WO2024112810A1 - Swab - Google Patents

Abstract

A swab for collecting samples from a user, the swab including a handle having a first swab end, and a head extending from the handle opposite the first swab end to provide a second swab end. Where a predetermined break point is positioned along a length of the swab between the first swab end and the second swab end.

Description

SWAB

CROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims priority to U.S. Provisional Patent Application No. 63/427,405, filed on November 22, 2022, the entire contents of which are fully incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The embodiments described here relate to a molded swab for taking biological samples, and more particularly, to a swab having a handle formed with a predetermined break point and a flexible swab head formed with an opening and inwardly projecting fingers.

BACKGROUND

[0003] Swabs are generally used to collect and temporarily retain biological samples.

SUMMARY

[0004] In one aspect, a swab for collecting samples from a user, the swab including a handle having a first swab end, and a head extending from the handle opposite the first swab end to provide a second swab end, where a predetermined break point is positioned along a length of the swab between the first swab end and the second swab end.

[0005] Alternatively or additionally, in any combination, where the predetermined break point is positioned along a length of the handle.

[0006] Alternatively or additionally, in any combination, where the predetermined break point is positioned in a range from 1.4 inches to 1.6 inches from the second swab end.

[0007] Alternatively or additionally, in any combination, where the handle and the head are monolithic.

[0008] Alternatively or additionally, in any combination, where the handle includes a grasping handle portion and a connecting handle portion at the predetermined break point, and where the predetermined break point has a diameter that is in a range between 30% and 60% less than the diameter of the connecting handle portion. [0009] Alternatively or additionally, in any combination, where the predetermined break point includes a narrowing in cross-sectional shape compared to the handle.

[0010] In another aspect, a swab including a handle defining a handle axis, and a head extending axially from the handle, where the head includes a perimeter wall completely enclosing an aperture, and where the aperture passes completely through the head, and where the head includes a plurality of fingers extending from the perimeter wall into the aperture.

[0011] Alternatively or additionally, in any combination, where the perimeter wall includes a first side portion and a second side portion, and where the plurality of fingers extend from at least one of the first side portion and the second side portion.

[0012] Alternatively or additionally, in any combination, where the fingers are positioned to protrude alternately from the first side portion and the second side portion.

[0013] Alternatively or additionally, in any combination, where at least one of the fingers includes a rounded tip with constant radius.

[0014] Alternatively or additionally, in any combination, where the radius of the at least one of the fingers is in a range from 0.5 millimeters to 0.7 millimeters.

[0015] Alternatively or additionally, in any combination, where the first side portion includes a first edge projecting outwardly about the aperture and transverse to the handle axis, and where the second side portion includes a second edge projecting outwardly about the aperture and transverse to the handle axis.

[0016] Alternatively or additionally, in any combination, where the first edge projecting outwardly on the first side portion includes a first notch and the second edge projecting outwardly on the second side portion includes a second notch, the first notch and the second notch each reducing a dimension of the respective first edge and second edge projecting outwardly, where the first notch and the second notch define a path having a path axis perpendicular to the handle axis and offset from the handle axis.

[0017] Alternatively or additionally, in any combination, where the first side portion and the second side portion each have an elongate length and the aperture is slit shaped. [0018] Alternatively or additionally, in any combination, where the handle includes a first swab end and the head includes a second swab end away from the handle, where the aperture defines an aperture width measured perpendicular to the handle axis, and where a tip at the second swab end is deflectable from the handle axis at least a distance equal to the aperture width.

[0019] Alternatively or additionally, in any combination, where the head and the handle are formed integrally or monolithically and at least the head is formed from a flexible material.

[0020] In another aspect, a head including a perimeter wall completely enclosing an aperture, the perimeter wall including a first side portion and a second side portion, and where the aperture passes completely through the head, and a plurality of fingers extending from at least one of the first side portion and the second side portion into the aperture.

[0021] Alternatively or additionally, in any combination, where the fingers are positioned to protrude alternately from the first side portion and the second side portion.

[0022] Alternatively or additionally, in any combination, where at least one of the fingers includes a rounded tip with constant radius, and wherein the radius is in a range from 0.5 millimeters to 0.7 millimeters.

[0023] Alternatively or additionally, in any combination, where the first side portion includes a first edge projecting outwardly about the aperture and transverse to a handle axis, and where the second side portion includes a second edge projecting outwardly about the aperture and transverse to the handle axis, where the first edge and the second edge define the aperture.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Fig. 1 is a top view of the swab of the present invention.

[0025] Fig. 2 is an enlarged view of an embodiment for a break point of the swab of Fig.

1.

[0026] Fig. 3 is an enlarged top view of the head of the swab of Fig. 1.

[0027] Figs. 4 and 5 are perspective views of the head of the swab of Fig. 1. [0028] Fig. 6 is a top view illustrating the deflection of the head of the swab of Fig. 1.

[0029] FIG. 7 is a perspective view of another embodiment of a swab.

[0030] FIG. 8 is a top view of the swab of FIG. 7.

[0031] FIG. 9 is a side view of the swab of FIG. 7.

[0032] FIG. 10 is an end view of the swab of FIG. 7.

[0033] FIG. 11 is a section view taken along line 11-11 of FIG. 9.

[0034] FIG. 12 is a detailed top view of the head portion of the swab of FIG. 7.

[0035] FIG. 13 is a detailed side view of the head portion of the swab of FIG. 7.

DETAILED DESCRIPTION

[0036] Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

[0037] Figures 1 -6 illustrate a swab 10 for collecting biological samples. The swab 10, in turn, includes a handle portion 14 defining a handle axis 16 and a first end 18, and a head or tip portion 22 extending from the handle portion 16 to form a second end 26 opposite the first end 18. While the illustrated embodiment includes a single head portion 22 extending from one end of the handle portion 14, it is to be understood that in alternative embodiments a second head portion (not shown) may extend from the handle portion 14 opposite the first head portion 22. Still further, while the illustrated handle portion 14 is approximately 6 inches in length (±10%), in alternative embodiments different lengths may be used, such as but not limited to, 8 inches, 3 inches, and the like.

[0038] The swab 10 of the illustrated embodiment is configured to provide a relatively soft touch during the sample collection process by spreading the interacting forces over a relatively large surface area (e g., a relatively longer swab head 22) and by having a head portion 22 that is able to flex and deform to accommodate to the contour of the surface along which the swab is traveling to collect the sample. More specifically, the head portion 22 is configured so that the second end 26 may deflect laterally away from the handle axis 16 during operation to produce a deflection distance 101 measured perpendicular to the handle axis 16 (see deflected head portion 22’ and deflected second end 26’ relative to undeflected head portion 22 and undeflected second end 26 of FIG. 6). In still other embodiments, the head portion 22 may deform such that the second end 26 may deflect laterally away from the handle axis 16 at least a distance 101 equal to the aperture width 74.

[0039] Furthermore, the head portion 18 is shaped such that it may be used for oral, pharyngeal, nasopharyngeal, and vaginal sample collection. The illustrated swab 10 is also autoclavable, being at least partially formed from medical-grade polypropylene or other materials that can withstand the heat produced therein without excessive deformation or losing the ability to operate as intended. By being autoclavable, the swab 10 may be disinfected and reused.

[0040] As shown in FIG. 1, the handle portion 14 and the head portion 22 are formed together as a single piece of material. More specifically, the handle portion 14 and the head portion 22 are molded together, monolithically, from a non-fibrous and non-foam type material. In the illustrated embodiment, the handle portion 14 and the head portion 22 are molded together from a material such as, but not limited to, a thermoplastic elastomer (TPE), polyethylene, polypropylene, silicone, and the like. Stated differently, the head portion 22 and the handle portion 14 are formed from the same material.

[0041] As shown in FIG. 1, the handle portion 14 of the swab 10 includes an elongated body extending along the handle axis 16. The handle portion 14 includes a predetermined break point 30 sized and shaped so that the swab 10 will snap or break into two separate pieces at a pre-determined break location 32 when subject to an external force. More specifically, the predetermined break point 30 includes geometric features formed into the handle portion 14 configured to produce a high stress area at the break location 32 whereby any bending, flexing, and/or twisting of the swab 10 (e.g., the handle portion 14) beyond a pre-determined limit will cause the material to break at the break location 32. [0042] In the illustrated embodiment, the break point 30 includes a narrowing or decrease in cross-sectional area whereby the minimum cross-sectional area coincides with the break location 32. More specifically, the break point 30 includes a conical surface 38 tapering radially inwardly to form an apex 42 at the intersection with a radially oriented surface 46. The resulting apex 42 is coincident with the break location 32. While the illustrated break point 30 includes the intersection of conical and radial surfaces 38, 46, it is understood that in other embodiments different geometric forms of a break point 30 may be used. For example, in some embodiments, the break point may include the intersection of two conical surfaces, a notch or groove cut into the handle portion 14, perforations formed into the handle portion 14, and the like. In still other embodiments, the break point 30 may include a decrease in cross-sectional shape whereby the break location 32 has a cross-sectional area that is between 30% and 60% less than the cross-sectional area of the adjacent handle portion 14. In still other embodiments, the break location 32 may have a cross-sectional area that is approximately 70%, 80%, 85%, 90% and 95% of the cross-sectional area of the adjacent handle portion 14. In still other embodiments, the break point 30 may include a groove extending around the perimeter of the handle 14 at the break location 32.

[0043] As shown in FIG. 1, the break point 30 and break location 32 are positioned along the length of the handle portion 14 of the swab 10. However, in other embodiments the break point 30 and break location 32 may be incorporated into the head portion 22 of the swab 10. In still other embodiments, the break point 30 and break location 32 may be positioned at the midpoint between the first end 18 and the second end 26. In still other embodiments, the break point 30 and break location 32 may be positioned approximately 1 inch, 1.25 inches, 1.5 inches, 1.75 inches, 2 inches and 2.5 inches from the second end 26 (± 10%). In still other embodiments, the break point 30 and break location 32 may be positioned at the intersection between the head portion 22 and the handle portion 14. In still other embodiments, the predetermined break point 30 and break location 32 is positioned along a length of the handle portion 14 in a range preferably from 1.4 inches to 1.6 inches from the second end 26. Other ranges, such as from 1 inch to 2 inches are also contemplated. In another embodiment, the predetermined break point 30 is positioned along a length of the handle portion 14 in a range preferably from 1.4 inches to 1.6 inches from the second end 26.

[0044] In still other embodiments, the break location 32 may be positioned so that the resulting sub-portion including the head portion 22 (e.g., the head portion 22 and at least a portion of the handle portion 14), has an axial length that generally corresponds and is slightly less than the axial length of a test tube or other sample container. As such, the resulting sub-portion can be positioned in and separated from the remainder of the swab 10 within a sample container and sealed therein.

[0045] As shown in FIG. 1, the break point 30 separates the handle portion 14 into a first handle portion 14a (e.g., extending between the break point 30 and the first end 18), and a second handle portion 14b (e.g., extending between the break point 30 and the head portion 22). In the illustrated embodiment, the first handle portion 14a and the second handle portion 14b have different cross-sectional sizes and/or shapes. More specifically, the second handle portion 14b is smaller in cross-sectional shape than the first handle portion 14a. During use, the difference in diameter accommodates the general use of the two portions with the first handle portion 14a being configured for the user to grasp and manipulate the sw ab 10 while the second handle portion 14b is smaller to more readily fit within a test tube.

[0046] While the illustrated embodiment includes a single head portion 22 extending from the handle 14 opposite the first end 18 (see Fig. 1), it is to be understood that in alternative embodiments a second head portion (not shown) may extend from the handle 14 at the first end 18 (e.g.. opposite the single head 22). In such embodiments, the swab 10 may then include a second break point (not shown) corresponding with and positioned relative to the second head portion in a similar manner as the first break point 30 described above.

[0047] FIG. 3 illustrates an enlarged view of the head portion 22 of the swab 10. The head portion 22 includes a perimeter wall 34 at least partially enclosing an aperture 40, and a plurality of fingers or protrusions 54, 58, 60 extending from the perimeter wall 34 into the aperture 40. More specifically, the perimeter wall 34 is shaped to form an elongated loop that completely encloses the aperture 40 about a plane 64 that is coincident with the handle axis 16 while the aperture 40 completely passes through the head 22 being open to opposite ends thereof. More specifically, the aperture 40 generally extends along an aperture axis 66 that is normal to the plane 64 and oriented approximately perpendicular to the handle axis 16 (e.g., 90 degrees ±10%).

[0048] As shown in FIG. 3, the perimeter wall 34 of the head portion 22 forms a generally elongated loop defining an aperture length 70 (e.g., parallel to the handle axis 16) and an aperture width 74 (e.g., perpendicular to the handle axis 16). In the illustrated embodiment the aperture length 70 is between 4 and 8 times greater than the aperture width 74. In still other embodiments, the aperture length 70 is between 5 and 7 times greater than the aperture width 74. In still other embodiments the aperture length 70 is approximately 6 times greater than the aperture width 74 ±10%.

[0049] In the illustrated embodiment, the perimeter wall 34 includes a first side portion 34a, a second side portion 34b, a first end portion 34c connecting to the handle portion 14, and a second end portion 34d forming the second end 26. In one embodiment, the first side portion 34a and the second side portion 34b each have an elongate length and form a mirror image about the handle axis 16. However, in other embodiments the first side portion 34a, second side portion 34b may have different contours to make an asymmetric shape.

[0050] As shown in FIGS. 4 and 5, the perimeter w all 34 of the head portion 22 tapers as it extends perpendicular to the plane 64, in both directions therefrom, to form a pair of ridges 84 extending around the perimeter of the aperture 40. The tip 88 of each ridge 84, in turn, is radiused to provide a smooth surface as it travels across the desired sample surface. The perimeter wall 34 also includes a lip 92 extending outw ardly therefrom along the plane 64. In the illustrated embodiment, the lip 92 extends along the first side portion 34a, the second side portion 34b, and the second end portion 34d. Similar to the ridge 84, the edges of the lip 92 are all radiused to provide a smooth surface as the swab 10 travels across the desired sample surface.

[0051] The perimeter wall 34 also includes a plurality of notches 96 formed therein. Each notch 96, in turn, is complemented by a corresponding protrusion 108 extending outwardly from lip 92 (see FIG. 4). While the illustrated embodiment includes two lip/protrusion combinations along the perimeter wall 34 (e.g., one on the first side portion 34a and one on the second side portion 34b), it is understood that in other embodiments more or fewer lip/protrusion combinations may be present as needed.

[0052] The head portion 22 of the sw ab 10 also includes one or more first fingers or protrusions 54 extending from the first side portion 34a of the perimeter wall 34 into the aperture 40, one or more second fingers or protrusions 58 extending from the second side portion 34b of the perimeter w all 34 into the aperture 40, and one or more third protrusions 60 extending from the end portions 34c, d of the perimeter wall 34 into the aperture 40. The resulting fingers 54, 58 are positioned to protrude alternately from the first side portion 34a and the second side portion 34b along a length of the aperture 40 with a pair of end protrusions 60 extending into the aperture 40 from the end walls 34c. 34d. In the illustrated embodiment, the first and second protrusions 54, 58 extend from their corresponding side portion 34a, 34b of the perimeter wall 34 parallel to the plane 64 and beyond the axis 16 without contacting or otherwise being coupled to the opposing side portion 34b, 34a forming a cantilevered construction.

[0053] In the illustrated embodiment, each finger 54, 58, 60 includes an elongated shaft 100 and a rounded tip 104. In some embodiments, the rounded tip 104 includes a constant radius that is between 0.5 millimeters to 0.7 millimeters, and preferably 0.6 millimeters. In still other embodiments, the constant radius of the rounded tip 104 is between 0.4 millimeters to 0.8 millimeters. As shown in FIG. 3, the center point of each rounded tip 104 of the first, second, and third plurality of fingers 54, 58, 60 are all coincident with the handle axis 16. However, in other embodiments, only a portion of the center points of the rounded tips 104 may be coincident with the handle axis 16. As shown in FIG. 4. the tips 104 of each finger 54, 58, 60 are generally cylindrical in shape having an axis that is oriented perpendicular to the handle axis 16.

[0054] The shafts 100 of the first and second sets of fingers 54. 58 are oriented oblique to the handle axis 16 to form an overall chevron pattern (see FIG. 3.) being angled generally toward the second end 26. In the illustrated embodiment, the shaft 100 of each finger 54, 58 is generally oriented at a finger angle 102 between 20 degrees to 40 degrees relative to the handle axis 16. However, in other embodiments each shaft 100 may be angled between 10 degrees and 50 degrees relative to the handle axis 16. In still other embodiments the finger angle is approximately 30 degrees ±10%. Furthermore, while the illustrated fingers 54, 58 are all oriented at the same angle ±10%, in other embodiments each finger or a subset of fingers may be oriented at a unique angle relative to the handle axis 16. The shafts 100 of the third set of fingers 60 are oriented parallel to the handle axis 16.

[0055] In one arrangement, the tip of the fingers 54, 58, 60 provide a cylindrical shape as shown in Fig. 4 with the axis of the resulting cylinder being perpendicular to the handle axis 16. The fingers 54, 58 are spaced from one another at equidistant intervals in one arrangement. However, in alternative embodiments, other alternative or different ergonomic shapes may be used for the fingers 54, 58, 60. [0056] In some alternative embodiments, the head 22 of the swab 10 may be molded onto an existing handle 14. In such embodiments, the head 22 may be formed from a non-fibrous and non-foam type material including, but not limited to, TPE, polyethylene, polypropylene, silicone and the like. Furthermore, the handle 14 may be formed from the same or other materials such as, but not limited to, wood, TPE, poly ethylene, polypropylene, silicone, and the like, including combinations thereof.

[0057] To use the swab 10, a user places the swab 10 in contact with the corresponding surface from which the user wants to collect a sample (e.g., the interior surface of a nasal cavity, and the like). The swab 10 is then twisted or moved to scrape and dislodge cells from the surface of the patient by passing surfaces of the swab 10 (e.g., the tip 88 and lip 92) over the sample surface. By doing so, any fluid and/or biological material that has been dislodged can collected within the aperture 40. The swab 10 (e.g., the head portion 22) also flexes during operation to increase the surface area of the swab 10 in contact with the sample surface thereby increasing comfort and the volume of tissue collected. When flexing, the fingers 54 58, 60 are able to move within the aperture 40 due in part to their cantilevered configuration allowing for greater flexibility and comfort. In this manner, a sample is collected that remains within the aperture 40 including the fingers 54, 58, 60.

[0058] Once the sample is collected, the user may then deposit the head portion 22 of the swab 10 in a corresponding test tube or other sample receptacle. To do so, the user first inserts the head portion 22 into the receptacle. The user then applies a force to the handle portion 14 of the swab causing the break point 30 to snap or separate at the break location 32. By doing so. the first portion 14a of the handle 14 can be detached and removed - shortening the overall length of the remaining swab 10 (e.g., the head portion 22 and second handle portion 14b) so that it can be completely positioned within the corresponding test tube. The test tube may then be sealed and transferred for analysis.

[0059] In use for obtaining an oral sample or a nasal sample, the swab 10 includes the aperture 40 that can be easily filled with a minimal amount of oral fluid that is kept therein by surface tension during a cheek scrubbing process or nasal scrubbing process. The liquid, in turn, acts like a magnet that pulls cells in and keep them stuck and piling up during the collection process adding more captured cells. Also, the head 22 of the swab 10 is capable of flexing inwards when it enters the nasal cavity’, making it less invasive and easier to insert and capture more cells on the way out. Therefore, the illustrated swab 10 achieves greater cell capture and comfort than alternative designs.

[0060] FIGS. 7-11 illustrate another embodiment of the swab 1010. The swab 1010 is substantially similar to the swab 10 so only the difference will be described in detail herein. The swab 1010 includes a handle portion 1014 defining a handle axis 1016 and a first end 1018, and a head or tip portion 1022 extending from the handle portion 1016 to form a second end 1026 opposite the first end 1018. In the illustrated embodiment, the overall axial length of the swab 1010 (e.g., between the first end 1018 and the second end 1022) is 3 inches (±10%). However, in other embodiments, different axial lengths may be present.

[0061] The handle portion 1014 of the swab 1010 includes a first portion 1500 having a first cross-sectional shape and a second portion 1504 having a second cross-sectional shape that is different than the first cross-sectional shape. More specifically, the handle portion 1014 is configured so that the first portion 1500 forms the first end 1018 while the second portion 1504 extends between the first portion 1500 and the head portion 1022. In the illustrated embodiment, the first portion 1500 has an axial length of approximately 1.5 inches while the second portion 1504 has an axial length of approximately 0.63 inches.

[0062] As shown in FIGS. 8, 10, and 11, the first portion 1500 of the handle portion 1014 has an enlarged cross-sectional shape configured to provide a suitable grip for the user to grasp. More specifically, the cross-sectional shape of the first portion 1500 includes four semi-circular protrusions extending radially outwardly from the handle axis 1016. Overall, the cross-sectional shape of the first portion 1500 is larger than the cross-sectional shape of the second portion 1504 which is generally cylindrical in shape.

[0063] The break point 1030 of the swab 1010 is positioned at the axial mid-point of the swab 1010 (e.g., 1.5 inches from the second end 1026). More specifically, the break point 1030 is positioned along the second portion 1504 of the handle portion 1014 and includes a groove formed into and extending about the exterior of the second portion 1504 perpendicular to the handle axis 1016. The shape of the groove may include a shape that forms one or more sharp comers into the swab 1010 to form high stress points to help aid the severing of the material at the desired point.

[0064] As shown in FIGS. 12 and 13, the head portion 1022 of the swab 1010. The head portion 1022 includes a perimeter wall 34 at least partially enclosing an aperture 1040. and one or more fingers or protrusions 1054, 1058, 1060 extending from the perimeter wall 1034 into the aperture 1040. More specifically, the perimeter wall 1034 is shaped to form an elongated loop that completely encloses the aperture 1040 about a plane 1064 that is coincident with the handle axis 1016 while the aperture 1040 completely passes through the head 1022 being open to opposite ends thereof. In the illustrated embodiment, the head 1022 geometry is symmetrical about the plane 1064 to aid the molding procedure. In some embodiment, the mold may be configured so that the parting line between molding parts is aligned with plane 1064.

[0065] As shown in FIGS. 12 and 13, the perimeter wall 1034 of the head portion 1022 forms a generally elongated loop defining an aperture length 1070 (e.g., parallel to the handle axis 1016) and an aperture width 1074 (e g., perpendicular to the handle axis 16). In the illustrated embodiment the aperture length 1070 is between 8 and 9 times greater than the aperture width 1074. In still other embodiments, the aperture length 1070 is between 7 and 10 times greater than the aperture width 1074. In still other embodiments the aperture length 1070 is approximately 8.7 times greater than the aperture width 1074 ±10%. Still further, the illustrated aperture 1040 has a constant aperture width 1074 over the majority of its length.

[0066] As shown in FIG. 12, the perimeter wall 34 also includes a plurality of notches 1096 formed therein. Each notch 96, in turn, is complemented by a corresponding protrusion 1108 extending outwardly from lip 1092. More specifically, the head portion 1022 includes four notch/protrusion combinations spaced equally along the axial length of each side portion 1034a, 1034b. During use, each combination helps to dislodge and collect sample material from the desired surface as it is dragged along during the swabbing process. In other embodiments, more or fewer notch/protrusion combinations may be present.

[0067] During use. the head portion 1022 of the swab 1010 is configured to flex generally along the plane 1064 to accommodate the different contours and orientations of the bodily surface from which the sample is to be extracted. More specifically, the perimeter wall 1034 of the head portion 1022 is sized and shaped so that the side portions 1034a, 1034b can curve and elastically deflect when encountering a bodily surface (not shown). Furthermore, the fingers 1054. 1058, 1060 are sized and shaped so that they are able to move relative to each other and relative to the perimeter wall 1034 to accommodate such deflection. For example, the tips 1104 of each finger 1054, 1058, 1060 are rounded so that they can engage wdth and slide along the opposite side portion 1034a, 1034b in addition to engaging with and sliding along opposing fingers 1054, 1058, 1060. By doing so, the fingers 1054, 1058, 1060 are able to both increase the retention capabilities of the head portion 1022 while not unduly stiffening the head portion 1022 such that it can no longer comfortably and readily elastically deflect to the contour of the bodily surface to be sampled.

[0068] The following examples are offered to illustrate but not limit the herein described embodiments.

[0069] Example 1.

[0070] Buccal samples were self-collected from 12 individuals (2 samples each) in the AM using NextSwab3 by creating a saliva pool in their cheek, dipping the swab head in the pool for 10-20 seconds while simultaneously rubbing the side of their cheek. Samples were then ejected in the iSWAB-DNA device, making sure that all of the sample within the swab head is removed. With the exception of 2 iSWAB-250 devices and 1 iSWAB01200, most samples were released in iSWAB-DSC devices. Samples collected in -DSC used 1 NextSWAB3, 2 swabs for -250, and 4 swabs for -1200. The samples were then rocked for 2 hours in a Chemistry /Hemotology Mixer to simulate ground transport. Samples were then processed by DNA extraction using the Qiagen QIAmp DNA Blood Mini Kit. Extracted DNA was further analyzed using the Qubit procedure.

[0071] Results from this process resulted in a Qubit Concentration of 21.48 ng/pL with a standard deviation of 20.66 ng/pL.

[0072] Table 1.

[0073] Example 2.

[0074] Buccal samples were self-collected from 11 individuals (2 samples each) in the AM using Copan Flocked swabs rubbing up and dow n their cheek for 10-20 seconds. Each sample used only 1 swab. Samples were then ejected in the iSWAB-DNA device, making sure that all of the sample within the swab head is removed.

[0075] Samples were then processed by DNA extraction using the Qiagen QIAamp DNa Blood Mini Kit. Extracted DNA was further analy zed using the Qubit procedure.

[0076] Results from this process resulted in a Qubit Concentration of 9.98 ng/pL with a standard deviation of 5.58 ng/pL. [0077] Table 2

[0078] Although the arrangements have been described in detail with reference to certain preferred embodiments, variations and modifications exist within the scope and spirit of one or more independent aspects of the invention as described.

[0079] Clause 1. A swab for collecting samples from a user, the swab comprising a handle having a first swab end, and a head extending from the handle opposite the first swab end to provide a second swab end, where a predetermined break point is positioned along a length of the swab between the first swab end and the second swab end.

[0080] Clause 2. The swab according to clause 1, where the predetermined break point is positioned along a length of the handle.

[0081] Clause 3. The swab according to clause 2, where the predetermined break point is positioned in a range from 1.4 inches to 1.6 inches from the second swab end.

[0082] Clause 4. The swab according to clause 2, where the handle and the head are monolithic.

[0083] Clause 5. The swab according to clause 2, where the handle includes a grasping handle portion and a connecting handle portion at the predetermined break point, and where the predetermined break point has a diameter that is in a range between 30% and 60% less than the diameter of the connecting handle portion.

[0084] Clause 6. The swab according to clause 1, where the predetermined break point includes a narrowing in cross-sectional shape compared to the handle.

[0085] Clause 7. A swab comprising a handle defining a handle axis, and a head extending axially from the handle, where the head includes a perimeter wall completely enclosing an aperture, and where the aperture passes completely through the head, and where the head includes a plurality of fingers extending from the perimeter wall into the aperture.

[0086] Clause 8. The swab according to clause 7, where the perimeter wall includes a first side portion and a second side portion, and where the plurality of fingers extend from at least one of the first side portion and the second side portion.

[0087] Clause 9. The swab according to clause 8, where the fingers are positioned to protrude alternately from the first side portion and the second side portion. [0088] Clause 10. The swab according to clause 9, where at least one of the fingers includes a rounded tip with constant radius.

[0089] Clause 11. The swab according to clause 10, where the radius of the at least one of the fingers is in a range from 0.5 millimeters to 0.7 millimeters.

[0090] Clause 12. The swab according to clause 8, where the first side portion includes a first edge projecting outwardly about the aperture and transverse to the handle axis, and where the second side portion includes a second edge projecting outwardly about the aperture and transverse to the handle axis.

[0091] Clause 13. The swab according to clause 12, where the first edge projecting outwardly on the first side portion includes a first notch and the second edge projecting outwardly on the second side portion includes a second notch, the first notch and the second notch each reducing a dimension of the respective first edge and second edge projecting outwardly, where the first notch and the second notch define a path having a path axis perpendicular to the handle axis and offset from the handle axis.

[0092] Clause 14. The swab according to clause 12. where the first side portion and the second side portion each have an elongate length and the aperture is slit shaped.

[0093] Clause 15. The swab according to clause 7, where the handle includes a first swab end and the head includes a second swab end away from the handle, where the aperture defines an aperture width measured perpendicular to the handle axis, and where a tip at the second swab end is deflectable from the handle axis at least a distance equal to the aperture width.

[0094] Clause 16. The swab according to clause 7, where the head and the handle are formed integrally or monolithically and at least the head is formed from a flexible material.

[0095] Clause 17. A head comprising a perimeter wall completely enclosing an aperture, the perimeter wall including a first side portion and a second side portion, and where the aperture passes completely through the head, and a plurality of fingers extending from at least one of the first side portion and the second side portion into the aperture.

[0096] Clause 18. The head according to clause 17, where the fingers are positioned to protrude alternately from the first side portion and the second side portion. [0097] Clause 19. The head according to clause 18, where at least one of the fingers includes a rounded tip with constant radius, and where the radius is in a range from 0.5 millimeters to 0.7 millimeters.

[0098] Clause 20. The head according to clause 17, where the first side portion includes a first edge projecting outwardly about the aperture and transverse to a handle axis, and where the second side portion includes a second edge projecting outwardly about the aperture and transverse to the handle axis, where the first edge and the second edge define the aperture.

Claims

CLAIMS:

1. A swab for collecting samples from a user, the swab comprising: a handle having a first swab end: and a head extending from the handle opposite the first swab end to provide a second swab end, wherein a predetermined break point is positioned along a length of the swab between the first swab end and the second swab end.

2. The swab according to claim 1, wherein the predetermined break point is positioned along a length of the handle.

3. The swab according to claim 2, wherein the predetermined break point is positioned in a range from 1.4 inches to 1.6 inches from the second swab end.

4. The swab according to claim 2, wherein the handle and the head are monolithic.

5. The swab according to claim 2, wherein the handle includes a grasping handle portion and a connecting handle portion at the predetermined break point, and wherein the predetermined break point has a diameter that is in a range between 30% and 60% less than the diameter of the connecting handle portion.

6. The swab according to claim 1, wherein the predetermined break point includes a narrowing in cross-sectional shape compared to the handle.

7. A swab comprising: a handle defining a handle axis; and a head extending axially from the handle, wherein the head includes a perimeter wall completely enclosing an aperture, and wherein the aperture passes completely through the head, and wherein the head includes a plurality of fingers extending from the perimeter wall into the aperture.

8. The swab according to claim 7, wherein the perimeter wall includes a first side portion and a second side portion, and wherein the plurality of fingers extend from at least one of the first side portion and the second side portion.

9. The swab according to claim 8, wherein the fingers are positioned to protrude alternately from the first side portion and the second side portion.

10. The sw ab according to claim 9, wherein at least one of the fingers includes a rounded tip with constant radius.

11. The swab according to claim 10, w herein the radius of the at least one of the fingers is in a range from 0.5 millimeters to 0.7 millimeters.

12. The swab according to claim 8, wherein the first side portion includes a first edge projecting outwardly about the aperture and transverse to the handle axis, and wherein the second side portion includes a second edge projecting outwardly about the aperture and transverse to the handle axis.

13. The swab according to claim 12, wherein the first edge projecting outwardly on the first side portion includes a first notch and the second edge projecting outwardly on the second side portion includes a second notch, the first notch and the second notch each reducing a dimension of the respective first edge and second edge projecting outwardly, wherein the first notch and the second notch define a path having a path axis perpendicular to the handle axis and offset from the handle axis.

14. The swab according to claim 12, wherein the first side portion and the second side portion each have an elongate length and the aperture is slit shaped.

15. The swab according to claim 7, wherein the handle includes a first swab end and the head includes a second swab end away from the handle, wherein the aperture defines an aperture width measured perpendicular to the handle axis, and wherein a tip at the second swab end is deflectable from the handle axis at least a distance equal to the aperture width.

16. The swab according to claim 7, wherein the head and the handle are formed integrally or monolithically and at least the head is formed from a flexible material.

17. A head comprising: a perimeter wall completely enclosing an aperture, the perimeter wall including a first side portion and a second side portion, and wherein the aperture passes completely through the head, and a plurality of fingers extending from at least one of the first side portion and the second side portion into the aperture.

18. The head according to claim 17, wherein the fingers are positioned to protrude alternately from the first side portion and the second side portion.

19. The head according to claim 18, wherein at least one of the fingers includes a rounded tip with constant radius, and wherein the radius is in a range from 0.5 millimeters to 0.7 millimeters.

20. The head according to claim 17, wherein the first side portion includes a first edge projecting outwardly about the aperture and transverse to a handle axis, and wherein the second side portion includes a second edge projecting outwardly about the aperture and transverse to the handle axis, wherein the first edge and the second edge define the aperture.