U.S. patent application number 15/149890 was filed with the patent office on 2019-01-03 for filtration device.
The applicant listed for this patent is Warsaw Orthopedic, Inc.. Invention is credited to William F. McKay.
Application Number | 20190000522 15/149890 |
Document ID | / |
Family ID | 50484387 |
Filed Date | 2019-01-03 |
United States Patent
Application |
20190000522 |
Kind Code |
A9 |
McKay; William F. |
January 3, 2019 |
FILTRATION DEVICE
Abstract
A device for separating particulate matter (e.g., cells) from a
liquid including a housing defining an elongate chamber disposed
between a receiving end and a dispenser end, a plunger slidably
inserted within the chamber from the receiving end, an upper disc
and a lower disc each independently slidably affixed to the
plunger, the lower disc facing the dispenser end and including at
least one filter arrangement, and a liquid including particulate
matter disposed within the chamber when the upper disc and lower
disc are in an aspiration mode. The upper disc is independently
slidable with respect to the lower disc to achieve a filtration
mode.
Inventors: |
McKay; William F.; (Memphis,
TN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Warsaw Orthopedic, Inc. |
Warsaw |
IN |
US |
|
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20160249966 A1 |
September 1, 2016 |
|
|
Family ID: |
50484387 |
Appl. No.: |
15/149890 |
Filed: |
May 9, 2016 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
13655500 |
Oct 19, 2012 |
9333447 |
|
|
15149890 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
B01D 33/0158 20130101;
A61F 2/28 20130101; A61F 2002/2835 20130101; G06F 16/972 20190101;
A61B 17/8833 20130101 |
International
Class: |
A61B 17/88 20060101
A61B017/88; A61F 2/28 20060101 A61F002/28 |
Claims
1.-17. (canceled)
18. A method for separating particulate matter from a liquid
comprising: providing a housing defining an elongate chamber
disposed between a receiving end and a dispenser end; providing a
plunger slidably inserted within the chamber from the receiving
end; providing an upper disc and a lower disc each independently
slidably affixed to the plunger, the lower disc facing the
dispenser end and including at least one filter arrangement;
sliding the upper and lower discs upwards towards the receiving end
for aspirating a liquid including particulate matter within the
chamber; affixing a cap to the dispensing end; and sliding the
lower disc downwards to achieve a filtration mode for separating
the particulate matter from the liquid so as to cause the upper
disc to slide toward the receiving end.
19. A method of claim 18, wherein achieving the filtration mode
comprises dynamically forming an upper compartment containing
filtrate of the liquid and dynamically forming a lower compartment
containing a concentrated liquid comprising separated particulate
matter and the method further comprises removing the cap and
sliding the upper disc downwards to achieve a concentrated liquid
expulsion mode.
20. A method of claim 19, wherein the upper compartment is formed
between the upper disc and the lower disc and the lower compartment
is formed between the lower disc and the dispenser end.
Description
BACKGROUND
[0001] Bone is a composite material that contains impure
hydroxyapatite, collagen and a variety of non-collagenous proteins,
as well as embedded and adherent cells. Due to disease, a
congenital defect or an accident, a person may lose or be missing
part or all of one or more bones or regions of cartilage in his or
her body, and/or have improper growth or formation of bone and/or
cartilage.
[0002] That an organism is missing part of a bone or has a defect
is not necessarily a permanent condition, and there are known means
by which to address some of these conditions. For example,
mammalian bone tissue is known to contain one or more proteinaceous
materials that are active during growth and natural bone healing.
These materials can induce a developmental cascade of cellular
events that results in bone formation. Typically, the developmental
cascade of bone formation involves chemotaxis of mesenchymal cells,
proliferation of progenitor cells, differentiation of cartilage,
vascular invasion, bone formation, remodeling and marrow
differentiation. Thus, the control or use of this already existing
system can be advantageous when seeking to regenerate or to repair
bone.
[0003] Often times an allograft material can be used to aid in bone
growth and repair of the bone defect. To enhance bone growth, the
allograft can be seeded or hydrated with nucleated cells (e.g.,
white blood cells, red blood cells, progenitor cells, stem cells,
etc.) often obtained from blood or bone marrow aspirates. It is
desirable to have these nucleated cell types concentrated in the
delivery liquid so they can easily be delivered to the allograft
material.
[0004] Sometimes, it can be difficult to concentrate the cells in
the fluid it is obtained from unless laboratory facilities are
used. For example, when separating or removing cells from liquid, a
filter is used. However, some filters do not easily let the cells
through them and may require the use of a centrifuge. Further,
because the centrifuge spins the liquid at high speeds, it can
damage the nucleated cells causing them to be ineffective when they
are added to the allograft material.
[0005] When using a centrifuge, installing the sample holding
container assemblies in the centrifuge can only be done manually,
making it difficult to automate a series of operations including
preprocessing. Further, the speed of the centrifuge is the only
parameter that can be controlled, which makes fine motor control of
the device impossible. Still another problem is that an appropriate
centrifugal force needs to be set according to liquid volumes and
filter pore diameters, making the equipment difficult to
handle.
[0006] It is therefore desirable to provide a filtration device and
method, which can filter and concentrate cells from or in a liquid
conveniently and with a simple construction.
SUMMARY
[0007] The current device and method allow concentration of cells
in a liquid easily and efficiently at the point of care. The
current device and method avoids the need for expensive and
extensive laboratory equipment to filter cells. In some
embodiments, the device and method provided allow concentrated
cells (e.g., white blood cells, red blood cells, progenitor cells,
stem cells, etc.) to be obtained from blood or bone marrow
aspirates. These nucleated cell types can be concentrated in the
delivery liquid so they can easily be delivered to the allograft
material to enhance bone growth at the bone defect site.
[0008] In one embodiment, a filtration device is provided
comprising: a housing defining a chamber disposed between a
receiving end and a dispenser end; a plunger slidably inserted
within the chamber from the receiving end; a first disc slidably
affixed to the plunger; and a second disc slidably affixed to the
plunger below the first sliding disc and facing the dispenser end,
the second disc including at least one filter arrangement.
[0009] In another embodiment, a device for separating particulate
matter from a liquid is provided comprising: a housing defining an
elongate chamber disposed between a receiving end and a dispenser
end; a plunger slidably inserted within the chamber from the
receiving end; an upper disc and a lower disc each independently
slidably affixed to the plunger, the lower disc facing the
dispenser end and including at least one filter arrangement; a
liquid including particulate matter disposed within the chamber
when the upper disc and lower disc are in an aspiration mode; and a
removable cap affixed to the dispensing end, wherein the lower disc
is independently slidable with respect to the upper disc to achieve
a filtration mode when the cap is affixed to the dispensing
end.
[0010] In yet another embodiment, a method for separating
particulate matter from a liquid is provided comprising the steps
of: providing a housing defining an elongate chamber disposed
between a receiving end and a dispenser end; providing a plunger
slidably inserted within the chamber from the receiving end;
providing an upper disc and a lower disc each independently
slidably affixed to the plunger, the lower disc facing the
dispenser end and including at least one filter arrangement;
sliding the upper and lower discs upwards towards the receiving end
for aspirating a liquid including particulate matter within the
chamber; affixing a cap to the dispensing end; sliding the lower
disc downwards to achieve a filtration mode for separating the
particulate matter from the liquid; removing the cap; and sliding
the upper disc downwards to achieve a concentrated cell expulsion
mode.
[0011] Additional features and advantages of various embodiments
will be set forth in part in the description that follows, and in
part will be apparent from the description, or may be learned by
practice of various embodiments. The objectives and other
advantages of various embodiments will be realized and attained by
means of the elements and combinations particularly pointed out in
the description and appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] In part, other aspects, features, benefits and advantages of
the embodiments will be apparent with regard to the following
description, appended claims and accompanying drawings where:
[0013] FIG. 1 illustrates a cross-sectional view of an exemplary
filtration device according to an aspect of the present
application;
[0014] FIG. 2 illustrates a cross-sectional view of the exemplary
filtration device of FIG. 1 in a liquid aspiration mode according
to an aspect of the present application;
[0015] FIG. 3 illustrates a cross-sectional view of the exemplary
filtration device of FIG. 2 in a filtration mode according to an
aspect of the present application;
[0016] FIG. 4 illustrates a cross-sectional view of the exemplary
filtration device of FIG. 3 in a concentrated cell expulsion mode
according to an aspect of the present application;
[0017] FIG. 5 illustrates a top view of a lower disc according to
an aspect of the present application;
[0018] FIG. 6 illustrates a top view of an upper disc according to
an aspect of the present application; and
[0019] FIG. 7 illustrates a side view of an exemplary cannula
according to an aspect of the present application.
[0020] It is to be understood that the figures are not drawn to
scale. Further, the relation between objects in a figure may not be
to scale, and may in fact have a reverse relationship as to size.
The figures are intended to bring understanding and clarity to the
structure of each object shown, and thus, some features may be
exaggerated in order to illustrate a specific feature of a
structure.
DETAILED DESCRIPTION
[0021] For the purposes of this specification and appended claims,
unless otherwise indicated, all numbers expressing quantities of
ingredients, percentages or proportions of materials, reaction
conditions, and other numerical values used in the specification
and claims, are to be understood as being modified in all instances
by the term "about." Accordingly, unless indicated to the contrary,
the numerical parameters set forth in the following specification
and attached claims are approximations that may vary depending upon
the desired properties sought to be obtained by the present
application. At the very least, and not as an attempt to limit the
application of the doctrine of equivalents to the scope of the
claims, each numerical parameter should at least be construed in
light of the number of reported significant digits and by applying
ordinary rounding techniques.
[0022] Notwithstanding that the numerical ranges and parameters
setting forth, the broad scope of the application are
approximations, the numerical values set forth in the specific
examples are reported as precisely as possible. Any numerical
value, however, inherently contains certain errors necessarily
resulting from the standard deviation found in their respective
testing measurements. Moreover, all ranges disclosed herein are to
be understood to encompass any and all subranges subsumed therein.
For example, a range of "1 to 10" includes any and all subranges
between (and including) the minimum value of 1 and the maximum
value of 10, that is, any and all subranges having a minimum value
of equal to or greater than 1 and a maximum value of equal to or
less than 10, e.g., 5.5 to 10.
[0023] It is noted that, as used in this specification and the
appended claims, the singular forms "a," "an," and "the," include
plural referents unless expressly and unequivocally limited to one
referent.
[0024] Reference will now be made in detail to certain embodiments
of the application, examples of which are illustrated in the
accompanying drawings. While the application will be described in
conjunction with the illustrated embodiments, it will be understood
that they are not intended to limit the application to those
embodiments. On the contrary, the application is intended to cover
all alternatives, modifications, and equivalents, which may be
included within the application as defined by the appended
claims.
[0025] The headings below are not meant to limit the disclosure in
any way; embodiments under any one heading may be used in
conjunction with embodiments under any other heading.
Filtration Device
[0026] The current devices and methods allow concentration of cells
in a liquid easily and efficiently at the point of care. The
current devices and methods avoid the need for expensive and
extensive laboratory equipment to filter cells. In some
embodiments, the devices and methods provided allow concentrated
cells (e.g., white blood cells, red blood cells, progenitor cells,
stem cells, etc.) to be obtained from blood or bone marrow
aspirates. These nucleated cell types can be concentrated in the
delivery liquid so they can easily be delivered to the allograft
material to enhance bone growth at the bone defect site.
Advantageously, a filtration device comprising a specialized
syringe according to various embodiments greatly improves ease of
use by enabling easy and quick preparation of a concentrated liquid
of particles such as cells, with a minimum number of steps and
equipment.
[0027] In various embodiments, a filtration device is provided
which may be manually operated and comprises a housing including an
elongate chamber disposed between a top end and a bottom end. The
top end comprises an opening adapted for receiving a plunger, and
the bottom end comprises a dispenser end. A removable cap may be
provided affixable to the dispenser end of the housing for
providing an airtight seal of the dispenser end. Further, a needle
or cannula may be provided connectable to the dispenser end via,
e.g., a luer lock. In various embodiments, the plunger includes at
least a first disc and a second disc each affixed to the plunger
and adapted for slidable movement within the chamber along a
longitudinal axis. The first disc may comprise a solid disc-shaped
member and is configured to move in at least an upward direction
toward the top end. The first disc can move dependently or
independently of the second disc and/or plunger. The first disc can
be non-porous and prevent or inhibit fluid from moving through it
and can comprise plastic, rubber and/or another polymer that is
impervious to liquids. The second disc is affixed to the plunger
below the first disc, e.g., facing the dispenser end, and may
include a filter arrangement. The second disc is semi-permeable or
permeable to liquids. Thus, the second disc allows all or a portion
of the liquid to pass through it and the filter. The second disc
and/or filter may move dependently or independently of the first
disc and/or plunger. Alternatively, the plunger, the first disc,
the second disc and/or filter may be moved in unison in either the
upwards toward the top end or downwards directions toward the
dispensing end.
[0028] According to various embodiments, the plunger may be
deployed downwards to push the first and second discs towards the
dispenser end to achieve a starting position, and the device may be
positioned to insert the dispenser end into a desired fluid liquid
for aspiration. The plunger may be pulled upwards to pull the first
and second discs towards the top end, thus pulling the liquid into
the chamber of the device. A cap is connected to the dispenser end,
and the plunger may be pressed downwards to push the second disc
towards the dispenser end, thus forcing the liquid through the
second disc into an upper compartment dynamically formed between
the first and second discs. Particulate matter (e.g., cells) is
caused to be filtered out and remains in a lower compartment formed
between the dispenser end and the second disc. Once a desired
volume of concentrated liquid/cells is achieved in the lower
compartment, the cap may be removed and the plunger may be pressed
downwards to eject the concentrated cells from the dispenser end
for administration to a patient.
[0029] FIG. 1 illustrates a cross-sectional view of an exemplary
filtration device 101 depicted in a `starting mode`, or position
ready for aspiration of fluid, according to an aspect of the
present application. The device 101 comprises a housing 103 having
a receiving end 107 for receiving a plunger 111 and a dispenser end
109 which may in some embodiments comprise a conical shape having a
tip through which fluid may be aspirated or expelled. The housing
103 may comprise e.g., a hollow cylindrical or tubular body
defining an elongate chamber 105. The plunger 111 may comprise an
elongate rod having a handle at a first end, and is of a length at
least sufficient to be insertable within a depth of the chamber
105.
[0030] A first or upper disc 113 having an annular shape and
periphery which is dimensioned to form a sliding seal with the
walls of the chamber 105 may be provided slidably affixed to the
plunger 111. In various embodiments, the first disc 113 may be
oriented to face the receiving end 107 and forms an airtight seal
with respect to the sidewalls of the chamber 105 and the plunger
111 so as to prevent air or fluid flow between the receiving end
107 and the dispenser end 109. The first disc 113 may be formed of
any solid or substantially solid, non-porous rigid material, such
as plastic, metal, rubber, or similar materials.
[0031] FIG. 6 illustrates a top view of an exemplary upper disc
according to an aspect of the present application. The upper disc
113 may include a hole 601 adapted for slidably receiving the
elongate rod of the plunger there through in a manner which
maintains the airtight seal between the receiving end 107 and the
dispenser end 109.
[0032] The plunger 111 may further include a second or lower disc
115 having an annular shape and periphery which is also dimensioned
to form a sliding seal with sidewalls of the chamber 105. The
second disc 115 is slidably affixed to the plunger 111 below the
first disc 113 so that it faces the dispenser end 109.
[0033] In various embodiments, the second disc 115 may include at
least one filter arrangement 117 each comprising one or more types
and/or layers of filter media or porous media suitable to prevent
the passage of matter, such as particulate matter, there through.
The nature and properties of the filter or porous media or material
may be selected and configured as necessary to provide a desired
pore size/density suitable to prevent the passage of particulate
matter which is desired to be captured or concentrated.
[0034] FIG. 5 illustrates a top view of an exemplary lower disc 115
including filter arrangements 117 according to an aspect of the
present application. In various embodiments, the lower disc 115 may
comprise a frame 501 having an annular periphery and a central hole
503 adapted for receiving the plunger 111. The frame 501 comprises
any solid, non-porous rigid material and may include a plurality of
arms 505 defining at least one void at or within which the at least
one filter arrangement 117 may be disposed. The plurality of arms
505 may comprise any number or design, and in some embodiments,
advantageously imparts stability to the second disc 115 for
supporting the filter arrangements 117 especially during a
`filtration mode` when liquid is caused to flow there through, as
discussed further below. In various embodiments, the periphery of
the frame 501 is adapted to maintain a slidable airtight seal with
the walls of the chamber 105, while allowing liquid to flow through
the filter arrangements 117. For example, the filter arrangement
can be continuous throughout the frame and comprise recesses and/or
projections complementary to the lower disc such that the filter
arrangement can fit within the lower disc. In alternative
embodiments, the filter arrangement and the lower disc are one
piece. In some embodiments, the filter arrangement 117 is disposed
within, above or below the at least one void. In various
embodiments, the filter arrangements 117 rest on and/or is attached
to the top or bottom of arms 505 such that the filter arrangement
is a complete circular filter supported by arms 505 as fluid is
pushed through the filter arrangement.
[0035] The depiction shown in FIG. 5 is for exemplary purposes only
and any shape, location, number, configuration and orientation of
the filter arrangements 117 may be contemplated. In various
embodiments, alternate designs of the frame 501 and filter
arrangements 117 may be contemplated to provide for example,
desired flow and filtration characteristics.
[0036] In various embodiments, the first and second discs 113, 115
are independently slidably affixed to the plunger 111, that is, to
enable both independent movement of each disc 113, 115 in an
upwards or downwards direction, and their movement in unison in an
upwards or downwards direction. This enables the various modes
(e.g., `start mode,` aspiration mode,' `filtration mode,` and
`concentrated cell expulsion mode`) to be achieved, as described
herein and further below.
[0037] FIG. 2 illustrates a cross-sectional view of the exemplary
filtration device of FIG. 1 in an `aspiration mode` according to an
aspect of the present application. In operation, the device 101
allows for the drawing of liquid within the chamber 105 by
positioning the plunger 111 and discs 113, 115 proximate to the
dispenser end 109 as shown in FIG. 1, immersing the dispenser end
109 into a liquid, and withdrawing the plunger 111 and both discs
113, 115 upwards to a position in the chamber 105 which will cause
aspiration of the desired volume of liquid 201 into the chamber
105, for example, as shown in FIG. 2.
[0038] In various embodiments, the liquid may comprise any bodily
fluid (e.g., blood, aspirate fluid, cerebral fluid, spinal fluid,
plasma, marrow, etc.) that includes cells (e.g., eukaryotic cells,
white blood cells, red blood cells, progenitor cells, stem cells,
etc.) in it including, which are desired to be separated from the
liquid. In the aspiration mode in FIG. 2, the dispensing end has
the cap off and cells and liquid are drawn into the syringe
chamber. Disc 113 and 115 can contact each other and the plunger is
drawn up the syringe chamber to the top end so that the liquid
including cells fills the syringe chamber.
[0039] In various embodiments, during aspiration of liquid into the
chamber 105, the positions of the first and second discs 113, 115
are maintained adjacent to one another. Once the desired amount of
liquid is pulled into the chamber 105, a removable cap 309 in FIG.
3 is affixed to the dispenser end 109. The cap 309 may comprise any
non-porous material adapted to achieve and maintain an airtight
seal with the tip 109. In some embodiments, the cap, syringe,
plunger, filter, and/or discs can comprise polyurethane, polyurea,
polyether(amide), PEBA, thermoplastic elastomeric olefin,
copolyester, and styrenic thermoplastic elastomer, steel, aluminum,
stainless steel, nitinol, titanium, metal alloys with high
non-ferrous metal content and a low relative proportion of iron,
carbon fiber, glass fiber, plastics, ceramics or combinations
thereof.
[0040] FIG. 3 illustrates a cross-sectional view of the exemplary
filtration device 101 of FIG. 2 in a filtration mode according to
an aspect of the present application.
[0041] In FIG. 3, once the cap 309 is secured, the device may be
caused to commence a `filtration mode` in which the plunger 111 is
pressed downwards towards the dispensing end 109 to cause the
second disc 115 to move downward towards the dispenser end 109. In
this aspect, the liquid will pass through the filter of the second
or lower disc 115. The pressure generated by the downward force of
the plunger 111 on the liquid (e.g., blood, aspirate fluid,
cerebral fluid, spinal fluid, plasma, marrow, etc.) that includes
cells (e.g., eukaryotic cells, white blood cells, red blood cells,
progenitor cells, stem cells, etc.) will cause the fluid portion
307 of the sample to be separated and passed through the filter,
while the cells 305 will be separated by being retained by the
filter. Lower compartment 303 will contain a higher concentration
of cells in a smaller amount of liquid than in upper compartment
301. The pressure from liquid passing through the second or lower
disc 115 and filter will cause the first or upper disc 113 to move
in an upward direction away from the dispensing end. Upper
compartment 301 will contain predominately fluid 307 and little or
no cells. While lower compartment 303 will contain a high
concentration of cells 305 and very little fluid.
[0042] In operation, the downward movement of the lower or second
disc 115 subjects the liquid 307 to pressure and dynamically
creates an upper compartment 301 situated between the first disc
113 and the lower disc 115. In some embodiments, the first or upper
disc 113 can comprise a recess or projection complementary to the
syringe on one or both sides of the disc or portion 114 of the
chamber of the syringe can comprise a recess or projection that the
upper disc 113 can not slide above. In this way, fluid will not
travel above the first or upper disc 113 so that no fluid can leak
out of the syringe at its upper end. This recess and/or projection
locks the upper disc 113 in position and keeps it there so that it
can not go above it. However, the upper disc 113 can slide below
it.
[0043] In some embodiments, there is a plurality of recesses and/or
projections 114 that can be in the syringe chamber 105 that allows
the upper disc to be locked in place so that it can not move above
or below a certain position in the syringe chamber. In this way,
the cells can easily be expelled from the syringe by downward
movement of the plunger and the upper disc will not move to any
substantial extent in this embodiment.
[0044] In some embodiments, as the lower disc 115 is pushed down,
the liquid 307 is caused to flow through the filtration arrangement
of the lower disc 115 into the upper compartment 301. The
filtration arrangement allows for filtered liquid or filtrate 307
to pass through into the upper compartment 301 while substantially
preventing particulate matter (e.g., cells) from entering the upper
compartment 301 thus creating a concentrated liquid containing a
high concentration of cells 305.
[0045] At the same time, a lower compartment 303 is dynamically
formed and situated between the lower disc 115 and the dispenser
end 109, which holds the concentrated liquid containing a high
concentration of cells 305 proximate to the dispenser end 109.
[0046] The plunger 111 may be pushed downwards to any extent to
achieve a desired volume of concentrated liquid containing a high
concentration of cells 305, with the lower disc 115 effectively
maintaining separation of the concentrated liquid containing a high
concentration of cells 305 from the filtrate containing liquid 307
at all times.
[0047] A `concentrated cell expulsion mode` will now be described.
Once the desired volume of concentrated liquid containing a high
concentration of cells 305 within the lower compartment 303 is
achieved, the device may realize a `concentrated cell or
concentrated liquid expulsion mode` where there is a high
concentration of cells wherein the cap 309 is removed and a
downwards force is applied to the plunger 111 to cause at least the
second disc 115 to be pushed downwards, e.g., as far as possible so
as to abut the dispenser end 109. This results in the concentrated
liquid containing a high concentration of cells 305 being expelled
from the dispenser end 109, e.g., for administration to a treatment
site. FIG. 4 illustrates a cross-sectional view of the exemplary
filtration device of FIG. 1 in a concentrated liquid expulsion mode
according to an aspect of the present application. In this way,
high concentration of nucleated cells (e.g., eukaryotic cells,
white blood cells, red blood cells, progenitor cells, stem cells,
etc.) can be applied to a target tissue or to allograft material to
enhance bone growth.
[0048] FIG. 7 illustrates a side view of an exemplary cannula or
needle 701 for use with a filtration device according to an aspect
of the present application. The needle 701 may comprise a base 703
configured for attachment to the dispenser end 109, and a hollow
needle 705 having any size or configuration adapted for effective
flow of the therapeutically effective amount of desired
concentrated liquid containing a high concentration of cells for
administration to a treatment site, such as within a patient or to
a bone defect or to hydrate allograft material.
[0049] According to various embodiments, a method for separating
particulate matter (e.g., cells) from a liquid and administering
same to a site will now be discussed. A housing is provided
defining an elongate chamber disposed between a receiving end and a
dispenser end. A plunger is slidably inserted within the chamber
from the receiving end and an upper disc and a lower disc are
provided each dependently or independently slidably affixed to the
plunger, the lower disc facing the dispenser end and including at
least one filter arrangement.
[0050] In one embodiment, the lower disc comprises a filter and
moves dependently with the plunger. In this embodiment, the upper
disc is configured to move independently of the plunger, for
example, the upper disc can move in an upward direction toward the
upper end as fluid pass through the lower disc and filter. The
pressure from fluid will cause the upper disc to move away from the
dispensing end and toward the upper end of the syringe.
[0051] In one embodiment, to achieve the `start mode` the upper and
lower discs may be moved downwards together towards the dispenser
end and the dispenser end immersed in a liquid containing
particulate matter (e.g., cells) desired to be concentrated.
[0052] In one embodiment, to achieve the `aspiration mode,` the
upper and lower discs are moved upwards together towards the
receiving end for aspirating the liquid including particulate
matter (e.g., cells) within the chamber.
[0053] In one embodiment, to achieve the `filtration mode,` a
removable cap is affixed to seal the dispenser end. The lower disc
is moved downwards while the upper disc will move upward as fluid
passes through the filter and the lower disc and contacts the upper
disc. By forcing the plunger and lower disc in a downward
direction, the liquid is forced to pass through the at least one
filter arrangement of the lower disc. This results in dynamically
forming an upper compartment and a lower compartment
simultaneously, wherein the upper compartment is formed between the
upper disc and the lower disc for containing the filtered liquid,
and the lower compartment is formed between the lower disc and the
dispenser end for containing the concentration cells and little or
no liquid.
[0054] Once a desired volume of concentrated cells is attained, a
`concentrated cell or concentrated liquid expulsion mode` may be
achieved by removing the cap and moving at least the lower disc
downwards to abut the dispenser end, thus expelling the
concentrated cells to the target tissue site or bone defect or they
can be used to hydrate the allograft.
[0055] Alternate designs may be provided for providing and/or
regulating filtration of fluid, including but not limited to types,
placement, thickness and/or amount of filter media used,
orientation of the filter arrangements, and so on.
[0056] Advantageously, a filtration device according to the present
application comprises a minimum number of moving parts, minimizes
complexity and is extremely user friendly, ultimately reducing the
equipment and steps needed for achieving effective separation of
particulate matter from a liquid to form a concentrated liquid and
providing efficient delivery of a desired volume of the
concentrated liquid to a site.
Cannula or Needle
[0057] The cannula or needle of the filtration device may comprise
any size or configuration adapted for enabling effective flow of
the therapeutically effective amount of desired concentrated liquid
for administration to a treatment site or to the allograft
material. Cannulas or needles include tubes that may be made from
materials, such as for example, polyurethane, polyurea,
polyether(amide), PEBA, thermoplastic elastomeric olefin,
copolyester, and styrenic thermoplastic elastomer, steel, aluminum,
stainless steel, nitinol, titanium, metal alloys with high
non-ferrous metal content and a low relative proportion of iron,
carbon fiber, glass fiber, plastics, ceramics or combinations
thereof. The cannula or needle may optionally include one or more
tapered regions. In various embodiments, the cannula or needle may
be beveled. The cannula or needle may also have a tip style vital
for accurate treatment of the patient depending on the site for
implantation. Examples of tip styles include, for example,
Trephine, Cournand, Veress, Huber, Seldinger, Chiba, Francine,
Bias, Crawford, deflected tips, Hustead, Lancet, or Tuohey.
[0058] In various embodiments, the diameter of the cannula or
needle is substantially the same throughout. In other embodiments,
the diameter of the needle or cannula becomes smaller approaching
the distal end.
[0059] The dimensions of the hollow cannula or needle, among other
things, will depend on the site for implantation. For example, the
width of the epidural space is only about 3-5 mm for the thoracic
region and about 5-7 mm for the lumbar region. Thus, the needle or
cannula, in various embodiments, can be designed for these specific
areas. Some examples of lengths of the cannula or needle may
include, but are not limited to, from about 50 to 150 mm in length,
for example, about 65 mm for epidural pediatric use, about 85 mm
for a standard adult and about 150 mm for an obese adult
patient.
[0060] The thickness of the cannula or needle will also depend on
the concentration of particulate matter in the liquid desired to be
administered to the site or allograft. In various embodiments, the
thickness includes, but is not limited to, from about 0.05 to about
1.655. The gauge of the cannula or needle may be the widest or
smallest diameter or a diameter in between for insertion into a
human or animal body. The widest diameter is about 14 gauge, while
the smallest diameter is about 25 gauge. In various embodiments the
gauge of the needle or cannula is about 17 to about 25 gauge.
[0061] In various embodiments, the plunger and/or cannula may
include markings that indicate location at or near the site beneath
the skin.
[0062] In various embodiments, the needle or cannula may include a
transparent or translucent portion that can be visualizable by
ultrasound, fluoroscopy, x-ray, or other imaging techniques. In
such embodiments, the transparent or translucent portion may
include a radiopaque material or ultrasound responsive topography
that increases the contrast of the needle or cannula relative to
the absence of the material or topography.
[0063] In various embodiments, surrounding the opening of the
proximal end of the cannula or needle is a generally cylindrical
hub having an engagement means (shown as internal threading) for
engaging the dispensed end of the housing. Engagement means
include, but are not limited to, threading, tracks, clips, ribs,
projections, and the like that allow a secure connection between
the housing and the proximal end of the cannula. For example, in
various embodiments the engagement means may be a luer lock
connection, where the cannula has mating threads that mate with the
threads disposed on or in the housing.
Housing
[0064] The housing of the filtration device may be of various
shapes including, but not limited to, cylindrical or tubular such
that the housing defines a barrel or chamber which allows for
slidable insertion of a plunger as well as the annular disc members
there through.
[0065] The housing may comprise a variety of materials, such as,
for example, polyurethane, polyurea, polyether(amide), PEBA,
thermoplastic elastomeric olefin, copolyester, and styrenic
thermoplastic elastomer, steel, nitinol, aluminum, stainless steel,
titanium, metal alloys with high non-ferrous metal content and a
low relative proportion of iron, carbon fiber, glass fiber,
plastics, ceramics or combinations thereof.
[0066] Like the plunger, in various embodiments, the housing may
have dose indicator markings (e.g., numbers, lines, letters,
radiographic markers, etc.) to indicate, for example, the amount of
liquid therein and the amount of concentrated liquid delivered.
[0067] The housing may have contours and allow easy grasping of the
device during use. The housing can be angled for right and left
hand users or can be generic for both hands.
Plunger
[0068] Although a first end of the plunger is shown as a handle, it
will be understood that the knob can be a top, dial, or cap or any
member that allows the user to utilize the plunger. In various
embodiments, the plunger may comprise an elongate cylindrical rod
which may be solid, have a hollow interior, or any combination
thereof. Alternate shapes and configurations of the plunger may be
contemplated.
[0069] The plunger has a diameter which fits within the respective
holes of the first and second discs. The plunger may be longer than
or the same size as the length of the housing of the syringe.
[0070] The plunger may be made from materials, such as for example,
polyurethane, polyurea, polyether(amide), PEBA, thermoplastic
elastomeric olefin, copolyester, and styrenic thermoplastic
elastomer, steel, aluminum, stainless steel, titanium, nitinol,
metal alloys with high non-ferrous metal content and a low relative
proportion of iron, carbon fiber, glass fiber, plastics, ceramics
or combinations thereof. The plunger may optionally include one or
more tapered regions.
[0071] Like the cannula or needle, in various embodiments, the
plunger may have dose indicator markings (e.g., numbers, lines,
letters, radiographic markers, etc.) to indicate the amount of
liquid delivered.
[0072] The plunger may be affixed to the first and second discs in
various configurations to selectively enable movement of each of
the first and second discs independently as well as in unison, in
both upwards and downwards directions. In some embodiments, the
plunger can be disposed in the center of the upper and/or lower
disc and can be attached thereto by a rim. The rim can attach the
upper disc to the plunger loosely so that the upper disc can slide
in an upward direction toward the upper end when the device is in a
filtration mode.
Filter Material
[0073] Filtration is commonly the mechanical or physical operation
which is used for the separation of solids (e.g., cells) from
fluids (liquids or gases) by interposing a medium through which
only the fluid can pass. Oversize solids in the fluid are retained,
depending on the pore size and filter thickness). Fluids flow
through a filter due to a difference in pressure--fluid flows from
the high pressure side to the low pressure side of the filter,
leaving some material behind.
[0074] In various embodiments, with regards to the filter
arrangement according to the present application the nature of the
material used to make the filter arrangement, the compatibility of
the materials chosen for the filter arrangement with one another
and with the liquid to be processed are all factors which may be
considered in selecting a particular material for a filter
arrangement for a given application.
[0075] In various embodiments, the filter arrangement may comprise
a unitary structure and/or a composite structure. The filter
arrangement may include one or more portions having varying
densities and/or pore size. For example, the filter arrangement may
comprise a first portion having a density and/or pore size suitable
to prevent the passage of cells there through and a second portion
having a density and/or pore size suitable for passing the fluid
there through.
[0076] In various embodiments, the filter arrangement may include
various arrangements of porous media such as membranes, depth
filters, and other porous media, and any combination thereof,
suitable for preventing the passage of cells there through.
Exemplary materials of the porous media may include polypropylene
or high density polyethylene, porous plastics, or any combination
thereof.
[0077] It should be noted that various types of porous arrangements
can be used interchangeably with that of the present embodiment.
While a polycarbonate membrane is especially suitable for use in a
filtration device as disclosed herein, other porous membranes are
also suitable.
[0078] The porous media may be configured to have any desired pore
size. For example, exemplary pore sizes may include from about 0.1
or 0.5 to about 5.0 or 10.0 microns that will allow fluid flow to
pass there through while preventing the passage of particulate
matter.
[0079] As one skilled in the art will recognize, adjusting the pore
size of the porous membrane and the porous depth filter in
accordance with the type and/or size of matter to be collected
permits the collection of the desired particulate matter. It is
intended that the present disclosure should not be limited to a
certain range of pore size.
[0080] One or more layers of porous media may be positioned in any
fashion that functions to enable the desired filtration effect. As
one skilled in the art will recognize, the porous arrangement may
be variously configured and positioned as needed to achieve a
particular result. For example, one or more layers of porous media
may be separate, spaced apart, laminated together, integrally
formed with and/or removably engaged with each other. In some
embodiments, the filter may be continuous with the lower disc of
the device. In some embodiments, the filter is disposed at discrete
positions on the lower disc.
Liquid
[0081] As used herein, fluid or liquid refers to any fluid or
liquid for which it may be desirable to collect a component of the
fluid for the purpose of establishing its identity or presence in
the fluid. In various embodiments, the component in the fluid will
be a solid matter, such as particulate matter (e.g., cells). For
example, the fluid may be air or gas, or a biological fluid, and it
may be desirable to concentrate the number of cells in the
biological fluid. In various embodiments, the biological fluid may
be blood or bone marrow aspirate, and it may be desirable to
concentrate the number of certain cells such as nucleated cells in
the biological fluid.
[0082] Other exemplary fluids include but are not limited to body
fluids, such as spinal fluid, amniotic fluid; bronchial lavage;
sputum; fine needle aspirates; ground water; industrial processing
fluids; electronic or medical dialysis fluids; to name just a few.
It is intended that the present disclosure should not be limited by
the type of fluid being processed.
[0083] A "therapeutically effective amount" is such that when
administered, the concentrated liquid results in alteration of the
biological activity, such as, for example, inhibition of
inflammation, hydration of the treatment site, improvement in the
condition, bone growth, etc. The dosage administered to a patient
can be as single or multiple doses depending upon a variety of
factors, including the liquid's pharmacokinetic properties, the
route and/or location of administration, patient conditions and
characteristics (sex, age, body weight, health, size, etc.), extent
of symptoms, concurrent treatments, frequency of treatment and the
effect desired.
Particulate Matter
[0084] As used herein, particulate matter refers to any substance
in a fluid which is capable of collection. Exemplary particulate
matter includes, but is not limited to cells (e.g., eukaryotic
cells, white blood cells, red blood cells, progenitor cells, stem
cells, etc.)or cell fragments, proteins, molecules, polymers, or
the like. Specific exemplary biological matter includes red blood
cells, white blood cells, stem cells, including distinguishing
between nucleated and enucleated cells; cancer cells, including
distinguishing between metastatic and normal cancer cells;
proteins, nucleic acids, antibodies, or the like.
[0085] While a filtration device according to various aspects of
the present disclosure can be used for any biological fluid, it is
particularly useful for preparing concentrated liquids comprising
nucleated cells that are beneficial for, e.g., bone and soft tissue
repair.
[0086] It is intended that the present disclosure should not be
limited by the type of matter being processed. In various
embodiments, the fluid is blood or bone marrow aspirate and the
particulate matter is a cell.
Sterilization
[0087] The filtration device components (e.g., cannula or needle,
plunger, housing, discs, etc.) may be lightweight, disposable and
sterilizable such that when the device is assembled, the weight of
the device does not substantially increase. In various embodiments,
one or more components of the device are sterilized by radiation in
a terminal sterilization step in the final packaging. Terminal
sterilization of a product provides greater assurance of sterility
than from processes such as an aseptic process, which require
individual product components to be sterilized separately and the
final package assembled in a sterile environment.
[0088] In various embodiments, gamma radiation is used in the
terminal sterilization step, which involves utilizing ionizing
energy from gamma rays that penetrates deeply in the device. Gamma
rays are highly effective in killing microorganisms, they leave no
residues nor have sufficient energy to impart radioactivity to the
device. Gamma rays can be employed when the device is in the
package and gamma sterilization does not require high pressures or
vacuum conditions, thus, package seals and other components are not
stressed. In addition, gamma radiation eliminates the need for
permeable packaging materials.
[0089] In various embodiments, electron beam (e-beam) radiation may
be used to sterilize one or more components of the device. E-beam
radiation comprises a form of ionizing energy, which is generally
characterized by low penetration and high-dose rates. E-beam
irradiation is similar to gamma processing in that it alters
various chemical and molecular bonds on contact, including the
reproductive cells of microorganisms. Beams produced for e-beam
sterilization are concentrated, highly-charged streams of electrons
generated by the acceleration and conversion of electricity.
[0090] Other methods may also be used to sterilize one or more
components of the device, including, but not limited to, gas
sterilization, such as, for example, with ethylene oxide or steam
sterilization.
[0091] In various embodiments, a kit is provided for separating
particulate matter from a fluid, the kit comprising: a sterilized
filtration device, comprising: a housing defining an elongate
chamber disposed between a receiving end and a dispenser end; a
plunger slidably inserted within the chamber from the receiving
end; an upper disc and a lower disc each independently slidably
affixed to the plunger, the lower disc facing the dispenser end and
including at least one filter arrangement; and a removable cap
affixed to the dispensing end.
[0092] In various embodiments, a kit is provided which may include
additional parts along with the filtration device combined together
to be used to prepare and administer the therapeutically effective
amount of concentrated liquid. The kit may include the filtration
device in a first compartment. The second compartment may include a
needle or cannula, and any other instruments needed for the
administration of the concentrated liquid. A third compartment may
include gloves, drapes, wound dressings and other procedural
supplies for maintaining sterility of the implanting process, as
well as an instruction booklet. A fourth compartment may include
additional cannulas and/or needles. Each tool may be separately
packaged in a plastic pouch that is radiation sterilized. A cover
of the kit may include illustrations of the implanting procedure
and a clear plastic cover may be placed over the compartments to
maintain sterility.
[0093] The device and method may be used to treat a bone repair
site, e.g., one resulting from injury, defect brought about during
the course of surgery, infection, malignancy or developmental
malformation, which requires mechanical support. The device and
method can be utilized in a wide variety of orthopedic,
periodontal, neurosurgical and oral and maxillofacial surgical
procedures such as the repair of simple and compound fractures and
non-unions, external and internal fixations, joint reconstructions
such as arthrodesis, general arthroplasty, cup arthroplasty of the
hip, femoral and humeral head replacement, femoral head surface
replacement and total joint replacement, repairs of the vertebral
column including spinal fusion and internal fixation, tumor
surgery, e.g., deficit filling, discectomy, laminectomy, excision
of spinal cord tumors, anterior cervical and thoracic operations,
repairs of spinal injuries, scoliosis, lordosis and kyphosis
treatments, intermaxillary fixation of fractures, mentoplasty,
temporomandibular joint replacement, alveolar ridge augmentation
and reconstruction, onlay bone grafts, implant placement and
revision, sinus lifts, etc. Specific bones which can be repaired or
replaced with the device herein include the ethmoid, frontal,
nasal, occipital, parietal, temporal, mandible, maxilla, zygomatic,
cervical vertebra, thoracic vertebra, lumbar vertebra, sacrum, rib,
sternum, clavicle, scapula, humerus, radius, ulna, carpal bones,
metacarpal bones, phalanges, ilium, ischium, pubis, femur, tibia,
fibula, patella, calcaneus, tarsal and metatarsal bones. The device
can be implanted at the bone repair site, if desired, using any
suitable affixation means, e.g., sutures, staples, bioadhesives, or
the like.
[0094] Patients include a biological system to which a treatment
can be administered. A biological system can include, for example,
an individual cell, a set of cells (e.g., a cell culture), an
organ, or a tissue. Additionally, the term "patient" can refer to
animals, including, without limitation, humans.
[0095] Treating or treatment of a disease refers to executing a
protocol, which may include administering one or more
therapeutically effective doses to a patient (human or otherwise),
in an effort to alleviate signs or symptoms of the disease.
Alleviation can occur prior to signs or symptoms of the disease
appearing, as well as after their appearance. Thus, "treating" or
"treatment" includes "preventing" or "prevention" of disease. In
addition, "treating" or "treatment" does not require complete
alleviation of signs or symptoms, does not require a cure, and
specifically includes protocols that have only a marginal effect on
the patient.
[0096] It will be apparent to those skilled in the art that various
modifications and variations can be made to various embodiments
described herein without departing from the spirit or scope of the
teachings herein. Thus, it is intended that various embodiments
cover other modifications and variations of various embodiments
within the scope of the present teachings.
* * * * *