U.S. patent application number 13/446277 was filed with the patent office on 2013-10-17 for bone cement component injection system with reduced fume exposure and method.
This patent application is currently assigned to KYPHON SARL. The applicant listed for this patent is Neil Sasaki. Invention is credited to Neil Sasaki.
Application Number | 20130269826 13/446277 |
Document ID | / |
Family ID | 49324008 |
Filed Date | 2013-10-17 |
United States Patent
Application |
20130269826 |
Kind Code |
A1 |
Sasaki; Neil |
October 17, 2013 |
Bone Cement Component Injection System With Reduced Fume Exposure
And Method
Abstract
A system for containing fumes for a bone cement component
includes a vial holder configured for receiving and holding a vial
therein. A holder chamber is configured to receive and secure the
vial holder therein such that when engaged with the vial holder,
the vial holder and the holder chamber form an enclosure for
containing the vial. A vial-breaking device is disposed in the
holder chamber and is configured to break the vial to release
contents of the vial into the holder chamber. A port is in
communication with the holder chamber through a filter so that when
a vacuum is drawn at the port by a dispensing device, the contents
of the vial can be drawn through the filter and into the dispensing
device and the fumes are contained in the enclosure. Methods of use
are disclosed.
Inventors: |
Sasaki; Neil; (Santa Clara,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Sasaki; Neil |
Santa Clara |
CA |
US |
|
|
Assignee: |
KYPHON SARL
Neuchatel
CH
|
Family ID: |
49324008 |
Appl. No.: |
13/446277 |
Filed: |
April 13, 2012 |
Current U.S.
Class: |
141/2 ;
141/18 |
Current CPC
Class: |
A61B 17/8833 20130101;
A61B 17/8827 20130101 |
Class at
Publication: |
141/2 ;
141/18 |
International
Class: |
B65B 1/04 20060101
B65B001/04; B65B 3/04 20060101 B65B003/04 |
Claims
1. A system for containing fumes for a bone cement component
comprising: a vial holder configured for receiving and holding a
vial therein; a holder chamber configured to receive and secure the
vial holder therein when engaged with the vial holder, the vial
holder and the holder chamber forming an enclosure for containing
the vial; a vial-breaking device disposed in the holder chamber,
the vial holder being configured to be advanced toward the
vial-breaking device for breaking the vial and for releasing
contents of the vial into the holder chamber; a filter disposed
within the holder chamber; and a port is in communication with the
holder chamber through the filter such that when a vacuum is drawn
at the port by a dispensing device the contents of the vial are
drawn through the filter and into the dispensing device such that
fumes are contained in the enclosure and the dispensing device.
2. A system for containing fumes for a bone cement component as
recited in claim 1, wherein the vial holder is threadedly received
in the holder chamber and the vial holder is advanced against the
vial-breaking device by turning the vial holder.
3. A system for containing fumes for a bone cement component as
recited in claim 1, further comprising a one way valve disposed
between the holder chamber and the port to prevent back flow into
the holder chamber.
4. A system for containing fumes for a bone cement component as
recited in claim 1, wherein the dispensing device includes a
syringe configured to provide a sealed connection to the port and
the vacuum is pulled by drawing a plunger of the syringe.
5. A system for containing fumes for a bone cement component as
recited in claim 1, wherein the port includes a Luer-lock
fitting.
6. A system for containing fumes for a bone cement component as
recited in claim 1, wherein the holder chamber and the port are
disposed in a base assembly and the port connects to the dispensing
device such that the dispersing device is parallel to an advancing
direction of the vial holder.
7. A system for containing fumes for a bone cement component as
recited in claim 6, wherein the holder chamber and the port are
connected by a lumen transversely disposed to the advancing
direction of the vial holder
8. A system for containing fumes for a bone cement component as
recited in claim 1, wherein when the dispensing device is docked
with the port, the dispensing device is disposed transversely to an
advancing direction of the vial holder.
9. A system for containing fumes for a bone cement component as
recited in claim 1, wherein the vial breaking device includes a
spike or needle.
10. A system for containing fumes for a bone cement component as
recited in claim 1, wherein the vial holder includes a structure
for holding a vial therein.
11. A system for containing fumes for a bone cement component as
recited in claim 10, further comprising a vial securely held in the
vial holder, the vial holder having an opening to expose a surface
of the vial to the vial breaking device when installed on the
holder chamber.
12. A system for containing fumes for a bone cement component as
recited in claim 11, wherein the vial includes a monomer component
for bone cement.
13. A system for containing fumes for a bone cement component as
recited in claim 1, further comprising a mixing chamber including a
port for receiving the dispensing device and permitting dispensing
of the contents of the dispensing device through a wall of the
mixing chamber such that fumes are contained in the mixing chamber
and the dispensing device.
14. A system for containing fumes for a bone cement component as
recited in claim 13, wherein the contents of the dispensing device
include a monomer component of bone cement and the mixing chamber
includes a powder component of the bone cement.
15. A system for containing fumes for a bone cement component as
recited in claim 13, wherein the port for receiving the dispensing
device includes a Luer-lock fitting.
16. A system for containing fumes for a bone cement component as
recited in claim 13, wherein the port for receiving the dispensing
device includes a sealable membrane and the dispensing device
includes a needle injectable through the membrane.
17. A system for containing fumes for a bone cement component as
recited in claim 1, wherein the system is disposable.
18. A system for containing fumes for a bone cement component
comprising: a vial holder configured for receiving a vial therein
and including a holding structure for maintaining the vial in the
vial holder, the vial holder having an opening to expose a surface
of a vial, the vial including a monomer component for bone cement;
a holder chamber configured to receive and secure the vial holder,
the vial holder being threadedly received in the holder chamber and
advanced in an advance direction by employing threads, the vial
holder and the holder chamber forming an enclosure for containing
the vial; a vial-breaking device disposed in the holder chamber,
the vial holder being configured to be advanced toward the
vial-breaking device for engaging the surface of the vial, breaking
the vial and releasing contents of the vial into the holder
chamber; a filter disposed within the holder chamber; a port in
communication with the holder chamber through the filter; a one way
valve disposed between the holder chamber and a port to prevent
back flow into the holder chamber; and a dispensing device is
connectable to the port for drawing a vacuum at the port to draw
the contents of the vial through the filter and into the dispensing
device such that fumes are contained in the enclosure and the
dispensing device.
19. A method for containing fumes of a bone cement component, the
method comprising the steps of: providing a system including a vial
holder configured for receiving and holding a vial therein; a
holder chamber configured to receive and secure the vial holder
therein such that when engaged with the vial holder, the vial
holder and the holder chamber form an enclosure for containing the
vial; a vial breaking device disposed in the holder chamber, the
vial holder being configured to advance toward the vial breaking
device for breaking the vial and for releasing contents of the vial
into the holder chamber; a filter disposed within the holder
chamber; and a port in communication with the holder chamber
through the filter; providing a vial of a monomer component of bone
cement in the vial holder; advancing the vial holder in the holder
chamber to break the vial against the vial breaking device; and
drawing a vacuum at the port by a dispensing device to draw the
contents of the vial through the filter and into the dispensing
device such that fumes are contained in the enclosure and the
dispensing device.
20. A method for containing fumes of a bone cement component as
recited in claim 19, further comprising: injecting the monomer
component into a sealed mixing chamber with a powder component of
the bone cement to further contain the fumes and to mix the bone
cement.
Description
TECHNICAL FIELD
[0001] The present disclosure generally relates to medical devices
for bone repair, and more particularly to a component injection and
mixing system and method for reducing fumes during bone cement
preparation.
BACKGROUND
[0002] Many medical procedures employ medical grade cement in
connection with the restoration and strengthening of bone
structures. During such procedures, cement is typically dispensed
to a bone to fill in voids or spaces in the bone or between medical
devices or implants attached to or embedded within the bone. These
dispensing devices may include systems as simple as syringes and as
complex as electronically controlled valves.
[0003] Mixing bone cement, such as, e.g., High-Viscosity Radiopaque
(HV-R) bone cement, requires integration of two materials, a
monomer solution (a liquid that is packaged in a glass vial) and a
powder. One difficulty with the cement monomer is that it generates
toxic fumes that ideally need to be contained to prevent inhalation
exposure by medical staff. Current cement mixing techniques involve
breaking the monomer vial and pouring the fluid into the powder by
hand, then sealing a mixing chamber. This results in ambient
exposure to fumes from the monomer component. This disclosure
describes improvements over these prior art technologies.
SUMMARY
[0004] Accordingly, an injection system for mixing bone cement and
method are provided. In one embodiment, in accordance with the
principles of the present disclosure, a system for containing fumes
for a bone cement component is provided. The system comprises a
vial holder configured for receiving and holding a vial therein. A
holder chamber is configured to receive and secure the vial holder
therein such that when engaged with the vial holder, the vial
holder and the holder chamber form an enclosure for containing the
vial. A vial-breaking device is disposed in the holder chamber. The
vial holder is configured to be advanced toward the vial-breaking
device for breaking the vial and for releasing contents of the vial
into the holder chamber. A filter is disposed within the holder
chamber. A port is in communication with the holder chamber through
the filter such that when a vacuum is drawn at the port by a
dispensing device, the contents of the vial can be drawn through
the filter and into the dispensing device such that fumes are
contained in the enclosure and the dispensing device.
[0005] In one embodiment, the system comprises a vial holder
configured for receiving a vial therein and including a holding
structure for maintaining the vial in the vial holder. The vial
holder has an opening to expose a surface of a vial. The vial
includes a monomer component for bone cement. A holder chamber is
configured to receive and secure the vial holder. The vial holder
is threadedly received in the holder chamber and is advanced in an
advance direction by employing the threads. The vial holder and the
holder chamber form an enclosure for containing the vial. A
vial-breaking device is disposed in the holder chamber. The vial
holder is configured to be advanced toward the vial-breaking device
for engaging the surface of the vial, breaking the vial and
releasing contents of the vial into the holder chamber. A filter is
disposed within the holder chamber. A port is in communication with
the holder chamber through the filter. A one-way valve is disposed
between the holder chamber and the port to prevent back flow into
the holder chamber. A dispensing device is connectable to the port
for drawing a vacuum at the port to draw the contents of the vial
through the filter and into the dispensing device such that fumes
are contained in the enclosure and the dispensing device.
[0006] In one embodiment, a method for containing fumes of a bone
cement component is provided. The method comprises the steps of:
providing a system including a vial holder configured for receiving
and holding a vial therein; a holder chamber configured to receive
and secure the vial holder therein such that when engaged with the
vial holder, the vial holder and the holder chamber form an
enclosure for containing the vial; a vial breaking device disposed
in the holder chamber, the vial holder being configured to be
advanced toward the vial breaking device for breaking the vial and
for releasing contents of the vial into the holder chamber; a
filter disposed within the holder chamber; and a port in
communication with the holder chamber through the filter; providing
a vial of a monomer component of bone cement in the vial holder;
advancing the vial holder in the holder chamber to break the vial
against the vial breaking device; and drawing a vacuum at the port
by a dispensing device to draw the contents of the vial through the
filter and into the dispensing device such that fumes are contained
in the enclosure and the dispensing device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] The present disclosure will become more readily apparent
from the specific description accompanied by the following
drawings, in which:
[0008] FIG. 1 is a partial cross-sectional view showing a system
for extracting liquid from a vial for one embodiment in accordance
with the principles of the present disclosure;
[0009] FIGS. 2A-2C are perspective views of components of the
system shown in FIG. 1 in use for breaking a vial, drawing its
contents through a filter and loading the contents into a syringe
with minimal exposure to fumes in accordance with the principles of
the present disclosure;
[0010] FIG. 3 is a cross-sectional view of a mixing chamber having
a needle on a syringe passing through a membrane of a sealed
enclosure of the mixing chamber to provide minimal exposure to
fumes in accordance with the principles of the present
disclosure;
[0011] FIG. 4 is a partial cross-sectional view showing another
system for extracting liquid from a vial for one embodiment in
accordance with the principles of the present disclosure;
[0012] FIGS. 5A-5C are perspective views of components of the
system shown in FIG. 4 in use for breaking a vial, drawing its
contents through a filter and loading the contents into a syringe
with minimal exposure to fumes in accordance with the principles of
the present disclosure;
[0013] FIG. 6 is a cross-sectional view of a mixing chamber having
a port for connecting with a syringe on a sealed enclosure of the
mixing chamber to provide minimal exposure to fumes in accordance
with the principles of the present disclosure.
[0014] Like reference numerals indicate similar parts throughout
the figures.
DETAILED DESCRIPTION
[0015] The exemplary embodiments of an injection system for mixing
bone cement and related methods of use are disclosed in terms of
medical devices for the treatment skeletal disorders and more
particularly, in terms of a medical system and method for mixing
bone cement while limiting exposure to fumes. It is envisioned that
the medical system and method may be employed in applications such
as bone treatment and repair surgeries. For example, the medical
system and method can include new mixing chamber
configurations.
[0016] In particularly useful embodiments, injection and mixing
devices are provided that allow for breaking a monomer vial in an
enclosed space to prevent fume exposure, and for injecting the
monomer into a sealed mixing chamber via a fitting, such as, a
Luer-lock or similar fitting. These embodiments utilize a threaded
chamber, which advances the monomer vial onto a vial-breaking
device, e.g., a metal spike or needle. This spike causes the vial
to break, permitting fluid to seep out of the vial. A connected
syringe has its plunger drawn, which pulls the monomer through a
filter, preventing any glass shards from passing therethrough. The
monomer flows through the filter, into a syringe barrel. The device
is then attached to a sealed cement-mixing chamber (with powder
already in place). Once connected, the user will advance the
syringe plunger injecting the monomer. To prevent monomer from
flowing back into the vial chamber, a one-way valve is utilized and
permits flow into the syringe but not up into the chamber.
[0017] In one embodiment, a tool used to open and introduce the
monomer to bone cement powder is in a completely sealed system. The
tool prevents hazardous fumes from being released and permits for
the controlled introduction of monomer to powder. The present
embodiments may be employed in conjunction with known cement mixers
(e.g., Kyphon.TM. cement mixers) to introduce monomer into powder
in a controlled fashion. The tool in accordance with the present
principles may be integrated into cement mixer designs to prevent
fume exposure. Hospitals, in particular European hospitals, are
becoming increasingly sensitive to fume exposure during mixing of
cements. Use of the monomer introduction devices in accordance with
the present principles reduce or prevent fume exposure.
[0018] It is contemplated that one or all of the components of the
medical system may be disposable, peel-pack, pre-packed sterile
devices. One or all of the components of the medical system may be
reusable. The surgical system may be configured as a kit with
multiple sized and configured components.
[0019] It is envisioned that the present disclosure may be employed
to treat or repair bone injuries or disorders such as, for example,
osteoporosis, joint replacement, fracture repairs, bone breaks,
etc. It is contemplated that the present disclosure may be employed
with other osteal and bone related applications, including those
associated with diagnostics and therapeutics. It is further
contemplated that the disclosed medical systems and methods may be
alternatively employed in a surgical treatment with a patient in a
prone or supine position, and/or employ various surgical
approaches, including anterior, posterior, posterior mid-line,
direct lateral, postero-lateral, antero-lateral approaches, etc. in
any body region. The system and methods of the present disclosure
may also be used on animals, bone models and other non-living
substrates, such as, for example, in training, testing and
demonstration.
[0020] The present disclosure may be understood more readily by
reference to the following detailed description of the disclosure
taken in connection with the accompanying drawing figures, which
form a part of this disclosure. It is to be understood that this
disclosure is not limited to the specific devices, methods,
conditions or parameters described and/or shown herein, and that
the terminology used herein is for the purpose of describing
particular embodiments by way of example only and is not intended
to be limiting of the claimed disclosure. Also, as used in the
specification and including the appended claims, the singular forms
"a," "an," and "the" include the plural, and reference to a
particular numerical value includes at least that particular value,
unless the context clearly dictates otherwise. Ranges may be
expressed herein as from "about" or "approximately' one particular
value and/or to "about" or "approximately" another particular
value. When such a range is expressed, another embodiment includes
from the one particular value and/or to the other particular value.
Similarly, when values are expressed as approximations, by use of
the antecedent "about," it will be understood that the particular
value forms another embodiment. It is also understood that all
spatial references, such as, for example, horizontal, vertical,
top, upper, lower, bottom, left and right, are for illustrative
purposes only and can be varied within the scope of the disclosure.
For example, the references "upper" and "lower" are relative and
used only in the context to the other, and are not necessarily
"superior" and "inferior".
[0021] Further, as used in the specification and including the
appended claims, "treating" or "treatment" of a disease or
condition refers to performing a procedure that may include
administering one or more drugs to a patient (human, normal or
otherwise or other mammal), in an effort to alleviate signs or
symptoms of the disease or condition. Alleviation can occur prior
to signs or symptoms of the disease or condition appearing, as well
as after their appearance. Thus, treating or treatment includes
preventing or prevention of disease or undesirable condition (e.g.,
preventing the disease from occurring in a patient, who may be
predisposed to the disease but has not yet been diagnosed as having
it). In addition, treating or treatment does not require complete
alleviation of signs or symptoms, does not require a cure, and
specifically includes procedures that have only a marginal effect
on the patient. Treatment can include inhibiting the disease, e.g.,
arresting its development, or relieving the disease, e.g., causing
regression of the disease. For example, treatment can include
reducing acute or chronic inflammation; alleviating pain and
mitigating and inducing re-growth of new ligament, bone and other
tissues; as an adjunct in surgery; and/or any repair procedure.
Also, as used in the specification and including the appended
claims, the term "tissue" includes soft tissue, ligaments, tendons,
cartilage and/or bone unless specifically referred to
otherwise.
[0022] The following discussion includes a description of a mixing
system and related methods of employing the system in accordance
with the principles of the present disclosure. Alternate
embodiments are also disclosed. Reference will now be made in
detail to the exemplary embodiments of the present disclosure,
which are illustrated in the accompanying figures. Turning now to
FIGS. 1-6, there are illustrated components of a medical system,
such as, for example, a component extraction system 10 for use with
bone cement in accordance with the principles of the present
disclosure.
[0023] The components of system 10 (or 80) can be fabricated from
biologically acceptable materials suitable for medical
applications, including metals, synthetic polymers, ceramics, glass
and bone material and/or their composites, depending on the
particular application and/or preference of a medical practitioner.
For example, the components of system 10, individually or
collectively, can be fabricated from materials such as stainless
steel alloys, commercially pure titanium, titanium alloys, Grade 5
titanium, super-elastic titanium alloys, cobalt-chrome alloys,
stainless steel alloys, superelastic metallic alloys (e.g.,
Nitinol, super elasto-plastic metals, such as GUM METAL.RTM.
manufactured by Toyota Material Incorporated of Japan), ceramics
and composites thereof such as calcium phosphate (e.g., SKELITE.TM.
manufactured by Biologix Inc.), thermoplastics such as
polyaryletherketone (PAEK) including polyetheretherketone (PEEK),
polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK
composites, PEEK-BaSO.sub.4 polymeric rubbers, polyethylene
terephthalate (PET), fabric, silicone, polyurethane,
silicone-polyurethane copolymers, polymeric rubbers, polyolefin
rubbers, hydrogels, semi-rigid and rigid materials, elastomers,
rubbers, thermoplastic elastomers, thermoset elastomers,
elastomeric composites, rigid polymers including polyphenylene,
polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone
material including autograft, allograft, xenograft or transgenic
cortical and/or corticocancellous bone, and tissue growth or
differentiation factors, partially resorbable materials, such as,
for example, composites of metals and calcium-based ceramics,
composites of PEEK and calcium based ceramics, composites of PEEK
with resorbable polymers, totally resorbable materials, such as,
for example, calcium based ceramics such as calcium phosphate,
tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium
sulfate, or other resorbable polymers such as polyaetide,
polyglycolide, polytyrosine carbonate, polycaroplaetohe and their
combinations. Various components of system 10 may have material
composites, including the above materials, to achieve various
desired characteristics such as strength, rigidity, elasticity,
compliance, biomechanical performance, durability and radiolucency
or imaging preference. The components of system 10, individually or
collectively, may also be fabricated from a heterogeneous material
such as a combination of two or more of the above-described
materials. The components of system 10 may be monolithically
formed, integrally connected or include fastening elements and/or
instruments, as described herein.
[0024] System 10 is employed, for example, with an open, mini-open
or minimally invasive surgical technique to fill voids, provide
patches, attach prosthetic devices, etc., or any other bone related
repairs or treatments.
[0025] Referring to FIG. 1, an extraction device 10 is
illustratively shown in accordance with one embodiment. Device 10
includes a holder chamber 12 configured to receive a vial (not
shown), e.g., a vial containing a monomer for activating bone
cement. Device 10 may or may not be shipped with a vial contained
therein. Holder chamber 12 includes walls 17 that form a cavity 24
into which the vial can be inserted. The cavity 24 may include
threads 14 or other mechanism which positions and steadies the vial
on a vial-breaking device 16, e.g., a needle or spike 16. A vial
holder 52 is configured to receive and contain a vial therein. The
vial holder 52 includes a support structure 54 which can hold the
vial against gravity when assembling the vial holder 52 on the
holder chamber 12. Structure 54 may include elastic pieces or other
structures, which are configured to pinch, squeeze or otherwise
hold a vial therebetween.
[0026] During use, threads 56 of the vial holder 52 are engaged
with threads 14 of the holder chamber 12. Once the threads 14 and
56 are engaged the vial is enclosed therein to reduce fumes when
the vial is opened. In one embodiment, the vial-breaking device 16
includes a hollow needle to permit fluid flow therethrough.
Alternately, the vial-breaking device 16 may be solid (e.g., spike)
and permit fluid to flow over and into openings (not shown) in a
base 19. In either case, the fluid from the vial would flow onto
and cover a filter 15.
[0027] Filter 15 may include a porous solid, a fabric or mesh
configured to trap particles, or foreign material including glass
or fragments from the breakage of the vial. A one-way valve 18 is
provided to receive filtered material. The one-way valve 18 ensures
that liquid moving therethrough is not permitted to flow back and
reenter the cavity 24. A syringe-receiving cavity 20 fluidly
communicates with the one-way valve 18. A fitting or port 22
provides a sealed attachment point for a dispensing device or
syringe (not shown). The fitting 22 may include a Luer-lock fitting
or other fitting. When the dispensing device is docked with the
port 22, in this embodiment, the dispensing device is disposed
transversely to an advancing direction of the vial holder 52.
[0028] In use, a syringe is connected to the fitting 22. The vial
is drawn down on the needle or spike 16 to breach the vial to
release its contents. The contents flow down to the filter 15. A
plunger of the syringe is moved to draw the contents through the
filter 15, the one way valve 18 and into a barrel of the syringe
with minimal fumes escaping.
[0029] Referring to FIGS. 2A-2C, a method for employing the device
10 of FIG. 1 is illustratively shown in accordance with one
embodiment. FIG. 2A includes a vial 50 inside the vial holder 52.
The vial holder 52 includes a structure or spacer 54 to support the
vial 50 and provide a spacing to enable proper operation of the
device 10. The vial holder 52 encloses the vial 50 except at a base
of the vial 50, which will remain exposed to engage the needle or
spike 16. The vial holder 52 includes threads 56 or other
connection mechanism to engage threads 14 on walls 17 of the holder
chamber 12. A syringe 62 is attached to the fitting 22. A plunger
60 of the syringe is in a fully advanced (closed) position within a
barrel 58 of the syringe 62.
[0030] In FIG. 2B, the vial 50 is advanced by screwing down the
vial holder 52 using, e.g., threads 56. As the vial 50 is advanced,
the vial 50 is broken when it comes in contact with the needle 16
at a base of the holder chamber 12. The broken vial 50 permits the
fluid to flow to the filter 15.
[0031] In FIG. 2C, the plunger 60 is extended (opened) to draw
liquid contents of the vial 50 through the filter 15, through the
one-way valve 18 into the syringe chamber or barrel 58. The liquid
contents are contained at all times within the vial 50, the holder
chamber 12 (and vial holder 52), and, finally, the syringe barrel
58. Since the entire procedure maintains the contents of the vial
50 within the enclosure formed by the syringe 62 and components of
the system 10, fumes from the contents of the vial 50 are reduced,
minimized or eliminated.
[0032] Referring to FIG. 3, the syringe 62 carrying the contents of
the vial 50 is transported to an enclosed/sealed-mixing chamber 70.
The syringe 62 is fitted with a needle or tip 75 which may be
employed to pierce a membrane or other resealing material 77 in the
wall of the mixing chamber 70. The contents of the syringe barrel
58 are emptied into the mixing chamber 70 by advancing the plunger
60, which includes a powder 74 for forming bone cement. Since the
syringe is enclosed and the mixing chamber is enclosed, ambient
fumes are minimized. Other methods for injecting a liquid (e.g.,
monomer component) 79 into the chamber 90 are also contemplated
(See e.g., FIG. 6).
[0033] In this example, the bone cement may be formed from a powder
74 (e.g., pre-polymerized PMMA and/or PMMA or MMA co-polymer beads
and/or amorphous powder, radio-opacifer, initiator) and the liquid
79 (e.g., MMA monomer, stabilizer, inhibitor). The two components
are mixed, and a free radical polymerization occurs when the
components are mixed. The bone cement viscosity changes over time
from a runny liquid into a dough-like material that can be applied
and then finally hardens into solid hardened material. The mixture
is mixed or infused by a mixing element 76.
[0034] Referring to FIG. 4, another extraction device 80 is
illustratively shown in accordance with another embodiment. System
80 is equivalent to system 10 except as noted. Here, the dispersing
device or syringe (not shown) is docked in the fitting or port 22
in a parallel orientation relative an advancing direction of the
vial holder 52. Device 80 includes a base assembly 82, which
includes a vertically disposed holder chamber 12 configured to
receive a vial (not shown), e.g., a vial containing a monomer for
activating a bone cement. Device 80 may or may not be shipped with
a vial contained therein. Holder chamber 12 forms the cavity 24
into which the vial can be inserted. As before, the vial holder 52
is configured to receive and contain a vial therein. The vial
holder 52 includes the support structure 54 which can hold the vial
against gravity when assembling the vial holder 52 on the holder
chamber 12. Structure 54 may include elastic pieces or other
structures, which are configured to pinch, squeeze or otherwise
hold a vial therebetween.
[0035] During use, threads 56 of the vial holder 52 are engaged
with threads 14 of the holder chamber 12. Once the threads 14 and
56 are engaged the vial is enclosed therein to reduce fumes when
the vial is opened. The vial-breaking device 16 may include a
hollow needle or spike.
[0036] The contents of the vial may flow into a one-way valve 84
provided to receive filtered material. The one-way valve 84 ensures
that liquid moving therethrough is not permitted to flow back and
reenter the cavity 24. A lumen or tube 86 stores the liquid
released from the vial. The fitting 22 fluidly communicates with
the lumen 86. The fitting 22 provides a sealed attachment point for
a syringe (not shown). The fitting 22 may include a Luer-lock
fitting or other fitting.
[0037] In use, a syringe is connected to the fitting 22. The vial
is drawn down on the needle or spike 16 to breach the vial to
release its contents. The contents flow down to the filter 15. A
plunger of the syringe is moved proximally to draw the contents
through the filter 15, through the one-way valve 84, through the
lumen 86 and into a barrel of the syringe with minimal fumes
escaping.
[0038] Referring to FIGS. 5A-5C, a method for employing the device
80 of FIG. 4 is illustratively shown in accordance with one
embodiment. FIG. 5A includes the vial 50 inside the vial holder 52.
The vial holder 52 includes the structure or the spacer 54 to
support the vial 50 and provide spacing to enable proper operation
of the device 80. The vial holder 52 encloses the vial 50 except at
a base of the vial 50, which will remain exposed to engage the
needle or spike 16. The vial holder 52 includes threads 56 or other
connection mechanism to engage walls 17 of the holder chamber 12.
The syringe 62 is attached to the fitting 22. The plunger 60 of the
syringe is in a fully advanced (closed) position within the barrel
58 of the syringe 62.
[0039] In FIG. 5B, the vial 50 is advanced by screwing down the
vial holder 52 using, e.g., threads 56. As the vial 50 is advanced,
the vial 50 is broken when it comes in contact with the needle 16
at a base of the holder chamber 12. The broken vial 50 permits the
fluid to flow to the filter 15.
[0040] In FIG. 5C, the plunger 60 is extended (opened) to draw
liquid contents of the vial 50 through the filter 15, through the
one-way valve 84, through the lumen 86 and into the syringe chamber
or barrel 58. The liquid contents are contained at all times within
the vial 50, the holder chamber 12 (and vial holder 52), and,
finally, the syringe barrel 58. Since the entire procedure
maintains the contents of the vial 50, fumes from the contents of
the vial 50 are reduced, minimized or eliminated.
[0041] Referring to FIG. 6, the syringe 62 carrying the contents of
the vial 50 is transported to the enclosed mixing chamber 70 in the
same way as previously described. In this embodiment, the syringe
62 may be attached or injected into the mixing chamber 70 using a
fitting 72 instead of the needle 75 (FIG. 3). The contents of the
syringe barrel 58 are emptied into the mixing chamber 70 by
advancing the plunger 60. The mixing element 76 is employed to mix
the two components, e.g., monomer 79 and powder 74 to obtain bone
cement for a medical application. Throughout the entire process
including mixing the bone cement, the monomer is closed off to the
ambient environment to contain the disbursement of noxious fumes
before and during a medical procedure. Once the monomer is
extracted from the vial, the systems 10 or 80 may be discarded.
[0042] In assembly, operation and use, systems 10 and 80, described
above, are employed in a surgical procedure, such as, for the
treatment or repair of bones. For example, as shown in FIGS. 1-6,
systems 10 and 80 can be employed for safer mixing of bone cement
components for the treatment and repair of bones, to strengthen or
rebuild bones, etc. It is contemplated that one or all of the
components of systems 10 and 80 can be delivered or employed as a
pre-assembled device or can be assembled in situ. Systems 10 and 80
may be completely or partially revised, removed or replaced. In one
embodiment, the holder chamber 12 (and/or vial holder 52) may be
shipped having vials 50 contained therein. In other words, a packed
kit may include system 10 (or 80) including a vial 50 contained in
a vial holder 52 with structure 54 and an optional syringe 62 with
a compatible fitting.
[0043] For example, as shown in FIGS. 1-6, systems 10 and 80,
described above, can be employed during a surgical procedure for
mixing and dispensing bone cement. In use, a medical practitioner
obtains access to a surgical site including a bone in any
appropriate manner, such as through incision and retraction of
tissues. It is envisioned that system 10 or 80 can be used in any
existing surgical method or technique including open surgery,
mini-open surgery, minimally invasive surgery and percutaneous
surgical implantation, whereby the bone is accessed through a
mini-incision, or sleeve that provides a protected passageway to
the area. Once access to the surgical site is obtained, the
particular surgical procedure can be performed for treating or
repairing the bone.
[0044] An incision is made in the body of a patient and a cutting
instrument (not shown) creates a surgical pathway for implantation
of components for supplying bone cement mixed using systems 10 or
80. A preparation instrument (not shown) can be employed to prepare
tissue surfaces of the bone, as well as for aspiration and
irrigation of a surgical region according to the requirements of a
particular surgical application.
[0045] Holes, fractures, voids, depressions, etc. may exist in the
bone or may be created in the bone as part of the procedure. After
appropriate steps are taken for the treatment or repair, these
holes, fractures, voids, depressions, etc. are filled with the
mixed bone cement to maintain or improve the bone's structural
integrity. Components are delivered to the surgical site along the
surgical pathway(s) and into or onto bone tissue.
[0046] In one embodiment, an agent may be mixed with or delivered
with bone cement (in, e.g., in the two components) or delivered
separately. It is envisioned that the agent may include bone growth
promoting material.
[0047] It is contemplated that the agent may include therapeutic
polynucleotides or polypeptides. It is further contemplated that
the agent may include biocompatible materials, such as, for
example, biocompatible metals and/or rigid polymers, such as,
titanium elements, metal powders of titanium or titanium
compositions, sterile bone materials, such as allograft or
xenograft materials, synthetic bone materials such as coral and
calcium compositions, such as HA, calcium phosphate and calcium
sulfite, biologically active agents, for example, gradual release
compositions such as by blending in a bioresorbable polymer that
releases the biologically active agent or agents in an appropriate
time dependent fashion as the polymer degrades within the patient.
Suitable biologically active agents include, for example, BMP,
Growth and Differentiation Factors proteins (GDF) and cytokines.
Components can be made of radiolucent materials such as polymers.
Radiomarkers may be included for identification under x-ray,
fluoroscopy, CT or other imaging techniques. It is envisioned that
the agent may include one or a plurality of therapeutic agents
and/or pharmacological agents for release, including sustained
release, to treat, for example, pain, inflammation and
degeneration.
[0048] It is envisioned that the use of microsurgical and image
guided technologies may be employed to access, view and repair bone
deterioration or damage. Upon completion of the procedure, the
surgical instruments and assemblies are removed and the incision is
closed.
[0049] It will be understood that various modifications may be made
to the embodiments disclosed herein. Therefore, the above
description should not be construed as limiting, but merely as
exemplification of the various embodiments. Those skilled in the
art will envision other modifications within the scope and spirit
of the claims appended hereto.
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