U.S. patent application number 13/492421 was filed with the patent office on 2012-09-27 for disposable lancet device cap with integral lancet and/or test strip and testing device utilizing the cap.
This patent application is currently assigned to STAT MEDICAL DEVICES, INC.. Invention is credited to Steven SCHRAGA.
Application Number | 20120245611 13/492421 |
Document ID | / |
Family ID | 37464456 |
Filed Date | 2012-09-27 |
United States Patent
Application |
20120245611 |
Kind Code |
A1 |
SCHRAGA; Steven |
September 27, 2012 |
DISPOSABLE LANCET DEVICE CAP WITH INTEGRAL LANCET AND/OR TEST STRIP
AND TESTING DEVICE UTILIZING THE CAP
Abstract
Assembly for a testing or lancet device. The assembly includes a
lancet and a member. The member has an opening that allows a
portion of a needle of the lancet to pass therethrough.
Inventors: |
SCHRAGA; Steven; (Surfside,
FL) |
Assignee: |
STAT MEDICAL DEVICES, INC.
North Miami
FL
|
Family ID: |
37464456 |
Appl. No.: |
13/492421 |
Filed: |
June 8, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11138277 |
May 27, 2005 |
8211036 |
|
|
13492421 |
|
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|
Current U.S.
Class: |
606/181 |
Current CPC
Class: |
A61B 5/1519 20130101;
A61B 5/15186 20130101; A61B 5/150183 20130101; A61B 5/15194
20130101; A61B 5/150503 20130101; A61B 17/32093 20130101; A61B
2562/0295 20130101; A61B 5/15117 20130101; A61B 5/150358 20130101;
A61B 5/150022 20130101; A61B 5/150412 20130101; A61B 2010/0003
20130101; A61B 5/150824 20130101; A61B 5/150908 20130101; A61B
5/15113 20130101; A61B 5/14532 20130101 |
Class at
Publication: |
606/181 |
International
Class: |
A61B 17/34 20060101
A61B017/34 |
Claims
1. An assembly for a lancet or testing device, the assembly
comprising: a lancet comprising: a body; and a needle projecting
from a proximal end of the body; a member having an opening
allowing the needle of the lancet to project therethrough, wherein
the body of the lancet is sized and configured to releasably
connect to a movable member of the lancet or testing device when
the assembly is installed on the lancet or testing device.
2. The assembly of claim 1, wherein a distance between a most
proximal surface of the member and the proximal end of the body is
adapted to change between a puncturing portion of the assembly and
an initial position.
3. The assembly of claim 1, wherein the opening is less than
approximately 10 times a diameter of the needle and wherein the
body has a distal end sized and configured to releasably retained
within an opening of the movable member of the lancet or testing
device when the assembly is installed on the lancet device.
4. The assembly of claim 1, wherein, when the lancet is in a
puncturing position, the proximal end of the body contacts an
annular surface of the member.
5. The assembly of claim 1, wherein the member is a cap.
6. The assembly of claim 5, wherein the cap is structured and
arranged to be non-rotationally removably mounted to the
device.
7. The assembly of claim 1, further comprising an arrangement for
adjusting a depth of penetration of the needle of the lancet.
8. The assembly of claim 1, further comprising a test strip having
one end extending to the opening.
9. The assembly of claim 1, further comprising a test strip having
one end extending to the opening and another end extending along a
side wall of the member.
10. The assembly of claim 1, further comprising a test strip at
least partially arranged on an outer surface of the member.
11. The assembly of claim 1, further comprising a test strip having
contacts arranged on a side wall of the member.
12. The assembly of claim 1, further comprising a test strip having
contacts arranged in an area of the opening.
13. The assembly of claim 1, wherein the assembly is
disposable.
14. The assembly of claim 1, further comprising a mechanism for
retaining the assembly on the testing device.
15. The assembly of claim 14, wherein the mechanism comprises a
projection.
16. The assembly of claim 14, wherein the mechanism comprises an
inwardly facing circumferential projection.
17. A lancet device assembly comprising: a lancet comprising: a
body; a needle projecting from a proximal end of the body; and a
projection arranged on the body; a member coupled to the lancet and
comprising: an external surface; an internal surface; and an
opening allowing the needle of the lancet to project therethrough
and extending between the external surface and the internal
surface; said body at least one of: being releasably connected via
the projection to a movable member of the lancet device when the
assembly is installed on the lancet device; and having a distal end
insertable into an opening of a movable member of the lancet device
when the assembly is installed on the lancet device; and a distance
between the external surface of the member and the proximal end of
the body being less when the assembly is a puncturing position than
when the assembly is an initial position.
18. The assembly of claim 17, wherein the body is releasably
retainable via the projection to the movable member when the
assembly is installed on the lancet device.
19. A testing or lancet device assembly comprising: a lancet
comprising: a body; and a needle projecting from a proximal end of
the body; a member comprising: an external surface; an internal
surface; and an opening allowing the needle of the lancet to
project therethrough and extending between the external surface and
the internal surface; the body being sized and configured to be
releasably connected to a movable member of the testing or lancet
device when the assembly is installed on the testing or lancet
device; and a distance between the external surface of the member
and the proximal end of the body being less when the needle
projects out past the external surface than when the assembly is an
initial position.
20. The assembly of claim 19, wherein a proximal end of the body is
coupled to the member and wherein a distal end of the body is sized
and configured to extend into an opening in the movable member of
the testing or lancet device.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The instant application is a continuation of U.S.
application Ser. No. 11/138,277, filed May 27, 2005, the disclosure
of which is hereby expressly incorporated by reference hereto in
its entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The invention relates to a disposable lancet device cap
which includes a test strip and a lancet or lancet needle. The
invention also relates to a disposable cap for a testing device
such as glucose meter. The invention further relates to a method of
using a testing device such as a blood glucose meter with a
removable/replaceable cap. In particular, the invention relates to
a cap having both a lancet needle and a test strip which may be
disposable, i.e., which can be used once and discarded, and/or
which utilizes an arrangement which protects a user from contacting
his or her skin with needle after the testing device has been
triggered and/or fired.
[0004] 2. Discussion of Background Information
[0005] Lancet devices are commonly used to prick the skin of the
user so that one or more drops of blood may be extracted for
testing. Some users, such as diabetics, for example, may have to
test their blood sugar levels several times a day. This may be
accomplished by the user using a simple needle. However, this
procedure is often problematic for the user since the needle may be
difficult to handle. Additionally, many users simply cannot perform
the procedure owing to either a fear of needles or because they
lack a steady hand. As a result, lancet devices have been developed
which allow the user to more easily and reliably perform this
procedure.
[0006] Known single-use/disposable lancet devices are not
sufficiently and/or properly design to ensure that they cannot be
reused. Moreover, such devices generally do not protect a user from
coming into contact with the needle after the device has been used.
Known testing devices such a glucose meters do not utilize a
disposable cap which includes an integrally mounted lancet needle
and/or a test strip.
[0007] An improved device would allow the user to use the lancet
needle only a single time and more reliably and safely prevent
reuse of the lancet needle. The device should also ensure that a
contaminated needle cannot come into contact with a user after the
device is used or triggered. Finally, an improved device would
utilize a disposable cap which is safe to dispose of, is simple in
design, and is inexpensive to produce.
SUMMARY OF THE INVENTION
[0008] According to one illustrative aspect of the invention there
is provided a disposable lancet device cap for a testing device or
glucose meter.
[0009] The invention also provides a cap for a testing device,
wherein the cap comprises a lancet movably mounted within the cap
and a skin-engaging end having an opening that allows a portion of
a needle of the lancet to pass therethrough.
[0010] The cap may be structured and arranged to be removably
mounted to the testing device. The opening may be less than
approximately 10 times a diameter of the needle. The opening may be
less than approximately 5 times a diameter of the needle. The
opening may be less than approximately 3 times a diameter of the
needle. The opening may be less than approximately 2 times a
diameter of the needle.
[0011] The cap may further comprise an open end adapted to be
removably connected to the testing device.
[0012] The cap may further comprise a mechanism for ensuring that
the cap is mounted to the testing device in a single rotational
position.
[0013] The cap may be structured and arranged to be
non-rotationally removably mounted to the testing device. The cap
may comprise a generally cylindrical side wall. The cap may include
an arrangement for automatically retracting or moving the lancet to
the retracted position after the lancet moves to the extended
position.
[0014] The cap may further comprise a test strip having one end
extending to the opening.
[0015] The cap may further comprise a test strip having one end
extending to the opening and another end extending along a side
wall of the cap.
[0016] The cap may further comprise a test strip at least partially
arranged on an outer surface of the cap.
[0017] The cap may further comprise a test strip having contacts
arranged on a side wall of the cap.
[0018] The cap may further comprise a test strip having contacts
arranged in an area of the opening.
[0019] The cap may further comprise a mechanism for retaining the
cap on the testing device.
[0020] The cap may further comprise an arrangement for adjusting a
penetration depth of the needle of the lancet.
[0021] The cap may be disposable. The mechanism may comprise a
projection. The mechanism may comprise an inwardly facing
circumferential projection.
[0022] The cap may further comprise an arrangement for biasing the
lancet towards a retracted position. The arrangement may comprise a
spring. The arrangement may comprise at least one member connected
to a portion of the cap via a living hinge.
[0023] The cap may further comprise an arrangement for retaining
the lancet in a retracted position.
[0024] The arrangement for retaining the lancet in a retracted
position may comprise at least one projection arranged on the
lancet and at least one projection non-movably connected to the
cap. The arrangement for retaining the lancet in a retracted
position may comprise at least one projection arranged on the
lancet and at least one projection integrally formed with the cap.
The arrangement for retaining the lancet in a retracted position
may comprise at least one projection arranged on the lancet and at
least one projection arranged on an inner side wall of the cap. The
arrangement for retaining the lancet in a retracted position may
comprise at least one circumferential projection arranged on the
lancet and at least one circumferential projection arranged on an
inner cylindrical side wall of the cap.
[0025] The invention also provides a testing device comprising the
cap described above, wherein the testing device comprises a body
and a display.
[0026] The invention also provides a testing device comprising the
cap described above, wherein the testing device comprises a body, a
display, and a triggering system.
[0027] The invention also provides a testing device comprising the
cap described above, wherein the testing device comprises a body, a
display, and a mechanism for making electrical contact with a
portion of the cap.
[0028] The invention also provides a testing device comprising the
cap described above, wherein the testing device comprises a body, a
display, a triggering system, and contacts for making electrical
contact electrical contacts of the cap.
[0029] The invention also provides a method of puncturing a surface
of skin using a testing device comprising the cap described above,
wherein the method comprises arranging the skin-engaging end
adjacent against a user=s skin, triggering the testing device so
that the needle is caused to puncture the user=s skin, testing
fluid from the puncture, and removing the cap and installing a new
cap on the testing device.
[0030] The invention also provides a disposable cap for a testing
device, wherein the cap comprises a lancet movably mounted within
the cap, a skin-engaging end having an opening that allows a
portion of a needle of the lancet to pass therethrough, and a test
strip for testing a fluid in an area of the opening.
[0031] The cap may be structured and arranged to be removably
mounted to the testing device. The opening may be less than
approximately 5 times a diameter of the needle.
[0032] The cap may further comprise an open end adapted to be
removably connected to the testing device.
[0033] The cap may further comprise a mechanism for ensuring that
the cap is mounted to the testing device in a single rotational
position.
[0034] The cap may be structured and arranged to be
non-rotationally removably mounted to the testing device. The test
strip may be at least partially arranged on an outer surface of the
cap.
[0035] The cap may further comprise a mechanism for retaining the
cap on the testing device.
[0036] The cap may further comprise an arrangement for biasing the
lancet towards a retracted position.
[0037] The cap may further comprise an arrangement for retaining
the lancet needle in a retracted position.
[0038] The invention also provides for a testing device comprising
the cap described above, wherein the testing device comprises a
body and a display. The testing device may comprise may comprise
the cap described above and a body, a display, and a triggering
system. The testing device may comprise the cap described above and
a body, a display, and a mechanism for making electrical contact
with the test strip. The testing device may comprise the cap
described above and a body, a display, a triggering system, and
contacts for making electrical contact electrical contacts of the
test strip.
[0039] The invention also provides a method of puncturing a surface
of skin using a testing device described above, wherein the method
comprises arranging the skin-engaging end adjacent against a user's
skin, triggering the testing device so that the needle is caused to
puncture the user's skin, testing fluid from the puncture, and
removing the cap and installing a new cap on the testing
device.
[0040] The invention also provides a disposable cap for a testing
device, wherein the cap comprises a lancet movably mounted within
the cap, an arrangement for biasing the lancet towards a retracted
position, a skin-engaging end having an opening that allows a
portion of a needle of the lancet to pass therethrough, and a test
strip for testing a fluid in an area of the opening.
[0041] The invention also provides a glucose meter comprising the
disposable cap described above.
[0042] The invention also provides method of testing a fluid sample
using the glucose meter described above, wherein the method
comprises arranging the skin-engaging end adjacent against a user's
skin, triggering the glucose meter so that the needle is caused to
puncture the user's skin, testing fluid from the puncture, and
removing the cap and installing a new cap on the glucose meter.
[0043] Other exemplary embodiments and advantages of the present
invention may be ascertained by reviewing the present disclosure
and the accompanying drawing.
BRIEF DESCRIPTION OF THE DRAWINGS
[0044] The present invention is further described in the detailed
description which follows, in reference to the noted plurality of
drawings by way of non-limiting examples of exemplary embodiments
of the present invention, in which like reference numerals
represent similar parts throughout the several views of the
drawings, and wherein:
[0045] FIG. 1 shows a top or end view of one embodiment of the cap.
The contacts of the test strip is shown surrounding the lancet
needle opening and to extend to the side wall;
[0046] FIG. 2 shows a side view of the cap of FIG. 1;
[0047] FIG. 3 shows a cross-section view of the cap shown in FIG.
2;
[0048] FIG. 4 shows a bottom view of the cap of FIG. 1;
[0049] FIG. 5 shows a cross-section view of the spring used in the
cap shown in FIGS. 1-4;
[0050] FIG. 6 shows a side view of the lancet shown in the cap of
FIGS. 1-4;
[0051] FIG. 7 shows a cross-section view of the cap shown in FIG.
3, but with the spring and lancet removed therefrom;
[0052] FIG. 8 shows a cross-section view of the cap in FIG. 3 after
the lancet has been moved or forced to the extended position;
[0053] FIG. 9 shows side view of the cap shown in FIG. 3 arranged
above one embodiment of a testing device, which is shown in partial
cross-section. The electrical contacts of the testing device are
not shown;
[0054] FIG. 10a shows a top view of the cap shown in FIG. 1 prior
to being installed on the testing device shown in FIGS. 9 and
10b;
[0055] FIG. 10b shows a top view of the testing device of FIG.
9;
[0056] FIG. 11 shows a side view of the cap and testing device
shown in FIG. 9 after the cap is installed or mounted to the
testing device. The electrical contacts of the testing device are
not shown;
[0057] FIG. 12 shows a bottom view of the testing device shown in
FIG. 11;
[0058] FIG. 13 shows a top view of the testing device shown in FIG.
11;
[0059] FIG. 14 shows a side view of the testing device shown in
FIG. 11 after the testing device has been triggered. Triggering of
the testing device has caused the lancet to move to the extended
position and compress the spring. The electrical contacts of the
testing device are not shown;
[0060] FIG. 15 shows an enlarged partial view of FIG. 14 and
illustrates one non-limiting way in which the electrical contact
members can be arranged on the testing device;
[0061] FIG. 16 shows an enlarged partial view of FIG. 15 with the
cap removed to more clearly illustrate the mounting of the
electrical contact members to the testing device;
[0062] FIG. 17 shows a view similar to FIG. 16 but rotated 90
degrees. A portion of the testing device has been removed to more
clearly illustrate the positioning of the electrical contact
members in the testing device;
[0063] FIG. 18 shows a partial view of the testing device
previously illustrated but utilizing another non-limiting
embodiment of the cap which is shown in FIGS. 19-21;
[0064] FIG. 19 shows a cross-section view of the non-limiting
embodiment of the cap illustrated in the embodiment shown in FIG.
18. The cap is similar to the cap described previously but further
includes a depth adjustment system to control the depth of
penetration of the lancet needle. In the position shown in FIG. 19,
the lancet needle will penetrate a greater amount than in the
position shown in FIG. 20;
[0065] FIG. 20 shows the embodiment of FIG. 19 after the depth
adjustment system is positioned at a different position. In the
position shown in FIG. 20, the lancet needle will penetrate a
lesser amount than in the position shown in FIG. 19;
[0066] FIG. 21 shows a bottom view of depth adjustment system of
the cap. The surrounding portion of the cap has not been shown for
purposes of illustration;
[0067] FIG. 22 shows a side view of still another non-limiting
embodiment of the cap;
[0068] FIG. 23 shows an enlarged cross-section view of the cap
shown in FIG. 22. The external thread of the lower cap member is
not shown;
[0069] FIG. 24 shows a view similar to FIG. 23 after the bottom
portion of the cap has been moved or rotated to one of many
possible depth adjustment positions. The external thread of the
lower cap member is not shown;
[0070] FIG. 25 shows the cap illustrated in FIG. 24 prior to the
bottom portion being assembled and/or threaded onto the top portion
of the cap. The external thread of the lower cap member is not
shown;
[0071] FIG. 26 shows a cross-section view of still another
non-limiting embodiment of the cap. In this embodiment, the spring
is replaced with integrally formed protruding members which are
each connected to the cap by a living hinge;
[0072] FIG. 27 shows a partial enlarged cross-section view of
another non-limiting embodiment of a testing device and cap. The
testing device is similar to the one used in the embodiment shown
in FIG. 11 except that the plunger on the instant embodiment
contains an arrangement for removably connecting to the lancet. The
cap is similar to the one shown in FIGS. 1-4 except that the inner
cylindrical lancet receiving housing contains an arrangement for
securely retaining the lancet in the retracted position in order to
ensure that the lancet connects to the plunger of the testing
device. The cap of this embodiment does not need a spring or other
lancet biasing devices;
[0073] FIG. 28 shows the embodiment of FIG. 27 after the testing
device has been triggered. Triggering of the testing device causes
the lancet to break free from the retaining arrangement of the
inner cylindrical lancet housing. In this embodiment, the
penetration depth is adjusted electronically by setting the length
of travel of the plunger. Once triggered, the cap can be removed
from the testing device. The removal causes the lancet to move back
to the retained position shown in FIG. 27 prior to the lancet being
disconnected from the plunger;
[0074] FIGS. 29a-29c shows another non-limiting embodiment of a
lancet which can be used on the cap embodiment shown in, e.g.,
FIGS. 1-4. The lancet is designed to itself provide penetration
depth adjustment. In the lowered position shown in FIG. 29a, the
depth of penetration of the needle is lower than in the
intermediate position shown in FIG. 29b, and depth of penetration
of the needle shown in FIG. 29b is lower than in the higher
position shown in FIG. 29c; and
[0075] FIG. 30 shows an enlarged partial view of another embodiment
of the testing device. This embodiment utilizes a mechanism for
removing the cap from the testing device.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
[0076] The particulars shown herein are by way of example and for
purposes of illustrative discussion of the embodiments of the
present invention only and are presented in the cause of providing
what is believed to be the most useful and readily understood
description of the principles and conceptual aspects of the present
invention. In this regard, no attempt is made to show structural
details of the present invention in more detail than is necessary
for the fundamental understanding of the present invention, the
description taken with the drawings making apparent to those
skilled in the art how the several fauns of the present invention
may be embodied in practice.
[0077] FIGS. 1-4 show a first non-limiting embodiment of a cap 1.
The cap 1 is preferably made of a synthetic resin material and can
have any desired shape. In the illustrated embodiment, the cap 1
has a generally cylindrical shape including a generally cylindrical
side wall 2 which extends between a skin-engaging wall 3 and an
open end 4. The skin-engaging wall 3 includes an opening 5 which is
sized to allow a needle N to pass therethrough. The cap 1 also
includes a test strip which is at least partially arranged on an
outer surface of the cap 1. Preferably, the test strip is of
conventional design and can be laminated or otherwise adhered or
secured to an outer surface of the cap 1. As can be seen in FIGS. 1
and 2, the test strip includes two thin contact leads 6a and 6b
which have upper exposed contacts or ends 6a1 and 6b1 and lower
exposed contacts or ends 6a2 and 6b2. The exposed contacts 6a1 and
6b1 are arranged an area of the opening 5 in order to record blood
or other body fluid which results from a puncture by the needle N.
Such puncturing occurs when the skin-engaging wall 3 is placed
against a user's skin (after the cap 1 is placed on a testing
device) and the testing device triggered. The lower exposed
contacts 6a2 and 6b2 are arranged an area of the opened end 4 in
order to ensure that electrical contact is made with corresponding
contacts on the testing device, as will be described in detail
later on. Although not shown, the skin engaging wall 3, or the
surface thereof, need not be planar, and can also be either
slightly concave or slightly convex. The skin-engaging surface can
also include features known in the art such as projections, for,
e.g., stimulating blood flow or otherwise limiting the amount of
any pain which results from the puncture. The cap 1 also includes a
projection 7 for ensuring that the cap 1 is installed onto the
testing device in only a single position. This ensures that the
exposed contacts 6a2 and 6b2 are correctly aligned and make contact
with corresponding contacts of the testing device.
[0078] As can be seen in FIGS. 3 and 4, the cap 1 further includes
an integrally formed inner housing within which a lancet L is
movably mounted. The housing is formed by a generally cylindrical
wall 8 which has a bottom opened end and an upper end which extends
to the wall 3. A spring S is arranged within the housing in order
to bias the lancet N towards a retracted position. The spring S
ensures that after the lancet L is moved to a fully extended
position (see FIG. 8), the lancet L is moved automatically back to
the retracted position (see FIG. 3). The housing also includes a
stop shoulder 9 which is contacted by the upper or needle end of
the lancet L when the lancet L moves to the extended position (see
FIG. 8). The particular location of the stop shoulder 9 can be
"factory" set to produce a particular predetermined penetration
depth. According to one non-limiting aspect of the invention, the
cap 1 can be labeled with indicia indicating the set depth so that
the user will know, when the cap 1 is installed on a testing
device, that it will produce the indicated puncture depth. Thus, a
user having thicker skin may desired to procure a cap for his or
her testing device which contains indicia indicating that the cap
is a "deep" penetration cap. A user having somewhat thinner skin
may desire to procure a cap for his or her testing device which
contains indicia indicating that the cap is a "intermediate"
penetration cap. Finally, a user having thin skin may desire to
procure a cap for his or her testing device which contains indicia
indicating that the cap is a "shallow" penetration cap.
[0079] As can be seen in FIG. 3, the generally cylindrical wall 8
is designed to ensure that once the lancet L is inserted into the
inner housing, it is prevented from being removed. FIGS. 5 and 6
show the spring S and the lancet L removed from the cap 1. FIG. 7
shows that the lower or open end of wall 8 is formed by a plurality
of fingers which define an inwardly facing tapered projection 8a
separated by a plurality of slots 8b. The fingers forming the wall
8 can flex outwardly to allow the lancet L to be inserted in the
inner housing. Of course, the spring S is inserted prior to
insertion of the lancet L. As is evident from FIG. 6, when the
tapered circumferential projection of the lancet L slidably engages
the tapered projection 8a, the fingers are caused to deflect
outwardly until the lancet L is inserted sufficiently into the
inner housing to assume the position shown in FIG. 3. The lancet L
can be made of conventional materials which are used to make
lancets. Preferably, the lancet L is made by injection molding with
the needle N positioned therein in order to produce a lancet which
is of low cost. The spring S can be made of any desired material
and is preferably made of spring steel such as, e.g., stainless
steel. By way of non-limiting example, the cap 1 can have an outer
diameter of between approximately 0.25'' and 1'' and is preferably
between approximately 1/2'' and 3/4'' in diameter. The cylindrical
portion of the lancet L can be between approximately 1/8'' and
1/4'' and can be made of a synthetic resin material. The spring S
can be of any desired type and can preferably be a wire compression
spring. The test strip can be in the range of between approximately
0.15 and approximately 0.25 in width, approximately 0.015'' and
approximately 0.05'' in thickness and between approximately 0.5''
and approximately 1.25'' long.
[0080] As can be seen when comparing FIGS. 3 and 8, the lancet L
moves linearly and/or axially within the inner housing of the cap 1
between a retracted position (FIG. 3) and an extended position
(FIG. 8). This movement occurs as a result of a force F being
applied to the lancet L. The force F is preferably applied by a
plunger or other activating member that is part of a testing
device. In this way, when the cap 1 is mounted to the testing
device, and the user triggers the testing device (or otherwise
causes a plunger in the testing device to engage the lancet L), the
lancet L is caused to move to the extended position from the
retracted position. The force F, of course, must be greater than
the biasing force of the spring S in order to cause the lancet L to
move to the fully extended position. As explained above, the
maximum movement of the lancet L (which controls the amount of the
tip or the needle N that projects from, past or beyond the
skin-engaging surface of wall 3) within the inner housing is
determine or set by contact between the upper end of the lancet
body and the shoulder 9. Although not shown, the lancet L can
include a device that prevents the lancet L from rotating within
the inner housing. This device can be, e.g., a projection which
slidably engages a slot in the wall 8. Alternatively, the slot can
be arranged on the lancet L and the projection can be arranged on
the inner cylindrical surface of the wall 8. Still another way to
ensure that the lancet L does not rotate within the inner housing,
if such an arrangement is desired, is to replace the generally
cylindrical body of the lancet L with one that has, e.g., generally
oval, or triangular, or square, or polygonal shaped cross-section.
Of course, the shape of the space within the inner housing should
preferably correspond to the shape of the lancet L. There also
should be some amount of clearance between the lancet body and the
inner surface of the wall 8 to allow the lancet L to move freely
within the inner housing.
[0081] FIG. 9 shows one non-limiting embodiment of a testing device
100 which can utilize the cap 1. Preferably, the testing device 100
has a body 101 which can be made of synthetic resin. A trigger
button 102 is arranged on the body 101 in order to trigger movement
of a plunger 104. The testing device 100 also includes a display
103 in order to provide the user with information such as, e.g.,
blood glucose value or other information related to a fluid sample,
that is measured with the test strip of the cap 1. The testing
device may be of conventional design and include all of the
electronic circuits and devices generally utilized with
conventional glucose meters. However, the testing device further
requires an arrangement which allows the cap 1 to be removably
secured thereto. Such an arrangement can have the form of a
recessed area 105 which is sized to receive therein the open end 4
of the cap 1. The arrangement can also include a circumferential
projection 106 which is designed to releasably engage the
projection 4a of the cap 1. The circumferential projection 106 is
arranged on a plurality of axially arranged fingers which extend
from a wall 107 of the testing device 100. In order to ensure that
the plunger 104 can pass through the wall 107, an opening 108 (see
also FIG. 10b) is sized to be larger than a maximum diameter of the
plunger 104 and is provided in the wall 107. The opening 108 is
preferably generally centrally disposed relative to the projection
106 in order to ensure that the plunger 104 is properly aligned
with the lancet L of the cap 1.
[0082] As can be seen in FIGS. 10a and 10b, the cap 1 and the
testing device preferably include an alignment system which has the
form of a mechanism 7 on the cap 1 and a recess 109 on the testing
device 100. The alignment system ensures that the cap 1 is
correctly installed on the testing device 100 so that the contacts
6a2 and 6b2 line up with and make electrical contact with
electrical contacts 110a and 110b of the testing device 100. By way
of non-limiting example, the body 101 of the testing device can be
a two-piece body formed by an upper housing part 101a and a lower
housing part 101b. These body parts can be made by, e.g., injection
molding, and can be joined together by any desired connection
system such as bonding, snap connection, fasteners, etc,. FIGS. 11
and 13 show the cap 1 fully installed onto the testing device 100
and ready to be triggered. As can bee seen, the projection 4a has
moved axially past the projection 106 to cause the cap 1 to be
temporarily locked to the testing device 100. This occurred when
the cap 1 was forced onto the testing device 100 thereby forcing
the fingers containing the projection 106 to deflect inwardly. Once
the projection 4a moved past the projection 106, their natural
elasticity or memory caused them to move back to non-stressed or
relaxed position. In order to remove the cap 1 from the testing
device 100, however, one need only grip the cap 1 and pull it away
from the testing device 100 until the projection 106 releases
engagement with the projection 4a.
[0083] FIG. 14 shows the plunger 104 engaging with the lancet L
thereby causing it to move to the extended position. The testing
device 100 is designed so that once the plunger 104 moves to the
extended position it is automatically retracted, which then allows
the spring S to cause the lancet L to automatically retract. By way
of non-limiting example, the testing device 100 can include an
electrical actuator such as a solenoid to cause movement of the
plunger 104, in which case the trigger button 102 can function as
an electrical switch which causes activation of the solenoid and
the plunger 104 when depressed. Alternatively, the trigger button
102 can be a mechanical device which releases the plunger 104 from
a retracted position so a spring (not shown) which has been
previously compressed by the plunger 104 can cause the plunger 104
to more to the extended position, and thereby cause movement of the
lancet L. In this regard , the testing device 100 can include an
arrangement for arming the plunger 104 similar to the one disclosed
in U.S. Pat. No. 6,156,051, the disclosure of which is hereby
expressly incorporated y reference in its entirety. As explained
above, once the testing device 100 is triggered and the lancet L
moves to the extended position, and then to the retracted position
(which happens within a fraction of a second as is the case with
conventional lancet devices), the plunger 104 assumes the position
shown in FIG. 11. Thereafter, the testing device 100 produces a
value indicative of an aspect (i.e., blood glucose) the blood or
fluid sample which flows onto the contacts 6a1 and 6b1. After that,
the user can simple remove the cap 1 from the testing device 100 as
described above, and discard or properly dispose of it. The user
can then install a new cap 1 on to the testing device 100 for use
at another time or for use by another user.
[0084] FIGS. 15-17 show one non-limiting way in which the test
strip of the cap 1 can make electrical contact with the testing
device 100. As explained above with regard to FIG. 10b, the
contacts 110a and 110b make electrical contact with the exposed
contact ends 6a2 and 6b2. The contacts 110a and 110b are have a
portion that is connected to the wall 107 and another end that
which includes a generally spherical contacting portion. This
latter spherical portion extends through an opening formed in the
body 101 and into the region 105. As is evident from FIG. 15, once
the cap 1 is installed onto the testing device 100 the spherical
portions are caused to move into the body 101. Thus, the contacts
110a and 110b act like springs so as to make contact with the test
strip of the cap 1 at all times when the cap 1 is installed onto
the testing device 100. To facilitate insertion of the cap 1 and
proper displacement of the contacts 110a and 110b, the end 4 of the
cap 1 can preferably have a small chamfer opposite the projection
4a. Once the cap 1 is removed, however, the contacts 110a and 110b
can assume a relaxed position and extend back into the region 105
(see FIG. 16). To ensure that each contact 110a and 110b
communicates or is in electrical contact with the appropriate
circuits in the testing device 100, a wire W from the circuit(s) is
connected to each contact 110a and 110b via a connector C.
[0085] FIGS. 18-21 show another non-limiting embodiment of a cap 10
which includes an integral lancet L' and test strip, and which can
be used with the testing device 100. Corresponding reference
numbers have been increased by a factor of ten. The cap 10 is
similar to the cap 1 of the previous embodiment, but additionally
includes a depth adjustment system or arrangement. As can be seen
in FIGS. 19 and 20, the depth adjustment system comprises a
generally cylindrical inner sleeve 20 which includes an upper end
20b, a shoulder section 20a and a bottom end 20c. The upper end 20b
includes an internally threaded section which threadably engages
with external threads arranged at a lower area of the inner housing
wall 18. The shoulder 20a is designed to be contacted by a shoulder
SH of the lancet L'. This contact determines the amount of the
needle N which projects past the skin-engaging surface 13. As can
be seen when comparing FIGS. 19 and 20, rotation of the sleeve 20
relative to the cap 10, changes the position of the shoulder 20a
relative to the shoulder 19. Thus, in the position shown in FIG.
19, the shoulder SH may contact shoulder 20a in order to set the
depth of penetration of the needle N. However, to the extent that
the sleeve 20 is rotated to too great an amount, the depth of
penetration will instead be set by contact between an upper surface
of the lancet L' and the shoulder 19. This ensures that the user
will not be able to set the depth of penetration too deep. In the
position shown in FIG. 20, the shoulder 20a is set farther away
from the shoulder 19 to as to ensure that the needle N will
penetrate less deeply. This occurs because the shoulder SH contacts
the shoulder 20a sooner in its travel within the inner housing.
FIG. 21 shows one non-limiting way in which the user can be
informed of the particular depth adjustment. According to this
embodiment, the bottom end 14 of the cap 10 includes text or other
indicia and the bottom end of the sleeve 20 includes a reference
indicator such as, e.g., an arrow. In this way, when the user
rotates the sleeve 20 relative to the cap 10, the user will know
what the depth of penetration of the needle N. Thus, for example,
if the arrow is aligned with the number 1 on the cap 10, the needle
N will penetrate a lesser amount than when the sleeve 20 is rotated
until the arrow is set reference number 2, and so on, with
reference number 5 providing the deepest setting. Of course, the
invention contemplates that the arrow can be provided on the
surface 14 and the text on the sleeve 20. Alternatively, other text
can be utilized instead of numbers such as, e.g., letters or other
designations symbols. In order to ensure that the depth setting is
maintained, the cap 10 and also include a circumferential
projection which engages with a plurality of circumferential
recesses (not shown). Such arrangements are known in the art of
lancet devices and ensure that the device produces a clicking sound
when rotated between depth setting positions.
[0086] FIGS. 22-25 show another non-limiting embodiment of a cap
1010 which includes an integral lancet L and test strip, and which
can be used the testing device 100. Corresponding reference numbers
have been increased by a factor of a thousand. The cap 1010 is
similar to the cap 1 of the previous embodiment, but additionally
includes a depth adjustment system or arrangement. As can be seen
in FIGS. 23 and 24, the depth adjustment system comprises a
generally cylindrical upper cap member 1010a which is threadably
engaged with a generally cylindrical lower cap member 1010b. The
upper member 1010a includes an internally threaded lower section
which threadably engages with external threads arranged at an upper
area of the lower member 1010b. This depth adjustment system is
designed for use on a testing device which utilizes a plunger that
travels a set amount. Thus, by rotating the member 1010a relative
to the member 1010b one can change the position of the surface 1013
relative to the maximum movement of the plunger of the testing
device. As was the case with the previous embodiment, the cap 1010
can utilize indicia and an arrow to indicate the depth
adjustment.
[0087] FIG. 26 shows a cross-section view of still another
non-limiting embodiment of the cap 1'. This embodiment is similar
to the embodiment shown in FIGS. 1-8, except that the spring is
replaced with integrally formed protruding members 8'c which are
each connected to and/or integrally formed with the inner wall 8'
of the cap 1' by a living hinge. As was the case with the
embodiment shown in FIGS. 1-8, the fingers 8'c (instead of the
spring) bias the lancet L towards a retracted position and ensure
that the lancet L automatically moves to the retracted position
after being moved to the extended position by the plunger of the
testing device.
[0088] FIGS. 27 and 28 show another non-limiting embodiment of a
cap 1'' and testing device 100'. The testing device 100' is similar
to the one used in the embodiment shown in FIG. 11 except that the
plunger 104' of the instant embodiment contains an arrangement for
removably connecting to the lancet L''. The cap 1'' is similar to
the one shown in FIGS. 1-4 except that no spring is utilized and
the inner cylindrical lancet receiving housing or wall 8'' contains
an arrangement for securely retaining the lancet L'' in the
retracted position in order to ensure that the lancet L'' connects
to the plunger 104' of the testing device 100'. The cap 1'' relies
on plunger 104' to automatically move the lancet L'' to the
retracted position after being triggered instead of a spring or
other lancet biasing devices. However, the invention also
contemplates using a spring or integrally formed biasing fingers
with this cap embodiment. In use, the cap 1'' is initially
installed onto the testing device 100' so that the lancet L'' snaps
into the plunger 104'. Once the testing device 100' is triggered,
the lancet L'' is caused to disengage from the inner housing or
wall 8'' and allowed to move to the extended position until the
lancet L'' contacts the shoulder 9''. The plunger 104' then moves
back to the retracted position, but not completely so. The lancet
L'' is not made to locked to the wall 8'' as shown in FIG. 27.
However, when the user desires to remove the cap 1'' from the
testing device 100', the user will pull off the cap 1'' thereby
forcing the lancet L'' to snap back into the fully retracted
position/locked position shown in FIG. 27. This ensures that the
used lancet L'' will not move within the housing during removal
thereby providing a level of safety to the user. This arrangement
occurs because the lancet L'' is secured to the plunger 104' by
greater frictional resistance that to the locking mechanism of the
wall 8''. Further pulling of the cap 1'', however, will also cause
the lancet L'' to also disengage from the plunger 104', thereby
allowing the user to remove and discard the cap 1'' after use. The
lancet L'' is locked to the plunger 104' by way of spring fingers
and slots (similar to that of the wall 8 in FIG. 7) which
releasably engage with a circumferential projection of the lancet
L''. Of course, other releasable connection arrangements can be
provided between the lancet L'' and the plunger 104'.
[0089] FIG. 28 shows the testing device/cap of FIG. 27 after the
testing device 100' has been triggered. Triggering of the testing
device 100' causes the lancet L'' to break free from the retaining
arrangement of the inner cylindrical lancet housing wall 8''. In
this embodiment, the penetration depth is adjusted electronically
by setting the length of travel of the plunger 104'. Once
triggered, the cap 1'' can be removed from the testing device 100'.
The removal causes the lancet L'' to move back to the retained
position shown in FIG. 27 prior to the lancet L'' being
disconnected from the plunger 104'. Although not shown, this
embodiment can also utilize a depth adjustment system of the type
shown in FIGS. 18-25.
[0090] FIGS. 29a-29c shows another non-limiting embodiment of a
lancet L''' which can be used on the cap embodiment shown in, e.g.,
FIGS. 1-4. The lancet L''' is designed to itself provide
penetration depth adjustment. In the lowered position shown in FIG.
29a, the depth of penetration of the needle N is lower than in the
intermediate position shown in FIG. 29b, and depth of penetration
of the needle N shown in FIG. 29b is lower than in the higher
position shown in FIG. 29c. The adjustment is provides by external
threads arranged on a projecting portion of the lower part of the
lancet L''' and by corresponding internal threads formed within an
opening formed in the upper part of the lancet Indicia and an arrow
can be utilized to designated to the user a desired depth
setting.
[0091] FIG. 30 shows an enlarged partial view of another embodiment
of the testing device 100''. Instead of allowing the user to pull
off the cap from the testing device, this embodiment utilizes a cap
removal mechanism CRM for more easily removing the cap (i.e., any
of the cap embodiments disclosed herein) from the testing device
100''. By way of non-limiting example, the mechanism CRM includes a
sliding button portion SB which extends outside of the testing
device 100'', guiding projections GP which guide the movement of
the button portion SB, a spring SP for biasing the button portion
SB towards a retracted position, and a lifting member LM for
lifting or moving the cap out of engagement with the testing device
100''. As can be seen from FIG. 30, movement of the button SB into
the testing device 100'' will cause an angled upper surface to
engage with a corresponding lower surface of the member LM which
will, in turn, cause upward movement of the member LM thereby
forcing the cap to lift out of engagement with the testing device.
Although not shown, two of these mechanisms CRM may be utilized on
opposite sides of the testing device 100''. Of course, the
invention contemplates other ways of facilitating the removal of
the cap from the testing device.
[0092] The testing devices and caps disclosed herein can preferably
made transparent and/or translucent synthetic resin materials. Of
course, the invention is not limited to a body design which is
transparent and/or translucent.
[0093] The operation of a testing device using a cap of the type
described herein will now be explained with reference to the
embodiment shown in FIGS. 1-17. As an initial step, the user will
install the cap 1 into the mounting recess 105 of the testing
device 100. This is accomplished by aligning the projection 7 and
the notch 109. The user can then force the cap 1 downwards until
the bottom surface 4 of the cap 1 contacts a bottom surface of the
recess 105 and until there is engagement between the projections 4a
and 106. The user can then begin using the testing device by
switching on the testing device 100, placing, e.g., a finger, or
other body part against the skin-engaging surface 3, and triggering
the testing device 100 to cause the lancet needle N to puncture the
finger. The user will place a blood drop on the exposed end of the
test strip, i.e., on contacts 6a1 and 6b1. At this point, the
device can function to automatically provide a test result after
triggering and sensing the blood drop on the test strip, or upon
the user manually inputting a request for testing by, e.g., pushing
the trigger 102 a second time to activate the testing procedure.
Once the user has received a result, the user can then manually
remove the cap 1 by, e.g., pulling it off the testing device 100,
or as is preferred, by activating a cap removal mechanism (see FIG.
30). This activation can also occur automatically by an actuator
arranged within the testing device 100 (i.e., after a time delay)
or by, e.g., the user pressing the trigger button 102 a third time.
The used cap 1 can then de removed and discarded and a new cap 1
can then be installed onto the testing device 100. The device will
then be ready for use again at a later time and/or by a different
user.
[0094] The testing device can also be provided with a system which
senses the position of the cap 1 and indicates the cap 1 is
correctly installed. By way of non-limiting example, this can be
accomplished using a bar-code reader system. All the parts of the
cap 1, with the exception of the springs and needles (which can
respectively be made of spring steel and stainless steel), may be
made from plastic materials and can be formed using conventional
injection molding techniques or other known manufacturing methods.
However, when practical, other materials and manufacturing
processes may also be utilized.
[0095] It is noted that the foregoing examples have been provided
merely for the purpose of explanation and are in no way to be
construed as limiting of the present invention. While the present
invention has been described with reference to an exemplary
embodiment, it is understood that the words which have been used
herein are words of description and illustration, rather than words
of limitation. Changes may be made, within the purview of the
appended claims, as presently stated and as amended, without
departing from the scope and spirit of the present invention in its
aspects. Although the present invention has been described herein
with reference to particular means, materials and embodiments, the
present invention is not intended to be limited to the particulars
disclosed herein; rather, the present invention extends to all
functionally equivalent structures, methods and uses, such as are
within the scope of the appended claims.
* * * * *