U.S. patent application number 13/656786 was filed with the patent office on 2013-04-25 for composite mixer.
This patent application is currently assigned to SMITH & NEPHEW, INC.. The applicant listed for this patent is Smith & Nephew, Inc.. Invention is credited to JOSEPH M. FERRANTE, Sied W. Janna, Thomas Mayr, Jeremy Odegard, Wayne Phillips, David Schuelke.
Application Number | 20130100761 13/656786 |
Document ID | / |
Family ID | 35999533 |
Filed Date | 2013-04-25 |
United States Patent
Application |
20130100761 |
Kind Code |
A1 |
FERRANTE; JOSEPH M. ; et
al. |
April 25, 2013 |
COMPOSITE MIXER
Abstract
Devices and methods for mixing a clotting agent with other
inputs such as blood, blood derived product, bone marrow, and/or
bone marrow derived product to form a congealed mixture.
Inventors: |
FERRANTE; JOSEPH M.;
(Bartlett, TN) ; Janna; Sied W.; (Memphis, TN)
; Mayr; Thomas; (Hudson, WI) ; Odegard;
Jeremy; (River Falls, WI) ; Phillips; Wayne;
(Hudson, WI) ; Schuelke; David; (Hudson,
WI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Smith & Nephew, Inc.; |
Memphis |
TN |
US |
|
|
Assignee: |
SMITH & NEPHEW, INC.
MEMPHIS
TN
|
Family ID: |
35999533 |
Appl. No.: |
13/656786 |
Filed: |
October 22, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11791255 |
May 1, 2008 |
8308340 |
|
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PCT/US2005/042594 |
Nov 22, 2005 |
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13656786 |
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60630463 |
Nov 23, 2004 |
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Current U.S.
Class: |
366/338 ;
366/336 |
Current CPC
Class: |
A61B 2017/00495
20130101; A61B 17/00491 20130101; B01F 5/0602 20130101 |
Class at
Publication: |
366/338 ;
366/336 |
International
Class: |
B01F 5/06 20060101
B01F005/06 |
Claims
1.-2. (canceled)
3. A method of mixing a clotting agent with an input material,
comprising: providing a mixing device comprising a passageway, a
first container of the clotting agent in communication with the
passageway, and a second container of the input material in
communication with the passageway; and passing the clotting agent
and the input material at approximately the same time through a
mixer portion of a passageway with a turbulent flow inducing
shape.
4.-16. (canceled)
17. The method of claim 3, in which the mixer portion comprises an
hourglass-shaped tubular portion.
18. The method of claim 3, in which the mixer portion comprises a
shape of repeating hourglasses.
19. The method of claim 3, in which the mixer portion comprises a
first portion and a second portion, in which a diameter of the
first portion is greater than a diameter of the second portion.
20. The method of claim 3, in which the mixer portion comprises a
first portion, a second portion, and a third portion, in which a
diameter of the first portion is greater than a diameter of the
second portion and the diameter of the second portion is less than
a diameter of the third portion.
21. The method of claim 3, in which the mixer portion comprises a
tubular portion having a circular cross section.
22. The method of claim 3, in which the mixer portion comprises a
tubular portion having a cross section shape that varies along a
length of the portion.
23. The method of claim 3, in which the mixer portion comprises a
first portion and a second portion, in which a width of the first
portion is greater than a width of the second portion.
24. The method of claim 3, in which the mixer portion comprises a
first portion, a second portion, and a third portion, in which a
width of the first portion is greater than a width of the second
portion and the width of the second portion is less than a width of
the third portion.
25. The method of claim 3, in which the mixer portion comprises a
first portion and a second portion, in which a cross sectional area
of the first portion is greater than a cross sectional area of the
second portion.
26. The method of claim 3, in which the mixer portion comprises a
first portion, a second portion, and a third portion, in which a
cross sectional area of the first portion is greater than a cross
sectional area of the second portion and the cross sectional area
of the second portion is less than a cross sectional area of the
third portion.
27. The method of claim 3, in which the mixer comprises a first
portion, a second portion, a third portion, and a fourth portion in
which a cross sectional area of the first portion is greater than a
cross sectional area of the second portion, the cross sectional
area of the second portion is less than a cross sectional area of
the third portion, and the cross sectional area of the third
portion is greater than a cross sectional area of the fourth
portion.
28. The method of claim 3, in which the clotting agent is
thrombin.
29. The method of claim 3, in which the mixer portion comprises a
portion having a tortuous shape.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Patent Application Ser. No. 60/630,463, entitled "Composite Mixer"
filed Nov. 23, 2004, the entire contents of which are hereby
incorporated by this reference.
RELATED FIELDS
[0002] Embodiments of the present invention relate to methods and
devices for mixing a clotting agent with one or more other inputs
to form a congealed mixture.
BACKGROUND
[0003] Bone voids and non-unions are often the result of trauma,
fracture, tumor removal, or surgical implant procedures such as
total joint replacement. Bone voids and non-unions are treated in a
variety of ways. In many cases, surgeons take filler and apply it
at the site of the bone void or non-union to fill in gaps and help
the bone grow. This filler may be or include constituents from the
patient's own body, a donor's body, or another species' body, as
well as other naturally occurring and synthetic substances. The
filler is typically a mixture of a clotting agent with blood
platelets and/or bone graft. Some people believe that blood
platelets facilitate the healing of bone and other tissue and that
bone graft and similar substances provide useful scaffolding for
new bone to grow around.
[0004] In some surgical procedures, blood is taken from the patient
and used to create a platelet rich concentration by separating out
the platelets from other components of the blood. The platelet rich
concentrate is then mixed with one or more clotting agents, such as
thrombin, collagen (e.g. gelfoam, microfibrillar collagen), calcium
salts (e.g. calcium chloride), gelatin paste or foam, fibrin glue,
bone wax, epinephrine, and/or oxidized cellulose, which facilitate
congealing. Thrombin, for example, breaks down some of the blood
components and causes them to interdigitate or weave themselves
together. After a short period of time, the mixture congeals and
may be used to treat a bone fracture, a non-union area, or a bone
void. The presence of blood platelets may help the patient heal or
heal faster then he or she otherwise would. The area filled in may
eventually turn back into bone. Note that the use of the platelet
rich mixture is not limited to filling bones. Such mixtures are
thought to have healing benefits for other tissue types as well.
For example, a tissue wound such as a burn may benefit from
treatment with a platelet rich mixture. The mixture may be applied
to help the skin reform. A variety of other uses are possible.
[0005] In the case of bone voids and non-unions, the filler may
contain a scaffolding substance, such as bone graft, that provides
a scaffold for new bone to grow around. Bone graft is morcelized or
crumbled up bone and may come from a donor (allogenic), the
patient's own bones (autologous), or from another species' bones
(xenologous). In addition to naturally derived bone graft, a
synthetic substance such as a resorbable polymer may be used as a
scaffolding substance. Ceramics such as calcium phosphate, calcium
sulfate, or silicon oxide may be used. The scaffolding substances
may be any combination of osteoconductive, osteoinductive, or
biocompatible materials.
[0006] Generally, a filler mixture is composed of a clotting agent
and one or more of blood, blood derived product, bone marrow, or
bone marrow derived product. Thus, for example, filler may be a
mixture of a clotting agent, a scaffolding substance, and a
platelet rich concentrate. Such filler might be used in a bone
graft procedure in which the filler is inserted into a bone void to
provide an environment for and induce new bone growth. The mixture
may include a variety of other inputs like proteins, angiogenic
factors, osteogenic factors, antibacterial agents, drugs, pain
medication, and/or any other suitable medically beneficial
input.
[0007] The mixture of clotting agent with other input constituents
or materials is often performed at or around the time of the
surgical procedure in which the mixture is used. In some cases,
this is because the use-ability and ease of handling of the
congealed mixture begins to decrease after the mixture has
congealed for an hour or so, when it begins to shrink and secrete
liquid. For a relatively short period of time after congealing, the
mixture is typically easier to handle because it can be easily cut
and shaped. After congealing for five hours, many mixtures will
have become unusable. In addition, when inputs from the mixture
come from the patient (e.g., blood platelets), it is often
convenient to obtain those inputs from the patient at or around the
time of surgery rather than long before. Generally, within a minute
or a minute and a half of mixing, the mixture congeals into a
useable substance that is good for up to around five hours.
[0008] There are a variety of ways to mix the clotting agent with
the other input or inputs. For example, the surgeon may make the
mixture by adding the ingredients to a small dish or bowl and
mixing them. As another example, the materials may be placed
together into a syringe as in U.S. patent application 2002/0127720
to Erbe et al., which is incorporated herein by this reference.
Erbe et al. describe a syringe for bone marrow aspirate and other
biocompatible materials in which mixing can occur. However, there
is potential for the constituents not to mix as desired.
[0009] Similarly, there is, among other things, potential for the
constituents to not interact as desired in the Depuy Symphony Graft
Delivery System, which allows two liquids to enter a conveyance
device where they interact. The end user may or may not be
successful at facilitating sufficient interaction and mixing with
manual agitations such as by shaking the container. U.S. Patent
Publication No. 2004/0167617 to Voellmicke et al., which is
incorporated herein by this reference, describes an apparatus for
mixing and retaining biological fluids. A manifold is used to
deliver materials from two or more input syringes into a fluid
retention chamber. However, an object of the Voellmicke et al.
invention is "to provide a apparatus for mixing and retaining
biological fluids comprising a manifold which minimizes
intra-manifold mixing of the fluids." The manifolds do not
facilitate, and in many cases minimize, intra-manifold mixing.
There is again, among other things, the potential that the inputs
will fail to mix or interact sufficiently.
SUMMARY
[0010] Embodiments of the present invention provide a mixing device
for mixing a clotting agent with one or more input materials. The
clotting agent and other inputs may flow or be caused to flow
through a passageway having a mixer portion with a turbulent flow
inducing shape. The mixing device may also have a body having a
base for resting on a flat surface, a first input port on the body
for receiving the clotting agent, a second input port on the body
for receiving the input material, an output port on the body for
removing a mixture of the clotting agent and the input material(s),
with a passageway with a mixer portion through the body and
connecting the first input port, the second input port, and the
output port. Another embodiment is a method of mixing a clotting
agent with one or more input materials. The method may involve
passing the clotting agent and the input material through the mixer
portion of a passageway.
STATEMENT OF THE INVENTION
[0011] According to a first aspect of the invention, there is
provided:
[0012] A mixing device comprising a passageway for mixing a
clotting agent with an input material, a first container containing
the clotting agent, a second container containing the input
material, the containers in communication with the passageway,
characterized in that a mixer portion of the passageway has a
turbulent flow inducing shape.
[0013] According to a second aspect of the invention, there is
provided:
[0014] The above mixing device, in which there is further provided
(a) a body comprising the passageway and a base for resting on a
flat surface; (b) the first container containing the clotting agent
in communication with the passageway at a first input port on the
body; (c) the second container containing the input material in
communication with the passageway at a second input port on the
body; and (d) a receiving container in communication with the
passageway at an output port on the body, for removing a mixture of
the clotting agent and the input material; characterized in
that
[0015] the passageway through the body connects the first input
port, the second input port, and the output port, and comprises the
mixer portion with the turbulent flow inducing shape.
[0016] According to a third aspect of the invention, there is
provided:
[0017] A method of mixing a clotting agent with an input material,
characterized in that the method comprises:
[0018] providing a mixing device comprising a passageway, a first
container of the clotting agent in communication with the
passageway, and a second container of the input material in
communication with the passageway; and
[0019] passing the clotting agent and the input material at
approximately the same time through a mixer portion of a passageway
with a turbulent flow inducing shape.
[0020] According to a further aspect of the invention, there is
provided:
[0021] One of the mixing devices or methods above, in which the
mixer portion comprises an hourglass-shaped tubular portion.
[0022] According to a further aspect of the invention, there is
provided:
[0023] One of the mixing devices or methods above, in which the
mixer portion comprises a shape of repeating hourglasses.
[0024] According to a further aspect of the invention, there is
provided:
[0025] One of the mixing devices or methods above, in which the
mixer portion comprises a first portion and a second portion, in
which a diameter of the first portion is greater than a diameter of
the second portion.
[0026] According to a further aspect of the invention, there is
provided:
[0027] One of the mixing devices or methods above, in which the
mixer portion comprises a first portion, a second portion, and a
third portion, in which a diameter of the first portion is greater
than a diameter of the second portion and the diameter of the
second portion is less than a diameter of the third portion.
[0028] According to a further aspect of the invention, there is
provided:
[0029] One of the mixing devices or methods above, in which the
mixer portion comprises a tubular portion having a circular cross
section.
[0030] According to a further aspect of the invention, there is
provided:
[0031] One of the mixing devices or methods above, in which the
mixer portion comprises a tubular portion having a cross section
shape that varies along a length of the portion.
[0032] According to a further aspect of the invention, there is
provided:
[0033] One of the mixing devices or methods above, in which the
mixer portion comprises a first portion and a second portion, in
which a width of the first portion is greater than a width of the
second portion.
[0034] According to a further aspect of the invention, there is
provided:
[0035] One of the mixing devices or methods above, in which the
mixer portion comprises a first portion, a second portion, and a
third portion, in which a width of the first portion is greater
than a width of the second portion and the width of the second
portion is less than a width of the third portion.
[0036] According to a further aspect of the invention, there is
provided:
[0037] One of the mixing devices or methods above, in which the
mixer portion comprises a first portion and a second portion, in
which a cross sectional area of the first portion is greater than a
cross sectional area of the second portion.
[0038] According to a further aspect of the invention, there is
provided:
[0039] One of the mixing devices or methods above, in which the
mixer portion comprises a first portion, a second portion, and a
third portion, in which a cross sectional area of the first portion
is greater than a cross sectional area of the second portion and
the cross sectional area of the second portion is less than a cross
sectional area of the third portion.
[0040] According to a further aspect of the invention, there is
provided:
[0041] One of the mixing devices or methods above, in which the
mixer comprises a first portion, a second portion, a third portion,
and a fourth portion in which a cross sectional area of the first
portion is greater than a cross sectional area of the second
portion, the cross sectional area of the second portion is less
than a cross sectional area of the third portion, and the cross
sectional area of the third portion is greater than a cross
sectional area of the fourth portion.
[0042] According to a further aspect of the invention, there is
provided:
[0043] One of the mixing devices or methods above, in which the
clotting agent is thrombin.
[0044] According to a further aspect of the invention, there is
provided:
[0045] One of the mixing devices or methods above, in which the
mixer portion comprises a portion having a tortuous shape.
BRIEF DESCRIPTION OF FIGURES
[0046] FIG. 1 is perspective view of a mixing device according to
an embodiment of the present invention.
[0047] FIGS. 2a-b are schematic views showing the passageway and
mixer portion of the passageway within the mixing device of FIG.
1.
[0048] FIG. 3 is a perspective view of a mixing device according to
another embodiment of the present invention.
[0049] FIG. 4 is a schematic view showing the passageway and mixer
portion of passageway within the mixing device of FIG. 3.
[0050] FIGS. 5a-e are schematic views of alternative mixer portions
of passageways according to several embodiments of the present
invention.
[0051] FIGS. 6a-e are schematic views of alternative mixer portions
of passageways according to several embodiments of the present
invention.
[0052] FIG. 7 is a schematic view of a mixer portion of a
passageway according to one embodiment of the present
invention.
[0053] FIG. 8 is a schematic view of a mixer portion of a
passageway according to one embodiment of the present
invention.
DETAILED DESCRIPTION OF FIGURES
Introduction
[0054] FIG. 1 shows a mixing device 100 according to one embodiment
of the present invention. The mixing device 100 is used with a
first input syringe 102, a second input syringe 104, and a
receiving syringe 106. Alternative embodiments may substitute test
tubes, bags, or other suitable containers for one or more of the
syringes and may utilize other suitable methods, including gravity,
to cause the inputs to flow. For convenience all such structures
are included within the meaning of "syringes" or "containers" for
purposes of this document. The base 108 of the mixing device 100,
which may be a manifold, is preferably flat so that the mixing
device can rest on a flat surface. The first input syringe 102 is
controlled by plunger 110 and is connected to the mixing device 100
at port 114. The second input syringe 104 is controlled by plunger
112 and connected to the mixing device 100 at port 116. The
receiving syringe 106 also has a plunger 118 and connects to the
mixing device at a port 120. Preferably the receiving syringe 106
is angled with respect to the two input syringes 102, 104, which
are preferably aligned parallel with and near to one another.
Generally, the syringes 102, 104, 106 are attached to the base via
Luer lock, slip fit, threading, or other suitable quick-fit
mechanism.
[0055] The mixing device may be made from any hemocompatible
material including but not limited to stainless steel, titanium, or
other compatible metal, or suitable polymer. Various manufacturing
methods or combinations thereof are appropriate including but not
limited to compression molding, injection molding, lathe machining,
mill machining, centers machining, cold forging and/or warm
forging.
[0056] In use, a clotting agent is placed in one syringe 104 and
one or more input materials are placed in the other input syringe
102. Some input material may also be placed in the receiving
syringe 106, if desired. For example, bone graft may be placed in
the receiving syringe 106. Input materials generally include but
are not limited to constituents such as blood, blood derived
product, platelet rich concentrate, bone marrow, bone marrow
derived product, scaffolding substance, proteins, angiogenic
factors, osteogenic factors, antibacterial agents, drugs, pain
medication, and/or any other suitable medically beneficial input
material. To mix the input material or materials with the clotting
agent, the plungers 110, 112 on the input syringes 102, 104 are
depressed to push the clotting agent and input material(s) through
the body 108, where they mix together, and into the receiving
syringe 106.
[0057] It should be noted that embodiments of the present invention
involve mixing devices and methods that utilize any number of input
materials from any number of input syringes or other containers. As
examples, there may be a single input syringe for both the clotting
agent and one input material. There may be an input syringe for the
clotting agent and an input syringe for a first input material.
There may be an input syringe for the clotting agent, an input
syringe for a first and second input material, and an input syringe
for a third input material. Any suitable combination of input
syringes and input materials may be used. Likewise, any number of
receiving syringes may also be used.
The Mixer Portion of the Passageway
[0058] Referring now to FIGS. 2a-b, the first input port 114,
second input port 116, and receiving port 120 are connected by
intersecting passageways 122, 124, 126, 128, that together comprise
a passageway connecting the three ports 114, 116, 120. A mixer
portion 126 of the passageway has a geometry or shape that induces
turbulent flow of fluid flowing through it. When the clotting agent
and other input material(s) are injected into the body of the
mixing device 100, they mix together within the passageway and the
mixture is pushed into the output or receiving syringe 106. Mixing
occurs because a portion of the passageway through the mixing
device has a geometry or shape that facilitates mixing of the
clotting agent and input material(s). In many cases, the mixture
pushed into the receiving syringe will be sufficiently mixed such
that no shaking is required. The thorough mixing of the input
materials helps ensure that the resulting mixture will be
sufficiently congealed.
[0059] The internal geometry or shape of at least a portion 126 of
the passageway through the mixing device 100 causes turbulent flow
of fluid passing through the passageway. In some embodiments, the
shape of a mixer portion 126 of the passageway creates differences
in velocity and/or local pressure in the fluid flowing through the
passageway. The areas of different pressures and/or velocities lead
to turbulence. A portion 126 of the passageway can be shaped to
affect changes in velocity of fluids, pressure, or both, as well as
other factors that contribute to turbulence and mixing of the
fluid. Note that the changes in velocity can be with respect to the
magnitude and/or direction of the fluid velocity.
[0060] In the embodiment shown in FIGS. 2a-b, the mixer portion 126
has a repeating hourglass shape that induces turbulent flow upon
fluid moving through. The hourglass-shaped mixer portion 126 has a
generally tubular shape with varying diameters along its length.
The diameter of the mixer portion 126 decreases from first portion
126a to second portion 126b, increases to third portion 126c,
decreases again to fourth portion 126d, increases again to fifth
portion 126e, decreases again to sixth portion 126f, and increases
again to seventh portion 126g.
Input Syringe Diameter
[0061] The ratio of input material to clotting agent to other input
materials in the resulting mixture can be selected by the
appropriate selection of input syringes. For example, the ratio can
be selected by selecting input syringes have certain diameters. As
a specific example, a configuration of a tubular input syringe used
for Thrombin having a diameter one third of diameter of a tubular
input syringe used for platelet concentrate would yield a
thrombin/platelet concentrate ratio in the resulting mixture of
1:9, assuming that all of the Thrombin and platelet concentrate
passes into the mixture. In practice, some of the Thrombin and/or
platelet concentrate could remain in the input syringes and/or
passageway. Accordingly, for a desired resulting mixture ratio, a
more precise ratio may be determined by simple testing. In most
cases, the strength of the clotting agent will be such that the
ratio simple needs to be above a certain value to ensure sufficient
clotting. For example, because of the potency of Thrombin as a
clotting agent, in most cases a ratio of 1:10 will provide more
than enough clotting agent with enough margin of error that mixing
of all the clotting agent with all of the input material need not
occur.
[0062] The variations of the diameter of the mixer portion 126 may
cause fluid flowing through the mixer portion 126 to have areas of
relatively high and low pressure and/or areas of relatively high
and low velocity. These differences in velocity and pressure may
contribute to turbulence in the fluid flowing through the mixer
126, which may help the fluid to mix.
Input Plunger Coordination
[0063] The fluid may, and preferably does, contain some of the
input material(s) from the first input syringe 102 some of the
clotting agent from the second input syringe 104 and. As the fluid
is mixed by the turbulence created by the shape of the mixer
portion 126 of the passageway, the clotting agent and input
material(s) are mixed together. To help ensure that the fluid
flowing into the mixer portion has some material from each of the
input syringes 102, 104, the injection from the input syringes 102,
104 is preferably coordinated to occur at or around the same time.
Depressing the plungers 110, 112 of the input syringes 102, 104 at
or around the same time helps ensure that the fluid entering the
mixer portion 126 has some of both inputs.
[0064] FIGS. 3 and 4 illustrate a mixing device 300 according to
another embodiment of the present invention. This device 300 uses
two input syringes 302, 304, and a receiving syringe 306 and has a
base 308. A handle 310 is used to ensure that the plungers on the
two input syringes 202 and 204 are depressed at the same time and
rate. The handle 310 covers the plungers of the two input syringes
202, 204. Attachment member 312, 314 on the inside of the handle
310 may attach to or otherwise contact the syringe plungers so that
syringe plunger movement is controlled by the movement of the
handle 310. This contact may be secure or may have some extra room
for one or more of the input syringe plunger. For example, one of
the syringes could be secured such that its movement does not occur
until the handle has moved 1/4 inch, while the other syringe is
secured such that it begins to move immediately upon movement of
the handle. Virtually any suitable attaching, securing or
connecting technique between handle and plunger may be used.
Alternatively, the plungers could be molded together or otherwise
attached to one another or to a connector to ensure that the timing
of depression of the input syringe plungers is coordinated in the
desired manner.
[0065] FIG. 4 shows the internal passageway of the mixing device of
FIG. 3. A first input port 314, second input port 316, and
receiving port 320 are connected by intersecting passageways 322,
324, 326, 328, that together comprise a passageway connecting the
three ports 314, 316, 320. The mixer portion 326 of the passageway
has a turbulent flow inducing geometry or shape.
Turbulent Flow Inducing Shape
[0066] The turbulent flow in the mixer portion 326 contributes to
the mixing and dispersion of the molecules of the clotting agent
and input material(s) within the fluid flowing through the
passageway and into the receiving syringe 306. Turbulent flow is a
form of fluid flow in which particles of the fluid move with
irregular local velocities, pressures, and/or other fluid
characteristics, as described herein and otherwise known to those
of skill in the art. Note that irregularities in velocity may be
with respect to the magnitude and/or the direction of the fluid
flow.
[0067] The mixer or mixer portion of the passageway of the present
invention can have a variety of different shapes or geometries that
induce turbulent flow. For example, the cross section of the mixer
portion of certain embodiments is circular while the cross section
in other embodiments is not circular. Various geometric shapes
could be used to create the pressure and velocity differences,
including but not limited to regular and irregular polygons,
circles, ellipses, spheres, ellipsoids, wave forms, etc. These
mixing mechanisms can be used alone or in combination with others
or repeated as necessary with or without staging volumes between
mixing mechanisms. FIGS. 5-8 provide some examples of exemplary
geometric two and three-dimensional shapes, or combinations
thereof, used in alternative embodiments of the mixer portion of
the passageway, having turbulent flow inducing shapes.
[0068] FIGS. 5a-e illustrate alternative shapes for a mixer portion
having a turbulent flow inducing shape. In these embodiments, the
shape shown may be implemented in two dimensions (rectangular cross
section) or three dimensions (circular cross section), or a
combination of two and three dimensions. Generally, for these
embodiments, the diameter or width of the shape changes along the
length of the mixer portion of the passageway. Accordingly, fluid
flowing though such mixer portions would experience turbulence in
the form of at least irregular pressures, which may create
irregular velocities and cause the fluid components to
intermix.
[0069] FIGS. 6a-e also illustrate alternative shapes for a mixer
portion having a turbulent flow inducing shape. Also for these
embodiments, the shape shown may be implemented in two or three
dimensions, or a combination. For these embodiments, the direction
of fluid flow is manipulated by the shape of the mixer portion of
the passageway. The tortuous paths induce turbulence. Fluid flowing
though such mixer portions experience turbulence in the form of at
least irregular directional velocities, which may cause the fluid
components to intermix.
[0070] FIGS. 7 and 8 are combinations of different mixing shapes.
In FIG. 7, the different mixing shapes occur sequentially along the
length of the mixer portion of the passageway. Fluid could be
caused to flow in either direction through a mixing portion having
the shape depicted in FIG. 7.
[0071] In FIG. 8, different mixing shapes are combined together
along the mixing chamber to create a blended shape that produced
irregularities of pressure and velocity of fluid flowing
through.
[0072] Additional combinations of suitable shapes may also be used.
The creation of turbulence within the passageway of the mixing
device is not limited to the particular embodiments described
herein. The fluid may be affected in a variety of suitable manners
and combination of manners.
Other Turbulent Flow Inducing Factors and Mechanisms
[0073] Turbulence within the passageway of the mixing device can be
created using a variety of other suitable mechanisms. For example,
turbulence could be created by an electrically powered shaker
within the mixing device that vibrates the passageway through which
the fluid flows. As another example, turbulence could be created by
spinning or rotating the passageway through which the fluid flows.
As yet another example, the passageway could contain a rotating
mixer component that stirs or otherwise disturbs the fluid flowing
through the passageway.
[0074] Turbulent flow may also be caused or enhanced by a variety
of factors including the relative viscosity of the clotting agent
and input material(s), the speed at which the input plungers are
depressed, environmental factors, etc. Accordingly, turbulence may
affected by mechanisms that affect pressure, velocity, change in
pressure, acceleration, static velocity, dynamic velocity,
kinematic velocity, density, inertial force and other elements of
the Navier Stokes equations. A particular turbulence inducing
mechanism may be appropriate to facilitate mixing of one
combination of clotting agent with certain input material(s) while
another mechanism is appropriate for another combination.
[0075] In general, some embodiments of the invention have the
advantage of mixing the constituent input materials within a mixing
device to ensure substantially even, repeatable mixing, while
eliminating the need to shake or agitate the receiving syringe
containing the mixture.
[0076] Modifications, additions and deletions may be made to the
embodiments described above and shown in the accompanying figures
without departing from the scope or spirit of the present
invention. For example, while the devices and methods described
primarily relate to manually controlled and operated mixing
devices, the invention may also be utilized in a semi or
fully-automated mixing device. As another example, the mixing
device can be made of any biocompatible material (plastic, metal,
etc.), may itself define the passageway and mixer portion, and/or
may have internal tubing or other plumbing that defines the
passageway and mixer portion. As yet another example, while the
invention described is primarily for single use applications, it
could be used with appropriate cleaning and sterilization items
that facilitate multiple uses of the device. In addition, the
devices and methods described here are intended to mix a variety of
known and unknown inputs. The invention is not limited to any
particular inputs or input characteristics.
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