U.S. patent application number 15/620760 was filed with the patent office on 2017-10-19 for integrated ingestible event marker system with pharmaceutical product.
The applicant listed for this patent is Proteus Digital Health, Inc.. Invention is credited to Benedict Costello, Robert Duck, Hooman Hafezi, Timothy Robertson.
Application Number | 20170296799 15/620760 |
Document ID | / |
Family ID | 44115496 |
Filed Date | 2017-10-19 |
United States Patent
Application |
20170296799 |
Kind Code |
A1 |
Hafezi; Hooman ; et
al. |
October 19, 2017 |
INTEGRATED INGESTIBLE EVENT MARKER SYSTEM WITH PHARMACEUTICAL
PRODUCT
Abstract
A system and method are provided for securing an ingestible
electronic device to a pharmaceutical product without damaging the
ingestible electronic device. The product includes the ingestible
electronic device being placed on the product in accordance with
one aspect of the present invention, in accordance with another
aspect of the present invention, the ingestible electronic device
is placed inside the product. Various embodiments are disclosed in
accordance with the present invention for protecting and/or coating
of the electronic marker as well as securing the ingestible
electronic device onto the product.
Inventors: |
Hafezi; Hooman; (Redwood
City, CA) ; Duck; Robert; (San Francisco, CA)
; Robertson; Timothy; (Belmont, CA) ; Costello;
Benedict; (Piedmont, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Proteus Digital Health, Inc. |
Redwood City |
CA |
US |
|
|
Family ID: |
44115496 |
Appl. No.: |
15/620760 |
Filed: |
June 12, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14287851 |
May 27, 2014 |
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15620760 |
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13319309 |
Nov 7, 2011 |
8784308 |
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PCT/US2010/058721 |
Dec 2, 2010 |
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14287851 |
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61266103 |
Dec 2, 2009 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
B32B 38/0004 20130101;
A61B 5/4833 20130101; A61B 5/6873 20130101; B32B 2250/02 20130101;
Y10T 156/10 20150115; A61B 5/42 20130101; Y10T 156/1066 20150115;
A61B 5/6871 20130101; A61B 5/4839 20130101; A61J 3/007 20130101;
A61K 9/2886 20130101; A61J 2200/30 20130101; A61J 3/06 20130101;
A61B 5/06 20130101; A61B 5/073 20130101; A61J 2205/60 20130101;
A61M 31/002 20130101; Y10S 128/903 20130101; A61M 37/00 20130101;
A61B 5/6861 20130101; A61K 9/4825 20130101; B30B 11/34 20130101;
A61K 9/4833 20130101; A61K 9/0097 20130101; A61K 9/2086
20130101 |
International
Class: |
A61M 37/00 20060101
A61M037/00; A61B 5/00 20060101 A61B005/00; A61B 5/07 20060101
A61B005/07; A61B 5/00 20060101 A61B005/00; A61B 5/00 20060101
A61B005/00; A61K 9/48 20060101 A61K009/48; A61K 9/48 20060101
A61K009/48; A61K 9/28 20060101 A61K009/28; A61K 9/20 20060101
A61K009/20; A61K 9/00 20060101 A61K009/00; B32B 38/00 20060101
B32B038/00; B30B 11/34 20060101 B30B011/34; A61J 3/06 20060101
A61J003/06; A61J 3/00 20060101 A61J003/00; A61B 5/00 20060101
A61B005/00; A61B 5/00 20060101 A61B005/00; A61B 5/00 20060101
A61B005/00; A61B 5/06 20060101 A61B005/06; A61M 31/00 20060101
A61M031/00 |
Claims
1-21. (canceled)
22. A device for placement within a capsule, the device comprising:
an assembly, including: a unit comprising a partial power source;
and a non-conductive membrane secured to the unit, wherein the
non-conductive membrane is configured to engage an inner wall of
the capsule to hold the device in place within the capsule.
23. The device of claim 22, further comprising a protective coating
surrounding the assembly.
24. The device of claim 22, further comprising a first protective
layer secured to an upper surface of the assembly and a second
protective layer secured to a lower surface of the assembly.
25. The device of claim 24, wherein the first protective layer and
the second protective layer are secured to each other through a
plurality of holes defined in the non-conductive membrane.
26. The device of claim 24, wherein the first protective layer and
the second protective layer are secured to each other at the edge
of the assembly and extend beyond the perimeter of the assembly
such that the assembly is enclosed within the protective
layers.
27. The device of claim 22, wherein the unit includes: a first
material secured to a support structure; and a second material
secured to the support structure and electrically isolated from the
first material, such that the first material and the second
material represent a chemical voltage potential when in contact
with a conducting fluid.
28. The device of claim 27, wherein the support structure comprises
a control unit electrically connected to the first material and the
second material to control conductance between the first material
and the second material, and wherein the control unit encodes
information in a current signature by altering the conductance.
29. The device of claim 22, wherein the assembly further comprises
an adhesive layer to secure the device within the capsule.
30. The device of claim 29, wherein the adhesive layer is
configured to release the device from the capsule after exposure to
a fluid.
31. The device of claim 22, wherein the assembly is configured to
conform to a shape of the capsule.
32. The device of claim 22, wherein the assembly is configured to
engage the inner wall to surround at least a portion of the
circumference of the capsule.
33. The device of claim 22, wherein the capsule comprises a first
end and a second end, and wherein the assembly is configured to
engage the inner wall between the first end and the second end.
34. A device for positioning inside a pharmaceutical product, the
device comprising: an assembly, including: a control unit; a
partial power source comprising a first material and a second
material, wherein the first material and the second material are
electrically coupled to the control unit; and a skirt attached to
the control unit, wherein the skirt isolates the first material
from the second material, and wherein the skirt is configured to
engage an internal surface of the pharmaceutical product.
35. The device of claim 34, further comprising at least one
protective layer secured to the assembly.
36. The device of claim 34, wherein the assembly further comprises
an adhesive layer to secure the device within the pharmaceutical
product, and wherein the adhesive layer is configured to release
the device from the pharmaceutical product after exposure to a
fluid.
37. The device of claim 34, wherein the assembly is configured to
conform to a shape of the pharmaceutical product.
38. The device of claim 34, wherein the pharmaceutical product
comprises a capsule, and wherein the assembly is configured to
engage the internal surface to surround at least a portion of the
circumference of the capsule between a first end and a second end
of the capsule.
39. The device of claim 34, further comprising a protective coating
configured to dissolve after exposure to a fluid to delay
activation of the device.
40. A device for inclusion with a capsule, the device comprising:
an assembly, including: a control unit electrically coupled to a
partial power source; and a non-conductive membrane surrounding the
control unit, wherein the non-conductive membrane is configured to
engage a surface of the capsule; wherein the assembly engages the
surface to surround at least a portion of the circumference of the
capsule between a first end and a second end of the capsule.
41. The device of claim 40, wherein the assembly further comprises
an adhesive layer to secure the device to the capsule, and wherein
the adhesive layer is configured to release the device from the
capsule after exposure to a fluid.
Description
CROSS-REFERENCE AND RELATED APPLICATION
[0001] Pursuant to 35 U.S.C. .sctn.119 (e), this application claims
priority to the filing date of U.S. Provisional Patent Application
Ser. No. 61/266,103 filed on Dec. 2, 2009 and titled INTEGRATED
INGESTIBLE EVENT MARKER. SYSTEM WITH PHARMACEUTICAL PRODUCT, the
disclosure of which application is incorporated herein by
reference.
[0002] This application is related to and incorporates by reference
the following applications: U.S. Provisional Application Ser. No.
61/416,150 field on Nov. 22, 2010 and titled INGESTIBLE DEVICE WITH
PHARMACEUTICAL PRODUCT; U.S. application Ser. No. 12/447,172 filed
on Oct. 25, 2007 and titled CONTROLLED ACTIVATION INGESTIBLE
IDENTIFIER; U.S. Provisional Application 60/862,925 filed on Oct.
25, 2006 and titled CONTROLLED ACTIVATION PHARMA-INFORMATICS
SYSTEM; PCT Application US2007/82563 and filed on Oct. 25, 2007 and
titled CONTROLLED ACTIVATION INGESTIBLE IDENTIFIER.
FIELD OF INVENTION
[0003] The present invention relates to electronic devices with
partial power sources and, more specifically, to electronic devices
secured to a pharmaceutical product wherein the electronic devices
are activated upon contact with a conducting fluid.
BACKGROUND
[0004] Pharmaceutical products are delivered to a user in many
form, including a pill Integration of a pharmaceutical product with
an ingestible device is often a challenge due to the delicate
nature of the electronic components as well as the difficulty in
securing the electronic components to the pharmaceutical product,
such as a pill or tablet or capsule. For example, tablets are
typically made using a press that applies pressure to a powder
form. The pressures produced by the press can often damage the
electronic components that are placed inside the tablet or pill.
Additionally, securing the electronic component to the surface of
tablet using adhesive material often results in damage to the
device caused by the adhesive, which may be a thermally or
chemically activated type of adhesive. Furthermore, handling a
small electronic device is often a challenge during the assembly
process. Therefore, what is needed is a system and method for
securing an ingestible electronic device to a pharmaceutical
product without damaging the ingestible electronic device.
SUMMARY
[0005] The present invention provides a system and method for
securing an ingestible electronic device to a pharmaceutical
product without damaging the ingestible electronic device. The
product includes an electronic marker placed on the product in
accordance with one aspect of the present invention. In accordance
with another aspect of the present invention, the electronic marker
is placed inside the product Various embodiments are disclosed in
accordance with the present invention that allow for protection and
coating of the electronic marker.
DESCRIPTION OF THE DRAWINGS
[0006] FIG. 1 shows a tablet with a device assembly secured on one
surface in accordance with one aspect of the present invention,
[0007] FIG. 1A shows a tablet with a device assembly secured on one
surface in accordance with one aspect of the present invention,
[0008] FIG. 1B shows a tablet with a device assembly secured on one
surface in accordance with one aspect of the present invention.
[0009] FIG. 1C shows a tablet with a device assembly secured on one
surface in accordance with one aspect of the present invention,
[0010] FIG. 2 is an exploded view of the device assembly of FIG.
1.
[0011] FIG. 2A is an exploded view of the device assembly of FIG.
1A.
[0012] FIG. 2B is an exploded view of the device assembly of FIG.
1B.
[0013] FIG. 2C is an exploded view of the device assembly of FIG.
1B.
[0014] FIG. 3A shows a tablet with a device assembly secured on one
surface in accordance with one aspect of the present invention.
[0015] FIG. 3B shows a first tablet portion with a device assembly
secured on one surface and a second tablet portion secured over the
device assembly in accordance with one aspect of the present
invention.
[0016] FIG. 3C shows a device assembly with a laminated coating in
accordance with one aspect of the present invention.
[0017] FIG. 4 shows a tablet with a device assembly secured on one
surface in accordance with one aspect of the present invention.
[0018] FIG. 5 shows a tablet with a device assembly secured on one
surface in accordance with one aspect of the present invention.
[0019] FIG. 5A shows the assembling process of the tablet of FIG.
5.
[0020] FIG. 5B shows the assembling process of the tablet of FIG.
5.
[0021] FIG. 6 shows a tablet with a device assembly secured on one
surface in accordance with one aspect of the present invention.
[0022] FIG. 6A shows the assembling process of the tablet of FIG.
6.
[0023] FIG. 7 shows a tablet with a device assembly secured on one
surface and a coating that surrounds the tablet in accordance with
one aspect of the present invention.
[0024] FIG. 8 shows a capsule with a device assembly secured on one
end in accordance with one aspect of the present invention.
[0025] FIG. 9 shows a capsule with a device assembly secured on the
side surface in accordance with one aspect of the present
invention.
[0026] FIG. 10 is a flow process for assembling a device on a
tablet in accordance with one aspect of the present invention.
[0027] FIG. 11 is a flow process for assembling a device on a
tablet in accordance with one aspect of the present invention.
[0028] FIG. 12 is a flow process for assembling a device on a
tablet in accordance with one aspect of the present invention.
[0029] FIG. 13 is a flow process for assembling a device in a
tablet in accordance with one aspect of the present invention.
[0030] FIG. 14 is an assembling apparatus for assembling a device
on a tablet.
[0031] FIG. 15 is a close-up view of a portion of a portion of the
apparatus of FIG. 14 with specific indication of the direction of
force applied.
[0032] FIG. 16 is a close-up view of a portion of a feeder assembly
of the apparatus of FIG. 14.
[0033] FIG. 17 is a close-up view of a portion of a feeder assembly
that can be used with the apparatus of FIG. 14 in accordance with
another aspect of the present invention.
[0034] FIG. 18A is a close-up view of a portion of a feeder
assembly that can be used with the apparatus of FIG. 14 in
accordance with another aspect of the present invention.
[0035] FIG. 18B is a close-up view of a portion of the feeder
assembly shown in FIG. 18A at an advanced stage in the loading
process.
[0036] FIG. 19 is an assembly apparatus for the assembly of a
device on a tablet in accordance with one aspect of the present
invention.
[0037] FIG. 20 is a close-up view of a portion of the assembly
apparatus of FIG. 19.
[0038] FIG. 21 is a view of the assembly apparatus that includes
additional components used in assembling the device onto a tablet
or pill as shown partially in FIG. 19.
[0039] FIG. 22 is a close-up view of a pressing tool in accordance
with one aspect of the present invention.
[0040] FIGS. 23A-C show an assembly apparatus for assembling a
device onto a tablet according to another aspect of the present
invention.
[0041] FIGS. 24A-C show a process for loading a feeder or a feeder
assembly of any of FIG. 16, FIG. 17, FIG. 18A, and FIG. 185.
[0042] FIG. 25 shows an assembly apparatus using a process for
assembling a device onto a tablet or pill in accordance with
another aspect of the present invention.
DETAILED DESCRIPTION
[0043] The present invention discloses multiple approaches to
securing a device capable of indicating the occurrence of an event,
such as ingestion, to an ingestible product, such as a
pharmaceutical product in the form of a pill or tablet. In order to
better understand the process and systems involved the systems are
described in greater detail with respect to the devices being
secured within the product as well as the devices being secured
onto the product's outer surface. For example, the process of
securing the device onto the product may be done using pressure,
temperature, chemical reactions or a combination thereof. In
accordance with one aspect of the present invention, the device is
protected from these conditions through the various securing layers
and protective layers disclosed herein. The materials used are
effective in temperature ranges are 25-200 degrees Celsius,
including a target range of 80-150 degrees Celsius and the duration
of exposure time to such temperatures. The exposure times will vary
from 0.1 sec to 50 sec, including a target range of 1 sec to 15
sec. Additionally, the device will be protected from forces
involved, which range from 1 to 50 pounds, including 2-8 pounds, as
well the pressures exerted during integration of the device with
the pill, which pressures range from 100-400 PSI. Thus, the scope
of the present invention includes use of materials to protect the
device and product from the various environmental parameters (such
as pressure, time, forces, chemical reactions, and combinations
thereof) associated with the integration of the device with the
pill.
[0044] Furthermore, the scope of the present invention is not
limited by the shape or type of product. For example, the product
can be a pill, including capsule, a time-release oral dosage, a
tablet, a gel capsule, a sub-lingual tablet or any oral dosage
product. A pill may contain or be made of any of the following,
alone or in combination: an active agent, a drug, a placebo,
vitamins, or any food material. In accordance with one aspect of
the present invention, the product has the device positioned inside
or secured to the interior of the product. In an alternative
arrangement, the device is secured to the exterior of the
product.
[0045] Referring now to FIG. 1, an example of a pill 20 having a
convex surface is shown with a marker assembly 22 secured on the
outside. Additionally, the marker assembly 22 conforms to the shape
of the pill 20. In the current example, as shown in FIG. 2, the
marker assembly 22 includes an ingestible event marker or an ionic
emission module (IEM) unit 24, a lower protective layer 26, an
upper protective layer 28, an adhesive or securing layer 30, and a
decorative or printing layer 32. In accordance with one aspect of
the present invention, a non-conduction outer portion or skirt of
the IEM unit 24 includes holes 24a, as shown in FIG. 2A distributed
around the IEM unit 24 so that layers 26 and 28 maybe laminated
together at connection 25, as shown in FIG. 1A, through the holes
24a as the layers 26 and 28 are secured to or laminated onto the
IEM unit 24.
[0046] Referring now to FIG. 1B and 26, in accordance with another
aspect of the present invention, the protective player 26 and the
securing layer 30 of FIG. 1 are preplaced by a plurality of
securing dots or portions 27. As shown in FIG. 1C and 2C, in
accordance with another aspect of the present invention, the
protective player 26 is included and the securing layer 30 of FIG.
1 is preplaced by a plurality of securing dots or portions 27. The
marker assembly 22 is separated from the pill 20 by an air gap and,
hence, able to be secured to the pill 20 regardless of the shape of
the pill 20 since the dots 27 deform and adjust to contour to the
shape of the pill 20. Thus, when the shape of the pill 20 is such
that the marker assembly 22 cannot be easily conformed to the shape
of the pill 20, the dots 27 will deform and adapt. This ensures a
secure connection between the shape of the pill 20 and the shape of
the marker assembly 22. The dots 27 are distributed about the
marker assembly 22 and used to connect the marker assembly 22 to
the pill 20. Furthermore, the thickness or amount of securing
materials needed to secure each marker assembly 22 to the pill 20
would be reduced.
[0047] The IEM unit 24 includes a control unit surrounded by the
skirt and two dissimilar materials (not shown), each of which
dissimilar material is electrically connected to the control unit
and isolated from each other. The dissimilar materials represent a
portion of a power source or may be referred to as a partial power
source and when in contact with a conducting fluid, produce a
voltage potential across the materials as the materials dissolve.
Once the IEM unit 24 comes into contact with a conducting fluid,
such as body fluids found in the stomach, then the IEM unit 24 is
activated and a current flow is produced by the dissimilar
materials dissolving into solution and the voltage potential is
produced between the dissimilar materials as they go from solid
state to solution.
[0048] According to another aspect of the present invention, the
securing layer 30 may also be replaced by a layer that includes the
properties of adhesion and releasing. For example, the release
functionality is achieved by incorporating a disintegrant (e.g.
Sodium starch glycolate) or water soluble excipient (e.g.
Hydroxypropyl cellulose). Thus, then when the assembly 22 gets wet,
the layer 30 would eject the marker assembly 22 from the pill 20.
Accordingly, to the extent that reference is made in the present
invention to an adhesive or securing layer, the scope of the
present invention contemplates the use of either a layer that has
adhesive properties or a layer that has both adhesive and releasing
properties. The scope of the present invention is not limited by
the shape of the marker assembly 22. The IEM concept can be
expanded to a "galvanic tablet" or dosage form where the drug
release rate is galvanically controlled by an integrated circuit
(IC). The dosage form would consist of a chip, connected to a
partial power source (e.g. a CuCl-Mg materials similar to the
material used with IEM), and also connected to a matrix containing
a drug compound. Once activated, the IC controls the rate of drug
discharge by controlling the current or potential applied to the
matrix. An example of this is a matrix consisting of a drug
compound, a binder, and an electrochemically soluble material,
e.g., a salt. Electrochemical conversion of the salt to a soluble
species erodes or creates pores in the matrix that releases the
drug at a precise rate corresponding to the charge passed.
[0049] The IC can control the charge applied to the matrix at any
desirable rate, e.g., to achieve constant drug discharge, pulsatile
discharge, gradually ramped drug delivery. Discharge can be in
response to a physiological signal sensed by the IC, e.g., local
pH, impedance, motility, location in the GI tract, bleeding.
Discharge can also be externally triggered, e.g. the IC may contain
an RF antenna that allows the patient or a medical monitor, e.g.
personal health companion, blood monitor, to set off drug release
in response to a physical condition like pain. IEM configurations
of interest include, but are not limited to: those described in:
PCT application serial no. PCT/US20061016370 published as
WO/2006/116718; PCT application serial no. PCT/US2007/082563
published as WO/2008/052136; PCT application serial no.
PCT/US2007/024225 published as WO/2008/063626; PCT application
serial no. PCT/US2007/022257 published as WO/2006/066617; PCT
application serial no. PCT/US2008/052845 published as
WO/2008/095183; PCT application serial no. PCT/US2008/053999
published as WO/2008/101107; PCT application serial no.
PCT/US2008/056296 published as WO/2008/112577; PCT application
serial no. PCT/US2008/056299 published as WO/2008/112578; PCT
application serial no. PCT/US2008/077753 published as WO
2009/042812; U.S. patent application Ser. No. 12/546,017; and U.S.
Provisional Application Ser. Nos. 61/142,849; 61/142,861;
61/173,511, 61/173,564; and 61/177,611; the disclosures of which
applications are herein incorporated by reference.
[0050] The dosage form is capable of providing very precise drug
concentrations in the blood, rapid dose delivery for pain
management, or localized delivery in the GI tract. Medical
applications may include GI disease, e.g., motility, colitis, pain
management, localized delivery to tumors, customized dosing of
therapeutics, e.g., immunosuppressants, and others.
[0051] Other release mechanisms are also possible: the drug matrix
may contain an electroactive drug-binding polymer, e.g. Nafion,
proteins, whose state of charge or degree of swelling can be
altered by application of a current or potential. Application of a
potential by the IC alters the binding properties of the polymer to
the drug to effectuate release of the drug. Another possible
mechanism is that the IC controls the concentration of a solution
species around the dosage form. e.g. H+, which in turn can
increase/decrease the solubility of the drug matrix and modulate
drug release. The current may also be applied to an outer layer of
the dosage form rather than the entire matrix to control the
dissolution rate of a coating.
[0052] The power source and the drug matrix can be distinct or the
same. For example, a matrix may contain CuCl as the
electrochemically active species. CuCl can act both as a cathode to
power the IC and as a species whose conversion (to copper and
chloride ions) releases the drug. The IC location may be in the
bulk of the dosage form or on the surface. The sensors can be
incorporated into the IC and used to trigger drug release or report
physiological conditions to a receiver unit, e.g., pH, impedance,
chemical sensor, temperature (detect bleeding). The sheath,
coating, or manifold may be used to confine the matrix so that
dissolution occurs only at one surface while the other surfaces are
coated by a sheath that prevents dissolution. A coating may also be
applied to prevent drug release until the drug reaches a desired
location in the GI tract, e.g. intestine or colon.
[0053] One example of a pain management scenario is that there is
usually a basal rate of pain relief from a long-acting opioid
(e.g., Oxycontin) coupled with self-titrated short-acting opioid
for breakthrough pain. This paradigm is used for both injectable
and oral regimens. This invention could handle both basal and
breakthrough pain in the same pill or cluster of pills, or one
could use the invention solely for the breakthrough component, if
the patient were also taking a standard long-acting oral agent.
This relates to conceiving of this as an Ingestible
Patient-Controlled Analgesia system (analogous to the in-hospital,
IV-based PCA). One aspect of the present invention includes stably
associating the IEM with a pharmaceutically inactive excipient
material designed to: 1) protect the IEM from moisture, handling
and the nearby environment and 2) protect the active pharmaceutical
elsewhere in the formulation from damage or degradation by the IEM
itself. One or more protective IEM "sandwiches" could be developed
such that the final. IEM plus excipient module could be reliably
integrated into the final tablet or capsule oral dosage form with
minimal risk of deleterious effects on product dissolution or
stability. Over time, once characterization of IEM sandwich
performance has been completed in association with active
pharmaceuticals bracketing the range of essential drug
characteristics, e.g., pH, dissolution, bioavailability,
solubility, regulatory clearance-related testing of an IEM-enabled
medication might be streamlined, leading to a quicker
time-to-market for what would in essence become a new form of
proprietary medication, one where the market exclusivity would not
necessarily depend upon the molecular composition-of-matter patent,
but on the incorporation of the IEM and the attendant capabilities
enabled by such incorporation.
[0054] Referring now to FIG. 3A, a pill 40 having a near planar or
flat surface is shown with a marker assembly 42 secured on the
outside. The marker assembly 42 conforms to the shape of the pill
40. In the current example, the marker assembly 42 includes an IEM
unit 44, a lower protective layer 46, an upper protective layer 48,
an adhesive or securing layer 50 and a decorative or printing layer
52.
[0055] Referring now the FIG. 3B, in accordance with another aspect
of the present invention, the pill 40 is shown with a first tablet
portion 41. A marker assembly 42a is shown secured to the surface
of the first tablet portion 41. The marker assembly 42a is covered
by a second tablet portion 43. The portion 41 and the portion 43
may be similar or different materials. For example, in accordance
with one aspect of the present invention, the portion 41 may be the
drug product and the portion 43 may be fast dissolving material.
The marker assembly 42a may be similar to the marker assembly 42 of
FIG. 3A or it may simply be just the IEM unit 44 with the lower
layer 46 and the upper layer 48.
[0056] Referring now to FIG. 3B and FIG. 3C, in accordance with
another aspect of the present invention, the marker assembly 42a
may be replaced by the marker assembly 42b of FIG. 3C. The marker
assembly 42B includes the IEM unit 44 and a lamination or film
coating 45. The laminated layer is made of a dissolvable material
that delays the activation of the IEM unit 44 once the portion 41
and portion 43 of the pill 40 have dissolved or disintegrated to
release the marker assembly 42b. The film coating 45 may be made of
a variety of materials or films, such as polymer films, including
polyethylene oxide, hydroxypropyl cellulose, and triethyl citrate.
Other films that can be used include any dissolvable polymer or
plasticizer. The film coating 45 provides a moisture barrier and
dissolves under the proper conditions to delay activation of the
IEM unit 44. The film coating 45 is designed to provide sufficient
delay in exposure of the IEM unit to the surrounding fluids
relative to the disintegration and dispersion of the pill 40. The
film coating 45 may include any of the following: soluble
materials, barrier materials (such as lipids, polyvinyl alcohol),
processing aids (such as plasticizers, adhesion promoters), and
stabilizers. Furthermore, the film coating 45 may be manufactured
via lamination, application of a coating solution or slurry
followed by a cure. For example, in accordance with one aspect of
the present invention, the film coating 44 may be laminated to the
IEM unit 44, wherein the edge or extremities of the IEM unit 44 are
exposed as shown in FIG. 3A. For example, in accordance with
another aspect of the present invention, the film coating 44 may be
laminated around the IEM unit 44 to form a pocket, wherein the edge
or extremities of the IEM unit 44 are covered as shown in FIG. 3B.
In accordance with other aspects of the present invention, the film
coating 45 may be formed around the IEM unit 44 using dry
compression, such as a tablet press.
[0057] It will also be apparent that the various layers disclosed
can be eliminated or combined depending on the material employed
and the properties thereof. For example, referring to FIG. 2, the
lower protective layer 26 and securing layer 30 may be combined
into a single layer, which is shown in FIG. 4. More specifically
and referring to FIG. 4, a pill 52 is shown having a convex
surface, although a planar or concave surface may be employed
without limiting the scope of the present invention. A marker
assembly 54 is secured to the pill 52. In the current example, the
marker assembly 54 includes a lower layer 56, an upper layer 58,
and a device 60, such as an IEM. According to one aspect of the
present invention, the lower layer 56 is a material that combines
both the adhesive and protective properties of layer 30 and layer
26 of FIG. 2, respectively. In a similar manner, upper layer 58 is
a material that combines the protective and decorative properties
of layer 28 and layer 32 of FIG. 2, respectively. Also, in the
current example, the marker assembly 54 is a different size
relative to the pill 52. The scope of the present invention is not
limited by the shape or size of the marker assembly 54 in this
example or any other example disclosed herein.
[0058] Referring now to FIG. 5, a pill 62 is shown having a convex
surface, although a planar or concave surface may be employed
without limiting the scope of the present invention. A marker
assembly 64 is secured to the pill 62. In the current example, the
marker assembly 64 includes an upper layer 66 and a device 68, such
as an IEM. In the current example, the adhesive layer and its
properties, such as the adhesive layer 30 of FIG. 2, may be part of
the coating on the pill 62. Alternatively, according to another
aspect of the present invention, the adhesive layer may be part of
the device 68. In yet another aspect of the present invention the
adhesive properties may be provided by the upper layer 66 at the
contact points with the pill 62. Thus, depending on the properties
of the materials selected, the properties of each layer can be
altered to the specific needs of that aspect as shown in the
various examples.
[0059] Referring now to FIG. 5A, the process of assembling the
marker assembly 64 onto the pill 62 is shown in accordance with one
aspect of the present invention. The marker assembly 64 is built
one layer at a time onto the pill 62. The device 68 is positioned
on the pill 62. The device 68 is then formed to the shape of the
pill 62. The device 68 can be shaped to the shape of the pill 62
using any standard method, e.g., heat and/or pressure. Then the
upper layer 66 is added and shaped to the shape of the pill 62 as
well as secured thereto using pressure and/or heat.
[0060] Referring now to FIG. 5B, the process of assembling the
marker assembly 64 onto the pill 62 is shown in accordance with
another aspect of the present invention. In this example, the
marker assembly 64 is assembled prior to being presented to the
pill 62. The marker assembly 64 is positioned on the pill 62. Then
the marker assembly 64 is secured to and formed to the shape of the
pill 62 using heat and/or pressure.
[0061] Referring now to FIG. 6 and FIG. 6A, in yet another example
according to another aspect of the present invention, a pill 70
includes a convex surface, although a planar or concave surface may
be employed without limiting the scope of the present invention. A
marker assembly 72 is formed to the shape of and secured to the
pill 70 using heat and/or pressure. In the current example, the
marker assembly 72 includes a device coating layer 74 and a device
74a, such as an IEM. In the current example, the adhesive layer and
its properties and the protective layer and its properties, such as
the adhesive layer 30 and protective layers 26 and 28 of FIG. 2,
are part of the device coating layer 74. Additionally, the
properties of the decorative layer 32 of FIG. 2 may also be part of
the device coating layer 74.
[0062] Referring now to FIG. 7, in yet another example according to
another aspect of the present invention, a pill 76 includes a
convex surface, although a planar or concave surface may be
employed without limiting the scope of the present invention. A
marker 78 is secured to the pill 76. An enclosing layer 80
surrounds the pill 76 and the marker 78. In the current example,
the properties of the adhesive layer, the protective layers, and
the decorative layer (such as the layer 30 and layers 26/28 and
layer 32 of FIG. 2, respectively) may be part of the enclosing
layer 80. In an alternative aspect of the present invention, the
marker 78 may have the adhesive properties instead of or in
addition to the enclosing layer 80.
[0063] Referring now to FIG. 8, in yet another example according to
another aspect of the present invention, a capsule 84 is shown. A
marker 86 is secured to one end of the capsule 84. A layer 88
surrounds the marker 86 and is also secured to the capsule. In the
current example, the properties of the adhesive layer, the
protective layers, and the decorative layer (such as the layer 30
and layers 26/28 and layer 32 of FIG. 2, respectively) may be
incorporated into the layer 88. In an alternative aspect of the
present invention, the marker 86 may have the adhesive properties
instead of or in addition to the layer 88.
[0064] Referring now to FIG. 9, in yet another example according to
another aspect of the present invention, a capsule 90 is shown. A
marker assembly 92 is secured to mid-portion the capsule 90. The
marker assembly 92 surrounds the circumference of the capsule 90.
However, the marker assembly 92 may be designed to only partially
surround the capsule 90 (not shown). In accordance with another
aspect of the present invention. In the current example, the
properties of the adhesive layer, the protective layers, and the
decorative layer (such as the layer 30 and layers 26/28 and layer
32 of FIG. 2, respectively) may be incorporated into the marker
assembly 92.
[0065] Referring now to FIG. 10, the process steps of securing a
device or a device assembly onto a tablet or pill is shown
beginning with the step 100 wherein a raw core tablet or pill is
created. At step 102, the device or the device assembly is attached
to the raw core tablet to create an assembled tablet. At step 104,
a sub coating is added to the assembled tablet to create a coated
tablet. At step 106, which is an optional step, color coating is
added to the coated tablet to create a color coated tablet. At step
108, which is an optional step, the color coated tablet is
imprinted to produce an imprinted tablet that is ready for
distribution.
[0066] Referring now to FIG. 11, the process steps of securing a
device or a device assembly onto a tablet or pill in accordance
with another aspect of the present invention is shown beginning
with the step 110 wherein a raw core tablet or pill is created. At
step 112, a sub coating is added to the raw core tablet to create a
coated tablet. At step 114, the device or the device assembly is
attached to the coated tablet to create an assembled coated tablet.
At step 116, which is an optional step, color coating is added to
the assembled coated tablet to create a color coated tablet. At
step 118, which is an optional step, the color coated tablet is
imprinted to produce an imprinted tablet that is ready for
distribution.
[0067] Referring now to FIG. 12, the process steps of securing a
device or a device assembly onto a tablet or pill in accordance
with yet another aspect of the present invention is shown beginning
with the step 120 wherein a raw core tablet or pill is created. At
step 122, a sub coating is added to the raw core tablet to create a
coated tablet. At step 124, color coating is added to the coated
tablet to create a color coated tablet. At step 126, a device or
the device assembly is attached to the color coated tablet to
create an assembled color coated tablet. At step 128, a second
coating is added to the assembled color coated tablet to create an
enclosed assembled tablet. At step 129, which is an optional step,
the enclosed assembled tablet is imprinted to produce an imprinted
tablet that is ready for distribution.
[0068] Referring now to FIG. 14. FIG. 15, and FIG. 16, a tablet
press 150 is shown. The press 150 rotates in a counter-clockwise
direction as shown. The press 150 includes die cavity or punch
cavity 152 and an ejection tray 154. Starting at position A, as
shown, the pharmaceutical product is deposited in the cavity 152,
The press 150 rotates to position B, which is positioned below a
transfer wheel 160. The wheel 160 includes several openings 162. As
the wheel 160 passes position C, each opening 162 passes under a
feeder 170, as shown in FIG. 16.
[0069] The feeder 170 contains marker devices 200. The device 200
is an IEM that is activated upon contact with a conducting fluid.
The scope of the present invention is not limited by the
environment or type of the conducting fluid. Once ingested, the
device 200 comes into contact with a conducting fluid, such as
stomach fluids, and the device 200 is activated. Referring again to
the instance where the device 200 is used with the product that is
ingested by the living organism, when the product that includes the
device 200 is taken or ingested, the device 200 comes into contact
with the conducting liquid of the body and a voltage potential is
created and the system is activated. A portion of the power source
is provided by the device 200, while another portion of the power
source is provided by the conducting fluid.
[0070] Referring again to FIG. 14 and FIG. 15, each time an opening
162 passes under the feeder 170, one of the devices 200 is dropped
into the opening 162 directly under the feeder 170. As shown in
FIG. 15, a force "F" is shown to assist the movement of the device
200 from the feeder 170 into the opening 162. The force may be
provided by the use of a vacuum through a suction tube 168. In
accordance with other aspects of the present invention, the force
may be provided by a spring, an air burst, or an ejection pin in
addition to gravity. The wheel 160 rotates to position B. At
position B, the device 200 located in the opening 162 is dropped
into the cavity 152 of the press 150. The press 150 rotates to the
position D where additional pharmaceutical product is deposited
into the cavity 152 on top of the device 200. The press 150
continues to move in the counter-clockwise direction and at
position E, the content of the cavity 152 is pressed under high
pressure to form a tablet with the device 200 inside. The completed
tablet is ejected and moved to a collection point through the
ejection tray 154 for further processing, such as coating layers as
needed.
[0071] Referring now to FIG. 17, a feeder assembly 172 is shown as
alternative embodiment and in accordance with another aspect of the
present invention. The feeder assembly 172 can be used in place of
the feeder 170 of the FIG. 14. The feeder assembly 172 includes a
plurality of supporting fingers 174 that hold each device 200 in
position. The fingers 174 are connected to a belt 176. The fingers
174 lower the device 200 toward the wheel 160 of FIG. 14. When the
fingers 174 reach the lower portion near the wheel 160, the fingers
174 move apart and drop the device 200 into the opening 162 of the
wheel 160.
[0072] Referring now to FIG. 18A and FIG. 188, in accordance with
another aspect of the present invention, the feeder assembly 172
includes an ejector 173 with a spring 175. As the opening 162 moves
under the feeder assembly 172, the ejector 173 pushes the device
200 into the opening 162 of the wheel 160.
[0073] Referring now to FIG. 24A, FIG. 24B, and FIG. 24C, an
alternative example of a feeder assembly 170a is shown positioned
below a cutting tool 170b. A web sheet 177 is positioned between
the feeder assembly 170a and the tool 170b. The web sheet 177
delivers devices 179 to a position above the feeder assembly 170a.
As shown in FIG. 24B, the tool 170b moves toward the feeder
assembly 170a and cuts out the device 179. An ejector 170c moves
downward to push the device 179 out of the tool 170b and into the
feeder assembly 170a. As shown in FIG. 24C, the process continues
and the devices 179 are fed into the feeder assembly 170a. This
process can be used to load the feeder 170 of FIG. 16. In
accordance with another aspect of the present invention, the feeder
assembly 170a can be used to replace the feeder 170 of FIG. 14 and
FIG. 16.
[0074] Referring now to FIG. 13, the process steps of assembling a
device 200 within the tablet or pill is shown beginning with the
step 130 wherein the powder/raw material is loaded into the mold,
At step 132 the device 200 is inserted into the mold. At step 134
more powder/raw material is added and a raw core tablet or pill is
created. At step 134 a coating layer is added to the raw core
tablet to create a coated tablet. At step 138, color coating is
added to the coated tablet to create a color coated tablet. At step
139, which is an optional step, the color coated tablet is
imprinted to produce an imprinted tablet that is ready for
distribution.
[0075] In accordance with another aspect of the present invention,
the device 200 may be secured to the exterior of the product. The
process of assembling or securing the device 200 to the exterior of
the product can be done using an assembly array. Referring now to
FIG. 19 and FIG. 20, a wheel 180 is shown that includes positional
grooves 182. The grooves 182 are shown in greater detail in FIG.
20. Each groove 182 has an opening 184 therein. A vacuum is created
through the opening 184 that draws pills 186 into position as the
pills 186 are delivered to the wheel 180 from a hopper tray 188. In
accordance with other aspects of the present invention, the pills
186 can be positioned by other methods than vacuum draw. The pills
186 can be vibrated into position or brushed over with some form of
sweeper so they fall into the hole and excess are brushed off. As
the wheel 180 rotates the pill 186 moves to station 1 where an
adhesive layer is applied. As the wheel 180 moves to station 2, the
device 200 is secured to each pill 186. As the wheel 180 moves to
station 3 a protective layer is applied. As the wheel 180 moves to
station 4, a decorative or printed layer is applied. Thereafter,
the complete and printed tablets or pills 186 are removed from the
wheel 180 to a central collection point for further processing or
distribution. The scope of the present invention is not limited by
the number of stations on the wheel 180. For example, there wheel
180 can be designed to have one station, at which station a
pre-assembled device is applied to the pill 186. The pre-assembled
device can be as simple as the IEM with an adhesive layer or as
discussed above with respect to FIG. 1.
[0076] Referring now to FIG. 21, at each station shown in FIG. 19
various assembly steps are carried out including installation of
the device on the tablet as well as other components or parts. A
portion of a delivery arm 230 is shown positioned over a portion of
the pills 186. The delivery arm 230 moves between the wheel 180 and
a web 232. The web 232 contains devices 234 arranged in order to
allow for the delivery arm 230 to pick up the devices 234. The
delivery arm 230 removes the devices 234 from the web 232 and
secures the devices 234 to the pills 186. In accordance with
another aspect of the present invention the devices 234 are cut or
punched out of the web 232. At other stations, other delivery arms
remove or punch out or cut out other materials from different web
rolls and secure those materials to the pills 186. For example, the
delivery arm can remove a protection layer from the web sheet and
secure it to a tablet with a device already secured thereto.
According to another aspect of the present invention, the devices
positioned on the web may be a marker assembly unit such that a
single installation process is all that is needed and each station
can be used to perform the single task of moving the marker
assembly from the web to the pill 186 using the delivery arm
230.
[0077] Referring now to FIG. 22, an assembly process is shown
wherein a tool 210 includes a cavity 212. The tool 210 is
positioned above an assembly device 214, which includes circuitry
214a, prior to formation of the device onto a pill or tablet 216.
The tool 210 is formed to the shape of the tablet 216 and is
lowered onto the device 214. Through the application of temperature
and pressure the device 214 is reformed as device 218 and secured
to the tablet 216 as device 220. The cavity 212 prevents pressure
from being applied to the circuitry 214a of the device 214.
[0078] Referring now to FIG. 23A, FIG. 23B, and FIG. 23C, according
to another aspect of the present invention, an alternative assembly
process is shown wherein a pressing tool or cutting tool 240 is
positioned above a press table 242. The table 242 includes grooves
246 that have a central hole 248. The tablet 250 is held in the
groove 246 using a vacuum suction applied through the hole 248. A
web sheet 252 is positioned between the table 242 and the tool 240.
The sheet 252 includes devices 254. To begin the assembly process,
the tool 240 moves toward the table 242. The sheet 252 is punched
and the device 254 is secured to the tablet 250 as shown in FIG.
238. At a different station or position in the assembly process, a
sheet 256 that includes a different layer in the assembly process
is positioned between the table 242 that now holds the tablet 250
with the device 254 secured thereto and a cutting tool 260. The
cutting tool 260 moves toward the table 242 and secures the layer
256 onto the tablet 250 (not shown) to form a coated tablet 250
with a device 254 assembled thereto.
[0079] Referring now to FIG. 25, an assembly process is shown in
accordance with another aspect of the present invention. An
assembly unit 300 includes a press 302 and a press 304. The press
302 is positioned above a web 308. The web 308 has devices 306
positioned and held in place on the web 308. Devices 306 have an
adhesive layer holding them to the web 308 and a second adhesive
layer positioned on the opposite side adjacent to the tablets 312.
As the web 308 moves from a roller 310a to a roller 310b, the
devices are presented and positioned above tablets 312, which are
positioned on a tablet feeder belt 314. The feeder belt 314 moves
the tablets 312 towards the press 304 as the devices 306 move
toward the press 302. As the tablets 312 approach the press 304,
each tablet 312 falls into a groove 304a of the press 304. The
tablet 312 is then lifted by the press 304 toward the press 302 as
the press 302 pushes the device 306 toward the press 304. At
position 318 the device 306 is pressed onto the tablet 312 and
secured thereto. As the press 302 and press 304 rotate the web 308
moves toward the roller 310b. At the same time, an assembled tablet
320 is lowered onto a take away roller belt 322 that moves the
assembled tablet 320 away from the press 302 and the press 304. The
assembled tablets 320 may be moved to the next phase of the process
including packaging for distribution or additional preparation
steps such as adding additional layers or coatings.
[0080] Embodiments of interest include high-throughput fabrication
processes, e.g., where details regarding such embodiments are
provided above and/or in U.S. Provisional Application Ser. No.
61/142,849; the disclosure of which is herein incorporated by
reference.
[0081] As described herein, a system of the present invention is
used with a conducting fluid to indicate the event marked by
contact between the conducting fluid and the system. For example,
the system of the present disclosure may be used with a
pharmaceutical product and the event that is indicated is when the
product is taken or ingested. The term "ingested" or "ingest" or
"ingesting" is understood to mean any introduction of the system
internal to the in-vivo. For example, ingesting includes simply
placing the system in the mouth all the way to the descending
colon. Thus, the term ingesting refers to any instant in time when
the system is introduced to an environment that contains a
conducting fluid. Another example would be a situation when a
non-conducting fluid is mixed with a conducting fluid, in such a
situation the system would be present in the non-conduction fluid
and when the two fluids are mixed, the system comes into contact
with the conducting fluid and the system is activated. Yet another
example would be the situation when the presence of certain
conducting fluids needed to be detected In such instances, the
presence of the system, which would be activated, within the
conducting fluid could be detected and, hence, the presence of the
respective fluid would be detected.
[0082] It is noted that, as used herein and in the appended claims,
the singular forms "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,
[0083] As will be apparent to those of skill in the art upon
reading this disclosure, each of the individual embodiments
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 embodiments without departing
from the scope or spirit 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.
[0084] Although the foregoing invention has 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 this invention that certain
changes and modifications may be made thereto without departing
from the spirit or scope of the appended claims.
[0085] Accordingly, the preceding merely illustrates the principles
of the invention. It will be appreciated that those skilled in the
art will be able to devise various arrangements which, although not
explicitly described or shown herein, embody the principles of the
invention and are included within its spirit and scope.
Furthermore, all examples and conditional language recited herein
are principally intended to aid the reader in understanding the
principles of the invention and the concepts contributed by the
inventors to furthering the art, and are to be construed as being
without limitation to such specifically recited examples and
conditions. Moreover, all statements herein reciting principles,
aspects, and embodiments of the invention as well as specific
examples thereof, are intended to encompass both structural and
functional equivalents thereof. Additionally, it is intended that
such equivalents include both currently known equivalents and
equivalents developed in the future, i.e., any elements developed
that perform the same function, regardless of structure. The scope
of the present invention, therefore, is not intended to be limited
to the exemplary embodiments shown and described herein. Rather,
the scope and spirit of present invention is embodied by the
appended claims
* * * * *