U.S. patent application number 12/648776 was filed with the patent office on 2010-04-29 for lancing device and multi-lancet cartridge.
This patent application is currently assigned to FACET TECHNOLOGIES, LLC. Invention is credited to David ANDEL, William E. CONWAY, Stephen J. FLYNN, John C. IRWIN, Bradley KOEPPEL, Brian D. LEUTZ, Richard W. LEVAUGHN, Michael V. LIPOMA, Avi M. ROBBINS, Christopher J. RUF, Brian D. VANHIEL.
Application Number | 20100106174 12/648776 |
Document ID | / |
Family ID | 35783339 |
Filed Date | 2010-04-29 |
United States Patent
Application |
20100106174 |
Kind Code |
A1 |
CONWAY; William E. ; et
al. |
April 29, 2010 |
LANCING DEVICE AND MULTI-LANCET CARTRIDGE
Abstract
A medical lancing device including a replaceable multi-lancet
cartridge. The lancing device includes a drive mechanism, an
activation mechanism, and an advancing mechanism. The advancing
mechanism includes a linear-pull slide that is moved in and out to
operate an indexing ratchet mechanism, a cam-guided charger
mechanism, and a cam-guided lancet cap displacement mechanism. The
indexing ratchet mechanism sequentially advances the lancets in the
cartridge to an active position. The cam-guided charger mechanism
charges the drive mechanism and separates the cap from the active
lancet. And the cam-guided cap displacement mechanism moves the
separated cap from the lancing stroke path of the active lancet.
The activation mechanism then releases the charged active lancet to
traverse the unobstructed lancing stroke path to pierce the
subject's skin at a desired lancing site.
Inventors: |
CONWAY; William E.; (Smyrna,
GA) ; RUF; Christopher J.; (Marietta, GA) ;
IRWIN; John C.; (Woodstock, GA) ; FLYNN; Stephen
J.; (Peachtree City, GA) ; ROBBINS; Avi M.;
(Augusta, GA) ; VANHIEL; Brian D.; (Smyrna,
GA) ; LEUTZ; Brian D.; (McDonough, GA) ;
LEVAUGHN; Richard W.; (Newnan, GA) ; LIPOMA; Michael
V.; (Villa Rica, GA) ; KOEPPEL; Bradley;
(Smyrna, GA) ; ANDEL; David; (Lawrenceville,
GA) |
Correspondence
Address: |
GARDNER GROFF GREENWALD & VILLANUEVA. PC
2018 POWERS FERRY ROAD, SUITE 800
ATLANTA
GA
30339
US
|
Assignee: |
FACET TECHNOLOGIES, LLC
Kennesaw
GA
|
Family ID: |
35783339 |
Appl. No.: |
12/648776 |
Filed: |
December 29, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11571378 |
Dec 28, 2006 |
|
|
|
PCT/US05/23155 |
Jun 30, 2005 |
|
|
|
12648776 |
|
|
|
|
60584115 |
Jun 30, 2004 |
|
|
|
Current U.S.
Class: |
606/183 |
Current CPC
Class: |
A61B 5/15117 20130101;
A61B 5/150702 20130101; A61B 5/15161 20130101; A61B 5/150725
20130101; A61B 5/150503 20130101; A61B 5/15113 20130101; A61B
5/15153 20130101; A61B 5/150412 20130101; A61B 5/15182 20130101;
A61B 5/150564 20130101; A61B 5/150022 20130101; A61B 5/15176
20130101 |
Class at
Publication: |
606/183 |
International
Class: |
A61B 17/32 20060101
A61B017/32 |
Claims
1. A cartridge assembly for a lancing device having a
lancet-indexing ratchet mechanism with a pawl, the cartridge
assembly comprising: a housing; a carrier rotationally mounted
within the housing; an array of lancets carried by the carrier, the
lancets each having a detachable protective cap, the lancets each
moveable along a lancing stroke path; and a plurality of ratchet
teeth extending from the carrier and configured to be sequentially
engaged by the pawl to advance the array of lancets within the
housing.
2. The cartridge assembly of claim 1, wherein the ratchet teeth and
the lancets are provided in a one-to-one ratio.
3. The cartridge assembly of claim 1, wherein cartridge housing
defines a slot through which the ratchet teeth extend.
4. The cartridge assembly of claim 1, wherein the carrier defines
an array of transverse guide tracks along which the lancet caps are
displaced from the lancing stroke path.
5. The cartridge assembly of claim 4, wherein the lancet caps
define one or more cap guide surfaces that engage and ride along
the guide tracks as the caps are displaced from the lancing stroke
path.
6. The cartridge assembly of claim 5, wherein the guide tracks
engage the cap guide surfaces to retain the active-positioned cap
from moving and being retracted with the active-positioned lancet,
wherein the retained active-positioned cap separates from the
retracted active-positioned lancet.
7. The cartridge assembly of claim 5, wherein the guide tracks
comprise resilient elongated members extending from the carrier,
and the cap guide surfaces comprise two shoulders projecting from
opposing sides of the cap.
8. The cartridge assembly of claim 4, wherein the guide tracks are
adapted to retain the lancet caps after displacement from the
lancing stroke path.
9. The cartridge assembly of claim 1, wherein the carrier defines
radial guide channels that receive the lancets in a radial
arrangement.
10. A multi-lancet cartridge assembly for a lancing device
comprising: a generally circular housing comprising a base and a
cover with a central opening defining an annular shell having an
outer circumferential rim with a lancet opening formed therein; a
carrier disk rotationally mounted within the housing, the carrier
disk defining a plurality of radially-oriented guide channels; and
a plurality of lancets, each lancet positioned for translational
motion within a corresponding one of the plurality of
radially-oriented guide channels.
11. The multi-lancet cartridge assembly of claim 10, wherein the
base of the housing comprises a slot for receiving an advancing
member of a lancing device to rotationally advance the carrier disk
within the housing.
12. The multi-lancet cartridge assembly of claim 11, wherein the
carrier disk comprises a plurality of projections for sequential
alignment with the slot in the base of the housing, for engagement
with the advancing member of the lancing device.
13. The multi-lancet cartridge assembly of claim 10, wherein each
lancet has an outwardly-directed end with a sharp lancing tip that
is initially covered by a removable cap, and an inwardly-directed
end having a retainer foot projecting therefrom for engagement with
a drive mechanism of a lancing device.
14. The multi-lancet cartridge assembly of claim 13, wherein the
base of the housing comprises a channel for receiving the retainer
feet of the lancets.
15. The multi-lancet cartridge assembly of claim 13, wherein the
removable caps of the lancets have shoulders projecting laterally
outwardly on opposite sides thereof, and wherein the carrier disk
comprises a set of cap guide tracks associated with each of the
radially-oriented guide channels for engaging the shoulders of the
removable caps.
16. The multi-lancet cartridge assembly of claim 13, wherein the
housing comprises at least one opening therein for alignment with
the removable caps to permit passage of a plunger of the lancing
device to move the caps along the cap guide tracks.
17. The multi-lancet cartridge assembly of claim 10, further
comprising a ratchet mechanism for limiting rotation of the carrier
disk within the housing to a single direction of rotation.
18. A cartridge for use in connection with a lancing device,
comprising: a housing comprising a shell having an outer periphery
with a lancet opening therein and an interior chamber within the
shell; a carrier rotationally mounted within the interior chamber
of the housing and defining a plurality of lancet guide paths; an
array of lancets, each lancet mounted for translation along a
corresponding one of the plurality of lancet guide paths; and a
ratchet mechanism for allowing rotation of the carrier within the
housing in a first direction of rotation, but restricting rotation
of the carrier within the housing in a second direction of rotation
opposite the first direction of rotation.
19. The cartridge of claim 18, wherein the housing comprises an
annular ring-shaped external profile, having a circular outer rim
and a circular inner rim concentric with the outer rim.
20. The cartridge of claim 18, wherein the housing comprises a
lancet drive opening allowing sequential engagement of each lancet
of the array of lancets by a lancing device drive mechanism.
21. The cartridge of claim 18, wherein the housing comprises an
indexing slot allowing advancement of the carrier within the
housing by a lancing device advancing member.
22. The cartridge of claim 18, wherein the housing comprises at
least one cap-displacement opening allowing a plunger mechanism of
a lancing device to extend into the interior chamber to move a
removable endcap out of the lancet guide path.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a divisional of U.S. Non-Provisional
patent application Ser. No. 11/571,378 filed Dec. 28, 2006, which
is a U.S. National Phase Patent Application of International PCT
Patent Application Serial No. PCT/US2005/023155 filed Jun. 30,
2005, which claims priority to U.S. Provisional Patent Application
Ser. No. 60/584,115 filed Jun. 30, 2004, all of which are hereby
incorporated herein by reference in their entireties.
TECHNICAL FIELD
[0002] The present invention relates generally to medical devices
and procedures, and more particularly to cartridge assemblies for
lancing devices for the collection and/or analysis of samples of
blood or other bodily fluids.
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,
interstitial fluid or other body fluid, as for example in blood
glucose monitoring by diabetics and in blood typing and screening
applications.
[0004] In some instances, a person must periodically sample their
blood for multiple testing throughout the day or week. Because
re-use of a lancet can result in infection or spread of blood borne
contaminants, persons requiring repeated testing often must carry
multiple lancets with them, which are separately loaded into a
lancing device for each sampling. This can be inconvenient and may
lead to reduced compliance with a prescribed test regimen.
[0005] Accordingly, it has been discovered that needs exist for an
improved lancing device capable of carrying out multiple sampling
procedures without the need for separately loading individual
lancets. It has also been discovered that needs exist for a
convenient, disposable multi-lancet cartridge that can be loaded
into a multi-use lancing device for carrying out multiple sampling
procedures, and be removed and replaced when fully or partially
spent or when replacement is otherwise desired. It is to the
provision of an improved sampling device and cartridge meeting
these and other needs that the present invention is primarily
directed.
SUMMARY OF THE INVENTION
[0006] Briefly described, in one aspect, the present invention is a
lancing device comprising an outer housing for receiving a
replaceable cartridge. Preferably, the cartridge includes a static
outer shell that remains stationary relative to the housing and
drive mechanism of the lancing device, and an array of lancets that
are rotationally advanced within the outer shell and sequentially
indexed through an active position for carrying out multiple
lancing procedures. The cartridge preferably includes a
rotationally moveable carrier for retaining and rotationally
advancing the radial array of lancets within the outer shell, and
for constraining the active lancet along a controlled and
pre-defined path of travel during the lancing stroke. The cartridge
preferably also includes recesses, clips, or other retainers for
retaining protective endcaps that have been removed from the
lancets out of the path of travel of the lancets, and preventing
the caps from rattling around within the housing.
[0007] The lancing device preferably includes a drive mechanism,
including for example a pair of opposed biasing mechanisms (e.g.,
springs) working in tandem, to drive and return the plunger
mechanism of the lancing device and propel the active lancet
through its lancing stroke. In example embodiments, the jaw of the
drive mechanism engages the active lancet from the bottom only,
through a slot in the cartridge shell, so that a partially spent
cartridge can be removed from the lancing device and reinserted for
use at a later time. In further example embodiments, the lancing
device includes a one-way clutch or ratchet mechanism to advance
lancets sequentially through the active position and to prevent
re-use of lancets. The lancing device preferably also includes an
advancing and charging mechanism for sequentially indexing the
lancet carrier, charging the drive mechanism, and detaching the
endcap of the lancet at a controlled retraction rate during
de-capping, all with a single and continuous operation.
[0008] The lancing device optionally includes a depth ring for
adjusting the depth of penetration of the lancet. Preferably, the
depth ring has a plurality of openings with varying opening sizes
and varying countersink depths, and is rotatable through a sequence
of positions adjacent the lancet opening in the housing of the
lancing device, thereby forming a rotating shutter window,
providing a wide range of depth control. In further example
embodiments, the lancing device includes an improved activating
button operable to activate the drive mechanism, and including an
integral spring arm for biasing the activating button outwardly and
a retainer for securing the rotating depth ring.
[0009] In another aspect, the invention is an improved cartridge
assembly for use with a multi-use lancing device. The cartridge
assembly preferably includes a plurality of penetration elements or
lancets, each having its own protective covering or endcap,
arranged for sequential use in piercing the skin or other tissue of
a human or animal subject for obtaining a sample of blood,
interstitial fluid, and/or other body fluid(s). In example
embodiments, the cartridge has an outer shell or housing and a
carrier assembly rotationally enclosed within the outer shell for
retaining the lancets. Because the carrier rotationally advances
the lancets within the outer shell of the cartridge, only one
opening through the shell is required for allowing passage of the
active lancet tip upon actuation of the device, thereby reducing
the potential for contamination or accidental needle sticks.
[0010] In yet another aspect, the present invention is a cap
displacement mechanism that moves a sterility cap, after it has
been separated from the active lancet, out of the lancing stroke
travel path of the active lancet. In a first example embodiment,
the cartridge includes a cantilevered spring arm that is mounted
within the cartridge shell to bias the separated lancet cap out of
the path of the lancing stroke. In a second example embodiment, the
lancing device includes a spring-biased plunger that is driven
along a cam surface of the lancing device to engage a lancet cap
and push it transversely out of the path of the lancing stroke. In
both embodiments, the carrier defines transverse guide paths near
its outer perimeter for directing and retaining the lancet caps out
of the travel path of the lancet tip. The transverse guide paths
are preferably defined by one or more guide tracks (e.g., resilient
fingers, barbs, or other engagement features) extending from the
carrier for positively retaining the lancet caps that have been
removed from the lancet bodies.
[0011] And in still another aspect, the present invention is a
linear-pull advancing mechanism that replaces the rotational cam
drive advancing mechanism and the cap displacement mechanism
previously described. In an example embodiment, the advancing
mechanism includes a linear-pull slider that is moved in and out to
operate an indexing ratchet mechanism, a cam-guided charger
mechanism, and a cam-guided lancet cap displacement mechanism. The
indexing ratchet mechanism includes a resilient pawl extending from
the slider and a plurality of ratchet teeth extending downward from
the lancet carrier for sequentially advancing the lancets in the
cartridge to an active position. The cam-guided charger mechanism
includes a cam arm that is resiliently deflected by a follower on
the drive plunger and then guides the piston for charging the drive
mechanism and separating the cap from the active lancet. And the
cam-guided cap displacement mechanism includes a lifter with a
follower that rides along a cam surface for moving the separated
cap from the lancing stroke path of the active lancet. The
activation mechanism then releases the charged active lancet to
traverse the unobstructed lancing stroke path to pierce the
subject's skin at a desired lancing site.
[0012] 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
[0013] FIG. 1 is a perspective view of a multi-lancet cartridge
assembly for a lancing device in accordance with a first example
embodiment of the present invention.
[0014] FIG. 2 is an exploded perspective view of the cartridge
assembly of FIG. 1, showing a base housing, lancet array, carrier
disk, spring-arm cap displacer, and cover housing.
[0015] FIG. 3 is a cutaway perspective view of the lancet array,
carrier, and spring arm of FIG. 2, showing spring arm displacing a
separated cap of an active lancet.
[0016] FIG. 4 is a perspective view of a cartridge assembly for a
lancing device in accordance with a second example embodiment of
the present invention.
[0017] FIG. 5 is an exploded perspective view of the cartridge
assembly of FIG. 4, showing a base housing, lancet array, carrier
disk, and cover housing.
[0018] FIG. 6 is a partial perspective view of an advancer
mechanism of the lancing device for use with the cartridge of FIG.
4, showing a spring-loaded cap-displacing plunger driven by a cam
surface of the advancer mechanism.
[0019] FIG. 7 is a perspective view of a lancing device according
to the second example embodiment of the invention, suited for use
with the cartridge assembly of FIG. 4, showing the lancing device
in an opened position revealing the advancer mechanism of FIG. 6
situated therein, and showing the spring-loaded cam-driven plunger
extending through the upper shell of the advancer mechanism.
[0020] FIG. 8 is a partial cutaway perspective view of the advancer
mechanism of FIG. 6, showing the spring-biased cam-driven plunger
displacing a cap of an active-position lancet.
[0021] FIG. 9 is a side view of the advancer mechanism of FIG. 6,
showing the spring-biased cam-driven plunger reset to a position
clear of the lancing stroke travel path.
[0022] FIG. 10 is another exploded perspective view of the
cartridge assembly of FIG. 4.
[0023] FIG. 11 is a bottom view of the cartridge assembly of FIG.
10 with the bottom cover removed for clarity.
[0024] FIG. 12 is a perspective view of a drive and return
mechanism of the lancing device of FIG. 7.
[0025] FIG. 13 is a perspective view of a lancing depth adjustment
ring of the lancing device of FIG. 7.
[0026] FIG. 14 is a top view of an actuator button portion of the
lancing device of FIG. 7.
[0027] FIG. 15a is a detailed plan view of a portion of the
advancer mechanism of FIG. 6 located on the bottom of the housing
of the lancing device of FIG. 7.
[0028] FIG. 15b is a detailed plan view of the advancer mechanism
of FIG. 6, including the portion shown in FIG. 15a.
[0029] FIG. 16 is a perspective view of the cartridge of FIG. 4
installed in the lancing device of FIG. 7.
[0030] FIG. 17 is a perspective view of a portion of a lancing
device in accordance with a third example embodiment of the present
invention, showing a linear-pull slider of an advancer mechanism in
a retracted position in the bottom portion of the clam-shell
housing.
[0031] FIG. 18 is a perspective view of the lancing device portion
of FIG. 17, showing the slider being pulled from the housing.
[0032] FIG. 19 is a perspective view of the lancing device portion
of FIG. 17, showing the slider being pulled further from the
housing.
[0033] FIG. 20 is a perspective view of the lancing device portion
of FIG. 17, showing the slider pulled to an extended position.
[0034] FIG. 21 is a perspective detailed view of part of the
lancing device portion of FIG. 17, showing details of a cam-guided
cap displacement mechanism.
[0035] FIG. 22a is a top perspective view of the lancing device of
FIG. 17, showing the slider of the advancer mechanism being pulled
from the retracted position to the extended position to initiate a
process for inserting a new cartridge.
[0036] FIG. 22b is a top perspective view of the lancing device of
FIG. 22a, showing the housing being opened.
[0037] FIG. 22c is a top perspective view of the lancing device of
FIG. 22a, showing the cartridge being inserted into the
housing.
[0038] FIG. 22d is a top perspective view of the lancing device of
FIG. 22a, showing the housing being closed.
[0039] FIG. 22e is a top perspective view of the lancing device of
FIG. 22a, showing the slider being pushed back in to its retracted
position.
[0040] FIG. 22f is a top perspective view of the lancing device of
FIG. 22a, showing the activating button being pressed to activate
the lancing device for lancing with an initial one of the
lancets.
[0041] FIG. 22g is a partial side view of the lancing device of
FIG. 22a, showing the C-shaped handle that locks the housing closed
when the slider is in its retracted position.
[0042] FIG. 23a is a top perspective view of the lancing device of
FIG. 17, showing the slider being pulled from the retracted
position to the extended position to initiate a process for
advancing a next one of the lancets for lancing.
[0043] FIG. 23b is a top perspective view of the lancing device of
FIG. 23a, showing the slider being pushed back in to its retracted
position.
[0044] FIG. 23c is a top perspective view of the lancing device of
FIG. 23a, showing the activating button being pressed for lancing
with the next lancet.
[0045] FIG. 24a is a top perspective view of the lancing device of
FIG. 17, showing the slider being pulled from the retracted
position to the extended position to initiate a process for
removing a spent cartridge after all the lancets have been
used.
[0046] FIG. 24b is a top perspective view of the lancing device of
FIG. 24a, showing the housing being opened.
[0047] FIG. 24c is a top perspective view of the lancing device of
FIG. 24a, showing the spent cartridge being removed from the
housing.
[0048] FIG. 24d is a top perspective view of the lancing device of
FIG. 24a, showing the housing being closed.
[0049] FIG. 24e is a top perspective view of the lancing device of
FIG. 24a, showing the slider being pushed back in to its retracted
position.
[0050] FIG. 25a is a top perspective view of the lancing device of
FIG. 17, showing the slider being pulled from the retracted
position to the extended position to initiate a process for
removing a partially spent cartridge before all of the lancets have
been used.
[0051] FIG. 25b is a top perspective view of the lancing device of
FIG. 25a, showing the housing being opened.
[0052] FIG. 25c is a top perspective view of the lancing device of
FIG. 25a, showing the partially spent cartridge being removed from
the housing.
[0053] FIG. 25d is a top perspective view of the lancing device of
FIG. 25a, showing the housing being closed.
[0054] FIG. 25e is a top perspective view of the lancing device of
FIG. 25a, showing the slider being pushed back in to its retracted
position.
[0055] FIG. 26a is a top perspective view of the lancing device of
FIG. 17, showing the slider being pulled from the retracted
position to the extended position to initiate a process for
reinserting the partially spent cartridge that was removed prior to
all of the lancets being used.
[0056] FIG. 26b is a top perspective view of the lancing device of
FIG. 26a, showing the housing being opened.
[0057] FIG. 26c is a top perspective view of the lancing device of
FIG. 26a, showing the partially spent cartridge being reinserted
into the housing.
[0058] FIG. 26d is a top perspective view of the lancing device of
FIG. 26a, showing the housing being closed.
[0059] FIG. 26e is a top perspective view of the lancing device of
FIG. 26a, showing the slider being pushed back in to its retracted
position.
[0060] FIG. 26f is a top perspective view of the lancing device of
FIG. 26a, showing the activating button being pressed to activate
the lancing device.
[0061] FIG. 27a is a bottom perspective view of the lancing device
of FIG. 17, showing a fail-safe release of the advancer mechanism
being activated to initiate a process for clearing the lancing
device if it becomes jammed.
[0062] FIG. 27b is a top perspective view of the lancing device of
FIG. 27a, showing the slider being pulled from its retracted
position to its extended position.
[0063] FIG. 27c is a top perspective view of the lancing device of
FIG. 27a, showing the housing being opened.
[0064] FIG. 27d is a top perspective view of the lancing device of
FIG. 27a, showing the cartridge being removed from the housing.
[0065] FIG. 27e is a top perspective view of the lancing device of
FIG. 27a, showing the housing being closed.
[0066] FIG. 27f is a top perspective view of the lancing device of
FIG. 27a, showing the slider being pushed back in to its retracted
position.
[0067] FIG. 28 is a top perspective view of the lancing device of
FIG. 17, showing the use of the depth adjustment mechanism to set
the lancing puncture depth.
[0068] FIG. 29 is a perspective bottom view of the carrier of the
lancet cartridge of the lancing device of FIG. 17, showing ratchet
teeth of an indexing ratchet mechanism of the advancer
mechanism.
[0069] FIG. 30 is a side view of a portion of the indexing ratchet
mechanism of the lancing device of FIG. 17, showing a resilient
pawl and the ratchet teeth.
[0070] FIG. 31 is a side view of the ratchet mechanism of FIG. 30,
showing the pawl being advanced as the slider of FIG. 17 is
pulled/extended.
[0071] FIG. 32 is a side view of the ratchet mechanism of FIG. 30,
showing the pawl further advanced into engagement with one of the
teeth.
[0072] FIG. 33 is a side view of the ratchet mechanism of FIG. 30,
showing the pawl fully extended, the engaged tooth advanced, and
the lancet carrier rotated/indexed as the slider is moved to the
extended position of FIG. 20.
[0073] FIG. 34 is a side view of the ratchet mechanism of FIG. 30,
showing the pawl being retracted as the slider is
pushed/retracted.
[0074] FIG. 35 is a side view of the ratchet mechanism of FIG. 30,
showing the pawl retracted into engagement with, and resiliently
deflecting under, a next tooth.
[0075] FIG. 36 is a side view of the ratchet mechanism of FIG. 30,
showing the pawl fully retracted as the slider is moved to the
retracted position of FIG. 17.
[0076] FIG. 37 is a side view of the ratchet mechanism of FIG. 36,
showing the ratchet mechanism after all of the lancets in the
cartridge have been used.
[0077] FIG. 38 is a perspective view of a reciprocating plunger of
a cam-guided charger mechanism of the advancer mechanism of the
lancing device of FIG. 17.
[0078] FIG. 39 is a perspective view of a deflectable cam arm of
the cam-guided charger mechanism of the advancer mechanism of the
lancing device of FIG. 17.
[0079] FIG. 40 is a plan view of a portion of the cam-guided
charger mechanism of FIGS. 38 and 39, showing the cam arm and a
charging follower of the plunger when the slider is in its
retracted position of FIG. 17.
[0080] FIG. 41 is a plan view of the cam-guided charger mechanism
of FIG. 40, showing the cam arm being resiliently deflected by the
charging follower of the plunger as the slider is
pulled/extended.
[0081] FIG. 42 is a plan view of the cam-guided charger mechanism
of FIG. 40, showing the cam arm returned to its neutral position
after moving past the charging follower, as the slider is moved to
its fully extended position of FIG. 20.
[0082] FIG. 43 is a plan view of the cam-guided charger mechanism
of FIG. 40, showing the cam arm driving backward the charging
follower to charge the drive mechanism as the slider is
pushed/retracted.
[0083] FIG. 44 is a plan view of the cam-guided charger mechanism
of FIG. 40, showing the charging follower driven back until the
plunger is retained in its charged position as the slider is moved
to its fully retracted position of FIG. 17.
[0084] FIG. 45 is a perspective view of a lifter member of a
cam-guided lancet cap displacement mechanism of the advancer
mechanism of the lancing device of FIG. 17.
[0085] FIG. 46 is a perspective view of a cam surface of the
cam-guided lancet cap displacement mechanism of the advancer
mechanism of the lancing device of FIG. 17.
[0086] FIG. 47 is a side view of a portion of the cam-guided cap
displacement mechanism of FIGS. 45 and 46, showing a follower of
the lifter raised by its engagement with the cam surface when the
slider is in its retracted position of FIG. 17.
[0087] FIG. 48 is a side view of the cam-guided cap displacement
mechanism of FIG. 47, showing the lifter follower guided downward
along the cam surface as the slider is pulled/extended.
[0088] FIG. 49 is a side view of the cam-guided cap displacement
mechanism of FIG. 47, showing the lifter follower riding further
along the cam surface as the slider is pulled/extended further.
[0089] FIG. 50 is a side view of the cam-guided cap displacement
mechanism of FIG. 47, showing the lifter follower and the cam
surface when the slider is in the fully extended position of FIG.
20.
[0090] FIG. 51 is a side view of the cam-guided cap displacement
mechanism of FIG. 47, showing the lifter follower riding along the
cam surface as the slider is pushed/retracted.
[0091] FIG. 52 is a side view of the cam-guided cap displacement
mechanism of FIG. 47, showing the lifter follower guided up along
the cam surface as the slider is pushed/retracted further.
[0092] FIG. 53 is a side view of the cam-guided cap displacement
mechanism of FIG. 47, showing the lifter raised by the follower-cam
engagement to displace the lancet cap when the slider is in its
retracted position of FIG. 17.
DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS
[0093] 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.
[0094] In its various embodiments, the present invention relates to
multi-lancet lancing devices having multi-lancet cartridges,
disposable multi-lancet cartridges for use in the lancing devices,
and reusable lancing device housings for holding the multi-lancet
cartridges. The subject matter of the present invention relates
primarily to the improved advancer mechanism described in section 4
of this specification. The numbered preceding sections of the
specification provide details of the multi-lancet cartridge and
lancing device, which are improved by including the advancer
mechanism.
[0095] The improvements of the present invention are adaptable for
application in connection with various forms of multi-lancet
lancing devices. In particular, the improvements of the present
invention are of potential application to the multi-lancet lancing
devices and replaceable multi-lancet cartridges shown in PCT
International Publication No. WO 03/071940 A1 (International
Application No. PCT/US03/05159, filed Feb. 20, 2003), which is
hereby incorporated herein by reference. It will be recognized that
the improvements disclosed herein are of individual advantage, or
can be used in combination with one another. That is, the indexing
ratchet mechanism, the cam-guided charger mechanism, and the
cam-guided cap displacement mechanism described in section 4 can be
implemented independently of each other in a lancing device
including only one or any combination of these mechanisms. Or the
cap displacement mechanisms described in sections 1.a. and 1.b. can
be substituted in for the cap displacement mechanism described in
section 4, and vice versa. Whichever of these mechanisms are
included, they are preferably all operated by a single action such
as the pull and push of one handle or other actuating member.
[0096] In general, the lancing device of the present invention
comprises a housing defining a chamber for receiving the cartridge;
a drive mechanism for propelling an active lancet of the cartridge
through a lancing stroke, from a retracted position within the
cartridge to an advanced position wherein a sharp tip of the active
lancet projects through a lancet opening in the housing to pierce
the subject's skin at an intended lancing site; a charging
mechanism for energizing the drive mechanism; and an advancing
mechanism for sequentially advancing lancets of the cartridge into
and through the active position. Various of these mechanisms can be
combined; for example, a single mechanism optionally serves to
energize the drive mechanism and simultaneously or sequentially
advance the cartridge.
[0097] It will be understood that the lancet cap displacement
mechanisms of the present invention may be embodied in a variety of
styles of lancet cartridges and lancing devices. For example, the
cap displacement mechanisms can be adapted for use in a cartridge
having a radial arrays of lancets (as described herein), a linear
array of lancets, a cylindrical array of axially arranged lancets,
or other lancet and carrier configurations. And the cap
displacement mechanisms can be adapted for use in disposable
multi-lancet lancing devices (without a replaceable cartridge),
with the components of the cap displacement mechanisms being
elements of the lancing devices.
1. The Cartridge Assembly
[0098] With reference now to the drawing figures, FIGS. 1 and 2, as
a perspective and exploded view respectively, show a cartridge
assembly according to a first example embodiment of the present
invention, which as a whole is designated by the reference number
10. The cartridge assembly 10 comprises a housing 12 for an array
of lancets 20. The housing 12 preferably has two portions that
connect together, for example, a top portion or cover 14 and a
bottom portion or base 16. The top portion 14 and the bottom
portion 16 preferably comprise generally circular disk-like
structures with generally circular central aligned openings. The
bottom portion 16 preferably has guides thereon or therein for
engaging and guiding a rotatable carrier disk 18. When secured to
together, the top portion 14 and the bottom portion 16 collectively
form an annular outer shell of the cartridge assembly 10 for
containing the carrier 18 and the array of lancets 20. In addition,
the top cover 14 preferably defines a single lancet opening 15 on
its outer circumferential rim, through which the tip of an active
one of the lancets 20 passes during its lancing stroke.
[0099] The carrier disk 18 preferably includes guide channels 19
for permitting radial sliding movement of the lancets 20 in a
lancing stroke between a retracted position and an extended
position during the lancing operation. The guide channels 19 may be
formed by projections on or recesses in the face of the carrier
disk 18. In an example embodiment, the carrier 18 comprises twenty
radial guide channels 19 for holding twenty lancets 20. The carrier
18 may, however, be provided with more or less guide channels 19
and lancets 20, as desired.
[0100] The lancets 20 are radially arranged in the rotatable
carrier disk 18 in the guide channels 19, and can be driven through
their lancing strokes in their axial direction (i.e., along a
radius of the carrier disk 18) upon actuation of the lancing
device. The cartridge assembly 10 is arranged such that the carrier
disk 18, loaded with the lancets 20, is rotatably mounted on the
bottom portion 16 of the housing 12. The top portion 14 of the
housing 12 is then secured to the bottom portion 16, for example by
ultrasonic welding, such that the carrier disk 18 and the lancets
20 can rotate within the housing 12. A one-way clutch or ratchet
mechanism preferably limits the rotation of the carrier disk to
rotation in a single direction to prevent re-use of a lancet and
resultant potential contamination.
[0101] Referring additionally to FIG. 3, the lancets 20 each
preferably comprise a needle or blade forming a sharp lancet tip
22, and a lancet body 24, and are preferably arranged generally
radially in the guide channels 19 of the carrier disk 18 with their
tips 22 directed outwardly. Preferably, the lancet body 24 is
formed of plastic and is injection-molded around the lancet tip 22.
Each lancet tip 22 is preferably encapsulated by a protective
endcap 28, which may be integrally molded with the lancet body 24
and forms a sterility and safety barrier for the lancet tip.
[0102] The protective cap 28 of each lancet 20 is preferably
connected to the body 24 by one or more thin segments or a
reduced-thickness transition region such as a notch or slit, which
forms a weaker separation zone that gives easily so that the cap
can be removed. When the lancing device is charged or cocked (i.e.,
when the plunger of the drive mechanism pulls the lancet body 24
radially inwardly to energize the drive mechanism), the separation
zone 30 fails and allows the protective cap 28 to easily detach
from the lancet body 24. Alternatively, for lancets having caps
that are discrete structures, the separation zone is defined by the
gap between the cap and the lancet body.
[0103] Each lancet body 24 has a retainer that engages a
cooperating structure of the lancing device's drive mechanism
(described below) when the lancet is in the active position. For
example, each lancet body 24 may have a retainer foot 26 extending
downward from the back of the lancet body 24 to engage a
cooperating jaw or other structure of the drive mechanism's
reciprocating plunger when the lancet is in the active position.
The feet 26 of the lancets 20 that are not in the active position
preferably slide within a curved foot channel in the cartridge
bottom housing 16 to constrain the used lancets against movement in
the radial direction unless the lancet is in the active
position.
[0104] The cartridge bottom housing 16 preferably defines a radial
lancing channel 17 extending from the curved foot channel at a
position corresponding to the lancet opening 15 in the cartridge
top housing 14. The active lancet slides in the lancing channel 17
as it is driven along the lancing stroke upon activation or firing
of the lancing device.
[0105] One or more cap surfaces 29 are engaged and constrained by
cooperating cap guide tracks 31 of the carrier 18. The cap surfaces
29 may be defined by two shoulders projecting laterally outwardly
on opposite sides of the cap 28, as shown, or by other features
such as recesses formed into the caps. The cap guide tracks 31 hold
unused lancets 20 in position on the carrier 18 prior to use, and
to hold the cap 28 as the active lancet body 24 is retracted upon
charging or energizing of the drive mechanism to detach the cap.
The cap guide tracks 31 preferably define a transverse guide path
(i.e., out of the plane of the lancet array, preferably at about 90
degrees relative to the lancing stroke travel path) along which the
cap 28 is moved after it is detached from the lancet body 24. This
transverse guide path allows removal of the cap 28 from the path of
travel of the active lancet 20 as it is driven through its lancing
stroke upon activation. The cap guide tracks 31 preferably comprise
one or more resilient fingers or barbs for guiding the detached cap
28 along the transverse guide path and retaining the cap in its
transversely displaced position so that it is prevented from
rattling around within the housing 12 or potentially interfering
with the device's operation. As an example, four cap guide track
fingers 31 may be provided for receiving and guiding the two cap
shoulder surfaces 29, as shown. Alternatively, two cap guide track
fingers may be provided for guiding and being received by two cap
recessed surfaces.
[0106] As shown in FIGS. 1 and 3, the carrier disk 18 can
optionally be labeled with numbers or other indicia to indicate the
number of unused lancets 20 remaining (or alternatively the number
of lancets already used). The cartridge housing 12 preferably has
an opening 40 therethrough, and the lancing device has a
corresponding opening, such that the user can view the indicia.
[0107] The cartridge 10 preferably has a resilient member that is
biased into engagement with an underlying lancet 20 in the active
position. The resilient member thus prevents said active lancet 20
from being displaced if the cartridge 10 is removed from the
lancing device after the device is charged and the cap is detached,
at which point the active lancet would otherwise be unconstrained.
The resilient member preferably comprises a resilient tongue
portion 41 formed by a pair of cutout slots defined in the top
housing cover 14 of the cartridge 10. When the cartridge 10 is
installed in the lancing device, a cooperating portion of the drive
mechanism flexes the tongue 41 out of contact with the active
lancet, freeing it to traverse its lancing stroke upon actuation of
the lancing device. In an alternate embodiment, the carrier is
partially indexed within the cartridge housing (for example, a
half-step forward or back, to a position between adjacent lancets),
when the cartridge is removed from the lancing device, to prevent
displacement of an unconstrained lancet from the active
position.
[0108] a. Spring-Actuated Displacement of End-Caps
[0109] In this first example embodiment, the lancet cap
displacement mechanism is provided by a cantilevered spring member
50 that serves to press the detached protective cap 28 of each
sequential active lancet 20 along the transverse guide path and out
of the radial path of travel of that lancet prior to activation or
firing. The spring member 50 preferably has a first section 52, a
second section 54, and an intermediate section 56. The first
section 52 is attached (by conventional fastening structures or
techniques) to the inner surface of the top portion 14 of the
housing 12, or to another stationary part of the cartridge 10. The
second section 54 is configured to engage the protective cap 28 and
to push the cap 28 downwardly along the cap guide tracks 31 of the
carrier 18, towards the bottom portion 16 of the housing 12. The
intermediate section 56 connects the first section 52 to the second
section 54.
[0110] In a typical commercial embodiment, the spring member 50 is
leaf spring-type spring member, comprising a flexible, resilient
piece of metal or other material that does not readily take on a
set permanent deformation. The first section 52, the second section
54, and the intermediate section 56 each include an elongated
member. And the intermediate section 56 is angled or curved
downwardly from the first section 52 to the second section 54,
thereby offsetting the first and second sections. In this way, the
spring member 50 rides along the top surface of a lancet's endcap
28 as that lancet is advanced into the active position, and the
spring member 50 flexes upwardly and is charged to impart a
downward force on the cap. Then upon detachment of the cap 28 from
the active lancet 20 by the retraction of the lancet body 24, the
cap is pressed down along the guide tracks 31 under the influence
of the charged spring member 50.
[0111] In an alternative embodiment, the leaf spring-type spring
member 50 is inverted and attached to the housing bottom 16. In
another alternative embodiment, the member 50 is a coil spring,
with one end (the first section 52) attached to the housing 12 and
the other end (the second section 54) including a ramped extension
panel for riding along the caps as they are rotated to the active
position.
[0112] b. Cam-Actuated Displacement of End-Caps
[0113] Referring now to FIGS. 4-9, a second example embodiment of
the present invention will be described. The cartridge assembly 100
is substantially similar to the cartridge assembly 10 described
above, having a housing 112 with top and bottom sections 114 and
116, a carrier 118, and an array of lancets 120 each having a body
124 and a cap 28.
[0114] In this embodiment, however, the lancet cap displacement
mechanism is provided by a spring-biased cam-driven plunger
assembly. This assembly includes a plunger 232 that is positioned
at about the cartridge outer perimeter and adjacent (beneath or
above) the active lancet position. The plunger 232 is the form of a
pin, shaft, tube, T-member, angle piece, or other elongated
structure. With particular reference to FIGS. 6 and 9, the plunger
232 is ordinarily biased away from the active lancet (e.g.,
downwardly) under the influence of a spring element 233. The spring
element 233 may be provided by a cantilevered leaf spring arm that
is attached to (and integrally formed with) the plunger 232, as
shown. Alternatively, the spring element may be provided by a coil
spring (e.g., coaxially arranged with the plunger), an elastic
member (e.g., rubber band), or other biasing structure. In the
depicted embodiment, the plunger 232 extends through an opening 235
in the upper shell 237 of the advancing mechanism 230, and the
spring element 233 is attached to the upper shell and the
plunger.
[0115] The spring-biased cam-driven plunger assembly further
comprises a cam surface 234 formed, for example, on the lower shell
239 of the advancer mechanism 230 of the lancing device.
Preferably, the cam surface 234 is generally wedge-shaped, as
shown, with two of the wedges arranged at about 180 degrees apart,
though other specific shapes, numbers, and spacings of the cams may
be used. As the advancer mechanism 230 is actuated, a follower
surface of the plunger 232 traverses along the cam surface 234. The
plunger 232 rises as it moves along the upwardly inclined portion
of the cam surface 234, at the same time charging the spring arm
233. As the plunger 232 rises, it is pressed into engagement with
the cap 128 of the active lancet 120. The rising plunger 232 pushes
the cap 128 upwardly along the cap guide tracks 131 of the carrier
disk 118 along the transverse guide path at about 90 degrees
relative to the lancing stroke travel path, and out of the radial
path of the active lancet's lancing stroke. The cap guide tracks
131 are preferably resilient members (e.g., barbs or fingers) that
retain the cap 128 above the path of travel of the active lancet,
as seen best with reference to FIG. 8. Continued actuation of the
advancer mechanism 230 moves the inclined portion of the cam
surface 234 past the plunger 232, as seen best with reference to
FIG. 9, allowing the plunger to drop back down under the influence
of the charged spring arm 233. The plunger 232 is now reset and out
of the active lancet's path of travel as it is propelled along its
lancing stroke.
[0116] It will be understood that the spring-biased, cam-driven
plunger assembly may be provided as part of one or more other
components of the lancing device. For example, in an alternative
embodiment the spring and plunger are attached to and extend
upwardly from the housing bottom with the spring biased upwardly to
displace the lancet caps. And the cam surface is formed on a rotary
element (e.g., rotationally moved by the advancing mechanism)
within the lancing device housing. The cam surface may be
configured to drive the plunger downwardly away from the active
lancet cap except when the lancet is charged and ready for
activation, at which position the plunger moves under the influence
of the spring to displace the cap. For example, the cam surface may
be defined by two (or another number of) upwardly recessed notches
that permit the plunger to move upward to displace the caps. In
other alternative embodiments, the cam surface is defined on a
stationary element and the plunger is rotated relative to the cam
surface for driving the plunger to displace the lancet caps.
2. The Lancing Device
[0117] As shown in FIG. 16, a lancing device 200 according to an
example embodiment of the present invention preferably comprises a
clam-shell housing 202 having a top portion 204 hingedly connected
to a bottom portion 206. The housing 202 defines a lancing opening
208, preferably through a sidewall portion 210 thereof, that aligns
with the lancing opening 15 of an installed cartridge 100. The
housing 202 preferably also comprises a latch 216 that secures the
top 204 of the housing 202 to its bottom 206.
[0118] The lancing device preferably further comprises a drive
mechanism, seen best with reference to FIGS. 7, 12, and 16. The
drive mechanism preferably includes a reciprocating plunger 250
that engages the active lancet 20 and drives it radially along its
lancing stroke upon activation or firing of the device, through an
advanced position where the lancet tip punctures the subject's
skin, and back to a retracted position where the lancet tip is
shielded within the cartridge. The plunger 250 preferably comprises
a recess forming a jaw 256 for receiving and engaging the foot 26
of the active lancet. In a preferred embodiment, two springs, a
drive spring 252 and a return spring 254, operate in tandem to
drive and return the plunger 250 upon activation of the lancing
device by pressing the activating button 220. The springs can be,
for example, coil springs, leaf springs, torsion springs, spiral
springs, or the like, including other biasing mechanisms. The drive
spring 252 is the stronger of the two springs, and drives the
active lancet from its initial position into its extended position.
The return spring 254 serves to retract the active lancet after
lancing the skin. One or more limit members, such as posts or lugs
optionally interact with one or both springs, and/or with other
portion(s) of the drive mechanism, to more precisely define the
equilibrium, retracted, and/or extended position(s) of the plunger.
Because the jaw 256 of the plunger is open to the top, it securely
but releasably engages the foot 26 of the active lancet to drive
the lancet along its lancing stroke, yet allows the cartridge to be
removed and replaced at any point during its use. The plunger 250
preferably further comprises a flexible release arm 253 having a
catch portion 255 that retains the plunger in its armed state, with
drive spring 252 energized prior to activation, and is released by
the activating button upon actuation to propel the active lancet
through its lancing stroke.
[0119] The lancing device preferably further comprises a mechanism
for depth control, in one embodiment a depth-control ring 212,
shown in detail by FIG. 13. The depth ring 212 is positioned near
the perimeter of the housing 202 of the lancing device 204, and
generally follows the contour of the housing of the lancing device
200. The depth ring 212 defines a plurality of openings 214A, 214B
. . . 214N (collectively, the "openings 214") therethrough, through
which the tip of a lancet 20 is driven to pierce a skin surface of
the subject to obtain a sample of blood. The openings 214 vary in
diameter and/or in the depth to which their outer contact surfaces
are recessed or countersunk. The depth ring 212 is rotated by the
user to selectively position a particular opening 214 in alignment
with the puncture position 208, thereby controlling the depth of
penetration of the lancet tip into the subject's skin. Because the
openings can vary in diameter and in recess depth, the depth ring
212 provides a wide range of depth control. The travel of the
lancet 20 preferably is not affected by variation of the position
of the depth ring 212, and so the lancing stroke preferably remains
uniform regardless of the depth control position.
[0120] The lancing device preferably further comprises an
activating button positioned on the top half-shell 204 of the
housing 202 for activating the drive mechanism to propel the active
lancet through its lancing stroke. An example configuration of the
activating button member 220 is shown in FIG. 14. The activating
button member 220 preferably includes a button portion 222, which
releases the catch portion 255 of the plunger release arm when
pressed by the user to activate or fire the device. The activating
button member 220 preferably further comprises one or more integral
spring arms 224 for biasing the button 222 outwardly. The
activating button member 220 preferably further comprises a
retainer ring for securing the depth control ring 212 in place.
[0121] The lancing device 200 preferably further comprises an
advancer mechanism 230 as seen best with reference to FIGS. 8, 9,
15a, 15b, and 16. In preferred form, the advancer mechanism 230
generally comprises a manually-rotatable element that is operable
to advance the carrier to move sequential lancets 20 of a lancet
cartridge 118 into the active position. A finger preferably
projects from the advancer mechanism 230 through a slot in the
bottom housing of the lancet cartridge to engage and advance the
lancet carrier through indexed rotational increments corresponding
to one lancet position, while the outer housing of the lancet
cartridge remains fixed in position. Actuation of the advancer
mechanism 230 preferably also functions to engage the active lancet
in the jaw of the plunger and retract the plunger to de-cap the
active lancet and energize or arm the drive mechanism.
[0122] Actuation of the advancer mechanism 230 may also serve to
drive the spring-biased cam-driven plunger 232, as described above,
if implementing the second example embodiment. Preferably, the
advancer mechanism 230 is operable to rotate in one direction only
and in discrete increments (e.g., 180.degree. increments). Guide
channels or ribs 231 formed in or on the inner face of the advancer
mechanism act as cam paths to engage a cooperating follower element
of the drive mechanism to retract the drive plunger 250 into its
armed state, with drive spring 252 energized. Preferably, the guide
channels or ribs 231 are contoured to retract the plunger 250 more
slowly at the beginning of the advancing stroke, while the endcap
28 is being detached from the lancet, providing mechanical
advantage for smoother and easier operation. A ratchet mechanism
234 may be provided to prevent reverse rotation of the advancer
mechanism. Optionally, at the end of the advancing operation, a
locating pin is driven upwardly (as by a cam surface similar to the
motion of plunger 232 described above) through an opening in the
cartridge housing and engaged within a yoke 122 (see FIGS. 10 and
11) between lancet paths on the carrier disk 118, to more precisely
position the active lancet and prevent further movement of the
carrier disk until the lancing device is fired.
[0123] In further preferred embodiments, the carrier 118 comprises
a groove 124 that engages a pin on the bottom portion of the
housing of the cartridge assembly when all the lancets have been
used. This groove and pin combination prevents the cartridge 100
from being moved in either direction after all of the lancets have
been used, and thereby prevent a reuse of a non-sterile lancet.
3. Method of Operation
[0124] In operation, the user preferably releases a latch 216 to
open the lancing device 200. The user then places a preassembled
multi-lancet cartridge 100 into the lancing device 200 and closes
and latches the housing 202. The user turns the advancer mechanism
230 through a 180.degree. stroke. During the 180.degree. rotation,
the carrier 118 is indexed by one lancet position, thus indexing an
unused lancet 20 into the active position. The plunger 250 engages
foot 26 of the lancet and pulls the lancet radially inwardly. This
step energizes the drive spring of the drive mechanism. The catch
255 of the plunger engages a cooperating surface feature of the
housing, and the lancet is now in the energized or armed
position.
[0125] As the lancet 20 is retracted radially inward to charge the
drive spring, the cap 28 is held and prevented from moving radially
inward with the lancet by the guide track (e.g., detents, fingers,
or barbs) 119. In this way, the lancet cap 28 is separated from the
lancet body 24. Then the cap displacement mechanism then moves the
disengaged cap out of the travel path of the active lancet. In the
first example embodiment, the spring arm 50 engages and moves the
detached cap 28 out of the lancing stroke path where the cap is
held by the guide track, and then the spring element returns to its
reset or rest position clear of the lancing stroke. In the second
example embodiment, the spring-biased cam-driven plunger 232
engages and moves the detached cap 28 out of the path of travel of
the active lancet, then clears the cam and is biased back to its
rest or reset position. The guide track (e.g., detents, fingers, or
barbs) 119 capture the cap 28 and hold it above the path the lancet
20 will travel in the lancing stroke.
[0126] The user may adjust the depth ring 212 to the desired
setting to vary the penetration depth. If present, the position
lock pin is raised into engagement with the yoke 122 of the
cartridge 118 to prevent further movement of the cartridge until
activated or fired to release the active lancet to traverse its
lancing stroke.
[0127] The lancing device 200 is positioned against a finger or
other part of the subject's body. The activation button 220 is
pressed, releasing the catch 255 of the plunger and allowing the
drive spring 252 to drive the plunger 250 and the active lancet
engaged in the jaw thereof along a controlled radial path, through
an extended position where the lancet tip punctures the subject's
skin at the lancing site. The lancet is preferably guided
throughout its lancing stroke along three sides by the guide
channels of the carrier 118 and on the fourth side by the cartridge
housing. Upon reaching the extended position of the lancing stroke,
the return spring 254 is energized to bias the plunger 250 and
retract the lancet inwardly to a retracted position within the
lancet cartridge.
[0128] Additional details of the various aspects of the present
invention are disclosed in U.S. patent application Ser. No.
11/107,984, filed Apr. 15, 2005; U.S. Provisional Patent
Application No. 60/562,712, filed Apr. 16, 2004; and International
Application No. PCT/US03/05159 (International Publication No. WO
03/071940 A1), filed Feb. 20, 2003. The content of these patent
documents is hereby incorporated herein by reference in its
entirety.
4. Linear-Pull Advancing Mechanism
[0129] FIGS. 17-53 show a lancing device 300 according to a third
example embodiment of the invention. In this embodiment, a
linear-pull advancer mechanism 360 replaces the rotational cam
drive advancing mechanism 230 and the cap displacement mechanisms
previously described. The remainder of the lancing device 300
(including the reusable housing, drive mechanism, and activation
mechanism, and the replaceable multi-lancet cartridge) may remain
substantially the same as in the first and second example
embodiments.
[0130] FIGS. 17-20 show details of the construction and operational
positioning of the linear-pull advancer mechanism 360. The
linear-pull advancer mechanism 360 includes a slider member 362
that is translationally mounted in the base 306 of the clamshell
housing 302. The linear-pull slider 362 is preferably an integral
piece of molded of plastic, though other materials and fabrication
techniques can be used and the individual components can be
separated manufactured and assembled together. The linear-pull
slider 362 is pulled/extended out and pushed/retracted in through
an opening in the housing 302 between a first/retracted position
and a second/extended position. This single action operates an
indexing ratchet mechanism 363, a cam-guided charger mechanism 365,
and a cam-guided lancet cap displacement mechanism 366. In an
alternative embodiment, the slider has a laterally extending lever
that is slid back-and-forth, a laterally extending knob that is
rotated, or another actuating member that is otherwise controlled
in a single action to move the slider between its first and second
positions to operate the advancer mechanism.
[0131] In FIG. 17, the slider 362 is in its first/fully retracted
position relative to the housing 302. In FIG. 18 the slider 362 is
partially extended from the housing 302 (for example, about 5 mm),
and in FIG. 19 the slider is further extended from the housing (for
example, about 10 mm). In FIG. 20, the slider 362 is in its
second/fully extended position relative to the housing 302. After
the user moves the slider 362 to its fully extended position, the
user then moves the slider 362 back to its fully retracted position
of FIG. 17. This procedure sequentially advances the lancets in the
cartridge to an active position, charges the drive mechanism and
separates the cap from the active lancet, and then moves the
separated cap from the lancing stroke path of the active lancet. A
detent mechanism is preferably provided so that the slider 362
stays in its retracted position until it is pulled out by the user.
And cooperating stop surfaces are preferably provided on the slider
362 and the housing base 306 for stopping the slider in its
extended position.
[0132] Referring to FIGS. 17-20 and 29-30, the indexing ratchet
mechanism 363 includes a resilient pawl 367 extending from the
slider 362 and a plurality of ratchet teeth 368 for sequentially
advancing the lancets in the cartridge to an active position. The
pawl 367 is preferably integrally manufactured with the slider 362
and made of molded plastic, though other materials and
manufacturing techniques may be used. The materials and dimensions
of the pawl 367 are selected so that it is resiliently deflectable.
The teeth 368 are pin-like protrusions that extend downward from
the lancet carrier 318, and the teeth and the lancets are
correlated in a one-to-one ratio. In an alternative embodiment, the
teeth 368 are provided by notches in the carrier.
[0133] The pawl 367 has a head 369 that extends through a slot 370
in a cover panel 371 that attaches to the base 306 of the housing
302. The cover 371 protects the components of the advancer
mechanism under it from damage when replacing lancet cartridges. In
addition, the pawl 367 has two (or another number of) laterally
extending tabs 372 that prevent the pawl 3667 from being pulled up
through the slot 370.
[0134] The pawl head 369 engages the teeth 368, which extend
downward from the lancet carrier 318 through a circular slot 313 in
the cartridge housing 312. Advancing the pawl 367 advances the
lancet carrier through indexed rotational increments corresponding
to one lancet position, while the outer housing 312 of the lancet
cartridge 310 remains fixed in position. In an alternative
embodiment, the pawl head extends up into a circular slot in the
cartridge and the teeth are defined by the lancets. And in another
alternative embodiment, the teeth extend from the cartridge housing
so that the entire cartridge is rotated. The cartridge housing 312
and the cover 371 are shown in FIG. 30 but not in FIGS. 31-37 for
simplicity.
[0135] FIGS. 30-37 show details of the operation of the indexing
ratchet mechanism 363 of the advancer mechanism 360. FIG. 30 shows
the position of the pawl 367 and the ratchet teeth 368 when the
slider 362 is in its retracted position of FIG. 17. In FIG. 31, the
pawl 367 is being advanced (as indicated by the directional arrow)
as the slider 362 is pulled/extended. In FIG. 32, the pawl 367 is
advanced until a pushing surface of the pawl head 369 engages a
first one of the teeth 368a. Linearly advancing the pawl 367 (as
indicated by the linear directional arrow) rotationally advances
the lancet carrier 318 (as indicated by the rotational directional
arrow). The positions shown in FIGS. 31 and 32 correspond to the
slider positions shown in FIGS. 18 and 19, respectively. In FIG.
33, the pawl 367 is fully extended, the engaged first tooth 368a
advanced, and the lancet carrier 318 rotated/indexed to move the
next lancet to the active position for use. In this position, the
slider 362 is in the extended position of FIG. 20.
[0136] In FIG. 34, the pawl 367 is being retracted (as indicated by
the directional arrow) as the slider 362 is pushed/retracted. In
FIG. 35, the pawl 367 is further retracted until an angled
deflection surface of the pawl head 369 engages a second one of the
teeth 368b, which causes the pawl to resiliently deflect under the
second tooth (as indicated by the directional arrows). The lancing
device 300 has conventional cooperating ratchet features to prevent
reverse rotation of the carrier 318. And in FIG. 36, the pawl 367
is fully retracted, the lancet corresponding to the first tooth
368a is ready to be used, and the second tooth 368b is ready to
next be engaged to incrementally advance the carrier again. In this
position, the slider 362 is back in the retracted position of FIG.
17, ready for use to advance the second tooth 368b. In this way,
the lancing device 300 cycles used lancets back onto the carrier
318 so that there are no loose lancets in the cartridge.
[0137] FIG. 37 shows an empty position 368x in the series of teeth
where there is no tooth on the carrier 318. The empty position 368x
is between the last tooth 368n and the first tooth 368a. Because
there is no indexing tooth in the empty position 368x, the carrier
318 cannot be advanced further after all of the lancets in the
cartridge have been used. In this position, the lancing device 300
is locked and safe.
[0138] Referring to FIGS. 17-20 and 38-39, the cam-guided charger
mechanism 365 includes a reciprocating plunger or piston 350 and a
resiliently deflectable cam arm 373. The plunger 350 is
translationally mounted on the slider 362 and is driven by the
drive spring to propel the active lancet through its lancing
stroke. Preferably, the plunger 350 comprises a recess forming a
jaw 356 for receiving and engaging a foot or other part of the
active lancet. The plunger 350 preferably further comprises a
flexible release arm 353 having a catch portion 355 that retains
the plunger in its armed state, with the drive spring energized
prior to activation, and is released by actuating the activating
button to propel the active lancet through its lancing stroke. In
addition, a locking follower 374 extends from the plunger 350
(i.e., downward from the bottom of the plunger) for engagement with
an upstanding locking wall 375 defined by the slider 362. And a
charging follower 376 extends the plunger 350 (i.e., downward from
the bottom of the plunger and spaced apart from the locking
follower 374).
[0139] The resiliently deflectable cam arm 373 is preferably
integrally manufactured with the slider 362 and made of molded
plastic, though other materials and manufacturing techniques may be
used. The materials and dimensions of the cam arm 373 are selected
so that it is resiliently deflectable. In addition, the arm 373 has
a cantilevered member 377 defining a charging cam surface 378 and a
deflecting cam surface 379. The deflecting cam surface 379 engages
the plunger charging follower 376 to deflect the cam arm 373. And
the charging cam surface 378 engages and guides the plunger
charging follower 376 to retract the plunger 350 and energize the
drive spring.
[0140] Furthermore, a wall 380 extends upward from the housing base
306 and remains stationary as the slider 362 is moved through its
extending/retracting stroke. The wall 380 has an opening 381 for
the plunger charging follower 376 to pass through when the lancet
is propelled through its lancing stroke.
[0141] FIGS. 40-44 show details of the operation of the cam-guided
charger mechanism 365 of the advancer mechanism 360. FIG. 40 shows
the position of the cam arm 373 and the charging follower 376 of
the plunger 350 when the slider 362 is in its retracted position of
FIG. 17. The followers 374 and 376 of the plunger 350 are shown in
this series of figures, but not the body of the plunger, for
clarity. In FIG. 41, the slider 362 is being pulled/extended (as
indicated by the linear directional arrows) so that the deflecting
cam surface 379 comes into engagement with the plunger charging
follower 376, which deflects the cam arm 373 (as indicated by the
curved directional arrow). The followers 374 and 376 and the
plunger 350 remain stationary as they do not move in the stroke
direction of the slider 362. In FIG. 42, the slider 362 has been
moved to its fully extended position of FIG. 20, and the deflecting
cam surface 379 has been moved laterally past the charging follower
376 so that the cam arm 373 has resiliently returned to its neutral
position adjacent the wall 380.
[0142] In FIG. 43, the slider 362 is being pushed/retracted back in
(as indicated by the directional arrows) so that the charging cam
surface 378 now comes into engagement with the plunger charging
follower 376. The cam arm 373 is positioned adjacent the wall 380
with no gap for the charging follower 376 to slip or pry through,
and the cam member 377 is angled to prevent its deflection when
encountering the charging follower from this direction. In this
way, the cam arm 373 functions as a one-way valve for positioning
the charging follower 376 so that it can be driven by the charging
cam surface 378. The charging cam surface 378 then drives backward
the charging follower 376 (as indicated by the directional arrow)
and thus the plunger 350 to charge the drive mechanism as the
slider is pushed/retracted. In FIG. 44, the slider 362 is
pushed/retracted back to its fully retracted position of FIG. 17.
In this position, the charging cam surface 378 has driven back the
plunger 350 to its armed position, and the release arm catch 355 of
the plunger 350 has been engaged to retain the plunger in this
armed position.
[0143] The carrier 318 includes cap guide tracks similar to the cap
guide tracks 19 of the first embodiment. The cap guide tracks hold
the lancet caps in place so that, when the active lancet is
retracted by the plunger 350, the active lancet is separated from
its cap. In addition, the cap guide tracks guide the lancet caps
when they are transversely displaced out of the lancing travel
path, as described with respect to the cam-guided cap displacement
mechanism 366.
[0144] The plunger 350 then can be released from its armed position
to propel the active lancet through its lancing stroke by operation
of the activating button. In the position shown in FIG. 44, the
locking wall 375 that extends upward from the slider 362 has been
moved laterally from a blocking position in the path of the locking
follower 374 of the plunger 350. And the charging follower 376
remains aligned with the opening 381 in the stationary wall 380. So
there are no obstructions in the travel path of the plunger 350,
and it is ready to be activated. After the lancing device 300 is
activated to lance the subject's skin, the cam-guided charger
mechanism 365 of the advancer mechanism 360 is again in the
position shown in FIG. 40.
[0145] Referring to FIGS. 17-21 and 45-46, the cam-guided cap
displacement mechanism 366 includes a lifter member 382 with a
follower 383 that rides along a cam surface 384 for transversely
moving the separated lancet cap out of the lancing stroke path of
the active lancet. The lifter 382 moves transversely to the lancing
travel path and is guided by a lifter guide track 385. In addition,
the lifter 384 is preferably fork-shaped, with two (or another
number of) tines having displacing surfaces 386 and an opening 387
through which the lancet body passes when traveling to its
puncturing position. The cam surface 384 is preferably formed at
least in part by a slot defined in the slider 362, with a raising
cam surface 384a and a lowering cam surface 384b for positively
controlling the position of the lifter 382. In an alternative
embodiment, the cam-guided cap displacement mechanism 366 includes
only one cam surface for either raising or lowering the lifter, and
a spring element for moving the lifter in the other,
non-cam-driven, direction.
[0146] FIGS. 47-53 show details of the operation of the cam-guided
cap displacement mechanism 366 of the advancer mechanism 360. FIG.
47 shows the lifter follower 383 in its raised position due to its
engagement with the raising cam surface 384a, when the slider 362
is in its retracted position of FIG. 17. In FIG. 48, the lifter
follower 383 is being guided downward along the lowering cam
surface 384b as the slider 362 is pulled/extended (as indicated by
the directional arrow). In FIG. 49, the lifter follower 383 is
lowered and the slider 362 is further pulled/extended laterally
past the lifter follower 383. The positions shown in FIGS. 48 and
49 correspond to the slider positions shown in FIGS. 18 and 19,
respectively. With the lifter 382 in its lowered position, it is
out of the way so that the next lancet can be rotationally advanced
to the active position by the indexing ratchet mechanism 363. In
order to prevent the lifter 382 from moving lower, the lancing
device 300 may be provided with a base for the slider 362 on which
the lifter follower 383 rides, a guide surface on the interior wall
of the base 306 of the housing 302, and/or a stop surface on the
slider 362, the housing 302, the lifter guide track 385, or
elsewhere on the lancing device. And FIG. 50 shows the lowered
position of the lifter follower 383 relative to the slider 362 when
the slider is in the fully extended position of FIG. 20.
[0147] In FIG. 51, the slider 362 is being pushed/retracted back in
(as indicated by the directional arrow) laterally past the lowered
lifter follower 383. The lifter 382 remains lowered during this
first part of the slider retraction motion, while the lancet cap
328 is being separated from the lancet body 324 by operation of the
cam-guided charger mechanism 365. In FIG. 52, the lifter follower
383 is being driven up along the raising cam surface 384a as the
slider 362 is pushed/retracted further in the second part of the
slider retraction motion. And in FIG. 53, the lifter 382 is
returned to its raised position, with the lifter follower 383
driven to its raised position by the raising cam surface 384a as
the slider 362 is pushed/retracted back to its fully retracted
position of FIG. 17.
[0148] As the lifter 382 is raised its displacing surfaces 386 push
the now separated lancet cap 328 out of the lancing travel path of
the active lancet 320. Preferably, the displaced lancet cap 328 is
retained there by features of the cap guide track of the lancet
carrier 318. The lancet 320 now can be launched into its lancing
stroke, during which it will pass through the opening 387 in the
lifter 384 as it travels to its puncturing position. When the
lancet 320 passes through the lifter opening 387, this maintains
positioning of the active lancet and prevents rotation of the
lancet carrier.
[0149] Having described details of the construction, operation, and
use of the lancing device 300, we now refer to FIGS. 22a-22f, which
illustrate a process for inserting a new lancet cartridge 310 into
the housing 302 of the lancing device 300. In FIG. 22a, the slider
362 of the advancer mechanism 360 is being pulled from the
first/retracted position to the second/extended position. In FIG.
22b, the housing 302 is being opened. In FIG. 22c, the lancet
cartridge 310 is being inserted into the opened housing 302. In
FIG. 22d, the housing 302 is being closed. In FIG. 22e, the slider
362 is being pushed back in to its retracted position. The lancing
device 300 is now ready for use. In FIG. 22f, the activating button
320 is being pressed to activate the lancing device 300 for lancing
with an initial one of the lancets.
[0150] As shown in FIG. 22g, the advancer mechanism 360 includes a
handle 361 that extends from the slider 362 to push and pull it.
The handle 361 is preferably C-shaped with two flanges 361a that
wrap around the top and bottom portions of the clamshell housing
302 in a clamp-like fashion. When the advancer mechanism 360 is in
the fully retracted position, the flanges 361a of the handle 361
overlap the housing top and bottom portions to lock it closed. This
prevents a user from opening the housing 302 when a lancet has been
advanced into the active position and the drive member has been
charged. This is why the advancing mechanism 360 is pulled out and
pushed in as shown in the steps of FIGS. 22a and 22e. The flanges
361a of the handle 361 are long enough that, in order to have the
needed clearance to open the housing 302 (i.e., with the flanges
361a not overlapping the housing top and bottom), the handle must
be pulled all of the way out. This ensures that the housing 302
cannot be opened until the charged lancet has been advanced from
the active position and a next uncharged lancet advanced to the
active position.
[0151] FIGS. 23a-23c illustrate a process for advancing a next one
of the lancets for lancing. In FIG. 23a, the slider 362 of the
advancer mechanism 360 is being pulled from the retracted position
to the extended position to rotate the carrier, which advances the
spent lancet out of the active position and advances the next
lancet into the active position. In FIG. 23b, the slider 362 is
being pushed back in to its retracted position to charge and de-cap
the active lancet and then to displace the cap from the lancing
stroke path. The lancing device 300 is now ready for activation to
lance with the next lancet. And in FIG. 23c, the activating button
320 is being pressed to activate the lancing device 300 for lancing
with the next lancet.
[0152] FIGS. 24a-24e illustrate a process for removing a spent
cartridge 310 after each of the lancets have been sequentially
advanced to the active position and used. In FIG. 24a, the slider
362 of the advancer mechanism 360 is being pulled from the
retracted position to the extended position to unlock the housing
302. In FIG. 24b, the housing 302 is being opened. In FIG. 24c, the
spent cartridge 310 is being removed from the housing 302. If
desired, a new cartridge 310 can now be inserted into the housing
302 for use. Otherwise, in FIG. 24d the housing 302 is closed for
now, and in FIG. 24e, the slider 362 is pushed back in to its
retracted position to relock the housing. Then a new cartridge 310
can later be inserted according to the process shown in FIGS.
22a-22f.
[0153] FIGS. 25a-25e illustrate a process for removing a partially
spent cartridge 310 before all of its lancets have been used. In
FIG. 25a, the slider 362 of the advancer mechanism 360 is being
pulled from the retracted position to the extended position to
unlock the housing 302. In FIG. 25b, the housing 302 is being
opened. In FIG. 25c, the partially spent cartridge 310 is being
removed from the housing 302. In FIG. 25d, the housing 302 is being
closed. And in FIG. 25e, the slider 362 is being pushed back in to
its retracted position to relock the housing 302.
[0154] FIGS. 26a-26f illustrate a process for later reinserting the
partially spent cartridge 310 that was removed prior to all of its
lancets being used. In FIG. 26a, the slider 362 of the advancer
mechanism 360 is being pulled from the retracted position to the
extended position to unlock the housing 302. In FIG. 26b, the
housing 302 is being opened. In FIG. 26c, the partially spent
cartridge 310 is being reinserted into the housing 302. In FIG.
26d, the housing 302 is being closed. In FIG. 26e, the slider 362
is being pushed back in to its retracted position to relock the
housing 302. And in FIG. 26f, the activating button 320 is being
pressed to activate the lancing device 300 for lancing with the
then-active lancet. Of course, a new cartridge 310 can instead be
inserted according to the process shown in FIGS. 22a-22f.
[0155] FIGS. 27a-27f illustrate a process for clearing the lancing
device 300 if it becomes jammed. In FIG. 27a, a fail-safe release
mechanism 363 of the advancer mechanism 360 is being activated to
release the advancer mechanism. Preferably, the fail-safe release
mechanism 363 includes a small opening in the housing 302 through
which a thin elongated object (i.e., a paper clip wire or a pen
tip) can be inserted to engage a release that frees the slider 362
for movement. In FIG. 27b, the slider 362 is being pulled from its
retracted position to its extended position to unlock the housing
302. In FIG. 27c, the housing 302 is being opened. In FIG. 27d, the
jammed lancet cartridge 310 is being removed from the housing. In
FIG. 27e, the housing is being closed. And in FIG. 27f, the slider
362 is being pushed back in to its retracted position to relock the
housing 302. A new lancet cartridge 310 now may be inserted
according to the process shown in FIGS. 22a-22f, or this may be
done before closing the housing 302.
[0156] FIG. 28 shows the use of the depth adjustment mechanism 311
to set the lancing puncture depth. The depth adjustment mechanism
311 may include the depth-control ring 212 shown in FIG. 13 or
another conventional mechanism for selectively controlling the
puncture depth of the lancets.
[0157] 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.
* * * * *