U.S. patent application number 15/294999 was filed with the patent office on 2017-02-02 for syringe device, system and method for delivering ozone gas.
This patent application is currently assigned to Minimus Spine, Inc.. The applicant listed for this patent is Minimus Spine, Inc.. Invention is credited to Thomas FOSTER, Noel HENSON, David M. HOOPER.
Application Number | 20170028123 15/294999 |
Document ID | / |
Family ID | 40751776 |
Filed Date | 2017-02-02 |
United States Patent
Application |
20170028123 |
Kind Code |
A1 |
HOOPER; David M. ; et
al. |
February 2, 2017 |
SYRINGE DEVICE, SYSTEM AND METHOD FOR DELIVERING OZONE GAS
Abstract
In accordance with at least one exemplary embodiment, a syringe
device, method and system for delivering a therapeutic amount of
ozone are disclosed. A sterility case can enclose a syringe portion
and can maintain sterility while the syringe device is interfaced
to an ozone generator. A valvably-controlled fluid channel can
extend from the barrel of the syringe through the case. Conducting
elements can be attached to the case and can breach the case. The
conductive elements can be connected to electrodes. The electrodes
can be attached to the syringe. The syringe portion can be filled
with oxygen gas via the valvably-controlled fluid channel. An
electric current can be provided to the conductive elements from an
ozone generator resulting in a corona discharge from at least one
electrode. A therapeutic amount of ozone gas can be produced from
the oxygen gas and the syringe delivered into the sterile field
without compromise.
Inventors: |
HOOPER; David M.; (Austin,
TX) ; FOSTER; Thomas; (Boulder, CO) ; HENSON;
Noel; (Valley, WA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Minimus Spine, Inc. |
Austin |
TX |
US |
|
|
Assignee: |
Minimus Spine, Inc.
Austin
TX
|
Family ID: |
40751776 |
Appl. No.: |
15/294999 |
Filed: |
October 17, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14597906 |
Jan 15, 2015 |
9498569 |
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15294999 |
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12000374 |
Dec 12, 2007 |
8961471 |
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14597906 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2202/0216 20130101;
C01B 2201/10 20130101; A61M 5/002 20130101; A61M 2209/06 20130101;
C01B 13/115 20130101; A61M 5/001 20130101; A61M 2005/006 20130101;
A61M 5/3129 20130101; C01B 13/11 20130101; A61M 2205/7536 20130101;
A61K 9/0019 20130101; C01B 2201/64 20130101; A61M 39/16 20130101;
A61M 2039/167 20130101; A61M 2005/3117 20130101; A61K 33/00
20130101 |
International
Class: |
A61M 5/00 20060101
A61M005/00; A61K 33/00 20060101 A61K033/00; C01B 13/11 20060101
C01B013/11; A61K 9/00 20060101 A61K009/00 |
Claims
1. A syringe device, comprising: a syringe having a plunger
slidably engaged with a barrel, the barrel and the plunger
cooperating to define a gas chamber; a case for providing
substantial sterility, the case including an opening and configured
to enclose the syringe; a fluid channel penetrates through the
opening of the case when the case operatively encloses the syringe,
the fluid channel in fluid communication with the gas chamber;
wherein the syringe and case are configured to interface with an
ozone conversion unit, and the case maintains sterility of the
syringe while interfaced with the ozone conversion unit to
effectuate a corona discharge and produce an amount of ozone gas
from an amount of oxygen gas within the gas chamber.
2. The syringe device of claim 1, further comprising: a sterility
cap having a portion that is configured to be inserted into the
opening of the case and allows for the fluid channel to extend
through the sterility cap when the case operatively encloses the
syringe.
3. The syringe device of claim 1, further comprising: a filter in
fluid communication with the syringe, the filter within the case
when the case operatively encloses the syringe.
4. The syringe device of claim 1, further comprising: a first
electrode and a second electrode attached to, or contacting, the
syringe; and two or more conducting elements on the case, the two
or more conducting elements including a first conducting element
and a second conducting element configured to directly or
indirectly contact the first electrode and the second electrode,
respectively.
5. The syringe device of claim 4, wherein the first electrode is
one of a wire electrode and a foil electrode and the second
electrode is one of a wire electrode and a foil electrode.
6. The syringe device of claim 4, wherein at least one of the first
electrode and the second electrode is in a breaching relationship
with the barrel.
7. The syringe device of claim 4, wherein the first conducting
element and the second conducting element breach the case, the
first conducting element directly contacting the first electrode
and the second conducting element directly contacting the second
electrode.
8. The syringe device of claim 6 wherein at least one of the first
conducting element and the second conducting element have a
projection in a breaching relationship with the case, the
projection for contacting one of the first electrode and the second
electrode.
9. The syringe device of claim 1 wherein the case includes a
removable sterility cap permitting the syringe to be extracted
after a desired ozone concentration is produced.
10. The syringe device of claim 1 wherein the case is rigid or
flexible.
11. The syringe device of claim 1 wherein the case is tubular.
12. The syringe device of claim 1 wherein the ozone conversion unit
uses ultraviolet light to measure an amount of ozone.
13. The syringe device of claim 1 wherein the syringe device is
configured to interface with an oxygen concentrator, or a tank of
substantially pure oxygen.
14. The syringe device of claim 1 wherein the case and the barrel
allow for ultraviolet light transmission from the ozone generator
to reach an inside and through the gas chamber.
15. The syringe device of claim 1 wherein at least one element
springs out when the syringe device is removed to impede
reassembly.
16. The syringe device of claim 1, wherein the fluid channel is a
valvably-controlled fluid channel extending from the barrel and
defined through at least one of: one or more stopclock valves; one
or more filters; one or more luer fittings; one or more O-rings;
one or more sterility caps; and any combination thereof.
17. The syringe device of claim 4, wherein an electrical current is
passed from the first and second conducting elements to the first
and second electrodes.
18. A syringe device, comprising: a syringe having a plunger
slidably engaged with a barrel, the barrel and the plunger
cooperating to define a gas chamber; a case for providing
substantial sterility, the case including an opening and configured
to enclose the syringe; a fluid channel penetrates through the
opening of the case when the case operatively encloses the syringe,
the fluid channel in fluid communication with the gas chamber
wherein the syringe and case are configured to interface with an
ozone conversion unit, and the case maintains sterility of the
syringe while interfaced with the ozone conversion unit while the
ozone conversion unit uses ultraviolet light to convert an amount
of oxygen to an amount of ozone.
Description
BACKGROUND
[0001] Ozone is an unstable gas with a half-life of less than one
hour at room temperature. Ozone is a powerful oxidizer. It is a
known bactericide and viricide. Methods for converting oxygen to
ozone involve high-voltage corona discharge or ultraviolet light.
Ozone generators making use of such methods are available for
industrial uses.
[0002] Ozone has a variety of industrial applications. Applications
include deodorizing air, purifying water and sterilizing medical
instruments, among others. Ozone and conventional medical ozone
generators are being used therapeutically in many countries and
have been so for several years. Such applications include, but are
not limited to, autohemotherapy, rectal insufflations, intradiscal
injection, injection into knee and shoulder joints, and full body
exposure.
[0003] For example, ozone is used to treat diffuse bulging or
contained herniation of the spinal disc. Spinal discs are composed
of a fibrous outer ring made of Type I collagen and a softer more
flexible nucleus made of Type II collagen, proteoglycans and water.
Patients with disc bulging or herniation suffer from pain caused by
disc compression of the neurological elements, including the spinal
cord, cauda equina and nerve roots. Intradiscal ozone treatment
involves direct injection of a gaseous mixture of oxygen and ozone
into the nucleus of the disc. Ozone releases water from the
proteoglycans, reducing disc size and relieving compression of
neurological elements. Some investigators believe that ozone
stimulates anti-inflammatory mediators and initiates a healing
response.
[0004] The mechanism of action and reported success rates of ozone
treatment for spinal disc herniation are comparable to that of the
enzyme chymopapain. Chymopapain was first FDA-approved in 1983 and
was widely used with a success rate of 65-85%. A small number of
serious complications, including death and paralysis, caused the
product to lose favor in the U.S. market.
[0005] Ozone and chymopapain are two means of performing a chemical
discectomy through a needle puncture. This minimally invasive
approach may be preferred to surgical discectomy, which requires
general anesthesia and direct access to the spinal disc.
[0006] Therapeutic ozone must be delivered shortly after being
produced from oxygen. Conventional medical ozone generators pass
medical grade oxygen through an electric field or ultraviolet
light. This process converts an amount of oxygen into ozone.
Typically, a syringe is interfaced with the generator and ozone is
withdrawn from a gas chamber of the generator into the syringe for
subsequent injection therapy. Often, a spinal needle is already
positioned within a patient and then the syringe is placed in fluid
communication with the needle for injection.
[0007] The preferred concentration of ozone for intradiscal
injection is approximately 6%. The concentration of ozone is
important for medical uses. If the concentration is too low, the
treatment will not be effective. If the concentration of ozone is
too high, detrimental effects may follow.
[0008] As such, medical ozone generators include a means for
measuring the concentration of ozone. Conventional ozone generators
also have means for controlling the concentration and delivery of
ozone gas. For example, some generators include components that
neutralize excess ozone. Other generators continuously vent
ozone.
[0009] Conventional ozone generators typically include permanent
and reusable electrodes. The gas chambers of conventional
generators are often permanent and reusable as well. Reusable
electrodes tend to degrade over time. Sterility is an issue for
present ozone generators that pass oxygen through permanent and
reusable gas chambers. The bioburden of these machines is unknown.
Thus, the ability of ozone to sterilize these components cannot be
validated. To address such, medical professionals have been known
to inject the gas through a bacterial filter but compliance with
this practice is sporadic as filters may not be available or the
clinician may be trying to minimize equipment cost.
SUMMARY
[0010] According to at least one exemplary embodiment, a syringe
device for producing an amount of ozone from oxygen can include a
syringe having a plunger slidably engaged with a barrel. The barrel
and the plunger can cooperate to define a gas chamber. A case for
providing substantial sterility can be configured to enclose the
syringe. The syringe device can be configured to interface with an
ozone generator.
[0011] In another exemplary embodiment, a method of producing an
amount of ozone from oxygen for administering to a person can
include providing a valvably-controlled fluid channel extending
from a syringe through a sterility case enclosing the syringe. A
gas chamber of the syringe can be filled with substantially pure
oxygen gas via the valvably-controlled fluid channel. An electric
current can be provided to one or more conductive elements on the
sterility case. The one or more conductive elements can be
connected to one or more electrodes. The one or more electrodes can
be attached to the syringe. A corona discharge can be effectuated
from at least one electrode. An amount of ozone gas can be produced
from the oxygen gas.
[0012] In yet another exemplary embodiment, an ozone generation
system can include a syringe device having a syringe enclosed by a
sterility case. One or more electrodes can be attached to the
syringe. One or more conducting elements can be on the sterility
case. The one or more conducting elements can be directly or
indirectly connected to the one or more electrodes. An ozone
generator with a high voltage supply can be configured to provide
current to the one or more conducting elements.
BRIEF DESCRIPTION OF THE FIGURES
[0013] Advantages of embodiments of the present invention will be
apparent from the following detailed description of the exemplary
embodiments thereof, which description should be considered in
conjunction with the accompanying drawings in which:
[0014] FIG. 1 is a perspective view of an exemplary syringe
device.
[0015] FIG. 2A is a top view of the exemplary syringe device of
FIG. 1 that further includes an exemplary sterility case.
[0016] FIG. 2B is a cross-sectional view along line A of FIG.
2A.
[0017] FIG. 2C is a cross-sectional view along line B of FIG.
2A.
[0018] FIG. 2D is an enlarged view of the portion circumscribed by
line C of FIG. 2C.
[0019] FIG. 3A is a side view of the exemplary syringe device of
FIGS. 2A-2D in an initial state.
[0020] FIG. 3B is a side view of the exemplary syringe device of
FIGS. 2A-2D in a filled state.
[0021] FIG. 3C is a side view of the exemplary syringe device of
FIGS. 2A-2D with the exemplary sterility case detached.
[0022] FIG. 3D is a side view of the exemplary syringe device of
FIGS. 2A-2D with the exemplary sterility case detached and the
exemplary stopcock valve in a closed state.
[0023] FIG. 3E is a side view of the exemplary syringe device of
FIGS. 2A-2D with the exemplary sterility case detached and a
portion starting at the exemplary filter detached.
[0024] FIG. 4A is a perspective view of an exemplary ozone
conversion unit.
[0025] FIG. 4B is a perspective view of the exemplary ozone
conversion unit with the lid in an open position.
[0026] FIG. 4C is a perspective view of the exemplary ozone
conversion unit cooperating with an exemplary syringe device.
[0027] FIG. 4D is a perspective view of the exemplary ozone
conversion unit having the exemplary syringe device received in a
receptacle thereof.
DETAILED DESCRIPTION
[0028] Aspects of the invention are disclosed in the following
description and related drawings directed to specific embodiments
of the invention. Alternate embodiments may be devised without
departing from the spirit or the scope of the invention.
Additionally, well-known elements of exemplary embodiments of the
invention will not be described in detail or will be omitted so as
not to obscure the relevant details of the invention. Further, to
facilitate an understanding of the description discussion of
several terms used herein follows.
[0029] The word "exemplary" is used herein to mean "serving as an
example, instance, or illustration." Any embodiment described
herein as "exemplary" is not necessarily to be construed as
preferred or advantageous over other embodiments. Likewise, the
terms "embodiments of the invention", "embodiment" or "invention"
do not require that all embodiments of the invention include the
discussed feature, advantage or mode of operation.
[0030] Referring to FIG. 1, a syringe device (without a sterility
case portion) in accordance with at least one exemplary embodiment
is shown. Syringe device 100 (or any portion thereof) can be
single-use and may be reprocessable. Alternatively, syringe device
100 (or any portion thereof) may be multi-use with sterilization,
although such embodiments would stray from current trends in
healthcare. Syringe device 100 can be fabricated, in whole or in
part, by any conventional molding processes known to one having
ordinary skill in the art. Syringe device 100 can serve as a cell
for producing an amount of ozone from oxygen when used with a
suitable ozone conversion unit, as further described below.
Optionally, syringe device 100 can be filled with substantially
pure (e.g., medical grade) oxygen using a zeolite-based oxygen
concentrator, as further described below. An ozone conversion unit
and zeolite-based oxygen concentrator can be provided for in one
unit that can operatively engaged syringe device 100. Syringe
device 100, particularly, syringe portion 102 fitted (directly or
indirectly) with a hypodermic needle can be used to administer a
therapeutic amount of ozone to a human or an animal, as will be
readily recognized by one having ordinary skill in the art.
[0031] Syringe portion 102 of syringe device 100 can include barrel
104, plunger 106 and gas chamber 108. Gas chamber 108 can be
defined and bounded through the cooperation of barrel 104 and
plunger 106. In at least one exemplary embodiment, syringe portion
102 can be sized to hold between 10 ml and 30 ml of fluid in gas
chamber 108, including between 10 ml and 30 ml of medical grade
oxygen.
[0032] Barrel 104 can be made of any suitable material that allows
for at least some UV transmission. This can allow for the passage
of a UV beam through barrel 104 and a gas within gas chamber 108
for measuring the concentration of ozone gas. Furthermore, barrel
104 can be constructed of any material that sufficiently balances
the needs for ozone resistance and UV resistance while still
allowing for suitable UV transmission for measuring the
concentration of ozone. Flexibility in construction can be
increased because syringe device 100 may only be exposed to ozone
and UV light for a shortened/decreased period of time.
[0033] For example, barrel 104 (in which, syringe portion 102, as a
whole, can be constructed largely or wholly of the same) can be
constructed of polyethylene, polytetrafluoroethylene ("PTFE",
TEFLON.RTM.), polyacrylate (acrylic polymers), polycarbonate,
polystyrene, styrene copolymers, polypropylene and the like known
to one having ordinary skill in the art. Barrel 104 can also be
made of glass, as one more non-limiting example. In at least one
exemplary embodiment, barrel 104 can be made of polyethylene even
though polyethylene may only allow about 10% UV transmission. A UV
transmission of about 10% can be enough to measure ozone
concentration within gas chamber 108 with suitable accuracy.
[0034] Plunger 106 can be slidably engaged with a first open end
(i.e. top end) of barrel 104. The engagement of plunger 106 with
barrel 104 can define the bounds of gas chamber 108 within syringe
portion 102. Through sliding movements of plunger 106 within barrel
104, a fluid, including a gaseous fluid (e.g., oxygen gas), can be
drawn into and expelled from gas chamber 108. Plunger 106 can
include a plunger head 110 on one end of plunger shaft 112. On the
other end of plunger shaft 112 can be plunger piston 114. Plunger
piston 114 can form a gas-tight seal with barrel 104. Plunger
piston 114 may be made from or covered with rubber and the like
known to one having ordinary skill in the art. Tip portion 116 of
syringe portion 102 can extend in fluid communication from a second
end of barrel 104.
[0035] Wire electrodes 118, 120 can extend inwardly within barrel
104. Wire electrodes 118, 120 may be made to extend inwardly by
providing wire electrodes 118, 120 through barrel 104. Wire
electrodes 118, 120 can be provided through barrel 104 in a
gas-tight manner. Wire electrodes 118, 120 can be situated
proximate the end of barrel 104 from which tip portion 116 can
extend from. Placing wire electrodes 118, 120 towards the tip end
(i.e. bottom end) of barrel 104 can assist or prevent plunger 106
and wire electrodes 118, 120 from interacting in a non-beneficial
manner, such as causing damage to or misplacement of either, or
compromising the gas-tight sealing functionality of plunger piston
114, leading to leakage.
[0036] Wire electrodes 118, 120 can be made of any suitable
conductive material known to one having ordinary skill in the art.
Wire electrodes 118, 120 may be solid metal rods of a relatively
simple construction, which may be cost-effective. In addition, a
dielectric material may cover a portion(s) of wire electrode 118
and/or 120 in at least one exemplary embodiment.
[0037] Wire electrode 118 can extend inwardly towards the center of
hollow barrel 104 (i.e. the center of gas chamber 108). Wire
electrode 118 may breach barrel 104 once and may retain a gas-tight
seal proximate the breach. Wire electrode 118 can approach the
center of gas chamber 108 in cross-section. Wire electrode 118 can
be the discharge electrode. The end of wire electrode 118 situated
within gas chamber 108 can form a sharp point. Alternatively, the
end of wire electrode 118 can be blunt.
[0038] Wire electrode 120 can extend inwardly and can transverse a
cross section of gas chamber 108. Wire electrode 120 can be
straight (as shown) or can be curved. Wire electrode 120 may breach
barrel 104 twice and may retain gas-tight seals proximate the
breaches. Wire electrode 120 may transverse a cross section of gas
chamber 108 off-center. Wire electrode 118 and wire electrode 120
can exist in a substantially perpendicular relationship without
contacting one another. In other words, wire electrode 118 and wire
electrode 120 can extend from and/or enter barrel 104 at
approximately a right angle. Wire electrodes 118, 120 can also be
disposed at substantially the same planar orientation in
cross-section. Wire electrode 120 can be the ground electrode for
completing a circuit and may be used to sustain the current
flow.
[0039] Electrical contact points 122, 124 can be disposed on the
outside of barrel 104, as well as various other positions, as will
be readily recognized to one having ordinary skill in the art.
Electrical contact point 122 can be connected with wire electrode
118. Electrical contact point 122 may be an integral portion of
wire electrode 118. Electrical contact point 124 can be disposed on
an end of wire electrode 120 outside of syringe portion 102.
Electrical contact point 124 can be connected to wire electrode 120
and may be an integral portion thereof.
[0040] Electrical contact points 122, 124 can be indirectly
connected (described below) to an ozone generation unit for
effectuating a corona discharge via wire electrodes 118, 120. Wire
electrode 118 can be the discharge electrode and wire electrode 120
can be the ground electrode. The corona discharge can be used to
produce an amount of ozone gas from oxygen gas within gas chamber
108. A user can predetermine the amount (e.g., concentration) of
ozone desired through operation of a suitable ozone conversion
unit. For example, therapeutic levels for intradiscal injection may
be up to 6% ozone gas by volume and such concentrations may be
selected by a user of a suitable ozone conversion unit.
[0041] In other embodiments, a pair of electrodes (and portions
forming electrical contact points) can be provided in a variety of
configurations. Moreover, either one or both of the pair of
electrodes can be foil electrodes. Further, either one or both of
the pair of the electrodes can be positioned wholly outside of
syringe portion 102. Pending U.S. patent application Ser. No.
11/976,362 (incorporated by reference below) discloses exemplary
configurations for a pair of electrodes attached to syringe portion
102 and may be referred to for guidance.
[0042] In at least one exemplary embodiment, wire electrode 118 can
be paired with a foil electrode. The foil electrode can be disposed
on a portion of the inner wall of barrel 104. The foil electrode
can be curved, for example, consistent with the curvature of the
inner wall of barrel 104. Alternatively, the foil electrode can be
linear. The foil electrode can be relatively thin as is a known
characteristic of foil electrodes in general. The foil electrode
can be situated towards the tip end (bottom end) of barrel 104.
Foil electrode 222 can be the ground electrode.
[0043] An electrical contact point for the foil electrode can be
disposed on the outside of barrel 104, as well as various other
positions, as will be readily recognized by one having ordinary
skill in the art. The electrical contact point can be situated on a
bottom portion of barrel 104. The electrical contact point can be
connected to the foil electrode and may be an integral portion of
foil electrode. The foil electrode can be a one-piece insert having
the electrical contact point. The foil electrode can breach barrel
104 so as to have a face on a portion of the wall of barrel 104 and
the electrical contact point on the outside of barrel 104. The foil
electrode can breach barrel 104 in a gas-tight manner.
[0044] In another exemplary embodiment, wire electrode 118 can be
paired with a foil electrode attached on the outer wall of barrel
104 by any means known to one having ordinary skill in the art. The
foil electrode can be situated proximate the bottom end (tip end)
of barrel 104. Wire electrode 118 can extend towards and approach a
face of the foil electrode with a portion of barrel 104 interposed
there between. The foil electrode can be the ground electrode.
[0045] In yet another exemplary embodiment, a pair of wire
electrodes can be configured in a substantially opposing
relationship with one another. The wire electrodes can extend
inwardly within barrel. The wire electrodes may be made to extend
inwardly by providing wire electrodes through barrel 104. The wire
electrodes can be provided through barrel 104 in a gas-tight
manner.
[0046] The wire electrodes can extend inwardly towards the center
of barrel 104. The wire electrodes can approach the center of gas
chamber in cross-section. The wire electrodes can exist in a
substantially opposing relationship without contacting one another.
The wire electrodes may also be disposed at substantially the same
planar orientation in cross-section. Each of the wire electrodes
may breach barrel 104 once and may retain a gas-tight seal
proximate the breach.
[0047] Either of the wire electrodes can be the discharge electrode
depending on the connection to an ozone conversion unit. The other
electrode can then function as the ground electrode. The ends of
wire electrodes situated within gas chamber 108 can form a sharp
point. Alternatively, the ends of the wire electrodes can be blunt
or a combination of one sharp end and one blunt end,
respectively.
[0048] Each electrical contact point of each electrode can be
disposed on the outside of barrel 104, as well as various other
positions, as will be readily recognized to one having ordinary
skill in the art. The electrical contact points can be respectively
connected with the wire electrodes and may be integral portions
thereof.
[0049] In yet another exemplary embodiment, a pair of substantially
opposing wire electrodes can be angled. The electrodes can be
angled downwards proximate the inner bottom portion of barrel 104,
thus, not strictly occupying substantially the same planar
orientation in cross-section. As a result, the bottom portion of a
barrel 104 can be shaped so as to accommodate angled electrodes.
For example, barrel 104 can be shaped to have a conical bottom
portion.
[0050] In a further exemplary embodiment, syringe portion 102 can
include a pair of foil electrodes. The foil electrodes can be
elongated and generally resembling strips in configuration. The
foil electrodes can be disposed on the inner wall of barrel 104.
Alternatively, in at least one other exemplary embodiment, the foil
electrodes can be disposed on portions of the outer wall of barrel
104.
[0051] The foil electrodes can be disposed on opposing portions of
the inner wall of barrel 104. A face of each of the foil electrodes
can be in an opposing relationship. Also, the foil electrodes may
vertically transverse a midportion of barrel 104.
[0052] The electrical contact surfaces/points can be disposed on
the outside of barrel 104, as well as various other positions, as
will be readily recognized by one having ordinary skill in the art.
The electrical contact surfaces can be situated on opposite side
portions of barrel 104. The electrical contact surfaces can be
respectively connected to the foil electrodes and may be integral
portions thereof.
[0053] The foil electrodes can be one-piece inserts (e.g., molded
inserts) having the electrical contact surfaces. The foil
electrodes can breach barrel 104 so as to have a face on a portion
of the inner wall of barrel 104 and the electrical contact surfaces
on the outside of barrel 104. The foil electrodes can breach barrel
104 in a gas-tight manner. Either of the foil electrodes can be the
discharge electrode depending on the connection to an ozone
conversion unit. The other electrode can then function as the
ground electrode.
[0054] Referring to FIG. 1 and FIGS. 2A-2D, valvably-controlled
fluid channel 126 can extend in fluid communication from tip
portion 116 of syringe portion 102. Valvably-controlled fluid
channel 126 can be provided through the cooperation of multiple
valves and other fittings known to one having ordinary skill in the
art. Alternatively, valvably-controlled fluid channel 126 can be
provided by an integral structure (not shown). Valvably-controlled
fluid channel 126 can be connected to syringe portion 102 in a
variety of manners for providing valvably-controlled fluid
communication with gas chamber 108, as will be readily recognized
by one having ordinary skill in the art.
[0055] As shown, valvably-controlled fluid channel 126 can be
provided through the cooperation of first stopcock valve 128, first
luer fitting 130, filter 132, second luer fitting/adaptor 134,
sterility cap 136 with O-rings 138, third luer fitting/adaptor 140,
fourth luer fitting 141 and second stopcock valve 142. All or less
than all of the valves and other fittings can be coupled in a
removable manner. First stopcock valve 128 can be fitted onto tip
portion 116. First luer fitting 130 can couple first stopcock valve
128 to filter 132. Second luer fitting/adapter 134 can couple
sterility cap 136 to filter 132. Luer fittings 140, 141 can be used
to couple second stopcock valve 142. Alternatively, fourth luer
fitting 141 or any other suitable fitting known to one having
ordinary skill in the art can be connected to an oxygen supply
source for filling, such as an oxygen tank or hospital supply line,
as a couple non-limiting examples. Luer fittings 130, 134, 140, 141
can be press-on, twist-on and the like. In further embodiments,
other fittings and valves known to one of ordinary skill in the art
can be used to provide valvably-controlled fluid channel 126.
[0056] Filter 132 can be any suitable filter for protecting gas
chamber 108 from contamination known to one having ordinary skill
in the art. For example, suitable filters can include the QOSINA
hydrophobic filter with a pore size of 5 .mu.m and the
MILLIPORE.RTM. Aervent-50 hydrophobic filter with a pore size of
0.2 .mu.m. Smaller pore size provides greater filtration but
requires greater pressure to push gas into gas chamber 108 of
syringe portion 102. Both filters contain a PTFE membrane in a
polypropylene casing. After ozone generation and prior to
injection, sterility case 144 and filter 132 can be removed. By
disengaging filter 132, removed contaminants trapped by filter 132
are not forced back by reverse flow into the patient during
injection.
[0057] By providing filter 132 within sterility case 144, a
clinician does not have the option of removing filter 132 without
removing sterility case 144, thus destroying the integrity of
syringe device 102, if sterility case 144 is removed prior to ozone
conversion. Thus, filter 132 can be used as an integrated part of
syringe device 102 until sterility case 144 is removed after ozone
generation and prior to injection. This may be beneficial because
clinician will use filter 132, which is believed to be best
practice. It may be convenient as filter 132 can already be
provided as an integrated part of syringe device 102. It may also
urge the industry to adopt filtration as a standard industry-wide
practice, which may benefit the industry as a whole.
[0058] Sterility cap 136 can have a male portion and a grip
portion. The male portion can be designed to be inserted into an
open end of sterility case 144 in snug engagement. The male portion
may be cylindrical if sterility case 144 is tubular, as one
non-limiting example. Snug engagement of sterility cap 136 and
sterility case 144 can form a seal, which may or may not be
gas-tight. One or more O-rings 138 can be disposed around the male
portion of sterility cap 136 for facilitating snug engagement and
can promote the formation of a seal between sterility cap 138 and
sterility case 144.
[0059] During snug engagement, the grip portion of sterility cap
136 can border sterility case 144 and may project laterally in all
directions. The grip portion of sterility cap 136 can be circular.
The grip portion of sterility cap 136 can provide a useful area for
a user to manipulate sterility cap 136 to engage or disengage with
sterility case 144. The grip portion may be contoured or textured
for increased ease in manipulation by a user's hands and
fingers.
[0060] Sterility cap 136, as a whole, can have a channel defined
through it, which can form a portion of valvably-controlled fluid
channel 126. When sterility cap 136 is engaged with sterility case
144, valvably-controlled fluid channel 126 can extend from tip
portion 116 through sterility cap 136 and, hence, through sterility
case 144 because sterility cap 136 can be viewed as a component
thereof during engagement.
[0061] Referring particularly to FIGS. 2A-2D, the syringe device of
FIG. 1 is shown with a sterility case portion in accordance with at
least one exemplary embodiment. Syringe device 100 can include
sterility case 144. Sterility case 144 can be rigid, flexible or
any combination thereof. In at least one exemplary embodiment,
sterility case 144 can be made of a rigid plastic material.
Sterility case 144 can be tubular in shape, as one non-limiting
example.
[0062] Sterility case 144 can prevent direct handling and other
types of physical contact with syringe portion 102. By preventing
direct handling and other types of physical contact, sterility case
144 can decrease the likelihood of contamination. Particularly,
incidences of contamination of gas chamber 108 can be reduced.
Thus, the mere existence of sterility case 144 as a physical
barrier may provide substantial sterility to syringe portion 102.
Sterility case 144 may or may not be gas-tight. A gas-tight seal
may provide additional safeguards against contamination of gas
chamber 108. Overall, sterility case 144 can increase the
likelihood of a sterile dose of ozone being delivered to a
patient.
[0063] As shown, sterility case 144 can be engaged with sterility
cap 136 so as to house syringe portion 102, a portion of
valvably-controlled fluid channel 126, first stopcock valve 128,
first luer fitting 130, filter 132 and second luer fitting/adaptor
134 in a ship-in-a-bottle configuration. Sterility case 144 may or
may not be sealed in a gas-tight manner at its top end. For
example, sterility case 144 can be sealed by sterility end cap 146,
which can be considered a component of sterility case 144.
Alternatively, sterility case 144 can have an integral top portion.
The components and portions housed within sterility case 144 can
remain substantially sterile after sterilization of syringe device
100 because of the physical barrier provided by sterility case 144.
Sterilization can be performed by gamma irradiation or any other
method known to one having ordinary skill in the art. After
sterilization, syringe device 100 can be packaged in Tyvek pouch,
as one non-limiting example. Gas chamber 108 can remain substantial
sterile when fluid communication is obstructed through the
operation of one or more valves of valvably-controlled fluid
channel 126 and/or by retaining plunger 106 in a depressed state.
Filter 132 can also prevent contamination when fluid communication
is or is not obstructed.
[0064] Sterility case 144 (or portions thereof) can be made of any
suitable material and may allow for at least some UV transmission.
UV transmissibility can allow for the passage of a UV beam through
sterility case 144, barrel 104 (also having some UV
transmissibility) and a gas within gas chamber 108 for measuring
the concentration of ozone gas.
[0065] For example, sterility case 144 can be constructed of
polyacrylate because of its UV transmission properties. In other
embodiments, sterility case 144 can be constructed of polyethylene,
polytetrafluoroethylene ("PTFE", TEFLON.RTM.), polycarbonate,
polystyrene, styrene copolymers, polypropylene and the like known
to one having ordinary skill in the art. Sterility case 144 can
also be made of glass, as one more non-limiting example.
[0066] First conducting element 148 and second conducting element
150 can be attached to or otherwise disposed on sterility case 144.
Conducting elements 148, 150 can be of any conductive material,
including various metals, known to one having ordinary skill in the
art. As one non-limiting example, conducting elements 148, 150 can
be made of beryllium copper alloy ("Be--Cu"). Conducting elements
148, 150 can each be a one-piece construction. Alternatively,
conducting elements 148, 150 can have more than one piece, as will
be readily recognized by one having ordinary skill in the art.
Conducting elements 148, 150, whether one-piece or not, can have
portions outside of and inside of, as well as a portion(s) in a
breaching relationship with sterility case 144. Conducting elements
148, 150 may or may not breach sterility case 144 in a gas-tight
manner. In exemplary embodiments, the holes required to pass
conducting elements 148, 150 can be covered with tape or sealed
with epoxy, as couple non-limiting examples, if conducting elements
148, 150 are not already passed in a gas-tight manner.
[0067] In single-use embodiments, a fuse (not shown) or interfering
electrical contacts can be coupled to one or more of conducting
elements 148, 150. The fuse can be used as one means for
identifying that syringe device 100 has been previously used.
Alternatively, singularly or in conjunction, one or both of
conducting elements 148, 150 can "spring" out when the syringe
device 100 is removed from a suitable ozone conversion unit.
[0068] Conducting elements 148, 150 can be fashioned in a variety
of shapes and dimensions. As shown, conducting elements 148, 150
can each have a ring-shaped outer portion and a projecting portion
for breaching sterility case 144. The projecting portion can be
shaped (e.g., curved and/or bent) so as to respectively reach and
contact one of electrical contact points 122, 124 when sterility
case 144 is engaged with sterility cap 136.
[0069] When sterility case 144 is engaged with sterility cap 136,
conducting element 148 can contact electrical contact point 122 and
conducting element 150 can contact electrical contact point 124 for
providing current. Conducting elements 148, 150 can be electrical
contact points in their own right for interfacing with electrical
contact points of a medical ozone generator. A medical ozone
generator can supply electrical current through conducting elements
148, 150 and, in turn, through electrodes 118, 120 in order to
effectuate corona discharge. The corona discharge can be used to
produce an amount of ozone gas from oxygen gas within gas chamber
108. A user can predetermine the amount (e.g., concentration) of
ozone desired through operation of a suitable ozone conversion
unit. For example, therapeutic levels for intradiscal injection may
be up to 6% and such concentrations may be selected by a user of a
suitable ozone conversion unit.
[0070] Referring to FIGS. 3A-3E, syringe device 100 is shown in
various configurations for different states of use. Referring
particularly to FIG. 3A, syringe device 100 is shown in a pre-use
or initial state. Syringe device 100 can be provided as such, for
example, from a manufacturer or vendor to a user. A user can be a
clinician, such as a doctor or other medical personnel. Syringe
device 100 can be provided from a manufacturer or vendor in a
substantially sterile state. For example, syringe device 100 can be
provided in sterile packaging, such as a sterile pouch.
Sterilization can be performed by any method known to one having
ordinary skill in the art, including gamma irradiation. Notably,
plunger 106 can be provided in a depressed state. Second stopcock
valve 142 can be in a closed state to prevent contaminating
valvably-controlled fluid channel 126.
[0071] Referring particularly to FIG. 3B, syringe portion 102 of
syringe device 100 can be filled with substantially pure oxygen gas
(e.g., medical grade oxygen) via valvably-controlled fluid channel
126 and, thereafter, an amount of ozone gas can be produced from
the oxygen gas in gas chamber 108. In at least one exemplary
embodiment, syringe device 100 can be connected to an oxygen
concentrator for filling gas chamber 108 with substantially pure
oxygen gas. The oxygen concentrator can be part of the same unit as
an ozone conversion unit. In another embodiment, syringe device 100
may be pre-filled with oxygen, sealed in a sterility case and then
sterilized and packaged, in which case the sterility cap would not
require a gas passage.
[0072] The oxygen concentrator can be consistent with any
embodiment disclosed by U.S. patent application Ser. No. 11/976,362
(incorporated by reference below). Second stopcock valve 142 can be
manipulated to provision concentrated and substantially pure oxygen
gas via valvably-controlled fluid channel 126 to gas chamber 108
when syringe device 100 is connected to such a filling apparatus.
Filling can occur by pressurizing at least one zeolite chamber with
ambient air. The zeolite chamber can have at least one zeolite
material that selectively sorts nitrogen from oxygen. Stopcock
valve 142 can be set to the open position and syringe portion 102
(oxygen-ozone cell) can be filled with concentrated oxygen gas from
the at least one zeolite chamber via valvably-controlled fluid
channel 126. Filter 132 can decrease exposure of gas chamber 108 to
contaminating agents.
[0073] Plunger 106 can be elevated during the filling process,
whether being filled by an oxygen concentrator or other oxygen
supply, due to pressure from the oxygen gas entering gas chamber
108. Gas chamber 108 can, thus, expand upon ingress of oxygen gas.
Sterility end cap 146 (i.e. top end of sterility case 144) can act
as a stopper for abutting plunger head 110 to ensure that plunger
piston 114 of plunger 106 is retained within barrel 104.
[0074] Once filled by an oxygen concentrator or other oxygen
supply, syringe device 100 can be operatively connected to an ozone
generator, such as an exemplary ozone conversion unit disclosed in
U.S. patent application Ser. No. 11/527,414 (incorporated by
reference below). If the oxygen concentrator and ozone conversion
unit are conjunctively housed, then there may be no need to
disengaged syringe device 100. Alternatively, if the oxygen
concentrator is a separate unit from the ozone conversion unit,
then syringe device 100 can be disengaged from the oxygen
concentrator and operatively coupled to an ozone conversion
unit.
[0075] Conducting elements 148, 150 can be interfaced with
electrical contact points of an ozone generator. A medical ozone
generator can supply electrical current through conducting elements
148, 150 and, in turn, through electrodes 118, 120 in order to
effectuate corona discharge. The corona discharge can be used to
produce an amount of ozone gas from oxygen gas within gas chamber
108. A user can predetermine the amount (e.g., concentration) of
ozone desired through operation of a suitable ozone conversion
unit. Alternatively, an ozone generator relying on UV light for
conversion can be used and conducting elements 148, 150, as well as
wire electrodes 118, 120 may not be needed in such embodiments.
Therapeutic levels for intradiscal injection may be up to 6% and
such concentrations may be selected by a user of a suitable ozone
conversion unit.
[0076] Syringe device 100 can be disconnected from the ozone
generator, which may be done shortly after ozone gas is produced.
For example, the ozone-oxygen gaseous mixture for intradiscal
injection should be delivered shortly after ozone gas is produced
so that a significant amount of the ozone gas does not break down
due to its short half-life. The ozone conversion unit can have the
ability to hold the concentration of ozone at a specific level by
delivering voltage if the concentration falls. Once the syringe
device 100 is disconnected from the machine, a stopwatch function
can be activated to encourage the clinician to complete the
injection within a set time (e.g. three minutes). Second stopcock
valve 142 can be closed to decrease exposure to contaminating
agents as shown in FIG. 3C. Filter 132 can also function to
decrease exposure to contaminating agents whether or not stopcock
valve 142 is placed in a closed configuration.
[0077] Referring particularly to FIG. 3C-3E, after ozone is
produce, sterility case 144 can be removed. The bottom open end of
sterility case 144 can be uncoupled from sterility cap 136.
Nevertheless, gas in gas chamber 108 can remain in a substantially
sterile state, as would be expected. First stopcock valve 128 can
be placed in the closed position and filter 132 can be uncoupled
from first luer fitting 130 and a delivery device can be coupled to
luer fitting 130. Filter 132 can be removed prior to injection so
that the removed contaminants are not forced back into the patient
during injection. A clinician in the non-sterile field can remove
sterility case 144 and the clinician can couple syringe device 102
to a hypodermic needle. For example, a hypodermic needle can be
coupled with luer fitting 130 for intradiscal injection of a
substantially sterile dose of ozone gas by a clinician (e.g.,
doctor, nurse, etc.).
[0078] The disclosures of unpublished U.S. patent application Ser.
No. 11/527,414 (Hooper), Ser. No. 11/727,978 (Hooper, et al.) and
Ser. No. 11/976,362 entitled "SYSTEM FOR DELIVERING OZONE",
"APPARATUS, METHOD AND SYSTEM FOR DELIVERING OXYGEN-OZONE" and
"SYRINGE, SYSTEM AND METHOD FOR DELIVERING OXYGEN-OZONE",
respectively, are incorporated by reference herein in their
entireties. As will be recognized by one having ordinary skill in
the art, a syringe devices in accordance with at least one
embodiment of the present disclosure can be suitably designed to
functionally replace exemplary sterile vials (i.e. oxygen-ozone
cells) of the '414 application for use with exemplary ozone
conversion units as otherwise disclosed (and further described
herein below), with or without ordinary modification, in the '414
application. Alternatively, conventional ozone generators, with or
without ordinary modification, can be used to convert a portion of
oxygen gas to ozone gas within syringe devices in accordance with
embodiments of the present disclosure.
[0079] There may not be a need to remove excess ozone from an ozone
generator because the amount of ozone needed (without substantial
excess) can be produced directly in an exemplary syringe device. An
exemplary syringe device adapted for direct cooperation with a
medical ozone generator can decrease manufacturing costs by
combining the functionality of an ozone cell (e.g., sterile vial)
with a therapeutic delivery instrument (e.g., a conventional
syringe).
[0080] Moreover, syringe device embodiments can be suitably
designed to functionally replace exemplary oxygen-ozone cells of
the '978 application. Such embodiments can be filled with
concentrated oxygen using exemplary apparatuses for concentrating
oxygen from air as otherwise disclosed, with or without ordinary
modification, in the '978 application. Alternatively, oxygen can be
supplied to exemplary syringe devices by any other means known to
one having ordinary skill in the art. As a couple non-limiting
examples, medical grade oxygen can be supplied from supply tanks or
hospital supply lines.
[0081] An exemplary ozone conversion unit may include an ozone UV
measurement assembly, a data input mechanism such as a dial to
allow the user to select a desired ozone concentration, and a data
display to display input and output data such as desired
concentrations and measurements. After a syringe device according
to at least one exemplary embodiment is engaged to the ozone
conversion unit, an ozone concentration may be selected and power
applied to effect corona discharge and the resultant conversion of
oxygen to the selected concentration of ozone. An exemplary syringe
device may then be disengaged, thus allowing for therapeutic
treatment. Embodiments may be employed in any of a variety of
situations including, for example, the therapeutic treatment of
humans or animals by way of injection.
[0082] The ozone conversion unit may be used to convert an amount
of oxygen contained in an exemplary syringe device to ozone by
facilitating power. Ozone conversion unit may include a high
voltage transformer. In an exemplary embodiment, the high voltage
transformer may have a potential difference of about 3-25 kV. The
high voltage transformer may be connected to a power source and to
another set of electrical contact points. In another exemplary
embodiment, electrical contact points may be arranged to reversibly
interface with the electrical contact points of an exemplary
syringe device.
[0083] The ozone conversion unit may further include an input
device (e.g., dial, keypad, touch screen, etc.), a UV measurement
assembly and a data display. The UV measurement assembly may
include components relating to measurements using UV absorption
techniques, whereby a beam is passed through the ozone and oxygen
mixture to be received by a detector. Such a beam may have a
wavelength within a range on the UV spectrum known to those skilled
in the art to be absorbed by ozone such as ranges UV-A, UV-B, and
UV-C. In an exemplary embodiment, a beam having wavelengths of
about 253.7 nm, within the bounds of the UV-C range, may be used.
Also, in an exemplary embodiment, a mercury vapor lamp may be used
to measure the concentration of ozone. An alternative exemplary
embodiment may employ a UV light emitting diode or other
instruments known to one having ordinary skill in UV absorption
techniques. An exemplary detector may be a photodiode or other
photo detecting instruments known to those having ordinary skill in
the art. The dial may be used to regulate or input a desired ozone
concentration. An exemplary therapeutically effective concentration
of ozone is 6% or less by volume. An exemplary syringe device may
be constructed to be received by the ozone conversion unit in such
a way that orients an exemplary syringe device for successful UV
measurement.
[0084] In an exemplary embodiment, the electrical contact points
(e.g., conducting elements 148, 150) may be situated to interface
with the interior of a receptacle formed in the ozone conversion
unit that is capable of receiving an exemplary syringe device. The
UV measurement assembly may be arranged to orient a UV measurement
beam axially through and along the receptacle to be received by a
UV detector. In an alternative embodiment, the UV measurement
assembly may be arranged to orient the UV measurement beam through
the receptacle transversely. A further exemplary embodiment may
include a door to be closed upon or around an engaged exemplary
syringe device, thereby reducing ambient light from infiltrating
the receptacle and interfering with UV detector.
[0085] The data display may be used to display measurement data
collected by a UV measurement assembly, indicate power status, or
convey other relevant information such as input data or to confirm
engagement of an exemplary syringe device within the ozone
conversion unit and operating pressures. The data display may be
used to display any information or data that may be useful to one
having ordinary skill in the art. The ozone conversion unit may be
constructed to receive power, which can be made to pass through the
high voltage transformer, and both sets of electrical contact
points, thereby causing the corona discharge assembly to act upon
the oxygen contained by an exemplary syringe device and effect the
selected concentration of ozone.
[0086] Optionally, the exemplary ozone conversion unit may also be
constructed to detect nitrogen oxides (NOx). If an exemplary
syringe device is contaminated with nitrogen, for example, due to
ingress of air from such causes as a leak within the syringe device
or improper functioning of a filling apparatus and system, then NOx
will be produced by charging with the ozone conversion unit.
Absorption techniques can be used to indirectly detect nitrogen
ingress into the syringe device prior to charging. While nitrogen
itself is optically transparent, NO.sub.x molecules, which will be
created from the ionization of nitrogen and oxygen, absorb light at
various frequencies between 227 and 550 nm. Many NO.sub.x bands
overlap with that of ozone making it difficult to isolate these
oxides. However, NO.sub.2 has absorption bands (400-550 nm) that
are distinct from ozone (253.7 nm) making it well suited to detect
nitrogen ingress and formation of NO.sub.x's.
[0087] Also optionally, an exemplary ozone conversion unit or an
exemplary syringe device may be constructed to measure leaks within
the syringe device because at least one visual indicator or sensor
for measuring changes in pressure known to those having ordinary
skill in the art may be suitably placed for such a purpose.
Moreover, the dielectric property of gases may provide another way
to measure the amount of nitrogen potentially within the syringe
device. Oxygen and nitrogen have different dialectic constants and
may be detected based on this difference.
[0088] Referring to FIGS. 4A-4D, an exemplary ozone conversion unit
is shown. Ozone conversion units consistent with the description
above can be provided in various designs, as will be readily
recognized by one having ordinary skill in the art. FIGS. 4A-4D
show, inter alia, a design for an exemplary zone conversion unit in
accordance with at least one exemplary embodiment.
[0089] Ozone conversion unit 400 can include housing 402 for
housing components of ozone conversion unit 400. Housing 402 can
frame data input and display mechanism 404. In at least one
embodiment, data input and display mechanism 404 can be a touch
screen. Data input and display mechanism 404 can allow a user to
input a variety of data and view a variety of inputted and
outputted data. For example, data input and display mechanism 404
can allow a user to select a desired ozone concentration. Moreover,
data input and display mechanism 404 can be used to display
measurement data collected by a UV measurement assembly, indicate
power status, or convey other relevant information (e.g., input
data, data confirming engagement of syringe device 100 within ozone
conversion unit 400, operating pressures, etc.).
[0090] Ozone conversion unit 400 can include receptacle 406.
Receptacle 406 can be accessed through the operation of lid 408.
Within receptacle 406 can be holder 410. Holder 410 can be
pivotally mounted within receptacle 406. Ozone conversion 400 can
include guide 412 affixed to housing 402 proximate holder 410 for
guiding and confirming that holder 410 is in an upright position.
Syringe device 100 can be fitted on holder 410 and holder 410 can
be pivoted to provide syringe device 100 within receptacle 406 for
generating an amount of ozone gas from oxygen gas.
[0091] The foregoing description and accompanying drawings
illustrate the principles, preferred embodiments and modes of
operation of the invention. However, the invention should not be
construed as being limited to the particular embodiments discussed
above. Additional variations of the embodiments discussed above
will be appreciated by those skilled in the art.
[0092] Therefore, the above-described embodiments should be
regarded as illustrative rather than restrictive. Accordingly, it
should be appreciated that variations to those embodiments can be
made by those skilled in the art without departing from the scope
of the invention as defined by the following claims.
* * * * *