Method and apparatus for therapeutic gas treatment
11660250 · 2023-05-30
Assignee
Inventors
- Tibor Salamon (Little Rock, AR, US)
- Nagy Rihárd (Little Rock, AR, US)
- Hosszú Gergely (Little Rock, AR, US)
- Lászka Norbert (Little Rock, AR, US)
- Szakadati Zoltán (Little Rock, AR, US)
- Richard Rivers (Baltimore, MD, US)
Cpc classification
A61H33/14
HUMAN NECESSITIES
A61H21/00
HUMAN NECESSITIES
A61M2205/8225
HUMAN NECESSITIES
A61H33/06
HUMAN NECESSITIES
A61M31/00
HUMAN NECESSITIES
A61H2201/503
HUMAN NECESSITIES
A61M35/30
HUMAN NECESSITIES
A61M35/003
HUMAN NECESSITIES
International classification
A61H33/14
HUMAN NECESSITIES
A61H33/06
HUMAN NECESSITIES
Abstract
A handheld therapeutic apparatus and method of treatment are disclosed. In one example, the apparatus includes a valve system, a detachable gas cartridge housing unit that houses a gas cartridge or gas delivery from an outside gas cylinder in fluid communication with said valve system, a detachable treatment receptacle for the delivery of gas therapies is in fluid communication with said valve system, and a detachable nozzle in fluid communication with said valve system.
Claims
1. A handheld therapeutic apparatus for the delivery of therapeutic gases, the apparatus comprising: a handle portion adapted to receive a gas cartridge within an interior of the handle portion; a valve housing portion adapted to house a valve system comprising a three-way valve, the valve housing portion being detachably joinable to the handle portion at a collar and including a gas cartridge piercing pin that engages the gas cartridge when the handle portion is joined to the valve housing portion; a treatment receptacle portion detachably joinable to the valve housing portion at an attaching collar, the treatment receptacle portion being in fluid communication with the valve system and adapted to receive a treatment module; and a nozzle portion in fluid communication with the valve system.
2. The handheld therapeutic apparatus of claim 1, wherein the valve system contains one or more flow control pins.
3. The handheld therapeutic apparatus of claim 1, wherein the handle portion contains a gas cartridge clip capable of holding the gas cartridge in place.
4. The handheld therapeutic apparatus of claim 3, wherein the handle portion includes at least one channel arranged to receive a portion of the gas cartridge clip, and at least one window providing visibility of at least one of the gas cartridge or written indicia on the gas cartridge clip.
5. The handheld therapeutic apparatus of claim 1, wherein the handle portion is compatible: with at least one of gas cartridges of varying size or with gas delivery via a connection to an external gas source.
6. The handheld therapeutic apparatus of claim 1, wherein the nozzle portion rotates to control the gas-vapor concentration.
7. The handheld therapeutic apparatus of claim 1, wherein the nozzle portion attaches to a body member covering.
8. The handheld therapeutic apparatus of claim 1, wherein the nozzle portion attaches to a gas chamber.
9. The handheld therapeutic apparatus of claim 1, wherein the nozzle portion attaches to tubing.
10. The handheld therapeutic apparatus of claim 1, wherein the apparatus has a gas flow-control dial for regulating the flow of gas.
11. The handheld therapeutic apparatus of claim 1, wherein the apparatus has an actuator button that starts and stops the flow of gas.
12. A gas cartridge assembly for use in the handheld treatment apparatus, comprising: a silicone seal including a sealing portion having a plurality of perforations, and a gas cartridge, wherein the silicone seal is attached to the gas cartridge at a pierceable cartridge aperture of the gas cartridge.
13. The gas cartridge assembly of claim 12, wherein the gas containing cartridge silicone seal creates an airtight seal when pierced by a piercing pin.
14. A handheld therapeutic apparatus for the delivery of therapeutic gases, the apparatus comprising: a valve system within a valve housing portion, the valve system comprising a three-way valve with control pins for controlling the flow of gas through the valve system; a handle portion adapted to receive a gas source, the handle portion being removably attachable to the valve housing portion; a treatment receptacle portion removably attachable to the valve housing portion; a nozzle portion removably attachable to the valve housing portion; and wherein the valve housing portion is adapted to engage the treatment receptacle portion and the nozzle portion such that the receptacle treatment portion and nozzle portion are in fluid communication with the valve system.
15. A handheld therapeutic apparatus for the delivery of therapeutic gases, the apparatus comprising: a valve system comprising a three-way valve with control pins for controlling the flow of gas through the valve system; a handle portion adapted to receive a gas source; a treatment receptacle portion; a nozzle portion; and a valve housing portion adapted to house the valve system and adapted to engage the treatment receptacle portion and the nozzle portion such that the receptacle treatment portion and nozzle portion are in fluid communication with the valve system; wherein the treatment receptacle portion is a gas meter.
16. The handheld therapeutic apparatus of claim 14 wherein the treatment receptacle is a liquid reservoir.
17. The handheld therapeutic apparatus of claim 14, wherein the apparatus further comprises a piercing pin and piercing pin housing.
18. A method of treating an area of an individual user with medical or therapeutic gases, the method compromising: a) assembling a handheld therapeutic apparatus, said therapeutic apparatus comprising: (i) a valve system comprising a three-way valve with control pins for controlling the flow of gas through the valve system; (ii) a handle portion adapted to a gas cartridge assembly; (iii) a treatment receptacle portion; (iv) a nozzle portion; and (v) a valve housing portion adapted to house the valve system and adapted to engage the treatment receptacle portion and the nozzle portion such that the receptacle treatment portion and nozzle portion are in fluid communication with the valve system; b) placing the gas cartridge assembly in the handle portion; c) attaching the handle portion to the valve housing such that a piercing pin pierces the gas cartridge allowing gas to flow from the gas cartridge through the valve system to the treatment receptacle portion and the nozzle portion; d) delivering the gas to the patient through the nozzle portion.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
(54) As briefly described above, a handheld treatment apparatus is described herein for use in delivering pharmacopeia, medical, and food grade gases and gas mixtures to a designated treatment area of a body. The apparatus may be divided into several distinct, detachable portions: a handle portion of the apparatus for housing a gas cartridge; a valve housing portion of the apparatus for housing a valve system; a treatment receptacle portion of the apparatus; and a nozzle portion of the apparatus. The valve system, housed within the valve housing portion is adapted such that it is in fluid communication with a gas cartridge assembly, the treatment receptacle portion and the nozzle portion of the apparatus. The nozzle portion may include detachable components including: a nozzle cap and a gas-vapor separator. The treatment receptacle may also include detachable components including: a liquid reservoir and a gas meter. When portions of the apparatus are fully assembled and properly engaged, medical gases are allowed to flow from the gas cartridge assembly contained in the handle portion through the valve system, to the treatment receptacle, and out the nozzle portion.
(55) As shown in
(56) Handle portion 101 may be constructed from any number of appropriate light-weight materials such as thermoset plastic polymers and resins. Handle portion 101 is adapted to receive neck 107 of valve housing portion 102 at collar 108 (shown in
(57) In some embodiment neck 107 is adapted to have gas outlets. In other embodiments collar 108 is adapted to have gas outlet holes 108a as shown in
(58) Referring back to
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(60) Locking tab 201a is located on the outward facing surface of proximal end member 201. Referring back to
(61) Arm members 202 are adapted to both support gas cartridge 300 and engage handle portion 101. Arm members 202 are adapted to fit within channel 106 of handle portion 101. The engagement of arm members 202 with channel 106 prevents rotational movement of cartridge clip 200. In some embodiments arm members 202 may be adapted to have edge surface 202a which slides within recess 106b located on the inside edge of channel 106 which provides an additional mechanism for preventing rotational movement of cartridge clip 200 during use of apparatus 100. In some embodiments recess 106b and edge surface 202a are curved. In other embodiments recess 106b and edge surface 202a are tapered. In still yet other embodiments recess 106b and edge surface 202a are planar.
(62) Cartridge clip 200 may be inserted into handle portion 101 prior to insertion of the corresponding gas cartridge 300. The size of cartridge clip 200 is selected to ensure that gas cartridge assembly 300 is at the correct height. Cartridge clip 200 can be fashioned out of any rigid or semi-rigid material. Examples of appropriate materials include but are not limited to moldable plastics and metals such as aluminum. In some embodiments proximal end members 201, arm members 202, and distal end member 203 may be fabricated as individual components and assembled prior to use of apparatus 100. This feature allows the end user to adjust the size of gas cartridge clip 200 on demand, based on the size of the gas cartridge 301. In other embodiments cartridge clip 200 may be fabricated as a single piece, such as through an injection molding process or 3D printing. In these embodiments, the size of the cartridge clip 200 is predetermined based on reported standardized gas cartridge sizes or other specifications based on custom gas cartridge designs.
(63) As referenced above, gas cartridge assembly 300 can come in a variety of sizes as shown in
(64) In preferred embodiments seal 302 is construction from a silicon material. In some embodiments seal 302 is constructed from an epoxy-based resin. In other embodiments seal 302 is constructed from rubber based materials commonly used for high pressure gas cartridges. The internal structure seal 302 can be customized to any size, length or width with any type of thread or non-threaded gas cartridge.
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(66) Valve housing fastener 112 resides within valve housing portion 102 and provides for easy connection of treatment receptacle 104 to valve housing 102. Likewise, valve housing fastener 115 resides within valve housing portion 102 and provides for easy connection of nozzle portion 105. In some embodiments receptacle treatment portion 104 is attached to valve housing portion 102 by first engaging valve housing fastener 112 and then being further secured by collar 111. Similarly, in some embodiments nozzle portion 105 is attached to valve housing portion 102 by first engaging gas-vapor separator 116 with valve housing fastener 115 and then being further secured by collar 113.
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(68) The cross sectional view from
(69) Referring back to
(70) Port 120 contains valve pin 120a which operates in a similar manner to valve pin 122a. Valve pin 120a is outward biased and compressible inward. When treatment receptacle 104 is properly engaged, such that an airtight seal is created between valve housing 102 and treatment receptacle 104, valve pin 120a is compressed inward allowing for the flow of gas from flow channel 123 into treatment receptacle 104 through port 120 as illustrated by
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(72) Depressing actuator button 109a (
(73) Additionally, the quantity and the speed of gas allowed to pass through the system at any given time frame may be regulated by the gas-flow-control dial 110.
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(76) In other embodiments liquid reservoir 142 may be filled with liquid without being removed from apparatus 100. As shown in
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(78) The nozzle portion 105 of apparatus 100 may be further divided into nozzle cap 181, and gas-vapor separator 116 as shown by
(79) Treatment Processes
(80) Generally, apparatus 100 may be adapted to deliver medical gases to a patient. In some embodiments apparatus 100 is adapted to deliver a mixture of medical gas and water vapor to the patient. In other embodiments apparatus 100 is adapted such that only the medical gas is delivered to the skin, open wound, or various body cavities. In some embodiments apparatus 100 is adapted for delivery of CO.sub.2 with water vapor. In some embodiments the CO.sub.2/water vapor treatments are applied where skin barriers need to be broken non-invasively and pain free. In other embodiments the CO.sub.2/water vapor treatments are applied where skin barriers do not need to be broken such as gas application to open wounds and various body cavities.
(81) Transdermal Delivery of Medical Gases
(82) Scientists and researchers have explored ways of delivering drugs, such as medical gases, to the patient through the skin, which can be a safer, non-invasive method of delivery. Transdermal drug delivery offers numerous advantages over more traditional drug delivery forms. Transdermal delivery methods can avoid problems caused by oral dosages, such as gastrointestinal irritations, drug metabolism issues and interference due to the presence of food, and it may be administered to nauseated or unconscious patients. Transdermal methods are non-invasive compared to intravenous means and, due to the steady diffusion of the drug through the skin, they offer more consistent drug infusions, even in localized areas over several days, thereby reducing “peaks” that may cause side effect. Transdermal delivery is simpler and painless for patients and thus, more likely to achieve patient adherence to therapy regimens.
(83) However, a disadvantage of such drug delivery is that skin typically has a natural “barrier function” to prevent foreign substances from entering the body. Indeed, skin evolved for the purpose of protecting against unwanted substances such as toxins and microorganisms. Thus, drug absorption through the skin is difficult, and an effective transdermal delivery system must find ways to efficiently pass through this barrier.
(84) A mentioned above, in some embodiments apparatus 100 is adapted for the delivery of CO.sub.2 gas to a patient. CO.sub.2 gases are especially suited to such transdermal drug deliveries without side effects such as localized irritations. This is because CO.sub.2 has 25 times greater permeability to cell membranes than O.sub.2. Further CO.sub.2 is 30 times more soluble in water than O.sub.2. CO.sub.2 also easily dissolves into oil. Skin has a structure similar to that of water and oil, which may explain why skin can also easily absorb CO.sub.2.
(85) CO.sub.2 increases tissue O.sub.2, due to the O.sub.2 conveyance protein called hemoglobin contained in red blood cells, as well as the Bohr effect. The supply of O.sub.2 for supporting the activities of a creature is mainly performed by hemoglobin in red blood cells. After O.sub.2 binds to the hemoglobin in the lungs, it is released in the tissues. In the presence of increased CO.sub.2 in the blood within the tissues, the pH in the tissues decreases due to the conversion of the CO.sub.2 to bicarbonate molecules and acidic protons. With decreased pH, the O.sub.2 more easily dissociates from the hemoglobin. This reduction in O.sub.2 affinity to hemoglobin is referred to as the “Bohr effect”. Due to this effect, the increased O.sub.2 dumping in the tissues results in the many positive medical effects described above.
(86) Various research studies conducted have confirmed that CO.sub.2 absorbed in this manner has positive effects such as blood vessel dilations leading to healthier skin, greater O.sub.2 supply to the cells resulting the activation of cell metabolisms and improvements in skin texture, and anti-aging, and wound healing effects. Such systems for artificially and enhancing the positive effects of CO.sub.2 balneotherapy have a long history as a well-known therapy in Europe, Japan and many other countries. These therapies have had at least 120 years of success at healthcare establishments for treating major conditions such as cardiovascular conditions (high blood pressure and atherosclerosis), diabetes mellitus, arthritis, and osteoporosis without side effects. Furthermore, studies have shown that the addition of mineral salts and/or essential oils, or other additional substances, to the water may further enhance the positive effects of CO.sub.2 balneotherapy.
(87) In addition to the treatment of major conditions that affect millions of people around the globe, the above-described CO.sub.2 gas therapies have many other positive effects on the human organism, including exercising and refreshing the body, strengthening internal organ functions, relaxation and stress reduction benefits, anti-bacterial and blood cleansing tendencies, muscle and nervous system stimulations, skin beautification effects, etc. Evidence also shows that carbon dioxide has bactericidal effects in the supercritical (liquid) state that can only be obtained at very high pressure.
(88) Although transdermally absorbed CO.sub.2 may be referred to as “carbon dioxide gas”, in fact, the absorbed CO.sub.2 is actually not in the form of visible bubbles. Instead, transdermally absorbed carbon dioxide exists in the form of invisible water-dissolved molecular CO.sub.2. The positive medical effects described are obtained through exposure to this CO.sub.2/water vapor mixture. For example, if one simply blows CO.sub.2 bubbles from a tube onto the skin, no cosmetic effects can be obtained because the CO.sub.2 is hardly absorbed into the skin in the form of bubbles.
(89) The embodiments of the present disclosure provide a highly simple means for the topical application and transdermal delivery of CO.sub.2 or other such medical gases or biologically beneficial oils, minerals, and other pharmaceuticals in gaseous state utilizing a apparatus that is very simple and cost effective to manufacture and to use. The embodiments of the present disclosure are mechanical and require no electricity or technical assistance to operate, leave no residual, and are easy to clean and maintain. The apparatus is conveniently small in size and mobile and easy to use as one would screw in a cartridge into a soda syphon, or screwing in a light bulb. The apparatuses of the present disclosure are equally applicable for both commercial and home usage, and makes medical treatments as easy, pleasant and relaxing as taking a warm bath.
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(91) In addition to the above treatment methods, it is also encompassed within the present invention that the apparatus may be used to deliver the gas-vapor mixture to the skin without the use of an absorption suit. Transdermal delivery of the CO.sub.2 may be accomplished by “misting” the skin by holding an open end of the delivery tube (with the other end leading to the delivery unit) close to the skin (approximately 1 or 2 inches away, for example) or by “spraying” the skin with the high concentration of CO.sub.2. The absorption suits may produce higher efficacies because they keep the fog-like mist enclosed around body parts for controllable periods. However, due to the above-described high skin permeability of CO.sub.2, effective treatments may still occur without such suits.
(92) Intra-Cavity Delivery of Medical Gases
(93) As discussed above, studies clearly demonstrate that CO.sub.2 gas has significant physiological responses that can be generally applied to various diseases. Several studies show that elevated CO.sub.2 concentrations will moderate the inflammatory process. Exemplary disease that could benefit from CO.sub.2 therapy include. cystitis, endometritis, vaginitis, otitis, and colitis. Previously this could only be accomplished by using systemic medications such as non-steroidal anti-inflammatory medications with their well described side effects. CO.sub.2 is a clearly a novel approach to this difficult problem.
(94) The treatment of inflammation with CO.sub.2 may be effectuated by applying CO.sub.2 to organs or cavities in the body thus providing a local treatment of inflammatory diseases. Exemplary organs and cavities include but are not limited to the bladder, uterus, vagina, oral cavity, nasal sinuses, ear canal, and rectum.
(95) Apparatus 100 may be adapted for used in intra-cavity treatments CO.sub.2. As shown in
(96) In addition to direct delivery to a cavity, the patient may be place inside incubator chamber 605 for open body treatment during surgery or other medical procedures as shown in
(97) In other embodiments apparatus 100 may be used to deliver medical gases directly to organs. As illustrated in
(98) Further details regarding testing of CO.sub.2 delivery, and in particular using a similar apparatus, are described in U.S. Pat. No. 9,713,570, commonly assigned with the present application, the disclosure of which is hereby incorporated by reference in its entirety.
(99) The foregoing description of the embodiments of this invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the embodiments of the invention to the form disclosed, and, obviously, many modifications and variations are possible. For example, although in the present disclosure a certain size and arrangement of components of an apparatus for transdermal delivery of CO.sub.2 is described, it is noted that the present invention is not limited thereto. Various other sizes of apparatuses or arrangements are possible as well.
(100) Furthermore, the scope of the present disclosure can also encompass the use of a wide variety of medical, pharmaceutical or purified gases and related substances. In general, such gases present excellent opportunities for medical innovations, because gases are important biological messenger molecules and show promising biological effects, naturally occurring gases appear to have low toxicity profiles, their properties may enable the application of other medical principles. Current uses of gases in medicine have been minimally explored. Thus, the present invention can provide an effective medical apparatus or drug delivery apparatus for the safe, non-invasive injection of medical gases into the human or animal organism through the pores of the skin.
(101) The present invention may even have diversified application possibilities, including those in preventive medicine, sports medicine, veterinary medicine, the space biomedical industry (e.g., muscle and bone less in space), rehabilitation medicine, and troop health support for the military. One may also foresee additional applications of the dispersion technologies of the present invention in fields such as waste water treatment and gas-liquid dispersions (i.e., as a soft drink production alternative). Such modifications and variations that may be apparent to a person skilled in the art are intended to be included within the scope of this invention as defined by the accompanying claims.