U.S. patent application number 11/162180 was filed with the patent office on 2005-12-29 for bone marrow aspiration system.
Invention is credited to Pellegrino, Richard C., Voellmicke, John C..
Application Number | 20050288605 11/162180 |
Document ID | / |
Family ID | 32176214 |
Filed Date | 2005-12-29 |
United States Patent
Application |
20050288605 |
Kind Code |
A1 |
Pellegrino, Richard C. ; et
al. |
December 29, 2005 |
BONE MARROW ASPIRATION SYSTEM
Abstract
Bone marrow aspiration devices and methods are disclosed for use
in preparing a substrate. In general, the device includes an
elongate penetrating element, a chamber adapted to retain a
substrate, and a fluid extraction mechanism that is effective to
pull fluid through the elongate penetrating element, into the
chamber, and through the substrate. The device is particularly
advantageous in that it will allow for the removal of fluids from a
patient's body and the preparation of a substrate in a single
process, thereby providing a more efficient method and device for
preparing a substrate.
Inventors: |
Pellegrino, Richard C.;
(Mendon, MA) ; Voellmicke, John C.; (Cumberland,
RI) |
Correspondence
Address: |
NUTTER MCCLENNEN & FISH LLP
WORLD TRADE CENTER WEST
155 SEAPORT BOULEVARD
BOSTON
MA
02210-2604
US
|
Family ID: |
32176214 |
Appl. No.: |
11/162180 |
Filed: |
August 31, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11162180 |
Aug 31, 2005 |
|
|
|
10298371 |
Nov 18, 2002 |
|
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Current U.S.
Class: |
600/562 ;
600/565 |
Current CPC
Class: |
A61F 2002/4685 20130101;
A61B 2010/0258 20130101; A61F 2002/2835 20130101; A61B 10/025
20130101; A61B 2217/005 20130101; A61M 1/79 20210501; A61B
2017/00969 20130101; A61F 2/4644 20130101 |
Class at
Publication: |
600/562 ;
600/565 |
International
Class: |
A61B 010/00 |
Claims
What we claim is:
1. A bone marrow aspiration device, comprising: an elongate handle
having proximal and distal surfaces adapted to facilitate grasping
thereof, a pathway formed through the handle between the proximal
and distal surfaces, and an inlet formed in the proximal surface of
the elongate handle and in communication with a proximal end of the
pathway, the inlet being configured to allow a surgical syringe to
communicate with the pathway; an elongate hollow tissue-penetrating
element in communication with a distal end of the pathway and
extending from the distal surface of the handle; and a chamber
formed in the elongate handle between the proximal and distal ends
of the pathway, the chamber being adapted to hold a substrate
therein such that fluid is adapted to flow through the elongate
hollow tissue-penetrating element and through a substrate disposed
in the pathway.
2. The device of claim 1, wherein the distal surface of the handle
includes at least one finger-receiving recess formed thereon.
3. The device of claim 1, wherein the inlet comprises a receiving
well formed in the proximal surface of the handle, the receiving
well being adapted to seat a base of a surgical syringe.
4. The device of claim 3, wherein the receiving well includes a
mating element formed thereon for removably mating to a surgical
syringe.
5. The device of claim 1, further comprising a substrate removably
disposed within the chamber.
6. The device of claim 1, further comprising a surgical syringe
coupled to the inlet and adapted to draw fluid through the
pathway.
7. A bone marrow aspiration device, comprising: a housing defining
a fluid chamber; an implantable substrate disposed within the fluid
chamber; at least one filter disposed adjacent to the implantable
substrate; a tissue-penetrating element extending from the housing
and in communication with the fluid chamber; and a fluid extraction
mechanism coupled to the housing and adapted to draw fluid through
the tissue-penetrating element, into the fluid chamber, and through
the implantable substrate.
8. The device of claim 7, wherein the housing comprises a syringe
barrel, and the fluid extraction mechanism comprises a plunger
slidably disposed within the syringe barrel.
9. The device of claim 7, wherein a filter is disposed upstream of
the implantable substrate such that fluid travels from the elongate
penetrating element, through the filter, then through the
implantable substrate.
10. The device of claim 7, wherein a filter is disposed downstream
of the implantable substrate such that fluid travels from the
elongate penetrating element, through the implantable substrate,
then through the filter.
11. The device of claim 7, wherein a first filter is disposed
upstream of the implantable substrate, and a second filter is
disposed downstream of the implantable substrate.
12. The device of claim 7, wherein the implantable substrate
comprises a fusion cage.
13. The device of claim 7, further comprising a control mechanism
coupled to the fluid extraction mechanism and adapted to control a
rate of fluid being drawn through the device by the fluid
extraction mechanism.
14. The device of claim 7, further comprising a one-way valve
disposed between the tissue-penetrating element and the fluid
chamber.
15. A bone marrow aspiration device, comprising: a housing defining
a fluid chamber adapted to retain an implantable substrate; a
tissue-penetrating element extending from the housing and in
communication with the fluid chamber; a fluid extraction mechanism
coupled to the housing and adapted to draw fluid through the
tissue-penetrating element and the fluid chamber to infiltrate an
implantable substance disposed within the chamber with cells from
the fluid; and a fluid receptacle coupled to the housing and
adapted to collect fluid that has passed through the chamber.
16. The device of claim 1 5, wherein the chamber includes a first
outlet coupled to the fluid extraction mechanism, and a second
outlet coupled to the fluid receptacle.
17. A method for preparing a substrate, comprising: penetrating a
distal end of an elongate penetrating element into a patient;
actuating a fluid extraction mechanism to pull bone marrow from the
patient through the elongate penetrating element and through a
substrate disposed within a chamber formed in a housing coupled to
the elongate penetrating element such that the substrate is
concentrated with cells from the bone marrow; and collecting the
bone marrow in a receptacle that is separate from the chamber.
18. A method for preparing a fusion cage, comprising: penetrating a
distal end of an elongate penetrating element into a patient; and
actuating a fluid extraction mechanism to pull bone marrow from the
patient through the elongate penetrating element and through a
fusion cage disposed within a housing coupled to the elongate
penetrating element such that the fusion cage is concentrated with
cells from the bone marrow.
19. The method of claim 18, wherein the fusion cage is formed from
a material selected from the group consisting of allograft bone,
autograft bone, synthetic materials, purified materials, and
combinations thereof.
20. The method of claim 18, wherein the housing comprises a barrel,
and actuating the fluid extraction mechanism comprises pulling a
plunger disposed within the barrel to draw fluid through the
elongate penetrating element and the fusion cage.
21. The method of claim 18, wherein the fluid passes through a
filter prior to passing through the fusion cage.
22. The method of claim 18, wherein the fluid passes through a
filter after passing through the fusion cage.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/298,371 filed on Nov. 18, 2002 and entitled
"Bone Marrow Aspiration System," which is hereby incorporated by
reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to devices and methods for
preparing a substrate, and in particular to bone marrow aspiration
devices and methods for preparing implantable bone grafts.
BACKGROUND OF THE INVENTION
[0003] Bone grafts are often used to treat fractures, gaps in bones
caused by trauma or infection, revision joint surgery, and
oral/maxillofacial surgery. Bone grafts provide a framework into
which the host bone can regenerate and heal. Once implanted, the
bone cells weave into and through the porous microstructure of the
bone graft to support the new tissue, blood cells and soft tissue
as they grow to connect fractured bone segments.
[0004] Bone grafts can be prepared from a variety of materials,
including bone harvested from a patient. Bone harvesting
procedures, however, can result in significant cost and morbidity,
including scars, blood loss, pain, prolonged operative and
rehabilitation time and risk of infection. Furthermore, in some
clinical settings, the volume of the graft site can exceed the
volume of the available autograft. Accordingly, alternative graft
materials have been developed in an attempt to reduce the morbidity
and cost of bone grafting procedures. Such alternative materials
include purified or synthetic materials, such as ceramics,
biopolymers, processed allograft bone and collagen-based matrices.
These materials are typically used as carriers for bone marrow
cells, and thus need to be prepared prior to implantation.
[0005] Current procedures typically involve a two-step process
which includes the withdrawal of bone marrow from a patient into
several syringes, and then the subsequent preparation of the bone
graft. The bone graft can be prepared by flushing the aspirated
bone marrow one or more times to collect and concentrate the stem
cells contained in the marrow into the bone graft. While this
procedure can be very effective, it can also be time consuming
typically requiring around 20 minutes for the aspiration procedure,
and an additional 20 minutes for the graft preparation
procedure.
[0006] Accordingly, there is a need for more efficient methods and
devices for preparing substrates.
BRIEF SUMMARY OF THE INVENTION
[0007] In general, the present invention provides a bone marrow
aspiration device having a chamber adapted to retain a substrate,
an elongate penetrating element extending from a distal end of the
chamber and having a proximal end, a distal end, and an inner lumen
extending therebetween, and a fluid extraction mechanism coupled to
the proximal end of the chamber and effective to draw fluid into
the elongate penetrating element, and through a substrate disposed
in the chamber. The device can also include a fluid permeable tray
or container removably disposed within the chamber for retaining a
substrate.
[0008] In one embodiment, the chamber is an elongate, cylindrical
barrel, and the fluid extraction mechanism is a plunger disposed
within the barrel and having a handle adapted to move the plunger
proximally to extract fluid through the device. The chamber is
preferably adapted to retain a substrate in a position proximal to
an inlet port formed in the distal end of the chamber. In another
embodiment, the device includes a control member mated to the fluid
extraction mechanism and effective to control the amount of fluid
being extracted by the fluid extraction mechanism. The control
member is preferably effective to control the rate of fluid being
extracted by the fluid extraction mechanism. The control member can
be, for example, a trigger mechanism effective to actuate the fluid
extraction mechanism to extract a predetermined amount of
fluid.
[0009] In another embodiment, the device includes a fluid
receptacle in communication with the chamber. The fluid receptacle
is adapted to receive fluid passed through the chamber and through
a substrate disposed within the chamber. The substrate is
preferably disposed at an inlet port of the fluid receptacle, and
the fluid receptacle is preferably removably mated to the chamber.
The device can optionally include a unidirectional valve disposed
between the chamber and the fluid receptacle for allowing fluid to
flow only in a direction from the chamber to the fluid receptacle.
The unidirectional valve can be disposed at the proximal end of the
chamber such that fluid can flow from the chamber through the
unidirectional valve, then through a substrate, and into the fluid
receptacle.
[0010] In other aspects, the device includes a conduit extending
between the proximal end of the elongate penetrating element and
the inlet port of the chamber such that fluid can flow from the
elongate penetrating element, through the conduit, and into the
chamber. The conduit can be removably attached to the proximal end
of the elongate penetrating element and the inlet port in the
chamber. The device can also include a second conduit extending
from the outlet port of the chamber to an inlet port in the fluid
receptacle for allowing fluid to flow from the chamber to the
receptacle, and a third conduit extending from the outlet port of
the fluid receptacle to the fluid extraction mechanism.
[0011] The present invention also provides methods for preparing a
substrate. The method generally includes the step of providing a
bone marrow aspirator device having an elongate penetrating element
having a proximal end, a distal end adapted to penetrate bone, and
an inner lumen extending therebetween. A chamber is in fluid
communication with the proximal end of the elongate penetrating
element, and a substrate is disposed within the chamber. The
penetrating element also includes a fluid extraction mechanism
effective to pull fluid through the elongate penetrating element,
into the chamber, and through the substrate. The method further
includes the steps of penetrating the distal end of the elongate
penetrating element into a patient, and actuating the fluid
extraction mechanism to pull fluid from the patient through the
elongate penetrating element, into the chamber, and through the
substrate, thereby concentrating cells from a biological material
within the substrate.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The invention will be more fully understood from the
following detailed description taken in conjunction with the
accompanying drawings, in which:
[0013] FIG. 1 is a diagram illustrating one embodiment of a bone
marrow aspiration device having an elongate penetrating element, a
chamber, a fluid receptacle, and a fluid extraction mechanism;
[0014] FIG. 2 is a diagram illustrating another embodiment of a
bone marrow aspiration device according to the present invention in
which the chamber, fluid extraction mechanism, and fluid receptacle
are disposed within a housing;
[0015] FIG. 3 is a diagram illustrating another embodiment of a
bone marrow aspiration device having a chamber, an elongate
penetrating element extending from a distal end of the chamber, and
fluid extraction mechanism disposed within the chamber; and
[0016] FIG. 4 is a diagram illustrating yet another embodiment of a
bone marrow aspiration device having a substrate disposed within a
handle of an elongate penetrating element.
DETAILED DESCRIPTION OF THE INVENTION
[0017] The present invention provides bone marrow aspiration
devices and methods for preparing a substrate by extracting fluids
directly from a patient through a substrate. In general, the device
includes an elongate penetrating element, a chamber adapted to
retain a substrate, and a fluid extraction mechanism that is
effective to pull fluid through the elongate penetrating element,
into the chamber, and through the substrate. The device is
particularly advantageous in that it will allow for the removal of
fluids from a patient's body and the preparation of a substrate in
a single process, thereby providing a more efficient method and
device for preparing a substrate.
[0018] A person having ordinary skill in the art will appreciate
that a variety of substrates and fluids can be used with the system
of the present invention, and that the term "substrate" as used
herein is intended to encompass both implantable and
non-implantable substrates, used alone or in combination with other
substrates. By way of non-limiting example, suitable implantable
substrates include bone grafts, fusion cages, ceramic bone
substitutes, soft tissue grafts, such as skin tendons, and
ligaments, and other suitable implantable material, and suitable
non-implantable substrates include filters for filtering particular
elements from a fluid. In an exemplary embodiment, the present
invention is used to prepare an implantable substrate by flowing
fluid therethrough, and one or more filters are optionally used in
combination with the implantable substrate. The filter(s) can be
positioned upstream and/or downstream from the implantable
substrate, and can be adapted to filter particular elements from a
fluid, such as, for example, red blood cells from plasma.
Alternatively, or in addition, the filter can contain a biological
agent or fluid for treating fluid passing therethrough. Suitable
fluids for use with the present invention include, for example,
fluids having regenerative properties, such as bone marrow, blood,
platelet rich plasma, placenta, synovial fluid, and amniotic fluid,
and suspensions containing stem cells, growth factors, and
proteins.
[0019] FIG. 1 illustrates one embodiment of a bone marrow
aspiration device 80 according to the present invention. As shown,
the device 80 includes a chamber 82 that is adapted to retain at
least one substrate 84, a penetrating element 110 coupled to an
inlet 90 formed in the chamber 82, and a fluid extraction mechanism
114 coupled to an outlet 92 formed in the chamber 82. The device 80
can also optionally include a fluid receptacle 88 disposed between
the outlet 92 of the chamber 82 and the fluid extraction mechanism
114. In use, the fluid extraction mechanism 114 is effective to
draw fluid into the penetrating element 110 from an outside fluid
source, such as a patient's body, through the chamber 82 and the
substrate 84 disposed within the chamber 82. The fluid can then be
collected in the fluid receptacle 88.
[0020] The chamber 82 can have a variety of shapes and sizes, but
should be adapted to retain a substrate 84, and to allow fluid to
flow therethrough. As shown in FIG. 1, the chamber 82 has a
generally cylindrical shape and includes a first end 106 having an
inlet 90, a second end 108 having an outlet 92, and a hollow
interior 91 extending therebetween and adapted to receive and hold
a substrate 84. The inlet and outlet 90, 92 in the chamber 82 can
each have any shape and size and, by way of non-limiting example,
can be in the form of a port or a valve. Preferably, the inlet and
outlet 90, 92 are each in the form of a one-way valve that is
effective to control the direction of fluid flow therethrough. More
preferably, the inlet 90 allows fluid to flow into the chamber 82,
and the outlet 92 allows fluid to flow out of the chamber 82.
[0021] The chamber 82 can optionally include a basket (not shown)
or similar structure disposed therein for holding the substrate 84.
The basket, or a portion of the basket, can be permanently or
removably disposed within the chamber 82, or can be integrally
formed with the chamber 82. The basket, or at least a portion of
the basket, is fluid permeable to allow fluid to flow through a
substrate disposed therein. By way of non-limiting example, the
basket can include first and second porous members, e.g., screens,
positioned at a distance apart from one another and effective to
hold a substrate 84 therebetween. In another embodiment, the
chamber 82 can include a side-opening, slot, or door formed therein
for slidably receiving the substrate 84 or basket containing a
substrate. Examples of suitable chambers 82 and baskets for use
with the device of the present invention are disclosed in U.S.
patent application Ser. No. 10/223,674, filed on Aug. 19, 2002 and
entitled "Device For Controlling Fluid Flow Through a Medium," the
teachings of which are hereby incorporated by reference.
[0022] The inlet 90 in the chamber 82 is coupled to the penetrating
element 110, preferably via a first conduit 100, and is effective
to allow fluid to flow from the penetrating element 110 into the
chamber 82. The penetrating element 110 can have a variety of
configurations, and is adapted to penetrate into tissue and/or bone
to allow fluid to be extracted therefrom. As shown in FIG. 1, the
penetrating element 110 includes a handle 112 and an elongate
tissue piercing member 86, e.g., a needle. Suitable examples of an
elongate penetrating element 110 are disclosed in U.S. patent
application Ser. No. 10/194,752, filed on Jul. 12, 2002, and
entitled "Bone Marrow Aspirator," which is hereby incorporated by
reference in its entirety.
[0023] The outlet 92 in the chamber 82 is coupled to a fluid
extraction mechanism 114, preferably via a fluid receptacle 88. A
second conduit 108 can extend from the outlet 92 in the chamber 82
to an inlet 94 formed in the fluid receptacle 88, and a third
conduit 104 can extend from an outlet 96 in the fluid receptacle 88
to the fluid extraction mechanism 114. The fluid receptacle 88 can
have virtually any shape and size, but should be effective to hold
a predetermined amount of fluid extracted from a patient. The
receptacle 88 should also be airtight to allow fluid to be drawn
into the penetrating element 110 from an outside fluid source,
through the chamber 82, and into the fluid receptacle 88. As shown
in FIG. 1, the receptacle 88 includes an inlet 94 coupled to the
chamber 82 via conduit 108, and an outlet 96 coupled to a fluid
extraction mechanism 114 via conduit 104. The inlet and outlets 94,
96 can have any configuration, and can be formed anywhere in the
receptacle 88. Preferably, however, the inlet 94 is positioned to
allow fluid to drain into the receptacle 88 from the chamber 82,
and the outlet 96 is positioned at a location that will prevent
fluid from being pulled therethrough into conduit 104. This will
allow the fluid extraction mechanism 114 to create a vacuum force
within the device 80 without drawing fluid into the fluid
extraction mechanism 114.
[0024] The fluid extraction mechanism 114, which is coupled to the
fluid receptacle 88, or optionally directly to the outlet 92 in the
chamber 82, can also have a variety of configurations. The
extraction mechanism 114 should, however, be effective to create a
vacuum force in the device 80 to draw fluid into the penetrating
element 110, through the chamber 82 and the substrate 84 disposed
within the chamber 82, and into the fluid receptacle 88. As shown
in FIG. 1, the fluid extraction mechanism 114 is in the form of a
vacuum pump. A person having ordinary skill in the art will
appreciate that a variety of devices can be used to extract fluid
through the system 80, including both mechanical and/or electrical
devices.
[0025] In use, the penetrating element 110 is positioned at a fluid
site in a patient's body, or the inlet 90 in the chamber 82 is
mated to an external fluid source. The fluid extraction mechanism
114 is then activated to pull fluid from the patient through the
device 80, whereby fluid travels from the penetrating element 110
to the chamber 82 via conduit 100, through the substrate 84
disposed within the chamber 82, and to the fluid receptacle 88 via
conduit 108. The process of extracting fluid through the device 80
can be repeated several times, as desired.
[0026] The device 80 can also optionally include fluid flow control
mechanisms for controlling the rate of fluid flow through the
device 80. By way of non-limiting example, the fluid extraction
mechanism 114 can be adapted to pull fluid through the device 80 at
a predetermined rate. Alternatively, or in addition, the conduits
100, 108, and 104 can have a size effective to control the rate of
fluid flow therethrough. The inlets and outlets 90, 92, 94, 96 in
the chamber 82 and/or fluid receptacle 88 can also be adapted to
regulate the rate of fluid flow. A person having ordinary skill in
the art will appreciate that a variety of techniques can be used to
control the rate of fluid flow through the device 80.
[0027] FIG. 2 illustrates another embodiment of a bone marrow
aspiration device 40 according to the present invention. The device
40 is similar to device 80 described with respect to FIG. 1, except
that the fluid extraction mechanism 50, chamber 42, and fluid
receptacle 48 are disposed within a housing 51 and combined into a
single device 40 that is adapted to mate to an external fluid
source, such as an elongate penetrating element 110 described about
with respect to FIG. 1. As shown in FIG. 2, the device 40 generally
includes a housing 51 having proximal and distal ends 55, 57, a
chamber 42 formed within the distal end 57 of the housing 51, and a
fluid extraction mechanism 50 disposed within the proximal end 55
of the housing 51. The device 40 can also include a fluid
receptacle 48 or reservoir which forms part of the chamber 42 and
is preferably integrally formed with, fixedly attached to, or
removably attached to the housing 51. One of the fluid receptacle
48 and the chamber 42 is adapted to retain a substrate 46. In use,
fluid is drawn into the chamber 42 from an external fluid source,
such as a patient's body via the penetrating element 110, and is
pushed or pulled through the substrate 46 and collected in the
fluid receptacle 48.
[0028] The chamber 42 can have virtually any shape and size, but is
preferably formed within a distal portion of the housing 51 and
includes a proximal end 58, a distal end 56, and an inner lumen 60
extending therebetween. The proximal end 58 of the chamber 42 is
adapted to slidably receive the fluid extraction mechanism, e.g.,
plunger 50, and the distal end 56 of the chamber 42 is adapted to
mate with an external fluid source, or to a penetrating element
110. An inlet 62 is formed in the distal end 56 of the chamber 42
and is adapted to mate to the external fluid source, and an outlet
70 is formed adjacent the proximal end 58 of the chamber 42 and is
coupled to the fluid receptacle 48. The inlet 62 and outlet 70 can
each have a variety of configurations, but are preferably one-way
valves effective to control the direction of fluid flow. In an
exemplary embodiment, the inlet 62 is effective to allow fluid to
flow only in a direction into the inner lumen 60 of the chamber 42,
and the outlet 70 is effective to allow fluid to flow only in a
direction from the inner lumen 60 of the chamber 42 into the fluid
receptacle 48.
[0029] The fluid receptacle 48 can also have virtually any shape
and size, and can be permanently or removably mated to the chamber
42. The fluid receptacle 48 should be adapted to hold a
predetermined amount of fluid. Preferably, the fluid receptacle 48
has a generally cylindrical shape having an inner lumen 49 formed
therein, and is removably attached to the housing 51 such that the
inner lumen 49 of the fluid receptacle 48 is in fluid communication
with the inner lumen 60 of the chamber 42 via outlet 70. The fluid
receptacle 48 can be attached to the housing 51 using a variety of
mating techniques, but is preferably attached to the housing 51
using a threaded engagement (not shown).
[0030] The device 40 further includes a substrate 46 disposed
within the inner lumen 60 of the chamber 42, within the fluid
receptacle 48, or between the chamber 42 and fluid receptacle 48.
Preferably, the substrate 46 is disposed within the fluid
receptacle 48 just downstream of the outlet 70, as shown in FIG. 2.
The substrate 46 can be disposed within a fluid permeable basket or
container, as discussed above with reference to FIG. 1, or
alternatively, the fluid receptacle 48 itself can be modified to
retain the substrate 46. By way of non-limiting example, the fluid
receptacle 48 can include first and second porous members (not
shown) positioned a distance apart from one another and effective
to retain a substrate therebetween. A person having ordinary skill
in the art will appreciate that a variety of techniques can be used
to position a substrate within the fluid receptacle 48, or
alternatively within the chamber 42.
[0031] In another embodiment (not shown), the substrate 46 can be
disposed within the chamber 42, adjacent the inlet 62, thereby
eliminating the need for a fluid receptacle 48 and reducing the
volume of the system 40. The reduced volume will allow fluid to be
drawn into the system 40 without requiring significant vacuum
forces. In an exemplary embodiment, the chamber 42 and fluid
receptacle 48 are adapted to retain a volume of fluid in the range
of about 20 cc to 60 cc.
[0032] The fluid extraction mechanism 50, which is coupled to the
proximal end 58 of the chamber 42, can also have a variety of
configurations. Preferably, as shown in FIG. 2, the fluid
extraction mechanism 50 is a plunger slidably disposed within the
housing 51. The plunger 50 includes an elongate portion 52 having a
distal, sealing member 72, such as a gasket or grommet, formed on a
distal end thereof for creating a fluid-tight seal between the
chamber 42 and the proximal portion of the housing 51. The plunger
50 can also include a proximal, handle member 59 extending
proximally from the housing 51. The handle 59 can be used to grasp
and move the plunger 50 within the housing to create a vacuum force
to direct fluid through the device 40. The elongate portion 52 of
the plunger 50 can optionally be mated to a trigger mechanism 54
which is effective to engage and move the plunger 50 in one of a
proximal direction or a distal direction. Preferably, the trigger
mechanism 54 is used to move the plunger 50 in a proximal direction
to create a vacuum force to draw fluid into the chamber 42, and the
handle 59 is used to move the plunger 50 in a distal direction to
push fluid through outlet 70 and into the receptacle 48, wherein
the fluid passes through the substrate 46. The trigger mechanism 54
can also be adapted to move the plunger 50 in predetermined
increments. In an exemplary embodiment, the trigger mechanism 54 is
adapted to draw about 2 cc of fluid into the chamber 42. This is
particularly effective to allow 2 cc samples of fluid to be drawn
from several fluid sites within a patient's body. By way of
non-limiting example, the trigger mechanism 54 can be a
ratchet-type mechanism. A person having ordinary skill in the art
will appreciate that a variety of techniques can be used for moving
the plunger 50 within the housing 51.
[0033] In use, the inlet 62 formed in the distal end 57 of the
housing 51 is coupled to an external fluid source, such as an
elongate penetrating element 110 via a conduit 66. A substrate 46
is positioned within the fluid receptacle 48, which is mated to the
housing 51 and in fluid communication with the chamber 42 via
outlet 70. The trigger mechanism 54 is then grasped and actuated to
create a vacuum within the chamber 42, thereby drawing fluid
through the elongate penetrating element 44 and into the inner
lumen 60 of the chamber 42. The one-way valve 70 prevents fluid
from being drawn into the chamber 42 from the receptacle 48. The
fluid can then optionally flow freely into the fluid receptacle 48
via port 70, or the handle 59 can be grasped to move the plunger 50
distally, thereby forcing fluid into the receptacle 48 and through
the substrate 46. The one-way valve 62 prevents fluid from flowing
back out of the chamber 42 and into conduit 66. The process can be
repeated several times as desired.
[0034] FIG. 3 illustrates yet another embodiment of a bone marrow
aspiration device 10 according to the present invention. In this
embodiment, the chamber 12, fluid extraction mechanism 20, and
elongate penetrating element 16 are combined to form an all-in-one
device 10. As shown, the device 10 generally includes a chamber 12
adapted to retain a substrate 14, an elongate penetrating element
16 coupled to a distal end 18 of the chamber 12, and a fluid
extraction mechanism 20 slidably disposed within a proximal end 22
of the chamber 12. The fluid extraction mechanism 20 is effective
to draw fluid from a patient or other outside fluid source, through
the penetrating element 16, into the chamber 12, and through the
substrate 14.
[0035] The chamber 12 can have a variety of shapes and sizes, but
is preferably an elongate cylindrical member having a proximal end
22, a distal end 18, and an inner lumen 24 extending therebetween.
As shown in FIG. 3, the chamber 12 is in the form of a syringe
barrel and includes a tapered distal end 18 adapted to mate to a
penetrating element 16, and an open proximal end 22 adapted to
slidably receive the fluid extraction mechanism 20. The proximal
end 22 of the chamber 12 can optionally include a flange (not
shown) or similar feature formed around an outer surface of the
proximal end 22 to facilitate ease of handling. The inner lumen 24
of the chamber 12 should have a size sufficient to allow slidable
movement of the fluid extraction mechanism 20 therein, and to
retain a predetermined amount of fluid. Preferably, the inner lumen
24 has a length L that is sufficient to allow the fluid extraction
mechanism 20 to be moved between the proximal and distal ends 22,
18 to draw a predetermined amount of fluid into the chamber 12.
Moreover, the length L should be sufficient to enable the fluid
extraction mechanism 20 to be moved without coming into contact
with the substrate 14.
[0036] The chamber 12 is adapted to retain a substrate 14, which
can be positioned anywhere within the chamber 12, but is preferably
positioned in the distal portion of the chamber 12. In one
embodiment, the chamber 12 can include a basket or tray (not shown)
formed therein for receiving the substrate 14. The basket or tray
can be formed from first and second porous members, e.g., screens,
positioned a distance apart from one another and effective to
retain a substrate 14 therebetween. The porous members can be mated
to one another, and can be removably or permanently disposed within
the chamber. Alternatively, or in addition, the chamber 12 can
include a side opening or door (not shown) formed therein for
allowing the substrate 14, or a container holding a substrate 14,
to be inserted and withdrawn from the chamber 12. As previously
stated, examples of suitable containers 28 for use with the device
of the present invention are disclosed in U.S. patent application
Ser. No. 10/223,674, filed on Aug. 19, 2002 and entitled "Devices
For Controlling Fluid Flow Through A Medium," the teachings of
which are hereby incorporated by reference. A person having
ordinary skill in the art will appreciate that a variety of
techniques can be used to retain a substrate within the chamber
12.
[0037] The elongate penetrating element 16 can also have a variety
of shapes and sizes, but is preferably an elongate, cylindrical
member having a proximal end 32, a distal end 34, and an inner
lumen (not shown) extending therebetween. The distal end 34 should
be adapted to penetrate into tissue and/or bone, and thus
preferably includes a distal-most piercing tip 34' in fluid
communication with the inner lumen. In an exemplary embodiment, the
elongate penetrating element 16 is a needle that is removably mated
to the distal end 18 of the chamber 12. The elongate penetrating
element 16 can be mated to the distal end 18 of the chamber 12
using a variety of mating techniques. FIG. 3 illustrates one
embodiment of a mating element in the form of a standard luer 26.
The luer 26 includes an inner lumen having threads formed therein
for mating to corresponding threads formed on each of the distal
end 18 of the chamber 12 and the proximal end 32 of the penetrating
element 16. The luer 26 can alternatively be permanently mates to
the penetrating element 16 to allow removal of both the luer 26 and
the penetrating element 16 from the chamber 12. A person having
ordinary skill in the art will appreciate that a variety of
engagement techniques can be used to mate the penetrating element
16 to the chamber 12, including, for example, a snap fit
engagement, an interference fit, and a magnetic engagement. Those
skilled in the art will appreciate that various techniques can be
used for permanently or releasably mating the penetrating element
16 to the chamber 12.
[0038] While an elongate penetrating element 16 is shown, the
distal end 18 of the chamber 12 can be adapted to mate to any
device or external fluid source. For example, the elongate
penetrating element 16 can be replaced with a flexible tube that
can mate to a separate penetrating device, such as a needle, or to
a fluid source.
[0039] Still referring to FIG. 3, the fluid extraction mechanism
20, which is slidably disposed within the proximal end 22 of the
chamber 12, is effective to withdraw fluid from a patient or other
reservoir into the chamber 12 and through the substrate 14 disposed
within the chamber. The fluid extraction mechanism 20 can have
virtually any configuration, but is preferably a plunger having a
proximal end 32 and a distal end 30. The proximal end 32, e.g.,
handle, preferably has a shape adapted to facilitating grasping
thereof to allow a user to move the fluid extraction mechanism 20
with respect to the chamber 12. The distal end 30 of the fluid
extraction mechanism 20 is slidably disposed within the inner lumen
24 of the chamber 12, and has a size and shape adapted to form a
seal within the chamber 12 to create a vacuum force. The distal end
30 can optionally include a sealing member, such as a gasket or
grommet, to assist in maintaining a fluid-tight seal within the
chamber 12. The sealing member should, however, allow slidable
movement of the fluid extraction mechanism 20 with respect to the
chamber 12.
[0040] In use, the extraction mechanism 20 is movable between a
first position (shown in FIG. 3), in which the fluid extraction
mechanism 20 is substantially disposed within the chamber 12, and a
second position (not shown), in which the fluid extraction
mechanism 20 is substantially extended from the chamber 12.
Movement of the fluid extraction mechanism 20 from the first
position to the second position creates a vacuum force within the
chamber 12 that is effective to draw fluid from the external fluid
source, e.g., the patient, via the penetrating element 16 into the
chamber 12. Conversely, movement from the second position to the
first position will create a pressure in the chamber 12, thereby
causing fluid disposed within the chamber 12 to be pushed out of
the chamber through the penetrating element 16, or more preferably,
through an outlet port formed in the chamber 12.
[0041] Movement of the fluid extraction mechanism 20 can be
effected manually and/or mechanically. By way of non-limiting
example, the fluid extraction mechanism 20 can be mated to a
ratchet-style handle or similar mechanism for moving the plunger
20. A person having ordinary skill in the art will appreciate that
virtually any actuation mechanism can be employed with the devices
according to the present invention. Moreover, while a plunger 20 is
shown for creating a vacuum force within the chamber 12, a variety
of other fluid extraction mechanisms can be used. For example, the
chamber 12 can be coupled to a vacuum pump, as discussed with
respect to FIG. 2.
[0042] The device 10 can also optionally include a mechanism for
controlling the rate of fluid flow through the chamber 12 and the
substrate 14. By way of non-limiting example, the penetrating
element 16 can include an inner lumen having a diameter that is
adapted to restrict the flow of fluid therethrough. In another
embodiment, the device can include micro-bore tubing disposed
within the fluid flow path and having an internal lumen sized to
restrict the rate of fluid flow. The micro-bore tubing is
preferably disposed between the penetrating element 16 and the
chamber 12, for example, within the luer 26. One skilled in the art
will appreciate that a variety of fluid flow control devices can be
used with the present invention.
[0043] The direction of fluid flow through the device can also be
controlled. By way of non-limiting example, one or more one-way or
dual-check valves can be provided for controlling the direction of
fluid flow. Preferably, the luer 26 is one-way valve that allows
fluid to flow only in a direction from the elongate penetrating
element 16 into the chamber 12.
[0044] FIG. 4 illustrates yet another embodiment of an aspiration
device 200 having a handle 202 and an elongate penetrating element
204 coupled to the handle 202. A person having ordinary skill in
the art will appreciate that the device 200 can have a variety of
configurations, as generally described in U.S. patent application
Ser. No. 10/194,752, entitled "Bone Marrow Aspirator," filed on
Jul. 12, 2002, which is hereby incorporated by reference in its
entirety.
[0045] Preferably, as shown, the handle 202 includes proximal and
distal surfaces 212, 214, and first and second side surfaces 226,
228 extending between the proximal and distal surfaces 212, 214.
The shape of the handle 202 is preferably adapted to facilitate
single-handed use and manipulation thereof. For example, the distal
surface 214 of the handle 202 can include one or more
finger-receiving recesses 230. The elongate penetrating element 204
includes a proximal portion 210 coupled to the handle 202 and
having a proximal end with an inlet port 212 formed therein, and a
distal portion 216 having a smooth outer surface and a solid,
distal piercing tip 218. A substantially cylindrical sidewall 220
defines an inner lumen 222 in the elongate penetrating element 204
which extends from the inlet port 224 to a position proximal to the
distal piercing tip 218. The elongate penetrating element 204 also
includes at least one opening 232 formed in the sidewall and in
communication with the inner lumen. The opening 232 is preferably
positioned proximal to the distal piercing tip 218.
[0046] The device 200 further includes a chamber 206 disposed
within the handle 202 and adapted to retain a substrate 208. The
chamber 206 is in fluid communication with the elongate penetrating
element 204, and is preferably position between the proximal and
distal portions 210, 216 of the penetrating element 204. The handle
202 can include a side opening or door (not shown) formed therein
for providing access to the chamber 206, and the substrate 208, or
container holding the substrate 208, disposed within the chamber
206.
[0047] The proximal surface 212 of the handle 202 is preferably
adapted to allow access to the inlet port 224 of the elongate
penetrating element 204. By way of non-limiting example, the handle
202 can include a receiving well 238 formed in or mated to the
proximal surface 212 of the handle 202 and adapted to seat the base
of a medical device, such as a surgical syringe, to enable mating
between the medical device and the inlet port 224 on the elongate
penetrating element 202. In an exemplary embodiment, as shown, the
receiving well 238 has a cylindrical shape which conforms to the
shape of the base of a surgical syringe. The receiving well 238 is
preferably tapered along the inner surface toward the distal end to
provide an interference fit with the base of a surgical syringe,
and at least a portion of the receiving well 238 can extend outward
from the proximal surface 212 of the handle 202. The receiving well
238 can optionally include a mating element (not shown) for mating
with the surgical syringe, or other medical device. While a variety
of mating techniques can be used, the receiving well 238 preferably
includes threads (not shown) formed on the inner surface thereof.
Other suitable mating techniques include, for example, an
interference fit and a positive interlock engagement.
[0048] In use, the handle 202 is grasped and manipulated to
position the elongate penetrating element 204 at a fluid site in a
patient's body. A syringe or other fluid extraction mechanism is
then coupled to the inlet port 224 in the elongate penetrating
element 204, and activated to draw fluid up through the distal
portion 216 of the penetrating element 204, through the substrate
208 disposed within the chamber 206, and through the proximal
portion 210 of the penetrating element 204 where the fluid is drawn
into the syringe or other fluid extraction mechanism.
[0049] It will be understood that the foregoing is only
illustrative of the principles of the invention, and that various
modifications can be made by those skilled in the art without
departing from the scope and spirit of the invention. These three
embodiments are but of few of those possible, all of which provide
a bone aspiration device capable of infusing a fluid through a
substrate.
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