DK201600799A1

DK201600799A1 - A device for handling a biological material

Info

Publication number: DK201600799A1
Application number: DKPA201600799A
Authority: DK
Inventors: Thomas William Pedersen
Original assignee: Esco Medical Uab
Priority date: 2016-12-27
Filing date: 2016-12-27
Publication date: 2018-01-15
Also published as: DK179184B1; WO2018121818A1

Abstract

The invention related to a device 100 for culturing a biological material, said device comprising a first element 2 and a second element 4; wherein said first element 2 is having an extension in a lengthwise direction X, an extension in a transverse direction Y and an extension in a direction Z perpendicular to the lengthwise direction as well as to the transverse direction; wherein said second element 4 is having an extension in a lengthwise direction X, an extension in a transverse direction Y and an extension in a direction Z perpendicular to the lengthwise direction as well as to the transverse direction; wherein said first element comprises one or more culture wells 6,6',6'',6''',8,8',8''.8'''; wherein each well is being in the form of a recess in a surface 10 of said first element; wherein said second element comprises a compartment 12 extending in a lengthwise direction X from a rim 14 of said second element; wherein the outer dimensions of said first element 2 and the inner dimensions of said compartment 12 in said second element 4 are adapted to each other in such a way that the first element can be slit in and out of the compartment in the second element, in a lengthwise direction X, thereby changing the accessibility to one or more of the plurality of culture wells 6,6',6'',6''',8,8',8''.8''' between an exposed configuration in which the culture wells are accessible and not covered by the second element 4, and a closed configuration in which the culture wells are covered by the second element 4.

Description

(19) DANMARK <¹°> DK 2016 00799 A1

<¹²> PATENTANSØGNING

Patent- og

Varemærkestyrelsen (51) lnt.CI.: C12M 3/00(2006.01)

A01N 1/02(2006.01)

C 12 M 1/00(2006.01) (21) Ansøgningsnummer: PA 2016 00799 (22) Indleveringsdato: 2016-12-27 (24) Løbedag: 2016-12-27 (41) Aim. tilgængelig: 2018-01-15 (71) Ansøger: Esco Medical UAB , Draugystes g. 19, LT-51230 Kaunas, Litauen (72) Opfinder: Thomas William Pedersen, Skovlykkevej 7, 8660 Skanderborg, Danmark (74) Fuldmægtig: OTELLO ADVOKATANPARTSSELSKAB, Dalgasgade 25, 8., 7400 Herning, Danmark (54) Benævnelse: A device for handling a biological material (56) Fremdragne publikationer:

US 2011/0275153 A1 WO 2016/111217 A1 WO 2011/070973 A1 (57) Sammendrag:

The invention related to a device 100 for culturing a biological material, said device comprising a first element 2 and a second element 4;

wherein said first element 2 is having an extension in a lengthwise direction X, an extension in a transverse direction Y and an extension in a direction Z perpendicular to the lengthwise direction as well as to the transverse direction;

wherein said second element 4 is having an extension in a lengthwise direction X, an extension in a transverse direction Y and an extension in a direction Z perpendicular to the lengthwise direction as well as to the transverse direction;

wherein said first element comprises one or more culture wells 6,6',6,6',8,8',8.8'; wherein each well is being in the form of a recess in a surface 10 of said first element;

wherein said second element comprises a compartment 12 extending in a lengthwise direction X from a rim 14 of said second element;

wherein the outer dimensions of said first element 2 and the inner dimensions of said compartment 12 in said second element 4 are adapted to each other in such a way that the first element can be slit in and out of the compartment in the second element, in a lengthwise direction X, thereby changing the accessibility to one or more of the plurality of culture wells 6,6',6,6',8,8',8.8' between an exposed configuration in which the culture wells are accessible and not covered by the second element 4, and a closed configuration in which the culture wells are covered by the second element 4.

Fortsættes ...

DK 2016 00799 A1

Fig. 1

DK 2016 00799 A1

A device for handling a biological material

Field of the invention

The present invention relates to the field of in vitro fertilization. More specifically the present invention relates in a first aspect to a device for handling or culturing a biological material. In a second aspect the present invention relates the use of a device according to the first aspect in performing one or more processing steps relating to handling a biological material. In a third aspect the present invention relates to a method for performing one or more processing steps relating to handling a biological material by using a device according to the first aspect of the present invention.

Background of the invention

Within the latest decades considerably improved methods and techniques has been developed within the field of in vitro fertilization (IVF). These developments have resulted in enhanced success rates in terms of number of successful births originating from such techniques.

In vitro fertilization involves capturing a ripened egg from a female ovary, fertilizing the egg with a spermatozoon, incubating the fertilized egg under a controlled environment and subsequently inserting the fertilized and incubated egg in the female’s uterus.

Traditionally the incubation of the egg is being performed by accommodating the egg in a culture dish under a predetermined liquid and gaseous environment. Typically, the egg is monitored by camera or video means with the view of gain knowledge of the development of the egg for the purpose of only selecting a specific egg for the reinsertion into the female’s body, in case that specific egg is exhibiting a development which fulfills certain standards which are considered optimum.

As a plurality of ripened eggs are often harvested from the female’s ovary, prior to an IVF procedure (by subjecting the female to a hormone treatment, making her ovulate such a plurality of eggs) there is a need to be able to preserve such eggs until a point in time where one or more of these eggs is or are to be used in the IVF procedure.

DK 2016 00799 A1

To this end cryopreservation methods have been developed. A cryopreservation involves freezing one or more eggs at cryogenic conditions, for example by storing the one or more eggs in liquid nitrogen at approximately -196 °C.

However, in a cryopreservation procedure of a biological material there is a risk that mechanical damage of the biological material will result from the change of state from liquid to solid when the biological material transits from ambient temperatures to cryogenic temperatures. Such mechanical damage may involve destroying the organelles responsible for the metabolism taken place within that biological material.

Therefore, prior to a cryopreservation of an oocyte, a zygote or an embryo it will be necessary to prepare that oocyte, zygote or embryo to a cryopreservation. Such preparation prior to a cryopreservation is called a vitrificatiton.

Vitrification may involve treating the biological sample with one or more “vitrification liquids”, also denoted “cryoprotectants”. Osmosis may be involved in the vitrification so that water is being drained from the biological sample prior to the freezing step.

In the process of cryopreservation of a biological sample the biological material is accordingly, at the optimum point in time, subjected to a vitrification procedure and subsequently transferred to a vial suitable for storing the biological material during cryogenic storage which takes place subsequently.

In a cryopreservation process of an oocyte, a zygote or an embryo it is of paramount importance that the cooling from ambient temperature to cryogenic temperature takes place as quickly as possible, preferably almost instantaneously.

However, the prior art vials used for cryopreservation are either open, thus implying the risk of contamination during submerging and/or storage in liquid nitrogen; and/or the prior art vials are rather thick-walled, thus providing a rather large degree of thermal insulation and thereby preventing a close to instant temperature drop to a cryogenic temperature upon being submerged into liquid nitrogen. Same kind of insulation problems exist in certain kinds of cryopreservation vials having a design which implies that there is a rather large air gap between the biological sample and the wall of the vial. Other types of prior art vials for cryopreservation rely on a two-step cryopreservation in which an inner vial element holds the biological material as a suspended droplet which is to be frozen first. Next this vial element is

DK 2016 00799 A1 inserted into a second vial element which is subsequently submerged into liquid nitrogen. This type of vial implies a delayed freezing of the biological sample and poses the risk of partly thawing between the two freezing steps.

Examples of prior art vials can be seen on the follow internet addresses:

http://www.rbmoiournal.com/articleZS 1472-6483(10)61169-8/pdf http://www.kitazato-dibimed.com/vitrification-cryotop/ http ://humrep. oxfordi ournals. or g/content/early/2014/08/27/humrep. deu214. full. pdf

Accordingly, there exists a need for improved devices and processes in IVF involving culturing an oocyte, a zygote or an embryo and/or involving vitrification and/or cryopreservation.

It is an objective of the present invention to provide improved devices and processes for use in IVF processes involving handling, culturing, vitrification and/or cryopreservation of an oocyte, a zygote or an embryo.

Brief description of the invention

These objectives are fulfilled by the present invention in its various aspects. Accordingly, the present invention relates in a first aspect to a device for culturing a biological material, said device comprising a first element and a second element;

wherein said first element is having an extension in a lengthwise direction X, an extension in 20 a transverse direction Y and an extension in a direction Z perpendicular to the lengthwise direction as well as to the transverse direction;

wherein said first element comprises one or more rods;

wherein each rod comprises a first cylinder having a first axial end and a second axial end;

wherein each rod comprises a second cylinder having a first axial end and a second axial end;

DK 2016 00799 A1 wherein said first cylinder, at the second axial end thereof, being connected to said second cylinder, at the first axial end thereof, by a well portion; thereby defining a culture well in the area between the first cylinder and the second cylinder;

wherein the axial axis of said first cylinder coincides with the axial axis of said second cylinder;

wherein said second element comprising one or more cylindrical compartments;

wherein each cylindrical compartment comprises a first open end confined by a rim;

wherein the outer dimensions and the orientation of said rods of said first element, on the one hand, and the inner dimensions and orientations of said compartments of said second element, on the other hand, are being adapted to each other in such a way that the rod(s) of the first element can be slit in and out of the compartment(s) in the second element, in a lengthwise direction X, thereby changing the accessibility to one or more of the culture wells between an exposed configuration in which the culture wells are accessible and not covered by the second element, and a closed configuration in which the culture wells are covered by the second element.

In a second aspect the present invention relates to a use of a device according to the first aspect in performing one or more processing steps relating to handling a biological material.

In a third aspect the present invention relates to a method for performing one or more processing steps relating to handling a biological material; wherein said method comprises the steps of:

i) providing a device according to the first aspect of the present invention;

ii) arranging the first element of said device in relation to the second element of said device in such a way that each said rod of said first element is accommodated in a corresponding cylindrical compartment of said second element; and in such a way that one or more of said one or more culture wells is/are partly exposed and partly covered by said second element;

iii) arranging one or more biological materials in said one or more culture wells, respectively, while making sure that the device is arranged in an essentially upright orientation;

DK 2016 00799 A1 iv) optionally arranging one or more fluids in one or more of said one or more culture wells, respectively;

v) sliding in the first element in relation to the second element in such a way that the said one or more culture wells is/are fully covered by said second element;

vi) performing one or more processing steps of said biological material.

The present invention in its various aspects provides for improved handling of a biological material, especially in relation to IVF procedures, in which the biological material is being an oocyte, a zygote or an embryo.

Specifically, the present invention in its various aspects in particular provides for improved 10 handling of oocyte, a zygote or an embryo in a cryopreservation process.

The specific design of the device according to the first aspect of the present invention allows for handling and culturing a biological sample in a culture well which is surrounded by extremely thin walls, thus allowing easy handling of the biological sample and at the same time allowing very fast cooling in a cryopreservation procedure.

Brief description of the figures

Fig. 1 is a perspective view illustrating an embodiment of a device according to the first aspect of the present invention in a configuration in which the first element is separated from the second element.

Fig. 2a is a plan view illustrating an embodiment of the first element of a device according to the first aspect of the present invention.

Fig. 2b is a plan view illustrating the first element of fig 2a as seen from below.

Fig. 2c is a cross-sectional view showing a part of the first element shown in fig. 2a.

Fig. 3a is a plan view illustrating an embodiment of the second element of a device according 25 to the first aspect of the present invention.

Fig. 3b is a plan view illustrating the second element of fig 3a as seen from below.

Fig. 3c is a cross-sectional view showing a part of the second element shown in fig. 3a.

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Fig. 4 is a perspective view illustrating another embodiment of a device according to the first aspect of the present invention in a configuration in which the first element is separated from the second element.

Fig. 5a is a plan view illustrating the first element of the device of fig. 4.

Fig. 5b is a plan view illustrating the first element of fig 5a as seen from above.

Fig. 5c is a cross-sectional view showing a part of the first element shown in fig. 5a.

Fig. 5d is a close-up plan view of part of the first element illustrated in fig. 5b.

Fig. 5e is a close-up cross-sectional view showing a part of the first element shown in fig. 5c.

Fig. 6a is a plan view illustrating the second element of the device of fig. 4.

Fig. 6b is a plan view illustrating the second element of fig 6a as seen from above.

Fig. 6c is a close-up plan view of part of the second element illustrated in fig. 6b.

Fig. 7 is a perspective view of the device of fig. 1 in a partly assembled configuration.

Fig. 8 is perspective view of the device of fig. 1 in a fully assembled configuration.

Detailed description of the invention

In a first aspect the present invention relates to a device for culturing a biological material, said device comprising a first element and a second element;

wherein said first element is having an extension in a lengthwise direction X, an extension in a transverse direction Y and an extension in a direction Z perpendicular to the lengthwise direction as well as to the transverse direction;

wherein said second element is having an extension in a lengthwise direction X, an extension in a transverse direction Y and an extension in a direction Z perpendicular to the lengthwise direction as well as to the transverse direction;

wherein said first element comprises one or more rods;

DK 2016 00799 A1 wherein each rod comprises a second cylinder having a first axial end and a second axial end;

wherein said first cylinder, at the second axial end thereof, being connected to said second cylinder, at the first axial end thereof, by a well portion; thereby defining a culture well in the area between the first cylinder and the second cylinder;

wherein said second element comprising one or more cylindrical compartments;

The device accordingly comprises two separate parts which can be assembled into an assembled configuration. The first part of the device comprises one or more culture wells which can be accommodated within at least a part of the second part. In this way any biological material comprised in a culture well of the first part is efficiently isolated from the surroundings. The biological material when being housed in the culture well may, with the device according to the first aspect of the present invention, be subjected to a number of processing steps relating to processing of the biological materials.

These processing steps may relate to one or more of the following: handling or culturing the biological material, monitoring the development over time of the biological material, vitrification of the biological material and cryopreservation of the biological material.

The device according to the first aspect of the present invention is particularly well-suited for conducting processing steps relating to an IVF (in vitro fertilization) in which the biological material is a viable biological material, such as an oocyte, a zygote, or an embryo.

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With the device of the present invention a biological material can be accommodated in a culture well thereof and the device may in such a situation be arranged in either a horizontal direction (the XY-plane of the device being essentially horizontal) or in a vertical orientation (X direction of the device being essentially vertical) during performing the processing steps of the biological material, such as during monitoring the development of the biological material, e.g. by use of an image capturing device.

The device, seeing the particular use thereof within the field of IVF technology, may be sterilized and hence the first element and the second element of the device may be sterilized and may be packed in a sterilized package.

In one embodiment of the first aspect of the present invention, the one or more rods of the first element is having an outer extension, in a lengthwise direction X, within the ranges: 4 30 cm, such as 6 - 28 cm, for example, 8-26 cm, e.g. 10 - 24 cm, such as 12 - 22 cm, 14 20 cm or 16 - 18 cm.

In one embodiment of the first aspect of the present invention the one or more rods of the first element is having an outer extension, in a transversal direction Y, within the ranges: 0.5 - 20 mm, such as 1 - 18 mm, such as 2 - 17 mm, for example 3-16 mm, e.g. 4-15 mm, such as 5-14 mm, for example 6-13 mm, such as 7 - 12 mm, for example 8 - 11 or 9 - 10 mm.

In one embodiment of the first aspect of the present invention the one or more rods of the first element is having an outer extension, in a direction Z perpendicular to the lengthwise direction X and to the transversal direction Y, within the ranges: 0.5-20 mm, such as 1-18 mm, such as 2 - 17 mm, for example 3-16 mm, e.g. 4-15 mm, such as 5 - 14 mm, for example 6-13 mm, such as 7 - 12 mm, for example 8 - 11 or 9 - 10 mm.

In one embodiment of the first aspect of the present invention the culture well(s) arranged between the first cylinder and the second cylinder of the rod of the first element is/are having an extension, in a lengthwise direction X, within the ranges: 1-20 mm, such as 2 - 19 mm, for example 3-18 mm, such as 4 - 17 mm, e.g. 5-16 mm, such as 6 - 15 mm, for example 7-14 mm, e.g. 8-13 mm, such as 9 - 12 mm or 10 - 11 mm.

These dimensions of various parts of the first element are having suitable magnitudes, especially in relation to swift freezing of a biological material in a cryopreservation procedure.

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In one embodiment of the first aspect of the present invention the number of rods of the first element is two or more, and furthermore each pair of adjacent rods are being arranged in parallel and separated to each other by a distance; and/or the number of cylindrical compartments of the second element is two or more, and wherein each pair of adjacent cylindrical compartments are being arranged in parallel.

In case the device comprises more than one rod and more than one associated cylindrical compartment, this design ensures an easy assembly of the first element to the second element of the device.

In one embodiment of the first aspect of the present invention and in respect of one or more rods of the first element, the second axial end of the first cylinder is solid and/or the first axial end of the second cylinder is solid.

In one embodiment of this embodiment and in respect of one or more rods of the first element, the second axial end of the first cylinder comprises a cavity extending in a longitudinal direction X; and/or the first axial end of the second cylinder comprises a cavity extending in a longitudinal direction X.

These features aids in defining a culture well between the first and the second cylinder of the rods of the first element of the device.

It should be noted that it is preferred that the outer surface of each well portion follows the outer shape of the first cylinder and the second cylinder, respectively, of each rod.

In one embodiment of the first aspect of the present invention and in respect of one or more rods of the first element, the first cylinder and/or the second cylinder independently is/are having an extension, in a lengthwise direction X, within the ranges: 1-18 cm, such as 2 - 17 cm, for example 3-16 cm, such as 4 - 15 cm, e.g. 5-14 cm, such as 6 - 13 cm, e.g. 7-12 cm, for example 8-11 cm or 9 - 10 cm.

In one embodiment of the first aspect of the present invention the one or more cylindrical compartments of the second element is having an inner extension, in a longitudinal direction X, within the ranges: 4-30 cm, such as 6 - 28 cm, for example, 8-26 cm, e.g. 10 - 24 cm, such as 12 - 22 cm, 14 - 20 cm or 16 - 18 cm.

In one embodiment of the first aspect of the present invention the one or more cylindrical compartments of the second element is having an inner extension, in a transversal direction Y,

DK 2016 00799 A1 within the ranges: : 0.5 - 20 mm, such as 1-18 mm, such as 2 - 17 mm, for example 3-16 mm, e.g. 4-15 mm, such as 5 - 14 mm, for example 6-13 mm, such as 7 - 12 mm, for example 8 - 11 or 9 - 10 mm.

In one embodiment of the first aspect of the present invention the one or more cylindrical compartments of the second element is having an inner extension, in a direction Z perpendicular to the lengthwise direction and to the transversal direction, within the ranges:

0.5 - 20 mm, such as 1 - 18 mm, such as 2 - 17 mm, for example 3-16 mm, e.g. 4-15 mm, such as 5 - 14 mm, for example 6-13 mm, such as 7 - 12 mm, for example 8 - 11 or 9 - 10 mm.

In one embodiment of the first aspect of the present invention and in respect of one or more of said cylindrical compartments of the second element, the thickness of the material of the second element surrounding said cylindrical compartment, at a longitudinal position thereof corresponding to the position of a corresponding culture well of the first element, in a situation in which the culture well of the first element is fully surrounded by the second element, is selected within the ranges: 0.2 - 5 mm, such as 0.5 - 4 mm, such as 1.0 - 3.5 mm, for example 1.5 - 3.0 mm, such as 2.0 - 2.5 mm.

In one embodiment of the first aspect of the present invention the number rods in said first element is 1 - 24, such as 2 - 23, for example 3 - 22, such as 4 - 21, e.g. 5 - 20, such as 6 19, for example 7 - 18, such as 8 - 17, e.g. 9 - 16, such as 10 - 15, e.g. 11 - 14 or 12 - 13.

Providing the first element with more than one rod and thereby more than one culture wll allows for processing more than one biological material at the time.

Irrespective of the number of rods of the first element, the number of cylindrical compartments of the second element of the device should be identical to the number of of rods of the first element.

In one embodiment of the first aspect of the present invention the outer cross-section of each of the one or more rods of the first element corresponds to the inner cross section of each of the one or more cylindrical compartments of the second element.

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This will ensure a tight fit between the rods of the first element and the cylindrical compartments of the second element, thereby improving the quality of insulation from the surroundings of a biological material accommodated therein.

In one embodiment of the first aspect of the present invention the outer cross-section of each 5 of the one or more rods of the first element and wherein the inner cross section of each of the one or more cylindrical compartments of the second element, in the YZ-plane, defines a circle, or a polygon, such as a rectangle, such as a square, or a triangle, a pentagon, a hexagon, a heptagon, a heptagon, an octagon, an ennagon or a decagon.

These geometries are suitable with respect to the requirements of the culture wells defined in 10 the rods of the first element.

In one embodiment of the first aspect of the present invention the one or more rods of said first element is/are being arranged in a first handle at a first axial end of the first cylinder.

Providing the first element with a handle improves the handling by an operator.

In one embodiment of this embodiment the first handle, in the vicinity of the individual 15 positions of one or more of the rods, comprises a tag, such as an alphanumerical character for identification of said corresponding culture well.

Such tags will improve identification of individual biological materials and thereby minimize the risk of mistaken one biological material from another.

In one embodiment of these embodiments the first handle comprises a planar surface at the 20 positions of the first axial end of the first cylinders.

This design will improve sealing of the space between the rods of the first element and the cylindrical compartments of the second element.

In one embodiment of the first aspect of the present invention the one or more cylindrical compartments of the second element is/are being arranged in a second handle.

Providing the second element with a handle improves the handling by an operator.

In one embodiment of this embodiment the second handle, in the vicinity of the individual positions of one or more of the cylindrical compartment, comprises a tag, such as an alphanumerical character for identification of said corresponding culture well.

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In one embodiment of the first aspect of the present invention and in respect of one or more of the one or more cylindrical compartments of the second element, said cylindrical compartment(s) at least partly is being arranged within a tube.

In one embodiment of the first aspect of the present invention it is a feature that the one or more rods of said first element and/or the material of the second element surrounding the cylindrical compartments and/or the first handle and/or the second handle independently is being made from a polymer material, such as polyethylene, polypropylene or PTFE.

Such materials have proven suitable for the intended purpose and additionally are costefficient materials.

In one embodiment of the first aspect of the present invention the one or more rods of said first element and/or the material of second element surrounding the cylindrical compartments independently is being made from a transparent material.

Using a transparent material for these parts of the device makes it possible to monitor, such as by means of an image capturing device, such as by means of a time lapse image capturing device, the development of a biological material being housed in the culture well of the first element of the device, even in a configuration in which the culture well is covered by the second element of the device.

In one embodiment of the first aspect of the present invention it is a feature that the first element comprises a first set of engagement means; and/or that the second element comprises a second set of engagement means, wherein said first set of engagement means and the second set of engagement means are configured for entering into releasable engagement with each other, thereby enabling securing the first element to the second element.

Such releasable engagement means provides for improved safety in handing a biological material being accommodated in the culture well(s).

In one embodiment of the first aspect of the present invention the first element comprises one or more seals or gaskets for sealing a gap between the one more rods of the first element on the hand and the one or more cylindrical compartments of the second element on the other hand.

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In one embodiment of the first aspect of the present invention the one or more seals or gaskets comprises an O-ring arranged around each first cylinder of the first element near the first axial end thereof.

In one embodiment of the first aspect of the present invention the one or more seals or gaskets comprises a curable seal which is liquid or flowable in a non-cured state in the absence of air and/or moist; and which is able to cure into a solid upon exposure to air or moist; or wherein the one or more seals or gaskets comprises a curable seal which comprises two or more liquid or flowable components which, upon contact, are able to cure into a solid; or wherein the one or more seals or gaskets comprises a heat seal in form of a solid which may be heated to a liquid or flowable material which upon cooling is able to solidify.

Providing the device with a seal between the first element and the second element provides for improved insulation of a biological material from the surroundings during handling thereof.

The device according to the first aspect may in one embodiment be provided with one or more heat sinks arranged at one or more positions on the first element and/or on the second element for providing faster heat transfer.

Such heat sinks may preferably be made of a metal or an alloy, such as copper, steel aluminum.

Such an embodiment is advantageous in the situations in which the device is used for cryopreservation of a biological sample.

In a second aspect the present invention relates to a use of a device according the first aspect in performing one or more processing steps relating to handling a biological material.

In one embodiment of the second aspect of the present invention the one or more processing steps relating to handling a biological material is/are being processing steps relating to an IVF (in vitro fertilization) procedure.

In one embodiment of the second aspect of the present invention the one or more processing steps of an IVF (in vitro fertilization) procedure relates to one or more of the following: culturing a biological material; monitoring the development of a biological material during culturing thereof; vitrification of a biological material; cryogenic preservation of a biological material.

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In one embodiment of the second aspect of the present invention the biological material is a viable biological material, such as an oocyte, a zygote, or an embryo.

The device according to the first aspect of the present invention is particularly well-suited for such procedures in handling such biological materials.

In a third aspect the present invention relates to a method for performing one or more processing steps relating to handling a biological material, wherein said method comprises the steps of:

i) providing a device according to the first aspect of the present invention;

iv) optionally arranging one or more fluids in one or more of said one or more culture wells, respectively;

v) sliding in the first element in relation to the second element in such a way that the said one or more culture wells is/are being fully covered by said second element;

vi) performing one or more processing steps of said biological material.

In one embodiment of the third aspect of the present invention the processing steps relating to handling a biological material are processing steps relating to of an IVF (in vitro fertilization) procedure,

In one embodiment of the third aspect of the present invention, step vi) involves one or more of the following: culturing a biological material; monitoring the development of a biological material during culturing thereof.

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In one embodiment of the third aspect of the present invention, step vi) is a vitrification of said biological material; said vitrification involves the following steps:

a) arranging the device in an essentially upright orientation;

b) arranging the first element of said device in relation to the second element of said device in such a way that each said rod of said first element is accommodated in a corresponding cylindrical compartment of said second element; and in such a way that one or more of said one or more culture wells is/are partly exposed and partly covered by said second element;

c) replacing any fluid present in said one or more culture wells with one or more cryoprotectants;

d) sliding in the first element in relation to the second element in such a way that each said one or more culture wells of said first element is/are fully covered by said second element.

In one embodiment of the third aspect of the present invention, step vi) is a cryogenic 15 preservation of said biological material; said cryogenic preservation involves the following steps:

1) exposing the device to a cryogenic temperature;

2) storing the device comprising said one or more biological materials at a cryogenic temperature.

The device according to the first aspect of the present invention is particularly well-suited for performing methods involving such procedures in handling such biological materials.

Referring now to the drawings for illustrating the present invention, Fig. la is a perspective view illustrating an embodiment of the device 100 according to the first aspect of the present invention.

The device 100 is for culturing a biological material and/or for performing one or more other processing steps relating to handling of a biological material.

The device comprises a first element 2 and a second element 4.

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The first element 2 is having an extension in a lengthwise direction X, an extension in a transverse direction Y and an extension in a direction Z perpendicular to the lengthwise direction as well as to the transverse direction.

The second element 4 is also having an extension in a lengthwise direction X, an extension in a transverse direction Y and an extension in a direction Z perpendicular to the lengthwise direction as well as to the transverse direction.

The first element 2 comprises a rod 6 which comprises a first cylinder 10 having a first axial end 12 and a second axial end 14.

The rod 6 also comprises a second cylinder 16 having a first axial end 18 and a second axial end 20.

The first cylinder 10 of the rod 6, at the second axial end 14 thereof, is being connected to the second cylinder 16 of the rod 6, at the first axial end 18 thereof, by a well portion 22; and thereby defines a culture well 24 in the area between the first cylinder 10 and the second cylinder 16.

The axial axis of the first cylinder 10 coincides with the axial axis of the second cylinder 16.

The rod 6 is connected to a first handle 36.

The second element 4 comprises a cylindrical compartment 26. The cylindrical compartment 26 of the second element comprises a tube 42 which is integrated into a second handle 40.

The tube 42 extends from the handle 40 and ends in an open end 30 of the cylindrical compartment 26 at a rim 32 thereof.

In the device of the present invention and as shown in fig. 1 the outer dimensions and the orientation of the rods 6 of said first element 2, on the one hand, and the inner dimensions and orientations of the compartment 26 of said second element 4, on the other hand, are being adapted to each other in such a way that the rod 6 of the first element 2 can be slit in and out of the compartment 26 in the second element 4, in a lengthwise direction X, thereby changing the accessibility to the culture well 24 between an exposed configuration in which the culture well 24 is accessible and not covered by the second element 4, and a closed configuration in which the culture well 24 is covered by the second element 4.

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The device shown in fig. 1 is made from a transparent material and accordingly, the cylindrical compartment 26 of the second element 4 can be seen through the second handle 40.

In fig. 2a is seen the first element of fig. 1. It is seen that the rod 6 of the first element extends 5 from the first handle 36 at a first end thereof. The rod 6 is divided into a first cylinder 10 and a second cylinder 16. Between the first cylinder 10 and a second cylinder 16 the culture well 24 is located. The culture well served for the location of a biological material upon culturing thereof.

Fig. 2b illustrates the first element from fig. 2a as seen in a longitudinal direction X from the 10 end of the rod 6.

In fig. 2c is seen a cross-sectional cut in a transversal YZ-plane at a position (A-A) of the culture well as seen in fig. 2a.

The culture well 24 illustrated in fig. 2c is partly confined by the first cylinder 10 and the second cylinder 16, and partly confined by the well portion 22, which connects the first cylinder 10 to the second cylinder 16 of the rod 6 of the first element.

Fig. 2c also shows that the culture well 24 comprises a cavity 34 in an axial end of the first cylinder 10 of the rod 6 of the first element 2. Such a cavity aids in keeping the biological material in place in the culture well.

In fig. 3a is seen the second element 4 of fig. 1. It is seen that the cylindrical compartment 26 20 extends from the second handle 40. In fact, the cylindrical compartment 26 also extends into the second handle 40. In this way, the cylindrical compartment 26 is confined by the second handle 40 in one end thereof and by a tube 42 in an opposite end thereof. The tube 42 ends at a rim 32.

Fig. 3b illustrates the second element 4 from fig. 3a as seen in a longitudinal direction (X) from the end of the tube 42.

In fig. 3c is seen a close-up view of the tube 42 as seen in fig. 3b. Fig. 3c illustrates that the tube ends at a rim 32 thereof. In the interior of the tube 42 the cylindrical compartment 26 is arranged.

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In use of the embodiment of the device 100 as illustrated in fig. 1, 2a, 2b, 2c, 3a, 3b and 3c for subjecting a biological material to one or more processing steps, such as culturing a biological material, the rod 6 of the first element is slit into the cylindrical compartment 26 of the second element to an extent in which the culture well 24 of the rod 6 of the first element is partly exposed and partly covered by the second element 4.

This arrangement is shown in fig. 7. Fig. 7 is a perspective view illustrating the device of fig.

in a partly assembled configuration. Fig 7 shows that the first element 2 and the second element 4 have been assembled with each other in that the the rod 6 of the first element has been slit into the cylindrical compartment 26 of the second element to an extend where the culture well 24 of the rod 6 of the first element 2 is partly exposed and partly covered by the cylindrical compartment 26 of the second element.

In this arrangement, in which the device is being held in an upright position, the biological material may be carefully arranged and accommodated in the culture well 24.

Next one or more culturing fluids and/or nutrients may be transferred in the culture well 24.

Subsequently, the rod 6 of the first element 4 is being slit into the cylindrical compartment 26 of the second element 4.

This arrangement is shown in fig. 8. Fig. 8 is a perspective view illustrating the device of fig.

in a fully assembled configuration. Fig 8 shows that the device of fig. 7 in which the first element 2 and the second element 4 have been fully assembled with each other in that the the rod 6 of the first element has been fully slit into the cylindrical compartment 26 of the second element to an extend where the culture well 24 of the rod 6 of the first element 2 fully covered by the cylindrical compartment 26 of the second element.

In this configuration, the biological material is being safely accommodated and isolated form the surroundings and hence protected from contaminations. The device in this configuration can, during performing processing steps of the biological material, be arranged in an upright, vertical orientation or in a lying down, horizontal orientation.

Hereafter the biological material may be subjected to various processing steps.

The processing steps relating to handling a biological material may relate to an IVF (in vitro fertilization) procedure.

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Such processing steps of an IVF (in vitro fertilization) procedure may relate to one or more of the following: handling the biological material; culturing the biological material; monitoring the development of the biological material during culturing thereof; vitrification of the biological material; cryogenic preservation of the biological material. In such cases, the biological material is being a viable biological material in the form of an oocyte, a zygote, or an embryo.

The embodiment shown in utilizes the same principle of creating a culture well between two cylinders and protecting this culture well by accommodating it in a cylindrical compartment, as illustrated in any of the previous figures.

However, in the embodiment illustrated in fig. 4, the device comprises eight culture wells.

The device shown in fig. 4 comprises a first element 2 and a second element 4. The first element 2 comprises eight rods 6,6’,6”,6”’,8,8’,8”,8”’ each of which is arranged next to its adjacent rod in parallel. Each rod 6,6’,6”,6”’,8,8’,8”,8”’comprises a first cylinder 10 having a first axial end 12 and a second axial end 14.

Each rod 6,6’,6”,6”’,8,8’,8”,8”’ also comprises a second cylinder 16 having a first axial end

18 and a second axial end 20.

In respect of each rod 6,6’,6”,6”’,8,8’,8”,8”’ the first cylinder 10 of the rod 6, at the second axial end 14 thereof, is being connected to the second cylinder 16 of the rod 6, at the first axial end 18 thereof, by a well portion 22; and thereby defines a culture well 24 in the area between the first cylinder 10 and the second cylinder 16 of each rod.

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The axial axis of the first cylinder 10 coincides with the axial axis of the second cylinder 16 of the same rod.

Each rod 6,6’,6”,6”’,8,8’,8”,8”’ is connected to a first handle 36 by being integrated with it.

The second element 4 of the embodiment illustrated in fig. 4 comprises eight cylindrical compartments 26,26’,26”,26”,28,28’,28”,28”’. Each of the cylindrical compartments 26,26’,26”,26”,28,28’,28”,28’” of the second element comprises a tube 42 which is integrated into a second handle 40.

Each tube 42 extends from the handle 40 and ends in an open end 30 of the cylindrical compartment 26 at a rim 32 thereof.

In the device of the present invention and as shown in fig. 4 the outer dimensions and the orientation of each of the rods 6,6’,6”,6’”,8,8’,8”,8’” of said first element 2, on the one hand, and the inner dimensions and orientations of each of the compartment

26,26’,26”,26”,28,28’,28”,28’ ”of the second element 4, on the other hand, are being adapted to each other in such a way that each rod 6,6’,6”,6’”,8,8’,8”,8’”of the first element 2 can be slit in and out of a corresponding compartment 26,26’,26”,26”,28,28’,28”,28’” in the second element 4, in a lengthwise direction (X), thereby changing the accessibility to each of the culture wells 24 between an exposed configuration in which a culture well 24 is accessible and not covered by the second element 4, and a closed configuration in which that culture well 24 is covered by the second element 4.

Fig. 5a shows first element of fig. 4 in a plan view. It is seen that each rod

6,6’, 6”, 6’”,8,8’,8”, 8”’ of the first element extends from the first handle 36 at a first end thereof. Each rod 6 is divided into a first cylinder 10 and a second cylinder 16. In respect of each rod 6,6’,6”,6’”,8,8’,8”,8’”, between the first cylinder 10 and a second cylinder 16 a culture well 24 is located. The culture well serves the purpose of accommodating the biological material upon culturing thereof.

Fig. 5b illustrates the first element 2 of the device 100 from fig. 5a as seen in a longitudinal direction X from the end of the rods 6,6’,6”,6’”,8,8’,8”,8’”.

Fig. 5d illustrates a close-up plan view of a few of the rods 6,6’ seen in fig. 5b. Fig. 5d clearly shows that the rod 6 is arranged at a distance from the rod 6’.This applies in respect of all the rods 6,6’,6”,6’”,8,8’,8”,8’” of the first element 2 of the device 100 shown in fig. 4 and 5.

DK 2016 00799 A1

I.e., each rod 6,6’,6”,6”’,8,8’,8”,8”’ is separated by a distance to its adjacent rod 6,6’,6”,6”’,8,8’,8”,8”’

In fig. 5c is seen a cross-sectional cut in a transversal direction (YZ-plane) at a position (A-A) of the culture wells as seen in fig. 5a.

The culture wells 24 illustrated in fig. 5c are partly confined by the well portion 22, which connects the first cylinder 10 to the second cylinder 16 of the rod 6 of the first element. Irrespective of the specific design of the device, the well portion 22 may preferably have an outer shape which corresponds to the outer surface of the first cylinder 10 and the second cylinder 16.

Fig. 5e is a close-up cross-sectional view of a few of the culture wells seen in fig. 5c. Fig. 5e shows the culture well 24 of the rod 6 and the culture well 24 of the rod 6’. Each culture well 24 is confined by a well portion 22 which connects the first cylinder 10 of the rod 6,6’ to the second cylinder 16 of the rod 6,6’.

Fig. 5e also shows that the culture wells 24 comprise a cavity 34 in an axial end of the first cylinder 10 of the rod 6 of the first element 2. Such a cavity aids in keeping the biological material in place in the culture well.

Fig. 6a is a plan view illustrating the second element 4 of fig. 4. It is seen that the cylindrical compartments 26,26’,26”,26”,28,28’,28”,28’” extend from the second handle 40. In this way, each of the cylindrical compartments 26,26’,26”,26”,28,28’,28”,28’” are confined by the second handle 40 in one end thereof and by a tube 42 in an opposite end thereof. The tubes 42 end at a rim 32.

Fig. 6b illustrates the second element 4 from fig. 6a as seen in a longitudinal direction X from the end of the tubes 42.

In fig. 6c is seen a close-up view of two tubes 42 as seen in fig. 6b. Fig. 6c illustrates that the tubes 42 end at a rim 32 thereof. In the interior of the tube 42 the cylindrical compartment 26 is arranged.

The assembly of the first element 2 and the second element 4 of the device 100 shown in fig. 4, prior to performing any processing steps of a biological sample accommodated therein, follows in analogy with the description above with reference to the device of fig. 1.

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In using the device 100 for handling a biological material the following processing steps are adhered to:

i) providing a device 100 according to the first aspect of the present invention as disclosed above;

ii) arranging the first element 2 of said device in relation to the second element 4 of said device in such a way that one or more of said one or more culture wells 24 of the one or more rods 6,6’,6”,6”’,8,8’,8”.8”’ is/are partly exposed and partly covered by said second element 4;

iii) arranging one or more biological materials in said one or more culture wells

24 in the one or more rods 6,6’,6”,6”’,8,8’,8”.8”’, respectively, while making sure that the device is arranged in an essentially upright orientation;

iv) optionally arranging one or more fluids in one or more of said one or more culture wells 24 of the rods 6,6’,6”,6”’,8,8’,8”.8”’, respectively;

v) sliding in the first element 2 in relation to the second element 4 in such a way that the said one or more culture wells 24 of the rods 6,6’,6”,6”’,8,8’,8”.8”’ is/are fully covered by said second element 4, by being accommodated in one or more of the cylindrical compartments 26,26’,26”,26”,28,28’,28”,28”’, respectively;

vi) performing one or more processing steps of said biological material.

In case the processing steps to be performed on the biological material and relating to handling a biological material are processing steps relating to of an IVF (in vitro fertilization) procedure, the processing steps may involve one or more of the following: culturing a biological material or monitoring the development of a biological material during culturing thereof.

In case the processing steps to be performed with the biological material involve a vitrification; said vitrification may involve the following steps:

a) arranging the device 100 in an essentially upright orientation;

b) sliding out the first element 2 in relation to the second element 4 in such a way that the one or more culture wells in the one or more rods

DK 2016 00799 A1

6,6’,6”,6’”,8,8’,8”.8”’ is/are being partly exposed and partly covered by said second element 4, by being partly accommodated in one or more of the cylindrical compartments 26,26’,26”,26”,28,28’,28”,28’”, respectively;

c) replacing any fluid present in the said one or more culture wells 24 in one or more of the rods 6,6’,6”,6’”,8,8’,8”.8’” with one or more cryoprotectants;

d) sliding in the first element 2 in relation to the second element 4 in such a way that the said one or more culture wells24 in one or more of the rods

6,6’,6”,6’”,8,8’,8”.8’” is/are fully covered with said second element 4, by being fully accommodated in one or more of the cylindrical compartments

26,26’,26”,26”,28,28’,28”,28’”, respectively

In case the processing steps to be performed on the biological material is a cryogenic preservation of said biological material; said cryogenic preservation may involve the following steps:

1) exposing the device 100 to a cryogenic temperature;

2) storing the device 100 comprising said one or more biological materials at a cryogenic temperature.

It should be understood that all features and achievements discussed above and in the appended claims in relation to one aspect of the present invention and embodiments thereof apply equally well to the other aspects of the present invention and embodiments thereof.

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List of reference numerals

2	First element of device
4	Second element of device
6, 6’, 6”, 6”’	Rod of first element
5 8,8’,8”,8”’	Rod of first element
10	First cylinder of rod of first element
12	First axial end of first cylinder of rod of first element
14	Second axial end of first cylinder of rod of first element
16	Second cylinder of rod of first element
10 18	First axial end of second cylinder of rod of first element
20	Second axial end of second cylinder of rod of first element
22	Well portion of rod of first element
24	Culture well of rod of first element
26,26’,26”,26”’	Cylindrical compartment of second element
15 28,28’,28”,28’”	Cylindrical compartment of second element
30	Open end of cylindrical compartment of second element
32	Rim of open end of cylindrical compartment of second element
34	Cavity in axial end of cylinder of first element
36	First handle of first element
20 38	Tag
40	Second handle
42	Tube surrounding cylindrical compartment
100	Device

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Claims

Claims

1. A device (100) for culturing a biological material, said device comprising a first element (2) and a second element (4);

wherein said first element (2) is having an extension in a lengthwise direction (X), an

5 extension in a transverse direction (Y) and an extension in a direction (Z) perpendicular to the lengthwise direction as well as to the transverse direction;

wherein said second element (4) is having an extension in a lengthwise direction (X), an extension in a transverse direction (Y) and an extension in a direction (Z) perpendicular to the lengthwise direction as well as to the transverse direction;

10 wherein said first element comprises one or more rods (6,6’,6”,6’”,8,8’,8”,8”’);

wherein each rod (6) comprises a first cylinder (10) having a first axial end (12) and a second axial end (14);

wherein each rod (6) comprises a second cylinder (16) having a first axial end (18) and a second axial end (20);

15 wherein said first cylinder (10), at the second axial end (14) thereof, being connected to said second cylinder (16), at the first axial end (18) thereof, by a well portion (22); thereby defining a culture well (24) in the area between the first cylinder (10) and the second cylinder (16);

wherein the axial axis of said first cylinder (10) coincides with the axial axis of said second

20 cylinder (16);

wherein said second element comprising one or more cylindrical compartments (26,26’,26”,26”’,28,28’,28”,28”’);

wherein each cylindrical compartment (26,26’,26”,26’”,28,28’,28”,28’”) comprises a first open end (30) confined by a rim (32);

25 wherein the outer dimensions and the orientation of said rods (6,6’,6”,6”’,8,8’,8”,8”’) of said first element (2), on the one hand, and the inner dimensions and orientations of said compartments (26,26’,26”,26’”,28,28’,28”,28’”) of said second element (4), on the other hand, are being adapted to each other in such a way that the rod(s) of the first element (2) can

DK 2016 00799 A1 be slit in and out of the compartment(s) in the second element (4), in a lengthwise direction (X), thereby changing the accessibility to one or more of the culture wells (24) between an exposed configuration in which the culture wells (24) are accessible and not covered by the second element (4), and a closed configuration in which the culture wells (24) are covered by the second element (4).
2. A device (100) according to claim 1, wherein the one or more rods (6,6’,6”,6”’,8,8’,8”,8’”) of the first element (2) is having an outer extension, in a lengthwise direction (X), within the ranges: 4-30 cm, such as 6 - 28 cm, for example, 8-26 cm, e.g. 10 - 24 cm, such as 12 - 22 cm, 14 - 20 cm or 16 - 18 cm.
3. A device (100) according to claims 1 or 2, wherein the one or more rods (6,6’,6”,6”’,8,8’,8”,8’”) of the first element (2) is having an outer extension, in a transversal direction (Y), within the ranges: 0.5 - 20 mm, such as 1 - 18 mm, such as 2 - 17 mm, for example 3-16 mm, e.g. 4-15 mm, such as 5 - 14 mm, for example 6-13 mm, such as 7 12 mm, for example 8 - 11 or 9 - 10 mm.
4. A device (100) according to any of the claims 1-3, wherein the one or more rods (6,6’,6”,6”’,8,8’,8”,8’”) of the first element (2) is having an outer extension, in a direction (Z) perpendicular to the lengthwise direction (X) and to the transversal direction (Y), within the ranges: 0.5 - 20 mm, such as 1 - 18 mm, such as 2 - 17 mm, for example 3-16 mm, e.g. 4-15 mm, such as 5 - 14 mm, for example 6-13 mm, such as 7 - 12 mm, for example 8 11 or 9 - 10 mm.
5. A device (100) according to any of the claims 1-4, wherein the culture well(s) (24) arranged between the first cylinder (10) and the second cylinder (16) of the rod (6,6’,6”,6”’,8,8’,8”,8’”) of the first element (2) is having an extension, in a lengthwise direction (X), within the ranges: 1-20 mm, such as 2 - 19 mm, for example 3-18 mm, such as 4 - 17 mm, e.g. 5-16 mm, such as 6 - 15 mm, for example 7-14 mm, e.g. 8-13 mm, such as 9 - 12 mm or 10 - 11 mm..
6. A device (100) according to any of the claims 1-5, wherein the number of rods (6,6’,6”,6”’,8,8’,8”,8’”) of the first element is two or more, and wherein each pair of adjacent rods are being arranged in parallel and separated to each other by a distance; and/or wherein the number of cylindrical compartments (26,26’,26”,26’”,28,28’,28”,28”’) of the

DK 2016 00799 A1 second element is two or more, and wherein each pair of adjacent cylindrical compartments are being arranged in parallel.
7. A device (100) according to any of the claims 1-6, wherein in respect of one or more rods (6,6’,6”,6”’,8,8’,8”,8’”) of the first element (2), the second axial end (14) of the first cylinder (10) is solid and/or wherein the first axial end (18) of the second cylinder (16) is solid.
8. A device (100) according to any of the claims 1-7, wherein in respect of one or more rods (6,6’,6”,6”’,8,8’,8”,8’”) of the first element (2), the second axial end (14) of the first cylinder (10) comprises a cavity (34) extending in a longitudinal direction (X); and/or wherein the first axial end (18) of the second cylinder (16) comprises a cavity (34) extending in a longitudinal direction (X).
9. A device (100) according to any of the claims 1-8, wherein in respect of one or more rods (6,6’,6”,6”’,8,8’,8”,8’”) of the first element (2), the first cylinder (10) and/or the second cylinder (16) independently is/are having an extension, in a lengthwise direction (X), within the ranges: 1-18 cm, such as 2 - 17 cm, for example 3-16 cm, such as 4 - 15 cm, e.g. 5 14 cm, such as 6 - 13 cm, e.g. 7-12 cm, for example 8-11 cm or 9 - 10 cm.
10. A device (100) according to any of the claims 1-9, wherein the one or more cylindrical compartments (26,26’,26”,26”’,28,28’,28”,28’”) of the second element (4) is having an inner extension, in a longitudinal direction (X), within the ranges: 4-30 cm, such as 6 - 28 cm, for example, 8-26 cm, e.g. 10 - 24 cm, such as 12 - 22 cm, 14 - 20 cm or 16 - 18 cm.
11. A device (100) according to any of the claims 1-10, wherein the one or more cylindrical compartments (26,26’,26”,26’”,28,28’,28”,28’”) of the second element (4) is having an inner extension, in a transversal direction (Y), within the ranges: 0.5 - 20 mm, such as 1 - 18 mm, such as 2 - 17 mm, for example 3-16 mm, e.g. 4-15 mm, such as 5 - 14 mm, for example 6-13 mm, such as 7 - 12 mm, for example 8 - 11 or 9 - 10 mm.
12. A device (100) according to any of the claims 1-11, wherein the one or more cylindrical compartments (26,26’,26”,26’”,28,28’,28”,28’”) of the second element (4) is having an inner extension, in a direction (Z) perpendicular to the lengthwise direction and to the transversal direction, within the ranges: 0.5 - 20 mm, such as 1 - 18 mm, such as 2 - 17 mm,

DK 2016 00799 A1 for example 3-16 mm, e.g. 4-15 mm, such as 5 - 14 mm, for example 6-13 mm, such as 7-12 mm, for example 8 - 11 or 9 - 10 mm.
13. A device (100) according to any of the claims 1-12, wherein in respect of one or more of said cylindrical compartments (26,26’,26”,26”’,28,28’,28”,28”’) of the second element (4), the thickness of the material surrounding said cylindrical compartment (26,26’,26”,26’”,28,28’,28”,28’”), at a longitudinal position thereof corresponding to the position of a corresponding culture well of the first element, in a situation in which the culture well (24) of the first element (2) is fully surrounded by the second element (4), is selected within the ranges: 0.2 - 5 mm, such as 0.5 - 4 mm, such as 1.0 - 3.5 mm, for example 1.5 3.0 mm, such as 2.0 - 2.5 mm..
14. A device (100) according to any of the claims 1 - 13, wherein the number rods (6,6’,6”,6’”,8,8’,8”,8’”) in said first element (2) is 1 - 24, such as 2 - 23, for example 3 22, such as 4 - 21, e.g. 5 - 20, such as 6 - 19, for example 7 - 18, such as 8 - 17, e.g. 9 - 16, such as 10 - 15, e.g. 11 - 14 or 12 - 13.
15. A device (100) according to any of the claims 1 - 14, wherein the outer cross-section of each of the one or more rods (6,6’,6”,6”’,8,8’,8”,8’”) of the first element (2) corresponds to the inner cross section of each of the one or more cylindrical compartments (26,26’,26”,26’”,28,28’,28”,28’”) ofthe second element (4).
16. A device (100) according to any of the claims 1 - 15, wherein the outer cross-section of each of the one or more rods (6,6’,6”,6”’,8,8’,8”,8’”) of the first element (4); and wherein the inner cross section of each of the one or more cylindrical compartments (26,26’,26”,26’”,28,28’,28”,28’”) of the second element (4), in the YZ-plane, defines a circle, or a polygon, such as a rectangle, such as a square, or a triangle, a pentagon, a hexagon, a heptagon, a heptagon, an octagon, an ennagon or a decagon.
17. A device (100) according to any of the claims 1 - 16, wherein the one or more rods (6,6’,6”,6’”,8,8’,8”,8’”) of said first element (2) is/are being arranged in a first handle (36) at a first axial end (12) of the first cylinder (10).
18. A device (100) according to claim 17, wherein the first handle (36), in the vicinity of the individual positions of one or more of the rods (6,6’,6”,6’”,8,8’,8”,8’”), comprises a tag

DK 2016 00799 A1 (38), such as an alphanumerical character for identification of said corresponding culture well (24).
19. A device (100) according to claim 17, wherein the first handle (36) comprises a planar surface at the positions of the first axial end (12) of the first cylinders (10).

5 20. A device (100) according to any of the claims 1 - 19, wherein the one or more cylindrical compartments (26,26’,26”,26”’,28,28’,28”,28’”) of the second element is/are being arranged in a second handle (40).

21. A device (100) according to claim 20, wherein the second handle (40), in the vicinity of the individual positions of one or more of the cylindrical compartment

10 (26,26’,26”,26’”,28,28’,28”,28’”), comprises a tag (38), such as an alphanumerical character for identification of said corresponding culture well.

22. A device (100) according to any of the claims 1-21, wherein in respect of one or more of the one or more cylindrical compartments (26,26’,26”,26”’,28,28’,28”,28’”) of the second element (4), said cylindrical compartment(s) at least partly is being arranged within a tube

15 (42).

23. A device (100) according to any of the claims 1 - 22, wherein the one or more rods (6,6’,6”,6’”,8,8’,8”,8’”) of said first element (2) and/or wherein the material of the second element (4) surrounding the cylindrical compartments (26,26’,26”,26’”,28,28’,28”,28”’) and/or wherein the first handle (36) and/or the second handle (40) independently is being
20 made from a polymer material, such as polyethylene, polypropylene or PTFE.
24. A device (100) according to any of the claims 1 - 23, wherein the one or more rods (6,6’,6”,6’”,8,8’,8”,8’”) of said first element (2) and/or wherein the material of second element (4) surrounding the cylindrical compartments (26,26’,26”,26’”,28,28’,28”,28”’) independently is being made from a transparent material.
25 25. A device (100) according to any of the claims 1 - 24, wherein said first element (2) comprises a first set of engagement means; and/or wherein second element (4) comprises a second set of engagement means, wherein said first set of engagement means and the second set of engagement means are configured for entering into releasable engagement with each other, thereby enabling securing the first element to the second element.

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26. A device (100) according to any of the claims 1-25, wherein said first element (2) comprises one or more seals or gaskets for sealing a gap between the one more rods (6,6’,6”,6”’,8,8’,8”,8’”) of the first element (2) on the hand and the one or more cylindrical compartments (26,26’,26”,26”’,28,28’,28”,28’”) of the second element (4) on the other

5 hand.
27. A device (100) according to claim 26 wherein one or more seals or gaskets comprises an O-ring arranged around each first cylinder (10) of the first element (2) near the first axial end (12) thereof.
28. A device (100) according to claim 26 wherein one or more seals or gaskets comprises a 10 curable seal which is liquid or flowable in a non-cured state in the absence of air and/or moist;

and which is able to cure into a solid upon exposure to air or moist; or wherein the one or more seals or gaskets comprises a curable seal which comprises two or more liquid or flowable components which, upon contact, are able to cure into a solid; or wherein the one or more seals or gaskets comprises a heat seal in form of a solid which may be heated to a liquid

15 or flowable material which upon cooling is able to solidify.
29. Use of a device (100) according to any of the claims 1 - 28 in performing one or more processing steps relating to handling a biological material.
30. Use according to claim 29, wherein the said one or more processing steps relating to handling a biological material is/are being processing steps relating to an IVF (in vitro

20 fertilization) procedure.
31. Use according to claim 29 or 30, wherein the said one or more processing steps of an IVF (in vitro fertilization) procedure relates to one or more of the following: culturing a biological material; monitoring the development of a biological material during culturing thereof; vitrification of a biological material; cryogenic preservation of a biological material.

25
32. Use according to any of the claims 29-31, wherein the biological material is a viable biological material, such as an oocyte, a zygote, or an embryo.
33. A method for performing one or more processing steps relating to handling a biological material, wherein said method comprises the steps of:

i) providing a device (100) according to any of the claims 1-28;

DK 2016 00799 A1 ii) arranging the first element (2) of said device in relation to the second element 4 of said device in such a way that each said rod (6,6’,6”,6”’,8,8’,8”,8”’) of said first element (2) is accommodated in a corresponding cylindrical compartment (26,26’,26”,26’”,28,28’,28”,28”’) of said second element (4);

5 and in such a way that one or more of said one or more culture wells (24) is/are partly exposed and partly covered by said second element (4);

iii) arranging one or more biological materials in said one or more culture wells (24), respectively, while making sure that the device is arranged in an essentially upright orientation;

10 iv) optionally arranging one or more fluids in one or more of said one or more culture wells (24), respectively;

v) sliding in the first element (2) in relation to the second element (4) in such a way that the said one or more culture wells (24) is/are being fully covered by said second element (4);

15 vi) performing one or more processing steps of said biological material.
34. A method according to claim (33), wherein the processing steps relating to handling a biological material are processing steps relating to of an IVF (in vitro fertilization) procedure,
35. A method according to claim 33 or 34, wherein step vi) involves one or more of the following: culturing a biological material; monitoring the development of a biological

20 material during culturing thereof.
36. A method according to any of the claims 33 - 35, wherein step vi) is a vitrification of said biological material; said vitrification involves the following steps:

a) arranging the device (100) in an essentially upright orientation;

b) arranging the first element (2) of said device in relation to the second element 25 (4) of said device in such a way that each said rod (6,6’,6”,6’”,8,8’,8”,8’”) of said first element (2) is accommodated in a corresponding cylindrical compartment (26,26’,26”,26’”,28,28’,28”,28”’) of said second element (4); and in such a way that one or more of said one or more culture wells (24) is/are partly exposed and partly covered by said second element (4);

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c) replacing any fluid present in said one or more culture wells with one or more cryoprotectants;

d) sliding in the first element (2) in relation to the second element (4) in such a way that each said one or more culture wells (24) of said first element (2) is/are

5 fully covered by said second element (4).
37. A method according to any of the claims 33 - 36, wherein step vi) is a cryogenic preservation of said biological material; said cryogenic preservation involves the following steps:

1) exposing the device (100) to a cryogenic temperature;

10 2) storing the device (100) comprising said one or more biological materials at a cryogenic temperature.

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