Intelligent Vial Adapter and Method

Abstract

The present invention relates to intelligent vial adapters and methods. The intelligent vial adapter is capable of measuring the dosage of a drug withdrawn from a vial, measuring the time of a dosage capture event, monitoring the vial temperature, measuring the amount of movement or perturbation to which the vial is subjected, capturing various other parameters that can provide additional insights associated with the drug or the dosage withdrawn from the vial, and transmitting the recorded information to a companion application on a computer, smartphone, or other device. Related methods are also disclosed and claimed.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of priority under 35 U.S.C 119(e) to U.S. Provisional Patent Application Serial No. 62 / 616,688, filed on January 12, 2018, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention generally relates to vial adapters and dose capture systems. In particular, but without limitation, embodiments of the present invention relate to smart vial adapters that can not only provide physical access to a drug vial, but also perform dose capture, status monitoring, and information reporting functions using electronic components contained within the vial adapter. Related methods are also disclosed and claimed. Background Art

[0004] The effective administration of some types of drug injections, particularly in the case of insulin used by diabetic patients, requires keeping the drug under the correct storage conditions and maintaining a record of all administered doses. Although patients receiving home injections are provided with instructions, most patients still find it challenging to correctly follow the instructions on a daily basis. Healthcare providers can record dose - related information in a clinical setting, but there are significant overheads associated with capturing this information. It is also difficult to measure and record certain parameters (such as drug temperature and correct mixing) that can affect drug safety and efficacy.

[0005] Many types of drugs are provided in vials containing multiple individual doses. The vial is sealed with a rubber septum that can be pierced by a syringe needle when withdrawing a dose of the drug from the vial to prepare for injection. Instead of a needle, if the syringe has a blunt cannula or Luer tip that cannot pierce the septum, a vial adapter can be used to provide access to the vial for the syringe. The vial adapter has a sharp plastic spike or cannula that pierces the septum, and a fluid port, typically in the form of a needle - free valve or a pre - cut septum, that can be accessed through the blunt cannula or Luer tip of the syringe. After the vial adapter is installed on the vial, the vial adapter can remain in place, allowing multiple doses to be withdrawn from the vial without repeatedly piercing the vial septum.

[0006] Most vial adapters are purely mechanical in nature, providing only a fluid path between the vial and the syringe, as well as an auxiliary seal for the vial. However, the physical presence of the vial adapter on the vial and its insertion into the fluid path between the vial and the syringe present an opportunity for the vial adapter to perform additional functions, such as dose capture, status monitoring, and information reporting. The present invention takes advantage of this opportunity by providing a vial adapter having electronic components that allow the vial adapter to perform these and / or other functions. Related methods are also disclosed and claimed. SUMMARY OF THE INVENTION

[0007] According to an embodiment of the present invention, there is provided a vial adapter that is capable of not only providing a physical access to a pharmaceutical vial, but also performing dose capture, status monitoring, and information reporting functions using electronic components contained within the vial adapter. These functions may include measuring the dose withdrawn from the vial, measuring the time of a dose capture event, monitoring the vial temperature, measuring the amount of movement or perturbation to which the vial is subjected, capturing various other parameters that may provide additional insights related to the pharmaceutical or the dose withdrawn from the vial, and transmitting the recorded information to a companion application on a computer, smartphone, or other device.

[0008] More specifically, an embodiment of the present invention relates to a vial adapter comprising: a housing having a first end and a second end, the first end being open and attachable to a vial, and the second end having a fluid port sealed by a penetrable septum; a vial access cannula fixed to the housing and in communication with the fluid port, the vial access cannula being located within the open first end of the housing for penetrating the septum of the vial attached to the housing; and electrical components contained within the housing for performing at least one dose capture, status monitoring, or information reporting function on a pharmaceutical contained within the housing or withdrawn from a vial attached to the housing.

[0009] In another embodiment of the present invention, a method for storing and using a pharmaceutical contained in a vial includes: attaching a vial adapter to the vial, the vial adapter being capable of performing at least one dose capture, status monitoring, or information reporting function on the pharmaceutical when the pharmaceutical is contained within the vial or withdrawn from the vial through the vial adapter; and causing the vial adapter to perform at least one dose capture, status monitoring, or information reporting function on the pharmaceutical when the pharmaceutical is contained within the vial or withdrawn from the vial through the adapter. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Aspects and advantages of embodiments of the present invention will be more readily understood from the following detailed description in conjunction with the accompanying drawings, in which:

[0011] Figure 1is a schematic diagram showing a medicine vial, a smart vial adapter attachable to the medicine vial, and a mobile device wirelessly receiving information from the smart vial adapter;

[0012] Figure 2 is similar to Figure 1 a schematic diagram, but the smart vial adapter is attached to the medicine vial, the syringe is positioned to withdraw a dose from the vial through the smart vial adapter, and the mobile device is not shown;

[0013] Figure 3 is a detailed cross-sectional view of the smart vial adapter, which is shown detached from the medicine vial;

[0014] Figure 4 is a schematic diagram of the electronic components within the smart vial adapter that perform various dose capture, status monitoring, and information reporting functions;

[0015] Figure 5 and 6 are flowcharts of the operations performed when the smart vial adapter is operating in its sleep and active modes, respectively; and

[0016] Figures 7-9 is an exemplary screen display that can be generated by the mobile device, which is programmed with a software application associated with the smart vial adapter. DETAILED DESCRIPTION

[0017] Reference will now be made in detail to embodiments of the invention shown in the drawings, wherein like reference numerals throughout the drawings indicate like elements. The embodiments described and shown herein illustrate the invention but do not limit the invention, and the drawings are not necessarily drawn to scale relative to each other or relative to actual physical embodiments. Further, those skilled in the art will understand that the language and terminology used herein are for the purpose of description and should not be regarded as limiting. The use of "including", "comprising", or "having" and their variants herein is intended to cover the items listed hereinafter and their equivalents as well as additional items. Unless otherwise limited, the terms "connected", "coupled", and "mounted" and their variants are used herein broadly and include direct and indirect connections, couplings, and mountings. Additionally, the terms "connected" and "coupled" and their variants are not limited to physical or mechanical connections or couplings. Further, terms such as "upward", "downward", "bottom", "top", "distal", and "proximal" are relative and are used to aid in illustration but are not restrictive.

[0018] Figure 1 and 2Schematic of the overall combination of components employed in one embodiment of the present invention. A conventional glass or plastic pharmaceutical vial 10 containing insulin or another injectable drug in liquid form is sealed by an upper cap 12 having a rubber septum 14. A smart vial adapter 16 that wirelessly communicates with a smart phone 11 or other mobile electronic device can be attached to the vial 10. The vial adapter 16 has a cylindrical plastic housing 17 and a vial access cannula in the form of a downwardly projecting hollow plastic spike 18 having a sharp tip 21. The housing 17 can be attached above the cap 12 to provide a fluid passage to the interior of the vial 10 for filling a syringe 19.

[0019] The vial 10 and the vial adapter 16 are shown Figure 1 separate from each other, as would be the case before the vial adapter 16 is mounted on the vial 10 or after it is removed from the vial 10. In Figure 2 , the vial 10 and the vial adapter 16 are shown connected to each other, as they would be during syringe filling. In the connected state, the spike 18 passes through the vial septum 14 in a fluid-tight manner to communicate with the interior of the vial 10. Additionally, the entire lower skirt 20 of the vial adapter housing 17 is received above the vial cap 12, and the inwardly projecting stabilizing ring 22 of the skirt 20 engages an annular groove 24 below the cap 12 to provide a releasable snap or braking connection between the vial 10 and the vial adapter 16. The plastic material of the vial adapter housing 17 and the skirt 20 has sufficient flexibility and elasticity to allow a releasable snap or braking connection between the vial 10 and the vial adapter 16.

[0020] When the vial 10 and the vial adapter 16 are connected to each other as Figure 2 shown, the syringe 19 can be filled with a dose of the drug contained in the vial 10 via the vial adapter 16 in a manner substantially the same as when filling the syringe directly from the vial. Initially, the connected vial 10 and vial adapter 16 are inverted to allow the liquid drug to flow from the vial 10 through the lumen of the spike 18 into a cylindrical chamber 26 within the housing 17 of the vial adapter 16. A rubber diaphragm 28 seals the chamber 26 to provide a sterile environment and prevent air or liquid from leaking from (or entering) the chamber 26 during syringe filling. Once the chamber 26 is filled, the plunger 30 of the syringe 19 (which has not yet engaged the vial adapter 16) is pulled back to fill the syringe barrel 32 with an amount of air corresponding to the dose of drug withdrawn from the vial 10. The sharp tip 34 of the hollow metal syringe needle 36 is then pushed through the diaphragm 28 of the vial adapter 16, thereby placing the lumen of the hollow needle 36 in fluid communication with the interior of the chamber 26 containing the liquid drug. The plunger 30 of the syringe 19 is then depressed to inject air into the chamber 26.

[0021] Since the vial 10 and vial adapter 16 connected at this time are still inverted, air will immediately move into the vial 10, and the chamber 26 will refill with the liquid medicine. As in a traditional syringe filling process (i.e., without the vial adapter 16), air is initially injected into the vial 10 to compensate for the liquid to be removed from the vial 10, thus preventing the formation of a vacuum in the vial 10 when the syringe 19 is filled. After the air injection, and with the connected vial 10 and vial adapter 16 still inverted, the plunger 30 of the syringe 19 is pulled back again to draw the desired amount of liquid medicine from the chamber 26 into the syringe barrel 32. When the liquid medicine is removed from the chamber 26, the sealed chamber 26 refills with an equal amount of liquid medicine from the vial 10 through the inner lumen of the spike 18. Then the filled syringe 19 can be used to inject the medicine directly into the patient's body or directly into an IV line through a PRN or other type of medical port.

[0022] Figure 3 is a detailed cross-sectional view of the intelligent vial adapter 16, which is shown detached from the medicine vial 10. As shown, the chamber 26 communicates with the inner lumen 35 of the spike 18 through an opening 38 at the bottom of the chamber 26, allowing air and liquid to move freely between the chamber 26 and the interior of the vial 10 in either direction. Surrounding the chamber 26 is an annular chamber 40 containing various electronic components 42 that allow the intelligent vial adapter 16 to perform its dose capture, status monitoring, and information reporting functions, as discussed in more detail below. One or more access gates or plates (not shown) can be provided to allow the components 42 to be installed in the chamber 40 during the initial manufacture of the intelligent vial adapter 16 and to allow replacement of the battery that powers these components. A smaller annular chamber 44 is formed in surrounding relation with the inner lumen 35 of the spike 18 and opens into the inner lumen 35 of the spike 18. This chamber contains one or more electronic flow sensors 46 that are capable of measuring the liquid flow within the inner lumen 35, such that the volume of liquid medicine passing through the inner lumen 35 during syringe filling can be measured or calculated. This allows the intelligent vial adapter 16 to perform its dose capture function (i.e., determine how much liquid medicine is drawn from the vial and, by inference, determine how much liquid medicine the user has injected at a particular time or over a particular interval). The flow sensor 46 is preferably of the type of hybrid thermal time-of-flight (TTOF) flow sensor disclosed in detail in co-pending U.S. Patent Application Serial No. 15 / 226,638, filed on August 2, 2016, and published as U.S. Patent Application Publication No. 2018 / 0036495 on February 8, 2018, which is hereby incorporated by reference in its entirety. However, other types of thermal and non-thermal flow sensors can also be used.

[0023] During the final portion of the syringe filling process described above, as liquid medicament is withdrawn from chamber 26 of the inverted vial adapter 16 into syringe barrel 32, chamber 26 becomes completely filled with liquid medicament. Thus, the amount of liquid medicament transferred from chamber 26 to syringe 19 is replaced by an equal amount of liquid medicament withdrawn from vial 10 through the lumen 35 of the spike. Since fluid flows through flow sensor 46 via lumen 35, this amount can be calculated based on the measured flow rate and elapsed time. The calculated amount represents the dose of medicament transferred to syringe 19 and to be injected by the user.

[0024] Figure 3 It is also shown that septum 28 is not solid but may be pre-formed with a cutout 48 that permits it to be penetrated by a blunt cannula or Luer tip. This may be preferred when the medicament withdrawn from vial 10 is intended to be transferred to an IV line via a needleless valve or needleless injection site rather than being injected into the skin with a needle. In such cases, Figure 2 syringe 19 is provided with a Luer fitting or blunt cannula in place of needle 36.

[0025] Figure 4 is a schematic illustration of the electronic components 42 within the smart vial adapter that perform the dose capture function just described, as well as other status monitoring and information reporting functions. These components include a microcontroller 50 having an internal daily clock, the (one or more) flow sensors 46 previously described, a memory 52 for storing the programming and data used by microcontroller 50, a thermal sensor 54 for detecting ambient temperature (and inferring the temperature of vial 10 and its contents), an accelerometer 56 for measuring the amount of movement or perturbation to which vial adapter 16 is subjected (and inferring vial 10 and its contents), a Bluetooth module 58 for wireless communication with a smart phone 11 or other external electronic device such as a computer or tablet, one or more visual indicators 60 such as LEDs of different colors, one or more audible or tactile indicators 62 such as a beeper, buzzer, speaker or vibration device, one or more buttons 64, and a microswitch 66 for sensing the initial connection of vial adapter 16 to vial 10. A power source 68, typically in the form of a replaceable or rechargeable DC battery and a suitable voltage regulation circuitry, powers microcontroller 50 and Figure 4 any other components within that require power.

[0026] Figure 5It is a flowchart of the operations performed by the microcontroller 50 when the smart vial adapter 16 is operating in its sleep mode. This is the normal or default operating mode when the vial adapter 16 is not in use. In step 70, the microcontroller 50 records the ambient temperature using the thermal sensor 54 and stores the recorded value in the memory 52. In step 72, the microcontroller 50 records any movement or agitation that the vial adapter 16 may experience using the accelerometer 56 and stores the recorded value in the memory 52. In step 74, the microcontroller 50 records the current time of day and stores the recorded value in the memory 52 together with the associated temperature and movement readings. The time, temperature, and movement readings provide time-temperature and agitation data that can be used to verify that the medicine has been stored at the correct temperature, i.e., has been properly mixed before use and has not expired. In step 76, a sound alert is issued using the visual and / or audible indicators 60, 62 either when the user is due to receive a dose of medicine or when a situation requiring user intervention is detected. Such situations can include too high or too low a temperature over an extended period of time, the vial adapter 16 not moving for a sufficient amount of time, the medicine in the vial 10 may need to be stirred or mixed before use, or the medicine in the vial 10 has expired. When the smart vial adapter 16 is operating in its sleep mode, steps 70 - 76 are repeated at a predetermined sampling frequency (e.g., once per minute).

[0027] Figure 6is a flowchart of operations performed by the microcontroller 50 when the smart vial adapter 16 is operating in its active mode. This is an operating mode in which the vial adapter 16 is placed either by intentional user input (e.g., pressing one of the buttons 64) or by sensed conditions such as sudden movement (detected by the accelerometer 56) when the vial adapter is about to be used for injection. In step 80, a check is made to determine if the drug has expired by comparing the current time with a predetermined start time. The predetermined start time can be defined, for example, by user input (such as pressing another button 64) or by sensing the initial connection of the vial adapter 16 to the vial 10 by the microswitch 66. In steps 82 and 84, checks are made to determine if the drug is at the correct temperature for use and (based on previous agitation history) to determine if further mixing of the drug is required. If further mixing is required, then the user is alerted using visual and / or audible indicators 60, 62, and in step 86, a check is made to confirm that the user has in fact provided sufficient mixing. The user then fills the syringe 19 from the vial adapter 16 using the process described previously. In step 88, the microcontroller 50 calculates the dose drawn into the syringe 19 from the chamber 26 (compensating for any dead space within the syringe) using data from the flow sensor(s) 46. If desired, the audible indicator 62 can be made to beep with increasing frequency and / or intensity as the draw approaches a preset volume. In step 90, the calculated dose volume is stored in the memory 52 along with the corresponding temperature, time of day, and any other desired information. If a valid Bluetooth connection is detected, then the dose capture data is sent to the smartphone application using the Bluetooth module 58. The vial adapter then re-enters the sleep mode until the next dosing event is detected. Each time a dose is drawn from the vial 10 by the vial adapter 16, it re-enters Figure 6 the active mode and steps 80 - 90 are repeated.

[0028] Figures 7-9 is an exemplary screen display that can be generated on the smartphone 11 or other mobile device, which is programmed with a software application associated with the smart vial adapter 16. In the example shown, the drug being administered is insulin, and it is assumed that the user has entered or imported his or her blood glucose measurements into the smartphone application for processing along with the measured dose capture data from the vial adapter 16. In Figure 7 it, the information displayed includes the user's statistics for the day, including the number of injections administered 100, the percentage of blood glucose measurements within the desired range 102, a bar graph 104 showing the amount of insulin administered in each injection (e.g., number of units or volume in milliliters), and a line graph 106 showing the blood glucose level over time. In Figure 8In [description], an event panel 108 is added to the display to pair blood glucose measurement values with injection events. In Figure 9 it, the statistical information of the user within 7 days is shown. These statistical information include the A1c level 110 estimated based on the injection and glucose data within the 7-day period, the total number and daily average 112 of blood glucose measurements within the 7-day period, the number within the range 116, the out-of-range and above-range blood glucose measurements that make up the 7-day total, and the number of days of blood glucose balance, hypoglycemia, and hyperglycemia within the 7-day period 118.

[0029] In an alternative embodiment not shown in the drawings, an electric air pump and an air filter can be incorporated into the housing 17 of the vial adapter 16 to force filtered air into the vial 10 before a dose of liquid medicine is withdrawn from the vial 10 into the syringe 19. This enables the user not to manually perform this initial step using the syringe 19. Additional details regarding this embodiment can be found in the commonly assigned U.S. non-provisional application Ser. No. 16 / 051,249 filed on Jul. 31, 2018, which is incorporated herein by reference in its entirety.

[0030] Although only several embodiments of the present invention are shown and described, the present invention is not limited to the described embodiments. On the contrary, those skilled in the art will recognize that changes can be made to these embodiments without departing from the scope of the present invention. Additionally, any embodiments, features, and / or elements disclosed herein can be combined with each other to form various additional combinations not specifically disclosed, as long as the combined embodiments, features, and / or elements do not conflict with each other. All such changes and combinations are considered to be within the scope of the present invention defined by the appended claims and their equivalents.

Claims

1. A vial adapter, comprising: a housing having a first end and a second end, the first end being open and capable of being attached to a vial, and the second end having a fluid port sealed by a penetrable septum; a vial access cannula fixed to the housing and in communication with the fluid port, the vial access cannula being located within the open first end of the housing for penetrating the septum of a vial attached to the housing; electrical components contained within the housing for performing at least one of a dose capture, status monitoring, or information reporting function on a drug contained within or withdrawn from a vial attached to the housing; and an electronic flow sensor; wherein the housing includes an internal fluid chamber between the fluid port and the vial access cannula, the internal fluid chamber being sealed by a septum and in communication with the inner lumen of the vial access cannula through an opening that permits air and liquid to move freely in either direction between the internal fluid chamber and the interior of the vial through the inner lumen of the vial access cannula; the electronic flow sensor surrounds the inner lumen of the vial access cannula for sensing fluid flow within the vial access cannula; and the electronic flow sensor is disposed within a sensor cavity of the housing, the sensor cavity being open to the inner lumen.

2. The vial adapter according to claim 1, wherein the dose capture, status monitoring, or information reporting function is selected from the following: measuring the amount of drug withdrawn from the vial, measuring the time of drug withdrawal from the vial, monitoring the temperature of the vial, measuring the movement of the vial, generating a visual indication, generating an audible indication, and wirelessly transmitting information to an external device.

3. The vial adapter according to claim 1, wherein the electrical components contained within the housing include one or more of a flow sensor, a thermal sensor, an accelerometer, a microcontroller, a visual indicator, an audible indicator, and a Bluetooth module.

4. The vial adapter according to claim 1, wherein the electrical components contained within the housing include a flow sensor positioned adjacent to the inner lumen of the vial access cannula for sensing fluid flow within the vial access cannula.

5. The vial adapter according to claim 4, wherein the flow sensor comprises a thermal time-of-flight (TTOF) flow sensor.

6. The vial adapter according to claim 1, wherein the electrical components are housed within an inner lumen of the housing adjacent to the internal fluid chamber.

7. The vial adapter according to claim 6, wherein the inner lumen at least partially surrounds the internal fluid chamber.

8. The vial adapter according to claim 7, wherein the housing and the internal fluid chamber are each cylindrical, and wherein the inner lumen is annular.

9. The vial adapter according to claim 1, wherein the septum comprises a solid septum that can be penetrated by a syringe needle.

10. The vial adapter according to claim 1, wherein the septum comprises a pre-cut septum that can be penetrated by a blunt cannula or a Luer tip.

11. A method of storing and using a drug contained in a vial, comprising: Attach a vial adapter to a vial, the vial adapter being capable of performing at least one dose capture, status monitoring, or information reporting function on a medicament when the medicament is contained in the vial or withdrawn from the vial through the vial adapter; and such that the vial adapter performs at least one dose capture, status monitoring, or information reporting function on the medicament when the medicament is contained in the vial or withdrawn from the vial through the vial adapter, wherein the vial adapter includes a vial access cannula and a flow sensor positioned in a flow sensor cavity adjacent to and in fluid communication with the lumen of the vial access cannula for sensing fluid flow within the vial access cannula, and the one or more dose capture, status monitoring, or information reporting functions include a dose capture function performed by measuring the amount of medicament withdrawn from the vial using the flow sensor.

12. The method of claim 11, wherein the one or more dose capture, status monitoring, or information reporting functions further include functions selected from the group consisting of: measuring the amount of medicament withdrawn from the vial, measuring the time of withdrawal of the medicament from the vial, monitoring the temperature of the vial, measuring the movement of the vial, generating a visual indication, generating an audible indication, and wirelessly transmitting information to an external device.

13. The method of claim 11, wherein the vial adapter includes a Bluetooth module, and wherein the one or more dose capture, status monitoring, or information reporting functions include an information reporting function performed by wirelessly transmitting information to an external device using the Bluetooth module.

14. The method of claim 13, wherein the information is selected from the group consisting of: dose amount, dose time, vial temperature, and vial movement.

15. The method of claim 13, wherein the external device includes a computer, smartphone, or mobile device including a software application for processing the information and providing a user output.

16. The method of claim 15, wherein the user output includes a visual or graphical display of one or more of the following: (a) the number of doses withdrawn from the vial during a predetermined time period; (b) the dose amount of each of a plurality of doses withdrawn from the vial during a predetermined time period; (c) dose events paired with contemporaneously measured physiological data; and (d) physiological data estimated or predicted based on dose history.

17. The method of claim 16, wherein the medicament includes insulin, and the physiological data includes glucose level or A1c level.

18. A method for storing and using a medicament contained in a vial, comprising: attaching the vial adapter of claim 1 to the vial; such that the vial adapter performs at least one dose capture, status monitoring, or information reporting function on the medicament when the medicament is contained in the vial or withdrawn from the vial through the vial adapter.

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