Sampling assembly, in particular for collecting a relatively small quantity
10618049 ยท 2020-04-14
Assignee
Inventors
- Franz Ebetsberger (Kremsmuenster, AT)
- Georg Kofler (Inzersdorf, AT)
- Maximilian Mizelli (Ried im Traunkreis, AT)
Cpc classification
B29L2031/753
PERFORMING OPERATIONS; TRANSPORTING
B29C45/0081
PERFORMING OPERATIONS; TRANSPORTING
B01L3/5055
PERFORMING OPERATIONS; TRANSPORTING
A61B5/150259
HUMAN NECESSITIES
A61B5/150351
HUMAN NECESSITIES
International classification
B01L3/00
PERFORMING OPERATIONS; TRANSPORTING
Abstract
The invention relates to a sampling assembly (1), in particular for relatively small quantities of bodily fluids. The said sample assembly (1) comprises a sample container (2) and a support assembly (15). The sample container (2) has an open end (4), an end (5) closed by a bottom (6) as well as a side wall (7). The support assembly (15) protrudes axially over the sample container (2) in the area of the closed end (5) thereof, and comprises at least two container extension pieces (16). The container extension pieces (16) are each integrally connected with the sample container (2) via a hinge assembly (17) and are pivotable from a production position aligned at an angle (18) to the longitudinal axis (8) to a use position which is aligned approximately parallel to the longitudinal axis (8).
Claims
1. Sampling assembly (1), in particular for a lower quantity of bodily fluids, comprising a sample container (2), with an open end (4) and an end (5) closed by a bottom (6), whereby a side wall (4) and a longitudinal axis (8) defined by it, extend between the open end (4) and a neck area (14) of the bottom (6) in the area of the closed end (5), and whereby the side wall (7) has an outer surface (9) as well as an inner surface (11), and the side wall (7), as well as the bottom (6), define a collecting chamber (13), and a support arrangement (15), where the support arrangement (15) protrudes over the sample container (2) in the area of its closed end (5) in the axial direction, wherein the support arrangement (15) comprises at least two container extension pieces (16), where the container extension pieces (16) are each connected integrally via a hinge assembly (17) with the sample container (2), wherein each container extension piece (16) can be pivoted from a production position aligned at an angle (18) to the longitudinal axis (8) to a use position approximately parallel to the longitudinal axis (8), wherein the at least two container extension pieces (16) are directly connected in their use position.
2. The assembly (1) as claimed in claim 1, wherein the enclosed angle (18) in the production position is 90 between each container extension piece (16) and the longitudinal axis (8).
3. The sampling assembly (1) as claimed in claim 1, wherein each hinge assembly (17) is formed by a reduction in the wall thickness in some areas, in particular by an integral film hinge.
4. The sampling assembly (1) as claimed in claim 1, wherein the supporting assembly (15) also comprises in particular a tube-shaped wall portion (19), where the tube-shaped wall portion (19) is then located on the side wall (7) of the sample container (2) and designed integrally with the side wall (7), and the at least two container extension pieces (16) are connected by the hinge assemblies (17) with the wall portion (19), and thereby with the sample container (2).
5. The sampling assembly (1) as claimed in claim 1, wherein the at least two container extension pieces (16) each have a front surface (20) on their end areas facing the sample container (2), in their use position, on which the front surfaces (20) are positioned in a support plane (21) aligned at a right angle to the longitudinal axis (8).
6. The sampling assembly (1) as claimed in claim 5, wherein a support surface (22) is arranged in the support plane (21) in the area of the closed end (5) of the sample container (2) on its side wall (7) or on the wall portion (19).
7. The sampling assembly (1) as claimed in claim 1, wherein the side wall (7) has a wall thickness (10), starting from the open end (4) to the neck area (14) of the bottom (6), which corresponds to approximately the wall thickness (27) of the bottom (6).
8. The sampling assembly (1) as claimed in claim 1, wherein an end section of the bottom (6), facing away from the open end (4), protrudes in the axial direction over an end of the wall portion (19) facing away from the sample container (2).
9. The sampling assembly (1) as claimed in claim 1, wherein the at least two container extension pieces (16) are locked together in their use position by means of at least one locking assembly (23).
10. The sampling assembly (1) as claimed in claim 1, wherein the at least two container extension pieces (16) are positioned towards each other in their use position by means of at least one centering assembly (26).
11. The sampling assembly (1) as claimed in claim 1, wherein the at least two container extension pieces (16) are designed as closed, at least in some areas, in their use position at the ends facing away from the open end (4) of the sample container (2), over a respective section of a spherical end wall (33).
12. The sampling assembly (1) as claimed in claim 11, wherein the end walls (33) of the at least two container extension pieces (16) are each designed with a breakthrough (34) in the area of the longitudinal axis (8).
13. The sampling assembly (1) as claimed in claim 1, wherein the at least two container extension pieces (16) fully form the support assembly (15) in their use position, at least in the end areas facing away from the sample container (2), with the exception of mutual joints.
14. The sampling assembly (1) as claimed in claim 1, wherein the specimen container (2) and the at least two container extension pieces (16) have, in their use position and where applicable, with the wall portion (19), the outer shape of a sampling tube as per the document AUTO1-A, with number ISBN 1-56238-427-9 of the CLINICAL AND LABORATORY STANDARDS INSTITUTE.
15. The sampling assembly (1) as claimed in claim 1, wherein the open end (4) of the sample container (2) is closed by a closure device (3).
16. The sampling assembly (1) as claimed in claim 15, wherein the collecting chamber (13) closed by the closure device (3) is lowered to a reduced pressure compared to the surrounding pressure.
17. The sampling assembly (1) as claimed in claim 15, wherein the closure device (3) has a cap (30) protruding over the outer surface (9) of the side wall (7), as well as a sealing element (31) inserted into the collecting chamber (13), whose sealing element (31) circumferentially seals against the inner surface (11) of the side wall (7).
Description
(1) To help better understand the invention, it is explained in more detail by the following figures.
(2) In an extremely simplified, schematic view, you can see:
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(9) To begin with, it is stated that the different embodiments described are equipped with the same parts with the same reference signs or component names, whereby the declarations in the whole description can be transferred correspondingly to the same parts with the same reference signs or component names. The positional information selected in the description, such as above, below, side etc. is also related to the figure directly described and shown, and this information is to be transferred correspondingly to the new position, in the event of a change of position.
(10) The term in particular is understood below as concerning a possible special embodiment or more detailed specification of an object or a process stage, but must not necessarily represent a mandatory, preferred embodiment of the same or a procedure.
(11) In
(12) The sampling assemblies 1 shown here indicate a lower collection volume compared to the blood sampling tube in the normally standardised dimensions. The standard dimensions are understood, for example, by the external nominal diameter and the nominal axial length. For the laboratory automation, the standard dimensions of CLINICAL AND LABORATORY STANDARDS INSTITUTE have been specified (NCCLS. Laboratory Automation: Sample container/Specimen Carrier; Approved Standard. NCCLS document AUTO1-A [ISBN 1-56238-427-9]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pa. 19087-1898 USA, 2000.).
(13) In this document, the dimensions and the tolerances to be observed for this kind of sampling tubes, in particular blood sampling tubes, are specified.
(14) This means there are tubes with a nominal diameter of 13 mm or 16 mm. The nominal axial length can, for example, be 75 mm or 100 mm. As a short description for a closed tube with a nominal diameter of 13 mm and an axial length of 75 mm, 13/75 can be used, for example. Dimensions can also be used, which have nominal diameters or nominal axial lengths which deviate from the previously stated dimensions.
(15) The sampling assemblies 1 are preferred to be used for the collection of capillary blood, which is only done in low quantities and is stored for the subsequent examinations in the respective sampling assembly 1. Due to the progress of technology, a smaller and smaller sample quantity is also necessary to determine the clinical parameters. The sample quantity can also be defined as the sample volume. However, the previous sampling assemblies 1 have smaller dimensions than the standardised dimensions. To be able to insert and collect these sampling assemblies 1 in the standardised centrifugation equipment or laboratory equipment, the following designs have been improved so that they can be used in standardised centrifuges despite the lower collection volume.
(16) The following collection groups 1 each comprise a sample container 2 and, where applicable a closure device 3.
(17) The sample container 2 has an open end 4 and a closed end 5. The closed end 5 can be designed as closed with a bottom 6. The dimensional shape of the bottom 6 can differ. In this example embodiment, bottom 6 has a first bottom wall, viewed from the axial cross-section, starting from its outer edge, which tapered and is sealed in the centre with another bottom wall which is spherical in shape. Between the open end 4 and the closed end 5, there is a side wall 7. There is also a longitudinal axis 8 which extends between the open end 4 and the closed end 5, and can also preferably be defined as the central longitudinal axis. The longitudinal axis 8 is defined by the side wall 7, whereby the side wall 7 is designed as extensively continuous and runs in the axial direction. The dimensional shape of the sample container 2 can be generally designed as tube-shaped, whereby the surrounding side wall 7 defines the open end 4, and the other end 5 is designed as closed with the bottom 6.
(18) Different shapes of the cross-sectional shape of sample container 2 can be selected, whereby the preferred cross-section shape is normally a circular cross-section. To allow the demoulding of the sample container 2 produced in an injection-moulding process, corresponding drafts are intended as is normal with components of this kind. Thus, the side wall 7 exhibits a conicity starting from the open end 4 towards the closed end.
(19) Plastic material is preferred as the material for the sample container, as well as the connected support arrangement. Thus, the material can be largely transparent to crystal-clear and can be selected from the group of PP (polypropylene), PS (polystyrene), PET (polyethylene terephthalate), PE (polyethylene), PA (polyamide), PC (polycarbonate). The processing is preferably done in an injection moulding process. It would also be possible for sample container 2 with its side wall 7 and the bottom 6 to be made with a material that is different from the supporting assembly.
(20) The side wall 7 of the sample container 2 also has an external surface 9, as well as an internal surface 11 distanced from it by wall thickness 10. The side wall 7 also borders the front surface 12 in the open end 4 area. Furthermore, the side wall 7 with its inner surface 11, together with the bottom 6, defines or borders a collecting chamber 13, which is used to collect the bodily fluid to be removed or filled, in particular blood and especially capillary blood. Other biological fluids can, however, also be stored in collecting chamber 13. The collecting chamber 13 can also be defined as a storage chamber, which has a lower collection volume concerning the collecting tube with standard dimensions. For example, the collecting chamber 13 can have a collection volume with a lower limit of 1 ml and an upper limit of 4 ml, in particular between 1.5 ml and 3 ml (millilitres). Thus, the collecting chamber 13 has a reduced collection volume with regards to the collecting container, with standard dimensions and described above.
(21) In a neck area 14, the bottom 6 joins the side wall 7 on the side facing away from the open end 3, and thereby closes end 5 of the sample container 2.
(22) The sampling assembly 1 also comprises a support arrangement 15, which protrudes out of the sample container 2 in the area of its closed end 5, in the axial direction. This jutting-out or protruding position of the support arrangement 15 is defined below as a use position of the respective sampling assembly 1.
(23) As can be seen from an overview of
(24) The position of the container extension pieces 16, depicted in
(25) If the components described above are now designed in a joint mould cavity of a moulding tool, and are removed from it, the container extension pieces 16 can be pivoted in or out from their production position to the use position, in which the container extension pieces 16 are aligned approximately parallel to the longitudinal axis 8. This makes it possible to allow a closed wall formation with sample container 2, as well as with the support arrangement 15, in their use position. With sample container 2, the bottom 6 is completely closed and thereby at least liquid-tight.
(26) In the production position, the angle 18 of each container extension piece 16 with the longitudinal axis 8, can amount to 90, whereby the accessibility and the associated forming of the bottom 6 is allowed by the angle 18. An angle 18 can, however, be chosen of less than 90, whereby this can be selected depending on the number of container extension pieces 16 as well as the technical conditions.
(27) The hinge assembly 17 can be formed by reducing the wall thickness in some areas. An integral film hinge can be used here as a possible design.
(28) Furthermore, it would be possible for a wall portion 19 to be arranged or designed connected to the side wall 7, particularly with a tube-shape, in particular in the neck area 14 of the bottom 6. In this case, the container extension pieces 16 can each be connected integrally using the hinge assembly 17 with wall portion 19, and thereby with the sample container 2. The wall portion 19, mainly designed as a hollow cylinder, is another component of the support arrangement 15, which is designed integrally with the side wall 7. If the wall portion 19 is planned, this has an axial longitudinal length which, together with the axial length of the container extension pieces 16, forms the whole axial length of the supporting arrangement 15. The total axial length, comprising the axial length of the support arrangement 15, plus the axial length of the side wall 7, corresponds to the nominal axial lengths described above. The axial length of the wall portion 19 is to be adjusted according to the selected axial length of the container extension pieces 16.
(29) It would, however, also be possible, as shown and described in more detail in
(30) At least two container extension pieces 16 each have a front surface 20 in their use position at the end areas facing the sample container 2. In the use position, the front surfaces 20 are aligned so that they are positioned in a support plane 21 aligned at a right angle to the longitudinal axis 8. Due to this right-angled alignment of the front surface 20, centric support can be provided if the sample container 2 or the wall portion are correspondingly designed.
(31) Thus, a support surface 22 is to be designed on support plane 21, in the area of the closed end 5 of the sample container 2, on its side wall. If the extra wall portion 19 is also intended to be connected to the side wall 7, as described above, the support surface on wall portion 19 to the end facing away from the sample container 2 is shown with the same alignment towards the support plane 21, as shown in this example embodiment.
(32) Furthermore, it may be advantageous for a positional arrangement with cooperating positioning elements to be designed or positioned between the front surface 20 of the container extension piece 16, and the support surface 22 directly opposite it. Thus, a radial mutual positioning or fixation can be achieved, in the use position or insertion position, between the pivotable container extension pieces 16 and the sample container 2, or the wall portion 16 positioned on it and connected with the side wall.
(33) To prevent unwanted mutual displacement, in particular the tipping over of the container extension pieces 16 from their use position, they can be connected together when in the use position, in particular linked or coupled together. This can be done, for example, with at least one locking assembly 23. On the example embodiment shown in
(34) In this example embodiment, the locking assembly 23 comprises at least a first locking element 24, and a second meshing locking element 25. For example, the first locking element can be formed by a locking hook designed or positioned on the container extension pieces 16, which meshes into a notch formed by the second locking element 25 in the other container extension piece 16, in the use position. By providing wall openings in the area of locking elements 23 and/or 24, simple demoulding is possible without a slider. The notch or locking shoulder can either be positioned directly on an outer wall of one of the container extension pieces 16, or even within one of them. It would also be possible, however, to stick, weld or permanently connect in any other way, the container extension pieces 16, at least in some areas, to the separation joints facing each other and forming joints.
(35) In addition, it would also, however, be possible for at least two container extension pieces 16 to be positioned towards each other in their use position, by using at least one centering assembly 26. Different embodiments of the centering assembly 26 are shown in the respective examples.
(36) In
(37) In the example embodiment shown in
(38) With the example embodiments shown in
(39) Thus, it is possible to keep the container extension pieces 16, in addition to the locking assembly 23, in a better position to each other. This also applies under the high loads which occur, for example, during the centrifugation process.
(40) As can be seen better in
(41) Regardless of this however, as can be seen in
(42) Furthermore,
(43) As another possible different design, as per
(44) Thus, the wall portion 19, in its tube-shaped design, protrudes over the side wall 7, whereby the moulding of the bottom 6, as well as the moulding of the respective hinge assembly 17 to connect the container extension pieces 16 can be improved. This can also prevent the bottom 6 protruding or sticking out over the ring-shaped skirt.
(45) Due to the classification of the support arrangement 15 as pivotable container extension pieces 16, they exhibit joints on the sides facing each other when in the use position. They form a material interruption in the area of support arrangement 15. If the container extension pieces 16 are in their use position, they can form the support arrangement 15 in full, apart from the mutual joints. This concerns in particular the end areas of the container extension pieces 16, which face away from the sample container. An exception to this can also be the position or design of locking assembly 23, in particular the locking element 25 designed here as a recess or opening. Due to this almost complete design of the shape of the container extension pieces 16, as well as the sample container 2, the outline of a standardised blood collection tube can be modelled. For this the container extension pieces 16 must be in their use position. The outer geometric shape of the standardised blood collection tube means the dimensions and the shapes, which were listed above as examples.
(46) It also shows here that the open end 4 of the sample container 2 can be closed by the closure device 3. Furthermore, the collecting chamber 13 closed by the closure device 3, can also be lowered to a reduced pressure compared to the surrounding pressure. This reduction in pressure can, for example, be done in a vacuum chamber, in which the sample containers 2 are positioned when the closure devices 3 are not yet applied. If the pressure within the chamber, and therefore also in the collecting chamber 13 of the sample container 2, is reduced to the specified pressure, then closure device 3 can be applied to the respective sample container 2.
(47) After removing the sampling assembly 1 from the vacuum chamber, the closed collecting chamber 13 is reduced to a corresponding low pressure.
(48) The closure device 13 can have a cap 30 which spreads to the outer surface 9 of the side wall 7, as well as a sealing element 31 which is inserted in the collecting chamber 13 or the collecting room. The sealing element 31 can be formed on cap 30, in particular on its inner skirt, as shown as an example in
(49) In
(50) Both embodiments shown here correspond approximately to the ones already described in more detail previously in
(51) In the right part of
(52) In the left part of
(53) When providing two container extension pieces 16 of this kind, they are designed as a half-sphere or half-dome. Thus, when in closed position relative to the longitudinal axis 8, they do not just allow the design of the hollow cylindrical wall portion 19, but also the bottom 6, with a so-called false bottom of sample container 2.
(54) With these two example embodiments, the locking assembly 23 and/or the centering assembly 26 are also intended for reciprocal mounting or fixing, and for positioning aligned to each other.
(55) In addition, it would also be possible, however, as is indicated in
(56) It would also be possible, however, for the closure device 3 to be designed as the closure device is normally used on most collecting containers. This closure device 3 is shown in
(57) Depending on the application or purpose of sampling assembly 1, the collecting chamber 13 can be reduced to a lower pressure compared to the surrounding pressure, whereby this is not mandatory. There may be application cases, where the collecting chamber 13 is closed with the closure device 3, but the whole closure device has to be removed from the open end 4 of the sample container 2 to insert the sample, and only then can the corresponding sample be filled. It would also be possible for the inner surface 11, and where applicable the bottom 6, to be provided with coating to treat the filled sample, in the bottom surface facing the collecting chamber.
(58) In this example embodiment, the sampling assembly 1 comprises the sample container 2 as well as the support arrangement 15, and can also be designed as a sample collection tube, sample collecting container or sample collecting tube, in which bodily fluid, in particular blood or urine, can be filled and stored until the subsequent examination or for analysis purposes.
(59) The example embodiments show possible design versions of sampling assembly 1, whereby it is hereby pointed out that the invention is not restricted to the design versions specially shown, but rather that diverse combinations of the individual design versions are also possible, and these versions lie within the ability of the specialist working in this technical area, based on the instructions on the technical handling of the invention which is the subject matter of this patent.
(60) Furthermore, individual features or combinations of features from the different shown or described example embodiments can depict independent, inventive or invention-related solutions.
(61) The underlying task of the independent inventive solutions can be seen in the description.
(62) All the details of the value ranges in the description in question are to be understood as also comprising any and all partial areas, e.g. the range 1 to 10 is to be understood as comprising all partial areas, starting from the lower limit of 1 up to the upper limit of 10, i.e. all partial areas beginning with a lower limit of 1 or more, and ending with an upper limit of 10 or less, e.g. 1 to 1.7, 3.2 to 8.1, or 5.5 to 10.
(63) Above all, the individual designs shown in
(64) For the sake of clarity, it is hereby pointed out in closing, that to better understand the structure of the sampling assembly 1 this, or its components, in particular their sample container 2, are sometimes shown not to scale and/or larger/smaller.
REFERENCE NUMBERS
(65) TABLE-US-00001 1 Sampling assembly 2 Sample container 3 Closure device 4 Open end 5 Closed end 6 Bottom 7 Side wall 8 Longitudinal axis 9 Outer surface 10 Wall thickness 11 Inner surface 12 Front surface 13 Collecting chamber 14 Neck area 15 Support arrangement 16 Container extension piece 17 Hinge assembly 18 Angle 19 Wall portion 20 Front surface 21 Support plane 22 Support surface 23 Locking assembly 24 Locking element 25 Locking element 26 Centering assembly 27 Wall thickness 28 Wall thickness 29 Wall thickness 30 Cap 31 Sealing element 32 Lug 33 End wall 34 Breakthrough