Vitrification freezing device with textured surface for sealing - Patent Application 20070122997

Abstract

A sealable container for storing a biological sample is provided. The sealable container includes a cap and an elongate body. The cap has a proximal open end and a distal end, and a lumen extends from the proximal open end to the distal end. The elongate body extends from a handle portion to a sample portion, the sample portion being configured to receive a biological sample thereon. The elongate body further includes a closure portion disposed between the handle portion and the sample portion, the closure portion being configured to make surface contact with the cap when the sample portion of the elongate body is fully inserted into the lumen of the cap. At least one of an inner surface of the cap and an outer surface of the elongate body includes a textured region having a textured surface finish.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 416,119, filed October 14, 2022, which is hereby fully incorporated by reference in its entirety.

[0002] The devices described herein relate to devices for holding biological samples in a freezing container for long-term cryopreservation, and may be used for vitrification, particularly for vitrification of embryos, oocytes, or other biological material, such as in combination with or in preparation for an in vitro fertilization (IVF) cycle. [Background technology]

[0003] In the context of IVF, vitrification of embryos and oocytes has emerged over the past decade as an alternative to conventional cryopreservation. Vitrification is used to preserve unused embryos after an IVF cycle, for temporary storage of embryos during genetic analysis, and as a method of oocyte preservation for female fertility preservation. The technique itself completely avoids ice formation by using high concentrations of cryoprotectants and rapid cooling rates. Summary of the Invention [Problem to be solved by the invention]

[0004] While samples are stored immersed in liquid nitrogen for extended periods of time, it may be desirable to store these samples in a device capable of forming a seal to isolate the samples from the surrounding liquid nitrogen. If liquid nitrogen leaks into the interface between the elongated body and the cap, the pressure created by the increased temperature and resulting expansion of the nitrogen in the cap may cause the cap to be forced off the elongated body when the device is removed from the liquid nitrogen. Alternatively, instead of hermetically isolating the sample from the nitrogen, it may be desirable to provide a seal that is effective to protect the sample while also allowing for the evacuation of any nitrogen and / or other substances trapped between the cap and the elongated body. [Means for solving the problem]

[0005] One general aspect of the present disclosure includes a sealable container for storing a biological sample, the container comprising: a cap having a proximal open end and a distal end, a lumen extending from the proximal open end to the distal end; and an elongate body extending from a handle portion to a sample portion, the sample portion configured to receive a biological sample thereon, the elongate body further comprising a closure portion disposed between the handle portion and the sample portion, the closure portion configured to be in facial contact with the cap when the sample portion of the elongate body is fully inserted into the lumen of the cap, wherein at least one of an inner surface of the cap that contacts the closure portion when engaged with the closure portion and an outer surface of the closure portion that contacts the cap when engaged with the cap comprises a textured region having a textured surface finish.

[0006] Another general aspect of the present disclosure includes a sealable container for storing a biological sample, the container comprising: a cap having a proximal open end and a distal end, a lumen extending from the proximal open end to the distal end; and an elongate body extending from a handle portion to a sample portion, the sample portion configured to receive a biological sample thereon, the elongate body further comprising a closure portion disposed between the handle portion and the sample portion, the closure portion configured to be in facial contact with the cap when the sample portion of the elongate body is fully inserted into the lumen of the cap, wherein an inner surface of the cap that contacts the closure portion when engaged with the closure portion and an outer surface of the closure portion that contacts the cap when engaged with the cap each comprise a textured region having a textured surface finish.

[0007] Another general aspect of the present disclosure includes a sealable container for storing a biological sample, the cap having a proximal open end and a distal end, a lumen extending from the proximal open end to the distal end, and an elongate body extending from a handle portion to a sample portion, the sample portion configured to receive a biological sample thereon, the elongate body further comprising a closure portion disposed between the handle portion and the sample portion, the closure portion configured to be in facial contact with the cap when the sample portion of the elongate body is fully inserted into the lumen of the cap, an outer surface of the closure portion that contacts the cap when engaged with the cap comprises a textured region having a textured surface finish.

[0008] A sealable container according to the present disclosure may include any combination of the features described above and / or the original claims as filed.

[0009] The advantages of the present disclosure will become more apparent to those skilled in the art from the following description of preferred embodiments thereof, shown and described by way of example. As will be understood, the disclosed subject matter is capable of other and different embodiments, and its details are capable of modification in various respects. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as limiting. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a perspective view of a cryopreservation device comprising an elongate member and a cap. [Figure 2] FIG. 2 is a side view of the elongated member of FIG. 1. [Figure 3] FIG. 2 is a top view of the elongate member of FIG. 1. [Figure 4] FIG. 3 is a side view of detail A of FIG. 2. [Figure 5] FIG. 3 is a top view of detail A of FIG. 2. [Figure 6] FIG. 6 is a cross-sectional view of the cutting portion ZZ in FIG. 5. [Figure 7] FIG. 1 shows six cryopreservation devices aligned within a sleeve of a freezing container. [Figure 8] FIG. 2 is a perspective view of the cap of the cryopreservation device of FIG. 1. [Figure 9] FIG. 9 is a side cross-sectional view of the cap of FIG. 8. [Figure 10] 2 is a cross-sectional view of the elongate strip of FIG. 1 along cut TT when the sample portion of the elongate strip is fully inserted into the cap. [Figure 11] 2 is a cross-sectional view of the elongate member of FIG. 1 taken along cut TT. [Figure 12] 2 is an enlarged side view of a portion of the elongate member of FIG. 1 showing a closure portion having a textured surface finish. [Figure 13] 9 is an enlarged cross-sectional view of a portion of the cap of FIG. 8 showing the inner surface of the cap having a textured surface finish. [Figure 14]2 is an enlarged side view of a portion of the elongate member of FIG. 1 showing a portion of the closure portion having a textured surface finish. [Figure 15] 9 is an enlarged cross-sectional view of a portion of the cap of FIG. 8 showing a portion of the inner surface of the cap having a textured surface finish. DETAILED DESCRIPTION OF THE INVENTION

[0011] Various embodiments are described below with reference to the drawings, in which like elements are generally designated by like numerals. The relationship and function of the various elements of these embodiments can be better understood by reference to the detailed description that follows. However, the embodiments are not limited to those shown in the drawings. It should be understood that the drawings are not necessarily to scale (though drawings that are to scale should be recognized as such and may be relied upon as such) and that in some cases details unnecessary for understanding the embodiments disclosed herein, such as conventional manufacturing and assembly, may be omitted.

[0012] The present invention, as defined by the claims, may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey an enabling disclosure to those skilled in the art. As used herein and in the claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. References herein to any industry standards (e.g., ASTM standards, ANSI standards, IEEE standards) are defined as conforming to the standards published as of the original filing date of this disclosure with respect to the units, measurements, and test criteria defined by those standards, unless expressly stated otherwise herein.

[0013] As used herein, the terms "proximal" and "distal" are used in their commonly used sense to refer to the handle / doctor end of a device or related object and the opposite end of the device or related object, respectively. Terms such as "about," "approximately," "substantially," "roughly," and other terms of degree, when used in connection with any volume, dimension, proportion, or other quantitative or qualitative value, are intended to convey a clear and identifiable number within standard parameters understood by one of ordinary skill in the art (equivalent to a medical device engineer experienced in the field), and should be interpreted to include at least any legal equivalents, minor but functionally insignificant variations, standard manufacturing tolerances, and at least mathematically significant figures (but not necessarily as broad a range as the maximum range).

[0014] 1-15, a device 10 for receiving and storing materials for cryopreservation is provided. The device 10 may be a sealable container configured to contain a biological sample, which encloses and supports the biological sample for long-term storage within a cryopreservation container, such as a Dewar. The device 10 can sealingly hold the biological sample using various structures described herein.

[0015] As shown in FIGS. 1-11 and described in more detail below, the cap 120 is placed over the sample portion 70, and a pressure fit between the cap 120 and a portion of the elongate body 40 (e.g., the closure portion 60) forms a seal that prevents the ingress of liquid nitrogen. This seal must be formed at room temperature, maintained in liquid nitrogen (-196°C), and maintained until released by the user after the device is returned to room temperature. Formation of such a seal is crucial. Specifically, for example, when the closure portion 60 is inserted into the cap 120 at room temperature and atmospheric pressure, the tapered portion of the closure portion 60 deforms the cap 120 where the closure portion 60 and the cap 120 contact each other, forming an interference fit between them. The device 10 (together with the cap 120) is then inserted into liquid nitrogen (-196°C). The action of cap 120 shrinking at lower temperatures forms a seal around the location of this interference fit, preventing liquid nitrogen from leaking into device 10. If liquid nitrogen leaks into the interface between closure portion 60 and cap 120, when device 10 is removed from the liquid nitrogen, the pressure created by the nitrogen within cap 120 may push cap 120 away from elongated body 40. Furthermore, leaking liquid nitrogen may contaminate the sample (e.g., embryo, oocyte, etc.) on sample portion 70.

[0016] If the surfaces at the interface between cap 120 and elongated body 40 were provided with a textured surface finish rather than a highly polished surface finish, an improved seal against the ingress of liquid nitrogen could be achieved. This improved seal from direct contact with liquid nitrogen could keep the specimen safe from potential contamination, thereby improving the performance of vitrification freezing in a sealed environment. Applicant is not aware of any competitor's products that actually form such an airtight seal, and it goes without saying that the present invention provides improved sealing performance.

[0017] Various levels of textured surface finish can be achieved. In some embodiments, the average surface roughness (Ra value) of the textured region 205 may be in the range of about 1 μin to about 28 μin (equivalent to polishing with about a #6 diamond buff to about 400 grit stone), preferably in the range of about 2 μin to about 25 μin, and more preferably in the range of about 4 μin to about 5 μin (equivalent to polishing with about 400 grit paper). As a non-limiting example, the Ra value of the textured region 205 on the inner surface 202 of the cap 120 may be in the range of about 4 μin to about 5 μin, and the Ra value of the textured region 205 on the outer surface 204 of the closure portion 60 may be in the range of about 25 μin to about 28 μin (equivalent to polishing with about a 400 grit stone). In some embodiments, at least one of the cap 120 and the elongated body 40 may be made from a material including a styrene-acrylic copolymer. For example, materials used for cap 120 and / or elongate body 40 may include Zylar® 960 and / or methyl methacrylate butadiene styrene (MBS).

[0018] The textured surface on the outer surface 204 of the closure portion 60 and / or the inner surface 202 of the cap 120 can be implemented in a variety of configurations (e.g., lengths, sizes, shapes, etc.). Referring to FIGS. 12-15 , in some embodiments, at least one of the inner surface 202 of the cap 120 (e.g., the surface that contacts the elongate body when engaged therewith) and the outer surface 204 of the elongate body 40 (e.g., the surface that contacts the cap when engaged therewith, closure portion 60) can include a textured region with a textured surface finish to improve sealing performance. This textured surface finish can be implemented on either or both of these surfaces. In some embodiments, if a textured surface is present on only one of these surfaces, the preferred textured surface should be on the outer surface 204 of the elongate body 40.

[0019] The configuration (e.g., length, size, shape) of the textured region 205 can be varied as desired and / or needed without departing from the scope of the present invention. The textured region 205 may cover at least a portion of the inner surface 202 of the cap 120 and / or at least a portion of the outer surface 204 of the elongate body 40 (e.g., closure portion 60). As a non-limiting example, the textured region 205 may cover the entire inner surface 202 of the cap 120. As another non-limiting example, the textured region 205 may cover the entire outer surface 204 of the closure portion 60, or a portion of both surfaces. 14 and 15 , as another non-limiting example, the textured region 205 may encompass a portion (e.g., about 50% or less) of the inner surface 202 of the cap 120 and / or a portion (e.g., about 50% or less) of the outer surface 204 of the closure portion 60 (e.g., the textured region 205 forms a ring section having a length of about 1-6 mm along the longitudinal axis 1001 of the elongate body 40). It will be appreciated that the textured region 205 extending around at least a portion of the circumference of the outer surface 204 of the closure portion 60 and / or the inner surface 202 of the cap 120 can be discontinuous or continuous / complete as needed and / or desired to achieve various sealing performance characteristics. That is, the entire surface area of ​​the cap inner surface and / or the closure portion outer surface may be textured, or less than the entire surface area, and in preferred embodiments, provides a better interlocking seal or other attachment than conventional similar mating surfaces, effectively preventing accidental or spontaneous disengagement of the cap. As used herein, the term "about" as used in connection with a dimension (e.g., length, width, height, depth) or roughness (e.g., Ra values ​​used below) is defined to include not only the specific numerical value referenced, but also numerical values ​​within ±5% of the referenced numerical value.

[0020] By way of non-limiting example, in some embodiments, the textured area 205 on the outer surface 204 of the closure portion 60 and / or the inner surface 202 of the cap 120 may be larger than or substantially equal to the area of ​​contact or engagement between the closure portion 60 and the cap 120. In some embodiments, a user may not press the cap 120 all the way down along the tapered portion of the closure portion 60, such that only a portion of the textured area 205 on the outer surface 204 of the closure portion 60 contacts the inner surface 202 of the cap 120. As a non-limiting example, the total area of ​​the outer surface 204 of the closure portion 60 is approximately 43.3 mm 2 The sealing may be performed up to about 2 mm from the cap opening, which is about 10-14 mm between the closure portion 60 and the cap 120. 2 This may correspond to a contact area of

[0021] In some embodiments, the textured region 205 on the inner surface 202 of the cap 120 may extend along its length from about 3-10 mm from the edge 128 a of the open proximal end 128 of the cap 120, and / or the textured region 205 on the outer surface 204 of the closure portion 60 may extend along its length from about 3-10 mm from the proximal end 68 of the closure portion 60. In these embodiments, the Ra value of at least one of the textured regions 205 may vary from about 4 μin to about 5 μin, which corresponds to approximately 400 grit sanding paper.

[0022] Rougher textures with higher Ra values, e.g., having an Ra value greater than about 10 μ-inches or equivalent to about a 600-grit stone finish, may be difficult to consistently manufacture, and therefore smaller regions of the inner surface 202 of the cap 120 and / or the outer surface 204 of the closure portion 60 may be textured, e.g., extending from about 1-3 mm from the edge 128 a of the open proximal end 128 of the cap 120 and / or from about 1-3 mm from the proximal end 68 of the closure portion 60. For textures with lower roughness, e.g., between about 4-5 μ-inches or equivalent to about a 400-grit paper finish, the length of the textured region may be longer, e.g., extending from about 6-10 mm, more preferably about 6-7 mm, from the edge 128 a of the open proximal end 128 of the cap 120 and / or from the proximal end 68 of the closure portion 60.

[0023] It will be appreciated that the textured region 205 may or may not begin (e.g., due to manufacturing tolerances) at or adjacent the edge 128a of the proximal end 68 of the closure portion 60 and / or the open proximal end 128 of the cap 120. It will also be appreciated that the textured region 205 may or may not have the same height (measured along the longitudinal axis) around the circumference of the lumen 132 of the closure portion 60 and / or the cap 120.

[0024] It should be understood that the roughness / smoothness values ​​presented herein are stated according to standard values. That is, as described in ASME B46.1 (published 2020), Ra is the arithmetic mean of the absolute values ​​of the deviations of the profile height from the mean line recorded within the evaluation length. Simply put, Ra is the average of a set of individual measurements of the surface peaks and valleys measured from the centerline mean of those values. This roughness mean (Ra) can be expressed in microinches (μin). Alternatively, smoothness / roughness can be expressed as an SPI value or a finishing method. In this case, SPI is based on the surface finishing standard established by SPI (the Society of Plastics Industry). This standard covers 12 SPI grades of polished finishes, ranging from SPI Al to SPI D3 (RA 0 μin to Ra 230 μin), as published and recognized in the polymer surface finishing industry at the time of filing this patent application. Here, SPI Al is approximately equivalent to a grade #3 diamond buff finish, and SPI D3 is approximately equivalent to a #24 oxide dry blast finish.

[0025] Device 10 may include a cap 120 and an elongate body 40, with a portion of elongate body 40 inserted into and extending into a lumen 132 of cap 120. As discussed below, the elongate body has a closure portion 60 configured to engage lumen 132 of cap 120 when sample portion 70 of elongate body 40 is fully inserted into lumen 132.

[0026] The elongate body 40 is best seen in FIGS. 1-5. The elongate body 40 extends from a handle portion 50 to a sample portion 70. The handle portion 50 is configured to be manipulated by a user, such as to insert and remove the device 10 from a freezing container 800 (FIG. 7). The handle portion 50 is also configured to contain personal information regarding a biological sample stored within the device 10, as discussed below. It can be appreciated that the sample portion 70 is configured to receive and support a biological sample thereon, but the biological sample is disposed on and removed from the sample portion 70 when the cover is removed, and the device 10 is configured to be stored when the cap 120 is disposed on the sample portion 70 of the elongate body 40.

[0027] The sample portion is best shown in FIGS. 4-5. Sample portion 70 includes an upper surface 72 and a lower surface 76. In some embodiments, one or both of upper surface 72 and lower surface 76 are flat over at least a portion thereof. In other embodiments, one or both of upper surface 72 and lower surface 76 may be arcuate. Sample portion 70 further includes a right surface 77 and a left surface 78 bridging the edges of upper surface 72 and lower surface 76, respectively, or in some embodiments, between the end portions. In some embodiments, the cross section of the sample portion (other than one or more sample portions discussed in more detail below) may be rectangular, square, circular, oval, or other shape. For example, upper surface 72 and lower surface 76 may be flat and right surface 77 and left surface 78 may be arcuate, or vice versa.

[0028] The recessed portion 80 may be a single portion or multiple recessed portions spaced along the length of the sample portion 70. The recessed portion 80 may be a location where the thickness of the sample portion 70 (as measured between the upper surface 72 and the lower surface 76) is thinner than the thickness at other locations along the sample portion 70. In an exemplary embodiment of the present disclosure, the thickness of the recessed portion is 0.35 mm thinner than the thickness of the sample portion 70 adjacent to the recessed portion 80, which translates to a depth of 0.35 mm for this embodiment. In some embodiments, the depth of the recessed portion is greater than the maximum outer diameter of a biological sample expected to be positioned on the recessed portion 80 for storage within the device 10. The recessed portion 80 includes a surface 86 on which the biological sample rests when placed thereon. In some embodiments, the surface 86 may be arcuate, as shown in FIG. 6, and in some embodiments, is concave. In one exemplary embodiment, the cross section of the recessed portion has a center point that is 0.2 mm lower than the outer edges 82 a, 82 b of the recessed portion, as shown by dimension X in Figure 6. In some embodiments, the surface 86 of the recessed portion may have a constant profile along its length, while in other embodiments, the shape of the surface 86 may vary along its length, for example, the centerline of the surface 86 (which extends parallel to the longitudinal axis 1001 of the elongate body 40) is arcuate, and in some embodiments, concave.

[0029] The recessed portion 80 may be transitioned from the remainder of the sample portion 70 by sidewalls 82, 84. These sidewalls may be flat (as shown in FIG. 4 ), while in other embodiments, the sidewalls 82, 84 may be arcuate. In some embodiments, the sidewalls 82, 84 are perpendicular to the longitudinal axis 1001 of the elongated body 40, while in other embodiments, the sidewalls 82, 84 may extend at an acute angle β with respect to the longitudinal axis 1001. This angle β may be within a range of about 15 degrees to about 75 degrees, about 30 degrees to about 60 degrees, or about 40 degrees to about 50 degrees. When referring to angles herein, the term “about” is defined to include not only the nominal value but also values ​​within ±2.5 degrees from the nominal value. In some exemplary embodiments, the angle β may be 40 degrees, 45 degrees, 50 degrees, or other angles that will be understood by one of ordinary skill in the art after a thorough review of this specification and the drawings. In some embodiments, the first sidewall portion 82 and the second sidewall portion 84 may be of the same shape (but facing away from each other), or may be formed with different shapes.

[0030] In some embodiments, recessed portion 80 is disposed proximally from distal tip 79 of the sample portion. In these embodiments, the cross-sectional shape of distal tip 79 may be the same as the cross-sectional shape of sample portion 70 located proximal to recessed portion 80. Alternatively, in other embodiments, the cross-sectional shape of distal tip 79 may be different, and may even be different from the recessed portion. In one exemplary embodiment, the recessed portion may have a length of between about 4.0 mm and about 6.0 mm, inclusive of the limits of this range.

[0031] As will be understood by those skilled in the art after a thorough review of this specification and drawings, the size and dimensions of the various portions of device 10 can be varied based on the expected size and type of biological sample and the size of the freezing container.

[0032] The closure portion 60 is disposed between the handle portion 50 and the sample portion 70. In some embodiments, the closure portion 60 has an increasingly larger cross-sectional shape along at least a portion of its length. The closure portion 60 is disposed along the sample portion 70 such that, when the sample portion 70 is fully inserted into the lumen 132 of the cap 120, at least a portion of the inner surface 202 (discussed in more detail below) of the cap 120 contacts / engages with the closure portion 60. In this case, this contacting / engaging portion may be less than the entire surface area of ​​the cap and / or closure portion. In some embodiments, the outer diameter of the closure portion 60 may be the same as the inner diameter of the lumen 132 of the cap 120 within at least a portion of the contact area between the closure portion 60 and the cap 120 when the sample portion 70 is fully inserted into the cap 120. In another embodiment, the outer diameter of the closure portion 60 is slightly larger than the inner diameter of the lumen 132 of the cap 120 within at least a portion of the contact area between the closure portion 60 and the cap 120 when the sample portion 70 is fully inserted. In this embodiment, the material forming one or both of the cap 120 and the closure portion 60 may be soft enough to be slightly compressed, thereby increasing the strength of the connection between the cap and the closure portion.

[0033] As a non-limiting example, to form an interference fit between closure portion 60 and cap 120, the nominal outer diameter of the largest portion of closure portion 60 is approximately 0.05 mm larger than the nominal inner diameter of the largest portion of cap 120 (e.g., lumen 132 of cap 120). This diameter difference can vary without departing from the scope of the invention and may be, for example, in the range of approximately 0.0-0.1 mm. Depending on manufacturing tolerances and the diameter difference discussed above, device 10 may be closed (with cap 120 positioned over at least a portion of closure portion 60) by different amounts, even when a user closes the cap with the same force.

[0034] It will be appreciated that the user may or may not press the cap 120 all the way down the tapered portion of the closure portion 60. In some embodiments, the device 10 is configured to simultaneously apply a torque of about 0.08 N·m or less and an axial force of about 26.5 N or less to install the cap (e.g., position the cap 120 over at least a portion of the closure portion 60 to form a desired seal therebetween) and remove the cap (e.g., remove the cap 120 from the closure portion 60 after immersion in liquid nitrogen).

[0035] It will be understood that without departing from the scope of the present invention, the nominal outer diameter of the closure portion 60 may or may not be larger than the nominal inner diameter of the cap 120 (e.g., the lumen 132 of the cap 120) over the entire length of the closure portion 60, and that the nominal outer diameter of the closure portion 60 and the nominal inner diameter of the cap 120 may each vary along the length of the closure portion 60 and the cap 120, respectively. The interference fit area between the closure portion 60 and the cap 120 (e.g., the contact area where the nominal outer diameter of the closure portion 60 is greater than the nominal inner diameter of the cap 120), the overlap area between the closure portion 60 and the cap 120 (e.g., the area where the closure portion 60 is disposed within the lumen 132 of the cap 120), and the configuration (e.g., length, size, shape, etc.) of the textured surface 205 on the outer surface 204 of the closure portion 60 and / or on the inner surface 202 of the cap 120 may all be varied as desired and / or required without departing from the scope of the present invention, so long as the cap 120 and the closure portion 60 form a seal therebetween as desired and / or required when the sample portion 70 is fully inserted within the lumen 132 of the cap 120.

[0036] In some embodiments, the distal end 67 of the closure portion 60 has the same cross-sectional shape as the sample portion 70 at the transition between the two portions. In other embodiments, the closure portion 60 has a cross-sectional shape that is larger in at least one respect (e.g., thickness or width) than the cross-sectional shape of the sample portion, with a dimensional gradation between the cross-sectional shapes (with either a nominal fillet or a curved transition inherent in the manufacturing process). The sample portion 70 and the closure portion 60 may have the same cross-sectional shape near the transition between the two portions (which, as discussed above, in some embodiments have different dimensions), or the sample portion 70 and the closure portion 60 may have different cross-sectional shapes near the transition between the two portions.

[0037] In the embodiment shown in FIGS. 4-5, the closure portion 60 has a generally conical profile along its length, with a diameter that varies at a constant rate along its length. In one exemplary embodiment, the distal end 67 has a diameter of approximately 1.97 mm, and the diameter of the closure portion 60 increases along its length at an angle ranging from approximately 1.13 degrees to approximately 1.17 degrees (e.g., preferably approximately 1.15 degrees). While the angle of the taper on the closure portion 60 at any point along its length may vary as desired and / or required without departing from the scope of the present invention, advantageously, the angle of the taper on the closure portion 60 is relatively gradual. A significantly larger taper angle on the closure portion 60 may shorten the taper, reduce the surface area available for mating with the cap 120, and / or affect the sealing ability of the cap. Thus, in at least some embodiments, the taper angle along the closure portion is not the same as the taper angle along the cap.

[0038] The handle portion 50 extends proximally from the proximal end 68 of the closure portion 60. The handle portion may be elongated and may include an information portion 52 and one or more ergonomic features. As shown in FIG. 10 , the handle portion 50 may have a modified equilateral triangular cross-section along its length. In some embodiments, the handle portion 50 includes three flat side portions 61, 62, and 63. In some embodiments, adjacent flat side portions (e.g., 61 / 62, 62 / 63, and 63 / 61) form edges therebetween to form a regular triangular cross-section (indicated by the dotted lines forming the triangle in FIG. 10 ).

[0039] In other embodiments, adjacent flat side portions may transition between each other by arcuate portions 64, 65, 66 rather than extending toward each other at an edge. In some embodiments, these arcuate portions 64, 65, 66 may extend continuously from their respective flat side portions. In some embodiments, the maximum diameter of handle portion 50, i.e., the maximum diameter from the apex of one arcuate portion to the opposing flat side portion (line W in FIG. 10 ), may be approximately 3.39 mm. In some embodiments, the portion of handle portion 50 having a modified triangular cross-section may define an equilateral triangle (with arcuate portions that do not extend to the apex / side of the original equilateral triangle) such that a 60-degree angle is formed between each adjacent flat side portion 61, 62, 63. 7, the handle portions of six different devices 10 can be positioned within the cylindrical opening (e.g., a sleeve within the freezing container) of the freezing container 800 (the handle portion 50 of each device is designated as Z1, Z2, etc.), with the curved portions of each device 10 pointing toward each other. In one exemplary embodiment, the handle portions 50 may be sized such that six devices 10 can be simultaneously positioned within a sleeve within the freezing container 800 having a diameter of 9 mm.

[0040] The handle portion 50 may include one or more information portions 52. The information portion 52 is configured to display identifying information about a biological sample disposed on the recessed portion 80 of the sample portion 70, thereby allowing the device 10 to be identified as desired when stored in a cryocontainer with multiple devices. The information portion may be a recessed portion having a smaller outer diameter than the rest of the handle portion 50, such that when a label is applied to the information portion (which provides information about the biological sample, such as a barcode, QR code, text information, or color code), the overall cross-section of the information portion 52 (e.g., a cross-section including the label applied thereto) is equal to or smaller than the cross-section of the rest of the handle portion. As shown in FIG. 1 , the information portion 52 may be disposed between two portions of the handle portion 50 having a modified triangular profile, as discussed above. In some embodiments, the surface of the information portion 52 is textured.

[0041] In some embodiments, the handle portion 50 may include one or more ergonomic features 53, such as, for example, one or more diameter transitions, one or more slots, or a roughened surface, to assist the user in manipulating the handle portion 50 and the elongated portion 40 to position the elongated body 40 or insert the sample portion 70 into the lumen 132 of the cap 120 as desired.

[0042] 8-9 , a cap 120 is presented. The cap 120 includes an open proximal end 128 and a closed end 126. A lumen 132 extends from the open proximal end 128 and blindly extends along the cap 120 toward the closed end 126. An end portion of the closed end 126 can include ergonomic features 123, such as one or more diameter transitions, one or more slots, or a roughened surface, to assist a user in manipulating the closed end 126 of the cap 120 to move the cap relative to the sample portion 70 of the elongate body 40 so that the cap 120 can cover the sample portion 70.

[0043] In some embodiments, the lumen 132 may have a single inner diameter along its length. In this embodiment, the inner diameter of the lumen 132 is the same as the diameter of the closure portion 60 of the elongate body 40 when the elongate body 40, and specifically the sample portion 70, is fully inserted into the lumen 132 of the cap 120, and the closure portion 60 and the cap 120 may be in flush contact. In other embodiments, the diameter of the lumen 132 may be slightly smaller than the minimum diameter of the closure portion 60 (i.e., the diameter at the distal end 67 of the closure portion 60 in embodiments in which the diameter of the closure portion 60 increases proximally along the closure portion 60), such that the closure portion 60 is in flush contact with the lumen 132 along the entire length of the overlap between the cap 120 and the closure portion 60.

[0044] In other embodiments, the lumen 132 of the cap 120 may have one or more portions that vary in diameter along its length. For example, as shown in FIG. 9 , the lumen 132 has a proximal portion 138 and a distal portion 139, with the distal portion 139 being positioned at the distal tip of the cap 120. In some embodiments, the proximal portion 138 may have a diameter that varies along its length. In one exemplary embodiment, the proximal end 138a of the proximal lumen portion 138 may have a diameter that is larger than both the maximum diameter of the sample portion and the diameter of the closure portion 60, at least at the distal end 67 of the closure portion 60. In the exemplary embodiment disclosed herein, in which the diameter of the distal end 67 of the closure portion 60 is approximately 1.97 mm, the diameter of the proximal end 138a of the proximal lumen portion 138 may be approximately 2.1 mm, thereby providing the user with some play when inserting the distal tip 79 of the sample portion 70 into the lumen 132 of the cap 120.

[0045] In some embodiments, the diameter of lumen 132 along proximal portion 138 decreases distally along its length, such as at an angle of about 1 degree. In exemplary embodiments disclosed herein, distal end 138b of proximal portion 138 may have an inner diameter of about 1.82 mm. In some embodiments, distal end 138b of proximal portion 138 may have the same diameter as proximal end 139a of distal portion 139 of lumen. In some embodiments, the length of proximal portion 138 may be slightly longer than the length of closure portion 60, such as about 7.00 mm for proximal portion 138 and about 6.5 mm for closure portion 60.

[0046] In some embodiments, the proximal portion 138 of the lumen 132 (e.g., the portion extending from the cap opening to approximately 7 mm) may have a taper angle of approximately 0 degrees, while the remaining portions of the lumen 132 (e.g., the distal portion 139) may have a taper angle ranging from approximately 0.1 degrees to approximately 0.5 degrees (e.g., preferably approximately 0.3 degrees). While the angle of the taper of the lumen 132 of the cap 120 at any point along the length of the lumen 132 can be varied as desired and / or required without departing from the scope of the present invention, a gradual angle, particularly at the cap opening, is advantageous for achieving a good seal while maintaining low mating forces. For the remaining portions of the lumen 132 (e.g., the distal portion 139, or the portion extending beyond approximately 7 mm from the cap opening), a gradual angle provides manufacturability advantages. This is because the lumen 132 of the cap 120 needs to be as large as possible to accommodate the sample portion 70 of the device, while a slight angle allows for easier removal of some tools / accessories (e.g., mandrels, core pins, or other structures, these being non-limiting examples) during molding than would be possible without an angle.

[0047] In some embodiments, the outer diameter of cap 120 may be smaller than the maximum diameter of elongate body 40, or in other embodiments, the outer diameter of cap 120 may be such that a cross section of the cap may be inscribed within a cross section of the largest portion of elongate body 40, as shown generally by circle Y in FIG. 10 , where this largest portion may be handle portion 50. This relative geometry ensures that when multiple devices 10 are positioned within the same sleeve in a freezing container, such as in FIG. 7 , there will be space between the caps 120 of adjacent devices, allowing a coolant, such as liquid nitrogen, to flow between the caps 120 of adjacent devices 10 to ensure uniform cooling.

[0048] Furthermore, the subject matter of the present disclosure may also relate to, inter alia, the following aspects:

[0049] A first aspect relates to a sealable container for storing a biological sample, the sealable container comprising: a cap having a proximal open end and a distal end, a lumen extending from the proximal open end to the distal end; an elongate body extending from a handle portion to a sample portion, the sample portion configured to receive a biological sample thereon, the elongate body further comprising a closure portion disposed between the handle portion and the sample portion, the closure portion configured to be in facial contact with the cap when the sample portion of the elongate body is fully inserted into the lumen of the cap; and at least one of an inner surface of the cap that contacts the closure portion when engaged with the cap and an outer surface of the closure portion that contacts the cap when engaged with the cap comprises a textured region having a textured surface finish.

[0050] A second aspect relates to the sealable container of the first aspect, wherein the outer surface of the closure portion comprises a textured region.

[0051] A third embodiment relates to a sealable container according to any of the preceding embodiments, wherein the textured region extends over the entire inner surface of the cap, the entire outer surface of the closure portion, or both.

[0052] A fourth embodiment relates to a sealable container according to any of the preceding embodiments, wherein the textured region extends over a portion of the inner surface of the cap or a portion of the outer surface of the closure portion.

[0053] A fifth embodiment relates to a sealable container according to any of the preceding embodiments, wherein the textured region extends around at least a portion of the circumference of the outer surface of the closure portion or at least a portion of the circumference of the inner surface of the cap.

[0054] A sixth aspect relates to a sealable container according to any of the previous aspects, wherein the textured region has an average surface roughness (Ra value) in the range of about 1 μinch to about 28 μinch.

[0055] A seventh embodiment relates to a sealable container of any of the preceding embodiments, wherein the average surface roughness (Ra value) of the textured region on the inner surface of the cap is within a range of about 4 μin to about 5 μin, and the average surface roughness (Ra value) of the textured region on the outer surface of the closure is within a range of about 25 μin to about 28 μin.

[0056] An eighth embodiment relates to a sealable container of any of the preceding embodiments, wherein the textured region has an average surface roughness (Ra value) within the range of about 4 microinches to about 5 microinches.

[0057] A ninth embodiment relates to a sealable container of any of the preceding embodiments, wherein the textured region on the inner surface of the cap extends lengthwise from about 3 mm to about 10 mm from the edge of the proximal open end of the cap.

[0058] A tenth embodiment relates to a sealable container according to any of the preceding embodiments, wherein at least one of the cap and the elongate body is made from a material comprising a styrene-acrylic copolymer.

[0059] An eleventh aspect relates to a sealable container for storing a biological sample, the sealable container comprising: a cap having a proximal open end and a distal end, a lumen extending from the proximal open end to the distal end; an elongate body extending from a handle portion to a sample portion, the sample portion configured to receive a biological sample thereon, the elongate body further comprising a closure portion disposed between the handle portion and the sample portion, the closure portion configured to be in facial contact with the cap when the sample portion of the elongate body is fully inserted into the lumen of the cap; and an inner surface of the cap that contacts the closure portion when engaged with the cap and an outer surface of the closure portion that contacts the cap when engaged with the cap each comprise a textured region with a textured surface finish.

[0060] A twelfth embodiment relates to the sealable container of the eleventh embodiment, wherein the average surface roughness (Ra value) of the textured region on the inner surface of the cap is within a range of about 4 μin to about 5 μin, and the average surface roughness (Ra value) of the textured region on the outer surface of the closure is within a range of about 25 μin to about 28 μin.

[0061] A thirteenth aspect relates to a sealable container according to either the eleventh or twelfth aspects, wherein the textured area on the outer surface of the closure portion or the inner surface of the cap is larger than the contact area between the closure portion and the cap.

[0062] A fourteenth aspect relates to a sealable container according to any one of the eleventh to thirteenth aspects, wherein the textured region extends over at least a portion of the inner surface of the cap or at least a portion of the outer surface of the closure portion.

[0063] A fifteenth aspect relates to a sealable container according to any one of the eleventh to fourteenth aspects, wherein the closure portion and the cap form an interference fit between the closure portion and the cap due to a difference between an outer diameter of the closure portion and an inner diameter of the cap.

[0064] A sixteenth aspect relates to a sealable container for storing a biological sample, the sealable container comprising: a cap having a proximal open end and a distal end, a lumen extending from the proximal open end to the distal end; an elongate body extending from a handle portion to a sample portion, the sample portion configured to receive a biological sample thereon, the elongate body further comprising a closure portion disposed between the handle portion and the sample portion, the closure portion configured to be in facial contact with the cap when the sample portion of the elongate body is fully inserted into the lumen of the cap, and an outer surface of the closure portion that contacts the cap when engaged with the cap comprises a textured region having a textured surface finish.

[0065] A seventeenth embodiment relates to the sealable container of the sixteenth embodiment, wherein at least a portion of the closure portion tapers at an angle of about 1.15 degrees and at least a portion of the lumen of the cap does not have a taper.

[0066] An eighteenth aspect relates to a sealable container according to either the sixteenth or seventeenth aspects, wherein the textured area on the outer surface of the closure portion is greater than or substantially equal to the contact area between the closure portion and the cap.

[0067] A nineteenth aspect relates to the sealable container according to any one of the sixteenth to eighteenth aspects, wherein the textured region has an average surface roughness (Ra value) within the range of about 1 μinch to about 28 μinch.

[0068] A twentieth aspect relates to a sealable container according to any one of the sixteenth to nineteenth aspects, wherein a proximal portion of the lumen of the cap does not have a taper, and a distal portion of the lumen of the cap tapers at an angle of about 0.3 degrees.

[0069] In some embodiments, in addition to the features described in each of the independent aspects listed above, optional features described in the dependent aspects and / or optional features as disclosed in the above description and shown in the drawings may be present, either alone or in combination.

[0070] While preferred embodiments of the present disclosure have been described, it should be understood that the present disclosure is not limited thereto and can be modified without departing from the present disclosure. The scope of the present invention is defined by the appended claims, and all devices that fall within the meaning of the claims, whether literally or by the doctrine of equivalents, are intended to be encompassed within the scope of the present invention. [Explanation of symbols]

[0071] 10 devices 40 elongated body 50 Handle part 52 Information section 53 Ergonomic Features 60 Closed part 61 Flat side part 64 Arc-shaped part 67 Distal end 68 Proximal end 70 Sample part 72 Upper surface 76 Lower surface 77 Left surface 78 Right surface 79 Distal tip 80 recessed part 82 first side wall portion 82a outer edge 82b outer edge 84 Second side wall 86 Surface 120 Cap 123 Ergonomic Features 126 Closed end 128 Open proximal end 128a Edge 132 lumens 138 Proximal part 138a proximal end 138b distal end 139 Distal portion 139a proximal end 202 Inner surface 204 Outer surface 205 Textured Area 800 freezing container 1001 Longitudinal axis

Claims

1. 1. A sealable container for storing a biological sample, comprising: a cap having a proximal open end and a distal end, a lumen extending from the proximal open end to the distal end; an elongate body extending from a handle portion to a sample portion, the sample portion configured to receive a biological sample thereon, the elongate body further comprising a closure portion disposed between the handle portion and the sample portion, the closure portion configured to make facial contact with the cap when the sample portion of the elongate body is fully inserted into the lumen of the cap; Equipped with A sealable container, wherein at least one of an inner surface of the cap that contacts the closure portion when engaged with the closure portion and an outer surface of the closure portion that contacts the cap when engaged with the cap, comprises a textured region having a textured surface finish.

2. The sealable container of claim 1 , wherein an outer surface of the closure portion comprises the textured region.

3. 10. The sealable container of claim 1, wherein the textured area extends over the entire inner surface of the cap, the entire outer surface of the closure portion, or both.

4. The sealable container of claim 1 , wherein the textured area extends over a portion of the inner surface of the cap or a portion of the outer surface of the closure portion.

5. 2. The sealable container of claim 1, wherein the textured region extends around at least a portion of the circumference of the outer surface of the closure portion or at least a portion of the circumference of the inner surface of the cap.

6. 10. The sealable container of claim 1, wherein the textured region has an average surface roughness (Ra value) in the range of about 1 microinch to about 28 microinches.

7. 10. The sealable container of claim 1, wherein the average surface roughness (Ra value) of the textured region on the inner surface of the cap is within a range of about 4 μin to about 5 μin, and the average surface roughness (Ra value) of the textured region on the outer surface of the closure portion is within a range of about 25 μin to about 28 μin.

8. 10. The sealable container of claim 1, wherein the textured region has an average surface roughness (Ra value) in the range of about 4 microinches to about 5 microinches.

9. 10. The sealable container of claim 1, wherein the textured area on the inner surface of the cap extends lengthwise from about 3 mm to about 10 mm from an edge of the proximal open end of the cap.

10. 10. The sealable container of claim 1, wherein at least one of the cap and the elongate body is made from a material comprising a styrene-acrylic copolymer.

11. A sealable container according to claim 1 and any one of claims 2 to 10.

12. 1. A sealable container for storing a biological sample, comprising: a cap having a proximal open end and a distal end, a lumen extending from the proximal open end to the distal end; an elongate body extending from a handle portion to a sample portion, the sample portion configured to receive a biological sample thereon, the elongate body further comprising a closure portion disposed between the handle portion and the sample portion, the closure portion configured to make facial contact with the cap when the sample portion of the elongate body is fully inserted into the lumen of the cap; Equipped with A sealable container, wherein an inner surface of the cap that contacts the closure portion when engaged with the closure portion and an outer surface of the closure portion that contacts the cap when engaged with the cap each include a textured region having a textured surface finish.

13. 13. The sealable container of claim 12, wherein the average surface roughness (Ra value) of the textured region on the inner surface of the cap is within a range of about 4 μin to about 5 μin, and the average surface roughness (Ra value) of the textured region on the outer surface of the closure portion is within a range of about 25 μin to about 28 μin.

14. 13. The sealable container of claim 12, wherein the textured area on the outer surface of the closure portion or the inner surface of the cap is greater than the contact area between the closure portion and the cap.

15. 13. The sealable container of claim 12, wherein the textured region extends over at least a portion of the inner surface of the cap or at least a portion of the outer surface of the closure portion.

16. 13. The sealable container of claim 12, wherein the closure portion and the cap form an interference fit between the closure portion and the cap due to a difference between an outer diameter of the closure portion and an inner diameter of the cap.

17. A sealable container according to claim 12 and any one of claims 13 to 16.

18. 1. A sealable container for storing a biological sample, comprising: a cap having a proximal open end and a distal end, a lumen extending from the proximal open end to the distal end; an elongate body extending from a handle portion to a sample portion, the sample portion configured to receive a biological sample thereon, the elongate body further comprising a closure portion disposed between the handle portion and the sample portion, the closure portion configured to make facial contact with the cap when the sample portion of the elongate body is fully inserted into the lumen of the cap; Equipped with A sealable container, wherein an outer surface of the closure portion that contacts the cap when engaged against the cap comprises a textured region having a textured surface finish.

19. 20. The sealable container of claim 18, wherein at least a portion of the closure portion tapers at an angle of about 1.15 degrees and at least a portion of the lumen of the cap does not have a taper.

20. 20. The sealable container of claim 18, wherein the textured area on the outer surface of the closure portion is greater than or substantially equal to the contact area between the closure portion and the cap.

21. 20. The sealable container of claim 18, wherein the textured region has an average surface roughness (Ra value) in the range of about 1 microinch to about 28 microinches.

22. 20. The sealable container of claim 18, wherein a proximal portion of the lumen of the cap does not taper, and a distal portion of the lumen of the cap tapers at an angle of about 0.3 degrees.

23. 23. A sealable container according to claim 18 and any one of claims 19 to 22.

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