U.S. patent application number 11/917442 was filed with the patent office on 2010-10-07 for microneedle cartridge assembly and method of applying.
Invention is credited to Franklyn L. Frederickson, Michael D. Johnson.
Application Number | 20100256568 11/917442 |
Document ID | / |
Family ID | 37103001 |
Filed Date | 2010-10-07 |
United States Patent
Application |
20100256568 |
Kind Code |
A1 |
Frederickson; Franklyn L. ;
et al. |
October 7, 2010 |
MICRONEEDLE CARTRIDGE ASSEMBLY AND METHOD OF APPLYING
Abstract
A microneedle array cartridge includes a web of material having
a top face and an opposite bottom face. An adhesive and a
microneedle array are disposed on the bottom face of the web of
material. A container is disposed relative to the bottom face of
the web of material, and has a perimeter portion and a central
portion for covering at least part of the microneedle array. At
least part of the perimeter portion of the container contacts the
adhesive, and the central portion of the container does not contact
the adhesive. The perimeter portion and the central portion of the
container are integrally formed.
Inventors: |
Frederickson; Franklyn L.;
(White Bear Lake, MN) ; Johnson; Michael D.;
(Gollege Station, TX) |
Correspondence
Address: |
3M INNOVATIVE PROPERTIES COMPANY
PO BOX 33427
ST. PAUL
MN
55133-3427
US
|
Family ID: |
37103001 |
Appl. No.: |
11/917442 |
Filed: |
June 23, 2006 |
PCT Filed: |
June 23, 2006 |
PCT NO: |
PCT/US06/24672 |
371 Date: |
December 13, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60694446 |
Jun 27, 2005 |
|
|
|
Current U.S.
Class: |
604/173 |
Current CPC
Class: |
A61M 37/0015 20130101;
A61M 2037/0023 20130101 |
Class at
Publication: |
604/173 |
International
Class: |
A61M 5/00 20060101
A61M005/00 |
Claims
1. A microneedle array cartridge comprising: a web of material
having a top face and an opposite bottom face; an adhesive disposed
on the bottom face of the web of material; a microneedle array
disposed relative to the bottom face of the web of material; and a
container disposed relative to the bottom face of the web of
material having a perimeter portion and a central portion for
covering at least part of the microneedle array, wherein at least
part of the perimeter portion contacts the adhesive and the central
portion does not contact the adhesive, and wherein the perimeter
portion and the central portion are integrally formed.
2. The microneedle array cartridge of claim 1, wherein a first
region of the perimeter portion contacts the adhesive.
3. The microneedle array cartridge of claim 2, wherein a second
region of the perimeter portion does not contact the adhesive.
4. The microneedle array cartridge of claim 1, and further
comprising at least one stiffener disposed along the web of
material.
5. The microneedle array cartridge of claim 4, wherein a pair of
stiffeners are provided.
6. The microneedle array cartridge of claim 4, wherein the at least
one stiffener has an elongate shape.
7. The microneedle array cartridge of claim 4, wherein the at least
one stiffener has a length at least as long as a width or diameter
of the central portion of the container.
8. The microneedle array cartridge of claim 1, wherein the web of
material defines a web perimeter, and wherein at least a portion of
the perimeter portion of the container generally extends at least
to the web perimeter.
9. The microneedle array cartridge of claim 1, wherein the
perimeter portion of the container defines a pair of cutout regions
where the perimeter portion does not extend as far as the web
perimeter.
10. The microneedle array cartridge of claim 1, wherein a seal is
formed between the web of material and the perimeter portion of the
container.
11. The microneedle array cartridge of claim 10, and further
comprising a gasket disposed between the web of material and the
perimeter portion of the container for forming the seal.
12. The microneedle array cartridge of claim 10, and further
comprising a heat seal between the web of material and the
perimeter portion of the container for forming the seal.
13. The microneedle array cartridge of claim 12, wherein the seal
is hermetic.
14. The microneedle array cartridge of claim 1, wherein the central
portion of the container has a base and at least one sidewall, and
wherein the at least one sidewall has a low profile relative to the
microneedle array.
15. The microneedle array cartridge of claim 14, wherein the base
of the central portion of the cartridge is spaced from the
microneedle array.
16. The microneedle array cartridge of claim 1, wherein the array
and web of material are integrally formed.
17. A microneedle array package comprising: a plurality of adhesive
patches separably attached to each other, each of the adhesive
patches carrying a microneedle array.
18. The microneedle array package of claim 17, wherein the package
is in the form of a roll.
19. The microneedle array package of claim 17, wherein the package
is in the form of a sheet.
20. A microneedle array cartridge comprising: a web of material
disposed substantially in a first plane, the web of material having
a top face and an opposite bottom face; an adhesive disposed on the
bottom face of the web of material; a microneedle array disposed
relative to the bottom face of the web of material; and a container
disposed relative to the bottom face of the web of material having
a perimeter portion and a central portion for covering at least
part of the microneedle array, wherein a first region of the
perimeter portion is disposed substantially in a second plane that
is generally parallel to the first plane, and wherein a second
region of the perimeter portion is generally not disposed in the
second plane.
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Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims priority to U.S. Provisional
Application Ser. No. 60/694,446, filed on Jun. 27, 2005, which is
incorporated herein in its entirety.
FIELD
[0002] The present invention relates to microneedle array
cartridges.
BACKGROUND
[0003] Only a limited number of molecules with demonstrated
therapeutic value can be transported through the skin via
unassisted or passive transdermal drug delivery. The main barrier
to transport of molecules through the skin is the stratum corneum
(the outermost layer of the skin).
[0004] Devices including arrays of relatively small structures,
sometimes referred to as microneedles or micro-pins, have been
disclosed for use in connection with the delivery of therapeutic
agents and other substances through the skin and other surfaces.
The devices are typically pressed against the skin in an effort to
pierce the stratum corneum. The microneedle arrays are generally
used once and then discarded.
[0005] Microneedles on these devices pierce the stratum corneum
upon contact, making a plurality of microscopic slits that serve as
passageways through which molecules of active components (e.g.,
therapeutic agents, vaccines, and other substances) can be
delivered into the body. In delivering an active component, the
microneedle array can be provided with a reservoir for temporarily
retaining an active component in liquid form prior to delivering
the active component through the stratum corneum. In some
constructions, the microneedles can be hollow to provide a liquid
flow path directly from the reservoir and through the microneedles
to enable delivery of the therapeutic substance through the skin.
In alternate constructions, active component(s) may be coated and
dried on the microneedle array and delivered directly through the
skin after the stratum corneum has been punctured.
[0006] Transdermal adhesive patches are also available and are
generally constructed as an adhesive article with a pressure
sensitive adhesive coated onto the surface of a backing comprised
of a polymeric film, cloth or the like. Transdermal adhesive
patches are provided with an adhesive that allows the patch to be
releasably adhered to the surface of the skin where a predetermined
dosage of an active component can be put in contact with a small
surface area of the skin. An appropriate biocompatible carrier is
normally provided to facilitate the absorption of molecules through
the stratum corneum over a period of time while the patch remains
adhered to the skin.
BRIEF SUMMARY
[0007] Patches, with or without a microneedle array, can have
fragile and sanitary characteristics. It is generally desired that
the patch and array not be contacted before application to a target
site. This presents difficulties in storing and transporting
patches to desired locations for eventual application. In addition,
providing collars or other protection for microneedle arrays
produces bulky structures that require excessive amounts of
materials to manufacture and take up large amounts of space during
transportation and storage. Moreover, loading a microneedle array
on an applicator device can also be time consuming and difficult
for operators. Thus, the present invention provides an alternative
microneedle cartridge design.
[0008] In a first aspect of the present invention, a microneedle
array cartridge includes a web of material having a top face and an
opposite bottom face. An adhesive and a microneedle array are
disposed on the bottom face of the web of material. A container is
disposed relative to the bottom face of the web of material, and
has a perimeter portion and a central portion for covering at least
part of the microneedle array. At least part of the perimeter
portion of the container contacts the adhesive, and the central
portion of the container does not contact the adhesive. The
perimeter portion and the central portion of the container are
integrally formed.
[0009] In another aspect of the present invention, a microneedle
array package includes a plurality of adhesive patches separably
attached to each other, and each of the adhesive patches carrying a
microneedle array.
[0010] In another aspect of the present invention, a microneedle
array cartridge includes a web of material having a top face and an
opposite bottom face, an adhesive, a microneedle array and a
container. The web of material is disposed substantially in a first
plane. The adhesive is disposed on the bottom face of the web of
material. The microneedle array is disposed relative to the bottom
face of the web of material. The container is disposed relative to
the bottom face of the web of material, and has a perimeter portion
and a central portion for covering at least a portion of the
microneedle array. A first region of the perimeter portion is
disposed substantially in a second plane that is generally parallel
to the first plane, and a second region of the perimeter portion is
generally not disposed in the second plane.
[0011] In another aspect of the present invention, a microneedle
array cartridge includes a web of material having a top face, an
opposite bottom face and defining a perimeter, an adhesive disposed
on the bottom face of the web of material, a microneedle array, and
a container. The microneedle array is disposed relative to the
bottom face of the web of material. The container is disposed
relative to the bottom face of the web of material, and has a
perimeter portion and a central portion for covering at least a
portion of the microneedle array. The perimeter portion of the
container generally extends at least to the perimeter of the web of
material, and has a pair of opposing cutout regions that do not
extend as far as the perimeter of the web of material.
[0012] In another aspect of the present invention, a microneedle
array cartridge includes a web of material having a top face, an
opposite bottom face and defusing a perimeter, an adhesive disposed
on the bottom face of the web of material, a microneedle array, and
a container. The microneedle array is disposed relative to the
bottom face of the web of material. The container extends only from
the bottom face of the web of material, and has a perimeter portion
and a central portion for covering at least part of the microneedle
array. At least part of the perimeter portion of the container
contacts the adhesive and the central portion does not contact the
adhesive.
[0013] In another aspect of the present invention, a method for
microneedle array application includes slidably mounting a
microneedle array cartridge on an applicator device, simultaneously
exposing the microneedle array of the cartridge by removing a cover
portion of the cartridge when the cartridge is at least partially
mounted on the applicator device, and moving the microneedle array
toward a target site.
[0014] In another aspect of the present invention, a method of
mounting a microneedle array relative to a microneedle array
application device includes slidably positioning a microneedle
cartridge having a microneedle array and a removable cover at least
partially within a retaining portion of the microneedle array
application device, rotating the microneedle cartridge relative to
the microneedle array application device within the retaining
portion of the microneedle array application device in order to
break a seal to allow removal of the cover, and exposing the
microneedle array of the microneedle cartridge by removing the
cover when the microneedle cartridge is at least partially mounted
on the microneedle array applicator device.
[0015] The above summary is not intended to describe each disclosed
embodiment or every implementation of the present invention. The
figures and the detailed description, which follow, more
particularly exemplify illustrative embodiments.
BRIEF DESCRIPTION OF DRAWINGS
[0016] FIG. 1 is a perspective view of a first embodiment of a
microneedle cartridge.
[0017] FIG. 2 is a cross-sectional view of the microneedle
cartridge of FIG. 1.
[0018] FIG. 3 is a partial cross-sectional view of the microneedle
cartridge of FIGS. 1 and 2 mounted on an applicator device.
[0019] FIG. 4 is a perspective view of the patch of FIGS. 1, 2 and
3 mounted on the applicator device of FIG. 3.
[0020] FIG. 5 is a perspective view of a second embodiment of a
microneedle cartridge.
[0021] FIG. 6 is a front cross-sectional view of the microneedle
cartridge of FIG. 5.
[0022] FIG. 7 is a side cross-sectional view of the microneedle
cartridge of FIGS. 6 and 7, rotated 90.degree. relative to FIG.
6.
[0023] FIG. 8 is a bottom view of the microneedle cartridge of
FIGS. 5, 6 and 7.
[0024] FIG. 9 is a perspective view of a third embodiment of a
microneedle cartridge.
[0025] FIG. 10 is a cross-sectional view of the microneedle
cartridge of FIG. 9.
[0026] FIG. 11 is a perspective view of a number of microneedle
cartridges arranged as a sheet.
[0027] FIG. 12 is a side view of a number of microneedle cartridges
arranged as a roll.
[0028] FIG. 13 is a bottom perspective view of a microneedle
cartridge in a mounting fixture.
[0029] FIG. 14 is a bottom perspective view of another embodiment
of a microneedle cartridge.
[0030] FIG. 15 is a top perspective view of a mounting fixture and
microneedle cartridge partially inserted into an applicator.
[0031] FIG. 16 is bottom perspective view of a mounting fixture and
microneedle cartridge partially inserted into an applicator.
[0032] While the above-identified drawing figures set forth several
embodiments of the invention, other embodiments are also
contemplated, as noted in the discussion. In all cases, this
disclosure presents the invention by way of representation and not
limitation. It should be understood that numerous other
modifications and embodiments can be devised by those skilled in
the art, which fall within the scope and spirit of the principles
of the invention. The figures may not be drawn to scale. Like
reference numbers have been used throughout the figures to denote
like parts.
DETAILED DESCRIPTION
[0033] Patches can be used for transdermal delivery of molecules,
and can carry microneedle arrays, which have utility for the
delivery of large molecules that are ordinarily difficult to
deliver by passive transdermal delivery. As used herein, "array"
refers to the medical devices described herein that include one or
more structures capable of piercing the stratum corneum to
facilitate the transdermal delivery of therapeutic agents or the
sampling of fluids through or to the skin. "Microstructure,"
"microneedle" or "microarray" refers to the specific microscopic
structures associated with the array that are capable of piercing
the stratum corneum to facilitate the transdermal delivery of
therapeutic agents or the sampling of fluids through the skin. By
way of example, microstructures can include needle or needle-like
structures as well as other structures capable of piercing the
stratum corneum. The microneedles are typically less than 500
microns in height, and sometimes less than 300 microns in height.
The microneedles are typically more than 20 microns in height,
often more than 50 microns in height, and sometimes more than 125
microns in height.
[0034] FIG. 1 is a perspective view of a first embodiment of a
microneedle cartridge 20 that includes a patch 22 and a container
24. FIG. 2 is a cross-sectional view of the microneedle cartridge
20. The patch 22 shown in FIGS. 1 and 2 includes a web of material
26 that forms a backing, and a microneedle array 28 supported by
and attached to the web of material 26. The web of material 26 is
generally flat, and has an upper face 30 and a lower face 32. The
web of material 26 can be comprised of a polymeric film, cloth,
nonwoven or the like. An adhesive 34, such as a pressure sensitive
adhesive, is disposed on the lower face 32 of the web of material
26. The microneedle array 28 is located relative to the lower face
32 of the web of material 26 at a generally central portion of the
web of material 26, which has a circular shape. The microneedle
array 28 can be attached to the web of material 26, for example, by
adhesive, welding, heat bonding, and can be formed integrally with
the web of material 26.
[0035] Suitable materials for the microneedle array 28 include
those selected from materials such as
acrylonitrile-butadiene-styrene (ABS) polymers, polyphenyl
sulfides, polycarbonates, polypropylenes, acetals, acrylics,
polyetherimides, polybutylene terephthalates, polyethylene
terephthalates as well as other known materials and combinations of
two or more of the foregoing. The microneedle array 28 can carry
molecules for eventual delivery through the stratum corneum of a
patient's skin (i.e., the skin of a human or non-human test
subject). Those molecules can be therapeutic agents, vaccines, and
other materials. A reservoir can be included with the microneedle
array 28 for holding molecules for eventual delivery. Deployment of
the patch 22 to a target site permits the molecules to be delivered
through or to the stratum corneum.
[0036] The adhesive layer will generally be selected according to
the desired end use of the articles prepared by the present method.
Examples of suitable adhesives include acrylates, silicones,
polyisobutylenes, synthetic rubber, natural rubber, and copolymers
and mixtures thereof. Further description of suitable adhesives may
be found in U.S. Pat. Nos. 5,656,286 (Miranda et al.), 4,693,776
(Krampe et al.), 5,223,261(Nelson et al.), and 5,380,760 (Wendel et
al.) the disclosures of which are incorporated herein by
reference.
[0037] Typical examples of flexible films employed as conventional
tape backings which may be useful as a backing film include those
made from polymer films such as polypropylene; polyethylene,
particularly low density polyethylene, linear low density
polyethylene, metallocene polyethylenes, and high density
polyethylene; polyvinyl chloride; polyester (e.g., polyethylene
terephthalate); polyvinylidene chloride; ethylene-vinyl acetate
(EVA) copolymer; polyurethane; cellulose acetate; and ethyl
cellulose. Coextruded multilayer polymeric films are also suitable,
such as described in U.S. Pat. No. 5,783,269 (Heilmann et al.), the
disclosure of which is incorporated herein by reference. Layered
backings such as polyethylene terephthalate-aluminum-polyethylene
composites and polyethylene terephthalate-EVA composites are also
suitable. Foam tape backings, such as closed cell polyolefin films
used in 3M.TM. 1777 Foam Tape and 3M.TM. 1779 Foam Tape are also
suitable. Polyethylenes, polyethylene blends, and polypropylenes
are preferred polymer films. Polyethylenes and polyethylene blends
are most preferred polymer films. In one embodiment, the backing
film is translucent or transparent. Additives may also be added to
the backing film, such as tackifiers, plasticizers, colorants, and
anti-oxidants.
[0038] The container 24 is removably attached to the patch 22 to
cover the microneedle array 28. The container 24 includes a
circular central base portion 36, a sidewall 38 connected at or
near the perimeter of the central base portion 36, and a perimeter
lip 40 connected to the sidewall 38 opposite the central base
portion 36. A first portion 42 of the perimeter lip 40 is
adhesively affixed to the adhesive 34 on the web of material 26,
and a second portion 44 of the perimeter lip 40 is spaced from the
adhesive 34 so as not to adhere to it. This creates a gap or slight
separation 46 (see FIG. 2). The gap 46 facilitates separating the
container 24 from the patch 22 for application of the patch 22 to a
patient. However, in one embodiment, a continuous adhesive
connection is formed around the microneedle array 28 between the
web of material 26 and the perimeter lip 40 of the container 24.
That continuous connection can form a seal. In some instances, the
seal may be a hermetic seal, that is, a seal that can prevent entry
or escape of air or other vapors, such as moisture vapor. Sealing
the microneedle array 28 between the web of material 26 and the
container 24 helps protect the microneedle array 28 from
contamination and damage prior to deployment. In such a
configuration the web of material 26 may be considered to be
disposed substantially in a first plane and the first portion 42 of
the perimeter lip 40 is disposed substantially in a second plane
that is generally parallel to the first plane. It should be
understood by the term disposed substantially in a plane, that the
web 26 and first portion 42 are largely planar, but that minor
variations, for example, due to manufacturing imperfections or due
to the flexibility in the web and/or the carrier material may cause
slight, but insignificant, deviations from planarity. The second
portion 44 of the perimeter lip 40 is generally not disposed in the
second plane.
[0039] As shown, the shape of the container is a cylinder, but it
should be understood that other shapes are suitable as long as the
base portion is appropriately spaced from the microneedle array 28.
For example, the central base portion 36 and sidewall 38 may have
the form of a dome, in which case there may be no discernable
boundary between the sidewall 38 and the central base portion 36.
The sidewalls may be angled and in some embodiments may extend
until they contact an opposing sidewall, for example, forming a
cone-shaped container. Furthermore, the container may have
additional exterior protrusions or indentations to facilitate
handling and/or storage. For example, a handling tab may be affixed
to the exterior surface of the base portion to make the container
more easily graspable.
[0040] The central base portion 36 and the sidewall 38 of the
container 24 define a volume in which the microneedle array 28 can
rest. The container 24 is spaced from the microneedle array 28, as
the microneedle array 28 is generally susceptible to damage from
contact during storage, transportation, and at other times prior to
deployment. The container 24 can have a relatively low profile,
such that the sidewall 38 of the container 24 preferably has as
small a height, H, as possible without damaging or risking damage
to the microneedle array 28 through contact. A low profile
container 24 reduces space occupied by the cartridge 20, for
storage and transportation purposes, while still providing
protection to the microneedle array 28. A low profile container 24
also reduces the amounts of gases (i.e., air) and contaminants that
are exposed to the microneedle array 28 and molecules carried
thereon. Because many molecules intended for delivery with the
microneedle array 28 can have limited lifespans and may be
sensitive to contamination and deterioration, a low profile
container 24 reduces the volume of air that is exposed to the
microneedle array 28 to limit such negative effects. A suitable
low-profile height will depend upon the nature of the patch 22 and
microneedle array 28, but the height will typically be less than
2.0 cm, often less than 1.5 cm, and sometimes less than 1.0 cm.
[0041] The container 24 can be formed of a polymer material.
Generally, a rigid material is selected in order to better protect
the microneedle array 28 from damage and to facilitate storage
(e.g., for stacking a plurality of microneedle cartridges 20). In
one embodiment, the container 24 is a transparent or translucent
material. In one embodiment, the container 24 is opaque to protect
the microneedle array 28 from exposure to light.
[0042] FIG. 3 is a partial cross-sectional view of the microneedle
cartridge 20 held on an applicator device 50. As shown in FIG. 3,
the applicator device 50 has a skin-contacting face 52, a recess
54, a substantially circular opening 56 defined in a bottom portion
58 of the recess 54, and a pair of retainer members 60 that each
have substantially flat upper surfaces 62. The retainer members 60
are generally elongate and their substantially flat upper surfaces
62 are generally parallel to and facing the bottom portion 58 of
the recess 54. The pair of retainer members 60 are located at
opposite portions of the opening 56 and are connected at one side
of the recess 54. The retainer members 60 define an opening at one
end for accepting patches between the retainer members 60 and the
bottom portion 58 of the recess 54. The upper surfaces 62 of the
retainer members 60 may be non-stick or release surfaces. A
non-stick or release surface can be achieved, for example, by a
non-stick or release coating applied to the upper surfaces 62. The
non-stick or release coating can be selected according to the
desired use of the applicator device 50. For instance, a release
coating, such as a low surface energy silicone, fluoropolymer, or
fluoro-silicone release coating, can be selected based upon the
adhesives used with patches applied using the patch application
device 50
[0043] As shown in FIG. 3, the patch 22 is disposed between the
retainer members 60 and the bottom portion 58 of the recess 54. The
microneedle array 28 carried by the patch 22 faces away from
opening 56 in the applicator device 50. The patch 22 contacts the
upper surfaces 62 of the retainer members 60, but generally does
not adhere firmly to the retainer members 60 due to the non-stick
or release character of the upper surfaces 62.
[0044] FIG. 4 is a perspective view of the patch 22 mounted on the
applicator device 50. In a fully mounted position, as shown in FIG.
4, the patch 22 is generally aligned relative to the opening 56 in
the applicator device 50 (the opening 56 is not visible in FIG. 4).
The retainer members 60 have cutaway portions 64 that provide an
enlarged, partially circular open region that is generally aligned
with the opening 56 on the bottom portion 58 of the recess 54. The
open region defined by the cutaway portions 64 facilitates patch
application by reducing the amount of deflection of the patch 22
required to move the patch 22 from a mounted position on the
applicator device 50 to a target location, during deployment.
Further details of applicators suitable for use with microneedle
array cartridges of the present invention may be found in U.S.
Patent Application Ser. No. 60/694,447 (Attorney Docket No.
60874US002) filed on Jun. 27, 2005, the disclosure of which is
hereby incorporated by reference.
[0045] The microneedle cartridge 20 allows for simple and easy
mounting of the patch 22 to the applicator device 50, for
eventually applying the microneedle array 28 (the array 28 is not
visible in FIG. 4) to a target site. Mounting the microneedle patch
22 on the applicator device 50 includes the following steps. First,
the microneedle cartridge 20, with the container 24 affixed
thereto, is partially slid onto the retainer members 60. Ends of
the retainer members 60 are positioned in the gap 46 formed between
the web of material 26 and the perimeter lip 40 of the container 24
of the microneedle cartridge 20. Then the microneedle cartridge 20
is slid further along the retainer members 60, simultaneously
separating the container 24 from the web of material 26, until the
patch 22 is fully mounted on the applicator device 50 (e.g., such
that the microneedle array 28 is aligned with the opening 56
defined in the bottom portion 58 of the recess 54). The container
24 is removed from (i.e., separated from) the patch 22 to uncover
and expose the microneedle array 28 prior to microneedle
deployment. An operator may need to pull the container 24 away from
the applicator device 50 (e.g., by applying a force perpendicular
to the skin-contacting face 52 of the applicator device 50) in
order to fully separate the container 24 from the patch 22, during
the process of mounting or once mounted onto an applicator device.
The motion between the microneedle cartridge 20 and the applicator
device 50 is a relative motion which may be accomplished by moving
one or both of the applicator device 50 and the microneedle
cartridge 20. In one embodiment, a mounting fixture 100 may be used
to assist in mounting the patch 22 of the microneedle cartridge 20
to the applicator device 50. A perspective view of the bottom of a
mounting fixture 100 is shown in FIG. 13. The mounting fixture 100
comprises alignment members 110 and cartridge holder members 120.
The cartridge 20 (shown in more detail in FIG. 14) includes a patch
22 and a container 24. The patch 22 includes a web of material 26
that forms a backing, and a microneedle array 28 (not shown)
supported by and attached to the web of material 26. An adhesive
34, such as a pressure sensitive adhesive, is disposed on the lower
face 32 of the web of material 26. The container 24 is removably
attached to the patch 22 to cover the microneedle array 28. The
container 24 includes an asymmetric central base portion 36, a
sidewall 38 connected at or near the perimeter of the central base
portion 36, and a perimeter lip 40 connected to the sidewall 38
opposite the central base portion 36. A second portion 44 of the
perimeter lip 40 is spaced from the adhesive 34 so as not to adhere
to it. This creates a gap or slight separation 46. The gap 46
facilitates separating the container 24 from the patch 22 for
application of the patch 22 to a patient. The asymmetric shape of
the central base portion 36 may be selected so as to mate with the
opening provided by the cartridge holder members 120 in an
orientation that presents the gap 46 to the front of the mounting
fixture 100. This prevents the user from accidentally misaligning
the gap 46 with respect to the applicator device 50.
[0046] The mounting fixture 100 with mounted cartridge 20 is shown
partially mated with an applicator device 50 in FIGS. 15 and 16.
The alignment guides 110 contact an outer recess 55, thus providing
for alignment of the cartridge 20 with the retainer members 60 of
the applicator 50. The mounting fixture may be used to fully insert
the cartridge 20 into the applicator 50, at which time the mounting
fixture 100 and container 24 may be removed, thereby leaving the
patch 22 mounted in the applicator 50. In one embodiment, the
mounting fixture may be easily grasped by a user or otherwise fixed
in space, so that the user may bring the applicator 50 towards the
stationary mounting fixture to load the patch 22 into the
applicator 50. For example, the mounting fixture 100 may be part of
a base station that holds multiple cartridges 20 and advances them
to the cartridge holder members 120 one at a time. In another
embodiment, the mounting fixture 100 may be integrated with
packaging material used to hold one or more cartridges 20. For
example, a box of cartridges may have a mounting fixture affixed to
an outside surface so that a user could remove a cartridge from the
box, place the cartridge in the mounting fixture, and load the
cartridge into the applicator as described above. In still another
embodiment, a tray holding multiple cartridges could be provided,
wherein each cartridge is held in a mounting fixture integrally
molded into the tray. Thus each cartridge could be directly loaded
from the tray into an applicator.
[0047] The mounting configuration shown in FIGS. 3 and 4 is
provided by way of example, and not limitation. In further
embodiments, other means of mounting a patch on the applicator
device can be used. For instance, in further embodiments, one or
more patches can be stored inside the applicator device 50 prior to
application, and then dispensed for application to a target
site.
[0048] FIGS. 5-8 show a second embodiment of a microneedle
cartridge 70. FIG. 5 is a perspective view of the microneedle
cartridge 70. FIG. 6 is a front cross-sectional view of the
microneedle cartridge 70, and FIG. 7 is a side cross-sectional view
of the microneedle cartridge 70. FIG. 8 is a bottom view of the
microneedle cartridge 70.
[0049] The microneedle cartridge 70 includes a patch 22 and a
container 24. The patch 22 includes a web of material 26, a
microneedle array 28 and an adhesive 34 on a bottom face 32 of the
web of material 26, and is generally similar to that shown and
described with respect to FIGS. 1-4 above. The container 24 is
removably attached to the patch 22 to cover the microneedle array
28. The container 24 includes a circular central base portion 36, a
sidewall 38 connected at or near the perimeter of the central base
portion 36, and a perimeter lip 40 connected to the sidewall 38
opposite the central base portion 36. A pair of opposed cutouts 72
are provided in the perimeter lip 40. The cutouts 72 in the
perimeter lip 40 make the container 24 smaller than a width or
diameter of the patch 22 in particular regions, and expose portions
of the adhesive 34 on the bottom face 32 of the web of material
26.
[0050] A pair of stiffeners 74 are provided on an upper face 30 of
the web of material 26. The stiffeners 74 provide additional
rigidity to the patch 22 in order to reduce flexing, bending and
other undesired deformation of the microneedle array 28 prior to
and during handling and deployment. In particular, the stiffeners
74 will reduce flexing in the area of the patch 22 that is
suspended above the central base portion 36. As shown in FIGS. 6-8,
the stiffeners 74 are parallel to each other and generally aligned
relative to the sidewall 38 of the container 24. In further
embodiments, more or fewer stiffeners 74 can be provided.
Furthermore, the stiffeners 74 can be provided at different
locations on the patch 22 than those shown in FIGS. 6-8. It should
be understood that the stiffeners 74 are optional and that in
certain embodiments the patch 22 may have sufficient resistance to
bending or flexing without the need for additional stiffeners 74.
For example, the microneedle array 28 may extend near or up to the
inner surface of the sidewalls 38 and thereby provide sufficient
rigidity in the suspended portion of the patch 22.
[0051] FIG. 9 is a perspective view of a third embodiment of a
microneedle cartridge 80. FIG. 10 is a cross-sectional view of the
microneedle cartridge 80. As shown in FIGS. 9 and 10, the
microneedle cartridge 80 includes a patch 22 and a container 24.
The patch 22 includes a web of material 26, a microneedle array 28
and an adhesive 34 on a bottom face 32 of the web of material 26,
and is generally similar to those shown and described with respect
to FIGS. 1-8 above. The container is removably attached to the
patch 22 to cover the microneedle array 28. The container 24
includes a circular central base portion 36, a sidewall 38
connected at or near the perimeter of the central base portion 36,
and a perimeter lip 40 connected to the sidewall 38 opposite the
central base portion 36. A gasket 82 is disposed to adhere to the
lip 40 of the container 24 and patch (i.e., to the web of material
26 or the adhesive 34). The gasket 82 is disposed in a
substantially continuous band around the microneedle array 28 in
order to form a seal between the patch 22 and the container 24. In
one embodiment, the gasket 82 is an adhesive. In one embodiment a
different adhesive may be used for the gasket than that used for
the adhesive 34 adhered to the bottom face 32 of the web of
material 26.
[0052] Inserting the cartridge 80 into an applicator device can be
generally similar to that described above with respect to FIGS.
1-8. Additionally, the seal formed by the gasket 82 can be broken
during an inserting procedure. For example, an operator can rotate
the cartridge 80 relative to an applicator device to slice or
otherwise break the seal using a blade or other means disposed on
the applicator device.
[0053] A plurality of individual microneedle cartridges can be
arranged as a package for providing advantages in storage,
transportation and dispensing them. FIG. 11 is a perspective view
of a number of microneedle cartridges 90 arranged as a sheet 92.
The sheet 92 includes a liner 94 on which the cartridges 90 are
carried. The individual cartridges 90 can be removably adhered to
the liner 94, or secured together by other methods. In some
embodiments, perforations 96 can be provided in the liner 94 for
separating individual cartridges 90.
[0054] FIG. 12 is a side view of a number of microneedle cartridges
90 arranged as a roll 98. The roll 98 includes a liner 94 on which
the cartridges 90 are carried and a core 99 around which the liner
94 is wound. The individual cartridges 90 can be removably adhered
to the liner 94, or secured together by other methods. In some
embodiments, perforations 96 can be provided in the liner 94 for
separating individual cartridges 90.
[0055] The packages shown and described with respect to FIGS. 11
and 12 permit storage of a plurality of cartridges in close
proximity to each other. Individual cartridges can be separated
from the others as desired for use. Those packages can also help
reduce time between microneedle array deployments, by facilitating
"reloading" of applicator devices between array deployments.
[0056] Applicators used to apply a microneedle array or patch will
typically accelerate the microneedle device to reach a desired
velocity that is effective to pierce the microneedles into the
skin. The desired velocity is preferably controlled to limit or
prevent stimulation of the underlying nerve tissue. The maximum
velocity achieved by the microneedle array upon impact with the
skin is often 20 meters per second (m/s) or less, potentially 15
m/s or less, and possibly 10 m/s or less. In some instances, the
maximum velocity be 8 m/s or less. In other instances, the minimum
velocity achieved by the microneedle array upon impact with the
skin is often 2 m/s or more, potentially 4 m/s or more, and
possibly 6 m/s or more.
[0057] The microneedle arrays useful in the various embodiments of
the invention may comprise any of a variety of configurations, such
as those described in the following patents and patent
applications, the disclosures of which are herein incorporated by
reference. One embodiment for the microneedle arrays comprises the
structures disclosed in U.S. Patent Application Publication No.
2003/0045837. The disclosed microstructures in the aforementioned
patent application are in the form of microneedles having tapered
structures that include at least one channel formed in the outside
surface of each microneedle. The microneedles may have bases that
are elongated in one direction. The channels in microneedles with
elongated bases may extend from one of the ends of the elongated
bases towards the tips of the microneedles. The channels formed
along the sides of the microneedles may optionally be terminated
short of the tips of the microneedles. The microneedle arrays may
also include conduit structures formed on the surface of the
substrate on which the microneedle array is located. The channels
in the microneedles may be in fluid communication with the conduit
structures. Another embodiment for the microneedle arrays comprises
the structures disclosed in U.S. Patent Application Publication No.
2005/0261631, which describes microneedles having a truncated
tapered shape and a controlled aspect ratio. Still another
embodiment for the microneedle arrays comprises the structures
disclosed in U.S. Pat. No. 6,091,975 (Daddona, et al.) which
describes blade-like microprotrusions for piercing the skin. Still
another embodiment for the microneedle devices comprises the
structures disclosed in U.S. Pat. No. 6,313,612 (Sherman, et al.)
which describes tapered structures having a hollow central channel.
Still another embodiment for the micro arrays comprises the
structures disclosed in U.S. Pat. No. 6,379,324 (Gartstein, et al.)
which describes hollow microneedles having at least one
longitudinal blade at the top surface of tip of the
microneedle.
[0058] Microneedle patches of the present invention may be used to
deliver drugs (including any pharmacological agent or agents)
through the skin in a variation on transdermal delivery, or to the
skin for intradermal or topical treatment, such as vaccination.
[0059] In one aspect, drugs that are of a large molecular weight
may be delivered transdermally. Increasing molecular weight of a
drug typically causes a decrease in unassisted transdermal
delivery. Microneedle arrays of the present invention have utility
for the delivery of large molecules that are ordinarily difficult
to deliver by passive transdermal delivery. Examples of such large
molecules include proteins, peptides, nucleotide sequences,
monoclonal antibodies, DNA vaccines, polysaccharides, such as
heparin, and antibiotics, such as ceftriaxone.
[0060] In another aspect, microneedle patches of the present
invention may have utility for enhancing or allowing transdermal
delivery of small molecules that are otherwise difficult or
impossible to deliver by passive transdermal delivery. Examples of
such molecules include salt forms; ionic molecules, such as
bisphosphonates, preferably sodium alendronate or pamedronate; and
molecules with physicochemical properties that are not conducive to
passive transdermal delivery.
[0061] In another aspect, microneedle patches of the present
invention may have utility for enhancing delivery of molecules to
the skin, such as in dermatological treatments, vaccine delivery,
or in enhancing immune response of vaccine adjuvants.
[0062] Microneedle patches may be used for immediate delivery, that
is where they are applied and immediately removed from the
application site, or they may be left in place for an extended
time, which may range from a few minutes to as long as 1 week. In
one aspect, an extended time of delivery may be from 1 to 30
minutes to allow for more complete delivery of a drug than can be
obtained upon application and immediate removal. In another aspect,
an extended time of delivery may be from 4 hours to 1 week to
provide for a sustained release of drug.
[0063] Although the present invention has been described with
reference to several alternative embodiments, workers skilled in
the art will recognize that changes may be made in form and detail
without departing from the spirit and scope of the invention. For
instance, various types of microneedle arrays can be utilized
according to the present invention, as well as various types of
microneedle applicator devices.
* * * * *