阅读说明：本技术 药剂分配系统和分配方法 (Medicament dispensing system and dispensing method ) 是由 F.荣松 L.格拉迪纳斯基 于 2018-07-05 设计创作，主要内容包括：披露了一种用于从泡罩包装(30)分配单位剂型(38)的分配系统(2)和方法。该系统(2)包括用于接纳泡罩包装(30)的壳体(4),该泡罩包装(30)具有多个空腔(32),其中在这些空腔(32)中的每一个空腔中密封至少一个单位剂型(38),该壳体(4)包括至少一个壳体孔口。该系统(2)进一步包括感测层,该感测层包括：多个孔口,每个感测层孔口被配置为在泡罩包装(30)被接纳在该壳体(4)中时与该泡罩包装(30)的多个空腔(32)中的对应一个或多个空腔基本上对准；以及至少一个感测区域。该系统(2)进一步包括电子单元和用于向该感测层提供电压的电源。在使用中,例如通过对每个空腔(32)施加压力(P)而从该泡罩包装(30)通过这些感测层孔口并通过该至少一个壳体孔口来分配这些单位剂型(38),并且该感测层感测每个单位剂型(38)从该泡罩包装(30)被分配。(A dispensing system (2) and method for dispensing unit dosage forms (38) from a blister pack (30) is disclosed. The system (2) includes a housing (4) for receiving a blister package (30), the blister package (30) having a plurality of cavities (32), wherein at least one unit dosage form (38) is sealed in each of the cavities (32), the housing (4) including at least one housing aperture. The system (2) further comprises a sensing layer comprising: a plurality of apertures, each sensing layer aperture configured to substantially align with a corresponding one or more of a plurality of cavities (32) of a blister package (30) when the blister package (30) is received in the housing (4); and at least one sensing region. The system (2) further comprises an electronic unit and a power supply for providing a voltage to the sensing layer. In use, the unit dosage forms (38) are dispensed from the blister pack (30) through the sensing layer apertures and through the at least one housing aperture, for example by applying pressure (P) to each cavity (32), and the sensing layer senses that each unit dosage form (38) is dispensed from the blister pack (30).)

1. A dispensing system for dispensing unit dosage forms from a blister pack, the dispensing system comprising:

a housing for receiving a blister package having a plurality of cavities, wherein at least one unit dosage form is sealed in each of the cavities, the housing comprising at least one housing aperture;

a sensing layer, the sensing layer comprising:

a plurality of apertures, each sensing layer aperture configured to substantially align with a corresponding one or more of a plurality of cavities of a blister package when the blister package is received in the housing; and

at least one sensing region;

an electronic unit; and

a power supply for supplying a voltage to the sensing layer;

wherein:

in use, dispensing the unit dosage forms from the blister pack through the sensing layer apertures and through the at least one housing aperture; and is

The sensing layer senses that each unit dosage form is dispensed from the blister pack.

2. The dispensing system of claim 1, wherein the sensing layer comprises a pressure sensitive layer and a conductive layer, the conductive layer comprising at least one conductive area.

3. The dispensing system of claim 2, further comprising a plurality of electrically conductive regions, at least one electrically conductive region at least partially surrounding each sensing layer aperture, preferably comprising a segment or zone of electrically conductive region surrounding each sensing layer aperture, wherein the sensing layer senses the pressure applied in the vicinity of each cavity when each unit dosage form is dispensed from the blister package.

4. The dispensing system of claim 2, further comprising a plurality of conductive regions disposed at edges and/or in corners of the conductive layer, wherein the sensing layer senses pressure applied to the sensing layer when dispensing each unit dosage form from the blister package.

5. The dispensing system of claim 2, 3 or 4, wherein the sensing layer further comprises a spacer layer between the pressure sensitive layer and the conductive layer, the spacer layer spacing the pressure sensitive layer from the conductive layer such that they are not in electrical contact, and the spacer layer is compressible such that the pressure sensitive layer can be brought into electrical contact with a conductive area of the conductive layer.

6. The dispensing system of claim 5, wherein the spacer layer comprises foam.

7. The dispensing system of claim 5 or 6, wherein the sensing layer apertures are substantially circular or elliptical and the sensing layer aperture of the spacing layer has a larger diameter than the sensing layer aperture of the pressure sensitive layer and the sensing layer aperture of the conductive layer such that an air gap is provided between the pressure sensitive layer and the conductive layer in the vicinity of the apertures.

8. The dispensing system of claim 7, wherein the sensing layer is configured such that compression of the compressible spacer layer depletes the air gap until the pressure sensitive layer is brought into electrical contact with the conductive region of the conductive layer.

9. The dispensing system of any of claims 2 to 8, wherein the power source provides a voltage to the conductive region of the conductive layer.

10. The dispensing system of any of claims 2 to 9, wherein the pressure sensitive layer comprises a non-conductive material comprising conductive particles dispersed therein.

11. The dispensing system of any of claims 2 to 9, wherein the pressure sensitive layer comprises a polymer film layer, preferably a polyolefin layer such as polyethylene, impregnated with conductive particles, preferably carbon black particles.

12. The dispensing system of any of claims 2 to 11, wherein the conductive layer comprises a Printed Circuit Board (PCB) onto which the conductive areas of the conductive layer are printed.

13. The dispensing system of any of claims 3 to 12, wherein the conductive regions of the conductive layer are substantially annular and surround apertures in the conductive layer, each conductive region being discrete from any other conductive region of the conductive layer.

14. The dispensing system of any of claims 3 to 12, wherein the conductive region of the conductive layer comprises substantially all of the conductive layer.

15. The dispensing system of any of claims 2 to 14, wherein the sensing layer senses a distribution of pressure applied to the sensing layer to determine:

whether a unit dosage form has been dispensed from the blister pack; or

Whether the pressure has a non-dispensing pressure profile.

16. The dispensing system of claim 1, wherein the sensing layer comprises a first capacitive layer and a second capacitive layer, the first capacitive layer and the second capacitive layer being separated by a compressible spacer layer therebetween, wherein compression of the compressible layer upon dispensing of the unit dosage form from the blister package brings the first capacitive layer and the second capacitive layer closer together, thereby changing the capacitance of the system.

17. The dispensing system of claim 1, wherein the sensing layer comprises inductive sensors having inductive properties, wherein dispensing dosage units by displacing the sensing layer or by rupturing the blister package alters the inductive properties.

18. The dispensing system of claim 1, wherein the sensing layer comprises an inductive sensor having an inductive property, wherein dispensing the dosage unit by displacing the sensing layer, by displacing the blister package, or by bursting tear thereof changes the electrical property.

19. The dispensing system of claim 18, wherein the change in electrical characteristic is used to detect when a user changes a blister.

20. The dispensing system of claim 1, further comprising at least one transmitter and at least one receiver configured to receive a signal from the transmitter, wherein the receiver and the transmitter are aligned with each other such that at least one of the apertures of the sensing layer is located therebetween.

21. The dispensing system of claim 18, wherein the dispensing of a unit dosage form is from a blister package and passing through at least one of the apertures of the sensing layer interrupts a signal transmitted from the transmitter to the receiver as the unit dosage form passes through the at least one aperture.

22. The dispensing system of claim 19, wherein the emitter comprises an optical emitter and the signal is a light beam.

23. The dispensing system of any preceding claim, wherein the housing comprises a plurality of housing apertures arranged in an array such that each housing aperture is substantially aligned with at least one of a plurality of cavities of a blister package when the blister package is received in the housing, the blister package being a standard blister package.

24. The dispensing system of any preceding claim, wherein the electronic unit comprises a memory for storing data corresponding to at least the time and date at which the sensing layer senses that each unit dosage form is dispensed from the blister pack.

25. The dispensing system of any preceding claim, wherein the electronic unit comprises a transmitter, preferably a wireless transmitter, preferably a bluetooth LE, NFC, WiFi, 3G, 4G or 5G transmitter, for transmitting data to a remote device, the data corresponding at least to the time and date at which the sensing layer senses that each unit dosage form is dispensed from the blister package, and/or the data corresponding to a reminder that a unit dosage form should be dispensed at a predetermined date and time.

26. The dispensing system of claim 24 or 25, further comprising a display for displaying the data.

27. The dispensing system of any preceding claim, wherein the housing and the sensing layer are separable components and are configured such that sensing layers having different configurations are each receivable in the housing.

28. The dispensing system of any preceding claim, wherein the electronics unit is configured for any one or more of: detecting an identification of the blister package from a memory of the blister package, the memory having the identification stored therein; detecting the presence of a blister pack within the housing; detecting removal of the blister package from the housing; detecting insertion of a blister package into the housing; and/or detecting the orientation of the blister pack within the housing.

29. The dispensing system of any preceding claim, further comprising an accelerometer configured to determine movement of the system, preferably for determining movement above and/or below one or more thresholds, in order to detect whether the system is used by a user.

30. A method of dispensing a unit dosage form from a dispensing system having a blister pack received therein, the dispensing system comprising:

a housing for receiving a blister package having a plurality of cavities, wherein at least one unit dosage form is sealed in each of the cavities, the housing comprising at least one housing aperture;

a sensing layer, the sensing layer comprising:

a plurality of apertures, each sensing layer aperture configured to substantially align with a corresponding one or more of a plurality of cavities of a blister package when the blister package is received in the housing; and

at least one sensing region;

an electronic unit; and

a power supply for supplying a voltage to the sensing layer;

the method comprises the following steps:

sensing with the sensing layer when each unit dosage form is dispensed from the blister package through the sensing layer apertures and through the at least one housing aperture.

31. The method of claim 30, wherein the sensing layer comprises a plurality of pressure sensing regions, at least one pressure sensing region at least partially surrounding each sensing layer aperture, and wherein the step of sensing with the sensing layer when each unit dosage form is dispensed from the blister package comprises sensing with the sensing layer the pressure applied near each cavity.

32. The method of claim 31, wherein the sensing layer further comprises a spacer layer between the pressure sensitive layer and the conductive layer, the spacer layer spacing the pressure sensitive layer from the conductive layer such that they are not in electrical contact, and the method further comprises making the pressure sensitive layer in electrical contact with the conductive layer by compressing the spacer layer.

33. The method of claim 32, wherein the sensing layer apertures are substantially circular or elliptical and the sensing layer aperture of the spacing layer has a larger diameter than the sensing layer aperture of the pressure sensitive layer and the sensing layer aperture of the conductive layer such that an air gap is provided between the pressure sensitive layer and the conductive layer in the vicinity of the apertures, the method further comprising compressing the compressible spacing layer to deplete the air gap until the pressure sensitive layer is in electrical contact with the conductive layer.

34. The method of claim 32 or 33, further comprising providing a voltage from the power source to the conductive layer.

35. The method of any one of claims 32 to 33, further comprising storing in a memory of the electronic unit data corresponding to at least the time and date that the sensing layer senses the pressure applied proximate each cavity when each unit dosage form is dispensed from the blister package.

36. The method of any one of claims 32 to 35, further comprising transmitting data to a remote device, the data corresponding to at least the time and date at which the sensing layer senses the pressure applied in the vicinity of each cavity when each unit dosage form is dispensed from the blister pack, and/or the data corresponding to a reminder that a unit dosage form should be dispensed at a predetermined date and time.

37. The method of claim 36, wherein transmitting data comprises wirelessly transmitting data, preferably comprising bluetooth LE, WiFi or NFC transmission.

38. The method of claim 36 or 37, further comprising displaying the data on a display of the distribution system.

39. A method as claimed in any of claims 30 to 38, further comprising sensing the distribution of applied pressure in the vicinity of each cavity to determine:

whether a unit dosage form has been dispensed from the blister pack; or

Whether the pressure has a non-dispensing pressure profile.

Technical Field

The present invention relates to a dispensing device or system for dispensing a medicament, in particular a dispensing device or system for monitoring when a dose of medicament has been dispensed. The invention also relates to a method of dispensing a medicament, in particular to a method of monitoring when a dose of medicament has been dispensed.

Background

There are many ways of providing a dose of a pharmaceutical agent to a patient or other intended recipient of the pharmaceutical agent, particularly when it is desirable to provide multiple simultaneous and/or subsequent doses of the pharmaceutical agent, e.g., as part of a treatment regimen or otherwise. A popular and convenient dosage form is a unit dose, such as a tablet, pill, capsule, etc., for oral administration to a recipient. Typically, multiple unit doses are provided to the recipient in a convenient form for dispensing one or more unit doses at a time, for example with a container with a removable cover, or with a sheet sealing the doses in separate compartments, each compartment having a rupturable or frangible cover, commonly referred to as a blister pack.

Such devices enable recipients to access their medication in a portable and convenient manner when they determine that a dose is needed. However, especially in case the medication should be taken frequently at regular or irregular intervals, the recipient may not remember that the dose should be taken at the appropriate time. Even if the recipient does extract and take a dose from the device (at the appropriate time or at a later time when they remember to do so), the recipient may then forget that they have taken the particular dose and may then take another dose prematurely.

This non-compliance problem with treatment regimens is a significant problem in healthcare, which results in treatment inefficiencies and possible complications in patients with inadequate or excessive drug dosages, which may limit their efficacy of long-term treatment and/or lead to exacerbations, side effects, and the like. In addition, unused drug in missed doses must be properly and according to local restrictions and regulations discarded, which can be costly and inconvenient to implement.

Attempts have been made to overcome the above-mentioned problems of non-compliance with dosage regimens, for example by marking individual blisters on a blister pack with an indication of when the dosage should be taken. However, this requires that each blister package be customized to the specific needs and dosage regimen of the recipient. Newer devices and systems have been developed that typically contain multiple unit doses in compartments where the unit dose can be dispensed and contain some form of monitoring of the compartments to determine if the unit dose has been removed and (by implication) taken by the patient. However, despite several attempts to produce a suitable device or system, prior art solutions are typically very expensive to manufacture and consist of several relatively complex components, many of which are used only once (i.e., for one dosage cycle until all unit doses are removed) and then must be discarded. If the components of the device comprise electronics, which is typically the case, such components must also be handled in compliance with local regulations and the cost of such devices is prohibitive.

Thus, there remains a need for a medicament dispenser and a method of dispensing medicament that enables a patient or other intended recipient of the medicament to reliably dispense the medicament at an appropriate time and to check whether and when they are taking a particular dose at some time after the event. In addition, there remains a need for such dispensers and dispensing methods that can be provided at an acceptable associated price, and a cost-attractive, reliable, reusable, patient-and manufacturing-friendly adherence monitoring solution has the potential to address one or more of the above-mentioned patient needs.

Disclosure of Invention

In accordance with the present invention, a dispensing system and method are provided that overcome at least one or more of the disadvantages of the prior art. From a first broad aspect, there is provided a dispensing system for dispensing unit dosage forms from a blister pack, the dispensing system comprising: a housing for receiving a blister package having a plurality of cavities, wherein at least one unit dosage form is sealed in each of the cavities, the housing comprising at least one housing aperture; a sensing layer, the sensing layer comprising: a plurality of apertures, each sensing layer aperture configured to substantially align with a corresponding one or more of a plurality of cavities of a blister package when the blister package is received in the housing; and a plurality of pressure sensing zones, at least one pressure sensing zone at least partially surrounding each sensing layer aperture; an electronic unit; and a power supply for providing a voltage to the sensing layer; wherein: in use, the unit dosage forms are dispensed from the blister pack through the sensing layer apertures and through the at least one housing aperture by applying pressure to each cavity; and the sensing layer senses the pressure applied in the vicinity of each cavity as each unit dosage form is dispensed from the blister pack.

The dispensing system is advantageous in that a blister pack having a medicament dose or the like sealed in its cavity can be received in a housing of the system, and the patient or other recipient (or caregiver or the like) of the medicament dose can push the cavity to break the seal of the blister and dispense the dose in a conventional manner, and the dispensing system senses the pressure at which the patient expels the dose from the cavity, so that the dose dispensed can be reliably and more accurately determined than in the prior art. Furthermore, the modular arrangement of the dispensing system (i.e. the housing configured to receive a blister pack) enables the system to be reused multiple times with replacement blister packs being replenished as each previous blister pack is emptied. Thus, the electronic unit can be used multiple times, for example, thereby avoiding the cost and environmental issues associated with single use or disposal of the electronics after a brief use. Similarly, the sensing layer may be reused multiple times. Furthermore, since the sensing layer comprises an aperture, this enables the blister package to be inserted on top of the sensing layer in the housing, so it is easy and convenient for patients to drop their blister package into the assembled system.

The system is particularly beneficial for unit dosage forms (pills, tablets, capsules, etc.) provided to patients in standard blister packs, as is the case with many medicaments distributed in many countries. Standard blister packages typically have a plurality of cavities spaced in a regular or irregular array, with each cavity having a single dose of medicament therein, which can be expelled from the blister package by collapsing the cavity with pressure (e.g., from the patient's finger or thumb) and pushing the dose through a burstable seal over the cavity. The term "standard" is intended herein to indicate prior art blister packages of various sizes, shapes and configurations, which may be specific to a particular medication, but are typically mass produced in a similar fashion for each medication. Thus, a user of the system may simply insert a standard blister pack into the housing and dispense the doses at the required time, the system determining the dispensing event such that compliance or non-compliance with the dosage regimen is recorded for further reference. When all of the doses in the blister have been dispensed, the user simply removes the empty blister pack from the housing and inserts a replacement standard blister pack to continue to record their compliance or non-compliance with the treatment regimen. Advantageously, the system may comprise at least one sensor for detecting the removal of a blank blister package and/or the insertion of a replacement blister package, and the detection thereof enables the system to be adjusted or updated in response to this event, e.g. resetting any counters, displays etc. and/or displaying this information to the user etc.

As described above, the dispensing system uses the pressure applied by the patient to expel a dose to determine when the patient takes a dose of medicament. This is achieved by using a sensing layer having an orifice through which the doses are dispensed and a pressure sensing region. The sensing layer may include a pressure sensitive layer defining the pressure sensing regions and a conductive layer including conductive regions substantially aligned with the pressure sensing regions of the sensing layer. This arrangement is advantageous because a voltage can be applied to the conductive layer and when the conductive regions of the layer contact the pressure sensing regions, a current flows in the pressure sensing regions, thereby enabling pressure sensing.

The sensing layer may further comprise a spacer layer between the pressure sensitive layer and the conductive layer, the spacer layer spacing the pressure sensitive layer from the conductive layer such that they are not in electrical contact, and the spacer layer being compressible such that the pressure sensitive layer can be brought into electrical contact with the conductive layer. Thus, when the pressure sensitive layer is spaced apart from the conductive layer, any voltage supplied to the conductive layer will not be supplied to the pressure sensitive layer. However, as the patient pushes the blister package cavity to expel a dose, the spacer layer compresses and brings the pressure sensitive layer into electrical contact with the conductive layer, so that a voltage is provided to the pressure sensing layer and determines the pressure applied to the blister. This open/switch type arrangement is particularly advantageous in enabling the use of a low power supply in the system and improving the life of the system, since the circuit/switch is closed only when pressure is applied to the sensing layer and the gap is sufficiently compressed. The spacer layer may comprise a foam, which is a material that is easily configurable for a desired compressibility under a suitable amount of pressure.

The layers of the system may be configured in any suitable manner to achieve the above functionality. For example, the sensing layer aperture may be substantially circular or elliptical, and the sensing layer aperture of the spacing layer may have a larger diameter than the sensing layer aperture of the pressure sensitive layer and the sensing layer aperture of the conductive layer, such that an air gap is provided between the pressure sensitive layer and the conductive layer in the vicinity of the apertures. That is, there is a portion of the aperture surrounding each of the pressure sensitive layer and the conductive layer that is exposed even when in contact with the spacing layer such that when the spacing layer is compressed, the exposed portion is in direct contact. The aperture of the pressure sensitive layer may be substantially the same size as the aperture of the conductive layer, or one of the layers may have an aperture with a diameter larger than the other of the layers.

As mentioned above, it is desirable to space the conductive layer, to which a voltage can be supplied by a power supply, from the sub-sensitive layers unless sufficient pressure is applied to bring the layers into electrical contact in use. Thus, the sensing layer can be configured such that compression of the compressible spacer layer depletes air gaps until the pressure sensitive layer is brought into electrical contact with the conductive layer. The power source may be a battery, such as a button cell or other small battery device, and/or may be rechargeable via an external source (e.g., by inductive coupling) and/or may be a solar cell, etc.

The pressure sensitive layer may be configured in any suitable manner such that the pressure thereon is recorded and/or measured in a suitable form. In a particular arrangement, the pressure sensitive layer may comprise a non-conductive material comprising conductive particles dispersed therein. Such materials are typically semi-conductive materials, allowing current to flow through the material but to less than the same extent as conductive materials, and are pressure sensitive in that the resistance of the material changes (typically decreases) as pressure is applied to the material, as the dispersed conductive particles are more tightly compressed together. Thus, the change in resistance of the material can be measured at one or more different locations in the material to determine where and how much pressure has been applied to the material. Particularly useful materials for the pressure sensitive layer are flexible and relatively low cost materials such as polymeric film layers comprising impregnated conductive particles, preferably carbon black particles, polyolefins (materials of layers, examples of suitable materials include. polyolefin, polyethyleneAnd

andfor example,

is particularly useful because it is thin, flexible and easy to manufactureResulting in the desired layer (which can be cut to shape and cut apertures therefrom). However, any suitable material having suitable properties may be used.

The conductive layer may be configured in any suitable manner such that a voltage may be provided to/from the layer. Particularly for low cost dispensing systems, it is desirable that the conductive layer be simple to manufacture and mass produce. Thus, the conductive layer may comprise a Printed Circuit Board (PCB). Such printed electronics are convenient, easy to configure, low cost, and easy to print on thin and/or flexible materials well suited for use in the present system. In some arrangements, for example where it is desired to determine the particular location at which pressure is applied, the conductive regions of the conductive layer may be substantially annular and surround apertures in the conductive layer, each conductive region being discrete from any other conductive region of the conductive layer. Thus, the pressure at or around a particular blister may be identified, as a change in (for example) resistance of the material at a particular location may be detected. Such conductive areas may be printed around each aperture with traces connecting each aperture to control electronics and the like. Alternatively, for ease of manufacture, the conductive region of the conductive layer may comprise substantially all of the conductive layer. Thus, for example, the substrate may have an entire coating of the applied conductive material (or indeed the layer may comprise substantially conductive material), and appropriate apertures may be cut from the layer to form the conductive layer.

The housing of the dispensing system includes at least one housing orifice. This allows pills and the like to be pushed from the blister cavity and through the aperture in the housing. The housing aperture may, for example, cover substantially all of the base of the housing, with only the frame around the exterior of the aperture defining the housing base. This enables blister packages of different configurations to be used with the housing because the housing aperture is large and aligned with all of the blisters. However, to provide more structural rigidity to the housing, the housing may comprise a base comprising a plurality of housing apertures arranged in an array such that each housing aperture is substantially aligned with at least one of the plurality of cavities of a blister package when the blister package is received in the housing, the blister package being a standard blister package. The housing apertures may be configured to be substantially the same size (or slightly larger) and in a corresponding pattern as the footprint of each blister so as to match a particular blister pack. Alternatively, the housing apertures may be substantially larger than the footprint of each blister and configured to correspond with several blisters of a blister package. In some arrangements, the base portion of the housing may be removable and replaceable with a base portion having a differently configured aperture to enable the housing to be customised for different blister packs.

The dispensing system includes an electronics unit and a power source. The electronics unit may include components, such as a processor, for processing received signals indicative of pressure applied to the sensing layer, and the like. Thus, the electrical system of the distribution system is an active system, in contrast to the passive systems of some prior art arrangements. The electronic unit may include a memory for storing data corresponding to at least the time and date that the sensing layer senses the pressure applied in the vicinity of each cavity when each unit dosage form is dispensed from the blister package. The electronic unit may further comprise a transmitter, which may be a wireless transmitter, which may be a bluetooth LE transmitter for transmitting data to a remote device, the data corresponding to at least the time and date that the sensing layer senses the pressure applied in the vicinity of each cavity when each unit dosage form is dispensed from the blister pack, and/or the data corresponding to a reminder that a unit dosage form should be dispensed at a predetermined date and time. Other transmitters are contemplated in other embodiments of the present invention, such as transmitters that communicate via other wireless protocols, including WiFi, 3G, 4G, 5G, etc. Thus, information about when to press the blister and thus dispense the dose may be transmitted to an external device, such as a computer, smartphone, smartwatch, printer, etc., and the patient or caregiver can see data about whether the patient has followed their dosage regimen and whether there is a particular time when the patient has not followed the dosage regimen, etc.

The dispensing system may include other components, for example, within the electronics unit, to assist in the efficient operation of the system. The system may include an accelerometer so that the system may, for example, determine when a user is manipulating the dispensing system. The accelerometer may be configured to determine when an activity level above a certain threshold is detected, and thus determine that the user is likely to dispense a dose. The system may use this determination to wake up the necessary components of the device to detect the dispensing of a dose and/or select an appropriate algorithm to determine whether to dispense a dose, etc. The accelerometer may also be configured to determine when an activity level below a certain threshold is detected, and thus determine that the dispensing system may have been put in place by the user. The system may use this determination to shut down any components not required for the basic operation of the system, such as those used to detect dose dispensing (i.e., the system may switch to a sleep mode to conserve power).

As described above, the reminder may be transmitted to a remote device, such as to a smart phone or smart watch of the patient, to remind them when a dose of medication should be taken in order to help them follow the dosage regimen. Additionally or alternatively, an alert may be generated at the remote device based on information provided from the dispensing system. The alert may be in the form of a message displayed on the remote device, an alarm, a visual indication such as a light flash, and/or a vibratory alert. Additionally or alternatively, it may be useful for the patient to receive reminders at the dispensing system itself. Thus, the dispensing system may include a display for displaying reminders and/or other useful information, and/or may include other means for indicating when to dispense a dose, such as lights illuminated to indicate dose time, and/or a vibratory alert and/or an audible alarm, etc. The dispensing system display may additionally or alternatively display other information, for example the display may display the above data such as when a pill has been taken or missed.

The sensing layer of the dispensing system senses the pressure applied when dispensing a dose from a blister pack inserted into the dispensing system. Although the dispensing system may be configured to determine any pressure near the cavity as the dispensing pressure, the pressure may not be sufficient to dispense a dose of the medicament and/or the pressure is not due to the patient intentionally applying pressure to dispense a dose. For example, if a patient carries the dispensing mechanism in a pocket, purse, handbag, bag, etc., inadvertent pressure may be applied to the dispensing device by contact with other objects in the bag, etc., or while the patient is moving around, etc. Accordingly, it is desirable to determine whether the pressure applied to the dispensing system may be used to dispense a dose, or for other reasons. Thus, the sensing layer may sense the distribution of pressure applied in the vicinity of each cavity to determine whether a unit dosage form has been dispensed from the blister pack; or whether the pressure has a non-dispensing pressure profile. For example, a threshold may be determined for the sensed pressure above which it is determined that it is likely to dispense a dose. For example, where the pressure sensitive layer comprises a semiconductive material, a measured resistance below a certain threshold may be indicative of a sufficient amount of pressure for dispensing a dose. Additionally or alternatively, the shape of the pressure and/or its position may be used to determine whether a dose has been dispensed. For example, if the sensing layer senses pressure at multiple locations (perhaps of the same order of magnitude at each location), the system may determine that this is more likely because the dispensing system is pushing against other items in a bag or in a pocket, etc. By analyzing the pressure pattern, e.g., the amount of pressure, the pressure profile (if one side of the orifice is subjected to a higher pressure than the other side), the pressure profile (i.e., how quickly the pressure builds up and releases, etc.), the dispensing system can determine whether a pill has been taken. The algorithm may be implemented internally in the electronic device or may be implemented mechanically, for example by adjusting the thickness of the foam and the stiffness of the sensor structure to give an indication only if sufficient pressure is applied.

As mentioned above, a modular dispensing system is advantageous because many of the components of the system can be reused with multiple successive blister packages. Some components of the dispensing system may be more durable than others. For example, the housing may be formed of plastic and need infrequently be replaced. Other components of the system may need to be replaced more frequently if, for example, the power supply is out of date. However, in some arrangements, a replaceable and/or rechargeable battery is provided. The sensing layer may be relatively durable and need not be replaced periodically, but in alternative configurations it may be desirable to tailor the configuration of the sensing layer to different blister packages, even though they are standard blister packages, as they may have different configurations and differ for a particular medication, and so on. Thus, the housing and the sensing layer may be separable components and configured such that sensing layers having different configurations are each receivable in the housing. The patient can then remove the existing sensor layer and insert a replacement sensor layer to modify the dispensing system as needed. The electronics unit may be substantially enclosed within the housing, the housing having a connection opening to receive a connector of the sensing layer to connect to the electronics unit. This protects the electronic unit from damage, dirt, etc., thereby improving the service life of the electronic unit. However, the housing may be configured such that the closure may be opened to access the electronic unit or other parts of the system to replace the power source and/or any components of the electronic unit and/or the entire electronic unit. Thus, the system is configurable, updatable, and/or upgradeable, and is more flexible than prior art arrangements and prevents unnecessary discarding of system components.

From another broad aspect, there is provided a method of dispensing a unit dosage form from a dispensing system having a blister pack received therein, the dispensing system comprising: a housing for receiving a blister package having a plurality of cavities, wherein at least one unit dosage form is sealed in each of the cavities, the housing comprising at least one housing aperture; a sensing layer, the sensing layer comprising: a plurality of apertures, each sensing layer aperture configured to substantially align with a corresponding one or more of a plurality of cavities of a blister package when the blister package is received in the housing; and a plurality of pressure sensing zones, at least one pressure sensing zone at least partially surrounding each sensing layer aperture; an electronic unit; and a power supply for providing a voltage to the sensing layer; the method comprises the following steps: sensing, with the sensing layer, a pressure applied proximate each cavity as each unit dosage form is dispensed from the blister package through the sensing layer apertures and through the at least one housing aperture. According to a first broad aspect of the invention, a dispensing system for use in the method may have any one or more of the features discussed above. For example, the sensing layer of the dispensing device may further comprise a spacer layer between the pressure sensitive layer and the conductive layer, the spacer layer spacing the pressure sensitive layer from the conductive layer such that they are not in electrical contact, and the method further comprises bringing the pressure sensitive layer into electrical contact with the conductive layer by compressing the spacer layer.

The sensing layer apertures may be substantially circular or elliptical, and the sensing layer aperture of the spacing layer may have a larger diameter than the sensing layer aperture of the pressure sensitive layer and the sensing layer aperture of the conductive layer such that an air gap is provided between the pressure sensitive layer and the conductive layer in the vicinity of the apertures, the method further comprising compressing the compressible spacing layer to deplete the air gap until the pressure sensitive layer is in electrical contact with the conductive layer.

The method may further include providing a voltage from the power source to the conductive layer. The method may further include storing data in a memory of the electronic unit corresponding to at least the time and date that the sensing layer senses the pressure applied proximate each cavity as each unit dosage form is dispensed from the blister package. The method may further comprise detecting and/or storing other useful information, such as an Identification (ID) of the blister package inserted in the housing (which ID may be detected, for example, from a chip or tag of the blister package in which the ID is stored), and/or information about the removal and/or insertion of the blister package, and/or information about the orientation of the blister package, etc. The method may further comprise transmitting data to a remote device, the data corresponding to at least the time and date that the sensing layer senses the pressure applied in the vicinity of each cavity when each unit dosage form is dispensed from the blister pack, and/or the data corresponding to a reminder that a unit dosage form should be dispensed at a predetermined date and time. The method may further comprise wirelessly transmitting data, preferably comprising bluetooth LE transmission.

The method may further include displaying the data on a display of the distribution system. The method may further include sensing a distribution of the applied pressure in the vicinity of each cavity to determine: whether a unit dosage form has been dispensed from the blister pack; or whether the pressure has a non-dispensing pressure profile.

Drawings

Preferred aspects and embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

FIG. 1 is a perspective view of a dispensing system having a blister package received therein according to an embodiment of the present invention;

FIG. 2 is a perspective view of the dispensing system of FIG. 1 without the blister pack;

FIG. 3 is a schematic side view of a portion of the dispensing system of FIG. 1;

FIG. 4 is a schematic view of a portion of a layer of a sensing layer of a dispensing system according to an embodiment of the invention;

FIGS. 5A-5D are schematic top views illustrating embodiments of layers of the sensing layer of FIG. 4;

FIG. 6 is a schematic view of a conductive layer of a dispensing system according to an embodiment of the present invention;

FIG. 7 is a schematic diagram of a communication network for a distribution system according to an embodiment of the present invention;

FIG. 8 illustrates an example of information transmitted from a dispensing system and displayed on a device of a patient using the dispensing system, in accordance with an embodiment of the present invention;

FIG. 9A is a schematic side view of a portion of a layer of a sensing layer of a dispensing system according to an alternative embodiment of the invention;

FIG. 9B is a schematic top view of a portion of the conductive layer of FIG. 9A, wherein the conductive region surrounds the conductive aperture;

FIG. 9C is a schematic side view of the dispensing system layer of FIG. 9A in a compressed state when a dose is dispensed;

FIG. 10 is a schematic top view of an inductive sensing layer according to an alternative embodiment of the present invention;

11A and 11B are schematic side views of a capacitive sensing layer in an uncompressed state and a compressed state, respectively, according to an alternative embodiment of the invention;

FIG. 12A is a schematic side view of an optical sensing layer according to an alternative embodiment of the present invention;

FIG. 12B is a schematic top view of the optical measurement layer of FIG. 12A;

13A and 13B are schematic top views of conductive layers having conductive regions according to alternative embodiments of the present invention; and

FIGS. 14A and 14B are schematic side views of a sensing layer according to an alternative simplified embodiment of the present invention.

Detailed Description

A dispensing system (and method) according to embodiments of the present invention is configured to dispense unit doses from a blister pack, typically a standard blister pack. A blister package is considered a standard blister package when, for example, a particular medicament is dispensed in a blister package that typically remains in the same configuration for an extended period of time (e.g., mass production and/or a standard arrangement with multiple cavities, etc.). A typical standard blister package comprises flat foils (overlying and attached to each other). One relatively rigid foil, most commonly referred to as the base, includes cavities or open "blisters" for individually receiving tablets or capsules, while the other foil is flat and most commonly referred to as the lid and seals the openings of the cavities or blisters. The most common sealing process is heat sealing, at least one of the foils has thermoplastic properties, and the manufacture of the package is currently performed most rationally by continuously joining webs of foil for said sealing and cutting them into said packages. Whereby pressing the blister from the top will cause the medicament to pierce the cover foil, so that the medicament is released from the package for administration to the patient.

Referring to fig. 1, a dispensing system 2 according to an embodiment of the present invention is illustrated, the dispensing system 2 having a blister pack 30 received in a housing 4 of the dispensing system 2. The blister package includes a blister base 34 having a plurality of cavities 32 formed therein and each cavity 32 contains a unit dose 38 of medicament. The cavity 32 is sealed by a frangible layer 36 (not shown, see fig. 3). The housing 4 is sized and shaped to securely receive the blister pack 30 between the side edges 4a, 4b of the housing 4 and the cover 6 at one end and the end edge 4c at the other end. A cut-out 8 is provided in the end edge 4c to assist the patient in lifting out the blister pack 30 when it is necessary to replace the blister pack 30 with a new one.

The cover 6 of the housing 4 encloses the electronic unit 10. In the arrangement shown, an opening is provided in the cover 6 through which a connector 12 (not shown, see fig. 3) of the electronic unit 10 can be connected. However, in other arrangements, the electronic unit and the sensing component may be fabricated on the same printed circuit board. Typically, the housing is formed of plastic or other suitable material.

In fig. 2, the housing 4 is illustrated with the blister pack 30 removed. The housing 4 comprises a plurality of apertures 5 which in the embodiment of fig. 2 are arranged in a regular array of two by seven apertures 5, but of course in other embodiments other arrangements are possible. Thus, each cavity or blister 32 of the blister pack 30 of fig. 1 corresponds to one aperture 5. Thus, a dose 38 from each blister 32 may be pushed out through the aperture 5 in the housing 4 for dispensing to a patient. The base 7 of the housing 4 may be integrally formed with the housing 4 (e.g., the entire housing may be molded or similarly formed as a single component), or the base 7 may be removable from the remainder of the housing 4, e.g., the base may be slid off the end of the cover 6 or may be lifted from the housing 4. This enables an alternative base 7 to be inserted into the remainder of the housing 4, for example a base having a different number and/or arrangement of apertures 5, thereby enabling different types of blister packages 30 to be used with the same housing 4. Alternatively, the housing 4 may comprise only a single aperture 5, the size of the aperture 5 substantially defining the base 7, thus enabling all of the doses 38 to be dispensed from each blister 32 through the single aperture 5. Alternatively, the housing 4 may include two or more apertures 5 that are sufficiently sized to correspond with more than one blister 32.

Referring now to fig. 3, a portion of a dispensing system 2 such as that shown in fig. 1 is illustrated from a side cross-sectional view. Only the four blisters 32 and dose 38 are shown closest to the end of the cover 6 and the corresponding parts of the housing 4 are shown. It can be seen that the housing aperture 5 is aligned with the blister 32, thus enabling the dose 38 in the blister 32 to be expelled through the aperture 5. To dispense the dose 38, the patient simply pushes the blister 32 down (as indicated by arrow P, which shows the large direction of pressure from the patient's finger or thumb), for example with a finger or thumb, and then pushes the dose 38 into contact with the seal 36. Since the seal 36 is configured to be frangible or breakable, the pressure from the dose bursts the seal, and the dose 38 falls through the corresponding aperture 23, 25, 27 (not shown, see fig. 4) in the sensing layer 20 and through the corresponding aperture 5 in the housing 4. As also shown in fig. 3, the electronic unit 10 is enclosed in a housing cover 6 having an opening to enable the sensing layer to be inserted into the cover 6 for connection with a connector 12 of the electronic unit 10. Thus, a voltage from a power supply may be provided to the sensing layer 20 or at least a portion or layer thereof, as discussed further below.

Fig. 4 illustrates a portion of the sensing layer 20 that, when used with a blister package 30 inserted into a dispensing system 2 containing the sensing layer 20, will align with a single blister 32 of the blister package 30. The sensing layer 20 includes a plurality of component layers including a pressure sensitive layer 22, a conductive layer 24, and a compressible foam layer 26 separating the pressure sensitive layer 22 from the conductive layer 24. The pressure sensitive layer 22 is shown in fig. 5A and is formed of a material having at least one property that changes as pressure is applied in the layer 22. For example, the layer 22 can comprise a semiconductive layer comprising a polymer having conductive particles dispersed therein that changes resistance upon application of pressure (typically, the resistance decreases with applied pressure). Preferred materials for the sensing layer 24 include

And the like. Other sensing methods may be used, such as those illustrated in fig. 10-12, and include capacitive sensing, inductive sensing, piezoelectric sensing, and optical sensing and will be discussed further below. The pressure sensitive layer 22 includes a plurality of apertures 23 to allow the dose 38 to pass therethrough. The apertures 23 each have a diameter D which is larger than the largest dimension of the dose 38 in the blister pack 30₂₃. The pressure sensitive layer 22 is sized to fit within the housing 4 andretained therein so as to have an appropriate length L and width W.

Two different conductive layers 24, 24' are shown in fig. 5C and 5D, respectively. For example, other configurations are also contemplated and discussed below with respect to fig. 9A-9C and fig. 13 and 14. First conductive layer 24 of fig. 5C includes a substrate 29, such as a glass reinforced epoxy laminate, fiberglass, or other suitable substrate material, with conductive areas 25b printed or otherwise provided thereon. Conductive region 25b is generally ring-shaped or tablet-shaped (e.g., adapted to be substantially the same shape and slightly larger than a tablet of a particular blister pack) and surrounds aperture 25 of conductive layer 24. Conductive region 25b is formed of any suitable material, such as copper, for example. Conductive layer 24 may comprise a Printed Circuit Board (PCB) having an aperture 25a surrounded by a conductive area 25b and traces 11 or the like connecting the conductive layer to electronics unit 10, all of which are printed on substrate 29 or etched to expose the conductive area and traces, as shown in fig. 6. This arrangement provides discrete conductive areas 25b which, when in contact with the pressure sensitive layer 22 in the vicinity of the sensing layer apertures 23, 25, 27, can transmit a voltage to that layer. Diameter D of conductive region 25b_25bLarger than diameter D of orifice 25a_25a。

The alternative conductive layer 24' of fig. 5D is formed of a conductive material, such as a copper sheet or other suitable material, or may be formed of a substrate (not shown) having a layer of conductive material printed thereon. Diameter D of orifice 25₂₅Generally the same diameter as the embodiment of fig. 5C.

A spacer layer 26 is provided between the pressure sensitive layer 22 and the conductive layers 24, 24'. This spacer layer 26 is compressible, made of, for example, a compressible foam, and although it spaces the pressure sensitive layer 22 from the conductive layers 24, 24 'when no pressure is applied, pressure from a user dispensing the dose 38 from the blister 32 compresses the spacer layer 26 and brings the pressure sensitive layer 22 into electrical contact with the conductive layers 24, 24'. The apertures 27 of the spacer layer 26 are configured to enable the pressure sensitive layer 22 to make contact with the conductive layers 24, 24' because of the diameter D of the apertures 27 of the spacer layer 26₂₇Larger than the diameter D of the apertures 23, 25a of the pressure sensitive layer 22 and the conductive layers 24, 24₂₃、D₂₅、D_25a. That is, an air gap 21 is formed adjacent the edge of the spacer layer 26 surrounding the aperture 27, which air gap exposes the surface of the pressure sensitive layer 22 in the region of the aperture 23 to the surface of the conductive layer 24, 24' in the region of the aperture 25 of the conductive layer (i.e., exposes the conductive region 25b of the embodiment of fig. 5C). Thus, when the pressure sensitive layer 22 and the conductive layers 24, 24' are compressed toward each other, the exposed areas may be brought into direct electrical contact. Thus, current from the conductive layers 24, 24 'may flow through the pressure sensitive layer 22 and into the conductive contact layer 16, and back through the pressure sensitive layer 22 and further back into the conductive layers 22, 24', as the circuit is closed by the layers undergoing deformation to contact each other. This will be discussed in further detail below with respect to fig. 9.

As shown in fig. 4, in this embodiment, additional layers are provided on top of the above three layers 22, 24, 26, including a protective plastic layer 14, for example formed of polyethylene terephthalate alcohol (PET), and an additional conductive layer 16, which is hereinafter referred to as the contact layer 16 for ease of reference. The contact layer 16 is disposed over the pressure sensitive layer 22 and is formed of a preferably flexible and thin conductive material, such as carbon (e.g., graphite) or aluminum. The broken portion 17 of the protective layer 14 may extend into the apertures 23, 25, 27 of the layers of the three primary sensing layers 20 in use, or (as shown in figure 9) the protective layer 14 may simply bend without breaking, providing further protection to the system (if the protective layer 17 is above the dispensed dose). In the arrangement of fig. 4, the broken portion 17 of the protective layer 14 covers the contact layer 16 and protects the contact layer 16 and the edges of the apertures 23, 25 (and thus also the air gaps 21) of the pressure sensitive layer 22 and the conductive layers 24, 24' from dust and other contaminants. Similarly, the unbroken portion of the protective layer 14 of fig. 9A and 9C protects the contact layer 16 and the like.

Fig. 9A to 9C illustrate a portion of a sensing layer according to an alternative embodiment of the present invention. This arrangement again comprises a conductive layer 24 and the layer 24 is arranged on a substrate 29 comprising glass fibres. The conductive layer 24 is printed on a substrate 29 as is known in standard PCB arrangements (shown in fig. 9B). The conductive layer 24 includes at least one aperture 25a with conductive areas 25b disposed around the aperture, but in this embodiment, the conductive areas 25b are isolated from each other and do not form a solid ring around the aperture 25a, but are instead disposed in a generally annular shape. The substrate 29 also includes suitable apertures (not shown). The sensing layer 20 of fig. 9A further includes other layers in a similar manner to the previous embodiments, including a foam layer 26, a pressure sensitive layer 22 including Velostat or other suitable material, a contact layer 16 of carbon or the like, a protective layer 14 of PET or the like, and the like.

As shown in fig. 9C, when it is desired to dispense a unit dose, such as a tablet, a downward pressure P is applied to the dose inside the blister (not shown) and this pressure P compresses the layer of the sensing layer 20, in particular the foam layer 26. The layers are thus brought together and the conductive layer 24 is in contact with the pressure sensitive layer 22, which in turn is in contact with the contact layer 16. As indicated by lines a '-b', a voltage applied to the conductive layer 24 can thus pass through the conductive layer 24 to the pressure sensitive layer 22 and into the contact layer 16, and then back through the pressure sensitive layer 22 into the conductive layer 24. Comparing fig. 9C with fig. 9A, the circuit is closed in fig. 9C by the pressure P and the voltage is transmitted through the pressure sensitive layer 22, thereby enabling determination of the applied pressure and the location of the applied pressure (in particular due to the isolated conductive areas 25B shown in fig. 9B), whereas in fig. 9A, in the absence of any pressure, the circuit is open and no voltage is transmitted to the pressure sensitive layer 22.

Referring now to fig. 7, a distribution system 2 according to an embodiment of the present invention is illustrated for use in an exemplary network 40. Each dispensing system 2 includes a transmitter, such as a bluetooth LE transmitter, within or otherwise connected to the electronic unit 10. The electronic unit 10 further comprises a memory in which is stored information (relating to each dose 38 dispensed from the inserted blister pack 30 and determined by the sensing layer 20 to be dispensed) including at least the time and date the dose 38 of medicament was dispensed. The transmitter of the dispensing system 2 transmits data to a remote device, such as the smart phone device 42 of the patient, continuously or at regular or irregular intervals, or upon detection that the smart phone 42 is within range of the dispensing device 2, or upon supply of power to the generator of the electronic unit 10, etc. In alternative arrangements, the data may additionally or alternatively be transmitted to other remote systems, such as to a computer of the patient and/or a caregiver responsible for treatment of the patient, or the like.

The smartphone 42 is equipped with suitable software, such as a suitable application 50, to cause information contained in the data to be displayed on the smartphone 42, as shown in fig. 8A. Thus, the patient (or a caregiver or other recipient of the data) can easily view historical data relating to each dose 38 dispensed from the blister pack 30 using the dispensing device 2. For example, the patient may see if they are complying with the treatment regimen, e.g., as indicated by the traffic light arrangement 52, as shown in fig. 8A (where color may be used on the display device, but not shown in the figure). The "green" indicator 54 indicates that the dose 38 has been dispensed at the appropriate time, while the "red" indicator 56 indicates that the dose 38 has not been dispensed when it should be. A "white" indicator 55 indicates that the dose 38 has not been dispensed but has not been taken. For example, the location of the dose 38 in the blister pack 30 may be indicated with a display 52 having the same number and arrangement of blisters 32 as the blister pack 30. The application 50 may additionally or alternatively indicate other information 58 to the patient, such as the exact time and date each dose 38 was dispensed and which dose 38 of the treatment regimen was reused (i.e. first, second, third, etc. doses), with the zeroth dose 59 indicating the time at which a new blister pack 30 was inserted into the dispensing device 2 and thus a new treatment regimen was started.

Additionally or alternatively, as shown in fig. 7, information regarding the dispensed dose 38 may be sent from the dispensing system 2 directly or indirectly (e.g., via a smartphone 42 as shown) to another device of the patient, such as a smart watch 44. For example, the indicator 45 may be triggered on the patient's smart watch 44 immediately upon dispensing the dose 38 to notify the patient that the dose 38 they took has been successfully recorded, as shown in fig. 8B. Other information, including the same information that may be displayed on application 50 of smartphone 42, may also or alternatively be displayed on smart watch 44.

As also shown in fig. 7, data from the distribution system 2 may additionally or alternatively be transmitted to another remote location, such as a server 46 or the like. This facilitates long term storage of the data and, for example, allows a caregiver, such as a physician, to access the data if the data is available from the server 46 via the internet without the patient having to go to the physician's office or the like.

The above embodiments include pressure sensing arrangements, but alternative embodiments having alternative sensing layers are also contemplated within the scope of the invention. For example, as shown in fig. 10, an induction sensitive layer 122 (or induction layer 122) is disclosed that may be used in place of the pressure sensitive layer 22 in any suitable embodiment described above or below. The sense layer 122 includes a sense coil layer 126 (or any other suitable device in which an electromotive force can be induced) and a sense coil substrate 124. When the induction coil layer 126 and the induction coil substrate 124 deform (e.g., due to the pressure P applied to the layers according to the embodiments shown in fig. 9A-9C), a change in the electrical characteristics of the inductor may be detected. Thus, the pressure indicating that the dose is dispensed is determined in the area of the coils that surround the orifice 125 in the layer 122 through which the dose is dispensed. Alternatively, the induction coil layer 126 couples to the induction layer in the blister (34 in fig. 3), which coupling changes if the induction layer in the blister moves or bursts due to tablet removal. This change in coupling is then detected by the induction coil 126.

Fig. 11A and 11B illustrate another alternative embodiment according to the present invention, which includes a capacitance-sensitive layer 222 (or a capacitive layer 222). Much like the sense layer 122 embodiment described with respect to FIG. 10, this capacitive layer 222 operates on the same principle of bringing the layers closer together, and thus in this case the capacitance of the layers changes and thus indicates the pressure applied to the layers that brings them together. In more detail, the capacitance layer 222 includes a substrate 229 with a first capacitor layer 224 over the substrate 229. The foam layer 226 is disposed between the first capacitor layer 224 and the second capacitor layer 216, and the two capacitor layers 224, 216 form a capacitor having a capacitance C_uThe capacitor of (2). Other suitable layers, such as protective layer 214, are also provided, as in other embodiments. Upon application of pressure P to the capacitive layer 222 (upon pushing from the blister)At dynamic dose, not shown) to bring the capacitor layers 224, 216 closer together, thereby bringing the capacitance C_uDifferent capacitance C (from uncompressed state) to compressed state_c(e.g., increasing capacitance). Thus, a change in capacitance indicates that a dose is dispensed from the blister package associated with the capacitive layer 222.

Fig. 12A and 12B illustrate another alternative embodiment according to the present invention, which includes an optically sensitive layer 322 (or optical layer 322). In the illustrated embodiment, a blister package 30 is shown above the optical layer 322 having a blister 32 containing a unit dose of medicament 38. Beneath blister package 30, optical layer 322 comprises a substrate 329, wherein at least one optical emitter 304 is aligned with at least one optical receiver 306 across an aperture 329a in substrate 329. The optical emitter 304 is configured to emit the light beam 302 in the direction of the corresponding optical receiver and continuously or intermittently (e.g., only when energized and/or at regular intervals) across the corresponding aperture 329 a. If a dose 38 is dispensed from the blister pack 30 and passes through the aperture 329a, the light beam 302 will be temporarily interrupted by the passing dose 38 and thus the dispensing of the dose 38 is detected. Fig. 12B illustrates a top view of the optical layer 322 showing that a plurality of corresponding emitters 304 and receivers 304 may be used to detect dispensing through each aperture 329a in the substrate 329. Of course, other configurations of this layer are within the scope of the invention. Further, other layers from the previous embodiments, such as protective layer 314, may also be provided in this optical embodiment.

The above embodiments illustrate arrangements according to the invention, but are not limiting and the scope of the invention is defined by the claims. It is understood that other arrangements of each of the above examples are possible. For example, other resistance embodiments are illustrated in fig. 13A-13B and 14A-14B. Fig. 13A and 13B illustrate two alternative arrangements of the conductive regions of the conductive layer. In fig. 13A, the conductive region 426 does not surround each aperture 425 in the conductive layer 424, but is located at the corners of the conductive layer 424. This simplified construction will still detect pressure (not shown) applied to the pressure sensitive (or other) layer with which it is associated and is simpler to manufacture. Another arrangement is illustrated in fig. 13B, having a plurality of conductive regions 426 'arranged in an array around an elongated aperture 425' through which doses from a plurality of cavities of a blister package can be dispensed. This provides a more accurate determination of where to dispense a dose than the arrangement of figure 13A, but at the same time provides a more versatile configuration capable of accommodating a wider arrangement of blister cavities, thus allowing for potentially reduced manufacturing costs as the number of adaptations required for each particular product blister is reduced.

It should also be understood that while in some of the above embodiments, multiple layers form and/or are associated with the sensing layer, not all of these layers are required and/or additional layers may be provided as desired. FIG. 14A illustrates a simplified sensing layer 520, which is similar to sensing layer 20 of FIG. 9A and includes protective layer 514, foam layer 526, conductive layer 524, and substrate 529, but includes combined pressure sensitive and contact layer 522. Fig. 14B illustrates another simplified sensing layer 620, which is similar to sensing layer 20 of fig. 14A, and includes a protective layer 614 and a substrate 629, but includes a combined pressure sensitive, foam, conductive and contact layer 626. It will therefore be appreciated that many modifications may be made to the embodiments of the invention without departing from the scope thereof as defined in the appended claims.

A method of using the dispensing system 2 of some of the various embodiments will now be described. The patient is provided with the dispensing device 2 in which the entire blister pack 30 has been inserted into the housing 4 or has a separate blister pack 30 which can be dispensed to the patient, for example in a separate transaction with a pharmacy. In the latter case, the patient simply inserts the blister pack 30 into the housing 4, for example by dropping or sliding the blister pack 30 into position between the edges 4a, 4b of the housing 4 and the end defined by the cover 6 and the opposite end 4 c. The blister pack 30 fits tightly inside the housing 4, thus ensuring that the blister 32 is well aligned with the apertures 23, 25, 27 in the sensing layer 20.

In this rest configuration, voltage from a power source is provided to the conductive layer 24, but the pressure sensitive layer 22 is isolated from the conductive layer 24 by the air gap 21 defined by the larger aperture of the foam layer 26. Thus, the dispensing system 2 is in a low power mode, thereby saving, for example, battery power until a dose 38 needs to be dispensed.

The patient may receive an alert from the dispensing system 2 to prompt the patient to take the dose 38 at an appropriate time, or may otherwise determine that the dose 38 should be dispensed. To do so, the patient simply pushes the particular blister 32 downwardly, as generally indicated by arrow P in fig. 3. Pressure on the cavity 32 from the patient's finger or thumb or the like urges the dose 38 into contact with the seal 36 of the blister base 34 and through the seal 36, which is configured to burst at this pressure. The dose 38 thus falls out of the dispensing system 2 through the apertures 23, 25, 27 in the sensing layer 20 and the housing aperture 5, and the patient can take the dose 38.

As the patient pushes the blister 32 downward, not only does the dose 38 push through the seal 36 and out of the dispensing system 2, but the foam layer 26 of the sensing layer 20 is compressed. This brings the pressure sensitive layer 22 and the conductive layers 24, 24 ' closer together and, if the foam layer 26 is configured to be sufficiently compressible, the pressure sensitive layer 22 and the conductive layers 24, 24 ' may be pressed into direct electrical contact as portions of each layer 22, 24 ' are exposed to each other due to the larger apertures 27 of the foam layer 26. Thus, a voltage is provided to the pressure sensitive layer 22 through this direct electrical contact with the conductive layers 24, 24'. Thus, voltage is applied to the pressure sensitive layer 22 in a timely manner only when the dose 38 needs to be dispensed, and this layer is used to sense the pressure applied to the blister 32, for example by measuring the change in resistance of the pressure sensitive layer 22 when it is compressed. The electronics unit 10 stores this information about the change in resistance of the pressure sensitive layer 22 and transmits the information to a remote device 42, 44, 46 for further processing and/or processing the information to determine the time/date at which the dose 38 was dispensed. In other illustrated embodiments, the sensing layer senses different changes or variations in state to determine that a dose has been dispensed, such as a change in capacitance (as shown in FIG. 11) or interruption of a light beam (as shown in FIG. 12) or an induced voltage (as shown in FIG. 10), and the like.

In some embodiments, the sensing layer 20 is a component that is removable from the housing 4. If a different blister pack 30 is used with the dispensing system 2, a different sensing layer 20 having a configuration corresponding to that of the different blister pack 30 may be inserted into the housing 4 to replace the existing sensing layer 20. If the housing 4 includes apertures 5 in an array generally corresponding to the blisters 32 of the blister pack 30, the base 7 of the housing 4 may be configured to be removable from the remainder of the housing 4, and the replacement base 7 may be provided with a configuration corresponding to that of a different blister pack 30.

As disclosed in the various embodiments above, a modular dispensing system 2 is provided in which a standard blister pack 30 is received and in the event that a dose 38 is dispensed from a blister 32 of the blister pack 30, this is detected by the dispensing system 2 and the dispensing of the dose 38 is displayed or recorded for future reference. Thus, an improved dispensing system 2 is provided that is cost attractive, reliable, reusable, patient and manufacturing friendly, and facilitates patient compliance with a dosage regimen and provides relevant information for patient and/or caregiver review while dispensing a dose 38 and/or at an appropriate time after several doses 38 have been dispensed.