U.S. patent application number 14/222151 was filed with the patent office on 2014-07-24 for adjustable tip for a lancet device and method.
This patent application is currently assigned to STAT MEDICAL DEVICES, INC.. The applicant listed for this patent is STAT MEDICAL DEVICES, INC.. Invention is credited to Steven SCHRAGA.
Application Number | 20140207167 14/222151 |
Document ID | / |
Family ID | 23961236 |
Filed Date | 2014-07-24 |
United States Patent
Application |
20140207167 |
Kind Code |
A1 |
SCHRAGA; Steven |
July 24, 2014 |
ADJUSTABLE TIP FOR A LANCET DEVICE AND METHOD
Abstract
A lancet device and a lancet device tip for a lancet device. The
tip includes a first sleeve and a second sleeve at least partially
contained within the first sleeve. The second sleeve includes a
stop surface. Rotation of the first sleeve relative to the second
sleeve causes the second sleeve to move at least axially without
changing an overall length of the lancet device tip.
Inventors: |
SCHRAGA; Steven; (Surfside,
FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
STAT MEDICAL DEVICES, INC. |
North Miami |
FL |
US |
|
|
Assignee: |
STAT MEDICAL DEVICES, INC.
North Miami
FL
|
Family ID: |
23961236 |
Appl. No.: |
14/222151 |
Filed: |
March 21, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10322530 |
Dec 19, 2002 |
8709032 |
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14222151 |
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09493675 |
Jan 28, 2000 |
6530937 |
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10322530 |
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Current U.S.
Class: |
606/182 |
Current CPC
Class: |
A61B 5/1411 20130101;
A61B 5/15107 20130101; A61M 3/00 20130101; A61B 5/15186
20130101 |
Class at
Publication: |
606/182 |
International
Class: |
A61B 5/151 20060101
A61B005/151; A61B 5/15 20060101 A61B005/15 |
Claims
1. A tip for a lancet device, comprising: a front assembly
comprising a side wall portion, a skin-engaging portion at least
partially defining a plane beyond which a lancet needle may extend,
and a lancet stop element; a slot disposed in one of the sidewall
portion and the lancet stop element; at least one following element
extending into the slot; and an actuator comprising a generally
annular rotatable member that engages the at least one following
element; wherein the lancet stop element is moveable towards and
away from the plane in response to movement of the at least one
following element.
2. The tip of claim 1, wherein the slot is disposed on the sidewall
portion.
3. The tip of claim 2, wherein the slot comprises a camming
slot.
4. The tip of claim 1, further comprising an outer generally
annular rotatable member.
5. The tip of claim 1, wherein the at least one following element
is guided within the slot when the lancet stop element is moved
axially or rotated.
6. The tip of claim 1, wherein the lancet stop element comprises a
opening for allowing the needle to project therethrough.
7. The tip of claim 1, further comprising a rotatable nut disposed
on the front assembly comprising one of a plurality of projections
and grooves disposed on an outer surface.
8. The tip of claim 7, wherein the nut further comprises indicating
marks and the front cap further comprises a reference mark.
9. The tip of claim 7, wherein the nut further comprises a distal
wall which includes an opening for allowing the needle to project
therethrough.
10. A front cap mechanism for a lancet device wherein the front cap
mechanism includes a proximal end for attaching to the lancet
device and a distal end for allowing a needle to project therefrom,
a lancet of the lancet device having a surface from which the
needle projects, the mechanism comprising: a front cap having a
distal opening adapted to allow the needle to project therethrough;
a nut rotatably disposed on an outer surface of the front cap; a
stop cap movably disposed within the front cap and adapted to allow
the needle to project therethrough; the stop cap comprising a
lancet stop surface and an opening; wherein the lancet stop surface
is adapted to allow the needle to project through the opening and
is adapted to prevent further movement of the lancet when the
surface of the lancet contacts the lancet stop surface.
11. A method of puncturing a surface of skin using a lancet device
which includes a lancet firing mechanism and a tip for a lancet
device comprising a front assembly comprising a side wall portion,
a skin-engaging portion at least partially defining a plane beyond
which a lancet needle may extend, and a lancet stop element, a slot
disposed in one of the sidewall portion and the lancet stop
element, and at least one following element extending into the
slot, wherein the lancet stop element is moveable towards and away
from the plane in response to movement of the at least one
following element, the method comprising: adjusting a set depth of
penetration of the needle by moving the at least one following
element to a set position; disposing the distal end of the lancet
device against a surface of skin; and triggering the firing
mechanism to cause the needle to penetrate the surface of the skin
to the set depth; wherein the puncture allows a blood sample to be
taken.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S.
application Ser. No. 10/322,530 filed on Dec. 19, 2002 which
application is a continuation of U.S. application Ser. No.
09/493,675 filed Jan. 28, 2000 and which issued as U.S. Pat. No.
6,530,937, the disclosures of each application is expressly
incorporated by reference herein in their entireties.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The invention relates to a lancet device, an adjusting front
mechanism for use on a lancet device, and a method of using a
lancet device. In particular, the invention includes a lancet
device which utilizes an adjustable tip or front. Lancet devices
are used to penetrate and puncture the skin in order to allow the
taking of a blood sample for testing. The device allows the user to
control the depth of this penetration by a simple adjustment
mechanism.
[0004] 2. Discussion of Background Information
[0005] Lancet devices are commonly used to prick the skin of the
user so that one or more drops of blood may be extracted for
testing. Some users such as diabetics, for example, may have to
test their blood sugar levels several times a day. This may be
accomplished by the user using a simple needle. However, this
procedure is often problematic for the user since the needle may be
difficult to handle. Moreover, controlling the depth of penetration
cannot be reliably accomplished without the use of a mechanical
device. Additionally, many users simply cannot perform the
procedure owing to either a fear of needles or because they lack a
steady hand. As a result, lancet devices have been developed which
allow the user to more easily and reliably perform this
procedure.
[0006] Presently, most lancet devices lack convenient and flexible
adjustability. Such devices are typically made adjustable by
switching their tips. U.S. Pat. No. Re. 32,922 to LEVIN et al. is
one such device. That is, the user must remove one tip having a set
depth and replace it with another having a different set depth.
This, of course, creates the problem of storing the replaceable
tips, which if not properly done, may result in their misplacement,
damage, contamination, or the like.
[0007] An improved device would allow the user to more easily
adjust the depth of penetration and would overcome some of the
disadvantages described above. Moreover, since the skin thickness
can vary slightly from user to user and finger to finger, a need
exists for efficiently adapting the depth of penetration. For
example, an index finger may be more calloused than a middle
finger, and the more calloused finger will typically have a thicker
skin. By adjusting the depth of puncture so that the depth is no
greater than necessary for extracting a required amount of blood,
any pain experienced by the user may be minimized.
[0008] Lancets having an adjustable tip are known per se. For
example, U.S. Pat. No. 4,469,110 to SLAMA discloses a mechanism
which adjusts the penetration depth by rotating a threaded sleeve
relative to a body. The SLAMA device is characterized as a "single
bottom" device which employs a threaded design which can be
expensive to manufacture. Moreover, such a device may require the
user to rotate the threaded sleeve up to 360 degrees and more in
order to attain the proper depth setting. Further, such a threaded
resign is prone to inadvertent setting changes since there is
nothing but frictional engagement between the mating threads to
maintain the adjustment setting.
[0009] U.S. Pat. No. 4,895,147 to BODICKY et al. functions in a
similar manner to the device in SLAMA and therefore suffers from
similar disadvantages.
[0010] U.S. Pat. Nos. 5,464,418 and 5,797,942 and 5,908,434 to
SCHRAGA also disclose similar lancet devices and are hereby
incorporated herein by reference as though set forth in full
herein.
[0011] As disclosed in U.S. Pat. No. 5,908,434, the lancet device
has a body portion which encloses a lancet and a lancet firing
mechanism. The lancet typically has a needle extending therefrom
and is caused to move towards the tip of the device by a trigger or
firing mechanism. The lancet device forces the needle, by virtue of
the needle being fixed thereto, out of the device by some distance
or depth so that the needle can penetrate the skin of the user. The
function of this firing mechanism and the lancet body design is
disclosed in each of U.S. Pat. Nos. 5,797,942 and 5,908,434. These
patents are incorporated by reference herein in their entirety and
are therefore only briefly discussed herein.
[0012] What is needed is a front cap or tip design which can
accurately and precisely control the depth of penetration of the
needle relative to the surface of the user's skin. The front cap
forms the tip portion of the lancet device. It uses an adjustment
sleeve which resembles a nut and which is rotatable by the user.
The nut has circumferential grooves and projections which help the
user to grip it with his fingers. The nut is rotatable with respect
to the front cap and/or the lancet body. Located on the inside the
front cap is disposed a stop cap which is moveable in at least two
directions. The stop cap can move forwards and backwards in the
direction of the movement of the lancet and needle. Moreover, the
stop cap can also rotate.
[0013] Thus, while advances have been made, there is a continuing
need for a lancet device which provides for convenient and reliable
adjustment of penetration depth.
SUMMARY OF THE INVENTION
[0014] According to one aspect of the invention there is provided a
tip for a lancet device, which includes a front assembly comprising
a side wall portion, a skin-engaging portion at least partially
defining a plane beyond which a lancet needle may extend, and a
lancet stop element, a slot disposed in one of the sidewall portion
and the lancet stop element, and at least one following element
extending into the slot, wherein the lancet stop element is
moveable towards and away from the plane in response to movement of
the at least one following element. The tip may include at least
one actuator for engaging the at least one following element. The
actuator may be a rotatable annular member for engaging the at
least one following element. The at least one following element may
be fixed to the stop member. Alternatively, the at least one
following element may be fixed to the annular member. The slot may
be disposed on the sidewall portion. The slot may be a camming
slot. The slot may be both disposed on the stop member and may be a
camming slot.
[0015] The tip may also include an outer generally annular
rotatable member. The at least one following element may be fixed
to the generally annular rotatable member. The generally annular
rotatable member may have a slot. The slot on the generally annular
rotatable member may be a camming slot. The at least one following
element may be fixed to the stop member.
[0016] The tip may include at least one tooth disposed on one of
the stop member and the front assembly. The front assembly may
include an internal spline having a plurality of teeth for engaging
the at least one tooth disposed on the stop member. The tip may
have at least two ratchet teeth being disposed on the stop member
approximately 180 degrees apart from one another. The stop member
may include a first section which includes at least one ratchet
tooth and a second section which includes a camming lug, the first
section being partially separated from the second section by at
least one separating slot. The first section and the second section
may be partially separated by at least two separating slots such
that the separating slots define at least two connecting walls. The
second section may further include a deflecting wall for connecting
the camming lug to a cylindrical wall of the stop cap. The second
section may include a circumferential separating slot for
separating a portion of the deflecting wall from the cylindrical
wall of the stop member such that the deflecting wall is connected
to the cylindrical wall by a connecting wall. The connecting wall
allows the deflecting wall to deflect inward towards a center axis
of the stop member. The stop member may be moveably retained within
the front assembly such that it can rotate and move axially with
respect to the front assembly. The stop member may be moveable
towards and away from the plane such that at least one ratchet
tooth maintains engagement with an internal spline disposed on an
internal surface of the front assembly throughout this
movement.
[0017] The tip may provide that the at least one following element
is guided within the slot when the stop member is moved axially or
rotated. The front assembly may include a bearing surface disposed
between at least two shoulders, and wherein an annular member is
rotatably disposed on the bearing surface and is retained from
axial movement by at least one shoulder. The front assembly may
further include engaging lugs which cooperate with engaging grooves
on a lancet body and a manual lancet release button for separating
the lancet from the lancet body. The lancet stop element may
include a opening for allowing the needle to project
therethrough.
[0018] The tip may further include a rotatable nut disposed on the
front assembly which includes one of a plurality of projections and
grooves disposed on an outer surface. The nut may include
indicating marks and the front cap may further comprise a reference
mark. The nut may also include a distal wall which includes an
opening for allowing the needle to project therethrough.
[0019] According to still another aspect of the invention, there is
provided a lancet device, which includes a lancet body including a
lancet firing mechanism which is at least partially enclosed within
a lancet body shell, a front assembly including a side wall
portion, a skin-engaging portion at least partially defining a
plane beyond which a lancet needle may extend, and a lancet stop
element, a slot disposed in one of the sidewall portion, the lancet
stop element, and the outer generally annular member, and at least
one following element extending into the slot, wherein the lancet
stop element is moveable towards and away from the plane in
response to movement of the at least one following element.
[0020] The invention also provides for a front cap mechanism for a
lancet device wherein the front cap mechanism includes a proximal
end for attaching to the lancet device and a distal end for
allowing a needle to project therefrom, the lancet having a surface
from which the needle projects, the mechanism including a front cap
having a distal opening adapted to allow the needle to project
therethrough, a nut rotatably disposed on an outer surface of the
front cap, a stop cap disposed within the front cap and adapted to
allow the needle to project therethrough, the stop cap including a
lancet stop surface and an opening, wherein the lancet stop surface
is adapted to allow the needle to project through the opening and
is adapted to prevent further movement of the lancet when the
lancet surface contacts the lancet stop surface.
[0021] The mechanism may provide that the stop cap further includes
at least one ratchet tooth and wherein the front cap further
comprises an internal spline having a plurality of teeth for
engaging the at least one ratchet tooth. The at least one ratchet
tooth may be at least two ratchet teeth disposed approximately 180
degrees apart from one another. The stop cap may include a first
section which includes at least one ratchet tooth and a second
section which includes at least one camming lug, the first section
being partially separated from the section by at least one
separating slot. The first section and the section may be partially
separated by at least two separating slots such that the separating
slots define at least two connecting walls. The second section may
include a deflecting wall for connecting the camming lug to a
cylindrical wall of the stop cap. The camming lug may be guided
within the circumferential camming slot when the stop cap is moved
axially or rotated and wherein the camming lug engages a recess
formed on the nut. The second section may also include a
circumferential separating slot for separating a portion of the
deflecting wall from the cylindrical wall of the stop cap such that
the deflecting wall is connected to the cylindrical wall by a
connecting wall. The stop cap may be moveably retained within the
front cap such that it can rotate and move axially with respect to
the front cap. The rotation of the nut in one direction may cause
movement of the lancet stop surface towards the distal end and
wherein rotation of the nut in the opposite direction may cause
movement of the lancet stop surface away from the distal end.
[0022] According to another aspect of the invention, there is
provided a method of puncturing a surface of skin using a lancet
device which includes a lancet firing mechanism and a tip for a
lancet device comprising a front assembly comprising a side wall
portion, a skin-engaging portion at least partially defining a
plane beyond which a lancet needle may extend, and a lancet stop
element, a slot disposed in one of the sidewall portion and the
lancet stop element, and at least one following element extending
into the slot, wherein the lancet stop element is moveable towards
and away from the plane in response to movement of the at least one
following element, the method comprising adjusting a set depth of
penetration of the needle by moving the at least one following
element to a set position, disposing the distal end of the lancet
device against a surface of skin, and triggering the firing
mechanism to cause the needle to penetrate the surface of the skin
to the set depth, wherein the puncture allows a sample of blood to
be taken. The sample may comprise at least one drop of blood which
flows up to the surface of the skin.
[0023] The invention also provides for a method of puncturing a
surface of skin using a lancet device comprising a lancet body
comprising a lancet firing mechanism which is at least partially
enclosed within a lancet body shell, a front assembly comprising a
side wall portion, a skin-engaging portion at least partially
defining a plane beyond which a lancet needle may extend, and a
lancet stop element, a slot disposed in one of the sidewall
portion, the lancet stop element, and the outer generally annular
member, and at least one following element extending into the slot,
wherein the lancet stop element is moveable towards and away from
the plane in response to movement of the at least one following
element, the method comprising adjusting a set depth of penetration
of the needle by moving the at least one following element to a set
position, disposing the distal end of the lancet device against a
surface of skin, and triggering the firing mechanism to cause the
needle to penetrate the surface of the skin to the set depth,
wherein the puncture allows a blood sample to be taken. The sample
may comprise at least one drop of blood which flows up to the
surface of the skin.
[0024] The invention therefore provides for a lancet device and a
method of using the device to extract one or more drops of blood
for testing. The invention also provides a front mechanism which
may be in the form of a cap and which is adaptable to be used on
conventional lancet devices for facilitating precise needle depth
control. Moreover, the invention provides such a device which may
be a hand held device which is small enough to be placed in a
pocket or purse. It has a body portion and a front cap or tip
portion and functions in a manner similar to the devices disclosed
in U.S. Pat. No. 5,908,434 and U.S. Pat. No. 5,797,942, each issued
to SCHRAGA, the disclosure of each being incorporated by reference
herein in their entirety. Both these patents were issued to this
inventor.
[0025] The invention provides for a front mechanism having an
adjustment mechanism. This front mechanism may be utilized on many
conventional lancet devices, and in particular, may be used on the
above listed devices. Further, the invention provides for a new
type of lancet which utilizes this adjustment front cap mechanism.
In one embodiment, the front assembly or front mechanism is in the
form of a cap.
[0026] The stop cap also has a camming lug which travels in a
camming slot formed in a side wall of the front cap. The lug
projects through the camming slot and further into a recess formed
on an inside surface of the nut. In operation, this design allows
the stop cap to rotate as well as move forwards and backwards,
based upon rotational movement of the nut. The camming slot in the
front cap is angled in such a way to allow the stop cap to be
precisely positioned within the front cap. The stop cap functions,
as its name suggests, as a stop for the lancet. That is, it acts to
stop the movement of the lancet after it is fired in the direction
of the tip. For this purpose, the stop cap has a stop surface which
prevents the lancet from moving any further past a set point.
Moreover, the stop cap includes a through hole which allows the
needle to protrude therethrough. As a result of the needle being
fixed to the lancet, the stop cap also prevents the needle's
movement past a set point.
[0027] The device functions as follows: a user rotates the nut in
either a clockwise or counterclockwise direction to set or adjust
the device to a certain set needle depth. This is facilitated by
indicating marks formed on the nut with respect to a reference mark
formed on the from cap in the form of a reference arrow. The
rotation of the nut causes movement of the stop cap to a set
position for prevention further movement of the lancet and needle.
At this point, the user places the device with the front cap
positioned against the skin. Upon activation of the trigger
mechanism, the lancet and needle are caused to move towards the
skin. However, the lancet and needle will not be allowed to travel
past a stop point determined by the stop cap. As a result, the
needle protrudes into the skin only by the desired maximum amount.
That is the needle can penetrate only up to the point where the
lancet contacts the stop surface. The needle penetrates and is
retracted very quickly owing the speed of the spring activated
plunger and firing mechanism which causes the lancet to move. At
this point the user withdraws the device from the skin and stores
it for later use. A drop of blood should then flow up through the
puncture in the skin which can be tested.
[0028] However, should an insufficient amount of blood not surface
from the puncture, the device can be re-adjusted to allow the
needle to penetrate still a little further into the skin. To do so,
the user merely rotates the nut in the required direction to the
next indicating mark. This will in turn, cause the stop cap to move
closer toward the user's skin. The lancet device can then be
rearmed and triggered, and once released will allow the needle to
penetrate a little further into the skin. Of course, if an
excessive amount of blood flows up or if an excessive amount of
pain is experienced owing to the needle penetrating too much, then
the nut can be rotated in the opposite direction to reduce the
depth of needle penetration.
[0029] In one particular embodiment of the device, the nut is
located on the front cap and sits back some distance from a distal
surface. The distal surface being a surface which contacts the skin
of the user and through which the needle projects. One advantage of
this embodiment is that the nut may be easier to fabricate.
[0030] In another embodiment of the device, the nut itself includes
the distal surface with the corresponding distal opening. One
advantage of this embodiment is that the nut has a longer axial
length which can be easier to grip. Another advantage is that the
front cap may be easier to fabricate owing to its cylindrical shape
having both ends open.
[0031] The invention thus provides for a front cap adjusting
mechanism which can be adapted to fit on conventional lancet
devices for facilitating precise needle penetration. Moreover, the
invention provides for a lancet which uses the front cap. Finally,
the invention provides for a method of using the device to extract
blood for testing.
[0032] As explained above in connection with the device, the method
allows the user to extract one of more drops of blood more
efficiently, precisely, consistently, and with less discomfort to
the user.
[0033] Other exemplary embodiments and advantages of the present
invention may be ascertained by reviewing the present disclosure
and the accompanying drawing.
BRIEF DESCRIPTION OF THE DRAWINGS
[0034] The present invention is further described in the detailed
description which follows, in reference to the noted plurality of
drawings by way of non-limiting examples of exemplary embodiments
of the present invention, in which like reference numerals
represent similar parts throughout the several views of the
drawings, and wherein:
[0035] FIG. 1, shows a side view of one embodiment of the lancet
device;
[0036] FIG. 2, shows a side view of the front cap mechanism of the
embodiment of FIG. 1;
[0037] FIG. 3, shows the front cap mechanism of FIG. 2 with the nut
removed therefrom;
[0038] FIG. 4, shows a side view of the nut shown in FIG. 2 by
itself;
[0039] FIG. 5, shows a side view of the front cap looking from the
proximal direction or from a direction where the front cap attaches
to the body of the lancet device, it should be noted that the nut,
stop cap, and cylindrical washer are removed;
[0040] FIG. 6, shows a cross-section view along line 6-6 of FIG.
5;
[0041] FIG. 7, shows a side view of the front cap looking from the
proximal direction or from a direction where the front cap attaches
to the body of the lancet device, it should be noted that this
figure is similar to FIG. 5 except that the stop cap has been
added;
[0042] FIG. 8, shows a cross-section view along line 8-8 of FIG.
7;
[0043] FIG. 9, shows a greatly enlarged view of FIG. 7 in which the
interaction between the stop cap ratchet teeth and the front cap
internal spline are seen more clearly;
[0044] FIG. 10, shows a view similar to that of FIG. 8 and
illustrates movement of the stop cap towards the distal end of the
front cap, such movement indicating an adjustment towards greater
needle depth penetration;
[0045] FIG. 11, shows a view similar to that of FIG. 8 and
illustrates movement of the stop cap away from the distal end of
the front cap, such movement indicating an adjustment towards
lesser needle depth penetration;
[0046] FIG. 12, shows a view similar to that of FIGS. 2 and 3 with
the front cap main parts in a dis-assembled manner, the stop cap
being positionable inside the front cap from the proximal end, and
the nut being positionable onto the front cap from the distal
end;
[0047] FIG. 13, shows a enlarged cross-section view of the stop
cap;
[0048] FIG. 14, shows a enlarged cross-section view of the stop cap
and illustrates how the camming lug deflection wall flexes or
deflects so that the stop cap may be more easily assembled into the
front cap;
[0049] FIG. 15, shows how the cylindrical washer or retaining
sleeve fits within the stop cap and illustrates how it prevents the
camming lug from deflecting inward as it does in FIG. 14;
[0050] FIG. 16, shows a side view of the front cap mechanism of
another embodiment, in which an extended or axially longer nut is
employed;
[0051] FIG. 17, shows the front cap mechanism of FIG. 16 with the
nut removed therefrom;
[0052] FIG. 18, shows a side view of the nut shown in FIG. 16 by
itself;
[0053] FIG. 19, shows a side cross-section view of the nut shown in
FIG. 4;
[0054] FIG. 20, shows a side cross-section view of the nut shown in
FIG. 18;
[0055] FIG. 21, shows a side view of another embodiment of the
lancet device which uses the front cap of the embodiment shown in
FIG. 16;
[0056] FIG. 22, shows the embodiment of FIG. 1 in partial
cross-section and with the nut removed, and specifically how the
lancet, internal plunger, stop cap, cylindrical washer and front
cap cooperate to allow the needle to penetrate a setting depth
indicated by "z";
[0057] FIG. 23, shows the embodiment of FIG. 1 in partial
cross-section and with the nut removed, and specifically how the
lancet, internal plunger, stop cap, cylindrical washer and front
cap cooperate to allow the needle to penetrate another setting
depth indicated by
[0058] FIG. 24, shows the front cap mechanism of the embodiment of
FIG. 1 in cross-section (the lancet body, lancet plunger, lancet
and needle being removed), and specifically how the stop cap,
cylindrical washer, nut and front cap cooperate to adjust the axial
position of the stop cap within the front cap;
[0059] FIG. 25, shows the front cap mechanism of the embodiment of
FIG. 21 in cross-section (the lancet body, lancet plunger, lancet
and needle being removed), and specifically how the stop cap,
cylindrical washer, nut and front cap cooperate to adjust the axial
position of the stop cap within the front cap;
[0060] FIG. 26, shows a side cross-section view of a nut similar to
that shown in FIG. 4, but of another embodiment wherein the nut
itself has the camming slot instead of the front assembly which
engages the camming lug of the stop cap;
[0061] FIG. 27, shows a side cross-section view of a nut similar to
that shown in FIG. 18, but of another embodiment wherein the nut
itself has the camming slot instead of the front assembly which
engages the camming lug of the stop cap;
[0062] FIG. 28, shows a side cross-section view of a nut similar to
that shown in FIG. 4, but of another embodiment wherein the nut
itself has the camming lug instead of the stop cap;
[0063] FIG. 29, shows a side cross-section view of a nut similar to
that shown in FIG. 18, but of another embodiment wherein the nut
itself has the camming lug instead of the stop cap;
[0064] FIG. 30, shows a side view of a stop cap similar to the stop
cap shown in FIG. 12, but of another embodiment wherein the stop
cap has the camming slot instead of the front assembly which
engages a camming lug of the nut as shown in FIGS. 28 and 29;
[0065] FIG. 31, shows a side cross-section view of a front assembly
and lancet/needle with the needle penetrating the skin to a
depth;
[0066] FIG. 32, shows the front cap mechanism of another embodiment
in which the front cap has a longitudinal slot instead of the nut,
this design can be used with any of the nuts shown in FIGS. 26-29
and would function with stop cap 25 or 25a;
[0067] FIG. 33 is an isolated cross-sectional view illustrating a
biasing element of the present invention;
[0068] FIG. 34, shows another embodiment of a front cap mechanism
in cross-section (the lancet body, lancet plunger, lancet and
needle being removed), and specifically how the first sleeve and
the second sleeve cooperate to adjust the axial position of the
second sleeve within the first sleeve;
[0069] FIG. 35, shows still another embodiment of a front cap
mechanism in cross-section (the lancet body, lancet plunger, lancet
and needle being removed), and specifically how the first sleeve
and the second sleeve cooperate to adjust the axial position of the
second sleeve within the first sleeve;
[0070] FIG. 36, shows another embodiment of a front cap mechanism
in cross-section (the lancet body, lancet plunger, lancet and
needle being removed), and specifically how the first sleeve, the
second sleeve and the third sleeve cooperate to adjust the axial
position of the third sleeve within the first sleeve;
[0071] FIG. 37, shows still another embodiment of a front cap
mechanism in cross-section (the lancet body, lancet plunger, lancet
and needle being removed), and specifically how the first sleeve,
the second sleeve and the third sleeve cooperate to adjust the
axial position of the third sleeve within the first sleeve;
[0072] FIG. 38, shows another embodiment of a front cap mechanism
in cross-section (the lancet body, lancet plunger, lancet and
needle being removed), and specifically how the first sleeve, the
second sleeve, the third sleeve, and the fourth sleeve cooperate to
adjust the axial position of the third sleeve within the first
sleeve; and
[0073] FIG. 39, shows still another embodiment of a front cap
mechanism in cross-section (the lancet body, lancet plunger, lancet
and needle being removed), and specifically how the first sleeve,
the second sleeve, the third sleeve and fourth sleeve cooperate to
adjust the axial position of the third sleeve within the first
sleeve.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
[0074] The particulars shown herein are by way of example and for
purposes of illustrative discussion of the embodiments of the
present invention only and are presented in the cause of providing
what is believed to be the most useful and readily understood
description of the principles and conceptual aspects of the present
invention. In this regard, no attempt is made to show structural
details of the present invention in more detail than is necessary
for the fundamental understanding of the present invention, the
description taken with the drawings making apparent to those
skilled in the art how the several forms of the present invention
may be embodied in practice.
[0075] FIG. 1 shows one embodiment of lancet device 1. Lancet
device 1 has a lancet body portion 2 and a front assembly or front
cap mechanism 3 (also referenced herein as a tip or front portion).
In one particular embodiment lancet device 1 includes a rear
trigger mechanism 8 in the form of a push button. The details of
this type of trigger mechanism or a similar type device may be
found in, for example, U.S. Pat. Nos. 5,908,434 and/or 5,797,942,
which are hereby incorporated by reference herein in their entirety
for this purpose. Moreover, front cap mechanism 3 may include the
feature of a manual release mechanism 5, as is fully described in
U.S. Pat. No. 5,797,942. Front cap mechanism 3 is removably
attached to lancet body 2 by separating engaging mechanisms of the
two parts. For example, front cap 3 may have engaging lugs 22 (see
FIG. 6) disposed on an inside engaging surface which snap into
engaging grooves on an external surface of lancet body 2. The
attachment may also be a simple overlapping sliding interference
fit such as that disclosed in U.S. Pat. No. 5,464,418, which patent
is hereby incorporated by reference in its entirety for this
purpose.
[0076] As can be seen in FIG. 1, lancet device 1 includes front
assembly or front cap mechanism 3 having distal surface 4 which
forms the contact surface which is pressed against the surface of
the user's skin. A needle 7 is allowed to project past this surface
for a set depth after the trigger is pushed. This distal surface 4
may comprise a skin-engaging portion defining a plane through which
needle 7 may extend. Shortly after being triggered, needle 7 is
retracted back into device 1. It should be noted that although FIG.
1 shows needle 7 in a projected state, the reality is that this
extended state occurs only for a very short period of time, on the
order of for example, a fraction of a second. The mechanism
controlling the movement of lancet 37 and needle 7, and its ability
to retract back into device 1, is disclosed in the above noted
patents which have been incorporated by reference. Moreover, the
invention contemplates that front cap mechanism 3 can be used with
other lancet body types, provided a proper mating configuration is
established.
[0077] Front cap mechanism 3 may have a skin engaging portion which
at least partially defines a plane beyond which needle 7 may
project. In the embodiment of FIG. 1, this skin engaging portion is
defined by contact surface 4. However, the invention contemplates
that this plane may also be defined by any number of structures,
such as, two or more contact points or projections extending from
either nut 6 or some distal portion of front cap 3. In this case,
these structures would form the contact plane between lancet device
1 and a user's skin surface.
[0078] FIG. 2 shows an enlarged view of front cap mechanism 3 of
the embodiment of FIG. 1. Front cap mechanism 3 includes manual
release button 5 as previously discussed. A reference marker arrow
13 is also preferably provided and is preferably integrally formed
with front cap 3. A generally annular member 6 (also referred to as
an outer sleeve or nut) is disposed on front cap 3 and is allowed
to rotate with respect to front cap 3. Annular member or nut 6
includes projections 14 and grooves 15 which may be formed
integrally with nut 6. Projections 14 and grooves 15 allow nut 6 to
be gripped more easily by the user. In particular, the user clamps
nut 6 between his thumb and index finger, and then proceeds to
rotate it. Nut 6 may be rotated clockwise or counter clockwise for
some angle of rotation that should preferably be less than
approximately 360 degrees and preferably around approximately 180
degrees.
[0079] FIG. 3 shows front cap mechanism 3 with nut 6 removed. Front
cap 3 has a proximal end 39 which is adapted and/or configured to
attach conveniently to lancet body 2, so as to form lancet device
1. Front cap 3 also has bearing surface 10 which represents a
surface upon which nut 6 can rotate. As can be seen in FIG. 3,
front cap 3 also has a slot 17 in the form of a camming slot (or a
longitudinal slot in another embodiment, see for example FIG. 32)
and which is a slot extending through a front cap side wall 16.
Camming slot 17 acts as a guide for camming lug 18 of stop cap 25
member, which in this embodiment is in the form of a cap stop.
Camming slot 17 should extend approximately halfway through or
across the circumference of bearing surface 10 of front cap 3. This
would provide for approximately 180 degrees of total rotational
movement of nut 6. Nevertheless, greater or lesser ranges of
rotational movement are also contemplated by the invention.
Moreover, camming slot 17 may have many configurations, such as for
example, having a serpentine or snake shape which would facilitate
greater degrees of depth adjustment.
[0080] FIG. 4 shows nut 6 removed from front cap 3. Nut 6 also has
indicating marks 12 which may be in the form of numbers or letters
(not shown) or simply lines. Indicating marks 12 represent specific
needle depth settings. The device 1 may further utilize a zero
setting, which can represent a typical skin depth and include
positive and negative values disposed on either side, to designate
greater and lesser depth penetrations. Alternatively, indicating
marks 12 may indicate a range of letters or numbers (not shown)
designating from lesser to greater, the depth of penetration
values. For example, an "A" setting may represent one depth
penetration with the next mark adjacent mark being a "B" setting
and representing a slightly greater depth penetration. Moreover,
the particular configuration of nut 6 is important only with
respect to its ability to move the stop cap or member 25 to a
desired position. As such, the nut may alternatively utilize
indicating marks 12 and/or tapered section 11 on the distal side of
nut 6. In such a design, arrow 13 could be located in a position on
the side wall between the distal end of nut 6, once installed, and
distal end 9 of front assembly (not shown). Alternatively, nut 6
may include an arrow 13 while front assembly has indicating marks
12.
[0081] FIG. 5 shows a view of front cap 3 of FIG. 2 looking from
the direction of proximal end 39. A manual release button 5 is
shown but the details of its structure and operation are not
disclosed here since these aspects are discussed in detail in U.S.
Pat. No. 5,797,942, incorporated by reference herein. As can be
seen, front cap 3 has an internal spline 19 formed therein.
Moreover, internal spline 19 is preferably formed integrally with
front cap 3. Front cap also includes distal opening 20 which allows
needle 7 to project therethrough.
[0082] As seen above and in FIG. 6, front cap 3 has bearing surface
10. Bearing surface 10 is defined by a rear retaining shoulder 24
which prevents nut 6 from moving axially in the direction of
proximal end 39. Moreover, a front retaining shoulder 23 is also
utilized to prevent nut 6 from moving axially in the direction of
distal end 4. Bearing surface 10 is thus made with a smaller
diameter than either of the cylindrical surfaces arranged adjacent
retaining shoulders 23, 24. Preferably, shoulder 23 is only
slightly larger than bearing surface 10 in diameter. Moreover, nut
6 has an internal diameter 39 (see FIG. 19) which is slightly
smaller than front retaining shoulder diameter 23 so that nut 6 can
snap onto front cap 3 and be retained axially thereby. There should
also be a small clearance between nut 6 internal diameter 39 and
bearing surface 10 diameter so that nut 6 can rotate freely
thereon.
[0083] FIG. 7 is similar to FIG. 5 but includes lancet stop element
or stop cap 25 installed in front cap 3. Stop cap 25 has ratchet
teeth 26 (see also FIG. 9) which engage internal spline 19 of front
cap 3.
[0084] FIG. 8 shows a cross-section view of front cap 3 having stop
cap 25 installed therein. Stop cap 25 can move with respect to
inner sliding surface 21 of front cap 3. For this purpose a
clearance is shown between an outer diameter of stop cap 25 and
inner sliding surface 21 of front cap 3. Moreover, each of stop cap
25 and front cap 3 have distal openings 31 and 20 respectively
which should be aligned so that needle 7 can pass therethrough. The
size of these openings 20, 31 is not important unless it is so
large that lancet 37 (see FIG. 22) is not prevented from stopping,
or so small that needle 7, cannot pass therethrough without
interference.
[0085] FIG. 9 shows an enlarged view of FIG. 7. Stop cap 25 has at
least one and preferably two ratchet projections or teeth 26.
Ratchet teeth 26 may be integrally formed with stop cap 25. In
operation, the rotation of nut 6 causes camming lug 18 to be
engaged by recess 33 of nut 6 (see FIGS. 19 and 24). Camming lug 18
is also guided within camming slot 17 during its rotational
movement. This design means that stop cap 25 experiences both an
axial movement and a rotational movement when nut 6 is rotated.
That is, stop cap 25 may rotate clockwise when it moves towards
distal end 4 and counterclockwise when moving away from distal end
4 based upon corresponding rotational movements of nut 6. However,
this movement is to a great extent dependent on the configuration
of camming slot 17. Therefore, by changing the angle and/or shape
of camming slot 17, other complex movements may also be
achieved.
[0086] FIG. 9 also shows in detail how internal spline 19 is
arranged to cooperate with ratchet teeth 26. The number and/or size
of ratchet teeth 26 and spline teeth 19 may be designed with a fine
configuration (more smaller teeth), a medium configuration (less
teeth of medium size) or a large configuration (even fewer larger
teeth). These configurations can be chosen, along with the number
of ratchet teeth 26 so that a desired amount of torque resistance
is achieved. Thus, for example, using more and smaller teeth on
spline 19 would generally make it easier to rotate stop cap 25 and
nut 6. Alternatively, fewer and larger spline teeth 19 would
generally require more torque to rotate stop cap 25 and nut 6.
Moreover, the number of ratchet teeth 26 disposed on stop cap 25
also increases the required torque to rotate stop cap 25. In the
preferred device, the number of teeth of each is set so that an
average user can cause rotation, and therefore adjustment, with the
minimum of effort. However, providing for increased torque may be
advantageous as a way to child proof the device or as a way to
prevent inadvertent changes in the required depth settings. It
should be noted at this point, that the invention also contemplates
that front cap utilize one or two ratchet teeth while the stop cap
25 employs an external spline (not shown). The choice of which
configuration to use is a matter of ease of fabrication.
Additionally, as will be readily appreciated, other configurations
may be readily employed other than teeth and a spline.
[0087] FIG. 10 shows front cap 3 with stop cap 25 disposed within
in an assembled manner. The arrow indicates that stop cap 25 can
move axially in the indicated direction. As a result of this
movement, a greater needle depth of penetration will result.
[0088] FIG. 11 also shows front cap 3 with stop cap 25 disposed
within in the assembled manner. The arrow indicates that stop cap
25 can move axially in the indicated direction. As a result of this
movement, a lesser depth of needle penetration will result.
[0089] In both FIGS. 10 and 11 it is important to note that axial
length of internal spline 19 should be of sufficient length so that
ratchet teeth 26 always engage internal spline teeth 19, throughout
the entire range of movement of stop cap 25.
[0090] FIG. 12 shows front cap mechanism 3 in a dis-assembled state
except that cylindrical washer or retaining sleeve 32 is removed.
Stop cap 25 resembles a cap with one end open and the other end
substantially closed. However, the substantially closed end is
provided with an opening through which the lancet needle may
project. The proximal end or first section is defined by at least
one ratchet tooth and preferably two ratchet teeth 26 and a
cylindrical wall on which they are formed. A separating or
connecting wall 29 connects ratchet teeth 26 cylindrical wall to
the remaining portion of stop cap 25. Two proximal slots 30 act to
partially separate ratchet teeth 26 cylindrical wall from the
remaining part of stop cap 25 and as a result allows this section
to flex slightly when ratchet teeth 26 are moved and rotated with
respect to internal spline 19. The width and shape of these slots
30 and connecting wall 29 can be varied depending on factors such
as the material and wall thickness of stop cap 25. The remaining
cap shaped portion of stop cap 25 includes a circumferential
separating slot 27 which separates a deflecting wall 28 from a
portion of a circumferential wall of stop cap 25. Deflecting wall
28 connects to stop cap 25 by a connecting wall so that it can flex
inwardly towards a central axis (see FIG. 14). Disposed on
deflecting wall 28 is a following element or camming lug 18 which
projects therefrom (see FIGS. 13-15).
[0091] As indicated by the arrows in FIG. 12, stop cap 25 is
assembled into front cap 3 from proximal end 39, and as discussed
previously, nut 6 is assembled from distal end 4.
[0092] FIGS. 13-15 show a cross-sectional view of stop cap 25. A
distal opening 31 is disposed at distal end of stop cap 25. The
cooperation of camming lug 18 and deflecting wall 28 can be seen in
FIG. 14. It is important that camming lug 18 be allowed to move or
deflect in this way so as to facilitate assembly of stop cap 25
into front cap 3. However, once installed, the ability of
deflecting wall 28 to flex will no longer be desired (until and
unless one wishes to dis-assemble the stop cap from the front cap).
To prevent deflecting wall 28 from flexing inward at this point, or
when lancet device 1 is adjusted, a retaining sleeve or cylindrical
washer 32 can be disposed inside stop cap 25. As can be seen in
FIG. 15, cylindrical washer 32 prevents inward flexing of
deflecting wall 28. Alternatively, cylindrical washer 32 may not be
required if the material of stop cap 25 is of sufficient strength
or if the wall thickness of stop cap 25 is sufficiently thick to
resist deflection inward when nut 6 is rotated. Preferably there is
only a small clearance maintained between the outer diameter of
cylindrical washer 32 and the inner diameter of stop cap 25 so that
cylindrical washer 32 cannot move about or possibly back out of its
position of preventing deflecting of wall 28. It is also important
that the inner diameter of cylindrical washer 32 be large enough to
allow lancet 37 to move within it without interference (see FIG.
22).
[0093] FIGS. 16-18 show an enlarged view of front cap mechanism 3a
of the embodiment of FIG. 21. Front cap mechanism 3a again
preferably includes manual release button 5 and reference marker
arrow 13, as previously discussed with respect to the other
embodiment. An extended outer sleeve or nut 6a is located on front
cap 3 and is rotatable with respect to front cap 3a. Extended nut
6a also includes projections 14 and grooves 15 similar to those of
nut 6. Again, as explained with respect to FIG. 4, the particular
outside configuration of nut 6 less important than its ability to
move and position stop cap 25.
[0094] As seen in FIGS. 19 and 20, extended nut 6a is similar to
nut 6 except that extended nut 6a is longer axially and includes a
distal wall 40 having a distal opening 34. Moreover, extended nut
6a also includes distal retaining ledge 35 which allows extended
nut 6a to snap onto front cap 3a and be retained thereby. Each of
nut 6 and extended nut 6a also have camming lug recess 33 and 33a.
Recess 33 and 33a are in the form of a slot which is formed on the
inside surface of nut 6, 6a. This recess 33, 33a, engages camming
lug 18 of stop cap 25. The shape and size of recess 33, 33a can be
varied so long as it functions to engage camming lug 18 throughout
the range of adjustment. However, the invention contemplates that
this cooperation between nut 6, 6a and stop cap 25 can be reversed.
That is, nut 6, 6a could utilize a camming lug while stop cap 25
would have recess 33, 33a. However, such a design might prove to be
more difficult to manufacture and, for assembly purposes, would
likely require that camming lug 18 be made individually and
thereafter fitted into an aperture on nut 6, 6a.
[0095] FIG. 21 shows another embodiment which uses front cap
mechanism 3a and extended nut 6a, and will be described in more
detail with reference to FIG. 25.
[0096] FIG. 22 shows a partial cross-section of a condition of
operation of lancet device 1 of embodiment shown in FIG. 1, with
nut 6 removed. Lancet 37 contains needle 7 and is fitted onto
distal end 38 of plunger 36. Stop cap 25 is set by the user by
rotating nut 6 and the location of stop cap 25 prevents needle 7
from penetrating any further than a depth "z". After trigger 8 is
pushed on lancet device 1, plunger 36, lancet 37, and needle 7 are
caused to move towards distal end 4. Because of the position of
stop cap 25, the distal end of lancet 37 contacts stop surface 50
and is thus prevented from moving any further towards distal end 4.
As a result, needle 7 projects a maximum amount designated by a
depth "z". It should be noted again that needle 7 is almost
instantly and automatically withdrawn consistent with the operation
disclosed in the patents previously identified.
[0097] FIG. 23 shows another setting in which stop cap 25 has moved
back away from distal end 4. In this setting, stop cap 25 allows
needle 7 to penetrate to a depth designated as "a". Thus, with
respect to both FIGS. 22 and 23, since needle 7 is fixed to lancet
37, controlling the position of lancet 37 is tantamount to
controlling the position of needle 7.
[0098] FIG. 24 shows front cap mechanism 3 of the embodiment of
FIGS. 1-12 fully assembled. In operation, rotational movement of
nut 6 causes stop cap 25 to both rotate and move axially as camming
lug 18 is guided in camming slot 17. This movement sets the
position of stop cap 25 within front cap 3 and defines a maximum
depth of penetration of needle 7.
[0099] FIG. 25 shows front cap mechanism 3a of the embodiment of
FIGS. 16-18 and 21 fully assembled. In operation, rotational
movement of extended nut 6a causes stop cap 25 to both rotate and
move axially as camming lug 18 is guided in camming slot 17. This
movement sets the position of stop cap 25 within front cap 3a and
defines a maximum depth of penetration of needle 7.
[0100] As seen in FIGS. 26 and 27, nut 6b and extended nut 6c is
similar to nut 6 as previously described except that it now
utilizes a camming slot 41, 41a which is similar to camming slot
17. Moreover, these nut designs may be used with the embodiment
shown in FIG. 32 in which the front cap camming slot 17 is replaced
by a longitudinal slot 45.
[0101] FIGS. 28 and 29, show nut 6d and extended nut 6e which are
again similar to nut 6 as previously described except that it now
utilizes a following element or camming lug 42, 42a which is
similar to camming lug 18. Moreover, these nut designs may be used
with any of the embodiments previously described including the
embodiment shown in FIG. 32 in which the front cap camming slot 17
is replaced by a longitudinal slot 45. However, this design
requires that stop element or stop cap 25 be replaced by stop
element or stop cap 25a (see FIG. 30).
[0102] FIG. 30 shows stop cap 25a which differs from stop cap 25 in
that the camming lug 18 is replaced by a camming slot 43. This
configuration is design to work with nut 6d, 6e as shown in FIGS.
28 and 29. As can be seen from the various Figures, the invention
contemplates that the camming lug and camming slot configuration
may take many forms. Each of the many forms has advantages and
disadvantages in terms of ease of manufacturing, so the choice of
which to use can be dictated by cost considerations.
[0103] FIG. 31, shows a cross-section of one embodiment (FIG. 1) of
the lancet device puncturing the skin 44. Thus, the rear section of
the lancet device is not shown for clarity.
[0104] FIG. 32 shows another embodiment of the front cap in which
the camming slot 17 is replaced by a longitudinal slot 45. This
configuration is designed to work with stop cap 25, and nuts 6b,
6c.
[0105] One advantage of the invention is its simple design. There
are few moving parts and the user can quickly learn how to use it.
The device can also be manufactured relatively inexpensively since
the number of parts is small, resulting is fewer assembly steps.
Moreover, the parts themselves are designed to be easily
fabricated. The user can learn to operate the device quickly and
can realize consistent and precise results. Moreover, the device is
customizable to may users and many skin thicknesses owing to its
range of adjustability.
[0106] All the parts of the front cap mechanism may be made from
plastic materials and can be formed using conventional injection
molding techniques or other known manufacturing methods. The nut
for example can be integrally formed with the grooves, projections,
indicating marks, tapered end, and the stop cap lug slot. The stop
cap may be integrally formed with its slots, ratchet projections,
distal opening and camming lug. Moreover, the front cap itself may
be integrally formed with the camming slot, bearing surface, front
and rear retaining shoulders, internal spline, cap engaging lugs,
and distal opening. Alternatively, each of these devices may be
individually made as subassemblies in order to facilitate
manufacture or assembly.
[0107] It should be noted that it is preferred that all the above
referenced parts, except for needle 7, should ideally be made of
synthetic resin or plastic materials using conventional techniques
such as injection molding. However, when practical, other materials
and manufacturing processes may also be utilized.
[0108] In view of the above and the drawings, the lancet device 1
may comprise a housing 2 having an end; a lancet holding member 36
capable of holding a lancet 37, the lancet holding member 36 being
at least partially contained within the housing 2; a biasing
element 60 (see FIG. 33) capable of biasing the lancet holding
member 36 toward an extended position; a trigger 8 capable of
releasing the lancet holding member 36 from a retracted position;
and a cap 3 capable of covering the end of the housing 2 and
capable of positioning the lancet device 1 relative to a skin
surface, the cap 3 comprising: a front assembly 3 comprising a side
wall portion 16, a skin-engaging portion at least partially
defining a plane beyond which a lancet needle 7 may extend, and a
lancet stop element 25; a generally annular rotatable member 6
disposed on the front assembly 3, the generally annular rotatable
member 6 comprising a slot 41 a, the generally annular rotatable
member 6 comprising one of a plurality of projections 14 and
grooves 15 disposed on an outer surface; and at least one following
element 18 extending into the slot 41a; wherein rotation of the
generally annular rotatable member 6 relative to the skin engaging
portion causes movement of the at least one following element 18 to
move the lancet stop element 25 toward and away from the plane, to
allow adjustment of a penetration depth of the lancet 37.
[0109] The lancet device tip may comprise one sleeve 6; and another
sleeve 25 at least partially contained within the one sleeve 6, the
another sleeve 25 comprising a stop surface 50; wherein rotation of
the one sleeve 6 relative to the another sleeve 25 causes the
another sleeve 25 to move at least axially without changing an
overall length of the lancet device tip, as apparent from the
Figures, e.g., FIGS. 10 and 11.
[0110] The lancet device 1 may comprise a housing 2 having an end;
a lancet holding member 36 capable of holding a lancet 37, the
lancet holding member 36 being at least partially contained within
the housing 2; a lancet 37 held by the lancet holding member 36; a
biasing element 60 capable of biasing the lancet holding member 36
toward an extended position; a trigger 8 capable of releasing the
lancet holding member 36 from a retracted position; a cap 3 capable
of covering the end of the housing 2 and capable of positioning the
lancet device 1 relative to a skin surface, the cap 3 comprising: a
first sleeve 3; and a second sleeve 25 at least partially contained
within the first sleeve 3, the second sleeve 25 comprising a stop
surface 50; wherein rotation of the first sleeve 3 relative to the
second sleeve 25 causes the second sleeve 25 to move at least
axially without changing an overall length of the lancet device
tip, as apparent from the drawings, e.g., FIGS. 10-11.
[0111] The lancet device 1 may comprise a housing 2 having an end;
a lancet holding member 36 capable of holding a lancet 37, the
lancet holding member 36 being at least partially contained within
the housing 2; a lancet 37 held by the lancet holding member 36; a
biasing element 60 capable of biasing the lancet holding member 36
toward an extended position; a trigger 8 capable of releasing the
lancet holding member 36 from a retracted position; a cap 3 capable
of covering the end of the housing 2 and capable of positioning the
lancet device 1 relative to a skin surface, the cap 3 comprising: a
first sleeve 3; a second sleeve 6 rotatably connected to the first
sleeve 3 to allow relative rotation between the second sleeve 6 and
the first sleeve 3; and a third sleeve 25 contained within the
first sleeve 3, the third sleeve 25 comprising a stop surface 50;
wherein rotation of the second sleeve 6 relative to the first
sleeve 3 causes the third sleeve 25 to move within the first sleeve
3, and wherein the lancet 37 strikes the third sleeve 25 when the
lancet holding member 36 is released from the retracted position to
the extended position, and wherein a penetration depth of the
lancet 37 is adjustable by adjusting the position of the third
sleeve 25.
[0112] Still further, the lancet device tip 3 may comprise a first
sleeve 3; a second sleeve 6 rotatably connected to the first sleeve
3 to allow relative rotation between the second sleeve 6 and the
first sleeve 3; and a third sleeve 25 contained within the first
sleeve 3, the third sleeve 25 comprising a stop surface; and
wherein rotation of the second sleeve 6 relative to the first
sleeve 3 causes the third sleeve 25 to move within the first sleeve
3.
[0113] Additionally, the lancet device tip 3 may comprise a first
sleeve 3; a second sleeve 6 rotatably connected to the first sleeve
3; a third sleeve 25 contained within the first sleeve 3, the third
sleeve 25 comprising a stop surface; and a fourth sleeve 32
contained within the first sleeve 3 and the second sleeve 6;
wherein positions of the first, second, and third sleeves are
adjustable relative to each other.
[0114] The lancet device 1 may comprise a housing 2 having an end;
a lancet holding member 36 capable of holding a lancet 37, the
lancet holding member 36 being at least partially contained within
the housing 2; a lancet 37 held by the lancet holding member 36; a
biasing element 60 capable of biasing the lancet holding member 36
toward an extended position; a trigger 8 capable of releasing the
lancet holding member 36 from a retracted position; a cap 3 capable
of covering the end of the housing 2 and capable of positioning the
lancet device 1 relative to a skin surface, the cap 3 comprising a
first sleeve 3, a second sleeve 6, a third sleeve 25, and a fourth
sleeve 32, wherein positions of the first, second, and third
sleeves are adjustable relative to each other; and wherein the
lancet strikes 37 the third sleeve 25 when the lancet holding
member 36 is released from the retracted position to the extended
position, and wherein a penetration depth of the lancet 37 is
adjustable by adjusting the position of the third sleeve 25.
[0115] In one aspect, an overall length of the lancet device tip
does not change when the second sleeve 6 is rotated relative to the
first sleeve 3, as shown in the Figures, e.g., FIGS. 10 and 11.
[0116] In another aspect, the second sleeve 6 comprises a slot 41a,
and the third sleeve 25 comprises at least one following element 18
extending into the slot 41a.
[0117] In yet another aspect, the second sleeve 6 comprises indicia
12 that indicates a relative position of the first sleeve 3 and the
third sleeve 25.
[0118] In still another aspect, the second sleeve 6 comprises a
ridged surface 14 to facilitate rotation of the first sleeve 3 and
the second sleeve 25 relative to each other.
[0119] In another aspect, the third sleeve 25 moves axially
relative to the first sleeve 3 when the second sleeve 6 is rotated
relative to the first sleeve 3.
[0120] In yet another aspect, the lancet device tip further
comprises a fourth sleeve 32.
[0121] In still another aspect, the second sleeve 6 is rotatably
connected between discrete predetermined positions to the first
sleeve 3. The rotatable connection between discrete predetermined
positions may be accomplished by at least one tooth 26, which may
be in the form of a, e.g., projection and which engages spline
teeth 19, which may in the form of e.g., notches.
[0122] With reference to FIG. 34, it can be seen that another
embodiment of the lancet device tip may include one sleeve 101; and
another sleeve 102 at least partially contained within the one
sleeve 101, the another sleeve 102 comprising a stop surface 103;
wherein rotation of the one sleeve 101 relative to the another
sleeve 102 causes the another sleeve 102 to move at least axially
without changing an overall length of the lancet device tip.
[0123] With reference to FIG. 35, it can be seen that another
embodiment of the lancet device tip may include one sleeve 201; and
another sleeve 202 at least partially contained within the one
sleeve 201, the another sleeve 202 comprising a stop surface 203;
wherein rotation of the one sleeve 201 relative to the another
sleeve 202 causes the another sleeve 202 to move at least axially
without changing an overall length of the lancet device tip.
[0124] With reference to FIG. 36, it can be seen that another
embodiment of the lancet device tip may include a first sleeve 301;
a second sleeve 302 rotatably connected to the first sleeve 301 to
allow relative rotation between the second sleeve 302 and the first
sleeve 301; and a third sleeve 303 contained within the first
sleeve 301, the third sleeve 303 comprising a stop surface 304;
wherein rotation of the second sleeve 302 relative to the first
sleeve 301 causes the third sleeve 303 to move within the first
sleeve 301, and wherein the lancet (not shown) strikes the third
sleeve 303 when the lancet holding member (not shown) is released
from the retracted position to the extended position, and wherein a
penetration depth of the lancet is adjustable by adjusting the
position of the third sleeve 303.
[0125] With reference to FIG. 37, it can be seen that another
embodiment of the lancet device tip may include a first sleeve 401;
a second sleeve 402 rotatably connected to the first sleeve 401 to
allow relative rotation between the second sleeve 402 and the first
sleeve 401; and a third sleeve 403 contained within the first
sleeve 401, the third sleeve 403 comprising a stop surface 404;
wherein rotation of the second sleeve 402 relative to the first
sleeve 401 causes the third sleeve 403 to move within the first
sleeve 401, and wherein the lancet (not shown) strikes the third
sleeve 403 when the lancet holding member (not shown) is released
from the retracted position to the extended position, and wherein a
penetration depth of the lancet is adjustable by adjusting the
position of the third sleeve 403.
[0126] With reference to FIG. 38, it can be seen that another
embodiment of the lancet device tip may include a first sleeve 501;
a second sleeve 502 rotatably connected to the first sleeve 501; a
third sleeve 503 contained within the first sleeve 501, the third
sleeve 503 comprising a stop surface 505; and a fourth sleeve 504
contained within the first sleeve 501 and the second sleeve 502;
wherein positions of the first 501, second 502, and third sleeves
503 are adjustable relative to each other.
[0127] With reference to FIG. 39, it can be seen that another
embodiment of the lancet device tip may include a first sleeve 601;
a second sleeve 602 rotatably connected to the first sleeve 601; a
third sleeve 603 contained within the first sleeve 601, the third
sleeve 603 comprising a stop surface 605; and a fourth sleeve 604
contained within the first sleeve 601 and the second sleeve 602;
wherein positions of the first 601, second 602, and third sleeves
603 are adjustable relative to each other.
[0128] It is noted that the foregoing examples have been provided
merely for the purpose of explanation and are in no way to be
construed as limiting of the present invention. While the present
invention has been described with reference to an exemplary
embodiment, it is understood that the words which have been used
herein are words of description and illustration, rather than words
of limitation. Changes may be made, within the purview of the
appended claims, as presently stated and as amended, without
departing from the scope and spirit of the present invention in its
aspects. Although the present invention has been described herein
with reference to particular means, materials and embodiments, the
present invention is not intended to be limited to the particulars
disclosed herein; rather, the present invention extends to all
functionally equivalent structures, methods and uses, such as are
within the scope of the appended claims.
* * * * *