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 Compressible Annular Pain-Reduction Structure is pressed against the skin before one or more sharp probes is pressed into 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 being blocked by the pain gating effects of the Compressible Annular Pain-Reduction Structure. The Compressible Annular Pain-Reduction Structure provides a surround-effect that creates a plurality 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 is referred to as PAIN FENCE™ pain reduction technology. Thus, a PAIN FENCE™ is any arrangement of pain-gates that substantially block or inhibit pain signals that tend to not be blocked by a single dull probe.
The Compressible Annular Pain-Reduction Structure 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 Compressible Annular Pain-Reduction Structure.
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 Compressible Annular Pain-Reduction Structure (which effectively hides the sharp probes inside), and has been told to expect to “feel a dull pressure”, he/she fully expects to feel dull pressure, and so is even less likely to experience any discomfort.
A general aspect of the invention is an allergy skin testing device which is to be used by pressing the device against skin. The 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; and a compressible annular pain-reduction structure having an annular dull probe portion, a resilient compressible portion, and a base portion, the annular dull probe portion initially extending beyond the sharp portion of the central post, and having a passageway allowing passage of the sharp portion therethrough, the annular dull probe portion being configured to activate a surrounding pain gate effect when pressed against the skin, the resilient compressible portion being configured to compress along the longitudinal portion of the central post while the annular dull probe portion is pressed against the skin, the base portion being configured to be pushed by the guide portion of the central post when the annular dull probe portion is pressed against the skin, thereby compressing the resilient compressible portion until the one or more sharp probes are pressed into the skin so as to administer the allergen to the skin.
In some embodiments, the resilient compressible portion of the compressible annular pain-reduction 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 single bendable element configured to resiliently bend when compressed.
In some embodiments, the resilient compressible portion of the compressible annular pain-reduction structure includes: a bellows configured to resiliently shorten when compressed.
In some embodiments, the resilient compressible portion of the compressible annular pain-reduction structure includes: a spring configured to resiliently shorten when compressed.
In some embodiments, the annular dull probe portion has a C-shaped cross-section.
In some embodiments, the annular dull probe portion includes one or more bumps on an annular surface of the annular dull probe portion that contacts the skin.
In some embodiments, the device further includes: a sealing ring seated at a point along the sharp portion of the central post, the sealing ring being in slidable contact with an inner surface of the passageway of the annular dull probe portion so as to ensure that the sharp probes of the sharp portion contact the skin in substantial concentric relationship with the annular contact surface of the annular dull probe portion that contacts the skin.
In some embodiments, the device further includes: a friction-free coating applied to the inner surface of the passageway so as to reduce friction between the sealing ring and the inner surface of the passageway.
In some embodiments, the guide portion of the central post includes an attachment feature for attaching the guide portion to a handle of a multiple test allergy skin testing device. In further embodiments, the device also includes a handle of a multiple test allergy skin testing device.
Another general aspect of the invention is a multiple test allergy skin testing device, that is used by pressing the device against skin. This 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 annular pain-reduction structures, each compressible annular pain-reduction structure having an annular dull probe portion, a resilient compressible portion, and a base portion, the annular dull probe portion initially extending beyond the sharp portion of the central post, and having a passageway allowing passage of the sharp portion therethrough, the annular dull probe portion being configured to activate a surrounding pain gate effect when pressed against the skin, the resilient compressible portion being configured to compress along the longitudinal portion of the central post while the annular dull probe portion is pressed against the skin, the base portion being configured to be pushed by the guide portion of the central post when the annular dull probe portion is pressed against the skin, thereby compressing the resilient compressible portion until the one or more sharp probes are pressed into the skin so as to administer the allergen to the skin; and a gripping element configured to receive the plurality of central posts, the gripping element being for securely controlling the plurality of central posts and the respective plurality of compressible annular pain-reduction structures, so as to facilitate pressing the annular dull probe portion of each compressible annular pain-reduction structure, and then the sharp portion of each central post, into the skin using one press of the gripping element towards the skin.
In some embodiments, the resilient compressible portion of each compressible annular pain-reduction structure includes: a pair of bendable elements configured to resiliently bend when compressed.
In some embodiments, the resilient compressible portion of each compressible annular pain-reduction structure includes: a bellows configured to resiliently shorten when compressed.
In some embodiments, the resilient compressible portion of each compressible annular pain-reduction structure includes: a spring configured to resiliently shorten when compressed.
In some embodiments, each annular dull probe portion has a C-shaped cross-section.
In some embodiments, each annular dull probe portion includes one or more bumps on an annular surface of the annular dull probe portion that contacts the skin.
In some embodiments, the device further includes: a sealing ring seated at a point along the sharp portion of the central post, the sealing ring being in slidable contact with an inner surface of the passageway of the annular dull probe portion so as to ensure that the sharp probes of the sharp portion contact the skin in substantial concentric relationship with the annular contact surface of the annular dull probe portion that contacts the skin. In further embodiments, the device also includes: a friction-free coating applied to the inner surface of the passageway so as to reduce friction between the sealing ring and the inner surface of the passageway.
In some embodiments, the guide portion of each central post includes an attachment feature for attaching the guide portion to the gripping element.
Another general aspect of the invention is an allergy skin testing device that is used by pressing the device against skin, the device including: 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; and a compressible annular pain-reduction structure having an annular dull probe portion, and a resilient compressible portion, the annular dull probe portion initially extending beyond the sharp portion of the central post, and having a passageway allowing passage of the sharp portion therethrough, the annular dull probe portion being configured to activate a surrounding pain gate effect when pressed against the skin, the resilient compressible portion being configured to compress along the longitudinal portion of the central post while the annular dull probe portion is pressed against the skin.
In some embodiments, the compressible annular pain-reduction structure further includes: a cover portion that covers the resilient compressible portion, the cover portion being attached to the annular dull probe portion of the compressible annular pain-reduction structure.
In some embodiments, the resilient compressible portion of the compressible annular pain-reduction 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 single bendable element configured to resiliently bend when compressed.
In some embodiments, the resilient compressible portion of the compressible annular pain-reduction structure includes: a bellows configured to resiliently shorten when compressed.
In some embodiments, the resilient compressible portion of the compressible annular pain-reduction structure includes: a spring configured to resiliently shorten when compressed.
In some embodiments, the annular dull probe portion includes one or more bumps on an annular surface of the annular dull probe portion that contacts the skin.
In some embodiments, the device further includes: a friction-free coating applied to the inner surface of the passageway so as to reduce friction between the sharp portion and an inner surface of the passageway.
In some embodiments, the guide portion of the central post includes an attachment feature for attaching the guide portion to a handle of a multiple test allergy skin testing device.
In some embodiments, the device further includes a handle of a multiple test allergy skin testing device.
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, 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. The material tested was between 30-40 Shore A. “Shore A” is a hardness scale used to quantify hardness of rubber and plastics. 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.
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.