Vitrification freezing device with textured surface for sealing

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 based on U.S. Provisional Patent Application No. 63 / 416,119, filed on October 14, 2022. This provisional patent application is hereby incorporated by reference in its entirety into this specification.

[0002] The devices described herein relate to devices for holding biological samples within a cryogenic container for long - term cryopreservation. This device can be used for vitrification of embryos, oocytes, or other biological materials, specifically, for example, in combination with an in vitro fertilization (IVF) cycle or in preparation for an IVF cycle, for vitrification.

Background Art

[0003] In the context of IVF, over the past decade, vitrification of embryos and oocytes has emerged as an alternative to conventional cryopreservation. The vitrification procedure is performed for the purpose of storing unused embryos after an IVF cycle, for temporarily storing embryos during genetic analysis, and as an oocyte preservation method for maintaining female fertility. This technique itself completely avoids ice formation by using a high - concentration cryoprotectant and a rapid cooling rate.

Summary of the Invention

Problems to be Solved by the Invention

[0004] Samples are stored for extended periods immersed in liquid nitrogen, but it is desirable to store these samples in a device capable of forming a seal to isolate them from the surrounding liquid nitrogen. If liquid nitrogen leaks into the interface between the elongated body and the cap, the pressure generated by the temperature rise and subsequent expansion of the nitrogen inside the cap may push the cap away from the elongated body when the device is removed from the liquid nitrogen. Alternatively, instead of isolating and airtightly sealing the sample from nitrogen, it may be desirable to provide a seal that is effective in protecting the sample and also allows for the release of all nitrogen and / or other substances trapped between the cap and the elongated body. [Means for solving the problem]

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

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

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

[0008] The sealable containers described herein may include any combination of the features described above and / or the original claims at the time of filing.

[0009] The merits of this disclosure will become more apparent to those skilled in the art from the following description of preferred embodiments of this disclosure illustrated and described as examples. As should be understood, other different embodiments are possible of the subject matter disclosed, and its details are modifiable in various respects. Therefore, these drawings and descriptions should be considered as illustrative and not restrictive in nature. [Brief explanation of the drawing]

[0010] [Figure 1] This is a perspective view of a cryopreservation device comprising an elongated member and a cap. [Figure 2] This is a side view of the elongated member shown in Figure 1. [Figure 3] This is a top view of the elongated member shown in Figure 1. [Figure 4] This is a side view of detail A in Figure 2. [Figure 5] This is a top view of detail A in Figure 2. [Figure 6] Figure 5 is a cross-sectional view of section ZZ. [Figure 7] This figure shows six cryopreservation devices lined up inside the sleeve of a freezing container. [Figure 8] Figure 1 is a perspective view of the cap of the cryopreservation device. [Figure 9] This is a lateral cross-sectional view of the cap shown in Figure 8. [Figure 10] Figure 1 shows a cross-sectional view of the elongated member along the cut portion TT when the sample portion of the elongated member is fully inserted into the cap. [Figure 11] This is a cross-sectional view of the elongated member shown in Figure 1 along the cut section TT. [Figure 12] This is an enlarged side view of a portion of the elongated member shown in Figure 1, illustrating the closed section with a textured surface finish. [Figure 13] This is an enlarged cross-sectional view of a portion of the cap shown in Figure 8, illustrating the inner surface of the cap with a textured surface finish. [Figure 14]This is an enlarged side view of a portion of the elongated member shown in Figure 1, illustrating a part of the closed section with a textured surface finish. [Figure 15] This is an enlarged cross-sectional view of a portion of the cap shown in Figure 8, illustrating a part of the inner surface of the cap that has been given a textured surface finish. [Modes for carrying out the invention]

[0011] Various embodiments will be described below with reference to the drawings. In these drawings, similar elements are generally indicated by similar numbers. The relationships and functions of the various elements of these embodiments can be better understood by referring to the detailed description below. However, embodiments are not limited to those shown in the drawings. Please understand that these drawings are not necessarily to scale (drawings to scale will be recognized as to scale and can be relied upon for such purposes), and in some cases, details that are not necessary for understanding the embodiments disclosed herein, such as conventional manufacturing and assembly, may be omitted.

[0012] The present invention is defined by the claims and can be embodied in a number of different forms and should not be construed as being limited to the embodiments shown herein. Rather, these embodiments are provided to make this disclosure complete and comprehensive and to fully convey the implementable disclosure to those skilled in the art. In this specification and the claims, the singular forms "a, an" and "the" include the plural form unless explicitly indicated otherwise in the context. Any reference to industry standards in this specification (e.g., ASTM standards, ANSI standards, IEEE standards) is defined, unless explicitly specified otherwise herein, as conforming to the standards published as of the filing date of this disclosure with respect to the units, measurements, and test criteria specified by those standards.

[0013] As used herein, the terms "proximal" and "distal" are used in their generally accepted meanings to refer respectively to the handle / doctor-side end of the device or associated object and the opposite end of the device or associated object. Terms such as "about", "substantially", "essentially", "approximately", and other terms of degree, when used in connection with any volume, dimension, ratio, or other quantitative or qualitative numerical value, are intended to convey a clear and distinguishable numerical value within the range of standard parameters that can be understood by one of ordinary skill in the art (a person equivalent to a medical device engineer having experience in the relevant field), and are to be construed to include at least any legally equivalent, minor but functionally unimportant differences, standard manufacturing tolerances, and at least numerically significant figures (but not necessarily figures as broad as their maximum range).

[0014] Referring now to FIGS. 1-15, a device 10 is provided for receiving and storing materials for cryopreservation. The device 10 may be a sealable container configured to contain a biological sample, which container surrounds and supports the biological sample contained therein for an extended period of time within a cryopreservation container such as, for example, a dewar. The device 10 can hermetically hold the biological sample using various structures described herein.

[0015] As shown in FIGS. 1 to 11 and as further described in detail below, the cap 120 is arranged to cover the sample portion 70, and a seal is formed by a press fit between the cap 120 and a part of the elongated body 40 (for example, the closing portion 60) to prevent the entry of liquid nitrogen. This seal is formed at room temperature, maintained within liquid nitrogen (-196° C.), and needs to be maintained until it is released by the user even after the device is returned to room temperature. The formation of such a seal is extremely important. Specifically, for example, when the closing portion 60 is inserted into the cap 120 at room temperature and normal pressure, at the position where the closing portion 60 and the cap 120 come into contact with each other, the cap 120 is deformed by the tapered portion of the closing portion 60, and an interference fit portion is formed between the two. Next, the device 10 (together with the cap 120) is inserted into liquid nitrogen (-196° C.). Due to the action of the cap 120 shrinking at a lower temperature, a seal is formed around the position of this interference fit portion, so that liquid nitrogen does not leak into the device 10. If liquid nitrogen leaks into the interface between the closing portion 60 and the cap 120, when the device 10 is taken out of the liquid nitrogen, the cap 120 may be pushed out of the elongated body 40 and detached due to the pressure generated by the nitrogen in the cap 120. Furthermore, due to the leakage of liquid nitrogen, the sample on the sample portion 70 (for example, embryo, oocyte, etc.) may be contaminated.

[0016] If the surface located at the interference portion between the cap 120 and the elongated body 40 is subjected to a textured surface finish rather than a highly polished surface finish, the seal for preventing the entry of liquid nitrogen can be improved. By improving this seal that prevents direct contact with liquid nitrogen, it becomes possible to maintain the sample in a safe state from the possibility of contamination, and thereby the implementation of vitrification freezing in a sealed environment can be improved. The applicant is aware of no competing products that actually form such an airtight seal, and it is needless to say that the improvement of the seal performance is achieved by the present invention of the present application.

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

[0018] The textured surface on the outer surface 204 of the closing portion 60 and / or the inner surface 202 of the cap 120 can be realized in various configurations (e.g., length, size, shape, etc.). Referring to Figures 12 to 15, in some embodiments, the sealing performance can be improved by having a textured area with a textured surface finish on at least one of the inner surface 202 of the cap 120 (e.g., the surface that contacts the elongated body when engaged with the elongated body) and the outer surface 204 of the elongated body 40 (e.g., the surface that contacts the cap when engaged with the cap, closing portion 60). This textured surface finish can be applied to either one or both of these surfaces. In some embodiments, if the textured surface is present on only one of these surfaces, the preferred textured surface should be on the outer surface 204 of the elongated body 40.

[0019] The configuration of the textured area 205 (e.g., length, size, shape) can be modified as desired and / or required without departing from the scope of the present invention. The textured area 205 may include 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 elongated body 40 (e.g., the closing portion 60). In a non-limiting example, the textured area 205 may include the entire inner surface 202 of the cap 120. In another non-limiting example, the textured area 205 may include the entire outer surface 204 of the closing portion 60, or a portion of both surfaces. As shown in Figures 14 and 15, in another non-limiting example, the textured area 205 may include a portion of the inner surface 202 of the cap 120 and / or a portion of the outer surface 204 of the closing portion 60 (e.g., about 50% or less) (e.g., the textured area 205 forms a ring section having a length of about 1 to 6 mm along the longitudinal axis 1001 of the elongated body 40). The textured area 205 extending over at least a portion of the circumferential direction of the outer surface 204 of the closing portion 60 and / or the inner surface 202 of the cap 120 can be discontinuous or continuous / complete as needed and / or required, thereby enabling a variety of sealing performances. That is, the entire surface area or less of the surface area of ​​the inner surface of the cap and / or the outer surface of the closing portion may be textured, which in a preferred embodiment results in a better connecting seal or other mounting part than conventional similar engaging surfaces, effectively preventing accidental or spontaneous detachment of the cap. In this specification, the term “approximately” as used in relation to dimensions (e.g., length, width, height, depth) or roughness (e.g., Ra value as used below) is defined to include not only the specific numerical value mentioned, but also numerical values ​​within ±5% of the numerical value mentioned.

[0020] As a non-limiting example, in some embodiments, the textured area 205 on the outer surface 204 of the closing portion 60 and / or on the inner surface 202 of the cap 120 may be larger than, or substantially equal to, the area of ​​the contact or engagement portion between the closing portion 60 and the cap 120. In some embodiments, the user may not fully push down the cap 120 along the tapered portion of the closing portion 60, and only a portion of the textured area 205 on the outer surface 204 of the closing portion 60 may contact the inner surface 202 of the cap 120. As a non-limiting example, the total area of ​​the outer surface 204 of the closing portion 60 is approximately 43.3 mm². 2 This may also be the case, and sealing may be performed at a point up to approximately 2 mm from the cap opening, which is approximately 10-14 mm between the closing portion 60 and the cap 120. 2 This can be equivalent to the contact area.

[0021] In some embodiments, the textured area 205 on the inner surface 202 of the cap 120 may extend along the length of the cap 120 to a position of about 3 to 10 mm from the edge 128a of the proximal opening end 128 of the cap 120, and / or the textured area 205 on the outer surface 204 of the closing portion 60 may extend along the length of the closing portion 60 to a position of about 3 to 10 mm from the proximal end 68 of the closing portion 60. In these embodiments, the Ra value of at least one of the textured areas 205 may vary in the range of about 4 microinches to about 5 microinches, which corresponds to about 400 grit sandpaper abrasion.

[0022] For example, rougher textures with higher Ra values, such as those with an Ra value greater than approximately 10 microinches or equivalent to a 600-grit stone finish, can be difficult to manufacture consistently. Therefore, smaller areas of the inner surface 202 of the cap 120 and / or the outer surface 204 of the closing portion 60 may be textured, for example, extending to a position of approximately 1 to 3 mm from the edge 128a of the proximal opening end 128 of the cap 120 and / or to a position of approximately 1 to 3 mm from the proximal end 68 of the closing portion 60. For lower roughness textures, such as those between approximately 4 to 5 microinches or equivalent to a 400-grit paper finish, the length of the textured area can be longer, for example, extending to a position of approximately 6 to 10 mm, more preferably 6 to 7 mm, from the edge 128a of the proximal opening end 128 of the cap 120 and / or from the proximal end 68 of the closing portion 60.

[0023] It will be understood that the textured area 205 may or may not originate at the exact location of the edge 128a of the proximal end 68 of the closing portion 60 and / or the proximal end 128 of the opening of the cap 120, or at a location adjacent to them (for example, due to manufacturing tolerances). Furthermore, it will be understood that the textured area 205 may or may not have the same height (height measured along the longitudinal axis) along the circumferential direction of the lumen 132 of the closing 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 stated in ASME B46.1 (published 2020), Ra is the arithmetic mean of the absolute values ​​of the deviations of profile height from the mean line recorded within the evaluation length. Simply put, Ra is the average of individual measurements of surface peaks and valleys measured from the centerline mean of those values. This average roughness (Ra) can be expressed in microinches (μin). Alternatively, smoothness / roughness can be expressed as an SPI value or finishing method. In this case, SPI is based on the surface finishing standard set by the SPI (Plastics Industry Association). This standard includes a range of 12 SPI grades of polished finishes from SPI Al to SPI D3 (RA0 μin to Ra230 μin), as published and recognized in the polymer surface finishing industry at the time of filing of this patent application. Here, SPI Al roughly corresponds to a grade #3 diamond buff finish, and SPI D3 roughly corresponds to a dry blast finish using #24 oxide.

[0025] The device 10 may comprise a cap 120 and an elongated body 40, the portion of which is inserted into and extends within the lumen 132 of the cap 120. As will be discussed later, the elongated body has a closing portion 60 configured to engage with the lumen 132 of the cap 120 when the sample portion 70 of the elongated body 40 is fully inserted into the lumen 132.

[0026] The elongated body 40 is best shown in Figures 1 to 5. The elongated body 40 extends from the handle portion 50 to the sample portion 70. The handle portion 50 is configured to be operated by the user, for example, to insert the device 10 into and remove it from the freezing container 800 (Figure 7). The handle portion 50 is also configured to contain personal information relating to the biological sample stored in the device 10, as will be discussed later. It is understandable that the sample portion 70 is configured to receive and support the biological sample on it, but the biological sample is placed in 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 placed on the sample portion 70 of the elongated body 40.

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

[0028] The recessed portion 80 may be a single portion or may be a plurality of recessed portions spaced apart along the longitudinal direction of the sample portion 70. The recessed portion 80 may be a location where the thickness of the sample portion 70 (such as the thickness 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 a typical embodiment of this 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; in other words, the depth of this recessed portion in this embodiment is 0.35 mm. In some embodiments, the depth of the recessed portion is greater than the maximum outer diameter of the biological sample that is 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 the sample is placed on it. In some embodiments, this surface 86 may be arc-shaped as shown in Figure 6, and in some embodiments, it is concave. In a typical embodiment, as shown by dimension X in Figure 6, the cross-section of the recessed portion has its center point 0.2 mm lower than the outer edges 82a and 82b of the recessed portion. 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 center line of the surface 86 (extending parallel to the longitudinal axis 1001 of the elongated body 40) may be arc-shaped, and in some embodiments, concave.

[0029] The recessed portion 80 can be transitioned from the rest of the sample portion 70 by side walls 82, 84. These side walls may be flat (as shown in Figure 4), but in other embodiments, the side walls 82, 84 may be arc-shaped. In some embodiments, the side walls 82, 84 are perpendicular to the longitudinal axis 1001 of the elongated body 40, but in other embodiments, the side walls 82, 84 may extend at an acute angle β with respect to the longitudinal axis 1001. This angle β may be in the range of about 15 to about 75 degrees, about 30 to about 60 degrees, or about 40 to about 50 degrees. Where the term “about” is used herein to refer to an angle, it is defined to include not only the reference value but also values ​​of ±2.5 degrees from this reference value. In some representative embodiments, the angle β may be 40 degrees, 45 degrees, 50 degrees, or other angles that can be understood by those skilled in the art after a thorough examination of this specification and the drawings. In some embodiments, the first side wall portion 82 and the second side wall portion 84 may have the same shape (but facing in opposite directions), or they may be formed of different shapes.

[0030] In some embodiments, the recessed portion 80 is located proximal to the distal tip 79 of the sample portion. In these embodiments, the cross-sectional shape of the distal tip 79 may be the same as the cross-sectional shape of the sample portion 70 located proximal to the recessed portion 80. Alternatively, in other embodiments, the cross-sectional shape of the distal tip 79 may be different, and may also be different from that of the recessed portion. In a typical embodiment, the recessed portion may have a length between approximately 4.0 mm and approximately 6.0 mm (including boundary values ​​within this range).

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

[0032] The closing portion 60 is positioned between the handle portion 50 and the sample portion 70. In some embodiments, the closing portion 60 has a cross-sectional shape that gradually increases in size along at least a portion of its length. The closing portion 60 is positioned along the sample portion 70 such that at least a portion of the inner surface 202 (discussed in further detail later) of the cap 120 contacts / engages with the closing portion 60 when the sample portion 70 is fully inserted into the lumen 132 of the cap 120. In this case, the portion that contacts / engages may be smaller than the total surface area of ​​the cap and / or closing portion. In some embodiments, the outer diameter of the closing portion 60 may be the same as the inner diameter of the lumen 132 of the cap 120, within the range of at least a portion of the contact area between the closing 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 closing 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 closing 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 closing portion 60 may be sufficiently flexible to be slightly compressible, thereby increasing the bonding strength between the cap and the closing portion.

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

[0034] It will be understood that the user may or may not fully press down the cap 120 along the tapered portion of the closing portion 60. In some embodiments, the device 10 is configured to be used to simultaneously use a torque of about 0.08 N·m or less and an axial force of about 26.5 N or less to mount the cap (for example, to position the cap 120 so as to cover at least a portion of the closing portion 60, thereby forming a desired seal between them) and to remove the cap (for example, to remove the cap 120 from the closing portion 60 after immersion in liquid nitrogen).

[0035] Without departing from the scope of the present invention, the nominal outer diameter of the closing portion 60 may or may not be greater than or less than the nominal inner diameter of the cap 120 (e.g., lumens 132 of the cap 120) over the entire length of the closing portion 60, and the nominal outer diameter of the closing portion 60 and the nominal inner diameter of the cap 120, respectively, may vary along the respective lengths of the closing portion 60 and the cap 120. The interlocking region between the closing portion 60 and the cap 120 (e.g., the contact region where the nominal outer diameter of the closing portion 60 is greater than the nominal inner diameter of the cap 120), the overlapping region between the closing portion 60 and the cap 120 (e.g., the region where the closing portion 60 is positioned within the lumen 132 of the cap 120), and the configuration of the textured surface 205 on the outer surface 204 of the closing portion 60 and / or on the inner surface 202 of the cap 120 (e.g., length, size, shape, etc.) may be modified as desired and / or as required without departing from the scope of the present invention, insofar as the cap 120 and the closing portion 60 form a seal between them as desired and / or as required when the sample portion 70 is fully inserted within the lumen 132 of the cap 120.

[0036] In some embodiments, at the transition point between the two parts, the closing portion 60 and the sample portion 70, the distal end 67 of the closing portion 60 has the same cross-sectional shape as the sample portion. In other embodiments, the closing portion 60 has a cross-sectional shape that is larger than the cross-sectional shape of the sample portion at at least one point (e.g., thickness or width), and the dimensions of the cross-sectional shapes change in a stepwise manner between these cross-sectional shapes (with either a nominal fillet or a curved transition point specific to the manufacturing process). The sample portion 70 and the closing portion 60 may have the same cross-sectional shape near the transition point between these two parts (having different dimensions in some embodiments, as discussed above), or the sample portion 70 and the closing portion 60 may have different cross-sectional shapes near the transition point between these two parts.

[0037] In the embodiments shown in Figures 4 and 5, the closing portion 60 has a substantially conical profile along its longitudinal direction, and its diameter changes at a constant degree along its longitudinal direction. In one exemplary embodiment, the distal end 67 has a diameter of about 1.97 mm, and the diameter of the closing portion 60 increases along its longitudinal direction at an angle in the range of about 1.13 to about 1.17 degrees (preferably about 1.15 degrees). The angle of the tapered portion on the closing portion 60 at any position along the longitudinal direction of the closing portion 60 may be changed as desired and / or required without departing from the scope of the invention, but advantageously, the angle of the tapered portion on the closing portion 60 is relatively gentle. If the angle of the tapered portion of the closing portion 60 is significantly larger, the tapered portion may become shorter, the surface area available for fitting with the cap 120 may be reduced, and / or the sealing ability of the cap may be affected. For this reason, in at least some embodiments, the taper angle along the closing portion is not the same as the taper angle along the cap.

[0038] The handle portion 50 extends proximal from the proximal end 68 of the closing portion 60. The handle portion may be elongated and may include an information portion 52 and one or more ergonomic features. As shown in Figure 10, the handle portion 50 may have a deformed equilateral triangular cross-section along its length. In some embodiments, the handle portion 50 comprises three flat side portions 61, 62, and 63. In some embodiments, adjacent flat side portions (e.g., 61 / 62, 62 / 63, 63 / 61) form an edge between them, thereby forming a normal triangular cross-section (indicated by dotted lines forming a triangle in Figure 10).

[0039] In other embodiments, adjacent flat side portions may transition between each other via arc-shaped portions 64, 65, and 66, rather than extending toward each other at edges. In some embodiments, these arc-shaped portions 64, 65, and 66 may extend continuously from their respective flat side portions. In some embodiments, the maximum diameter of the handle portion 50, i.e., the maximum diameter from the top of one arc-shaped portion to the opposite flat side portion (line W in Figure 10), may be approximately 3.39 mm. In some embodiments, the portion of the handle portion 50 having a deformed triangular cross-section may define an equilateral triangle (with an arc-shaped portion rather than extending to the vertices / sides of a true equilateral triangle), so that a 60-degree angle is formed between the adjacent flat side portions 61, 62, and 63. In this embodiment, as shown in Figure 7, the handle portions of six different devices can be positioned within the cylindrical opening of the freezing container 800 (e.g., a sleeve inside the freezing container) (each device's handle portion 50 is represented as Z1, Z2, etc.), and the curved portions of each device 10 are oriented toward each other. In a typical embodiment, the handle portions 50 may be sized so that the six devices 10 can be simultaneously positioned within a sleeve inside the freezing container 800 having a diameter of 9 mm.

[0040] The handle portion 50 may comprise one or more information portions 52. The information portion 52 is configured to display identification information about a biological sample placed on the recessed portion 80 of the sample portion 70, thereby enabling the device 10 to be identified as desired when stored in a freezing container with multiple devices. This information portion may be a recessed portion having a smaller outer diameter than the other portion of the handle portion 50, so that when a label is affixed to this information portion (which provides information about a biological sample, such as a barcode, QR code®, text information, or color code), the overall cross-section of the information portion 52 (e.g., the cross-section including the label affixed to it) is smaller than or equal to the cross-section of the other portion of the handle portion. As shown in Figure 1, the information portion 52 may be positioned 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 be provided with one or more ergonomic features 53, such as one or more diameter transitions, one or more slots, or rough surfaces, to assist the user in operating the handle portion 50 and the elongated portion 40 for positioning the elongated body 40 as desired or for inserting the sample portion 70 into the lumen 132 of the cap 120.

[0042] Referring here to Figures 8 and 9, the cap 120 is presented. The cap 120 comprises an open proximal end 128 and a closed end 126. The lumen 132 extends from the open proximal end 128 and extends in a blind-hole manner along the cap 120 toward the closed end 126. The end portion of the closed end 126 may be provided with ergonomic features 123, such as one or more diameter transitions, one or more slots, or a rough surface finish, to assist the user in operating the closed end 126 of the cap 120 in order to move the cap relative to the sample portion 70 of the elongated 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 longitudinal direction. In this embodiment, the inner diameter of the lumen 132 is the same as the diameter of the closing portion 60 of the elongated body 40 when the elongated body 40, specifically the sample portion 70, is fully inserted into the lumen 132 of the cap 120, and the closing portion 60 and the cap 120 may be in surface contact. In other embodiments, the diameter of the lumen 132 may be slightly smaller than the minimum diameter of the closing portion 60 (i.e., the diameter at the distal end 67 of the closing portion 60 in embodiments where the diameter of the closing portion 60 increases proximal along the closing portion 60), so that the closing portion 60 is in surface contact with the lumen 132 over the entire length of the overlap between the cap 120 and the closing portion 60.

[0044] In other embodiments, the lumen 132 of the cap 120 may have one or more portions whose diameter changes along its length. For example, as shown in Figure 9, the lumen 132 has a proximal portion 138 and a distal portion 139, with the distal portion 139 positioned at the distal tip of the cap 120. In some embodiments, the proximal portion 138 may have a diameter that changes along its length. In one exemplary embodiment, the proximal end 138a of the proximal portion 138 of the lumen may have a diameter greater 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, where the diameter of the distal end 67 of the closure portion 60 is about 1.97 mm, the diameter of the proximal end 138a of the proximal portion 138 of the lumen may be about 2.1 mm, which provides 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 the lumen 132 along the proximal portion 138 is reduced distally along its longitudinal direction at an angle of, for example, about 1 degree. In typical embodiments disclosed herein, the distal end 138b of the proximal portion may have an inner diameter of about 1.82 mm. In some embodiments, the distal end 138b of the proximal portion 138 may have the same diameter as the proximal end 139a of the distal portion 139 of the lumen. In some embodiments, the length of the proximal portion 138 may be slightly longer than the length of the closing portion 60, for example, about 7.00 mm for the proximal portion 138 and about 6.5 mm for the closing portion 60.

[0046] In some embodiments, the taper angle of the proximal portion 138 of the lumen 132 (e.g., the portion up to about 7 mm from the cap opening) may be about 0 degrees, and the taper angle of other portions of the lumen 132 (e.g., the distal portion 139) may be in the range of about 0.1 degrees to about 0.5 degrees (preferably about 0.3 degrees). The angle of the taper portion of the lumen 132 of the cap 120 at any position along the longitudinal direction of the lumen 132 can be changed as desired and / or required without departing from the scope of the present invention, but having a gentler angle at the cap opening in particular is advantageous for forming a good seal while keeping the fitting force low. With respect to other portions of the lumen 132 (e.g., the distal portion 139, the portion beyond about 7 mm from the cap opening), having a gentler angle is advantageous in terms of manufacturability. 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, and at the same time, a slight angle allows for easier removal of some tools / accessories (e.g., mandrels, core pins, or other structures, these are not limiting examples) during molding compared to when there is no angle.

[0047] In some embodiments, the outer diameter of the cap 120 may be smaller than the maximum diameter of the elongated body 40, or in other embodiments, the outer diameter of the cap 120 may be such that the cross-section of the cap can be inscribed within the cross-section of the maximum portion of the elongated body 40, as schematically shown by circle Y in Figure 10. Here, this maximum portion may be the handle portion 50. This relative shape allows for space to exist between the caps 120 of adjacent devices when multiple devices 10 are positioned within the same sleeve in a freezing container, for example, as in Figure 7. This allows a refrigerant, such as liquid nitrogen, to flow between the caps 120 of adjacent devices 10, ensuring uniform cooling.

[0048] Furthermore, the subject matter of this disclosure may also relate, in particular, to the following aspects:

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

[0050] A second embodiment relates to a sealable container of the first embodiment, wherein the outer surface of the closing portion comprises a textured area.

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

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

[0053] A fifth aspect relates to a sealable container according to any of the preceding aspects, wherein the textured area extends over at least a portion of the outer surface of the closing portion or at least a portion of the inner surface of the cap in the circumferential direction.

[0054] The sixth aspect relates to a sealable container according to any of the above-described aspects, wherein the average surface roughness (Ra value) of the textured area is in the range of about 1 μm to about 28 μm.

[0055] The seventh aspect relates to a sealable container of any of the above-described aspects, wherein the average surface roughness (Ra value) of the textured area on the inner surface of the cap is in the range of about 4 μm to about 5 μm, and the average surface roughness (Ra value) of the textured area on the outer surface of the closing portion is in the range of about 25 μm to about 28 μm.

[0056] The eighth aspect relates to a sealable container of any of the preceding aspects, wherein the average surface roughness (Ra value) of the textured area is in the range of approximately 4 microinches to approximately 5 microinches.

[0057] The ninth aspect relates to a sealable container of any of the preceding aspects, wherein the textured area on the inner surface of the cap extends along the length from about 3 mm to about 10 mm from the edge of the proximal opening end of the cap.

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

[0059] The eleventh aspect relates to a sealable container for storing a biological sample, comprising a cap having a proximal open end and a distal end, with a lumen extending from the proximal open end to the distal end, and an elongated body extending from a handle portion to a sample portion, wherein the sample portion is configured to receive a biological sample thereon, and the elongated body further comprises a closure portion disposed between the handle portion and the sample portion, the closure portion being configured to surface contact with the cap when the sample portion of the elongated body is fully inserted into the lumen of the cap, and the inner surface of the cap that contacts the closure portion when engaged with the closure portion and the outer surface of the closure portion that contacts the cap when engaged with the cap each have a textured surface finish.

[0060] A twelfth aspect relates to a sealable container of the eleventh aspect, wherein the average surface roughness (Ra value) of the textured area on the inner surface of the cap is in the range of about 4 microinches to about 5 microinches, and the average surface roughness (Ra value) of the textured area on the outer surface of the closing portion is in the range of about 25 microinches to about 28 microinches.

[0061] A thirteenth aspect relates to a sealable container according to either the eleventh or twelfth aspect, wherein the textured area on the outer surface of the closing portion or the inner surface of the cap is larger than the contact area between the closing 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 area extends over the area of ​​at least a portion of the inner surface of the cap or at least a portion of the outer surface of the closing portion.

[0063] The 15th aspect relates to a sealable container according to any one of the 11th to 14th aspects, wherein the closing portion and the cap form a tight fit between the closing portion and the cap due to the difference between the outer diameter of the closing portion and the inner diameter of the cap.

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

[0065] The 17th aspect relates to a sealable container of the 16th aspect, wherein at least a portion of the closing part is tapered at an angle of about 1.15 degrees, and at least a portion of the lumen of the cap does not have a tapered portion.

[0066] The 18th aspect relates to a sealable container according to either the 16th or 17th aspect, wherein the textured area on the outer surface of the closing portion is larger than or substantially equal to the contact area between the closing portion and the cap.

[0067] The 19th aspect relates to a sealable container according to any one of the 16th to 18th aspects, wherein the average surface roughness (Ra value) of the textured area is in the range of about 1 μm to about 28 μm.

[0068] The 20th aspect relates to a sealable container according to any one of the 16th to 19th aspects, wherein the proximal portion of the lumen of the cap does not have a tapered portion, and the distal portion of the lumen of the cap is tapered at an angle of approximately 0.3 degrees.

[0069] In some embodiments, in addition to the features described in each of the independent embodiments listed above, optional features described in the dependent embodiments and / or optional features disclosed in the above description and shown in the drawings may be shown individually 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 included within the meaning of the claims are intended to be included within the scope of the present invention, whether literally or by doctrine of equivalents. [Explanation of Symbols]

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

Claims

1. A sealable container for storing biological samples, A cap comprising a proximal opening end and a distal end, wherein the lumen extends from the proximal opening end to the distal end, An elongated body extending from a handle portion to a sample portion, wherein the sample portion is configured to receive a biological sample thereon, and the elongated body further comprises a closing portion disposed between the handle portion and the sample portion, wherein the closing portion is configured to make surface contact with the cap when the sample portion of the elongated body is fully inserted into the lumen of the cap, and the elongated body and Equipped with, A sealable container wherein at least one of the inner surface of the cap that contacts the closing portion when engaged with the closing portion, and the outer surface of the closing portion that contacts the cap when engaged with the cap, is a textured area with a textured surface finish.

2. The sealable container according to claim 1, wherein the outer surface of the closed portion comprises the textured area.

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

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

5. The sealable container according to claim 1, wherein the textured area extends over at least a portion of the outer surface of the closing portion in the circumferential direction or over at least a portion of the inner surface of the cap in the circumferential direction.

6. The sealable container according to claim 1, wherein the average surface roughness (Ra value) of the textured area is in the range of about 1 μm to about 28 μm.

7. The sealable container according to claim 1, wherein the average surface roughness (Ra value) of the textured area on the inner surface of the cap is in the range of about 4 μm to about 5 μm, and the average surface roughness (Ra value) of the textured area on the outer surface of the closing portion is in the range of about 25 μm to about 28 μm.

8. The sealable container according to claim 1, wherein the average surface roughness (Ra value) of the textured area is in the range of about 4 μm to about 5 μm.

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

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

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

12. A sealable container for storing biological samples, A cap comprising a proximal opening end and a distal end, wherein the lumen extends from the proximal opening end to the distal end, An elongated body extending from a handle portion to a sample portion, wherein the sample portion is configured to receive a biological sample thereon, and the elongated body further comprises a closing portion disposed between the handle portion and the sample portion, wherein the closing portion is configured to make surface contact with the cap when the sample portion of the elongated body is fully inserted into the lumen of the cap, and the elongated body and Equipped with, A sealable container wherein the inner surface of the cap that contacts the closing portion when engaged with the closing portion, and the outer surface of the closing portion that contacts the cap when engaged with the cap, each have a textured surface finish.

13. The sealable container according to claim 12, wherein the average surface roughness (Ra value) of the textured area on the inner surface of the cap is in the range of about 4 μm to about 5 μm, and the average surface roughness (Ra value) of the textured area on the outer surface of the closing portion is in the range of about 25 μm to about 28 μm.

14. The sealable container according to claim 12, wherein the textured area on the outer surface of the closing portion or on the inner surface of the cap is larger than the contact area between the closing portion and the cap.

15. The sealable container according to claim 12, wherein the textured area extends to at least a portion of the inner surface of the cap or at least a portion of the outer surface of the closing portion.

16. The sealing container according to claim 12, wherein the closing portion and the cap form a tight-fitting portion between the closing portion and the cap due to the difference between the outer diameter of the closing portion and the inner diameter of the cap.

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

18. A sealable container for storing biological samples, A cap comprising a proximal opening end and a distal end, wherein the lumen extends from the proximal opening end to the distal end, An elongated body extending from a handle portion to a sample portion, wherein the sample portion is configured to receive a biological sample thereon, and the elongated body further comprises a closing portion disposed between the handle portion and the sample portion, wherein the closing portion is configured to make surface contact with the cap when the sample portion of the elongated body is fully inserted into the lumen of the cap, and the elongated body and Equipped with, A sealable container wherein the outer surface of the closing portion that contacts the cap when engaged with the cap has a textured area with a textured surface finish.

19. The sealable container according to claim 18, wherein at least a portion of the closing portion is tapered at an angle of about 1.15 degrees, and at least a portion of the lumen of the cap does not have a tapered portion.

20. The sealable container according to claim 18, wherein the textured area on the outer surface of the closing portion is larger than or substantially equal in size to the contact area between the closing portion and the cap.

21. The sealable container according to claim 18, wherein the average surface roughness (Ra value) of the textured area is in the range of about 1 μm to about 28 μm.

22. The sealable container according to claim 18, wherein the proximal portion of the lumen of the cap does not have a tapered portion, and the distal portion of the lumen of the cap is tapered at an angle of about 0.3 degrees.

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

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