This invention relates to apparatus and methods for microbaric oxygen delivery. More particularly, this invention relates to apparatus and methods for microbaric oxygen delivery for treatment of acute and/or chronic neurological conditions.
Research has shown that hyperbaric oxygen therapy can benefit a number of neurologic conditions, including cerebral palsy, autism, traumatic brain injury, stroke, spinal cord injury, chronic fatigue syndrome, fibromyalgia, reflex sympathetic dystrophy, migraine and cluster headaches, multiple sclerosis, and certain types of dementia.
Conventional hyperbaric oxygen delivery systems, such as hyperbaric oxygen chambers, however, have several drawbacks. In particular, conventional hyperbaric oxygen delivery systems typically are quite large, bulky and expensive, and may subject the patient to risks associated with full-body exposure to increased ambient pressures. Thus, improved apparatus and methods for therapeutic administration of increased partial pressures of oxygen are desirable.
A first aspect of the invention provides a system for delivering oxygen from an oxygen supply to a user. The system includes: (a) a hood adapted to fit over the user's head. The hood includes an inlet port, an outlet port, and a seal mechanism adapted to engage at least one of the user's head, neck and torso to restrict a flow of oxygen from the hood; (b) a flow control mechanism for coupling between the oxygen supply and the inlet port, and for controlling a flow of oxygen to the hood; and (c) a pressure control mechanism coupled to the outlet port, wherein the pressure control mechanism is adapted to regulate a pressure of the oxygen in the hood to between about 0.5 inches of water (“inH2O”) (0.00127 atm) and about 4 inH2O (0.01016 atm).
In a second aspect of the invention, a method is provided for delivering oxygen from an oxygen supply to a user. The method includes: (a) providing a hood adapted to fit over the user's head, the hood comprising an inlet port, an outlet port, and a seal mechanism adapted to engage at least one of the user's head, neck and torso to restrict a flow of oxygen from the hood; (b) controlling a flow of oxygen to the inlet port of the hood; and (c) regulating a pressure of the oxygen in the hood from the outlet port to between about 0.5 inH2O (0.00127 atm) and about 4 inH2O (0.01016 atm).
In a third aspect of the invention, a system is provided for use with a counterlung for delivering oxygen from an oxygen supply to a user. The counter lung has a first inlet port, a second inlet port, and an outlet port. The system includes: (a) a hood adapted to fit over the user's head, the hood comprising an inlet port, an outlet port, and a seal mechanism adapted to engage at least one of the user's head, neck and torso to restrict a flow of oxygen from the hood; (b) a flow control mechanism adapted to couple between the oxygen supply and the first inlet port of the counter lung, and to control a flow of oxygen to the hood; (c) a first pressure control mechanism coupled to the outlet port of the hood, wherein the first pressure control mechanism is adapted to regulate a pressure of the oxygen in the hood to between about 0.5 inH2O (0.00127 atm) and about 4 inH2O (0.01016 atm); and (d) a carbon dioxide scrubber adapted to couple between the second inlet port of the counter lung and an outlet port of the first pressure control mechanism.
Other features and aspects of the invention will become more fully apparent from the following detailed description, the appended claims, and the accompanying drawings.
Features of the present invention can be more clearly understood from the following detailed description considered in conjunction with the following drawings, in which the same reference numerals denote the same elements throughout, and in which:
This invention provides apparatus and methods for microbaric oxygen delivery for treating neurological conditions. Example apparatus include a hood, a flow control mechanism, and a pressure control mechanism. The hood is adapted to fit over a user's head, and includes an inlet port, an outlet port, and a seal mechanism adapted to engage the user's head, neck and/or torso to restrict a flow of oxygen from the hood. The flow control mechanism is adapted to couple to an oxygen supply and the inlet port of the hood, and controls a flow of oxygen to the hood. The pressure control mechanism is coupled to the outlet port of the hood, and regulates a pressure of the oxygen in the hood to a pressure between about 0.5 inH2O (0.00127 atm) and about 4 inH2O (0.01016 atm). Example apparatus may be used to provide microbaric oxygen delivery to patients for treatment of neurological conditions.
Research has shown that therapeutic administration of increased partial pressures of oxygen can benefit a number of neurologic conditions, including cerebral palsy, autism, traumatic brain injury, stroke, spinal cord injury, chronic fatigue syndrome, fibromyalgia, reflex sympathetic dystrophy, migraine and cluster headaches, multiple sclerosis, and certain types of dementia.
In some cases, the oxygen levels used to produce such positive impact have been slightly higher than that provided by air at one atmosphere. This has been most evident in studies of the effects of hyperoxia on cerebral palsy and autism. This latter research has been conducted with increased ambient pressures, with a focus on administering oxygen doses that only may be achieved under hyperbaric conditions. See Daniel A. Rossignol et al. “Hyperbaric Treatment For Children With Autism: A Multicenter, Randomized, Double-Blind, Controlled Trial,” BMC Pediatrics 2009, 9:21 (Mar. 13, 2009) and Dr. Pierre Marois et al. “Hyperbaric Oxygen Therapy and Cerebral Palsy,” Developmental Medicine & Child Neurology, 45:646-648 (2003).
In the course of these studies, however, it has been discovered that administration to “control” subjects of lower oxygen levels (e.g., ones achievable with slightly higher than ambient pressure conditions), produces outcomes statistically indistinguishable from those achieved with the higher, experimental oxygen levels. Further, the outcomes from both test conditions have been significantly better than therapy programs without any hyperoxic treatment.
Because there is no effect of increased ambient pressure or other therapy aspect that could mimic the impact of hyperoxia in neurological cases such as cerebral palsy and autism, it is believed that treatment with pure oxygen at low hyperbaric pressure (referred to herein as “microbaric”) offers the potential for great benefit to such patients. As used herein, “microbaric” pressure means between about 0.5 inH2O (0.00127 atm) and about 4 inH2O (0.01016 atm).
Conventional hyperbaric oxygen therapies usually are administered using a hyperbaric chamber, which is a transparent, cylindrical chamber, approximately 8 feet long and 3 feet in diameter. The patient lays on a cot-like stretcher, and is then rolled into the chamber. During treatment, the patient is surrounded by and inhales pure oxygen, while pressure within the chamber is increased from 1½ to 2 times the outside pressure. At the end of treatment, the patient is gradually decompressed to normal pressure, and is then removed from the chamber.
Although conventional hyperbaric chambers may be used for microbaric oxygen therapies, such chambers have several disadvantages that limit their effectiveness for microbaric oxygen therapy. Conventional hyperbaric chambers are large, expensive, and are typically found only in hospitals and specialized medical offices. Thus, hyperbaric chambers may not easily or cost-effectively be used in other environments, such as at home, or outdoors (e.g., in battle, or at the scene of an accident). Further, the patient typically must incur the cost and inconvenience of travelling to the site of the hyperbaric chamber. Additionally, although conventional hyperbaric chambers are generally safe, full-body exposure to hyperbaric pressures may cause the patient to experience confinement anxiety, claustrophobia, hyperthermia, hypothermia, or other problems.
Apparatus and methods in accordance with this invention do not have these disadvantages. Referring now to
Hood 12 is adapted to fit over the head of a user 18, and includes a dome portion 20 having a bottom opening 22, a flexible baffle 24 having a seal mechanism 26, an inlet port 28 having a coupling mechanism 30, an outlet port 32 having a coupling mechanism 34.
Dome portion 20 may be a clear lightweight material that may be used to restrict flow of a fluid, such as oxygen. For example, dome portion 20 may be glass, plastic, vinyl, Plexiglas or other similar material. Bottom opening 22 may have a circular, elliptical, rectangular or other similar shape opening, and should be sized to fit over and/or around the head of user 18. Persons of ordinary skill in the art will understand that all or any of dome portion 20 need not be clear. For example, dome portion 20 may be metal or other similar material. Additionally, although depicted in
Flexible baffle 24 may have a torroidal or other similar shape, with a first end 36 attached to an interior sidewall of dome portion 20, and a second end 38 attached to seal mechanism 26. Flexible baffle 24 may be a lightweight flexible material that may be used to restrict flow of a fluid, such as oxygen. For example, flexible baffle 24 may be a plastic, vinyl or other similar material. Flexible baffle 24 may have a shape other than torroidal.
Seal mechanism 26 may be a ring-shaped or otherwise suitably shaped flexible material with memory having an expandable opening that may be stretched to fit over the head of user 18, but that contracts to engage the head, neck and/or torso of user 18 to restrict flow of fluid (e.g., e.g., oxygen or other similar fluid) from hood 12. For example, seal mechanism 26 may be a plastic, Teflon, rubber or other similar material.
Hood 12 is configured so that user 18 inserts her head through bottom opening 22 and through the expandable opening of seal mechanism 26, which contracts to engage the head, neck and/or torso of user 18 to form a substantially sealed inner chamber 40 about the head of user 18. Although not shown in
Inlet port 28 and outlet port 32 may be disposed on sidewall portions of dome portion 20, and may be hollow cylindrical openings for allowing a fluid (e.g., oxygen, patient exhalation, or other similar fluid) to flow in and out of chamber 40. Persons of ordinary skill in the art will understand that inlet port 28 and outlet port 32 may have shapes other than cylindrical.
Coupling mechanisms 30 and 34 may be used to attach hoses 42 and 44, respectively, to inlet port 28 and outlet port 32, respectively. Coupling mechanisms 30 and 34 may include quick-connect or other similar mechanisms that permit easy connection to and disconnection from hoses 42 and 44, respectively.
Although not shown in
Control system 14 includes a first inlet port 46, a first outlet port 48, a second inlet port 50 and a second outlet port 52. First inlet port 46 may be coupled via a hose 54 to oxygen supply 16, first outlet port 48 may be coupled via hose 42 and coupling mechanism 30 to inlet port 28, second inlet port 50 may be coupled via hose 44 and coupling mechanism 34 to outlet port 32, and second outlet port 52 may be coupled via hose 56 to atmosphere. As described in more detail below, control system 14 controls a flow of oxygen from oxygen supply 16 to hood 12, and regulates a pressure of oxygen in hood 12 to between about 0.5 inH2O (0.00127 atm) and about 4 inH2O (0.01016 atm).
Referring now to
Switch 60 may be a pneumatic or other similar switch that may be used to turn ON or OFF the flow of oxygen from oxygen supply 16 (
Filter 62 may be used to filter any particulate or other unwanted matter in the flow of oxygen from oxygen supply 16. For example, filter 62 may be a model PN154 filter manufactured by Sea-Long Medical Systems, Inc., Louisville, Ky., although other filters may be used. Persons of ordinary skill in the art will understand that filter 62 optionally may be omitted.
Flow control mechanism 64 may be used to control a flow of oxygen from oxygen supply 16 to hood 12. For example, flow control mechanism 64 may be a model MMA-25 flow control mechanism manufactured by Dwyer Instruments, Inc., Michigan City, Ind., although other flow control mechanisms may be used.
Pressure control mechanism 66 may be used to regulate a pressure of oxygen in hood 12 to provide microbaric oxygen delivery to user 18. In particular, pressure control mechanism 66 may include a control mechanism (not shown in
Pressure control mechanism 66 may be a back pressure valve, a relief valve, backpressure regulator, or other similar device to regulate upstream (back) pressure. For example, pressure control mechanism 66 may be a model 9005B ACCU-PEEP™ back pressure valve manufactured by Vital Signs, Inc, Totowa, N.J., although other pressure control mechanisms may be used.
Referring now to
The return fluid flow from hood 12 includes a mixture of oxygen and carbon monoxide. Thus, some portion of the return fluid that is exhausted by pressure control mechanism 66 to atmosphere includes oxygen. In this regard, example control system 14a may be described as an “open” system. To avoid such waste, an alternative example “closed” control system 14 may be used to re-circulate the exhausted oxygen back into control system 14 for delivery to hood 12.
Referring now to
CO2 scrubber 72 may be used to receive at its inlet a mixture of oxygen and carbon dioxide, and substantially removes carbon dioxide from the mixture, to provide oxygen at its outlet port. For example, CO2 scrubber 72 may be a fabricated using Drägersorb 800+ soda lime canisters manufactured by Draeger Medical Inc., Telford, Pa., although other soda lime canisters may be used.
Pressure control mechanism 74 may be used to regulate a pressure of the closed system. In particular, pressure control mechanism 74 may include a control mechanism (not shown in
Control system 14b is adapted to be coupled via a counterlung 76 to hood 12. Counterlung 76 includes a first inlet port 78 and a second inlet port 80 coupled to first outlet port 48 and third outlet port 70, respectively, of control system 14b, and an outlet port 82 coupled via hose 42 and coupling mechanism 30 to inlet port 28 of hood 12. Counterlung 76 receives oxygen flow at its two inlet ports, and provides a single output oxygen flow at outlet port 82. Counterlung 76 may be a model 5063NL counterlung manufactured by Vital Signs, Inc, Totowa, N.J., although other counterlungs may be used.
Referring now to
The exhaled fluid and residual oxygen returns via tube 44 and second inlet port 50 to pressure control mechanism 66, which regulates pressure inside chamber 40 to a desired microbaric pressure level. Any excess flow of return fluid is exhausted to CO2 scrubber 72 and pressure control mechanism 74. CO2 scrubber 76 substantially removes carbon dioxide from the return fluid, and provides oxygen to second inlet port 80 of counterlung 76. Thus, rather than being exhausted to atmosphere, oxygen in the return fluid is re-circulated to hood 12. Any excess flow of return fluid is exhausted to atmosphere by pressure control mechanism 74 via second outlet port 52 and tube 56.
Referring now to
Switch 90 may be any conventional switch that may be coupled to switch 60 (
Referring again to
For example, for microbaric oxygen treatment of autism, one or more tests may be used to determine a patient's motivation, speech, cognitive functiom, gross motor function, fine motor function, or other similar abilities, and/or spasticity or other similar conditions prior to commencing microbaric oxygen treatment. In this manner, baseline measurements and assessments of the patient's degree of neurologic impairment may be determined. After this baseline evaluation, microbaric oxygen delivery system 10 may be used to provide microbaric oxygen treatments to the patient for a particular duration, at a specified frequency, for a particular time period.
For example, the patient may be administered microbaric oxygen treatments lasting an hour per day, every day for 40 consecutive treatments. At that point, the same cognitive function, motor function, or other tests used to establish baseline measurements may be re-administered to assess the efficacy of the treatment. Based on the results, microbaric oxygen treatments may resume, or some treatment parameter (e.g., duration, frequency, or other parameter) may be modified. This treatment/assessment process may be repeated iteratively to fine-tune treatment parameters based on the patient's response to treatment.
Although an example has been described for microbaric oxygen treatment of autism, persons of ordinary skill in the art will understand that similar treatment protocols may be used to provide microbaric oxygen treatment of other neurological conditions, such as cerebral palsy, traumatic brain injury, stroke, spinal cord injury, chronic fatigue syndrome, fibromyalgia, reflex sympathetic dystrophy, migraine and cluster headaches, multiple sclerosis, certain types of dementia, and other neurologic conditions.
The foregoing merely illustrates the principles of this invention, and various modifications can be made by persons of ordinary skill in the art without departing from the scope and spirit of this invention.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/320,570, filed 2 Apr. 2010, which is incorporated by reference herein in its entirety for all purposes.
Number | Date | Country | |
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61320570 | Apr 2010 | US |