阅读说明：本技术 低温容器 (Low temperature container ) 是由 J·L·希门尼斯-里奥斯 L·D·亨德利 V·W·哈维莱 E·E·罗伯茨 J·M·雅博 于 2019-09-27 设计创作，主要内容包括：提供了一种用于保存比如胚胎或卵母细胞的生物样本的可密封容器。容器包括盖帽(120),该盖帽包括近侧开口、内腔以及从手柄部分延伸到式样部分(70)的细长本体(40)。封闭部分(60)设置在手柄部分与式样部分之间,其中,封闭部分被配置用于当式样部分完全插入内腔内时与盖帽形成面与面接触。封闭部分包括在从手柄部分到式样部分的方向上逐渐减小的外径。式样部分包括勺形部分(80),该勺形部分的上表面与下表面之间的距离小于上表面和下表面之间沿式样部分的其余部分的距离,其中,勺形部分与式样部分的远端头间隔很近。(A sealable container for holding a biological sample such as an embryo or oocyte is provided. The container includes a cap (120) including a proximal opening, an interior cavity, and an elongated body (40) extending from the handle portion to the styling portion (70). A closure portion (60) is disposed between the handle portion and the styling portion, wherein the closure portion is configured to form a face-to-face contact with the cap when the styling portion is fully inserted into the cavity. The closing portion includes an outer diameter that gradually decreases in a direction from the handle portion to the style portion. The style portion includes a scoop portion (80) having a distance between an upper surface and a lower surface that is less than a distance between the upper surface and the lower surface along a remainder of the style portion, wherein the scoop portion is closely spaced to a distal tip of the style portion.)

1. A sealable container for holding a biological sample, comprising:

a cap including a proximal open end and a sealed distal end, a lumen extending from the open end to the sealed distal end;

and an elongated body extending from a handle portion to a style portion, wherein the style portion is configured to receive a biological sample thereon, the elongated body further comprising an enclosing portion disposed between the handle portion and the style portion, wherein the enclosing portion is configured to form a face-to-face contact with the cap when the style portion of the elongated body is fully inserted within the lumen of the cap,

wherein the closing portion includes an outer diameter that gradually decreases in a direction from the handle portion to the style portion, wherein an outer diameter of a portion of the closing portion is the same as or greater than an inner diameter of an inner cavity forming the cap;

wherein the pattern portion includes an upper surface and an opposing lower surface, the upper surface including a scoop portion, a distance between the upper surface and the lower surface of the scoop portion being less than a distance between the upper surface and the lower surface along a remainder of the pattern portion, wherein the scoop portion is closely spaced from a distal tip of the pattern portion.

2. The sealable container of claim 1, wherein an upper surface of the scoop portion is arcuate in a direction perpendicular to the longitudinal axis of the elongated body and is of constant cross-section in a direction along the longitudinal axis of the elongated body.

3. The sealable container of any of claim 1 or claim 2, wherein an upper surface of the scoop portion is arcuate in a direction perpendicular to the longitudinal axis of the elongate body.

4. The sealable container of any preceding claim, wherein the handle portion comprises a first portion comprising a triangular profile having a first planar side, a second planar side, and a third planar side, the planar sides being arranged along respective different sides of the triangular profile, wherein the triangular profile comprises curves between adjacent sides of the triangular profile, wherein both ends of each curve extend continuously from each respective end of the planar sides.

5. The sealable container of any preceding claim, wherein the first portion comprises a recessed portion disposed therealong.

6. The sealable container of claim 5, wherein the recessed portion is disposed between opposing portions having the triangular profile.

7. The sealable container of claim 2, further comprising an angled transition between the first and second ends of the scoop portion and the pattern portion.

8. The sealable container of any preceding claim, wherein an inner diameter of the inner cavity of the cap increases from the open proximal end of the closed distal end.

9. The sealable container of any preceding claim, wherein an upper surface of the scoop portion is planar.

10. The sealable container of any preceding claim, wherein the closure portion transitions with the pattern portion by a step change in outer diameter.

11. The sealable container of claim 10, wherein the closure portion transitions with the handle portion by a step change in outer diameter.

Background

The devices described in this specification relate to devices configured to retain biological samples for long term cryopreservation within a cryogenic container. The device may be used for vitrification, in particular for vitrification of embryos or oocytes or other biological material, such as in conjunction with or in preparation for In Vitro Fertilization (IVF) cycles.

Disclosure of Invention

Representative embodiments of the present disclosure are provided. This embodiment includes a sealable container for holding a biological sample. The vessel includes a cap including a proximal open end and a sealed distal end, a lumen extending from the open end to the sealed distal end, and an elongated body extending from a handle portion to a styling portion, wherein the styling portion is configured to receive a biological sample thereon, the elongated body further including a closure portion disposed between the handle portion and the styling portion, wherein the closure portion is configured to form a face-to-face contact with the cap when the styling portion of the elongated body is fully inserted into the lumen of the cap. The closing portion includes an outer diameter that gradually decreases in a direction from the handle portion to the styling portion, wherein the outer diameter of a portion of the closing portion is the same as the inner diameter of the inner cavity forming the cap. The style portion includes an upper surface and an opposite lower surface, wherein the upper surface includes a scoop portion, the distance between the upper surface and the lower surface of the scoop portion being less than the distance between the upper surface and the lower surface along the remainder of the style portion, wherein the scoop portion is closely spaced from the distal tip of the style portion.

The advantages of the present disclosure will become more apparent to those skilled in the art from the following description of the preferred embodiments of the disclosure, which is shown and described by way of illustration. As will be realized, the disclosed subject matter is capable of other and different embodiments and its details are capable of modifications in various respects. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

Drawings

Fig. 1 is a perspective view of an elongated member of a cryopreservation apparatus.

Fig. 2 is a side view of the elongated member of fig. 1.

Fig. 3 is a top view of the elongated member of fig. 1.

Figure 4 is a side view of detail a of figure 2.

Fig. 5 is a top view of detail a of fig. 2.

Fig. 6 is a cross-sectional view of section Z-Z of fig. 5.

Fig. 7 is a view of six cryopreservation devices aligned within the sleeve of a cryogenic container.

Fig. 8 is a perspective view of a cap of the cryopreservation apparatus.

Fig. 9 is a side cross-sectional view of the cap of fig. 8.

Fig. 10 is a cross-sectional view of the handle portion of the elongated member of fig. 1 taken along section T-T.

FIG. 11 is another cross-sectional view of the handle portion of the elongated member of FIG. 1 taken along section R-R.

Detailed Description

Brief description of the drawings and detailed description of the presently preferred embodiments

Turning now to fig. 1-11, an apparatus 10 for receiving and storing material for cryopreservation is provided. The device 10 may be a sealable container configured for receiving a biological sample, enclosing the biological sample and supporting long-term reception of the biological sample in a cryopreservation vessel, such as a dewar. The device 10 can sealingly retain biological samples having different configurations as described herein.

The device 10 can include a cap 120 and an elongated body 40, wherein a portion of the elongated body 40 is inserted into and extends within the interior cavity 132 of the cap 120. As discussed below, the elongated body has an enclosed portion 80 configured to engage the interior cavity 132 of the cap 120 when the patterned portion 70 of the elongated body 40 is fully inserted within the interior cavity 132.

The elongated body 40 is best shown in fig. 1-5. The elongated body 40 extends from the handle portion 50 to the patterned portion 70. Handle portion 50 is configured to be manipulated by a user, such as inserting and removing device 10 from cryogenic vessel 800 (fig. 7). As discussed below, the handle portion 50 is also adapted to include biological information about biological patterns stored within the device 10. The patterned portion 70 is configured for receiving and supporting a biological sample thereon, as can be appreciated, the biological sample is disposed on and removed from the patterned portion 70 when the patterned portion is uncovered, and the device 10 is configured for storage when the cap 120 is disposed on the patterned portion 70 of the elongated member 40.

The pattern section is best shown in fig. 4-5. Patterned portion 70 includes 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 planar along at least a portion thereof. In other embodiments, one or both of the upper and lower surfaces may be curved. The patterned portion 70 additionally includes right and left surfaces 77, 79 that bridge between opposing edges or, in some embodiments, between ends of the respective upper and lower surfaces 72, 76. In some embodiments, the cross-section of the patterned portion (in addition to one or more patterned portions discussed in additional detail below) may be rectangular, square, circular, oval, or other geometric shapes. For example, the upper surface 72 and the lower surface 76 may be planar, while the left surface 77 and the right surface 79 may be arcuate, or vice versa.

The scoop portion 80 can be a single portion or a plurality of scoop portions spaced along the length of the pattern portion 70. The scoop portion 80 can be a location where the thickness of the patterned portion 70 (measured between the upper surface 72 and the lower surface 76) is less than the thickness elsewhere along the patterned portion 70. In one representative embodiment of the present disclosure, the thickness of the scoop portion is 0.35mm less than the thickness of the style portion 70 adjacent to the scoop portion 80, in other words, in this embodiment, the depth of the scoop portion is 0.35 mm. In some embodiments, the depth of the scoop portion is greater than the maximum outer diameter of a biological sample that is expected to be positioned on the scoop portion 80 for storage within the device 10. The scoop portion 80 includes a surface 86 on which a biological specimen rests when placed on the scoop portion. In some embodiments, the surface may be as depicted in fig. 6, in which the surface 86 is arcuate, and in some embodiments concave. In one representative embodiment, the cross-section of the scoop portion has a center point that is 0.2mm lower than the outer edges 82a, 82b of the scoop portion, as depicted by dimension X on fig. 6. In some embodiments, the profile of the surface 86 of the scoop portion may be constant along its length, while in other embodiments, the shape of the surface 86 may vary along its length, such as the centerline of the surface 86 (extending parallel to the longitudinal axis 1001 of the elongate member 40) being arcuate, and in some embodiments concave.

The scoop portion 80 may transition from the remainder of the style portion 70 through a sidewall 82 and a sidewall 84. These sidewalls may be planar (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 elongate body 40, while in other embodiments, the sidewalls 82, 84 may extend at an acute angle β relative to the longitudinal axis 1001. The angle β may be in the range of about 15 degrees to about 75 degrees, or about 30 degrees to 60 degrees, or about 40 degrees to about 50 degrees. As used herein, the term "about" when referring to an angle is defined to include the value of the reference as well as values plus or minus 2.5 degrees above the reference value. In some representative embodiments, the angle β may be 40 degrees, 45 degrees, 50 degrees, or other angles as will be appreciated by one of ordinary skill in the art upon thorough review of the subject specification and drawings. In some embodiments, the first and second sidewalls 82, 84 may be the same geometric shape (although facing in opposite directions) or the sidewalls 82, 84 may be formed of different geometric shapes.

In some embodiments, the scoop portion 80 is positioned proximate the distal tip 79 of the patterned portion. In these embodiments, the cross-sectional geometry of the distal tip 79 can be the same as the cross-sectional geometry of the patterned portion 70 adjacent the scoop portion 80, or in other embodiments, the cross-sectional geometry can be different and distinct from the scoop portion. In representative embodiments, the length of the scoop portion can be about 4.0mm to about 6.0mm, including the limits of this ratio. The word "about" as used herein in connection with a dimension is defined as the reference dimension plus or minus 5% of the reference dimension.

As will be understood by those of ordinary skill in the art upon a thorough review of the subject specification and drawings, the size and dimensions of the various portions of the device 10 may vary based on the intended size and type of biological specimen and the size of the cryogenic container.

The closing portion 60 is disposed between the handle portion 40 and the patterned portion 70. The closure portion 60 includes a cross-sectional geometry that gradually increases along its length. The closure portion 60 is positioned along the patterned portion 70 such that when the patterned portion 70 is fully inserted into the interior cavity 132 of the cap 120, an interior surface of the interior cavity 132 of the cap 120 (discussed in further detail below) contacts the closure portion 60. In some embodiments, the outer diameter of the closure portion 60 may be the same as the inner diameter of the interior cavity 132 of the cap 120 when the patterned portion 70 is fully inserted into the cap 120. In other embodiments, the outer diameter of the enclosure portion 60 is slightly larger than the inner diameter of the interior cavity 132 of the cap 120 when the patterned portion 70 is fully inserted. In this embodiment, the material forming one or both of the cap and the closure portion 60 may be sufficiently soft to compress slightly, which increases the strength of the connection between the cap and the closure portion.

In some embodiments, the distal end 62 of the blocking portion 60 has the same cross-sectional geometry as the pattern portion at the location where the two portions transition. In other embodiments, the cross-sectional geometry of the closed portion 60 is greater in at least one aspect (e.g., thickness, width, etc.) than the cross-sectional geometry of the patterned portion, with a step change in dimension between the closed portion and the patterned portion (including any nominal sheet or curved transition inherent in the manufacturing process). The patterned portion 70 and the closed portion 60 may have the same cross-sectional shape adjacent the transition between the two (as discussed above, and in some embodiments, different dimensions), or the patterned portion 70 and the closed portion 60 may have different cross-sectional shapes adjacent the transition between the two. In the embodiment depicted in fig. 4-5, the closure portion 60 has a conical profile along its length with a constant varying diameter along its length. In an exemplary embodiment, the distal end 62 has a diameter of 1.97mm, and the diameter of the closure portion 60 increases at an angle of 1.15 degrees along its length. .

The handle portion 50 extends proximally from the proximal end of the closure portion 60. The handle portion may be elongated and may include an information portion 52 and one or more ergonomic features. The handle portion 50 may have a triangular cross-section modified along its length (as shown in fig. 10). In some embodiments, the handle portion 50 includes three planar side portions 61, 62, and 63. In some embodiments, edges are formed between adjacent planar side portions (e.g., 61/62, 62/62, 63/61) to form a generally triangular cross-section (depicted in fig. 10 with dashed lines forming a triangle).

In other embodiments, adjacent planar side portions may transition between each other in arcuate portions 64, 65, 66 rather than extending toward each other at the edges. In some embodiments, the arcuate portions 64, 65, and 66 may extend continuously from the respective planar side portions. In some embodiments, the maximum diameter of the handle portion 50, i.e., from the top of one arcuate portion to the opposite planar side portion, (line W in fig. 10) may be about 3.39 mm. In some embodiments, the portion of the handle portion 50 that includes the modified triangular cross-section may define an equilateral triangle (the arc-shaped portion instead of extending to a point/edge of an actual equilateral triangle) such that an angle of 60 degrees is formed between each adjacent planar side portion 61, 62, and 63. In this embodiment, handle portions of six different devices can be positioned within a cylindrical opening of cryogenic vessel 800 (such as a sleeve within the cryogenic vessel), as depicted in fig. 7 (handle portion 50 of each device is denoted as Z1, Z2, etc.), with the curved portions of each device 10 pointing toward each other. In a representative embodiment, the handle portion 50 may be sized such that six devices 10 can be simultaneously positioned in the sleeve 800 of a 9mm diameter cryogenic container.

The handle portion 50 may include one or more information portions 52. The information portion 52 is configured to receive identification information about a biological specimen disposed on the scoop portion 80 of the style portion 70 so that the device 10 can be identified when needed when stored in a cryogenic container having multiple devices. The information portion may be a recessed portion that includes a smaller outer diameter than the remainder of the handle portion 50 such that when the label is attached to the information portion (which provides information related to a biometric pattern, a bar code, a QR code, written information, a color code, etc.), the overall cross-section of the label + information portion 52 is less than or equal to the cross-section of the remainder of the handle portion. As shown in fig. 1, the information portion 52 may be disposed between two portions of the handle portion 40 having a modified triangular profile as discussed above.

In some embodiments, the handle portion 50 may include one or more ergonomic features 53 (such as one or more diameter transitions, one or more slots, a rough surface finish, etc.) to assist the user in manipulating the handle portion 50 and the elongate member 40 to position the elongate member 40 or insert the patterned portion 70 into the lumen 132 of the cap 120 as desired.

Turning now to fig. 8-9, a cap 120 is provided. The cap 120 includes an open distal end 128 and a closed end 126. A lumen 132 extends from the open distal end 128 and blindly extends therealong toward the closed end 126. The end of the closed end 126 may include ergonomic features 123 (such as one or more diameter transitions, one or more slots, a rough surface finish, etc.) to assist the user in manipulating the closed end 126 of the cap 120 to move the cap relative to the patterned portion 70 of the elongate member 40 to allow the cap 120 to cover the patterned portion 70.

In some embodiments, the lumen 132 may be a single inner diameter along its length. In this embodiment, the inner diameter of the lumen 132 may be the same as the diameter of the enclosed portion 60 of the elongate member 40 at: in this position, the elongated member 40, and in particular the pattern 70, is fully inserted into the interior cavity 132 of the cap 120 such that the closure portion 60 and the cap 120 form a face-to-face contact. In other embodiments, the diameter of the lumen 132 may be slightly smaller than the smallest diameter of the closure portion 60 (i.e., the diameter of the distal end 62 of the closure portion 60 in embodiments where the diameter of the closure portion 60 increases proximally along the closure portion 60) such that the closure portion 60 makes surface-to-surface contact with the lumen 132 throughout the length of the overlap between the cap 120 and the closure portion 60.

In other embodiments, the interior cavity 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 distal portion 138 and a proximal portion 139, wherein the distal portion 138 is positioned on the distal tip of the cap 120. In some embodiments, the distal portion 138 may have a diameter that varies along its length. In an exemplary embodiment, the distal end 138a of the distal portion 138 of the lumen may have a diameter that is larger than both the largest diameter of the pattern portion and the diameter of the blocking portion 60 (at least at the distal end 62 of the blocking portion 60). In the exemplary embodiment disclosed herein, the distal end 62 of the closure portion 60 is 1.97mm and the distal end 138a of the distal portion 138 of the lumen may be 2.1mm to allow some play for the user when inserting the distal tip 79 of the styling portion 70 into the lumen 132 of the cap 120.

In some embodiments, the diameter of the lumen 132 along the distal portion 138 decreases proximally along its length, such as by an angle of about 1 degree. In representative embodiments disclosed herein, the proximal end 138b of the distal portion may have an inner diameter of 1.82 mm. In some embodiments, the diameter of the proximal end 138b of the distal portion 138 may be the same as the diameter of the distal end 139a of the proximal portion 139 of the lumen. In some embodiments, the length of distal portion 138 may be slightly longer than the length of closure portion 60, e.g., distal portion 138 is 7.00mm and closure portion 60 is 6.5 mm.

In some embodiments, the outer diameter of the cap 120 may be smaller than the maximum diameter of the elongated member 40, or in other embodiments, the outer diameter of the cap 120 may be such that the cross-section of the cap is capable of inscribed within the cross-section of the largest portion of the elongated member 40, which may be the handle portion 50, as schematically illustrated by circle Y in fig. 10. This relative geometry ensures that when multiple devices 10 are positioned within the same sleeve within a cryogen vessel, such as between caps 120 of adjacent devices in fig. 7, there is space to allow coolant (such as liquid nitrogen) to flow between caps 120 of adjacent devices 10 to ensure uniform cooling.

While the preferred embodiments of the present disclosure have been described, it is to be understood that the present disclosure is not so limited and that modifications may be made without departing from the disclosure. The scope of the invention is defined by the appended claims, and all devices that come within the meaning of the claims, either literally or by equivalence, are intended to be embraced therein.