U.S. patent application number 12/900127 was filed with the patent office on 2011-04-14 for kit for separation of biological fluids.
This patent application is currently assigned to Cytomedix, Inc.. Invention is credited to Gilad LAVI.
Application Number | 20110083978 12/900127 |
Document ID | / |
Family ID | 43853973 |
Filed Date | 2011-04-14 |
United States Patent
Application |
20110083978 |
Kind Code |
A1 |
LAVI; Gilad |
April 14, 2011 |
KIT FOR SEPARATION OF BIOLOGICAL FLUIDS
Abstract
For containing a biological fluid and draining a constituent of
the biological fluid, a kit includes a barrel, a piston assembly, a
removable element, which is configured to move the piston assembly,
a drainage element, which interacts with the piston assembly, and
an interacting element, which interacts with the piston assembly.
The kit allows for fluid separation without risk of contamination
from the biological fluid itself or contamination of the biological
fluid itself. Further, the kit offers the advantage of involving no
needles or other sharp elements.
Inventors: |
LAVI; Gilad; (Rishon Lezion,
IL) |
Assignee: |
Cytomedix, Inc.
|
Family ID: |
43853973 |
Appl. No.: |
12/900127 |
Filed: |
October 7, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61272609 |
Oct 13, 2009 |
|
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|
Current U.S.
Class: |
206/223 |
Current CPC
Class: |
A61B 5/150755 20130101;
A61B 5/153 20130101; Y10T 436/25375 20150115; B01L 2400/0605
20130101; A61B 5/15003 20130101; A61B 5/150236 20130101; A61B
5/150221 20130101; B01L 2300/0832 20130101; A61B 5/150244 20130101;
A61B 5/150229 20130101; B01L 2400/0478 20130101; B01L 2400/0409
20130101; G01N 33/491 20130101; B01L 3/5021 20130101 |
Class at
Publication: |
206/223 |
International
Class: |
B65D 71/00 20060101
B65D071/00 |
Claims
1. A kit for containing biological fluid and draining a constituent
of the biological fluid, the kit comprising: (A) a barrel, which
has a first static opening for receiving the biological fluid; (B)
a piston assembly, disposed within the barrel, that comprises a
shut-off valve, wherein the shut-off valve is configured to form a
second movable opening for receiving or draining the constituent
when the shut-off valve is engaged to be open; (C) a removable
element that is configured to aspirate the biological fluid through
the first static opening, wherein the removable element is
configured to move the piston assembly, without engaging the
shut-off valve, so that the first static opening receives the
biological fluid; (D) a drainage element configured to engage the
shut-off valve, such that the shut-off valve opens and the second
movable opening receives the constituent; and (E) an interacting
element, at least a portion of which is positioned in the barrel
and which is configured to engage the shut-off valve, such that the
shut-off valve opens and the second moveable opening receives a
substance, and a sealing element that is configured to seal the
first static opening when the shut-off valve opens, wherein the
interacting element comprises (a) a rod and (b) an adapter element,
a portion of which is positioned in the rod, that is configured to
transport the substance.
2. The kit of claim 1, wherein the biological fluid comprises
platelet-rich plasma.
3. The kit of claim 1, wherein the constituent comprises
plasma.
4. The kit of claim 1, wherein the removable element comprises: (a)
a shaft, (b) snapping elements, coupled to the shaft that are
configured to engage the piston assembly, and (c) a stabilizing
element, coupled to the shaft and adjacent to the snapping
elements, that is configured to restrict radial movement of the
shaft when the snapping elements engage the piston assembly, and
(d) release knobs configured to disengage the snapping elements
only when the barrel contains a sufficient amount of the biological
fluid.
5. The kit of claim 1, wherein the removable element comprises: (a)
a static plug that comprises (i) a base, within the barrel, and
(ii) stopping elements, extending from the base in an axial
direction, and (b) a static shut-off valve, positioned within the
static plug, that is configured to create a vacuum within the
barrel.
6. The kit of claim 1, wherein the drainage element comprises a
male luer or a syringe that is configured to engage the shut-off
valve and drain the constituent.
7. The kit of claim 1, wherein the adapter element comprises: (a) a
housing, (b) an engagement element, forming a distal end of the
housing, that is configured to engage with and open the shut-off
valve, and (c) a proximal connector, adjacent to a proximal end of
the housing, that is configured to receive the substance.
8. The kit of claim 7, wherein the housing is configured to create
a fluid path between the engagement element and the proximal
connector.
9. The kit of claim 1, wherein the sealing element is a check
valve, enabling flow only into the barrel, or a plug.
10. The kit of claim 1, wherein the substance is anti-coagulant.
Description
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
[0001] This application claims priority from U.S. Provisional
Application No. 61/272,609, filed Oct. 12, 2009, incorporated
herein by reference in its entirety.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to a kit for
containing biological fluid and draining a constituent of the
biological fluid.
[0003] Conventional kits, such as those described in EP 2077115 and
U.S. Pat. No. 6,123,687, have been used to house biological fluids,
drain a constituent of the biological fluid, and/or separate the
biological fluid into constituents. Conventional kits present
disadvantages associated with the use sharp elements, such as
needles, or with enabling fluid separation at a substantial risk of
contamination, either of the kit from the biological fluid or of
the biological fluid itself.
SUMMARY OF THE INVENTION
[0004] In view of these disadvantages and other drawbacks to the
conventional technology, the present invention provides a kit for
containing biological fluid and draining a constituent of the
biological fluid. The kit comprises a barrel, a piston assembly, a
removable element, a drainage element, and an interacting element
and a sealing element. The barrel includes a first static opening
for receiving the biological fluid. The piston assembly is disposed
within the barrel and comprises a shut-off valve. The shut-off
valve is configured to form a second movable opening for receiving
or draining the constituent when the shut-off valve is engaged to
be open. The removable element is configured to aspirate the
biological fluid through the first static opening and is configured
to move the piston assembly, without engaging the shut-off valve,
so that the first static opening receives the biological fluid. The
drainage element is configured to engage the shut-off valve, such
that the shut-off valve opens and the second movable opening
receives the constituent. The interacting element is configured to
engage the shut-off valve, such that the shut-off valve opens and
the second moveable opening receives a substance. At least a
portion of the interacting element is positioned in the barrel. The
sealing element is configured to seal the first static opening when
the shut-off valve opens. The interacting element comprises a rod
and an adapter element. A portion of the adapter element is
positioned in the rod, that is configured to transport the
substance.
[0005] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory only, and are not restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] These and other features, aspects, and advantages of the
present embodiments will become apparent from the following
description and the accompanying exemplary embodiments shown in the
drawings, which are synopsized below.
[0007] FIG. 1A is a schematic illustration of a component of a kit,
showing a barrel and a piston assembly, for containing a biological
fluid and draining a constituent of the biological fluid.
[0008] FIG. 1B is a schematic illustration of a component of the
kit of FIG. 1A, including a first removable element.
[0009] FIG. 1C is a schematic illustration of a component of the
kit of FIG. 1A, including a second removable element.
[0010] FIG. 1D is a schematic illustration of a component of the
kit of FIG. 1A, including a drainage element.
[0011] FIG. 1E is a schematic illustration of a component of the
kit of FIG. 1A, including an interacting element.
[0012] FIG. 2A is side, partial cross section, perspective view of
the piston assembly of FIGS. 1A-1E.
[0013] FIG. 2B is a side, elevated view of the active element of
FIG. 2A.
[0014] FIG. 3A is a cross-sectional view of the component of the
kit of FIG. 1B before aspiration of the biological fluid.
[0015] FIG. 3B is a cross-sectional view of the component of the
kit of FIG. 1B after aspiration of the biological fluid and after a
plug has been inserted into a first opening.
[0016] FIG. 4 is a side, partially exploded perspective view of the
piston assembly and the removable element of FIG. 1B.
[0017] FIG. 5 is a cross-sectional view of the component of the kit
of FIG. 1C before aspiration of the biological fluid.
[0018] FIG. 6A is a cross-sectional view of the component of the
kit of FIG. 1C before aspiration of the biological fluid and
showing the distance the piston assembly moves in the barrel and
the predetermined volume in the barrel.
[0019] FIG. 6B is a cross-sectional view of the component of the
kit of FIG. 1C after aspiration of the biological fluid.
[0020] FIG. 7A is a cross-sectional view of the component of the
kit of FIG. 1C after aspiration of the biological fluid and after a
plug has been inserted into a first opening.
[0021] FIG. 7B is a cross-sectional view of the component of the
kit of FIG. 1C after the removable element has been removed from
the kit.
[0022] FIG. 8A is a cross section of the component of the kit of
FIG. 1A before the biological fluid is separated into
constituents.
[0023] FIG. 8B is a cross section of the component of the kit of
FIG. 1A after the biological fluid is separated into
constituents.
[0024] FIG. 9 is a cross section of the component of the kit of
FIG. 1D before a constituent of the biological fluid is
drained.
[0025] FIG. 10A is a cross section of the component of the kit of
FIG. 1D while the constituent of the biological fluid is
drained.
[0026] FIG. 10B is a cross section of the component of the kit of
FIG. 1D after the constituent of the biological fluid is
drained.
[0027] FIG. 11 is a cross section, partially exploded view of the
component of the kit of FIG. 1E before a substance is added to the
barrel.
[0028] FIG. 12A is a cross section of the component of the kit of
FIG. 1E before the substance is been added to the barrel.
[0029] FIG. 12B is a cross-sectional view of the component of the
kit of FIG. 1E after the substance is added to the barrel.
[0030] FIG. 13 is a cross-sectional view of the component of the
kit of FIG. 1E after the substance is added to and the adapter
element is removed from the barrel.
DETAILED DESCRIPTION
[0031] For containing a biological fluid and draining a constituent
of the biological fluid, a kit is provided (components of the kit
shown in FIGS. 1A-1E) that includes a barrel 10, a piston assembly
20, a removable element 30, 70, which is configured to move the
piston assembly 20, a drainage element 60, which interacts with the
piston assembly 20, and an interacting element 300, which interacts
with the piston assembly 20. For the purposes of this application,
components of the kit will collectively be referred to as reference
numeral 100.
[0032] The biological fluid passes through a first opening 12 or
distal port 12 when the first opening 12 is connected to the
biological fluid and when the piston assembly 20 moves to aspirate
the biological fluid. The biological fluid, such as blood, is
contained in the barrel 10, which has the first opening 12. The
first opening 12 may be a first static opening 12 for receiving the
biological fluid. The piston assembly 20 includes a shut-off valve
40, disposed within the barrel 10, that is configured to form a
moveable second opening 5, through which the same or a different
biological fluid can pass when the shut-off valve 40 is open, which
happens when the shut-off valve 40 is engaged by the drainage
element 60. Conversely, the shut-off valve 40 is closed when it is
not so engaged. More specifically, the shut-off valve 40 is engaged
when the drainage element 60 engages the shut-off valve 40. The
shut-off valve 40 is not engaged by the removable element 30,
70.
[0033] Alternately, the kit 100 may include the interacting element
300, which serves initially as a conduit for a substance, such as
an anti-coagulant, that becomes mixed with the biological fluid
when introduced into the barrel 10. The interacting element 300
engages the shut-off valve 40 to open the shut-off valve 40. When
the interacting element 300 engages the shut-off valve 40, the
first opening 12 is sealed. Sealing may be provided by a one way
valve 350, applied to the first opening 12, that only allows fluid
to enter the barrel 10 via the first opening 12 or by a plug (not
shown) that plugs the first opening 12.
[0034] Kit 100 thus allows for fluid separation without risk of
contamination from the biological fluid itself or contamination of
the biological fluid itself. Further, the kit 100 offers the
advantage of involving no needles or other sharp elements. For the
purposes of the application, the distal end/direction refers to the
end/direction farther away from the operator of the kit 100 and the
proximal end/direction refers to the end/direction closest to the
operator of the kit 100. Additionally, for the purposes of the
application, the biological fluid may be any suitable fluid.
Preferably the biological fluid is platelet-rich plasma.
[0035] Referring to FIGS. 2A-2B, the piston assembly 20 includes a
piston housing 21 and a housing bore 23. The piston housing 21 is
the outermost side boundary of the piston assembly 20, which
contains a shut-off valve 40, and the housing bore 23 is the
innermost side boundary of the piston assembly 20, which contains a
shut-off valve 40.
[0036] The piston assembly 20 includes a seal 50 and a shut-off
valve 40 or valve assembly 40. The seal 50 may be any suitable
seal, for example an O-ring seal 50. The shut-off valve 40 is
housed in a housing 44, where the housing 44 is positioned within a
valve cavity of the piston assembly 20 by any suitable mechanism.
For example, the valve housing 44 may be glued to the cavity
22.
[0037] The shut-off valve 40 may include an active element 42 or a
flexible element 42 that is configured to open the shut-off valve
40. The active element 42 may be positioned with the valve housing
44. The active element 42 may include a luer connector 46, a
triggering neck 422, a collar 424, and a sealing lip 426. The luer
connector 46 is configured to engage an external element (e.g., a
drainage element or an interacting element) in order that the
active element 42 is able to open the shut-off valve 40. The
sealing lip 426 connects the triggering neck 422 to the collar 424.
The collapsible collar 424 may be a tubular element that behaves
similar to a spring. The collar 424 may provide pressure over the
sealing lip 426 to keep the shut-off valve 40 closed. When the luer
connector 46 is engaged by the drainage element 60 or the
interacting element 300, the triggering neck 422 is pushed toward
the collar 424. The collar 424 stops providing pressure to the
sealing lip 426 and the shut-off valve 40 opens. In contrast, when
the luer connector 46 is not engaged by the drainage element 60 or
the interacting element 300, the triggering neck 422 is not pushed
toward the collar 424 and the collar 424 provides pressure over the
sealing lip 426, thereby keeping the shut-off valve 40 closed. The
active element 42 also may include triggering neck slits 423 and a
flow path detent 428. The triggering neck slits 423 prevent any
potential sealing of the drainage element or the interacting
element if the drainage element or the interacting element
interacts with the active element 42. The flow path dent 428
ensures a proper fluid path to the first static opening 12 when the
triggering neck 422 is pushed toward the collar 424. The flow path
dent 428 ensures the proper fluid path by preventing the collar 424
from sealing a surrounding cavity of the active element 42 when the
collar 424 is collapsing. The active element 42 may be made of any
suitable material, e.g., a medical grade rubber.
[0038] The piston assembly 20 may additionally include snapping
traps 24, a rod release recess 26, and an axial stop 25. The
snapping traps 24 may house engaging elements of an external
element (e.g., the removable element 30), where the engaging
elements snap into the snapping traps 24. When the engaging
elements snap into the snapping traps 24, the snapping traps 24
help maintain the connection of the removable element 30 to the
piston assembly 20. The rod release recess 26 helps an operator of
the kit 100 find the location where the operator should press to
release the engaging elements, which snap into the snapping traps
24, from the snapping traps 24. The rod release recess 26 is only
accessible to the operator of the kit 100 when the biological fluid
has completely aspirated into the barrel 10. The rod release recess
26 also guides the insertion of the removable element 30 in the
barrel 10 to ensure that the engaging elements snap into the
snapping traps 24. Additionally, the rod release recess 26 provides
a large enough surface for an operator's finger, as opposed to
merely the tip of the operator's finger, to exert pressure on the
removable element 30 so as to release the engaging elements from
the snapping traps 24. The axial stop 25 interacts with the
removable element 30 by positioning the removable element 30 with
respect to the piston assembly 20.
[0039] The removable element 30, 70 is configured to aspirate
biological fluid through the first static opening 12. Additionally,
the removable element 30, 70 is configured to move the piston
assembly 20, without engaging the shut-off valve 40, so that the
first static opening 12 receives the biological fluid. FIGS. 3A-4
show one example of a removable element 30. FIGS. 5-7B show a
second example of a removable element 70.
[0040] Referring to FIGS. 3A-4, a removable element 30 is shown
that includes a shaft 39, snapping elements 32, and annular
elements 341, 342, 37. The removable element 30 may be any suitable
element capable of being removed from the barrel 10. For example,
the removable element 30 may be a rod 30. At least a portion of the
removable element 30 (e.g. an accessible element 37 or elongating
ribs 391) is able to fit within the barrel 10.
[0041] The shaft 39 of the removable element 30 may include
elongating ribs 391. The elongating ribs 391 may stabilize the
removable element 30 when a portion of the removable element 30 is
within the barrel 10. The shaft 39 may include one or more
elongating ribs 391. For example, as shown in FIG. 4, the shaft 39
may include four elongating ribs 391.
[0042] The snapping elements 32 are coupled to the shaft 39 and are
configured to engage the piston assembly 20 because the snapping
elements 32 are flexible. A flexibility notch 38, of the removable
element 30, enables the snapping elements 32 to be flexible. The
flexibility notch 38 enables the snapping elements 32 to be
flexible because two arms 401, 402 are configured to deflect and
break off from an axial cross section of the shaft 39. The arms are
relatively stiff when an axial force is applied to the arms 401,
402 but are relatively flexible when a radial force is applied to
the arms 401, 402. The arms 401, 402 carry the annular elements
341, 342, 37. When the snapping elements 32 engage the piston
assembly 20, the snapping elements 32 fit within the snapping traps
24 of the piston assembly 20.
[0043] The annular elements 341, 342, 37 help stabilize the
removable element 30 within the piston assembly 20. The stabilizing
element 341 or distal stabilizing rib 341 is coupled to the shaft
30 and is adjacent to the snapping elements 32. The stabilizing
element 341 is configured to restrict radial movement of the shaft
when the snapping elements 32 engage the piston assembly 20. For
example, when the snapping elements 32 engage the piston assembly
20, the stabilizing elements 341 interact with the axial stop 25 of
the piston assembly 20. The axial stop 25 axially positions the
stabilizing elements 341. The stabilizing element 341 may also
provide radial support for the removable element 30 when at least a
portion of the removable element 30 is within the piston assembly
20. When the stabilizing element 341 provides the radial support,
stabilizing element 341 and proximal stabilizing rib 342 may be
centered by the bore 23 of the piston assembly 20.
[0044] The release knob 37 or accessible element 37 provides radial
stabilization of the removable element 30 when at least a portion
of the removable element 30 is within the piston assembly 20
located within the barrel 10 (see FIG. 3A) and is configured to
disengage the snapping elements 32 from the piston assembly 20. The
release knob 37 can only disengage the snapping elements 32 when
the barrel 10 contains a sufficient amount of the biological fluid
500. The release knob 37 functions as a pressing knob that manually
releases the snapping elements 32 from the piston assembly 20 when
a suitable radial pressure is exerted on the release knob 37. A
suitable pressure, however, can only be exerted on the release knob
37 when a sufficient amount of biological fluid 500 has entered the
barrel 10 through the first static opening 12. Generally, a
sufficient amount of biological fluid 500 has entered the barrel 10
when the removable element 30 is fully extracted from the barrel
10. As shown, for example in FIG. 3A, a suitable pressure cannot be
exerted on the release knob 37 because a portion of the removable
element 30 is within the barrel 10. However, as shown for example
in FIG. 3B, a suitable pressure can be exerted on the release knob
37 because the removable element 30 is fully extracted from the
barrel 10. The release knob 37 also allows internal sliding of the
removable element 30 within a bore 13 of the barrel 10.
[0045] The removable element 30 may also include a finger flange 36
or flange 36 (FIG. 4). The finger flange 36 allows a user to grip
the removable element 30. The flange 36 is similar to a
conventional flange of a rod of a syringe.
[0046] FIGS. 3A-3B show the removable element 30 before and after
the biological fluid 500 is aspirated into the barrel 10 through
the first static opening 12, respectively. As shown in FIG. 3A, at
least a portion of the removable element 30 fits within the barrel
10 and engages the piston assembly 20. Specifically, the snapping
elements 32 or snaps 32 of the removable element 30 engage the
piston assembly 20. The engagement of the snapping elements 32 to
the piston assembly 20 allows a user to grip the finger flange 36
of the removable element 30 and pull the removable element 30 and
the piston assembly 20 in the proximal direction. As the removable
element 30 is pulled out of the barrel 10, biological fluid 500
enters the barrel through the first opening 12. The movement of the
removable element 30 within the barrel 10 has no affect on the
opening or closing of the shut-off valve 40 because the engagement
of the snapping elements 32 to the piston assembly 20 does not
affect the active element 42 of the shut-off valve 40. The
biological fluid 500 may be any suitable fluid. For example, the
biological fluid may be platelet-rich plasma.
[0047] As the removable element 30 is pulled out of the barrel 10,
the release knobs 37 are moved toward a position where they will no
longer be located within the barrel 10. When the release knobs 37
are outside of the barrel 10, a sufficient amount of the biological
fluid 500 has entered the barrel 10 and the release knobs 37 may be
pressed so that the snapping elements 32 can be disengaged from the
piston assembly 20. Much as the engagement of the snapping elements
32 to the piston assembly 20 does not affect the active element 42
of the shut-off valve 40, the disengagement of the snapping
elements 32 to the piston assembly 20 does not affect the active
element 42.
[0048] After the biological fluid 500 has finished aspirating
through the first static opening 12, a plug 15 or valve (not shown)
is inserted into the first static opening 12 to prevent the
biological fluid 500 from exiting the barrel 10. The plug 15 may be
any suitable plug. For example, the plug 15 may be a luer plug.
[0049] The removable element 30 most conveniently aspirates
biological fluid when the diameter of the barrel 10 is smaller and
when the volume of biological fluid that can be aspirated into the
barrel 10 is smaller. The greater the volume of biological fluid
that can be aspirated in the barrel 10, the more cumbersome it gets
for the operator of the kit 100 to manually aspirate the biological
fluid into the barrel 10 using the removable element 30. For
example, when about 50 ml of biological fluid can be aspirated into
the barrel 10, it gets more cumbersome for the operator of the kit
100 to manually aspirate the biological fluid into the barrel 10 of
the removable element 30. When the diameter of the barrel 10 is
smaller, the rate at which the biological fluid aspirates into the
barrel 10 is relatively fast because there is a smaller volume for
which the piston assembly 20 must travel. As the diameter of the
barrel 10 increases, however, the rate at which the biological
fluid aspirates into the barrel 10 decreases. For instance,
aspiration of larger doses of biological fluid, e.g., 20-30 ml,
when the diameter of the barrel 10 increases, may take as long as
30 to 60 seconds. The longer time may inconvenience the person
operating the kit 100 and may inhibit safety of using the kit
100.
[0050] Referring to FIGS. 5-7B, a removable element 70 is shown
that comprises a static plug 70 and a static shut-off valve 72 or
shut-off valve 72 or static plug valve 72. Unlike the removable
element 30, the removable element 70 does not inconvenience the
person operating the kit 100 or inhibit safety of using the kit 100
when the diameter of the barrel 10 is larger. The static plug 70
allows the person operating the kit 100 to generate a vacuum within
the kit 100. The vacuum turns the kit 100 into an aspiration pump.
After the kit 100 is connected to a biological fluid source, (e.g.,
an IV port, butterfly needle, etc.), the person operating the kit
100 takes a specific volume of air off the kit 100. Because the
removable element 70 includes a shut-off valve 72, the removable
element 70 is able to maintain the vacuum inside the barrel 10 and
the piston assembly 20 is able to move in the proximal direction,
thereby aspirating a desired amount of biological fluid into the
barrel 10. The desired amount of biological fluid is accurately
obtained in the barrel 10 because the removable element 70 includes
a mechanical stop that stops the piston assembly 20 from moving in
the proximal direction when aspiration of the biological fluid is
completed.
[0051] The static plug 70 may include a base 77 and stopping
elements 78. The base 77 is positioned within the barrel 10 of the
kit 100. The base 77 is flush with the inner sides of the barrel 10
and the stopping elements 78 extend from the base 77 in an axial
direction.
[0052] Additionally, the static plug 70 may include a seal 80, a
valve housing 74, and a valve connector 76. The seal 80 enables the
static plug 70 to seal a proximal end 79 of the bore 13 of the
barrel 10. The seal 80 is similar to the seal 50 of the removable
element 30. For example, the seal 8--may be an O-ring seal 80. The
valve housing 74 houses the shut-off valve 72. The valve connector
76 may be similar in structure to the valve housing 44, active
element 42, and luer connector 46. For example, the valve connector
76 opens the shut-off valve 72 when the valve connector 76 is
engaged by a suitable external element (e.g., external syringe or
vacuum pump).
[0053] The shut-off valve 72 is positioned within the static plug
70 and is configured to create a vacuum within the barrel 10. The
shut-off valve 72 creates a vacuum within the barrel 10 when the
valve connector 76 is engaged by the suitable external element.
[0054] The removable element 70 is configured to aspirate
biological fluid through the first static opening 12 of the barrel
10. The removable element 70 is also configured to move the piston
assembly 20 so that the first static opening 12 receives the
biological fluid.
[0055] As shown in FIG. 6A, before the removable element 70
aspirates biological fluid through the first static opening 12 of
the barrel 10, the static plug 70 is separated from the piston
assembly 20 by an axial distance 90 or lengthwise distance 90. The
distance 90 is set in accordance with the required amount of
biological fluid that needs to be aspirated. To generate the
required vacuum to allow aspiration of the biological fluid within
the barrel 10 an air volume that is greater than a predetermined
volume 92 or initial vacuumed compartment 92 must be taken out of
the barrel 10.
[0056] When the valve connector 76 is engaged by the suitable
external element, the piston assembly 20 travels the distance 90
and moves toward the proximal side of the barrel 10 (see FIGS.
6A-6B). As the piston assembly 20 moves toward the proximal side of
the barrel 10, the biological fluid 500 enters the barrel 10. FIG.
6B shows the kit 100 after the piston assembly 20 has traveled the
distance 90. The base 77 provides a mechanical stop for the piston
assembly 20 to ensure that amount of biological fluid 500 aspirated
does not exceed the required amount of biological fluid. Because
the vacuum level decays as the piston assembly 20 moves travels the
distance 90, the vacuum level within a volume 93 or concluded
vacuum compartment 93 is significantly lower than the predetermined
volume 92. A minimum vacuum, however, is still maintained to ensure
completion of the aspiration and overcome friction. The minimum
vacuum is known as the residual vacuum.
[0057] After the biological fluid 500 is aspirated into the barrel
10, a plug 15 or valve is inserted into the first static opening 12
(see FIG. 7A) and the removable element 70 is removed from the
barrel 10 (see FIG. 7B). The plug 15 prevents the biological fluid
500 from exiting the barrel 10. The plug 15 may be any suitable
plug. For example, the plug 15 may be a luer plug. The residual low
level vacuum 93 does not prevent the ability to remove the static
plug 70 from the barrel 10 or bring the kit 100 into a position
where centrifugation may occur.
[0058] As shown in FIGS. 8A-8B, after the plug 15 or valve is
inserted into the first static opening 12 and the removable element
30, 70 is removed from the barrel 10, centrifugation occurs. During
centrifugation, the biological fluid is separated into components
502, 504. For example, if the biological fluid 500 is platelet-rich
plasma, the first component 502 may include a residue or red blood
cells and the second component 504 or constituent 504 may include
plasma. Any suitable method of centrifugation may be used to
separate the biological fluid into separate components.
[0059] After centrifugation, it should be appreciated that removal
of the second component 504 is required, while the goal is to
minimize the risk of contaminating or mixing the second component
504 with the first component 502 or residue.
[0060] As shown in FIGS. 9-10B, a drainage element 60 may be used
to remove the second component 504 from the barrel 10. The drainage
element 60 is configured to engage the shut-off valve 20 of the
piston assembly 40, such that the shut-off valve 20 opens and the
second movable opening receives the constituent 504. Specifically,
the drainage element 60 engages the active element 42 of the piston
assembly 20. When the drainage element 60 connects to the luer
connector 46 of the active element 42 (see FIG. 9), thereby
engaging the active element 42, the shut-off valve 40 opens. When
the shut-off valve 40 opens, a fluid path to the movable second
opening opens. The drainage element 60 may be any suitable element
that is configured to engage the shut-off valve 20 and drain the
constituent 504. For example, the drainage element 60 may include a
male luer (not shown) or a syringe 60.
[0061] If the drainage element 60 is a syringe 60, the drainage
element may include a barrel 61 and a rod 62. The barrel 61 of the
drainage element 60 receives the constituent 504 and the rod 62
moves in the proximal direction when the barrel 61 receives the
constituent 504. Specifically, when the drainage element 60 is
pushed in the distal direction, as shown in FIG. 10A, the
constituent 504 is expelled toward the proximal direction into the
barrel 61 of the drainage element 60. As the constituent 504 enters
the barrel 61, the rod 62 moves in the proximal direction.
[0062] Once the constituent 504 is contained within the barrel 61
of the drainage element 60, the drainage element 60 is disengaged
from the luer connector 46 of the active element 42 (FIG. 10B).
Once the drainage element 60 is disengaged, the barrel 10 only
contains the first component 502 and the fluid path to the movable
second opening closes because the shut-off valve 40 closes. After
the drainage element 60 is disengaged, the constituent 504 is ready
for further processing. For example, the constituent 504 may be
mixed with additional ingredients to create an autologous formula
or the constituent 504 may again undergo centrifugation.
[0063] As shown in FIGS. 11-13, the kit 100 may also include the
interacting element 300 and a sealing element 350. The interacting
element 300 is configured to engage the shut-off valve 40, such
that the shut-off valve 40 opens and the second movable opening
receives a substance 750 before the biological fluid enters the
barrel 10. When the interacting element 300 engages the shut-off
valve 40, at least a portion of the interacting element 300 is
positioned within the barrel 10. The interacting element 300 may
engage the shut-off valve 40 before the biological fluid is
aspirated into the barrel 10 using the removable element 30 or the
removable element 70. The substance 750 may be any substance
desired to mix with the biological fluid. For example the substance
750 may be an anti-coagulant.
[0064] The interacting element 300 comprises a rod 310 and an
adapter element 700. The adapter element 700 is configured to
transport the substance 750. A portion of the adapter element 700
is positioned in an inner diameter 320 of the rod 310. The adapter
element 700 comprises a housing 710, an engagement element 720, and
a proximal connector 730. The housing 710 is configured to create a
fluid path for the substance 750 between the engagement element 720
and the proximal connector 730. The engagement element 720 forms a
distal end of the housing 710 and is configured to engage with and
open the shut-off valve 40. The engagement element 720 may be any
suitable element. For example, the engagement element 720 may be a
male luer connector. The proximal connector 730 is adjacent to a
proximal end of the housing 710 and is configured to receive the
substance 750 from a suitable element (not shown). The proximal
connector 730 may be any suitable element that can house the
substance 750. For example, the proximal connector 730 may be a
female luer connector. The suitable element, from which the
proximal connector 730 receives the substance 750 may be, for
example, a syringe that includes a male luer connector able to
connect to the proximal connector 730. When the proximal connector
730 is connected to the suitable element and when the engagement
element 720 opens the shut-off valve 40, the fluid path in the
housing 710 is open and the substance 750 may be transferred from
the suitable element to the proximal connector 730, from the
proximal connector 730 to the housing 710, through the housing 710
to the engagement element 720, and from the engagement element 710
to the inside of the syringe 300.
[0065] To prevent the substance 750 from leaking out of the barrel
10 through the first static opening 12, the first static opening 12
must be closed by the sealing element 350. The sealing element 350
is configured to seal the first static opening 12 when the shut-off
valve opens 40 so that the substance 750 does not exit the barrel
10 through the first static opening 12. The sealing element 350 may
be any suitable element. For example, the sealing element 350 may
be a one-way check valve 350 (see FIGS. 11-13) or a plug (not
shown). If the sealing element 350 is a one-way check valve, the
sealing element 350 may include a first luer connector 352 or
female luer connector 352 and a second luer connector 354 or male
luer connector 354. The luer connectors 352, 354 are able to engage
one another around an element 356 (e.g., a duck-bill type valve, an
umbrella valve, a butterfly valve, etc). The luer connectors may be
made of any suitable material, for example biocompatible plastic,
and the element 356 may be made of any suitable material, for
example, biocompatible rubber. The sealing element 350 helps
prevent the operator of the kit 100 from injecting anti-coagulant
into a patient's vein.
[0066] The kit 100 thus allows for drainage of all or part of the
kit's 100 contents in a safe manner without the usage of sharp
elements and with minimal exposure to additional biological fluids
because the movable second opening allows draining of all or a part
of the kit's contents through the proximal side of the kit 100
while the first static opening 12 is plugged. The contents, such as
the constituent 504, are able to be drained into a clean, sterile
drainage element or container 60, thereby preventing contamination
by residues (e.g. RBC or red blood cells) that may be left in the
barrel 10 of the kit 100. Specifically, the biological fluid 500
enters the kit 100 through the first static opening 12 and the
constituent 504 exits through the movable second opening. The
movable second opening is not used until the constituent 504 exits
the barrel 10 of the kit 100. Accordingly, the constituent 504 is
not contaminated by the biological fluid 500 because the
constituent 504 exits the barrel 10 through a different opening
from which the biological fluid 500 enters the barrel 10. The first
component 502, which remains in the barrel 10 after the drainage
element 60 drains the constituent 504 from the barrel 10, can be
safely disposed of without requiring the first component 502 to be
drained from the kit 100.
[0067] It should be noted that the term "exemplary" as used herein
to describe various embodiments is intended to indicate that such
embodiments are possible examples, representations, and/or
illustrations of possible embodiments (and such term is not
intended to connote that such embodiments are necessarily
extraordinary or superlative examples).
[0068] The terms "coupled," "connected," and the like as used
herein mean the joining of two members directly or indirectly to
one another. Such joining may be stationary (e.g., permanent) or
moveable (e.g., removable or releasable). Such joining may be
achieved with the two members or the two members and any additional
intermediate members being integrally formed as a single unitary
body with one another or with the two members or the two members
and any additional intermediate members being attached to one
another.
[0069] It is important to note that the construction and
arrangement of the kit for containing biological fluid and draining
a constituent of the biological fluid as shown in the various
exemplary embodiments is illustrative only. Although only a few
embodiments have been described in detail in this disclosure, those
skilled in the art who review this disclosure will readily
appreciate that many modifications are possible (e.g., variations
in sizes, dimensions, structures, shapes and proportions of the
various elements, values of parameters, mounting arrangements, use
of materials, colors, orientations, etc.) without materially
departing from the novel teachings and advantages of the subject
matter described herein. For example, elements shown as integrally
formed may be constructed of multiple parts or elements, the
position of elements may be reversed or otherwise varied, and the
nature or number of discrete elements or positions may be altered
or varied. The order or sequence of any process or method steps may
be varied or re-sequenced according to alternative embodiments.
Other substitutions, modifications, changes and omissions may also
be made in the design, operating conditions and arrangement of the
various exemplary embodiments without departing from the scope of
the present embodiments.
* * * * *