PORTABLE MEMORY DEVICE FOR USE WITH AN INFUSION DEVICE - Patent application

Abstract

A portable memory device for use with an injection device, the portable memory device including a memory containing information that, when received by the injection device, causes the injection device to set a predetermined injection rate; causes the information to output confirmation that the predetermined injection rate has been properly programmed into the injection device; and is configured to automatically transmit the information to the injection device in response to the portable memory device being brought into a transmitting position relative to the injection device.

Description

[Technical field]

[0001] The present disclosure relates to a portable memory device for programming an infusion device, and to an infusion device configured to be programmed by a portable memory device. [Background technology]

[0002] There are various diseases that require regular treatment by injection of drugs using subcutaneous or intravenous routes of administration. Such injections can be performed using an injection device prepared and operated by medical personnel or the patient himself. As an example, type 1 and type 2 diabetes can be treated by the patient himself, for example, by subcutaneous injection of one or several insulin doses per day. Insulin can be administered by an infusion device, also known as an infusion pump.

[0003] Currently, there are two broad categories of infusion pumps available: 1) full-function pumps, which require the user to manually adjust the infusion rate or manually select a rate from an existing menu; and 2) pre-programmed infusion pumps, which are simply programmed to deliver a pre-programmed infusion rate.

[0004] Currently, most hospital or clinic-based infusion pumps require the nurse, medical professional, or patient to manually select the correct drug and concentration to be infused from built-in menu options and / or then program the correct infusion rate. In the context of insulin infusion pumps, there is an emerging trend to develop insulin pumps that are simple to use for patients who do not want to use full-featured pumps due to their complexity. Several pre-configured infusion pumps have been introduced that require manufacturers to develop and manage a variety of pre-configured devices, each with its own pre-configured infusion rate. This requirement can sometimes lead to increased costs and complexities associated with both manufacturing and distribution management. Summary of the Invention [Problem to be solved by the invention]

[0005] There is a need to simplify the manufacturing and supply chain management process while maintaining simplicity for the patient by not requiring manual programming of the infusion pump, and there is also a need to reduce the likelihood of infusion pumps being inaccurately programmed by either the patient or healthcare professionals. [Means for solving the problem]

[0006] A first aspect disclosed herein is a portable memory device for use with an infusion device, the memory including information that, when received by the infusion device, provides to the infusion device: Set a desired infusion rate; outputting a confirmation that the predetermined infusion rate has been properly programmed into the infusion device; A portable memory device is provided that is configured to automatically transmit information to the infusion device in response to the portable memory device being brought into a transmitting position relative to the infusion device.

[0007] The information may include an indication of one of a number of pre-configured infusion programs stored in the infusion device.

[0008] The information may include executable instructions configured to be executed by the infusion device to cause the infusion device to set a predetermined infusion rate.

[0009] The color of the portable memory device may be correlated with a given infusion rate.

[0010] The read-only memory may further include data relating to the predetermined injection rate and may be further configured to automatically transmit the data relating to the predetermined injection rate to the injection device when the portable memory device is brought into a transmitting position relative to the injection device.

[0011] The memory may be a read-only memory. The information may further be, when received by the infusion device, to cause the infusion device to prevent changes to the predetermined infusion rate until a further portable memory device is brought into transmitting position with respect to the infusion device.

[0012] The transmission position may require the portable memory device to be inserted into a port of the infusion device. The transmission position may require the portable memory device to be placed in contact with a housing of the infusion device. The transmission position may be a non-contact position.

[0013] The portable memory device can be configured to use radio frequency bands to transmit information to the infusion device.

[0014] A second aspect disclosed herein provides a drug container configured to be coupled to an injection device such that a drug contained in the drug container is deliverable by the injection device, the drug container including a portable memory device according to the first aspect.

[0015] A third aspect disclosed herein is an infusion device configured for use with a portable memory device, comprising: a receiver configured to receive information from the portable memory device in response to the portable memory device being brought into a transmitting position relative to the injection device; a processor configured to read the information and responsively set a predetermined infusion rate; The infusion device is further configured to automatically output a confirmation that the predetermined infusion rate has been properly programmed into the infusion device.

[0016] The infusion device may further include a display device on which a visual confirmation that the infusion device has been properly programmed is displayed.

[0017] The infusion device may further include a speaker, which may be used to provide an audible confirmation that the infusion device has been properly programmed.

[0018] The infusion device may further include one or more LEDs, which may be used to provide confirmation that the infusion device has been properly programmed.

[0019] The one or more LEDs may include a plurality of different colored LEDs, and confirmation that the infusion device has been properly programmed may include illuminating one of the plurality of different colored LEDs that corresponds to a color of the portable memory device brought into a transmitting position with respect to the infusion device.

[0020] The infusion device may further be configured to prevent manual adjustment of the predetermined infusion rate setting.

[0021] The infusion device may be further configured to allow the predetermined infusion rate setting to be adjusted within a predetermined range of infusion rate settings.

[0022] A fourth aspect disclosed herein is a medical device system including an infusion device and a portable memory device for use with the infusion device, the portable memory device comprising: a memory containing information, the information, when received by the infusion device, to the infusion device: Set a desired infusion rate; outputting a confirmation that the predetermined infusion rate has been properly programmed into the infusion device; The portable memory device is configured to automatically transmit information to the infusion device in response to the portable memory device being brought into a transmitting position relative to the infusion device; the infusion device is configured to: a receiver configured to receive information from the portable memory device in response to the portable memory device being brought into a transmitting position relative to the injection device; a processor configured to read the information and responsively set a predetermined infusion rate; A medical device system is provided in which the infusion device is further configured to automatically output a confirmation that the predetermined infusion rate has been properly programmed into the infusion device. [Brief description of the drawings]

[0023] [Figure 1] FIG. 1 is a schematic diagram of an insulin infusion pump. [Figure 2a] 1A-1D illustrate three different designs of a portable memory device. [Figure 2b] 1A-1D illustrate three different designs of a portable memory device. [Figure 2c] 1A-1D illustrate three different designs of a portable memory device. [Diagram 3] 2A, 2B and 2C and the infusion pump of FIG. 1 in a home use setting in which the infusion pump is programmed by a nurse, pharmacist or other medical personnel. [Figure 4] 2A, 2B and 2C and the infusion pump of FIG. 1 in a home use setting in which the infusion pump is programmed by the patient. [Diagram 5] 1 is a flow chart illustrating an exemplary use of a portable memory device and an infusion pump in a clinic or hospital setting where the infusion pump is programmed and operated by medical personnel. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] In the following disclosure, embodiments are described with reference to insulin infusion pumps, although the disclosure is not limited to such applications and can be equally well extended to injection devices for injecting other medications.

[0025] 1 is a schematic diagram of an insulin infusion pump 100 (also referred to herein as an infusion device) including a processor 102, memory 104, infusion mechanism 106, transceiver 108, and port 110. The infusion pump may be a wearable device, such as, for example, a portable patch pump, and may be operated by the patient. In some other embodiments, the infusion pump is a larger volume device designed for use in a clinic or hospital setting and operated only by qualified medical personnel.

[0026] The processor 102 may be, for example, a microprocessor, a microcontroller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), etc., and may include RAM.

[0027] The memory 104 may store both program code (e.g., software or firmware) and data. The processor 102 is configured to execute the program code stored in the memory and to read, write and / or delete data from the memory 104. The memory 104 may be a read-only memory (ROM) or a writable memory, such as a flash memory or a solid-state drive. The memory 104 stores several pre-programmed programs 112-1, 112-2, 112-3, etc. and / or a set of executable instructions 114. Each of the pre-programmed programs 112-1, 112-2, 112-3 defines an infusion rate or infusion profile to be used by the infusion pump 100. The processor 102 uses the executable instructions 114 to control the infusion mechanism 106 to deliver insulin at a rate defined by one of the pre-programmed programs 112-1, 112-2, 112-3.

[0028] Infusion pump 100 also has a transceiver 108 for bidirectional communication with a portable memory device (described with reference to FIGS. 2a-2c), and a port 110 for receiving and reading the portable memory device. Depending on its design, infusion pump 100 may include both transceiver 108 and port 110, or may include only one of these components.

[0029] Infusion pump 100 may optionally include a display 116, a speaker 118, and one or more LEDs 120 for providing information and feedback to the user.

[0030] The infusion pump 100 may be of the disposable variety, intended for a single use or just a few uses by a patient. For example, the infusion pump may be a wearable patch pump designed for a single use by a patient. In some other embodiments, the infusion pump is a larger capacity device designed to be used in a clinic or hospital setting and operated only by qualified medical personnel.

[0031] 2a, 2b, and 2c, there are shown three different designs of portable memory device 200. In some embodiments, portable memory device 200 may be color coded to indicate the predetermined injection rates stored therein. For example, the entire housing of portable memory device 200 may be made from a colored material, such as plastic.

[0032] The first portable memory device 200-1 shown in FIG. 2a includes a memory 202-1 and an interface 204-1. The memory 202-1 is a read-only memory. In some embodiments, the memory 202-1 cannot be reprogrammed after manufacture. The interface 204-1 allows the portable memory device to be coupled to the port 110 of the infusion pump 100 of FIG. 1 and read by the infusion pump. The interface 204-1 may include electrical contacts that allow electronic data exchange with the port 110. The memory 202-1 stores information regarding a predetermined infusion rate. The information may be an indication of a pre-set program stored in the memory 104 of the infusion pump 100. Alternatively or additionally, the information may define the infusion rate in suitable units, such as mL / hour or units / hour. In some other embodiments, the memory 202-1 stores both the information and executable instructions defining the infusion rate required by the infusion pump 100 to control the administration of a medication contained therein.

[0033] The port 110 of the infusion pump 100 is sized to receive at least the interface 204-1 of the first portable memory device 200-1. Both the port 110 and the interface 204-1 may have an unusual shape to ensure that the infusion pump 100 cannot accept a memory device designed for another purpose. When the first portable memory device 200-1 is inserted into the port 110, the memory 202-1 is automatically read by the infusion pump 100 to retrieve information therein. Such retrieval of information occurs automatically, without further user input or programming in either the infusion pump 100 or the first portable memory device 200-1. In embodiments where the information explicitly defines an infusion rate, the processor 102 then uses the executable instructions 114 to program the infusion pump 100 with the defined infusion rate. In embodiments where the information represents one of the pre-set programs stored in the memory 104 of the infusion pump 100, the processor 102 uses the executable instructions 114 to program the infusion pump 100 with the infusion rate defined by the represented program. In embodiments where the information includes executable instructions as well as information defining an infusion rate, the processor 102 uses the executable instructions provided by the first portable memory device 200-1 to program the infusion pump 100 accordingly.

[0034] Referring to FIG. 2b, a second portable memory device 200-2 is shown. The second portable memory device 200-2 also includes a memory 202-2, which may be similar or identical to the memory 202-1. The memory 202-2 is a read-only memory. In some embodiments, the memory 202-2 cannot be reprogrammed after manufacture. The second portable memory device 200-2 also includes a processor 206-2, a transceiver 208, and a battery 210. The processor 206-2 is configured to control the transceiver 208 to at least transmit information stored in the memory 202-2. The transceiver 208 may enable the second portable memory device 200-2 to communicate at radio frequencies, for example, via the industrial, scientific and medical (ISM) radio band. The transceiver 208 may be configured for short-range communication only.

[0035] The battery 210 is configured to power both the processor 206-2 and the transceiver 208. The second portable memory device 200-2 may be configured to determine when it is in proximity to the infusion pump 100. For example, the transceiver 108 of the infusion pump 100 may periodically or continuously transmit a signal that can be received by the transceiver 208. The signal may include an identifier of the infusion pump 100 or may be a more general notification of presence. The strength of the signal may be detectable by the second portable memory device 200-2 only when it is in close proximity to the infusion pump 100, such as within 10 cm. Alternatively, the second portable memory device 200-2 may be configured to recognize the proximity of the infusion pump 100 only when the strength of the signal detected by the transceiver 208 exceeds a predetermined threshold. In practice, this may only occur when the second portable memory device 200-2 is placed in contact with the housing of the infusion pump 100.

[0036] Upon determining that the second portable memory device 200-2 is in the vicinity of the infusion pump 100, the information stored in memory 202-2 is communicated to the infusion pump via the transceiver 208 / 108 of each device. Such communication of information occurs automatically, without further user input or programming in either the infusion pump 100 or the second portable memory device 200-2. In embodiments in which the information explicitly defines an infusion rate, the processor 102 then uses the executable instructions 114 to program the defined infusion rate into the infusion pump 100. In embodiments in which the information indicates one of the pre-set programs stored in the memory 104 of the infusion pump 100, the processor 102 then uses the executable instructions 114 to program the infusion pump 100 with the infusion rate defined by the indicated program. In embodiments in which the information includes executable instructions as well as information defining an infusion rate, the processor 102 uses the executable instructions provided by the second portable memory device 200-2 to program the infusion pump 100 accordingly.

[0037] Referring to FIG. 2c, a third portable memory device 200-3 is shown. The third portable memory device 200-3 also includes a memory 202-3 that may be similar or identical to the memories 202-1 and 202-2. The memory 202-3 is a read-only memory. In some embodiments, the memory 202-3 cannot be reprogrammed after manufacture. The third portable memory device 200-3 also includes a processor 206-3 that may be similar or identical in configuration to the processor 206-2. The third portable memory device 200-3 includes an NFC antenna 212. In some embodiments, the third portable memory device 200-3 includes an internal power source (not shown) to power at least the processor 206-3. In some other embodiments, the third portable memory device 200-3 does not have an internal power source and relies on a signal emitted by the transceiver 108 of the infusion pump 100 to provide the power necessary to transmit the information stored in the memory 202-3 in the manner of a proximity card or RFID tag. The NFC antenna 212 can be configured to operate in the ISM radio band.

[0038] The transceiver 108 of the infusion pump 100 may periodically or continuously transmit a signal receivable by the NFC antenna 212. For example, the infusion pump 100 may transmit at radio frequencies using the ISM radio band. When the third portable memory device 200-3 approaches the infusion pump 100, the signal emitted by the transceiver 108 induces a current in the NFC antenna 212. The processor 206-3 uses the energy absorbed from the signal to transmit information stored in the memory 202-3 using the NFC antenna 212. Such transmission of information occurs automatically, without further user input or programming in either the infusion pump 100 or the third portable memory device 200-3. In embodiments where the information explicitly defines an infusion rate, the processor 102 then programs the defined infusion rate into the infusion pump 100 using the executable instructions 114. In embodiments in which the information indicates one of the pre-set programs stored in memory 104 of infusion pump 100, processor 102 uses executable instructions 114 to program infusion pump 100 with the infusion rate defined by the indicated program. In embodiments in which the information includes executable instructions as well as information defining an infusion rate, processor 102 uses executable instructions provided by third portable memory device 200-3 to program infusion pump 100 accordingly.

[0039] The effective range of the NFC antenna 212 may be very short, for example, less than 5 cm, which is advantageous because it may prevent accidental programming of the infusion pump 100. The housing of the infusion pump 100 may include an area that includes an indication that a third portable memory device 206-3 should be placed near or against the housing in that area to affect the transfer of information stored in the memory device.

[0040] It will be understood that the portable memory device 200 shown in Figures 2a, 2b and 2c is schematic and omits certain other components and connections that may be necessary for the operation of the device, such as capacitors, resistors, secondary memory, antennas and other standard circuit elements.

[0041] Whatever the design of the portable memory device 200, once the predetermined infusion rate has been successfully programmed into the infusion pump 100, the executable instructions 114 cause the infusion pump 100 to output a confirmation that the infusion pump has been properly programmed. The feedback may be provided visually on the display 116 and / or by an audible notification provided via the speaker 118. In some other embodiments, one or more colored LEDs 120 may be illuminated to indicate that the infusion pump has been properly programmed. In embodiments in which the portable memory device 200 is color-coded, the LEDs 120 may be configured to emit light that matches the color of the inserted portable memory device to provide confirmation that the infusion pump 100 has been properly programmed. The LEDs 120 may be provided in lieu of or in addition to the display 116 and / or speaker 18. For example, if the infusion pump is a single-use disposable device, it may be advantageous to omit the display 116 and speaker 18 and provide user feedback exclusively through the use of colored LEDs.

[0042] In embodiments compatible with the first portable memory device 200-1, after verifying that the predetermined infusion rate has been properly programmed into the infusion pump, the user removes the portable memory device 200 from the port 110. In some other embodiments, the portable memory device 200 remains in the port 110 until the infusion process is complete to prevent the possibility of reprogramming the infusion pump during an infusion. In some embodiments, both the infusion pump 100 and the first portable memory device 200-1 are disposable, and the memory devices cannot be removed from the infusion pump 100 once inserted.

[0043] 2b and 2c, it is sufficient for portable memory device 200 to be in close proximity to or in contact with infusion pump 100 to program the infusion pump. Portable memory device 200-2 / 200-3 can be used multiple times to program different infusion pumps 100. Conversely, infusion pump 100 is configured to receive programming instructions from different portable memory devices 200-2 / 200-3 and be reprogrammed multiple times.

[0044] In all embodiments, the infusion pump 100 may not be able to change the programmed infusion rate until a different portable memory device 200 is inserted into or in close proximity to the infusion pump. Alternatively, some limited adjustment of the set infusion rate may be allowed.

[0045] The portable memory device 200 described above is advantageous to users of infusion pumps because it reduces the burden of properly programming the infusion pump and reduces the likelihood of errors on the part of the user when programming. The complexity and likelihood of errors when programming an infusion pump can be a hindrance to many users involved in self-medication therapy and can increase the burden on the medical infrastructure and medical personnel. This can be especially true for users who are unfamiliar with such technology or who are visually impaired or clumsy. Providing a system that can automatically program a range of different pre-defined infusion rates into the infusion pump 100 without the user having to manually input information alleviates such challenges. Providing a portable memory device that not only allows the infusion pump to automatically program the correct infusion rate, but also outputs confirmation that it has been properly programmed, leads to a system that is intuitive and easy to use for all users.

[0046] In a further embodiment, the portable memory device 200 is integrated with the drug container or co-packaged with a pharmaceutical product intended for intravenous delivery. Thus, when the drug container is coupled to the infusion pump 100, the infusion pump is programmed with a predetermined infusion rate that is also stored in the portable memory device. This is advantageous because it reduces the possibility of an incorrect infusion rate being programmed by a user of the infusion pump 100. For example, the infusion pump 100 can be used in a hospital setting to deliver a wide range of different drugs that require different infusion rates. Packaging the portable memory device 200 with the pharmaceutical product allows the product to be clearly identified when the portable memory device is inserted into the infusion pump 100, thereby reducing the possibility of an incorrect drug being administered to a patient. The name of the drug and other important attributes (e.g., concentration) can be displayed on the display 116 of the infusion pump 100. Furthermore, delivering a drug too fast or too slow can be very dangerous for a patient in some cases. Providing a system in which a predetermined infusion rate is automatically programmed into the infusion pump 100, with a nurse or medical professional only needing to verify that the correct rate has been programmed, can significantly reduce the likelihood of error.

[0047] The portable memory device 200 may implement certain protections to prevent programming of unsafe or inconsistent infusion rates. For example, use of the portable memory device 200 with the infusion pump 100 may prevent any other infusion rate from being programmed into the infusion pump 100 other than the infusion rate defined by the portable memory device 200. In some embodiments, the infusion pump 100 may have no user input capabilities and the only manner in which the infusion pump is programmed is through the use of the portable memory device 200. In some other embodiments, the infusion pump 100 may retain the ability to receive infusion rate input from the user. In those embodiments, the infusion rate, once set, may only be adjusted within a limited range to prevent programming of a potentially unsafe infusion rate.

[0048] The infusion device 100 may include audible and / or visual alarms to alert the user and others if an infusion rate different from that defined by the portable memory device 200 is programmed into the infusion device. The display 116 and / or speaker 118 may be used to provide such alarms. In some embodiments, if a user attempts to program an infusion rate outside of a predetermined range, the infusion device 100 may activate an electronic lockout feature that prevents the infusion mechanism 106 from being operated.

[0049] The portable memory device 200 and infusion pump 100 described above may have a variety of usage scenarios. For example, the infusion pump may be intended for use by a patient at home and may be programmed by the patient's medical professional or the patient themselves using the portable memory device 200. Alternatively, the infusion pump may be intended for use in a hospital or clinic and may be operated and programmed by a nurse or other medical professional. These usage scenarios are discussed in further detail with reference to the flow charts of FIGS. 3-5.

[0050] FIG. 3 is a flow chart illustrating an exemplary use of the portable memory device 200 and infusion pump 100 in a home use setting (eg, for insulin therapy) where the infusion pump 100 is programmed by a nurse, pharmacist, or other medical personnel.

[0051] At step 300, a clinic or medical practitioner's office receives a universal infusion pump 100 as well as an associated portable memory device 200. The portable memory devices 200 may represent a range of different infusion rates and may have housings that are color coded according to the infusion rates stored on each portable memory device 200.

[0052] At step 302, a physician or other medical practitioner prescribes a treatment for the patient, including an infusion delivery rate. The infusion delivery rate may be specified, for example, in ml / hour or units / hour. The physician may record the color on the portable memory device 200 that corresponds to the prescribed infusion rate, or a program may do so automatically. Color information may be added to the prescription.

[0053] A nurse or other medical personnel then provides the infusion pump to the patient. At step 304, the nurse or other medical personnel selects the correct portable memory device 200 as indicated on the patient's prescription. Optional color coding of the portable memory device 200 assists the nurse in verifying that the correct portable memory device 200 has been selected. At step 306, the nurse or other medical personnel programs the infusion pump using the portable memory device 200, as described in detail above with reference to Figures 2a, 2b, and 2c. As part of providing the infusion pump 100 to the patient, the nurse may train the patient on the use of the infusion pump 100.

[0054] At step 308, the infusion pump 100 provides visual and / or audible feedback that programming is complete. For example, a message may be displayed on the infusion pump's display 116 indicating that the infusion pump is now programmed and the infusion rate setting is indicated. Alternatively or additionally, the confirmation may include a graphic or animated display. The visual indication may be supplemented by a sound emitted by the speaker 118, such as a series of sounds. In some embodiments, the infusion pump 100 does not have a display and only audible feedback is provided. In some other embodiments, the infusion pump 100 includes one or more LEDs 120. The LEDs 120 may be used to provide feedback that the infusion pump 100 has been properly programmed. In some embodiments, several different colored LEDs 120 may be provided on the housing of the infusion pump 100 for clear visibility to the user. The LEDs 120 may be color coded according to the portable memory device 200. The corresponding colored LEDs 120 may be illuminated or flashed to indicate successful programming of the infusion pump 100 with the portable memory device 200.

[0055] After successful programming of the infusion pump 100, the nurse hands the infusion pump over to the patient, who takes it home for use, step 310. In the embodiment of Figure 3, the patient does not own the portable memory device 200 and therefore cannot reprogram the infusion pump 100 once in the patient's possession. Even if the infusion device has a user interface for setting the infusion rate, that function can be electronically locked out through the use of the portable memory device 200, thus preventing any accidental or deliberate reprogramming of the infusion rate.

[0056] At optional step 312, the physician or other medical personnel determines whether an updated infusion rate is needed. For example, the patient's records may indicate that a different infusion rate may provide better treatment outcomes than the original rate prescribed, or the patient may be on a treatment plan that requires a change in infusion rate. If no change is needed, the process ends at step 314. If the user requires more infusion therapy, the therapy may continue as originally prescribed. If a change is needed, the physician prescribes a new infusion rate at step 312, and the process returns to step 304.

[0057] 3 is that the patient does not need to be involved in any programming of the infusion pump 100. Some patients may not want or be able to program the infusion pump 100, allowing them to be provided with a generic infusion pump programmed with their prescribed infusion rate. Additionally, infusion pump manufacturers can provide clinics with one type of infusion pump and rely on the doctor / nurse to properly configure the infusion pump for patient use.

[0058] FIG. 4 is a flow chart illustrating an exemplary use of the portable memory device 200 and infusion pump 100 in a home use setting where the infusion pump 100 is programmed by the patient (eg, for insulin therapy).

[0059] At step 400, a physician or other medical professional prescribes a treatment for the patient, including an infusion delivery rate. The infusion delivery rate may be specified, for example, in ml / hour or units / hour. The physician may record the color on the portable memory device 200 that corresponds to the prescribed infusion rate, or a program may do so automatically. Color information may be added to the prescription.

[0060] At optional step 402, a nurse, pharmacist, or other medical personnel trains the patient in the use of the infusion pump 100. Alternatively, the infusion pump may come with written instructions for use.

[0061] At step 404, the patient receives an unprogrammed infusion pump 100. The patient may, for example, collect the infusion pump 100 from a pharmacy or have the infusion pump delivered to their residence. Also as part of step 404, the patient receives a portable memory device 200 that defines the infusion rate according to their prescription. The patient's prescription may indicate a color code for the portable memory device 200 prescribed to the patient. In some embodiments, the portable memory device 200 is integrated with or co-packaged with a medication container. The patient can then match the color of the portable memory device 200 or medication / memory device combination to the color indicated on the prescription.

[0062] At step 406, the patient programs the infusion pump 100 using the portable memory device 200 as described in detail above with reference to Figures 2a, 2b and 2c. The process is intuitive and simple for the patient, as it only requires inserting the portable memory device 200 into the port 110 of the infusion pump 100 or bringing the portable memory device 200 into close proximity to the infusion pump 100.

[0063] At step 408, the infusion pump 100 provides visual and / or audible feedback that programming is complete. For example, a message may be displayed on the infusion pump's display 116 indicating that the infusion pump is now programmed and the infusion rate setting is indicated. Alternatively or additionally, the confirmation may include a graphic or animated display. The visual indication may be supplemented by a sound emitted by the speaker 118, such as a series of sounds. In some embodiments, the infusion pump 100 does not have a display and only audible feedback is provided. In some other embodiments, the infusion pump 100 includes one or more LEDs 120. The LEDs 120 may be used to provide feedback that the infusion pump 100 has been properly programmed. In some embodiments, several different colored LEDs 120 may be provided on the housing of the infusion pump 100 for clear visibility to the user. The LEDs 120 may be color coded according to the portable memory device 200. The corresponding colored LEDs 120 may be illuminated or flashed to indicate successful programming of the infusion pump 100 with the portable memory device 200. The feedback gives the user confidence that the infusion pump 100 has been programmed correctly. Although this usage scenario requires the user to do some programming of the infusion pump 100, the programming technique is fairly simple and the chance of error is low as long as the user is provided with the correct portable memory device 200. If an incorrect portable memory device 200 has been provided, the user can be made aware of this by also being informed of the color of the portable memory device 200 that corresponds to the prescribed infusion rate.

[0064] At optional step 410, the physician or other medical personnel determines whether an updated infusion rate is needed. For example, the patient's records may indicate that a different infusion rate may provide better treatment outcomes than the original rate prescribed, or the patient may be on a treatment plan that requires a changing infusion rate. If no change is needed, the process ends at step 412. If the user requires more infusion therapy, the therapy may continue as originally prescribed. If a change is needed, the physician prescribes a new infusion rate at step 312, and the process returns to step 404. The patient may not receive a new infusion pump 100, as the pump is generic and reprogrammable.

[0065] FIG. 5 is a flow chart illustrating an exemplary use of the portable memory device 200 and infusion pump 100 in a clinic or hospital setting where the infusion pump 100 is programmed and operated by medical personnel.

[0066] At step 500, a physician or other medical professional prescribes a treatment for the patient, including an infusion delivery rate. The infusion delivery rate may be specified, for example, in ml / hour or units / hour. The physician may record the color on the portable memory device 200 that corresponds to the prescribed infusion rate, or a program may do so automatically. The color information may be added to the patient's record.

[0067] At step 502, the pharmacy prepares the medication as ordered and supplies the correct portable memory device 200. An initial cross-check of the prescribed infusion rate can be performed by the pharmacist by looking at the color of the portable memory device 200 supplied with the medication. In some embodiments, the portable memory device 200 is integral with or co-packaged with the medication container.

[0068] At step 504, a nurse or other medical professional prepares the infusion pump 100 by programming it using the portable memory device 200 provided at step 502, as described in detail above with reference to Figures 2a, 2b and 2c.

[0069] At step 506, the infusion pump 100 provides visual and / or audible feedback that programming is complete. For example, a message may be displayed on the infusion pump's display 116 indicating that the infusion pump is now programmed and the infusion rate setting is indicated. Alternatively or additionally, the confirmation may include a graphic or animation. The visual indication may be supplemented with a sound emitted by the speaker 118, such as a series of sounds. Such feedback allows the nurse to compare the programmed flow rate with that specified in the instructions. The infusion pump 100 may require positive confirmation that the programmed infusion rate is correct. Once programmed with the portable memory device 200, the infusion pump 100 cannot allow adjustments to the infusion rate, which helps prevent inconsistent or dangerous infusion rates from being administered to the patient. In some other embodiments, the amount by which the programmed infusion rate can be adjusted is limited to within a predetermined range. If the nurse notices a discrepancy between the programmed rate and the rate specified in the order, or if the color of the portable memory device 200 does not match the color of the order, the physician (or similarly qualified medical practitioner) who prescribed the treatment can be contacted to confirm the correct infusion rate and / or provide a new portable memory device 200. Such a system provides another level of check that the infusion rate is correct without affecting the time that physicians and nurses need to prescribe and administer the infusion.

[0070] In some embodiments, the infusion pump 100 does not have a display and only audible feedback is provided. In some other embodiments, the infusion pump 100 includes one or more LEDs 120. The LEDs 120 can be used to provide feedback that the infusion pump 100 has been properly programmed. In some embodiments, several different colored LEDs 120 can be provided on the housing of the infusion pump 100 for clear visibility to the user. The LEDs 120 can be color coded according to the portable memory device 200. The corresponding colored LED 120 can light up or flash to indicate successful programming of the infusion pump 100 with the portable memory device 200.

[0071] At step 508 , the nurse or other medical personnel initiates the infusion with the infusion pump 100 .

[0072] As is evident from the embodiments described above, infusion pump 100 can be of a standardized type, which means that the manufacturer of infusion pump 100 only needs to design, develop, manufacture and distribute one type of infusion device. The manufacturer does not need to change any aspect of the manufacturing process to produce an infusion pump that can be programmed for various infusion rates and is also easy to use without error by the patient. This significantly reduces the costs associated with the development and manufacturing process, as well as the logistics of distributing the device to clinics, pharmacies and patients.

[0073] In one particular embodiment, color-coded portable memory devices 200 may be provided that store predetermined infusion rates in increments of 1 ml per hour. For example, six different portable memory devices 200 may be provided that correspond to the following predetermined infusion rates: White - 1 ml / hour; Yellow - 2 ml / hour; Blue - 3 ml / hour; Green - 4 ml / hour; Red - 5 ml / hour; Black - 6 ml / hour. This embodiment is given by way of example only, and other ranges of predetermined rates may be provided, as well as different increments. If the infusion pump 100 allows limited adjustment of the predetermined rate, the limited adjustment may be ±0.5 ml / hour or may be determined as half the standard increment between different portable memory devices 200.

[0074] The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or their pharma- ceutically acceptable salts or solvates, and optionally a pharma- ceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medicines are used to treat, cure, prevent, or diagnose diseases or otherwise improve physical or mental well-being. Drugs or medicines can be used for a limited duration or periodically for chronic disorders.

[0075] As described below, drugs or agents may include at least one API or combinations thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules with molecular weights of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0076] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. Storage can be at room temperature (e.g., about 20° C.) or at refrigerated temperatures (e.g., from about −4° C. to about 4° C.). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components prior to and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0077] The drugs or agents contained in the drug delivery devices described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders are acute coronary syndromes (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those found in handbooks such as Rote Liste 2014 (e.g., but not limited to, main groups 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.

[0078] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharma-ceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or replaced amino acid residue can be either a codable amino acid residue or another naturally occurring residue or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, e.g., the molecular structure of human insulin in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable ones, are added to the naturally occurring peptide.

[0079] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline in position B28 may be replaced by Asp, Lys, Leu, Val or Ala and in which the Lys in position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0080] Examples of insulin derivatives are e.g. B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl-LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. ; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0081] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flatfish), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rexendin -4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C, CM-3, GLP-1 Erigen, ORMD-0901, NN-9924, NN-9926, NN-9927, nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, exenatide-XTEN and glucagon-Xten.

[0082] An example of an oligonucleotide is, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia.

[0083] Examples of DPP4 inhibitors are vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0084] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0085] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or derivatives thereof, or sulfated polysaccharides, such as the above-mentioned polysaccharides in polysulfated form, and / or their pharma- ceutically acceptable salts. An example of a pharma-ceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F20 (Synvisc®), sodium hyaluronate.

[0086] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins (CODV) with crossover binding region orientation.

[0087] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to an antigen. An antibody fragment can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present disclosure include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0088] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences in the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences in the variable regions of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the proper arrangement of the CDR sequences to allow antigen binding. Although the framework region itself typically does not directly participate in antigen binding, as is known in the art, certain residues in the framework region of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0089] Exemplary antibodies are anti-PCSK-9 mAb (eg, alirocumab), anti-IL-6 mAb (eg, sarilumab), and anti-IL-4 mAb (eg, dupilumab).

[0090] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use in the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0091] Those skilled in the art will appreciate that modifications (additions and / or omissions) of the various components, formulations, devices, methods, systems and embodiments of the API described herein may be made without departing from the overall scope of the present disclosure, and that the present disclosure encompasses such modifications and all equivalents thereof. In this regard, any elements that are equivalent to the elements specified in the claims are to be given full consideration.

Claims

1. 1. A portable memory device for use with an infusion device, comprising a memory containing information which, when received by the infusion device, provides to the infusion device: Setting a predetermined infusion rate; outputting a confirmation that the predetermined infusion rate has been properly programmed into the infusion device; the portable memory device is configured to automatically transmit information to the infusion device in response to the portable memory device being brought into a transmitting position relative to the infusion device; The color of the portable memory device is correlated with a given injection rate; The portable memory device.

2. the information includes an indication of one of a plurality of pre-defined infusion programs stored in the infusion device; The indication is an indication regarding the injection rate.

10. The portable memory device of claim 1.

3. 10. The portable memory device of claim 1, wherein the information includes executable instructions configured to be executed by the infusion device to cause the infusion device to set a predetermined infusion rate.

4. A portable memory device as described in any one of claims 1 to 3, wherein the read-only memory further contains data relating to a predetermined injection rate, and is further configured to automatically transmit the data relating to the predetermined injection rate to the injection device when the portable memory device is brought into a transmitting position relative to the injection device.

5. A portable memory device according to any preceding claim, wherein the memory is a read-only memory.

6. A portable memory device according to any one of claims 1 to 5, wherein the information, when received by the injection device, causes the injection device to prevent alteration of the predetermined injection rate until a further portable memory device is brought into transmitting position with respect to the injection device. 。

7. A portable memory device according to any preceding claim, wherein the transmission location requires the portable memory device to be inserted into a port of an injection device.

8. A portable memory device according to any preceding claim, wherein the transmission position requires the portable memory device to be placed in contact with a housing of the injection device.

9. A portable memory device according to any one of claims 1 to 6, wherein the transmitting position is a contactless position.

10. 10. A portable memory device according to claim 8 or claim 9, adapted to use radio frequency bands to transmit information to the injection device.

11. A drug container configured to be coupled to an injection device such that a drug contained in the drug container is deliverable by the injection device, the drug container comprising a portable memory device according to any one of claims 1 to 10.

12. 1. An infusion device configured for use with a portable memory device, comprising: a receiver configured to receive information from the portable memory device in response to the portable memory device being brought into a transmitting position relative to the injection device; a processor configured to read the information and responsively set a predetermined infusion rate; and further configured to automatically output a confirmation that the predetermined infusion rate has been properly programmed into the infusion device; and further comprising one or more LEDs, wherein the one or more LEDs are used to indicate confirmation that the infusion device has been properly programmed; the one or more LEDs include a plurality of differently colored LEDs, and confirmation that the infusion device has been properly programmed includes illuminating one of the plurality of differently colored LEDs that corresponds to a color of the portable memory device brought into a transmitting position with respect to the infusion device; The injection device.

13. 13. The infusion device of claim 12, further comprising a display device, wherein a visual confirmation is displayed on the display device that the infusion device has been properly programmed.

14. 14. An infusion device according to claim 12 or claim 13, further comprising a speaker, wherein the speaker is used to provide audible confirmation that the infusion device has been properly programmed.

15. An injection device according to any one of claims 12 to 14, further configured to prevent manual adjustment of the predetermined injection rate setting.

16. An injection device according to any one of claims 12 to 14, further configured to allow the predetermined injection rate setting to be adjusted within a predetermined range of injection rate settings.

17. 1. A medical device system including an infusion device and a portable memory device for use with the infusion device, the portable memory device comprising: a memory containing information which, when received by the infusion device, causes the infusion device to: Setting a predetermined infusion rate; outputting a confirmation that the predetermined infusion rate has been properly programmed into the infusion device; The portable memory device is configured to automatically transmit information to the infusion device in response to the portable memory device being brought into a transmitting position relative to the infusion device; the infusion device is configured to: a receiver configured to receive information from the portable memory device in response to the portable memory device being brought into a transmitting position relative to the injection device; a processor configured to read the information and responsively set a predetermined infusion rate; The infusion device is further configured to automatically output a confirmation that the predetermined infusion rate has been properly programmed into the infusion device; The color of the portable memory device is correlated with a given injection rate, and further comprising one or more LEDs, wherein the one or more LEDs are used to indicate confirmation that the infusion device has been properly programmed; the one or more LEDs include a plurality of differently colored LEDs, and confirmation that the infusion device has been properly programmed includes illuminating one of the plurality of differently colored LEDs that corresponds to a color of the portable memory device brought into a transmitting position with respect to the infusion device; The medical device system.

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