Smart liquid drug application

Abstract

In general, devices, systems, and methods of intelligent liquid drug administration are provided. In an exemplary embodiment, a pump is configured to receive a reservoir therein. The reservoir contains a medicament and includes a data storage component configured to store data. The pump includes a reader configured to read data from the data storage component. The pump is configured to deliver the medicament from the pump to a patient if the reservoir is received in the pump.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 317,789, filed on March 8, 2022, the entire disclosure of which is hereby incorporated by reference as if fully set forth herein. Technical Field

[0003] The present disclosure generally relates to smart liquid drug administration. Background Art

[0004] Drug products (including macromolecular drugs and small molecule drugs, hereinafter referred to as "drugs") are administered to patients in a variety of different ways to treat specific medical indications. Pumps are a type of drug administration device that can administer liquid drugs to patients. Some pumps can be worn by patients and can include a reservoir (such as a vial or cartridge) that contains liquid drugs for delivery to the patient through a needle or cannula inserted into the patient's body.

[0005] When administering the drug to the patient, care must be taken to avoid side effects to the patient. For example, care must be taken not to administer more than a safe amount of drug to the patient. Different patients may require different dosage forms of the drug. In addition, during the patient's treatment, the dosage of the drug to be delivered to the patient may change. Traditionally, pumps are configured to deliver a preset amount of drug to the patient, so the use of such pumps may not meet the needs of different patients and patients changing dosages. For another example, care must be taken to deliver the drug to the patient at a safe and comfortable rate. Different drugs can be delivered more comfortably at different rates. Traditionally, pumps are configured to deliver drugs at a preset rate, so such pumps may not be able to achieve different delivery rates, and therefore patients may feel uncomfortable. For yet another example, different reservoirs can hold different amounts of drug when loaded into the pump, but pumps traditionally do not take into account different drug volumes in the reservoir.

[0006] Furthermore, when it is possible to utilize different drugs in a given drug administration device or system, there is an increased risk that an incorrect dosing regimen will be used for the drug actually delivered to the patient.

[0007] Therefore, there remains a need for improved drug administration. Summary of the invention

[0008] Generally speaking, devices, systems, and methods for intelligent liquid drug administration are provided.

[0009] In one aspect, a drug administration system is provided, which in one embodiment includes a first reservoir, a second reservoir, and a pump. The first reservoir contains a first volume of a first drug therein and includes a first data storage component storing data indicating the first volume. The second reservoir has the same size as the first reservoir, contains a second volume of a second drug therein and includes a second data storage component storing data indicating the second volume. The second volume is different from the first volume. The pump is configured to receive each of the first reservoir and the second reservoir therein. The pump includes: a reader configured to read the stored data from the first data storage component and the second data storage component; a pumping assembly configured to drive the first drug from the pump for delivery to a patient and drive the second drug from the pump for delivery to the patient; and a control circuit operably connected to the reader and to the pumping assembly. The control circuit is configured to: receive first data from the reader indicating the stored data read from the first data storage component, use the received first data to establish a first dosing regimen for delivering the first drug, cause the pumping component to drive the first drug from the pump based on the first dosing regimen, receive second data from the reader indicating the stored data read from the second data storage component, use the received second data to establish a second dosing regimen for delivering the second drug, and cause the pumping component to drive the second drug from the pump based on the second dosing regimen.

[0010] The drug administration system can be varied in any manner. For example, the control circuit may be configured to establish the first dosing regimen before any delivery of the first drug from the pump to the patient, and the control circuit may be configured to establish the second dosing regimen before any delivery of the second drug from the pump to the patient. For another example, the first reservoir may be configured to be removed from the pump before the second reservoir is received in the pump. For another example, the reader may include a near field communication (NFC) reader, the first data storage component may include a first NFC tag, and the second data storage component may include a second NFC tag. For another example, the reader may include a QR code scanner, the first data storage component may include a first QR code, and the second data storage component may include a second QR code. For another example, the first data storage component may include a first electrically erasable programmable read-only memory (EEPROM), and the second data storage component includes a second EEPROM. For another example, the first drug may be the same as the second drug. For another example, the first drug may be different from the second drug. For yet another example, the first reservoir and the second reservoir may be configured to be preloaded into the pump. For yet another example, the first reservoir and the second reservoir may be configured to be loaded into the pump by a user. For another example, the first volume of the first drug may be delivered to the patient in the first dosing regimen, and the second volume of the second drug may be delivered to the patient in the second dosing regimen. For yet another example, the first volume of the first drug may be delivered to the patient in the first dosing regimen, and less than the second volume of the second drug may be delivered to the patient in the second dosing regimen.

[0011] In another embodiment, a drug administration system includes a pump and a reservoir. The pump includes a housing, a reader, and a control circuit. The reservoir is configured to contain a drug therein. The reservoir includes a data storage component configured to be preprogrammed with data indicating the dose of the drug to be delivered to the patient using the pump before the reservoir is received in the housing of the pump. The reader is configured to read the data indicating the dose from the data storage component when the reservoir is received in the housing of the pump. The control circuit is configured to receive data indicating the read data from the reader, the read data indicating the dose. The control circuit is configured to cause a dose of the drug at the dose to be delivered to the patient from the pump.

[0012] The drug administration system may have any number of variations. For example, the dose may be based on at least one of a pre-identified therapy and a pre-identified prescription for the drug for the patient. For another example, the dose may be based on the pre-identified weight of the patient. For yet another example, the dose may be based on at least one of gender, race, and genetic makeup. For yet another example, the reader may include a near field communication (NFC) reader, and the data storage component may include an NFC tag. For yet another example, the reader may include a QR code scanner, and the data storage component may include a QR code. For yet another example, the data storage component may include an EEPROM. For yet another example, the control circuit may be configured to cause one or more additives of the drug to be delivered to the patient from the pump, and each of the one or more additives of the drug may be at the dose. For another example, the reservoir may be configured to be non-removably received in the housing of the pump. For yet another example, the reservoir may be configured to be removably and replaceably received in the housing of the pump. For another example, the drug administration system may further include a second reservoir configured to contain a second drug therein, the second reservoir may include a second data storage component configured to be preprogrammed with data indicating a second dose of the second drug to be delivered to the patient using the pump before the second reservoir is received in the housing of the pump, the reader may be configured to read the data indicating the second dose from the second data storage component when the second reservoir is received in the housing of the pump, the control circuit may be configured to receive data indicating the read data from the reader, the read data indicating the second dose, and the control circuit may be configured to cause a dose of the second drug at the second dose to be delivered from the pump to the patient. For yet another example, the reservoir may be configured to be preloaded into the housing. For another example, the reservoir may be configured to be loaded into the housing by a user.

[0013] In another embodiment, a drug administration system includes a reservoir and a pump. The reservoir is configured to contain a drug therein. The reservoir includes a data storage component configured to store data about the drug therein. The reservoir includes a first alignment mechanism. The pump is configured to receive the reservoir therein. The pump includes a reader, a second alignment mechanism, and a control circuit. The reader is configured to read the stored data from the data storage component when the reservoir is received in the pump. The second alignment mechanism is configured to engage the first alignment mechanism. The engagement of the first alignment mechanism and the second alignment mechanism is configured to ensure that the data storage component is positioned within the effective reading range of the reader. The control circuit is configured to receive data indicating the stored data read from the data storage component from the reader, establish a dosing regimen for delivering the drug using the received data, and deliver the drug to the patient based on the dosing regimen.

[0014] The drug administration system can be varied in any manner. For example, in the case where the first alignment mechanism and the second alignment mechanism are not aligned, the reservoir cannot be fully received in the pump. For another example, the reader may include a near field communication (NFC) reader, and the data storage component may include an NFC tag. For another example, the reader may include a radio frequency identification (RFID) scanner, and the data storage component may include an RFID tag. For another example, the data storage component may include an EEPROM. For another example, the position of the data storage component may maximize the number of electromagnetic field lines generated by the reader passing through the data storage component. For another example, one of the first alignment mechanism and the second alignment mechanism may be a concave member, and the other of the first alignment mechanism and the second alignment mechanism may be a convex member configured to slide in the concave member. For another example, the reservoir may be configured to be pre-loaded into the pump. For another example, the reservoir may be configured to be loaded into the pump by a user.

[0015] In another aspect, a method of administering a drug is provided, the method comprising: a reader of a pump reads stored data from a first data storage component and a second data storage component; a control circuit of the pump establishes a first dosing regimen and causes a pumping component of the pump to drive a first drug from a first reservoir in the pump based on the first dosing regimen; and the control circuit establishes a second dosing regimen and causes the pumping component to drive a second drug from a second reservoir in the pump based on the second dosing regimen. The first reservoir contains a first volume of the first drug therein and includes the first data storage component storing data indicating the first volume. The second reservoir has the same size as the first reservoir, contains a second volume of the second drug therein and includes the second data storage component storing data indicating the second volume. The second volume is different from the first volume. The control circuit receives first data from the reader indicating the stored data read from the first data storage component, establishes the first dosing regimen using the received first data, receives second data from the reader indicating the stored data read from the second data storage component, and establishes the second dosing regimen using the received second data.

[0016] The drug administration method can be varied in any manner. For example, the control circuit can establish the first dosing regimen before any delivery of the first drug from the pump to the patient, and the control circuit can establish the second dosing regimen before any delivery of the second drug from the pump to the patient. For another example, the drug administration method may also include removing the first reservoir from the pump before the second reservoir is received in the pump. For another example, the reader may include a near field communication (NFC) reader, the first data storage component may include a first NFC tag, and the second data storage component may include a second NFC tag. For another example, the reader may include a QR code scanner, the first data storage component may include a first QR code, and the second data storage component may include a second QR code. For another example, the first data storage component may include a first EEPROM, and the second data storage component includes a second EEPROM. For another example, the first drug may be the same as the second drug. For another example, the first drug may be different from the second drug. For another example, each of the first reservoir and the second reservoir may be preloaded into the pump. For yet another example, each of the first reservoir and the second reservoir may be loaded into the pump by a user.

[0017] In another embodiment, a method of administering a drug includes: a reader of a pump reads data indicating a dosage from a data storage component of a reservoir with the reservoir received in a housing of the pump; and control circuitry of the pump causes a dose of the drug at the dosage to be delivered from the pump to the patient. The reservoir contains the drug therein. The data storage component is preprogrammed with data indicating the dosage of the drug to be delivered to the patient using the pump before the reservoir is received in the housing of the pump. The control circuitry receives data indicating the read data from the reader, the read data indicating the dosage.

[0018] The drug administration method may have any number of variations. For example, the dose may be based on at least one of a pre-marked therapy and a pre-marked prescription for the drug for the patient. For another example, the dose may be based on the pre-marked weight of the patient. For another example, the dose may be based on at least one of gender, race, and genetic makeup. For another example, the reader may include a near field communication (NFC) reader, and the data storage component may include an NFC tag. For another example, the reader may include a QR code scanner, and the data storage component may include a QR code. For another example, the data storage component includes an EEPROM. For another example, the control circuit may cause one or more additives of the drug to be delivered to the patient from the pump, and each of the one or more additives of the drug may be at the dose. For another example, the reservoir may be non-removably received in the housing of the pump. For another example, the reservoir may be removably and replaceably received in the housing of the pump. For another example, the reservoir may be preloaded into the housing. For yet another example, the reservoir may be loaded into the housing by a user.

[0019] For another example, the drug administration method may also include: the reader of the pump reads data indicating a second dose from a second data storage component of the second reservoir when the second reservoir is received in the housing of the pump; and the control circuit of the pump causes a second dose of the second drug at the second dose to be delivered from the pump to the patient. The second reservoir may contain the second drug therein. The second data storage component may be preprogrammed with data indicating the second dose of the second drug to be delivered to the patient using the pump before the second reservoir is received in the housing of the pump. The control circuit may receive data indicating the read data from the reader, the read data indicating the second dose.

[0020] In another embodiment, a method of administering a drug includes engaging a first alignment mechanism of a reservoir and a second alignment mechanism of a pump, and then causing the reservoir to be received in the pump. The reservoir contains a drug therein. The reservoir includes a data storage component that stores data about the drug therein. The pump includes a reader and a control circuit. The reader reads the stored data from the data storage component when the reservoir is received in the pump. The second alignment mechanism engages the first alignment mechanism. The engagement of the first alignment mechanism and the second alignment mechanism ensures that the data storage component is positioned within an effective reading range of the reader. The control circuit receives data from the reader indicating the stored data read from the data storage component, uses the received data to establish a dosing regimen for delivering the drug, and causes the drug to be delivered to a patient based on the dosing regimen.

[0021] The drug administration method can be varied in any manner. For example, in the case where the first alignment mechanism and the second alignment mechanism are not aligned, the reservoir cannot be fully received in the pump. For another example, the reader may include a near field communication (NFC) reader, and the data storage component may include an NFC tag. For another example, the reader may include a radio frequency identification (RFID) reader, and the data storage component may include an RFID tag. For another example, the data storage component may include an EEPROM. For another example, the position of the data storage component may maximize the number of electromagnetic field lines generated by the reader passing through the data storage component. For another example, one of the first alignment mechanism and the second alignment mechanism may be a concave member, and the other of the first alignment mechanism and the second alignment mechanism may be a convex member sliding in the concave member. For another example, the reservoir may be preloaded into the pump. For another example, the reservoir may be loaded into the pump by a user.

[0022] In yet another example, a drug administration system includes a pump assembly, a reader, and a control circuit. The pump assembly is configured to drive a drug from a reservoir for delivery to a patient. The reader is configured to read configuration data for configuring an operating parameter of the drug administration system from a data storage component of the reservoir. The control circuit is configured to set the operating parameter of the drug administration system to a first value based on the configuration data, so that when the pump assembly drives the drug from the reservoir, the drug administration system operates with the operating parameter set to the first value.

[0023] Yet another example is a method of administering a drug using a drug administration system. The method includes communicatively coupling a reader of the drug administration system to a data storage component of a reservoir of the drug administration system. The reader reads configuration data for configuring an operating parameter of the drug administration system from the data storage component of the reservoir. The operating parameter of the drug administration system is set to a first value based on the configuration data. The pump assembly of the drug administration system is operated to drive the drug from the reservoir so that the drug administration system operates with the operating parameter set to the first value. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The present invention is described with reference to the following drawings:

[0025] Figure 1 is a schematic diagram of one embodiment of a pump configured to deliver a liquid medication to a patient;

[0026] Figure 2 is a perspective view of one embodiment of a reservoir including one embodiment of a data storage component;

[0027] Figure 3 is a perspective view of another embodiment of a reservoir including another embodiment of a data storage component attached to a bottom of the reservoir;

[0028] Figure 4 yes Figure 3 A perspective view of a reservoir with a data storage component attached to one side of the reservoir;

[0029] Figure 5 is a front view of one embodiment of a reader antenna;

[0030] Figure 6 is a perspective view of one embodiment of a flexible printed circuit board assembly;

[0031] Figure 7 yes Figure 6 Another perspective view of the flexible printed circuit board assembly;

[0032] Figure 8 is a schematic diagram of another embodiment of a pump configured to deliver a liquid medication to a patient and one embodiment of a reservoir configured to be received in the pump;

[0033] Fig. 9 yes Figure 8 A schematic diagram of a pump having a reservoir received therein;

[0034] Fig.10 is a schematic diagram of one embodiment of the relative positioning of a near field communication (NFC) tag antenna and an NFC tag reader;

[0035] Fig.11 yes Fig.10 Schematic diagram of the relative positioning and alternative relative positioning implementation scheme;

[0036] Fig.12 is a schematic cross-sectional view of another embodiment of a reservoir received in a pump, wherein alignment mechanisms of the reservoir and the pump are engaged with one another and wherein a data storage component of the reservoir is positioned relative to a reader of the pump;

[0037] Fig.13 is a schematic cross-sectional view of another embodiment of a reservoir received in a pump including a multiplexed reader;

[0038] Fig.14 is a schematic diagram of another embodiment of a pump configured to deliver a liquid medication to a patient;

[0039] Fig.15 is a perspective view of yet another embodiment of a pump configured to deliver a liquid medication to a patient; and

[0040] Fig.16 is a schematic diagram of yet another embodiment of a pump configured to deliver liquid medication to a patient. DETAILED DESCRIPTION

[0041] Certain exemplary embodiments will now be described to understand the principles of the structure, function, manufacture and use of the devices, systems and methods disclosed herein as a whole. One or more examples of these embodiments are illustrated in the accompanying drawings. It will be appreciated by those skilled in the art that the devices, systems and methods specifically described herein and shown in the accompanying drawings are non-restrictive exemplary embodiments, and the scope of the present invention is limited only by the claims. The features illustrated or described in conjunction with an exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

[0042] In addition, in the present disclosure, components with similar names in various embodiments generally have similar features, so in a specific embodiment, each feature of each component with similar names may not necessarily be fully described. In addition, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. Those skilled in the art will recognize that equivalent dimensions of such linear and circular dimensions can be easily determined for any geometric shape. Those skilled in the art will understand that the dimensions may not be exact values, but are considered to be approximately at the values ​​due to any number of factors such as manufacturing tolerances and the sensitivity of the measuring equipment. The size and shape of the systems and devices and their components may depend at least on the size and shape of the components to be used with the systems and devices.

[0043] Generally speaking, devices, systems and methods for intelligent liquid drug administration are provided. In an exemplary embodiment, a pump is configured to receive a reservoir therein. The reservoir (e.g., a vial, a cartridge, etc.) holds the drug and includes a data storage component configured to store data. The pump includes a reader configured to read data from the data storage component. The pump is configured to deliver the drug from the pump to the patient when the reservoir is received therein.

[0044] The pump can use the data read from the data storage component to control the drug delivery from the pump. Therefore, the pump can be configured to deliver the drug in different ways under different circumstances, depending on the stored data associated with the specific reservoir received by the pump. Therefore, multiple pumps can be manufactured similarly, each of which has the same stock keeping unit (SKU), even if different pumps in these pumps will eventually be used to deliver different drugs and / or deliver the same or different drugs in different ways. Traditionally, pumps are manufactured with different SKUs for different pump uses, for example, a first SKU for a pump for a specific therapy, a second SKU for a pump for a specific indication, etc. Manufacturing a pump with a single SKU instead of manufacturing a pump with multiple different SKUs can reduce costs and / or simplify inventory management and shipping / tracking. Different reservoirs that can be used with such pumps can have different SKUs to facilitate programming of the pumps in which the reservoirs are received. For various reasons, manufacturing reservoirs with different SKUs can be simpler and cheaper than manufacturing pumps with different SKUs, such as the manufacturing technology of the pump is more complex than the reservoir, the production quantity of the reservoir is more than the pump, etc.

[0045] Using data read from the data storage component to control drug delivery from the pump can simplify complex therapies, such as high volume therapies and multiple therapies. The pump does not require manual programming to ensure that the therapy is delivered correctly, which can help reduce errors in delivering the therapy.

[0046] In some embodiments, the pump may be configured to receive only one reservoir therein. The reservoir may not be replaceable (e.g., not removable from the pump), in which case the pump cannot deliver any more medication once the medication in the reservoir has been completely delivered (or the patient's treatment with the medication has ended without all of the medication in the reservoir being delivered to the patient). Alternatively, once the medication contained in the reservoir has been completely delivered from the pump to the patient (or the patient's treatment with the medication has ended without all of the medication in the reservoir being delivered to the patient), the reservoir is configured to be replaced with another reservoir so that the pump can deliver more medication to the patient.

[0047] In some embodiments, the pump may be configured to receive at least two reservoirs therein so that the pump has at least two reservoirs contained therein at the same time. Each of the at least two reservoirs may include a data storage component, each data storage component being readable by a reader of the pump, which may be one or more readers. In this way, the pump may use data read from a specific one of the data storage components to control the delivery of the drug from the specific reservoir. Thus, for different reservoirs in these reservoirs and the drugs contained therein, the pump may control drug delivery in different ways. Similar to what is discussed above, each of these reservoirs may be replaceable or non-replaceable.

[0048] In some embodiments, the data storage component of each reservoir that can be received in the pump can store thereon data related only to its associated reservoir. In some embodiments, the data storage component of the first reservoir received in the pump can store thereon data related to at least one additional reservoir to be received in the pump. Each of these reservoirs can be received in the pump sequentially (e.g., in a scenario where the pump is configured to receive only a single reservoir therein), or can be received in the pump simultaneously (e.g., in a scenario where the pump is configured to receive two or more reservoirs therein simultaneously). For example, in a dual therapy scenario where a first drug is delivered to a patient and then a second drug is delivered to the patient, the data can indicate that the second reservoir to be received in the pump subsequently should contain a specific drug or a specific type of drug therein. The pump can use this data to verify that the second reservoir contains a specific drug or a specific type of drug therein after receiving the second reservoir therein (e.g., by comparing the data read from the data storage component of the first reservoir with the data read from the data storage component of the second reservoir). If the pump determines that the second reservoir does not contain an expected drug or expected drug type, the pump may be configured to enter an error state in which the pump is unable to deliver the drug contained in the reservoir because the drug is not the expected drug or expected drug type.

[0049] The medicine delivered using a pump as described herein can be any medicine in a variety of medicines. The example of a medicine that can be delivered using a pump as described herein includes antibodies (such as monoclonal antibodies), hormones, antitoxins, analgesic substances, substances for controlling thrombosis, substances for controlling infection, peptides, proteins, human insulin or human insulin analogs or derivatives, polysaccharides, DNA, RNA, enzymes, oligonucleotides, antiallergic agents, antihistamines, anti-inflammatory agents, corticosteroids, anti-rheumatic disease relief drugs, erythropoietin and vaccines.

[0050] The smart drug administration described herein can be used with a variety of drug delivery pumps configured to deliver drugs to a patient. The pump can be an "in vivo" pump configured to be removably attached to a patient, or the pump can be an "extracorporeal" pump configured to deliver drugs to a patient through an infusion set extending between the pump and the patient. Various embodiments of the drug delivery pump include pumps described in, for example, the following documents: International Patent Publication WO 2021 / 124002, entitled “Liquid Drug Pumps Including User Feedback Indicating Pump Orientation,” published on June 24, 2021, International Patent Publication WO 2021 / 123995, entitled “Liquid Drug Pumps With A Flexible Drug Reservoir,” published on June 24, 2021, International Patent Publication WO 2021 / 059202, entitled “Drug Administration Device And System For Establishing a Dosing Regimen And Compatibility Of Components,” published on April 1, 2021, International Patent Publication WO 2021 / 059203, entitled “Drug Administration Devices That Communicate With External Systems And / Or Other Devices,” published on April 1, 2021, Configured To Determine A Drug Dosing Scheme” published on May 31, 2018, International Patent Publication No. WO 2021 / 059214, entitled “Apparatus For Delivering A Therapeutic Substance” published on May 31, 2018, U.S. Patent Publication No. WO2019 / 0134295, entitled “Local Disinfection For Prefilled Drug Delivery System” published on May 9, 2019, U.S. Patent No. 7,976, entitled “Disposable Infusion Device Negative Pressure Filling Apparatus And Method” published on July 12, 2011,No. 505, and U.S. Pat. No. 7,815,609, entitled “Disposable Infusion Device Positive Pressure Filling Apparatus And Method”, issued on October 19, 2010, the entire contents of which are hereby incorporated by reference herein. Other examples of drug delivery pumps include, Drug delivery platform, purchased from West Pharmaceutical Services, Inc..of Exton, PA; Purchased from Insulet Corp. of Acton, MA; Patch syringe, purchased from Ypsomed AG of Burgdorf, Switzerland; BD Libertas TM Wearable syringe, purchased from Becton, Dickinson and Co. of Franklin Lakes, NJ; Sorrel medical pump, purchased from Sorrel Medical of Netanya, Israel; SteadyMed purchased from SteadyMed Ltd. of Rehovot, Israel; Sensile Medical infusion pumps purchased from Sensile Medical AG of Olten, Switzerland; SonceBoz wearable syringes purchased from SonceBoz SA of Sonceboz-Sombeval, Switzerland; Purchased from Enable Injections of Cincinnati, OH; In vivo syringe, purchased from Amgen, Inc. of Thousand Oaks, CA; system, available from Amgen, Inc. of Thousand Oaks, CA; and Pumps were purchased from Unilife Corp. of King of Prussia, PA.

[0051] Although the smart drug administration described herein is described with respect to a drug delivery pump, the smart drug administration may also be similarly used with other drug administration devices configured to deliver liquid drugs to patients, such as autoinjectors and jet injectors. Various embodiments of drug administration devices configured to deliver liquid drugs are described in, for example, the previously mentioned literature: WO 2021 / 059202, entitled "Drug Administration Device And System For Establishing a Dosing Regimen And Compatibility Of Components," published on April 1, 2021, International Patent Publication WO 2021 / 059203, entitled "Drug Administration Devices That Communicate With External Systems And / Or Other Devices," published on April 1, 2021, and International Patent Publication WO 2021 / 059214, entitled "Drug Administration System Configured To Determine ADrug Dosing Scheme," published on April 1, 2021.

[0052] Figure 1 One embodiment of a pump 20 (e.g., a patch pump or other pump) is illustrated that is configured to deliver a liquid drug (also referred to herein as a "therapeutic substance") 22 to a patient. The pump 20 includes a therapeutic substance reservoir 24 containing the drug 22 therein. The pump 20 can be configured to be removably attached to the patient in any of a variety of ways as will be appreciated by those skilled in the art (such as by including a backing or label that is configured to be removed from the body of the pump 20 to expose an adhesive that can be attached to the patient). Alternatively, the pump 20 can be configured as an "extracorporeal" pump, as discussed further below.

[0053] In an exemplary embodiment, the reservoir 24 is a vial, but the reservoir 24 may have other forms, such as a cartridge, a syringe, or a bag. The reservoir 24 is configured to be received in the pump 20 (e.g., received in the housing of the pump 20) to allow the drug 22 held in the reservoir 24 to be administered to the patient via the pump 20. The reservoir 24 may be completely contained within the pump 20 (e.g., completely contained within the housing of the pump) when fully inserted into the pump 20, or may be partially contained within the pump 20 (e.g., a first portion of the reservoir 24 is located inside the housing and a second portion of the reservoir 24 is located outside the housing). In some embodiments, the reservoir 24 is preloaded into the pump 20 by being installed in the pump 20 at the time of manufacture. Therefore, the user can receive the pump 20 with the reservoir 24 already received therein, which can facilitate the user's use of the pump 20 and / or help ensure that the pump 20 delivers the correct drug 22 to the patient. In such embodiments, the reservoir 24 may be non-removably received in the pump 20, such that the pump 20 may be a single-use pump 20 that is configured to deliver only the drug 22 in the reservoir 24 (via one or more individual doses of the drug 22). In other embodiments, the reservoir 24 is loaded into the pump 20 by the user by being installed in the pump 20 by the user. In such embodiments, the reservoir 24 may be non-removably received in the pump 20, such that the pump 20 may be a single-use pump 20, or may be removably and replaceably received in the pump 20, such that the pump 20 may be a reusable, multiple-use pump 20 that is configured to be used with each of a plurality of reservoirs received in the pump 20.

[0054] In an exemplary embodiment, the reservoir 24 is pre-filled by a medical supplier or device manufacturer before the reservoir 24 is loaded into the pump 20 and thus before the pump 20 is used.

[0055] In the illustrated embodiment, the pump 20 is configured to receive a single reservoir 24 at a time. In other embodiments, the pump can be configured to receive multiple reservoirs at a time.

[0056] The reservoir 24 includes a data storage component 48, which is attached to the reservoir 24 (such as by adhering to the reservoir 24 or embedding in the reservoir 24) or is otherwise a part of the reservoir 24 (such as by printing on the reservoir). The data storage component 48 is configured to store data about the reservoir 24 and / or about the drug 22 contained in the reservoir 24. The data storage component 48 may have a variety of configurations. For example, the data storage component 48 may include an integrated circuit configured to transmit reservoir data from the reservoir. An example of an integrated circuit is a near field communication (NFC) tag, also known as a proximity integrated circuit card (PICC). ISO14443-A passive NFC tags, ISO15693 passive NFC tags, ISO18000-3 passive NFC tags, ISO14443-A / B passive NFC tags, passive FeliCaNFC tags or other types of NFC tags (passive or active) can be used. For another example, the data storage component 48 may include a radio frequency identification (RFID) tag. As another example, the data storage component may be in the form of a barcode. An example of a barcode is a QR code. Another example of a barcode is a universal product code (UPC) code.

[0057] In the illustrated embodiment, the storage 24 includes a single data storage component 48, but may also include multiple data storage components. If multiple data storage components are used, each data storage component may be different from each other, which can help provide redundancy and / or allow data retrieval, even if a certain type of data communication is currently unavailable (e.g., in the case where the RFID tag is not present or damaged so as to be unreadable), but the QR code can still be read.

[0058] Figure 2 One embodiment of a reservoir that can be used as a reservoir 24 with a data storage component 48 attached is illustrated. The reservoir is in the form of a vial 60 that has a data storage component in the form of an NFC tag 62 on a flexible substrate adhered to the exterior of the vial 60. In the illustrated embodiment, the NFC tag 62 is located on one side of the vial 60, but may be located elsewhere, such as on the top of the vial 60 or on the bottom of the vial 60. It should be understood that the data storage component may be a data storage component other than an NFC tag. Figure 2, the top of the vial 60 is obscured by a removable protective cover 64 that is configured to be removed from the vial 60 before the vial 60 is inserted into the pump 20 (or other pump or drug administration device). The location of the NFC tag 62 (or other data storage component on the vial 60 or other reservoir) can be selected to correspond to the location of the reader 50 in the pump 20 so that the reader 50 is within the effective reading range of the NFC tag 62. In the illustrated embodiment, the NFC tag 62 has a square shape, but may have other shapes.

[0059] Figure 3 One embodiment of a reservoir that can be used as a reservoir 24 with a data storage component 48 attached is illustrated. The reservoir is in the form of a vial 70 having a data storage component in the form of an NFC tag 72 on a flexible substrate adhered to the exterior of the vial 70. In the illustrated embodiment, the NFC tag 72 is located on the bottom of the vial 70 and has a circular shape. It should be understood that the data storage component can be a data storage component other than an NFC tag.

[0060] Figure 4 Another embodiment of a reservoir is illustrated, wherein the reservoir is in the form of a container 75. The container 75 is shown as a cartridge, but may alternatively be a syringe. The container 75 has a container body 75a for containing a drug therein. The data storage component is in the form of an NFC tag 72 located on one side of the container body 75a. It should be understood that the data storage component may be a data storage component other than an NFC tag. The container body 75a defines a cavity configured to hold a liquid drug therein. The container body 75a has a first end 75b and a second end 75c. The container body 75a may have a central axis extending in an axial direction. The first end 75b may define an opening therein, which leads to the cavity. The drug container 75 may include a seal 76 disposed in the cavity, which forms a seal with the inner surface of the container body 75a. The seal 76 may be received in the cavity through an opening in the first end 75b. The seal 76 is configured to translate toward the second end 75c to drive the liquid drug from the cavity.

[0061] In some examples, such as when the drug container 75 is a cartridge, the drug container 75 may include a cap 77 on the second end 75c. The cap 77 may be formed of any suitable material, such as metal. The cap 77 may be crimped onto the head of the container body 75a at the second end 75c. The drug container 75 may include a septum (not shown) configured to seal the second end 75c. The septum may be supported by the cap 77 and may be configured to be pierced by a puncture needle to open a fluid path into the drug container 75.

[0062] Reference again Figure 1, the pump 20 also includes a reader 50 configured to read the data storage component 48. Generally speaking, the type of reader 50 depends on the form of the data storage component 48, so that the reader 50 can obtain data from the data storage component 48, because obtaining data from the data storage component 48 requires using an appropriate communication interface to receive data from the data storage component 48. For example, when the data storage component 48 includes an RFID tag, the reader 50 includes an RFID scanner. For another example, when the data storage component 48 includes a barcode, the reader 50 includes a barcode scanner. For yet another example, when the data storage component 48 includes an integrated circuit, the integrated circuit can be powered and can transmit data to a receiving communication interface (such as an NFC reader configured to read an RFID tag). The reader is configured to be communicatively coupled to the data storage component when the reader and the data storage component are close to each other, so that the reader and the data storage component communicate. In some examples, the reader is configured to be communicatively coupled to the data storage component when the reservoir is received in the housing of the pump, but not communicatively coupled to the data storage component before that. In some such examples, the reservoir must be received in the housing of the pump in a particular orientation in order for the reader to communicatively couple with the data storage component.

[0063] In some examples, the reader 50 can transmit data as well as receive data, and optionally cause the data to be written to the data storage component 48. In some such examples, the data storage component 48 can be updated at regular intervals (e.g., when each mL of delivery is completed) so that it contains a reasonably accurate record of the progress of the delivery at any given time. If the pump 20 fails during delivery, resulting in a partially delivered dose, the reservoir containing the partial dose record can be transferred to the secondary pump, where the remaining dose can be delivered. In some such examples, the data storage component 48 can also be updated with any information related to delivery and the pump status during delivery.

[0064] For example, the information may include the date and time of delivery, the model and serial number of the pump, the ambient pump and reservoir temperature, the pump user input settings, the pump wireless communication events, the pump warning or alarm events, the user-initiated pauses and durations, the user interface events and / or the relevant pump parameter settings and measurements (force, pressure, battery voltage / current, etc.) during delivery. Therefore, the data storage component 48 can serve as a record of delivery (e.g., a delivery "black box" record). The data storage component 48 can be designed to be easily stripped from the reservoir so that it can be transferred to the monitoring party or HCP for subsequent reading, recording and analysis. When the delivery is completed, the data storage component 48 can be updated with a "delivery completed" status, thereby preventing the reservoir from being refilled and reused in a pump (including a pump having the capabilities described in the present disclosure).

[0065] In an exemplary embodiment, the reader 50 is a single reader, which can help reduce the cost of the pump 20, help save space within the pump 20 for other components, and / or help reduce the overall size of the pump 20. The reader 50 may alternatively include a multiplexed reader, which may allow the use of one of the readers that has the best communication with the data storage component 48, and / or may help provide redundancy and allow mutual confirmation of the accuracy of the data read.

[0066] The reader 50 is configured to read data from the data storage component 48, wherein the data storage component 48 is within the effective reading range of the reader 50 and the reader 50 is in the "on" state. The reader 50 is in the "on" state when the reader 50 is sufficiently powered to read data. In an exemplary embodiment, the pump 20 that is powered is configured to power on the reader 50. Therefore, if the reservoir 24 has been inserted into the pump 20 so that the data storage component 48 is within the effective reading range of the reader 50, the reader 50 can be configured to read data from the data storage component 48 when the pump 20 is powered on. The reservoir 24 is usually inserted into the pump 20 when the pump 20 is powered off or in a low power or energy saving mode. Therefore, powering on the pump 20 can trigger the reader 50 to automatically read data from the data storage component 48. Therefore, the reader 50 can be configured to read data from the data storage component 48 before the first delivery of the drug 22 from the pump 20, because the pump 20 cannot deliver the drug 22 to the patient when the pump 20 is powered off or in a low power or energy saving mode.

[0067] The pump 20 may be powered on by a user of the pump 20, thereby allowing data to be read from the data storage component 48 after the user has received the pump. In such embodiments, the reservoir 24 may have been loaded or preloaded by the user. Alternatively, in embodiments where the reservoir 24 is preloaded into the pump 20 during manufacturing, the pump 20 may be powered on during manufacturing, thereby allowing data to be read from the data storage component 48. Thus, data may be read from the pump 20 before the user receives the pump 20. After the data has been read from the data storage component 48, the pump 20 may be powered off or placed in a low power or energy saving mode to wait for being turned on by the user at a later time.

[0068] In one embodiment, the reader 50 may include a printed circuit board (PCB) on which an NFC transceiver (such as a DLP7970A NFC transceiver available from DLP Design Inc. of McKinney, TX, or other types of NFC transceivers) and a microcontroller (such as an MSP430G2553 microcontroller available from Texas Instruments, Inc. of Dallas, TX, or other types of microcontrollers) are mounted. The DLP7970A transceiver is configured to read passive NFC tags. In such embodiments, the reader 50 is not configured to directly contact the data storage component 48.

[0069] Figure 5 One embodiment of a reader antenna 80 that can be used as the reader 50 is illustrated. In the illustrated embodiment, the reader antenna 80 is an RFID / NFCR25 reader antenna configured for use with RFID tags and NFC tags. In the illustrated embodiment, the reader antenna 80 is on a thin polyester or polyimide flexible film substrate, which can facilitate reading on a curved surface of a reservoir (such as on a cylindrical side of a reservoir (such as, for example). Figure 2 and Figure 4 70)) because the reader antenna 80 can be attached to a curved surface within the pump 20 that corresponds to the curvature of the data storage component on one side of the reservoir 24 to facilitate positioning of the reader relative to the data storage component 48. In the illustrated embodiment, the reader 50 is not configured to directly contact the data storage component 48.

[0070] Figure 6 and Figure 7 An embodiment of a flexible printed circuit board assembly (PCBA) 90 that can be used as a reader 50 is illustrated. The PCBA 90 is configured to read a passive NFC tag. The PCBA 90 includes a single-line electrically erasable programmable read-only memory (EEPROM) with exposed pads. The spring contacts the main PCB of the PCBA 90 to read from the single-line EEPROM. In the illustrated embodiment, the reader 50 is configured to directly contact the data storage component 48.

[0071] Reference again Figure 1, the pump 20 includes a control circuit 36 ​​configured to control the administration of the drug 22 from the pump 20 based at least in part on data received from the reader 50, so as to be based at least in part on data stored on a data storage component 48 of the reservoir 24 and read by the reader 50. In some embodiments, the reader 50 is configured to automatically read data from the data storage component 48 and transmit data indicative of the data read from the data storage component 48 to the control circuit 36. In other embodiments, the control circuit 36 ​​is configured to transmit instructions to the reader 50, for example, when the pump 20 is powered on, to read data from the data storage component 48 and transmit data indicative of the data read from the data storage component 48 to the control circuit 36.

[0072] The control circuit 36 ​​is configured to control the administration of the drug 22 from the pump 20 according to a dosing regimen. The dosing regimen refers to the specific manner in which the drug is delivered, including (but not limited to) formulation, route of administration, dosage interval (dose frequency), dose or volume, delivery rate (flow rate), delivery duration, delivery pause, pause between delivery stages in a multi-drug delivery sequence, and the sequencing order of the multi-drug delivery sequence. The dosing regimen can be stored as an algorithm in the memory of the control circuit 36, and the processor of the control circuit 36 ​​is configured to execute the algorithm. The algorithm is stored in the form of one or more sets of multiple data points that define and / or represent instructions, notifications, signals, etc. to control the administration of the drug from the pump 20.

[0073] The algorithm includes one or more variable parameters that can be changed by the control circuit 36 ​​so that the dosing regimen can be changed. The variable parameters are among the data points of the algorithm, and therefore each variable parameter can be changed by changing one or more of the stored multiple data points of the algorithm. The control circuit 36 ​​(e.g., its processor) is configured to establish at least one of the one or more variable parameters based on the data received from the reader 50, so as to be based at least in part on the data stored on the data storage component 48 of the reservoir 24. The data received by the control circuit 36 ​​from the reader 50 identifies the variable parameters to be established and the value of each variable parameter to allow the control circuit 36 ​​to update the algorithm to include the variable parameter value indicated by the data. After the dosing parameters have been established, the algorithm is then executed by the control circuit 36 ​​(e.g., its processor) to administer the dose of the drug 22 according to the algorithm reflecting the current dosing regimen. Therefore, the drug 22 can be administered to the patient on a customized basis, because different data storage components will store different variable parameter values ​​based on specific drugs 22, specific therapies based on drugs 22 for treating specific diseases, and / or specific patients to whom the drugs 22 are intended to be delivered using the pump 20. Thus, by allowing the pump 20 to deliver the drug 22 according to the requirements of a specific therapy, a specific drug, and / or a specific patient and / or by facilitating personalized medication, patient outcomes may be improved. Thus, the pump 20 can be manufactured in a generic manner and later programmed to take into account the requirements of a specific therapy, a specific drug, and / or a specific patient. Thus, the supply chain may be simplified, making it more cost-effective.

[0074] The pump 20 also includes a conduit 38 through which the drug 22 is configured to be discharged from the reservoir 24 and enter the inlet fluid path 30 of the syringe assembly 46 operably connected to the pump 20, which is configured to deliver the drug 22 to the patient. Therefore, the conduit 38 is a tube in which the drug 22 can flow. The pump 20 can be an "extracorporeal" pump configured to deliver the drug to the patient through an infusion kit extending between the pump and the patient, rather than an "extracorporeal" pump configured to be removably attached to the patient. The "extracorporeal" pump is generally configured and used in a manner similar to the pump 20, except that the syringe assembly 46 can be configured in a different manner or replaced with another type of assembly for use with the infusion kit.

[0075] The pump 20 also includes a user interface 40 that is configured to provide information to a user of the pump 20, such as a patient associated with the pump 20 (e.g., wearing the pump 20 by removably attaching the pump to the patient using an adhesive or other attachment mechanism, or the patient operably connected to the pump 20 via an infusion kit); a patient caregiver assisting the patient in using the pump 20, a health care professional assisting the patient in using the pump 20, etc. The user interface 40 can have a variety of configurations, and the pump 20 can include a single type of user interface or can include more than one type of user interface. For example, the user interface 40 can include a plurality of lights (e.g., light emitting diodes (LEDs) or other types of lights) that are configured to illuminate to provide various information. Examples of information indicated by the user interface 40 include power (on / off) status, error status (e.g., an indication that an error in the pump 20 has been detected, such as a low power source, an incorrect needle advancement into the patient, an incompatible type of reservoir 24 loaded into the pump 20, etc.), drug delivery status (e.g., an indication that drug delivery is currently occurring), drug delivery progress information, the orientation of the pump 20 relative to gravity, an indication of the dose of the drug 22 to be provided each time the drug 22 is delivered to the patient, and other types of information. For another example, the user interface 40 may include a display configured to display information thereon, such as by using text and / or graphics. The display may include a display screen having any of a variety of configurations, such as a cathode ray tube (CRT), a liquid crystal display (LCD), a touch screen, etc. For yet another example, the user interface 40 may include a vibration mechanism configured to vibrate, wherein the vibration is configured to be felt by a patient wearing the pump 20. For yet another example, the user interface 40 may include a speaker configured to provide an audio signal. For another example, the user interface 40 may include a mechanical level configured to indicate the orientation of the pump.

[0076] The control circuit 36 ​​is operably coupled to the user interface 40 and is configured to cause the user interface 40 to provide information to the user. The control circuit 36 ​​is also operably coupled to the reader 50 and is configured to receive data from the reader 50 indicative of data read from the data storage component 48, such as to receive a signal from the reader 50 indicative of the data read. The control circuit 36 ​​is configured to control the pump 20 using the data received from the reader 50, as discussed further herein.

[0077] The electromechanical pumping assembly 26 (e.g., its motor) is operably coupled to the reservoir 24 and is configured to deliver the therapeutic substance 22 to the patient via the syringe assembly 46 (e.g., through a needle or cannula of the syringe assembly 46 that has been inserted into the patient's body). The electromechanical pumping assembly 26 is shaped to define a rigid pump chamber 28, which includes a therapeutic substance inlet 30 through which the therapeutic substance 22 is received from the catheter 30 and thus enters the pump chamber 28 from the reservoir 24. The rigid pump chamber 28 also includes a fluid path outlet 32 ​​through which the therapeutic substance 22 is delivered from the pump chamber 28 to the patient via the syringe assembly 46. Although the pumping assembly 26 is electromechanical in the illustrated embodiment, the pumping assembly of the pump 20 (and for other embodiments of the pump described herein) may alternatively be any suitable alternative pumping assembly, such as a mechanical pumping assembly (e.g., with a spring), a pneumatic pumping assembly, or a hydraulic pumping assembly. The mechanical pumping assembly need not include any electronic components or controls. For example, a mechanical pumping assembly may include a balloon diaphragm configured to be activated to cause drug delivery via mechanical action.

[0078] The pump 20 also includes a plunger 34 slidably disposed within the pump chamber 28 and sealably contacting the interior of the pump chamber 28. The plunger 34 is configured to directly contact the drug 22 in the pumping chamber 28.

[0079] In the illustrated embodiment, the electromechanical pumping assembly 26 is configured to be driven by the control circuit 36 ​​to operate in two pumping stages. In other embodiments, the control circuit 36 ​​may be configured to drive the electromechanical pumping assembly 26 in another manner (such as by operating in a single stage, by operating in more than two stages, or by operating with a first pumping stage and a second pumping stage configured differently than the first pumping stage and the second pumping stage discussed below).

[0080] In the first pumping stage, the control circuit 36 ​​is configured to drive the plunger 34 (e.g., to slideably move the plunger 34 in the pump chamber 28) to draw the drug 22 from the reservoir 24 into the conduit 38, then into the inlet fluid path 30, and then through the inlet valve 42 and into the pump chamber 28. The inlet valve 42 is configured to open and close, such that when the inlet valve 42 is open, there is fluid communication between the reservoir 24 and the pump chamber 28, and when the inlet valve 42 is closed, there is no fluid communication between the reservoir 24 and the pump chamber 28. During the first pumping stage, the control circuit 36 ​​is configured to open the inlet valve 42, close the outlet valve 44, and drive the plunger 34 to draw the therapeutic substance 22 from the reservoir 24 into the pump chamber 28, for example, the control circuit 36 ​​is configured to set the inlet valve 42 and the outlet valve 44 so that the therapeutic substance 22 can flow only between the reservoir 24 and the pump chamber 28. Thus, as the plunger 34 is withdrawn, the therapeutic substance 22 is drawn into the pump chamber 28. The control circuit 36 ​​that causes the inlet valve 42 to open and the outlet valve 44 to close may be an active control or may be a passive control where the valves 42, 44 are mechanical valves that automatically open / close due to the actuation of the plunger 34.

[0081] In the second pumping phase, the control circuit 36 ​​is configured to drive the plunger 34 to deliver the drug 22 from the pump chamber 28 through the outlet valve 44 to the outlet fluid path 32, and then to the syringe assembly 46 for delivery to the patient. The outlet valve 44 is configured to open and close so that when the outlet valve 44 is open, there is fluid communication between the pump chamber 28 and the patient, and when the outlet valve 44 is closed, there is no fluid communication between the pump chamber 28 and the patient. During the second pumping phase, the control circuit 36 ​​is configured to close the inlet valve 42, open the outlet valve 44, and drive the plunger 34 to deliver the therapeutic substance 22 from the pump chamber 28 in multiple discrete movements of the plunger 34. For example, the control circuit 36 ​​can be configured to set the inlet valve 42 and the outlet valve 44 so that the therapeutic substance 22 can flow only between the pump chamber 28 and the patient, and the plunger 34 is incrementally pushed back into the pump chamber 28 in multiple discrete movements, thereby delivering the therapeutic substance 22 to the patient in multiple discrete doses. Similar to what was discussed above, the control circuit 36 ​​that causes the inlet valve 42 to close and the outlet valve 44 to open may be an active control or may be a passive control where the valves 42 , 44 are mechanical valves that open / close automatically due to driving the plunger 34 .

[0082] In some embodiments, the control circuit 36 ​​is configured to drive the plunger 34 to draw the therapeutic substance 22 into the pump chamber 28 with a single movement of the plunger 34, for example, the plunger 34 is pulled back in a single movement to draw a volume of the therapeutic substance 22 into the pump chamber 28 during the first pumping phase. Alternatively, the control circuit 36 ​​may be configured to drive the plunger 34 to draw the therapeutic substance 22 into the pump chamber 28 with one or more discrete expansion movements of the plunger 34, for example, the plunger 34 may be pulled out of half of the pump chamber 28 in one movement, and then pulled out of the remainder of the pump chamber 28 in a second separate movement. In this case, the duration of some or all of the expansion movements of the plunger 34 during the first pumping phase is typically longer than the duration of any of the multiple discrete movements of the plunger 34 during the second pumping phase.

[0083] In other embodiments, the control circuit 36 ​​is configured to drive the plunger 34 so that the duration of the first pumping phase is not equal to the duration of the second pumping phase. For example, the duration of the second pumping phase can be five to fifty times longer than the duration of the first pumping phase, such as at least ten times, thirty times, fifty times, etc., longer than the duration of the first pumping phase.

[0084] The pump 20 may also include a power source (not shown) configured to provide power to components that require power, such as the control circuit 36 ​​and the reader 50. In an exemplary embodiment, the power source is a single power source that is configured to provide power to each component of the pump 20 that requires power, which can help reduce the cost of the pump 20, help save space within the pump 20 for other components, and / or help reduce the overall size of the pump 20. However, the power source may include multiple power sources, which can help provide redundancy and / or help reduce the cost of the pump 20 because some components can be manufactured with a dedicated power source onboard. In an exemplary embodiment, the power source is onboard the pump 20, which can facilitate the use of the pump 20 at any location at any time. In other embodiments, the power source may include a mechanism configured to connect the pump 20 to an external power source.

[0085] The amount (e.g., volume) of the drug 22 delivered to the patient by the pump 20 per dose may vary according to each disease and / or each patient. The dose may vary for a variety of reasons. For example, different drugs may be administered in different doses because, for example, some drugs may have greater and / or stronger side effects than other drugs at higher volumes, some drugs are at higher concentrations than other drugs, etc. Therefore, the amount of drug 22 that the pump 20 should deliver to the patient per dose may vary depending on the specific drug 22 contained in the reservoir 24. For another example, different patients may receive different amounts of the same drug according to the prescription of a specific patient. Therefore, depending on the specific patient to whom the drug 22 is to be delivered from the reservoir 24, even if the pump 20 is the same, the dose may vary. For yet another example, depending on the disease indicated for treating a specific disease, the amount of drug 22 that the pump 20 should deliver to the patient per dose may vary. Therefore, depending on the specific therapy for which the drug 22 is used, the dose is variable, even if different doses may be used for other therapies involving the delivery of the same drug 22. This disease is an example of a pre-identified characteristic of a patient. For another example, even if the pump 20 remains the same, the dose of the drug 22 may also vary for the same patient because the patient's therapy may change over time. For yet another example, depending on gender as a patient population factor, the dose may vary even if the pump 20 is the same. For another example, depending on race as a patient population factor, the dose may vary even if the pump 20 is the same. For yet another example, depending on genetic makeup as a patient population factor, the dose may vary even if the pump 20 is the same. Patients with a particular genetic makeup (e.g., including a particular gene such as a tumor suppressor gene) may affect how much drug a particular patient should receive. The reservoir 24 may include a sensor configured to read a biomarker of a patient indicating the genetic makeup. Data about the read biomarker may be included in the data read from the data storage component 48. For yet another example, the dose may be based on the weight of a particular patient to whom the drug 22 is to be delivered from the reservoir 24. In such a weight-based dosing regimen, the amount of drug 22 delivered to the patient from the reservoir 24 per dose is calculated based on the weight of the particular patient. The patient's weight is an example of a pre-identified characteristic of the patient. Thus, because different patients have different weights, even if the pump 20 is the same for the patient and even if the medication 22 is the same for the patient, the dosage may vary between patients.

[0086] In at least some embodiments, the reservoir 24 is intended for use with a specific patient, such that the drug 22 contained in the reservoir 24 is intended to be delivered to the specific patient. The data storage component 48 is configured to store data indicating a dose of the drug 22 to be delivered to the specific patient from the pump 20 to which the reservoir 24 is operably coupled. Before the reservoir 24 is received in the pump 20, the data indicating the dose is preprogrammed into the data storage component 48. The data may be preprogrammed in a variety of ways suitable for the specific type of data storage component 48. With the reservoir 24 operably coupled to the pump 20, the reader 50 of the pump is configured to read the preprogrammed dose data from the data storage component 48. As discussed herein, the reader 50 is configured to read the data storage component 48 to collect data therefrom, and is configured to transmit data indicating the read data to the control circuit 36. As also discussed herein, the control circuit 36 ​​(eg, a processor thereof) is configured to adjust an algorithm stored in the control circuit 36 ​​(eg, a memory thereof) to control future delivery of the drug 22 from the pump 20 based at least in part on the data.

[0087] In at least some embodiments, the preprogrammed dose reflects a weight-based dosing regimen and is based on the weight of the particular patient who will be using the pump 20. The weight-based dosing regimen can help ensure that the patient receives enough drug 22 per dose so that the drug 22 effectively provides the intended treatment, without causing the patient to receive too much drug 22, thereby wasting the drug 22 and / or increasing the risk and / or magnitude of side effects.

[0088] In at least some embodiments, the preprogrammed dose reflects the prescribed, non-weight-based dose for the particular patient who will be using the pump 20. Thus, the pump 20 can deliver the appropriate amount of drug 22 to the patient to maximize the therapeutic effect for the particular patient.

[0089] In at least some embodiments, the preprogrammed dose reflects a specific therapy for treating a specific disease. Thus, pump 20 can deliver an appropriate amount of drug 22 to the patient to maximize the effectiveness of the therapy.

[0090] In at least some embodiments, the preprogrammed dose does not change with each dose of drug 22 that pump 20 delivers to the patient.

[0091] In at least some embodiments, the preprogrammed doses are different for different doses of the drug 22 delivered to the patient by the pump 20. Over time, the patient may receive different amounts of the drug 22 from the pump 20 to maximize the patient's treatment with the drug 22. For example, some drugs are delivered in a split dosing arrangement, wherein an initial dose of a first amount of the drug 22 is delivered to the patient, at least one transitional dose of a second amount of the drug 22 is delivered to the patient after the initial dose, and at least one maintenance dose of a third amount of the drug 22 is delivered to the patient after the transitional dose. The first amount, the second amount, and the third amount of the drug 22 are different from each other. The data stored on the data storage component 48, read by the reader 50 and transmitted to the control circuit 36 ​​may reflect each of the first amount, the second amount, and the third amount. Thus, a dosing regimen may be established so that the dose of the drug 22 varies over time, with the initial dose (at the first dose), then the transitional dose (at the second dose), and then the maintenance dose (at the third dose) delivered to the patient via the pump 20.

[0092] In at least some embodiments, the data storage component 48 is configured to store data indicating the delivery rate of the drug 22 to be delivered from the pump 20 to which the reservoir 24 is operably coupled. For example, the delivery rate may vary from one therapy to another to take into account drug viscosity. Before the reservoir 24 is received in the pump 20, the data indicating the delivery rate is preprogrammed into the data storage component 48. The data may be preprogrammed in a variety of ways suitable for the particular type of data storage component 48. With the reservoir 24 operably coupled to the pump 20, the reader 50 of the pump is configured to read the preprogrammed delivery rate data from the data storage component 48. As discussed herein, the reader 50 is configured to read the data storage component 48 to collect data therefrom, and is configured to transmit data indicating the read data to the control circuit 36. As also discussed herein, the control circuit 36 ​​(e.g., its processor) is configured to adjust an algorithm stored in the control circuit 36 ​​(e.g., its memory) to control future delivery of the drug 22 from the pump 20 based at least in part on the data, such as causing the drug 22 to be delivered at a delivery rate read from the data storage component 48.

[0093] As mentioned above, the reservoir 24 can be removably and replaceably received in the pump 20, so that the pump 20 can be a reusable, multiple-use pump 20 that is configured to be used with each of the multiple reservoirs 24 received in the pump 20. Each of the reservoirs 24 that can be received in the pump 20 includes its own data storage component 48, so that the pump 20 can control the delivery of the drug 22 from each of the reservoirs 24 in a customized manner, wherein the pump 20 updates the dosing regimen based on the stored data of the particular reservoir. Therefore, a single pump 20 can be used to deliver drugs according to different dosing regimens. In some embodiments, each of the multiple reservoirs 24 received in the pump 20 contains the same type of drug 22 therein, so that the pump 20 can control the delivery of the same type of drug 22 to one patient in different ways based on the data preprogrammed into the data storage component 48 of each reservoir. In other embodiments, one or more of the plurality of reservoirs 24 received in the pump 20 contains therein a different type of drug 22 than one or more of the other plurality of reservoirs 24, such that the pump 20 can deliver at least two different types of drugs 22 to a patient, and can control the delivery of each of the different types of drugs 22 based on data preprogrammed into the data storage component 48 of each reservoir.

[0094] In embodiments where the pump 20 is a reusable, multiple-use pump 20 configured to be used with each of the plurality of reservoirs 24 received in the pump 20, each of the reservoirs 24 may have the same size as one another, wherein each of the reservoirs 24 is configured to contain the same maximum amount of medication therein. Having each of the reservoirs 24 of the same size may help ensure that the reservoir 24 is properly seated in the pump 20 so that the medication 22 contained therein may be properly in fluid communication with the syringe assembly 46 of the pump 20. The same amount of medication 22 may be contained in each of the plurality of reservoirs 24 of the same size. Figure 1 A first fill level 52 of a drug 22 that may be used in each of a plurality of reservoirs 24 of the same size is shown. Figure 1) It may be efficient and cost effective to manufacture multiple reservoirs 24 identical to one another, with each reservoir loaded with the same amount of medication 22. However, not all patients need to receive all of the medication 22 contained therein, for example due to different prescriptions, different patient weights, etc. Thus, remaining medication 22 may remain in the reservoir 24 because it has not yet been delivered to the patient. Thus, in some embodiments, different amounts of medication 22 may be contained in different reservoirs of the same size of multiple reservoirs 24, such that at least one reservoir of the multiple reservoirs 24 contains a different amount of medication 22 than at least another reservoir of the multiple reservoirs 24. Thus, a reservoir 24 containing an amount of medication 22 suitable for a particular patient, a particular therapy, etc. may be inserted into the pump 20. Thus, drug may not remain in the reservoir 24 because the remaining drug is discarded with the reservoir 24, while still allowing efficient, cost-effective manufacturing of reservoirs 24 of the same size, each configured for use with the pump 20. For example, one or more reservoirs in the plurality of reservoirs 24 may have a first fill level 52, and one or more reservoirs in the other plurality of reservoirs 24 may have a different second fill level 54. One or more additional different fill levels may be used.

[0095] The fill level between reservoirs 24 of the same size may vary in any increment, such as by about 0.5 mL, about 1 mL, about 1.5 mL, about 2 mL, about 5 mL, etc. Those skilled in the art will appreciate that the amount may not be an exact value, but is still considered to be about that value, due to any number of factors, such as manufacturing tolerances and the sensitivity of the measuring equipment. For example, the first fill level 52 and the second fill level 54 may differ by about 0.5 mL, about 1 mL, about 1.5 mL, about 2 mL, about 5 mL, etc.

[0096] Brief reference Fig.16 , an alternative pump 20' (e.g., a patch pump or other pump) is shown that is configured to deliver a liquid drug 22 to a patient. The pump 20' includes a therapeutic substance reservoir 75 that contains the drug 22 therein. The pump 20' can be configured to be attached to the patient in any of a variety of ways as will be appreciated by those skilled in the art (such as by including a backing or label that is configured to be removed from the body of the pump 20 to expose an adhesive that can be attached to the patient). Alternatively, the pump 20' can be configured as an "extracorporeal" pump.

[0097] In an exemplary embodiment, the reservoir 24 is a Figure 4The pump 20' includes a control circuit 36, a user interface 40, a reader 50, and a syringe assembly 46, which can be configured as discussed above. The pump 20' includes a pumping assembly 33 having an actuator 35 and a plunger 34. The actuator 35 controlled by the control circuit 36 ​​is configured to cause the plunger 34 to translate the seal 76 of the container 75 within the container body 75 to drive the drug 22 out of the container 75. The drug is driven to the syringe assembly 46 through the fluid path outlet 32, and the syringe assembly delivers the drug to the patient. The actuator 35 of the pumping assembly can be any suitable actuator, such as (but not limited to) a mechanical actuator, an electromechanical actuator, a pneumatic actuator, or a hydraulic actuator.

[0098] Although the above examples describe the data storage component 48 as storing data such as volume, dose, and delivery rate (or flow rate), the examples of the present disclosure are not limited thereto. In various examples, the data stored by the data storage component of the reservoir may store any suitable data for configuring the operating parameters of the drug administration system, and the control circuit 36 ​​may be configured to set the operating parameters of the drug administration system to a first value based on the configuration data, so that when the pump assembly drives the drug from the reservoir, the drug administration system operates with the operating parameters set to the first value. In this way, the data storage component can store information that can be used to configure the hardware and software of the pump to preferably deliver its associated drug. It should be understood that the control circuit 36 ​​can be configured to change the operating parameters of the drug administration system to one or more values ​​based on the configuration data after setting the operating parameters to the first value, and the drug administration system can further operate with the operating parameters set to one or more super values. Of course, the data storage component can store configuration data for configuring more than one operating parameter (such as multiple operating parameters), and the control circuit 36 ​​can be configured to set the operating parameters of the drug administration system based on the configuration data, so that when the pump assembly drives the drug from the reservoir, the drug administration system operates with the set operating parameters.

[0099] The control circuitry may be configured to set an operating parameter of the drug administration system by changing the operating parameter of the drug administration system from a different value to a first value. However, in some examples, changing the operating parameter may not be required. For example, the control circuitry may check the value of the operating parameter of the drug administration system, and if the value of the operating parameter matches the configuration data, the control circuitry may set the value of the operating parameter by confirming the value without changing the value of the operating parameter.

[0100] In some examples, such as in a multi-dose dosing regimen or a multi-drug dosing regimen, the drug administration system may include a second reservoir configured to receive a second drug therein, wherein the second reservoir includes a second data storage component. The second drug may be the same drug as the first drug or may be a different drug. The reader may be configured to read second configuration data for configuring an operating parameter of the drug administration system from the second data storage component. In addition, the control circuit may be configured to set the operating parameter of the drug administration system to a second value based on the configuration data, so that when the pump assembly drives the drug from the second reservoir, the drug administration system operates with the operating parameter set to the second value.

[0101] The configuration data may relate to volume, dosage, or delivery or flow rate as discussed above, or to any other suitable operating parameter. For example, the configuration data may be related to the identification of the drug in the reservoir. The control circuit 36 ​​may use the identification information to verify whether the drug in the reservoir is a counterfeit drug or an unauthorized drug. For example, before delivery begins, the pump may cause the data storage component to participate in a "challenge-response" authentication process to identify the use of counterfeit drugs or unauthorized drugs. The control circuit 36 ​​may be configured to set the operating parameters of the drug administration system based on the detection of counterfeit drugs or unauthorized drugs, to (i) shut down the drug administration system so that the drug administration system cannot deliver drugs and / or (ii) provide an alarm or warning about counterfeit drugs or unauthorized drugs to the operator.

[0102] The control circuit 36 ​​can use the identification information to verify whether the drugs loaded into the pump are loaded in the correct sequence during multi-sequence delivery. In such examples, the control circuit 36 ​​can be configured to set operating parameters of the drug administration system based on the detection of an incorrect drug sequence to (i) shut down the drug administration system so that the drug administration system cannot deliver drugs and / or (ii) provide an alarm or warning to the operator regarding the incorrect drug sequencing.

[0103] The configuration data may be related to the expiration date of the drug in the reservoir. In such an example, the control circuit 36 ​​may be configured to set operating parameters of the drug administration system based on detecting the expired drug to (i) shut down the drug administration system so that the drug administration system cannot deliver the expired drug and / or (ii) provide an alarm or warning to an operator regarding the expired drug.

[0104] Configuration data may relate to the expected delivery force to be used to deliver the drug stored in the reservoir, and the operating parameters of the pump (e.g., parameters of the motor) may be set to deliver the drug using the expected delivery force. For example, a high viscosity drug may be more difficult to deliver at a specific flow rate than a low viscosity drug, and may require the use of a higher force (e.g., applying a higher force on the plunger 34 of the pump), a higher pressure in the pumping chamber 28, and / or more power from the power source 420 of the pump to dispense the high viscosity drug from the pump. Therefore, the control circuit 36 ​​that monitors the operation of the pump and detects faults may be programmed with a set of different thresholds in response to the configuration data read from the data storage component to evaluate the correct pump operation during the delivery of the high viscosity drug. These thresholds may be pre-programmed in the data storage component so that they can be implemented in the hardware and software of the pump before the drug delivery begins. Alternatively, these thresholds may be pre-programmed in the control circuit 36, and the control circuit 36 ​​may select an appropriate threshold based on the configuration data (e.g., the identification of the drug) stored on the data storage component 48.

[0105] As a specific example, the expected plunger force range during the delivery of low viscosity drugs can be 10N to 15N, and the force outside this range will be considered as abnormal operation and cause an alarm. In contrast, the expected plunger force range of higher viscosity drugs can be 20N to 30N. Each data storage component can be pre-programmed with data related to the expected operating parameters of the associated drug, and the control circuit 36 ​​can reconfigure the pump for the expected operating range. The control circuit 36 ​​can reconfigure the pump by changing the software threshold and / or selecting different software algorithms. The control circuit 36 ​​can also reconfigure the hardware by modifying the settings of various hardware components such as (but not limited to) digital potentiometers, electronic range switching circuits, sensors, transducers and / or amplifiers.

[0106] The configuration data may be related to the desired temperature of the drug when it is delivered. For example, a particular drug may require refrigerated storage and the drug may need to be heated to a specific temperature before the pump begins delivery. The temperature information may be stored on a data storage component, and the pump may be equipped with a temperature measuring component, such as a thermistor. The control circuit 36 ​​may be configured to detect the temperature of the drug and set operating parameters of the drug administration system based on the detected temperature of the drug. In some examples, the control circuit 36 ​​may (i) shut down the drug administration system until the drug has been heated to the desired temperature and / or (ii) provide an alarm or warning to the operator that the drug has not yet been heated to the desired temperature.

[0107] The configuration data may store information that the control circuit 36 ​​uses to modify the user interface behavior of the pump according to the associated drug. For example, upon reading the data storage component, the display of the pump may notify the user of special instructions / warnings associated with a particular drug, and / or instructions on how to prepare the next drug in a manually implemented multi-bottle sequence. Similarly, the control circuit 36 ​​may adjust the operation of other user interface devices such as (but not limited to) a tactile buzzer, a speaker, a piezoelectric transducer, and / or an LED to generate special alarms and warnings associated with the delivery of a particular drug or the delivery of a drug sequence.

[0108] Figure 8 and Fig. 9 Another embodiment of a pump 100 configured to deliver a liquid medication 148 to a patient is illustrated. Figure 8 and Fig. 9 The pump 100 is typically operated in a manner similar to Figure 1 The pump 100 is configured and used in a manner similar to that described above with respect to the pump 20. The pump 100 is configured to engage with a therapeutic substance reservoir 132. The reservoir 132 can have any of a variety of configurations, similar to that described above with respect to the therapeutic substance reservoir 132. Figure 1 The configuration discussed above is for a reservoir 24 of the pump 100. Within the pump 100 is a sterile fluid path 122 for delivering a drug 148 to a patient wearing the pump 100. The sterile fluid path 122 has a conduit 126 at an upstream end 124 of the sterile fluid path 122 and an injection assembly (also referred to herein as a "syringe assembly") 130 at a downstream end 128 of the sterile fluid path 122.

[0109] The pump 100 also includes: a control circuit 138; a user interface (UI) 150 operably coupled to the control circuit 138 and configured to provide information to a user of the pump 100; and a reader 136 operably coupled to the control circuit 138 and configured to read the data storage component 134 of the reservoir 132. The user interface 150 may have any of a variety of configurations, similar to the above description of the Figure 1 The data storage component 148 and the reader 136 may each have a variety of configurations, similar to the above description of the configuration of the user interface 40. Figure 1 The control circuit 136 is configured in accordance with the configuration similar to that discussed above with respect to the data storage component 48 and the reader 50. Figure 1 The control circuit 136 of the pump 100 controls the administration of the drug 148 from the pump 100 according to the dosing regimen discussed above. Thus, the control circuit 136 (e.g., its processor) is configured to establish at least one of the one or more variable parameters of the algorithm based on data received from the reader 136 so as to be based at least in part on data stored on the data storage component 134 of the reservoir 132.

[0110] The pump 100 and the reservoir 132 are configured to engage with each other, such as when the reservoir 132 is Figure 8 The reservoir 132 is shown as being moved in the direction of the arrow 133 into the housing 110 of the pump 100. Thus, the reservoir 132 is configured to be inserted into the pump 100. Figure 1 As discussed above with respect to the pump 20 of FIG. 1 , the reservoir 132 may be non-removably received in the pump 100 or may be removably and replaceably received in the pump 100. The conduit 126 is configured to be driven through the reservoir 132 when the pump 100 and the reservoir 132 are engaged with each other, so that fluid communication is established between the reservoir 132 and the sterile fluid path 122, as shown in FIG. Fig. 9 In embodiments where the data storage component 134 is located on top of the reservoir 132 that is pierced by the catheter 126, the catheter 126 can be configured to pierce the data storage component.

[0111] Once fluid communication is established between reservoir 132 and sterile fluid path 122, and control circuit 138 has adjusted the dosing regimen based on data received from reader 136, control circuit 138 is configured to drive pump assembly 140 of pump 100 to draw drug 148 from reservoir 132 and deliver drug 148 to the patient via injection assembly 130, similar to the above description of the method for controlling the drug administration regimen. Figure 1 The control circuit 36 ​​and injection assembly 46 are discussed above.

[0112] In the illustrated embodiment, the data storage component 134 is located on one side of the reservoir 132, but as discussed above, the reservoir 132 may include the data storage component 134 at another location. The reader 136 is located within the pump 100 so as to be configured to align with the data storage component 134, wherein the reservoir 132 is received in the pump 100, such as Fig. 9 shown.

[0113] Generally speaking, in embodiments where the data storage component comprises an NFC tag, the data storage component of the reservoir received in the pump is located within the effective range of the pump's reader. In this manner, the reader can effectively read data from the NFC tag. In some embodiments, the reader is within the effective range of the pump regardless of the alignment of the reservoir relative to the pump. For example, if the data storage component is located on the top of the reservoir or on the bottom of the reservoir (e.g., as in Figure 3In the embodiment shown in FIG. 1 , where the NFC tag 72 is located on the bottom of the vial 70), the rotational alignment of the reservoir relative to the pump does not affect the effective distance of the reader from the data storage component. In other embodiments, the alignment of the reservoir relative to the pump may affect the reader's ability to effectively read the data storage component. In such embodiments, minimizing the distance between the pump's reader and the reservoir's data storage component can help ensure that the reader is within the effective distance to properly read data from the data storage component.

[0114] In an exemplary embodiment, the data storage components of the reader and reservoir of the pump are at a minimum distance from each other, have windings that are substantially coaxially aligned and orthogonal in the same plane, and have substantially the same shape and size, and have a maximum number of electromagnetic field lines generated by the reader (e.g., by its antenna) that pass through the data storage component (e.g., through its antenna). Those skilled in the art will understand that the axes may not be exactly coaxially aligned, the planes may not be exactly orthogonal, and the sizes and shapes may not be exactly the same, but still be considered to be substantially coaxially aligned, substantially orthogonal, or substantially the same size and shape due to many factors such as manufacturing tolerances and the sensitivity of the measurement equipment.

[0115] Fig.10 An embodiment of a relative positioning of an NFC tag antenna 200 of a data storage component and an NFC reader antenna 202 of a reader that are substantially coaxially aligned and orthogonal in the same plane and have substantially the same shape and size is illustrated. A maximum number of electromagnetic field lines 204 generated by the NFC reader antenna 202 pass through the NFC tag antenna 200, which is at a minimum distance D from the NFC reader antenna 202. The data storage component in the illustrated embodiment also includes an NFC tag chip 206 operably coupled to the NFC tag antenna 200, and the reader in the illustrated embodiment also includes a reader chip 208 operably coupled to the NFC reader antenna 202. Fig.11 Shows Fig.10 1 and 2. A comparison of the NFC tag antenna 200 and the NFC reader antenna 202 is shown, wherein the position and orientation of the NFC tag antennas 200a, 200b, 200c, 200d, 200e relative to the NFC reader antenna 202 is less than ideal.

[0116] The pump and the reservoir configured to be received in the pump may include cooperating alignment mechanisms configured to facilitate optimal performance of the reader of the pump and the data storage component of the reservoir by cooperating to optimally position the reader and the data storage component relative to each other. The cooperating alignment mechanisms may have a variety of configurations.

[0117] Fig.12An embodiment is illustrated in which a pump 300 includes a female alignment mechanism 302 configured to engage a male alignment mechanism 304 of a reservoir 306, which in the illustrated embodiment is a syringe, but may be of another type as discussed herein. In other embodiments, the pump 300 may include a male alignment mechanism and the reservoir 306 may include a female alignment mechanism. The illustrated embodiment includes a single male alignment mechanism 302 and a single female alignment mechanism 304, but another equal number of cooperating male and female alignment mechanisms may also be used.

[0118] The alignment mechanisms 302, 304 are configured to slidably engage when the reservoir 306 is inserted into the pump 300. In the event that the alignment mechanisms 302, 304 are not engaged with each other (e.g., in the event that the male alignment mechanism 304 is not seated in the female alignment mechanism 302), the reservoir 306 cannot be inserted into the pump 300 because the space for the reservoir 306 within the pump 300 is too small to insert the reservoir 306 into the pump 300. Therefore, the reservoir 306 can only be inserted into the pump 300 in a predetermined orientation relative to the pump 300. Therefore, the data storage component 308 of the reservoir 306 (e.g., its antenna) will be positioned at an effective position relative to the reader 310 (e.g., its antenna) of the pump 300, wherein the reservoir 306 is received in the pump 300, as shown in FIG. Fig.12 In the illustrated embodiment, the data storage component 308 is on the cylindrical side of the reservoir 306, but the cooperating alignment mechanism may be similarly used with a data storage component of a reservoir in another location.

[0119] As mentioned above, in some embodiments, the reader of the pump may include a multiplexed reader, in which case the data storage component of the reservoir has multiple active positions relative to the reader. In such embodiments, it is not necessary to use a cooperative alignment mechanism. Fig.12 As an example, the embodiment of the reservoir 306 is Fig.13 One embodiment of a pump 312 comprising a multiplexed reader including multiple reader antennas 314 is illustrated. Fig.13 Reservoir 306 is shown inserted into pump 312.

[0120] Fig.14 Another embodiment of a pump 400 configured to deliver medication to a patient is illustrated. Fig.14 The pump 400 is usually similar to Figure 1The pump 400 is configured and used in a manner similar to that of the pump 20. The pump 400 includes a reservoir 402 that is configured to contain therein a liquid medication to be delivered from the pump 400. The reservoir 402 can have a variety of configurations, as discussed herein. The pump 400 also includes a pumping assembly 404 that is configured to cause the dispensing of the medication contained in the reservoir 402 so that the medication can be delivered to a patient. The pump 400 also includes a syringe assembly that includes an infusion line 406 (e.g., a needle or cannula) that is configured to be removably attached to a patient. When the pumping assembly 404 is actuated via the infusion line 406, the medication is delivered from the reservoir 402. Thus, in Fig.14 In the illustrated embodiment of the present invention, the pump 400 is configured as an "extracorporeal" pump. In some embodiments, the pump 400 is a single-use pump, wherein the pump 400 is used only before the infusion line 406 is removed from the patient. In other embodiments, the pump 400 is a multiple-use pump, wherein the pump 400 can be reused with different infusion lines 406.

[0121] The pump 400 also includes a user interface 408 configured to provide information to a user of the pump 400, and a reader 410 configured to read data from a data storage component 412 of the reservoir 402. The user interface 408, the reader 410, and the data storage component 412 can each have a variety of configurations, as discussed herein. The pump 400 and the reservoir 402 can include a cooperating alignment mechanism, as discussed herein.

[0122] Pump 400 also includes control circuitry 414, which includes processor 416 and memory 418. Processor 416 is operably coupled to memory 418, user interface 408, reader 410, and pumping assembly 404. Actuation of pumping assembly 404 is controlled by processor 416.

[0123] The pump 400 also includes a power source 420 that is configured to provide power to any components of the pump 400 that require power to operate, such as the pumping assembly 404, the processor 416, and the user interface 408.

[0124] The reservoir 402, pumping assembly 404, user interface 408, power source 420, and control circuit 414 are located within a housing 422 of the pump 400 (also referred to herein as the "body" of the pump). The infusion line 406 is partially located within the housing 422 and extends from the housing 422 for penetration into the patient. The infusion line 406 can be fixedly positioned partially within the housing 422 and partially outside the housing 422, such as Fig.14 As shown, the infusion line 406 may be capable of moving, for example under the control of the circuit 414, from an initial position completely within the housing 422 to a delivery position partially within the housing 422 and partially outside of the housing 422.

[0125] Fig.15 Another embodiment of a pump 500 configured to be worn by a patient and to deliver liquid medication to the patient is illustrated. Fig.15 The pump 500 is usually similar to Figure 1 The pump 20 is configured and used in a manner such as to include: a housing 502; a user interface 504; a reservoir 506, which is configured to contain a liquid drug to be delivered from the pump 500; a pumping assembly 508, which is configured to cause the dispensing of the drug contained in the reservoir 506; a syringe assembly 510, which is configured to deliver the drug into a patient; a reader 512, which is configured to read a data storage component 514 of the reservoir 506; a plunger 516, which is configured to slide within the pump chamber; and a control circuit 518, which is operably connected to the reader 512, the user interface 504 and the pumping assembly 508.

[0126] The pump 500 also includes a removable backing or label 520 and a depressible button 522. The backing or label 520 is configured to be removed from the housing 502 of the pump 500 to expose an adhesive that can be attached to the patient, thereby allowing the pump 500 to be removably attached to the patient. The button 522 is configured to be pressed by a user to start the operation of the pump 500 to deliver the drug to the patient according to the stored dosing regimen.

[0127] In the illustrated embodiment, the user interface 504 includes a plurality of lights arranged circumferentially around the button 522. These lights can be illuminated to provide various information to the user. In the illustrated embodiment, these lights include multiple lights (e.g., two, three, four, five, etc.), but may also include a single light. As an alternative or supplement to the button 522, the lights may be arranged in a line, for example. Various embodiments of lights and light illumination for providing information are further described in, for example, the previously mentioned international patent publication WO 2021 / 124002, entitled "Liquid Drug Pumps Including User Feedback Indicating Pump Orientation," published on June 24, 2021.

[0128] The present disclosure has been described above by way of example only in the context of the overall disclosure provided herein. It should be understood that modifications may be made within the spirit and scope of the claims without departing from the overall scope of the present disclosure. All publications and references cited herein are expressly incorporated herein by reference in their entirety for all purposes.

Claims

1. A drug administration system, comprising: a first reservoir containing a first volume of a first medicament therein and comprising a first data storage component storing data indicative of the first volume; a second reservoir having the same dimensions as the first reservoir, the second reservoir containing a second volume of a second medicament therein and including a second data storage component storing data indicative of the second volume, the second volume being different from the first volume; and A pump configured to receive each of the first reservoir and the second reservoir therein, the pump comprising: a reader configured to read the stored data from the first data storage component and the second data storage component; a pumping assembly configured to drive the first drug from the pump for delivery to a patient and to drive the second drug from the pump for delivery to the patient, and a control circuit operably coupled to the reader and to the pumping assembly and configured to: receiving from the reader first data indicative of stored data read from the first data storage component, using the received first data to establish a first dosing regimen for delivering the first drug, causing the pumping assembly to drive the first drug from the pump based on the first dosing regimen, receiving from the reader second data indicative of stored data read from the second data storage component, using the received second data to establish a second dosing regimen for delivering the second medicament, and The pumping assembly is caused to drive the second drug from the pump based on the second dosing regimen.

2. The system of claim 1, wherein the control circuit is configured to establish the first dosing regimen prior to any delivery of the first drug from the pump to the patient; and The control circuit is configured to establish the second dosing regimen prior to any delivery of the second drug from the pump to the patient.

3. The system of claim 1 or 2, wherein the reader comprises a near field communication (NFC) reader, the first data storage component comprises a first NFC tag, and the second data storage component comprises a second NFC tag.

4. The system of claim 1 or 2, wherein the reader comprises a QR code scanner, the first data storage component comprises a first QR code, and the second data storage component comprises a second QR code.

5. The system of claim 1 or 2, wherein the first data storage component comprises a first electrically erasable programmable read-only memory (EEPROM), and the second data storage component comprises a second EEPROM.

6. The system of any one of claims 1 to 5, wherein the first drug is the same as the second drug.

7. The system of any one of claims 1 to 5, wherein the first drug is different from the second drug.

8. The system of any one of claims 1 to 7, wherein the first reservoir and the second reservoir are configured to be pre-loaded into the pump.

9. The system of any one of claims 1 to 7, wherein the first reservoir and the second reservoir are configured to be loaded into the pump by a user.

10. The system of any one of claims 1 to 9, wherein the first reservoir is configured to be removed from the pump before the second reservoir is received in the pump.

11. A method for administering a drug, comprising: A reader of the pump reads the stored data from the first data storage component and the second data storage component; The control circuit of the pump establishes a first dosing regimen and causes a pumping component of the pump to drive a first drug from a first reservoir in the pump based on the first dosing regimen; and The control circuit establishes a second dosing regimen and causes the pumping assembly to drive a second drug from a second reservoir in the pump based on the second dosing regimen; wherein the first reservoir contains a first volume of the first medicament in the first reservoir and includes the first data storage component storing data indicative of the first volume; the second reservoir having the same size as the first reservoir, the second reservoir containing a second volume of the second medicament therein and including the second data storage component storing data indicative of the second volume; the second volume is different from the first volume; and The control circuit receives first data from the reader indicating stored data read from the first data storage component, establishes the first dosing regimen using the received first data, receives second data from the reader indicating stored data read from the second data storage component, and establishes the second dosing regimen using the received second data.

12. The method of claim 11, wherein the control circuit establishes the first dosing regimen prior to any delivery of the first drug from the pump to the patient, and the control circuit establishes the second dosing regimen prior to any delivery of the second drug from the pump to the patient.

13. The method of claim 11 or 12, wherein the reader comprises a near field communication (NFC) reader, the first data storage component comprises a first NFC tag, and the second data storage component comprises a second NFC tag.

14. The method of claim 11 or 12, wherein the reader comprises a QR code scanner, the first data storage component comprises a first QR code, and the second data storage component comprises a second QR code.

15. The method of claim 11 or 12, wherein the first data storage component comprises a first electrically erasable programmable read-only memory (EEPROM) and the second data storage component comprises a second EEPROM.

16. The method of any one of claims 11 to 15, wherein the first drug is the same as the second drug.

17. The method of any one of claims 11 to 15, wherein the first drug is different from the second drug.

18. The method of any one of claims 11 to 17, wherein each of the first reservoir and the second reservoir is pre-loaded into the pump.

19. The method of any one of claims 11 to 17, wherein each of the first reservoir and the second reservoir is loaded into the pump by a user.

20. The method of any one of claims 11 to 19, wherein the first volume of the first drug is delivered to the patient in the first dosing regimen and the second volume of the second drug is delivered to the patient in the second dosing regimen.

21. The method of any one of claims 11 to 19, wherein the first volume of the first drug is delivered to the patient in the first dosing regimen, and less than the second volume of the second drug is delivered to the patient in the second dosing regimen.

22. The method of any one of claims 11 to 21, further comprising removing the first reservoir from the pump before a second reservoir is received in the pump.

23. A drug administration system, comprising: a pump comprising a housing, a reader, and a control circuit; and a reservoir configured to contain a drug therein, the reservoir comprising a data storage component configured to be preprogrammed with data indicating a dose of the drug to be delivered to a patient using the pump before the reservoir is received in the housing of the pump; wherein the reader is configured to read the data indicative of the dosage from the data storage component with the reservoir received in the housing of the pump; The control circuit is configured to receive data from the reader indicative of read data, the read data indicative of the dosage; and The control circuit is configured to cause a dose of the drug at the dosage to be delivered from the pump to the patient.

24. The system of claim 23, wherein the dosage is based on at least one of a pre-identified therapy and a pre-identified prescription for the drug for the patient.

25. The system of claim 23, wherein the dosage is based on a pre-identified weight of the patient.

26. The system of claim 23, wherein the dosage is based on at least one of sex, race, and genetic makeup.

27. The system of any one of claims 23 to 26, wherein the reader comprises a near field communication (NFC) reader and the data storage component comprises an NFC tag.

28. The system of any one of claims 23 to 26, wherein the reader comprises a QR code scanner and the data storage component comprises a QR code.

29. The system of any one of claims 23 to 26, wherein the data storage component comprises an electrically erasable programmable read-only memory (EEPROM).

30. The system of any one of claims 23 to 29, wherein the control circuit is configured to cause one or more additional doses of the drug to be delivered from the pump to the patient, each dose of the one or more additional doses of the drug being at the dosage.

31. The system of any one of claims 23 to 30, wherein the reservoir is configured to be non-removably received in the housing of the pump.

32. The system of any one of claims 23 to 30, wherein the reservoir is configured to be removably and replaceably received in the housing of the pump.

33. The system of any one of claims 23 to 32, wherein the reservoir is configured to be pre-loaded into the housing.

34. The system of any one of claims 23 to 32, wherein the reservoir is configured to be loaded into the housing by a user.

35. The system of any one of claims 23 to 34, further comprising a second reservoir configured to contain a second drug therein, the second reservoir comprising a second data storage component configured to be preprogrammed with data indicating a second dose of the second drug to be delivered to the patient using the pump before the second reservoir is received in the housing of the pump; wherein the reader is configured to read the data indicative of the second dose from the second data storage component with the second reservoir received in the housing of the pump; The control circuit is configured to receive data from the reader indicative of read data, the read data indicative of the second dose; and The control circuit is configured to cause a dose of the second medicament at the second dose to be delivered from the pump to the patient.

36. A method for administering a drug, comprising: a reader of the pump reading data indicative of a dosage from a data storage component of the reservoir with the reservoir received in the housing of the pump; and control circuitry of the pump causes a dose of the drug at the dosage to be delivered from the pump to the patient; wherein said reservoir contains said drug therein; the data storage component is preprogrammed with data indicating the dose of the drug to be delivered to the patient using the pump before the reservoir is received in the housing of the pump; and The control circuit receives data from the reader indicative of read data, the read data indicative of the dosage.

37. The method of claim 36, wherein the dosage is based on at least one of a pre-identified therapy and a pre-identified prescription for the drug for the patient.

38. The method of claim 36, wherein the dosage is based on a pre-identified weight of the patient.

39. The method of claim 36, wherein the dosage is based on at least one of sex, race, and genetic makeup.

40. A method according to any one of claims 36 to 39, wherein the reader comprises a near field communication (NFC) reader and the data storage component comprises an NFC tag.

41. A method according to any one of claims 36 to 39, wherein the reader comprises a QR code scanner and the data storage component comprises a QR code.

42. A method according to any one of claims 36 to 39, wherein the data storage component comprises an Electrically Erasable Programmable Read Only Memory (EEPROM).

43. The method of any one of claims 36 to 42, further comprising the control circuit causing one or more additional doses of the drug to be delivered from the pump to the patient, each dose of the one or more additional doses of the drug being at the dosage.

44. The method of any one of claims 36 to 43, wherein the reservoir is non-removably received in the housing of the pump.

45. A method according to any one of claims 36 to 43, wherein the reservoir is removably and replaceably received in the housing of the pump.

46. ​​A method according to any one of claims 36 to 45, wherein the reservoir is pre-loaded into the housing.

47. A method according to any one of claims 36 to 45, wherein the reservoir is loaded into the housing by a user.

48. The method of any one of claims 36 to 47, further comprising the reader of the pump reading data indicative of a second dose from a second data storage component of the second reservoir with the second reservoir received in the housing of the pump; and the control circuitry of the pump causing a second dose of the second drug at the second dose to be delivered from the pump to the patient; wherein the second reservoir contains the second medicament in the second reservoir; the second data storage component is preprogrammed with data indicating the second dose of the second drug to be delivered to the patient using the pump before the second reservoir is received in the housing of the pump; and The control circuit receives data from the reader indicative of read data, the read data indicative of the second dose.

49. A drug administration system, comprising: a reservoir configured to contain a medication therein, the reservoir comprising a data storage component configured to store data regarding the medication therein, and the reservoir comprising a first alignment mechanism; and a pump configured to receive the reservoir therein, the pump comprising: a reader configured to read the stored data from the data storage component when the reservoir is received in the pump, a second alignment mechanism, the second alignment mechanism being configured to engage the first alignment mechanism, the engagement of the first alignment mechanism and the second alignment mechanism being configured to ensure that the data storage component is positioned within an effective reading range of the reader, and A control circuit configured to receiving from the reader data indicative of stored data read from the data storage component, using the received data to establish a dosing regimen for delivering the drug, and The drug is delivered to the patient based on the dosing regimen.

50. The system of claim 49, wherein the reservoir cannot be fully received in the pump if the first alignment mechanism and the second alignment mechanism are not aligned.

51. The system of claim 49 or 50, wherein the reader comprises a near field communication (NFC) reader and the data storage component comprises an NFC tag.

52. The system of claim 49 or 50, wherein the reader comprises a radio frequency identification (RFID) scanner and the data storage component comprises an RFID tag.

53. The system of claim 49 or 50, wherein the data storage component comprises an electrically erasable programmable read-only memory (EEPROM).

54. The system of any one of claims 49 to 51 and 53, wherein the data storage component is positioned to maximize the number of electromagnetic field lines generated by the reader that pass through the data storage component.

55. The system of any one of claims 49 to 54, wherein one of the first alignment mechanism and the second alignment mechanism is a female member and the other of the first alignment mechanism and the second alignment mechanism is a male member configured to slide within the female member.

56. The system of any one of claims 49 to 55, wherein the reservoir is configured to be pre-loaded into the pump.

57. The system of any one of claims 49 to 55, wherein the reservoir is configured to be loaded into the pump by a user.

58. A method for administering a drug, comprising: engaging a first alignment mechanism of a reservoir and a second alignment mechanism of a pump and then causing the reservoir to be received in the pump; wherein said reservoir contains a drug in said reservoir; The reservoir includes a data storage component that stores data about the drug in the data storage component; The pump includes a reader and a control circuit; The method further includes the reader reading the stored data from the data storage component with the reservoir received in the pump; the second alignment mechanism engages the first alignment mechanism, the engagement of the first alignment mechanism and the second alignment mechanism ensuring that the data storage component is positioned within an effective reading range of the reader; The method also includes the control circuit receiving data from the reader indicative of the stored data read from the data storage component, establishing a dosing regimen for delivering the drug using the received data, and causing the drug to be delivered to the patient based on the dosing regimen.

59. The method of claim 58, wherein the reservoir cannot be fully received in the pump if the first alignment mechanism and the second alignment mechanism are not aligned.

60. The method of claim 58 or 59, wherein the reader comprises a near field communication (NFC) reader and the data storage component comprises an NFC tag.

61. The method of claim 58 or 59, wherein the reader comprises a radio frequency identification (RFID) reader and the data storage component comprises an RFID tag.

62. The method of claim 58 or 59, wherein the data storage component comprises an electrically erasable programmable read-only memory (EEPROM).

63. A method according to any one of claims 58 to 60 and 62, wherein the data storage component is positioned to maximize the number of electromagnetic field lines generated by the reader that pass through the data storage component.

64. The method of any one of claims 58 to 63, wherein one of the first alignment mechanism and the second alignment mechanism is a female member and the other of the first alignment mechanism and the second alignment mechanism is a male member that slides within the female member.

65. The method of any one of claims 58 to 64, wherein the reservoir is pre-loaded into the pump.

66. The method of any one of claims 58 to 64, wherein the reservoir is loaded into the pump by a user.

67. A drug administration system, comprising: a pump assembly configured to drive the drug from the reservoir for delivery to a patient; a reader configured to read configuration data for configuring operating parameters of the drug administration system from a data storage component of the reservoir; and A control circuit is configured to set the operating parameter of the drug administration system to a first value based on the configuration data, so that when the pump assembly drives the drug from the reservoir, the drug administration system operates with the operating parameter set to the first value.

68. A system according to claim 67, wherein the operating parameter is a flow rate, and the control circuit is configured to set the flow rate of the drug administration device to the first value based on the configuration data, so that when the pump assembly drives the drug from the reservoir, the drug administration system delivers the drug at the flow rate set to the first value.

69. A system according to claim 67, wherein the operating parameter is a delivery force, and the control circuit is configured to set the delivery force of the drug administration device to the first value based on the configuration data, so that when the pump assembly drives the drug from the reservoir, the drug administration system delivers the drug with the delivery force set to the first value.

70. The system of claim 67, wherein the operating parameter is a delivery volume to be delivered to the patient, and the control circuit is configured to set the delivery volume of the drug administration device to the first value based on the configuration data, such that when the pump assembly drives the drug from the reservoir, the drug administration system delivers the drug at the delivery volume set to the first value.

71. The system of claim 67, wherein the control circuit is configured to set the operating parameter of the drug administration system by changing the operating parameter of the drug administration system from a different value to the first value.

72. The system of claim 67, wherein the reader comprises a near field communication (NFC) reader and the data storage component comprises a first NFC tag.

73. The system of claim 67, wherein the reader comprises a QR code scanner and the data storage component comprises a first QR code.

74. The system of claim 67, wherein the data storage component comprises an electrically erasable programmable read-only memory (EEPROM).

75. The system of claim 67, comprising a housing configured to receive the reservoir.

76. The system of claim 75, wherein the reader is configured to communicatively couple with the data storage component when the data storage component is received in the housing to read the configuration data.

77. The system of claim 67, comprising the reservoir configured to contain a drug therein, the reservoir comprising the data storage component, wherein the configuration data is preprogrammed on the data storage component.

78. The system of claim 77, comprising a second reservoir configured to contain a second medicament therein, the second reservoir comprising a second data storage component, wherein the reader is configured to read second configuration data for configuring the operating parameters of the drug administration system from a second data storage component; and Wherein the control circuit is configured to set the operating parameter of the drug administration system to a second value based on the configuration data, such that when the pump assembly drives the drug from the second reservoir, the drug administration system operates with the operating parameter set to the second value.

79. A method of administering a drug using a drug administration system, the method comprising: communicatively coupling a reader of the drug administration system to a data storage component of a reservoir of the drug administration system; reading, with the reader, configuration data for configuring operating parameters of the drug administration system from the data storage component of the reservoir; setting the operating parameter of the drug administration system to a first value based on the configuration data; as well as A pump assembly of the drug administration system is operated to drive the drug from the reservoir such that the drug administration system operates with the operating parameter set to the first value.

80. The method of claim 79, wherein the communicatively coupling step includes bringing the reader and a data storage component of the reservoir into proximity with each other so as to enable the reader to communicate with the data storage component.

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