The present application generally relates to a hyperbaric oxygen chamber, and more specifically, to a hyperbaric oxygen chamber manufactured utilizing additive manufacturing to provide advantages over other hyperbaric oxygen chambers.
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 Isehernia'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 BIB S 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 “monoplace” 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.
Currently, monoplace hyperbaric oxygen chambers can be located in rooms that are no less than 10 feet wide by 22 feet long, as described in Chapter III, Section B.4 of “MONOPLACE HYPERBARIC CHAMBER SAFETY GUIDELINES”, the entirety of which is incorporated by reference herein. A two-place hyperbaric oxygen chambers must be at least twice as wide.
A standard physician's office (interchangeably referred to herein as a “normal-sized physician's office” or a “generic physician's office”) may be less than 10 feet by 10 feet or 10 feet by 12 feet. The dimensions may vary slightly without affecting the function(s) of the room. Each standard physician's office may be designed to have enough space to comfortably accommodate a physician, a nurse or an assistant, a patient, and at least one family member. The standard physician's office may be wheelchair accessible to accommodate patients with disabilities, such as enough room for a 60-inch diameter wheelchair to turn, under the Americans with Disabilities Act (ADA) guidelines as described in “Efficient Office Design for a Successful Practice,” the contents of which are hereby incorporated by reference in their entireties.
In some aspects, the standard physician's office may conform to local and/or national codes. For example, the standard physician's office may be fire-resistant. The office may include firefighting equipment, such as fire extinguishers and/or sprinklers. The standard physician's office may include sufficient space for performing emergency procedures (e.g., seizure, cardiac arrest, etc.). Aspects of the present disclosure includes a hyperbaric oxygen chamber configured to fit into a standard physician's office while conforming to ADA guidelines and/or fire regulations.
Standard physician's offices may include exam rooms or procedure rooms. For exam rooms, the minimum clear floor area and room dimensions vary depending on whether it is a hospital-based exam (120 square feet, 10 feet wide), outpatient-based exam (80 square feet) or outpatient-based specialty exam (100 square feet) room. With respect to procedure rooms, minimum clear floor area and room requirements are the same whether the procedure room is hospital-based or outpatient-based. These rooms can be planned for procedures that do not require inhalation anesthetic (130 square feet, 10 feet wide) or for procedures that do (160 square feet, which includes the anesthesia work zone; 10 feet wide) as described in “Design distinctions for exam, procedure and operating rooms,” the contents of which are hereby incorporated by reference in their entireties.
It is currently not possible to place and/or operate a monoplace or multi-place hyperbaric oxygen chamber in a standard physician's office.
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.
The present invention relates to a hyperbaric oxygen chamber therapy device.
As shown in
Utilization of this new, Additive Manufacturing technology surpasses all previously constructed hyperbaric oxygen chambers 1010 (
Existing hyperbaric oxygen chamber, even ones for single person use, may be too big for a traditional physician's office, which is typically 10 feet by 10 feet, or 10 feet by 12 feet. This means that, a patient must visit a medical facility (that may not be in the same vicinity as the physician's office) when receiving hyperbaric oxygen treatments. As such, a patient who arrives at the physician's office for consultation must travel to a different location to receive the hyperbaric oxygen treatments prescribed by the physician. Further, many remote locations (e.g., physician's offices in rural areas) may not have a medical facility that can support a traditional hyperbaric oxygen chamber. As a result, patients in the remote locations may be required to travel a long distance to receive hyperbaric oxygen treatments.
In some aspects of the present disclosure, a hyperbaric oxygen chamber may be constructed using additive manufacturing technology. The hyperbaric oxygen chamber may be sufficiently small to fit into an office of a physician or a standard examination room, for example. In some instances, the medical device (e.g., hyperbaric oxygen chamber) may be designed to fit into a standard physical treatment room. Currently, standard physician's offices and/or examination rooms have dimensions that are approximately 10 feet by 10 feet, or 10 feet by 12 feet. The hyperbaric oxygen chamber constructed according to aspects of the present disclosure may be smaller in dimension. In one aspect, the hyperbaric oxygen chamber may be 8 feet by 6 feet. Other sizes are also possible.
In one aspect of the present disclosure, the hyperbaric oxygen chamber may be configured to fit inside a regularly-sized physician's office while conforming to the Americans with Disability Act standards and Fire regulations that require 3 feet of walk space at the lower section of the hyperbaric oxygen chamber and 3 feet of space at the upper section of the hyperbaric oxygen chamber. As such, an implementation of the hyperbaric oxygen chamber may be smaller than 7 feet by 7 feet, for example 6 feet by 4 feet or smaller. Such hyperbaric oxygen chamber may be configured to be transported by an elevator (e.g., a passenger elevator) without the need of a freight elevator.
Example materials for constructing the hyperbaric oxygen chamber via additive manufacturing may include Kevlar, carbon fiber, stainless steel, or other suitable materials. Various synthetic materials (e.g., plastics) and/or metals may also be used. In some aspects of the present disclosure, a portion of the hyperbaric oxygen chamber may be constructed using additive manufacturing while other portions may be constructed using various methods (e.g., mold cast). In other aspects of the present disclosure, the entire hyperbaric oxygen chamber may be constructed using additive manufacturing.
In an aspect, the hyperbaric oxygen chamber in the current application may be referred to as a clinical hyperbaric oxygen chamber configured to maintain an internal pressure of greater than 1 atmosphere and less than or equal to 6 atmospheres. A patient sitting in the clinical hyperbaric oxygen chamber may be seated upright or in a Fowler's lying position. Example materials for the chamber may include metal, glass, acrylic, plastic, etc. The chamber may optionally include heat exchangers to maintain the temperature of the gases entering the chamber for patient comfort and/or avoid hypothermia or hyperthermia. The chamber may optionally include devices for humidification.
The clinical hyperbaric oxygen chamber may include invasive and/or non-invasive monitoring devices, such as devices for monitoring blood pressure, electrocardiography, blood flow, body temperature, tidal volume, gas contents, etc.
Referring to
This hyperbaric oxygen chamber 1010 utilizes a control panel with the functions as listed in
There are no other multiple biometric scan access systems designed into or coordinating with hyperbaric oxygen chambers at this time. We are solving the previous limitations that exist with unapproved personnel operating a hyperbaric oxygen chamber as well as in cases where the incorrect patient may have been treated with an incorrect protocol. The security of having only the assigned and approved/certified hyperbaric personnel being able to start and operate the medical device as well as having the certainty of the correct patient being treated, adds to the safety and validity of the therapy sessions.
This hyperbaric oxygen chamber 1010 has a seat 1040 designed as shown in
Other hyperbaric oxygen chambers are horizontal where patients are lying down on a gurney and are very restrictive, frequently causing emotional distress and claustrophobia. Patients then become non-compliant to their physician's original orders for the number of prescribed treatments, and become non-compliant and elect to avoid the medical plan of care and not complete their therapy.
Referring to
This hyperbaric oxygen chamber as shown in
Language used in this specification should not be interpreted as a general disavowal of any one specific embodiment or used to limit the claims beyond the meaning of the terms used therein. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications, and equivalents consistent with the principles and features disclosed. For purposes of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention.
In the description and claims of the application, each of the words “comprise,” “include” and “have” are forms thereof, are not necessarily limited to members in a list with which the words may be associated.
It should be noted herein that any feature or component described in association with a specific embodiment may be used and implemented with any other embodiment unless clearly indicated otherwise.
In this disclosure, “compromises,” “compromising,” “containing” and “having” and the like can have the meaning as basic or novel characteristics of that which is recited is not changed by the presence of more than that which is recited but excludes prior art embodiments.
In a particular embodiment of the invention, a hyperbaric oxygen chamber is adapted to function as a medical apparatus to treat a patient from various wounds or to heal various other maladies approved by the FDA. This hyperbaric oxygen chamber includes a unique sealable chamber similar in design to an overhead cabin door 1060 as shown in
The separate chamber control panel, which is located in the same room as the hyperbaric oxygen chamber 1010, is monitored by the medical personnel. When the hyperbaric oxygen chamber is being utilized, the items as depicted in
The Nitrogen scrubber 1030 is attached to the discharge duct 1035 of the hyperbaric oxygen chamber therapy device as shown in
The present invention is directed towards multiple embodiments. The following disclosure is provided to enable a person having the required hyperbaric training and certification to administer the oxygen treatments to a patient. Language used in this specification should not be interpreted as a general disavowal of any one specific embodiment or used to limit the claims beyond the meaning of the terms used therein. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications, and equivalents consistent with the principles and features disclosed. For purposes of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention.
In the description and claims of the application, each of the words “comprise” “include” and “have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated.
It should be noted herein that any feature or component described in association with a specific embodiment may be used and implemented with any other embodiment unless clearly indicated otherwise.
In this disclosure, “comprises,” “comprising,” “containing” and “having” and the like can have the meaning as basic or novel characteristics of that which is recited is not changed by the presence of more than that which is recited but excludes prior art embodiments.
In a particular embodiment of the invention, a hyperbaric oxygen chamber 1010 is adapted to function as a medical apparatus in order to treat a subject suffering from any approved condition indicated by the FDA, governing body.
The hyperbaric oxygen chamber 1010 is designed and erected in such a way that only one subject can be allowed to sit in an upright seated position, unless in the situation where a parent is seated with a child for emotional security and safety during the hyperbaric treatment. This positioning allows the subject to inhale maximum usage of oxygen in a predefined amount of time. The ergonomics of the hyperbaric oxygen chamber 1010 allows for the comfortable seating for patients so that they do not experience any sort of discomfort during the treatment.
Additionally, it is pertinent to note that the Hyperbaric oxygen chamber is designed to function with patients of varying height and weight, wherein the height could range up to seven feet and weight of around one hundred and eighty kilograms. Pediatric patients can be accompanied by an adult while being seated in the pull-out apparatus of the patient chair. The seated cushion is made of medical grade rubber or foam.
In an embodiment only one hundred percent of oxygen in pure gaseous form is used. The pure gaseous form of oxygen is used to pressurize a vessel in the hyperbaric oxygen chamber.
It is pertinent to note that in the hyperbaric oxygen chamber, the oxygen is not in liquid form.
In another embodiment, the hyperbaric oxygen chamber is constructed using additive manufacturing products and methods. One of the additive manufacturing methods used could be 3D/4D printing technology.
Additive manufacturing primarily known as 3D printing is used in industrial production to enable the creation of lighter, stronger parts and systems.
Herein, additive manufacturing uses data computer-aided design (CAD) software 3D/4D or other forms of additive manufacturing formats. This technology utilizes scanners to direct hardware to deposit material, layer upon layer, in precise geometric shapes. Typically, additive manufacturing adds material to create an object.
In an embodiment, the Hyperbaric oxygen chamber is made up of either plastic components or metal components or a combination of both based specifically on the additive manufacturing technology. These plastic components and metal components or other materials used in additive manufacturing are designed to be utilized in a specific format designed for additive manufacturing that conform to the safety and functionality standards for the pressure vessel medical industry.
It is pertinent to note that in reference to the embodiment, that only certain intravenous lines and ventilation ducts can be used to penetrate through a hull of the pressure vessel, since the hyperbaric oxygen chamber is fully designed to provide oxygen therapy to utilize a specific pressure profile for the patient.
The hyperbaric oxygen chamber includes basic controls to monitor and supervise the functioning of the hyperbaric oxygen chamber.
The hyperbaric oxygen chamber comprises a series of manual gas valves that allow a trained operator to control input pressure ventilation and exhaust.
Further, the hyperbaric oxygen chamber requires one hundred percent oxygen in order to maintain a desired pressure while simultaneously adapted to provide adequate ventilation and control the mixture of carbon dioxide, water vapor and patient cooling gases.
In a preferred embodiment, the hyperbaric oxygen chamber provides two hundred-five hundred liters of one hundred percentage oxygen per minute to the pressure vessel.
In another preferred embodiment, a nitrogen scrubber 1030 is connected to a discharge air duct of a hyperbaric oxygen chamber that converts the oxygen being expelled through the air duct to one hundred percent nitrogen into the ambient air atmosphere.
The nitrogen scrubber 1030 is primarily used to control gaseous emissions.
Additionally, a complete control and monitoring system (see
The hyperbaric oxygen chamber utilizes an independent pressure time recorder and a precise pressure control. The functionality could also be performed through flow control check valves supplied with static preference or set pressures.
In an embodiment, standard ventilation circuits, flow controllers, valve types and sizes, volume gas compositions and pressures, then those disclosed herein, may be employed and that unique features provided by the design, technology are not limited in their expression to the embodiment thereof. It should be understood that other embodiments may fall within the spirit and scope of this invention.
In an embodiment, the hyperbaric oxygen chamber is used to treat; Air or Gas Embolism, Carbon Monoxide Poisoning, Diabetic Foot Ulcers, Exceptional Blood Loss, Intracranial Abscess, Gas Gangrene, Crush Injury, Compartment Syndrome, other Acute Traumatic Ischernia's, Decompression Sickness, Necrotizing Soft Tissue Infections, Osteomyelitis (Refractory), Delayed Radiation Injury (Soft Tissue and Bone Necrosis), Skin Grafts and Flaps, (Compromised), Thermal Burns, Actinomycosis, Cyanide Poisoning, Delayed Radiation Injury, (Soft tissue and bony necrosis).
The hyperbaric oxygen chamber provides oxygen therapy to diminish the size of the bubbles, not simply through pressure, but also by using an oxygen gradient.
In an embodiment, the hyperbaric oxygen chamber can be of rigid or flexible construction along with a means of delivery of one hundred percent gaseous oxygen. The operation is performed to a predetermined schedule by trained personnel who monitor the patient and may adjust the schedule as required.
In an exemplary embodiment, the hyperbaric oxygen chamber 1010 is a rigid shelled pressure vessel.
Aspects of the present disclosure include a hyperbaric oxygen chamber having a sealable chamber sized and shaped to accommodate a seated whole body of a subject, wherein the subject is seated in an upright position within the sealable chamber and 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, wherein the hyperbaric oxygen chamber is constructed using additive manufacturing and configured to fit inside a regularly-sized physician's office.
Aspects of the present disclosure include the hyperbaric oxygen chamber above, wherein the sealable chamber may be sealed by an overhead door.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, wherein the hyperbaric oxygen chamber may be constructed using carbon fibers, Kevlar, or other plastic or metal materials utilizing additive manufacturing.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, wherein the sealable chamber may be configured to hold one adult or one adult and a pediatric patient.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, further comprising at least one pressure sensor within the sealable chamber, the 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.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, wherein a length of the hyperbaric oxygen chamber may be less than 10 feet and a width of the hyperbaric oxygen chamber may be less than 10 feet.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, wherein the length of the hyperbaric oxygen chamber may be less than 8 feet and the width of the hyperbaric oxygen chamber may be less than 6 feet.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, wherein the length of the hyperbaric oxygen chamber may be less than 6 feet and the width of the hyperbaric oxygen chamber may be less than 4 feet.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, wherein the hyperbaric oxygen chamber is configured to fit inside an elevator.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, wherein the hyperbaric oxygen chamber meets the criteria of the FDA standards.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, wherein the hyperbaric oxygen chamber may be of a rigid construction.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, wherein the hyperbaric oxygen chamber may be configured to maintain an internal pressure of greater than 1 atmosphere and less than or equal to 6 atmospheres.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, wherein the hyperbaric oxygen chamber may be configured to maintain an atmosphere having more than 21% oxygen.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, wherein the hyperbaric oxygen chamber may be configured to deliver one hundred percent gaseous oxygen.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, further comprising an independent pressure time recorder and a pressure control circuit coupled to the monitoring unit control panel.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, further comprising at least one or more controls to have the device function with a medical standard monitoring system to monitor or supervise the functioning of the hyperbaric oxygen chamber.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, wherein the sealable chamber may be configured to accommodate the subject having a height up to seven feet and a weight up to one hundred and eight kilograms.
Aspects of the present disclosure include any of the hyperbaric oxygen chambers above, further comprising a biometric access system configured to verify identities of the hyperbaric technician and the subject.
It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modifications.
This application is a continuation-in-part of U.S. patent application Ser. No. 18/130,056, filed Apr. 3, 2023, which is a continuation of U.S. patent application Ser. No. 17/367,916, filed Jul. 6, 2021, which claims the benefit of U.S. Provisional Application No. 63/019,847, filed on May 4, 2020. The disclosures of the priority applications are incorporated in their entireties herein by reference.
Number | Date | Country | |
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63019847 | May 2020 | US |
Number | Date | Country | |
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Parent | 17367916 | Jul 2021 | US |
Child | 18130056 | US |
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Parent | 18130056 | Apr 2023 | US |
Child | 18216836 | US |