Patent Application
20130172690
The present invention is related to electronic systems and, more specifically, to electronic systems for determining and confirming delivery of a dose of medication.
Commonly used medication delivery systems include a chamber for storing the dose. As needed, a patient will use the system to take a dose of the medication. However, there is no accurate way of determining if the patient took the dose or when the patient took the dose. For example, there are delivery systems that track the number of times a dose was dispensed or delivered. However, the delivery systems lack the ability to determine if and when the doses were delivered to a patient. For example, a patient may discharge the delivery system several times in a short period of time to give the appearance that several doses were taken over a period of time. There are some delivery systems that time-stamp the delivery, but lack the ability to determine if the patient actually received the dose as required. For example, the patient may discharge the delivery system over a long period of time without actually taking or inhaling the dose to give the appearance that the doses were taken regularly over a longer period of time. Thus, these delivery systems are not capable of determining if the patient actually received the dose. Furthermore, there is no accurate way of determining if the dose that was delivered was actually delivered to the patient as intended. For example, the delivery system may have been discharged by someone other than the patient. Additionally, in some instances, the delivery systems may have been accidentally discharged.
Therefore, what is needed is a system and method for determining if a medicinal dose was delivered to a patient as intended as well as tracking the delivery time and thereby providing an accurate determination of when the patient actually received the dose.
In accordance with aspects of the systems and teaching of the present invention, a system and method are provided that track the delivery time of a medicinal dose to the patient as well as providing confirmation that the patient actually received the dose. The system includes a detector and an apparatus. The detector is communicatively coupled to the user and is capable of detecting a current flow through the user's body. The current flow is produced when the user makes contact with the apparatus. The apparatus includes at least two contact areas connected to a power source such that a circuit and, hence, a current path is completed through the user's body as the user makes contact with each of the two contact areas and a current flow is detected by the detector, which is coupled to the user.
In another aspect, the system includes a detector and an apparatus with an acoustic unit. The detector is communicatively coupled to the user and is capable of detecting a current flow through the user's body as well as acoustic information produced by the acoustic unit. The current flow is produced when the user makes contact with the apparatus. The apparatus includes at least two contact areas connected to a power source such that a circuit and, hence, a current path is completed through the user's body as the user makes contact with each of the two contact areas and a current flow is detected by the detector, which is coupled to the user.
Notwithstanding the claims, the present invention is also defined by the following clauses:
1. An apparatus for delivering a dose to a user and track the timing of the delivery of the dose, the apparatus comprising:
a detector configured to couple to the user;
an apparatus, wherein the apparatus comprises:
a hermetically sealed housing;
a power source secured within the housing;
a processor electrically coupled to the power source and secured within the housing;
at least one sensing probe secured to the housing wherein the probe is electrically coupled to the processor so that the processor detects physiological parameters associated with the user and the current flow through the user; and
a memory unit electrically coupled to the processor and secured to or within the housing to store data;
wherein the transceiver is electrically coupled to the processor and secured within the housing to receive and decode information transmitted from the apparatus.
6. The apparatus of clause 4 or 5 wherein the detector is configured to be implanted within the user's body or on the user's skin, wherein the probe is at least partially exposed to contact the user's tissue or skin.
7. The apparatus of any of the clauses 4-6 wherein the transceiver is communicatively coupled to a data management center to provide two-way wireless communication of the data from the detector to the data management center.
8. The apparatus according to any of the preceding clauses further comprising an acoustic unit secured to the housing, preferably wherein the acoustic unit comprises:
a support layer comprising an adhesive layer on one surface for securing the acoustic unit to the apparatus;
a vibration detection unit secured to the support layer to detect acoustic information produced by the apparatus and the user inhaling through the apparatus and produce a detection signal;
a controller secured to the support layer and in communication with the vibration detection unit, wherein the controller receives the detected signal from the vibration detection unit and produces a digital signal representing the detected signal;
a sound generation unit secured to the support layer and in communication with the controller, wherein the sound generation unit receives the digital signal and produces the acoustic signal; and
a top layer secured to the support layer to define a cavity that contains and protects the vibration unit, the controller, and the sound generation unit within the cavity,
wherein the acoustic signal represents information associated with the inhalable dose being loaded into the chamber and the user inhaling through the apparatus and wherein the acoustic signal is detected by the detector to confirm delivery of the dose.
9. The apparatus of clause 8, wherein the acoustic unit is coupled to a control module secured to the housing.
10. The apparatus of clause 8 or 9, wherein the acoustic unit provides an activation signal to the control module upon detection of a vibration representing the loading of a medication into the chamber.
11. The apparatus of any of the clauses 8-11 wherein a sound of the dose being loaded into the chamber activates the control module and wherein a current path is completed through the user's body as the user makes contact with each of the contact areas indicating that the user is about the receive a dose of a medication.
12. The apparatus of any of the clauses 8-12 wherein the acoustic unit provides an activation signal to the control module and the control module records acoustic information associated with the user inhaling, wherein the information is provided to the control module through the acoustic detector.
13. The apparatus according to any of the preceding clauses 8-12 wherein the control module provides a unique time stamp associated with the delivery of the dose and wherein the control module receives an identifier signal that is associated with the user wherein the combination of the time stamp and the identifier signal confirms deliver of the dose to the user.
14. The apparatus according to any of the preceding clauses 4-13 wherein the transceiver is electrically coupled to the control module and secured to the housing and wherein the transceiver allows the apparatus to transmit and/or receive information associated with the delivery of the dose to the user.
15. The apparatus of clause 14, wherein the transceiver comprises at least one of an optical transmitter module for optical communication and a wireless transmitter module for wireless communication.
16. The apparatus of clauses 14 or 15, wherein the transceiver encodes information from the memory unit and transmits that information to a system external to the apparatus.
17. The apparatus of clause 16, wherein the transceiver sends an activation signal to the external system once a circuit is completed through the user's body wherein the activation signal is an indicator that the user is prepared to initiate delivery of the dose.
18. The apparatus according to any of the preceding clauses 8-17 wherein the acoustic unit is activated by a processor to detect acoustic information from the user's lungs upon the acoustic unit receiving the activation signal from the apparatus.
19. A system to deliver a dose to a user and to confirm delivery of the dose, the system comprising an apparatus preferably according to any of the preceding clauses and a detector configured to couple to the user.
20. A system according to clause 21 wherein the detector includes a capacitive coupler.
21. A system according to clauses 19 or 20 further comprising,
a housing defining a chamber to store the dose;
a power source secured to the housing and including a positive terminal and a negative terminal, wherein the power source comprises an isolating source that produces a carrier wave;
a control module electrically coupled to the power source, wherein the control module alters the characteristics of the isolating source to encode information in the carrier wave; and
at least two areas positioned on the housing wherein one area is a partially exposed contact area and one area is capacitive coupled area, wherein the two areas are electrically isolated from each other,
wherein one output of the isolating source is coupled to the contact area and the other output of the isolating source is coupled to the capacitive coupled area,
wherein the contact area is touched by the user and the capacitive coupled area is capacitively coupled to the capacitive coupler worn by the user, and
wherein a portion of the carrier wave's path is through the user's body using the contact area and a portion of carrier wave's path is through capacitive conductance using the capacitive coupling between the capacitive coupled area and the capacitive coupler worn by the user.
22. The system of clause 21, wherein the housing defines an aperture to generate an acoustic wave as the user inhales through the apparatus and wherein the detector further comprises an acoustic unit for detecting acoustic wave associated with the user inhaling through the apparatus, which acoustic waves traveling through the user's body and through the air, wherein the acoustic unit correlates the acoustic wave through the user's body and the acoustic wave through the air to confirm delivery of the dose to the user.
23. The system according to any of the clauses 19-22 further comprising a vibration detection unit to detect acoustic information and produce a detection signal;
a controller in communication with the vibration detection unit, wherein the controller receives the detection signal from the vibration detection unit and produces a digital signal representing the detection signal;
a sound generation unit secured to the support layer and in communication with the controller, wherein the sound generation unit receives the digital signal and produces an acoustic signal that indicates delivery of the dose.
24. An apparatus for detection of delivery of a dose to a user, the apparatus comprising:
a vibration detection unit to detect acoustic information and produce a detection signal;
a controller in communication with the vibration detection unit, wherein the controller receives the detection signal from the vibration detection unit and produces a digital signal representing the detection signal;
a sound generation unit secured to the support layer and in communication with the controller, wherein the sound generation unit receives the digital signal and produces an acoustic signal that indicates delivery of the dose.
25. The apparatus of clause 24, further comprising a transceiver in communication with the controller, wherein the transceiver receives the digital signal and communicates with a wireless apparatus to indicate the inhalation event has occurred.
26. The apparatus of clause 24 or 25, further comprising a transconduction unit in communication with the controller, the transconduction unit comprising:
at least two contact areas electrically isolated from each other and positioned to allow contact with each of the contact areas;
a power source, wherein at least one contact area is electrically coupled to one terminal of the power source and at least one other contact area is electrically coupled to another terminal of the power source,
wherein a current path is completed through the user's body to allow current flow as the user makes contact with each of the two contact areas and current flow is detected by the controller.
27. The apparatus of clause 26, wherein the transconduction unit further comprises a control module electrically connected between the power source and one of the at least two contact areas, wherein the control module is configured to encode information in the current flow.
28. A method for recording the time that a dose is taken by a user, the method comprising the steps of:
activating a power module of an apparatus when the user makes contact with the exterior of the apparatus in such a manner to complete a circuit to allow for current flow between two terminals of the power module and through the user's body;
altering the current characteristics through changes in a conductance of the circuit that is formed through the user's body using a conductance control module;
detecting the current characteristics through the user's body using a detector, wherein the current characteristics comprises information associated with at least one of the apparatus and the dose; and
recording the timing of delivery of the inhalable dose.
29. The method of clause 28, comprising:
generating an acoustic signal using an acoustic unit; and
detecting the acoustic signal using an acoustic unit, wherein the acoustic signal comprises information associated with delivery of the dose to the user.
30. Use of a system or apparatus according to any of the preceding clauses for delivering a dose to a user and tracking the timing of the delivery of the dose, or for delivering a dose to a user and confirming delivery of the dose.
The novel features of the various aspects of the present invention are set forth with particularity in the appended claims. The various aspects, however, both as to organization and methods of operation, are described herein by way of example in conjunction with the following figures and corresponding description, where like reference numbers refer to like elements throughout.
Referring to
In the present illustrated example, the detector 20 is shown as a detector that is external to the user's body. In accordance with another aspect of the present invention, the detector 20 may be positioned or implanted within the user's body. In yet another aspect of the present invention, the detector 20 may be partially implanted within the user's body. The externally secured detector 20 of interest includes those that are sized to be stably associated with a living subject in a manner that does not substantially impact movement of the living subject. As such, the detector 20 may have dimensions that, when secured to the user 10, will not cause the user 10 to experience any difference in mobility or movement.
In accordance with some aspects of the present invention, the detector 20 is dimensioned such that its size does not hinder the ability of the subject to physically move. For example, in one aspect the detector 20 has a small size and may occupy a volume of space of 5 cm3 or less, such as 3 cm3 or less, including 1 cm3 or less. In another aspect the detector 20 has a small size and may occupy a volume of space of 25 cm3 or less, such as 12 cm3 or less, including 5 cm3 or less. In another aspect the detector 20 has a small size and may occupy a volume of space of 25 cm3 or less, such as 5 cm3 or less, including 1 cm3 or less. In accordance with one aspect of the present invention a receiver (not shown) can be included in the apparatus 3. In such instances, the receiver has a chip size limit ranging from 2 mm2 to 2 cm2.
The user 10 holds the apparatus 3 in the user's hand and places the apparatus 3 to the user's mouth, thereby making contact with the apparatus 3 in at least two locations, as shown. In the case of a small child, the parent may hold the apparatus 3. In various aspects, if the child makes contact with the parent, then as described hereinbelow, a circuit is completed through the parent and child. The apparatus 3 is shown in block diagram form for clarity of describing the functionality thereof as well as the components therein. However, the apparatus 3 can be made is a variety of shapes according to the various aspects of the present invention.
Referring now to
In various aspects, the example apparatus 3, may include an acoustic unit or acoustic unit in accordance with various aspects of the present invention as shown, for example, in connection with apparatus 30 and apparatus 25 as shown in
Referring now to
In accordance with another aspect of the present invention, the contact areas 38, 40 may include functionality that allow for reading and recording of biometric information, such as finger print data. This information may be communicated to the apparatus 3 and stored therein for confirmation of the user's identity.
The contact areas 38, 40 are electrically isolated from each other and at least partially exposed or exposable to allow the user 10 to make contact therewith. In one aspect, the contact areas 38, 40 may also be coated with a thin dielectric, such as plastic, and the electrical communication is accomplished using capacitive coupling through this dielectric to the user. Capacitive coupling may be accomplished at signal frequencies greater than about 20 kHz and in some aspects about 80 kHz for good signal-to-noise ratio (SNR, e.g., signal to ambient noise). In accordance with one aspect of the present invention, the contact areas 38, 40 are positioned such that one contact area 38, for example, makes contact with the user's hand and the other contact area 40, for example, makes contact with the user's mouth. In accordance with alternative aspect of the present invention, additional contact areas may be added to allow for secondary contacts with the hand or mouth as well as to accommodate using a different hand, such as a left hand grip as well or a right hand grip. Furthermore, additional contact areas on the housing 32 can be included to ensure that the apparatus 3 is held properly. If the contact areas 38, 40 are covered by dielectric, then the apparatus makes contact with the mouth of the user, and the electrodes may or may not be visible to the user. For example, the electrodes could be embedded in the plastic and sense the presence of the mouth using capacitive coupling and looking for a large change in impedance between the two capacitive plates that occurs when the mouth contact both of these plates. It will be appreciated that the contact areas 38, 40 may be located near or on the exterior of the housing 32. In one aspect, the contact areas 38, 40 may be “partially exposed” and in another aspect may be “embedded” in the housing 32. In other aspects, the user may couple to the contact areas 38, 40 using noncontact means such as detection changes of an electric field when user is in proximity to the contact areas 38, 40.
The power source 34 is electrically connected to the control unit 36 and coupled to the contact areas 38, 40. One terminal of the power source 34 is electrically connected to the contact area 40. The other terminal of the power source 34 is electrically connected to the control unit 36. As shown, the power source 34 has two outputs; one output is electrically connected to the control unit 36 and the output is connected to the contact area 38. In this example, the control unit 36 is connected in series with the power source 34. However, the scope of the present invention is not limited by the relative circuit relationship between the control unit 36 and the power source 34. For example, the control unit 36 may be positioned in parallel with the power source 34, such that the control unit 36 is electrically connected to both of the contact areas 38, 40 as well as both terminals of the power source 34. It will be appreciated that in certain aspects, the power source 34 produces alternating current (AC) signals so as not to fibrillate the heart. Other signals may be employed provided that safe operation for living subjects is considered.
As the apparatus 3 is brought into contact with the user's hand and mouth, the contact areas 38, 40 come into contact with the user 10 resulting in a complete circuit that includes the user 10. Thus, the circuit that defines the current path includes the user 10, the contact area 40, the power source 34, the control unit 36, and the contact area 38. Once the circuit path is completed the power source 34 provides the voltage potential needed to cause a current flow through the user's body. The presence of the current flow is an indicator that the apparatus 3 is in position for dispensing the inhalable dose because the apparatus 3 is now in the user's hand and has made contact with the user's mouth. The detector 20 identifies the presence of the current flow through the user's body and can record the timing of the occurrence of the event, as discussed in greater detail hereinbelow. Additionally, the apparatus 3 can also detect the presence of the current flow and record the time the event occurred. Thus, once the circuit is complete and the current flow is detected, then the control unit 36 can also record the timing of the completed circuit in the memory unit 42.
In accordance with another aspect of the present invention, the control unit 36 provides additional control functionality. According to one aspect, the control unit 36 can control the conductance of the circuit, which is completed through the user's body, to encode information in the current flow. In addition, the control unit may superimpose information that is stored in the memory in the current flow as well. For example, the timing of the completion of the circuit, information about the dose, or additional identifying information can be encoded in the current flow. The control unit 36 alters the conductance of the circuit. The altered conductance results in an alteration of the characteristics of the current flow. It is the altered characteristics that contain the information and, thus, the information is encoded in the current flow, as disclosed in U.S. patent application Ser. No. 12/564,017 entitled COMMUNICATION SYSTEM WITH PARTIAL POWER SOURCE filed on Sep. 21, 2009, and published as US 2010/0081894, the entire specification of which is incorporated herein by reference. The encoded information is then detected by the detector 20 and decoded. In addition, information disclosed in U.S. patent application Ser. No. 11/912,475 entitled PHARMA-INFORMATICS SYSTEM filed on Apr. 28, 2006, and published as US 2008/0284599 the entire specification of which is incorporated herein by reference.
Additionally, in accordance with another aspect of the present invention the control unit 36 may enter a sleep state to minimize power consumption. The control unit may return to an active state by any one or more known methods that involve electric power, heat, pressure, sound, etc. In cases when sound is used, sound vibrations generated by the dose being loaded into the chamber 44 may be used to generate an activation signal that is send from an acoustic unit, for example, to the control unit 36. The activation signal may be used to place the control unit 36 in an active state from the sleep state. Once activated, the control unit 36 can record additional acoustic information, especially information associated with the user 10 inhaling through the apparatus 3.
Referring now to
The apparatus 3 can communicate with various other devices such as a computer with a built-in or peripheral monitor (such as may be found in a bedside monitor or a health information system), a personal digital assistant (PDA), a smart phone, a messaging device, a data center, etc. Additionally, the apparatus 3 may be configured to be communicatively coupled to, e.g., interrogated by, an external device to provide and/or receive data to an external location. Any convenient data transmission protocol may be employed, including both conduction through a physical medium (for example, through the user's body using the current flow) and through the air, such as wireless data transmission protocols.
In accordance with another aspect of the present invention, the detector 20 communicates identification code or information to the apparatus 3. The identification code or information activates the apparatus 3 to deliver the dose. Additionally, the detector 20 can confirm delivery of the dose and send confirmation information to the apparatus 3 indicating that the dose was delivered.
In accordance with yet another aspect of the present invention, both the detector 20 and the apparatus 3 communicate directly and independently with a third device, such as a cell phone or a computer. The information communicated is related to the delivery of the dose. This third device will then reconcile the data and information to correlate delivery time, dose amount, patient identity, and other related factors, each of which may be received from the detector 20 and/or the apparatus 3.
Referring still to
Referring now to
The user 10 holds the apparatus 30 in the user's hand and places the apparatus 30 to the user's mouth, thereby making contact with the apparatus 30 in at least two locations, as shown. In the case of a small child, the parent may hold the apparatus 30. The apparatus 30 is shown in block diagram form for clarity of describing the functionality thereof as well as the components therein. However, the apparatus 30 can be made is a variety of shapes according to the various aspects of the present invention.
Referring now to
Referring now to
Thus, by controlling the isolating characteristics of the source 30a, using the control module of the apparatus 30a, information is encoded in the carrier wave by using known technologies. For example, using Frequency-shift Keying (FSK) information may be encoded in the carrier wave, including binary FSK.
Referring now to
The contact areas 38, 40 are electrically isolated from each other and at least partially exposed to allow the user 10 to make contact therewith. In accordance with one aspect of the present invention, the contact areas 38, 40 are positioned such that one contact area 38, for example, makes contact with the user's hand and the other contact area 40, for example, makes contact with the user's mouth. In accordance with alternative aspect of the present invention, additional contact areas may be added to allow for secondary contacts with the hand or mouth as well as to accommodate using a different hand, such as a left hand grip as well or a right hand grip. Furthermore, additional contact areas on the housing 32 can be included to ensure that the apparatus 30 is held properly.
In accordance with another aspect of the present invention, the contact areas 38, 40 may include functionality that allow for reading and recording of biometric information, such as finger print data. This information may be communicated to the apparatus 30 or the acoustic unit 33 and stored therein for confirmation of the user's identity.
The power source 34 is electrically connected to the acoustic unit 33, the control unit 36, and coupled to the contact areas 38, 40. The acoustic unit 33 is also electrically coupled to the control unit 36 and the operation thereof is discussed with respect to
Additionally, in accordance with another aspect of the present invention the control unit 36 may enter a sleep state to minimize power consumption. In such a condition, any event causing a change of state may serve as an activation signal e.g., the sound vibrations generated by the dose being loaded into the chamber 44 may be used to generate an activation signal that is sent from the acoustic unit 33 to the control unit 36. The activation signal may be used to place the control unit 36 in an active state from the sleep state. Once activated, the control unit 36 can record additional acoustic information, especially information associated with the user 10 inhaling through the apparatus 30.
As the apparatus 30 is brought into contact with the user's hand and mouth, the contact areas 38, 40 come into contact with the user 10 resulting in a complete circuit that includes the user 10. Thus, the circuit that defines the current path includes the user 10, the contact area 40, the power source 34, the control unit 36, and the contact area 38. Once the circuit path is completed the power source 34 provides the voltage potential needed to cause a current flow through the user's body. The presence of the current flow is an indicator that the apparatus 30 is in position for dispensing the inhalable dose because the apparatus 30 is now in the user's hand and has made contact with the user's mouth. The detector 20 identifies the presence of the current flow through the user's body and can record the timing of the event, which is discussed in greater detail hereinbelow. Additionally, the apparatus 30 can also detect the presence of the current flow and record the time the event occurred. Thus, once the circuit is complete and the current flow is detected, then the control unit 36 can also record the timing of the completed circuit in the memory unit 42.
Referring now to
The apparatus 30 can communicate with various other devices such as a computer with a built-in or peripheral monitor (such as may be found in a bedside monitor or a health information system), a PDA, a smart phone, a messaging device, a data center, etc. Additionally, the apparatus 30 may be configured to be interrogated by an external device to provide data to an external location. Any convenient data transmission protocol may be employed, including both conduction through a physical medium (for example, through the user's body using the current flow) and through the air, such as wireless data transmission protocols.
In accordance with another aspect of the present invention, the detector 20 communicates identification code or information to the apparatus 30. The identification code or information activates the apparatus 30 to deliver the dose. Additionally, the detector 20 can confirm delivery of the dose and send confirmation information to the apparatus 30 indicating that the dose was delivered.
In accordance with yet another aspect of the present invention, both the detector 20 and the apparatus 30 communicate directly and independently with a third device, such as a cell phone or a computer. The information communicated is related to the delivery of the dose. This third device will then reconcile the data and information to correlate delivery time, dose amount, patient identity, and other related factors, each of which may be received from the detector 20 and/or the apparatus 30.
Referring still to
Referring now to
Referring now to
Referring now to
One advantage is that the acoustic sensors of the present invention may be fabricated at a low cost using manufacturing techniques borrowed from printed circuit board (PCB) fabrication—either etching or additive/printing. Further advantage may be gained by incorporating the circuits associated with the controller unit, which are in accordance with the various aspects of the present invention, onto the “circuit” board using additive/printing techniques. Furthermore, in accordance with another aspect of the present invention, the power source may be incorporated into the assembly.
In accordance with various aspects of the present invention, the acoustic unit 33, as indicated hereinabove, may be positioned in various locations within the apparatus 30 (
Referring now to
The user 10 holds the apparatus 25 in the user's hand and places the apparatus 25 to the user's mouth, thereby making contact with the apparatus 25 in at least two locations, as shown. In the case of a small child, the parent may hold the apparatus 25. If the child makes contact with the parent, then as described hereinbelow, a circuit is completed through the parent and the child. The apparatus 25 defines a chamber for holding the inhalable doses. The chamber may also include a chamber control unit for controlling dispensing of the dose. The chamber also includes an opening through which the inhalable dose is delivered to the patient, as discussed with respect to
Referring now to
In accordance with another aspect of the present invention, the dose confirmation apparatus 23 and the acoustic unit 31 are independent units that can be individually secured to the apparatus 25. For example, referring to
Additional examples and shapes for the delivery of an inhalable dose are considered and within the scope of the present invention. Thus, according to various aspects of the present invention, the apparatus 25 can be in various shapes and dose delivery set-ups, as shown in
Furthermore, the scope of the present invention is not limited by the inclusion of the acoustic unit 31 within the apparatus 25 or the separation of the acoustic unit 31 from the apparatus 25. More specifically, each have specific functionality and purpose and as such operate independent of the other as well as in cooperation with each other. Thus, any device, including any commonly known or conventional inhaler, can be used with either or both the apparatus 25 and/or the acoustic unit 31 to confirm delivery of a dose to a user 10 without structural changes or modification to the apparatus 25.
In accordance with one aspect of the present invention, the acoustic unit 31 includes an aperture that generates sound as the user 10 inhales. The sound is generated by the airflow through the acoustic unit 31, in a manner similar to a whistle. The acoustic unit 31 is placed in the path of the airflow. As the user 10 inhales, the airflow through the apparatus 25 and the acoustic unit 31 generates an acoustic signal.
Referring now to
Referring now to
The range of acoustic information generated by the loading of the dose and the inhaling event has typically known characteristics. Thus, the acoustic information captured or collected by the microphone 31d has known characteristics. For example, a particular device may produce a unique sound as the dose is loaded or as the user 10 inhales through the apparatus 25. Given the known range of acoustic information or sound produced by each device as the dose is loaded and the unique characteristics of the sound produced as the user 10 inhales, a state machine or a finite state machine can be used instead of a microprocessor. Thus, in accordance with one aspect of the present invention, the controller 31h is a state or a finite state machine.
The controller 31h provides a signal, which passes through an amplifier 31k and a filter 31m, to a sound generation unit or speaker 31n that produces an acoustic signal. The signal sent from the controller 31h to the speaker 31n includes any one or more of the following types of data: identification information that is unique to the acoustic unit 31 to identify the type of medication or dose delivered; information associated with the timing of the dose being loaded into the apparatus 25; and the timing of the user 10 inhaling. This information is then transmitted from the acoustic unit 31 to the detector 20 using the acoustic signal.
The acoustic signal generated by the acoustic unit 31 is detected, as described below, by the detector 20 secured to the user 10. In this way, any device, including any commonly known or conventional inhaler, can be used with the acoustic unit 31 to confirm delivery of a dose to the user 10 without structural changes or modification to the device used to deliver the dose. As indicated above, in accordance with another aspect of the present invention the acoustic unit 31 can communicate through a transceiver to indicate that the inhalation event has occurred.
In accordance with another aspect of the present invention, the acoustic unit 31 also includes contact connections 31p and 31q. The contact connections 31p and 31q are electrically coupled to or connected to contact areas 38 and 40, which are described with respect to
The information gathered by the controller 31h, such as physiological or environmental information, is stored in the memory unit 31r for later retrieval and aggregation.
In accordance with another aspect of the present invention, the acoustic unit 31 includes a wireless communication module, such as a Bluetooth® module, that communicates using ultra low power consumption with an external device. For example, the external device may be any commercially available hardware/software device such as a cell phone, a computer, a network router, a telemedicine base station, as well as embedded technology such as a single chip device, a transceiver, and a key fob. Thus, the scope of the present invention is not limited by the type of device that communicates with the acoustic unit 31. Similarly, the scope of the present invention is not limited by the type of device that communicates with the apparatus 25. Furthermore, the data exchanged includes firmware images, raw collected data, generated information, data management information, and configuration data.
Referring now to
In accordance with another aspect of the present invention, the contact areas 38, 40 may include functionality that allow for reading and recording of biometric information, such as finger print data. This information may be communicated to the dose confirmation apparatus 23 or the acoustic unit 31 and stored therein for confirmation of the user's identity.
As the apparatus 25 is brought into contact with the user's hand and mouth, the contact areas 38, 40 come into contact with the user resulting in a complete circuit that includes the user 10. Thus, the circuit that defines the current path includes the user, the contact area 40, the power source 34, the control unit 36, and the contact area 38. Once the circuit path is completed the power source 34 provides the voltage potential needed to cause a current flow through the user's body. The presence of the current flow is an indicator that the apparatus 25 is in position for dispensing the inhalable dose because the apparatus 25 is now in the user's hand and has made contact with the user's mouth. The detector 20 identifies the presence of the current flow through the user's body and can record the timing of the event, which is discussed in greater detail below. Thus, once the circuit is complete and the current flow is detected, then the control unit 36 can also record the timing of the completed circuit in the memory unit 42.
Referring again to
In accordance with another aspect of the present invention, the control unit 36 provides additional control functionality. According to one aspect, the control unit 36 can control the conductance of the circuit, which is completed through the user's body, to encode information in the current flow. For example, the timing of the completion of the circuit, information about the dose, or additional identifying information can be encoded in the current flow. The control unit 36 alters the conductance of the circuit. The altered conductance results in an alteration of the characteristics of the current flow. It is the altered characteristics that contain the information and, thus, the information is encoded in the current flow, as disclosed in U.S. patent application Ser. No. 12/564,017 entitled COMMUNICATION SYSTEM WITH PARTIAL POWER SOURCE filed on Sep. 21, 2009, the entire specification of which is incorporated herein by reference. The encoded information is then detected by the detector 20 and decoded.
Additionally, in accordance with another aspect of the present invention the control unit 36 may enter a sleep state to minimize power consumption. In such a condition, the sound vibrations generated by the dose being loaded into the chamber 44 may be used to generate an activation signal that is send from the acoustic unit 31 (
Referring now to
The dose confirmation apparatus 23 can communicate with various other devices such as a computer with a built-in or peripheral monitor (such as may be found in a bedside monitor or a health information system), a PDA, a smart phone, a messaging device, a data center, etc. Additionally, the dose confirmation apparatus 23 may be configured to be interrogated by an external device to provide data to an external location. Any convenient data transmission protocol may be employed, including both conduction through a physical medium (for example, through the user's body using the current flow) and through the air, such as wireless data transmission protocols.
Referring again to
Referring again to
Referring now to
Referring now to
In accordance with another aspect of the present invention, the chamber 44 may also include an optical gap 58 prior to the diaphragm 52. In the optical gap, at least one optical sensor 60 is positioned to detect an optical emission from a light source 62 also included in the optical gap, such as a Light Emitting Diode (LED). As the dose is released into the optical gap of the chamber 44, the optical sensor 60 detects a drop in the intensity of the light due to the dose being present, which is a powder-like opaque substance. The optical sensor 60 is electrically coupled to the control unit 36. The optical sensor 60 signals the control unit 36 to indicate the presence of the dose once a change in optical intensity is detected.
Referring now to
In accordance with another aspect of the present invention, the device 20 includes a capacitive tactile sensor control unit (not shown). Once the device 20 comes into contact with the user's hand and mouth, then the control unit 36 receives a signal from the sensor control unit and the control module activates a chamber control unit. The chamber control unit initiates dispensing of the dose. According to one aspect to the present invention, the device 20 continues to dispense the inhalable dose to the user 10 (
Referring now to
Referring now to
The processing unit 70 also includes a power source 87 electrically coupled to a microprocessor 88. The microprocessor 88 is electrically coupled to all the components and coordinates the function between the various functional blocks as well as power management. In accordance with another aspect of the present invention, the components of the processing unit 70, including the microprocessor 88, may be all connected to a bus and, hence, interconnected electrically to each other through the bus and controlled by the microprocessor.
According to other aspects of the present invention, the overall system that includes the detector 20 and the apparatus 3, 25, 30 (as described in connection with
According to another aspect of the present invention, the processing unit 70 of the detector 20 wherein the module 90 is an acoustic detector. The acoustic detector 90 would detect the sound associated with the user 10 taking a deep breath. In accordance with another aspect of the present invention, the acoustic detector 90 also detects the sound or acoustic signal produced by the acoustic unit 33 of
According to another aspect of the present invention, the processing unit 70 is coupled to the module 90 that includes an optical detector. The optical detector of the module 90 would be positioned within the detector 20 such that a portion of the housing would be transparent and allowing for an optical beam to reach the optical detection unit 90.
According to another aspect of the present invention, the processor 70 of the detector 20 can include any combination of the accelerometer, the acoustic detector, and the optical detector.
According to various aspects of the present invention, the system of the invention may include a single detector or multiple detectors. For systems that include a single detector, the detector may include three or more distinct electrodes, and may be configured to be positioned in an abdominal or xyphoid region of the subject. The detector of such systems may be positioned at any convenient location, such as the front of a torso, the back of a torso, etc., as desired. In systems that have multiple detectors, each receiver may have a single electrode and such receivers may be in communication with one another to create an array of detectors.
In accordance with another aspect of the present invention, the acoustic detector and the current flow detection may occur within the apparatus 3, 25, 30 (as described in connection with
In accordance with another aspect of the present invention, an activation signal may be generated from a mechanical action using a mechanical switch that is triggered as the dose is loaded in to the chamber or through a mechanical motion required by the inhaler to arm the dose delivery.
Referring now to
In accordance with another aspect of the present invention, a detector 210 may be used in the form of a watch worn on the wrist of the user 10.
In accordance with yet another aspect of the present invention, the detector may be implanted and capable of communicating with a detector located external to the body of the user. In this manner, acoustic waves traveling through the user's body may be detected and correlated with acoustic waves traveling external to the user's body.
Referring now to
With all of these devices there are high incidences of infections that result from general use and cleaning. The proper care of the access device 100 involves the proper cleaning and disinfecting of the port before it is used, especially for the access device 100 that remains in place for more than a single use. In its most basic form, the cleaning involves the act of wiping the access port 106 with a disinfectant like alcohol before inserting a syringe or other device into the access port 106. There are generally accepted good practices for this activity which involve proper technique and time spent with each activity. The data collection module 104 is coupled to the needle 102 and the rim of the access port 106. Information regarding the management, cleaning, and use of the access device 100 can be collect and stored by the data collection module 104. This information may be transmitted or communicated to a detector on the users' body, such as the detector 20 of
In accordance with various aspects of the present invention, the data collection module 104 can be added to the access device 100 as either an add-on device or a redesigned assess port that tracks the care of the port. For example, contact with the rim of the access port 106 can be detected and, hence, the time spent cleaning of the access port 106, including the amount of time spent wiping and the drying the cleaned access port 106 is recorded. Furthermore, the time of insertion of a syringe or other device into the port may be recorded as well as the amount of time the syringe spends in the access port 106. The collection of data can be used to show that the maintenance of the access port 106 had been done properly and in the proper sequence, and that it was done with each use of the port, as disclosed in U.S. Provisional Patent Application Ser. No. 61/377,072 entitled SYSTEM AND METHOD FOR PATIENT ACCESS PORT REPORTING filed on Aug. 25, 2010, incorporated herein by reference in its entirety.
In accordance with various aspects of the present invention, the data collection module 104 senses the cleaning or wiping of the access port 106 using a number of methods, including impedance measurement, acoustic measurement, and pressure measurement. For example, impendence measurement is achieved by first measuring the impedance between electrodes positioned at the access port 106 without the presence of a conduction fluid, such as the alcohol. As the access port is cleaned by alcohol or similar conducting fluid, the impedance between the electrodes is altered by the alcohol or disinfecting wipe and the change in impedance can be measured and the timing of the change can be recorded. As the alcohol evaporates and the wiping action is ended, the impedance returns to the previous level.
In accordance with another aspect of the present invention, acoustic detection devices may be used to detect the signature or vibrations associated with the wiping action. Additionally, the data collection module 104 can detect the pressure associated with the wiping action at the access port 106. The access device 100 makes an electrical connection to the patient to allow the information to be communicated to the detector using alteration of the current signature. In accordance with various aspects of the present invention, the electrical connection between the access device 100 necessary for communication between the data collection module 104 and the detector 20 worn by the user may be made physically or mechanically with any number of methods including: conductive tape, conductive or conductor imbedded tubing.
In accordance with another aspect of the present invention, the communication connection between the detector 20 worn by the user and the data collection module 104 of the access device 100 may be through capacitive conductance using the tubing wall or using the fluid in the tubing as the conductor.
In accordance with other aspects of the present invention, sensors on the access device 100 may be used to verify proper handling or holding of the access device 100 and to activate the data collection module 104 to document the cleaning and use of the access device 100. For example, the device could be designed to verify that the nurse was using gloves when handling and accessing the port.
In accordance with another aspect of the present invention, the data collection module 104 may also be used, through its contact with the user, to measure local skin/body temperature and send a signal to the detector, which would warn of infection.
Aspects of implantable versions of the detector may have a hermetically sealed and biologically compatible cavity defined to act as the enclosure, e.g., Chipskin™ technology one or more sensing electrodes, a power source, which could either be a primary cell or rechargeable battery, or one that is powered by broadcasting inductively to a coil. For the external signal receivers, aspects include structures that have electrodes in contact with the user's skin. The communication may be wireless or performed over one or more conductive media, e.g., wires, optical fibers, etc. Where desired, the same electrodes may be used for receiving and transmitting signals.
Having described various aspects of medication delivery systems for the delivery of an inhalable dose, the description now turns to various additional aspects of medication delivery systems for the delivery of medication products in a variety of forms generally. In various aspects such medication delivery systems can be adapted and configured to deliver medication products in the form of an ingestible product such as, for example, a pill, a tablet, a sub-lingual tablet, a polymeric dissolvable tablet, a capsule, a gel capsule, a time-release oral dosage, a suppository, a liquid, a liquid capsule, a liquid in combination with a pill, tablet (dissolvable or otherwise), or capsule, a blister pack containing a pill, tablet (dissolvable or otherwise), capsule, liquid, gel, among other forms of medication. In various aspects, the medication may include ingestible devices, such as, for example, ingestible event markers (IEMs) as disclosed in U.S. patent application Ser. No. 12/564,017 entitled COMMUNICATION SYSTEM WITH PARTIAL POWER SOURCE filed on Sep. 21, 2009, and published as US 2010/0081894, the entire specification of which is incorporated herein by reference. In another example, the medication may include ingestible devices comprising radio-frequency identification (RFID) functionality, e.g., active RFID devices or passive RFID devices. The medication may be sealed or unsealed depending on the particular configuration. The scope of the disclosed aspects, however, is not limited by the shape or type of product. An ingestible product along with the terms “ingested” or “ingest” or “ingesting” is understood to mean any introduction of the product internal to the body and may include oral, anal, vaginal introduction of the product or any introduction of the product into a natural body orifice.
Referring now to
As discussed hereinabove, the detector 20 may be located external to the user's body. In accordance with another aspect of the present invention, the detector 20 may be positioned or implanted within the user's body especially in connection with detection of the movement of the tongue associated with the act of swallowing. For example, during the act of swallowing, the tongue moves upwardly towards the palate. Accordingly, the detector 20 or contact areas in communication with the detector may be positioned to detect such movement to confirm the act of swallowing. In yet another aspect of the present invention, the detector 20 may be at least partially implanted within the user's body. The externally secured detector 20 of interest includes those that are sized to be stably associated with a living subject in a manner that does not substantially impact movement of the living subject. As such, the detector 20 may have dimensions that, when secured to the user 10, will not cause the user 10 to experience any difference in comfort, mobility or movement.
Also illustrated in
Also illustrated in
Referring now to
It will appreciated that the tape medication delivery configuration is not limited to holding a pill. As shown in
In one aspect, the apparatus 500 as shown in and described in connection with
Although not explicitly shown, for clarity of disclosure it is to be understood that the apparatus 500 as shown in and described in connection with
Referring now to
Although not explicitly shown, for clarity of disclosure it is to be understood that the apparatus 600 as shown in and described in connection with
Referring now to
Although not explicitly shown, for clarity of disclosure it is to be understood that the apparatus 700 as shown in and described in connection with
The apparatuses 400, 500, 600, 700 as shown in and describe in connection with
In accordance with another aspect of the present invention, the contact areas 38, 40 (corresponding to contact areas 412, 414 in
The contact areas 38, 40 (corresponding to contact areas 412, 414 in
The apparatuses 400, 500, 600, 700 as shown in and described in connection with
In various aspects, the apparatuses 400, 500, 600, 700 as shown in and described in connection with
In aspects when an IEM is delivered by the medicinal delivery apparatuses 400, 500, 600, 700 as shown in and described in connection with
Accordingly, in one aspect, the medicinal delivery apparatuses 400, 500, 600, 700 as shown in and described in connection with
When the product that includes the IEM system is taken or ingested, the device comes into contact with the conducting liquid of the body. When the IEM system comes into contact with the body fluid, a voltage potential is created and the system is activated. A portion of the power source is provided by the device, while another portion of the power source is provided by the conducting fluid.
An ingestible product that includes an IEM system may be configured as an orally ingestible pharmaceutical formulation in the form of a pill or capsule. Upon ingestion, the pill moves to the stomach. Upon reaching the stomach, the product is in contact with stomach fluid and undergoes a chemical reaction with the various materials in the stomach fluid, such as hydrochloric acid and other digestive agents. Although the IEM system is discussed in reference to a pharmaceutical environment, the scope of the disclosed aspects of the IEM system is not limited thereby. The IEM system can be used in any environment where a conducting fluid is present or becomes present through mixing of two or more components that result in a conducting liquid.
A pharmaceutical product may be combined with an IEM system or an ionic emission module. The IEM system uses the voltage potential difference to power up and thereafter modulates conductance to create a unique and identifiable current signature. Upon activation, the IEM system controls the conductance and, hence, current flow to produce the current signature. The encoded information is then detected by the detector 20 and decoded.
In one specific example, the IEM system combined with a pharmaceutical product, as the product or pill is ingested, the IEM system is activated. The IEM system controls conductance to produce a unique current signature that is detected, thereby signifying that the pharmaceutical product has been taken. The IEM system includes a framework, that acts as a chassis for the IEM system and multiple components are attached to, deposited upon, or secured to the framework. In this aspect, a digestible material is physically associated with the framework. The material may be chemically deposited on, evaporated onto, secured to, or built-up on the framework all of which may be referred to herein as “deposit” with respect to the framework. The material is deposited on one side of the framework. The materials of interest that can be used as material include, but are not limited to: Cu or Cul. The material is deposited by physical vapor deposition, electrodeposition, or plasma deposition, among other protocols. The material may be from about 0.05 to about 500 μm thick, such as from about 5 to about 100 μm thick. The shape is controlled by shadow mask deposition, or photolithography and etching. Additionally, even though only one region is shown for depositing the material, each system may contain two or more electrically unique regions where the material may be deposited, as desired.
At a different side, which is the opposite side, for example, another digestible material is deposited, such that the two ingestible materials are dissimilar. The different side selected may be the side next to the side selected for the material. The scope of the present invention is not limited by the side selected and the term “different side” can mean any of the multiple sides that are different from the first selected side. The dissimilar materials may be selected such that they produce a voltage potential difference when the IEM system is in contact with conducting liquid, such as body fluids. The materials of interest for the first material include, but are not limited to: Mg, Zn, or other electronegative metals. As indicated above with respect to the first material, the second material may be chemically deposited on, evaporated onto, secured to, or built-up on the framework. Also, an adhesion layer may be necessary to help the material(s) to adhere to the framework. Typical adhesion layers for the material(s) are Ti, TiW, Cr or similar material. Anode material and the adhesion layer may be deposited by physical vapor deposition, electrodeposition or plasma deposition. The second (anode) material may be from about 0.05 to about 500 μm thick, such as from about 5 to about 100 μm thick. However, the thickness or deposition process are not limiting aspects of the IEM system or any of the materials used to deposit or secure the materials to the framework.
According to one aspect, the dissimilar materials can be any pair of materials with different electrochemical potentials. Additionally, wherein the IEM system is used in-vivo, the dissimilar materials may be vitamins that can be absorbed. More specifically, the dissimilar materials can be made of any two materials appropriate for the environment in which the IEM system will be operating. For example, when used with an ingestible product, the dissimilar materials are any pair of materials with different electrochemical potentials that are ingestible. An illustrative example includes the instance when the IEM system is in contact with an ionic solution, such as stomach acids. Suitable materials are not restricted to metals, and in certain embodiments the paired materials are chosen from metals and non-metals, e.g., a pair made up of a metal (such as Mg) and a salt (such as CuCI or Cul). With respect to the active electrode materials, any pairing of substances—metals, salts, or intercalation compounds—with suitably different electrochemical potentials (voltage) and low interfacial resistance are suitable.
In various aspects, the apparatus 3, 25, 30, 400, 500, 600, 700 as shown in and described in connection with respective
In one aspect, the transconduction unit further comprises a control module electrically connected between the power source and one of the at least two contact areas. The control module is configured to encode information in the current flow.
In one aspect, the apparatus 3, 25, 30, 400, 500, 600, 700 (as described in connection with
The detectors of interest include, but are not limited to, those receivers disclosed in: PCT application serial no. PCT/US2006/016370 published as WO 2006/116718; PCT application serial No. PCT/2007/24225 published as WO 2008/063626; PCT application serial no. PCT/US2008/52845 published as WO/2008/095183; the disclosures of which applications are herein incorporated by reference.
In accordance with other aspects of the present invention, the system may include two or more (such as three or more, including four or more) detectors. In such systems, the two or more detectors may be adaptively arranged at any desired location on the body of the user. For example, all of the body-associated detectors may be present on the same side of a body, such as the front torso of a body, or they may be present on opposite sides of a body, such as the front and back of the torso of a body. In the specific examples where the detector 20 is receiving acoustic information from within the lungs or the acoustic unit 33 of
In accordance with another aspect of the present invention, where the detector 20 includes the accelerometer 90 that monitors the motion of the lungs associated with a rapid inhale, then the detectors are positioned close to the lungs. If the detector 20 has also detected the presence of a current indicative of the user holding the apparatus 3, 25, 30, 400, 500, 600, 700 (as described in connection with
Depending on the needs of a particular application, the current detected by the detector 20 may be generic, such that it merely identifies that the apparatus 3, 25, 30, 400, 500, 600, 700 (as described in connection with
The apparatus 3, 25, 30, 400, 500, 600, 700 (as described in connection with
In certain aspects, the components or functional blocks of the detector and the apparatus are present on integrated circuits, where the integrated circuits include a number of distinct functional blocks, i.e., modules and at least some of, e.g., two or more, up to an including all of, the functional blocks may be present in a single integrated circuit. By single integrated circuit is meant a single circuit structure that includes all of the different functional blocks. As such, the integrated circuit is a monolithic integrated circuit that is a miniaturized electronic circuit (which may include semiconductor devices, as well as passive components) that has been manufactured in the surface of a thin substrate of semiconductor material. The integrated circuits of certain aspects of the present invention may be hybrid integrated circuits, which are miniaturized electronic circuits constructed of individual semiconductor devices, as well as passive components, bonded to a substrate or circuit board.
Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, the following description is directed to additional aspects of the present invention in a more general form. Accordingly, in one aspect, a system is provided to deliver a medicinal dose to a user and to confirm delivery of the dose. The system comprises a detector configured to couple to the user and an apparatus. The apparatus includes a housing defining a chamber to store the dose, at least two contact areas positioned on the housing and the at least two contact areas are electrically isolated from each other, and a power source secured to the housing and including a positive phase terminal and a negative phase terminal, wherein at least one contact area is electrically coupled to the positive terminal and at least one other contact area is electrically coupled to the negative terminal. In one aspect, the contact areas may be at least partially exposed on the exterior of the housing. A current path is completed through the user's body as the user makes contact with each of the two contact areas and current flow is detected by the detector that is coupled to the user.
In one aspect, the apparatus further comprises a control module electrically connected between the power source and one of the at least two contact areas, wherein the control module is configured to control information output from the apparatus.
In one aspect, the control module is configured to vary the conductance of the current path to encode information in the current flow and the detector decodes the information.
In one aspect, the apparatus further comprises a memory unit electrically connected to the control module to store information associated with delivery of the dose to the user.
In one aspect, the apparatus further comprises a transceiver electrically coupled to the control module wherein information can be transmitted and/or received from the apparatus to the detector other than through the current flow.
In one aspect, the detector is configured to be implanted within the user's body. The detector comprises a hermetically sealed housing, a power source secured within the housing, a processor electrically coupled to the power source and secured within the housing, and at least one sensing probe secured to the housing wherein the probe is at least partially exposed to contact the user's tissue. The probe is electrically coupled to the processor so that the processor detects physiological parameters associated with the user and the current flow through the user. A memory unit is electrically coupled to the processor and secured within the housing to store data. The transceiver is electrically coupled to the processor and secured within the housing to receive and decode information transmitted from the apparatus.
In one aspect, the detector is configured to be secured to the user's skin. The detector comprises a housing, a power source secured to the housing, a processor electrically coupled to the power source and secured to the housing, at least one sensing probe secured to the housing wherein the probe is at least partially exposed to contact the user's skin, wherein the probe is electrically coupled to the processor to allow the processor to detect physiological parameters associated with the user and the current flow through the user, and a memory unit is electrically coupled to the processor and secured to the housing to store data. The transceiver is electrically coupled to the processor and secured to the housing to receive and decode information transmitted from the apparatus.
In one aspect, the transceiver provides an activation signal to the detector and the detector includes an accelerometer electrically coupled to the processor and secured to the housing. The accelerometer is activated by the processor to detect motion upon the detector receiving the activation signal from the apparatus.
In one aspect, the transceiver includes an optical communication apparatus that encodes information in an optical beam and wherein the detector includes an optical receiver electrically coupled to the processor and secured to the housing. The optical receiver captures the optical beam and decodes the information.
In one aspect, the transceiver provides wireless communication of the data from the detector to a data management center.
In one aspect, the transceiver provides an activation signal to the detector and the detector further comprises an acoustic module electrically connected to the processor and secured to the housing. The acoustic module is activated by the processor to detect acoustic information from the use's lungs upon the detector receiving the activation signal from the apparatus.
In one aspect, an apparatus is provided to deliver a medicinal dose to a user and track the timing of the delivery of the dose. The apparatus comprises a housing that defines a chamber to store the dose, at least two contact areas positioned on the exterior of the housing wherein the contact areas are configured to make contact with the user and wherein the contact areas are electrically insulated from each other, and a power source secured to the housing to provide power to produce a current flow through the user's body, wherein the power source includes two terminals and each terminal is electrically coupled to one contact area. The circuit is completed as the user's skin contacts each of the at least two contact areas to create a circuit causing a current flow through the user's body.
In one aspect, the apparatus further comprises a control module secured to the housing and electrically coupled to each of the two contact areas. The control module alters the conductance of the current path between the two terminals to vary the current flow characteristics through the user thereby encoding information in the current flow.
In one aspect, the apparatus further comprises a memory unit electrically coupled to the control module and secured to the housing. The memory module stores information associated with completing the circuit through the user's body and delivery of the dose.
In one aspect, the apparatus further comprises a transceiver electrically coupled to the control module and secured to the housing. The transceiver unit allows the apparatus to transmit and/or receive information associated with the delivery of the dose to the user.
In one aspect, the transceiver includes an optical transmitter module for optical communication.
In one aspect, the transceiver includes a wireless transmitter module for wireless communication.
In one aspect, the transceiver encodes information from the memory unit and transmits that information to a system external to the apparatus.
In one aspect, the transceiver sends an activation signal to the external system once a circuit is completed through the user's body wherein the activation signal is an indicator that the user is holding the apparatus and prepared to initiate delivery of the dose.
In one aspect a method is provided for recording the time that a medicinal dose is taken by a user. The method comprises the steps of activating a power module of a apparatus when the user makes contact with the exterior of the apparatus in such a manner to complete a circuit to allow for current flow between two terminals of the power module and through the user's body, altering the current characteristics through changes in the conductance of the circuit that is formed through the user's body using a conductance control module, detecting the current characteristics through the user's body using a detector, the current characteristics includes information associated with at least one of the apparatus and the dose, and recording the timing of delivery of the inhalable dose.
In one aspect, an apparatus is provided to deliver a medicinal dose to a user and to confirm delivery of the dose. The apparatus comprises a housing defining a chamber to store the dose, a power source secured to the housing and including a positive terminal and a negative terminal, a control module electrically coupled to the power source, an acoustic detector secured to the housing and electrically coupled to the control module, wherein the acoustic detector detects vibrations, and at least two contact areas positioned on the housing wherein the contact areas are at least partially exposed on the exterior of the housing and the at least two contact areas are electrically isolated from each other. The at least one contact area is electrically coupled to one terminal of the power source and at least one other contact area is electrically coupled to the other terminal. A current path is completed through the user's body as the user makes contact with each of the two contact areas and current flow is detected by the control module.
In one aspect, the control module is electrically connected between the power source and one of the at least two contact areas. The control module is configured to control conductance to encode information in the current flow.
In one aspect, the control module is electrically coupled to the at least two contact areas and to both terminals of the power source.
In one aspect, the acoustic detector is secured to the outside of the housing.
In one aspect, the apparatus further comprises a memory unit electrically connected to the control module to store information associated with delivery of the dose to the user.
In one aspect, the apparatus further comprises a transceiver electrically coupled to the control module wherein information can be transmitted and/or received from the apparatus to an external computer other than through the current flow.
In one aspect, the acoustic detector is secured inside the housing.
In one aspect, the acoustic detector provides an activation signal to the control module upon detection of a vibration representing the loading of the medication into the chamber.
In one aspect, the acoustic detector provides an activation signal to the control module and the control module records acoustic information associated with the user inhaling. The information is provided to the control module through the acoustic detector.
In one aspect, the control module provides a unique time stamp associated with the delivery of the dose and wherein the control module receives an identifier signal that is associated with the user wherein the combination of the time stamp and the identifier signal confirms deliver of the dose to the user.
In one aspect, an apparatus is provided to deliver a dose to a user and track the timing of the delivery of the dose. The apparatus comprises a housing defining a chamber to store the dose, at least two contact areas positioned on the housing wherein the contact areas are at least partially exposed on the exterior of the housing and the at least two contact areas are electrically isolated from each other, a power source secured within the housing to provide power to produce a current flow through the user's body, wherein the power source includes two terminals and wherein each terminal is electrically coupled to one contact area, a control module electrically coupled to the power source, wherein the control module enters a sleep mode while the apparatus is inactive, and an acoustic detector secured to the housing and electrically coupled to the control module, wherein the acoustic detector detects vibrations and sends an activation signal to the control module to activate the control module. A sound of the dose being loaded into the chamber activates the control module and wherein a current path is completed through the user's body as the user makes contact with each of the contact areas indicating that the user is about the receive a dose of the medication.
In one aspect, the apparatus further comprises a memory unit electrically coupled to the control module and secured to the housing. The memory module stores information associated with delivery of the dose to the user.
In one aspect, the apparatus further comprises a transmitter unit electrically coupled to the control module and secured to the housing. The transmitter unit allows the apparatus to transmit information.
In one aspect, the apparatus further comprises an optical detector module for detecting that a dose was delivered to the user and the optical information is compared to acoustic information associated with the sound vibrations generated from inhaling through the apparatus to confirm delivery of the dose to the user.
In one aspect, a system is provided to deliver a medicinal dose to a user and to confirm delivery of the dose. The system comprises a detector including a capacitive coupler, wherein the detector is worn by the user, and an apparatus comprising a housing defining a chamber to store the dose, a power source secured to the housing and including a positive terminal and a negative terminal, wherein the power source includes an isolating source that produces a carrier wave, a control module electrically coupled to the power source, wherein the control module alters the characteristics of the isolating source to encode information in the carrier wave, and at least two areas positioned on the housing wherein one area is a partially exposed contact area and one area is capacitive coupled area, wherein the two areas are electrically isolated from each other. The one output of the isolating source is coupled to the contact area and the other output of the isolating source is coupled to the capacitive coupled area. The contact area is touched by the user and the capacitive coupled area is capacitively coupled to the capacitive coupler worn by the user. A portion of the carrier wave's path is through the user's body using the contact area and a portion of carrier wave's path is through capacitive conductance using the capacitive coupling between the capacitive coupled area and the capacitive coupler worn by the user. The same principle described here for the detector also may be applied to an actuator located on the medicine delivery device apparatus.
In one aspect, the housing defines an aperture to generate an acoustic wave as the user inhales through the apparatus and wherein the detector further comprises an acoustic detector for detecting acoustic wave associated with the user inhaling through the apparatus, which acoustic waves traveling through the user's body and through the air, wherein the acoustic detector correlates the acoustic wave through the user's body with the acoustic wave through the air to confirm delivery of the dose to the user.
In one aspect, a system is provided to deliver a medicinal dose to a user and to confirm delivery of the dose. The system comprises a detector coupled to the user, wherein the detector gathers physiological information about the user to create a personal profile about the user, an apparatus, wherein the apparatus includes a housing defining a chamber to store the dose and an opening through which the user inhales to receive the dose, and an acoustic unit for producing an acoustic signal. The acoustic unit is secured to the housing of the apparatus. The acoustic unit comprise a support layer comprising an adhesive layer on one surface for securing the acoustic unit to the apparatus, a vibration detection unit secured to the support layer to detect acoustic information produced by the apparatus and the user inhaling through the apparatus and produce a detection signal, a controller secured to the support layer and in communication with the vibration detection unit, wherein the controller receives the detected signal from the vibration detection unit and produces a digital signal representing the detected signal, a sound generation unit secured to the support layer and in communication with the controller, wherein the sound generation unit receives the digital signal and produces the acoustic signal, and a top layer secured to the support layer to define a cavity that contains and protects the vibration unit, the controller, and the sound generation unit within the cavity. The acoustic signal represents information associated with the inhalable dose being loaded into the chamber and the user inhaling through the apparatus and wherein the acoustic signal is detected by the detector to confirm delivery of the dose.
In one aspect, the system further comprises at least two contact areas positioned on the housing. The contact areas are at least partially exposed on the exterior of the housing and the at least two contact areas are electrically isolated from each other. The acoustic unit includes a power source. The at least one contact area is electrically coupled to a positive terminal of the power source and at least one other contact area is electrically coupled to the negative terminal. A current path is completed through the user's body as the user makes contact with each of the two contact areas and current flow is detected by the detector that is coupled to the user.
In one aspect, the controller is configured to control information output from the acoustic unit.
In one aspect, the controller is configured to vary the conductance of the current path to encode information in the current flow.
In one aspect, the acoustic unit further comprises a memory unit electrically connected to the controller to store.
In one aspect, the detector is configured to be implanted within the user's body. The detector comprises a hermetically sealed housing, a power source secured within the housing, a processor electrically coupled to the power source and secured within the housing, at least one sensing probe secured to the housing wherein the probe is at least partially exposed to contact the user's tissue, wherein the probe is electrically coupled to the processor so that the processor detects physiological parameters associated with the user and the current flow through the user, a transceiver module electrically coupled to the processor and secured within the housing to receive and decode information transmitted from the apparatus, and a memory unit electrically coupled to the processor and secured within the housing to store data.
In one aspect, the detector is configured to be secured to the user's skin. The detector comprises a housing, a power source secured to the housing, a processor electrically coupled to the power source and secured to the housing, at least one sensing probe secured to the housing, wherein the probe is electrically coupled to the processor to allow the processor to detect physiological parameters associated with the user and the current flow through the user, a transceiver module electrically coupled to the processor and secured to the housing to receive and decode information transmitted from the apparatus, and a memory unit electrically coupled to the processor and secured to the housing to store data.
In one aspect, the system further comprises an apparatus secured to the housing of the apparatus. The apparatus provides an activation signal to the detector and the detector includes an accelerometer electrically coupled to the processor and secured to the housing of the detector. The accelerometer is activated by the processor of the detector to detect motion upon the detector receiving the activation signal from the apparatus.
In one aspect, the transceiver module provides wireless communication of the data from the detector to a data management center.
In one aspect, an apparatus is provided for detection of delivery of inhalable medication to a user. The apparatus comprises a vibration detection unit to detect acoustic information and produce a detection signal, a controller in communication with the vibration detection unit, wherein the controller receives the detection signal from the vibration detection unit and produces a digital signal representing the detection signal, a sound generation unit secured to the support layer and in communication with the controller, wherein the sound generation unit receives the digital signal and produces an acoustic signal that indicates delivery of the inhalable dose.
In one aspect, the apparatus further comprises a transmission unit in communication with the controller. The transmission unit receives the digital signal and communicates with a wireless apparatus to indicate the inhalation event has occurred.
In one aspect, the apparatus further comprises a transconduction unit in communication with the controller. The transconduction unit comprises at least two contact areas electrically isolated from each other and positioned to allow contact with each of the contact areas, and a power source. The at least one contact area is electrically coupled to one terminal of the power source and at least one other contact area is electrically coupled to another terminal of the power source. A current path is completed through the user's body to allow current flow as the user makes contact with each of the two contact areas and current flow is detected by the controller.
In one aspect, the transconduction unit further comprises a control module electrically connected between the power source and one of the at least two contact areas. The control module is configured to encode information in the current flow.
In one aspect, an apparatus is provided to confirm delivery of a medicinal dose to a user. The apparatus comprises at least two contact areas that are electrically isolated from each other, a power source including a first terminal and second terminal, wherein at least one contact area is electrically coupled to the first terminal and at least one other contact area is electrically coupled to the second terminal, and a control module electrically connected between the first terminal of the power source and one of the contact areas. The control module is configured to vary the conductance of a current path that is created once the user makes contact with each of the two contact areas. A current path is completed through the user's body as the user makes contact with each of the two contact areas. The variation in the conductance encodes information in the current flow.
In one aspect a method is provided for recording the time that a medicinal dose is taken by a user. The method comprises the steps of activating a power module of an apparatus when the user makes contact with the exterior of the apparatus in such a manner to complete a circuit to allow for current flow between two terminals of the power module and through the user's body, altering the current characteristics through changes in the conductance of the circuit that is formed through the user's body using a conductance control module, generating an acoustic signal using an acoustic unit, detecting the acoustic signal using a detector, wherein the acoustic signal includes information associated with delivery of the dose to the user, and recording the timing of delivery of the inhalable dose.
Depending on the particular application, the detector may be positioned in a variety of different configurations relative to the organ of interest. For example, where a single body-associated signal detector is employed, the methods may include initially positioning or implanting the single receiver at a location proximal to the organ of interest. Where the organ of interest is the lung, the single receiver may be positioned near the lungs, as desired. With other systems that include two or more signal detectors, the detectors may be positioned at a variety of body locations. For example, the methods may include positioning two or more distinct detectors at distinct locations near the lungs or positioning one detector at a front abdominal location and a second detector at a back location. This latter configuration is representative of instances where the detectors are placed on opposite sides of a target organ, e.g., to measure impedance through the organ, motion, or sound.
It is to be understood that this invention is not limited to particular aspects described, and as such may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, representative illustrative methods and materials are now described.
All publications and patents cited in this specification are herein incorporated by reference as if each individual publication or patent were specifically and individually indicated to be incorporated by reference and are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. The citation of any publication is for its disclosure prior to the filing date and should not be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.
It is noted that, as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.
Certain ranges have been presented herein with numerical values being preceded by the term “about.” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.
As will be apparent to those of skill in the art upon reading this disclosure, each of the individual aspects described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several aspects without departing from the scope of the present invention. Any recited method can be carried out in the order of events recited or in any other order which is logically possible.
Although the foregoing aspects of the present invention have been described in some detail by way of illustration and example for purposes of clarity of understanding, it is readily apparent to those of ordinary skill in the art in light of the teachings of the various aspects of the present invention that certain changes and modifications may be made thereto without departing from the scope of the appended claims.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/322,893, filed Apr. 11, 2010 and entitled “System and Method for Delivery of an Inhalable Dose”; U.S. Provisional Patent Application Ser. No. 61/357,506, filed Jun. 22, 2010 and entitled “System and Method for Detection of Delivery of an Inhalable Dose”; and U.S. Provisional Patent Application Ser. No. 61/373,803, filed Aug. 13, 2010 and entitled “System and Method for Delivery and Detection of an Inhalable Dose”; and U.S. Provisional Patent Application Ser. No. 61/377,072, filed Aug. 25, 2010 and entitled “System and Method for Patient Access Port Reporting” each of which is hereby incorporated by reference in its entirety.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US2011/031986 | 4/11/2011 | WO | 00 | 2/19/2013 |
| Number | Date | Country | |
|---|---|---|---|
| 61322893 | Apr 2010 | US | |
| 61357506 | Jun 2010 | US | |
| 61373803 | Aug 2010 | US | |
| 61377072 | Aug 2010 | US |
