巴西专利BR112012010672B1 ingestible device and system for tracking a product from source to destination

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专利摘要:
ingestible device and system to system to track a product from source to destination. a system for tracking a product from source to destination is described. the system includes a probe comprising two plates (20, 80, 30, 82), a power source and a processor to produce an oscillating output from the plates. using the oscillating voltage, the probe interrogates a device (10) through capacitive coupling. the device (10) includes a control unit, and first (14, 84) and second (16, 86) materials physically associated with the device (10) for communication using capacitive coupling. the information associated with the device (10) is transferred from the device to the probe through the capacitive coupling between the first (14, 84) and second (16, 86) materials and the first (20, 80) and second (30 , 82) plates, respectively.
公开号:BR112012010672B1
申请号:R112012010672-4
申请日:2010-11-04
公开日:2020-10-13
发明作者:Mark J. Zdeblick
申请人:Proteus Digital Health, Inc；
IPC主号:

专利说明:

CROSS REFERENCE TO RELATED ORDERS
[0001] This order claims priority under 35 USC 119 of US Provisional Order serial number 6 / 258,182 filed on November 4, 2009, entitled Method, Device and System to Supply Chain Management of Ingestible Event Markers by inventor Mark Zdeblick, which is incorporated into this document. FIELD OF THE INVENTION
[0002] The present invention relates to methods and systems for using electronic devices to track products. More specifically, the present disclosure includes methods, devices and systems for tracking inventory measured from source to the consumer. BACKGROUND
[0003] Pharmaceutical products suppliers are concerned with counterfeit products being replaced by original products from the time the products leave the manufacturer until the time the products are released to the end user. In addition, there is a need to determine precisely the quantity and content of a package so that distributors can identify products throughout the supply chain. Known methods and systems use near-field communication, such as RFID. These known methods have inherent limitations such as lack of data integrity, confidentiality, etc. Therefore, what is needed is a system for interrogating a product to ensure the validity and origin of the product throughout the supply chain, from the manufacturer to the end user or consumer. SUMMARY
[0004] A system for managing the supply of products in a supply chain environment is disclosed. In several respects, the invention includes capacitive plates that probe a variety of products, resulting in indications of product validity and non-validity. In this way, several supply chains or other searches can be carried out.
[0005] Products include, for example, IV bags, syringes, ingestible event markers (IEMS) and similar devices, as disclosed and described in PCT application serial number PCT / US2006 / 016370 published as WO / 2006/116718; PCT application serial number PCT / US2007 / 082563 published as WO / 2008/052136; order PCT order serial number PCT / US2007 / 024225 published as WO / 2008/063626; PCT application serial number PCT / US2007 / 022257 published as WO / 2008/066617; PCT order serial number. PCT / US2008 / 052845 published as WO / 2008/095183; PCT application serial number PCT / US2008 / 053999 published as WO / 2008/101107; PCT application serial number PCT / US2008 / 056296 published as WO / 2008/112577; PCT application serial number PCT / US2008 / 056299 published as WO / 2008/112578; PCT application serial number PCT / US2008 / 077753 published as WO 2009/042812; PCT application serial number PCT / US09 / 53721; and PCT application serial number PCT / US2007 / 015547 published as WO 2008/008281; as well as Provisional Orders US serial numbers 61 / 142,849; 61 / 142,861; 61 / 177,611; 61 / 173,564; each published in this document in its entirety by reference. Such products can typically be designed to include conductive materials / components. The use of capacitive coupling to probe the conductive materials and components of the product through the capacitive plates may indicate the presence of the correct configuration of conductive components of the product. Alternatively, failure to engage in communication when polled may indicate non-compliant product, for example, one or more conductive materials is missing, incorrectly configured, etc. BRIEF DESCRIPTION OF THE DRAWINGS
[0006] Figure 1A shows a pharmaceutical product with a device that can be interrogated using capacitive coupling in accordance with an aspect of the present invention.
[0007] Figure 1B shows a pharmaceutical product with a device that can be interrogated using capacitive coupling according to another aspect of the present invention.
[0008] Figure 1C shows a pharmaceutical product with a device that can be interrogated using capacitive coupling according to another aspect of the present invention.
[0009] Figure 1D shows a device that can be probed or interrogated using capacitive coupling in accordance with yet another aspect of the present invention.
[00010] Figure 1E shows a pharmaceutical product with a device that can be probed or interrogated with a coaxial probe / plate using capacitive coupling in accordance with yet another aspect of the present invention.
[00011] Figure 2 shows a circuit diagram for the device of figures 1 A-1D according to another aspect of the present invention.
[00012] Figure 2A shows a use of diode bridge in the device of figure 2.
[00013] Figure 2B shows a logic unit of the device of figure 2 in communication with a probe through the plates and the conductive material, which is associated with the device according to the present invention.
[00014] Figure 2C shows a finite period of time for an energy transfer cycle and an information transfer cycle using capacitive coupling in accordance with the teachings of the present invention.
[00015] Figure 3A shows a product with the device passing through a tubular section to confirm the authenticity of the product and the operation of the device according to the present invention.
[00016] Figure 3B is a specific moment of the device passing between the plates during interrogation to confirm the authenticity of the product according to the present invention.
[00017] Figure 4A is a top view of the device associated with a product according to the present invention.
[00018] Figure 4B is a side view of a product with a conductive composite and the device according to the present invention.
[00019] Figure 5 shows a side view of a device being interrogated by a pair of probes according to the present invention. DETAILED DESCRIPTION
[00020] With reference to figure 1A, a device 10a within a pharmaceutical product 12a, such as a pill or tablet, which is completely packaged and tested using a probe, as discussed in detail below. According to various aspects of the present invention, device 10a can be located within product 12a or secure on the surface of product 12a, as contemplated within the scope of the present invention. Device 10a includes a control module for communication and a memory for storing information, such as identity. Probing of device 10a is carried out to ensure, for example, that deviceWa is still functioning. The probe uses a capacitive coupling approach where there is a capacitive coupling of a first capacitive probe plate 20a to a first metal or material 14a on one side of the device 10a and a second capacitive probe plate 30a to a second metal or material 16a on the other side of device 10a. As is apparent to a person skilled in the art, plate 20a is electrically isolated from plate 30a even though insulation is not specifically shown. Various ways of probing using capacitive coupling can be obtained, for example, metal, metal inserts, etc. According to an aspect of the present invention, for example, there is a capacitive coupling between material 14a and capacitive plate 20a and material 16 a and capacitive plate 30a. The plates 20a and 30a are probes that can communicate with the device 10a through the capacitive coupling. The plates 20a and 30a are electrically connected to a system (not shown) that can receive information from plates 20a and 30a as well as from the information process. Also, according to various aspects of the present invention, the product can be coated with a non-conductive material.
[00021] According to various aspects of the present invention, there are several components included as part of device 10. For example, device 10 can be an ingestible event marker (EMI) with a unique identity that can be read using pre-ingestion. capacitive coupling and communicated using transconduction post-consumption. Various aspects of an IEM are disclosed in US Patent Application 12 / 564,014 entitled PARTIAL ENERGY SOURCE COMMUNICATION SYSTEM filed on September 21, 2009, the full disclosure of which is incorporated into this document by reference.
[00022] With reference now to Figure 1B, a device 10b is shown as part of a product 12b according to an aspect of the present invention. The device 10b includes a first material 14b and a second material 16b deposited on the surface of the device 10b to form a capacitive connection. Materials 14b and 16b are in communication with the device 10b control module. Probes 20b and 30b are capacitively coupled with materials 14b and 16b, respectively. Thus, as probes 20b and 30b are supplied with alternating current (AC) voltage, then materials 14b and 16b are capacitively coupled to probes 20b and 30b. Thus, the information associated with device 10b which is stored in the memory of device 10b can be encoded by a control module of device 10b and communicated to the probes using capacitive coupling.
[00023] With reference now to figure 1C, a device 10c is shown to be safe for a product 12c according to the present invention. The device 10c includes a first material 14c and a second material 16c deposited around the perimeter of a skirt 18c of the device 10c with at least a portion of the materials 14c and 16c being deposited on the skirt 18c. In addition, materials 14c and 16c are coupled to the control module of the device 10c to allow communication through capacitive coupling from the control module of the device 10c to allow the identity of the device 10c to be communicated to a system via the probes 20c and 30c. According to one aspect of the present invention, materials 14c and 16c are conductive inks, such as a carbon-based paint or paste or ingestible graphite. Probes 20c and 30c are powered by an AC source and when brought close to materials 14c and 16c, probes 20c and 30c can communicate with device 10c using capacitive coupling through materials 14c and 16c, respectively. In addition, according to another aspect of the present invention, probes 11c and 32c are positioned close to material 14c and 16c in different locations to allow for alternate positioning of device 10c or to provide probing of the device from an alternative direction. Since probes 20c and 30c are energized with an AC voltage and device 10c is located close to probes 20c and 30c, then materials 14c and 16c can be used to pass information between device 10c and the system connected to probes 20c and 30c through capacitive coupling.
[00024] With reference now to figure 1D, a device 10d is shown in accordance with another aspect of the present invention. A conductive material 14d is deposited on the surface of a material 19a that is associated with the device 10d. Material 19a and material 19b of device 10d are dissimilar materials and form a partial energy source for device 10d. For example, material 19a can be CuCl and material 19b can be Mg. Device 10d also includes connected transistors 19c that are capable of being electrically connected to composite 14d for high V or material 19b, which is at the same potential as low V. Device 10d includes a composite material 16d that is physically associated with the device 10d and rests on top of an oxide layer 17d. Material 16d can be CuCI deposited on a gold plate. Thus, as the probes or plates, similar to those shown in figures 1A-1C and powered by an oscillating voltage source or AC, are brought close to the device 10d, there is a capacitive coupling between the composite 14d and the composite 16d and the probes. According to one aspect of the present invention, as the voltage source isolates the energy transferred to material 14d and material 16d varies accordingly and is stored on device 10d. As the voltage source is reduced to zero or silent, then the device 10d switches from the received energy to send energy to the probes using capacitive coupling. In order to create an oscillating power source, transistors 19c are used to connect and disconnect material 14d between material 19b (representing low V) and high voltage. As material 14d switches energy levels from high V to low V, the information can be transferred to the probes. Thus, during a portion of the cycle when the power is deactivated or silent (as shown in figure 2C), the device 10d is capable of transferring energy to the probes, the energy of which includes information about the device 10d. In this document, using capacitive coupling, information can be communicated between device 10d and the system connected to the probes near device 10d.
[00025] Referring now to figure 1E, a coaxial probe with two conductive probes / plates 20e and 30e separated by an insulating material 25e. The probe or internal conductive plate 20e is surrounded by the insulating material 25e, which is surrounded by the probe or external conductive plate 30e. The device 10e is shown as part of a pharmaceutical product 12e. The device 10e includes a conductive material or paint 15e deposited on the opposite side of the coaxial probe. As the coaxial probe is positioned close to product 12e, probe 20e is positioned over the center of device 10e and probe 30e is positioned above the outer edges of device 10e and close to material 15e. Thus, as described above and with respect to figure 2C, as the energy source is insulating, energy is transferred from the coaxial probe to device 10e and as the energy source is turned off or silent, then the energy is transferred to from device 10e to the system connected to the coaxial probe.
[00026] With reference now to figure 2, a voltage source, for example, an AC voltage or other insulating or alternating source 40, works at a high frequency, for example, 1 MHz, etc. The voltage source is connected to the process or boards. The device 10 includes a control module 50 and connection pads 52 to which the materials (for example, materials 14 and 16 of figure 1A) are coupled. According to one aspect of the present invention, inside device 10 is a diode 54, such as a Schottky diode or other type of diode that creates an internal supply voltage, and a switch 56 with some impedance that is turned on and off that changes the impedance of the device 10. The impedance variation is used to communicate information about the identity of the device 10. The impedance change allows the information associated with the device 10 to be encoded and sent to a system through the probes using the capacitive coupling, as represented by capacitors 58 and 60. The information is captured by the system connected to the probes represented by the capacitors and read as VfOra through the sampling amplifier through the sample R labeled with impedance.
[00027] Once the control module 50 is brought close to or exposed to the voltage source through the plates, there is energy transfer through the capacitive coupling and the device 10 can produce an oscillation signal, which can be detected. The oscillation signal contains information and the isolating signal can be encoded within, for example, a 1 MHz signal or similar frequency, for example, 500 KHz, as it may be dependent on the degree of capacitive coupling. The voltage of the source 40 will be determined by how much capacitive coupling is obtained between the capacitive plate or probe 20 and 30 of figure 1 and the materials 14 and 16 thereof. Thus, at a high frequency that represents, perhaps, 5 volts, the capacitive value between the probe, such as probe 20 or 30, and the material is represented by capacitors 58 and 60.
[00028] Referring now to figures 2A and 2B, according to another aspect of the present invention, a diode bridge is shown which is a circuit representation of the interaction between plates 20 and 30 and materials 14 and 16 of device 10 The insulating voltage present on plates 20 and 30 (labeled "PLATE 1" and "PLATE 2") results in a transfer of energy in the form of high voltage and a low voltage to device 10. Device 10 includes a control module as part of the processor or logic unit. The logic unit can be a processor, a microprocessor, a multi-module device or any form of integrated circuit. The logic unit is in communication with conductive materials 1 and 16 and plates 20 and 30 (labeled "PLATE 1" and "PLATE 2"). Since cards 20 and 30 are powered by an AC source, the logic unit stores energy and then uses that energy to send information.
[00029] With reference now to figure 2C, the power cycle is shown with an active period and a silent period and the transfer cycle of device 10 is shown as the transfer window. According to the present invention, the duration of energy in the active period is transferred from the energy source to device 10. Then, during the silent phase, the energy stored by device 10 is used to transfer energy from device 10 for the system connected to the probes. In this way, information associated with the device can be transferred from device 10 through probes 20 and 30 to the system connected to the probes. According to various aspects of the present invention, the information sent from device 10 to the system of probes 20 and 30 during the silent phase is based on information stored in the device's memory. Thus, even though there is a "1" shown during the transfer window or silent phase of the power source, the information transferred during the silent phase or phase of the power source can be "0".
[00030] According to an aspect of the present invention, if there is a microfarad capacitor between the capacitive plate / probe and a material physically associated with device 10, then at a high insulation frequency that represents a lower voltage required for capacitive coupling. According to another aspect of the present invention, if a pF capacitor exists, then a higher voltage may be required, as will be recognized by one skilled in the art. The amount of current going through today will depend on the impedance between the electrical circuit caused between the capacitive plates / probes 20 and 30, as shown in figure 1, for example. Thus, the shortening of the capacitive plate 20 and the capacitive plate 30 of figures 1A-1C will result in significant current going through that can be detected, for example, by a sampling magnifier as shown in figure 2. The output is through an magnifier which is essentially geared towards the current going through the loop and the modulation of that current caused by the control module 50.
[00031] According to various aspects of the present invention, capacitive coupling can be used with devices that are DC source devices, which are modified for intermediate operability, for example, a device having a rectifier on the board to provide a stable voltage over the chip, the impedance of which can be modulated.
[00032] With reference now to figures 3A and 3B, according to various aspects of the present invention, the capacitive plates / probes and the system connected to them for receiving information can be integrated or otherwise associated with various structural components and other devices , for example, a tubular structure 60, as shown in figure 3A, having capacitive plates 20 and 30. For illustration, one or more pharmacists having an EMI or similar device 10 can be introduced into the structure. Device 10 can be inserted manually or automatically by automatic means. As the device travels through structure 60, device 10 is probed by capacitive plates 20 and 30 on tube 60. In several aspects, other devices and / or components can be associated. In one example, a programmable device can be communicatively associated with the capacitive coupling device to receive and / or transmit data and / or information derived by the capacitive coupling device. To continue with the illustration above, since all or a portion of the number of products 10, which can be pills, is probed or "read" by the capacitive coupling system associated with probes / plates 20 and 30, the coupling system capacitive can communicate, for example, wirelessly, wired, etc., to a database with a monitor device for other storage, display, manipulation, etc. In this way, individual data, data, large volumes of data, etc., can be processed for various purposes. One of these purposes could be, for example, tracking pharmacists in a chain application, for example, during the manufacturing process such as pressing tablets or another process, during the pharmacy verification process, during a pharmacy prescription process, etc. Several processes can be complementary, incorporated, etc. One such example is validation by reading the number. If it is valid, for example, readable, the tablet is accepted. If not, the pill is discarded. Thus, using a simple portable reader with an oscillating power source, a user or caregiver can probe the product, which can be a pill or tablet according to an aspect of the present invention, with the device 10 associated with it and determine whether the pill is authentic or a counterfeit product.
[00033] Referring now to figures 4A and 4B, according to another aspect of the present invention, a pill having a device 10 is shown with a coating 74 which is a non-conductive or reasonably impermeable coating and the pill itself comprises a non-conductive medicinal powder. A region 72, for example, a cone-shaped region, as shown, comprises a conductive material 70, for example, small particles or grains of conductive material intermixed with other pharmaceutical material (s), excipient (s), placebo material (s), etc., so that region 72 is converted into a conductive region. For example, graphite and other conductive materials can be used, for example, one part is ten, five parts in ten, etc. so that region 72 is conductive. Other materials and compositions are possible, for example, a gel or liquid capsule having conductive particles in it, etc. Thus, at frequencies high enough, the particles of conductive material 70 in region 72 can be shortened together. One skilled in the art will recognize that the conductive material 70 may include various materials and shape factors, as well as combinations thereof, for example, particles of varying size, threads, metal films, filaments, etc. The scope of the present invention is not limited by the type or shape of the conductive material 70 used in the region 72.
[00034] According to another aspect of the present invention, conductive material 70 can be integrated or formed using a variety of methods and proportions. In one example, device 10 is embedded or otherwise mechanically associated with a "thread-shaped" powder and the orifice formed therein is filled or otherwise associated with the conductive particles, etc., to form the conductive region. The size, area, volume, locations or other parameters of the conductive regions may vary as the functionality described in this document can be realized.
[00035] According to another aspect of the present invention and as shown in figure 5, the capacitive plates or probes 80 and 82 are coupled to a system to collect the data. Probes 80 and 82 are used to probe a device 10 through capacitive coupling to materials 84 and 86, respectively. An impedance feedback system can be used to conduct them reasonably close to each other and once the current reaches a certain amount to use to measure the distance. When using an impedance high enough, this system can be useful in a variety of applications, for example, a manufacturing environment to validate that device 10 is present, is operating correctly, etc.
[00036] According to another aspect of the present invention, a proximity between the capacitive coupling probes / plates and the device 10 can facilitate, promote, etc., the privacy aspects. In certain respects, certain related devices may include, for example, a circuit with a Schottky diode in parallel with a CMOS transistor that is programmed to be open and closed, open up, etc. Other circuit designs and modifications are possible.

权利要求:
Claims (19)
[0001]
1. Ingestible device (10) configured to be tested using a probe located external to the ingestible device, the ingestible device characterized by the fact that it comprises: a substrate comprising a control and memory unit to store information; a first and second materials (14a, 14b, 14c, 16a, 16b, 16c) physically associated with the substrate; the first material (14a, 14b, 14c) configured to be capacitively coupled to a first plate (20a) of a probe located external to the ingestible device (10) and the second material (16a, 16b, 16c) configured to be coupled capacitively to the second plate (30a) of the probe, so that information can be communicated between the first material (14a, 14b, 14c) and the first plate (20a) and the second material (16a, 16b, 16c) and the second plate (30a); wherein the first and second materials (14a, 14b, 14c, 16a, 16b, 16c) are configured to energize the ingestible device (10) by transferring energy from the first and second plates (20a, 30a) to the first and second materials (14a, 14b, 14c, 16a, 16b, 16c) corresponding to validate the functionality of the ingestible device (10).
[0002]
2. Device according to claim 1, characterized by the fact that the first and second materials (14a, 14b, 14c, 16a, 16b, 16c) are coupled in communication with the control unit.
[0003]
Device according to claim 1, characterized by the fact that it also comprises a region of conductive material (72) physically associated with the substrate;
[0004]
Device according to claim 3, characterized in that the region of conductive material (72) comprises a mixture of particles of a conductive material (70) and at least one other material.
[0005]
5. Device according to claim 4, characterized in that the at least one other material comprises at least one pharmaceutical material, at least one excipient or at least one placebo material.
[0006]
6. Device according to claim 1, characterized in that the first material (14a, 14b, 14c) comprises a material different from the material of the second material (16a, 16b, 16c).
[0007]
7. Device according to claim 6, characterized by the fact that the first and second materials are configured to provide a difference in stress potential when materials other than the first material (14a, 14b, 14c) and the second material ( 16a, 16b, 16c) are in contact with an electrically conductive liquid and the control unit is configured to change a conductance between the first and second materials (14a, 14b, 14c, 16a, 16b, 16c) so that a current is varied to encode information in a signal communicated by the electrically conductive liquid so that the encoded information can be remotely detectable by a receiver.
[0008]
8. Device, according to claim 1, characterized by the fact that it also comprises an antenna coupled to the control unit, the antenna configured to communicate with an external device.
[0009]
9. Device according to claim 8, characterized by the fact that the antenna includes a coil.
[0010]
10. System to track, from the origin to a destination, an ingestible device (10) configured to be tested using a probe located external to the ingestible device, characterized by the fact that it comprises: a probe comprising: an energy source ; a processor coupled to the power source configured to receive and send information; a first card (20a) coupled to the processor, and a second card (30a) coupled to the processor, wherein the power source is configured to be controlled by the processor to produce an output on the first and second cards (20a, 30a); and an ingestible device comprising: a substrate comprising a control unit and a memory for storing information; and first and second materials (14a, 14b, 14c, 16a, 16b, 16c) physically associated with the substrate, the first material (14a, 14b, 14c) configured to be capacitively coupled to the first plate (20a) of the external located probe to the ingestible device and the second material (16a, 16b, 16c) is configured to be capacitively coupled to the second probe plate (30a) so that information can be communicated between the first material (14a, 14b, 14c) and the first plate (20a) and between the second material (16a, 16b, 16c) and the second plate (30a); wherein the first and second materials are configured to energize the ingestible device by transferring energy from the first and second plates (20a, 30a) to the corresponding first and second materials to validate the functionality of the ingestible device.
[0011]
11. System according to claim 10, characterized by the fact that the first plate (20a) has a surface facing a surface of the second plate (30a) so that the ingestible device is configured so that it is in capacitive communication with the probe when the ingestible device is positioned between the surfaces of the first and second plates (20a, 30a).
[0012]
12. System according to claim 10, characterized by the fact that the first plate (20a) is positioned adjacent to the second plate (30a) so that the ingestible device is configured so that it is in capacitive communication with the probe when the ingestible device is placed in operational proximity to the probe.
[0013]
13. System according to claim 10, characterized in that the probe further comprises a tube having the first and second sounding plates (20a, 30a) contained therein.
[0014]
14. System, according to claim 10, characterized by the fact that the first and second materials are configured so that they are communicatively coupled to the control unit.
[0015]
15. System according to claim 10, characterized by the fact that the ingestible device comprises a region of conductive material (72) physically associated with the substrate.
[0016]
16. System according to claim 15, characterized in that the region of conductive material (72) comprises a mixture of materials, wherein at least a portion of the mixture of materials is a conductive material (70).
[0017]
17. System according to claim 16, characterized by the fact that the mixture of materials comprises a conductive paint.
[0018]
18. System according to claim 10, characterized by the fact that the ingestible device is configured to communicate with an external device.
[0019]
19. System according to claim 18, characterized by the fact that the ingestible device comprises a communication element configured to communicate with an external device, the communication element including at least one among: an antenna, or the first material (14a, 14b, 14c) and the second material (16a, 16b, 16c) different from the first material (14a, 14b, 14c), wherein the first material (14a, 14b, 14c) and the second material (16a , 16b, 16c) are selected to provide a voltage potential difference as a result of the different materials being in contact with an electrically conductive liquid, and in which the control unit is configured to change a conductance between the first and second materials so that a current is varied to encode information in a signal communicated by the electrically conductive liquid to produce encoded information so that the encoded information is remotely detectable by a receiver.

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