Patent Publication Number: US-2018036020-A1

Title: Devices and methods for applying antigens for allergy testing

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims priority to U.S. Provisional Patent Application Ser. No. 62/369,874 filed Aug. 2, 2016, the contents of which are incorporated by reference herein. 
    
    
     BACKGROUND INFORMATION 
     Existing devices and methods for applying antigens to a skin surface for allergy testing include numerous shortcomings. For example, existing devices make it difficult for a user to apply a consistent and desired amount of pressure to the skin surface. In addition, existing devices and methods can present challenges in confirming the antigens are applied to the device in the proper location and are applied to the skin surface effectively. 
     As discussed in further detail below, exemplary embodiments of the present disclosure address shortcomings of existing devices and methods, and accordingly provide notable benefits in comparison to such systems and methods. 
     SUMMARY 
     Exemplary embodiments of the present disclosure include devices and methods for applying antigens for allergy testing. 
     Exemplary embodiments include a device for applying antigens to a subject skin surface for allergy testing, the device comprising: an elongated body comprising a first end and a second end; a curved lower surface extending between the first and second ends; a substantially planar upper surface extending between the first and second ends; and a plurality of prongs extending from the curved lower surface. In certain embodiments, the plurality of prongs comprises at least a first prong and a second prong, and the angle between the first prong and the second prong is between 45 and 90 degrees when the device is viewed from the first end. In particular embodiments, each of the plurality of prongs comprises a first end distal to the curved lower surface, and each of the plurality of prongs comprises a plurality of tines at the first end. In some embodiments, the plurality of tines at the first end of each prong comprises eight tines. In specific embodiments, the plurality of tines are triangle-shaped. 
     In certain embodiments, the plurality of tines are distributed around an outer perimeter of the first end of each prong. In particular embodiments, the outer perimeter is circular. In some embodiments, the first end comprises a first textured gripping surface, and the second end comprises a second textured gripping surface. In specific embodiments, the curved lower surface comprises a third textured gripping surface extending between the first end and the second end, and the curved lower surface comprises a fourth textured gripping surface extending between the first end and the second end. 
     In certain embodiments, the curved lower surface is a semi-circular shape when viewed from the first end. Particular embodiments further comprise an antigen receptacle configured to couple to the substantially planar upper surface. In some embodiments, the antigen receptacle comprises a plurality of antigen containers. In specific embodiments, the antigen receptacle comprises a first plurality of numeric indicators, where: each numeric indicator in the first plurality of numeric indicators indicates a position of an antigen container; the elongated body comprises a second plurality of numeric indicators, wherein each numeric indicator in the second plurality of numeric indicators indicates a position of prong; and each numeric indicator in the first plurality of numeric indicators has an equivalent numeric indicator in the second plurality of numeric indicators. 
     In certain embodiments, each of the antigen containers is covered by a seal. In particular embodiments, the seal comprises a metallic foil. In some embodiments, the plurality of prongs are configured to align with the plurality of antigen containers when the antigen receptacle is positioned such that the seal is proximal to the curved lower surface. In specific embodiments, the antigen receptacle is configured to couple to the substantially planar upper surface via a first snap member proximal to the first end and via a second snap member proximal to the second end. In certain embodiments, the elongated body comprises a first orientation indicator directed toward the first end of the elongated body; and the antigen receptacle comprises a second orientation indicator directed toward the first end of the elongated body when the antigen receptacle is coupled to the substantially planar upper surface. 
     In particular embodiments, the elongated body comprises a first rocking member proximal to the first end, and a second rocking member proximal to the second end. In some embodiments, the plurality of prongs comprises ten prongs and in specific embodiments, the plurality of prongs comprises twelve prongs. 
     Certain embodiments include a method of applying antigens to a subject skin surface for allergy testing, where the method includes obtaining a device comprising: an elongated body comprising a first end and a second end; a curved lower surface extending between the first and second ends; a substantially planar upper surface extending between the first and second ends; and a plurality of prongs extending from the curved lower surface. In certain embodiments, the plurality of prongs comprises at least a first prong and a second prong; and the angle between the first prong and the second prong is between 45 and 90 degrees when the device is viewed from the first end. Certain embodiments include: applying a plurality of antigens to the plurality of prongs of the device, wherein a single antigen is applied to each prong of the plurality of prongs; gripping the elongated body of the device; engaging the curved lower surface of the device to the subject skin surface; and rotating the device along an axis extending between the first end and the second end of the elongated body such that the first prong initially contacts the subject skin surface and the second prong subsequently contacts the subject skin surface after the first prong. 
     In particular embodiments, applying a plurality of antigens to the plurality of prongs of the device comprises: obtaining an antigen receptacle comprising a plurality of antigen containers, wherein each of the antigen containers contains an antigen and is covered by a seal; positioning the antigen receptacle such that antigen containers are proximal to the curved lower surface of the device; aligning the plurality of prongs with the plurality of antigen containers; and piercing the seal with the plurality of prongs so that each prong is inserted into an antigen container. 
     In certain embodiments, the antigen receptacle is initially coupled to the device, and further comprise separating the antigen receptacle from the device prior to positioning the antigen receptacle such that antigen containers are proximal to the curved lower surface of the device. In particular embodiments, the antigen receptacle is initially coupled to the substantially planar upper surface. In some embodiments, the device comprises a first orientation indicator, and the antigen receptacle comprises a second orientation indicator. Specific embodiments, further comprise positioning the antigen receptacle such that the first orientation indicator and the second orientation indicator are both oriented in a same direction. 
     In certain embodiments, the antigen receptacle comprises a first plurality of numeric indicators, where each numeric indicator in the first plurality of numeric indicators indicates a position of an antigen container; and the elongated body comprises a second plurality of numeric indicators, wherein each numeric indicator in the second plurality of numeric indicators indicates a position of prong; and each numeric indicator in the first plurality of numeric indicators has an equivalent numeric indicator in the second plurality of numeric indicators. 
     Particular embodiments, further comprise verifying each numeric indicator in the first plurality of numeric indicators is proximal to the equivalent numeric indicator in the second plurality of numeric indicators. In some embodiments, the first end of the device comprises a first textured gripping surface; the second end of the device comprises a second textured gripping surface; the curved lower surface of the device comprises a third textured gripping surface extending between the first end and the second end; and the curved lower surface of the device comprises a fourth textured gripping surface extending between the first end and the second end. 
     In some embodiments, gripping the elongated body of the device comprises gripping one or more of the first textured gripping surface, the second textured gripping surface, the third textured gripping surface and the fourth textured gripping surface. In particular embodiments, the elongated body comprises a first rocking member proximal to the first end and comprises a second rocking member proximal to the second end; and the method further comprises verifying a desired amount of pressure is being applied to the subject skin surface by confirming that the first and second rocking members make an impression on the subject skin surface while rotating the device along the axis extending between the first end and the second end of the device. In some embodiments, the plurality of prongs comprises ten prongs and in specific embodiments, the plurality of prongs comprises twelve prongs. 
     In the present disclosure, the term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically. 
     The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and/or the specification may mean “one,” but it is also consistent with the meaning of “one or more” or “at least one.” The term “about” means, in general, the stated value plus or minus 5%. The use of the term “or” in the claims is used to mean “and/or” unless explicitly indicated to refer to alternatives only or the alternative are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and/or.” 
     The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”) and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes” or “contains” one or more steps or elements, possesses those one or more steps or elements, but is not limited to possessing only those one or more elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes” or “contains” one or more features, possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed. 
     Other objects, features and advantages of the present invention will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating specific embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will be apparent to those skilled in the art from this detailed description. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       The following drawings form part of the present specification and are included to further demonstrate certain aspects of the present invention. The invention may be better understood by reference to one or more of these drawings in combination with the detailed description of specific embodiments presented herein. 
         FIG. 1  illustrates an exploded side view of a first embodiment of a device for applying antigens for allergy testing. 
         FIG. 2  illustrates an end view of a first component of the embodiment of  FIG. 1 . 
         FIG. 3  illustrates a top view of the component of  FIG. 2 . 
         FIG. 4  illustrates a top view of a second component of the embodiment of  FIG. 1 . 
         FIG. 5  illustrates a partial perspective view of a feature of the embodiment of  FIG. 1 . 
         FIG. 6  illustrates an end view of the feature of  FIG. 5 . 
         FIG. 7  illustrates an exploded side view of a second embodiment of a device for applying antigens for allergy testing. 
         FIG. 8  illustrates a top view of a second component of the embodiment of  FIG. 7 . 
     
    
    
     DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS 
     Referring initially to  FIG. 1 , a device  100  for applying antigens to a subject skin surface for allergy testing is shown with an elongated body  110  comprising a first end  111 , a second end  112 , a curved lower surface  120 , and a substantially planar upper surface  130 , each extending between the first end  111  and second end  112 . As shown in  FIG. 1 , device  100  also comprises a plurality of prongs  140  extending from curved lower surface  120 . As shown in the end view of  FIG. 2 , prongs  140  are arranged in two rows such that an angle A between a prong in the first row and a prong in the second row is between 45 and 90 degrees when device  100  is viewed from first end  111 . In specific embodiments, the angle between the rows of prongs may be approximately 45, 50, 55, 60, 65, 70, 75, 80, or 85 degrees. As explained in more detail below, this configuration can enable a user to effectively apply antigens to a subject skin surface for allergy testing. 
     In the embodiment shown, device  100  also comprises an antigen receptacle  150  configured to couple to substantially planar upper surface  130  via a first snap member  151  proximal to first end  111  and a second snap member  152  proximal to second end  112 . Antigen receptacle  150  can be initially coupled to elongated body  110  (e.g., for shipment purposes) and then separated prior to use. 
     Antigen receptacle  150  comprises a plurality of antigen containers  160  covered by a seal  165 . In particular embodiments, seal  165  may comprise individual metallic foil covers for each antigen container  160 . In other embodiments, seal  165  may comprise a single cover layer that covers all of antigen containers  160 . As explained in further detail below, an antigen from each antigen container  160  can be applied to each prong  140  prior to applying the antigens to a subject skin surface. For example, antigen receptacle  150  can be positioned such that seal  165  is proximal to curved lower surface  120  and prongs  140  are aligned with antigen containers  160 . Elongated body  110  and antigen receptacle  150  can then be engaged such that prongs  140  pierce seal  165  and each prong  140  is inserted into an antigen container  160 . 
     Device  100  may also comprise features to assist a user in aligning elongated body  110  and antigen receptacle  150  to ensure prongs  140  and antigen containers  160  are properly aligned. Referring now to  FIGS. 3 and 4 , for example, antigen receptacle  150  may comprise a first plurality of numeric indicators  161 , each indicating a position of an antigen container  160 . In addition, elongated body  110  may comprise a second plurality of numeric indicators  162 , each indicating a position of prong in the plurality of prongs  140 . In the embodiment shown, each numeric indicator in the first plurality of numeric indicators  161  has an equivalent numeric indicator in the second plurality of numeric indicators  162 . This can assist a user in confirming elongated body  110  and antigen receptacle  150  are properly positioned such that the corresponding antigen containers  160  and prongs  140  are aligned when antigens are applied to prongs  140 . 
     In addition, elongated body  110  may comprise a first orientation indicator  153  (e.g. an arrow) directed toward first end  111 . Antigen receptacle  150  may also comprise a second orientation indicator  154  directed toward first end  111  when the antigen receptacle  150  is coupled to substantially planar upper surface  130 . Orientation indicators  153  and  154  can be used to verify that elongated body  110  and antigen receptacle  150  are properly aligned when prongs  140  are used to pierce seal  165  and apply antigens to prongs  140 . 
     While the embodiment shown in  FIGS. 1-4  illustrates an antigen receptacle with ten prongs and antigen containers, other embodiments may comprise a different number of prongs and antigen containers. For example, as shown in  FIGS. 7-8 , device  100  may comprise an elongated body  110  with a plurality of prongs  140  that comprises twelve prongs. In addition, antigen receptacle  150  comprises twelve antigen containers  160  and seals  165 . Similar to the embodiment of  FIG. 4 , antigen receptacle  150  also comprises numeric indicators  161  and orientation indicator  154 . In other aspects, the embodiment shown in  FIGS. 7-8  is equivalent to the embodiment of  FIGS. 1-4 . For sake of clarity and to avoid redundancy, the remaining features and components in the embodiment of  FIGS. 7-8  are not labeled with reference numbers. Embodiments with a higher number of prongs and antigen containers can be less costly, allow less storage and the test is faster in and out for the patient. For example, such embodiments can reduce the testing time and costs by allowing a greater number of antigens to be applied at one time. Still other embodiments may comprise different numbers of antigen containers and prongs. 
     After antigens have been applied to prongs  140 , elongated body  110  can be used to apply antigens to a subject skin surface for allergy testing. Elongated body comprises also comprises features to assist a user in applying the antigens to the subject skin surface. For example, first end  111  may comprise a first textured gripping surface  116  and second end  112  may comprise a second textured gripping surface  117  to assist a user in grasping elongated body  110  when applying antigens to the subject skin surface. In certain embodiments, curved lower surface  120  comprise a third textured gripping surface  118  and a fourth textured gripping surface  119  extending between first end  111  and second end  112 . While the fourth textured gripping surface is not visible in the figures, it is understood to be equivalent to third textured gripping surface  118  but on the opposing side of curved lower surface  120  from third textured gripping surface  118 . 
     During application of antigens to a subject skin surface, a user can grip any of the textured gripping surfaces and engage elongated body  110  with the skin surface. For example, referring now to  FIG. 2 , elongated body  110  can be positioned so that curved lower surface  120  initially engages skin surface  125  on one side of prongs  140 . Elongated body  110  can then be rotated along an axis  135  extending between first end  111  and second end  112  of elongated body  110  such that a first prong  141  initially contacts skin surface  125  and a second prong  142  subsequently contacts  125  skin surface after first prong  141 . In exemplary embodiments, curved lower surface can extend through an arc of approximately 180 degrees to allow a user to roll elongated body  110  in an even manner and apply uniform pressure to skin surface  125  in a natural and ergonomic motion. In particular embodiments, elongated body  110  comprises rocking members  113  and  114  proximal to first end  111  and second end  112 , respectively. In the embodiment shown, rocking members  113  and  114  extend slightly below curved lower surface  120 . During use, rocking members  113  and  114  can be used to confirm that a proper amount of pressure is being applied to skin surface  125  by elongated body  100  during the application of antigens. For example, a user can verify the desired amount of pressure is being applied by confirming that rocking members  113  and  114  are making an impression skin surface  125 . 
     Referring now to  FIGS. 5 and 6 , more detailed views of a prong  140  are shown. In  FIG. 5 , a partial perspective view is shown of prong  140  having a first end  143  comprising a plurality of tines  145 . In this embodiment, tines  145  are triangle-shaped and are distributed around an outer perimeter  149  of first end  143  of prong  140 .  FIG. 6  illustrates an end view of prong  140 , which shows eight tines  145  in this embodiment. During application of antigens to skin surface  125 , tines  145  will make an impression in skin surface  125  which can provide visual confirmation to a user that the desired amount of pressure is being applied to elongated body  110 . 
     As discussed herein, exemplary embodiments of the present disclosure address shortcomings of existing devices and methods. 
     Accordingly, embodiments of this disclosure provide notable benefits in comparison to such devices and methods. 
     All of the devices, systems and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices, systems and methods of this invention have been described in terms of particular embodiments, it will be apparent to those of skill in the art that variations may be applied to the devices, systems and/or methods in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the invention. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the invention as defined by the appended claims. 
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