U.S. patent application number 10/894865 was filed with the patent office on 2005-03-31 for single use lancet assembly.
Invention is credited to Schraga, Steven.
Application Number | 20050070945 10/894865 |
Document ID | / |
Family ID | 46302379 |
Filed Date | 2005-03-31 |
United States Patent
Application |
20050070945 |
Kind Code |
A1 |
Schraga, Steven |
March 31, 2005 |
Single use lancet assembly
Abstract
A single use lancet device having a housing, with an open
interior and an access opening defined therein, a lancet, with a
body and a piercing tip, and disposed in the open interior of the
housing so as to move between a cocked orientation and a piercing
orientation, a driving assembly structured to move the lancet into
the piercing orientation, and a restrictor assembly having a
shoulder element and a restrictor panel operatively associated with
the lancet and the housing and structured to pass over the
restrictor panel upon the lancet moving from its cocked orientation
to its piercing orientation, and to abut the restrictor panel upon
attempted movement of the lancet back into its cocked orientation
after movement into the piercing orientation, thereby preventing
the lancet from moving back into the cocked orientation and
preventing re-use of a contaminated piercing tip.
Inventors: |
Schraga, Steven; (Surfside,
FL) |
Correspondence
Address: |
MALLOY & MALLOY, P.A.
2800 S.W. Third Avenue
Historic Coral Way
Miami
FL
33129
US
|
Family ID: |
46302379 |
Appl. No.: |
10/894865 |
Filed: |
July 20, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10894865 |
Jul 20, 2004 |
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09903877 |
Jul 10, 2001 |
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6764496 |
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09903877 |
Jul 10, 2001 |
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09432351 |
Nov 2, 1999 |
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6258112 |
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Current U.S.
Class: |
606/182 |
Current CPC
Class: |
A61B 5/150412 20130101;
A61B 5/150022 20130101; A61B 5/1513 20130101; A61B 5/150564
20130101; A61B 5/15144 20130101; A61B 5/150618 20130101; A61B
5/15117 20130101; A61B 5/15113 20130101; A61B 5/150916 20130101;
A61B 5/150717 20130101; A61B 5/150183 20130101 |
Class at
Publication: |
606/182 |
International
Class: |
A61B 017/32 |
Claims
What is claimed is:
1. A single use lancet device comprising: a housing; a lancet; said
lancet including a piercing tip; said lancet at least partially
disposed in said housing and structured to move at least between a
cocked orientation and a piercing orientation; a biasing element
structured to move said lancet at least temporarily into said
piercing orientation; an actuator structured to be actuated by a
user so as to result in said biasing element moving said lancet at
least temporarily into said piercing orientation; and a restrictor
assembly independent of said biasing element and structured to
engage said lancet and thereby prevent said lancet from being moved
back into said cocked orientation after movement of said lancet at
least temporarily into said piercing orientation even if an
implement pushes said lancet.
2. A single use lancet as recited in claim 1 wherein said biasing
element comprises a spring.
3. A single use lancet as recited in claim 1 wherein said actuator
comprises a button structured to protrude from said housing when
said lancet is disposed in said cocked orientation.
4. A single use lancet as recited in claim 1 wherein said
restrictor assembly comprises an abutment structure cooperatively
disposed between said housing and said lancet and structured to
prevent said lancet from moving into said cocked orientation after
movement into said piercing orientation.
5. A single use lancet as recited in claim 4 wherein said abutment
structure comprises a shoulder element and a restrictor panel, said
restrictor panel and said shoulder element structured to pass one
another upon said lancet moving from said cocked orientation to
said piercing orientation, and to abut one another upon attempted
movement of said lancet into said cocked orientation after movement
into said piercing orientation.
6. A single use lancet as recited in claim 5 wherein said shoulder
element is structured to move relative to said restrictor panel so
as to facilitate passage of said restrictor panel and said shoulder
element past one another in a first direction corresponding
movement of said lancet from said cocked orientation to said
piercing orientation, and to block movement of said restrictor
panel in a second direction generally opposite said first direction
subsequent to said passage past one another in said first
direction.
7. A single use lancet as recited in claim 6 wherein said shoulder
element comprises a biased finger extending from said lancet, and
said restrictor panel comprises a protruding element protruding
from said housing.
8. A single use lancet as recited in claim 7 wherein said
protruding element includes a sloped configuration which downwardly
slopes away from said piercing tip of said lancet so as to
facilitate passage thereof past said biased finger upon said lancet
moving in a first direction towards said access opening.
9. A single use lancet as recited in claim 4 wherein said abutment
structure further comprises said actuator structured to release
said lancet from said cocked orientation.
10. A single use lancet as recited in claim 1 further comprising a
protective cover structured to at least partially and removably
cover said piercing tip of said lancet at least prior to movement
of said lancet into said cocked orientation.
11. A single use lancet device comprising: a housing; a lancet;
said lancet disposed at least partially in an interior of said
housing and structured to move relative to said housing; a biasing
element structured to move said lancet into a second position
relative to said housing wherein said lancet pierces a patient's
skin from a first position relative to said housing wherein said
lancet is disposed immediately prior to being moved by said biasing
element towards and into said second position; an actuator
structured to be actuated by a user so as to result in said biasing
element moving said lancet; and an abutment structure independent
of said biasing element and cooperatively disposed between said
housing and said lancet, said abutment structure structured to
prevent movement of said lancet back into said first position
relative to said housing after movement of said lancet into said
second position relative to said housing even if an implement
pushes said lancet towards said first position relative to said
housing.
Description
CLAIM OF PRIORITY
[0001] The present application is a Continuation-In-Part
application of previously filed, now pending application having
Ser. No. 09/903,877 which was filed on Jul. 10, 2001, which is a
continuation-in-part patent application having Ser. No. 09/432,351
which was filed on Nov. 2, 1999 and which issued as U.S. Pat. No.
6,258,112 on Jul. 10, 2001, both of which are hereby incorporated
by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to a single use lancet
assembly which is substantially compact, yet effective for piercing
a patient's finger or other body part to obtain a blood sample. The
single use lancet device is further configured to be substantially
safe to transport and to ensure that subsequent uses of a
contaminated lancet tip cannot occur.
[0004] 2. Description of the Related Art
[0005] Lancets are commonly utilized instruments which are employed
both in hospitals and other medical facilities, as well as by
private individuals, such as diabetics, in order to prick or pierce
a patient's skin, typically on a finger of a patient, thereby
leading to the generation of a blood sample which can be collected
for testing. Because of the wide spread use of such lancets, there
are a variety of lancet devices which are available for utilization
by patients and/or practitioners in a variety of different
circumstances.
[0006] For example, a typical lancet may merely include a housing
with a sharp piercing tip that is pushed into the patient's skin.
More commonly, however, lancet devices, which house a piercing tip
and/or a lancet, have been developed which effectively encase and
fire the lancet into the patient's skin, thereby eliminating the
need for the person taking the sample to actually push the lancet
tip into the skin.
[0007] Within the various types of specialized lancet devices, one
variety are typically configured for multiple and/or repeated uses,
while another category is particularly configured for single use,
after which the entire device is disposed of. Looking in particular
to the single use, disposable lancet devices, such devices
typically include a housing which contains and directs or drives a
piercing tip into the patient's skin, and which is disposed of
along with the used lancet. Naturally, so to make such disposable
devices cost effective for frequent use, such devices tend to be
rather simplistic in nature providing only a sufficient mechanism
for firing, and not overly complicating the design so as to
minimize that cost.
[0008] While existing single use devices are generally effective
for achieving the piercing of the skin required for effective
operation, such single use, disposable devices typically do not
incorporate a large number of safety features to ensure the safe
use and disposal of the device. For example, one primary area of
safety which must be addressed with all lancet devices pertains to
the purposeful and/or inadvertent reuse of a contaminated lancet.
Unfortunately, most currently available single use lancet devices
are configured such that after a use thereof has been achieved, it
is possible for a patient to re-cock the device, thereby allowing
for a subsequent, inappropriate use.
[0009] As a result, it would be highly beneficial to provide a
single use lancet device which is substantially compact and
disposable, can be manufactured in a substantially cost effective
manner, and which nevertheless is substantially safe to utilize,
affirmatively preventing re-use, once contaminated.
SUMMARY OF THE INVENTION
[0010] The present invention relates to a single use lancet device
configured to pierce a patient's skin and be useable only a single
time, thereby preventing reuse of a contaminated lancet piercing
tip. In particular, the present single use lancet device includes a
housing having an open interior area and an access opening defined
therein. The housing is preferably compact and includes a lancet
disposed within its open interior.
[0011] Looking to the lancet, it is preferably of the type which
includes a body and a piercing tip. It is the piercing tip which
includes the pointed configuration structured to penetrate or
pierce a patient's skin for the drawing of blood. Moreover, the
lancet is cooperatively disposed within the open interior of the
housing such that the lancet may move between at least a cocked
orientation and a piercing orientation wherein the patient's skin
is penetrated by the piercing tip.
[0012] Also operatively associated with the lancet is a driving
assembly. The driving assembly is structured to move or drive the
lancet, at least temporarily, into the piercing orientation from
the cocked orientation. Preferably, however, the device is
configured such that the cocked orientation is generally maintained
until affirmatively released by a user. Along these lines, the
present single use lancet device also includes an actuation button
operatively associated with the lancet. The actuation button is
structured to protrude from the housing, at least when the lancet
is disposed in the cocked orientation, so as to be effectively
actuatable. When the lancet is in the cocked orientation, the
actuation assembly maintains the lancet in that cocked orientation,
however, when it is actuated, such as by being pushed inward, the
lancet is released from the cocked orientation and the driving
assembly propels the lancet at least temporarily into its piercing
orientation wherein the piercing tip protrudes through the access
opening of the housing.
[0013] In order to ensure that lancet device can only be used a
single time, the present single use lancet device further includes
abutment structure cooperatively disposed between the housing and
the lancet. The abutment structure is configured to prevent the
lancet from moving into the cocked orientation after movement into
the piercing orientation. Preferably, the abutment structure
includes a shoulder element and a restrictor panel operatively
associated with the lancet and the housing. In particular, the
shoulder element is structured to pass over the restrictor panel
when the lancet moves from its cocked orientation to its piercing
orientation. Conversely, however, when a user attempts to move the
lancet back into the cocked orientation after it moved into the
piercing orientation, the restrictor panel abuts the shoulder
element preventing further movement. As a result, movement of the
lancet into the cocked orientation is prevented once the lancet has
been used a single time, and subsequent uses of a contaminated
lancet are prevented.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] For a fuller understanding of the nature of the present
invention, reference should be had to the following detailed
description taken in connection with the accompanying drawings in
which:
[0015] FIG. 1 is a perspective illustration of an embodiment of the
single use lancet device of the present invention;
[0016] FIG. 2 is a side cross section view of the single use lancet
device of the present invention in an unused, initially un-cocked
orientation;
[0017] FIG. 3 is a side cross section view of the single use lancet
device of the present invention in a cocked orientation;
[0018] FIG. 4 is a side cross section view of the single use lancet
device of the present invention after it has moved into a piercing
orientation from the cocked orientation;
[0019] FIG. 5 is a front cross section view of the single use
lancet device of the present invention; and
[0020] FIG. 6 is a side cross section view of another embodiment of
the single use lancet device of the present invention after the
lancet has moved from the cocked orientation through the piercing
orientation.
[0021] Like reference numerals refer to like parts throughout the
several views of the drawings.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0022] Shown throughout the Figures, the present invention is
directed towards a single use lancet device, generally indicated as
10. In particular, the single use lancet device 10 of the present
invention includes a housing, generally indicated as 20. The
housing 20 is preferably substantially small and compact, and may
be made of one or a plurality of segments, preferably of a
generally rigid, disposable material, such as plastic. The housing
20 includes an at least partially open interior 28 and at least one
access opening 22 defined therein. The open interior 28 of the
housing 20 is preferably sized and configured to effectively
receive a lancet, generally 30 therein.
[0023] In particular, the lancet device 10 of the present invention
also comprises a lancet 30. The lancet 30 preferably includes a
body 32 and a piercing tip 34. The piercing tip 34 is what will be
used to pierce a person's skin so as to draw blood to be utilized
for a sample and or test procedure. Moreover, the body 32 may be
the shaft of the piercing tip 34 and/or an additional structure
such as that depicted in the Figures. Regardless, however, the
lancet 30 is structured to move within the open interior 28 of a
housing 20, preferably at least between a cocked orientation, as
depicted in FIG. 3, and a piercing orientation wherein the piercing
tip 34 of lancet 30 at least temporarily protrudes through the
access opening 22.
[0024] Looking in further detail to the illustrated lancet device
10, and the path of movement of the lancet 30 within the housing
20, when the lancet device 10 is initially obtained for use, the
lancet 30 is preferably maintained in an un-used, initially
un-cocked and pre-fired orientation, as best seen in FIG. 2. In
this initially un-cocked and pre-fired orientation a protective
cover 40 preferably extends into the open interior 28 of the
housing 20 so as to at least partially and removably cover the
piercing tip 34 of the lancet 30, thereby maintaining the safety
and sterility of the piercing tip 34 when not being used. In this
regard, the protective cover 40 may be formed from a variety of
preferably rigid materials and is structured to protrude from the
housing 20. Furthermore, the protective cover 40 may include an
enlarged head 42 configured to facilitate grasping thereof.
[0025] Preferably utilizing the protective cover 40, the protective
cover 40 is structured to be pushed inwardly into the housing by a
user, as depicted by the arrows on FIG. 2, thereby pushing the
lancet 30 further into the housing 20. Such pushing of the lancet
30 into the housing 20 results in a positioning of the lancet 30 in
its cocked orientation, best illustrated in FIG. 3. Once in the
cocked orientation, the protective cover 40 is then structured to
be removable from the piercing tip 34, such as by a twisting
thereof, thereby leaving the piercing tip 34 completely exposed for
use.
[0026] The single use lancet of the present invention further
includes a driving assembly, generally 38. The driving assembly 38
is particularly configured to move the lancet 30 at least
temporarily into its piercing orientation wherein the piercing tip
34 protrudes through the access opening 22 of the housing 20 a
desired amount. In particular, if desired, a depth adjustment
structure could be positioned at the access opening to control the
amount which the piercing tip protrudes from the housing 20. For
example, a threaded washer type element could be adjustably secured
to the housing 20 in generally surrounding relation to the access
opening 22.
[0027] Looking further to the driving assembly, preferably the
driving movement occurs when the lancet 30 is released from its
cocked orientation. In the illustrated embodiment, the driving
assembly 38 includes a biasing element operatively disposed between
the lancet 30 and the housing 20. Moreover, in the illustrated
embodiment a spring is preferably utilized, however, it is
recognized that a variety of other driving assemblies can be
utilized, including a wedge assembly, a hammer type assembly and/or
a resilient material plate, segment or extension, all of which may
be configured to move the lancet 30 from the cocked orientation
into the piercing orientation. Further, it is preferred that based
upon the sizing of the housing 20 and the nature and size of the
driving assembly 38, that after the lancet 30 has moved into the
piercing orientation wherein the piercing tip 34 protrudes through
the access opening 22, the lancet tends to be retracted back into
the housing, as best illustrated in FIG. 4. As a result, the used
piercing tip 34 is effectively concealed within the housing 20
subsequent to usage, protecting against inadvertent engagement
between a person and the used piercing tip 34.
[0028] In order to retain, and subsequently effectively release the
lancet 30 from its cocked orientation, the single use lancet 10 of
the present invention further includes an actuation assembly,
generally, 50. Although a variety of different actuation assemblies
may be incorporated so as to retain and then release the lancet 30
from its cocked orientation, which in the illustrated embodiment
allows the driving assembly to be released from its compressed
orientation, the actuation assembly 50 includes an actuation button
52. In the illustrated embodiment, the actuation button 52 is
structured to at least temporarily protrude from the housing 20,
such as through an actuation aperture 24. Furthermore, the
actuation button 52 is preferably secured, either directly or
indirectly to the lancet 30, so as to generally restrict movement
of the lancet 30 from the cocked orientation when it protrudes from
the housing 20. As a result, the cocked orientation is maintained
while the actuation button protrudes from the housing 20.
Specifically, in the illustrated embodiment, the actuation button
52 extends from the body 32 of the lancet 30 by a biased segment,
and as such, by abutting the housing 20 within the actuation
opening 24, movement of the lancet 30 from the cocked orientation
is prevented. When, however, the actuation button 52 is actuated,
such as by being pushed inwardly, into the housing, it is at least
temporarily concealed within the housing 20, removing the abutting
engagement and allowing the lancet 30 to freely move within the
housing 20, at least temporarily into the piercing orientation.
Although the preceding defines the illustrated actuation assembly,
it is understood that a variety of alternative actuation
assemblies, such as including separate elements to retain and to
release the lancet may also be provided, and or including
structures which are actually part of the driving assembly and/or
remain at least partially exposed and actuatable at all times, may
also be provided.
[0029] Looking in particular to FIG. 5, movement of the lancet 30
through the housing 20 is preferably maintained in a substantially
linear path by a guide assembly. In the illustrated embodiment, the
guide assembly includes at least one guide ridge 33 protruding from
the body 32 of the lancet 30, and at least one corresponding guide
track 25 structured to movably receive the guide ridge 33 therein.
The guide track 25 preferably extends at least partially along a
length of the open interior 28 of the housing 20 so as to maintain
the guide ridge 33 effectively therein during a necessary range of
motion of the lancet 30. As depicted in FIG. 5, preferably a pair
of guide ridges 33 are disposed on opposite sides of the lancet
body 32, with a corresponding pair of oppositely disposed guide
tracks 25 being defined in the housing. It is of course, however,
understood that the guide tracks 25 need not necessarily be
directly defined in the housing 20, but may be additional elements
secured therein, and conversely the guide track(s) may be defined
in or on the lancet body 32, with the guide ridge(s) extending
inwardly from the housing 20.
[0030] The single use lancet 10 of the present invention further
includes a restrictor assembly, generally 60. The restrictor
assembly 60 is structured to substantially prevent the lancet 30
from moving back into the cocked orientation of FIG. 3 after it has
moved, even momentarily, into the piercing orientation wherein a
patient's skin may be pierced and the piercing tip 34 become
contaminated. In this regard, the cocked orientation may be defined
by the lancet being positioned such that actuation of the actuation
assembly causes the driving assembly to urge the lancet into the
piercing orientation. In the illustrated embodiment, the restrictor
assembly 60 is structured such that when the lancet 30 is disposed
in the initially un-cocked orientation, as best seen in FIG. 2,
movement of the lancet 30 back into the cocked orientation can
effectively result despite the restrictor assembly 60. After,
however, the lancet 30 has moved into its piercing orientation
wherein the piercing tip 34 has protruded through the access
opening 22 of the housing 20, the restrictor assembly is configured
such that the lancet 30 can no longer be pushed back into the
cocked orientation. As a result, a patient, can neither
accidentally nor purposefully reuse the single use lance 10 of the
present invention after it has been fired.
[0031] In the illustrated embodiment, the restrictor assembly 60
includes an abutment structure cooperatively disposed between the
housing 20 and the lancet 30. The abutment structure is configured
to physically prevent movement of the lancet back into the cocked
orientation. Preferably, the abutment structure comprises a
shoulder element 62 and a restrictor panel 64 configured to freely
pass one another when the lancet 30 moves from the cocked
orientation to the piercing orientation, but also configured to
abut one another upon attempted movement of the lancet 30 back into
the cocked orientation after it has moved into the piercing
orientation. Looking to FIG. 4, the illustrated shoulder element 62
includes an at least partially slopped and preferably biased
configuration, such as an elongate biased finger that at least
partially retracts inward towards the body 32 of the lancet 30 so
as to facilitate passage thereof past the restrictor panel 64. In
this regard, preferably mating slopped surfaces are provided on the
shoulder element 62 and the restrictor panel 64, thereby
facilitating the sliding passages past one another, and indeed,
promoting an at least partial retraction of the shoulder element 62
to further facilitate this passage past one another, upon movement
of the lancet 30 in a first direction towards the access opening 22
of the housing 20. The shoulder element 62 is also, however,
structured to generally expand after it has passed the restrictor
panel 64, such as back into its normal unretracted and/or
un-compressed orientation, such that it will abut the restrictor
panel 64 upon attempted movement of the lancet 30 in a second
direction opposite the access opening 22 of the housing 20.
[0032] Although an opposite configuration could be just as
effectively utilized, in the illustrated embodiment, the biased
finger 62 of the shoulder element extends from the lancet 30,
preferably generally toward the piercing tip 34 of the lancet 30.,
while the restrictor panel 64 protrudes from the housing 20,
extending into the open interior 28 of the housing 20. Along these
lines, the restrictor panel 64 includes a protruding element
preferably with the aforementioned slopped configuration which
downwardly slopes away from the piercing tip 34 of the lancet 30
facilitating the aforementioned sliding passage past the shoulder
element 62.
[0033] So as to provide generally secure movement restriction
through effective abutment, both the shoulder element 62 and the
restrictor panel 64 each preferably include abutment surfaces 63
and 65, respectably. The abutment surfaces 63 and 65 are structured
to generally engage and abut one another, as best illustrated in
FIG. 4, thereby preventing movement of the lancet 30 back into the
cocked orientation. In the illustrated embodiment, the abutment
surfaces 63, 65 are generally flat, although it is recognized that
interlocking fingers or wedges, and/or other types of engaging
structures that prevent relative movement in at least one direction
could also be effectively utilized.
[0034] Addressing further the restrictor assembly of the present
invention, it is understood that a variety of different restrictor
assemblies may be effectively utilized which prevent movement of a
lancet 30 back into a cocked orientation after the lancet 30 has
moved sufficiently forward and/or has moved into the piercing
orientation. As such, the embodiment illustrated in FIGS. 2 through
5 is merely a single illustration of a preferred contemplated
embodiment, and other alternative embodiments are also considered
within the scope of the restrictor assembly of the present
invention. By way of example, and looking specifically to FIG. 6,
the actuation button 52 itself may comprise part of the restrictor
assembly. In such an embodiment, a restrictor panel 25 is defined
in the housing 20, and the actuation button 52 as part of the
biased finger of the shoulder element, includes an abutment surface
54 which engages a confronting surface of the restrictor panel 25.
In such an embodiment, the initially un-cocked orientation provides
for the actuation button 52 to be initially disposed rearward of
the restrictor panel 25 so as to permit movement of the lancet 30
at least initially into the cocked orientation. Moreover, in this
embodiment, the previous embodiment, and/or any other alternative
embodiment, if desired, the protective cover 40 may be equipped
with an interior shield segment or other configuration which
extends into the housing and maintains the biased finger of the
shoulder element 62, or another component of the restrictor
assembly, in a generally compressed and/or retracted orientation
until the protective cover 40 is removed. As a result, in such an
embodiment, so long as the protective cover 40 is maintained on the
piercing tip 34, the lancet 30 is always able to return the cocked
orientation. Preferably, however, re-positioning of the protective
cover onto the piercing tip in such a manner as to be able to
"reset" the lancet 30, allowing to move once again into the cocked
orientation will be prevented.
[0035] Since many modifications, variations and changes in detail
can be made to the described preferred embodiment of the invention,
it is intended that all matters in the foregoing description and
shown in the accompanying drawings be interpreted as illustrative
and not in a limiting sense. Thus, the scope of the invention
should be determined by the appended claims and their legal
equivalents.
[0036] Now that the invention has been described,
* * * * *