SPECIMEN COLLECTION DEVICE

Abstract

A specimen collection device includes a test stick with an absorbent pad and a stick receptacle with a squeeze chamber and an outlet port at a distal end of the stick receptacle. The test stick has a stick body which extends through a pad channel. A stick tip extends through the outlet port when squeezing the absorbent pad against a chamfer end face of the squeeze chamber. The absorbent pad does not pass through the outlet port but remains in the squeeze chamber. Only the stick passes through the outlet port during squeezing. Advantageously, the test stick remains aligned inside the stick receptacle during squeezing which contributes to a proper release of fluid from the absorbent pad to obtain the fluid specimen in a specimen tube.

Claims

1-24. (canceled)

25. A specimen collection device for collecting a fluid specimen in a specimen tube, the specimen collection device comprising: a test stick for absorbing the fluid specimen, the test stick comprising an elongated stick body having a proximal stick end to be held by a user and a distal stick end with a stick tip, the stick body being provided with an absorbent pad at the distal stick end, and the absorbent pad containing a liquid absorbing material for absorbing the fluid specimen; a stick receptacle for receiving the test stick, the stick receptacle having an interior squeeze chamber for squeezing the absorbent pad to extract fluid out of the absorbent pad, the stick receptacle being open at a proximal end for inserting the stick tip into the squeeze chamber, the squeeze chamber having a chamber end face at a distal end of the stick receptacle for compressing the absorbent pad to release fluid from the absorbent pad when the absorbent pad is squeezed against the chamber end face, and the stick receptacle having a spout with an outlet port at the distal end for discharging fluid away from the squeeze chamber to the specimen tube; a specimen tube, the specimen tube being connectable to the spout of the stick receptacle for receiving the fluid specimen, wherein the absorbent pad comprises a pad channel extending from a first pad end face to or near a second pad end face, wherein the stick body extends inside the absorbent pad through the pad channel, such that when inserting the test stick into the stick receptacle, the stick tip is received in the outlet port for aligning the test stick during squeezing whilst the absorbent pad abuts the chamber end face, and wherein the stick tip is arranged to pass through the outlet port, such that the outlet port aligns and supports the stick body.

26. The specimen collection device according to claim 25, wherein the absorbent pad comprises a fully through pad channel extending from the first to the second pad end face.

27. The specimen collection device according to claim 25, wherein the stick tip has a tip head positioned beyond the absorbent pad.

28. The specimen collection device according to claim 25, wherein the stick body has a pressure member positioned in abutting engagement with the first pad end face of the absorbent pad.

29. The specimen collection device according to claim 27, wherein the absorbent pad is enclosed between the pressure member and the tip head by a form closure.

30. The specimen collection device according to claim 25, wherein the stick tip has a tapered tip head, the tapered tip head being mushroom-shaped.

31. The specimen collection device according to claim 25, wherein the absorbent pad has an absorbent capacity of at least 0.5 mL and at most 12 mL.

32. The specimen collection device according to claim 25, wherein the absorbent pad comprises a foam material, in the form of a urine sponge.

33. The specimen collection device according to claim 25, wherein the proximal stick end is provided with a grip, and wherein the grip is a plate-shaped finger grip including an outer circumferential upstanding ridge.

34. The specimen collection device according to claim 33, further comprising a stick extension, the grip having an aperture forming a grip snap member for attaching the stick extension, wherein in particular the aperture is a non-circular aperture positioned in a central region of the grip.

35. The specimen collection device according to claim 34, further comprising a stick extension provided with a complementary shaped snap member for connecting the stick extension to the grip snap member of the test stick, wherein the snap member comprises at least one snap finger for snapping the stick extension to the grip snap member.

36. The specimen collection device according to claim 25, wherein the outlet port is non-circular, comprising at least one outlet port dent.

37. The specimen collection device according to claim 25, wherein the outlet port is star-shaped.

38. The specimen collection device according to claim 25, wherein the chamber end face is tapered in a length direction of the squeeze chamber.

39. The specimen collection device according to claim 25, wherein the chamber end face of the squeeze chamber comprises at least one rib for squeezing the absorbent pad.

40. The specimen collection device according to claim 25, wherein the stick receptacle has a spout for connecting the specimen tube to the stick receptacle by inserting the spout into the specimen tube, and wherein the spout has an elongated spout body having a spout length in which along the length, the spout body has a first outer diameter which is larger than a second outer diameter for fitting different sizes of specimen tubes.

41. The specimen collection device according to claim 25, wherein the stick receptacle further comprises a spout adapter which fits onto the spout for adapting an outer diameter of the spout to an opening of a specimen tube head.

42. A kit comprising: the specimen collection device according to claim 25, wherein specimen tube has a tube volume of at most 4 mL, and wherein the kit is provided with instructions for obtaining a fluid specimen, the instructions comprising the steps of: providing the specimen collection device comprising the test stick with the absorbent pad and the stick receptacle with the squeeze chamber and the outlet port at the distal end of the stick receptacle; collecting a fluid specimen by placing the test stick in contact with a fluid and absorbing a volume of fluid in the absorbent pad; and inserting and pressing the test stick into the squeeze chamber of the stick receptacle, such that the stick tip extends through the outlet port before squeezing a main portion of the absorbent pad in the squeeze chamber.

43. The kit according to claim 41, wherein the specimen tube is closable by a tube closure, the specimen tube comprising engagement means, in the form of screw threads or a snap-fit, at an outer surface of a tube head to engage a tube cap of the tube closure.

44. A method for collecting a fluid specimen in a specimen tube, wherein the method comprises the steps of: providing the specimen collection device according to claim 25, comprising the test stick with the absorbent pad and the stick receptacle with the squeeze chamber and the outlet port at the distal end of the stick receptacle; collecting a fluid specimen by placing the test stick in contact with a fluid and absorbing a volume of fluid in the absorbent pad; and inserting and pressing the test stick into the squeeze chamber of the stick receptacle, such that the stick tip extends through the outlet port before squeezing a main portion of the absorbent pad in the squeeze chamber.

45. The method according to claim 44, wherein the method is a urinalysis method.

46. The method according to claim 44, wherein the method comprises the step of removing the test stick out of the stick receptacle before collecting the fluid specimen.

Description

[0051] The invention will be explained in more detail with reference to the appended drawings. The drawings show a practical embodiment according to the invention, which may not be interpreted as limiting the scope of the invention. Specific features may also be considered apart from the shown embodiment and may be taken into account in a broader context as a delimiting feature, not only for the shown embodiment but as a common feature for all embodiments falling within the scope of the appended claims, in which:

[0052] FIG. 1 shows a perspective view two main components of the specimen collection device according to the invention in combination with a connectable specimen tube;

[0053] FIG. 2 shows in an enlarged view a specimen tube connected to a spout of a stick receptacle;

[0054] FIG. 3 shows the spout of the stick receptacle in an enlarged view; and

[0055] FIG. 4 shows an absorbent pad of a test stick and protruding stick tip in an enlarged view;

[0056] FIG. 5-9 show successive steps of a method of collecting a fluid specimen;

[0057] FIG. 10 shows a stick extension for lengthening a test stick.

[0058] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Generally, the nomenclature used herein and the manufacture or methods described below are well known and commonly employed in the art. Conventional methods are used for laboratory procedures, such as those provided in the art and various general references.

[0059] Terms of orientation such as “up” and “down”, “upper” or “lower” or “proximal” and “distal” and the like refer to orientation of the parts during use of the device. Where a term is provided in the singular, the inventors also contemplate the plural of that term. The nomenclature used herein and the laboratory methods described below are those well known and commonly employed in the art.

[0060] ‘Specimen’ or ‘sample’ may be used interchangeably. A sample is here considered to be the same as a specimen. ‘Sample’ or ‘specimen’ denotes any material to be assayed for the presence and/or concentration of an analyte in a sample or specimen, or to determine the presence and/or numbers of one or more components of a sample or specimen, or to make a qualitative assessment of a sample or specimen.

[0061] Viscous liquid, semi-solid, or solid specimens may be used to create liquid solutions, eluates, suspensions, or extracts that can be samples. For example, throat or genital swabs may be suspended in a liquid solution to prepare for a fluid specimen. Fluid specimens can include a combination of liquids, solids, gasses, or any combination thereof, as, for example a suspension of cells in a buffer or solution. Specimens can comprise biological materials, such as cells, microbes, organelles, and biochemical complexes.

[0062] A fluid specimen to be absorbed by the specimen collection device according to the present invention can be made from solid, semisolid or highly viscous materials, such as soils, fecal matter, tissues, organs, biological fluids or other samples that are not fluid in nature. For example, these solid or semi-solid samples can be mixed with an appropriate solution, such as a buffer, such as a diluent or extraction buffer. The sample can be macerated, frozen and thawed, or otherwise extracted to form a fluid sample. Residual particulates can be removed or reduced using conventional methods, such as filtration or centrifugation.

[0063] Examples of fluid specimens that may be collected by using a specimen collection device of the present invention include bodily fluids including blood, serum, plasma, saliva, urine, ocular fluid, semen, and spinal fluid; water samples, such as samples of water from oceans, seas, lakes, rivers, and the like, or samples from home, municipal, or industrial water sources, runoff water or sewage samples; and food specimens, such as milk or wine.

[0064] Identical reference signs are used in the drawings to indicate identical or functionally similar components.

[0065] FIG. 1 shows a perspective view of the specimen collection device 1 according to the invention. The device 1 comprises two main components respectively a test stick 10, a stick receptacle 20 which can be assembled in combination with a specimen tube 30.

[0066] As shown in FIG. 1, the specimen collection device 1 comprises a test stick 10. The test stick is arranged to be gripped by a user and to absorb the fluid specimen. The test stick comprises an elongated stick body 11. The stick body 11 has a proximal stick end 110 which is provided with a grip 12. The grip 12 is formed by a plate shaped portion which has a substantially circular shape, more in particular elliptical shape. The grip 12 has an upstanding outer circumference formed by a ridge 120. Herewith, the grip 12 is configured to be held by two fingers of a user. The user may stably held the test stick 10 by holding the finger grip 12 in between a thumb and an index finger.

[0067] The specimen tube 30 has a tube body 31. The tube body 31 has a tube head 32 which may be provided with a tube cap or other tube closure 33. The tube body 31 has a tube bottom 34. The tube bottom 34 may be flat or tapered for carrying out related test methods.

[0068] The device 1 is arranged for collecting a fluid specimen in the specimen tube 30. The fluid specimen is a volume of liquid. The volume of liquid is to be used in a testing or analysing method.

[0069] The illustrated specimen collection device 1 is in particular configured to carry out an urinalysis method in which a urine specimen is to be collected in a urine tube 30. Here, the depicted specimen tube 30 is a urine tube which is widely available for carrying out urinalyses methods. Typically, such a urine tube has a tube volume of at most 15 mL. The tube volume may be indicated by a scale 35 at an outer side of the tube body 31. Preferably, the specimen collection device 1 is configured for a single collecting step to obtain a fluid specimen with a volume of at most 4 mL in one step in which the specimen collection device is used in combination with a 4 mL specimen tube.

[0070] As shown in FIG. 2, the urine tube 30 is connectable to a distal end 23 of the stick receptacle 20. After filling the urine tube, the urine tube is removed from the stick receptacle. The stick receptacle 20 and the test 10 are disposed. The urine tube 30 is closed and ready to be transferred to a test apparatus for analysing the fluid specimen.

[0071] As indicated above, the specimen collection device 1 according to the invention is not limited to urinalysis methods. All kind of fluid specimens may be collected by the specimen collection device 1, like blood, beverage samples, water samples etc. for corresponding sample analyses, like blood tests, beverage or water quality tests.

[0072] As further shown in FIG. 4, the stick body 11 has a distal stick end 111 with a stick tip 13. An absorbent pad 15 is positioned at the distal stick end 111. The absorbent pad 15 contains a liquid absorbing material. Here, the absorbent pad 15 is made of a urine sponge which is configured to absorb a volume of urine when the absorbent pad 15 is held in a stream of urine. Here, the absorbent pad 15 has a cylindrical shape with an absorbent pad length 150. The absorbent pad has a first pad end face 151 and a second pad end face 152. A pad channel 153 extends from the first pad end face 151 to the second pad end face 152. The absorbent pad 15 circumvents the distal stick end 111. The absorbent pad 15 is configured to absorb a volume of liquid of at least 0.5 mL, in particular 2 mL, more in particular at least 4 mL. Advantageously, the absorbent pad 15 has a sufficient absorbent capacity to fill a specimen tube in one step in which the test stick 10 is only held once in contact with a liquid to absorb a required quantity of liquid.

[0073] After absorbing a fluid specimen, the test stick 10 is to be received in the stick receptacle 20. Here, the stick receptacle 20 has an elongated tubular shape. The stick receptacle 20 has a tubular body 21. The stick receptacle 20 is a hollow sleeve. The stick receptacle 20 has an interior squeeze chamber 210. The squeeze chamber 210 is configured to compress the absorbent pad 15. During compression, the absorbent pad 15 slides along the stick body 11. When compressing the absorbent pad 15 in the squeeze chamber 210, the fluid specimen is extracted under pressure.

[0074] As shown in FIGS. 1 and 2, the stick receptacle 20 is open at a proximal end for inserting the stick tip 13 into the squeeze chamber 210. The squeeze chamber 210 has a chamber end face 211 at a distal end of the stick receptacle 20 for compressing the absorbent pad 15. The fluid specimen is released from the absorbent pad 15 when the absorbent pad 15 is pressed against chamber end face 211.

[0075] Here, the chamber end face 211 is tapered. The tubular body 21 has a tapered bottom region. The interior squeeze chamber 210 is provided with at least one squeeze rib 212. Preferably, a plurality of squeeze ribs 212 is provided in the squeeze chamber 210. Each squeeze rib 212 extends in a length direction of the stick receptacle 20. The squeeze rib contributes to an optimal squeezing of the absorbent pad 15 when received in the squeeze chamber 210. To further optimise the squeezing of the absorbent pad 15, the stick body 11 is provided with a pressure member 16. The pressure member 16 is disc-shaped. Here, the pressure disc is integral with the stick body 11. The stick body 11 is made by injection moulding in which the grip 12, the pressure member 16 and the tip head 14 are integral parts.

[0076] An outlet port 24 is positioned in the chamber end face 211. The outlet port 24 is shown in an enlarged view in FIG. 3. The outlet port 24 is positioned at the distal end of the stick receptacle for discharging the fluid specimen. Here, the outlet port 24 has a non-circular shape, in particular a star-shape. The outlet port 24 comprises at least one dent 240 positioned at the circumference. The non-circular shape is beneficial in that it prevents an obstruction of a liquid flow when the tip head 14 passes through the outlet port 24. Further, the at least one dent 240 contributes to an alignment of the stick tip 13 during operation.

[0077] The squeeze chamber 210 and a connected specimen tube 30 is shown in FIG. 2. The specimen tube 30 is detachably connected to a spout 25 of the stick receptacle 20. The specimen tube 30 is connectable to the stick receptacle 20 by placing the specimen tube head 32 over the spout 25. The spout 25 is insertable into the specimen tube head 32. The spout 25 has a spout outer surface 250 which is configured in correspondence with an inner surface diameter 320 of a specimen tube head 32. A placement of the specimen tube 30 overlying the spout 25 is beneficial for using common tubes for test apparatuses, because this placement does not affect a closure of the specimen tube by a tube cap or seal at an outer side of the specimen tube.

[0078] As shown in an enlarged view in FIG. 4, the stick tip 13 protrudes the absorbent pad 15. The stick tip 13 extends beyond the absorbent pad 15. The absorbent pad 15 is positioned behind the stick tip 13. The positioning of the stick tip 13 close to an end face of the absorbent pad, preferably outside the absorbent pad 15 is functional which will be explained in further detail hereafter. In short wordings, in operation, after absorbing a fluid specimen and inserting the test stick 10 into an inner space of the stick receptacle 20, the stick tip 13 at a front, will first reach a bottom region of the inner space in the stick receptacle before substantially squeezing the absorbent pad 15 in the inner space. This is beneficial to obtain a proper operation of the specimen collection device 1.

[0079] The stick tip 13 has a converting tip head 14 which is here pointed. The tip head 14 may be tapered or conical and may have a shape of a mushroom. The mushroom -shaped tip head 14 has an outer diameter which is larger than a diameter of the stick body 11.

[0080] FIG. 5-9 show in successive drawings several steps of a method of collecting a fluid specimen and filling a specimen tube.

[0081] FIG. 5 shows the specimen collection device formed by an assembly of a test stick 10 positioned inside a stick receptacle 20 which is connected to a specimen tube 30. After connecting the specimen tube 30 to the spout 25 of the stick receptacle 20, the assembly is ready for use.

[0082] FIG. 6 shows a collection of a fluid specimen. The test stick 10 is held by the user at a proximal stick end 110. The absorbent pad 15 is positioned at the distal stick end 111 and exposed to a fluid to obtain the fluid specimen. Here, the fluid is a stream of urine. The absorbent pad 15 is configured to absorb a volume of the stream of urine.

[0083] FIG. 7 shows a successive step in which the test stick 10 is inserted into the stick receptacle 20. The test stick 10 is pressed to a bottom region of the stick receptacle and fluid is squeezed out of the absorbent pad. The released fluid is discharged under gravity from the stick receptacle 20 to the specimen tube 30.

[0084] FIG. 8 shows a removal of the specimen tube 30 from the assembly of the test stick 10 and the stick receptacle 20. The assembly can be disposed in a garbage bin and the specimen tube 30 can be closed by a screw cap or snap-cap as shown in FIG. 9 to preserve the specimen tube for further steps of and analyses method;

[0085] FIG. 10 shows a stick extension 121 for lengthening a stick body 11 of a test stick 10. The stick extension 121 may be connectable in several manners. Here, as shown, the grip 12 of the stick body 11 has a grip snap member 122 which is here formed by an aperture 123 in a central region. The grip snap member 122 is configured to snap a distal end of the stick extension 121 to the grip 12 of the stick body 11. The aperture 123 has a non-circular shape, such that a rotational freedom of movement is blocked. The stick extension 121 has a complementary shaped snap member 124 at a distal end. The snap member 124 will change in the has at least one snap finger 125 to snap the stick extension 121 to the grip 12 of the stick body 11. The stick extension 121 has a grip which is equally shaped to the grip 12 of the test stick 10. The stick extension 121 is in particular beneficial in use of the specimen collection device as a veterinary specimen collection device for collecting a urine sample of an animal.

[0086] Although the present invention has been described in detail, it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the scope of the invention as hereinafter claimed. It is intended that all such changes and modifications be encompassed within the scope of the present disclosure and claims.

[0087] Thus, the invention provides a specimen collection device comprising a test stick with an absorbent pad and a stick receptacle with a squeeze chamber and an outlet port at a distal end of the stick receptacle. The test stick has a stick body which extends through a pad channel, such that a stick tip of the stick body extends through the outlet port when squeezing the absorbent pad against a chamfer end face of the squeeze chamber. The absorbent pad 15 does not pass through the outlet port 24 but remains in the squeeze chamber 210. Only the stick tip passes through the outlet port. Advantageously, the test stick remains aligned inside the stick receptacle during squeezing which contributes to a proper release of fluid from the absorbent pad to obtain the fluid specimen in a specimen tube.

TABLE-US-00001 Reference list 1 specimen collection device 14 tip head 10 test stick 15 absorbent pad 11 stick body 150 absorbent pad length 110 proximal stick end 151 first pad end face 111 distal stick end 152 second pad end face 12 grip 153 pad channel 120 ridge 16 pressure disc 121 stick extension 20 stick receptacle 122 grip snap member 21 tubular body 123 aperture 210 squeeze chamber 124 stick extension grip 211 chamber end face 124 snap member 212 squeeze rib 125 snap finger 22 proximal end 24 outlet port 23 distal end 13 stick tip 240 outlet port dent 25 spout 320 tube head inner surface 250 spout outer surface 33 tube cap; tube closure 34 tube bottom 35 scale 30 specimen tube 36 tube label 31 tube body 32 tube head