U.S. patent application number 11/328035 was filed with the patent office on 2007-06-28 for valved intradermal delivery device and method of intradermally delivering a substance to a patient.
This patent application is currently assigned to Becton, Dickinson and Company. Invention is credited to Charles G. Hwang, Bradley M. Wilkinson.
Application Number | 20070149945 11/328035 |
Document ID | / |
Family ID | 28453418 |
Filed Date | 2007-06-28 |
United States Patent
Application |
20070149945 |
Kind Code |
A1 |
Wilkinson; Bradley M. ; et
al. |
June 28, 2007 |
Valved intradermal delivery device and method of intradermally
delivering a substance to a patient
Abstract
An intradermal delivery device for delivery a substance into the
skin of a patient has a fluid chamber for containing the substance,
at least one micro skin penetrating member, and a valve controlling
the flow of the substance from the fluid chamber to the micro skin
penetrating member. An adhesive releasably attaches the device to
the skin of the patient, the fluid chamber can be sized to hold a
unit dose of the substance, and, in some embodiments, the fluid
chamber can be releasably coupled to a housing of the device.
Inventors: |
Wilkinson; Bradley M.;
(North Haledon, NJ) ; Hwang; Charles G.;
(Ridgewood, NJ) |
Correspondence
Address: |
DAVID W. HIGHET, VP AND CHIEF IP COUNSEL;BECTON, DICKINSON AND COMPANY
1 BECTON DRIVE, MC 110
FRANKLIN LAKES
NJ
07417-1880
US
|
Assignee: |
Becton, Dickinson and
Company
Franklin Lakes
NJ
|
Family ID: |
28453418 |
Appl. No.: |
11/328035 |
Filed: |
January 9, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10112756 |
Apr 2, 2002 |
7047070 |
|
|
11328035 |
Jan 9, 2006 |
|
|
|
Current U.S.
Class: |
604/500 ;
604/47 |
Current CPC
Class: |
A61B 17/205 20130101;
A61M 5/148 20130101; A61M 2037/003 20130101; A61M 37/0015 20130101;
A61M 5/14248 20130101; A61M 5/425 20130101; A61M 5/16881 20130101;
A61M 2037/0023 20130101 |
Class at
Publication: |
604/500 ;
604/047 |
International
Class: |
A61B 17/20 20060101
A61B017/20; A61M 37/00 20060101 A61M037/00; A61M 31/00 20060101
A61M031/00 |
Claims
1. A method for delivering a substance into the skin of a patient,
comprising: positioning on the skin of a patient a delivery device
including a housing, a fluid chamber having an outlet, a substance
in the fluid chamber, a manually operated valve for controlling
movement of the substance through the outlet of said fluid chamber,
and at least one skin penetrating member in fluid communication
with said channel; applying a pressure sufficient for said skin
penetrating members to penetrate said skin to a depth sufficient to
deliver said substance to the patient; and opening said valve to
enable the substance to move from said fluid chamber, through said
skin penetrating members, and into the skin of the patient.
2. The method of claim 1, further comprising applying pressure to
the substance in the fluid chamber to help move the substance into
the skin of the patient.
3. The method of claim 2, wherein the fluid chamber is defined at
least in part by a movable wall, and the step of applying pressure
to the substance in the fluid chamber comprises applying pressure
to the movable wall.
4. The method of claim 3, further comprising, prior to the step of
positioning, coupling the fluid chamber to the housing.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] This Application is a divisional of U.S. patent application
Ser. No. 10/112,756, filed on Apr. 2, 2002, now U.S. Pat. No.
X,XXX,XXX.
FIELD OF THE INVENTION
[0002] The present invention relates to an intradermal delivery
device having a fluid chamber to contain a substance to be
delivered intradermally to a patient in a target area of the skin.
The present invention also relates to a method of delivering a
substance into the skin of a patient.
BACKGROUND OF THE INVENTION
[0003] Drugs and pharmaceutical agents are delivered to patients by
a variety of methods. A typical method delivers the drug or
pharmaceutical agent subcutaneously by a stainless steel cannula.
Although the subcutaneous sampling and delivery methods using a
cannula are effective for many applications, the pain normally
induced by the cannula has prompted the development of less painful
delivery methods.
[0004] The skin is made up of several layers, with the upper
composite layer being the epithelial layer. The outermost layer of
the skin, the stratum corneum, is a waterproof membrane with well
known barrier properties that prevent the influx of undesirable
molecules and various foreign substances while preventing the
outflux of various analytes. The stratum corneum is a complex
structure of compacted keratinized cell remnants having a thickness
of about 10-30 microns.
[0005] The natural impermeability of the stratum corneum prevents
the administration of most pharmaceutical agents and other
substances through the skin. Numerous methods and devices have been
proposed to enhance the permeability of the skin and to increase
the diffusion of various drugs through the skin for utilization by
the body. Typically, the delivery of drugs through the skin is
enhanced by increasing either the permeability of the skin or the
force or energy used to direct the drug through the skin.
[0006] Another method of sampling and delivering various substances
through the skin is by forming micropores or cuts through the
stratum corneum. By piercing the stratum corneum and delivering a
drug to the skin in or below the stratum corneum, many drugs can be
administered effectively. In a similar manner, some substances can
be extracted from the body through cuts or pores formed in the
stratum corneum. The devices for piercing the stratum corneum
generally include a plurality of micron size needles or blades
having a length to pierce the stratum corneum without passing
completely through the epidermis. Examples of these devices are
disclosed in U.S. Pat. No. 5,879,326 to Godshall et al.; U.S. Pat.
No. 5,250,023 to Lee et al., and WO 97/48440.
[0007] The above-noted devices that include micron-sized needles or
blades can be effective in delivering substances to the body.
However, these needles and blades having a length of a few microns
to a few hundred microns typically do not penetrate skin to a
uniform depth. The natural elasticity and resilience of the skin
will often result in the skin being deformed by the needles rather
than pierced. A microneedle array when pressed against the skin
often results in the outermost needles penetrating the skin while
the innermost needles do not penetrate or only penetrate to depth
less than the outermost needles.
[0008] The prior methods and devices for the intradermal
administration of substances have exhibited limited success.
Accordingly, an unmet need exists in the industry for an improved
device for the sampling and administration of various drugs and
other substances to the body.
SUMMARY OF THE INVENTION
[0009] The present invention is directed to a method and device for
the intradermal sampling or delivery of a substance into the skin
of a patient. More particularly, the invention is directed to a
method and device for controlling the flow of a pharmaceutical
agent, such as a drug or vaccine, through the device for delivery
into or below the stratum corneum of the skin to a depth sufficient
for the pharmaceutical agent to be absorbed and utilized by the
body.
[0010] Accordingly, it is an object of the invention to provide a
sampling or delivery device having at least one skin penetrating
member having a length that provides an increased comfort level to
the patient.
[0011] A further object of the invention is to provide a method of
penetrating the skin for sampling or delivering a substance through
the skin substantially without pain to the patient.
[0012] Another object of the invention is to provide a delivery
device having a plurality of micro skin penetrators, such as
microtubes, needles, microneedles, blades or lancets, selected for
piercing the stratum corneum of the skin to a depth that is short
of the nerve endings.
[0013] Still another object of the invention is to provide a
delivery device having a manually operated valve to control the
delivery of a substance to the at least one micro skin penetrating
member of the delivery device.
[0014] A further object of the invention is to provide a pre-filled
delivery device having a reservoir containing a substance, at least
one micro skin penetrating member, and a reservoir outlet for
supplying a substance to the micro skin penetrating member for
delivery to the patient.
[0015] Another object of the invention is to provide a delivery
device having a reservoir containing a substance to be delivered to
a patient, wherein the reservoir is defined, at least in part, by a
movable wall that is depressed to dispense the substance to the
patient.
[0016] Still another object of the invention is to provide a
delivery device having at least one micro skin penetrating member
for delivering a substance to a target area on the skin of a
patient and a ridge encircling the micro skin penetrating members
to form a containment area around the target area.
[0017] These and other aspects of the invention are substantially
achieved by providing a device for delivering a substance into the
skin of a patient. The device comprises a housing having a fluid
chamber having an outlet. A valve member is coupled to the housing
for controlling the flow of the substance through the outlet of the
chamber. A skin penetrating device is coupled to the housing and is
in fluid communication with the fluid chamber for delivering the
substance to the patient.
[0018] The objects and advantages of the invention are further
attained by providing a device for intradermally delivering a
substance to a patient. The device comprises a housing having a
bottom face dimensioned to contact the skin of the patient. The
housing has a fluid chamber with an outlet, and a manually operated
valve coupled to the housing for controlling the flow of the
substance through the outlet of the chamber. A micro skin
penetrating member is coupled to the housing and is in fluid
communication with the chamber. An arrangement is provided for
applying to the substance a pressure sufficient to deliver the
substance into the skin of a patient.
[0019] A yet further object of the invention is to provide a method
for delivering a substance into or through the skin of a patient.
The method comprises positioning on the skin of a patient a
delivery device including a housing; a fluid chamber on the housing
for containing the substance, said chamber having an outlet for the
substance; a valve member connected to said housing to control the
flow of the substance through the outlet; and a skin penetrating
device on the housing and in fluid communication with the chamber
for delivering the substance into the skin of the patient. A
sufficient pressure is applied for the micro skin penetrating
members to penetrate the skin to a depth sufficient to deliver the
substance to the patient. The valve is opened, the substance is
introduced from the fluid chamber to the micro skin penetrating
members under pressure, and the substance is delivered to the
patient. In some embodiments, the fluid chamber is removably
coupled to the housing before the delivery device is positioned on
the skin.
[0020] The aspects, advantages and other salient features of the
invention will become apparent from the following detailed
description which, taken in conjunction with the annexed drawings,
discloses preferred embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The following is a brief description of the drawings in
which:
[0022] FIG. 1 is a top plan view of the device in accordance with a
first embodiment of the invention for delivering a substance into
the skin of a patient;
[0023] FIG. 2 is a perspective view of the device of FIG. 1 showing
the device on the skin of a patient;
[0024] FIG. 3 is a side elevational view of the device of FIG. 1
showing the micro skin penetrating members extending from the
bottom face of the device;
[0025] FIG. 4 is a bottom plan view of the device of FIG. 1 showing
the micro skin penetrating members;
[0026] FIG. 5 is a cross-sectional side view of the device of FIG.
1 taken along line 5-5 of FIG. 1 showing the fluid chamber, the
cavity and the control valve;
[0027] FIG. 6 is an enlarged cross-sectional view of the control
valve;
[0028] FIG. 7 is a cross-sectional side view similar to FIG. 5 but
showing the device in contact with the skin of a patient and
dispensing the substance to the patient;
[0029] FIG. 8 is a top plan view of a delivery device in a second
embodiment of the invention;
[0030] FIG. 9 is a side elevational view of the device of FIG.
8;
[0031] FIG. 10 is a bottom plan view of the device of FIG. 8;
[0032] FIG. 11 is a cross-sectional side view of the skin
penetrating device taken along line 11-11 of FIG. 8 showing the
reservoir filled with a substance;
[0033] FIG. 12 is a cross-sectional view of the device of FIG. 8
showing the device penetrating the skin and the top wall depressed
to dispense the substance;
[0034] FIG. 13 is a perspective view of the device in another
embodiment of the invention;
[0035] FIG. 14 is a top plan view of the device of FIG. 13;
[0036] FIG. 15 is a side view of the device of FIG. 13 showing a
protective strip partially removed from the device;
[0037] FIG. 16 is a side view of the device of FIG. 13 showing the
rib around the micro skin penetrating members;
[0038] FIG. 17 is a plan bottom view of the device of FIG. 13;
[0039] FIG. 18 is a cross-sectional view taken axially to the line
of 18-18 of FIG. 14; and
[0040] FIG. 19 is a cross-sectional view similar to FIG. 13, but
showing the device in contact with the skin of a patient and the
device delivering the substance through the micro skin penetrating
members.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0041] The present invention is directed to a device for sampling,
monitoring or delivering a substance into the skin of a patient.
More particularly, the invention is directed to a delivery device
and to a method for administering a substance to below the stratum
corneum of the skin of a patient.
[0042] As used herein, the term "penetrate" refers to entering a
layer of the skin without passing completely through. The term
"pierce" refers to passing completely through a layer of the
skin.
[0043] The device and method of the present invention are suitable
for use in administering various substances, including
pharmaceutical agents, to a patient, and especially to a human
patient. As used herein, a pharmaceutical agent includes a
substance having biological activity that can be delivered through
the body membranes and surfaces, and particularly into the skin.
Examples include antibiotics, antiviral agents, analgesics,
anesthetics, anorexics, antiarthritics, antidepressants,
antihistamines, anti-inflammatory agents, antineoplastic agents,
vaccines, including DNA vaccines, and the like. Other substances
that can be delivered intradermally to a patient include proteins,
peptides and fragments thereof. The proteins and peptides can be
naturally occurring, synthesized or recombinantly produced.
[0044] The device of the invention is primarily for delivering a
substance into selected layers of the skin. In alternative
embodiments of the invention, the device is suitable for
withdrawing a substance or monitoring the level of a substance in
the body. Examples of substances that can be monitored or withdrawn
include blood, interstitial fluid or plasma that can then be
analyzed for analytes, glucose, drugs and the like.
[0045] Referring to FIGS. 1-7, the invention in a first embodiment
is directed to a device 10 having a supporting body 12 with a skin
penetrating device 14 and a valve assembly 16. Device 10 is
constructed for penetrating one or more selected layers of the
dermis of a patient to attain the desired depth of penetration. The
desired depth of penetration is determined by the substance being
delivered, the delivery rate and the absorption rate. Penetration
to a depth of 1 mm results in a high uptake by the body.
Penetration to a depth on the order of 5 mm would slow delivery.
The device is provided with one or more penetrating members each
having a length to pierce the stratum corneum substantially without
penetrating the dermis, which is below the stratum corneum and
below the other layers of the epidermis. By delivering a substance
to just below the stratum corneum, the substance can be absorbed
and utilized by the body substantially without pain or discomfort
to the patient. The device penetrates the dermis to a depth without
contacting pain inducing nerves in the skin. Each penetrating
member has a length sufficient to pierce the stratum corneum to a
depth at which pain is reduced or minimized and the substance is
absorbed by the body.
[0046] Referring to the drawings, body 12 forms a housing that has
a generally flat profile when attached to the skin of a patient.
The flat profile provides an ease of attachment to the skin and
less obstruction to the patient. As shown in the embodiment of FIG.
1, body 12 has an elongated shape, although in alternative
embodiments, body 12 can have a circular, square, rectangular or
other shape.
[0047] As shown in FIG. 1, body 12 includes a base 18 having a
generally elongated configuration. In this embodiment, base 18 has
a generally planar shape with a rounded front end 20 and a straight
rear end 22. Base 18 has a substantially flat bottom face 24 and a
top face 26. A reservoir 28 is defined on the top face 26 of base
18 for containing a substance to be delivered to the patient as
discussed hereinafter in greater detail.
[0048] Base 18 is dimensioned and configured to be placed against
the skin of a patient for delivering a substance such as a drug or
pharmaceutical. As shown in FIGS. 4 and 5, base 18 has a recess 30
dimensioned to receive skin penetrating device 14. Recess 30
includes a ledge 32 and a side wall 34 for supporting skin
penetrating device 14. Side wall 34 preferably has a height
sufficient to receive skin penetrating device 14 such that the
outer face of skin penetrating device 14 lies in the plane of
bottom face 24 of base 18. Ledge 32 has a width sufficient to
support skin penetrating device 14. As shown in FIG. 4, recess 30
has a dimension complementing the outer dimension of skin
penetrating device 14 so that skin penetrating device 14 can be
coupled to base 18. In preferred embodiments, skin penetrating
device 14 is coupled to base 18 by a suitable adhesive. In other
embodiments, skin penetrating device 14 can be integrally formed
with base 18. Other coupling arrangements can also be used.
[0049] Referring to FIG. 5, base 18 includes a top wall 36
overlying recess 30. Recess 30 has a depth extending between top
wall 36 and bottom face 24 of base 18 that is greater than the
thickness of skin penetrating device 14. Recess 30 forms a cavity
38 between top wall 36 and skin penetrating device 14. Cavity 38 is
dimensioned to allow the flow of a liquid while providing a volume
to minimize the dead space in base 18.
[0050] Reservoir 28 has an outer wall 40 integrated with the body
12 and spaced from top wall 36 of base 18 to define an internal
chamber 42. Chamber 42 is dimensioned to contain a sufficient
volume, for example, a predetermined unit dose, of a substance to
be delivered to a patient. The chamber 42 is prefilled with the
substance. In the embodiment illustrated, outer wall 40 of
reservoir 28 has a generally dome shape with a convex outer surface
44 and a concave inner surface 46. Outer wall 40 is coupled to top
face 26 of base 18 by a suitable adhesive or a weld to form a
fluidtight seal for enclosing reservoir 28.
[0051] Reservoir 28 includes an end wall 48 having a channel 50
extending between cavity 38 and chamber 42, the channel 50 defining
an outlet of the chamber 42. Outer wall 40 includes a movable
dispensing member 52 for applying sufficient pressure to the
chamber 42 to dispense a substance from chamber 42 through channel
50 to cavity 38. In the embodiment illustrated, dispensing member
52 is a flexible member that can be depressed inwardly toward
chamber 42 to dispense the substance. Dispensing member 52
initially has a concave inner surface 54 to form a generally bubble
shape. Preferably, dispensing member 52 is made of a resilient,
flexible plastic material that can be depressed and deflected
inward by manual pressure by the user. In this embodiment, outer
wall 40 is substantially rigid.
[0052] Valve assembly 16 is positioned in channel 50 to control the
flow of the substance from chamber 42 through channel 50. In this
embodiment, valve assembly 16 is a rotatable valve having a valve
element, or valve body 56, having a portion exposed to the exterior
of the delivery device 10 for manipulation between a closed
position and an open position. In the illustrated embodiment, the
exposed portion has an actuator handle 58. Referring to FIG. 6,
valve body 56 has a substantially cylindrical shape for rotating
within aperture 60 in base 12. Aperture 60 has a shape and
dimension complementing valve body 56 and extends from top face 26
of base 18 to cavity 38. As shown in FIG. 6, handle 58 is coupled
to a top end 62 of valve body 56. Valve body 56 has a lower end 64
positioned at the opening to cavity 38. The exposed portion of the
valve body 56 serves as an indicator indicating whether the valve
body is in a closed position or an open position. For example, as
can be appreciated from FIGS. 2 and 6, pointing of the handle 58 in
the longitudinal direction of the delivery device 10 indicates that
the valve body 56 is open. On the other hand, as can be seen from
FIGS. 1 and 6, pointing of the handle 58 in the transverse
direction of the delivery device 10 indicates that the valve body
56 is closed.
[0053] Valve body 56 includes an axial passage 66 extending from
lower end 64. A radial passage 68 extends through valve body 56 and
intersects axial passage 66. Radial passage 68 is aligned with
channel 50 in end wall 48 of reservoir 28 to provide fluid
communication between reservoir 28 and cavity 38. Valve body 56 is
rotatable within aperture 60 as depicted in FIG. 1 to open and
close valve assembly 16. In the embodiment illustrated, a recess 70
is provided in top face 26 of base 18 to receive handle 58 of valve
assembly 16. Recess 70 allows handle 58 to rotate about 90.degree.
from the closed position shown in FIG. 1 to the open position shown
in FIG. 6.
[0054] Referring to FIG. 6, skin penetrating device 14 includes a
base 72 having at least one micro skin penetrating member 74
extending outwardly from base 72. In the illustrated embodiment,
there are a plurality of micro skin penetrating members 74 arranged
in an array of spaced apart rows and columns, as can best be
appreciated from FIG. 4.
[0055] In the illustrated embodiment, micro skin penetrating
members 74 are hollow needles each having a beveled tip 76 for
penetrating the skin of a patient and an axial passage 78 extending
between tip 76 and a top face 80 of base 72. Base 72 has a bottom
face 82 supporting micro skin penetrating members 74. Preferably,
bottom face 82 of base 72 has a substantially planar configuration
and is oriented in the plane of bottom face 24 of base 18.
[0056] Skin penetrating device 14, having at least one micro skin
penetrating member 74, can be made from various materials. In one
embodiment, a plurality of micro skin penetrating members 74 are
spaced apart from each other a uniform distance and have a uniform
length. The skin penetrating device 14 is made from silicon by, for
example, suitable silicon etching or micromachining steps. In other
embodiments, device 14 is made from stainless steel, tungsten
steel, or alloys of nickel, molybdenum, chromium, cobalt and
titanium. Alternatively, the micro skin penetrating members can be
made of ceramic materials, polymers and other non-reactive
materials.
[0057] The micro skin penetrating members 74 have a length suitable
to achieve the desired depth of penetration in the skin. The length
and thickness of the micro skin penetrating members 74 are selected
based on the substance being administered or withdrawn and the
thickness of the skin in the location where the device is to be
applied. The micro skin penetrating members can be microneedles,
microtubes, solid or hollow needles, lancets and the like.
Generally, the micro skin penetrating members have a length,
measured from the base to the tip of the member, of about 50
microns to about 4,000 microns and preferably, about 250 microns to
1,000 microns. The needles are typically mounted in a suitable base
and have a substantially uniform length. In some embodiments, the
micro skin penetrating members are about 30-gauge to about 50-gauge
needles having a length of about 500 microns to about 1,000
microns. The micro skin penetrating members have a substantially
square cross-sectional shape. Alternatively, the micro skin
penetrating members can be triangular, cylindrical, or
pyramid-shaped, or they can be flat blades.
[0058] The skin penetrating members 74 can be in an array covering
an area of from about one cm.sup.2 to about 10 cm.sup.2. The array
can have a width and length of about one centimeter to about five
centimeters. The base 40 has a thickness of about 200 to 400
microns, and typically about 250 microns.
[0059] Generally, when the device is used as a delivery device, a
pharmaceutical agent or drug solution is provided in the reservoir
28. In alternative arrangements, a dried or lyophilized drug or
pharmaceutical agent can be provided in the cavity 38 or in the
axial passages 78 of the skin penetrating member 74. A diluent such
as distilled water or saline solution can be provided in the
reservoir 28 and selectively allowed to flow by manipulation of the
valve handle 58 into the cavity 38 and the axial passages 78 of the
micro skin penetrating members 74 to dissolve and reconstitute the
drug or pharmaceutical agent and then deliver the drug to the
patient.
[0060] Bottom face 24 of base 18 in the embodiment of FIGS. 1-7
includes a pressure sensitive adhesive 84 surrounding skin
penetrating device 14. Preferably, adhesive 84 forms a continuous
circle around skin penetrating device 14 and has an area sufficient
to releasably attach device 10 to the surface of a patient's skin.
In all embodiments of the invention, a protective cover can be
coupled to bottom face 24 of base 18 to cover adhesive 84 and skin
penetrating device 14 until ready for use. The cover can be a rigid
member or a flexible sheet material that can be peeled from the
adhesive 84.
[0061] Device 10 is primarily intended to be a prefilled delivery
device containing a pharmaceutical agent or drug to be delivered to
a patient. In use, device 10 is removed from its protective
packaging and positioned on the surface of skin 86 as shown in FIG.
7. A downward pressure is applied against body 12 with a force
sufficient to cause micro skin penetrating members 74 to penetrate
skin 86 to a desired depth, as determined by the length of skin
penetrating members 74. Adhesive 84 attaches device 10 to the
surface of skin 86 to prevent lateral movement of device 10 during
delivery of the substance contained within reservoir 28. Adhesive
84 also forms a seal to prevent leakage of the substance from a
target area of skin 86 penetrated by micro skin penetrating members
74.
[0062] After device 10 is positioned on skin 86, valve assembly 16
is rotated to the open position shown in FIGS. 6 and 7 to provide
fluid communication between chamber 42 of reservoir 28 and cavity
38 of base 18. The position of the valve handle 58 indicates
whether the valve is open or closed. A manual pressure is applied
against dispensing member 52 as indicated by arrow 88 in FIG. 7 to
deflect dispensing member 52 inwardly into chamber 42, thereby
imposing a dispensing pressure on the substance in the chamber. The
dispensing pressure forces the substance from chamber 42 through
channel 50 and valve body 66 to cavity 38 where the substance can
flow through the axial passages 78 of skin penetrating members 74.
The dispensing pressure and the substance is accordingly dispensed
so long as so long as the dispensing member 52 is depressed; and
the dispensing pressure is gradually released upon release of the
dispensing member 52. The manual pressure is maintained for a time
sufficient to enable a sufficient amount of the substance to be
delivered to a desired depth in the skin 86 where the substance can
be absorbed and utilized by the body. Manual pressure is maintained
throughout the delivery operation.
[0063] Device 10, including body 12 and valve assembly 16, is
preferably made of a polymeric material that is non-reactive with
the substance being delivered to the patient and non-irritating to
the patient. Typically, base 12 is made of a suitable plastic
material that allows some flexibility to conform to the contour of
the skin of the patient while being sufficiently rigid to maintain
the structural integrity of device 10. Examples of suitable
polymers include polyethylene, polypropylene, polystyrene,
polyesters, polyamides, polycarbonates, and copolymers thereof.
Embodiment of FIGS. 8-12
[0064] Referring to FIGS. 8-12, a second embodiment of the
invention is illustrated for delivering a substance intradermally
to a patient. Device 90 includes a body 92, a skin penetrating
device 94 and a valve assembly 96. As shown in FIG. 8, body 92 has
a generally circular configuration with a substantially flat planar
top surface 98 and a planar bottom surface 100.
[0065] Top surface 98 of body 92 includes a recess 102 defined by a
bottom surface 104 and a side wall 106. A flexible closure member
108 is coupled to top face 98 to close recess 102. Closure member
108 defines a reservoir having a chamber 110 between bottom surface
104 and closure member 108. As shown in FIG. 9, closure member 108
has a generally hemispherical shape having a convex top surface 112
and a concave bottom surface 114. A movable dispensing member is in
the form of a closure member 108, which is preferably made of a
material having the same characteristics as the material of the
movable dispensing member 52 of the embodiment of FIGS. 1-7. In
this embodiment, closure member 108 forms a top wall of chamber 110
and covers an area at least equal to the area of recess 102.
[0066] Side wall 106 of recess 102 includes a channel 116 extending
radially outward from side wall 106. An aperture 118 defining a
cylindrical channel extends between top surface 98 of body 92 and
bottom surface 100. As shown in FIG. 11, channel 116 intersects
with aperture 118.
[0067] Bottom surface 100 of body 92 includes a recess 120
dimensioned to receive skin penetrating device 94. Recess 120
includes a ledge 122 having a side wall 124 for receiving skin
penetrating device 94. As shown in FIG. 11, side wall 124 has a
height corresponding substantially to the thickness of skin
penetrating device 94, so that the outer face of skin penetrating
device 94 lies in the plane of bottom surface 100 of body 92.
[0068] Recess 120 has a bottom surface 106 that is spaced from
bottom surface 100 by a distance greater than the thickness of skin
penetrating device 94 to define a cavity 128. Aperture 118
communicates with cavity 128 to provide fluid communication between
chamber 110 and cavity 128.
[0069] Skin penetrating device 94 includes a base 130 having at
least one micro skin penetrating member 132 extending outwardly
therefrom. As shown in FIG. 11, base 130 is dimensioned to fit on
ledge 122 of recess 120. Micro skin penetrating members 132 are
preferably microneedles in an array, the members each having a
length sufficient to penetrate the surface of the skin to a
selected depth for delivering a substance into the skin to a depth
at which the substance can be utilized by the body.
[0070] Valve assembly 96 includes a cylindrical element body 134
dimensioned to fit in aperture 118. An actuating handle 136 is
coupled to a top end 138 of valve body 134. Valve body 134 has a
bottom end 140 with an axial passage 142. A radial passage 144
extends through a side face 146 of valve body 134 and intersects
with axial passage 142. As shown in FIG. 11, radial passage 144 is
aligned with channel 116. Valve body 134 can be rotated within
aperture 118 between the closed position of FIG. 11 and the open
position of FIG. 12, the handle 136 indicating the position of the
valve. Valve body 134 effectively closes chamber 110 to contain the
substance within chamber 110 during storage and shipping of device
90. Valve body 134 can be rotated to the open position of FIG. 12
to provide fluid communication between chamber 110 and cavity
128.
[0071] Device 90 is used in a manner similar to the embodiment of
FIGS. 1-7. Bottom surface 110 in the embodiment illustrated has an
adhesive 148 such as a pressure-sensitive adhesive around the
peripheral edge of body 92. As shown in FIG. 10, adhesive 148
surrounds skin penetrating device 94. Device 90 is positioned on
the skin 150 of a patient and pressed downwardly to enable micro
skin penetrating members 132 to penetrate the skin 150 and to allow
adhesive 148 to attach device 190 to skin 150. Valve body 134 is
rotated to the open position to provide fluid communication between
chamber 110 and cavity 128. A downward pressure indicated by arrow
152 is applied to closure member 108 to produce a dispensing
pressure sufficient to deliver a substance intradermally to the
patient.
Embodiment of FIGS. 13-19
[0072] FIGS. 13-19 show another embodiment of a device 160 for
delivering a substance intradermally to a patient. Device 160
includes a housing 162, a skin penetrating device 164 and a valve
element or body 166.
[0073] Housing 162, as shown in the embodiment of FIGS. 13 and 14,
has a substantially oval shape, a planar top surface 168 and a
bottom surface 170. Bottom surface 170 includes a recess 172 having
a ledge 174 and a side wall 176. As in the previous embodiments,
ledge 174 and side wall 176 are dimensioned to support skin
penetrating device 164. Recess 172 is dimensioned to form an
internal cavity 178 communicating with skin penetrating device 164.
Valve body 166 is mounted on housing 162 for controlling the flow
of liquids into cavity 178. In this embodiment, valve body 166
includes a collar 180 coupled to top surface 168 of housing 162.
Collar 180 has a substantially annular shape with an axial passage
182. Axial passage 182 extends from a top end 184 of collar 180 to
cavity 178. A cylindrical valve body 186 fits in axial passage 182
and is rotatable within collar 180. An actuating handle 188 is
coupled to a top end 190 of valve body 186. Handle 188 is
positioned for rotating valve body 186 about the longitudinal axis
of collar 180.
[0074] A supply tube 192 is coupled to collar 180 and extends
radially outward from collar 180 in a direction generally parallel
to top surface 168 of housing 162. Supply tube 192 includes an
axial passage 194 extending radially through collar 180 and
intersecting axial passage 182 of collar 180. Supply tube 192 has
an outer end with a coupling member 196 for removably coupling a
supply device or container 198 to the delivery device 160.
[0075] Supply device 198 is removably coupled to coupling member
196. Coupling member 196 can be a luer-type fitting, friction fit
or other suitable coupling member capable of forming a fluid
coupling with supply device 198.
[0076] Supply device 198 is preferably a single use disposable
device containing a unit dose of the substance to be delivered to
the patient. In the embodiment illustrated, supply device 198
includes a collar 200 and a compressible hollow body 202 containing
the substance to be delivered to the patient. Collar 200
complements coupling member 196 for coupling supply device 198 to
device 160. In the embodiment illustrated, body 202 is a bladder
formed from a flexible material that can be compressed to dispense
the contents of supply device 198. In other embodiments, supply
device 198 can be a commercially available device containing a
predetermined unit dose of a substance to be delivered and being
squeezable to deliver the substance. One such device is sold under
the trademark UNIJECT by Becton Dickinson and Company. Other unit
dose delivery devices can be used instead.
[0077] As in the previous embodiments, skin penetrating device 164
includes a base 202 having a top face 206 and a planar bottom face
208. At least one micro skin penetrating member 210 in the form of
a microneedle extends outwardly from bottom face 208. Micro skin
penetrating members 210 have an axial passage extending between top
face 206 in communication with cavity 178 and the tip of skin
penetrating member 210. Bottom surface 170 of body 162 includes a
rib 212 extending outwardly from body 162. Rib 212 surrounds skin
penetrating device 164 and has a substantially annular shape as
shown in FIG. 17. In the embodiment illustrated, rib 212 has an
inner face 214 extending generally perpendicular to bottom face 170
of body 162. Rib 212 also includes an outer face 216 converging
toward inner face 214 to form a crest 218. Outer face 216 is formed
at an incline with respect to bottom face 170.
[0078] In the embodiment illustrated, rib 212 is spaced outwardly
from micro skin penetrating members 210 and is impressed on the
skin to define a target area on the skin for the micro skin
penetrating members 210. Preferably, micro skin penetrating members
210 have an axial length slightly greater than the height of rib
212 as shown in FIG. 19.
[0079] Device 160 is placed on the skin 220 of a patient and
pressed downwardly. The downward pressure on device 160 causes rib
212 to contact skin 220 and stretch the skin in a target area 222
surrounded by rib 212. Stretching the skin in target area 222
enables micro skin penetrating members 210 to pierce the surface of
the skin. The normal elasticity of the skin provides a penetrating
resistance to micro skin penetrating members 210. By stretching the
skin in the target area 222, micro skin penetrating members 210 are
better able to pierce the surface of the skin. In addition, rib 212
forms a seal against the surface of skin 220 to contain the
substance that can leak from target area 222.
[0080] After device 160 is positioned on skin 220, valve body 166
is rotated to the open position shown in FIG. 19, the position of
the handle 188 indicating the position of the valve body 166. A
dispensing pressure indicated by arrow 224 is provided on supply
device 198 to dispense the contents of supply device 198 through
axial passage 194 and into cavity 178 where the substance can be
delivered to micro skin penetrating members 210. Preferably, supply
device 198 is able to provide a pressure sufficient to dispense the
contents and deliver the contents through micro skin penetrating
members 210 into the skin of the patient. After the contents of
supply device 198 is delivered to the patient, device 160 is
separated from skin 220 and discarded.
[0081] Device 160 is preferably designed and constructed to be a
disposable, single use device. The device is prepackaged in a
sterile condition for immediate use. In the illustrated embodiment,
bottom face 170 of body 162 includes a protective cover sheet 226.
Cover sheet 226 is attached to bottom surface 170 in a manner that
can be peeled easily from device 160 at the time of use. Cover
sheet 226 is preferably a flexible sheet material such as
Tyvek.RTM. Cover sheet 226 has a dimension to cover skin
penetrating device 164 to maintain skin penetrating device 164 in
sterile conditions until ready for use. Cover sheets similar to
cover sheet 226 can be used in connection with other embodiments
according to the present invention.
[0082] The illustrated embodiments of the device can be used safely
and effectively for the intradermal delivery of a pharmaceutical
agent or other substance to a patient. The device is particularly
suitable for introducing a vaccine intradermally for efficiently
delivering a small amount of a vaccine antigen. The length, width
and spacing of the microneedles can vary depending on the
pharmaceutical agent being administered and the desired depth of
penetration for delivery. When delivering a vaccine, the
microneedles are dimensioned to target the optimum intradermal
delivery site to promote the desired immune response.
[0083] While several exemplary embodiments have been chosen to
illustrate the invention, it will be appreciated by those skilled
in the art that various additions and modifications can be made to
the invention without departing from the scope of the invention as
defined in the appended claims.
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