• 专利附录
  • 专利说明
  • 权利要求
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    • 专利摘要:
    INGERIBLE MINIATURE DEVICE.The present invention has multiple approaches to prevent the capsule walls of another material from interfering with the performance of an electronic device, since the device is activated by surrounding fluid. According to the teachings of the present invention, a miniature ingestible device (MID) can be created using excipients and films. The MID, according to various aspects of the present invention, will have a coating or lamination surrounding an electronic device and separating and isolating the device from the pharmaceutical product or drug inside the capsule, since the capsule is ingested as well as the capsule itself when the capsule walls begin to collapse during the disintegration process.
    公开号:BR112012025650A2
    申请号:R112012025650-5
    申请日:2011-04-07
    公开日:2020-08-18
    发明作者:Timothy Robertson；Hooman Hafezi；Raymond Schmidt
    申请人:Proteus Digital Health, Inc.；
    IPC主号:
    专利说明:

    AAA A r 146 s Invention Patent Description Report for "DEVICE. INGERIBLE MINIATURE". | : Related claims - Under US law (35 USC $ 119 (e)), this claim claims priority from the filing date of US Interim Patent Application 61 / 321,846, filed on April 7, 2010, entitled MI- NIATURE INGESTIBLE EVENT MARKER IN TABLET, and Interim Patent Application US 61 / 416,150, filed on November 22, 2010, entitled INGESTIBLE DEVICE WITH PHARMACEUTICAL PRODUCT, the disclosures of which are incorporated herein by reference.
    This order is related to and incorporates the following orders including content incorporated in them, by reference: (A) US Patent Application 12 / 564,017, entitled COMMUNICATION SYSTEM WITH PARTIAL POWER SOURCE and filed on September 21, 2009 and published as US 2010/0081894; (B) PCT / US12 / 447172, filed on October 25, 2007 and entitled "CONTROLLED ACTIVATION IN-GESTIBLE IDENTIFIER" and published as US-2010-0239616. Field of invention The present invention relates to electronic devices and, more specifically, to electronic devices for use with a pharmaceutical product.
    State of the art | Capsules are made of a material that becomes similar to a gel once in contact with fluids.
    Such gel-like materials can interfere with the operation of an ingestible device that depends on contact with the surrounding fluid when the device is transported inside the capsule.
    For example, gelatinous materials have low conductivity, so if the device works using conduction through fluids, then it will not work properly.
    Thus, it is important to prevent the gel-like capsule material, as it is disintegrating, from coming into contact with the components of the device.
    AAA Í 2/16 |
    * In addition, the capsules contain pharmaceutical materials that 2 may interact with or damage the device. For example, as with the capsule: if it disintegrated, the pharmaceutical material will dissolve in the surrounding fluid: and change the chemical composition of the fluid that immediately surrounds the pharmaceutical material and the change can prevent the device from functioning optimally. The contents of the capsule may include material, such as a drug or excipient or compound, which when dissolved in high concentrations, will interfere with the functioning of the ingested device placed inside the same capsule. As the material enters the solution at the location where the capsule is dissolved, there is a high concentration located around the device. Stomach movement and diffusion disperse the contents of the | capsule across the stomach and reduce concentration. During this time, the device will not function optimally if activated in localized areas of high concentration.
    In addition, during long-term storage, pharmaceutical material can begin to interact with the device and prevent optimal performance when the device is activated. For example, the product inside the capsule can be acidic and harmful to electronic components. Alternatively, the content can be very basic, which can also damage electronic components. In addition, the material or product inside the capsule will begin to interact with the surrounding fluids, once the capsule is ingested and the capsule begins to disintegrate.
    Therefore, what is needed is a device that is manufactured and assembled such that the walls of the capsule or other materials present in the fluid environment immediately surrounding the device do not interfere with the optimal performance of the device.
    Summary The present invention describes several approaches to prevent the capsule walls and other materials from interfering with the performance of a device, since the device is activated by surrounding fluid. Description of the drawings Fig. 1 shows a capsule containing an ingestible device NOR DM
    FP & 3/16% miniature and an active agent according to the present invention. 2 Fig. 2A shows a miniature ingestible device with a powdered container in the form of a miniature tablet, according to one aspect of the present invention. Fig. 2B shows a miniature ingestible device with a film and powder in the form of a miniature tablet, in accordance with an aspect of the present invention. Fig. 2C shows a miniature ingestible device with a film, in accordance with an aspect of the present invention.
    Fig. 2D shows a miniature ingestible device with a powder adhered to an ingestible device, in accordance with an aspect of the present invention.
    Fig. 2E shows a miniature ingestible device with a film, in accordance with an aspect of the present invention. '15 Fig. 2F shows a miniature ingestible device with a film | surrounded by a powder, in accordance with an aspect of the present invention. | Fig. 3 shows a capsule containing a miniature ingestible device and an active agent before coming into contact with a fluid. Fig. 4 shows the capsule of Fig. 3 in the initial stage in contact with fluid, with the capsule walls beginning to collapse and the miniature ingestible device according to the present invention.
    Fig. 5 shows the capsule of Fig. 4 in a more advanced stage of being in contact with the fluid, according to the present invention. Fig. 8 shows a mounting unit for creating a miniature ingestible device, according to the present invention.
    Fig. 7 shows a mounting unit for creating a miniature ingestible device, according to the present invention. Fig. 8 shows a mounting unit for creating a miniature ingestible device, according to the present invention. | Fig. 9 shows a mounting unit for creating a miniature ingestible device according to the present invention. Fig. 10 shows an end of a capsule with a
    : | 4/16 3 positive ingestible in miniature. . Fig. 11 is a process flow chart for making a 'miniature ingestible device. z Detailed description In accordance with the teachings of the present invention, a miniature ingestible device (MID) can be created using films and excipients.
    According to the various aspects of the present invention, an ingestible event marker (or an ion emission module, here "IEM"), such as that disclosed in patent application US 12 / 564,017, entitled COMMUNICA- TION SYSTEM WITH PARTIAL POWER SOURCE and deposited on September 21, 2009, can be covered with a disintegrating or super-disintegrating material and / or a disintegrating film using various manufacturing methods to produce the MID.
    The MID, according to various aspects of the present invention, may have a coating or lamination surrounding the iEMe, separating and isolating the EMI from the pharmaceutical product or drug within the capsule, since the capsule is ingested, as well as the capsule itself. , as the capsule walls begin to collapse during the disintegration process.
    In many respects, the MID or the device can be co-encapsulated with an active agent in a degel capsule, or another capsule or vehicle.
    The compositions in question include an active agent / vehicle component.
    The term "active agent" refers to a composition, which can be a solid or fluid, for example, liquid, which has an amount of active agent, for example, a dosage, present in a pharmaceutically acceptable carrier.
    The active agent may comprise, for example, a pharmaceutical product such as a tablet, cap, softgel, powder and other forms of medication.
    Referring now to Fig. 1, a capsule 10 includes a product 12 with a cavity 14. As understood in accordance with the present invention, product 12 can be any pharmaceutical product or active agent.
    Also within cavity 14 of the capsule 10 is an ingestible device | miniature (MID) 20. Cavity 14 can also be filled with any excipient or product, according to the teachings of this | is 586 | t invention.
    Capsule 10 is made of a soluble / disintegrating material, such as. a gelatin or hydroxypropyl methylcellulose (HPMC) material. When: ingestion and contact with the fluid, the walls of the capsule 10 are transformed. in a material similar to a soft gel, due to contact with fluids.
    Referring now to Fig. 2A, in accordance with an aspect of the present invention, a MID 20a is shown with an excipient material 22a surrounding an IEM 24. The scope of the present invention is not limited by the type of electronic device positioned within the material excipient 22a.
    Any electronic device can be used.
    In addition, the scope of the present invention is not limited by the type of excipient material used.
    For example, according to an aspect of the present invention, the excipient material 22a can be a disintegrating material or a super de-material. sensegrante.
    Examples of materials include, but are not limited to, crospovidone disintegrants (eg Kollidon & BASF disintegrants), polyvinyl polymer disintegrants (eg Polyplasdone6 disintegrants), sodium croscarmellose disintegrants (eg , Ac-Di-Sol & disintegrants, sodium starch glycolates (eg Primojel & disintegrants, Explotab & disintegrants and Vivastar disintegrants), povidone, starch and microcrystalline cellulose.
    MID 20a, according to another aspect of the present invention, can be coated with a soluble polymer or film, such as HPMC or hydroxypropyl cellulose (HPC) or mixtures thereof, whose function is to delay | further dissolving or disintegrating the tablet to allow a delayed or timed separation between IEM 24 and the capsule, such as | 25 capsule 10 of Fig. 1. Examples of film materials can include any or a combination of the following: HPC, polyethylene oxide (PEO), forms | of sugar such as sucrose or dextrose, sugar alcohol such! like manito! | or zilitol.
    For the film material, additional materials can be added
    including any or a combination of the following: plasticizer and / or bold, which includes sodium chloride, potassium or any edible salt compound.
    Thus, in accordance with various aspects of the present invention, examples of film materials include, but are not limited to: a
    : 6/16 d combination of HPC and plasticizer with either PEO, sugar or alcohol! of sugar; a combination of HPC and plasticizer, a combination: of PEO and plasticizer and any of the above combinations with salt. | - The scope of the present invention is not limited by the chemical composition of the film material and any combination above can be used to produce the film material, as discussed in the present invention.
    Referring now to Fig. 2B, according to another aspect of the present invention, a MID 20b is shown with excipient material 22a surrounding IEM 24. In addition, MID 20b includes a film material 32 positioned on the bottom surface and upper surface of MID 20b and physically in contact or laminated to excipient material 22a. In accordance with another aspect of the present invention, the film material 32 is soluble and disintegrates when in contact with a fluid. According to another aspect of the present invention, the film material 32 does not disintegrate when in contact with a fluid. MID 20b is manufactured in such a way that the excipient material 22a is exposed at the ends, as shown, in accordance with another aspect of the present invention.
    Referring now to Fig. 2C, according to another aspect of the present invention, a MID 20c is shown with a film material 22c surrounding the! IEM 24. According to another aspect of the present invention, the film material 22c disintegrates up when in contact with a fluid. The film material 22c can be made of and includes the following examples: at least one of polyethylene oxide and hydroxypropyl cellulose with a plasticizer comprising at least one of triethylcitrate, glycerol, polyethylene glycol sebacate.
    Referring now to Fig. 2D, a MID 20d is shown with excipient material 22a in a precast form. The excipient material 22a is glued or laminated to the EMI 24 using a material 30. The material! it can be a liquid adhesive or a dry adhesive that is pressure sensitive. Excipient material 22a is shown in the form of a dome, with an air gap between excipient material 22a and IEM 24. However, the cup of the present invention is not limited by the shape of the excipient material!
    It's 7116. 22a or the distance that separates the excipient material 22a from IEM 24. From; According to other aspects of the present invention, the excipient material 22a can be molded to fit the size of the EMI 24 exactly on the inner surface and maintain a convex or dome shape on the outside. This is useful in the process of manipulating and assembling the MID 20d in the capsule, as shown in Fig. 1, since many of the facilities in the pharmaceutical industry are designed to manipulate objects in convex forms.
    Referring now to Fig. 2E, a MID 20e includes a film 22e surrounding IEM 24. MID 20e is shown with a space 26 separating olEM 24 from film 22e. The scope of the present invention is not limited by the type of material used to make film 22e. Film 22e is similar to film 32 in Fig. 2B and can be made of any suitable material including, but not limited to: polyethylene oxide and hydroxypropyl cellulose with a plasticizer comprising at least one of triethylcitrate, glycerol, sebum. dibutyl and polyethylene glycol. The scope of the present invention is not limited by the size of the gap 26. According to another aspect of the present invention, the gap 26 may be minimal so that portions of film 22e are in contact with IEM 24. According to Another aspect of the present invention, space 26 can be filled with a material or drug as appropriate.
    Referring now to Fig. 2F, a MID 20f is shown with an IEM 24, surrounded by a 22f film. Film 22f is surrounded by excipient material 22a. As shown, film 22f is in direct contact with! EM 24 and surrounds IEM 24. In addition, MID 20f is presented with excipient material 22a surrounding and in contact with film 22f., According to the teachings of the present invention , the shapes of the various MIDs 20 shown by Figs. 2A, 2B, 2C, 2D, 2E and 2F are illustrative and are not intended to be a limitation. For example, the shape of the MID 24, according to various aspects of the present invention, can be oval - gold or rectangular or somewhere between, for example, vertical sides and top and bottom CONVEX.
    Referring now to Figs. 3, 42 5, a capsule 10 is shown
    with a MID 20. There may be other materials, including pharmaceutical material. co or drugs or active agents, inside the capsule 10. However, in order to: demonstrate the capsule designation steps and the MID 20,: only these two elements are shown.
    In Fig. 3, capsule 10 is shown when it is stored and is not in contact with the fluid.
    Once the capsule 10 comes into contact with the fluid, the capsule 10 begins to disintegrate and the walls of the capsule 10 begin to collapse to become the capsule 10a.
    AA fluid enters the cavity defined by capsule 10a.
    As such, the BB fluid comes into contact with the MID 20. According to the aspect of the present invention, the excipient material of the MID 20 begins to dissolve and expand and the MID 20 begins to lose its shape and becomes MID 40 is shown. As shown in Fig. 5, in a more advanced stage with greater contact with the AA fluid that entered the capsule 10, the capsule 10 is shown with the walls falling apart and collapsing as parts of the capsule 10b .
    The fluid advances to contact the MID 20 as a BB fluid to result in further expansion and disintegration of the MID 20, which is shown as MID 50. | Referring now to Fig. 6, a process for creating a MID, in accordance with an aspect of the present invention, includes loading an excipient material 60a into a press 62. The mass of the excipient material 60a used is in the order of 0.045 g of powdered material.
    However, the scope of the present invention is not limited by the amount of material used.
    IEM 24 is placed in press 62. Then, additional excipient material 60b, similar in mass to the amount of excipient material 60a, is added to the press62e at the top of IEM 24. Then, a plunger 64 is used to apply pressure and mounting the materials on the MID, such as MID 20a in Fig. 1. The pressure used to mount the MID varies and the scope of the present invention is thus not limited.
    The industry standard combined with tolerances for the amount of pressure that can be applied to IEM 24 are the decisive factors.
    According to one aspect of the present invention, typical pressures are in the order of 1000 psi.
    Referring now to Fig. 7, a process for creating a MID, from |
    | ; is 9/16; 4 according to an aspect of the present invention, includes placing a film material 70 on a press table 72. The EMI 24 is placed on the | * top of film material 70 and another sheet of film material 70 is placed | : each at the top of IEM 24. Film material 70 is dimensioned in such a way that the ends 70a, 70b, 70c and 70d extend beyond the ends of IEM 24. Then, a thermal plunger 74 is used to apply pressure and heat to the film material 70, such that the ends 70a and 70b are laminated or fastened together. Similarly, the | ends 70c and 70d are laminated together. Referring now to Fig. 8, a process for creating a MID, in accordance with an aspect of the present invention, includes placing a film material 80 on a press table 82. An internal MID 20, such as - | as created by the process shown in Fig. 6, it is placed on top of the film material 80 and another sheet of film material 80 is placed on top of the internal MID 20. The film material 80 is dimensioned in such a way that the ends 80a, 80b, 80c and 80d extend beyond the ends of the internal MID 20. Next, a thermal plunger 84 is used to apply pressure and heat to the film material 80, such that the ends 80a and 80b are laminated or fastened together. Likewise, former | tremors 80c and 80d are laminated together.
    Referring now to Fig. 9, the process for creating a MID 96, like the MID 20b of Fig. 2B, includes the process of placing a film material 90, similar to the film material disclosed throughout the present invention. , on a press table 92, similar to the press table 72 from Fig 7. Then, a second film 90 is placed on top of the MID 20. Then, a thermal plunger 94 is used to apply pressure and heat to the film materials 90 to secure the film material to the upper and lower portions of the MID 20, which results in the MID 96 with the exposed side ends.
    Referring now to Fig. 10, the MID 96 of Fig. 9 is placed within one end of the capsule 10, such as the capsule 10 of Fig. 1, in accordance with an aspect of the present invention. MID 96 includes materials from es - $ ÂÀ O A20A $ 22 AMXAO2Ó ºº ““ ““ ““ “” ”” ORSON - | It is 10/16 + 90 film that does not dissolve or are not soluble. As such, when it flows; When it comes into contact with the MID 20, the MID 20 expands and breaks the walls of the capsule 10 to further guarantee the separation of IEM 24, which is inside the MID 20, of the material of the capsule. '| 5 Referring now to Fig. 11, the process for making or assembling the MID, such as the MID 20, according to the present invention, begins at step 1110. In step 1120, the first material is added to | mounting unit. As mentioned above, the first material can be in the form of powder or a film material and be loaded onto a press or placed on a press table, respectively. In the step | 1130, the device, like the IEM, is loaded into the mounting unit. In step 1140, a second material is added. In step 1150, the assembly is completed by fixing the materials and the device to form the MID. As mentioned above, fixation can be done by pressure, by thermal means or by bonding materials. The scope of the present invention is not limited by the approach used to fix and produce the MID.
    As mentioned above, the film material can be made from a variety of materials or films, such as polymer films that include polyethylene oxide, hydroxypropyl cellulose and triethyl citrate. Other films that can be used include any soluble, plasticizer polymer. The film material, according to one aspect of the present invention, provides a moisture barrier and dissolves under the appropriate conditions to delay the activation of the EMI or device. The film layer is designed to provide sufficient delay in exposing the device to the surrounding fluids in relation to the disintegration and dispersion of the capsule material and the contents of the capsule. The film layer can include soluble materials, barrier materials (such as lipids, polyvinyl alcohol), processing aids (such as plasticizers, adhesion promoters) and stabilizers. In addition, the film can be manufactured by laminating, applying a coating solution or paste, followed by curing. According to other aspects of the present invention, the film or layer can be formed using dry compression, such as a tablet press.
    It is 116 * There is a variety of active agents or pharmaceuticals. that can be placed inside a capsule. For example, there are drugs approved by the FDA, drugs that are chemically disclosed l v in a patent application or in a granted patent, there are drugs' 5 released in the Orange Book as part of approved drugs and | generic. According to the teachings of the present inventions, any or any combination of such drugs can be placed inside the capsule, together with the device. Each of these drugs can have a specific and unique impact on the functioning of the device, as well as on the disintegration of the used film, because of the unique chemical composition. As such, the type of material used as the film material may vary to be compatible with the chemical composition of the products used. Thus, the scope of the present invention is not limited by the type of contents of the capsule and the film or coating layer around the electronic components of the device.
    In accordance with another aspect and benefit of the present invention, the film or coating will also prevent the interaction of the device components with the drug within the capsule and, as such, the device will not alter or affect the effectiveness of the drug.
    As indicated above, various disintegration materials can be used to surround the electronic components. For example, a disintegrant can be sodium starch glycolate or a water-soluble excipient, such as hydroxypropyl cellulose. It will also be evident that the various layers disclosed can be eliminated or combined, depending on the material used and its properties.
    As described herein, the term "ingested" or "ingested" or "ingestion" means any introduction of the system internally into in vivo. For example, ingestion includes simply putting the product in your mouth all the way to the descending colon. Thus, the term ingestion refers to any time in time when the system is introduced into an environment that contains a conductive fluid. Another example would be a situation when a non-conductive fluid is mixed with a conductive fluid. In such a situation, the
    MT "990 27" “" 2 JAÂ27m — u - 2Õ12a; "" - = "CA“, “25252>“ “2“ ““ XmSiTú »“. NO A CCC ——-..— npn —- eÓuur É 12116 * MID would be present in the non-conductive fluid and when the two fluids were 'mixed, the system would come in contact with the conductive fluid and the! EM' within the MID would be activated. Yet another example would be the situation when + the presence of certain conductive fluids needed to be detected. In such cases, the presence of the system, which would be activated within the conducting fluid, could be detected and, therefore, the presence of the respective fluid would be detected.
    According to another aspect, modalities of the invention can be defined in at least one of the following clauses.
    Clause 1: A device for placing inside a capsule, comprising: an ingestible unit; and a material in physical communication with at least part of the ingestible unit, in which the material facilitates the physical separation of the ingestible unit from at least a portion of the capsule during a disintegration.
    Clause 2: The provision of clause 1, in which the ingestible unit comprises an ingestible event marker.
    Clause 3: The provision of clause 1 or 2, where the material | comprises a disintegrant and comprises at least one of povidone, crospovidone, croscarmellose sodium, sodium starch glycolate, starch and microcrystalline cellulose.
    Clause 4: The clause 3 device, in which the super disintegrator is physically coupled to the ingestible unit using pressure.
    Clause 5: The clause 3 device, in which the super disintegrant is physically coupled to the ingestible unit using an adhesive material.
    Clause 6: The device of any of the foregoing clauses, wherein the material includes a soluble film material comprising at least one of polyethylene oxide and hydroxypropyl cellulose with a plasticizer comprising at least one of triethylcitrate, glycerol, dibutyl sebacate and polyethylene glycol.
    Clause 7: The provision of any of the previous clauses
    s 7 13/16; res, in which the film material is physically coupled to the ingestible unit i using thermal application.
    Í Clause 8: A unit including a pharmaceutical product, where the unit is ingestible and activated by contact with a fluid, the unit comprising: a capsule including a wall, in which the capsule defines a cavity to retain the pharmaceutical product and in which the wall loses its shape and disintegrates upon contact with the fluid; and a device, preferably a device according to any of the preceding clauses, the device including a partial energy source located within the cavity of the capsule, wherein the device is capable of encoding information in a current flow that occurs when the device is activated when the partial energy source contacts the fluid, the device further comprising: a first surface with a first portion of the partial energy source; a second surface with a second portion of the partial energy source; and | | a control unit for encoding information in the current flow, in which the control unit is electrically coupled between the first and second portions of the partial energy source; and a material positioned on the first portion and the second portion of the partial energy source, wherein the material disintegrates upon contact with the fluid to provide physical separation between the device and the disintegrating wall of the capsule.
    Clause 9: The clause 8 unit, in which the material surrounds the device and is attached to the device to define a cavity between the material and the device.
    Clause 10: A system for tracking distribution of a pharmaceutical agent, the system comprising: a capsule defining a cavity; miniature ingestible tablet located in the cavity of the capsule
    It's 14116 |
    It is a miniature, ingestible tablet comprising: an ingestible device in accordance with any of the | Only 1-7, preferably a device in a unit according to | ; any of clauses 8-9, the device being activated by contact with a fluid and comprising an ingestible element and a tablet material in physical communication with at least part of the in- | manageable; and a material at least partially surrounding the miniature ingestible tablet, wherein the tablet material facilitates the physical separation of the ingestible device from at least a portion of the capsule during a disintegration process.
    Clause 11: The clause 10 system, where the material and / or the tablet material is a soluble film material! which includes at least one of polyethylene oxide and hydroxypropyl cellulose with a plasticizer comprising at least one of triethyl citrate, glycerol, dibutyl sebacate and polyethylene glycol.
    Clause 12: The clause 11 system, in which the material is a non-soluble film material that defines an opening at each end of the miniature ingestible tablet, so that when the compressed material comes in contact with the fluid and expands, the film material controls the direction of expansion.
    Clause 13: The clause 11 or 12 system, in which the film material delays the contact between the fluid and the ingestible device to delay activation.
    Clause 14: A method for manufacturing a device, preferably for mounting on a pharmaceutical product to prevent damage to the device and to allow handling and manipulation of the device during assembly and for reliable activation of the device upon ingestion of the pharmaceutical product, the method comprising the steps of: providing a first layer of material; position the device, including a first portion and a second portion, where the first portion of the device is in contact
    EºS53, 7> SÊ É $: 19 / ““ “Ú A ...) pi võÁô Á — úâú 200 lr O PO OO (€ Ô (OO NV O ———— | o 15/16 | | |:: with the first layer of material, i provide a second layer of material, wherein the second | Í layer of material is in contact with the second portion of the device; e]: attach the first and second materials to the device for production | 5 zirum miniature ingestible marker. | Clause 15: The method of clause 14, further comprising the step of physically associating the miniature ingestible marker with the pharmaceutical product, in which physically associating the miniature ingestible marker with the pharmaceutical product comprises incorporating the miniature ingestible marker in a gelatin capsule.
    Clause 16: The method according to clause 14 or 15, where the device is a device according to any of clauses 1-7. It is noted that, as used herein and in the appended claims, the forms of the singular "a (a)" and "o / a" include said plurals, unless the context clearly dictates otherwise.
    It is also noted that the claims may be written to exclude any optional elements.
    As such, this statement is intended to serve as an antecedent basis for the use of such exclusive terminology as "only," "only" and similar with respect to the recitation of the elements of the claim or the use of a "negative" limitation. As will be evident to those skilled in the art when reading this disclosure, each of the individual modalities described and illustrated here has discrete characteristics and components that can be easily separated from or combined with the characteristics of any of the other several. modalities without departing from the scope or spirit of the present invention.
    Any recited method can be performed in the order of the recited events or in any other order that is logically possible.
    Although the above invention has been described in some detail | them by way of illustration and example for the sake of clarity of understanding, it is easily perceptible to those versed in the technique, in the light of of this invention, that certain changes and modifications can be made to it without departing from the spirit or scope of the appended claims.
    Consequently, the aforementioned merely illustrates the principles of the invention. It will be appreciated that those skilled in the art will be able to conceive various arrangements that, although not explicitly described or shown here, incorporate the principles of the invention and are included within its spirit and scope. In addition, all the examples and the conditional language recited here are primarily intended to assist —lithe understanding of the principles of the invention and the concepts contributed by the inventors to promote the technique and should be interpreted as being imitation of such examples and conditions specifically cited. In addition, all statements that recite principles, aspects and modalities of the invention, as well as specific examples thereof, are intended to encompass their respective functional and structural equivalents. In addition, the intention is that such equivalents include equivalents currently known and equivalents developed in the future, that is, any elements developed that perform the same function, regardless of the structure. The scope of the present invention, therefore, is not intended to be limited to the exemplary embodiments shown and described here. Instead, the scope and spirit of the present invention are realized by the appended claims.
    权利要求:
    Claims (22)
    [1]
    1. An apparatus comprising: a partial energy source having a first portion and a second portion and configured to generate energy upon contact of the first portion and the second portion with a fluid; a control unit electrically coupled between the first portion and the second portion of the partial energy source and configured to be activated by receiving energy from the partial energy source and to encode information in a current flow between the first portion and the second portion through fluid; a material disposed in and insulating the first portion and the second portion of the partial energy forehead from a surrounding environment and formulated to disintegrate upon contact with the fluid to expose the first portion and the second portion of the partial energy source to the fluid.
    [2]
    Apparatus according to claim 1, wherein the material comprises an excipient material which is a disintegrant and comprises at least one of povidone, crospovidone, croscarmellose sodium, sodium starch glycolate, starch and cellulose microcrystalline cellulose.
    [3]
    Apparatus according to claim 1, wherein the material is attached to the partial energy source using pressure.
    [4]
    Apparatus according to claim 1, wherein the material is fixed to the partial energy source using an adhesive material.
    [5]
    Apparatus according to claim 1, in which the material is fixed to the partial energy source using thermal application.
    [6]
    6. Apparatus according to claim 1, in which the material involves the partial energy source and is fixed to itself to define a cavity between the material and the partial energy source.
    [7]
    Apparatus according to claim 1, wherein the material is a soluble film material comprising at least one of polyethylene oxide and hydroxypropyl cellulose.
    [8]
    8. Apparatus according to claim 1, further comprising a pharmaceutical product and a capsule, the capsule including:
    a wall, in which the wall defines a cavity to retain the pharmaceutical product and in which the wall loses its shape and disintegrates upon contact with a fluid and in which a device is located within the cavity of the capsule and in which the cavity disintegrates through contact with the fluid to provide physical separation between the device and the disintegrated wall of the capsule.
    [9]
    9. Apparatus comprising: an ingestible unit configured to be arranged in a capsule suitable for ingestion; and a material disposed in at least part of the ingestible unit and formulated and configured to inhibit interaction of the ingestible device and the capsule during disintegration of the capsule.
    [10]
    An apparatus according to claim 9, wherein the ingestible unit comprises an ingestible event marker.
    [11]
    Apparatus according to claim 10, wherein the material comprises a super disintegrant and comprises at least one of povidone, crospovidone, croscarmellose sodium, sodium starch glycolate, starch and cellulose microcrystalline cellulose.
    [12]
    Apparatus according to claim 11, wherein the super disintegrant is physically coupled to the ingestible unit using pressure.
    [13]
    Apparatus according to claim 11, wherein the super disintegrant is physically coupled to the ingestible unit using an adhesive material.
    [14]
    Apparatus according to claim 9, wherein the material includes a soluble film material comprising at least one of polyethylene oxide and hydroxypropyl.
    [15]
    Apparatus according to claim 14, in which the soluble film material is physically coupled to the ingestible unit using thermal application.
    [16]
    16. Apparatus comprising: an ingestible tablet configured for association with a pharmaceutical agent including:
    an ingestible device configured to be activated upon contact with a fluid; and a tablet material in contact with at least part of the ingestible device; and a material partially surrounding at least a portion of the ingestible tablet and formulated and configured to inhibit interaction of the ingestible device and the pharmaceutical agent during the disintegration of the pharmaceutical agent.
    [17]
    Apparatus according to claim 16, wherein the material is a soluble film material that includes at least one of polyethylene oxide and hydroxypropyl cellulose.
    [18]
    18. Apparatus according to claim 16, in which the material is a non-soluble film material that defines an opening at each end of the ingestible tablet, so that when the compressed material comes into contact with the fluid and expands the film material controls the direction of expansion.
    [19]
    19. Apparatus according to claim 16, in which the material delays the contact between the fluid and the ingestible device to delay activation.
    [20]
    An apparatus according to claim 16, wherein the apparatus further comprises a capsule defining a cavity in which the ingestible tablet is located within the cavity of the capsule.
    [21]
    21. Method comprising the steps of: disposing between a first layer of material and a second layer of material a device configured to be contained within a pharmaceutical product and to be activated by a liquid following the dissolution of the pharmaceutical product in liquid, the device having a first portion and a second portion, the arrangement including arranging the device with the first portion in contact with the first layer and the second portion in contact with the second layer; and fixing the first layer of the material to one of the device and the second layer of the material, and attaching the second layer of the material to one of the device and the first layer of the material.
    [22]
    22. The method of claim 21, further comprising the step of physically associating the device with the pharmaceutical product, wherein physically associating the device with the pharmaceutical product comprises incorporating the device into a gelatin capsule.
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    同族专利:
    公开号 | 公开日
    CA2795746C|2019-10-01|
    IL222279A|2017-07-31|
    MX2012011693A|2013-02-15|
    HK1176545A1|2013-08-02|
    SG10201502720VA|2015-05-28|
    CN102905672B|2016-08-17|
    CN102905672A|2013-01-30|
    WO2011127252A3|2012-02-23|
    TWI638652B|2018-10-21|
    IL222279D0|2012-12-31|
    US11173290B2|2021-11-16|
    KR20170121299A|2017-11-01|
    US10207093B2|2019-02-19|
    TWI679011B|2019-12-11|
    TW201735896A|2017-10-16|
    AU2011237612B2|2016-05-12|
    SG184494A1|2012-11-29|
    US20200001061A1|2020-01-02|
    ZA201207592B|2014-11-26|
    RU2012143791A|2014-05-20|
    IL253008D0|2017-08-31|
    KR20130045261A|2013-05-03|
    JP2019022655A|2019-02-14|
    CA2795746A1|2011-10-13|
    US20170274194A1|2017-09-28|
    AU2011237612A1|2012-11-01|
    EP2555737A4|2013-09-18|
    JP6463599B2|2019-02-06|
    JP6689324B2|2020-04-28|
    JP2013523835A|2013-06-17|
    IL253008A|2019-07-31|
    TW201201789A|2012-01-16|
    JP2020116416A|2020-08-06|
    EP2555737A2|2013-02-13|
    WO2011127252A2|2011-10-13|
    US9597487B2|2017-03-21|
    US20130030366A1|2013-01-31|
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    法律状态:
    2020-09-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-02-02| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|
    2021-05-18| B09B| Patent application refused [chapter 9.2 patent gazette]|
    2021-08-03| B09B| Patent application refused [chapter 9.2 patent gazette]|Free format text: MANTIDO O INDEFERIMENTO UMA VEZ QUE NAO FOI APRESENTADO RECURSO DENTRO DO PRAZO LEGAL |
    2021-11-03| B350| Update of information on the portal [chapter 15.35 patent gazette]|
    优先权:
    申请号 | 申请日 | 专利标题
    US32184610P| true| 2010-04-07|2010-04-07|
    US61/321,846|2010-04-07|
    US61/414,150|2010-11-16|
    US41615010P| true| 2010-11-22|2010-11-22|
    PCT/US2011/031536|WO2011127252A2|2010-04-07|2011-04-07|Miniature ingestible device|
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