SAMPLE COLLECTION DEVICE

Abstract

The present invention relates to a sample collection device for collecting a sample of a fluid of a user, e.g. blood, in particular capillary blood. Further, the present invention relates to a push button section.

Claims

1. A sample collection device for extracting and collecting a sample of a fluid of a user, the sample collection device comprising: an outer shell; an inner shell having a pierceable membrane, wherein a pre-packaged vacuum is sealed in a first chamber defined between the outer shell and the inner shell, and a partially elastically deformable push button section, integrally formed with the outer shell, wherein the push button section includes: a center portion having a sharp piercing element for piercing the pierceable membrane of the inner shell when a pushing force is applied on the push button section, for allowing releasing of the vacuum in a second chamber, defined by the inner shell; a peripheral wall, extending toward the inside from a flat wall of the outer shell; a bottom wall, protruding toward the center portion; a first connection portion, connecting the peripheral wall and the bottom wall; a second connection portion, connecting the bottom wall and the center portion, the second connection portion having a reduced thickness, wherein a first circular groove is formed at the first connection portion between the peripheral wall and the bottom wall, and wherein a second circular groove is formed at the second connection portion between the bottom wall and the center portion.

2. The sample collection device according to claim 1, wherein the first connection portion and the second connection portion are circular walls.

3. The sample collection device according to claim 1, wherein the push button section has a circular shape having a diameter between 26 and 32 mm, and the center portion of the push button section has a circular shape having a diameter between 3 and 5 mm.

4. The sample collection device according to claim 3, wherein the push button section has a circular shape having a diameter of 29 mm, and the center portion of the push button section has a circular shape having a diameter of 4 mm.

5. The sample collection device according to claim 1, wherein the push button section has an activation force between 15 N and 25 N.

6. The sample collection device according to claim 1, wherein the outer shell and the push button section are integrally formed through injection molding.

7. The sample collection device according to claim 1, wherein the push button section is partially or fully formed through overmoulding.

8. The sample collection device according to claim 7, wherein the push button section is partially or fully formed through overmoulding with an elastomer or a material, which is softer than the material of the outer shell.

9. The sample collection device according to claim 1, wherein the outer shell and the push button section are made of Copolyester and/or polyethylene terephthalate (PET).

10. The sample collection device according to claim 1, wherein at least one reinforcing rib is provided on opposite sides of an inner surface of a peripheral wall of the outer shell, for preventing collapsing of the outer shell when under-pressurized.

11. The sample collection device according to claim 1, wherein the absolute vacuum pressure in the first chamber is between 400 mbar and 600 mbar.

12. A push button section for a sample collection device, comprising the push button section features according to claim 1.

Description

[0044] The invention will be better understood with the aid of the description of an embodiment given by way of example and illustrated by the figures, in which:

[0045] FIG. 1 shows a perspective view of an outer part of a sample collection device according to one embodiment of the invention;

[0046] FIG. 2 shows a perspective view of the inner part of the outer shell of the sample collection device of FIG. 1;

[0047] FIG. 3 shows a cross-section view of the detail of a push button section of the sample collection device of FIG. 1;

[0048] FIG. 4 shows a cross-section view of a part of the sample collection device of FIG. 1, i.e. the inner and the outer casing with the pierceable membrane in between;

[0049] FIG. 5 a perspective view of a further embodiment of an outer part and inner part of a sample collection device with an overmoulded push button section (concept splitting, splitline);

[0050] FIG. 6a-c a further perspective view of the embodiment of FIG. 5, with the unmounted push button section and the overmoulded part of the push button section;

[0051] FIG. 7 a detail of the mounting and attachment of the push button section to the outer shell of the embodiment of FIG. 5 and of FIG. 6;

[0052] FIG. 8 a perspective view of a further embodiment of an outer part of a sample collection device with an overmoulded push button section (concept cut outs in housing); and

[0053] FIG. 9 a-d several views on the embodiment of FIG. 8.

[0054] In the following description provided by way of example, reference will be made, for reasons of simplicity, to a sample collection device. However, it must be understood that the sample indicated in those expressions is a sample of a fluid, in particular a bodily fluid, e.g. blood, in particular capillary blood.

[0055] FIG. 1 shows a perspective view of an outer part of a sample collection device 100 for extracting and collecting a sample of a fluid (e.g., blood) of a user according to one embodiment of the invention.

[0056] Furthermore, FIG. 2 shows a perspective view of the inner part of the outer shell of the sample collection device 100 according to the invention.

[0057] Still further, FIG. 4 shows cross-section view of a part the sample collection device 100 according to the invention, i.e. the inner and the outer casing with the pierceable membrane in between.

[0058] As illustrated in detail in FIG. 4, the sample collection device 100, comprises an outer shell 101 and an inner shell 102.

[0059] Moreover, the sample collection device 100 comprises an inner shell 102.

[0060] As can be further seen from FIG. 4, the sample collection device 100 has a push button section 200.

[0061] The push button section 200 is partially elastically deformable.

[0062] Additionally, in the shown embodiment the push button section 200 is integrally formed with the outer shell 101.

[0063] A first chamber 1000 is defined between the outer shell 101 and the inner shell 102, and a pre-packaged vacuum is sealed in the first chamber 1000.

[0064] In a possible embodiment, the internal relative vacuum pressure in the first chamber 1000 can between 0.01 and 0.10 MPa, preferably 0.06 MPa.

[0065] Preferably, the absolute pressure is between 400 mbar (=40000 Pa) and 600 mbar (=60000 Pa). This range is an adaptable range.

[0066] The partially elastically deformable push button section 200 of the sample collection device 100 is shown in detail in FIG. 3.

[0067] The push button section 200 comprises a center portion 201.

[0068] The center portion 201 is equipped with a sharp piercing element 300.

[0069] Further, the push button section 200 comprises a peripheral wall 202.

[0070] The peripheral wall 202 extends toward the inside from a flat wall 1010 of the outer shell 101.

[0071] Moreover, the push button section 200 has a bottom wall 203.

[0072] The bottom wall 203 is protruding toward the center portion 201.

[0073] As can be further seen from FIG. 3 and FIG. 4, the push button section 200 has a first connection portion 204.

[0074] The connecting portion 204 is connecting the peripheral wall 202 and the bottom wall 203.

[0075] Further, the push button section 200 has a second connection portion 205.

[0076] The second connection portion 205 is connecting the bottom wall 203 and the center portion 201, the second connection portion 205 having a reduced thickness.

[0077] The piercing element 300 is configured to pierce a pierceable membrane 1021 (e.g., an Aluminium membrane) formed in the inner shell 102 such that, when a pushing force is applied on the push button section 200, vacuum that is present in the first chamber 1000 is released in a second chamber 1001, defined by and placed on the inner shell 102 (FIG. 4).

[0078] Transfer of the vacuum into the second chamber 1001 has the effect of sucking and stretching the skin of the patient.

[0079] The piercing element 300 is provided under the center portion 201 of the sample collection device 100, and may be cross-shaped for improving piercing capabilities (FIG. 2).

[0080] As shown in FIG. 3, a first circular groove 2040 is formed at the first connection portion 204 between the peripheral wall 202 and the bottom wall 203.

[0081] Additionally, there is a second circular groove 2050 formed at the second connection portion 205 between the bottom wall 203 and the center portion 201.

[0082] The first circular groove 2040 facilitates elastic deformation of the push button section 200 when a pressing force is exerted by the user on the center portion 201. This allows the user easily operating the push button section 200, without being requested exerting a particularly strong pressing force.

[0083] Furthermore, the first circular groove 2040 allows improving elasticity of the push button section 200 and facilitating elastic return of the bottom wall 203 once the pressing force has ceased.

[0084] The elasticity of the push button section 200 is further enhanced by the presence of the second circular groove 2050.

[0085] The improved elasticity of the push button section 200 allows preventing the push button section 200 from breaking upon being pressed.

[0086] Advantageously, the push button section 200 has an activation force between 15 N and 25 N, preferably of 20 N.

[0087] In a preferred embodiment, as shown in FIG. 3 and FIG. 4, the first connection portion 204 and the second connection portion 205 are circular walls.

[0088] The push button section 200 may have a circular shape having a diameter between 26 and 32 mm, preferably between 26.1 and 31.9 mm, and the center portion 201 of the push button section 200 may have a circular shape having a diameter between 3 and 5 mm, preferably between 3.6 and 4.4 mm.

[0089] In a more preferred configuration, the push button section 200 has a circular shape having a diameter of 29 mm, and the center portion 201 of the push button section 200 has a circular shape having a diameter of 4 mm.

[0090] The wall thickness of the push button section 200 can be as follows:

[0091] In section 200a (connecting end to the outer shell 101) the wall thickness can be approx. 0.6 mm, e.g. chosen between 0.5 mm to 0.7 mm.

[0092] In section 200b (right before the first connection portion 204 and the first circular groove 2040) the wall thickness can be approx. 0.73 mm, e.g. chosen between 0.65 mm to 0.8 mm.

[0093] In section 200c (right after the first connection portion 204 and the first circular groove 2040) the wall thickness can be approx. 0.86 mm, e.g. chosen between 0.8 mm to 0.9 mm.

[0094] In section 200d (after the section 200c, middle of the bottom wall 203) the wall thickness can be approx. 0.78 mm, e.g. chosen between 0.7 mm to 0.8 mm.

[0095] In section 200e (right before the second connection portion 205) the wall thickness can be approx. 0.73 mm, e.g. chosen between 0.65 mm to 0.8 mm.

[0096] In section 200f (in the second connection portion 205) the wall thickness can be approx. 0.5 mm, e.g. chosen between 0.45 mm to 0.55 mm.

[0097] The outer shell 101 and the push button section 200 may be integrally formed through injection molding and/or overmoulding. In such a case, the injection point can be conveniently located at the center portion 201 of the push button section 200. This allows easily manufacturing the outer shell 101 and the integrated push button section 200 on a large scale with low manufacturing costs.

[0098] The outer shell 101 and the push button section 200 are preferably made of polyethylene terephthalate (PET).

[0099] Alternatively, the outer shell 101 and the push button section 200 can be made of copolyester and/or polyethylene terephthalate (PET).

[0100] The structure of the sample collection device 100 can be reinforced by the provision of at least one reinforcing rib 1011, provided on opposite sides of an inner surface 1111 of a peripheral wall of the outer shell 101.

[0101] For instance, as illustrated in FIG. 2, each opposite side may have a pair of reinforcing ribs 1011, formed on its inner surface and extending parallel to one another. In particular, the reinforcing ribs 1011 allow preventing collapsing of the outer shell 101 when under-pressurized.

[0102] FIG. 5 shows a perspective view of a further embodiment of an outer part of a sample collection device 100 with an overmoulded push button section 200 of the concept splitting, splitline.

[0103] The sample collection device 100 has the same structural and functional features as the sample collection device 100 as described above, especially in connection with FIG. 1 to FIG. 4. The following below differences or additional features exist:

[0104] Here, the whole push button section 200 is made of a less rigid and softer material than the outer shell 101 of the sample collection device 100. In particular, in the embodiment, the push button section 200 is made of an elastomer E.

[0105] The push button section 200 is with its edge section mounted by means of overmoulding to the outer shell 101.

[0106] FIG. 6a-c shows a further perspective view of the embodiment of FIG. 5, with the outer shell 101 without the unmounted push button section 200 (cf. FIG. 6a) and the overmoulded part of the push button section 200 (cf. FIG. 6b and FIG. 6c).

[0107] FIG. 7 shows a detail of the mounting and attachment of the push button section to the outer shell of the embodiment of FIG. 5 and of FIG. 6. As can be seen from FIG. 7, the push button has step-shape section 210, which is attached to an also step-shaped counter-section on the outer shell 101. In this area, the attachment is realized by overmoulding. Due to the step-shaped section a bigger contact surface for the material connection of the push button section 200 to the outer shell 101 can be increased and thus the bonding can be enhanced.

[0108] FIG. 8 shows a perspective view of a further embodiment of an outer part of a sample collection device 100 with an overmoulded push button section 200 (concept cut outs in housing). In FIG. 8, the overmoulded push button section 200 is not shown, if the overmoulded push button section 200 is overmoulded to the outer shell 101, the outer appearance of the sample collection device 200 looks more or less the same like the outer appearance embodiment shown in FIG. 5.

[0109] The sample collection device 100 has the same structural and functional features as the sample collection device 100 as described above, especially in connection with FIG. 1 to FIG. 4. The following below differences or additional features exist:

[0110] In the outer shell 101 and in the area of the push button section 200 several cut-outs 220 are provided, which define four 90-sectors in the rigid material of the outer shell 101 of the push button section 200. By this, the push button section 200 is made more elastic.

[0111] Generally speaking, also a different number of cut-outs is possible. The more cut-outs are provided, the less rigid and flexible will the push button section 200 be defined.

[0112] Each cut-out 220 can be identical in form, structure and dimension to the other cut-out or cut-outs.

[0113] The cut-outs 220 can be arranged symmetrically or asymmetrically.

[0114] The cut-out 220 can be of made by means of a recess in the wall of the outer shell 101 in the push button section 200.

[0115] FIG. 9 a-d shows several views on the embodiment of FIG. 8. As can be seen from FIG. 9a and FIG. 9b, the button surface is overmoulded with an elastomer E (or a material which is less rigid and softer than the material used for the outer shell 101. This softer material can be placed and overmoulded there with a so-called second shot.

[0116] FIG. 9c shows a view of the detached elastomer E from the outer shell 101.

[0117] FIG. 9d shows a cross-sectional view of the embodiment shown in FIG. 8.

REFERENCE SIGNS USED IN THE FIGURES

[0118] 100 Sample collection device [0119] 101 Outer shell [0120] 102 Inner shell [0121] 200 Push button section [0122] 200a section [0123] 200b section [0124] 200c section [0125] 200d section [0126] 200e section [0127] 200f section [0128] 201 Center portion [0129] 202 Peripheral wall [0130] 203 Bottom wall [0131] 204 First connection portion [0132] 205 Second connection portion [0133] 300 Piercing element [0134] 1000 First chamber [0135] 1001 Second chamber [0136] 1010 Flat wall [0137] 1011 Reinforcing rib [0138] 1111 Inner surface [0139] 1021 Pierceable membrane [0140] 2040 First circular groove [0141] 2050 Second circular groove [0142] 100 Sample collection device [0143] 101 Outer shell [0144] 200 Push button section [0145] 210 Step-shape section [0146] 100 Sample collection device [0147] 101 Outer shell [0148] 200 Push button section [0149] 220 Cut-out [0150] E Elastomer