This invention relates generally to allergy skin testing devices, and particularly to allergy skin testing devices with structures to reduce pain.
Traditional allergy skin testing devices inflict pain while introducing allergens to the skin using sharp probes. According to pain-gate theory, applying dull pressure shortly before the sharp probes penetrate the skin to introduce the allergens reduces perception of the pain caused by the sharp probes. Reduced-pain allergy skin testing devices employing pain-gate theory to allergy skin testing were first taught by Harish et al. For example, Harish et al first taught using a single dull probe for each plurality of sharp probes. Heine et al then taught a version of this approach using a single dull probe for each plurality of surrounding sharp probes. However, each single dull probe of Heine et al does not provide an acceptable level of pain reduction for the corresponding plurality of surrounding sharp probes.
According to the invention, an annular surface of a rigid annular pain-reduction structure supported by a respective compressible sleeve is pressed against the skin before one or more sharp probes is pressed against the skin surrounded by the annular surface so as to deliver an allergen to the skin for testing purposes. The pain typically caused by the one or more sharp probes is blocked by the pain gating effects of the surrounding skin contact and pressure caused by the rigid annular pain-reduction structure supported by the respective compressible sleeve. The rigid annular pain-reduction structure supported by the respective compressible sleeve provides a surround-effect that creates a plurality of pain gates substantially surrounding an area of sharp probe penetration that would be painful if not blocked by the surrounding pain gates.
The plurality of surrounding pain gates thereby induced is referred to as a PAIN FENCE™, and the annular surface of a rigid annular pain-reduction structure supported by a respective compressible sleeve to be pressed against the skin is an example of PAIN FENCE™ pain reduction technology. Thus, a single dull probe pain-reduction structure cannot induce a PAIN FENCE™.
The rigid annular pain-reduction structure supported by a respective compressible sleeve also tends to visually hide the one or more sharp probes surrounded thereby, as like being hidden behind a fence, which makes the skin testing device of the invention less intimidating, and consequently less upsetting to children.
Further, by avoiding upsetting a child to be tested by the device, pain perception is further reduced beyond the physiological “pain gate” effect caused by the surrounding rigid annular pain-reduction structure supported by a respective compressible sleeve.
In addition, the physician or nurse administering the test can suggest to the patient to expect to feel a dull pressure, such as by saying “you will feel a dull pressure”. Since the patient only sees the rigid annular pain-reduction structure about to contact the skin (which effectively hides the sharp probes inside), and has been told to expect to “feel a dull pressure”, or similar expression, he/she fully expects to feel dull pressure, and so is even less likely to experience any discomfort or distress. Thus, the allergy skin testing device of the invention provides significantly enhanced patient comfort over all known skin testing devices.
A general aspect of the invention is an allergy skin testing device, the device to be used by pressing the device against skin. The allergy skin testing device includes: a central post having a sharp portion, a longitudinal portion, and a guide portion, the sharp portion having one or more sharp probes extending longitudinally and being configured to administer an allergen to the skin, the guide portion being configured to facilitate guiding the sharp portion towards the skin, the longitudinal portion extending between the sharp portion and the guide portion; a compressible structure having a leading portion surrounding the sharp portion of the central post, a resilient compressible portion, and a base portion, the resilient compressible portion being configured to compress along the longitudinal portion of the central post while the base portion is urged towards the leading portion by the guide portion, the leading portion having a first passageway to allow passage of the sharp portion therethrough; and a rigid annular probe portion having an annular skin-contacting surface, and a second passageway extending through the rigid annular probe portion, the rigid annular probe portion extending longitudinally beyond the sharp portion of the central post, before the resilient compressible portion is compressed, the second passageway allowing passage of the sharp portion therethrough, while the resilient compressible portion is compressed, the annular skin-contacting surface being configured to activate a surrounding pain gate effect when pressed against the skin before and while the one or more sharp probes are pressed against the skin so as to administer the allergen to the skin.
In some embodiments, the resilient compressible portion of the compressible structure includes: a plurality of bendable elements configured to resiliently bend when compressed.
In some embodiments, the resilient compressible portion of the compressible annular pain-reduction structure includes: a plurality of bendable elements configured to resiliently bend outwards when compressed.
In some embodiments, an inner diameter of the first passageway is substantially similar to an inner diameter of the second passageway.
In some embodiments, an outer diameter of the annular skin-contacting surface is greater than an outer diameter of the leading portion of the compressible structure.
In some embodiments, an outer diameter of the annular skin-contacting surface is substantially similar to an outer diameter of the leading portion of the compressible structure.
In some embodiments, the annular skin-contacting surface includes: one or more bumps configured to contact the skin so as to activate a surrounding pain gate effect when pressed against the skin.
In some embodiments, the annular skin-contacting surface of the rigid annular probe portion includes: surface features that depart from being flat.
In some embodiments, the annular skin-contacting surface of the rigid annular probe portion includes a convex surface of revolution defined by rotating a generatrix curve about a central axis of the rigid annular pain-reduction structure, the generatrix curve being one of: a semi-circle, a semi-ellipse, a convex half sine curve, a convex spline curve.
In some embodiments, the annular skin-contacting surface of the rigid annular probe portion includes: a half ring torus surface as the annular skin-contacting surface, thereby providing a rounded end of the of the rigid annular probe portion having enhanced dullness to augment the surrounding pain gate effect of the rigid annular probe portion.
Another general aspect of the invention is a multiple test allergy skin testing device, the device to be used by pressing the device against skin. The multiple test allergy skin testing device includes: a plurality of central posts, each central post having a sharp portion, a longitudinal portion, and a guide portion, the sharp portion having one or more sharp probes extending longitudinally and being configured to administer an allergen to the skin, the guide portion being configured to facilitate guiding the sharp portion towards the skin, the longitudinal portion extending between the sharp portion and the guide portion; a plurality of compressible structures, each compressible structure having a leading portion surrounding the sharp portion of the central post, a resilient compressible portion, and a base portion, the resilient compressible portion being configured to compress along the longitudinal portion of the central post while the base portion is urged towards the leading portion by the guide portion, the leading portion having a first passageway to allow passage of the sharp portion therethrough; a plurality of rigid annular probe portions, each rigid annular probe portion having an annular skin-contacting surface, and a second passageway extending through the rigid annular probe portion, the rigid annular probe portion extending longitudinally beyond the sharp portion of the central post, before the resilient compressible portion is compressed, the second passageway allowing passage of the sharp portion therethrough, while the resilient compressible portion is compressed, the annular skin-contacting surface being configured to activate a surrounding pain gate effect when pressed against the skin before and while the one or more sharp probes are pressed against the skin so as to administer the allergen to the skin; and a gripping element, connected to each guide portion of each of the plurality of central posts, the gripping element being for pressing each rigid annular probe portion against the skin, and then pressing the sharp portion of each respective central post against the skin, using one press of the gripping element.
In some embodiments, the resilient compressible portion of each compressible structure includes: a plurality of bendable elements configured to resiliently bend when compressed.
In some embodiments, the resilient compressible portion of each compressible structure includes: a plurality of bendable elements configured to resiliently bend outwards when compressed.
In some embodiments, an inner diameter of each first passageway is substantially similar to an inner diameter of each respective second passageway.
In some embodiments, an outer diameter of each annular skin-contacting surface is greater than an outer diameter of the leading portion of each respective compressible structure.
In some embodiments, an outer diameter of each annular skin-contacting surface is substantially similar to an outer diameter of each respective leading portion of the compressible structure.
In some embodiments, each annular skin-contacting surface includes one or more bumps configured to contact the skin so as to activate a surrounding pain gate effect when pressed against the skin.
In some embodiments, each annular skin-contacting surface of each rigid annular probe portion includes: surface features that depart from being flat.
In some embodiments, each annular skin-contacting surface of each rigid annular probe portion includes a convex surface of revolution defined by rotating a generatrix curve about a central axis of the rigid annular pain-reduction structure, the generatrix curve being one of: a semi-circle, a semi-ellipse, a convex half sine curve, a convex spline curve.
In some embodiments, each annular skin-contacting surface of each rigid annular probe portion includes: a half ring torus surface as the annular skin-contacting surface, thereby providing a rounded end of the of the rigid annular probe portion having enhanced dullness to augment the surrounding pain gate effect of the rigid annular probe portion.
The invention will be more fully understood from the following detailed description, in conjunction with the following figures, wherein:
With reference to
Extending through a passageway 112 of the compressible annular pain-reduction structure 102 is a central post 114 having a sharp portion 116, a longitudinal portion 118, and a guide portion 120. The sharp portion 116 has one or more sharp probes 117 extending longitudinally and being configured to administer an allergen to the skin. The guide portion 120 is configured to facilitate guiding the sharp portion 116 towards the skin. The longitudinal portion 118 extends between the sharp portion 116 and the guide portion 120. The central post can be made from plastic, composite, or other light-weight material.
The annular dull probe portion 108 initially extends beyond the sharp portion 116 of the central post 114, and has a passageway 112 that allows passage of the sharp portion 116 therethrough when the guide portion 120 is pressed towards the skin. The annular dull probe portion 108 is configured to activate a surrounding pain gate effect (also called a Pain Fence™) when the annular surface 122 of the annular dull probe portion 108 is pressed against the skin.
The resilient compressible portion 104 is configured to compress along the longitudinal portion of the central post 114 while the annular surface 122 of the annular dull probe portion 108 is pressed against the skin. Thus, the resilient compressible portion 104 provides a pushing force to the annular dull probe portion 108 while the sharp probes 117 of the sharp portion 116 penetrate the skin enough to introduce the allergen that adheres to the sharp probes 117.
The base portion 110 of the compressible annular pain-reduction structure 102 is configured to be pushed by the guide portion 120 of the central post 114 when the annular dull probe portion 108 is pressed against the skin, thereby compressing the resilient compressible portion 104 until the one or more sharp probes 117 are pressed into the skin so as to administer the allergen to the skin. As the base portion 110 is pulled away from the skin by the guide portion 120 of the central post 114, the resilient compressible portion 104 expands, the sharp probes 117 move away from the skin, and then the annular dull probe portion 108 moves away from the skin.
In a preferred embodiment, reduction of pain was demonstrated when annular dull probe portion 108 extended beyond the sharp probes 117 by 1/16 inch, and the pair of bendable elements 106 resisted buckling until a force of 1-2 pounds was applied. The annular surface 122 of the annular dull probe portion 108 measured ¼ inch in diameter, with a wall thickness of 1/16 inch. The wall thickness is uniform all along the compressible annular pain-reduction structure 102, from the annular surface 122 of the annular dull probe portion 108, all the way to the base portion 110, including the bendable elements 106.
In this preferred embodiment, the bendable elements 106 are ½ inch long by 1/16 inch wide. As the bendable elements 106 buckle, or bend outward, the sharp probes 117 move through the passageway 112 to make contact with the skin, delivering the allergen to be tested thereto.
In this preferred embodiment, the material used for the bendable elements 106 is silicone with a hardness between 30-40 Shore A Durometer. The material tested was between 30-40 Shore A Durometer. “Shore A Durometer” is a hardness scale used to quantify hardness of rubber and plastics. Durometer is a dimensionless quantity.
Other materials can also be used, such as thermoplastic elastomer (TPE), polyurethane (PU), polyethylene (PE), natural rubber, or synthetic rubber, for example.
When force A is reversed, as when the device 402 is pulled away from the skin 600, the sharp probes 117 retreat back into the passageway 112 of the annular dull probe portion 108. The annular dull probe portion 108 shields the sharp probes 117 from sight, thereby reducing anxiety of the patients who may fear sharp probes.
Extending through a passageway 1808 is a central post 1810 having a sharp portion 1812, a longitudinal portion 1814, and a guide portion 1816. The sharp portion 1812 has one or more sharp probes 1818 extending longitudinally and being configured to administer an allergen to the skin.
Note that in this embodiment 1800, the sharp portion 1812 is maintained in concentric alignment with the annular dull probe portion 1806 by the narrowing 1820 having a slightly larger diameter than the diameter of the sharp portion 1812, such that they are in concentric sliding contact with each other. A friction-free coating, such as Slik-Sil® from Surface Solutions Group, Chicago, Ill., or parylene types N, C, or D, internal lubricated silicone, or a dry lubricant, or similar coating, can be used to achieve substantially friction-free relative movement.
With reference to
Due to the compressibility of the compressible structure 102, the rigid annular pain-reduction structure 2002 supported by the compressible structure 102 is movable with respect to the central post 114, and therefore the rigid annular pain-reduction structure 2002 is movable with respect to the one or more sharp probes 117 of the sharp portion 116 of the central post 114, as shown in
Also, since the rigid annular structure 2002 is movable, there is a time delay between the contact made by the annular skin contacting surface 2004 of the rigid annular pain-reduction structure 2002, and contact made by the sharp probes 117 of the sharp portion 116. During the time delay, the sharp probes 117 of the sharp portion 116 move through the rigid annular pain-reduction structure 2002 towards the skin, as the compressible structure 102 compresses so as to press the annular skin contacting surface 2004 of the rigid annular pain-reduction structure 2002 against the skin.
In other embodiments, the annular skin contacting surface 2004 can include surface features that depart from being flat, such as texture, ridges, bumps, and/or protrusions.
The annular skin contacting surface 2004 could also include a surface of revolution. A surface of revolution is a surface in Euclidean space created by rotating a curve (the generatrix) around an axis of rotation. A circle that is rotated about an axis that does not intersect the interior of a circle generates a torus which does not intersect itself (a ring torus), which is the general shape of a bagel, for example. A closed semi-circle (a half-circle closed by a straight line) rotated about the central axis of the rigid annular pain-reduction structure 2002 would generate a half of a ring torus, which would look like a half of a bagel, such as would result from slicing a bagel in half before making a sandwich, each half having a flat annular surface, each half also having a convex surface.
Thus, an embodiment of the annular skin contacting surface 2004 can have the shape of the convex side of a half ring torus. Another embodiment can be a half ring torus extending from the annular skin contacting surface 2004, but the half ring torus having a larger inner diameter and a smaller outer diameter than the annular skin contacting surface 2004, so that it forms a rounded ridge that runs around a central annular portion of the annular skin contacting surface 2004.
The half ring torus can be added to a substantially flat version of the annular skin contacting surface 2004 as a separate half ring torus glued or otherwise bonded to the annular skin contacting surface 2004, or it can be co-molded to provide a convex half ring torus end without need for adhesive or attachment features.
The convex surface of a half ring torus provides a soft inviting appearance to the surface of the device 2000 that will contact the skin, while also providing increased dullness that can enhance the surrounding pain gate effect of the rigid annular probe portion 2002 when pressed against the skin.
The rigid annular probe portion 2002 includes a second passageway 2006, through which the sharps 117 of the sharp portion 116 of the central post 114 (as shown in
The rigid annular probe portion 2002 can be made from similar or the same rigid material as used to make the central post 114. In other embodiments, the rigid annular probe portion 2002 is made from another material that is relatively “rigid” in that it is less compressible (i.e., having a greater Shore A Durometer) than the material of the compressible structure 102. In this preferred embodiment, the material used for the compressible structure 102 is silicone with a hardness between 30-40 Shore A Durometer.
In some embodiments, the rigid annular probe portion 2002 is larger in outer diameter, e.g., ⅜″ than the outer diameter, e.g., 2/8″ of the base portion 110 of the compressible structure 102. In some embodiments, the rigid annular probe portion 2002 has the same outer diameter, e.g., 2/8″ as the outer diameter, e.g., 2/8″ of the base portion 110 of the compressible structure 102.
The rigid annular probe portion 2002 can be made as a part that is distinct from the base portion 110 of the compressible structure 102, or can be co-molded as two materials that are joined together during the molding process without the need for adhesives or snapping together, for example.
The leading portion 108 of the compressible structure 102 has a first passageway 112 through which the sharp portion 116 and then the longitudinal portion 118 will pass as the sharp portion 116 moves towards the skin via the second passageway 2006 through the rigid annular pain-reduction structure 2002. Thus, the second feature of the device that presses against the skin, after the annular skin-contacting surface 2004, is the one or more sharp probes 117 of the sharp portion 116.
Referring to
It is also clear in this view of the single allergy skin testing device 2000 that the central post 114 has a sharp portion 116, a longitudinal portion 118, and a guide portion 120. The sharp portion 116 has one or more sharp probes 117 extending longitudinally and being configured to administer an allergen to the skin, such as an allergen in solution into which at least the sharp probes 117 are dipped before being pressed against the skin. The guide portion 120 serves to facilitate guiding the sharp portion 116 towards the skin. The longitudinal portion 118 extends between the sharp portion 116 and the guide portion 120.
The compressible structure 102 has a leading portion 108 surrounding the sharp portion 116 of the central post 114, a resilient compressible portion 104, and a base portion 110. The resilient compressible portion 104 is configured to compress along the longitudinal portion of the central post 114 while the base portion 110 is urged towards the leading portion 108 by the guide portion 120. The leading portion 108 has a first passageway 112 that allows passage of the sharp portion 116 therethrough.
The rigid annular probe portion 2002 has an annular skin-contacting surface 2004, and a second passageway 2006 extending through the rigid annular probe portion 2002. The rigid annular probe portion 2002 extends longitudinally beyond the sharp portion 116 of the central post 114, before the resilient compressible portion 104 is compressed. The second passageway 2006 allows passage of the sharp portion 116 therethrough, while the resilient compressible portion 104 is compressed. The annular skin-contacting surface 2004 is configured as discussed with reference to
Also shown in
In some embodiments, each compressible structure 102 included in a multiple test allergy skin testing device 2400 can be of a lesser stiffness then the compressible structure 102 for use in a single tester device 2000 used separately.
The multiple test allergy skin testing device 2400 is placed onto a multi-well allergen solution tray before performing an allergy test upon the skin of a patient. Each well of the multi-well allergen solution tray can contain a solution of a different allergen, such as pet dander, grass, tree pollen, and household dust, for example.
Each well of the multi-well allergen solution tray that is configured to be cooperative with the multiple test allergy skin testing device 2400 has an opening that is of slightly greater diameter than the diameter of the rigid annular probe portion 2002. The opening is the wide end of the surface of a right conic frustum (i.e., a cone truncated by two parallel planes perpendicular to the central axis of the cone), such that the inner walls of the truncated cone guide the rigid annular probe portion 2002 to the annular ledge at the bottom of the truncated cone, the diameter of the annular ledge being just slightly lesser diameter than the opening of the well, such that the rigid annular probe portion 2002 rests snugly at the bottom of the well.
Then, the grip 2402 can be used to push against the respective central post 114 of the respective testing device 2000 such that the sharp portion 116, having the one or more sharp probes 117 extending therefrom, moves through the first passageway 112, and then out through the second passageway 2006 so as to extend down into the well until a central stop extending upwards from the center of the well impacts upon the center of the end of the sharp portion 116. In the embodiment shown in
Once thereby fully inserted into the well, the sharp probes 117 are immersed in the allergy solution of that particular well, such that when the device 2000 of the device 2400 is pulled out of the well, an effective quantity of allergen solution adheres to each of the sharp probes 117.
The central stop is of a length that prevents the sharp probes from impacting upon the bottom of the well, thereby reducing their sharpness. Thus, the central stop prevents damage to the plurality of sharp probes 117 when applying allergy solution using the wells configured to work cooperatively with the rigid annular probe portion 2002 of the device 2000.
Alternatively, the bottom of the well can be deep enough such that the sharps cannot reach the bottom, but nevertheless are immersed in allergen solution, thereby preventing damage to the plurality of sharp probes 117 when applying allergy solution.
In other embodiments, the device 2000 can include a rigid probe portion having a cross-section that is not annular, i.e., circular, instead of the rigid annular probe portion 2002, which has a circular ring cross-section. The rigid probe portion 2002 could instead have a cross section of another shape, such as one of the regular convex polygons: a triangle, a square, a pentagon, a hexagon, a heptagon, or an octagon, for example. Further, any regular convex polygon would work well, as would other shapes that could be inscribed in a circle, such as a rectangle. Thus, any of the regular polygonal shapes can provide an effectively “annular” shape for the cross-section of the rigid annular probe portion 2002. Alternatively, an ellipsoidal shape can also be used. Likewise, the compressible structure 102 can have a cross section of another shape, such as a triangle, a square, a pentagon, a hexagon, a heptagon, or an octagon, for example.
Further, although the compressible structure 102 is taught as having a resilient compressible portion 104 having a pair of bendable elements 106 as shown in
Other modifications and implementations will occur to those skilled in the art without departing from the spirit and the scope of the invention as claimed. Accordingly, the above description is not intended to limit the invention, except as indicated in the following claims.
This application is a Continuation-in-Part of application Ser. No. 15/419,738, filed Jan. 30, 2017, entitled “Allergy Skin Testing Devices with Compressible Annular Pain-Reduction Structures”, the entire contents of which are herein incorporated by reference.
Number | Date | Country | |
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Parent | 15419738 | Jan 2017 | US |
Child | 15796104 | US |