Patent Description:
Injections are employed millions of times daily all over the world to deliver medicines into people as well as animals. Many times, injections are made in areas of the body that are sensitive to pain as the needle is inserted. Cooling of the skin in the vicinity of injection site using vapocoolant is known to reduce pain, but existing dispensing techniques and devices can be cumbersome to employ, may cause injury to the injection site, and employ flammable or environmentally unfriendly materials. Recently, products designed for dispensing vapocoolants have been found to contain or be contaminated with microorganisms, leading to recalls and other issues. <CIT> and <CIT> disclose sterlizable dispensers according to the prior art.

A sterilizable vapocoolant dispenser according to claim <NUM> and a method of manufacturing a sterilized vapocoolant dispenser according to claim <NUM> are provided.

To address the technical problem of vapocoolant dispensing devices suffering from the delirious effects of microorganism contamination, the present disclosure provides a technical solution that provides a sterilizable and/or sterile vapocoolant dispenser and methods of manufacturing same. As disclosed herein, the dispenser is configured to hermetically receive and contain a vapocoolant container, be subject to high-energy radiation sterilization, and provide for dispensing of sterile vapocoolant. The dispenser disclosed herein is also configured for single use. The presently disclosed dispenser is designed to maintain a sterile fluid pathway until used. The presently disclosed dispenser does not require packaging in a sterile pouch or any other system designed to keep the entire device sterile, although, it is optionally configured to be packaged in such a manner.

As used in this disclosure, the term "sterile" is understood to mean, for example, a medical device that is free of viable microorganisms as determined by International standards that specify requirements including validation and routine control of sterilization processes, and require, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to sterilization be minimized and/or reduced to a level as prescribed by one or more of the validation standards set by the International Standards Organization (ISO). Whereas, medical devices produced under standard manufacturing conditions in accordance with the requirements for quality management systems (see, for example, ISO <NUM>) may, prior to sterilization, have microorganisms on them, albeit in low numbers, such products are non-sterile. Thus, "sterile" as used herein is the result of sterilization sufficient to inactivate microbiological contaminants and thereby transform the non-sterile product into sterile product in accordance with the one or more ISO validation standards.

As used in this disclosure, the term "sterilizable" is understood to mean an article's or chemical's ability to substantially retain its chemical and physical properties and minimization or absence of transformations to or production of radiation-induced reaction products after receiving a sterilizable high energy radiation dose, such ability being maintained for period of time after receiving the high energy radiation dose. For example, a vapocoolant, after receiving a sterilizable high energy radiation dose would substantially or completely retain its chemical and physical properties with acceptably low or undetectable levels of radiation-induced reaction products for at least <NUM> months after receiving the high energy radiation dose. Likewise, a dispenser configured to hermetically seal a vapocoolant and its associated container, after receiving a sterilizable high energy radiation dose would substantially or completely retain its chemical and physical properties and provide for the maintaining of stability of the vapocoolant, for at least <NUM> months after exposure to the high energy radiation dose.

As used in this disclosure, the term "hermetically" is understood to mean completely sealed, so as to prevent or significantly reduce the escape or entry of air, moisture, microorganisms and other contamination directly or indirectly affecting sterility.

In one aspect, the present devices are intended for providing topical application of a vapocoolant to skin. By skin, it is intended to include the dermis and epidermis, intact mucous membranes, the oral cavity, nasal passageways and the lips. In one aspect, the present device is intended to provide pain management associated with injections, e.g., pre-injection anesthesia, including but not limited to venipuncture, IV starts, minor surgical procedures, vaccinations, pediatric care, and the temporary relief of pain from injuries, e.g., topical anesthesia, such as sprains, bruising, cuts, abrasions, and insect bites. The present device can also provide myofacial pain management. The dispenser can be configured to dispense other compositions, such as medicaments, dissolved or dispensed or distributed in such vapocoolants (e.g., low boiling solvents), such as ether or fluorocarbons, for non-invasive peroral (through the mouth), topical (skin), transmucosal (nasal, buccal/sublingual, vaginal, ocular and rectal) and inhalation dispensing to infants or adults. Other compositions that can be dispensed by the present dispenser can include removable or indelible inks, e.g., for tattooing or otherwise marking skin with indicia, e.g., phosphorescent inks.

Exemplary examples and discussions that now follow recite the use of a vapocoolant to describe manner and method of the presently disclosed dispenser. When the dispenser is employed with a vapocoolant, e.g., as a "vapocoolant dispenser," vapocoolant is released and caused to contact the skin, producing a rapid cooling effect upon contact. In one aspect, the dispenser is configured to provide the vapocoolant in the form of an aerosol, in either a mist or stream spray. Upon contact with the skin or mucosal membranes, the dispensed vapocoolant evaporates rapidly due to the low boiling point of the vapocoolant and the relatively high temperature associated with skin, causing a rapid cooling effect at the application site by the evaporation of the vapocoolant.

The container configured for containing the vapocoolant can be comprised of any material suitable for containing vapocoolant, which typically involves pressure slightly above that of atmospheric. Suitable materials include metals such as stainless steel and aluminum, plastics, reinforced plastics, glass, and ceramics.

In one portion of the housing one or more suitable structures are provided that receives the container and its associated valve member and renders the valve member substantially stationary in a first state. Longitudinal traversal of the container (along the longitudinal axis of the dispenser housing) causes the valve member to open so as to affect dispensing of the vapocoolant from within the container and to exit from the dispenser. The dispenser of the present disclosure is intended, in one variation, to be provided in a sterile condition or state and used continuously until the container is depleted of vapocoolant and then discarded. The device may be used multiple times and, even, on multiple patients. Of course, the device may be used solely with a single patient and discarded after such use.

The housing can be made of metal, glass, or ceramic. In one aspect, the housing and any or all of its components can be made of plastic, e.g., by any desired method including injection molding, compression molding, rotational molding, <NUM>-D printing, and the like. The container can be of any material suitable for a vapocoolant, e.g., a plastic, metal, glass, or ceramic material capable of containing a liquid and/or gas at a pressure above atmospheric. The container can be sized to hold <NUM>-<NUM> of vapocoolant. In one aspect, the container is sized to contain about <NUM> fl. In other aspects, the container is sized to hold <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> or more of vapocoolant.

The vapocoolant can be any liquid or combination of liquids having properties suitable for use as a vapocoolant. Such properties would include, low toxicity, low flammability and low combustibility, and/or includes materials having suitable boiling point and vapor pressure at typical or envisioned end-use temperature/pressure conditions. In one aspect, one or more halogenated hydrocarbons can be used as vapocoolants. According to the invention, suitable vapocoolants include one or more refrigerants as defined by American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE) as hydrochlorofluoroolefin, hydrochloric carbon hydrochloroolefin, hydrocarbon, hydroolefin, perfluorocarbon, perfluroolefin, perchlorocarbon, perchloroolefin, or mixtures thereof, for example, <NUM>,<NUM>,<NUM>,<NUM>,<NUM>-pentafluoropropane, and <NUM>,<NUM>,<NUM>,<NUM>-tetrafluoroethane mixture. One or more chemical compounds, e.g., medicaments, can be at least partially dispersed or dispensed or dissolved in the vapocoolant. According to the invention the contents of the container, without pressurized air or inert gas, provides its own head-space pressure of above ambient atmospheric pressure, e.g., <NUM> to about <NUM> atmospheres at ambient temperature. For example, <NUM>-<NUM> atmospheres of pressure (about <NUM>,<NUM> kPa (<NUM> psi) to about <NUM>,<NUM> kPa (<NUM> psi)) is achievable by one or more vapocoolants or combinations of one or more vapocoolants and one or more hydrofluorocarbon alkanes (HFA), which can be safely contained in the container of the present disclosure. This head-space pressure without pressurized air or other gas is obtainable, for example, by providing a <NUM>% mixture of a vapocoolant and a <NUM>% mixture of a HFA, e.g., <NUM> wt. % of <NUM>,<NUM>,<NUM>,<NUM>,<NUM>-Pentafluoropropane and <NUM> wt. % of <NUM>,<NUM>,<NUM>,<NUM>-Tetrafluoroethane. Other combinations are possible to achieve the head-space pressure and encompassed by the present disclosure. Vapocoolants can include, without limitation, one or more non-halogen containing low boiling fluids suitable for topical skin application, provided that the non-halogen containing the fluid is capable of operating as a self-propellant by providing a suitable pressure for discharge in a vapor space above the liquid supply of the vapocoolant.

With reference to <FIG>, and exploded views 2A, 2B an embodiment of a dispenser is generally designated by the reference numeral 100a, 100b (hereinafter collectively also referred to by callout <NUM>), depicted as having an elongated housing 101a, 101b, (hereinafter collectively also referred to by callout <NUM>). In one aspect, the housing <NUM> is generally cylindrical. Housing <NUM> comprises shoulder <NUM> and adjacent taper portion <NUM> having an inward/outward taper in proximity to a distal end, a dispensing end <NUM> with lid <NUM> adjacent to the distal end, the dispensing end <NUM> and lid <NUM> configured for coupling together. Taper <NUM> is configured to allow for comfortable and secure interaction with of a pair of human digits, for example the index and ring finger, and thus, can provide for one-handed operation when coupled with the thumb as described herein.

Proximal end of housing <NUM> includes a bottom cover <NUM> configured for coupling with housing <NUM> and designed with a sealing interface to preserve fluid path sterility. Removable pull-tab <NUM> is reversibly sealed to lid <NUM> and hermetically covers opening <NUM> and vent holes <NUM> preventing contamination and preserving fluid path sterility. Pull-tab <NUM> covering also preserves the sterility of all area inside of the seal to lid <NUM>, ensuring that surfaces proximate to the spray opening <NUM> remain sterile until use. Pull tab <NUM> may be Tyvek. Thus, the fluid path sterility for the dispenser <NUM> is preserved during shipping and up to the point of use with a combination of the bottom cover <NUM>, and the air permeable, sterile barrier pull tab <NUM>.

Proximal end of housing <NUM> receives a majority of vapocoolant container <NUM> that contains, e.g., vapocoolant. A remainder portion <NUM> (<FIG>) of the container <NUM> extends from the housing <NUM>. Container <NUM> includes shoulder <NUM> adjacent tapered neck adjacent distal end <NUM> with nozzle <NUM> projecting therefrom. In one example, the contents of the container <NUM> are under pressure such that the pressure inside of the container <NUM> is greater than the ambient pressure. Alternate dispenser 100b includes optional projections from the distal end and/or dispensing end <NUM> so as to present an appealing, friendly, animal-like appearance, for example, a "teddy bear" with a pair of ears <NUM> and nose <NUM> for use in pediatrics.

Tamper evident seal <NUM> with extensions <NUM> drape over the side of cover <NUM> potentially preventing contamination associated with dislodgement of cover <NUM> and can also provide for a visual indication of sterility for the end user. An optional cylindrical label <NUM> is sized to surround circumference of housing <NUM> in some embodiments providing additional security to tamper evident seal extensions <NUM> by additionally affixing the seal extensions <NUM> to housing <NUM>. In one example, label <NUM> comprises artwork or other indicia complimenting optional projections <NUM> and <NUM>. In yet other example, label <NUM> comprises an integrated bandage or a sticker for use with pediatric patients.

In one example, the combination of tamper evident seal <NUM> and cover <NUM> functions cooperatively to retain the container in the housing and isolates the interior of the housing from the ambient environment, thus improving and/or maintaining sterility after sterilization of the dispenser <NUM>. Because nozzle <NUM> of container <NUM> may or may not seal completely with the channel 135b of the housing <NUM>, entrapped air within the housing of the device can vent through the existing opening <NUM> in the absence of hermetic seal of pull tab <NUM>. In one example, in order to keep the fluid path of the vapocoolant sterile within the dispenser until use, the presently disclosed dispenser <NUM> implements improved design elements. In one example, the vapocoolant is kept sterile, as well as all surfaces on the vapocoolant container <NUM>, all internal surfaces of the housing <NUM>, internal surfaces of bottom cover <NUM>, and the region bounded by the pull tab <NUM> and lid <NUM>, e.g., pull tab <NUM> creates a peelable, hermetic seal. The bottom cover <NUM> creates a microbial barrier with housing <NUM>, by creating an annual hermetic seal between the bottom cover <NUM> and the body of the housing <NUM>. In an alternative design, housing <NUM> - bottom cover <NUM> microbial barrier can be configured to include a tortuous path, rather than a hermetic seal.

In one example, dispenser <NUM>, pull tab <NUM> and lid <NUM> utilizes a breathable, sterile barrier material (e.g., Tyvek), which in addition to preventing the ingress of microbial contaminants, permits the interior of the device to remain at ambient pressure through vent holes <NUM>, and prevents changes in barometric pressure or temperature, e.g., from popping off the bottom cover <NUM>, due to the breathability of pull tab <NUM>. In another example, pull tab <NUM> could be replaced with another element such as a cap or non-breathable element.

In the presently disclosed dispenser <NUM>, two design configurations are possible to maintain the sterile fluid pathway of the system. In a first example, either or both of the pull tab <NUM>-lid <NUM> mating junction or bottom cover <NUM>-housing <NUM> mating junction are configured to provide a sterile barrier and/or provide a tortuous path. In a second both the pull tab <NUM>-lid <NUM> mating junction and bottom cover <NUM>-housing <NUM> mating junction are hermetically and non-breathably sealed but are otherwise capable of preventing changes in pressure from rupturing the hermetic seal.

The presently disclosed dispenser <NUM> in one example is configured so that the pull tab <NUM>-lid <NUM> and bottom cover <NUM>-housing <NUM> configuration both essentially provide sterile barrier junctions so as to maintain sterility of dispenser <NUM>, e.g., even if the dispenser are carried around in pockets of clinicians, etc., prior to use.

<FIG> and <FIG> depict orthogonal views of the dispenser <NUM>, with <FIG> and <FIG> providing corresponding section views along section line 3B-3B and 4B-4B, respectively. Housing <NUM> includes nozzle receiving members <NUM> with channel 135b essentially centered along the longitudinal axis 3B-3B of the housing <NUM>. As shown in <FIG>, depicting enlarged view of section 3C of <FIG>, nozzle receiving members <NUM> includes shoulder <NUM> configured for engaging nozzle <NUM> of container <NUM> in a first state prior to activation/release of vapocoolant via opening <NUM> of valve member <NUM> and aligns distal conduit 135a of nozzle <NUM> with channel 135b of housing. Channel 135b fluidically couples with opening <NUM> of lid <NUM>. Distal conduit 135a is cooperatively engaged with valve member <NUM> which is held under the pressure of the contents of container <NUM> in a closed position in the first state prior to activation. Valve member <NUM> can be a press-down valve or other suitable valve for releasing pressurized contents.

Displacement of valve member <NUM> along longitudinal axis 3B-3B in a second state or activation state, allows pressurized contents of container <NUM> to enter channel <NUM> for release through opening <NUM>. Projections <NUM> from inner surface of housing <NUM> are positioned between shoulder <NUM> and distal end <NUM> of container <NUM> securing container in housing when support afforded by bottom cover <NUM> is removed. Interior of housing <NUM> adjacent to taper <NUM> provides for a predetermined reversible longitudinal travel distance of the distal end <NUM> of container <NUM> within the housing <NUM> during transition from the first state to the activation state sufficient for displacement of valve member <NUM> and the release of vapocoolant.

Inner diameter of lid <NUM> is sized for receiving by housing <NUM> and provides for hermetic sealing, for example, by ultrasonic, sonic welding, or adhesive, such that lid <NUM> forms an airtight, sterile seal with housing <NUM>. Inner surface of housing <NUM> includes inwardly projecting protrusions <NUM> which prevent unintentional longitudinal movement of container <NUM> within housing towards bottom cover <NUM> while in the first state.

Bottom cover <NUM> has annular ring <NUM> configured to be received by the annular region 101c of housing <NUM>. The annular ring <NUM> and annular region 101a can be sized for an interference fit which provides a sterile barrier seal. Additional sealing elements can be employed, such as o-rings or sealing compounds. The housing <NUM> may also employ locking features <NUM> that engage below the annular ring <NUM> to provide additional securement for the bottom cover <NUM>. Bottom cover <NUM> can include inwardly projecting protrusion <NUM> to securely position container <NUM> in the interior of housing <NUM> and maintain alignment or fitment of nozzle receiving members <NUM> with nozzle <NUM>.

<FIG> depict perspective bottom and top views, respectively, of the housing <NUM> with the container <NUM>, bottom cover <NUM>, and lid <NUM> removed. Interior inner surface <NUM> of housing <NUM> includes a plurality of spaced-apart longitudinally-extending projections <NUM> which can function to guide container <NUM> upon assembly to prevent discharge of container <NUM>. Additionally, inwardly tapered extending projections <NUM> can provide a predetermined resistance of longitudinal motion of the container <NUM> and the subsequent activation of valve member <NUM> by the user. Longitudinally extending projections <NUM> can vary in extension into the interior of housing <NUM>, for example, a longitudinal taper.

Distal portion <NUM> encircles projecting annular platform <NUM> terminating in dispensing assembly <NUM>. Annular ring <NUM> of dispensing assembly <NUM> encircles post <NUM>. Annular ring <NUM> includes a plurality of spaced apart cutouts <NUM> on exposed surface of annular ring <NUM>.

<FIG> depict a top plan view of distal portion <NUM> an enlarged view of dispensing assembly <NUM>. <FIG> provide a sectional view and enlarged views of dispensing assembly <NUM>. As shown, opening <NUM> fluidically coupled to conduit <NUM> partially encircles post <NUM> and provides for a fluidic path of the contents of container <NUM> of dispenser <NUM> when in the activated state.

<FIG> depict a bottom plan view of housing and enlarged section 9B of <FIG> showing nozzle receiving member <NUM>, post <NUM>, and opening <NUM>. <FIG> depicts an alternate embodiment of housing <NUM> whereby nozzle receiving members <NUM> is radiantly supported by a plurality of supporting walls <NUM>.

<FIG> depict top and bottom perspective views of lid <NUM>. <FIG> depicts a plan view of the underside of lid <NUM>. <FIG> is a sectional view along line 11D-11D. <FIG> is an enlarged view of section 11E of <FIG> is an enlarged view of section 11F of <FIG>. Lid <NUM> includes reduced diameter annular ring 105a sized to encircle annular platform <NUM>, for example in an interference fit relationship or may loosely fit for subsequent ultrasonic welding. Top surface of lid includes vent holes <NUM> surrounding opening <NUM>. Vent holes <NUM> provide a pathway for pressure equalization of the internal volume of the housing, preventing pressure build up and dislodgment of bottom cover <NUM> and pull tab <NUM> preserving the sterile fluid path. Vent holes may also provide for outgassing during sterilization using high-energy radiation such as x-rays, gamma rays, or electron-beam as well as maintaining pressure equilibrium during transportation/storage and temperature changes. Pull tab <NUM> is made of an air permeable sterile barrier material (e.g. Tyvek) and is continuously sealed around vent holes <NUM> and opening <NUM>. Interior surface of lid <NUM> includes projecting annular wheel <NUM> and annular protrusion <NUM> providing two annular welds when joined to the distal portion <NUM> of housing <NUM>. Annular wheel <NUM> encircles annular protrusion <NUM> sized to encircle post <NUM>. Raised platform <NUM> having projecting posts defines channels <NUM> when lid <NUM> is joined to the housing <NUM> and brought in contact with the distal surface of post <NUM>, a dispenser "spray nozzle" is formed, providing for efficient diffusion of escaping contents of container <NUM> and working cooperatively with opening <NUM> for efficient and even dispensing of vapocoolant. In one example, the aforementioned components of lid <NUM> comprise a micromist assembly configured to split the flow of the vapocoolant upon release from the container <NUM> so that one or more flows of vapocoolant can recombine in and/or interact with one or more components of lid <NUM> so as to provide a vortex that aids in making a finer mist of vapocoolant.

<FIG> depicts a partial section view of the housing <NUM> and lid <NUM> joining. <FIG> is an enlarged view of section 12B of <FIG> showing various ultrasonic welding spots 155a, 155b complementarily positioned among lid <NUM> and distal portion <NUM> of housing <NUM> for hermetically sealing lid <NUM> to distal portion <NUM> of housing <NUM>. Welds 155a, 155b provide for the formation of a space above annular ring <NUM> on housing <NUM> and the inside of lid <NUM>, the space fluidly communicates with the vent holes <NUM> and vent holes <NUM> of housing <NUM>, allowing the interior of the dispenser to vent to the outside environment through the sterile barrier pull tab <NUM> that is sealed around the vent holes <NUM> on the external surface of lid <NUM>.

<FIG> depicts a perspective view of bottom cover <NUM> having ergonomic features <NUM> for assisting in removing cover from housing <NUM>. Bottom cover <NUM> includes smaller diameter annular ring <NUM> for engaging annular region 101a. <FIG> depicts a perspective view of bottom cover <NUM> showing surface <NUM>. <FIG> depicts a top plan view of inner surface of the bottom cover <NUM> showing protrusion <NUM>. <FIG> is a section view along section line 13D-13D of <FIG>. In one variation, the container <NUM> is not refillable and dispenser <NUM> is intended for single use. In another example, dispenser <NUM> is configured to be used at least once or until depleted of contents, the dispenser <NUM> would then be disposable.

With the various embodiments having been described in detail above, a method of operation will now be explained. Container <NUM> has vapocoolant contained therein by valve member <NUM>, e.g., tilt-valve, press-valve, with nozzle <NUM> received by a plurality of nozzle receiving members <NUM>, which is shown as three members integral with housing <NUM>. The fixed relationship between the interval nozzle receiving members <NUM> of the housing and the nozzle <NUM> of valve member <NUM> provides, in a first state, a sealed relationship of the container and allows transition to a second state where the nozzle <NUM> of container <NUM> is urged towards the nozzle receiving members <NUM> of the housing (via linear translation of the container into the housing along the longitudinal axis housing by the user's thumb, for example) causing the nozzle <NUM> to engage the nozzle receiving members <NUM> allowing release of the vapocoolant essentially parallel with the longitudinal axis of housing <NUM>. This guides the escaping vapocoolant perpendicularly towards raised platform <NUM> and channels <NUM> and ultimately exiting via opening <NUM>. When the user releases the force on the container, the valve member <NUM>, alone or in combination with inwardly projecting protrusions <NUM>, provides a restoring force to translate the container in the opposite direction, disengaging the nozzle <NUM> from nozzle receiving member and back to the first state while also discontinuing dispensing of the vapocoolant.

In one aspect, peel away tamper evident seal <NUM> and tab <NUM> is removed. Alternatively, the entire bottom cover assembly <NUM> can be removed together with tamper evident seal <NUM>. With bottom cover <NUM> removed, portion of container <NUM> is exposed from housing <NUM>. In one example, as shown, a user may grasp the tapered portion of housing <NUM> between index finger <NUM> and ring finger <NUM> and position thumb <NUM> against container <NUM>. Exerting a force on container <NUM> using thumb <NUM> translates container longitudinally within housing <NUM> and places device and an activated state whereby valve member <NUM> is actuated releasing the contents <NUM> of container <NUM> through opening <NUM> thus, the present dispenser <NUM> avoids needing a "second hand" and the need to put dispenser <NUM> down so as to access and use another device. In one example, a user may grasp the tapered portion of housing <NUM> between index finger <NUM> and ring finger <NUM> and position thumb <NUM> against container <NUM> so as to use the dispenser <NUM> in a one-handed, "pen-like" or "air-brush-like" manner.

Referring to <FIG>, a packaging method providing for aseptic or semi-aseptic assembly is depicted by flowchart <NUM>. Step <NUM> includes container <NUM> and valve member <NUM> assembly and vapocoolant filling step <NUM>. Independently, or concurrently, housing components, typically via injection molding or other thermoplastic molding technique are used to construct housing <NUM>, lid <NUM>, and bottom cover <NUM> as depicted in step <NUM>. Step <NUM> brings housing <NUM> and container <NUM> together for device assembly. Step <NUM> can be performed in a sterile environment, clean room environment, or under other aseptic or semi-aseptic conditions and includes, for example, lid <NUM> welding to housing <NUM>, heat sealing of pull tab <NUM> to lid <NUM>, introducing container <NUM> to housing <NUM>, and press attachment of bottom cover <NUM> to housing. Likewise, step <NUM> involves applying the tamper seal and/or optional labeling. Step <NUM> involves dispenser <NUM> sterilization using high energy radiation so as to sterilize the vapocoolant contents of container <NUM> as well as dispenser <NUM>. Step <NUM> involves packaging of the nonsterile and hermetically sealed dispenser <NUM>.

In one aspect, the dispenser <NUM> can be configured to release vapocoolant for a time of approximately <NUM> to <NUM> seconds, or longer. In one aspect the dispenser is configured to release vapocoolant for <NUM>-<NUM> seconds, <NUM> to <NUM> seconds, <NUM>-<NUM> seconds, or longer. In other aspects, the dispenser <NUM> is configured to release vapocoolant continuously.

Either while the vapocoolant is flowing or just after the flow of the vapocoolant is stopped, the skin can then be accessed e.g., penetrated by a needle of the syringe to a desired depth, insertion of catheter or other medical device or the like. In using the dispenser <NUM> disclosed, various types of dermal/sub-dermal accesses may be subsequently employed, such as subcutaneous, intramuscular or intradermal.

If desired, additional injections may be carried out at the same or at different locations. During the process of injection multiple injections at the same or different sites, additional vapocoolant may be dispensed as desired to provide or maintain the numbness of the skin at that location. In one example, dispenser <NUM> can be optionally packaged before sterilization. Thus, in one example, a secondary packaging configuration is employed comprising shipper boxes arranged so that each packaged dispenser is in a single layer so as to complement the low-penetration properties of e-beam radiation and avoid a multi-layered packaged device system would otherwise require a higher maximum dosage to obtain the requisite sterility than the envisioned single-layered packaging. Reducing the maximum dose of radiation for product sterilization reduces radiation damage to components, e.g., valve member <NUM> of container <NUM>.

The devices and assemblies presently described provide for a configuration and function that is advantageous for a person in need of numbing an injection site prior to self-injection, for pediatrics, or for example, injections in proximity to the buttocks or other locations such as the lower legs, back, shoulders, etc..

Claim 1:
A sterilizable vapocoolant dispenser (<NUM>), comprising:
a container (<NUM>) comprising vapocoolant selected from hydrochlorofluoroolefin, hydrochloric carbon hydrochloroolefin, hydrocarbon, hydroolefin, perfluorocarbon, perfluroolefin, perchlorocarbon, perchloroolefin, or mixtures thereof, the container having a valve member (<NUM>) configured to release the vapocoolant under its own head-space pressure of above ambient atmospheric pressure, without pressurized air or inert gas;
a housing (<NUM>) having a distal open end; a proximal open end sized to receive a majority portion of the container and exposing a remainder portion (<NUM>) of the container;
a bottom cover (<NUM>) sealing the proximal open end and the remainder portion of the container;
a lid (<NUM>) sealing the distal open end, the lid coupled to the valve member; and
a nozzle receiving member (<NUM>) positioned in the housing and configured to engage the valve member for releasing the vapocoolant;
characterized in that the container and its contents are hermetically sealed in the housing and configured for sterilization by high energy radiation.