U.S. patent application number 10/641101 was filed with the patent office on 2005-12-01 for adjustable lancet device and method.
This patent application is currently assigned to Stat Medical Devices, Inc.. Invention is credited to Shraga, Steven.
Application Number | 20050267505 10/641101 |
Document ID | / |
Family ID | 34136255 |
Filed Date | 2005-12-01 |
United States Patent
Application |
20050267505 |
Kind Code |
A9 |
Shraga, Steven |
December 1, 2005 |
Adjustable lancet device and method
Abstract
Lancet device that includes a body. A trigger is mounted to the
body. A front cover has a skin engaging end that includes a lancet
opening through which a lancet needle extends. A holding member is
movably mounted within the body and includes a front end a rear
end. The front end can be configured to receive a lancet. A stop
surface moves with the holding member. A cam wheel includes cam
surfaces which can be contacted by the stop surface. The cam wheel
is configured to rotate at least partially. The cam wheel rotates
about an axis that is parallel to an axis running through at least
one of the lancet opening and the holding member.
Inventors: |
Shraga, Steven; (Surfside,
FL) |
Correspondence
Address: |
GREENBLUM & BERNSTEIN, P.L.C.
1950 ROLAND CLARKE PLACE
RESTON
VA
20191
US
|
Assignee: |
Stat Medical Devices, Inc.
Miami
FL
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 0038464 A1 |
February 17, 2005 |
|
|
Family ID: |
34136255 |
Appl. No.: |
10/641101 |
Filed: |
August 15, 2003 |
Current U.S.
Class: |
606/182; 606/167;
606/181; 606/185 |
Current CPC
Class: |
A61B 5/1519 20130101;
A61B 5/15029 20130101; A61B 5/150412 20130101; A61B 5/15019
20130101; A61B 5/150022 20130101; A61B 5/15113 20130101; A61B
5/15194 20130101; A61B 5/1513 20130101; A61B 5/15186 20130101; A61B
5/150824 20130101; A61B 5/15117 20130101 |
Class at
Publication: |
606/182; 606/181;
606/167; 606/185 |
International
Class: |
A61B 017/32; A61B
017/14; A61B 017/34 |
Claims
What is claimed is:
1. A lancet device, comprising: a body; a trigger; a front cover
comprising a skin engaging end that includes a lancet opening
through which a lancet needle extends; a holding member movably
mounted within the body and comprising a front end and a rear end;
the front end being configured to receive a lancet; a stop surface
that moves with the holding member; a cam wheel comprising cam
surfaces which can be contacted by the stop surface; and the cam
wheel being configured to rotate at least partially, wherein the
cam wheel rotates about an axis that is at least substantially
parallel to an axis running through at least one of the lancet
opening and the holding member.
2. The lancet device of claim 1, further comprising a back cap
configured to move between a retracted position and an original
position.
3. The lancet device of claim 2, wherein the back cap is configured
to move the holding member to a retracted position.
4. The lancet device of claim 2, wherein the back cap is coupled to
a surface that engages the rear end of the holding member.
5. The lancet device of claim 2, wherein the back cap is coupled to
an inner sleeve that includes a surface that engages the rear end
of the holding member.
6. The lancet device of claim 5, wherein the inner sleeve comprises
an opening that receives a rear end of the holding member.
7. The lancet device of claim 2, wherein the back cap is coupled to
in inner sleeve that includes a surface that engages projections
disposed on the rear end of the holding member.
8. The lancet device of claim 2, further comprising a spring for
biasing the back cap towards an original position.
9. The lancet device of claim 1, further comprising a first spring
for biasing the holding member towards an extended position and a
second spring for biasing the holding member in an opposite
direction.
10. The lancet device of claim 9, wherein the first and second
springs are arranged within an axial opening of the holding
member.
11. The lancet device of claim 9, wherein the first spring contacts
one side of a projection extending inwardly from the body and
wherein the second spring contacts another side of the
projection.
12. The lancet device of claim 11, wherein the projection extends
into an elongated slot formed in the holding member.
13. The lancet device of claim 11, further comprising an end plug
mounted to the rear end of the holding member.
14. The lancet device of claim 13, wherein the first spring is
disposed between the projection and an inner wall surface arranged
in the area of the front end of the holding member and wherein the
second spring is disposed between the projection and the end
plug.
15. The lancet device of claim 1, wherein the trigger is movably
mounted to the body.
16. The lancet device of claim 1, wherein the front cover is
removably mounted to the body.
17. The lancet device of claim 1, wherein the holding member
comprises a projection that includes the stop surface.
18. The lancet device of claim 1, wherein the holding member
comprises an integrally formed projection that includes the stop
surface.
19. The lancet device of claim 1, wherein the front end comprises
an opening that is configured to removably receive the lancet.
20. The lancet device of claim 1, further comprising a deflecting
member configured to be deflected by the trigger.
21. The lancet device of claim 20, wherein the deflecting member is
coupled to the holding member.
22. The lancet device of claim 20, wherein the deflecting member
comprises a first stop surface that contacts a first surface of a
holding projection extending inwardly from the body.
23. The lancet device of claim 22, wherein the deflecting member is
integrally formed with the holding member.
24. The lancet device of claim 1, wherein the cam wheel comprises
indicia.
25. The lancet device of claim 24, wherein the cam surfaces are
arranged on an annular cam section of the cam wheel and wherein the
indicia is arranged on an outer circumferential surface of the cam
wheel.
26. The lancet device of claim 1, wherein the cam wheel comprises a
centrally disposed opening that is mounted about the holding
member.
27. The lancet device of claim 26, wherein the holding member
comprises a front portion that includes the front end and a rear
portion that includes the rear end, wherein the front and rear
portions are connected together.
28. The lancet device of claim 26, wherein the rear portion
comprises a slot which at least partially receives a projection
that extends from the body.
29. The lancet device of claim 28, wherein the front portion
comprises a deflecting member configured to be deflected by the
trigger.
30. The lancet device of claim 1, wherein the cam wheel rotates
about an axis that runs through the lancet opening and the holding
member.
31. The lancet device of claim 1, wherein the cam wheel is disposed
between the trigger and a back cap.
32. The lancet device of claim 1, wherein the body comprises a
two-piece body.
33. The lancet device of claim 32, wherein the cam wheel is axially
retained between walls of the two-piece body.
34. The lancet device of claim 33, wherein the front cover is
removably mounted to the two-piece body.
35. The lancet device of claim 34, further comprising a back cap
movably mounted to the two-piece body.
36. The lancet device of claim 1, wherein the body comprises at
least one curved side indentation through which the cam wheel
protrudes.
37. The lancet device of claim 1, wherein the body comprises two
oppositely arranged curved side indentations.
38. The lancet device of claim 1, wherein the body comprises a
mechanism for viewing indicia of the cam wheel.
39. The lancet device of claim 1, wherein the mechanism for viewing
indicia of the cam wheel comprises a slot.
40. The lancet device of claim 1, further comprising a ratchet pawl
which engages an annular undulating surface of the cam wheel,
whereby the cam wheel is maintained at a desired set-depth
position.
41. A method of puncturing a surface of skin using the lancet
device of claim 1, the method comprising: adjusting a set depth of
penetration of the needle by rotating the cam wheel to a desired
set position; disposing the skin engaging end of the lancet device
against a user's skin; and triggering the trigger to cause the
lancet needle to penetrate the user's skin, wherein the puncture
allows a blood sample to be taken.
42. A method of using the lancet device of claim 1, the method
comprising: rotating the cam wheel to a desired set position;
moving the holding member to a retracted position; maintaining the
holding member in the retracted position until the trigger is
triggered; disposing the skin engaging end of the lancet device
against a user's skin; and triggering the trigger to cause movement
of the holding member.
43. A lancet device, comprising: a body; a trigger; a front cover
comprising a skin engaging end that includes a lancet opening
through which a lancet needle extends; a holding member movably
mounted within the body, the holding member comprising a front end
and a rear end; the front end being configured to receive a lancet;
a stop projection coupled to the holding member; and a cam wheel
comprising indicia and annular cam surfaces which can be contacted
by the stop projection; the cam wheel being configured to rotate at
least partially, wherein the cam wheel is axially retained between
walls of the body.
44. A lancet device, comprising: a body; a trigger; a front cover
comprising a skin engaging end that includes a lancet opening
through which a lancet needle extends; a holding member movably
mounted within the body, the holding member comprising a front end
and a rear end; the front end being configured to receive a lancet;
a back cap configured to move the holding member to a retracted
position; a stop surface coupled to the holding member; a cam wheel
at least partially arranged within the body; the cam wheel
comprising indicia and annular cam surfaces which can be contacted
by the stop projection; and the cam wheel being configured to
rotate at least partially, wherein the cam wheel protrudes from at
least one side wall of the body.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The invention relates to a lancet device having an adjusting
capability, and a method of using a lancet device. In particular,
the invention relates to a lancet device which utilizes an
adjustable depth penetration. Lancet devices are used to penetrate
and puncture the skin in order to allow the taking of a blood
sample for testing. The present device allows the user to control
the depth of this penetration by a simple adjustment mechanism.
[0003] 2. Discussion of Background Information
[0004] 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.
[0005] 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.
[0006] 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 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.
[0007] 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.
[0008] 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.
[0009] U.S. Pat. Nos. 5,464,418, 5,797,942, 5,908,434, 6,156,051
and 6,530,937 to SCHRAGA also disclose similar lancet devices and
are hereby incorporated herein by reference as though set forth in
full herein.
[0010] 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 5,797,942 and 5,908,434. These Patents are
incorporated by reference herein in their entirety and are
therefore only briefly discussed herein.
[0011] What is needed is a lancet device which can accurately and
precisely control the depth of penetration of the needle relative
to the surface of the user's skin while also being easy to use. It
is also desirable for the user to be able to use and adjust the
depth penetrating setting with just one hand and/or with less
effort that currently required with existing lancet devices.
[0012] Thus, while advances have been made, there is a continuing
need for a lancet device which provides for convenient, reliable
and easy adjustment of penetration depth.
SUMMARY OF THE INVENTION
[0013] According to one aspect of the invention there is provided a
lancet device that includes a body. A trigger is preferably mounted
to the body, although it can be operatively associated with the
body in any other way. A front cover includes a skin engaging end
that includes a lancet opening through which a lancet needle
extends. A holding member is movably mounted within the body and
comprises a front end and a rear end. The front end is configured
to receive a lancet. A stop surface moves with the holding member.
A cam wheel includes cam surfaces which can be contacted by the
stop surface. The cam wheel is configured to rotate at least
partially. The cam wheel rotates about an axis that is parallel to
an axis running through at least one of the lancet opening and the
holding member.
[0014] The lancet device may further comprise a back cap configured
to move between a retracted position and an original position. The
back cap may be configured to move the holding member to a
retracted position. The back cap may be coupled to a surface that
engages the rear end of the holding member. The back cap may be
coupled to in inner sleeve that includes a surface that engages the
rear end of the holding member. The inner sleeve may comprise an
opening that receives a rear end of the holding member. The back
cap may be coupled to an inner sleeve that includes a surface that
engages projections disposed on the rear end of the holding
member.
[0015] The lancet device may further comprise a spring for biasing
the back cap towards an original position. The lancet device may
further comprise a first spring for biasing the holding member
towards an extended position and a second spring for biasing the
holding member in an opposite direction. The first and second
springs may be arranged within an axial opening of the holding
member. The first spring may contact one side of a projection
extending inwardly from the body and the second spring may contact
another side of the projection. The projection may extend into an
elongated slot formed in the holding member.
[0016] The lancet device may further comprise an end plug mounted
to the rear end of the holding member. The first spring may be
disposed between the projection and an inner wall surface arranged
in the area of the front end of the holding member and the second
spring may be disposed between the projection and the end plug. The
trigger may be movably mounted to the body. The front cover may be
removably mounted to the body. The holding member may comprise a
projection that includes the stop surface. The holding member may
comprise an integrally formed projection that includes the stop
surface. The front end of the holding member may comprise an
opening that is configured to removably receive the lancet.
[0017] The lancet device may further comprise a deflecting member
configured to be deflected by the trigger. The deflecting member
may be coupled to the holding member. The deflecting member may
comprise a first stop surface or end that contacts a first surface
of a holding projection extending inwardly from the body. The cam
wheel may comprise indicia. The cam wheel may be a thumb wheel. The
cam surfaces of the cam wheel may be arranged on a cam section of
the cam wheel. The cam section may be disposed on an annular side
of the cam disk while an outer circumferential surface of the cam
wheel includes the indicia. The cam wheel may comprise a centrally
disposed opening that is mounted about or around the holding
member. The opening in the cam wheel may be large enough to allow
the holding member to move within it. The opening may comprise a
center axis that is generally the same as the axis running through
the holding member. The cam wheel may rotate about an axis that is
generally the same as an axis running through at least one of the
lancet opening and the holding member. The cam wheel may be
disposed between the trigger and a back cap. The body may comprise
a two piece body. The cam wheel may be axially retained between
inwardly projecting portions of the body. The cam wheel may be
disposed between a main projection of the body and a back cap. The
front cover may be removably mounted to the two piece body. The
lancet device may further comprise a back cap movably mounted to
the two piece body. The body may comprise at least one curved side
indentation through which the cam wheel protrudes. The body may
comprise two oppositely arranged curved side indentations. The body
may comprise a mechanism for viewing indicia of the cam disk. The
mechanism for viewing indicia of the cam disk may comprise an
opening. The opening may be a generally rectangular slot. The
lancet device may further comprise projecting walls for one of
axially retaining the cam wheel, whereby the walls allow the cam
wheel to rotate within the body while being axially retained
therein.
[0018] The invention also provides a method of puncturing a surface
of skin using the lancet device described above, wherein the method
comprises adjusting a set depth of penetration of the needle by
moving the cam wheel to a desired set position, disposing the skin
engaging end of the lancet device against a user's skin, and
triggering the trigger to cause the lancet needle to penetrate the
user's skin, wherein the puncture allows a blood sample to be
taken.
[0019] The invention also provides a method of using the lancet
device described above, wherein the method comprises at least
partially rotating the cam wheel to a desired set position, moving
the holding member to a retracted position, maintaining the holding
member in the retracted position until the trigger is triggered,
disposing the skin engaging end of the lancet device against a
user's skin, and triggering the trigger to cause movement of the
holding member.
[0020] The invention also provides a lancet device, that includes a
body, a trigger, a front cover comprising a skin engaging end that
includes a lancet opening through which a lancet needle extends. A
holding member is movably mounted within the body and comprising a
front end a rear end. The front end is configured to receive a
lancet. A stop projection is coupled to the holding member. A cam
wheel comprises indicia and cam surfaces which can be contacted by
the stop projection. The cam wheel is configured to rotate at least
partially. The cam wheel is mounted to rotate about or around the
holding member.
[0021] The invention also provides a lancet device comprising a
body, a trigger, a front cover comprising a skin engaging end that
includes a lancet opening through which a lancet needle extends. A
holding member is movably mounted within the body and comprising a
front end a rear end. The front end is configured to receive a
lancet. A back cap is configured to move the holding member to a
retracted position. A stop surface is coupled to the holding
member. A cam wheel is at least partially arranged within the body.
The cam wheel comprises indicia and cam surfaces which can be
contacted by the stop projection. The cam wheel is configured to
rotate at least partially on an axis that is parallel to an axis of
the holding member. The cam wheel protrudes from at least one side
wall of the body.
[0022] 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
[0023] 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:
[0024] FIG. 1 shows a side cross-section view of one embodiment of
the lancet device. The device is shown in the loaded (trigger set)
position. The lancet is also shown in cross-section;
[0025] FIG. 2 shows a side cross-section view of the embodiment of
FIG. 1. The device is shown with the lancet needle moving toward a
pre-set depth position after it has been triggered;
[0026] FIG. 3 shows a side cross-section view of the embodiment
shown in FIG. 1. The device is shown with the lancet needle at a
pre-set depth position;
[0027] FIG. 4 shows a top cross-section view of the embodiment
shown in FIG. 1 and in the position shown in FIG. 3;
[0028] FIG. 5 shows a side cross-section view of the embodiment
shown in FIG. 1. The device is shown in the loaded (trigger set)
position after it has been so positioned by retracting the trigger
setting mechanism;
[0029] FIG. 6A shows a right side view of the embodiment shown in
FIG. 1;
[0030] FIG. 6B shows a top view of the embodiment shown in FIG.
6A;
[0031] FIG. 6C shows a left side view of the embodiment shown in
FIG. 6B;
[0032] FIG. 6D shows a front end view of the front cap of the
embodiment shown in FIG. 6C;
[0033] FIG. 6E shows a front end view of the embodiment shown in
FIG. 6B, except that the trigger is not shown;
[0034] FIG. 6F shows a rear end view of the embodiment shown in
FIG. 6B;
[0035] FIG. 7A shows a cross-section view of the right body part of
the lancet device shown in FIG. 1;
[0036] FIG. 7B shows an inside view of the right body part shown in
FIG. 7A;
[0037] FIG. 7C shows an outside view of the right body part shown
in FIG. 7A;
[0038] FIG. 7D shows a front cross-section view of the left-most
sectioning arrows shown in FIG. 7B;
[0039] FIG. 7E shows a front end view of the right body part shown
in FIG. 7C;
[0040] FIG. 7F shows a rear end view of the right body part shown
in FIG. 7A;
[0041] FIG. 7G shows a rear cross-section view of the right-most
sectioning arrows shown in FIG. 7B;
[0042] FIG. 7H shows a rear cross-section view of the middle
sectioning arrows shown in FIG. 7B;
[0043] FIG. 8A shows an outside view of the left body part of the
lancet device shown in FIG. 1;
[0044] FIG. 8B shows a cross-section view of the left body part
shown in FIG. 8A;
[0045] FIG. 8C shows a bottom view of the left body part shown in
FIG. 8B with inner surfaces shown in hidden lines;
[0046] FIG. 8D shows an inside view of the left body part shown in
FIG. 8A;
[0047] FIG. 8E shows a front end view of the left body part shown
in FIG. 8A;
[0048] FIG. 8F shows a front cross-section view of the left-most
sectioning arrows shown in FIG. 8D;
[0049] FIG. 8G shows a rear end view of the left body part shown in
FIG. 8B;
[0050] FIG. 8H shows a rear cross-section view of the right-most
sectioning arrows shown in FIG. 8D;
[0051] FIG. 8I shows a rear cross-section view of the middle
sectioning arrows shown in FIG. 8D;
[0052] FIG. 9A shows a side cross-section view of the front portion
of the holding member used in the lancet device shown in FIG.
1;
[0053] FIG. 9B shows a top view of the front portion shown in FIG.
9A;
[0054] FIG. 9C shows another side cross-section view of the front
portion shown in FIG. 9A;
[0055] FIG. 9D shows a front end view of the front portion shown in
FIG. 9A;
[0056] FIG. 10A shows a side cross-section view of the rear portion
of the holding member used in the lancet device shown in FIG.
1;
[0057] FIG. 10B shows a bottom view of the rear portion shown in
FIG. 10A;
[0058] FIG. 10C shows a front end view of the rear portion shown in
FIG. 10B;
[0059] FIG. 11A shows a rear view of the cam wheel of the lancet
device shown in FIG. 1;
[0060] FIG. 11B shows a cross-section view of the cam wheel shown
in FIG. 11A;
[0061] FIG. 11C shows a front view of the cam wheel shown in FIG.
11B;
[0062] FIG. 11D shows an outside view of the cam wheel shown in
FIG. 11B;
[0063] FIG. 11E shows a rear view of the cam wheel in which the cam
surfaces and the indicia can be arranged;
[0064] FIG. 12A shows a rear view of the end plug shown in FIG.
1;
[0065] FIG. 12B shows a side view of the end plug shown in FIG.
1;
[0066] FIG. 12C shows a front view of the end plug shown in FIG.
12B;
[0067] FIG. 13A shows a side view of the first spring shown in FIG.
1;
[0068] FIG. 13B shows an end view of the first spring shown in FIG.
13A;
[0069] FIG. 14A shows a side view of the second spring shown in
FIG. 1;
[0070] FIG. 14B shows an end view of the second spring shown in
FIG. 14A;
[0071] FIG. 15A shows a side view of the third spring shown in FIG.
1;
[0072] FIG. 15B shows an end view of the third spring shown in FIG.
15A;
[0073] FIG. 16A shows a top cross-section view of the front cap of
the lancet device shown in FIG. 1;
[0074] FIG. 16B shows a side cross-section view of the front cap of
the lancet device shown in FIG. 1;
[0075] FIG. 16C shows a side view of the front cap of the lancet
device shown in FIG. 16C;
[0076] FIG. 16D shows a top view of the front cap shown in FIG.
16A;
[0077] FIG. 16E shows a front end view of the front cap shown in
FIG. 16C;
[0078] FIG. 17A shows a front end view of the trigger element of
the lancet device shown in FIG. 1;
[0079] FIG. 17B shows a top view of the trigger element shown in
FIG. 17A;
[0080] FIG. 17C shows a rear view of the trigger element shown in
FIG. 17B;
[0081] FIG. 17D shows a side view of the trigger element shown in
FIG. 17B;
[0082] FIG. 17E shows a bottom view of the trigger element shown in
FIG. 17B;
[0083] FIG. 17F shows a partial enlarged view of a front part of
the trigger element shown in FIG. 17D;
[0084] FIG. 17G shows a partial enlarged view of the textured part
of the trigger element shown in FIG. 17B;
[0085] FIG. 18A shows a top view of the back cover shown in FIG.
1;
[0086] FIG. 18B shows a rear view of the back cap shown in FIG.
18A;
[0087] FIG. 18C shows a side view of the back cap shown in FIG.
18A;
[0088] FIG. 18D shows a cross-section view of the back cap shown in
FIG. 18A;
[0089] FIG. 18E shows a cross-section view of the back cap shown in
FIG. 18C;
[0090] FIG. 19A shows a cross-section view of the inner sleeve
member of the lancet device shown in FIG. 1;
[0091] FIG. 19B shows a rear view of the inner sleeve member shown
in FIG. 19A; and
[0092] FIG. 19C shows a top cross-section view of the inner sleeve
member shown in FIG. 19A.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
[0093] 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.
[0094] FIG. 1 shows a side cross-section view of one embodiment of
lancet device (the lancet 10 is also shown in cross-section).
Lancet device LD has a lancet body made up of a right side body
portion 100 and a left side body portion 110 (see FIG. 4). These
parts 100 and 110 are connected, e.g., using adhesives and/or
fasteners and/or welding and/or snap-together holding mechanisms
(not shown) to each other when the lancet device LD is initially
assembled. A holding member 30/40 is movably disposed within the
body parts 100, 110. Also, a front cover 20 is removably connected
or attached to a front portion of the body parts 100, 110. By
removing the front cover 20, one can gain access to the lancet 10.
The lancet 10 can thus be removed and replaced with a new lancet
10, as needed, once the front cover 20 is removed. As in many prior
art lancet devices, the lancet device defines a plane P which is
configured to contact (i.e., be positioned against) a user's skin.
However, unlike known lancet devices, the instant embodiment may
utilize an inwardly curved surface plane P beyond which the lancet
need can extend. Next, a back cap 80 is arranged at a rear portion
of the body parts 100, 110. The back cap 80 has a rear portion that
can be gripped by a user and a front portion that slides within the
body parts 100, 110. An inner sleeve 70 is connected (after being
slid into the back cap 80) to the back cap 80 upon assembly of the
lancet device. As will be described in more detail later on,
movement of the back cap 80 rearwardly (see FIG. 5), causes the
holding member 30/40 to retract until it reaches the loaded
position shown in FIG. 1. The lancet 10, itself, is conventional
and includes a needle. It can be removed and replaced with a new
one, as is the case in many prior art lancet devices. To ensure
that lancet 10 is securely (yet removably) retained within the
lancet device, the front portion 30 of the holding member 30/40
includes a lancet holding end which receives the lancet 10
therein.
[0095] As can be seen in FIG. 1, the holding member 30/40
arrangement preferably has three springs mounted thereto. In this
regard, a first spring S1, which can be made of spring steel, is
arranged within the holding member 30/40, just behind the lancet
receiving portion. Preferably, the first spring S1 has a diameter
of approximately 6.2 mm, a freelength of approximately 36.7 mm, and
a wire size of 0.5 mm. This spring S1 causes (and/or biases) the
holding member 30/40 to move towards an extended position once a
trigger 50 is activated (see FIG. 2). The trigger 50 includes a
portion that is arranged within the body parts 100/110, and is
mounted to these body parts 100, 110. The trigger 50 also has a
finger engaging (e.g. push button) portion 50a that can be pushed
and/or deflected into the lancet device. The trigger 50 functions
as a spring in that it is capable of deflecting inwards (see FIG.
2) when force is applied to the finger engaging portion 50a, and is
also capable of returning to a pre-deflection position (see FIGS. 1
and 3). A second spring S2, which can be made of spring steel, is
also arranged within the holding member 30/40 arrangement, but
behind the first spring S1. Preferably, the second spring S2 has a
diameter of approximately 6.2 mm, a freelength of approximately
25.5 mm, and a wire size of 0.5 mm. This spring S2 causes (and/or
biases) the holding member 30/40 arrangement to move back towards a
retracted position once the lancet 10 reaches the extended
position. In this way, the lancet 10 (and holding member 30/40) is
automatically retracted after puncturing the skin of a user. A
third spring S3, which can also be made of spring steel, is
externally mounted to a rear portion 40 of the holding member
arrangement 30/40. Preferably, the third spring S3 has a diameter
of approximately 10.1 mm, a freelength of approximately 13.6 mm,
and a wire size of 0.25 mm. This spring S3 causes (and/or biases)
the back cap 80 (and attached inner sleeve 70) to move inwardly
within body parts 100, 110. When a user wishes to place the lancet
device LD in the loaded position (see FIG. 1), a user need only
move back cap 80 rearwardly (see FIG. 5) until the holding member
arrangement 30/40 reaches the position shown in FIG. 1. This, in
turn, compresses the third spring S3 to a certain extent. However,
when the user releases the back cap 80, spring S3 causes the back
cap 80 to return to the position shown in FIGS. 1-4.
[0096] The lancet device LD also utilizes a cam wheel 60 to adjust
the penetration depth of the lancet needle. The cam wheel 60 is
preferably mounted within both body parts 100, 110 so as to be at
least partially rotatable in each of two directions. Of course, the
cam wheel 60 can be mounted within the body in any desired manner
provided it functions properly in the intended manner. To ensure
that the cam wheel 60 is axially retained to body parts 100, 110,
yet allowed to rotate with respect to the lancet device body,
retaining walls 100h, 100i, 110h and 110i are utilized. These will
be more fully described with regard to FIGS. 7 and 8. The cam wheel
60 also has a plurality of cam surfaces 60e1-60e8 (see FIG. 11E)
which are configured to be engaged by a stop projection 40i (in
particular stop surface 40i1 of stop projection 40i) that is formed
on or coupled to the rear portion 40 of holding member 30/40.
Finally, the lancet device LD also utilizes an end plug 90 that
ensures that the spring S2 is retained within the holding member
30/40.
[0097] As described above, FIG. 1 shows the lancet device LD with
the lancet member 30/40 in the loaded position, i.e., ready to move
to an extended position when the trigger 50 is pressed. The holding
member 30/40 retains the loaded position of FIG. 1 as a result of
engagement between a deflecting member 30c and shoulders that are
formed by projections 100g and 110g of the body parts 100, 110. On
the other hand, FIG. 2 shows what happens when the trigger 50 is
pressed, i.e., the trigger 50 is caused to be deflected inwardly.
That is, the holding member 30/40 is released from the loaded
position of FIG. 1, and is caused to move towards plane P. This
occurs because the trigger 50 causes the deflecting member 30c to
disengage from the projections 100g/110g of the body parts 100/110.
As discussed above, this movement is caused by the expansion (in
the direction of the axis of the holding member 30/40) of first
spring S1. The holding member 30/40 continues to move towards the
plane P until the stop projection 40i contacts or engages one of
the stop surfaces 60e1-60e8 of the cam wheel 60. Once the trigger
50 is released (once a user stops pressing on the trigger 50), the
trigger 50 preferably moves back (e.g., automatically) to an
un-deflected state shown in FIG. 3. The lancet device LD is then
ready to be reloaded, i.e., it can then be placed back into the
position shown in FIG. 1.
[0098] FIG. 3 shows the lancet device LD with the holding member
30/40 in one of the pre-set extended positions, i.e., in one of the
extended positions that will cause a desired puncture depth in the
skin of a user (not shown). The distance that the lancet needle
projects past plane P is thus determined by rotating the cam wheel
60 until the desired setting is reached. This setting, in turn,
causes a particular stop surface (i.e., one of surfaces 60e1-60e8)
to be placed in the path of the stop projection 40i. The various
stop surfaces (e.g., 8 surfaces shown in FIG. 11E) of the cam wheel
60 thus determine how much the holding member 30/40 will move in
the extended position relative to the plane P. The depth setting is
thus controlled by contact between the stop projection 40i and one
of the surfaces 60e1-60e8 of the cam wheel 60 (see FIG. 4). FIG. 3
also shows the needle tip projecting through the opening LO in the
front cover 20 and past the plane P. And, as discussed above, the
trigger 50 has returned to a non-deflected original position.
[0099] FIG. 4 shows a top cross-section view of the lancet device
of FIG. 1. In this regard, the holding member 30/40 is in the
position shown in FIG. 3. As in FIGS. 1-3, the front cover 20, back
cap 80, inner sleeve 70, end plug 90, holding member 30/40 and
lancet 10 can be seen in their installed and/or assembled position.
However, this FIGURE allows one to more clearly see that the first
spring S1 is arranged within the holding member 30/40, just behind
the lancet receiving portion. The first spring S1 is preferably
sized to slide into internal openings 30f and 40l of the holding
member 30/40. More particularly, the first spring S1 is preferably
disposed inside the holding member 30/40 and between an inner wall
30g (just behind lancet 10) of the front part 30 of the holding
member 30/40 and a projecting guide member 100m/110m of the right
and left body parts 100, 110. That is, the first spring S1 is
axially retained between a left side surface of projecting guide
member 100m/110m and the inner wall 30g of the front portion 30 of
the holding member 30/40. As a result, the first spring S1 is
caused to be compressed when the holding member 30/40 is moved back
(i.e., to the right) to a retracted position relative to the body
parts 100, 110. The projecting guide member 100m/110m does not move
because it is fixed to the body portions 100 and 110. Of course,
the projecting guide member 100m/110m can be arranged and/or
mounted within the body in any desired manner provided it functions
for its intended purpose. It can even be formed only on one of the
body parts 100, 110. As discussed above, the first spring S1 causes
(and/or biases) the holding member 30/40 towards an extended
position once a trigger 50 (not shown in FIG. 4) is activated. As a
result, the holding member 30/40 cannot be moved back to a
retracted position without causing the first spring S1 to be
compressed thereby.
[0100] The second spring S2 is also preferably sized to slide into
an internal opening 40l of the holding member 30/40. More
particularly, the second spring S2 is disposed inside the holding
member 30/40 and between an inner wall 90b of the end plug 90 and
the projecting guide member 100m/110m of the body parts 100, 110.
That is, the second spring S2 is axially retained between a right
side surface of projecting guide member 100m/110m and the inner
wall 90b of the end plug 90. The second spring S2 is caused to be
compressed when the holding member 30/40 is moved forward (i.e., to
the left) to an extended position relative to the body parts 100,
110. Again, the projecting guide member 100m/110m does not move
because it is fixed to the body portions 100, 110. As discussed
above, the second spring S2 causes (and/or biases) the holding
member 30/40 towards a retracted position once the holding member
30/40 reaches the various pre-set extended positions (see e.g.,
FIG. 3). Thus, the second spring S2 is compressed when the holding
member 30/40 is extended by the first spring S1. Spring S2 then
expands axially to retract the holding member 30/40. In this way,
the lancet needle only momentarily projects past the plane P in the
extended position before it is caused to retract back in the lancet
device by the second spring S2. As a result, the lancet needle only
projects past or beyond the plane P for a very brief time (i.e., a
fraction of a second when the trigger 50 is pressed) and is
otherwise not exposed to a user while the front cover 20 is
installed thereon. Accordingly, a user or other innocent bystanders
can be protected from being injured unintentionally by an exposed
needle.
[0101] The third spring S3 is preferably sized to slide over a rear
end of the rear portion 40 of the holding member 30/40. More
particularly, the third spring S3 is disposed over a rear end of
the rear portion 40 and between an inner wall 70d of the inner
sleeve 70 and an annular shoulder 40e of the rear portion 40. That
is, the third spring S3 is axially retained between a left side
inner surface 70d of the inner sleeve 70 and the annular shoulder
40e. As a result, the third spring S3 is caused to be compressed
when the back cap 80 is moved rearward (i.e., to the right as in
FIG. 5) to an extended position relative to the body parts 100,
110. As discussed above, the third spring S3 causes (and/or biases)
the back cap 80 towards a retracted position (i.e., sliding back
into the lancet device) once a user releases the back cap 80
(compare FIG. 5 to FIG. 1). Thus, the third spring S3 is compressed
when the back cap 80 is pulled backwards (to the right in FIG. 5)
to cause the deflecting member 30c to seat onto the projections
100g/110g (adjacent the trigger 50) of the body parts 100, 110. The
third spring S3 then expands axially to cause the back cap 80 to
move to the left until shoulders 80c of the back cap 80 contact end
edges 100b, 110b of the body parts 100, 110. However, the spring S3
does not compress completely when the back cap 80 is extended
(moved to the right). This is because the left side inner surface
70d of inner sleeve 70 contacts surfaces 40j1 and 40k1 two
oppositely arranged projections 40j and 40k of the rear portion 40
of the holding member 30/40.
[0102] FIG. 5 shows another cross-section side view of the lancet
device LD shown in FIG. 1. In FIG. 5, the back cap 80 is shown in
the extended position. As described above, this movement is used to
retract the holding member 30/40 until the deflecting member 30c
engages the projections 100g/110g of the body parts 100, 110. At
this point, the user need only release the back cap 80 so that the
third spring S3 will automatically cause the back cap 80 to move or
retract towards the lancet device until it assumes the position
shown in FIG. 1. As can be seen when comparing FIGS. 2 and 5, the
first spring S1 becomes compressed axially when the back cap 80
causes the holding member 30/40 to move to a retracted position (to
the right). As a result, the second spring S2 expands axially
(compare FIGS. 2 and 5), while the third spring S3 compresses
axially (see FIG. 5). However, once the back cap 80 is released,
the third spring S3 expands axially--which causes the back cap 80
(and the attached inner sleeve 70) to retract back into the lancet
device (see FIG. 1).
[0103] FIGS. 6A-F show right side, top, left, front and rear views
of the lancet device LD shown in FIGS. 1-5. As discussed above, the
lancet device has a lancet body made up of a right body portion 100
and a left body portion 110. These parts 100 and 110 are connected
to each other when the lancet device is initially assembled. In
this regard, a seam line SL is preferably formed and/or provided
between the edges 100a/110a and 100b/110b of the body parts 100,
110. The front cover 20 is preferably removably connected or
attached to a front portion of the body parts 100, 110. As is shown
in FIGS. 6B and 6E, the curved surface plane P has a lancet opening
LO through which the lancet needle passes. The back cap 80 is
arranged at a rear portion of the body parts 100, 110. The back cap
80 preferably has a rear portion with textured portions 80q and 80n
(i.e., on each side of the back cap 80). These textured portions
allow a user to more easily grip the back cap 80. As discussed
above, movement of back cap 80 rearwardly (as in FIG. 5) causes the
holding member 30/40 to retract until it reaches the loaded
position shown in FIG. 1.
[0104] Again, with reference to FIGS. 6A-F, the trigger 50
preferably has a tear-drop shaped button 50a which can be pressed
by a user to cause the lancet 10 to move to the extended position.
The cam wheel 60 can be seen to project partially from a recessed
portion 110n of the left body part 110. In this regard, the recess
110n preferably has an inwardly curved surface whose radius is
greater than a radius of the cam wheel 60. In order to allow the
user to see which cam surface (one of surfaces 60e1-60e8) is
arranged in the path of the stop projection 40i (i.e., to adjust
the desired depth setting) the left body part 110 has a window W
(e.g., a through opening or slot 110p) through which one can read
the indicia (e.g., numbers or other desired indicia such as letters
or marks) of the cam wheel 60. As should be evident, the lancet
device LD is configured with curved surfaces 100q, 110q and an
ergonomic shape to enable a user to grip the device more securely,
while also being able to rotate the cam wheel 60 with one or more
fingers of the same hand. Unlike the devices of the prior art, one
can adjust the depth of penetration without using both hands. Of
course, some users may require two hands to place the lancet device
in the loaded position, since they may not be able to pull the back
cap 80 backwards without using both hands.
[0105] To ensure that there is a smooth transition between the
various parts of the lancet device, certain edges are preferably
made to have a curved and/or profiled arrangement. Thus, the front
cover 20 has circular or curved upper and lower edges 20b (see also
FIG. 16) and complex profile side edges 20a. Similarly, the right
and left body parts 100, 110 have top, side and bottom edges which
are shaped to correspond to the circular or curved upper side and
lower edges of the front cover 20. The back cap 80 has straight
upper, lower and side shoulder edges 80c (see also FIG. 18).
Similarly, the right and left body parts 100, 110 preferably have
rear top, bottom and side straight edges 100b/110b which are shaped
to correspond to the straight shoulder edges 80c of the back cap
80. Additionally, the external surfaces of both the back cap 80 and
the front cover 20 have a shape, arrangement and/or configuration
which continues the curved and/or tapered external surfaces of the
right and left body parts 100, 110.
[0106] FIGS. 7A-H show various views of the right body part 100.
The right body part 100 can preferably be made as one-piece
structure by e.g., injection molding. In this regard, it is
preferably made of a plastic or synthetic resin such as, e.g., ABS
plastic. The body part 100 may also be made of ABS--Metallic Silver
and have a finish designated as SPI-A2. Additionally, the body part
100 may have an overall length that is approximately 3.04" (i.e.,
between edges 100a and 100b). This will ensure that the assembled
lancet device can have an overall length of approximately 4.1". Of
course, other materials and/or finishes may be utilized, without
leaving the scope of the invention. Moreover, the body part 100 may
even be made of a plurality of sections of parts which are joined
together to form the complete body part 100, without leaving the
scope of the invention.
[0107] The right body part 100 preferably has a curved front edge
100a and curved sides 100a1. The radius of this edge 100a may be
approximately 0.38". As will be described later on with regard to
FIG. 16, the front edge 100a is configured to abut curved edges
20a. Moreover, curved side edges 100a1 of body part 100 similarly
abuts curved edges 20b of front cap 20. Recesses or indentations
100a2 are disposed between front edge 100a and a projecting
shoulder or wall 100a3. The recesses 100a2 are arranged or
configured to receive within it or otherwise engage with a
projection 20c (see FIG. 16C) of front cap 20. In this regard, the
projections 20c similarly have rounded portions that corresponds to
the rounded bottom of recesses 100a2. Of course, the recess 100a2
may be continuous, or it need not extend continuous from side 100c
to side 100d. It can instead be formed as intermitted recesses or
it may have the form of a single short recess that is arranged only
on inner surfaces of sides 100c and 100d. Alternatively, the body
part 100 can have the projection while the front cap 20 has the
recess. Of course, other connecting mechanisms, whether
conventional or otherwise, may also be utilized in place of the
projection and recess connection.
[0108] The body part 100 also has a curved upper surface US. This
surface US extends from front edge 100a to rear edge 100b, and may
have a radius of approximately 30" (or may be essentially
straight). Arranged within the curved side 100c is a tear-drop
shaped through opening 100f (note that the full opening is defined
by partial opening 100f and partial opening 110f when the two body
parts are connected). This partial opening 100f is sized and
configured to receive the push button portion 50a of the trigger 50
(see FIG. 17). Of course, the opening 100f can have any desired
size, shape or configuration provided it allows a user access to
the trigger 50 and/or provided that it generally corresponds to the
size, shape and configuration of the trigger 50. The opening 100f
is formed in the upper wall 100c near an inwardly projecting
shoulder 100g. As was described previously, this shoulder 100g is
sized, shaped and/or configured to be engaged by the deflecting
member 30c (see FIG. 9). In this regard, the projection 100g has a
straight contact surface that is generally parallel to edge 100b
and a bottom surface or edge that can range from being generally
perpendicular to edge 100b, to being tapered or angled by as much
as 15 degrees or more. As will be described later on with regard to
FIG. 9, the straight contact surface of projection shoulder 100g is
configured to be engaged by surface 30c1 of deflecting member
30c.
[0109] The upper body part 100 additionally preferably includes two
plate-like projections or walls 100h and 100i which connect sides
100c and 100d to side 100e. The purpose of these projections 100h
and 100i is to axially retain cam wheel 60. These projections 100h
and 100i have inwardly curved edges 100h1 and 100i1. In this
regard, the projections 100h and 100i are spaced apart by a
distance that is slightly greater than a width "w1"of cam wheel 60
(see FIG. 11B). By ensuring that the projections 100h and 100i are
spaced apart by an amount that is greater than a width "w1" of the
cam wheel 60, the cam wheel 60 will be allowed to rotate with ease.
In this regard, the width "w1" between inner surfaces of
projections 100h and 100i should be slightly greater than
approximately 0.16" to accommodate width w1 of cam wheel 60 being
approximately 0.16". A C-shaped projection 100j (similar to
projection 110j of FIG. 8D) also extends inwardly from the wall
100c (similar to wall 110c) of the body part 100 (similar to body
part 110). The projection 100j forms a right half portion of a
bearing system for the trigger 50. Together with the projection
110j (see FIG. 8), the parts 100j and 110j form two circular
bearing supports for the trigger 50. As will be described later on
with regard to FIG. 17, the journal elements 50c of the trigger 50
are mounted to the bearing supports 100j/110j. The body part 100
also preferably includes a connecting rib 100k that provides
strength to the body part 100 and serves to guide holding member
30/40. In order to allow the holding member 30/40 move freely
within the lancet device and without being obstructed by the rib
100k, a circular or curved recess 100k1 (see FIG. 7D) is formed in
the center of the rib 100k. This recess 100k1 of the rib 100k can
have a radius of approximately 0.17".
[0110] The right body part 100 further preferably includes a curved
indentation 1001 disposed on side 100d. The radius of indentation
1001 can be approximately 1.76". A main projection 100m extends
inwardly from body portion 100. The projection 100m has an internal
opening and polygonal outer shape (i.e., square). The purpose of
this projection is to guide the holding member 30/40 and to prevent
it from rotating when it moves axially. It this regard, the
projection 100m (together with projection 110m) is sized to fit
within slot 40f of the rear portion of holding member 30/40. A pawl
member 100p extends inwardly from body part 100. The pawl member
100p has a rounded projecting portion that engages a ratchet
surface, i.e., undulating surfaces 60b1 (notches) and 60b2
(projections), of the cam wheel 60. The pawl 100p deflects towards
and away from cam wheel 60 as the cam wheel 60 rotates. In this
way, the cam wheel 60 is locked and/or temporarily retained at a
desired set-depth position. The interaction between pawl 100p and
cam wheel 60 can produce a sound such as, e.g., clicking, when the
cam wheel 60 is rotated. In order to accommodate the cam wheel 60,
the body part 100 includes an outward projecting portion 100n. The
body part 100 also includes an inwardly curved finger engaging
section 100q which may have a radius of approximately
0.82.degree..
[0111] As seen in FIG. 7C, the sides 100c and 100d can be planar or
slightly curved outwardly (i.e., convex). The sides 100c and 100d
can also preferably be curved or tapered outwardly in the width
direction (i.e., see FIGS. 7G and H) and may be angled at an angle
"a" of approximately 7 degrees (see FIG. 7F). The corners 100s
where the side walls 100c and 100d meet wall 100e can be rounded
and have a radius of approximately 0.1". The rear edge 100b of the
body part 100 is a continuous straight edge that is configured to
make contact with shoulder 80c of back cap 80 (see FIG. 18).
[0112] FIGS. 8A-I show various views of the left body part 110. The
body part 110 can preferably be made as one-piece structure by
e.g., injection molding. In this regard, it is preferably made of a
plastic or synthetic resin such as, e.g., ABS plastic. The body
part 110 may also have be made of ABS--Metallic Silver and have a
finish designated as SPI-A2. Additionally, the body part 110 may
have an overall length that is approximately 3.04" (i.e., between
edges 110a and 110b). This will ensure that the assembled lancet
device can have an overall length of approximately 4.1". Of course,
other materials and/or finishes may be utilized, without leaving
the scope of the invention. Moreover, the body part 110 may even be
made of a plurality of sections of parts which are joined together
to form the complete body part 110, without leaving the scope of
the invention.
[0113] The body part 110 preferably has a front curved edge 110a
and includes circular and/or curved side edges 110a1. The radius of
curved edge 110a may be approximately 0.38". As will be described
later on with regard to FIG. 16, the front edge 110a is configured
to abut a curved edge 20a of front cap 20 until contact occurs
between circular and/or curved edge 20a and edge 110a. A recess
110a2 is disposed between front edge 110a and connecting wall
110a3. This recess 110a2 is arranged on each of sides 110c, 110d,
and possibly on side 110e. Moreover, they have a rounded bottom
that is configured to receive or otherwise engage projections 20c
(see FIG. 16C). In this regard, the projections 20c similarly has a
rounded edge that generally corresponds to the rounded bottom of
recesses 110a2. Of course, the recess 110a2 can be either a partial
recess or a continuous one, i.e., it can extend continuously from
side 110c to side 110d. Alternatively, it can instead be formed as
intermitted recesses or it may have the form of a single short
recess that is centrally arranged with respect to walls 110c and
100c and walls 100d and 110d (when the body parts 100 and 110 are
assembled together). As another alternative, the body part 110 can
have the projection while the front cap 20 has the recess. Of
course, other connecting mechanisms, whether conventional or
otherwise, may also be utilized in place of the projection and
recess connection.
[0114] The body part 110 also preferably has a curved lower surface
LS. An inwardly curved surface 110l is also provided which may have
a radius of approximately 1.76". The lower body part 110
additionally preferably includes two plate-like projections or
walls 110h and 110i which are generally arranged to connect sides
110c and 110d. The purpose of these projections 110h and 110i is to
axially retain the cam wheel 60 in the same way described above
with regard to walls 100h and 100i. In this regard, the projections
110h and 110i are spaced apart a distance similar to projections
100h and 100i described with respect to FIG. 7. These projections
110h and 110i also similarly have inwardly curved recesses of
different sizes which allow portions of the cam wheel 60 to axially
project therethrough (see e.g., FIG. 1). As can be seen in FIG. 1,
walls 100h and 110h are generally aligned with one another and have
inwardly curved recesses that serve as a bearing for surface 60c.
Similarly, walls 100i and 110i are generally aligned with one
another and have inwardly curved recesses that serve as a bearing
for surface 60i. A C-shaped projection 110j extends from wall 110c
of the body part 110 in the same way as projection 100j of body
part 100 (but oppositely arranged therefrom). This projection 110j
forms the other half of a bearing system for the trigger 50.
Together with the projection 100j (see FIG. 7), i.e., right half of
the bearing system, the parts 100j and 110j form two circular
bearing supports for the trigger 50. As will be described later on
with regard to FIG. 17, the journal elements 50c of the trigger 50
are mounted to or within the bearing supports formed by parts
100j/110j. The body part 110 additionally includes connecting ribs
110a3 and 110k that provides strength to the body part 110 and act
to axially guide the holding member 30/40. In order to allow the
holding member 30 move freely within the lancet device LD and
without being obstructed by the ribs 110a3 and 110k, circular or
curved recesses (see FIGS. 8D, 8E and 8G) are formed in the center
of the ribs 110a3 and 110k. These recesses of the ribs 110a3 and
110k can have a radius of approximately 0.17".
[0115] The body part 110 further preferably includes a polygonal or
square shaped main projection 110m that is generally centrally
disposed relative to sides 110c and 110d. The purpose of this
projection 110m is to axially and/or non-rotatably guide the
holding member 30/40 within the lancet device and to serve as stop
surfaces for springs S1 and S2 (see e.g., FIG. 1). The projection
110m has a polygonal (i.e., four sided or square) shaped outer
surface. A left side surface of the projection 110m serves a
contact or engage right end of spring S1 (see e.g., FIG. 1). A
right side surface of the projection 110m serves a contact or
engage left end of spring S2 (see e.g., FIG. 1). The projection
110m also has an inner recess or blind opening. This opening is
mainly for ease of manufacture and to reduce material costs. As can
be seen from FIG. 4, the length of the projection 110m is sized to
abut projection 100m of body part 100 when body parts 100 and 110
are assembled together. Of course, there may be some clearance
between projections 100m and 110m when the body parts 100 and 110
are assembled together. However, each projection 100m and 110m
should be of sufficient length so as to project at least partially
into the slot 40f of the back portion 40 of holding member
30/40.
[0116] The body part 110 also preferably includes circular or
curved indented side portions 110q and 110n. Recess 110q may have a
radius of approximately 0.82". Recess 110n may have a radius that
is greater than approximately 1". As described previously, recessed
portion 110n allows a user to access the cam wheel 60. That way,
the user can use a finger to rotate the cam wheel 60 from side
110e. As seen in FIG. 8I, the sides 110c and 110d can be angled
with an angle "a" of approximately 7 degrees. The sides 110c and
110d can also have outer surfaces US and LS which are curved
outwardly in the length direction (i.e., see FIG. 8A) and have a
radius of approximately 30" and 55" respectively. The corners 110s
where the side walls 110c and 110d meet wall 110e can be rounded
and have a radius of approximately 0.1". The rear edge 110b of the
body part 110 is preferably a continuous straight edge that is
configured to make contact with shoulder 80c of back cap 80 (see
FIG. 18).
[0117] As discussed above, surface 110c extends from front edge
110a to rear edge 110b, and may have a radius of approximately 30".
Alternatively, it may be essentially straight. Arranged within the
curved side 110c is a tear-drop shaped through opening 110f (note
that the full opening is defined by partial opening 100f and
partial opening 110f when the two body parts are connected). This
opening 110f is sized and configured to receive the push button
portion 50a of the trigger 50 (see FIG. 17). Of course, the opening
110f can have any desired size, shape or configuration provided it
allows a user access to the trigger 50 and provided that it
generally corresponds to the size, shape and configuration of the
trigger 50. The opening 110f is formed in the upper wall 110c near
an inwardly projecting shoulder 110g. As was described previously,
this shoulder 110g (as with shoulder 100g) is sized, shaped and/or
configured to be engaged by the deflecting member 30c (see FIG. 9).
In this regard, the projection 110g has a straight contact surface
that is generally parallel to edge 110b and a bottom surface or
edge that can range from being generally perpendicular to edge 110b
to being tapered or angled by as much as 15 degrees or more. As
will be described later on with regard to FIG. 9, the straight
contact surface of projection shoulder 110g is configured to be
engaged by surface 30c1 of deflecting member 30c.
[0118] FIGS. 9A-D show various views of the front portion 30 of the
two-piece holding member 30/40. The front portion 30 can preferably
be made as one-piece structure by e.g., injection molding. In this
regard, it is preferably made of a plastic or synthetic resin such
as, e.g., Delrin plastic. The front portion 30 may also be made of
Delrin--Natural and have a finish designated as SPI-C1.
Additionally, the front portion 30 may have an overall length that
is approximately 1.6" (i.e., between edges 30a and 30b). Of course,
other materials and/or finishes may be utilized, without leaving
the scope of the invention. Moreover, the front portion 30 may even
be made of a plurality of sections of parts which are joined
together to form the complete front portion 30, without leaving the
scope of the invention.
[0119] Front portion 30 preferably has a front end 30a and a
cylindrical section 30d which may have a diameter of approximately
0.32". A front opening 30e is arranged within the cylindrical
section 30d. The opening 30e extends from a wall 30g to edge 30a.
The diameter "d" of the opening 30e at the edge 30a may be
approximately 0.26" and may taper slightly inwards, e.g., by
approximately 0.25 degrees (per side), i.e., towards wall 30g. This
tapered opening 30e is sized and configured to securely and/or
snugly retain and receive the lancet 10 (see e.g., FIG. 1) which
may be a conventional lancet. Axial slot 30h and circumferential
slot 30m allow walls of the opening 30e to expand and contract with
removal and replacement of the lancet 10. The front portion 30 of
holding member 30/40 also includes another cylindrical section 30i
which may have a diameter of approximately 0.46". Another internal
opening 30f extends from shoulder 30l to a wall 30g. The opening
30f is sized and configured to receive spring S1 (see e.g., FIG.
1). The internal diameter of the opening 30f at the shoulder 30l
may be approximately 0.24" and may taper slightly, e.g., by
approximately 0.25 degrees (per side), towards wall 30g.
Cylindrical section 30i also has an internal opening 30j that
extends from edge 30b to shoulder 30l. The opening 30j is sized and
configured to receive end 40a of rear portion 40 of holding member
30/40 (see e.g., FIG. 1).
[0120] A deflecting member 30c preferably extends from cylindrical
section 30i. This deflecting member 30c has a stop surface 30c1
which is configured to abut shoulders 100a3 and 110a3 of the body
parts 100 and 110. An upper surface 30c2 of the deflecting member
30c, near end 30c1, is designed to be engaged by the trigger 50
(see FIG. 1). Specifically, this surface 30c2 is configured to be
engaged by projection 50e of the trigger 50. As explained above,
the deflecting member 30c is capable of deflecting inwards towards
the front portion 30 when it is forced inwards towards holding
member 30/40. However, because the deflecting member 30c acts like
a natural spring, the deflecting member 30c is capable of
deflecting away from the front portion 30 when it is not being
forced towards holding member 30/40. In this regard, the deflecting
member 30c is formed with an angle "a" of approximately 2 degrees
relative to cylindrical surface 30i. The end 30c1 of the deflecting
member 30c can be spaced from surface 30d by approximately 0.09".
In the area 30c2 where the deflecting member 30c is engaged by the
projection 50e of the trigger 50, the outer surface may be parallel
to cylindrical surface 30d. Thus, the distance "sp" can be about
0.09". The deflecting member 30c also has a width "w" (measured in
the direction of FIG. 9D) of approximately 0.1".
[0121] Inner diameter 30j of front portion 30 also preferably
includes a continuous rounded recess 30k which is sized and shaped
to receive the continuous rounded projection 40c of the rear
portion 40. In this way, the two parts 30 and 40 can be coupled
and/or assembled together. Of course, the projection can be formed
on the part 30 and the recess formed on part 40 without leaving the
scope of the invention. Moreover, the recess and projection need
not be made continuous and can instead be intermittently formed.
The invention also contemplates other connecting mechanisms besides
a projection/recess connection such as, e.g., an adhesive
attachment.
[0122] FIGS. 10A-C show the rear portion 40 of the two-piece
holding member 30/40. The length between end 40a and end 40b can be
approximately 1.72". As discussed above, front end of rear portion
40 has a projection 40c which engages recess 30k of the front
portion 30. A cylindrical section 40d extends from projection 40c
to circumferential shoulder 40e. The cylindrical section 40d may
have a diameter of approximately 0.32". Between the projection 40c
and end 40a, the outer surface may taper or curve inwards to
facilitate entry of end 40a into opening 30j. A through opening 40l
is arranged within the cylindrical section 40d. The opening 40l
extends from end 40a to end 40b. The diameter of the opening 40l
may be approximately 0.24" and, at the edge 40b, may be
approximately 0.244" and may taper slightly, e.g., by approximately
0.25 degrees (per side), towards end 40a. This tapered opening
section 40g is sized and configured to securely retain and receive
the plug 90 (see e.g., FIG. 1). The opening 40l is sized and
configured to receive springs S1 and S2 (see e.g., FIG. 1). A
recess 40h is arranged within opening 40g and is designed to
receive projection 90d of plug 90 (see FIG. 12). The rounded recess
40h may be continuous and may be sized and shaped to receive the
continuous rounded projection 90d of the plug 90. In this way, the
parts 40 and 90 can be coupled and/or assembled together. Of
course, the projection can be formed on the part 40 and the recess
formed on part 90 without leaving the scope of the invention.
Moreover, the recess and projection need not be made continuous and
can instead be intermittently formed. The invention also
contemplates other connecting mechanisms besides a
projection/recess connection such as, e.g., an adhesive
attachment.
[0123] End 40b of the rear part 40 also preferably includes three
projections 40l, 40j and 40k. Short projections 40j and 40k extend
in the direction of the axis of the rear portion 40 and are
arranged opposite one another, i.e., 180 degrees apart. These
projections 40j and 40k may have a length of approximately 0.21"
and a width of approximately 0.05". Short projections 40j and 40k
also have stop surfaces 40j1 and 40k1. These surfaces 40j1 and 40k1
are adapted to be engaged and/or contacted by surface 70d of the
inner sleeve 70 when the back cap 80 is moved backwards to load the
lancet device (see FIG. 5). Longer projection 40i includes a stop
shoulder or surface 40i1. As explained previously, the stop surface
40i1 engages and/or contacts the various cam surfaces 60e1-60e8 of
the cam wheel 60. Thus, the stop surface 40i1 serves to adjust the
depth of the lancet needle based upon the position of the cam wheel
60, as will be described later on. As will be explained more
clearly later on, the projection 40i is configured to slide within
a recess 70e of the inner sleeve 70 when the back cap 80 is moved
from the positions shown in FIGS. 1 and 5. An elongated through
slot 40f is arranged on the cylindrical section 40d. As discussed
above, this slot 40f is sized and configured to receive projections
100m and 110m of the body parts 100 and 110. In this regard, the
width of the slot 40f can be approximately 0.16" while the length
SL of the slot 40f can be approximately 0.74". The slot 40f also
has rounded ends whose radius SR can be approximately 0.08". The
diameter of shoulder 40e may be approximately 0.42".
[0124] As discussed above, continuous recess or indentation 40h is
sized and configured to receive a projection 90d of the end plug
90. In this regard, the recess 40h may have a radius of
approximately 0.007" and a depth of approximately 0.004". As can be
seen in FIG. 1, diameter 90c of the end plug 90 is configured to
slide into opening 40g of end 40b. Once the projection 90d engages
recess 40h, the end plug 90 is secured to the rear portion 40 of
holding member 30/40. As explained previously, surface 90b of the
end plug 90 serves to engage or contact one end of spring S2. The
end plug 90 is installed once springs S1 and S2 are arranged within
the openings 30f and 40l.
[0125] FIGS. 11A-E show various views of the cam wheel 60. The cam
wheel 60 can preferably be made as one-piece structure by e.g.,
injection molding. In this regard, it is preferably made of a
plastic or synthetic resin such as, e.g., ABS plastic. The cam
wheel 60 may also have be made of ABS--Dark Blue and have a finish
designated as MT-11040. Additionally, the cam wheel 60 may have an
overall diameter that is approximately 0.71". Of course, other
materials and/or finishes may be utilized, without leaving the
scope of the invention. Moreover, the cam wheel 60 may even be made
of a plurality of sections of parts which are joined together to
form the complete cam wheel 60, without leaving the scope of the
invention.
[0126] The cam wheel 60 preferably has an outer circumferential
surface 60e that includes indicia I which may be numbers, e.g.,
numbers 1-8, or letters. Of course, any desired indicia may be
utilized. This indicia I can be, e.g., pad printed or silk screen
raised numbers in white ink. The height of the indicia I can be
approximately 0.09". A centrally disposed opening 60j extends
through the cam disk 60. The opening 60j may have a diameter of
approximately 0.36". As explained previously, the opening 60j is
sized and configured to rotate around and/or about surface 40d.
Surface 40d also slides within opening 60j when holding member
30/40 moves within lancet device LD. The cam wheel 60 also includes
an enlarged diameter opening 60k that is defined by annular cam
surfaces 60e1-60e8 and annular shoulder 60a. The diameter of the
cylindrical surface 60c is sized to rotate (with a clearance)
within the circular bearing recess formed by projecting walls 100h
and 110h. The cam wheel 60 includes a plurality of cam surfaces
60e1-60e8 formed on a cam section 60e. As can be partially seen in
FIG. 11B, the cam surfaces 60e1-60e8 are all spaced from edge 60a
by different amounts. As was explained previously, these surfaces
60e1-8 are configured to be contacted by stop surface 40i1 of the
holding member 30/40. Thus, for example, when contact is made
between stop surface 40i1 and surface 60e1, the lancet needle will
penetrate to its deepest setting. On the other hand, when contact
is made between stop surface 40i1 and surface 60e8, the lancet
needle will penetrate to its shallowest setting. Of course,
surfaces 60e2-60e7 will set the penetrating depth in between these
extreme settings. Although, the cam wheel 60 is configured with
eight settings (designated by the number of cam surfaces and the
indicia), the cam wheel 60 can have any number of desired settings
that can range from two to as many as 20 or more, if desired. The
distance or width "w1" can be approximately 0.16" whereas the width
"w2" can be approximately 0.33".
[0127] A cylindrical recess 60i is formed between end 60b and
annular surface 60f. The recess surface 60i is sized to rotate
(with a clearance) within the circular bearing recess formed by
projecting walls 100i and 110i. The cam wheel 60 also includes a
plurality of angled and/o undulating surfaces 60b1 which form
pointed tips 60b2. As was explained previously, these surfaces 60b1
engage with projection or pawl 100p and served to temporarily
retain the cam wheel 60 in a desired set-depth position. A
plurality of raised textured portions 60h are arranged between the
indicia I. These allow the user to more easily grip the cam wheel
60 so as to cause its rotation. As was described with regard to
FIG. 8, the cam wheel 60 partially projects through slot 110p.
[0128] With reference to FIG. 11E, it can be seen that indicia
numbers 1-8 can be arranged to correspond to the annular cam
surfaces 60e1-60e8 based upon the position of projection 40i.
Although FIG. 11E shows one possible arrangement, it should be
noted that the cam surfaces 60e1-60e8 can be arranged in any
desired arrangement relative to the indicia and stop projection
40i, provided that the correct cam surface corresponds to the
desired indicia setting.
[0129] FIGS. 12A-C show various views of the end plug 90. The end
plug 90 can preferably be made as one-piece structure by e.g.,
injection molding. In this regard, it is preferably made of a
plastic or synthetic resin such as, e.g., Delrin plastic. The end
plug 90 may also be made of Delrin--Natural and have a finish
designated as SPI-C1. Additionally, the end plug 90 may have an
overall length L that is approximately 0.31" (i.e., between edges
90e and 90b). Of course, other materials and/or finishes may be
utilized, without leaving the scope of the invention. Moreover, the
end plug 90 may even be made of a plurality of sections of parts
which are joined together to form the complete end plug 90, without
leaving the scope of the invention.
[0130] The end plug 90 preferably has a rear planar wall 90e and a
front planar wall 90b. A shoulder 90f is arranged between surfaces
90e and 90b. The diameter of cylindrical surface 90a can be
approximately 0.42". The diameter of cylindrical surface 90c can be
sized to slide into opening 40g. A projection 90d extends from
surface 90c and is configured to engage recess 40h. The projection
90d may have a radius of 0.007" and may extend from surface 90f by
approximately 0.004". End 90b can also have a chamfer that extends
from surface 90c.
[0131] FIGS. 13A-B show various views of the plunger spring S1. The
spring S1 is preferably be made as one-piece structure. In this
regard, it is preferably made of 0.05 mm wire. The spring S1 may
also have be made of stainless steel 0.05 mm wire. Additionally,
the spring S1 may have an overall freelength of approximately 36.7
mm and an outer diameter of approximately 6.2 mm. In this way, the
spring S1 will be able to move freely within openings 30f and 40l.
Of course, other materials may be utilized, without leaving the
scope of the invention.
[0132] FIGS. 14A-B show various views of the return spring S2. The
spring S2 is preferably be made as one-piece structure. In this
regard, it is preferably made of 0.05 mm wire. The spring S2 may
also have be made of stainless steel 0.05 mm wire. Additionally,
the spring S2 may have an overall freelength of approximately 25.5
mm and an outer diameter of approximately 6.2 mm. In this way, the
spring S2 will be able to move freely within opening 40l. Of
course, other materials may be utilized, without leaving the scope
of the invention.
[0133] FIGS. 15A-B show various views of the cocking spring S3. The
spring S3 is preferably be made as one-piece structure. In this
regard, it is preferably made of 0.025 mm wire. The spring S3 may
also have be made of stainless steel 0.025 mm wire. Additionally,
the spring S3 may have an overall freelength of approximately 13.6
mm and an outer diameter of approximately 10.1 mm. In this way, the
spring S3 will be able to move freely over surface 40d and
projections 40i, 40j and 40k. Of course, other materials may be
utilized, without leaving the scope of the invention.
[0134] FIGS. 16A-E show various views of the front cover 20. The
front cover 20 can preferably be made as one-piece structure by
e.g., injection molding. In this regard, it is preferably made of a
plastic or synthetic resin such as, e.g., ABS plastic. The front
cover 20 may also be made of ABS--Light Blue and have a finish
designated as SPI-A2. Additionally, the front cover 20 may have an
overall length that is approximately {fraction (3/4)}" (i.e.,
between left end of projection 20c and end 20f). Of course, other
materials and/or finishes may be utilized, without leaving the
scope of the invention. Moreover, the front cover 20 may even be
made of a plurality of sections of parts which are joined together
to form the complete front cover 20, without leaving the scope of
the invention.
[0135] The front cover 20 preferably has a front wall 20f that
includes a circular and/or curved indentation 20d (i.e., defining
plane P) and a centrally disposed through opening 20e (i.e.,
defining lancet opening LO). The radius of this indentation 20d may
be approximately {fraction (3/8)}" and the diameter of the through
opening 20e may be approximately 0.13". Of course, the invention
also contemplates a plane P which is straight or which curves
outwardly (not shown). As was described previously, the left edges
20c are configured to slide into front edges 100a and 110a until
contact occurs between circular and/or curved edges 20b and edges
100a1 and 110a1. The projections 20c may have a radius of
approximately 0.02". As explained previously, these projections 20c
are configured to engage with the recesses 100a2 and 110a2 (see
FIGS. 7A and 8C).
[0136] Side walls 20g and 20h are preferably tapered inwardly from
edge 20a to surface 20d and may form rounded corners (e.g., with a
radius of approximately 0.1") where walls 20g and 20h meets wall
20d. Walls 20g and 20h can also be curved along their length (see
FIG. 16C), having a radius of approximately 30", and may also be
curved outwardly (i.e., convex, see FIG. 16C). Side walls 20g and
20h may further be formed of tapered surfaces which meet at a
center (see FIG. 16E). These surfaces may tapered outwards from a
center at an angle "a" of approximately 7 degrees. Rounded corners
20m (e.g., with a radius of approximately 0.1") are provided
between walls 20g-j. The width "w1" of the front cap 20 can be
approximately {fraction (1/2)}" while the height H1 can be
approximately 0.56" (see FIG. 16E). Walls 20g and 20h can also
include raised and/or textured surfaces 20k which allow a user to
more easily grip the front cap 20, thus facilitating its removal.
Similarly, walls 20i and 20j can also include raised and/or
textured surfaces 201 which allow a user to more easily grip the
front cap 20. The width "w2" of the front cap 20 can be
approximately 0.38" and can taper inwards by about 1 degree per
side towards end 20d.
[0137] FIGS. 17A-G show various views of the trigger 50. The
trigger 50 can preferably be made as one-piece structure by e.g.,
injection molding. In this regard, it is preferably made of a
plastic or synthetic resin such as, e.g., ABS plastic. The trigger
40 may also be made of ABS--Red and have a finish designated as
SPI-A2. Additionally, the trigger 50 may have an overall length
that is approximately 1.1". Of course, other materials and/or
finishes may be utilized, without leaving the scope of the
invention. Moreover, the trigger 50 may even be made of a plurality
of sections of parts which are joined together to form the complete
trigger 50, without leaving the scope of the invention.
[0138] The trigger 50 preferably has a rear end that includes a
rounded projection 50d. This rounded projection 50d is configured
to contact an inner surface of body parts 100 and 110 (see FIG. 1),
and serves to brace or counter the movement of the trigger 50 when
the trigger 50 is pressed into the lancet device (See FIG. 2). The
projection 50d may have a radius of approximately 0.03". The
trigger 50 also has front end 50b that includes a rounded
projection 50e. This rounded projection 50e is configured to
contact surface 30c2 of deflecting member 30c of the holding member
30/40 (see FIG. 9) upon movement of the trigger 50, when the
trigger 50 is pressed into the lancet device. The projection 50e
may have a radius of approximately 0.03". The trigger 50 also
includes a connecting member 50g which connects the push button 50a
to the support 50f. Two shaft members or journals 50c project from
opposite sides of the support 50f. The journals 50c may have a
diameter of approximately 0.06" and the width "w1" may be 0.36".
These journals 50c also have rounded ends whose radius can be
approximately 0.03". As explained previously, these journals 50c
are configured to be mounted in the bearing supports formed by
projections 100j and 110j. In this regard, the openings formed by
these projections 100j and 110j should be sized to be the same or
slightly larger than the diameter of journals 50c. In this way, the
journals 50c can fit snugly in the supports 100j/110j. The width
(measured in the direction of FIG. 17E) of the support 50f may be
approximately 0.1".
[0139] The push button 50a preferably has a tear-drop shape and
includes a inwardly curved (i.e., concave) surface that has a
radius of approximately 1.9". A lip member 50b projects from the
front of the push button 50a. This lip member 50b is approximately
0.06" wide and may extend from the push button 50a by approximately
0.04". The thickness T2 of the lip member 50b (measured in the
direction of FIG. 17F) can be approximately 0.02" and the distance
T1 can be approximately 0.04". Angle "x" can be approximately 5
degrees and angle "y" can be approximately 18 degrees. The lip
member 50b limits the upward movement of the push button 50a by
contacting an inner surface of the body parts 100 and 110 when the
trigger 50 is in the original non-deflected position (see e.g.,
FIG. 1). The push button 50a can have a width "w2" of approximately
0.25". The length L1 can be approximately 0.51" while the length L2
can be approximately 0.57". Finally, the curved surface 50a can
also include a texture (see FIG. 17G) formed of projections and
recesses to prevent a user's finger from slipping off of the button
50a.
[0140] As explained above with regard to FIG. 1, the trigger 50 is
designed to preferably deflect inwardly when a user pushes against
the push button 50a (see FIG. 2) and to return to an original
position (see FIG. 1 or 3). In this regard, the deflection occurs
in the area between journals 50c and connecting element 50g and/or
possibly somewhat between projection 50d and journals 50c. The
design is such that the material properties of the trigger 50
allows it to act like a natural spring.
[0141] FIGS. 18A-E show various views of the back cap 80. The back
cap 80 can preferably be made as one-piece structure by e.g.,
injection molding. In this regard, it is preferably made of a
plastic or synthetic resin such as, e.g., ABS plastic. The back cap
80 may also be made of ABS--Light Blue and have a finish designated
as SPI-A2. Additionally, the back cap 80 may have an overall length
L2 that is approximately 0.9" (i.e., between ends 80a and 80b). Of
course, other materials and/or finishes may be utilized, without
leaving the scope of the invention. Moreover, the back cap 80 may
even be made of a plurality of sections of parts which are joined
together to form the complete back cap 80, without leaving the
scope of the invention.
[0142] The back cap 80 preferably has a rear wall 80b that has a
planar outer surface and a planar inner surface 80d. The back cap
80 also has an opening 80e that extends from end 80a to surface
80d. This opening 80e is generally rectangular and has a width "w1"
of approximately 0.49" and a width "w2" of approximately 0.66".
This opening 80e extends from edge 80a and tapers inwardly towards
surface 80d at an angle of approximately 1 degrees (per side). The
width "w3" between outer surfaces 80i and 80h may be approximately
0.53" and may taper outwardly from edge 80a to shoulder 80c by
approximately 1 degree per side. The width "w4" between outer
surfaces 80f and 80g may be approximately 0.72" and may taper
outwardly from edge 80a to shoulder 80c by approximately 1 degree
per side. The length L1 from end 80b to shoulder 80c may be
approximately 0.49". The walls 80f-80i are configured to slide into
rear ends 100b and 110b until contact occurs between the shoulder
80c and edges 100b and 110b. As will be explained later on with
regard to FIG. 19, the back cap 80 and specifically opening 80e, is
configured to receive or otherwise engage with the inner sleeve 70.
Although not shown, a recess and projection connection may be
utilized between the sleeve 70 and back cap 80. Of course, other
connecting mechanisms, whether conventional or otherwise, may also
be utilized in place of the projection and recess connection such
as, e.g., a friction fit connection and/or adhesive attachment.
[0143] Side walls 80j, 80k, 80l and 80m may also taper and/or curve
from the top of shoulder 80c to surface 80b. The approximately
square shaped surface 80b may have a width "w5" of approximately
0.84 and a width "w6" of approximately 0.66". In this regard, walls
80j-80m may also have a radius of approximately 1.44" and may be
outwardly curved, i.e., concave. Walls 80l and 80m may also have
textured surfaces 80n and the walls 80j and 80k may have a textured
surface 80q. As can be seen in FIG. 18B, walls 80l and 80m may be
formed by tapered surfaces that meet at the center and which have
an angle "a" of approximately of 7 degrees.
[0144] FIGS. 19A-C show various views of the inner sleeve 70. The
inner sleeve 70 can preferably be made as one-piece structure by
e.g., injection molding. In this regard, it is preferably made of a
plastic or synthetic resin such as, e.g., ABS plastic. The inner
sleeve 70 may also be made of ABS--Light Blue and have a finish
designated as SPI-C1. Additionally, the inner sleeve 70 may have an
overall length L that is approximately 0.6" (i.e., between edges
70a and 70b). Of course, other materials and/or finishes may be
utilized, without leaving the scope of the invention. Moreover, the
inner sleeve 70 may even be made of a plurality of sections of
parts which are joined together to form the complete inner sleeve
70, without leaving the scope of the invention.
[0145] The inner sleeve 70 has a front wall 70a that has a planar
outer surface and a planar inner surface 70d. An opening 70c is
provided in the wall 70a. This opening 70c has a circular central
part and a generally polygonal recess 70e. Recess 70e is
approximately 0.05" wide. As was previously explained, the recess
70e is sized and configured to receive projection 40i. The inner
sleeve 70 is able slide over the rear portion 40 (from the front)
of the holding member 30/40 when the lancet device is
assembled.
[0146] Surfaces 70f-70i are preferably tapered to match the tapered
inner surfaces of opening 80e. In this way, when the sleeve 70 is
inserted into back cap 80, the shoulder 70j will abut edge 80a of
the back cap 80. The width "w1" can be approximately 0.42". The
width "w2" can be approximately 0.53". The width "w3" can be
approximately 0.65". Finally, the width "w4" can be approximately
0.72". The walls 70h and 70i can taper from walls 70f and 70g by an
angle "a" of approximately 7 degrees from a center position (see
FIG. 19B).
[0147] All the parts of the lancet device, with the exception of
the springs S1-S3 (which can be made of spring steel) and with the
exception of the lancet needle (which can be a conventional metal
needle mounted to a conventional plastic lancet 10), may be made
from plastic materials and can be formed using conventional
injection molding techniques or other known manufacturing methods.
The cam disk for example can be integrally formed with peripheral
grooves and/or projections (similar to a coin), and with the
indicating marks. However, when practical, other materials and
manufacturing processes may also be utilized.
[0148] 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.
* * * * *