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  Apparatus and method for the reduction of pain using vibration, cold and distractive elementsUSPTO Application #: 20080086063Title: Apparatus and method for the reduction of pain using vibration, cold and distractive elements Abstract: A device for reduction of pain, comprising a casing comprising a flexible sheet of material having a first end and a second end; at least one thermal source associated with the casing; a fastener for removably joining the first end and the second end; at least one vibration source; at least one power source; at least one switch for actuating the at least one vibration source, the at least one vibration source, the at least one power source and the at least one switch being in electrical communication with each other. The device further includes a distraction aid in the form of a still or animated image associated with the casing which can distract the patient from the perception of pain. (end of abstract) Agent: Powell Goldstein LLP - Atlanta, GA, US Inventors: Amy L. Baxter, Louis A. Calderon USPTO Applicaton #: 20080086063 - Class: 601046000 (USPTO) Related Patent Categories: Surgery: Kinesitherapy, Kinesitherapy, Vibrator The Patent Description & Claims data below is from USPTO Patent Application 20080086063. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCE TO RELATED APPLICATION [0001] This application is a continuation-in-part of copending application Ser. No. 11/538,718, filed Oct. 4, 2006, entitled DEVICE AND METHOD FOR THE REDUCTION OF PAIN ASSOCIATED WITH NEEDLE STICKS, and commonly assigned to the assignee of the present application, the disclosure of which is incorporated by reference in its entirety herein TECHNICAL FIELD [0002] The present invention generally relates to devices and methods for the reduction of pain, such as that associated with needle sticks as well as other forms of acute or chronic pain. The present invention further relates to a device using vibration or a combination of vibration, cold and/or distractive elements that is applied to a patient for the reduction of the pain, for example, prior to and/or during the application of a needle or other sharp to the patient. Also disclosed are methods for using the device, and methods for using vibration or a combination of vibration, cold and/or distractive elements for the reduction of the pain. The foregoing characterization of the invention is meant solely for the purpose of establishing the technical field of the invention and is not intended to fully describe or limit the scope of the invention or the embodiments. BACKGROUND [0003] Transitory, acute and ongoing pain reduction and management have been the subject of many studies and efforts. Transitory pain may be the result of localized trauma or nerve activation, or the like. Needle sticks, such as for injection, are one such cause. According to many children, needle sticks are the most painful procedure performed in the hospital. The effects of untreated pain are remembered even by children too young to talk. Fear of needles and immunizations affect children's other healthcare experiences and parents' willingness to have them immunized. Needle phobia does not end in childhood. Some geriatric patients cite it as a reason not to get a flu shot. Some human immunodeficiency virus (HIV) patients say it is a reason for delaying being tested. While the avoidance of obtaining dental care due to needle phobia is legendary, less well known is that up to 75% of adults cite needle pain as a reason not to donate blood. [0004] Needle phobia is not isolated to the United States. In a survey asking for a blood sample for a study, 38% of adults in Singapore cited fear of needles and injections as their reason not to participate. [0005] Effective means to decrease needle pain include local analgesia, distracting the patient, and confusing the nerves. Topical analgesics can reduce or eliminate needle pain, but may cost between US$12 and US$150 per patient use. In addition, topical analgesics require prolonged application times or can cause vasoconstriction decreasing venipuncture success. Several devices deliver lidocaine using either electrical current (iontophoresis) or ultrasound, but the cost for these starts at US$50 per delivery and can take up to 10 minutes. [0006] The nerve fibers that transmit pain also transmit cold and vibration senses. Vibrating the skin while injecting lidocaine has long been used to decrease the pain of dental injections, but vibrating needles have not been found to be effective in other dermal situations. Use of a simple hand-held vibrating massager has decreased injection pain in adults, but has been used alone without the adjuvant of cold therapy and has not been tested in children. [0007] The related art devices generally are designed to be used at the site of the needle pain to deliver lidocaine (local anesthetic), rather than several centimeters proximal to the site. Further, none of the related devices incorporates the application of cold. Applying cold or vibration at the site, or immediately proximal to the site, can create logistical problems for the medical practitioner, and can cause a heightened anxiety in the patient, by requiring a plurality of devices to be located in a single location. Thus, such devices have a disadvantage. [0008] Therefore, there is a need for device to decrease the pain associated with immunization, infiltration, injection and venipuncture, which would include both cold and vibration stimulation. Such a device should be reusable, easy to clean, tolerable to children and adults, and should incorporate a method to be adapted for use in the developing world (for example, operation with a power cord, with a battery, with a solar or light cell, with a wind-up motor, or without the need for external power). [0009] Distraction of the patient from the impending or present pain (or anticipation of such) is another known technique (in addition to vibration and cold) for alleviating or preventing pain, particularly in children. It would be desirable for a device intended for pain reduction to have a mechanism or component which might include bright colors, attraction-getting ornamental designs, still or animated images, or simple tasks. [0010] Accordingly, there is a need for a method for reducing of the pain associated with hypodermic needle sticks and other transitory, acute and chronic pain. There also is a need for a device and method using vibration or a combination of vibration and cold that is applied to a patient prior to and/or during the application of a hypodermic needle to the patient for the reduction of the pain associated with the application of the hypodermic needle. It is to these needs and others that the present invention is directed. SUMMARY [0011] One aspect of the present disclosure provides a device for reduction of pain comprises a casing comprising a flexible sheet of material having a first end and a second end; at least. one thermal source associated with the casing; a fastener for removably joining the first end and the second end; at least one vibration source; at least one power source; at least one switch for actuating the at least one vibration source, the at least one vibration source, the at least one power source and the at least one switch being in electrical communication with each other. The device further includes a distraction aid in the form of a still or animated image associated with the casing which can distract the patient from the perception of pain. [0012] Another aspect of the present disclosure provides a device for reduction of pain, comprising: a casing comprising a flexible sheet of material having a first end and a second end; at least one thermal source associated with the casing; a fastener for removably joining the first end and the second end; at least one vibration source; at least one power source; at least one switch for actuating the at least one vibration source, the at least one vibration source, the at least one power source and the at least one switch being in electrical communication with each other. This aspect of the present invention may also include a distraction aid comprising an image or other indicia associated with the device and capable of attracting the attention of a patient. [0013] Another aspect of the present disclosure provides a method for reducing pain, comprising the steps of: a) providing a device comprising a casing having an application area, at least a portion of the application area constructed to contact a subject's skin; b) providing a thermal source contained within the casing, the thermal source capable of being cooled, and cooling the thermal source; c) providing a vibrational source contained within the casing, the vibrational source capable of producing vibration; d) contacting the application area to the subject's skin; e) activating the vibrational source so that the vibrational source produces vibrations; f) maintaining the thermal source and the vibrational source on the patient's skin for a time period; and, g) providing a distraction aid associated with the device so that the subject is able to see the distraction aid, wherein the application area is constructed to allow the transmission of cold from the thermal source to the subject's skin and the transmission of the vibration from the vibrational source to the subject's skin, whereby after contacting the application area to the subject's skin and activating the vibrational sources, cold and vibration is transmitted to the subject via the application area, whereby the combination of the transmission of cold and vibration produces a thermal analgesia and vibrational analgesia effect on the subject and the presence of distraction aid so as to reduce pain. [0014] These and other features of the present disclosure will become more apparent to those of ordinary skill in the relevant art when the following detailed description of exemplary embodiments is read in conjunction with the appended drawings in which like reference numerals represent like components throughout the several views. BRIEF SUMMARY OF THE DRAWINGS [0015] FIG. 1 is a perspective view of an exemplary embodiment of the invention. [0016] FIG. 2 is a top view of an embodiment of the invention with both vibration and cold capabilities. [0017] FIG. 3 is a bottom view of an embodiment of the invention with both vibration and cold capabilities. [0018] FIG. 4 is sectional side view of the embodiment of the invention as shown along line 4-4' of FIG. 2. [0019] FIG. 5 is a circuit diagram of an embodiment of the invention. Continue reading... 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