 with the required data, identification code, or other identifying information. As part of the programming function, the programming device 220 may also program an additional identification portion of the identifier 218 to be used in a separate phase of the system 200. It should be understood that the identifier 218 is a device that includes a well-known memory that can be reconfigured, rearranged or altered. Once programmed by the programming device 220, the MEMS pump 212 may be activated by the controller 230. The controller 230 may be affiliated with an overall patient care system that operates according to the hospital settings. In one configuration, controller 230 may be a handheld computer such as a personal digital assistant. The controller 230 recognizes the identifier 218 and activates the pump 212. Once activated, the controller 230 controls the pump 212, wherein the pump 212 is operated to deliver medication to a patient. The pump 212 has the ability to recognize certain predetermined events, such as the pump 212 being able to determine that the container is substantially empty when fluid is substantially pumped from the container 216. For example, the MEMS pump 212 may be caused to shut down once the pump 212 senses that the pressure has reached a predetermined value. Once the MEMS pump 212 is turned off, this state will trigger an additional identification portion stored in a memory to alter the state of the additional identification portion, thereby signaling that the MEMS pump has been turned off. The additional identification component may be stored on a memory device that is associated with the identifier 218 or on a separate memory device. Thus, when the pump 212 recognizes that the container 216 is empty, the additional identification portion changes its state in memory and may be considered to have triggered. The portion of the supplemental identifier when triggered can be recognized by the system in several different ways. For example, in one embodiment, a signal is fed back to the controller 230 and/or the programming device 220 to indicate to the programming device 220 that the original identification data can be reused in a later operation of the system 200. Optionally, the controller 230 and/or the programming device 220 may pull down (pull) or otherwise read the additional identification member from a location such as the location of the additional identification member on the identifier 218 on the pump 212. Thus, the additional identification component allows the identifier 218 to include a reusable identification component. Further, the system of the present invention is capable of setting, resetting, or otherwise configuring, reconfiguring (e.g., changing) the identifier 218. In one configuration, the identifier 218 is an RFID tag. The component may also include any form of electrically alterable, non-volatile memory. It should be understood that the communication may be directly to programming device 220 or through controller 230 to programming device 220. By using the additional identification portion or additional information bits (bits), the identification code can be reused, thereby improving the overall operating performance of the system. Further, it should be understood that the predetermined event described above may also be an event such as when the controller issues an instruction to terminate an infusion therapy (i.e., independent of the amount of medication remaining in the reservoir).

It should also be appreciated that while the additional identification component may be reused for a new infusion therapy with a new system component, the system is configured such that the additional identification component does not allow the original system component to be used again as the original therapy. Thus, the additional identification portion used for the first infusion therapy and the disposable element such as the MEMS pump cannot be reused together for the second infusion therapy. When one attempts to do so, the system will not operate at the second treatment. The additional identification portion can only be used in a new treatment with a new system component.

Any of the embodiments described above may use the following additional features. As described above, a kit may be formed that includes the container 16, the line set 14, and the identifier 18. The identifier 18 may be associated with or connected to either the container 16 or the line set 14. In some embodiments, the container 16 may contain a pre-attached reconstitution device having a pre-attached medicament container such as a long neck bottle (visual). The reconstitution device may be activated to reconstitute the agent in fluid 17 within container 16. It should be understood that the identifier 18 may also include information about a flask that may be pre-attached to the reconstitution device. In another embodiment, a disposable pump, such as a micro-pump or MEMS pump, may also be connected to the line set 14 and considered part of the kit. The identifier 18 associated with such a kit may include any information needed for the overall system to function properly, as described above. In yet another embodiment, the container 16 or the container 16 associated with the kit may include a pre-mixed medicament 17. The identifier 18 associated with the pre-blended medication 17 may include an expiration date associated with the medication 17. The infusion device or pump used with such a kit has a recognition system that recognizes the identifier 18 and the date the pump was run. The pump is configured such that the pump will not operate if the identification system determines that the pump is on a date after the identified expiration date of the medication. Thus, if the identification system of the pump reads an expired date for the medication, the pump will not operate and will signal that the medication is expired. In a preferred embodiment, the system will further include an alarm system operatively associated with the system, the alarm system being capable of emitting an alarm signal when an expired medicament is detected. The alarm signal may take many different forms and may have an audio portion, a video portion or a combination of both.

It should also be understood that the pump used in the present invention will incorporate a safety software. The safety software is capable of generating an alarm signal of a substantial failure of a task when the pump is subjected to a failure condition, such as no medicament flowing through the pump successfully. The present invention may employ different software/pump configurations. For example, all software may be located on the pump head, or all software may be located remotely from the pump head. Furthermore, it is also possible that certain safety software is located on the pump head, while other software is located remotely from the pump head.

Specific examples of the invention

Two specific examples of applications of the principles of the present invention are described below.

In a first example, an administration line set having an identifier is loaded into a pump. The identification system of the pump obtains identification information from the identifier when the slide clamp is inserted into a slide clamp receptacle on the pump. In this example, the identification information indicates to the pump that the type of administration associated with the loaded line set is enteral administration. Since the identified type of administration is enteral, the pump software configures the pump for enteral administration based on data relating to the enteral administration in a set of administration line set profile data. In this particular example, the pump initiates recording of the history of fluid volume changes.

In a second example, an administration line set having an identifier is loaded into a pump. The identification system of the pump obtains identification information from the identifier when a slide clamp is inserted into a slide clamp receptacle on the pump. In this example, the identification information indicates to the pump that the type of administration associated with the loaded line set is epidural. Since the identified type of administration is epidural, the pump software configures the pump for epidural administration. In such a case, the pump activates a function including continuous drip irrigation of the fluid, and disables an automatic piggyback feature function of the pump, an air line sensing function of the pump, and an occlusion detection function of the pump.

It will be appreciated by those skilled in the art that the present invention may be embodied in many other specific forms without departing from the essential characteristics thereof. Therefore, the detailed description of the embodiments herein is for the purpose of illustration only and is not intended to limit the scope of the invention.

Claims (9)

1. A medical delivery system (10, 30) for delivering medication to a patient, the system comprising:

-a line set (14, 34) adapted to be connected to a container containing a drug;

an identifier (18) integrated with a slide clamp (42) associated with the line set, the identifier having identification information associated with the identifier; and

an infusion device (12, 32) configured to engage the line set and deliver medication to a patient, the infusion device including a recognition system (20) capable of obtaining identification information associated with the identifier and a slide clamp receptacle (44) integrated with the recognition system (20) configured to receive the slide clamp (42) associated with the line set (14, 34), the infusion device being configured based on the identification information, wherein the identification information includes a type of administration associated with the line set.

2. The system of claim 1, wherein the delivery device (12, 32) is automatically configured when the identification information is obtained from the identifier (18).

3. The system of claim 1 or 2, wherein the infusion device (12, 32) is capable of being functionally associated specifically with the obtained identification information when configured.

4. The system of claim 1, wherein the identification information includes information relating to an identification of at least one of a type of line set (14, 34) and a medication (17).

5. The system of claim 1, wherein the infusion device (12, 32) is an infusion pump (32).

6. The system of claim 1, wherein the drug (17) is one of a parenterally delivered fluid, a medicament, an electrolyte, blood, and a blood product.

7. A system as in claim 4, wherein the type of administration is one of intravenous, arterial, subcutaneous, epidural, interstitial fluid irrigation.

8. The system of claim 1, wherein the identifier (18) is one of a bar code, a passive RF device, a magnetic device, a non-volatile memory device.

9. The system of claim 1, wherein the infusion device (12, 32) is capable of being functionally associated specifically with a type of administration when configured.