U.S. patent application number 11/388451 was filed with the patent office on 2006-09-07 for method for extracting a medical device from a medical device package.
Invention is credited to David K. Lang, Gordon George Sansom, Bryan Windus-Smith.
Application Number | 20060200046 11/388451 |
Document ID | / |
Family ID | 34194775 |
Filed Date | 2006-09-07 |
United States Patent
Application |
20060200046 |
Kind Code |
A1 |
Windus-Smith; Bryan ; et
al. |
September 7, 2006 |
Method for extracting a medical device from a medical device
package
Abstract
A medical device package for receiving, and securely and
removably retaining, a medical device includes main and minor cap
members. The main cap member has a proximal end, a distal end and a
cavity with a cavity opening at the proximal end. The cavity is
configured to receive, and to securely and removably retain, the
medical device at least partially therein. The minor cap member is
configured to seal the cavity opening once the medical device has
been received in the cavity. A method for extracting a medical
device from a medical device package includes first providing a
medical device package as described above, with a medical device
therein, and a connector. The method also includes breaching the
minor cap member with the connector such that at least a portion of
the connector enters the cavity of the medical device package.
Next, the medical device is engaged by the connector and extracted
from the medical device package.
Inventors: |
Windus-Smith; Bryan;
(Elmswell, GB) ; Sansom; Gordon George;
(Inverness, GB) ; Lang; David K.; (Edinburgh,
GB) |
Correspondence
Address: |
PHILIP S. JOHNSON;JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
34194775 |
Appl. No.: |
11/388451 |
Filed: |
March 24, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10666154 |
Sep 19, 2003 |
|
|
|
11388451 |
Mar 24, 2006 |
|
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|
Current U.S.
Class: |
600/583 |
Current CPC
Class: |
A61B 50/3001 20160201;
A61B 17/3215 20130101; A61B 5/150824 20130101; A61B 5/150305
20130101; A61B 5/150572 20130101; A61B 5/150022 20130101; A61B
5/150717 20130101; A61B 5/150923 20130101; A61B 5/150358 20130101;
A61B 5/1486 20130101; A61B 5/15142 20130101; A61B 5/150427
20130101; A61B 5/157 20130101; A61B 50/362 20160201 |
Class at
Publication: |
600/583 |
International
Class: |
A61B 5/00 20060101
A61B005/00 |
Claims
1. A method for extracting a medical device from a medical device
package, the method comprising: providing: a medical device package
with a medical device contained therein, the medical device package
including: a main cap member with a cavity therein, the main cap
member including: a proximal end; and a distal end; a minor cap
member; and wherein: the cavity has a cavity opening at the
proximal end of the main cap member; the cavity is configured to
receive, and to securely and removably retain, a medical device at
least partially therein in at least one lateral channel of the main
cap member; the at least one lateral channel has a longitudinal
axis and the at least one lateral channel restrains free movement
of the medical device package in at least one direction
perpendicular to the longitudinal axis; and the minor cap member is
sealing the cavity opening; and a connector; breaching the minor
cap member with the connector such that at least a portion of the
connector has entered the cavity of the medical device cavity;
engaging the medical device with the connector; and extracting the
connector and engaged medical device from the cavity of the medical
device package.
2. The method of claim 1, wherein the medical device is an
integrated medical device that includes a tissue penetration member
and a test strip.
3. A method for extracting a medical device from a medical device
package and subsequently disabling the medical device, the method
comprising: providing: a medical device package with a medical
device contained therein at a first position, the medical device
package including: a main cap member with a cavity therein, the
main cap member including: a proximal end; and a distal end; a
minor cap member; and wherein: the cavity has a cavity opening at
the proximal end of the main cap member; the cavity is configured
to receive, and to securely and removably retain, a medical device
at least partially therein in at least one lateral channel of the
main cap member; the at least one lateral channel has a
longitudinal axis and the at least one lateral channel restrains
free movement of the medical device package in at least one
direction perpendicular to the longitudinal axis; and the minor cap
member is sealing the cavity opening; and a connector; breaching
the minor cap member with the connector such that at least a
portion of the connector has entered the cavity of the medical
device cavity; engaging the medical device with the connector;
extracting the connector and engaged medical device from the cavity
of the medical device package; and subsequently inserting the
connector and engaged medical device into a cavity of the medical
device package to a second position whereby the medical device is
disabled from subsequent use.
4. The method of claim 3, wherein the inserting step includes
inserting the engaged medical device into the cavity of the main
cap member.
5. The method of claim 3, wherein the inserting step includes
inserting the engaged medical device into a distal end cavity of
the medical device package.
6. The method of claim 3 further including: disengaging the
connector from the disabled medical device; and withdrawing the
connector from the medical device package.
Description
CROSS-REFERENCE
[0001] This application is a continuation-in-part application of
U.S. application Ser. No. 10/666,154, filed Sep. 19, 2003, which is
incorporated herein by reference in its entirety and to which
application we claim priority under 35 USC .sctn.120.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates, in general, to medical device
packages and, in particular, to medical device packages for
receiving, and securely and removably retaining, a medical
device.
[0004] 2. Description of the Related Art
[0005] A variety of medical devices require packaging to, for
example, protect the medical device from damage prior to use and to
maintain sterility of the medical device. For integrated medical
devices that combine a dermal tissue penetration member (e.g., a
lancet or micro-needle) with a test strip, the associated package
should provide for an uncomplicated deployment of the dermal tissue
penetration member during use, while also providing for protection
of a user from inadvertent contact with the dermal tissue
penetration member prior and subsequent to use. Furthermore, the
packaging should provide humidity resistance for the test strip
during storage.
[0006] Single-use (i.e., disposable) integrated medical devices are
illustrative of the above requirements in that they require a
medical device package that maintains sterility and protects the
single-use integrated medical device contained therein from damage
prior to use. Such medical device packages should also provide
humidity resistance and UV protection for a test strip of such
single-use integrated medical devices prior to use. Furthermore,
the medical device package should provide for deployment of a
dermal tissue penetration member of such a single-use integrated
medical device during use, as well as for disabling (i.e.,
preventing subsequent use) and safely discarding the single-use
integrated medical device following use.
[0007] Conventional medical device packages do not fulfill all or
even most of the requirements described above in a cost effective
manner. Still needed in the field, therefore, is a medical device
package that provides a sterility barrier and/or for protection of
a medical device enclosed therein, while also providing for an
uncomplicated deployment of the medical device during use.
Furthermore, for integrated medical devices that include a dermal
tissue penetration member (e.g., a lancet or micro-needle), a need
exists for a medical device package that protects the dermal tissue
penetration member from damage, humidity, and/or contamination
prior to use, that protects a user from accidental contact
therewith and that also disables the medical device following use,
thereby preventing its repeated use. In addition, the materials and
methods used to manufacture the medical device package should be
cost effective.
SUMMARY OF THE INVENTION
[0008] Medical device packages according to the present invention
provide a sterility barrier and/or protection for a medical device
(e.g., an integrated medical device) enclosed therein. Embodiments
of medical device packages according to the present invention also
provide for an uncomplicated deployment of the medical device
during use. Furthermore, with respect to integrated medical devices
that include a dermal tissue penetration member (e.g., a lancet or
micro-needle), medical device packages according to embodiments of
the present invention protect the dermal tissue penetration member
from damage, humidity, and/or contamination prior to use, and
protect a user from accidental contact therewith. Embodiments of
the medical device packages according to the present invention are
also adapted to disable the medical device following use, thereby
preventing its repeated use. In addition, due to relative
simplicity of configuration, medical device packages according to
the present invention are cost effective.
[0009] A medical device package according to embodiments of the
present invention includes a main cap member and a minor cap
member. The main cap member has a proximal end, a distal end and a
cavity with a cavity opening at the proximal end. The cavity is
configured to receive, and to securely and removably retain, a
medical device (e.g., an integrated medical device that includes a
dermal tissue penetration member and a test strip) at least
partially therein. The minor cap member is configured to seal the
cavity opening once the medical device has been received in the
cavity.
[0010] Medical device package kits according to embodiments of the
present invention include a main cap member, a minor cap member and
a connector. The main cap member has a proximal end, a distal end
and a cavity. The cavity has a cavity opening at the proximal end
of the main cap member. The cavity is configured to receive, and to
securely and removably retain, a medical device at least partially
therein. The minor cap member is configured to seal the cavity
opening once the medical device has been received in the cavity.
The connector is configured to engage the medical device during
removal of the medical device from the cavity.
[0011] Methods according to the present invention enable the
uncomplicated deployment (i.e., extraction) of a medical device
from a medical device package. Methods for extracting a medical
device from a medical device package according to embodiments of
the present invention first include providing a medical device
package, with a medical device (e.g., an integrated medical device)
therein, and a connector. The provided medical device package
includes a main cap member having a cavity and proximal and distal
ends, and a minor cap member. The cavity of the main cap member has
a cavity opening at the proximal end of the main cap member and is
configured to receive, and to securely and removably retain, the
medical device at least partially therein. The minor cap member is
configured to seal the cavity opening.
[0012] The methods also include breaching the minor cap member with
the connector such that at least a portion of the connector enters
the cavity. Next, the medical device is engaged by the connector
and extracted from the medical device package.
[0013] Other methods according to the present invention include
disabling a medical device that has been extracted from a medical
device package by inserting the medical device back into a cavity
of the medical device package to a position that results in a
disabling of repeated use of the medical device. Such disablement
can be obtained by, for example, a wedging of the medical device
into a fixed position within the cavity of the medical device
package.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] A better understanding of the features and advantages of the
present invention will be obtained by reference to the following
detailed description that sets forth illustrative embodiments, in
which the principles of the invention are utilized, and the
accompanying drawings (wherein like numerals represent like
elements), of which:
[0015] FIG. 1 is a simplified exploded perspective view of a
medical device package according to the present invention;
[0016] FIGS. 2A-2D are simplified top, side, proximal end and
perspective proximal end views of the main cap member of the
medical device package of FIG. 1;
[0017] FIG. 3A is a simplified cross-sectional side view of the
main cap member of the medical device package of FIGS. 1A through
2D, representing a view along line 3A-3A of FIG. 2A in the
direction of the arrows;
[0018] FIG. 3B is a simplified cross-sectional top view of the main
cap member of the medical device package of FIGS. 1A through 2D,
representing a view along line 3B-3B of FIG. 2C in the direction of
the arrows;
[0019] FIGS. 4A and 4B are simplified perspective and side views,
respectively of a medical device that can be contained within
exemplary embodiments of medical device packages according to the
present invention;
[0020] FIG. 5A is a simplified proximal-end view of the main cap
member of FIG. 1, containing the medical device of FIGS. 4A and 4B,
along with a legend defining X and Z directions in the perspective
of FIG. 5A;
[0021] FIG. 5B is a simplified cross-sectional view of the main cap
member and medical device of FIG. 5A, representing a view along
line 5B-5B of FIG. 5A in the direction of the arrows;
[0022] FIG. 5C is a cross-sectional, top view of the main cap
member and medical device of FIG. 5A, representing a view along
line 5C-5C of FIG. 5A in the direction of the arrows;
[0023] FIG. 5D is an enlargement of a portion of the
cross-sectional, top view of the main cap member and medical device
of FIG. 5C;
[0024] FIGS. 6A and 6B are simplified top and perspective views of
an exemplary embodiment of a connector for use with exemplary
embodiments of medical device packages according to the present
invention;
[0025] FIG. 6C is a side view of an exemplary embodiment of a
connector, representing a view along line 6C-6C in FIG. 6A in the
direction of the arrows;
[0026] FIG. 6D is a perspective view of the proximal end of an
exemplary embodiment of a connector that is used with the preferred
embodiment of the medical device package according to the present
invention;
[0027] FIG. 7 is a top view of a connector and a proximal end view
of an exemplary embodiment of a medical device package according to
the present invention;
[0028] FIG. 8 is a flow chart illustrating a sequence of steps in a
process for extracting a medical device from a medical device
package according to an exemplary embodiment of the present
invention;
[0029] FIGS. 9A-D are schematic, cross-sectional views depicting
various stages of the process of FIG. 8;
[0030] FIGS. 10A-E are schematic, perspective views depicting
various stages of the process of FIG. 8;
[0031] FIGS. 11A-C are schematic, top cross-sectional views
depicting various stages of the process of FIG. 8;
[0032] FIGS. 12A-C are schematic enlargements of portions of FIGS.
11A-C, respectively;
[0033] FIG. 13 is a flow chart illustrating a sequence of steps in
a process for extracting a medical device from a medical device
package and subsequently disabling the medical device according to
an exemplary embodiment of the present invention;
[0034] FIGS. 14A-D are schematic, cross-sectional views depicting
various stages of the process of FIG. 13;
[0035] FIGS. 15A-D are schematic, perspective views depicting
various stages of the process of FIG. 13;
[0036] FIGS. 16A and 16B are schematic, top cross-sectional
depictions of a stage in the process of FIG. 13;
[0037] FIG. 17 is a simplified perspective view of a medical device
package according to another exemplary embodiment of the present
invention containing a medical device;
[0038] FIG. 18 is an exploded perspective view of yet another
exemplary embodiment of a medical device package containing an
integrated medical device according to the present invention;
[0039] FIG. 19 is an exploded perspective view of yet another
exemplary embodiment of a medical device package containing an
integrated medical device according to the present invention;
[0040] FIG. 20 is a simplified cross-sectional top view of an
additional exemplary embodiment of a medical device package
according to the present invention;
[0041] FIG. 21 is a simplified cross-sectional top view of the
medical device package of FIG. 20 with a medical device retained
therein;
[0042] FIG. 22 is a simplified cross-sectional top view of the
medical device package of FIG. 21 with a medical device disabled
therein;
[0043] FIG. 23A is a simplified perspective view of a medical
device package according to another exemplary embodiment of the
present invention with a medical device retained therein;
[0044] FIG. 23B is a simplified perspective proximal end view of
the main cap member of the medical device package of FIG. 23A,
representing a view along line 23B-23B of FIG. 23A in the direction
of the arrows, along with a legend defining X and Z directions in
the perspective of FIG. 23B
[0045] FIG. 24A is a simplified perspective view of a medical
device package according to yet another exemplary embodiment of the
present invention with a medical device retained therein; and
[0046] FIG. 24B is a simplified perspective proximal end view of
the main cap member of the medical device package of FIG. 24A,
representing a view along line 24B-24B of FIG. 24A in the direction
of the arrows, along with a legend defining X and Z directions in
the perspective of FIG. 24B.
DETAILED DESCRIPTION OF THE INVENTION
[0047] FIGS. 1, 2A-2D, 3A and 3B are various simplified views of a
medical device package 100 according to an exemplary embodiment of
the present invention. Medical device package 100 includes a main
cap member 110 and a minor cap member 150.
[0048] Main cap member 110 includes a cavity 116 therein, a
proximal end 112 and a distal end 114. Cavity 116 has a cavity
opening 118 at the proximal end 112 of the main cap member 110 and
is configured to receive, and to securely and removably retain, a
medical device (e.g., integrated medical device 300, illustrated in
FIGS. 4A and 4B), at least partially therein.
[0049] FIGS. 4A and 4B are simplified perspective and side views,
respectively, of an exemplary integrated medical device 300 that
can be securely and removably contained within medical device
package 100. Integrated medical device 300 includes a test strip
304 and a dermal tissue penetration member 302, as illustrated in
FIGS. 4A-4B. Test strip 304 has a reaction area (not shown) and
electrical contacts 306 that terminate on a distal end 310 of
integrated medical device 300. Electrical contacts 306 are made of
any suitable conductive material, such as carbon. Dermal tissue
penetration member 302 includes a lancet 320 adapted to pierce a
user's skin and draw blood into the reaction area of test strip
304. Further descriptions of integrated medical devices that can be
contained within embodiments of medical device packages according
to the present invention are in International Application No.
PCT/GB01/05634 (published as WO 02/49507 on Jun. 27, 2002) and U.S.
patent application Ser. No. 10/143,399, both of which are fully
incorporated herein by reference. In addition, dermal tissue
penetration member 302 can be fabricated, for example, by a
progressive die-stamping technique, as disclosed in the
aforementioned International Application No. PCT/GB01/05634
(published as WO 02/49507 on Jun. 27, 2002) and U.S. patent
application Ser. No. 10/143,399.
[0050] Referring again to FIGS. 1, 2A-2D, 3A and 3B, in the
embodiment of medical device package 100, cavity opening 118 is
bounded by a rim 120 of sufficient surface area to enable minor cap
member 150 to be adhered to rim 120 by processes known to those
skilled in the art, including, but not limited to, heat sealing
processes. In this manner, minor cap member 150 and main cap member
110 of medical device package 100 provide a sterility barrier and
humidity protection for a medical device contained therein.
[0051] External features of main cap member 110 include a first
peripheral edge 122, a second peripheral edge 124, a main cap upper
surface 126 and a main cap lower surface 128. As shown in FIG. 2A,
first peripheral edge 122 and second peripheral edge 124 are
truncated to end at the distal edge 121 of rim 120. If desired, the
first and second peripheral edges 122, 124 can be asymmetrically
disposed about a longitudinal axis of the main cap member. Such an
asymmetric configuration can serve to properly orient the medical
device package during its insertion into a receiving slot of
associated hardware (for example, an analytical meter receiving
slot configured to direct the medical device package to a connector
described below with respect to FIGS. 6A-6D).
[0052] As shown in FIGS. 1 and 2A, main cap upper surface 126
optionally includes a directional marker 130 that is discontinuous
with (e.g., raised above or, alternatively, recessed below) the
remainder of main cap upper surface 126. Directional marker 130 may
include, but is not limited to, an ellipse 132 and an arrow 134, as
depicted in FIGS. 1 and 2A. Directional marker 130 provides a user
with both tactile and visual cues for proper orientation of medical
device package 100 during use.
[0053] Cavity 116 is defined (at least in part) by a first smooth
inner surface 127 and a second smooth inner surface 129 and
includes first and second lateral channels 140 and 142,
respectively, as shown in FIGS. 2C-2D and 3B. In addition, cavity
116 is also defined by first lateral surface 170 located internally
to first peripheral edge 122 and a second lateral surface 172
located internally to second peripheral edge 124. In the vicinity
of proximal end 112, first lateral surface 170 has a first sloped
land 160, and second lateral surface 172 has a second sloped land
162. First sloped land 160 terminates at the beginning of first
lateral channel 140, while second sloped land 162 terminates at the
beginning of second lateral channel 142. First lateral channel 140
and second lateral channel 142 extend about half way along first
and second laterals surfaces 170 and 172, respectively. First and
second sloped lands 160, 162 begin at cavity opening 118, and slope
inwardly and distally towards distal end 114 of main cap member
110.
[0054] First and second lateral channels 140 and 142 begin at the
end of first and second sloped lands 160 and 162, respectively, and
extend approximately half way into cavity 116. First and second
lateral channels 140 and 142 are divided into a post-use portion
202, a transition point 204, and a pre-use portion 206 (see FIGS.
3A and 3B). As is evident from FIG. 3B, first lateral channel 140
is the mirror image of second lateral channel 142. One skilled in
the art will recognize from the entirety of the present disclosure
that first and second sloped lands 160, 162, first and second
lateral channels 140, 142, transition point 204, and pre-use
portion 206 are configured to receive, and securely and removably
retain, a medical device within cavity 116. In addition, post-use
portion 202 is configured to disable a used medical device (as
explained in detail below with respect to, for example, FIGS. 16A
and 16B).
[0055] Main cap member 110 can be formed of any suitable material
known to those of skill in the art including, for example, rigid
plastic materials such as polystyrene, polycarbonate and polyester.
Such rigid plastic materials are impervious to puncturing and to
air and/or air-borne bacteria and, therefore, provide a sterility
barrier and a puncture-resistant protective barrier. It can be
particularly beneficial in terms of humidity protection for main
cap member 110 to be formed of a desiccant-loaded high-density
polyethylene (e.g., 2AP desiccant-loaded high-density polyethylene,
commercially available from Airsec in France).
[0056] Minor cap member 150 is configured to seal cavity opening
118 once a medical device has been received in cavity 116. In the
embodiment of FIG. 1, minor cap member 150 is a breachable film
such as breachable metallic foil. Other suitable materials for
minor cap member 150 include paper, polymer and Tyvek. However, as
described with respect to other embodiments below, minor cap member
150 can take a variety of forms, all of which are capable of
sealing the cavity opening of an associated main cap member once a
medical device has been at least partially received within the
cavity of the main cap member.
[0057] FIG. 2D is a proximal end perspective view of main cap
member 110. Transition point 204 includes a vertical shoulder 204A
and a horizontal shoulder 204B, as shown in FIG. 2D. Upon insertion
of an unused medical device (e.g., integrated medical device 300 of
FIGS. 4A and 4B prior to use) into cavity 116 of main cap member
110, vertical shoulder 204A prevents the medical device (not shown)
from being inserting past transition point 204 (see FIGS. 3A and
3B). In other words, the unused medical device is inserted only to
a first position, which is defined by contact of the unused medical
device with transition point 204. However, once a medical device is
used, such a used medical device can be inserted back into cavity
116 of main cap member 110 for disablement and disposal purposes.
In doing so, the used medical device (e.g., integrated medical
device 300 of FIGS. 4A and 4B subsequent to use) is inserted beyond
the first position to a second position, wherein the used medical
device extends past transition point 204 toward distal end 114 and
is irreparably damaged (i.e., disabled) by horizontal shoulder
204B. Such damage prevents a subsequent removal, and thus repeated
use, of the once used medical device.
[0058] FIGS. 5A-5D are various views of main cap member 100 of FIG.
1 with integrated medical device 300 of FIGS. 4A and 4B inserted
therein prior to use of integrated medical device 300 (i.e.,
integrated medical device 300 is "unused"). In FIGS. 5A-5D,
integrated medical device 300 extends between first lateral channel
140 and second lateral channel 142 and lies parallel to first
smooth inner surface 127 and second smooth inner surface 129.
Unused integrated medical device 300 is securely retained within
cavity 116 via a friction fit with first lateral channel 140 and
second lateral channel 142 such that integrated medical device 300
is engaged by first and second lateral channels 140 and 142 in at
least one direction (i.e., integrated medical device 300 is
restrained from free movement in at least one of the X and/or Z
directions of FIG. 5A). Distal end 310 of integrated medical device
300 remains within proximal end 112 of medical device package 100
and is not in contact with first lateral channel 140 and second
lateral channel 142. Furthermore, it should be noted that lancet
320 is within cavity 116 and thus protected from inadvertent
damage. Unused integrated medical device 300 is positioned within
first and second lateral channels 140 and 142 such that proximal
end 312 of integrated medical device 300 touches, but goes no
further than, transition point 204, and distal end 310 of
integrated medical device 300 remains free from contact with first
and second lateral channels 140 and 142 in cavity 116 (see FIGS. 5C
and 5D) of main cap member 110.
[0059] FIGS. 6A through 6D depict an exemplary embodiment of a
connector 500 adapted to extract integrated medical device 300 from
medical device package 100. In addition, connector 500 can
advantageously be used to mechanically and/or manually manipulate
such a medical device once the medical device has been extracted
from the medical device package. For example, connector 500 can be
used to transfer a medical device from a medical device package to
a metering system. As will be appreciated by those skilled in the
art, connector 500 may be a component (either a removable component
or a permanently integrated component) of a metering system (e.g.,
an analytical meter configured to determine analyte concentrations
in biological fluid samples). Alternatively, connector 500 can be
combined with medical device packages to form a kit according to an
exemplary embodiment of the present invention.
[0060] Connector 500 includes a strip extracting member 502 and a
connector body 504. In addition, connector 500 includes a proximal
end 510, a distal end 512, an upper surface 514 and a lower surface
516. Connector body 504 includes a connector directional marker 518
on upper surface 514. Connector directional marker 518 (optional)
is discontinuous with (e.g., raised above or recessed below) upper
surface 514 of connector 500. Connector directional marker 518 may
include, but is not limited to, an ellipse 530 and an arrow 532.
Connector directional marker 518 provides a user with both tactile
and visual cues for proper orientation of connector 500 when
inserted into medical device package 100.
[0061] Strip extracting member 502 includes a lower strip engaging
arm 540, an upper strip engaging arm 542 and a plurality of strip
engaging elements 544, as illustrated in FIGS. 6C-6D. Connector 500
also includes electrical leads (not shown) for providing an
electrical connection(s) between strip engaging elements 544 and an
analytical meter. In addition, strip extracting member 502 includes
a vertical barrier 550 that contacts distal end 310 of integrated
medical device 300 when integrated medical device 300 is engaged by
connector 500. Although three strip engaging elements 544 are
depicted in FIG. 6D for the purpose of illustration and
explanation, strip extracting member 502 can include any suitable
number of strip-engaging elements. Strip engaging elements 544 are
located on inner surface 543 of upper strip engaging arm 542. Strip
engaging elements 544 are spring-loaded connections formed, for
example, by being molded into connector 500 by any suitable process
known to those skilled in the art. Strip engaging elements 544 are
used to contact test strip 304 of integrated medical device 300
through electrical contacts 306. One skilled in the art will
recognize that connector 500 can provide electrical communication
between test strip 304 and an analytical meter via strip engaging
elements 544 and the connector's electrical leads.
[0062] FIG. 7 is a top view of connector 500 and a proximal end
view of main cap member 110, with dashed vertical lines showing
proper alignment of connector 500 during extraction of a medical
device. Solids horizontal line 5F-5F indicates width of the medical
device (for example, approximately 5.5 mm), while solid horizontal
line 5G-5G indicates the width of strip extracting element 502 (for
example, approximately 4.5 mm).
[0063] FIG. 8 is a flow chart illustrating a sequence of steps in a
process 800 for extracting a medical device from a medical device
package according to an exemplary embodiment of the present
invention. Process 800 is described below utilizing FIGS. 9A-D
(schematic, cross-sectional views depicting various stages of
process 800), FIGS. 10A-E (schematic, perspective views depicting
various stages of process 800), FIGS. 11A-C (schematic, top
cross-sectional views of various stages of process 800) and FIGS.
12A-C (schematic enlargements of portions of FIGS. 11A-C,
respectively).
[0064] Process 800 includes first providing (i) a medical device
package with a minor cap member and a medical device contained
therein and (ii) a connector, as set forth in step 810 of FIG. 8.
One skilled in the art will recognize that the provided medical
device package and connector can be any suitable medical device
package according to the present invention that includes a
breachable minor cap member (e.g., the medical device package of
FIG. 1) and any suitable connector according to the present
invention. The provision of an exemplary medical device package and
connector are depicted in FIG. 9A and FIG. 10A, wherein like
elements of the medical device package and connector of earlier
figures are identified with like numerals.
[0065] Next, as set forth in step 820, the minor cap member is
breached (e.g., ruptured) with the connector such that at least a
portion of the connector has entered into the cavity of the main
cap member (see FIGS. 9B, 10B, 11A and 12A). Subsequently, the
medical device is engaged by the connector (see FIGS. 9C, 10C, 11B
and 12B), as set forth in step 830. The force required for the
connector to engage with the medical device is, for example,
approximately 2N. The connector and engaged medical device are then
extracted from the cavity of the medical device package, as set
forth in step 840 (see FIGS. 9D, 10D-10E, 11C and 12C). Each of the
steps of process 800 can be performed, for example, either manually
by a user or with the aid of a mechanical and/or electrical
device.
[0066] It should be noted, that beaching the minor cap member (such
as a breachable film) and engaging the medical device with the
connector do not result in the medical device moving past the
transition points 204 of the first and second lateral channels 140,
142 (as depicted in FIGS. 12A and 12B, which correspond to the
breaching and engaging steps of process 800) since the force
required to move the medical device past transition points 204
(e.g., 7N) is significantly greater than the force required to
engage the connector with the medical device (e.g., 2N). In the
embodiment of FIGS. 9A-9D, 10A-10E, 11A-11C and 12A-12C, during the
engaging step, strip engaging elements of the connector engage a
test strip 304 of integrated medical device 300 and a vertical
barrier of the connector contacts the distal end of the integrated
medical device 300. The force required for the breaching the minor
cap member and engagement of the medical device can be, for
example, in the range of about 1.5 N to 2.5 N.
[0067] Solid line 5F-5F of FIG. 10E represents a dimension that is
identical to the dimension of solid horizontal line 5F-5F of FIG. 7
(i.e., the width of integrated medical device 300). Solid line
10H-10H in FIG. 10E represents the width of the medical device's
lancet. Solid line 10I-10I of FIG. 10E represents the width of
cavity opening of medical device package, which is larger than the
dimension represented by solid line 5F-5F to assure a medical
device's smooth insertion into, and removal from the cavity.
[0068] Process 800 can be performed manually or automatically.
Furthermore, process 800 can be, for example, performed by an
integrated device that combines an analytical meter and a connector
in a configuration that provides for (i) a medical device to be
extracted from a medical device package; (ii) a sample (e.g., a
whole blood sample) to be obtained from a user and (iii) an
analytical result (e.g., blood glucose concentration of the whole
blood sample) to determined, all by a single operation of the
integrated device. Mechanical motions may be incorporated into a
lancet cocking action, new test strip deployment and/or
ejection.
[0069] FIG. 13 is a flow chart illustrating a sequence of steps in
a process 1300 for extracting a medical device from a medical
device package for use and subsequently disabling the medical
device after use according to an exemplary embodiment of the
present invention. Process 1300 is described below utilizing FIGS.
14A-14D (schematic, cross-sectional views depicting various stages
of process 1300), FIGS. 15A-15D (schematic, perspective views
depicting various stages of process 1300) and FIGS. 16A-16B
(schematic, top cross-sectional views of a stage of process
1300).
[0070] Process 1300 includes first providing (i) a medical device
package with a minor cap member and a medical device contained
therein at a first position and (ii) a connector, as set forth in
step 1310 of FIG. 13. One skilled in the art will recognize that
the provided medical device package and connector can be any
medical device package according to the present invention that
includes a breachable minor cap member (e.g., the medical device
package of FIG. 1).
[0071] Next, at step 1320, the minor cap member is breached (e.g.,
ruptured) with the connector such that at least a portion of the
connector has entered the cavity of the main cap member. The
medical device is then engaged by the connector, as set forth in
step 1330. The connector and engaged medical device are then
extracted from the cavity of the medical device package for use, as
set forth in step 1340.
[0072] Subsequently, at step 1350, the connector and engaged
medical device are inserted back into a cavity of the medical
device package to a second position, whereby the medical device is
disabled from reuse (see FIGS. 14A-14C, 15A-15C and 16A-16B). The
connector is then disengaged from the medical device and withdrawn
from the medical device package, as set forth in step 1360. It is
envisioned that during step 1350, the medical device is disabled by
virtue of the medical device being wedged into the cavity such that
the force required to remove the medical device from the cavity is
greater than the force required to disengage the connector from the
medical device. Therefore, an attempt to re-extract the medical
device with the connector would be unsuccessful since the connector
would become disengaged from the medical device before sufficient
force could be applied to extract the wedged medical device.
[0073] It should be noted that during insertion of the connector
and engaged medical device into the cavity at step 1350, the
medical device is inserted to a second position within post-use
portion 202 that is beyond transition points 204 of the first and
second lateral channels (see, in particular, FIG. 16B), i.e.,
beyond the first position. The force required to insert the medical
device into the medical device package and disable the medical
device is, for example, approximately 7N. As noted above,
disablement of the medical device is a result of the medical device
being wedged into the cavity such that it cannot be re-extracted
using the connector.
[0074] FIG. 17 depicts a medical device package 1900 according to
another exemplary embodiment of the present invention. In FIG. 17,
dashed lines indicate certain features that are hidden due to the
perspective nature of FIG. 17. In addition, FIG. 17 depicts the
circumstance where a medical device (i.e., integrated medical
device 300 of FIGS. 4A and 4B) is retained partially within medical
device package 1900. In the embodiment of FIG. 17, electrical
contacts 306 project from the cavity opening and minor cap member.
Since electrical contacts 306 project from both the cavity opening
and the minor cap member, engagement of the electrical contacts
with a connector can be simplified. For example, there is no need
to breach or otherwise remove any component of the medical device
package to obtain access to the electrical contacts and the
electrical contacts are free to deflect upon engagement with a
connector.
[0075] Medical device package 1900 includes a main cap member 1910
with a proximal end 1912, a distal end 1914, a cavity 1918 and a
cavity opening 1916. Distal end 1914 is configured to function as a
handle during manually removal of medical device package 1900 from
secondary packaging (not illustrated).
[0076] Medical device package 1900 can be constructed, for example,
of molded plastic or other material that is impervious to air
and/or air-borne bacteria, to provide a sterile-protective and
puncture-resistant barrier. Suitable materials include, but are not
limited to, polystyrene, polyethylene, polycarbonate and
polyester.
[0077] Cavity 1918 of medical device package 1900 is defined by
surfaces depicted with dashed lines in FIG. 17. Cavity opening 1916
is configured to provide for the placement of dermal tissue
penetration member 302 of integrated medical device 300 wholly
within cavity 1918, as shown in FIG. 17. Medical device package
1900 includes internally disposed ribs 1960, located distally to
cavity opening 1916. Ribs 1960 serve to seal cavity 1918 once a
medical device has been inserted partially therein, and provide a
sterile and protective barrier for dermal tissue penetration member
302 by creating a tortuous path between the external environment
and the cavity of the medical device package. Ribs 1960, together
with an at least partially inserted medical device, serve as a
minor cap member for medical device package 1900. As an alternative
to ribs 1960, elastomeric o-rings could be employed to seal cavity
1918 once a medical device has been inserted partially therein, and
to provide a sterile and protective barrier for dermal tissue
penetration member 302.
[0078] FIG. 18 is an exploded perspective view of a medical device
package 2000 according to yet another exemplary embodiment of the
present invention containing a integrated medical device 300 (as
depicted in FIGS. 4A and 4B). Medical device package 2000 includes
a main cap member 2010 and a minor cap member 2020. Main cap member
2010 has a proximal end 2012, a distal end 2014, a cavity opening
(not shown), and a cavity (also not shown). The cavity and cavity
opening of main cap member 2010 are configured for placement of a
dermal tissue penetration member of an integrated medical device
wholly therein, thus providing a protective barrier for such a
dermal tissue penetration member.
[0079] Minor cap member 2020 has a proximal end 2022, a distal end
2024, a minor cap opening 2026, and a minor cap cavity (not shown
in FIG. 18). Minor cap opening 2026 and the minor cap cavity are
configured for the placement of a test strip 304 of an integrated
medical device wholly or partially therein. Furthermore, proximal
end 2012 of main cap member 2010 is adapted to fit wholly within
minor cap opening 2026 and the minor cap cavity. Once main cap
member 2010 is fit within minor cap opening 2026 and the minor cap
cavity, integrated medical device 300 is completely enclosed and
provided with a sterile-protective and moisture-free barrier.
[0080] Both main cap member 2010 and minor cap member 2020 are
beneficially constructed of molded plastic or other rigid material
that is impervious to air and/or air-borne bacteria, to provide a
sterile-protective and puncture-resistant barrier. Suitable
materials for main cap member 2010 and minor cap member 2020
include, but are not limited to, polystyrene, polyethylene,
polycarbonate and polyester.
[0081] FIG. 19 is an exploded perspective view of a medical device
package 2100 according to yet another exemplary embodiment of the
present invention. Medical device package 2100 includes a main cap
member 2110 and a minor cap member 2120. Main cap member 2110 has a
proximal end 2112, a distal end 2114, a cavity opening 2116 and a
cavity (not shown). Cavity opening 2116 and the cavity of medical
device package 2100 are configured for placement of a dermal tissue
penetration member 302 of an integrated medical device and a minor
cap member proximal end 2122 (described below) wholly therein, thus
providing a protective barrier for dermal tissue penetration member
302.
[0082] Minor cap member 2120 of medical device package 2100 has a
proximal end 2122 and a distal end 2124. Moreover, integrated
medical device 300 is permanently attached to minor cap member 2120
at proximal end 2122. The permanent attachment of such an
integrated medical device to minor cap member 2120 is envisioned to
provide handling benefits during use of the integrated medical
device. For example, minor cap member 2120 could be gripped by a
meter, with the main cap member then being easily removed by a user
(e.g., by pulling, twisting or snapping) to deploy the integrated
medical device.
[0083] FIGS. 20, 21 and 22 depict the main cap member 2450 of a
medical package device according to yet another exemplary
embodiment of the present invention (for purposes of clarity, the
minor cap member of this medical device package is not
illustrated). FIG. 21 depicts an integrated medical device 300
retained within main cap member 2450 and FIG. 22 depicts an
integrated medical device 300 disabled within main cap member 2450.
Main cap member 2450 is identical to main cap member 110 of FIG.
3B, with the exception that main cap member 2450 has a distal end
cavity 2452 configured for disablement and disposal of an
integrated medical device.
[0084] FIGS. 23A and 23B are simplified views of a medical device
package 2500 according to another exemplary embodiment of the
present invention with an integrated medical device 300 (as
depicted in FIGS. 4A and 4B) retained therein. In FIG. 23A, dashed
lines indicate certain features that are hidden from view due to
the perspective nature of FIG. 23A.
[0085] Referring to FIGS. 23A and 23B, medical device package 2500
includes a main cap member 2510 and a minor cap member 2520 (see
FIG. 23A). Main cap member 2510 has a proximal end 2512, a distal
end 2514, a cavity opening 2516, and a cavity 2518. Cavity 2518 and
cavity opening 2516 of main cap member 2510 are configured for
placement of a dermal tissue penetration member of an integrated
medical device wholly therein, thus providing a protective barrier
for such a dermal tissue penetration member.
[0086] Cavity opening 2516 is bounded by rim 2522 of Main cap
member 2510. Rim 2533 is configured to mate with surface 2523 of
minor cap member 2520. In FIG. 23A, minor cap member 2520 is
depicted as a cap that is permanently attached to main cap member
2510 by flexible minor cap member portion 2520'. Flexible minor cap
member portion 2520' is configured such that the minor cap member
can be position to close cavity opening 2516 (for example, by snap
fitting of minor cap member 2520 onto proximal end 2512 of main cap
member 2510. However, it is noted that minor cap member can also be
a foil seal that is adhered to rim 2522 by processes known to those
skilled in the art, including, but not limited to, heat sealing
processes. In this manner, minor cap member 2520 and main cap
member 2510 of medical device package 2500 provide a sterility
barrier and humidity protection for a medical device contained
therein.
[0087] Both main cap member 2510 and minor cap member 2520 (other
than flexible minor cap member portion 2520') are beneficially
constructed of molded plastic or other rigid material that is
impervious to air and/or air-borne bacteria, to provide a
sterile-protective and puncture-resistant barrier. Suitable
materials for main cap member 2510 and minor cap member 2520
include, but are not limited to, polystyrene, polyethylene,
polycarbonate and polyester.
[0088] Cavity 2518 is defined (at least in part) by a first smooth
inner surface 2524 and a second smooth inner surface 2526 and
includes first and second lateral channels 2528 and 2530,
respectively, as shown in FIG. 23B. In addition, cavity 2518 is
also defined by first lateral surface 2532 and a second lateral
surface 2534. In FIG. 23B, first lateral channel 2528 and second
lateral channel 2530 extend along about the middle third of first
and second lateral surfaces 2532 and 2534, respectively. However,
once apprised of the present disclosure, one skilled in the art
will recognize that first and second lateral channels 2528 and 2530
can also extend along the entire first and second lateral surfaces
2532 and 2534, respectively, or along any suitable portion of first
lateral surface 2532 and second lateral surface 2534.
[0089] Integrated medical device 300 extends between first lateral
channel 2528 and second lateral channel 2530 and lies parallel to
first smooth inner surface 2524 and second smooth inner surface
2526. Unused integrated medical device 300 is securely retained
within cavity 2518 via a friction fit with first lateral channel
2528 and second lateral channel 2530 such that integrated medical
device 300 is engaged by first and second lateral channels 2528 and
2530 in at least one direction (i.e., is restrained in the X and/or
Z direction of FIG. 23B). The X and Z directions of FIG. 23B are
perpendicular to a longitudinal axis of first and second lateral
channels 2528 and 2530. Therefore, first and second lateral
channels 2528 and 2530, respectively, serve to restrain the free
movement of integrated medical device 300 in at least one direction
perpendicular to the longitudinal axis of the lateral channels
[0090] Distal end 310 of integrated medical device 300 is within
proximal end 2512 of medical device package 2500 and is not in
contact with first lateral channel 2528 and second lateral channel
2530. Furthermore, it should be noted that lancet 320 is within
cavity 2518 and thus protected from inadvertent damage.
[0091] FIGS. 24A and 24B are simplified views of a medical device
package 2600 according to yet another exemplary embodiment of the
present invention with an integrated medical device 300 (as
depicted in FIGS. 4A and 4B) retained therein. In FIG. 24A, dashed
lines indicate certain features that are hidden from view due to
the perspective nature of FIG. 24A.
[0092] Medical device package 2600 includes a main cap member 2610
and a minor cap member (not shown). Main cap member 2610 has a
proximal end 2612, a distal end 2614, a cavity opening 2616, and a
cavity 2618. Cavity 2618 and cavity opening 2616 of main cap member
2610 are configured for placement of a dermal tissue penetration
member of an integrated medical device wholly therein, thus
providing a protective barrier for such a dermal tissue penetration
member. Although the minor cap member of medical device package
2600 is not shown, it is configured to cover cavity opening 2616 in
a removable manner.
[0093] Cavity opening 2616 includes a rim 2622 of sufficient
surface area to enable the minor cap member to be adhered to rim
2622 by processes known to those skilled in the art, including, but
not limited to, heat sealing processes. In this manner, minor cap
member and main cap member 2610 of medical device package 2600
provide a sterility barrier and humidity protection for a medical
device contained therein.
[0094] Main cap member 2610 is beneficially constructed of molded
plastic or other rigid material that is impervious to air and/or
air-borne bacteria, to provide a sterile-protective and
puncture-resistant barrier. Suitable materials for main cap member
2610 include, but are not limited to, polystyrene, polyethylene,
polycarbonate and polyester.
[0095] Cavity 2618 is defined (at least in part) by a first smooth
inner surface 2624 and a second smooth inner surface 2626 and
includes first and second lateral channels 2628 and 2630,
respectively, as shown in FIG. 24B. In addition, cavity 2618 is
also defined by first lateral surface 2632 and a second lateral
surface 2534. First lateral channel 2628 and second lateral channel
2630 extend along approximately the entire first and second lateral
surfaces 2632 and 2634, respectively.
[0096] Integrated medical device 300 extends between first lateral
channel 2628 and second lateral channel 2630 and lies parallel to
first smooth inner surface 2624 and second smooth inner surface
2626. Unused integrated medical device 300 is securely retained
within cavity 2618 via a friction fit with first lateral channel
2628 and second lateral channel 2630 such that integrated medical
device 300 is engaged by first and second lateral channels 2628 and
2630 in at least one direction (i.e., in the X and/or Z direction
of FIG. 24B). Distal end 310 of integrated medical device 300
remains within proximal end 2612 of medical device package 2600 and
is not in contact with first lateral channel 2628 and second
lateral channel 2630. Furthermore, it should be noted that lancet
320 is within cavity 2618 and thus protected from inadvertent
damage.
[0097] Those skilled in the art will recognize that embodiments of
medical device packages according to the present invention can be
secondarily packaged for single use in, for example, a vial or
cartridge configured for dispensing the medical device packages.
The secondary package may be constructed of material containing
desiccant or may contain separately packaged desiccant for
maintaining contents moisture free. Moreover, functional
characteristics of the various embodiments of medical device
packages (e.g., restraint of a medical device in an X or Z
direction by at least one lateral channel) can be employed, if
desired, in methods according to the present invention.
[0098] Once apprised of the present disclosure, one skilled in the
art will also recognize that a variety of medical devices can be
beneficially employed with embodiments of medical device packages
according to the present invention. Such medical devices include,
but are not limited to, integrated medical devices that include a
combination of a test strip and a lancet, examples of which are
described in the aforementioned International Application No.
PCT/GB01/05634 (published as WO 02/49507 on Jun. 27, 2002) and U.S.
patent application Ser. No. 10/143,399, both of which are fully
incorporated herein by reference. One skilled in the art will also
recognize that such test strips may have, but are not limited to,
an electrochemical or photometric configuration. For illustrative
purposes only, medical devices in various figures of the present
disclosure were depicted as having an electrochemical
configuration.
[0099] Moreover, those skilled in the art will appreciate that
medical device packages according to embodiments of the present
invention can be employed with medical device adapted for the
measurement of, for example, glucose, ketones, glycated albumin,
coagulation parameters and cholesterol of a sample.
[0100] In addition, one skilled in the art will also recognize that
medical device packages according to the present invention may be
contained within a combined sample collection and metering system
designed for in-situ testing. Examples of such systems designed for
in-situ testing are disclosed in International Patent Application
No. PCT/US01/07169 (published as WO 01/64105 A1 on Sep. 7, 2001)
and International Patent Application No. PCT/GB02/03772 (published
as WO 03/015627 A1 on Feb. 27, 2003), each of which is fully
incorporated herein by reference.
[0101] It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
* * * * *