The present invention relates to a pain reducing device, and more particularly to a pain reducing device that uses a cold portion to anesthetize a target area of the body.
Fear of needles is often associated with pain and anxiety in both pediatric and adult patients. These negative associations often begin at an early age with childhood vaccinations and continue throughout adulthood. Several techniques are used to mitigate this pain and anxiety but are used infrequently because they have limitations which do not make them feasible for use in routine vaccinations and other injection procedures. They are particularly difficult to use during large scale vaccination efforts such as COVID-19 and influenza vaccination administration. Currently, the most common practice to alleviate fear and anxiety in a pediatric patient is having the adult accompanying the child hold the child while distracting them. This technique has limitations as it does not anesthetize the target area for the needle procedure so the child will still feel discomfort which then leads to associating needle injections with pain, which contributes to the cycle of needle anxiety and fear. Another option, for both pediatric and adult patients, requires the application of topical numbing agents available in various creams, sprays or patches. This option is expensive and requires a long period of time for the target area to be anesthetized for it to be a practical solution in a clinic setting or large-scale vaccination events. Another option is the use of vapocoolant sprays. These sprays comprise gases that are flammable and are irritants to the eyes. The spray anesthetizes any area of the body that is exposed and comes into contact with the spray, thus it fails to precisely target the area to receive the needle procedure. Additionally, these sprays may cause occupational exposure issues and are toxic to the environment. Another device attempts to reduce pain by combining vibration and ice. This device is expensive and is designed for multi-use applications resulting in infection control complexity and thus is not suited for large scale vaccination events.
Thus there is a need for a pain reduction device suitable and adaptable to pediatric and adult subjects that is inexpensive, single-use, fast acting, safe, easily stored in large quantities and precisely targets the area for the needle injection or procedure, without any of the above listed or other disadvantages.
The present invention is drawn to an apparatus for facilitating needle procedures in pediatric and adult subjects, it is more specifically directed to reduce pain by anesthetizing a targeted area of the body for patients receiving vaccines and other medical procedures requiring a needle, without deleteriously affecting body surfaces outside of the localized area. The device is useful in hospital, clinic and home settings. It is easily used by healthcare professionals, self-administering patients or a non-professional care giver. This is particularly useful in settings providing large scale vaccinations such as COVID-19 vaccines, influenza vaccines and other vaccines.
The invention is drawn to reducing pain and anxiety for children or adults prior, during and post injections. Reducing pain and anxiety is instrumental in vaccine and other medical procedures to ensure compliance. It has been reported in the literature such as Relevant Statistics: McLenon, J. “The fear of needles: A systemic review and meta-analysis” Journal of Advanced Nursing, 2019, vol 75, Issue 1, pp. 30-42 that 20-50% of adolescents have needle fear and anxiety, 20-30% of young adults have needle fear and anxiety, 16% of adults avoid flu vaccination because of needle fear, 50% of women with pregnancy-induced diabetes fear self-injections with a needle, 40% of caregivers for diabetic children fear injecting their child and 65% of dialysis patients try to avoid injecting themselves. These statistics demonstrate that fear of needles is a significant contributing factor to the lack of vaccine compliance and other medical procedures as well as avoiding self-administration procedures, pain abortive infusions, fertility treatments and other treatments, and contributes to a patient's avoidance of often necessary diagnostic testing and therapeutic procedures. The search for better ways to improve the experience of vaccinations or other medical injections becomes even more critical for diseases like Covid-19 or other pandemic diseases which require large scale vaccinations and treatments.
The present invention is based on an understanding of human physiology and of the laws of thermodynamics. When an injection is administered the needle injures the tissue as it penetrates the injection location, the nerves in the area respond by sending a pain signal to the brain. Injections are administered into three types of tissue: the skin, subcutaneous and intramuscular. The human skin has far more nerve endings than the subcutaneous or intramuscular locations which results in a sharp and focal pain response. The subcutaneous or intramuscular injections, by contrast, produce a duller, vague ache from a needle puncture. A theory posited by research suggests that one type of nerve transmission can block another type of sensation at the spinal cord where nerves merge in a hub-like manner. Effective counter pain sensations may include pressure, cold and vibration applied to an injection site. Cooling of the nerve tissue is particularly effective to reduce pain. It has been found that cooling of nerve tissue to only 50 degrees Fahrenheit reduces conduction of nerve signals by a third. Warm blood circulating back to the cooled tissue however reduces some of the benefits of cooling the injection site. The present invention mitigates the warming of the injection site and enhances the pain reduction provided by cooling of the targeted area for an injection by also applying pressure to a small circle of nerves affected by the needle. The pressure compresses superficial blood vessels trying to rewarm the area; the cold and pressure sensations may block the pain signals at the spinal cord thus enhancing pain reduction. Further, the structure of the device around the ice allows the person applying the pressure to not feel the cold of the ice and the device insulates the ice from the environmental warmth.
Another benefit of the present invention is post-injection when the re-application of the device to the area having received the injection continues to impart pain reducing benefits. The application of the pain reducing cooling device and pressure minimizes the deeper pain associated with the muscle and reduces bleeding from injured vessels which contribute to pain after an injection. Another embodiment of the present invention that enhances pain reduction, especially in pediatric patients is distraction. Distraction is known to block pain transmission at higher levels of the nervous system such as in the brain stem and the cortex. An embodiment of the present invention includes a toy which amongst other features may spin, rotate, reveal a surprise to engage and distract the child while an injection is being administered. Other features may include sound or light.
The present invention utilizes principles of thermodynamics to reduce pain. An embodiment of the invention uses the concepts and properties of ice and its melting point. It is a basic scientific tenet that adding certain compounds to water causes it to freeze at lower temperature. For example, an ice cube comprising essentially of water is warmer than an ice cube comprising water and salt additives. The extra cooling stored in the solid phase of ice is another important principal. Cool gel packs traditionally store less cooling power because the additive gelling agent does not allow for an ice melting phase, resulting in a gel pack that warms up faster than a non-gel containing pack. An embodiment of the present invention specifically maximizes thermodynamic properties of materials for maximum cooling of the targeted area. Even more targeted cooling is achieved by the shape of the coolant containing structure. For example, a flat disc shaped ice pack has an ice phase, but it loses cooling ability at an unacceptable rate due to the high surface to volume ratio. Thus, the present invention uses water solutions containing an additive to reach a freezing temperature below 32 degrees Fahrenheit. The additive is preferably a salt such as sodium chloride. The additive may also be other non-toxic additives known in the art. The solution may contain other additives known in the art that do not affect the freezing phase of the solution, for example additives that may prevent leakage. As the ice feature in the ice phase pulls heat from the body it will remain at a temperature below 32 degrees Fahrenheit for a period of time to cool the injection site to receive the injection and it is still sufficiently cold to be applied to the injection site post injection to continue to cool the skin and muscle to reduce pain. The coolant cartridges are preferably a cylinder shape. This shape is the best shape to maximize the surface area to volume ratio to deliver the most beneficial cooling to the targeted body area.
Another embodiment of the present invention is the application of the pain reducing cooling apparatus to provide a cooling numbing device that targets nerve pain conduction associated with minor superficial injuries to the skin from accidents, insect bites, small abrasions, cuts, contusions or burns. The cooling device is suited for home, office, school, and medical facility settings. Its convenient size and design appeal contribute to the timeliness of applying the cooling device to the injury to achieve the desired reduction of pain and swelling. Additionally, the device may be re-cooled and re-applied to the injury as needed.
The pain reducing cooling anesthetic devices of the present invention are not only effective to cool a very specific, targeted area of the body receiving a needle procedure, but they are also useful post procedure, where they may be reapplied to further reduce pain and discomfort from the procedure. The shape and size of the devices are particularly suited for targeted applications, delivering pain reducing benefits without deleteriously affecting surrounding tissue. Although the invention is described with human patients, it is understood that it may be applied to animals requiring targeted pain reduction.
The invention is a pain reducing anesthetic cooling device having a coolant which is applied prior to an injection to cool the targeted area for an anesthetic effect. The device having a cartridge housing and coolant may be two separate parts. The device is particularly suited to provide targeted anesthetic properties without impacting surrounding tissues. The pain reducing cooling is maximized by the shape of the device, where the surface area and volume are designed to impart maximum, rapid cooling of the body area while the coolant retains its freezing temperature for a period of time to make it particularly useful post injection or for a minor injury where it can be applied multiple times.
The invention may further comprise a retaining cap attached to the cartridge housing. The retaining cap may be attached by, e.g., a snap-fit or screw fit. The retaining cap allows for efficient cooling. For example, it may have a ring-shaped cap having an orifice or it may be a ring-shaped cap having a thin layer which allows efficient cooling of the subject's targeted body area. The ring-shaped cap with the orifice is a preferred embodiment as it allows for the coolant containing cartridge to protrude through the orifice for optimal contact with the targeted body area to achieve maximum cooling. The retaining cap may have a flange on its perimeter for snap fitting to the cartridge housing. Alternatively, the retaining cap may snap fit to the cartridge housing with a plurality of tabs spaced apart on its perimeter.
The pain reducing anesthetic cooling device may further comprise an attachment to the cartridge housing and extends therefrom, such as a ring member or a protruding member. A ring member facilitates holding the cooling apparatus to the target area for the necessary time period to cool the skin to reduce pain for the needle injection. Alternatively, a protruding member therefrom can assist in holding the cooling apparatus to the target area. Additionally, the protruding member may be configured to removably attach a toy. The toy may provide a distraction to a child especially during the cooling of the injection site and during the injection. Any toy having a receiving slot to complement the protruding member is suitable to removably attach to the protruding member. Examples of toys include, but are not limited to, action figures, seasonal toys, teddy bears, dolls, promotional merchandise, and all animal shapes. To increase the distraction of a child the toy may also contain movable parts and/or reveal compartments as well as sound and light features. The housing also provides insulation of the cold to the fingers holding the device and the environmental warmth which will melt the ice.
The pain reducing device's retaining cap may be configured to freely spin in either direction. The spinning movement provides distraction to a pediatric patient. The retaining cap which spins may be shaped in any form. Examples of the spinning retaining cap include but are not limited to flowers, stars, badges, dinosaurs, and other animals.
The pain reducing device may further comprise a flexible hinge joining the cartridge housing and retaining cap.
The invention is also particularly useful for preparing the body part receiving multiple needle injections, for example during childhood vaccinations when often multiple injections are given at the same time. The pain reducing device comprises a second cartridge housing and a second coolant, wherein the cartridge housings are attached to each other at an appropriate distance for medical professionals to administer separate vaccines.
The invention is drawn to a method of anesthetizing a targeted area of a body part in preparation for a needle injection. The method comprises applying pressure with a pain reducing cooling device described above for a period of time to cool the targeted area to numb the pain by reducing nerve conduction, then removing the cooling device before the injection. The pain reducing cooling device, when removed from the targeted body area after being held to achieve the necessary cooling, may leave a gentle impression on the skin. The impression may serve as a guide to the person injecting the needle. A particular benefit of an impression on the skin is that it identifies the area that has been cooled where it is most beneficial to perform the needle injection. The center of the impression is the most ideal spot for the needle injection since that is the area of the skin and muscle that is at the lowest temperature and thus imparts the greatest pain reduction. Optionally, the coolant device may be placed on the injection site post-injection to further minimize pain.
Yet another embodiment of the invention is drawn to a method of using the device to reduce swelling and pain resulting from minor injuries, cuts, insect bites, minor burns and abrasions. The method precisely targets the injured area and delivers pain and swelling reducing benefits without engaging the non-injured areas surrounding the injured body portion. The method comprises applying pressure to the injured body portion, with the pain reducing device, for a sufficient amount of time to stem blood flow and reduce pain. The pain reducing device is removed once a desired level of comfort has been reached. The procedure may be repeated until the subject reaches a further acceptable level of comfort and reduction of pain.
The pain reduction cooling device not only reduces pain but minimizes the anxiety often associated with needle injection procedures. The cooling device of the invention reduces pain by precisely anesthetizing a targeted area in a manner that prevents cooling excessive areas of the skin, targets the injection site with a temporary skin impression as a guide for needle injection placement, and makes it easy for medical staff, home care givers or the patient to use and store the device. Additional features of the invention contribute to distracting the patient, in addition to toys, and spinning elements, sound and light features, the coolant may contain colorants such as dyes and particulate additives such as glitter to increase the visual appeal.
The coolant may be a small plastic cartridge containing a frozen substance such as ice comprising water, a solution of water and sodium chloride or other salts, a solution of water and non-toxic additives known in the art to reduce the freezing point of water, or other cold substances which can be stored in a freezer, preferably in sheets of multiple units.
The cartridge shells could be made of vacuum formed polyethylene terephthalate glycol (PETG) sheet material that is transparent. This sheet material may be about 0.015 inch thick. The cartridge shells are easily grouped and filled with cooling material. The refrigerant cooling agent may contain coloring agents or particulates such as glitter for additional appeal and interest. The material could be sealed in place with a heat-sealed foil utilizing standard sealing techniques. The cartridge sheets may be die-cut in a way that would allow individual cartridges to be snapped off as needed. The two-part pain reducing device may be made by the injection molding process using High Impact Styrene or Polypropylene. The choice of materials will be based on the need for the retaining cap to snap over the cartridge housing and be able to spin freely. The retainment cap snap-fit could be designed to allow for the replacement of the cartridge with a fresh cartridge from the refrigerator or designed to be permanently fixed once snapped in place. The retaining cap may contain a plurality of tabs on the outer perimeter, or a continuous flange to snap fit over the cartridge housing. The retaining cap and cartridge housing may also be configured to close as a screw cap.
The embodiments above may be used together in any combination thereof. For example, the cartridge housing, cartridge and retaining cap may be used with an optional ring; or the cartridge housing, cartridge and retaining cap may be used with a protruding member and an optional removable toy; another example is a double cartridge with a protruding member with the optional removable toy; yet another combination is the cartridge housing and cartridge; yet another combination is a cartridge housing, a cartridge, and the spinning retaining cap; yet still another combination is the cartridge housing, cartridge, retaining cap and the flexible connection holding the cartridge housing and the retaining cap together.
The present disclosure will be better understood by those skilled in the pertinent art by referencing the accompanying drawings, where like elements are numbered alike in the several figures, in which:
The invention is best described by referring to the figures.
The disclosed pain reduction device has many advantages. It will anesthetize a precise targeted area on a patients ‘body in preparation for an injection without the need for drugs. The pain reduction device has a toy such as a figurine, or a spinning element, that will keep a child occupied and distracted from the injection. For an adult the device can be made without a toy. One embodiment of the pain reduction device will prepare the patient for two injections on the same limb. The pain reduction device is inexpensive and disposable for proper infection control. However, the pain reduction device may be reusable if the family wants to take it home to use on wounds or insect bites. The toy on the pain reduction device may be replaced with other toys or figurines to appeal to a wide variety of children. The device is designed to be used and stored in a medical clinic in order to give greater access to patients, yet not disrupt medical staff workflow. The small size of the cartridge makes it easy to store many units in a freezer. The small size of the cartridge also minimizes the area cooled on the skin, minimizing the feeling of the cold cartridge on surrounding skin area making vaccinations more comfortable and in turn increasing vaccination compliance rates.
While the disclosure has been described with reference to several embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the disclosure. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the disclosure without departing from the essential scope thereof. Therefore, it is intended that the disclosure not be limited to the particular embodiments disclosed as the best mode contemplated for carrying out this disclosure, but that the disclosure will include all embodiments falling within the scope of the appended claims.
This application claims benefit to provisional application 63/040,108 filed on Jun. 17, 2020.
Number | Date | Country | |
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63040108 | Jun 2020 | US |