Patent Application
20250144385
A portion of the disclosure of this patent document contains material which is subject to copyright protection. This patent document may show and/or describe matter which is or may become trade dress of the owner. The copyright and trade dress owner has no objection to the facsimile reproduction by anyone of the patent disclosure as it appears in the Patent and Trademark Office patent files or records, but otherwise reserves all copyright and trade dress rights whatsoever.
This disclosure relates to chemical delivery and novel methods of treating wounds during times of high stress and where conventional medical treatment is unavailable. More specifically, an ampule loaded with a proprietary polymer which allows mixing of several constituent chemical's when activated is disclosed.
An ampoule, often spelled “ampul” in some regions, is a small, sealed vial made of glass that contains a sterile solution or medication for injection. Ampoules are used in the healthcare and pharmaceutical industries to store and administer a variety of substances, including vaccines, drugs, and other injectable fluids.
Ampoules are designed to be tamper-proof and airtight, ensuring that the contents remain sterile and uncontaminated until they are ready for use. To access the contents of an ampoule, the neck is usually scored or pre-scored so that it can be easily broken off. Once opened, the contents can be drawn into a syringe for injection or further medical use. Ampoules are often preferred for certain medications and applications because they provide an effective way to maintain the sterility and stability of the contents, and they eliminate the need for preservatives or other additives that may be required in multi-dose vials.
Ampoules made of glass however, limit the type of contents that can be stored. Some chemical make ups require mixing of the chemicals for a final reaction requiring multiple ampoules to store respective chemical mixtures. It further, requires a separate apparatus to combine the chemicals before administering the mixed solution. Administering the final mixture also requires a secure environment, such as a lab or doctor's office, to achieve an accurate mixture. The ability to combine chemicals in an unsecure environment, such as a battlefield or a traumatic situation, with accuracy and efficiency is needed.
Throughout this description, elements appearing in figures are assigned three-digit reference designators, where the most significant digit is the figure number and the two least significant digits are specific to the element. An element that is not described in conjunction with a figure may be presumed to have the same characteristics and function as a previously-described element having a reference designator with the same least significant digits.
A wound treatment system is herein described. The wound treatment system has an ampoule, a cap and at least two silicone-containing elastomers. The wound treatment system may further have a cap cover.
Referring now to
The container body 103 has a general tubular shape with a posterior closed end. The container body 103 is not limited to tubular shapes and may have any alternative shape capable of containing contents within. The container body 103 extends upwardly from the closed end and narrows inwardly into the collar 108. The collar 108 expands radially outward from the container body 103 a predetermined distance. From the collar 108 the container top-end 112 extends upwardly a predetermined distance then curves inwardly into a flat surface. The predetermined distances of the collar 108 and the container top-end 113 are dependent on the dimensions as set by the cap (not shown) for which the container top-end 112 is to engage as will be discussed. The volumetric capacity of the container 102 is dependent on the application of the wound treatment contents stored therein. For example, if the wound treatment system is designed to aid with small scrapes or cuts, a smaller container size is needed whereas larger wounds and larger cuts would requires a larger container size to house more of the wound treatment solution.
Removably secured to the container top-end 112 is the tab-seal 104. The tab-seal 104 has at least one crest 114 that is removably secured to the container top-end 112. The crest 114 forms a seal with the container 102 to encapsulate the contents of the container 102 via at least one aperture (not shown) as will be discussed. The crest 114 forms an airtight seal with the container top-end 112 that is broken when the tab-seal 104 is removed exposing the contents of the container 102 to the atmosphere via the aperture (not shown). The crest 114 is configured such that sufficient radial/lateral exertion (twisting force) upon the tab-seal 104 will break the seal formed by the crest 114 and the container top-end 112. From the crest 114, a tab 116 extends laterally outward and then extends upwardly some distance before curving inwardly toward the distal end of the tab 116. The tab 116 serves as a pull tab for users to grip when removing the tab-seal 104 from the container top-end 112. For example, when a user is attempting to remove the tab-seal 104 the user will grip the tab 116 on either side and exert a twisting force to break the seal between the crest 114 and the container top-end 112.
The tab-seal 104 may be configured with plugs (not shown) in lieu of the crests 114. In such a manner, the tab-seal 104 may be used to reseal the container 102. The plugs would be removably secured to the container top-end 112 such that an airtight seal is formed when the plugs are engaged with the apertures. The user may then proceed with the application of the wound treatment system as described in this disclosure, and then may put back the tab-seal 104 to store unused contents of the container 102. A benefit of utilizing plugs for the tab-seal is the reusability of the container 102. For example, the container 102 may have a larger volumetric capacity for multiple uses, wherein the plugs prevent the contents stored in the container from mixing/leaking between uses. In this way, the container 102 may be more cost effective because less ampoule units would be wasted between treatments without losing sterility. The tab-seal 104 may also be integrally formed with the container 102 via a hinge, such that the tab-seal 104 may freely dangle from the container when applying the contents of the container 102 during use.
The tab 116 may take the form of various shapes such as but not limited to: a sphere, a rectangle, or any desirable shape such that a user may take hold of the tab-seal 104 and exert a twisting force to break the seal formed by the crest 114 and the container top-end 112. The tab 116 may also have protrusions 118 that extend outwardly from the exterior of the tab 116 to aid with tactile grip. For example, if a user in a combat setting may have blood on their hands when aiding a wounded person and can use the protrusions 118 to aid with traction to remove the tab-seal 104 from the container 110.
Located on the peripheral edge of the container top-end 112 is the engagement member 106. In the present disclosure, there are two engagement members 106 located on the front and rear of the container top-end 112. The engagement members 106 protrude outwardly from the container top-end 112 a predetermined distance and is located a predetermined distance from the collar 108. The predetermined distances of the engagement members are determinative of the cap's (not shown) dimensions for which the engagement member 106 is to engage as will be discussed. The engagement member 106 is formed to securely engage with a cap as discussed later in this disclosure (see
The collar 108 supports the cap (not shown) when it is securely fastened to the container top-end 112 via the engagement member 106. The collar 108 is integrally formed with the container top-end 112 extending radially outward from the container body 103. The collar 108 has a plurality of ridges 120 along it's peripheral edge. The benefit of the plurality of ridges 120 is to provide additional grip for a user when securing the cap to the ampoule 100. Further, the collar 108 may have a circular segment 122 on the lateral sides of the collar 108. The benefit of the circular segment 122 is to aid with gripping the ampoule 100 and may aid with the manufacturing of the ampoule 100. For example, the circular segment 122 may serve as a connection point for manufacturing molded ampoules 100.
Extending from the lateral side of the container body 103 are a set of tabs 124. The set of tabs 124 are integrally formed with the container body 103. The set of tabs 124 extend outwardly from the container body 103 and have a general rectangular shape of a predetermined thickness. The set of tabs 124 may assist the user with gripping the ampoule 100 when fastening the cap or serve as structural support during the manufacturing process of the ampoule. The set of tabs 124 may have any alternative shape and of varying thickness capable of providing sufficient structural support and/or provide a user the ability to adequately grip the set of tabs 124.
The ampoule 100 is made of a pliable material such as plastic. The ampoule may be made from such plastics such as but not limited to: polypropylene, polyethylene, polycarbonate or any other type of plastic capable of mixing with the at least two different chemicals as disclosed. The benefits of utilizing a plastic material for the ampoule 100 is increased durability of the ampoule 100 during transportation. For example, common forms of ampoules are formed of glass which limits the applicable settings for use. In using a plastic material, the ampoule 100 is less likely to break, and thus preserves the contents of the ampoule 100 for its intended use. Furthermore, the increased durability in using plastic permits the ampoule 100 to be squeezed without permanent deformation when a user is applying a wound treatment.
The ampoule 100 may be manufactured using one of numerous techniques such as but not limited to: injection molding, compression molding, blow molding, thermoforming, transfer molding, reaction injection molding or any methods of forming plastic into the ampoule 100 as described in the present disclosure.
As shown in
The container 102 is configured to have at least two chambers 126. The chambers 126 are formed by a partitioning wall 128 that extends from the container top-end 112 downward toward the closed posterior end of the container 102. The partitioning wall 128 extends laterally to the side walls of the container 102, thus forming at least two chambers 126. It is to be understood that there may be a plurality of partitioning walls 128 such that a plurality of chambers 126 may be formed within the container 102. For example, there may be two partitioning walls 128 that extend laterally to the sides of the container 102 forming a cross shape, thus forming four separate chambers 126. The partitioning wall 128 further differs in thickness, respective to where the partitioning wall 128 is positioned within the container 102. For example, the partitioning wall 128 is thicker when extending through the container top-end 112 and tapers into a thinner portion when extending through the container body 103. The aperture 130 is located on the flat surface of the container top-end 112. The number of apertures 130 is respective to the number of chambers 126 in the container 102. For example, if the container 102 has two chambers 126 then there are two apertures 130, or if there are three chambers 126 then there are three apertures 130. The apertures 130 are centrally located to the respective chambers 126. The aperture 130 are formed after the removal of the tab-seal 104. The crest 114 of the tab-seal 104 is formed with the container top-end 112 such that the lateral walls of the crest 114 circumscribe the diameter of the apertures 130. In this way, when the tab-seal 104 is removed from the container 102, the crest 114 breaks away from the container top-end 112 along the peripheral edge forming the apertures 130. The crest 114 are generally hollow to reduce the amount of material needed to seal the apertures 130. A benefit of forming the seal this way is to provide ease of removing the tab-seal 104, such that the contents of the ampoule 100 may freely exit the chambers 126 without obstruction. For example, traditional ampoules formed of glass are broken along a perforated edge wherein glass particles may mix with the contents. The reduced material in the crest 114 allows for a user to shear the tab-seal 104 from the container top-end 112 such that no material mixes with the contents stored within the chambers 130. Further, the container top-end 112 having a thickness greater than the crest 114 permits container top-end 112 to withstand the shear force applied when removing the tab-seal 104.
Further, the crest 114 forms an air-tight seal with the aperture 130, such that the contents of the chambers 126 cannot escape. It is to be understood that the number of crests 114 is respective to the number of apertures 130 of the ampoule 100. For example, if the ampoule 100 has two chambers 126 then there are two apertures 130, and thus two crests 114 or if there are three chambers 126 then there are three apertures 130 and thus three crests 114.
The benefits of having numerous chambers 126 is the ability for the ampoule 100 to store various chemicals within each respective chamber 126. In the present embodiment, by including at least two chambers 126, two different chemicals can be stored in each of the respective chambers 126. The benefits of storing and separating chemicals in the chambers 126 is that it reserves a polymerization reaction to take place in real time. For example, the stored chemicals described herein may be used to treat a wound, and if the chemicals were to polymerize before applying it to a user's wound, there would be a loss in effectiveness. Instead, the ampoule 100 permits a user to cause the polymerization on location upon an would be applicant's skin, such as on the battlefield.
Polymerization reactions are chemical processes in which small molecules, called monomers, join together to form larger, more complex molecules known as polymers. Polymers are composed of repeating structural units, which are essentially the monomers linked together in a chain or network. Polymerization reactions can be broadly categorized into two main types: addition (chain-growth) polymerization and condensation (step-growth) polymerization.
Several appropriate polymerization reactions are discussed below. Addition (Chain-Growth) Polymerization. Monomers: In this type of polymerization, monomers with unsaturated bonds (typically double bonds) are used. Common examples include ethylene, propylene, and styrene. Initiation: The polymerization reaction begins with the initiation step, where a chemical initiator, such as a free radical, is introduced. Initiators are compounds that can break the double bond in the monomers, creating highly reactive species called free radicals. Propagation: During the propagation step, the free radicals generated in the initiation step attack the double bond of other monomers, causing them to join the growing polymer chain. This process repeats as more and more monomers add to the chain, making it longer. Termination: Termination can occur when two free radicals combine or when a free radical reacts with an inactive species, effectively ending the growth of the polymer chain.
Another appropriate polymerization reaction includes Condensation (Step-Growth) Polymerization. Monomers: In condensation polymerization, monomers contain functional groups that can react with each other by forming covalent bonds. Common examples include polyesters and polyamides. Reaction: In this process, two different monomers or a bifunctional monomer react with each other. When the monomers combine, a small molecule, typically water, is eliminated as a byproduct. Repeating units: The reaction continues until all the functional groups on the monomers have reacted, forming a long polymer chain with repeating units. End groups: The resulting polymer may have end groups left from the original monomers or other byproducts, depending on the specific reaction conditions.
A multitude of factors and chemicals were considered when determining S-polymer was the appropriate compound to include within the S-ampoule. Please note S-ampoule along with present disclosure are used to refer to the ampoule and method of producing ampoule discussed through this disclosure.
Monomers Selection: The first step is to select two different monomers, each containing reactive functional groups. These functional groups can react with each other to form covalent bonds. The choice of monomers determines the type of polymer that will be formed and its properties. S-polymer and the monomers that are used to create it was selected because S-polymer can harden in an environment where blood and human tissue is present. More importantly the monomers making up S-polymer do not react with other chemicals within the blood nor do they affect the buffer system or pH of blood. This is crucial to the present disclosure because other monomers may form polymers with chemicals within the blood resulting in blood clots and death of the user.
Combining Monomers: The selected monomers are mixed together. In the reaction, the functional groups on one monomer interact with the functional groups on the other monomer, leading to the formation of covalent bonds between the monomers. Typically, one monomer contains two reactive groups (bifunctional monomer), and the other monomer also contains two reactive groups. Polydimethylsiloxane is an appropriate polymer for the presently disclosed Ampoule The following monomers derived from the below chemical are also appropriate:
[—Si(CH3)2—O—]n
In this representation, n represents the number of repeating units, and each unit consists of a silicon atom (Si) bonded to two methyl groups (CH3) and two oxygen atoms (O). These units are linked together through silicon-oxygen-silicon (Si—O—Si) bonds.
S-Polymer is an ideal choice for several reasons. Biocompatibility: PDMS is known for its biocompatibility. It has been extensively used in medical and biological applications for many years, including in devices like catheters, artificial organs, and medical implants. It is generally well-tolerated by the human body and doesn't trigger significant immune responses or adverse reactions. Inertness: The Si—O—Si bonds in PDMS create a highly inert material. Inert materials do not readily interact with other substances, including blood. This inertness helps prevent the material from undergoing chemical reactions or degradation when exposed to biological fluids.
In other embodiments S-Polymer may take the form of Diphenylmethane diisocyanate. Some sources including the SDS for Cyanoacrylate indicate that Cyanoacrylate should not be used on the skin. However, in the experience of the inventors Cyanoacrylate only caused eye and respiratory harm, but does not harm the epidermis.
Stability: Silicones, in general, are known for their stability over a wide range of environmental conditions, including exposure to bodily fluids. The Si—O—Si bonds are robust and do not break down easily in the presence of blood or other biological fluids, ensuring the integrity of the material. Low Surface Energy: PDMS has a low surface energy, which means it is not very “sticky” and does not tend to interact strongly with molecules in the blood. This characteristic helps prevent protein adsorption and cell adhesion, which can be beneficial in certain medical applications. Hydrophobic Nature: PDMS is hydrophobic, meaning it repels water. While blood contains water, the hydrophobic nature of PDMS helps keep it separate from the material, reducing the risk of undesirable interactions.
Elimination of Small Molecules: As the monomers react and form covalent bonds, a small molecule is often eliminated as a byproduct. For example, in the formation of a polyester, water (H2O) is typically produced as a byproduct. This byproduct is often a molecule with one atom from each of the reacting monomers.
Repeating Units: The reaction continues until all of the functional groups on the monomers have reacted. The result is a polymer with a chain of repeating structural units, which are covalently bonded to each other. These repeating units form the backbone of the polymer chain. End Groups: The resulting polymer may still have end groups left from the original monomers, which are typically unreacted functional groups. The presence of these end groups may affect the properties of the polymer, and sometimes they are modified or removed in post-polymerization steps. Polymerization Conditions: The specific conditions under which the reaction is carried out, such as temperature, pressure, and the presence of catalysts or initiators, can influence the rate of polymerization and the properties of the resulting polymer. Chain length and structure: The length and structure of the polymer chain depend on factors like the monomer's reactivity, the type of initiator used, and reaction conditions.
In the present embodiment, each chamber 126 of the ampoule 100 is intended to house a silicone containing elastomer, that when combined allow for polymerization to form a skin treatment composition. The skin treatment composition, comprises: a solution for forming a first layer over damaged skin, the solution comprising: isopropyl alcohol, colloidal silver, chamomile extract, and gotu kola extract; a silicone mixture for forming a second layer over the first layer, the silicone mixture comprising: polydimethylsiloxane, noncrystalline silicone dioxide, a methylhydride crosslinker, a platinum catalyst, and hydroxyl terminated polymethylphenylsiloxane; and a mineral powder for forming a third layer over the second layer, the mineral powder comprising: mica and a natural mineral kaolinite. The skin treatment composition may be applied to a user's burn, wound, scar and/or a keloid on the user's skin.
The skin treatment composition may have an alternative composition wherein one chamber 126 has a first silicone elastomer including: 50-80% by wt. of a polydimethylsiloxane, 10-25% by wt. of a noncrystalline silicone dioxide, 0.03-0.09% by wt. of a platinum catalyst, and 0.18-0.49% by wt. of a hydroxyl terminated polymethylphenylsiloxane; and another chamber 126 has a second silicone elastomer including: 50-80% by wt. of a polydimethylsiloxane, 10-25% by wt. of a noncrystalline silicone dioxide, no more than 10% by wt. of a methylhydride crosslinker, and 0.18-0.49% by wt. of a hydroxyl terminated polymethylphenylsiloxane, wherein the first and second silicone elastomers are configured to react when mixed in order to form a film layer for treating a skin area.
In alternate embodiments of the ampoule 100 having numerous chambers 126, the ampoule 100 may store a solution in a first chamber, the solution including: 0.5-3% by wt. of an isopropyl alcohol, 73-90% by wt. of a colloidal silver, 1-5% by wt. of a chamomile extract, and 1-5% by wt. of a gotu kola extract; a second chamber 126 holding a first silicone elastomer, the first silicone elastomer including: 50-80% by wt. of a polydimethylsiloxane, 10-25% by wt. of a noncrystalline silicone dioxide, 0.03-0.09% by wt. of a platinum catalyst, and 0.18-0.49% by wt. of a hydroxyl terminated polymethylphenylsiloxane; and a third chamber 126 holding a second silicone elastomer, the second silicone elastomer comprising: 50-80% by wt. of a polydimethylsiloxane, 10-25% by wt. of a noncrystalline silicone dioxide, no more than 10% by wt. of a methylhydride crosslinker, and 0.18-0.49% by wt. of a hydroxyl terminated polymethylphenylsiloxane; and a fourth chamber 126 having a mineral powder, the mineral powder including 3-5% by wt. of a natural mineral kaolinite.
Each of the described embodiments that house various contents in respective chambers 126 of the ampoule 100 involve the process of removing the tab-seal 104 from the container 102, depressing the container 102 such that each of the respective contents are free to exit the container 102 to combine through polymerization. The process includes adequate mixing of the components through the cap as will now be described.
Referring now to
As shown in
Referring back to
The cap 140 may be made of plastic or metal or other material that can be sterilized, such that the cap 140 can be re-used for other applications. For example, it may be cost effective for the ampoule to be made from plastic, and the cap 140 made from a re-usable material, such as metal, such that after use, the ampoule is disposed of but the cap 140 is sterilized for the next use. Furthermore, the cap 140 may also be configured to use a cap cover, as will be discussed, such that the cap cover and ampoule may be disposed of after use but a re-usable cap 140 can be interchanged between uses. For example, a user may apply the contents of a first ampoule using a cap 140 with a first cover to one user and then interchange the first cap cover and ampoule for a second unused cap cover and ampoule using the same cap 140, then apply the treatment to a second application while maintaining the same cap 140 with safety and sterility.
In other embodiments, the cap 140 may be integrally formed with the ampoule 100 such that the cap 140 is securely fastened to the ampoule 100 via a hinge. In this way, the cap 140 and the ampoule are an all-in-one system. For example, once the tab-seal is removed from the ampoule, the user can immediately secure the cap 140 to the ampoule. The benefits of an all-in-one system is ease of use and increased efficiency during deployment of the wound treatment. In alternative embodiments, the cap 140 may be press fit atop the ampoule 100 such that the engagement member and locking groove 146 may be omitted. In this embodiment, the container may also have a locking tab to engage with an indentation in the cap 140 such that the cap 140 locks into place when the locking tab and indentation marry. The cap 140 may also be configured with the tab-seal such that when the user twists off the cap, the tab-seal disengages with the container. The tab-seal may then be removed from the cap 140, and the cap 140 can then be placed atop the ampoule as presently described.
Referring to
Referring now to
The cap 140 and the mixing member 164 may be formed of the same or different material including but not limited to: polypropylene, polyethylene, polycarbonate, aluminum, steel, glass or any other type of material capable of performing the functions of the cap 140 and the mixing member 160 as described herein. Further, the mixing member 160 may also be made from a reusable material that can be sterilized for multiples uses.
Referring now to
As used herein, “plurality” means two or more. As used herein, a “set” of items may include one or more of such items. As used herein, whether in the written description or the claims, the terms “comprising”, “including”, “carrying”, “having”, “containing”, “involving”, and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of” and “consisting essentially of”, respectively, are closed or semi-closed transitional phrases with respect to claims. Use of ordinal terms such as “first”, “second”, “third”, etc., in the claims to modify a claim element does not by itself connote any priority, precedence, or order of one claim element over another or the temporal order in which acts of a method are performed, but are used merely as labels to distinguish one claim element having a certain name from another element having a same name (but for use of the ordinal term) to distinguish the claim elements. As used herein, “and/or” means that the listed items are alternatives, but the alternatives also include any combination of the listed items.
This patent claims priority from provisional patent application 63/596,197, filed Nov. 3, 2023, entitled NOVEL AMPOULE FOR DELIVERY OF POLYMERS FOR WOUND TREATMENT, the content of which is included by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63596197 | Nov 2023 | US |
