U.S. patent application number 12/333526 was filed with the patent office on 2009-06-18 for blood collection device with tube retaining structure.
This patent application is currently assigned to Tyco Healthcare Group LP. Invention is credited to Todd M. Chelak, Michael J. Noble.
Application Number | 20090156963 12/333526 |
Document ID | / |
Family ID | 40428240 |
Filed Date | 2009-06-18 |
United States Patent
Application |
20090156963 |
Kind Code |
A1 |
Noble; Michael J. ; et
al. |
June 18, 2009 |
Blood Collection Device with Tube Retaining Structure
Abstract
A blood collection device is disclosed which includes a body
defining a receptacle dimensioned to receive a blood collection
tube. The body has a first open end and a second end supporting a
needle having a proximal end extending into the receptacle and a
distal end extending distally of the body. Retaining structure is
supported on the body. The retaining structure extends into the
receptacle and is configured to releasably retain the blood
collection tube within the receptacle.
Inventors: |
Noble; Michael J.; (St.
Charles, MO) ; Chelak; Todd M.; (Westborough,
MA) |
Correspondence
Address: |
TYCO HEALTHCARE GROUP LP
15 HAMPSHIRE STREET
MANSFIELD
MA
02048
US
|
Assignee: |
Tyco Healthcare Group LP
Mansfield
MA
|
Family ID: |
40428240 |
Appl. No.: |
12/333526 |
Filed: |
December 12, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61007639 |
Dec 14, 2007 |
|
|
|
Current U.S.
Class: |
600/582 |
Current CPC
Class: |
A61B 5/154 20130101;
A61B 5/1405 20130101; A61B 5/150389 20130101; A61B 5/15 20130101;
A61B 5/15003 20130101; A61B 5/1438 20130101; A61B 5/150473
20130101; A61B 5/150572 20130101; A61B 5/1444 20130101; A61B
5/150732 20130101 |
Class at
Publication: |
600/582 |
International
Class: |
A61B 5/15 20060101
A61B005/15 |
Claims
1. A blood collection device comprising: a body defining a
receptacle dimensioned to receive a blood collection tube, the body
having a first open end and a second end supporting a needle, the
needle having a proximal end extending into the receptacle, and a
retaining structure extending into the receptacle configured to
releasably retain the blood collection tube within the
receptacle.
2. The blood collection device according to claim 1, wherein the
needle further comprises a distal end extending distally of the
body.
3. The blood collection device according to claim 1, wherein the
retaining structure is integrally formed with the body defining the
receptacle.
4. The blood collection device according to claim 1, wherein the
retaining structure defines one or more teeth which are configured
to engage the blood collection tube.
5. The blood collection device according to claim 1, wherein the
retaining structure is supported on an inner surface of the body
defining the receptacle.
6. The blood collection device according to claim 1, wherein the
retaining structure includes at least one arm pivotally supported
on the body and configured to engage a blood collection tube
positioned within the receptacle.
7. The blood collection device according to claim 6, wherein the at
least one arm includes a pair of spaced arms.
8. The blood collection device according to claim 6, wherein the at
least one arm includes a surface positioned to engage a blood
collection tube which is slip-resistant.
9. The blood collection device according to claim 8, wherein the
slip-resistant surface is textured.
10. The blood collection device according to claim 9, wherein the
textured surface is selected from the group consisting of ratchet
teeth, granules, serrations and knurling.
11. The blood collection device according to claim 8, wherein the
slip-resistant surface includes an elastomeric layer of
material.
12. The blood collection device according to claim 6, wherein the
retaining structure includes at least one finger nub, each of the
at least one finger nubs being connected to one of the at least one
arms by a pivot member, the at least one finger nubs being actuable
to disengage the at least one arm from engagement with the blood
collection tube positioned within the receptacle of the body.
13. The blood collection device according to claim 1, wherein the
retaining structure includes at least one resilient biasing member
disposed on an inner surface of the body, the at least one
resilient biasing member having first and second ends, wherein at
least one of the first and second ends is secured to the inner
surface of the body such that a central portion of the at least one
resilient biasing member bows inwardly from the inner surface into
the receptacle.
14. A blood collection device comprising: a body defining a
receptacle dimensioned to receive a blood collection tube, the body
having a first open end and a second end supporting a needle, the
needle having a proximal end extending into the receptacle, and a
retaining structure extending into the receptacle configured to
releasably retain the blood collection tube within the receptacle,
wherein the retaining structure includes a pair of spaced arms,
each of the pair of spaced arms being pivotally supported on the
body and configured to engage a blood collection tube positioned
within the receptacle and, wherein each of the pair of spaced arms
includes a surface positioned to engage a blood collection tube
which is slip-resistant.
15. The blood collection device according to claim 14, wherein the
needle further comprises a distal end extending distally of the
body.
16. The blood collection device according to claim 14, wherein the
retaining structure includes at least one finger nub, each of the
at least one finger nubs being connected to one of the pair of arms
by a pivot member, the at least one finger nub being actuable to
disengage a respective one of the pair of arms from engagement with
the blood collection tube positioned within the receptacle of the
body.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims the benefit of and priority
to U.S. Provisional Patent Application No. 61/007,639, filed on
Dec. 14, 2007, which is incorporated herein by reference in its
entirety.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates to the field of medical fluid
transfer devices and, more particularly, to devices for safely
transferring bodily fluids to a receptacle.
[0004] 2. Description of Related Art
[0005] In the medical field, fluid transfer devices, particularly,
blood collection devices are used to draw blood from patients for
blood tests and other medical procedures. At all times,
phlebotomists have to be careful of the being exposed to
life-threatening bloodborne pathogens (BBP) such as HIV and
hepatitis.
[0006] Blood collection devices are well known in the medical field
and typically include a body defining a receptacle which is
dimensioned to receive a blood collection tube. The body includes
an open proximal end and a distal end, which supports a needle. The
needle has a distal end extending from the distal end of the body
and a proximal end extending into the receptacle. The proximal end
of the needle positioned within the receptacle is covered by a
flexible valve member which is provided to reseal the proximal end
of the needle after a blood collection tube has been removed from
the receptacle.
[0007] In use during a blood draw procedure, a phlebotomist will
insert the distal end of the needle into a patient's vein.
Thereafter, the phlebotomist will insert a blood collection tube
into the receptacle of the blood collection device. Generally, the
blood collection tube includes a pierceable septum such that when
the tube is inserted into the receptacle, the proximal end of the
needle will engage the septum and pierce both the valve member and
the septum. As the tube is pressed into the receptacle, the valve
member is compressed distally about the needle.
[0008] The valve member is formed from a resilient material, which
will return to a position to seal the proximal end of the needle
when the blood collection tube is removed from the receptacle. When
the valve member is in a compressed state, the valve member tends
to urge the blood collection tube from the receptacle of the blood
collection device, which results in slowing or stopping the blood
flow into the blood collection tube. To prevent or ensure that a
blood collection tube is not pushed from the valve member, medical
personnel may have to grip the blood collection tube while holding
the blood collection device in position. If a blood collection tube
were to become disengaged from a blood collection device, it is
likely that the tube would break and blood would be spilled
exposing medical personnel to the dangers of BBP's and also broken
glass.
[0009] Accordingly, it would be useful and beneficial, in the art
of medical devices, for an inexpensive, simple device capable of
securing and holding a blood collection tube, or the like, within
the receptacle of a blood collection device.
SUMMARY
[0010] A blood collection device is disclosed which includes a body
defining a receptacle dimensioned to receive a blood collection
tube. The body has a first open end and a second end supporting a
needle having a proximal end extending into the receptacle and a
distal end extending distally of the body. Retaining structure is
supported on the body. The retaining structure extends into the
receptacle and is configured to releasably retain the blood
collection tube within the receptacle. In one embodiment, the
retaining structure is integrally formed with the body defining the
receptacle and includes at least one arm pivotally supported on the
body and configured to engage a blood collection tube positioned
within the receptacle. The at least one arm may include a pair of
spaced arms. In one embodiment, each of the at least one arms
includes a surface positioned to engage a blood collection tube
which is slip-resistant. The slip-resistant surface may be
textured, e.g., ratchet teeth, granules, serrations, knurling, etc.
Alternately, the slip-resistant surface may include an elastomeric
layer of material.
[0011] In one embodiment, the retaining structure includes at least
one finger nub. Each of the at least one finger nubs is connected
to one of the at least one arms by a pivot member and is actuable
to disengage the at least one arm from engagement with a blood
collection tube positioned within the receptacle of the body. The
retaining structure may include one or more teeth which are
configured to engage the blood collection tube.
[0012] In one embodiment, the retaining structure is supported on
an inner surface of the body defining the receptacle. The retaining
structure may include at least one resilient biasing member
disposed on an inner surface of the body. The at least one
resilient biasing member has first and second ends secured to the
inner surface of the body such that a central portion of the at
least one resilient biasing member bows inwardly from the inner
surface of the body into the receptacle.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Various embodiments of the presently disclosed medical
access device are disclosed herein with reference to the drawings,
wherein:
[0014] FIG. 1 is a perspective view of one embodiment of the
presently disclosed blood collection device;
[0015] FIG. 2 is a perspective view of the blood collection device
shown in FIG. 1 with a blood collection tube inserted therein;
[0016] FIG. 3 is a side cross-sectional view of the blood
collection device shown in FIG. 1 taken along section lines
3-3;
[0017] FIG. 4 is a side cross-sectional view of the blood
collection device shown in FIG. 2 with the blood collection tube
inserted therein;
[0018] FIG. 5 is a side cross-sectional view of the blood
collection device shown in FIG. 2 as the blood collection tube is
removed therefrom;
[0019] FIG. 6 is a side cross-sectional view of another embodiment
of the presently disclosed blood collection device;
[0020] FIG. 7 is a side cross-sectional view of the blood
collection device shown in FIG. 6 with a blood collection tube
inserted therein;
[0021] FIG. 8 is a perspective view of another embodiment of the
presently disclosed blood collection device with a blood collection
tube inserted therein;
[0022] FIG. 9 is a side cross-sectional view of the blood
collection device shown in FIG. 8 with the blood collection tube
removed;
[0023] FIG. 10 is a side cross-sectional view of the blood
collection device shown in FIG. 8 with the blood collection tube
inserted therein;
[0024] FIG. 11 is a side cross-sectional view of yet another
embodiment of the presently disclosed blood collection device;
and
[0025] FIG. 12 is a side cross-sectional view of the blood
collection device shown in FIG. 11 with a blood collection tube
inserted therein.
DETAILED DESCRIPTION
[0026] Embodiments of the presently disclosed medical device will
now be described in detail with reference to the drawings wherein
like reference numerals designate identical or corresponding
elements in each of the several views. In the discussion that
follows, the term "proximal" refers to a portion of a structure
that is closer to a user, and the term "distal" refers to a portion
that is further from the user.
[0027] Referring initially to FIGS. 1-5, a medical blood collector
is provided, which includes a blood collection device 10 having a
substantially tubular housing 2 defining a receptacle 11. Housing 2
includes a proximal open end 4 and a distal end 6 having a hub 14
disposed thereon. A finger flange 12 is provided on the proximal
end 4 of housing 2 to facilitate insertion of a blood collection
tube 30 into receptacle 11. Proximal open end 4 is configured and
dimensioned to allow a blood collection tube 30 to be inserted
therethrough.
[0028] Hub 14 defines a channel (not shown) for receiving and
securing a transfer needle 34 and patient needle 16 to housing 2 of
blood collection device 10. Transfer needle 34 extends proximally
from hub 14 into receptacle 11. Patient needle 16 extends distally
from hub 14 to a location distally of housing 2. In one embodiment,
transfer needle 34 and patient needle 16 are manufactured in a
one-piece configuration as a double-ended needle. Alternatively,
transfer needle 34 and patient needle 16 may be manufactured in a
multiple-piece construction and maintained in fluid communication
with each other through hub 14. It is also contemplated that
transfer needle 34 and patient needle 16 or the one-piece needle
equivalent may be secured to a needle hub which is received by and
attached to hub 14.
[0029] A resealable valve member 36 is positioned over transfer
needle 34 to seal transfer needle 34 when a blood collection tube
30 is not positioned within receptacle 11. Resealable valve member
36 is formed from a resilient, pierceable material.
[0030] Patient needle 16 is configured to pierce through a
patient's blood vessel to perform a blood draw procedure. Transfer
needle 34 and patient needle 16 are in fluid communication to allow
blood flow from the patient's blood vessel to transfer needle 34.
When blood collection tube 30 is longitudinally inserted into
proximal end 4 of housing 2 towards distal closed end 6 of housing
2, transfer needle 34, which has a sharpened proximal end 34a,
pierces a pierceable septum 32 of blood collection tube 30 to allow
blood to flow from transfer needle 34 into blood collection tube
30.
[0031] Referring also to FIGS. 3-5, blood collection device 10
includes retaining structure 20. Embodiments of the presently
disclosed blood collection device 10 include one or more
substantially identical retaining structures. For purposes of
brevity, only one retaining structure will be explained in
detail.
[0032] Retaining structure 20 is configured and dimensioned to
releasably retain a blood collection tube 30 within receptacle 11
of blood collection device 10. Retaining structure 20 includes a
retaining arm 22 and a finger actuation member or nub 24, which are
integrally formed with receptacle 11. Retaining arm 22 and finger
nub 24 are pivotably connected at a pivot member 26, which is also
integrally formed with receptacle 11. Retaining arm 22 includes an
inner surface 28 which defines a portion of a wall of receptacle 11
and is configured to retain blood collection tube 30 within
receptacle 11. Inner surface 28 of retaining arm 22 may be
constructed from any type of suitable gripping surface, e.g.,
ratchet teeth, elastomeric material, granular material, etc.,
suitable to retain and/or engage a blood collection tube 30.
[0033] As depicted in FIGS. 3-5, one or more ratchet teeth 28a are
disposed on inner surface 28 of retaining arm 22 and are configured
to allow substantially non-resistive movement in the insertion
direction, but prevent movement in the removal direction. Ratchet
teeth 28a may have a different slope on proximal and distal sides
of each tooth to effect this result. Retaining arm 22 is configured
to be biased in an inward direction towards longitudinal axis "A"
of receptacle 11 such that ratchet teeth 28a engage blood
collection tube 30 to retain tube 30 within receptacle 11 (FIG. 4).
Arms 22 may be biased inwardly due to the natural resilience of the
material used to construct arms 22, e.g., plastic, or
alternatively, a biasing member, e.g., spring steel, may be secured
to arms 22 to provide a biasing force. When medical personnel
desire to remove tube 30 from receptacle 11, finger nub 24 can be
pressed inwardly to pivot retaining arm 22 about pivot member 26
outwardly out of engagement with tube 30 (FIG. 5).
[0034] In summary, as blood collection tube 30 is inserted into
receptacle 11 of device 10, transfer needle 34 pierces valve member
36 and pierceable septum 32 of blood collection tube 30. As blood
collection tube 30 is longitudinally moved towards distal end 6 of
receptacle 11, valve member 36 compresses and creates a biasing
effect, thus urging blood collection tube 30 out of receptacle 11.
Ratchet teeth 28a of retaining structure 20 are dimensioned and
configured to engage and retain blood collection tube 30 within
receptacle 11 of device 10.
[0035] As mentioned above, blood collection tube 30 is removed from
receptacle 11, as shown in FIG. 5, by pushing finger nub 24 inwards
towards the longitudinal axis of device 10. When this occurs,
retaining arm 22 is pivoted about living hinge 26 to pivot
retaining arm 22 outwardly to disengage ratchet teeth 28a from
blood collection tube 30. As this occurs, the user can pull on the
blood collection tube 30 to remove tube 30 from receptacle 11.
[0036] FIGS. 6 and 7 illustrate another embodiment of the presently
disclosed blood collection device shown generally as 100. Blood
collection device 100 defines a receptacle 111 and includes a
transfer needle 134 and a valve member 136, which function in the
same manner as the like elements described above. Collection device
100 also includes a patient needle (not shown) which can be fixedly
secured to device 100, removably secured to device 100 using, for
example, a luer type connector, or otherwise attached to device 100
in combination with transfer needle 134 as described previously.
Retaining structure 120 includes a biasing member 122 disposed on
inner surface 113 of receptacle 111. Biasing member 122 may be
composed of a resilient metal strip, or any suitable biasing
material known in the art. Biasing member 122 includes a first end
124 and a second end 126. First and second ends, 124 and 126,
respectively, are secured to a side wall 113 of receptacle 111 such
that a central portion of member 122 bows into receptacle 111. It
is also contemplated that biasing member 122 may be secured to side
wall 113 by only first end 124 or second end 126 of biasing member
122.
[0037] In use, as shown in FIG. 7, blood collection tube 130 is
inserted longitudinally into receptacle 111. Biasing members 122 of
retaining structure 120 are configured to provide a smaller
diameter to engage and retain tube 130 within receptacle 111. A
tube engaging surface of retaining structure 120 may comprise a
textured surface (e.g., serrated, granular, tacky, etc.) to more
securely engage tube 130 and prevent slippage of tube 130 in
relation to biasing members 122. Retaining structure 120 may also
be configured and adapted to retain different shapes and sizes of
blood collection tubes within receptacle 111, i.e., retaining
members 122 may be dimensioned and configured to retain tubes
having a variety of different shapes within receptacle 111 of
device 100.
[0038] As shown in FIGS. 8-10, in another embodiment of blood
collection device 200 retaining structure 220 defines one or more
resilient bump-like raised inner wall portions 222 (i.e., one, two,
three, four, etc.) alongside inner wall 224 of device 200.
Retaining structure 220 provides a smaller inner diameter of
receptacle 211 to secure a blood collection tube 230 within
receptacle 211. The wall thickness of raised wall 222 may be
thinner than surrounding inner wall 224 to facilitate engagement
with blood tube 230. The raised wall 222 may be formed during a
forming process (e.g., an injection molding process or a
deformation process) and/or by a forming device.
[0039] In one embodiment, the forming device may be a heating
element (not shown) that is configured to heat the outside wall 226
of receptacle 211 to form indentations in outside wall 226 of
receptacle 211 and thus, form raised-wall 222 along the internal
wall of device 200. In other embodiments, the forming device may be
a roller-type element (not shown) having, for example, a
star-shaped element. Alternatively, the forming device may be a
collet (not shown) with forming detents on an inner diameter of the
collet.
[0040] FIGS. 11 and 12 illustrate another embodiment of the
presently disclosed blood collection device shown generally as 300.
Blood collection device 300 includes a tubular shaped body 302
defining a receptacle 311 having a proximal and distal ends 304 and
306, respectively. Body 302 includes a retaining structure 320
having a retaining arm 322 and finger member or nub 324. Retaining
arm 322 and finger nub 324 are pivotably connected to body 302 at a
living hinge 326, which is located on proximal side 304 of body
302.
[0041] Blood collection tube 330 is retained within the receptacle
311 by retaining arms 322 of retaining structure 320. Retaining
arms 322 include an elastomeric coating on an inner surface 328 of
retaining arms 322 positioned to frictionally engage blood
collection tube 330 located within receptacle 311. The elastomeric
coating on inner surface 328 provides a tight, non-slip surface for
releasably retaining blood collection tube 330 within receptacle
311 (FIG. 12). In one embodiment, the elastomeric coating is
overmolded onto arms 322. Alternately, other techniques can be used
to secure the elastomeric coating to the arms 322 of retaining
structure 320.
[0042] While several embodiments of the disclosure have been shown
in the drawings and/or discussed herein, it is not intended that
the disclosure be limited thereto, as it is intended that the
disclosure be as broad in scope as the art will allow and that the
specification be read likewise. Therefore, the above description
should not be construed as limiting, but merely as exemplifications
of particular embodiments. Those skilled in the art will envision
other modifications within the scope and spirit of the claims
appended hereto.
* * * * *