U.S. patent application number 14/457977 was filed with the patent office on 2014-11-27 for lancet having adjustable penetration depth.
The applicant listed for this patent is STAT MEDICAL DEVICES, INC.. Invention is credited to Steven SCHRAGA.
Application Number | 20140350586 14/457977 |
Document ID | / |
Family ID | 29587527 |
Filed Date | 2014-11-27 |
United States Patent
Application |
20140350586 |
Kind Code |
A1 |
SCHRAGA; Steven |
November 27, 2014 |
LANCET HAVING ADJUSTABLE PENETRATION DEPTH
Abstract
Lancet device including a first housing. A first guide wall is
disposed within the first housing. The first guide wall includes an
opening. A cap removably mounted to the first housing. A needle
holding member for holding a lancet. At least a portion of the
needle holding member being able to move within the opening. A
first spring for biasing the needle holding member toward an
extended position. The first spring surrounding a portion of the
needle holding member and being disposed between the first guide
wall and a shoulder of the needle holding member. A movable trigger
having a first position and a second position. A movable second
housing including a proximal end, a distal end and a second guide
wall arranged at the proximal end. The second guide wall including
an opening. A portion of the needle holding member being able to
move within the opening of the second guide wall. The second
housing being configured to move the needle holding member to the
retracted position when the second housing is moved away from the
first housing. The proximal end of the second housing being
configured to move axially within the distal end of the first
housing. A second spring for biasing the second housing towards the
first housing. The second spring surrounding a portion of the
needle holding member and being disposed between the second guide
wall and another shoulder of the needle holding member. At least a
portion of the needle holding member is always retained within the
first housing.
Inventors: |
SCHRAGA; Steven; (Surfside,
FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
STAT MEDICAL DEVICES, INC. |
N. Miami Beach |
FL |
US |
|
|
Family ID: |
29587527 |
Appl. No.: |
14/457977 |
Filed: |
August 12, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13087957 |
Apr 15, 2011 |
8834503 |
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14457977 |
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|
11929164 |
Oct 30, 2007 |
7947057 |
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13087957 |
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|
10463535 |
Jun 18, 2003 |
7311718 |
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11929164 |
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09592680 |
Jun 12, 2000 |
7175641 |
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10463535 |
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09433366 |
Nov 3, 1999 |
6156051 |
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09592680 |
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09095902 |
Jun 11, 1998 |
6022366 |
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09433366 |
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Current U.S.
Class: |
606/182 |
Current CPC
Class: |
A61B 5/1513 20130101;
A61B 5/15132 20130101; A61B 5/1519 20130101; A61B 5/150503
20130101; A61B 5/150175 20130101; A61B 5/15019 20130101; A61B
5/150198 20130101; A61B 5/150351 20130101; A61B 5/15113 20130101;
A61B 5/15117 20130101; A61B 5/150412 20130101; Y10T 29/53657
20150115; A61B 5/150022 20130101 |
Class at
Publication: |
606/182 |
International
Class: |
A61B 5/15 20060101
A61B005/15; A61B 5/151 20060101 A61B005/151 |
Claims
1. A lancet device comprising: a main housing comprising a proximal
end and a distal end; a guide wall arranged in the main housing and
extending transverse to an axis running through the main housing;
the guide wall comprising an opening; a cap removably mounted to
the proximal end of the main housing; the cap having a proximal end
for engaging a skin surface; a movable needle holding member for
holding a lancet, the needle holding member being at least
partially contained within the main housing; at least a portion of
the needle holding member being able to move within the opening of
the guide wall; a first spring for biasing the needle holding
member toward an extended position; the first spring surrounding a
portion of the needle holding member; the first spring being
disposed between the guide wall and a shoulder of the needle
holding member; a movable trigger arranged on a side of the main
housing; the trigger being movable between a first position and a
second position, wherein when the trigger is moved to the second
position, the needle holding member is allowed to move from a
retracted position to an extended position; a distal housing
arranged at the distal end of the main housing; the distal housing
comprising a proximal end, a distal end and a guide wall arranged
at the proximal end of the distal housing; the distal housing being
configured to move the needle holding member to the retracted
position when the distal housing is moved away from the main
housing; the guide wall of the distal housing comprising an
opening; a portion of the needle holding member being able to move
within the opening of the guide wall of the distal housing; the
proximal end of the distal housing being configured to move axially
within the distal end of the main housing; a second spring that
biases the distal housing towards the main housing; and the second
spring surrounding a portion of the needle holding member and being
disposed between the guide wall of the distal housing and a distal
end of the needle holding member, wherein at least a portion of the
needle holding member is always retained within the first
housing.
2. The lancet device of claim 1, further comprising a lock retainer
mounted to the distal end of the needle holding member.
3. The lancet device of claim 1, wherein the main housing is one of
triangular, D-shaped, and polygonal.
4. The lancet device of claim 2, further comprising a distal
shoulder arranged at the distal end of the needle holding
member.
5. The lancet device of claim 4, wherein the needle holding member
comprises a mechanism that cooperates with the trigger to retain
the needle holding member in a retracted position.
6. The lancet device of claim 5, wherein the mechanism comprises a
shoulder.
7. The lancet device of claim 4, further comprising a fastening
mechanism for securing the cap to the main housing.
8. The lancet device of claim 4, wherein the proximal end of the
main housing is open and wherein the distal end of the main housing
is open.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation application of
U.S. application Ser. No. 13/087,957 filed on Apr. 15, 2011, which
is a continuation application of U.S. application Ser. No.
11/929,164 filed on Oct. 30, 2007, now U.S. Pat. No. 7,947,057,
which is a continuation application of U.S. application Ser. No.
10/463,535 filed on Jun. 18, 2003, now U.S. Pat. No. 7,311,718,
which is a continuation application of U.S. application Ser. No.
09/592,680, filed Jun. 12, 2000, now U.S. Pat. No. 7,175,641, which
is a continuation of U.S. application Ser. No. 09/433,366, filed
Nov. 3, 1999, now U.S. Pat. No. 6,156,051 and which is a divisional
application of U.S. application Ser. No. 09/095,902, filed Jun. 11,
1998, now U.S. Pat. No. 6,022,366. The entire disclosures of U.S.
application Ser. Nos. 13/087,957, 11/929,164, 10/463,535,
09/592,680, 09/433,366 and 09/095,902 are considered as being part
of the disclosure of the present application, and the entire
disclosures of U.S. application Ser. Nos. 13/087,957, 11/929,164,
10/463,535, 09/592,680, 09/433,366 and 09/095,902 are expressly
incorporated by reference herein their entireties.
[0002] The present application also expressly incorporates by
reference herein the entire disclosure of U.S. application Ser. No.
09/095,905, entitled "Adjustable Length Member Such as a Cap of a
Lancet Device for Adjusting Penetration Depth", filed Jun. 11,
1998, which issued as U.S. Pat. No. 6,346,114.
BACKGROUND OF THE INVENTION
[0003] 1. Field of the Invention
[0004] The present invention relates to a lancet device whose
penetration depth is adjustable. The lancet device is adapted to be
substantially inexpensive to manufacture and easy and safe to use
by physically impaired individuals who take their own blood
samples.
[0005] 2. Description of Background Information
[0006] The field relating to disposable and reusable lancet devices
is substantially crowded. U.S. Pat. No. 5,464,418 to SCHRAGA, the
disclosure of which is incorporated by reference herein in its
entirety, discloses a reusable lancet device having an elongate
triangular housing and triangular cap segment.
[0007] Lancets which allow adjustment of the penetration depth
include U.S. Pat. No. 5,318,584 to LANGE et al., the disclosure of
which is incorporated by reference herein in its entirety. This
document discloses a blood lancet device for withdrawing blood for
diagnostic purposes. The penetration depth of this blood lancet
device may be adjusted by adjusting the position of a sealing cap
relative to a housing.
[0008] U.S. Pat. No. 4,924,879 to O'BRIEN, the disclosure of which
is incorporated by reference herein in its entirety, discloses a
blood lancet device. The penetration depth may be adjusted by
adjusting the position of a skin surface sensor which may be a
small socket head screw.
[0009] U.S. Pat. No. 5,613,978 to HARDING, the disclosure of which
is incorporated by reference herein in its entirety, discloses an
adjustable tip for a lancet device. The penetration depth of this
lancet may be adjusted by adjusting the position of an outer
cylindrical sleeve relative to an inner sleeve.
[0010] U.S. Pat. No. 4,895,147 to BODICKY et al., the disclosure of
which is incorporated by reference herein in its entirety,
discloses a lancet injector which includes an elongate tubular
housing with a penetration depth selector provided thereon.
Rotation of the penetration depth selector causes a control member
to contact different contact edges to thereby control the distance
that a lancet tip protrudes through a central opening.
[0011] U.S. Pat. No. 1,135,465 to POLLOCK, the disclosure of which
is incorporated by reference herein in its entirety, discloses a
lancet. The distance that a plunger is allowed to move forward may
be changed by an adjustable movement limiting or regulating
collar.
[0012] Canadian Patent No. 523,078, the disclosure of which is
incorporated by reference herein in its entirety, discloses a
surgical device for use in the treatment of snake bites. The
surgical device includes a lance or blade whose penetration depth
may be adjusted by inserting or removing a stop bar from the path
of the lance or blade.
[0013] SUTOR et al., "Bleeding from Standardized Skin Punctures:
Automated Technic for Recording Time, Intensity, and Pattern of
Bleeding", A.J.C.P., Vol. 55, pp. 542-549 (May 1971), the
disclosure of which is incorporated by reference herein in its
entirety, discloses a Mayo automatic lancet. A knurled thumb screw
allows adjustment of depth of cut by regulating distance between a
plunger and a striking head by means of a millimeter scale.
[0014] Although there are several devices which allow adjustment of
the penetration depth, there are important factors relating to the
safe and effective use of lancet assemblies which have not been
addressed by such devices. Specifically, there is a need for a
lancet device having an adjustable penetration depth whose
penetration depth adjustment mechanism is reliable and difficult to
accidentally change.
SUMMARY OF THE INVENTION
[0015] The present invention is directed toward a lancet device,
such as a reusable lancet device, to be utilized with a lancet
whose penetration depth is adjustable.
[0016] It is an object of the present invention to provide a lancet
device which has an adjustable penetration depth. The penetration
depth may be adjusted by adjusting the length of a needle holding
member, by adjusting the length of a housing, by adjusting the
position of a stop, and/or by adjusting the depth of a cavity of a
proximal segment of a needle holding member.
[0017] It is another object of the present invention to provide a
lancet device having a penetration depth adjustment mechanism which
is contained entirely within a housing to reduce the possibility of
accidental misadjustment of the penetration.
[0018] It is another object of the present invention to provide a
lancet device having a penetration depth adjustment mechanism with
a simplified cap construction.
[0019] It is an object of the present invention to provide a lancet
device which is substantially cost effective to manufacture due to
a small number of individual pieces to be put together, yet will
still be substantially safe during use.
[0020] Still another object of the present invention is to provide
a lancet device which provides for facilitated and effective cap
positioning by impaired individuals.
[0021] Yet another object of the present invention is to provide a
lancet device which is comfortably positionable within a user's
hand and will not roll around within a user's hand or on a flat
surface.
[0022] A further object of the present invention is to provide an
improved lancet device which does not necessitate that an
exteriorly exposed plunger assembly be utilized in order to
position the lancet in a retracted, ready-to-use position.
[0023] Further, the device of the present invention is designed to
be utilized by individuals to do their own routine blood test such
as individuals who do home monitoring of their blood such as
diabetes patients. As a result, the present invention requires
precise adaptation to make it effective yet safe for the user. As a
result, the device of the present invention is comprised of a small
number of individual pieces, thereby making the lancet device
easier and substantially more cost effective to manufacture and
provide for use by patients, without compromising any of the safety
needs and in fact increasing the safety of use.
[0024] In accordance with one aspect, the present invention is
directed to a lancet device, including: a housing; a cap for
covering the housing and for positioning the lancet device relative
to a skin surface; a needle holding member for holding a lancet,
the needle holding member being at least partially contained within
the housing; a biasing element for biasing the needle holding
member toward an extended position; a trigger for releasing the
needle holding member from a retracted position; and a travel
adjustment mechanism capable of adjusting a length of travel of
said needle holding member, said travel adjustment mechanism being
positioned within at least one of said housing and said cap during
at least a portion of the length of travel of said needle holding
member. The travel adjustment mechanism may be completely
positioned or completely contained within at least one of the
housing and the cap during at least a portion of the length of
travel of the needle holding member.
[0025] In accordance with another aspect, the needle holding member
comprises a first component and a second component, and the travel
adjustment mechanism comprises a threaded connection between the
first component and the second component. The travel adjustment
mechanism may further include a protruding element on one of the
first component and the second component, and grooves on the other
of the first component and the second component, with the
protruding element being capable of engaging the grooves. The
protruding element may comprise a nipple or a spring-biased
ball.
[0026] In accordance with yet another aspect, the needle holding
member comprises a first component and a second component, and the
travel adjustment mechanism comprises a spring-biased element on
one of the first component and the second component, and a
plurality of recesses in the other of the first component and the
second component, with the spring-biased element being capable of
engaging the recesses.
[0027] In accordance with still another aspect, the needle holding
member comprises a first component and a second component, and the
travel adjustment mechanism comprises grooves in one of the first
component and the second component, and a ridge on the other of the
first component and the second component, with the ridge being
capable of engaging the grooves.
[0028] In accordance with still another aspect, the needle holding
member comprises a first component and a second component, and the
travel adjustment mechanism comprises grooves in one of the first
component and the second component, and at least one leaf spring on
the other of the first component and the second component, with the
at least one leaf spring being capable of engaging the grooves.
[0029] In accordance with still another aspect, the housing
comprises a plurality of stops, and the needle holding member
comprises a protrusion for engaging the stops one at a time. The
needle holding member and the housing may be capable of rotating
relative to each other.
[0030] In accordance with another aspect, the travel adjustment
mechanism is positioned within said housing and said cap during the
length of travel of said needle holding member.
[0031] In accordance with another aspect, the present invention is
directed to a lancet device, comprising: a housing; a cap for
covering the housing and for positioning the lancet device relative
to a skin surface; a needle holding member for holding a lancet,
the needle holding member being at least partially contained within
the housing, a length of the needle holding member being
adjustable; a biasing element for biasing the needle holding member
toward an extended position; and a trigger for releasing the needle
holding member from a retracted position.
[0032] In accordance with another aspect, the present invention is
directed to a lancet device, comprising: a housing containing at
least one stop; a cap for covering the housing and for positioning
the lancet device relative to a skin surface; a needle holding
member for holding a lancet, the needle holding member being at
least partially contained within the housing, the needle holding
member having at least one protrusion for striking the at least one
stop of the housing; a biasing element for biasing the needle
holding member toward an extended position; a trigger for releasing
the needle holding member from a retracted position; and an
alignment mechanism capable of aligning the at least one stop of
the housing and the at least one protrusion of the needle holding
member to adjust the extended position of the needle holding
member.
[0033] In accordance with another aspect, the housing comprises an
upper housing and a lower housing, and the alignment mechanism
comprises a threaded connection between the upper housing and the
lower housing. The at least one stop may comprise a guide collar on
the lower housing.
[0034] In accordance with still another aspect, the housing
comprises an upper housing and a lower housing, and the alignment
mechanism comprises a spring between the upper housing and the
lower housing to bias the lower housing into the upper housing, and
the alignment mechanism comprises a spacer between the upper
housing and the lower housing to act against a biasing force of the
spring. The at least one stop may comprise a guide collar on the
lower housing.
[0035] In accordance with yet another aspect, the housing comprises
an upper housing and a lower housing, with the lower housing having
the at least one stop which comprises a plurality of stops, and the
alignment mechanism comprises a threaded connection between the
upper housing and the lower housing. The plurality of stops may
comprise stops at different radial and axial positions on an
interior of the lower housing.
[0036] In accordance with another aspect, the at least one stop
comprises a plurality of stops, and the alignment mechanism
comprises a rotary connection between the housing and the needle
holding member. The plurality of stops may comprise stops at
different radial and axial positions on an interior of the
housing.
[0037] In accordance with another aspect, the present invention is
directed to a lancet device, comprising: a housing; a cap for
covering the housing and for positioning the lancet device relative
to a skin surface; a needle holding member comprising a cavity
having a depth for holding a lancet, the needle holding member
being at least partially contained within the housing; a biasing
element for biasing the needle holding member toward an extended
position; a trigger for releasing the needle holding member from a
retracted position; and an adjustable member disposed within the
cavity of the needle holding member for adjusting the cavity depth
of the needle holding member.
[0038] In accordance with still another aspect, the adjustable
member comprises a screw.
[0039] In accordance with yet another aspect, the needle holding
member comprises a turn-key having a pinion, and the adjustable
member comprises a nail having a tail which has a rack for engaging
the pinion.
[0040] In accordance with another aspect, the present invention is
directed to a lancet device, comprising: a housing; a cap for
covering the housing and for positioning the lancet device relative
to a skin surface; a needle holding member for holding a lancet,
the needle holding member being at least partially contained within
the housing; a biasing element for biasing the needle holding
member toward an extended position; a trigger for releasing the
needle holding member from a retracted position; and means for
adjusting a penetration depth of a lancet by adjusting a travel
distance of the needle holding member, the means for adjusting the
penetration depth being capable of being contained within the
housing and the cap.
[0041] In accordance with another aspect, the present invention is
directed to a lancet device, comprising: a housing; a cap for
covering the housing and for positioning the lancet device relative
to a skin surface; a needle holding member for holding a lancet,
the needle holding member being at least partially contained within
the housing; a biasing element for biasing the needle holding
member toward an extended position; a trigger for releasing the
needle holding member from a retracted position; and means for
adjusting a penetration depth of a lancet by adjusting a length of
the needle holding member.
[0042] In accordance with another aspect, the present invention is
directed to a lancet device, comprising: a housing containing at
least one stop; a cap for covering the housing and for positioning
the lancet device relative to a skin surface; a needle holding
member for holding a lancet, the needle holding member being at
least partially contained within the housing, the needle holding
member having at least one protrusion for striking the at least one
stop of the housing; a biasing element for biasing the needle
holding member toward an extended position; a trigger for releasing
the needle holding member from a retracted position; and means for
adjusting a penetration depth of a lancet by aligning the at least
one stop of the housing and the at least one protrusion of the
needle holding member.
[0043] In accordance with another aspect, the present invention is
directed to a lancet device, comprising: a housing; a cap for
covering the housing and for positioning the lancet device relative
to a skin surface; a needle holding member comprising a cavity
having a depth for holding a lancet, the needle holding member
being at least partially contained within the housing; a biasing
element for biasing the needle holding member toward an extended
position; a trigger for releasing the needle holding member from a
retracted position; and means for adjusting a penetration depth of
a lancet by adjusting the cavity depth of the needle holding
member.
[0044] The invention also provides for a lancet device that
includes a first housing comprising a proximal end and a distal
end. A first guide wall is disposed within the first housing. The
first guide wall comprises an opening. A cap is removably mounted
to the proximal end of the first housing and is utilized for
positioning the lancet device relative to a skin surface. A needle
holding member is provided for holding a lancet. The needle holding
member is at least partially contained within the first housing. At
least a portion of the needle holding member is able to move within
the opening of the first guide wall. A first spring is utilized for
biasing the needle holding member toward an extended position. The
first spring surrounds a portion of the needle holding member and
is disposed between the first guide wall and a shoulder of the
needle holding member. A movable trigger is arranged on a side of
the first housing. The trigger has a first position and a second
position, wherein when the trigger is moved to the second position,
the needle holding member is allowed to move from a retracted
position to an extended position. A movable second housing
comprises a proximal end, a distal end and a second guide wall
arranged at the proximal end of the second housing. The second
guide wall comprises an opening. A portion of the needle holding
member is able to move within the opening of the second guide wall.
The second housing is configured to move the needle holding member
to the retracted position when the second housing is moved away
from the first housing. The proximal end of the second housing is
configured to move axially within the distal end of the first
housing. A second spring is utilized for biasing the second housing
towards the first housing. The second spring surrounds a portion of
the needle holding member and is disposed between the second guide
wall and another shoulder of the needle holding member. At least a
portion of the needle holding member is always retained within the
first housing.
[0045] The lancet device may further comprise a lock retainer
mounted to a distal end of the needle holding member. The first
housing may be one of triangular, D-shaped, and polygonal. The
other shoulder of the needle holding member may be arranged at a
distal end of the needle holding member.
[0046] The invention also provides for a lancet device comprising a
first housing comprising a proximal end and a distal end. A first
guide wall is arranged within the first housing. The first guide
wall comprises an opening. A cap is removably mounted to the
proximal end of the first housing and is utilized for positioning
the lancet device relative to a skin surface. A needle holding
member is utilized for holding a lancet. The needle holding member
is at least partially contained within the first housing. At least
a portion of the needle holding member is able to move within the
opening of the first guide wall. A first spring is utilized for
biasing the needle holding member toward an extended position. The
first spring surrounds a portion of the needle holding member and
is disposed between the first guide wall and a shoulder of the
needle holding member. A trigger is arranged on a side of the first
housing. The trigger having a first position and a second position,
wherein when the trigger is moved to the second position, the
needle holding member is allowed to move from a retracted position
to an extended position. A second housing comprises a proximal end,
a distal end and a second guide wall. The second housing is
configured to move the needle holding member to the retracted
position when the second housing is moved away from the first
housing. The second guide wall comprises an opening. At least a
portion of the needle holding member is able to move within the
opening of the second guide wall. The proximal end of the second
housing is configured to move axially within the distal end of the
first housing. A second spring is utilized for biasing the second
housing towards the first housing. The second spring surrounds a
distal portion of the needle holding member and is disposed between
the second guide wall and a distal end of the needle holding
member. A lock retainer is mounted to the distal end of the needle
holding member. At least a portion of the needle holding member is
always retained within the first housing.
[0047] The second spring may be arranged between the lock retainer
and the second guide wall. The first housing may be one of
triangular, D-shaped, and polygonal. The distal end of the needle
holding member may comprises a shoulder.
[0048] The invention also provides for a lancet device comprising a
first housing comprising a proximal end and a distal end. A first
guide wall is arranged inside the first housing. The first guide
wall comprises an opening. A cap is removably mounted to the
proximal end of the first housing. The cap has a proximal end for
engaging a skin surface. A movable needle holding member is
utilized for holding a lancet. The needle holding member is at
least partially contained within the first housing. At least a
portion of the needle holding member is able to move within the
opening of the first guide wall. A first spring is utilized for
biasing the needle holding member toward an extended position. The
first spring surrounds at least a portion of the needle holding
member. The first spring is disposed between the first guide wall
and a shoulder of the needle holding member. A trigger is arranged
on a side wall of the first housing. The trigger is movable between
a first position and a second position, wherein when the trigger is
moved to the second position, the needle holding member is allowed
to move from a retracted position to an extended position. A
movably mounted second housing comprises a proximal end and a
distal end. The second housing comprises a second guide wall. The
second housing is configured to move the needle holding member to
the retracted position when the second housing is moved axially
away from the first housing. The second guide wall comprises an
opening. A portion of the needle holding member is able to move
within the opening of the second guide wall. The proximal end of
the second housing is configured to move axially within the distal
end of the first housing. A second spring is utilized for biasing
the second housing towards the first housing. A lock retainer is
mounted to a distal end of the needle holding member. The second
spring surrounds a portion of the needle holding member and is
disposed between the second guide wall and the lock retainer. At
least a portion of the needle holding member is always retained
within the first housing.
[0049] The first housing may be one of triangular, D-shaped, and
polygonal. The distal end of the needle holding member may comprise
a shoulder.
[0050] The invention also provides for a lancet device comprising a
main housing comprising a proximal end and a distal end. A guide
wall is arranged in the main housing and extends transverse to an
axis running through the main housing. The guide wall comprises an
opening. A cap is removably mounted to the proximal end of the main
housing. The cap has a proximal end for engaging a skin surface. A
movable needle holding member is utilized for holding a lancet. The
needle holding member is at least partially contained within the
main housing. At least a portion of the needle holding member is
able to move within the opening of the guide wall. A first spring
biases the needle holding member toward an extended position. The
first spring surrounds a portion of the needle holding member. The
first spring is arranged between the guide wall and a shoulder of
the needle holding member. A trigger is arranged on a side wall of
the main housing. The trigger is movable between a first position
and a second position, wherein when the trigger is moved to the
second position, the needle holding member is allowed to move from
a retracted position to an extended position. A distal housing
comprises a proximal end and a distal end. The distal housing
comprises a guide wall. The distal housing is configured to move
the needle holding member to the retracted position when the distal
housing is moved away from the main housing. The guide wall of the
distal housing comprises an opening. A portion of the needle
holding member is able to move within the opening of the guide wall
of the distal housing. The proximal end of the distal housing is
configured to move axially within the distal end of the main
housing. A second spring is utilized for biasing the distal housing
towards the main housing. A lock retainer is mounted to a distal
end of the needle holding member. The second spring surrounds a
distal portion of the needle holding member and is disposed between
the guide wall of the distal housing and the lock retainer. At
least a portion of the needle holding member is always retained
within the first housing.
[0051] The main housing may be one of triangular, D-shaped, and
polygonal. The distal end of the needle holding member comprises a
shoulder.
[0052] The invention also provides for a lancet device comprising a
main housing comprising a proximal end and a distal end. A guide
wall is arranged in the main housing and extends transverse to an
axis running through the main housing. The guide wall comprises an
opening. A cap is removably mounted to the proximal end of the main
housing. The cap has a proximal end for engaging a skin surface. A
movable needle holding member is utilized for holding a lancet. The
needle holding member is at least partially contained within the
main housing. A portion of the needle holding member is able to
move within the opening of the guide wall. A first spring is
utilized for biasing the needle holding member toward an extended
position. The first spring surrounds a portion of the needle
holding member. The first spring is disposed between the guide wall
and a shoulder of the needle holding member. A movable trigger is
arranged on a side of the main housing. The trigger is movable
between a first position and a second position, wherein when the
trigger is moved to the second position, the needle holding member
is allowed to move from a retracted position to an extended
position. A distal housing is arranged at the distal end of the
main housing. The distal housing comprises a proximal end, a distal
end and a guide wall arranged at the proximal end of the distal
housing. The distal housing is configured to move the needle
holding member to the retracted position when the distal housing is
moved away from the main housing. The guide wall of the distal
housing comprises an opening. A portion of the needle holding
member is able to move within the opening of the guide wall of the
distal housing. The proximal end of the distal housing is
configured to move axially within the distal end of the main
housing. A second spring biases the distal housing towards the main
housing. The second spring surrounds a portion of the needle
holding member and is disposed between the guide wall of the distal
housing and a distal end of the needle holding member. At least a
portion of the needle holding member is always retained within the
first housing.
[0053] The lancet device may further comprise a lock retainer
mounted to the distal end of the needle holding member. The main
housing may be one of triangular, D-shaped, and polygonal. The
lancet device may further comprise a distal shoulder arranged at
the distal end of the needle holding member. The needle holding
member may comprise a mechanism that cooperates with the trigger to
retain the needle holding member in a retracted position. The
mechanism may comprise a shoulder. The lancet device may further
comprise a fastening mechanism for securing the cap to the main
housing. The proximal end of the main housing may be open and the
distal end of the main housing may be open.
[0054] The invention also provides for a lancet device comprising a
first housing comprising a proximal end and a distal end. A first
guide wall is disposed within the first housing. The first guide
wall comprises an opening. A cap is removably mounted to the
proximal end of the first housing and utilized for positioning the
lancet device relative to a skin surface. A needle holding member
is utilized for holding a lancet. The needle holding member is at
least partially contained within the first housing. At least a
portion of the needle holding member is able to move within the
opening of the first guide wall. A first spring is utilized for
biasing the needle holding member toward an extended position. The
first spring surrounds a portion of the needle holding member and
is disposed between the first guide wall and a shoulder of the
needle holding member. A movable trigger is arranged on a side of
the first housing. The trigger has a first position and a second
position, wherein when the trigger is moved to the second position,
the needle holding member is allowed to move from a retracted
position to an extended position. A movable second housing
comprises a proximal end, a distal end, a shoulder arranged between
the proximal end and the distal end, and a second guide wall
arranged at the proximal end of the second housing. The second
guide wall comprises an opening. A portion of the needle holding
member is able to move within the opening of the second guide wall.
The second housing is configured to move the needle holding member
to the retracted position when the second housing is moved away
from the first housing. The proximal end of the second housing is
configured to move axially within the distal end of the first
housing. A second spring is utilized for biasing the second housing
towards the first housing. The second spring surrounds a portion of
the needle holding member and is disposed between the second guide
wall and another shoulder of the needle holding member. At least a
portion of the needle holding member is always retained within the
first housing.
[0055] The lancet device may further comprise a lock retainer
mounted to a distal end of the needle holding member. The first
housing may be one of triangular, D-shaped and polygonal. The other
shoulder of the needle holding member may be arranged at a distal
end of the needle holding member. The shoulder of the second
housing may be sized to be larger than the proximal end of the
second housing, whereby the shoulder of the second housing limits
movement of the second housing towards the first housing.
[0056] The invention also provides for a lancet device comprises a
first housing comprising a proximal end and a distal end. A second
housing is at least partially disposed in the first housing. A
guide wall is arranged on the second housing. The guide wall is
disposed within the first housing. The guide wall comprises an
opening. A removably mounted cap is utilized for positioning the
lancet device relative to a skin surface. A needle holding member
is utilized for holding a lancet. The needle holding member is at
least partially contained within the first housing and the second
housing. At least a portion of the needle holding member is able to
move within the opening of the guide wall of the second housing. A
first spring is utilized for biasing the needle holding member
toward an extended position. The first spring surrounds a portion
of the needle holding member and is disposed between the guide wall
of the second housing and a shoulder of the needle holding member.
A trigger is arranged on a side of the first housing. The trigger
has a first position and a second position, wherein when the
trigger is moved to the second position, the needle holding member
is allowed to move from a retracted position to an extended
position. A third housing comprises a proximal end, a distal end
and a guide wall. The third housing is configured to move the
needle holding member to the retracted position when the third
housing is moved away from the first housing. The guide wall of the
third housing comprises an opening. At least a portion of the
needle holding member is able to move within the opening of the
guide wall of the third housing. The proximal end of the third
housing is configured to move axially within the distal end of the
first housing. A second spring is utilized for biasing the third
housing towards the first housing. The second spring surrounds a
distal portion of the needle holding member and is disposed between
the guide wall of the third housing and a distal end of the needle
holding member. A lock retainer is mounted to the distal end of the
needle holding member. At least a portion of the needle holding
member is always retained within the first housing.
[0057] The second spring may be arranged between the lock retainer
and the guide wall of the third housing. The first housing may be
one of triangular, D-shaped, and polygonal. The distal end of the
needle holding member may comprise a shoulder.
[0058] The invention also provides for a lancet device comprising a
first housing comprising a proximal end and a distal end. A first
guide wall is arranged on a second housing. The second housing is
at least partially disposed within the first housing. The first
guide wall is disposed inside the first housing. The first guide
wall comprises an opening. A removably mounted cap. The cap has a
proximal end for engaging a skin surface. A movable needle holding
member for holding a lancet, the needle holding member being at
least partially contained within the first housing. At least a
portion of the needle holding member is able to move within the
opening of the first guide wall. A first spring is utilized for
biasing the needle holding member toward an extended position. The
first spring surrounds at least a portion of the needle holding
member. The first spring is disposed between the first guide wall
and a shoulder of the needle holding member. A trigger is arranged
on a side wall of the first housing. The trigger is movable between
a first position and a second position, wherein when the trigger is
moved to the second position, the needle holding member is allowed
to move from a retracted position to an extended position. A
movably mounted third housing comprises a proximal end and a distal
end. The third housing comprises a second guide wall. The third
housing is configured to move the needle holding member to the
retracted position when the third housing is moved axially away
from the first housing. The second guide wall comprises an opening.
A portion of the needle holding member is able to move within the
opening of the second guide wall. The proximal end of the third
housing is configured to move axially within the distal end of the
first housing. A second spring is utilized for biasing the third
housing towards the first housing. A lock retainer is mounted to a
distal end of the needle holding member. The second spring
surrounds a portion of the needle holding member and is disposed
between the second guide wall and the lock retainer. At least a
portion of the needle holding member is always retained within the
first housing.
[0059] The first housing may be one of triangular, D-shaped, and
polygonal. The distal end of the needle holding member may comprise
a shoulder.
[0060] The invention also provides for a lancet device comprising a
main housing comprising a proximal end and a distal end. An inner
housing is at least partially disposed in the first housing. A
guide wall is arranged at an end of the inner housing. The guide
wall extends transverse to an axis running through the main
housing. The guide wall comprises an opening. A cap is disposed at
the proximal end of the main housing. The cap is removable and has
a proximal end for engaging a skin surface. A movable needle
holding member is utilized for holding a lancet, the needle holding
member being at least partially contained within the main housing.
At least a portion of the needle holding member is able to move
within the opening of the guide wall. A first spring biases the
needle holding member toward an extended position. The first spring
surrounds a portion of the needle holding member. The first spring
is arranged between the guide wall and a shoulder of the needle
holding member. A trigger is arranged on a side wall of the main
housing. The trigger is movable between a first position and a
second position, wherein when the trigger is moved to the second
position, the needle holding member is allowed to move from a
retracted position to an extended position. A distal housing
comprises a proximal end, a distal end and a guide wall. The distal
housing is configured to move the needle holding member to the
retracted position when the distal housing is moved away from the
main housing. The guide wall of the distal housing comprises an
opening. A portion of the needle holding member is able to move
within the opening of the guide wall of the distal housing. The
proximal end of the distal housing is configured to move axially
within the distal end of the main housing. A second spring is
utilized for biasing the distal housing towards the main housing. A
lock retainer is mounted to a distal end of the needle holding
member. The second spring surrounds a distal portion of the needle
holding member and is disposed between the guide wall of the distal
housing and the lock retainer. At least a portion of the needle
holding member is always retained within the first housing.
[0061] The main housing may be one of triangular, D-shaped, and
polygonal. The distal end of the needle holding member may comprise
a shoulder.
[0062] The invention also provides for a lancet device comprising a
main housing comprising an open proximal end and an open distal
end. An inner housing is at least partially disposed in the main
housing. A guide wall is arranged on the inner housing and within
the main housing. The guide wall comprises an opening. A removably
mounted cap is provided. The cap has a proximal end for engaging a
skin surface. A movable needle holding member is utilized for
holding a lancet, the needle holding member being at least
partially contained within the main housing. A portion of the
needle holding member is able to move within the opening of the
guide wall. A first spring is utilized for biasing the needle
holding member toward an extended position. The first spring
surrounds a portion of the needle holding member. The first spring
is disposed between the guide wall and a shoulder of the needle
holding member. The needle holding member has a proximal end that
projects from the open proximal end of the main housing when the
needle holding member is in the extended position. A movable
trigger is arranged on a side of the main housing. The trigger is
movable between a first position and a second position, wherein
when the trigger is moved to the second position, the needle
holding member is allowed to move from a retracted position to an
extended position. A distal housing is disposed at the distal end
of the main housing. The distal housing comprises a proximal end, a
distal end and a guide wall arranged at the proximal end of the
distal housing. The distal housing is configured to move the needle
holding member to the retracted position when the distal housing is
moved away from the main housing. The guide wall of the distal
housing comprises an opening. A portion of the needle holding
member is able to move within the opening of the guide wall of the
distal housing. The proximal end of the distal housing is
configured to move axially within the distal end of the main
housing. A second spring biases the distal housing towards the main
housing. The second spring surrounding a portion of the needle
holding member and is disposed between the guide wall of the distal
housing and a distal end of the needle holding member. At least a
portion of the needle holding member is always retained within the
first housing.
[0063] The lancet device may further comprise a lock retainer
mounted to the distal end of the needle holding member. The main
housing may be one of triangular, D-shaped, and polygonal. The
lancet device may further comprise a distal shoulder arranged at
the distal end of the needle holding member. The needle holding
member may comprise a mechanism that cooperates with the trigger to
retain the needle holding member in the retracted position. The
mechanism comprises a shoulder. The lancet device may further
comprise a fastening mechanism for securing the cap to the main
housing.
[0064] The invention also provides for a lancet device comprising a
first housing comprising a proximal end and a distal end. A movable
trigger is arranged on a side wall of the first housing. A first
guide wall is disposed within the first housing. The first guide
wall extends transverse to an axis running through the first
housing and comprising an opening. A removably mounted cap is
utilized for positioning the lancet device relative to a skin
surface. A needle holding member is utilized for holding a lancet,
the needle holding member being at least partially contained within
the first housing. At least a portion of the needle holding member
is able to move within the opening of the first guide wall. A first
spring biases the needle holding member toward an extended
position. The first spring surrounds a portion of the needle
holding member and is disposed between the first guide wall and a
shoulder of the needle holding member. The needle holding member
comprises a projecting portion arranged between a proximal end of
the needle holding member and the shoulder of the needle holding
member. The projecting portion acts to retain the needle holding
member in the retracted position. The trigger has a first position
and a second position, wherein when the trigger is moved to the
second position, the needle holding member is allowed to move from
a retracted position to an extended position. A movable second
housing comprises a proximal end, a distal end and a second guide
wall arranged at the proximal end of the second housing. The second
guide wall comprises an opening. A portion of the needle holding
member is able to move within the opening of the second guide wall.
The second housing is configured to move the needle holding member
to the retracted position when the second housing is moved away
from the first housing. The proximal end of the second housing is
configured to move axially within the distal end of the first
housing. A second spring is utilized for biasing the second housing
towards the first housing. The second spring surrounds a portion of
the needle holding member and is disposed between the second guide
wall and a distal end of the needle holding member. At least a
portion of the needle holding member is always retained within the
first housing.
[0065] The invention also provides for a lancet device comprising a
main housing comprising a proximal end and a distal end. A movable
trigger is arranged on a side wall of the first housing. A guide
wall is disposed within the first housing. The guide wall comprises
an opening. A removably mounted cap is utilized for positioning the
lancet device relative to a skin surface. A needle holding member
is utilized for holding a lancet, the needle holding member being
at least partially contained within the first housing. At least a
portion of the needle holding member is able to move within the
opening of the guide wall. A first spring biases the needle holding
member toward an extended position. The first spring surrounds a
portion of the needle holding member and is disposed between the
guide wall and a shoulder of the needle holding member. The needle
holding member comprises a projecting portion arranged between a
proximal end of the needle holding member and the shoulder of the
needle holding member. The projecting portion acts to retain the
needle holding member in the retracted position. The trigger has a
first position and a second position, wherein when the trigger is
moved to the second position, the needle holding member is allowed
to move from a retracted position to an extended position. A
movable distal housing comprises a proximal end, a distal end and a
guide wall arranged at the proximal end of the distal housing. The
guide wall of the distal housing comprises an opening. A portion of
the needle holding member is able to move within the opening of the
guide wall of the distal housing. The distal housing is configured
to move the needle holding member to the retracted position when
the distal housing is moved away from the main housing. The
proximal end of the distal housing is configured to move axially
within the distal end of the main housing. A second spring biases
the second housing towards the first housing. The second spring
surrounds a portion of the needle holding member and is disposed
between the guide wall of the distal housing and a distal end of
the needle holding member. At least a portion of the needle holding
member is always retained within the main housing.
BRIEF DESCRIPTION OF THE DRAWINGS
[0066] The present invention is further described in the detailed
description which follows, in reference to the noted plurality of
non-limiting drawings, and wherein:
[0067] FIG. 1 is a partially exploded perspective view of the
lancet device of the present invention.
[0068] FIG. 2 is a cross-sectional view along line 2-2 of FIG.
1.
[0069] FIGS. 3A, 3B, 3C, and 3D are isolated, cross-sectional views
of the lancet device illustrating the functioning of the
lancet.
[0070] FIG. 4 is an isolated view of the trigger button of the
lancet device of the present invention.
[0071] FIG. 5 is a bottom plan view of the triangular cap segment
of the lancet device of the present invention.
[0072] FIG. 6 is an isolated perspective view of the lancet device
illustrating the positioning of a disposable lancet therein.
[0073] FIG. 7 is an isolated cross-sectional view illustrating the
positioning of the biasing element of the lancet device according
to one embodiment of the present invention, wherein the needle
holding member is shown in its fully extended position.
[0074] FIG. 8 is an isolated perspective view of a second
embodiment of the stopper of the lancet device.
[0075] FIG. 9 is a top view of the proximal central segment of the
present invention showing grooves for engaging a protruding element
of the proximal segment.
[0076] FIG. 10 is a cross-sectional view of an embodiment for
adjusting the length of the needle holding member involving a
spring-biased element for engaging holes.
[0077] FIG. 11 is a cross-sectional view of an embodiment for
adjusting the length of the needle holding member involving a
proximal segment having grooves and a proximal central segment
having ridges for engaging the grooves of the proximal segment.
[0078] FIG. 12 is a cross-sectional view of an embodiment for
adjusting the length of the needle holding member involving a
proximal segment having grooves and a proximal central segment
having a pair of leaf springs for engaging the grooves of the
proximal segment.
[0079] FIG. 13 is a cross-sectional view of the proximal central
segment of FIG. 12 before insertion into the proximal segment.
[0080] FIG. 14 is a cross-sectional view of an embodiment for
adjusting the length of the housing involving a threaded upper
housing which engages a threaded lower housing having a guide
collar for engaging a flanged end of the needle holding member,
wherein the needle holding member is shown in its fully extended
position.
[0081] FIG. 15 is a cross-sectional view of an embodiment for
adjusting the length of the housing involving a spring which biases
an upper housing and a lower housing against a spacer, wherein the
needle holding member is shown in its fully extended position.
[0082] FIG. 16 is a cross-sectional view of an embodiment for
adjusting the length of the housing, involving a spring which
biases a needle holding member in a retracted position and threaded
members for adjusting the length of the housing, wherein the needle
holding member is shown in its retracted position.
[0083] FIG. 17 is a cross-sectional view of an embodiment for
adjusting which stop is engaged involving a threaded upper housing
which engages a threaded lower housing having a plurality of stops
for engaging a finger of a needle holding member, wherein the
needle holding member is shown in its fully extended position.
[0084] FIG. 18 is a cross-sectional view of an embodiment for
adjusting which stop is engaged involving a housing having a
plurality of stops and a rotatable needle holding member which has
a finger for engaging the plurality of stops one at a time, wherein
the needle holding member is shown in its fully extended
position.
[0085] FIG. 19 is a cross-sectional view of an embodiment for
adjusting a cavity depth involving an adjustable bottom member
which is a screw.
[0086] FIG. 20 is a cross-sectional view of an embodiment for
adjusting a cavity depth involving an adjustable bottom member
which is adjusted by use of a rack and pinion.
[0087] Like reference numerals refer to like parts throughout the
several views of the drawings.
DETAILED DESCRIPTION
[0088] The particulars shown herein are by way of example and for
purposes of illustrative discussion of the various 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 invention. In this regard, no attempt is made to show details
of the invention in more detail than is necessary for a fundamental
understanding of the invention, the description taken with the
drawings making apparent to those skilled in the art how the
several forms of the invention may be embodied in practice.
[0089] Before referring to the Figures, a broad overview of
preferred aspects of the invention is provided. The lancet device
includes an elongate housing, which is preferably triangular,
adapted to fit within the user's hand. This housing includes a
first end, which can be closed or open, an open second end, and an
elongate channel therein which extends from the first end to the
second end.
[0090] Disposed within this elongate channel is an elongate needle
holding member. This needle holding member is movable between a
cocked, retracted position and an extended position. The needle
holding member is structured to hold a disposable lancet therein,
such that a point thereof extends away from the needle holding
member.
[0091] A biasing element is disposed within the housing. The
biasing element is adapted to urge the needle holding member into
an extended position for penetrating a user's skin when not held in
a retracted position.
[0092] According to the present invention, there are several
different embodiments for adjusting the penetration depth of the
lancet, i.e., for adjusting the maximum distance which the lancet
in the needle holding member extends out of the housing. The
penetration depth may be adjusted by adjusting the length of the
needle holding member, by adjusting the length of the housing, by
adjusting the position of a stop, and/or by adjusting the depth of
a cavity of the needle holding member. Adjusting the penetration
depth is important because different penetration depths are
necessary to draw blood from different people due to differences in
skin thickness, differences in healing time of the skin puncture,
differences in pain tolerances, and differences in the amount of
blood needed to be drawn.
[0093] Regardless of how the penetration depth is adjusted, the
present invention includes a stopper system to prevent axial
movement of the needle holding member within the housing. Utilizing
the stopper system, the needle holding member will always be
retained within the channel despite its movement from the cocked,
retracted position to the extended position.
[0094] The needle holding member is held in the cocked, retracted
position, and accordingly a biasing element is held in a retracted,
compressed position, until released by a trigger. The trigger
releases the needle holding member from the cocked, retracted
position which results in an immediate movement of the needle
holding member to the extended position as a result of the
functioning of the biasing element.
[0095] The lancet device also includes a cap segment, which is
preferably triangular, with an open first side and a closed second
side containing a piercing opening therein. The open first side is
adapted to be matingly fitted over the open second end of the
housing, thereby containing the needle holder member and disposable
lancet therein. When in a cocked, retracted position, or after use,
the needle holding member is disposed such that the point of the
disposable lancet is concealed within the cap segment. During use,
upon release by the trigger, the needle holding member is
immediately moved to the extended position wherein the point of the
disposable lancet will momentarily extend through a piercing
opening into a piercing position which punctures a hole in a user's
skin and then retracts back beneath the cap segment.
[0096] Moreover, before referring to the Figures, the illustrated
reusable lancet device is similar to that disclosed in U.S. Pat.
No. 5,464,418 to SCHRAGA, the disclosure of which is herein
incorporated by reference in its entirety.
[0097] FIGS. 1-9 illustrate embodiments of the present invention
which involve adjusting the penetration depth of a disposable
lancet by adjusting the length of a needle holder member via a
threaded connection between two segments of the needle holder
member. The reusable lancet device 10 is preferably formed of a
lightweight, rigid or semi-rigid, and substantially inexpensive
plastic material and is adapted for use with a standard type of
disposable lancet 60. The reusable lancet device 10 includes
primarily an elongate, substantially triangular shaped housing 20.
The housing 20 includes the substantially triangular shape, with
slightly rounded corners, such that it will be easy to manipulate
and will not unnecessarily roll around within a user's hand,
especially if the user is sick, old, or otherwise impaired.
Although the most preferred shape of the housing 20 is triangular,
the housing 20 may be other shapes such as round but is preferably
any shape that will not roll around on a flat surface such as
D-shaped, rectangular, or octagonal. As evident from the above
discussion and from the drawings, the housing 20 preferably has a
longitudinal axis A.
[0098] The elongate triangular housing 20, as illustrated in FIG.
2, includes a closed first end 22, an open second end 24, and an
elongate channel 26. Further, the housing 20 is preferably molded
of two halves to be joined together, so as to facilitate
manufacture. The elongate channel 26 extends from the closed first
end 22 to the open second end 24.
[0099] Slidably positioned within the channel 26 is an elongate
needle holding member or lancet holding member 30. This needle
holding member 30, which is movable between a cocked, retracted
position, illustrated in FIG. 2, and an extended position,
illustrated in FIG. 3B, includes four segments. Specifically, the
needle holding member 30 is formned of a distal segment 32, a
distal central segment 35, a proximal central segment 31, and a
proximal segment 38. As evident from the above discussion and from
the drawings, the lancet holding member or lancet holder 30
preferably has a longitudinal axis B.
[0100] The proximal segment 38 and the proximal central segment 31
cooperate to form an adjustment mechanism 70 for adjusting the
length of the needle holding member 30. The length adjustment
mechanism 70 involves a threaded connection between the proximal
segment 38 and the proximal central segment 31. The proximal
segment 38 includes external threads 72 and the proximal central
segment 31 includes internal threads 74 for engaging each other. In
an alternative embodiment which is not shown in the drawings, the
threading is reversed such that the proximal segment 38 has
internal threading and the proximal central segment 31 has external
threading.
[0101] To allow the length of the needle holding member to be set
at a particular length, the threaded length adjustment mechanism
includes a protruding element 76 on the proximal segment 38 which
engages grooves 78 on the proximal central segment 31. The
protruding element 76 is shown as a single nipple but may be more
than one nipple and may be one or more spring-biased balls in
alternative embodiments.
[0102] Upon rotation of the proximal segment 38 and the proximal
central segment 31 relative to each other about the threaded
connection of the length adjustment mechanism 70, the overall
length of the needle holding member 30 is increased or decreased
depending upon the direction of rotation. During rotation, the
protruding element 76 snaps into and out of grooves 78 such that
the length of the needle holding member may be fixed at a
particular length by leaving the protruding element 76 engaged in a
particular groove 78. FIG. 9 shows how the grooves 78 and internal
threads 74 are positioned within the interior of the proximal
central segment 31. Other techniques for setting the position of
threaded elements may also be used to fix the length of the needle
holding member 30, such as using a set screw, using washers, or
using screws often used on bicycles which have nylon inserts for
deterring rotation of the screw.
[0103] The proximal segment 38, which protrudes from the open
second end 24 of the housing 20 is adapted to hold the disposable
lancet 60 therein. Specifically, the disposable lancet 60 includes
a main body 65 and a point 61, which until use is contained within
a protective cap 62. When used, the body 65 is inserted into a
cavity 39 of the proximal segment 38, as illustrated in FIG. 2,
then the protective cap 62 is pulled or twisted from the point 61.
Although the cavity 39 and disposable lancet 60 are shown as being
round, the cavity 39 and disposable lancet 60 could be any other
shapes, such as square, octagonal, etc., so long as the disposable
lancet can be engaged in the cavity 39. The disposable lancet 60 is
held in the proximal segment 38 such that the point 61 points away
from the housing and such that sliding movement of the needle
holding member 30 will result in corresponding movement of the
disposable lancet 60. As evident from the above discussion and from
the drawings, the needle holding member or lancet holding member or
lancet holder 30 may be separate from the disposable lancet 60.
[0104] The overall sliding and axial movement of the needle holding
member 30 is regulated by a stopper system. In the preferred
embodiment, detailed in FIG. 2, the stopper system includes a guide
collar or guide wall 28 disposed within the housing 20. The guide
collar or guide wall 28 extends transversely to the housing axis
A-A and is adapted to receive the distal segment 32 of the needle
holding member 30 slidably therethrough. This occurs because the
guide wall 28 has a through opening that allows a portion of the
needle holding member 30 to move within it. The needle holding
member 30 is preferably flat such that it will slide through the
opening in the guide wall or collar 28, but will not rotate axially
therein, thereby assuring that the needle holding member 30 will
remain properly oriented when moved into its cocked, retracted
position. Further, the guide collar 28 is sized to retain a flanged
end 33 of the distal segment 32 of the needle holding member 30
between the closed first end 22 of the housing 20 and the guide
collar 28. In this manner, inward movement of the needle holding
member within the housing 20 is limited by the flanged end 33
contacting the closed first end 22 of the housing 20, and outward
movement of the needle holding member 20 is limited by the flanged
end 33 of the distal segment 32 contacting the guide collar 28. In
this manner, the needle holding member 30 will be retained within
the channel 26.
[0105] Turning to FIG. 7, an alternative embodiment of the stopper
system includes an elongate slot (also referred to as elongate
opening and elongate hole) disposed in the distal segment 32 of the
needle holding member 30. The slot or opening or hole is positioned
such that a peg (also referred to as post) 28' which extends from
an interior of the housing 20 passes therethrough. The peg or post
28' remains within the elongate slot or opening or hole at all
times thereby limiting movement of the needle holding member 30 to
a length of the slot or opening or hole and assuring that the
needle holding member 30 is retained within the channel 26 of the
housing 20. Also, positioning of the peg or post 28' within the
slot or opening or hole will not allow axial rotation of the needle
holding member 30.
[0106] Turning to FIG. 8, an alternative embodiment of the stopper
system includes an elongate slot (also referred to as elongate
opening and elongate hole) 33' disposed in the distal segment 32 of
the needle holding member 30. The slot or opening or hole is
positioned such that a peg (also referred to as post) 28'' which
extends from an interior of the housing 20 passes therethrough. The
peg or post 28'' remains within the elongate slot or opening or
hole 33' at all times thereby limiting movement of the needle
holding member 30 to a length of the slot or opening or hole 33'
and assuring that the needle holding member 30 is retained within
the channel 26 of the housing 20. Also, positioning of the peg or
post 28'' within the slot or opening or hole 33' will not allow
axial rotation of the needle holding member 30.
[0107] Although the stopper systems of FIGS. 7 and 8 involve an
interaction between the distal segment 32 of the needle holding
member 30 and a stationary element, the stopper system could
involve an interaction between another segment of the needle
holding member and a stationary element. For instance, the stopper
system could involve interaction of the distal central segment 35
with an element attached to the housing 20.
[0108] So as to contain and shield the exposed point 61 of the
disposable lancet 60, a triangular cap segment 50 is included. The
triangular cap segment 50 includes an open first side 51 and a
closed second side 52. The cap segment 50 is adapted to have
substantially the same configuration as the housing 20 and is sized
such that the open first side 51 may be matingly fitted over the
open second end 24 of the housing 20. Of course, although the cap
segment 50 is shown as being triangular, the cap segment 50 may be
other shapes depending upon the shape of the housing 20.
[0109] Further, the open second end 24 of the housing 20 extends
from a lip 25 formed in the housing 20, the lip 25 being disposed
such that the open first side 51 of the cap segment 50 slides onto
the housing 20 over the open second end 24 of the housing 20 and
will abut the lip 25 providing a smooth contoured finish. The cap
segment 50 will be removably fitted on the housing 20 preferably
through corresponding proportioning of an interior dimension of the
open first side 51 of the cap segment 50 relative to the open
second end 24 of the housing 20, but alternatively engagement
ridges or a similar removable fastener system may be included to
secure the cap segment 50 on the housing 20. Other removable
fastener systems include threads, locking clips, and locking
buttons.
[0110] Disposed in the closed second side 52 of the cap segment 50
is a piercing opening 53. The piercing opening 53 is positioned
such that when the needle holding member 30, containing a
disposable lancet 60 therein, is moved to its fully extended
position, the point 61 of the disposable lancet 60 will protrude
through the piercing opening 53 to puncture a desired surface. FIG.
3B shows the needle holding member 30 in its fully extended
position with the length of the needle holding member 30 adjusted
such that the disposable lancet 60 will strike the cap segment 50
in the fully extended position.
[0111] FIG. 3C also illustrates the needle holding member 30 in its
fully extended position. The length of the needle holding member
30, however, has been shortened such that the disposable lancet 60
does not strike the cap segment 50 in the fully extended position.
Thus, adjusting the length of the needle holding member 30 adjusts
the penetration depth of the disposable lancet 60.
[0112] So as to move the needle holding member 30 from its cocked,
retracted position to its fully extended position, a biasing
element is included. While other types of biasing elements may be
used, the biasing element is preferably in the form of a coil
spring 40 disposed about the distal segment 32 of the needle
holding member 30. Other types of springs which may be useful as
biasing elements include leaf springs and C-springs. The spring 40
is positioned such that it will abut a flanged lip 34 formed in the
needle holding member 30 and will abut the housing 20. Preferable a
side of the spring 40 which abuts the housing 20 will have a larger
relaxed diameter than an opposite side of the spring 40. In a first
embodiment, illustrated in FIG. 2, one end of the spring 40 is
positioned to contact the guide collar 28 of the housing 20 and is
preferably embedded in an annular ridge 42 formed in the housing
20. The opposite side of the spring 40, which abuts the needle
holding member 30 is preferably contained within an annular ridge
43 formed at the flanged lip 34. In the embodiment of FIGS. 1-7,
the spring 40 abuts the housing 20 at peg 28' which is positioned
through the slot 33' in the distal segment 32 as shown in FIG. 7.
In an alternative embodiment illustrated in FIG. 8, the spring 40
abuts peg 28'' which is also positioned through the slot 33' in the
distal segment 32.
[0113] With the spring 40 positioned appropriately, when extended,
the spring 40 will urge the needle holding member 30 toward the
open second end 24 of the housing 20. When the needle holding
member 30 is in its retracted, cocked position, as detailed in FIG.
2, the spring 40 is compressed. Once the needle holding member 30
is allowed to move to its extended position, the spring 40 will
quickly and immediately move the needle holding member 30 to the
fully extended position with the point 61 of the disposable lancet
60 protruding through the piercing opening 53 to puncture a desired
surface. As evident from the above discussion and from the
drawings, the spring or biasing element 40 preferably expands in a
direction of the longitudinal axis B of the lancet holding member
or lancet holder 30 and preferably pushes the lancet holding member
or lancet holder 30. Depending upon how the length of the needle
holding member 30 is set, the disposable lancet 60 will strike the
cap segment 50, (see FIG. 3B), or will not strike the cap segment
50, (see FIG. 3C), in the fully extended position.
[0114] After this initial release and movement to the fully
extended position, the spring 40 relaxes such that the needle
holding member 30 will move slightly back toward the closed first
end 22 of the housing 20, as illustrated in FIG. 3D, into a relaxed
position wherein the point 61 of the disposable lancet 60 is
contained within the cap segment 50 and will not accidentally
contact a user unnecessarily.
[0115] In order to hold the needle holding member 30 in its cocked,
retracted position, and subsequently allow release by a user in
order to initiate movement of the needle holding member 30 to its
extended position, a trigger is included. The trigger preferably
includes an aperture 29 foamed in the housing 20 near the open
second end 24 thereof. Also included as part of the trigger is an
outwardly biased engagement segment or cantilever extension 36
which extends from the distal central segment 35 of the needle
holding member 30. The engagement segment or cantilever extension
36 includes a distal lip segment 37 which contacts an interior of
the housing 20 as the needle holding member 30 slides within the
channel 26. Contact is made due to the outwardly biasing nature of
the engagement segment 36, and when the needle holding member 30 is
pushed into the housing 20 so as to be in its retracted, cocked
position, the distal lip segment 37 extends upwardly into the
aperture 29 formed in the housing 20 so as to contact the housing
20 inside the aperture 29 and maintain the needle holding member 30
in its retracted, cocked position and the spring 40 in its
compressed position.
[0116] In order to release the needle holding member 30 from its
retracted, cocked position, the engagement segment 36 must be
pushed such that the distal lip segment 37 exits the aperture 29
and the needle holding member 30 can move freely to its fully
extended position due to the biasing force of the spring 40. In
order to push the engagement segment 36, a trigger button 45 is
disposed within the aperture 29. The trigger button 45, as detailed
in FIG. 4, includes an upper section 46 which protrudes through the
aperture 29 to an exterior of the housing 20 and a flanged base
portion 47 which is disposed within the housing 20 so as to assure
that the trigger button 45 does not get pushed out of the housing
20 through the aperture 29. Disposed within the base 47 is a
channel 48 positioned such that the distal lip segment 37 of the
engagement segment 36 will slide therethrough and be able to engage
the housing 20 within the aperture 29.
[0117] The reusable lancet device 10 of the present invention, as
recited, includes a relatively small number of distinct pieces. The
use of such a small number of pieces enables quick and
substantially inexpensive manufacturing of the reusable lancet
device 10 of the present invention, thereby making a cost effective
product which can be available to the public without compromising
safety.
[0118] During use, the needle holding member 30 is moved to its
retracted, cocked position by removing the cap segment 50, placing
the disposable lancet 60 within the needle holding member 30, and
pushing the disposable lancet 60 and accordingly the needle holding
member 30 into the housing 20 until the trigger engages. Once
properly positioned, the protective cap 62 can be removed from the
disposable lancet 60 so as to expose the point 61, and the cap
segment 50 is replaced thereover. Due to the triangular shape, the
cap segment 50 will securely and properly fit over the housing 20
no matter which orientation a user utilizes to push the cap segment
50 onto the housing 20. After a single use of the disposable lancet
60, the cap 50 is removed, the disposable lancet 60 is removed and
discarded appropriately, and the reusable lancet device 10 of the
present invention is ready for an additional use. As evident from
the above discussion and from the drawings, the lancet holding
member or lancet holder 30 is preferably separate from the lancet
60.
[0119] When a user wishes to adjust the length of the needle
holding member 30, the cap segment 50 is removed. The proximal
segment 38 and the proximal central segment 31 are rotated relative
to each other by use of the threaded connection such that the
protruding element 76 snaps into and out of grooves 78. To fix the
length of the needle holding member, the user leaves the protruding
element 76 engaged in a particular groove 78. The cap segment 50 is
then put back on the housing to cover the length adjustment
mechanism 70 so that the reusable lancet device is again ready for
use. At this point, it should be noted that once the user adjusts
the penetration depth to an appropriate depth, the penetration
depth usually does not need to be adjusted again.
[0120] FIG. 10 shows another embodiment for adjusting the length of
the needle holding member. The proximal central segment 31 is
provided with a spring-biased cylindrical element 80 comprised of a
protruding element 82 and a spring 84. Although the spring-biased
element 80 is shown as being cylindrical, other shapes such as
square may be useful. The spring-biased element 80 is perpendicular
to an axis of the proximal central segment 31. Of course, the
spring-biased element 80 does not need to be exactly perpendicular
to the proximal central segment 31.
[0121] The proximal segment 38 is provided with a plurality of
holes 86. The holes 86 are located at different positions with
respect to the axial length of the proximal segment 38. For
example, the holes 86 may be located at different axial and radial
positions so as to foam a spiral effect about the proximal segment
38. Instead of holes 86, the proximal segment 38 could be provided
with recesses for the spring-biased element 80 to engage.
[0122] The spring-biased element 80 and the holes 86 are designed
to engage each other to fix the length of the needle holding member
30. The length of the needle holding member 30 may be adjusted by
changing the hole 86 in which the spring-biased element 80 is
engaged. The embodiment shown in FIG. 10 may be modified such that
the proximal segment is provided with the spring-biased element and
the proximal central segment is provided with the holes.
[0123] FIG. 11 illustrates another embodiment for adjusting the
length of the needle holding member 30. The proximal segment 38 has
an interior provided with a plurality of grooves 90 formed by
ridges 92. The proximal segment 38, which is formed of a resilient
material, also has a pair of handles 94 on a distal end which can
be grabbed by a user to separate the sides having the grooves
90.
[0124] The proximal central segment 31 includes a neck 96 provided
with two ridges 98. The ridges 98 are designed to engage the
grooves 90 of the proximal segment 38.
[0125] The length of the needle holding member 30 is adjusted by
changing the groove 90 in which the ridges 98 of the neck 96 are
engaged. To facilitate changing the length, a user may grab handles
94 to increase the distance between the grooves 90.
[0126] The embodiment shown in FIG. 11 may be modified to form the
ridges as a single ridge which forms a circle about the top of the
head of the proximal central segment. In this modified embodiment,
the groove in which the ridge is engaged is changed by forcing the
ridge from one groove to another groove. Accordingly, handles are
omitted from this modified embodiment. The ridges, of course, may
also number greater than two.
[0127] FIG. 12 shows another embodiment for adjusting the length of
the needle holding member. The proximal segment 38 has an interior
which is provided with a plurality of grooves 100 formed by ridges
102.
[0128] The proximal central segment 31 has a pair of leaf springs
104 for engaging the grooves 100. Although a pair of leaf springs
104 are shown, a different number of leaf springs may be used. A
distal end of each leaf spring is preferably provided with a pair
of buttons 106 which allow a user to push the leaf springs 104
together. FIG. 13 shows the proximal central segment 31 as molded
to show the direction in which the leaf springs 104 are biased.
Although the leaf springs 104 are shown as being made of a
resilient plastic, the leaf springs may be a separate piece formed
of a metal such as stainless steel or brass.
[0129] The length of the needle holding member 30 is adjusted by
changing the groove 100 in which the leaf springs 104 are engaged.
To facilitate changing the length, a user squeezes the leaf springs
104 together through use of buttons 106 to reduce the distance
between the leaf springs 104.
[0130] In another group of embodiments, the length of the needle
holding member may be fixed and the length of the housing is
adjusted to adjust the penetration depth of the lancet. In this
group of embodiments, the device is similar to that disclosed in
U.S. Pat. No. 5,464,418 to SCHRAGA, the disclosure of which is
herein incorporated by reference in its entirety, except for the
housing length adjustment mechanisms as discussed below. Thus, in
this group of embodiments, the needle holding member includes a
distal segment, a central segment, and the proximal segment.
[0131] FIG. 14 illustrates one embodiment for adjusting the housing
length. In FIG. 14, the needle holding member 30 is shown in its
fully extended position. The housing 20 comprises an upper housing
20A and a lower housing 20B. The upper housing 20A includes
internal threads 110, and the lower housing 20B includes external
threads 112. The position of the upper housing 20A relative to the
lower housing 20B may be adjusted via rotation about threads 110,
112.
[0132] The guide collar 28 of this embodiment is provided on the
lower housing 20B. The flanged end 33 of the distal segment 32 of
the needle holding member cooperates with the guide collar in the
same manner as described above. Thus, the guide collar 28 engages
the flanged end 33 provided on the needle holding member 30 to
thereby limit the amount of travel of the needle holding member 30.
Thus, the guide collar 28 of the lower housing 20A limits the
extent to which the needle holding member 30 extends in its fully
extended position such that adjusting the position of the guide
collar 28 adjusts the penetration depth.
[0133] FIG. 15 illustrates another embodiment for adjusting the
length of the housing. In FIG. 15, the needle holding member 30 is
shown in its fully extended position. The housing 20 comprises an
upper housing 20A and a lower housing 20B. A spring 120 is disposed
between the upper housing 20A and the lower housing 20B to bias the
housing 20 into a short length. Spacers 122 of varying lengths may
be inserted between the spring-biased members of the housing 20 to
set the length of the housing 20 at desired lengths. The spacers
122 may be formed of most any material but are preferably formed of
rubber or nylon. Alternatively, the spacers may be in the form of
C-clip spacers.
[0134] The lower housing 20B includes a guide collar 28 for
engaging a flanged end 33 of the needle holding member 30 to
thereby limit the amount of travel of the needle holding member 30.
Thus, similar to the embodiment shown in FIG. 14, adjusting the
position of the guide collar 28 limits the extent to which the
needle holding member 30 extends in its fully extended
position.
[0135] FIG. 16 illustrates yet another embodiment for adjusting the
length of the housing. In FIG. 16, the needle holding member 30 is
shown in its fully retracted position. The housing 20 comprises an
upper housing 20A, a lower housing 20B, and a middle housing 20C.
The upper housing 20A includes internal threads 170 which cooperate
with external threads 172 on the middle housing 20C for adjusting
the length of the housing 20. Thus, adjusting the length of the
housing involves screwing or unscrewing the lower housing 20B
relative to the middle housing 20C.
[0136] Adjusting the length of the housing 20 adjusts the position
of a guide collar 174 located on the middle housing 20C. The guide
collar 174 is designed to cooperate with a flange 176 located on
the needle holding member 30 to thereby limit the amount of travel
of the needle holding member 30. Thus, similar to the embodiments
of FIGS. 14 and 15, adjusting the position of the guide collar 174
limits the extent to which the needle holding member 30 extends in
its fully extended position.
[0137] A coil spring 178 is disposed between a lower housing guide
collar 180 and a lock retainer 182. The lock retainer 182 includes
two holes 184 into which two fingers 186 of the needle holding
member 30 are inserted and snapped into place. The lower housing
20B includes a cap 188 which provides access into the lower housing
20B. Access into lower housing 20B facilitates positioning of coil
spring 178 during assembly.
[0138] During assembly, the needle holding member 30 is inserted
into lower housing 20B. After the coil spring 178 is placed around
the needle holding member 30, the lock retainer is attached to the
needle holding member 30 to hold the coil spring 178 in position.
After this assembly, the cap 188 is inserted into the lower housing
20B to prevent access to the interior of the lower housing 20B.
[0139] Once the device has been assembled, to cock the needle
holding member 30, the lower housing 20B is pulled out of the
middle housing 20C to pull the needle holding member 30 until a
trigger, not shown, which is similar to the trigger of the
embodiment shown in FIGS. 1-7, engages the needle holding member
30. Upon release of the lower housing 20B, the coil spring 178
biases the lower housing 20B back into the middle housing 20C.
[0140] As evident from the above discussion and from the drawings,
the housing 20A may comprise a distal end opening. The lancet
device may further comprise an end cap (20B and 188) covering the
distal end opening of the housing 20A. The lancet device may
further comprise an additional biasing element 178 which biases the
end cap (20B and 188) toward the housing 20A. The end cap (20B and
188) may be associated with the lancet holding member 30, wherein
the lancet device is cocked by pulling the end cap (20B and 188)
away from the housing 20A until the trigger 45 engages the lancet
holding member 30. A portion of the end cap (20B and 188) may be
positioned within the housing 20A.
[0141] Thus, as evident from the above discussion and from the
drawings, the lancet device may include a generally elongate
housing 20A having a forward end opening and a back end opening; a
cap 50 with a through hole 53 at a forward end; a lancet holder 30,
slidably mounted within the housing 20A; a biasing element 40 which
biases the lancet holder 30 toward the forward end opening of the
housing 20A; a button 45, movable between a first position in which
the lancet holder is restrained when the lancet device is cocked
and a second position in which the restraint is removed, permitting
the biasing element 40 to thrust the lancet holder 30 forward; and
a closure (188, 20B) at the back end of the housing, including an
adjustment element comprising a protrusion 174 that stops the
forward motion of the lancet holder 30 at a predetermined position,
and wherein the adjustment element adjusts the position of the
protrusion 174 to controllably change and reset the predetermined
position at which the lancet holder 30 is stopped. The lancet
device may be cocked by pulling the closure (188, 20B) away from
the housing until the button 45 engages the lancet holder 30. The
adjustment element may comprise a threaded connection for attaching
the closure (188, 20B, 20C) to the housing 20A, whereby rotating
the closure (188, 20B, 20C) on the housing 20A positions the
protrusion 174 forward and back.
[0142] FIG. 16 also relates to an embodiment in which a first guide
wall 174 is disposed within a first housing 20A. The first guide
wall 174 extends transverse to an axis A-A running through the
first housing 20A and the wall 174 includes an opening. The needle
holding member 30 is at least partially contained within the first
housing 20A. At least a portion of the needle holding member is
able to move within the opening of the first guide wall 174. A
first spring 40 biases the needle holding member 30 toward an
extended position. The first spring 40 surrounds a portion of the
needle holding member 30 and is disposed between the first guide
wall 174 and a shoulder 34 of the needle holding member 30. The
needle holding member 30 includes a projecting portion 37 arranged
between a proximal end of the needle holding member 30 and the
shoulder 34 of the needle holding member 30. The projecting portion
37 acts to retain the needle holding member 30 in the retracted
position (see e.g., FIG. 2). A movable second housing 20B includes
an upper or proximal end, a lower or distal end and a second guide
wall 180 arranged at the proximal end of the second housing 20B.
The second guide wall 180 extends transversely to axis A-A and
includes an opening. A portion of the needle holding member 30 is
able to move within the opening of the second guide wall 180. The
second housing 20B is configured to move the needle holding member
30 to the retracted position when the second housing 20B is moved
away from the first housing 20A. The proximal end of the second
housing 20B is configured to move axially within the lower or
distal end of the first housing 20A. A second spring 178 is
utilized for biasing the second housing 20B towards the first
housing 20A. The second spring 178 surrounds a portion of the
needle holding member 30 and is disposed between the second guide
wall 180 and a distal end 186 of the needle holding member 30. A
lock retainer 182 is mounted to the distal end 186 of the needle
holding member 30 and the distal end 186 of the needle holding
member 30 has shoulders that engage the lock retainer 182. As is
evident from the embodiment shown in FIG. 16, at least a portion of
the needle holding member 30 is always retained within the first
housing 20A.
[0143] FIG. 16 also relates to an embodiment in which a first
housing 20A includes a proximal end and a lower or distal end. A
second housing 20C is at least partially disposed in the first
housing 20A. A guide wall 174 is arranged on the second housing
20C. The guide wall 174 extends transversely to the axis A-A and is
disposed within the first housing 20A. The guide wall 174 include
an opening. The needle holding member 30 is at least partially
contained within the first housing 20A and the second housing 20C.
At least a portion of the needle holding member 30 is able to move
within the opening of the guide wall 174 of the second housing 20C.
A first spring 40 is utilized for biasing the needle holding member
30 toward an extended position. The first spring 40 surrounds a
portion of the needle holding member 30 and is disposed between the
guide wall 174 of the second housing 20C and a shoulder 34 of the
needle holding member 30. A third housing 20B includes an upper or
proximal end, a lower or distal end and a guide wall 180. The third
housing 20B is configured to move the needle holding member 30 to
the retracted position when the third housing 20B is moved away
from the first housing 20A. The guide wall 180 of the third housing
includes an opening. At least a portion of the needle holding
member 30 is able to move within the opening of the guide wall 180
of the third housing 20B. The proximal end of the third housing 20B
is configured to move axially within the distal end of the first
housing 20A. A second spring 178 is utilized for biasing the third
housing 20B towards the first housing 20A. The second spring 178
surrounds a distal portion of the needle holding member 30 and is
disposed between the guide wall 180 of the third housing 20B and a
distal end 186 of the needle holding member 30. A lock retainer 182
is mounted to the distal end 186 of the needle holding member 30.
As is evident from FIG. 16, at least a portion of the needle
holding member 30 is always retained within the first housing
20A.
[0144] In yet another group of embodiments, the penetration depth
is adjusted by rotating the housing relative to the needle holding
member to cause the needle holding member to engage different
stops. The stops are arranged such that aligning the needle holding
member with different stops results in different penetration
depths. In this group of embodiments, the needle holding member may
be of fixed length with a distal segment, a central segment, and a
proximal segment as disclosed in U.S. Pat. No. 5,464,418 to
SCHRAGA, the disclosure of which is herein incorporated by
reference in its entirety.
[0145] FIG. 17 illustrates an embodiment for adjusting the
penetration depth by changing which stop is engaged by rotating a
portion of the housing 20 relative to the needle holding member 30.
The housing comprises an upper housing 20A and a lower housing 20B.
The upper housing 20A includes internal threads 130, and the lower
housing 20B includes external threads 132. The position of the
upper housing 20A relative to the lower housing 20B may be adjusted
via rotation about threads 130, 132.
[0146] The lower housing 20B includes a plurality of stops 134 for
limiting the travel of the needle holding member 30. The stops 134
are located at different radial positions and at different axial
positions to preferably form a spiral staircase effect on the
interior of the lower housing 20B.
[0147] The needle holding member 30 includes a finger 136 for
engaging one of these stops 134 at a time. Rotation of the upper
housing 20A and lower housing 20B relative to each other causes the
finger 136 of the needle holding member 30 to become aligned with
different stops 134, one at a time. Since the stops 134 are located
at different positions relative to the axial length of the lower
housing 20B, the amount of travel of the needle holding member 30
is limited to different lengths. Thus, changing which stop engages
the finger 136 of the needle holder member 30 adjusts the extent to
which the needle holding member 30 extends in its fully extended
position such that the penetration depth is adjusted.
[0148] As evident from the above discussion and from FIGS. 14, 16,
and 17, the depth adjustment mechanism (20B, FIG. 14; 20C, FIG. 16;
20B, FIG. 17) may be rotatably mounted on the housing 20A. Also as
evident from the above discussion and from FIGS. 14, 16, and 17,
rotation of the depth adjustment mechanism may be limited by the
housing.
[0149] FIG. 18 illustrates another embodiment for adjusting which
stop is engaged, wherein rotation of the needle holding member
relative to the housing adjusts the penetration depth. A housing 20
includes a plurality of stops 140 for limiting the travel of the
needle holding member 30. The stops 140 are located at different
radial positions and at different axial positions to preferably
form a spiral staircase effect on the interior of the housing
20.
[0150] The needle holding member 30 includes a finger 142 for
engaging one of these stops 140 at a time. Rotation of the needle
holding member 30 relative to the housing 20 causes the finger 142
of the needle holding member 30 to become aligned with different
stops 140, one at a time. Since the stops 140 are located at
different positions relative to the axial length of the housing 20,
the amount of travel of the needle holding member 30 is limited to
different lengths. Thus, changing which stop 140 engages the finger
142 of the needle holder member 30 adjusts the extent to which the
needle holding member 30 extends in its fully extended position to
adjust the penetration depth.
[0151] In yet another group of embodiments, the reusable lancet
device is similar to that disclosed in U.S. Pat. No. 5,464,418 to
SCHRAGA, the disclosure of which is herein incorporated by
reference in its entirety, and includes a needle holding member
which includes a distal segment, a central segment, and a proximal
segment. In this group of embodiments, the structure of the
proximal segment for holding the disposable lancet includes a
cavity. The bottom of this cavity includes a member whose location
may be adjusted. By adjusting the location of this member, the
depth of the cavity is adjusted such that the distance which the
lancet extends out of the cavity is adjusted to adjust the
penetration depth.
[0152] FIG. 19 illustrates an embodiment for adjusting the cavity
depth. A proximal segment 38 of the needle holding member 30
includes a cavity 150 for holding a disposable lancet 60. The shape
of the cavity 150 is preferably round, but is designed to accept a
disposable lancet. The bottom of the cavity 150 is formed by an
adjustable bottom member such as a screw 152. By screwing or
unscrewing the screw 152 before the disposable lancet 60 is placed
in the cavity 150, the depth of the cavity 150 may be adjusted to
change the distance that the disposable lancet 60 extends out of
the cavity 150. By changing the distance that the disposable lancet
60 extends out of the cavity 150, the penetration depth is
adjusted.
[0153] FIG. 20 shows another embodiment for adjusting the cavity
depth. A proximal segment 38 of the needle holding member includes
a cavity 160 for holding a disposable lancet 60. The preferred
shape of cavity 160 is round. The bottom of the cavity 160 is
formed by an adjustable bottom member which comprises a nail 162
having a tail 164 provided with a rack 166. The proximal segment 38
of the needle holding member 30 also includes a turn-key 168
disposed perpendicular to the nail 162, and a head (not shown)
which is exposed on the exterior of the proximal segment 38. The
turn-key 168 is a screw provided with a pinion 169 at a distal end
for engaging the rack 166 of the nail 162. By rotating the turn-key
168, the location of the adjustable bottom member may be changed to
adjust the depth of the cavity 160 of the proximal segment.
Changing the location of the adjustable bottom member changes the
distance that the disposable lancet 60 extends out of the cavity
160 to thereby adjust the penetration depth. Once the height of the
adjustable bottom member is set appropriately, the rotational
position of the turn-key 168 could be locked by changing the
vertical position of the turn-key 168 such that the pinion 169
engages a surface or a notch (not shown in the drawings) of the
proximal segment 38. The turn-key may also interact with the
adjustable bottom member in other manners in which rotational
motion in one direction may be converted into translational motion
in a perpendicular direction, such as a worm gear arrangement in
which the turn key and the adjustable bottom member have threads
which interact with each other.
[0154] As evident from the above discussion and from the drawings,
the depth adjustment mechanism is preferably disposed out of
contact with the cover when the cover is covering the proximal end
opening of the housing.
[0155] Preferably, the components of the reusable lancet device of
the present invention are made of plastic. Examples of desirable
plastics include polypropylene (PP), polyvinyl chloride (PVC),
acrylonitrile butadiene styrene (ABS), nylon, linear
polyoxymethylene-type acetal resin, e.g., "DELRIN", and
polycarbonate (PC), e.g., "LEXAN".
[0156] To assist in determining the penetration depth of the
lancet, indicia can be included on members that change position
relative to each other when the penetration depth is adjusted. For
example, as illustrated in FIG. 1, indicia 87 and 88 can be
included on proximal segment 38 and proximal central segment 31.
The indica can comprise elements which can be viewed by shape
and/or color, such as reference numerals, letters, lines and
geometric shapes. Moreover, the indica may be sensed by touch, such
as raised elements, including braille. As illustrated, indica 87
includes a line and indica 88 includes reference numerals. The
reference numerals can be numbers, such as from 0 to 5, with 0
being no penetration to 5 being maximum penetration.
[0157] While the invention has been described in connection with
certain preferred embodiments so that aspects thereof may be more
fully understood and appreciated, it is not intended to limit the
invention to these particular embodiments. On the contrary, it is
intended to cover all alternatives, modifications and equivalents
as may be included within the scope of the invention as defined by
the appended claims.
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