WO2019054862A1

WO2019054862A1 - Collection device for a substantially liquid biological specimen

Info

Publication number: WO2019054862A1
Application number: PCT/NL2018/050598
Authority: WO
Inventors: Dennis Cornells Wilhelmus POLAND
Original assignee: Labonovum B.V.
Priority date: 2017-09-12
Filing date: 2018-09-12
Publication date: 2019-03-21
Also published as: NL2019531B1; WO2019054862A8

Abstract

The various aspects relate to a collection tube for collecting biological specimen such as blood, urine and saliva. The collected amount is kept as low as possible for convenience. Keeping the collected amount in the tube is therefore very important, for which reason the collection tube has a narrow opening. However, a narrow opening is incompatible with automated sampling equipment. Therefore, the collection tube comprises a main body with a container cavity, to which a collection part is releasably mounted. The container cavity, with the collection member removed, has a significantly wider opening that is compatible with automated sampling probe stations. The main body and the collection part may comprise indentations or protrusions that allow engagement with a tool for separating both parts of the collection tube. The tool may be provided as a pair of tweezers of which extremities engage with both parts for forcing them apart.

Description

Title: Collection device for a substantially liquid biological specimen

TECHNICAL FIELD

The various aspects and embodiments thereof relate to a collection device for collecting a substantially liquid biological specimen.

BACKGROUND

Liquid biological specimen hke blood, sahva, urine and other provide information on potential pathological disorders of a living being, like a human or animal. Such specimen may be collected in containers for scrutiny. Commonly used containers have a tubular or cyhndrical shape. These containers for acquisition of blood are usually provided with a rubber cap and have a pressure inside lower than ambient. Due to the lower pressure, blood from a blood vessel, acquired by means of a needle, is withdrawn.

In certain practical environment, acquisition by other means is preferred. In particular in a home environment, smaller and more practical collection tubes are preferred. Such tubes may be smaller than usual tubes. This may result in issue with existing equipment for testing the blood for pathological issues.

SUMMARY

It is preferred to provide a collection device and container for substantially liquid biological specimen that provides enhanced

compatibility with existing lab equipment.

An aspect provides a collecting device for collecting a

substantially liquid biological specimen. The device comprises a container member comprising a cavity having a container opening at a proximal end of the container member and a collection member releasably connected to the proximal end of the container member, the collection member having a hollow body having collection openings at opposite sides and a flange radially extending from an axis between the collection openings of body and extending beyond the diameter of the container member. In this device, the container member comprises a first mating section at the opening the collection member comprises a second mating section provided at a first collection opening at a first side of the flange, the second mating member being arranged to releasably mate with the first mating section such that the first collection opening is provided in the cavity and the inner diameter of the cavity at a distance from the first mating member is larger than an outer diameter of the collection member at a distance from the second mating member, at the first side of the flange.

As the size of collection and holding tubes for liquid specimen, like blood or sahva, decreases, compatibility with existing lab equipment becomes an issue. Small size collection tubes for home use are known from NL2014739. Such tubes comprise a liquid barrier having relatively small opening towards the inner container to prevent any leakage or at least reduce the leakage. The small opening is part of an inset in the collection tube that is comprised by the collection tube in a fixed way.

The access opening of the container has a diameter of about 6 millimetres. A container with an opening of such diameter is not compatible with currently available probing equipment, as a tube with an opening of such size is detected as closed. This means that content acquired by means of such container first needs to be transferred to another container. Which provides another problem as this is made very difficult due to the liquid barrier.

By providing the inset, the collection member, releasably in the container, the larger container cavity is fully open, which may have an opening having a larger diameter, preferably between 10 millimetres and 11 millimetres. A cavity having an opening of such size is compatible with existing probing equipment. This means that a detector, provided with a probing needle for taking samples from a sample container, will detect the opening and will be able to automatically take a sample from the container.

For this way of working, it is important that the collection member may be conveniently removed from the cavity. The collection member is preferably connected to the container member by means of a friction coupling, which makes it not very easy to remove by hand.

Therefore, the flange and the indents are provided. This allows the collection member to be conveniently removed by means of the device according to the second aspect, which will be discussed later.

This combination of features provides a collection device, a tubular container for liquid samples, that on one hand is provided with a hquid barrier that is suitable for home use and that prevents or at least reduces leakage on one hand and that is compatible with existing probing equipment by virtue of the convenient method and device for removal of the collection member as provided by this and the second aspect.

In an embodiment, the first mating member comprises a substantially smooth inner wall of the cavity and the second mating member comprises a substantially smooth outer wall of the collection member. With friction between both members, along the substantially straight or at least substantially evenly shaped walls, both members are secured relative to one another on one hand and may be conveniently separated on the other hand.

In another embodiment, the container member comprises at least a first indentation at the outer perimeter of the container member in the vicinity of the opening of the cavity. The indentation provides a locking point for the device according to the second aspect. In another alternative, the container member may be provided with a flange at the same location providing substantially the same functionahty.

A further embodiment comprises a cap having a closing member having a distal end and a proximal end, the closing member having an outer diameter perpendicular to a centre axis from the proximal end to the distal end being substantially equal to an inner diameter of at least part of the hollow body of the collection member for providing a substantially fluid- tight seal between the closing member and an inner wall of the hollow body.

Rather than being closed by a conventional cap that seals the tube at the outside by means of a skit fitting closely over the rim of the tube, this cap closes the collection device at the inside. This makes the cap more convenient to remove. A reason is that such cap is more convenient to remove than the large skirt portion closely fit around the tube. The cap according to this embodiment may also be considered in an additional aspect itself.

Again another embodiment comprises a top portion provided at the distal end of the closing member and a skirt portion extending from the top portion towards the proximal end of the cap, wherein an inner diameter of the skirt portion is substantially equal or slightly larger than an outer diameter of the collection member at a second side of the flange.

Such skirt portion may be convenient for locking the cap to the collection device at the outer perimeter of the collection device, but it does not have to be fit as tightly as a convention cap. A reason for this is that the cap according to this aspect seals off the tube long an inner surface of the tube. This means that the skirt only need to provide enough friction to prevent the cap sliding off in any way. To this purpose, the skit may have a smooth inner surface or, alternatively or additionally, a rim that may fit over a flange portion protruding radially from the tube.

Again a further embodiment comprises a waist portion having a diameter smaller than a the diameter of the cavity portion of the container member in which the cavity is provided. Such waist portion improves handling and holding comfort of the collection device.

A second aspect provides Separation device for separating the collection member from the container member of the collecting device according the first aspect. The separation device comprises a first separation member comprising a first separation body in which a first separation indentation is providing having a first separation width substantially equal to or wider than the outer diameter of the container member and narrower than the flange and a second separation member comprising a second separation body in which a second separation indentation is providing having a second separation width substantially equal to or wider than the diameter of the container member at the position of the indentation and narrower than the outer diameter of the container member just above the indentation. The device further comprises a joining connection connecting the first separation member to the second separation member enabling a movement of the first separation member relative to the second separation member. In this device, the first separation member and the second separation member a connected such that the first separation indentation is aligned with the second separation indentation.

The first separation indentation is provided around the container member, just below the flange of the collection member. The second separation indentation is provided in the indentation provided in the container member. Subsequently, the separation indentations are moved apart to separate the collection member and the container member. If a flange is provided to the container member additionally or alternatively to the indentation, the first separation width and the second separation width may be substantially the same.

A third aspect comprises the collection device according to the first aspect and a separation device according to the second aspect.

BRIEF DESCRIPTION OF THE DRAWINGS

The various aspects and embodiments thereof will now be discussed in further detail. In the drawings,

Figure 1 A: shows a cross-section of a first collection tube; Figure 1 shows a cross-section of a second collection tube; Figure 2 shows a cap;

Figure 3: shows oss-section of the cap and a collection member; and

Figure 4: shows an isometric view of a separation device.

DETAILED DESCRIPTION

Figure 1 A shows a cross-section of a first collection tube 100 for collection of bodily fluids of a living being and in particular human or /animal blood as a liquid biological specimen. The collection tube comprises a tubular body 110 as a container member and a collection member 160. The tubular body 110 comprises a container cavity 114 at a proximal side of the body 110 for holding the blood and, optionally and preferably, a preservation fluid.

At a distal side of the body 110, the body 110 comprises an empty space 112. The empty space 112 is provided to provide a longer body 110 that makes is more convenient to handle and to yet provide a small size of the container cavity 114. In another embodiment, the body 110 is massive at the location of the empty space 112.

Near the top of the body, an indentation 116 is provided. The indentation 116 is preferably provided circumferentially, around the circumference of the tubular body 110. In another embodiment, multiple indentations may be provided, preferably opposite to one another at the side of the body 110. In yet another alternative, the indentation 116 is not fully circumferentially provided, but only around half the circumference of the body 110 or in a range between, for example, 40% and 60% of the

circumference.

The container cavity 114 of the first collection tube 100 has three segments, a broad upper part, a funnel middle part and a narrow bottom part. This shape is arranged for collecting blood samples for tests that require a centrifugal processing step. At the level of the narrow bottom part, a waist portion 118 is provided at the outside of the body 110. The waist portion 118 allows the first collection tube to be handled in a more

convenient way, in particular by hand. Preferably, the diameter of the waist portion 118 is 80% of the diameter of the rest of the body 110 or at least of a portion of the body 110 directly adjacent to the waist portion 118.

At the inside of part, a smooth inner wall 122 is provided that extends inwardly from a rim 124. The rim 124 and the inner wall 122 provide a first mating member for receiving a collection member 160. The collecting member 160 comprises a cylindrical body having a through hole along the axis of the cylinder. The through -hole comprises a funnel through section 162 and a straight through section 164. At the outer side of the collection member 160, a step section 174 is provided such that the outer diameter proximal to a pickup section 168 is larger than the outer diameter distal to the pickup section 168.

Above the step section 174, a flange 166 is provided. Whereas the flange 166 is preferably provided around the full circumference of the collection member 160, this is not required. Alternatively, the flange is provided along a part of the circumference of the upper part of the collection member 160. Alternatively or additionally, a flange is provided in multiple flange segments. For the use of the first collection tube 100, it is preferred that at least two flange segments are provided opposite to one another at the circumference of the collection member 160.

The collection member 160 is arranged for collecting blood or other bodily fluids. The collection member comprises the pickup section 168 to make this process more convenient. For collecting blood, the pickup section 168 may for example be scraped along a puncture in a finger to pick up blood and guide the blood to the container cavity 114.

As discussed, the outer diameter of the collection member 160 is below the step section 174 narrower than above. The diameter of the collection member 160 above the step section 174 is preferably substantially equal to the inner diameter of the inner wall 122 of the body 110. With the collection member 160 inserted in the body 110, a circumferential space is provided between a lower outer wall 172 and the inner wall 122.

If the first collection tube 100 is held under an angle relative to the gi'avitational field of the earth, any fluid or at least part thereof flows to this circumferential space and is prevented to flow out of the first collection tube 100. Hence, the lower part of the collection member 160 acts as a fluid barrier. This provides a space between the lower outer wall and the inner wall 122 for containing a (hquid) preservation fluid.

With the diameter of the collection member 160 above the step section 174 being substantially equal to the inner diameter of the inner wall 122, the lower part of the collection member 160 may be inserted in the body 110 and in the container cavity 114 in particular. Optionally, the outer diameter of an upper outer wall 176 is slightly larger than the inner diameter of the inner wall 122 to provide a certain amount of friction between the upper outer wall 176 and the inner wall 122 of the container cavity 114 to secure the collection member to the body 110.

The collection member 160 and the body 110 are thus paired, preferably with the flange 166 abutting the rim 124. Hence, the inner wall 122 with the rim 124 are comprised by a first mating member comprised by the body 110 and the upper outer wall 176 and the flange 166 are comprised by a second mating member comprised by the collection member 160. The first mating member and the second mating member are arranged to mate for providing a releasable connection between the body 110 and the collection member 160.

For providing the releasable connection, the upper outer wall 176 and the inner wall 122 preferably do not comprise any protrusions, viewed along the walls from the step section 174 downward and from the rim 124 downward, respectively, such that the collection member 160 would be locked to body 110. This does not exclude any unevennesses along a radial hne that would prevent the collection member 160 to be twisted in the body 110 along the centre hne of the body. Yet, it does exclude permanent or semi-permanent snap-fit connections.

In a preferred embodiment, the outer diameter of the lower outer wall 172 decreases towards the lower end of the collection member. In one embodiment, the lower part of the collection member 160 is shaped as a truncated cone having a top angle between 1° and 5° and preferably at 2°. Additionally or alternatively, the upper outer wall 176 may be shaped as a cylinder with straight sides and the diameter of the inner wall 122 increased away from the rim 124. In yet another embodiment, lower outer wall 172 as well as the inner diameter of the inner wall 122 are

substantially constant.

Figure 1 B shows a cross-section of a second collection tube 130 for collecting bodily fluids. The second collection tube 130 comprises a tubular body 140 comprising a collection cavity 144 and an empty space 142. Near and preferably at the boundary between the empty space 142 and the collection cavity, a waist section 148 with reduced diameter is provided at the outside of the body 140. Near the top of the collection cavity 144, one or more indentations 156 are provided around the circumference of the body 156 in a manner equivalent to as discussed in conjunction with Figure 1 A. At the top of the second collection tube 130, a rim 154 is provided from which an inner wall 152 extends downwardly. The rim 154 and the inner wall 152 provide a second mating member for receiving the lower outer wall of the collection member 160.

The second collection tube 130 provides a functionality equivalent to that of the first collection tube 100; the main difference is that the container cavity 144 of the second collection tube 130 is shaped differently. The second collection tube 130 may be used for collection of samples of bodily fluids Hke blood to be used for direct probing, without a need for centrifugal processing.

Figure 2 shows a cap 200 as a closing device for sealing off the first collection tube 100 and the second collection tube 130. The cap 200 comprises a closing member 210 with circumferential protrusions 212 and a skirt section 230 having optional substantially equidistantly distributed protrusions 232 substantially parallel to the centreline of the cap 200. The closing member 210 is arranged to be received by the straight through section 164 of the collection member 160.

Figure 3 shows a cross-section of the cap 200 and the collection member 160. Figure 3 shows that the closing member 210 comprises a substantially cylindrical lower part fitting the straight through section 164 and a cone-shaped part fitting the funnel through section 162. At the top of the closing member 210 the closing member 210 and the sldrt 230 are joined via a top portion 240. Between the skirt 230 and the closing member 210, a narrow circumferential space 246 is provided for accommodating the pickup section 168.

The circumferential space 246 widens towards the bottom of the skirt 230 to a circumferential inner indentation 232 that is arranged to accommodate the flange 166 when the cap 200 is placed on the collection member of the applicable collection device. Below the circumferential inner indentation 232, a closing rim 234 is provided for delimiting the

circumferential inner indentation 232.

The cap 200 and the closing member 210 are provided to close the through-hole in the collection member 160 and the straight through section 164 in particular. The optional circumferential protrusions 212 provide an improved sealing. Furthermore, the cap 200 preferably comprises a resilient material and is more preferably fully or at least mostly provided in the resilient material. The resilient material is preferably an elastomer, including, but not limited to natural rubber, synthetic rubber, other, or a combination thereof. In a preferred embodiment, a type of rubber is used such that the closing member 210 may be pierced by a sampling needle for accessing the content of the collection tube 100.

Figure 4 shows a separation tool 400 for separating the collection member 160 from the tubular body 110. The separation tool 400 comprises a first separation member 410 that is hingedly connected to a second separation member 420 via an axle 432. The axle 432 is provided through a first hinging member 412 comprised by the first separation member 410 and a second hinging member comprised by the second separation member 420.

At a distal end of the first separation member 410, a first handling surface 416 is provided. At a distal end of the second separation member 420, a second handling surface 426 is provided. An optional spring 434 arranged as an urging member urges the first handling surface 416 and the second handling surface 426 apart from one another, to the position as depicted by Figure 4.

At a proximal end of the first separation member 410, a first receiving indentation 414 is provided and at a proximal end of the second separation member 420, a second receiving indentation 424 is provided. As the first handling surface 416 and the second handling surface 426 are urged apart, the proximal ends of the separation members are urged towards one another by the spring 434.

The width of the first receiving indentation 414 is substantially equal to or wider than the outer diameter of the body 110 (Figure 1 A) near the rim 124 and narrower than the flange 166 of the collecting member. The width of the second receiving indentation 424 is substantially equal to or wider than the diameter of the body 110 at the position of the indentation 116 and narrower than the outer diameter of the body 110 just above the indentation 116. If the body 110 is provided with multiple indentations of which two are provided opposite to one another, the smallest width of the body 110 at the height of the indentions is substantially the same as or less than the width of the second receiving member.

In use, the body 110 is placed in the second receiving indentation 424 at the position of the indentation 116, with the first receiving

indentation 414 above the second receiving indentation 424. In this position, the second separation member 420 abuts to the lower surface of the indentation 116. Subsequently, the first handling surface 416 and the second handling surface 426 are pushed towards one another. As a result, the first separation member 410 and the second separation member 420 pivot relative to one another and the first receiving indentation 414 is moved apart from the second receiving indentation 424.

By virtue of the dimensions of the second receiving indentation 424 on one hand and the indentation 116 of the body 110 on the other hand, the first separation member 410 has a substantially stationary position relative to the body 110 and the first collection tube 100 as it abuts to the upper and lower limitations of the indentation 116. This means that the first

separation member 410 moves upward relative to the body 110, towards the flange 166 of the collection member 160 and abuts to the flange 166.

As the flange 166 is wider than the first receiving indentation 414, the flange 166 and with that, the collection member 160 is moved upward relative to the body 110 and out of the container cavity 114. This action may be continued until the collection member 160 is fully separated from the body 110 or until the collection member 160 may be conveniently separated from the body 110, without too much effort due to friction between the upper outer wall 176 of the collection member and the inner wall 122 of the container cavity 114 - or any other friction between two mating members of the collection member 160 and the body 110.

Hence, the second receiving indentation 424 engaged with a first abutment of the main body 110 having a face directed towards the rim 124 and the first receiving indentation 414 engages with a second abutment of the collection member 160 having a face directed away from the pick up section 168. The first abutment is preferably provided as part of the indentation 116, because this allows safe holding of the body 110.

Alternatively, the first abutment may be provided as one or more

protrusions provided at the upper part of the body 110.

Thus far, the separation tool 400 has been discussed comprising two members that are connected over a pivoting connection. Other

embodiment may be envisaged as well in which the separation indentations are moved apart in another way, for example via a linear movement.

In summary, the various aspects relate to a collection tube for collecting biological specimen such as blood, urine and saliva. The collected amount is kept as low as possible for convenience. Keeping the collected amount in the tube is therefore very important, for which reason the collection tube has a narrow opening. However, a narrow opening is incompatible with automated sampling equipment. Therefore, the collection tube comprises a main body with a container cavity, to which a collection part is releasably mounted. The container cavity, with the collection member removed, has a significantly wider opening that is compatible with automated sampling probe stations. The main body and the collection part may comprise indentations or protrusions that allow engagement with a tool for separating both parts of the collection tube. The tool may be provided as a pair of tweezers of which extremities engage with both parts for forcing them apart.

In the description above, it will be understood that when an element such as layer, region or substrate is referred to as being "on" or

"onto" another element, the element is either directly on the other element, or intervening elements may also be present. Also, it will be understood that the values given in the description above, are given by way of example and that other values may be possible and/or may be strived for. Furthermore, the invention may also be embodied with less components than provided in the embodiments described here, wherein one component carries out multiple functions. Just as well may the invention be embodied using more elements than depicted in the Figures, wherein functions carried out by one component in the embodiment provided are distributed over multiple components.

It is to be noted that the figures are only schematic representations of embodiments of the invention that are given by way of non-hmiting examples. For the purpose of clarity and a concise description, features are described herein as part of the same or separate embodiments, however, it will be appreciated that the scope of the invention may include

embodiments having combinations of all or some of the features described. The word 'comprising' does not exclude the presence of other features or steps than those listed in a claim. Furthermore, the words 'a' and 'an' shall not be construed as limited to 'only one', but instead are used to mean 'at least one', and do not exclude a plurality.

A person skilled in the art will readily appreciate that various parameters and values thereof disclosed in the description may be modified and that various embodiments disclosed and/or claimed may be combined without departing from the scope of the invention.

It is stipulated that the reference signs in the claims do not limit the scope of the claims, but are merely inserted to enhance the legibility of the claims.

Claims

1. Collecting device for collecting a substantially Liquid biological specimen, the device comprising:

a container member comprising a cavity having a container opening at a proximal end of the container member;

a collection member releasably connected to the proximal end of the container member, the collection member having a hollow body having collection openings at opposite sides and a flange radially extending from an axis between the collection openings of body and extending beyond the diameter of the container member;

Wherein:

the container member comprises a first mating section at the opening;

the collection member comprises a second mating section provided at a first collection opening at a first side of the flange, the second mating section being arranged to releasably mate with the first mating section such that the first collection opening is provided in the cavity;

the inner diameter of the cavity at a distance from the first mating member is larger than an outer diameter of the collection member at a distance from the second mating section, at the first side of the flange.

2. Collecting device according to claim 1, wherein the first mating section comprises a substantially smooth inner wall of the cavity and the second mating section comprises a substantially smooth outer wall of the collection member.

Collecting device according to claim 2, wherein the first mating section is a substantially straight inner wall of the cavity ranging from the opening of the cavity to a point in the cavity where the outer diameter of the collection member is smaller than the inner diameter of the cavity.

Collecting device according to any of the claims 1 to 3, wherein the container member comprises at least a first abutment at the outer perimeter of the container member in the vicinity of the opening of the cavity having a face directed to the opening of the opening of the container member.

Collecting device according to any of the preceding claims, wherein, when the collection member is placed on the container member such that the flange abuts the first mating section, a distance between the opening of the container member and the first abutment is larger than a distance between the opening of the container member and a side of the flange facing the first mating section.

Collecting device according to any of the preceding claims, wherein, when the collection member is placed on the container member such that the flange abuts the first mating section, the flange is provided at a first side of a plane of the opening and the abutment is provided at a second side of a plane of the opening opposite to the first side.

Collecting device according to any of the preceding claims, wherein, when the collection member is placed on the container member such that the flange abuts the first mating section, the flange is arranged to be abutted by the first separation member of the separation device according to claim 15 and the first abutment is arranged to be abutted by the second separation member of the separation device according to claim 15.

Collecting device according to any of the claims 4-7, wher abutment is comprised by a first indentation at the outer perimeter of the container member.

9. Collecting device according to claim 8, wherein the first

indentation covers at least half the circumference of the outer perimeter of the container member.

Collecting device according to any of the preceding claims, further comprising a cap having a closing member having a distal end and a proximal end, the closing member having an outer diameter perpendicular to a centre axis from the proximal end to the distal end being substantially equal to an inner diameter of at least part of the hollow body of the collection member for providing a substantially fluid-tight seal between the closing member and an inner wall of the hollow body.

Collecting device according to claim 10, the closing member comprising at least one concentric ring extending from the centre axis of the closing member protruding from the closing member.

Collecting device according to claim 10 or 11, further comprising a top portion provided at the distal end of the closing member and a skirt portion extending from the top portion towards the proximal end of the cap, wherein an inner diameter of the skirt portion is substantially equal or slightly larger than an outer diameter of the collection member at a second side of the flange.

Collecting device according to any of the preceding claims, the container member comprising a waist portion having a diameter smaller than a the diameter of the cavity portion of the container member in which the cavity is provided.

Collecting device according to claim 13, wherein the diameter of the waist portion is 80% or less, preferably less than 70% and more preferably less than 60% of the diameter of the container member in which the cavity is provided.

Separation device for separating the collection member from the container member of the collecting device according to any of the claims 4 to 9 and any of the claims 11 to 14 to the extent dependent on claims 4 to 9, the separation device comprising: a first separation member comprising a first separation body in which a first separation indentation is providing having a first separation width substantially equal to or wider than the outer diameter of the container member and narrower than the flange; a second separation member comprising a second separation body in which a second separation indentation is providing having a second separation width substantially equal to or wider than the diameter of the container member at the position of the

indentation and narrower than the outer diameter of the container member just above the indentation;

a joining connection connecting the first separation member to the second separation member enabling a movement of the first separation member relative to the second separation member; the first separation member and the second separation member a connected such that the first separation indentation is aligned with the second separation indentation.

16. Separation device according to claim 15, wherein the joining connection is a pivotal connection provided between a distal end of the first separation member at which the first separation indentation is provided and an opposite proximal end on one hand and between a distal end of the second separation member at which the second separation indentation is provided and an opposite proximal end on the other hand.

17. Separation device according to claim 16, further comprising an urging member for urging the distal end of the first separation member towards the distal end of the second separation member.

18. Kit of parts comprising the collecting device according to any of the claims 1 to 14 and the separation device according to any of the claims 15 to 17.