U.S. patent application number 12/429736 was filed with the patent office on 2009-08-13 for method for administering a therapeutic agent into tissue.
Invention is credited to Kieran P. Murphy, Mario Muto.
Application Number | 20090204062 12/429736 |
Document ID | / |
Family ID | 34396446 |
Filed Date | 2009-08-13 |
United States Patent
Application |
20090204062 |
Kind Code |
A1 |
Muto; Mario ; et
al. |
August 13, 2009 |
METHOD FOR ADMINISTERING A THERAPEUTIC AGENT INTO TISSUE
Abstract
An apparatus for administering a therapeutic agent is provided.
The apparatus, in an embodiment, includes an ozone generator
connected to a scavenger and an ozone administrator via network of
tubing and valves. When activated and the valves placed in the
proper position, the ozone generator will fill the ozone
administrator with ozone. The ozone generator can then be turned
off and the valves moved so that the administrator can be
disconnected from the remainder of the apparatus. The administrator
is typically in the form of a syringe and needle. Once the syringe
and needle is filled with ozone, the needle can be inserted into a
tissue and the ozone expressed therefrom into the tissue. Various
other apparatuses and methods are also contemplated.
Inventors: |
Muto; Mario; (US) ;
Murphy; Kieran P.; (Towson, MD) |
Correspondence
Address: |
CERAMATEC, INC.
2425 SOUTH 900 WEST
SALT LAKE CITY
UT
84119
US
|
Family ID: |
34396446 |
Appl. No.: |
12/429736 |
Filed: |
April 24, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10867215 |
Jun 15, 2004 |
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12429736 |
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60508300 |
Oct 6, 2003 |
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Current U.S.
Class: |
604/25 |
Current CPC
Class: |
A61M 5/31511 20130101;
A61M 2005/3114 20130101; A61M 25/065 20130101; A61M 5/28 20130101;
A61P 19/02 20180101; A61K 45/06 20130101; A61B 17/3478 20130101;
A61M 2202/0208 20130101; A61K 33/40 20130101; A61M 2202/0216
20130101; A61K 33/00 20130101; A61M 2210/1003 20130101; A61P 25/04
20180101; A61M 2005/3128 20130101; A61K 33/00 20130101; A61K
2300/00 20130101; A61K 33/40 20130101; A61K 2300/00 20130101 |
Class at
Publication: |
604/25 |
International
Class: |
A61M 37/00 20060101
A61M037/00 |
Claims
1. A method of treating pain, comprising: identifying a pain site
and injecting medical ozone into the pain site.
2. The method of claim 1, wherein injecting medical ozone comprises
utilizing an apparatus for the self-contained generation and
administration of medical ozone.
3. The method of claim 2, wherein the apparatus comprises: a
chamber for holding said agent; a catheter for connecting said
chamber to an area for administration of said agent; a power
supply; a therapeutic agent generator in communication with said
chamber, said generator connected to said power supply; and a
switch in operable communication with said power supply such that
when said switch is activated said therapeutic agent generator
generates said therapeutic agent.
4. The method of claim 2, wherein said medical ozone comprises a
ratio of ozone (O.sub.3) to oxygen (O.sub.2).
5. The method of claim 4, wherein said ratio of ozone to oxygen is
about 1 .mu.g/ml.
6. The method of claim 4, wherein said ratio of ozone to oxygen is
about 10 .mu.g/ml.
7. The method of claim 4, wherein said ratio of ozone to oxygen is
about 20 .mu.g/ml.
8. The method of claim 4, wherein said ratio of ozone to oxygen is
about 30 .mu.g/ml.
9. The method of claim 4, wherein said ratio of ozone to oxygen is
about 40 .mu.g/ml.
10. The method of claim 4, wherein said ratio of ozone to oxygen is
about 50 .mu.g/ml.
11. The method of claim 4, wherein said ratio of ozone in
micrograms to oxygen in milliliters is between about 1 .mu.g/ml and
about 90 .mu.g/ml.
12. The method of claim 11, wherein said ratio of ozone in
micrograms to oxygen in milliliters is between about 10 .mu.g/ml
and about 80 .mu.g/ml.
13. The method of claim 12, wherein said ratio of ozone in
micrograms to oxygen in milliliters is between about 20 .mu.g/ml
and about 70 .mu.g/ml.
14. The method of claim 13, wherein said ratio of ozone in
micrograms to oxygen in milliliters is between about 10 .mu.g/ml
and about 34 .mu.g/ml.
15. The method of claim 14, wherein said ratio of ozone in
micrograms to oxygen in milliliters is between about 27 .mu.g/ml to
about 28 .mu.g/ml.
16. A method of treating pain, comprising: activating an ozone
generator external to the patient; creating a specific
concentration of O3/O2 gas mixture on the ozone generator;
aspirating the O3/O2 gas mixture into the syringe; and injecting a
predetermined volume of a fixed concentration of ozone/oxygen gas
mixture into the pain site.
17. The method of claim 16, wherein injecting medical ozone
comprises utilizing an apparatus for the self-contained generation
and administration of medical ozone.
18. The method of claim 17, wherein the apparatus comprises: a
chamber for holding said agent; a catheter for connecting said
chamber to an area for administration of said agent; a power
supply; a therapeutic agent generator in communication with said
chamber, said generator connected to said power supply; and a
switch in operable communication with said power supply such that
when said switch is activated said therapeutic agent generator
generates said therapeutic agent.
19. The method of claim 17, wherein said medical ozone comprises a
ratio of ozone (O.sub.3) to oxygen (O.sub.2).
20. The method of claim 19, wherein said ratio of ozone to oxygen
is about 1 .mu.g/ml.
21. The method of claim 19, wherein said ratio of ozone to oxygen
is about 10 .mu.g/ml.
22. The method of claim 19, wherein said ratio of ozone to oxygen
is about 20 .mu.g/ml.
23. The method of claim 19, wherein said ratio of ozone to oxygen
is about 30 .mu.g/ml.
24. The method of claim 19, wherein said ratio of ozone to oxygen
is about 40 .mu.g/ml.
25. The method of claim 19, wherein said ratio of ozone to oxygen
is about 50 .mu.g/ml.
26. The method of claim 19, wherein said ratio of ozone in
micrograms to oxygen in milliliters is between about 1 .mu.g/ml and
about 90 .mu.g/ml.
27. The method of claim 26, wherein said ratio of ozone in
micrograms to oxygen in milliliters is between about 10 .mu.g/ml
and about 80 .mu.g/ml.
28. The method of claim 27, wherein said ratio of ozone in
micrograms to oxygen in milliliters is between about 20 .mu.g/ml
and about 70 .mu.g/ml.
29. The method of claim 28, wherein said ratio of ozone in
micrograms to oxygen in milliliters is between about 10 .mu.g/ml
and about 34 .mu.g/ml.
30. The method of claim 29, wherein said ratio of ozone in
micrograms to oxygen in milliliters is between about 27 .mu.g/ml to
about 28 .mu.g/ml.
31. The method of claim 16, further comprising capturing unused
ozone in a scavenger.
32. A method of treating pain, comprising: identifying the pain
site with an imaging device; inserting a needle at or near the pain
site; injecting nonionic x-ray dye through the needle into the area
or the pain site; performing a discogram of the pain site;
activating an ozone generator external to the patient; selecting a
specific concentration of O3/O2 gas mixture on the ozone generator;
attaching a scavenger and a syringe to the ozone generator;
aspirating the O3/O2 gas mixture into the syringe; injecting a
predetermined volume of a fixed concentration of ozone/oxygen gas
mixture into the pain site; capturing unused ozone in the charcoal
scavenger; and, removing all needles.
33. The method of claim 32, wherein injecting medical ozone
comprises utilizing an apparatus for the self-contained generation
and administration of medical ozone.
34. The method of claim 33, wherein the apparatus comprises: a
chamber for holding said agent; a catheter for connecting said
chamber to an area for administration of said agent; a power
supply; a therapeutic agent generator in communication with said
chamber, said generator connected to said power supply; and a
switch in operable communication with said power supply such that
when said switch is activated said therapeutic agent generator
generates said therapeutic agent.
35. The method of claim 33, wherein said medical ozone comprises a
ratio of ozone (O.sub.3) to oxygen (O.sub.2).
36. The method of claim 35, wherein said ratio of ozone to oxygen
is about 1 .mu.g/ml.
37. The method of claim 35, wherein said ratio of ozone to oxygen
is about 10 .mu.g/ml.
38. The method of claim 35, wherein said ratio of ozone to oxygen
is about 20 .mu.g/ml.
39. The method of claim 35, wherein said ratio of ozone to oxygen
is about 30 .mu.g/ml.
40. The method of claim 35, wherein said ratio of ozone to oxygen
is about 40 .mu.g/ml.
41. The method of claim 35, wherein said ratio of ozone to oxygen
is about 50 .mu.g/ml.
42. The method of claim 35, wherein said ratio of ozone in
micrograms to oxygen in milliliters is between about 1 .mu.g/ml and
about 90 .mu.g/ml.
43. The method of claim 42, wherein said ratio of ozone in
micrograms to oxygen in milliliters is between about 10 .mu.g/ml
and about 80 .mu.g/ml.
44. The method of claim 43, wherein said ratio of ozone in
micrograms to oxygen in milliliters is between about 20 .mu.g/ml
and about 70 .mu.g/ml.
45. The method of claim 44, wherein said ratio of ozone in
micrograms to oxygen in milliliters is between about 10 .mu.g/ml
and about 34 .mu.g/ml.
46. The method of claim 45, wherein said ratio of ozone in
micrograms to oxygen in milliliters is between about 27 .mu.g/ml to
about 28 .mu.g/ml.
Description
PRIORITY CLAIM
[0001] The present application is a divisional application of, and
claims priority to and the benefit of U.S. patent application Ser.
No. 10/867,215, filed Jun. 15, 2004, which claimed the benefit of
and priority to U.S. Provisional Patent Application No. 60/508,300,
filed Oct. 6, 2003. The contents of both of these prior
applications are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to a method,
apparatus and kit for administering a therapeutic agent into tissue
and in particular, for the administration of a therapeutic agent
such as medical ozone.
BACKGROUND OF THE INVENTION
[0003] Back joint disc or tendon pain is a common and potentially
debilitating ailment that affects an estimated 80% of the worldwide
population at least once in a lifetime. In many instances, the
cause of the pain can be attributed to a degenerated intervertebral
disc that has further deteriorated into a condition known as disc
herniation. This occurs when the disc nucleus pulposus extrudes
through a tear or fissure in the outer lining of the disk, thereby
exerting pressure on spinal nerves. The compression caused by the
herniated nucleus leads to inflammation and is directly responsible
for the pain felt down the leg (also referred to as sciatica).
Available treatments for this type of back pain vary according to
the severity of the hernia. If mild, the patient's condition can be
appeased with rest and inactivity for an extended period of time.
However, for patients suffering from a severe herniation or who do
not respond to non-invasive treatment (pharmacological and/or
physical therapy), surgical intervention is often recommended. With
this invasive treatment come several disadvantages such as: [0004]
i) irreversibility of the procedure [0005] ii) formation of scar
tissue [0006] iii) slower recovery time [0007] iv) longer hospital
stays
[0008] Since the late 1950s, many attempts have been made to treat
sciatica and lower back pain with percutaneous procedures to avoid
surgery. Well known treatments for example are percutaneous
discetomy and chemonucleolysis but the cost of these procedures has
kept researchers looking for another alternative. It was in 1984
that an Italian orthopedic surgeon by the name of Dr. Cesare Verga
first proposed the use of ozone/oxygen mixtures to treat the
pathology of a herniated disk. (See for example,
http://www.cleanairassociationlcom/6/ca.sub.--3.htm, Ozone Therapy:
New breakthrough for Back Treatment, by Gaetano Morello, M.D., the
contents of which are incorporated herein by reference.)
[0009] Other prior art references include: Percutaneous Treatment
of Herniated Lumbar Disc by Intradiscal Oxygen-Ozone Injection, M.
Muto and F. Avella, Interventional Neuroradiology 4:279-286,
1998.
[0010] In other situations such as rheumatoid arthritis,
osteoarthritis or a repetitive injury through sports or occupation,
such as tennis elbow, frozen shoulder, or house maids knee,
inflammation can develop between two surfaces the are involved in
allowing joint function, such as a tendon and the sheath or
lubricated tube in which that tendon moves. Inflammation such as
bursitis in the knee shoulder hip, or other anatomic bursa may
benefit from ozone therapy; this includes epicondylitis, and other
tendonitis and bursitis, including the wrist, hand and the tendon
sheaths of the hand and wrist. Inflammation can occur at a site
where a tendon or a ligament insert to bone or pass through a
sheath from trauma, tension, over use or disease.
[0011] Inflammation can develop through pathologies of any joint,
and these may again include the inflammatory arthropatic conditions
of rheumatoid arthritis, psoriatic arthritis and the like, or
osteoarthritis. Joints that may be involved in these processes that
are amenable to ozone injection include the synovial joints such as
the, temperomandibular joint, the hip joint, knee joint, ankle
joint, elbow joint or sacro-iliac joint. Vertebral facet and
sacro-iliac joints may also benefit, inflammatory involvement of
joints in the hand, wrist and feet with rheumatoid arthritis,
osteoarthritis or a repetitive injury through sports or
occupational such as carpal tunnel syndrome.
[0012] The inflammatory and arthritic or degenerative discussions
described above are usually treated with a combination of
anti-inflammatory agents such as ibuprofen, or more powerful drugs
such as steroids or chemotherapy such as methotrexate. It is a
common medical practice to inject steroid medications or lidocaine
directly into the inflamed tissue or joint. This is often done
repeatedly. These drugs can be associated with side effects of
infection and even death from gastric ulcer bleeding or
immunosurpression and infection. We believe that ozone therapy
whether as a liquid or a gas would have advantages over the current
practice.
[0013] Lavage of a surgical space prior to placement of a permanent
surgical implant such as a hip or knee prosthesis, or pacemaker or
treatment of an infected joint can be facilitated by the use of
medical ozone as a sterilizing substance. Similarly a colostomy
stoma can be created such that the adhesive disk is infused with an
ozone as a liquid or gas to aid in healing and inhibit infection.
The post surgical recovery from sternotomy after cardiac surgery is
often complicated wound infection. Placement of a resorbable
catheter in the wound that could be irrigated with ozone liquid or
gas would aid healing. Indeed any wound could have a resorbable
multisided hole catheter placed in it to allow ozone be injected
through it. This would have anti-infective, analgesic and promote
wound healing properties. This would shorten recovery time and
decrease complication rates after surgery.
[0014] Enhance liquid ozone could be applied to the wound/surgical
site healing at a site of high probability of infection such an
abdominal incision/wound after appendectomy, or urgent colectomy
with colostomy or after percutaneous endoscopic
cholecystectomy.
[0015] Endoscopic procedural infusion of ozone and trans catheter
infusion of ozone can be used to inhibit the complications
endoscopic medical intervention or image guided or non-image guided
catheter based intervention for example in endoscopic evaluation of
the pancreatic duct.
[0016] Dental injection of liquid or gas ozone may augment the
preparation and repair of dental cavities, and aid in reduction of
root canal inflammation or periodontal disease.
[0017] There are veterinary applications of minimally invasive
ozone administration in animals diseased with disc and degenerative
syndromes. Few other options are available in that arena. Some
animals are destroyed due to debilitating pain secondary to pain
from disc disease, and arthritis.
[0018] While the full therapeutic potential of ozone continues to
unfold with ongoing research, it is already clear that this form of
therapy for the treatment of disc herniation has significant
advantages over other surgical and percutaneous procedures. Some of
these advantages include: [0019] fewer clinical and
neuroradiological contraindications [0020] success rates greater
than about 70% in the intervertebral disc [0021] little or no
recovery time [0022] little or no side effects [0023] little or no
scar tissue formed [0024] minimally invasive procedure in [0025]
effective alternative treatment for which response to conservative
management, such as rest and reduced daily activity, has failed to
treat
[0026] As the success of ozone gas therapy continues to gain
recognition in the medical arena as a non-invasive alternative for
the treatment of disc herniation, current methods of administering
an effective dose of the ozone are solely as a gas and are far from
optimum. There also lacks a sterile methodology through which the
ozone can be delivered selectively to the pain-affected area, i.e.
the herniated disk. The gas is unstable with a half life measured
in seconds. There are no dedicated medical ozone generators that
are disposable single use units. In accordance with this, there is
a need for equipment especially designed for the treatment of disc
herniation and other medical conditions affecting the body with
medical ozone so that it can be done in an efficient and sterile
manner. There is a need to develop kits for intervention in
inflammatory and degenerative disease, that are disposable, or
reusable, but aid in creating sterile, stable, ozone rapidly on
demand. The generation of ozone from sterile water would allow
storage of injector/generators in all medical dental and veterinary
facilities.
SUMMARY OF THE INVENTION
[0027] It is therefore an object of the present invention to
provide a novel apparatus and method for administering a gas into a
tissue that obviates or mitigates at least one of the disadvantages
of the prior art.
[0028] In a first aspect of the invention there is provided a kit
for administering therapeutic gas mixture into soft tissue, wherein
said gas mixture includes ozone. The kit can comprise of the
following items: [0029] Disinfectant [0030] Drape [0031] Skin
preparation material [0032] Local anaesthetics contained in vials
[0033] Syringes [0034] Short and long needles, some with side holes
[0035] Gantry drape [0036] Radiolucent needle holder [0037]
Nonionic x-ray dye-for discogram [0038] Infusion wire [0039]
Charcoal ozone scavenger [0040] Steroids contained in vials [0041]
A source of ozone either generated as a gas or a liquid in a
disposable single use unit that is sterilizable. The ozone can be
generated in the delivery system as a battery powered electronic
hand held disposable device [0042] The ozone generator based in the
injector will be available in a variety of sizes, capable of
delivering a range of ozone volumes, from 1 cc to 5 cc, but could
be made to generate volumes of ozone liquid or gas form 0.1 cc to 1
litre. [0043] It is probable that the commonly used volumes would
be between 1 cc and 10 cc allowing for dead space in the connecting
tubing/needle etc. [0044] Disposable filtered attachment [0045]
Stop cocks [0046] Non-compliant tubing [0047] Post-operative
dressing for skin closure [0048] Adhesive bandages with gauze pad
in the centre
[0049] An example of a local anaesthetic is, but not limited to,
Lidocaine HCl
[0050] An example of a nonionic x-ray dye is, but not limited to,
Omnipaque 300 M.
[0051] An example of a post-operative dressing is, but not limited
to, Povidone gel.
[0052] Any suitable source of ozone can be used such as an ozone
generator, the AOS-1M Medical Ozonator or AOS-1MS Stainless Medical
Ozonator for example, or a disposable injector filled with
ozone.
[0053] In another aspect of the invention, there is a method for
the treatment of pain caused by a herniated disc and comprising of
first identifying the herniated disk using an imaging technique and
subsequently injecting a known volume of medical ozone into the
disc and paraspinous soft tissues in a sterile manner and
environment.
[0054] In another aspect of the invention, there is provided an
apparatus for administering a therapeutic agent comprising a
therapeutic agent generator and a scavenger connected to the
generator via a first valve for capturing the therapeutic agent.
The therapeutic agent administrator is connectable to the generator
via at least one additional valve such that when the valves are in
a first position the generator communicates with the administrator
for filling the administrator with the agent. When the valves are
in a second position the administrator retains the agent therein
upon disconnection from the generator, and the scavenger captures
any excess agent intermediate the administrator and the
generator.
[0055] The agent can be ozone in a gaseous mixture or dissolved in
a liquid. The generator can be a medical ozone generator. The
medical ozone can be a ratio of oxygen (O2) and ozone (O3).
[0056] The ratio of ozone in micro grams to oxygen in milliliters
can be about 1 .mu.g/ml, or about 10 .mu.g/ml, or about 20
.mu.g/ml, or about 30 .mu.g/ml, or about 40 .mu.g/ml, or about 50
.mu.g/ml.
[0057] The ratio of ozone in micro grams to oxygen in milliliters
can be between about 1 .mu.g/ml and about 90 .mu.g/ml. The ratio of
ozone to oxygen can be between about 10 .mu.g/ml and about 80
.mu.g/ml. The ratio of ozone to oxygen can be between about 20
.mu.g/ml and about 70 .mu.g/ml. The ratio of ozone to oxygen can be
between about 10 .mu.g/ml and about 34 .mu.g/ml. More preferably,
the ratio of ozone to oxygen can be between about 27 .mu.g/ml to
about 28 .mu.g/ml.
[0058] The administrator can be a syringe.
[0059] Another aspect of the invention provides a method of
treating the pain caused by a herniated disc comprising identifying
the herniated disk and injecting medical ozone into the disc and
paraspinous soft tissues.
[0060] Another aspect of the invention provides a syringe for
self-contained generation and administration of a therapeutic agent
comprising a barrel for holding the agent, and a plunger for
insertion into a first end of the barrel and expressing the agent
from a second end of the barrel. The syringe also includes a power
supply integrally mounted coaxially with the plunger. The syringe
also includes a therapeutic agent generator integrally mounted
coaxially with the plunger and in communication with the barrel
through a channel in the plunger. The generator is connected to the
power supply and mounted coaxially with the plunger. The syringe
also includes a switch connected to the power supply such that when
the switch is activated the therapeutic agent generator generates
the therapeutic agent and fills the barrel therewith.
[0061] In another aspect of the invention the ozone can be
generated either as a liquid or a gas, in a syringe type structure
where the electronics are housed in the area normally occupied by
the plunger of the syringe and the anode is in the syringe. The
syringes can be any desired volumes, such as those ranging from 1
cc to 60 cc, more preferably 1 cc to 10 ccs. The syringes are
typically made of polyethylene to resist the corrosive effect of
ozone even in the short time it in contact with the plastic.
[0062] Another aspect of the invention provides an implantable
apparatus for self-contained generation and administration of a
therapeutic agent comprising: a chamber for holding the agent and a
catheter for connecting the chamber to an area for administration
of the agent. The apparatus also includes a power supply and a
therapeutic agent generator in communication with the chamber, the
generator connected to the power supply. The apparatus also
includes a switch activatable externally by a patient implanted
with the apparatus. The switch is connected to the power supply
such that when the switch is activated the therapeutic agent
generator generates the therapeutic agent and fills chamber
therewith.
[0063] Another aspect of the invention provides a method of
treating pain caused by a herniated disc comprising of the
following steps: [0064] identifying the herniated disk with an
imaging device; [0065] preparation of the skin above the affected
area; [0066] applying local anaesthetics to the operation site;
[0067] inserting a needle down to the disc level at the herniated
disc; [0068] injecting nonionic x-ray dye down the needle; [0069]
performing a discogram of the disc; [0070] activating an ozone
generator external to the patient; [0071] selecting a specific
concentration of O3/O2 gas mixture on the ozone generator; [0072]
attaching a scavenger and a syringe to the ozone generator; [0073]
aspirating the O3/O2 gas mixture into the syringe; [0074] injecting
a predetermined volume of a fixed concentration of ozone/oxygen gas
mixture into the disc and paraspinous soft tissues of the disc;
[0075] capturing unused ozone in the charcoal scavenger; and,
[0076] removing all needles; and [0077] dressing the operative
site.
BRIEF DESCRIPTION OF THE DRAWINGS
[0078] Preferred embodiments of the invention will now be
discussed, by way of example only, with reference to the attached
Figures, in which:
[0079] FIG. 1 shows an apparatus for administering a gas into a
tissue in accordance with an embodiment of the invention;
[0080] FIG. 2 shows the hip area of a patient where a therapeutic
agent can be administered;
[0081] FIG. 3 shows the spinal disc area of a patient where a
therapeutic agent can be administered;
[0082] FIG. 4 shows a normal spinal disc;
[0083] FIG. 5 shows a herniated spinal disc where a therapeutic
agent can be administered;
[0084] FIG. 6 shows an apparatus for administering a gas into a
tissue in accordance with another embodiment of the invention;
[0085] FIG. 7 shows the administrator of FIG. 6 with the needle
placed thereon;
[0086] FIG. 8 shows an apparatus for administering a gas into a
tissue in accordance with another embodiment of the invention;
[0087] FIG. 9 shows an apparatus for administering a therapeutic
agent into a hip region in accordance with another embodiment of
the invention;
[0088] FIG. 10 shows the apparatus of FIG. 9 in greater detail;
[0089] FIG. 11 shows an infusion wire through which a therapeutic
agent can be administered;
[0090] FIG. 12 shows the infusion wire being passed through a
needle towards the centre of a herniated disc;
[0091] FIG. 13 shows the infusion wire being placed in centre of a
herniated disc with the needle having been removed;
[0092] FIG. 14 shows the infusion wire of FIG. 11 in greater
detail; and,
[0093] FIG. 15 shows an apparatus for administering a therapeutic
agent into a tissue in accordance with another embodiment of the
invention.
DETAILED DESCRIPTION OF THE INVENTION
[0094] Referring now to FIG. 1, an apparatus for administering a
therapeutic agent, such as an ozone gas, into a tissue in
accordance with an embodiment of the invention is indicated
generally at 20. In a present embodiment, apparatus 20 comprises an
ozone generator 24 that connects to a charcoal scavenger 28 and an
ozone administrator 32. Generator 24 can be based on any known
medical ozone generator. Generator 24 connects to scavenger 28 and
administrator 32 via a network of flexible tubing and valves for
selectively directing the flow of gas therebetween. More
specifically, a first segment of tubing 36 connects generator 24 to
a three-way valve 40. A second segment of tubing 44 connects valve
40 to scavenger 28. A third segment of tubing 48 connects valve 40
to another valve 52, which in turn connects to administrator 32.
The tubing is made of any suitable material, such as silicon of the
known medical type, and has a diameter and wall thickness to
withstand the pressure of ozone gas being carried therethrough. The
valves, also known as stopcocks, are also of the known medical type
and have fittings complementary to the various portions of
tubing.
[0095] Administrator 32 is comprised of a syringe 56, a three-way
valve 60, and a needle 64. Syringe 56 is typically made of
polyethylene to resist the corrosive effect of ozone, but other
materials will occur to those of skill in the art. Three-way valve
60 is releasably connectable directly to valve 52, providing a
selective pathway between syringe 56 and generator 24 and/or
scavenger 28.
[0096] Valve 40 has a first position wherein generator 24
communicates only with tubing 48. Valve 52 has a first position
wherein tubing 48 communicates with administrator 32. Valve 60 has
a first position wherein syringe 56 communicates only with tubing
48. Thus, when valves 40, 52 and 60 are all in the first position,
generator 24 is in communication with syringe 56, and thus when
generator 24 is "on", syringe 56 will be filled with ozone. (It is
to be noted that in of the Figures attached hereto, for this
embodiment subsequent embodiments, the various valves depicted
therein are not intended to be shown in any specific position, and
are merely illustrated to show their physical orientation in
relation to the rest of the components in the apparatus.)
[0097] Valve 40 has a second position wherein tubing 44
communicates with both tubing 36 and 48. Valve 52 has a second
position wherein tubing 48 is effectively capped, preventing
communication between administrator 32 and tubing 48. When valves
40 and 52 are in the second position, any ozone generated by
generator 24 is captured by scavenger 28. In a present embodiment,
scavenger 28 is of the charcoal type, but any type of scavenger for
capturing excess ozone can be used.
[0098] Once generator 24 is turned "off" after filling syringe 56
as described above, then when valves 40 and 52 are each moved from
their respective first position to their respective second position
then any excess ozone still present in tubing 48 and 36 will be
captured by scavenger 28 and thereby reduce and/or substantially
eliminate the unwanted escape of ozone into the atmosphere where it
may harm the operator or other individuals proximal to apparatus
20.
[0099] Valve 60 also has a second position wherein syringe 56 is
prevented from communicating with either valve 52 (or the open
fitting on valve 60 that connects to valve 52), or with needle 64.
Thus, once syringe 56 has been filled with ozone, leaving
administrator 32 `charged` with ozone, valve 60 will also be placed
in its second position to retain the ozone within syringe 56 once
administrator 32 is disconnected from valve 52.
[0100] Once administrator 32 is charged with ozone, it can be
disconnected from the remainder of apparatus 20 so that it can be
used to administer ozone to a target area. Thus, valve 60 also has
a third position that places syringe 56 in communication with
needle 64. Referring now to FIG. 2, when charged, valve 60 can be
placed in the second position to prevent ozone from escaping from
syringe 56. Administrator 32 can then be disconnected from the
remainder of apparatus 20 and then needle 64 can be inserted into
tissue (or other target area) where the ozone is to be
administered. In FIG. 2, needle 64 is shown inserted into a hip 68.
Having inserted needle 64 into hip 68, valve 60 is placed in the
third position, allowing syringe 56 to communicate with needle 64.
At this point syringe 56 is depressed, and the ozone gas therein is
expressed out of needle 64 into hip tissue, thereby providing
localized pain relief around hip 68. Such administration of ozone
can be helpful to relieve pain after some types of hip surgeries,
such as hip replacement, or after bone is harvested from the pelvis
to use as a bone graft material.
[0101] Other types of localized pain relief can also be provided.
While FIG. 2 depicts pain relief being provided to hip 68, FIG. 3
depicts the provision of pain relief to a spinal disc 72. By way of
background, as seen in FIG. 4 a normal disc is shown in cross
section at 72n. Disc 72n has an outer annulus fibrosus 76n, an
inner annulus fibrosus 80n, a transition zone 84n, and a nucleus
pulposus 88n. However, in FIG. 5, disk 72 is also shown in cross
section, wherein nucleus pulposus 88 is protruding, and thereby a
cause of pain. However, the administration of ozone into the
protruding nucleus pulposus 88 using administrator 32 via needle 64
pain can be relieved and/or substantially eliminated at least
temporarily.
[0102] It should now be apparent that having administered ozone
from administrator 32, administrator 32 can then be reconnected to
the remainder of apparatus 20, and the appropriate valves 40, 50
and 62 adjusted to either allow any remaining ozone to be expressed
from administrator 32 for capture by scavenger 28, or to refill
syringe 56.
[0103] Referring now to FIG. 6, an apparatus for administering a
gas into a tissue in accordance with another embodiment of the
invention is indicated generally at 20a. Apparatus 20a includes
many similar components to apparatus 20, and like components are
indicated with like references but followed by the suffix "a". In
contrast to apparatus 20, however, administrator 132a includes
certain differences from administrator 32. Specifically,
administrator 132a has a two way valve 160a, one end of which
connects to syringe 132a, the other end of which has a fitting to
allow administrator 132a to be connected to either valve 52a, as
shown in FIG. 6, or to needle 164a as shown in FIG. 7. When
administrator 132a is connected to valve 52a as shown in FIG. 6,
valves 52a and 160a can be placed in an open position so that
syringe 132a communicates with generator 24a. When generator 24a is
"on", syringe 132a will be filled with ozone. Once syringe 132a is
filled with ozone, valves 52a and 160a can be placed in the closed
position, and valve 40a can be turned so that once apparatus 160a
is disconnected from valve 52a, any ozone remaining in tubes 48a,
36a or elsewhere in that remaining portion of apparatus 24a can be
captured by scavenger 28a.
[0104] Having filled syringe 132a with ozone, and closed valve
160a, needle 164a can then be affixed thereto as shown in FIG. 7.
Valve 160a can then be selectively opened or closed to allow the
administration of ozone to tissue, in much the same manner as
previously described in relation to FIGS. 2 and 3.
[0105] Referring now to FIG. 8, an apparatus for administering a
therapeutic agent into tissue is indicated generally at 20b.
Apparatus 20b is a self-contained, portable version of apparatuses
20 and 20a. Specifically, apparatus 20b includes a needle 164b and
a two-way valve 160b that are substantially the same as needle 164a
and valve 160a as described above. Apparatus 20b also includes a
syringe 132b comprising a barrel 156b (or other chamber) and a
plunger 192b (or other means to express the contents of the
chamber). Plunger 192b is configured as a normal plunger on a
syringe, but also includes a miniature ozone generator 196b mounted
on the shaft of plunger 192b. In turn, ozone generator 196b is
connected to a power supply 200b and an on-off switch 204b that is
disposed on the exterior tip of the shaft of plunger 192b. A small
channel 208b joins generator 196b to the opposite tip of the shaft
of plunger 192b, such that when plunger 192b is disposed in barrel
156b, generator 196b is in communication with the interior of
barrel 156b. In this manner, switch 204b can be activated and
thereby cause ozone to be generated and fill barrel 156b. Of
particular note, in the present embodiment ozone can be generated
in either gaseous or liquid form.
[0106] While switch 204b is activated, it is generally desired to
have valve 160b placed in the closed position to prevent ozone from
flowing from barrel 156b into needle 164b. Once a sufficient or
otherwise desired amount of ozone has been generated and filled
barrel 156b, switch 204b is turned "off" to discontinue generation
of ozone, and then apparatus 20b is used in much the same manner as
administrator 32 as described above in relation to FIGS. 2 and 3.
The ozone generator 196b can be provided in a variety of sizes,
capable of delivering a range of ozone volumes, for example from
about one cc to about five cc, but could be made to generate
volumes of ozone liquid or gas form of about 0.1 cc to about one
litre.
[0107] Referring now to FIGS. 9 and 10, an apparatus for
administering a therapeutic agent into tissue is indicated
generally at 20c. Apparatus 20c is a self-contained, implantable
version of apparatuses 20, 20a and 20b. As shown in FIG. 9,
apparatus 20c is implanted subcutaneously proximal to hip 68. In a
present embodiment, apparatus 20c includes a separate, external
switchable power supply 212c that is disposed just above the skin
of the patient and is thereby activatable on demand by the patient.
Power supply 212c connects to a miniature ozone generator 196c
disposed percutaneously. In turn, generator 196c is connected to an
oxygen source 220c, such that when power supply 212c is "on",
generator 196c will interact with source 220c of either oxygen or
sterile water, to generate ozone in either in liquid or gaseous
form, inside a cavity 224c. In turn, cavity 224c is connected to a
catheter 228c, which interconnects with cavity 224c with the tissue
inside hip 68 to which the ozone is being administered to relieve
pain associated therewith.
[0108] As a variation of apparatus 20c, power supply 212c can be
disposed subcutaneously, and a wireless switching means can be
disposed on the outside of the patient, such as a magnetic switch
or other types of wireless means for activating or deactivating the
ozone generator. Advantageous to this technique is that the overall
use of needles is diminished, and thus beam hardening artifacts
that are generated by metallic objects that can prevent proper
visualization of the disc details (as might occur when doing
injections by means of image guidance, and as may be done in
certain other embodiments herein,) are reduced. In sum, by reducing
the use of needles, visualization is improved and allows the dorsal
root ganglion to be clearly seen.
[0109] Referring now to FIGS. 11-14, in another variation an
infusion wire 232d is passed through needle 168d until it coils
inside nucleus pulposus 88 (or other tissue area for treatment.)
Since infusion wire 232d is perforated along its length, as shown
in FIG. 14, once a desired or sufficient amount of wire 232d has
been inserted into nucleus pulposus 88, an ozone source can be
connected to the opposite end of the infusion wire 232d and
injected into nucleus pulposus 88 via the infusion wire. Due to the
perforations along infusion wire 232d, ozone is dispersed more
readily into nucleus pulposus 88.
[0110] Referring now to FIG. 15, in another variation of the
foregoing embodiments, it can be seen that various other
configurations of how administration of the ozone are within the
scope of the invention. Specifically, FIG. 15 shows a syringe 132e
connected to a valve 160e via tubing 232e.
[0111] In another embodiment of the invention, a kit of parts for
performing an injection of medical ozone for the treatment of a
herniated disc or the like. The kit includes a sterile tray with a
number of compartments to hold: [0112] a disinfectant, drape and
skin preparation material, [0113] lidocaine and a 10 cc syringe
with a 22-G long needle, [0114] nonionic x-ray dye-for discogram
such as Omnipaque 300 M, [0115] outer 16 or 18 G needle to act as
the co-axial introducing needle, [0116] 20 or 22 G needle with
possible side holes for injecting the ozone into the disc, [0117]
outer large needle of 16-18 G for steroid injection (can also be
used to inject ozone into the paraspinous soft tissue), [0118] an
infusion wire for even distribution of the ozone into the disc
space [0119] a charcoal ozone scavenger (a bottle with charcoal and
100% 0.sub.2), [0120] steroids and local anaesthetics contained in
a vial, ready for injection, [0121] a source of ozone such as a
generator, examples include the AOS-1M Medical Ozonator or AOS-1MS
Stainless Medical Ozonator, or a disposable injector in which then
ozone can be generated filled with ozone, [0122] a disposable
filtered attachment for the syringe a one way stop cock attached to
the ozone generator, [0123] connecting, non-compliant tubing of
20-30 cm in length to reduce radiation to the operator hands during
injection under image guidance. [0124] a three-way stop cock
linking the tubing to the charcoal ozone scavenger bottle [0125] a
one-way stop cock linking the tubing to the syringe via the said
disposable filtered adapter, [0126] pharmaceutical gel such as
Povidone, and [0127] adhesive bandages with a gauze pad in the
center, such as Band-aid, or small dressing.
[0128] In another embodiment of the invention, there is a method
consisting of first introducing the patient into the computer
tomography ("CT") scanner and performing a diagnostic CT scan in
order to identify the herniated disc such as disc 72. The CT gantry
is subsequently draped and readied, the skin is prepared and local
anaesthetic is applied to the skin and adjacent soft tissue. A
16-18 G needle is pinned down to the disc level and a 22 G needle
is inserted into the disc. A discogram is performed to check
symptoms by injection of x-ray dye. The ozone apparatus (in the
form of any of the previously described apparatus or such other
apparatus as may now occur to those of skill in the art) is
subsequently switched on and the ozone/oxygen concentration chosen.
The ratio of ozone/oxygen mixtures to choose from are in the about
0 .mu.g/ml, about 10 g/ml, about 20 .mu.g/ml, about 30 .mu.g/ml,
about 40 .mu.g/ml or about 50 .mu.g/ml. A presently preferred range
is between about 10 .mu.g/ml and about 34 .mu.g/ml, but more
preferably about 27 .mu.g/ml to about 28 .mu.g/ml. In other
embodiments other gases or therapeutic agents can be used, such as
pure oxygen if found to be therapeutically effective or
desirable.
[0129] As a next step, the syringe is fitted with a disposable
filtered attachment which is itself attached to 20-30 cm of
non-compliant tubing fitted with a 3-way to cock on one end and a
one-way stop cock on the other, such as that shown in FIG. 15.
Ozone gas is then aspirated into the 10-cc syringe (can also use a
calibrated cardiac syringe) via the disposable filtered adapter and
the connecting tubing such that the entire dead space is filled
with a known concentration of ozone. The total volume of deadspace
should be known so appropriate amounts of ozone are actually
injected to the desired area. CT fluoro imaging or the like can be
subsequently used to inject the ozone into the disc and paraspinous
soft tissues. An infusion wire with a stiff stylet could be used,
as previously described. Once the ozone injection is completed, a
stop cock on the connecting tubing is closed. All of the leftover
ozone is injected into the charcoal scavenger or a pure oxygen
tube/bottle attached to the connecting tubing via a Luer lock.
Steroids are then injected through the coaxial outer large needle.
Finally, all needles are removed, the skin is appropriately dressed
and a bandage is used to cover the perforated skin.
[0130] In another embodiment of the invention, there is provided
the combined intradiscal and periganglionic injection of medical
ozone and periganglionic injection of steroids which has a
cumulative effect and enhances the overall outcome of
treatment.
[0131] While only specific combinations of the various features and
components of the present invention have been discussed herein, it
will be apparent to those of skill in the art that desired subsets
of the disclosed features and components and/or alternative
combinations of these features and components can be utilized, as
desired. For example, other types of pain can be treated using the
teachings herein. For example, joints, tendons, ligaments are other
areas that can be treated. Joints that may be involved in these
processes that are amenable to ozone injection include the synovial
joints such as the, temperomandibular joint, the hip joint, knee
joint, ankle joint, elbow joint or sacro-iliac joint. Vertebral
facet and sacro-iliac joints may also benefit, inflammatory
involvement of joints in the hand, wrist and feet with rheumatoid
arthritis, osteoarthritis or a repetitive injury through sports or
occupational such as carpal tunnel syndrome.
[0132] Another example includes irrigating a wound site, such as a
colostomy, with ozone to reduce pain at the wound site. As another
example, an implantable device could put into the teeth (or other
dental area) of a patient, similar to apparatus 20c to reduce pain
in the dental region. As another example is to irrigate a
subcutaneous pouch for holding a pacemaker or the like for
sterilization and/or treatment of pain and/or decrease of
inflammation and such other advantage corresponding to the
therapeutic agent as will occur to those of skill in the art. The
term "pain site" as used herein includes various types of
articulations, including without limitation joints of all kinds,
wound sites, inflammation sites, dental sites, tendons, ligaments
are other areas that can be treated. "Pain site" also includes the
tissues or area adjacent to any of the foregoing pain sites. For
example, a herniated disc may be the source of pain, however some
discs are difficult to penetrate with the needle and thus the
therapeutic agent is delivered to the paraspinous soft tissue
adjacent the herniated disc. This surrounding tissue or area is
also considered to be the pain site.
[0133] The above-described embodiments of the invention are
intended to be examples of the present invention and alterations
and modifications may be effected thereto, by those of skill in the
art, without departing from the scope of the invention which is
defined solely by the claims appended hereto.
* * * * *
References