U.S. patent application number 11/397058 was filed with the patent office on 2006-10-26 for narrow-profile lancing device.
Invention is credited to David R. Buenger, Avi M. Robbins, Jeffrey T. Stout.
Application Number | 20060241669 11/397058 |
Document ID | / |
Family ID | 36676568 |
Filed Date | 2006-10-26 |
United States Patent
Application |
20060241669 |
Kind Code |
A1 |
Stout; Jeffrey T. ; et
al. |
October 26, 2006 |
Narrow-profile lancing device
Abstract
A lancing device having a substantially narrow profile housing,
optionally configured for attachment in place of a battery cover of
a blood-glucose testing meter. A miniature lancet has an oversized
sterility cap with a T-shaped end for ease of handling and loading
into a lancing device. A flattened portion of the sterility cap is
angularly offset, for example generally perpendicular to, a
flattened portion of the lancet body, such that twisting the
sterility cap into alignment with the lancet body serves to detach
the sterility cap from the lancet body.
Inventors: |
Stout; Jeffrey T.; (Smyrna,
GA) ; Robbins; Avi M.; (Marietta, GA) ;
Buenger; David R.; (Roswell, GA) |
Correspondence
Address: |
GARDNER GROFF SANTOS & GREENWALD, P.C.
2018 POWERS FERRY ROAD
SUITE 800
ATLANTA
GA
30339
US
|
Family ID: |
36676568 |
Appl. No.: |
11/397058 |
Filed: |
April 4, 2006 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
60667958 |
Apr 4, 2005 |
|
|
|
Current U.S.
Class: |
606/182 ;
606/181 |
Current CPC
Class: |
A61B 5/15186 20130101;
A61B 5/15194 20130101; A61B 5/150618 20130101; A61B 5/157 20130101;
A61B 5/14532 20130101; A61B 5/150549 20130101; A61B 5/150503
20130101; A61B 5/150717 20130101; A61B 5/1519 20130101; A61B
5/150022 20130101; A61B 5/15113 20130101; A61B 5/150412 20130101;
A61B 5/15117 20130101; A61B 5/1513 20130101; A61B 2560/04
20130101 |
Class at
Publication: |
606/182 ;
606/181 |
International
Class: |
A61B 17/32 20060101
A61B017/32 |
Claims
1. A lancing device comprising: a lancet carrier translationally
mounted within a housing and movable along a path of travel between
a retracted position and an extended position; at least one drive
spring engaged between the lancet carrier and the housing; a
charging mechanism for moving the lancet carrier into the retracted
position and energizing the at least one drive spring; and a
release mechanism for holding the lancet carrier in the retracted
position until actuated to release the lancet carrier to move along
the path of travel under the influence of the at least one drive
spring toward the extended position; wherein the lancet carrier,
the at least one drive spring, the charging mechanism and the
release mechanism are all intersected by a reference plane
containing the path of travel.
2. The lancing device of claim 1, wherein each drive spring is
positioned within a slot formed in the lancet carrier.
3. The lancing device of claim 2, further comprising a return
spring positioned within a slot formed in the lancet carrier.
4. The lancing device of claim 3, wherein the return spring and
each drive spring are positioned within separate slots formed in
the lancet carrier.
5. The lancing device of claim 1, wherein the housing has an
overall thickness of less than 0.25'' (0.6 cm).
6. The lancing device of claim 1, wherein the housing has an
overall thickness of less than 0.125'' (0.3 cm).
7. The lancing device of claim 1, wherein the housing has a height
to thickness aspect ratio of at least 4:1.
8. The lancing device of claim 1, wherein the housing has a height
to thickness aspect ratio of at least 5:1.
9. The lancing device of claim 1, wherein the housing couples to a
blood glucose test meter in place of a battery cover component
thereof.
10. The lancing device of claim 1, wherein the housing comprises a
slotted lancet opening having a length dimension considerably
greater than a width dimension.
11. The lancing device of claim 1, wherein the housing comprises
first and second side walls having internal faces in sliding
contact, respectively, with first and second sides of the lancet
carrier to provide lateral guidance of the lancet carrier along the
path of travel.
12. The lancing device of claim 1, further comprising a lancet
releasably engaged between opposed forks of the lancet carrier.
13. The lancing device of claim 12, wherein the housing comprises
retaining panels at a proximal end thereof to prevent the forks
from spreading apart and releasing the lancet as the lancet carrier
moves into the extended position.
14. The lancing device of claim 12, wherein the lancet has a lancet
body with a thickness equal to a thickness of the lancet
carrier.
15. The lancing device of claim 12, wherein the housing has a
lancet-removal opening through a sidewall portion thereof, whereby
a lancet removal member inserted through the lancet-removal opening
projects between the opposed forks of the lancet carrier and behind
the lancet.
16. The lancing device of claim 1, wherein the housing has a
detachable endcap for accessing the lancet carrier to install a
lancet therein.
17. The lancing device of claim 1, wherein the housing has a hinged
cover for accessing the lancet carrier to install a lancet
therein.
18. The lancing device of claim 17, wherein the hinged cover has at
least one clip for retaining the lancet upon opening the hinged
cover.
19. The lancing device of claim 1, further comprising a clip
containing a plurality of lancets for sequential loading into the
lancet carrier.
20. A lancing device having an overall thickness of less than
0.25'' (0.6 cm).
21. The lancing device of claim 20, having an overall thickness of
less than 0.125'' (0.3 cm).
22. The lancing device of claim 20, having a height to thickness
aspect ratio of at least 4:1.
23. The lancing device of claim 20, having a height to thickness
aspect ratio of at least 5:1.
24. The lancing device of claim 20, comprising at least one
coupling for attachment in place of a battery cover of a blood
glucose test meter.
25. In combination, a blood glucose test meter comprising a battery
compartment, and a lancing device for releasable coupling to the
blood glucose test meter over the battery compartment.
26. The combination of claim 25, wherein the lancing device
releasably couples directly to the blood glucose test meter over
the battery compartment.
27. The combination of claim 25, wherein the lancing device is
mounted to a mounting clip releasably coupled to the blood glucose
test meter over the battery compartment.
28. A lancing device comprising a housing having a slotted lancet
opening with a first opening dimension greater than a second
opening dimension thereof, and a lancet releasably engagable with
said lancing device; said lancet having a lancet body with a sharp
lancet tip projecting therefrom and a cap removably covering the
sharp lancet tip; wherein the lancet body has a first lancet body
dimension less than the first opening dimension but greater than
the second opening dimension, and has a second lancet body
dimension less than the second opening dimension; whereby the
lancet body resists rotation within the slotted lancet opening upon
twisting of the cap to detach the cap from the lancet body.
29. The lancing device of claim 28, wherein at least a portion of
the cap has a flattened profile initially unaligned with an
adjacent flattened profile portion of the lancet body.
30. The lancing device of claim 28, wherein the removable cap has a
flared gripping portion.
31. The lancing device of claim 28, wherein the removable cap
comprises a release finger portion for insertion into the housing
to release the lancet from engagement with the lancing device.
32. The lancing device of claim 31, wherein the release finger
portion of the cap comprises an inclined removal surface.
33. A lancet comprising a lancet body having a sharp lancet tip
projecting therefrom, and a protective cap removably covering the
sharp lancet tip, said protective cap comprising a release member
for releasing the lancet body from engagement with a lancing
device.
34. The lancet of claim 33, wherein the protective cap has a
generally T-shaped profile.
35. The lancet of claim 33, wherein the release member comprises a
release finger projecting axially from a flared end of the
protective cap.
36. The lancet of claim 33, wherein the release member comprises an
inclined surface projecting laterally from the protective cap.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Patent Application Ser. No. 60/667,958, filed Apr. 4, 2005; which
application is incorporated herein by reference in its entirety for
all purposes.
TECHNICAL FIELD
[0002] The present invention relates generally to lancing devices
for medical sampling of blood or other body fluids of a human or
animal subject. More particularly, the invention relates to a
miniature lancing device having components arranged in a compact
planar configuration allowing the device to have a narrow profile
relative to typical lancing devices.
BACKGROUND OF THE INVENTION
[0003] Many medical procedures require puncturing of the skin, and
sometimes underlying tissues, of an animal or human subject. For
example, a sharp lancet tip is commonly used to puncture the
subject's skin at a lancing site to obtain a sample of blood or
other body fluid, as for example in blood glucose monitoring by
diabetics and in blood typing and screening applications. A lancing
device having a spring-loaded or otherwise energized drive
mechanism is often used to carry the lancet along a path of travel,
between a retracted or shielded position and an extended position
wherein the lancet tip punctures the skin.
[0004] Various forms of lancing devices are known. Many users,
however, have found known lancing devices to be too bulky and
inconvenient to carry and stow in a pocket or bag. Also, some users
find it inconvenient to carry multiple separate components for
sampling and testing, such as a lancing device and a meter.
Perceived inconvenience can lead to non-compliance with a
prescribed testing regimen, potentially adversely affecting the
subject's health.
[0005] Thus it can be seen that needs exist for improvements to
lancing devices to provide a smaller and thinner lancing device.
Needs further exist for a lancing device that can be attached to a
blood glucose meter for convenience and to avoid loss. It is to the
provision of an improved lancing device meeting these and other
needs that the present invention is primarily directed.
SUMMARY OF THE INVENTION
[0006] In example forms, the present invention relates to a
miniature lancing device having a thin profile, for easy and
convenient stowage. Optionally, the lancing device is configured to
be provided as an original component of, or to be attached as a
retrofit component onto a glucose test meter. For example, an
example embodiment of the invention is a miniature lancing device
configured to be used in place of a battery compartment cover of a
glucose test meter. This allows the device to be retrofitted on
existing meters, or provided as original equipment on a new meter,
thereby providing an integrated device.
[0007] In one aspect, the present invention is a lancing device,
preferably including a housing having a narrow profile and a
slotted opening through a proximal end thereof. The lancing device
preferably also includes a lancet carrier translationally mounted
to slide along a path of travel within the housing, and having a
pair of engagement fingers for releasably receiving a lancet
therebetween. The lancing device preferably also includes an
energizing member translationally mounted to slide within a
lengthwise channel in the housing, generally parallel to the path
of travel of the lancet carrier. The lancing device preferably also
includes a release member translationally mounted to slide within a
transverse channel in the housing, generally perpendicular to the
path of travel of the lancet carrier.
[0008] In another aspect, the invention is the combination of a
body fluid testing meter having a battery cover opening, and a
lancing device configured for engagement with the meter over the
battery cover opening.
[0009] In still another aspect, the invention is a lancet,
preferably including a body portion having a sharp lancing tip
projecting therefrom, and along at least a portion of its length
having a flattened profile with a first dimension substantially
larger than a second dimension. The lancet preferably also includes
a sterility cap detachable from the body portion, and along at
least a portion of its length having a flattened profile with a
first dimension substantially larger than a second dimension. Prior
to detachment of the sterility cap from the body portion, the
flattened profile portion of the sterility cap is unaligned with
the flattened profile portion of the body portion.
[0010] In another aspect, the invention is a lancing device
including a lancet carrier translationally mounted within a housing
and movable along a path of travel between a retracted position and
an extended position, at least one drive spring engaged between the
lancet carrier and the housing, a charging mechanism for moving the
lancet carrier into the retracted position and energizing the at
least one drive spring, and a release mechanism for holding the
lancet carrier in the retracted position until actuated to release
the lancet carrier to move along the path of travel under the
influence of the at least one drive spring toward the extended
position. The lancet carrier, the at least one drive spring, the
charging mechanism and the release mechanism are all intersected by
a single reference plane containing the path of travel.
[0011] In another aspect, the invention is a lancing device having
an overall thickness of less than 0.25'' (0.6 cm).
[0012] In another aspect, the invention is the combination of a
blood glucose test meter having a battery compartment, and a
lancing device for releasable coupling to the blood glucose test
meter over the battery compartment.
[0013] In still another aspect, the invention is a lancing device
including a housing having a slotted lancet opening with a first
opening dimension greater than a second opening dimension thereof,
and a lancet releasably engagable with said lancing device. The
lancet has a lancet body with a sharp lancet tip projecting
therefrom and a cap removably covering the sharp lancet tip. The
lancet body has a first lancet body dimension less than the first
opening dimension but greater than the second opening dimension,
and has a second lancet body dimension less than the second opening
dimension. In this manner, the lancet body resists rotation within
the slotted lancet opening upon twisting of the cap to detach the
cap from the lancet body.
[0014] And in another aspect, the invention is a lancet including a
lancet body having a sharp lancet tip projecting therefrom, and a
protective cap removably covering the sharp lancet tip. The
protective cap includes a release member for releasing the lancet
body from engagement with a lancing device.
[0015] These and other aspects, features and advantages of the
invention will be understood with reference to the drawing figures
and detailed description herein, and will be realized by means of
the various elements and combinations particularly pointed out in
the appended claims. It is to be understood that both the foregoing
general description and the following brief description of the
drawings and detailed description of the invention are exemplary
and explanatory of preferred embodiments of the invention, and are
not restrictive of the invention, as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is a perspective view of a lancing device according
to an example form of the present invention, with an outer cover
portion removed to show internal components thereof.
[0017] FIG. 2 shows the lancing device of FIG. 1 with its drive
mechanism in an equilibrium position and receiving a lancet.
[0018] FIG. 3 shows the lancing device of FIG. 1 with the lancet
engaged in the drive mechanism.
[0019] FIG. 4 shows the lancing device of FIG. 1 with the drive
mechanism charged and the endcap of the lancet removed to expose
the sharp lancet tip.
[0020] FIG. 5 shows the lancing device of FIG. 1 with its
activation mechanism released, the drive mechanism in its forward
or lancing position, and the tip of the lancet projecting outwardly
from the device's lancet opening.
[0021] FIG. 6 shows the lancing device of FIG. 1 with the drive
mechanism returned to its equilibrium position and the lancet tip
retracted back into the device after lancing, and with a release
member positioned for lancet removal.
[0022] FIG. 7 is a top view of the lancing device of FIG. 1 showing
its narrow profile.
[0023] FIGS. 8a-8h show a lancing device and lancet according to
another embodiment of the present invention.
[0024] FIGS. 9a-9e show a lancing device according to another
embodiment of the present invention.
[0025] FIGS. 10a-10i show a lancing device and lancet according to
another embodiment of the present invention.
[0026] FIGS. 11a-11d show a lancing device according to another
embodiment of the present invention.
[0027] FIG. 12 shows a lancing device according to another
embodiment of the present invention.
[0028] FIGS. 13a-13e show a lancing device according to another
embodiment of the present invention, the lancing device being
installed in place of a battery cover on a blood-glucose testing
meter.
[0029] FIGS. 14a-14f show a lancing device according to another
embodiment of the present invention, the lancing device being
engaged onto a mounting clip installed in place of a battery cover
on a blood-glucose testing meter.
DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS
[0030] The present invention may be understood more readily by
reference to the following detailed description of the invention
taken in connection with the accompanying drawing figures, which
form a part of this disclosure. It is to be understood that this
invention is not limited to the specific devices, methods,
conditions or parameters described and/or shown herein, and that
the terminology used herein is for the purpose of describing
particular embodiments by way of example only and is not intended
to be limiting of the claimed invention. Also, as used in the
specification including the appended claims, the singular forms
"a," "an," and "the" include the plural, and reference to a
particular numerical value includes at least that particular value,
unless the context clearly dictates otherwise. Ranges may be
expressed herein as from "about" or "approximately" one particular
value and/or to "about" or "approximately" another particular
value. When such a range is expressed, another embodiment includes
from the one particular value and/or to the other particular value.
Similarly, when values are expressed as approximations, by use of
the antecedent "about," it will be understood that the particular
value forms another embodiment.
[0031] With reference to FIGS. 1-7, an example form of a lancing
device 10 according to the present invention is shown. A lancet
holder or carrier 20 is translationally mounted within a housing
30. The housing 30 is shown in the attached drawing figures with
its side cover panels removed to more clearly show internal
components. The unshown cover panels are preferably attached by
screws, rivets, crush-pins, snap-fittings, adhesive, solvent or
thermal welding, or other attachment means, to substantially fully
enclose the internal components of the device. Alternatively, the
housing 30 is an integral component including the unshown side
cover portions, for example formed as a single molding of plastic
or other structurally stable material(s). The housing 30 preferably
has a very compact, flat and slim exterior profile, for example
having dimensions of about 0.125'' thick.times.1.85''
long.times.0.725'' high (0.3 cm.times.4.7 cm.times.1.8 cm) in one
example embodiment. In preferred forms, the aspect ratio
(height:thickness) of the device is at least 4:1, and more
preferably at least 5:1. It is preferred that the overall thickness
of the device be less than 0.25'' (0.6 cm), and more preferably
less than 0.125'' (0.3 cm). The compact size and thin profile of
the internal componentry of the lancing device of the present
invention advantageously permit the device to be used as a standard
or generic "core" or chassis platform for various different lancing
device formats (i.e., lancing devices having distinct external
appearances and geometries may have common internal workings in the
form of the device described herein), facilitate easier and more
convenient stowage and use, and allow the device to be mounted to a
meter or other device without negatively impacting its utility or
appearance in a significant manner.
[0032] The lancet carrier 20 preferably comprises a pair of
resilient fingers or forks 22 for releasably engaging a miniature
lancet 40. The lancet 40 is preferably inserted and removed through
a slotted opening 32 in the proximal end of the housing 30. The
slotted opening 32 has a length considerably greater than its
width, most preferably having a length at least twice its width.
The lancet carrier 20 preferably also comprises slots 24 and/or
contact faces for receiving and/or engaging one or more drive
springs 50 and/or one or more retraction springs 52 for advancing
and retracting the lancet carrier along its path of travel within
the housing 30 to carry the lancet along its lancing stroke. In the
depicted embodiment, two drive springs 50 and one retraction spring
52 are included in the form of coil springs, positioned within
separate slots extending generally parallel to one another within
the carrier 20. In alternate embodiments, a single drive spring is
provided, having a substantially greater stiffness than the return
spring, and/or torsion springs, leaf springs, or other forms of
drive mechanisms are provided. The drive and return springs 50, 52
are preferably captured in compression or otherwise engaged between
the contact faces of the lancet carrier 20 and lugs 34 or other
surface features, recesses or projections of the housing 30. The
walls of the slots and the sidewalls of the housing assist in
maintaining the various biasing springs of the lancing device
aligned and in place.
[0033] An energizing or charging member 60 is preferably
translationally mounted to slide within a lengthwise channel 36 in
the housing 30, generally parallel to the path of travel of the
lancet carrier 20. A gripping pad or surface 62 preferably projects
from the energizing member 60, outwardly of the housing, to
facilitate actuation by a user. A tooth or pawl 64 projects
laterally from the energizing member 60, for engagement with a
cooperating projection 26 or other surface feature of the lancet
carrier 20. An energizing member return spring 66 is preferably
engaged in compression between the energizing member 60 and the
housing 30, to bias the energizing member 60 toward the proximal
end of the lancing device.
[0034] A release member 70 is preferably translationally mounted to
slide within a transverse channel 38 in the distal end of the
housing 30, generally perpendicular to the path of travel of the
lancet carrier 20. The release member 70 preferably includes a
release button 72 projecting outwardly from the housing 30 to
facilitate user actuation. A release member return spring 74 is
preferably engaged in compression between the release member 70 and
the housing 30, to bias the release member 70 in the direction of
the release button 72. The release member 70 preferably also
comprises a sear 76 or other surface feature for releasably
engaging a cooperating portion of the lancet carrier 20, to retain
the lancet carrier retracted in its energized position until
released by the user actuating the release button 72. The lancet
carrier 20, the energizing member 60, and the release member 70 are
all preferably intersected by a single common reference plane R,
are relatively thin in the direction normal to the reference plane,
and have generally flat and contiguous side faces lying parallel to
the reference plane. Additionally, the associated biasing members
50, 52, 66 and 74 preferably each have their axes of bias along the
reference plane R or closely parallel thereto. And the line or path
of travel of the lancet 40 preferably also lies in the reference
plane R. The thin and planar arrangement of components in this
manner allows the overall device 10 to be contained within a very
compact and narrow-profile external housing, as seen in example
form in FIG. 7.
[0035] The lancet 40 of the present invention preferably comprises
a small and lightweight lancet body portion 42, preferably having a
sharp lancet tip 43 projecting therefrom in the form of a metal
needle or blade. Preferably, the lancet body 42 is a molded plastic
member having a shank portion of the needle or blade 43 securely
embedded therein. The lancet body 42 preferably has a flattened
profile along at least a proximal portion of its length, having a
first dimension (height) substantially larger than a second
dimension (width), and configured to pass freely through the
slotted opening 32 in the housing 30 when aligned therewith, but to
prevent rotation of the lancet body within the slotted opening of
the housing. Notches or recesses in the sides of the lancet body 42
are preferably provided to receive and releasably engage
cooperating projections formed on the resilient fingers 22 of the
lancet carrier 20. The lancet 40 preferably further comprises a
removable sterility cap 44. The sterility cap 44 is preferably
co-molded with the lancet body portion 42, and the two are
connected at a narrow or notched neck portion for ease of
separation upon removal of the sterility cap. The sterility cap 44
is preferably relatively large or oversized, as compared to the
lancet body 42, to facilitate easier handling and loading of the
lancet into the lancing device, which is of particular advantage to
users having reduced visual acuity and/or reduced manual dexterity.
The sterility cap 44 optionally has a flared or T-shaped
configuration for better gripping during insertion of the lancet
and removal of the cap. The sterility cap 44 preferably has a
flattened profile along at least a distal portion of its length,
generally matching the flattened profile of the proximal portion of
the lancet body portion, but initially oriented generally
perpendicularly or obliquely relative thereto. The sterility cap 44
preferably also has a release finger 46 projecting therefrom, to
assist in release of a used lancet from the fingers or forks of the
lancet carrier, as detailed below.
[0036] In use, the user loads a lancet 40 into the lancing device
10 by inserting the lancet body 42 into the slotted opening 32 of
the housing, until the flattened profile of the lancet's sterility
cap 44 contacts the proximal face of the housing 30, with the
profile of the sterility cap being oriented generally crosswise to
the slotted opening (FIG. 2). The sterility cap 44 is then twisted
about 90.degree., while the lancet body is prevented from twisting
due to its flattened profile being engaged within the slotted
opening 32, thereby aligning the flattened profile of the cap with
the slotted opening. This twisting of the sterility cap 44 serves
to sever or detach the sterility cap from the lancet body 42 at the
neck portion therebetween, and to loosen the attachment between the
sterility cap and the lancet needle. The T-shaped configuration of
the sterility cap 44 assists the user in gripping and twisting the
cap in this manner. With the profile of the sterility cap 44 now
aligned with the slotted opening 32 of the housing, the lancet 40
is inserted further into the housing, until the lancet body 42
snaps into engagement in the resilient fingers 22 of the lancet
carrier (FIG. 3). The sterility cap 44 may then be removed, or can
be left in place until the device is energized and ready for
use.
[0037] The user then actuates the energizing member 60 by sliding
the gripping pad 62 rearwardly, away from the end of the housing 30
having the slotted opening 32 therein. Engagement of the pawl 64 of
the energizing member 60 with the projection 26 of the lancet
carrier 20 as the energizing member is operated retracts the lancet
carrier and energizes the drive springs 50. Alternatively, pushing
the lancet further into the housing energizes the drive spring(s).
As the lancet carrier 20 moves into its retracted position, the
lancet carrier contacts an inclined surface of the sear 76 of the
release member 70, depressing the release member against the bias
of the release member return spring 74. Upon reaching its fully
retracted position, the sear 76 of the release member 70 snaps
upwardly into engagement with the lancet carrier 20 under the
influence of the release member return spring 74, to retain the
lancet carrier retracted in its energized position (FIG. 4). The
user then releases the energizing member 60 to return to its
forward position under the influence of the energizing member
return spring 66.
[0038] The sterility cap 44 is removed, and the slotted proximal
face of the housing is placed against the subject's skin at the
intended lancing site. The user presses the release button 72 of
the release member 70, releasing the sear 76 from engagement with
the lancet carrier 20. The lancet carrier 20 is propelled forward
into its advanced position under the influence of the drive springs
50, driving the sharp lancet tip through the slotted opening 32 and
outwardly of the housing 30, to penetrate the subject's skin at the
lancing site (FIG. 5). The lancet carrier 20 is then retracted
under the influence of the retraction spring 52, to return the
lancet tip into a shielded equilibrium position within the housing
(FIG. 6).
[0039] After use, the lancet body 42 is preferably removed from the
lancing device 10, for replacement with a fresh lancet for
subsequent use. The release finger 46 of the sterility cap 44 is
inserted into a hole 39 in the housing, extending between the forks
22 of the lancet carrier, and behind the lancet body 42 (FIG. 6).
The lancet carrier 20 is then retracted out of engagement with the
lancet body 42 by sliding the energizing member 60 rearwardly,
causing the forks 22 to flex outwardly and release the lancet body,
and the used lancet is discharged from the slotted opening 32 or
otherwise removed from the device 10. In alternate forms, an
integral removal member is provided for releasing the lancet from
the carrier, for example comprising an internal finger selectively
positionable between the forks 22 of the lancet carrier and behind
the lancet body 42, and an external actuation button or lever.
[0040] One or more guides or limit members 28 are optionally
provided on the lancet carrier 20, moving within one or more
corresponding guide channels formed in the housing 30, to maintain
transverse alignment of the lancet carrier (i.e., limiting
up-and-down movement of the carrier and lancet perpendicular to the
lancet stroke), and to provide a forward stop to limit the stroke
of the lancet in the forward axial direction thereby more precisely
controlling the depth of penetration of the lancet into the skin.
The forks 22 of the lancet carrier 20 are preferably guided between
a pair of retaining panels 35 at the proximal end of the housing
adjacent the slotted opening 32 as the lancet carrier 20 moves into
its advanced or lancing position, preventing the forks from
spreading apart and potentially releasing the lancet 40 during the
lancing operation (FIG. 5) and providing additional transverse
guidance and stability. The retaining panels do not extend so far
distally, however, as to interfere with the forks 22 spreading
apart to receive or release the lancet 40 when the carrier 20 is
positioned in its retracted or equilibrium positions. In preferred
form, the lancet body 42 is of substantially the same thickness as
the lancet carrier 20, and the lancet body and the lancet carrier
are coplanarly aligned when the lancet is installed, so that
lateral guidance (i.e., limiting side-to-side movement of the
carrier and lancet perpendicular to the lancet stroke) and
stability are provided to both the lancet and the carrier during
the lancing stroke as a result of smoothly-sliding, low-friction,
close interaction of the parts along the interior faces of the side
panels of the housing 30. By utilizing the interior faces of the
housing as lateral guidance features in this manner, the need for
separate lateral guidance components is eliminated and a more
compact and narrow profile is enabled (FIG. 7).
[0041] FIGS. 8a-8h show another example embodiment of a lancing
device 110 and a lancet 140 according to the present invention. In
this embodiment, the endcap 144 of the lancet 140 comprises an
inclined or curved removal surface 145, which acts as a wedge or
cam when pushed into the lancet-removal opening 139, to release the
lancet body 142 from the forks of the lancet carrier. Viewed from
its end, the endcap 144 of the lancet 140 preferably has a
generally T-shaped profile, with the removal surface 145 being
positioned on the free end of its upright, and the lancet-removal
opening 139 is preferably correspondingly T-shaped. In alternate
embodiments, the endcap of the lancet comprises a wedge or pin,
which is inserted through the lancet-removal opening, and the
endcap is pivotally toggled to pry the spent lancet body from out
of engagement with the forks of the lancet carrier.
[0042] Another example embodiment of a lancing device 210 according
to the present invention is shown in FIGS. 9a-9e. In this
embodiment, a detachable endcap 280 is provided at the proximal end
of the housing 230. The endcap 280 is removed for access to insert
a fresh lancet 240 into engagement with the lancet carrier, and/or
to remove a spent lancet. The endcap 280 preferably comprises a
proximal portion having a contact face defining the lancet opening
232, and at least one side panel portion extending distally
therefrom to cover a cutout access portion of the housing 230
permitting lancet removal and insertion. The detachable endcap may
be entirely removable from the remainder of the housing, or may be
tethered or hingedly connected to the remainder of the housing to
prevent loss.
[0043] In the example embodiment of the present invention depicted
in FIGS. 10a-10i, the lancing device 310 comprises a housing 330
having a hinged access panel or door 380 providing access for
removal and/or insertion of the lancet 340 to/from the lancet
carrier 320. Additionally, a drive spring 350 and a return spring
352 are positioned within a single elongate slot formed in the
lancet carrier 320, and are aligned coaxially with one another on
opposite sides of a biasing lug 334 of the housing 330. This
aligned spring configuration enables a housing geometry that is
shorter in height than the parallel spring arrangement described
above.
[0044] Another example embodiment of a lancing device 410 having a
hinged access door 480 in the housing 430 is shown in FIGS.
11a-11d. In this embodiment, the inner face of the door 480
includes one or more clips 485 for retaining the lancet 440. A
lancet 440 is installed into the device by placing the lancet body
into the carrier 420 (FIG. 11A), or alternatively by engaging the
lancet body with the clips 485 on the access door. The access door
480 is closed, and the device is operated in similar fashion to
that described above. After use, removal of the spent lancet 440 is
facilitated by the retention of the lancet on the access door 480
by the clips 485, such that the lancet may be more easily removed
when the door is opened. The clips 485 optionally also provide
lancet guidance.
[0045] FIG. 12 shows another example embodiment of a lancing device
510 according to the present invention. In this embodiment, a clip
590 containing a plurality of lancets, preferably in a stacked or
sequential array, is provided. Actuation of the energizing member
562 preferably loads a fresh lancet for use and discharges a used
lancet from the lancet carrier. The clip optionally includes a
collection reservoir for used lancets, or alternatively used
lancets are discharged from the device for external disposal. Other
than the clip-feeding lancet mechanism, the remainder of the device
510 is substantially similar to that described above, having a
housing 530 containing a translational lancet carrier and drive
mechanism, a lancet opening 532 through which the lancet tip
projects in its extended position, a charging or energizing
mechanism actuated by the energizing member 562, and a release
mechanism actuated by the release button 572.
[0046] Due to the compact size and narrow profile of example
embodiments, the lancing device of the present invention is
suitable for mounting or attachment to a blood glucose test meter
or other device or carrier. Preferably, the lancing device of the
present invention is mountable on or in place of a removable
portion or component of the meter, removal or alteration of which
does not negatively impact the meter's operation. For example,
various forms of the invention can be mounted to or in place of the
removable battery cover of a blood glucose test meter, such that
the lancing device is carried with the meter for greater
convenience and ease of use. The lancing device can be provided as
original equipment as a detachable or integral part of a new meter,
and/or can be provided as an upgrade or retrofit component for
backwards-compatible attachment to an existing meter, such as for
example the Bayer Ascensia Contour.TM. blood glucose meter sold by
Bayer Healthcare LLC of Mishawaka, Ind.; the BD Logic Meter; the
Lifescan OneTouch Ultra Meter, and/or the Abbott FreeStyle Flash
Meter. The housing of the lancing device is preferably similar in
size and shape to the battery cover of the particular blood-glucose
testing meter to which it is intended to be mounted, and the narrow
profile of the lancing device does not significantly alter the
overall external geometry of the meter. The housing of the lancing
device preferably comprises external surface features substantially
conforming to the attachment clips, channels, tabs, slots and/or
other corresponding coupling members of a battery cover, whereby
the lancing device can be snapped or clipped onto a meter in place
of the standard battery cover. Preferably, one or more of the
actuator components and/or the lancet opening of the lancing device
project beyond or adjacent the outer peripheral edges of the meter
or other object to which the device is mounted, for easier access
during use.
[0047] For example, as shown in FIGS. 13a-13e, the lancing device
610 is configured for attachment in place of a battery cover 682 of
a blood glucose testing meter 680. The blood glucose testing meter
680 is preferably of standard form, having a slot 684 for receiving
a test strip, a display 686, and one or more controls 688. The
external geometry of the lancing device 610 generally matches the
shape and size of the battery cover 682, and includes one or more
coupling member(s) for coupling to the meter 680 substantially
similar to the corresponding coupling member(s) of the battery
cover. The lancet opening 632 preferably projects a small distance
beyond the side edge of the meter, such that the user can readily
place a finger or alternate lancing site against the contact face
surrounding the lancet opening. And the energizing member 662 and
release button 672 preferably also project a small distance beyond
the outer periphery of the meter, for ease of access and use.
[0048] In an another example form of the present invention shown in
FIGS. 14a-14f, the lancing device 710 is mountable into or onto a
mounting clip 790 that replaces the standard battery cover 782 of a
test meter 780. The mounting clip preferably has a geometry and
coupling member configuration substantially similar to the original
battery cover, and includes one or more fingers, fittings or other
retention means for engaging cooperative elements of the lancing
device 710 to permanently or removably secure the lancing device
thereto. The lancet opening 732, the energizing member 762, and/or
the release button 772 preferably project a distance beyond the
back panel of the meter, for ease of access and use.
[0049] In other embodiments, the lancing device of the present
invention is integrally formed with or mountable onto a meter
elsewhere other than the battery cover, as by integral molding,
adhesive attachment, snap-fitting connection or other attachment
means. In further alternate embodiments, the lancing device of the
present invention is integrally formed with or mountable onto a
carrier other than a blood glucose meter. For example, the lancing
device can comprise a clip allowing it to be mounted or attached
onto a purse, belt or other item, similar to a pen, a tie-clip or a
small pager. Alternatively or additionally, the lancing device
includes a ring or loop for attachment to key-ring or other object,
in similar fashion to a key-fob.
[0050] While the invention has been described with reference to
preferred and example embodiments, it will be understood by those
skilled in the art that a variety of modifications, additions and
deletions are within the scope of the invention, as defined by the
following claims.
* * * * *