Patent Issued for Hyperbaric oxygen chamber manufactured utilizing additive manufacturing (USPTO 11648164): Thaw Stanley

2023 JUN 06 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- According to news reporting originating from Alexandria, Virginia, by NewsRx journalists, a patent by the inventors Thaw, Stanley (Fort Lauderdale, FL, US), filed on July 6, 2021, was published online on May 16, 2023.

The assignee for this patent, patent number 11648164, is Thaw Stanley (Fort Lauderdale, Florida, United States).

Reporters obtained the following quote from the background information supplied by the inventors: “This invention relates to chambers for hyperbaric oxygen therapy. Hyperbaric oxygenation is a mode of medical treatment in which the patient is entirely enclosed in a pressure chamber breathing 100% oxygen at a pressure greater than one atmosphere.

“Hyperbaric oxygen chambers are generally elongated horizontal cylinders pressurized with 100% oxygen in which a patient must lie down in a prone position, often experiencing the discomfort of claustrophobia and becoming non-compliant whereby not completing the regime of prescribed treatments of their physician which would be needed to achieve the medical benefits of their therapy. Hyperbaric oxygen chambers are required to be cleared by the FDA as Class II medical device based on the standards of a 510K review.

“Currently the following list of medical conditions have been approved by the FDA for treatment utilizing hyperbaric oxygen treatments that use between 1 to 6 ATA/s of pressure. Air or Gas Embolism, Acute Traumatic Ischemia, Acute Anemia, Exceptional Blood Loss (Anemia), Intracranial Abscess, Crush Injury, Compartment Syndrome, and other Acute Traumatic Ischemia’s, Carbon Monoxide Poisoning, Compromised Skin Grafts or Flaps, Cyanide Poisoning, Decompression Sickness, Gas Gangrene, Necrotizing Soft Tissue Infections, Radiation Effects, Osteomyelitis (Refractory), Non-Healing Wounds, Diabetic Foot Ulcers and Thermal or Extensive Burns, Delayed Radiation Injury (Soft Tissue and Bony Necrosis). These treatments generally last for a period of one hour, not requiring an air-break.

“All treatments are performed at a predetermined schedule by a trained and certified Hyperbaric technician who monitors the patient at all times. The hyperbaric technician may not leave the chamber or the patient unattended at any time during the course of the hyperbaric treatment period, usually, one hour in duration.

“The typical hyperbaric oxygen chamber used in hyperbaric oxygen therapy is a hard-shelled pressure vessel having an entry hatch for patients along with small viewing ports to allow technicians or medical staff outside the chamber to monitor the patient inside the chamber, and a control panel outside the chamber that functions to control the flow of oxygen and pressure within the chamber. Hyperbaric oxygen chambers are required to always have a communication system between the patient and the certified technician to that they communicate if necessary.

“In the larger multi-place chambers, patients inside the chamber breathe from either “oxygen hoods”-flexible, transparent soft plastic hoods with a seal around the neck like a space suit helmet-or tightly fitting oxygen masks, which supply pure oxygen and may be designed to directly exhaust the exhaled gas from the chamber. During treatment patients breathe 100% oxygen most of the time to maximize the effectiveness of their treatment, but have periodic breaks during which the patient may breathe chamber air (21% oxygen) to reduce the risk of oxygen toxicity. The exhaled treatment gas must be removed from the chamber to prevent the build-up of oxygen, which could present a fire risk. Attendants may also breathe oxygen some of the time to reduce their risk of decompression sickness when they leave the chamber. The pressure inside the chamber is increased by opening valves allowing high-pressure air to enter from storage cylinders, which are filled by an air compressor. Chamber air-oxygen content is kept between 19% and 23% to control fire risk (US Navy maximum 25%).

“Other hyperbaric oxygen chambers called multi-place hyperbaric oxygen chambers can be run at absolute pressures typically about 6 bars (87 psi), 600,000 Pa or more in special cases. They range in size from semi-portable, one-patient units to room-sized units that can treat eight or more patients. The larger units may be rated for lower pressures if they are not primarily intended for treatment of diving injuries.

“A rigid chamber may consist of a pressure vessel with the view ports (windows) made of acrylic and have one or more human entry hatches -small and circular or wheel-in type hatches for patients on gurneys; the entry lock that allows human entry -a separate chamber with two hatches, one to the outside and one to the main chamber, which can be independently pressurized to allow patients to enter or exit the main chamber while it is still pressurized. A low volume medical or service airlock for medicines, instruments, and food; transparent ports or closed-circuit television that allows technicians and medical staff outside the chamber to monitor the patient inside the Chamber; an intercom system allowing two-way communication.

“A control panel outside the chamber to open and close valves that control air flow to and from the chamber and regulate oxygen to hoods or masks. The prior art hyperbaric oxygen chambers have an over-pressure relief valve; a built-in breathing system (BIBS) to supply and exhaust treatment gas and a fire suppression system.

“Flexible chambers are available ranging from collapsible flexible aramid reinforced chambers which can be disassembled for transport via truck or SUV, with a maximum working pressure of 2 bar above ambient complete with BIBS allowing full oxygen treatment schedules to portable, air inflated “soft” chambers that can operate at between 1.3 and 0.5 bars (4.4 and 7.3 psi) above atmospheric pressure with no supplemental oxygen, and longitudinal zipper closure. These flexible chambers are not cleared by the FDA to provide any medical benefit nor can any of the patient treatments utilizing these flexible chambers be paid for by any medical insurance provider nor Medicare or Medicaid and they are not considered a medical device.

“Smaller “Mono-plane” chambers can only accommodate the patient, and no medical staff can enter. The chamber may be pressurized with pure oxygen or compressed air. If pure oxygen is used, no oxygen breathing mask or helmet is needed, but the cost of using pure oxygen is much higher than that of using compressed air. If compressed air is used, then for alert, cooperative patients, air brakes provided by mask are more effective than changing the chamber gas because they provide a quicker gas change and a more reliable gas composition both during the break and treatment periods.

“The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments.”

In addition to obtaining background information on this patent, NewsRx editors also obtained the inventors’ summary information for this patent: “The present invention relates to a hyperbaric oxygen chamber therapy device.

“As shown in FIG. 1, this Hyperbaric Oxygen chamber 1050 is manufactured utilizing additive manufacturing technology, constructed of any form of matter that meets or exceeds the following regulations: NFPA-99, (FIRE CODE), PVHO-1, (HUMAN OCCUPANCY CODE), ASME (BOILER CODE FOR PRESSURE VESSELS).

“Utilization of this new, Additive Manufacturing technology surpasses all previously constructed hyperbaric oxygen chambers 1010 (FIGS. 1-3) because it is constructed with materials such as carbon fiber and Kevlar and other materials that are stronger than steel, less than the comparable weight of steel and can be constructed more rapidly in order to advance this therapy to be used in the offices of physicians who specialize in the treatment of the currently FDA approved conditions or that will become approved medical conditions. This factor will significantly reduce the patient cost compared to the current charges from hospitals in the United States.

“Referring to FIGS. 1-3, a hyperbaric oxygen chamber 1010 may be shown. The hyperbaric oxygen chamber 1010 is designed with a retractable overhead access door 1060. This retractable overhead access door 1060 is operated pneumatically from the remote-control panel and includes remote telemetry sensors 1020 (see FIG. 1), that indicate the safe and secure closure with a door locked light 14 indicator which is located on the remote-control panel, which is constantly being monitored by a hyperbaric trained and certified technician. This unique overhead chamber access door 1060 is the largest patient access door than any other hyperbaric oxygen chamber. This design is for the safety of the patient while both entering and exiting the hyperbaric oxygen chamber. This hyperbaric oxygen chamber 1010 includes the largest view port 1001 made of acrylic or other approved clear material.

“This hyperbaric oxygen chamber 1010 utilizes a control panel with the functions as listed in FIG. 4, items 1 thru 23. The technician utilizes a patient verification biometric access system. This technology includes, iris scan, palm scan as well as vein scan processes. This system validates approved, trained, and certified personnel to operate the hyperbaric oxygen chamber 1010 as well as verification for the correct patient to be treated. These scans are shown on the display of the control panel, which is located on a desk in the same room.”

The claims supplied by the inventors are:

“1. A hyperbaric oxygen chamber therapy medical device, comprising: a. a sealable chamber sized and shaped to accommodate a seated whole body of a subject, wherein the subject is seated in an upright position in a perpendicular manner within the sealable chamber; b. a monitoring unit control panel which displays an oxygen supply regulator, a plurality of pressure gauges, an oxygen flow meter, an emergency shut-off switch, and a use counter, wherein the monitoring unit control panel includes a communication device used between a hyperbaric technician operating the device and the subject seated within the sealable chamber; and c. a nitrogen scrubber connected to a discharge duct of the hyperbaric oxygen chamber therapy medical device, wherein the nitrogen scrubber is designed to convert oxygen gas received from the discharge duct into nitrogen gas.

“2. The device as claimed in claim 1, wherein the sealable chamber is sealed by an overhead door.

“3. The device as claimed in claim 2, wherein the overhead door is made of material comprising of plastic components and metal components or other components that are formed by utilizing additive manufacturing technology.

“4. The device as claimed in claim 1, wherein the sealable chamber is wide enough to hold one adult or an adult with a pediatric patient.

“5. The device as claimed in claim 2, wherein the overhead enclosure is held closed by a pressure exerted within the sealable chamber.

“6. The device as claimed in claim 1, further comprising at least one pressure sensor within the sealable chamber, that at least one pressure sensor communicating with the control panel to allow the monitoring unit to determine one or more pressure conditions within the sealable chamber.

“7. The device as claimed in claim 1, wherein the sealable chamber is manufactured using additive manufacturing processes.

“8. The device as claimed in claim 1, wherein the sealable chamber is made of carbon fibers, kevlar, or other like materials utilizing additive manufacturing and that meet the criteria of the FDA standards for a hyperbaric oxygen chamber.

“9. The device as claimed in claim 1, wherein the nitrogen scrubber comprises a hollow fiber member to convert the flow of oxygen gas into nitrogen gas.

“10. The device as claimed in claim 1, wherein the nitrogen scrubber expels the nitrogen gas into ambient air.

“11. The device as claimed in claim 1, wherein the device of a rigid construction.

“12. The device as claimed in claim 1, wherein the device is adapted to deliver one hundred percent gaseous oxygen.

“13. The device as claimed in claim 1, comprising an independent pressure time recorder and a pressure control circuit coupled to the monitoring unit control panel.

“14. The device as claimed in claim 1, wherein the nitrogen scrubber is adapted to control gaseous emissions out of the device.

“15. The device as claimed in claim 1, comprising at least one or more controls to have the device function with a medical standard monitoring system to monitor/supervise the functioning of the device.

“16. A hyperbaric oxygen chamber therapy device, comprising: a. a sealable chamber sized and shaped to accommodate a seated whole body of a patient and or an adult accompanying a pediatric patient, wherein the subject is seated in an upright position in a perpendicular manner within the sealable chamber; b. a monitoring unit comprising an oxygen supply regulator, a plurality of pressure gauges, an oxygen flow meter, an emergency shut-off switch and a use counter; c. a nitrogen scrubber connected to a discharge duct of the hyperbaric oxygen chamber therapy device, wherein the nitrogen scrubber is adapted to convert oxygen gas received from the discharge duct into nitrogen gas; and d. wherein the hyperbaric oxygen chamber therapy device is manufactured using additive manufacturing technology.

“17. A hyperbaric oxygen chamber therapy device, comprising: a. a sealable chamber sized and shaped to accommodate a seated whole body of a subject, wherein the subject is seated in an upright position in a perpendicular manner within the sealable chamber; b. a monitoring unit comprising an oxygen supply regulator, a plurality of pressure gauges, an oxygen flow meter, an emergency shut-off switch, and a use counter; c. a nitrogen scrubber connected to a discharge duct of the hyperbaric oxygen chamber therapy device, wherein the nitrogen scrubber will convert oxygen gas received from the discharge duct into nitrogen gas; d. wherein the hyperbaric oxygen chamber therapy device is manufactured using additive materials using additive manufacturing; e. wherein the hyperbaric oxygen chamber therapy device utilizes an independent pressure time recorder and a pressure control circuit.

“18. The device as claimed in claim 1, wherein the hyperbaric technician and the subject are verified via a patient verification biometric access system.”

For more information, see this patent: Thaw, Stanley. Hyperbaric oxygen chamber manufactured utilizing additive manufacturing. U.S. Patent Number 11648164, filed July 6, 2021, and published online on May 16, 2023. Patent URL (for desktop use only): https://ppubs.uspto.gov/pubwebapp/external.html?q=(11648164)&db=USPAT&type=ids

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