TISSUE SAMPLING CARTRIDGE

Abstract

The present invention relates to a sampling cartridge comprising a sampling cartridge body. The sampling cartridge body includes a storage container holding region, at where a storage container is or is able to be located. It also includes a sample collector holding region at where a sample collector is or is able to be located. In use, the body holds the sample collector and storage container in alignment with each other in a pre-sampling condition spaced apart with a sufficient gap to allow part of an item to be sampled to locate at the gap.

Claims

1. A sampling cartridge, adapted and configured to be loadable to and unloadable from a sampler device that comprises a driver and a sampling cartridge receptacle region for receipt of the sampling cartridge, the sampling cartridge comprising a sampling cartridge body that comprises: a. a storage container holding region at where a removable storage container is located; b. a sample collector holding region at where a removable sample collector is located; and c. a bridge section extending between the storage container holding region and the sample collector holding region and that in use holds the sample collector and the storage container in alignment with each other in a pre-sampling condition spaced apart with a sufficient gap to allow part of a tissue to be sampled to locate at the gap, the bridge section spanning the gap, wherein the sample collector holding region includes a bore in which the sample collector is located when in the pre-sampling condition, wherein the sampling cartridge is adapted and configured, such that, when the sampling cartridge is loaded to the sampler device and received by the receptacle region, the sample collector of the sampling cartridge is aligned with the driver of the sampler device to allow the sample collector to be moved by the driver from the sample collector holding region across the gap and into the aligned sample storage container, and wherein at least the bridge section of the sampling cartridge body is adapted and configured to conform with the receptacle region of the sampler device such that, when the sampling cartridge is loaded to the sampler device and is received by the receptacle region, at least the bridge section of the sampling cartridge body shields at least the receptacle region of the sampler device from contact with the tissue to be sampled when the tissue is placed at the gap, together with any exudates expressed or expelled from the tissue during sampling.

2. A sampling cartridge as claimed in claim 1 wherein the gap is substantially U-shaped.

3. A sampling cartridge as claimed in claim 1 wherein the storage container holding region and said sample collector holding region are next to respective opposed sides of said gap.

4. A sampling cartridge as claimed in claim 1 wherein said storage container holding region comprises a cavity of said sampling cartridge body in which at least part of said storage container is located.

5. A sampling cartridge as claimed in claim 4 wherein a passage leads from said cavity to said gap and via which the sample collector can move to engage with said storage container.

6. A sampling cartridge as claimed in claim 5 wherein the passage is blocked by a removable seal.

7. A sampling cartridge as claimed in claim 5 wherein the passage includes a mouth opening presented at said gap at where said sample collector enters the passage, upon the taking of a sample from the tissue to be sampled placed at the gap, to advance for engagement via an opening of the storage container and into the storage container.

8. A sampling cartridge as claimed in claim 7 wherein the material about said mouth is harder than said material of the storage container about its said opening.

9. A sampling cartridge as claimed in claim 7 wherein at said mouth opening said sampling cartridge body together with said sample collector act as a punch and die set, the mouth opening acting as the die acting in shear with the sample collector acting as said punch to facility the removal of the sample from the tissue to be sampled.

10. A sampling cartridge as claimed in claim 9 wherein said mouth opening is of a shape and configuration to allow said sample collector to enter into said passage in a snug fit manner.

11. A sampling cartridge as claimed in claim 1 wherein said storage container holding region comprises a cavity closed by a removable closure, and wherein at least one of the components selected from the following list: a. the removable closure, b. the storage container, c. the sample collector, d. the sampling cartridge body, comprises at least one form of visible and/or machine readable identification.

12. A method of taking and storing a sample from tissue using a sampling cartridge adapted and configured to be loadable to and unloadable from a sampler device that comprises a driver and a sampling cartridge receptacle region for receipt of the sampling cartridge, the sampling cartridge comprising a sampling cartridge body that comprises: a. a storage container holding region at where a removable storage container is located; b. a sample collector holding region at where a removable sample collector is located; and c. a bridge section extending between the storage container holding region and the sample collector holding region and that in use holds the sample collector and the storage container in alignment with each other in a pre-sampling condition spaced apart with a sufficient gap to allow part of a tissue to be sampled to locate at the gap, the bridge section spanning the gap, wherein the sample collector holding region includes a bore in which the sample collector is located when in the pre-sampling condition, wherein the sampling cartridge is adapted and configured such that, when the sampling cartridge is loaded to the sampler device and received by the receptacle region, the sample collector of the sampling cartridge is aligned with the driver of the sampler device to allow the sample collector to be moved by the driver from sample collector holding region across the gap and into the sample storage container, and wherein at least the bridge section of the sampling cartridge body is adapted and configured to conform with the receptacle region of the sampler device such that, when said sampling cartridge is loaded to said sampler device and is received by said receptacle region, at least the bridge section of the sampling cartridge body shields at least the receptacle region of the sampler device from contact with the tissue to be sampled when said tissue is placed at the gap, together with any exudates expressed or expelled from the tissue during sampling, the method comprising: i. loading the sampling cartridge to the sampler device so that the sample collector and the storage container are in alignment with the driver of said sampler device, the driver to act, directly or indirectly on said sample collector, ii. placing a part of the tissue to be sampled in said gap so that part of the tissue is also in alignment, iii. causing the driver to move in a driving direction to drive said sample collector from the sample collector holding region, across the gap and towards said storage container so that said sample collector is driven into the storage container so that said punch becomes held by said storage container, and iv. causing the driver to move in a direction opposite said driving direction.

13. The method as claimed in claim 12 wherein an identification carried by or of the tissue from which the sample is taken is recorded at the time of taking of the sample.

14. The method as claimed in claim 13 wherein the identification carried by or of the tissue from which the sample is taken is matched to an identification of said sampling cartridge.

15. A tissue sampling set comprising: i) a plurality of sampling cartridges including the sampling cartridge of claim 1, and ii) a sampling device comprising a driver and a sampling cartridge receptacle region for receipt of at least one of the plurality of sampling cartridges, each sampling cartridge of the plurality of sampling cartridges individually and successively loadable with the sampling device to align the driver with the sample collector and to allow the sample collector to be moved by the driver from sample collector holding region across the gap and into the aligned sample storage container to allow each of the plurality of sampling cartridges to collect one sample from an item to be sampled.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0085] A preferred form of the invention will now be described with reference to the accompanying drawings in which:

[0086] FIG. 1 is a perspective view of a sampler device and sampling cartridge associated therewith,

[0087] FIG. 2 is an alternative perspective view of a sampler device and sampling cartridge associated therewith,

[0088] FIG. 3 is a view of the sampling device and sampling cartridge in a pre- or post-engaged condition showing the removable nature of the sampling cartridge,

[0089] FIG. 4 is a perspective view of FIG. 3,

[0090] FIG. 5 is a perspective view of the sampling cartridge,

[0091] FIG. 6 is a perspective and partial sectional view of the sampling cartridge,

[0092] FIG. 7 is an exploded view of the sampling cartridge,

[0093] FIG. 8 is a sectional view of the sampling cartridge in a preloaded and ready for use condition,

[0094] FIG. 9 is a sectional view of the sampling cartridge in a condition where the sample collector has advanced from its stored condition towards its sample storage container registered condition, and immediately prior to penetrating an item to be sampled,

[0095] FIG. 10 is a sectional view of the sampling cartridge where the sample collector has moved from its storage condition and to its sample storage container registered condition,

[0096] FIG. 11 illustrates the sampling cartridge engaged with the sampling device and parts of the internal mechanism of the sampling device wherein the sampling cartridge is in its pre-use condition,

[0097] FIG. 12 shows the mechanism of the sampling device with its driver having driven the sample collector towards and into the storage container.

DETAILED DESCRIPTION OF THE INVENTION

[0098] With reference to FIG. 1, there is shown a sampling device (1) and a sampling cartridge (2). The sampling device includes a body (3) that includes a handle region (4) including a trigger (5). The trigger can be manipulated by a user to cause a sample to be taken and which will hereinafter be described in more detail. The sampling device (1) includes a sampling cartridge receptacle region (6) as can be seen in FIGS. 3 and 4.

[0099] The receptacle region is able to receive the sampling cartridge in a removable manner. Once received at the receptacle region, the cartridge is securely held by the sampling device. The sampling device can receive multiple cartridges in succession. The receptacle is adapted and configured together with the sampling cartridge (2), to allow the sampling cartridge to register with the body (3) of the sampling device (1) in a manner to present the sampling components of the sampling cartridge in an appropriate location relative to the driver (7) of the sampling device (1). In the preferred form, the receptacle region (6) and the sampling cartridge (2) are shaped and configured so that a snap-fit or close tolerance or interference fit relationship can be established between the body (3) and the sampling cartridge (2) when the sampling cartridge is full registered at the receptacle region (6) of the body (3). Such a relationship will ensure that the sampling cartridge is sufficiently securely engaged to the body (3) yet removeable therefrom upon a pulling or prying force being applied such as by a users hand or fingers. This may be important because once loaded with the sampling device (1), the cartridge should remain engaged therewith until a sample has been taken whereafter the sampling cartridge can then be removed by the user from the body (3). The sampling cartridge loaded sampling device (1) may be dropped or placed on a surface or hung from a peg or otherwise manoeuvred, prior to a sampling being taken, and it is therefore important for the sampling cartridge to remain securely engaged with the sampling device when so loaded to the sampling device. It is envisaged that a tool may also be used to remove the cartridge.

[0100] The sampling cartridge (2) preferably comprises of a sampling cartridge body (8) that in a pre-use condition holds a sample collector (9) and a storage container (10) in a space apart condition to define a gap (11) there between. At the gap (11), as can be seen in FIG. 9, an item to be sampled (12) can be placed. The item to be sampled (12) may, for example, be part of an ear of an animal. The gap (11) is sufficiently wide in the direction WW to accommodate such an item as part of an ear of an animal. It is preferably also sufficiently deep in direction DD so that, for example, the ear of an animal can be located in the gap (11) and be aligned to the direction LL of the sampling components that will hereinafter be described, of the sampling cartridge (2). The gap is preferably U-shaped.

[0101] The sampling components of the sampling cartridge primarily include the sample collector (9) and the storage container (10). The sampling container body (8) preferably holds these two components in alignment with each other in the pre sampling condition. In the preferred form, the sample collector is of an elongated form and as such the sampling collector body preferably includes a bore in which the sample collector is located when in the pre sampling condition. Preferably the sample collector (9) is completely located within the bore (13) of the sample collector body (8). This can be seen in FIG. 8. It is less desirable for part of the sample collector to be protruding from the bore because of the prospect then of pre sampling contamination of the sample collector (9). The bore at a gap end (14) may be sealed by way of a plug or a foil or the like to enclose the sample collector within the bore. At the opposed end (15) to the bore (13), a seal may also be provided. In the preferred form, a snug-fit relationship exists between the body of the sampling cartridge at the bore (13) and the sample collector (9) so that the bore can guide the movement of the sampling cartridge as it moves from its pre-use condition as shown in FIG. 8 to its sample storage container registered condition as shown in FIG. 10. Preferably the shape and configuration of the sampling cartridge body and the storage container and sample collector is such that the sample collector (9) is guided by the bore (13) and/or by the storage container during its movement from its pre-use stored condition to its sample storage container registered condition.

[0102] At the other side of the gap (11) to where the sample collector (9) is located in the pre sampling and stored condition, is a storage container (10). The storage container (10) is removably engaged to the sampling cartridge body (8). The storage container (10) preferably includes a storage tube (20) and a removable cap (21) that is removably engaged to the storage tube (20). In the preferred form the removable cap (21) is threadingly engaged to the storage tube (20). However, in alternative forms the storage container (10) may be provided as a unitary body where no separate storage tube and cap are provided. The storage tube (20) preferably includes a containment region (22) at where ultimately a sample that has been collected by the sample collector is placed during the sampling process. The containment region (22) may include an additive such as a desiccant or the like (not shown). The containment region (22) is bounded by a tube side wall (23) and the end wall (24) at the mouth opening (25) of the storage tube (20) is where the cap (21) is located. As can be seen such location is by way of a threaded engagement (26). The storage container, preferably defined by the cap (21) when provided, includes an opening (27) via which the sample collector (9) can enter the storage container (10).

[0103] The opening (27) is sufficiently large to receive the sample collector (9). The opening (27) leads to a passage (28) of the cap (21). The passage (28) leads to the containment region (22). The passage may be occluded, in the pre sampling condition by a frangible web (29) that extends across the passage (28). The frangible web (29) is preferably of a construction that will allow for the sample collector (9) to sever it at least partially from the cap (21) and thereby open the containment region (22) and allow for at least part of the sample collector to enter into the containment region (22) or at least allow for the sample collected by the sample collector to be dispensed into the containment region (22). The frangible web (29), in the pre sampling condition helps ensure that no contaminants can enter into the containment region (22). In addition, or alternatively, a plug, or seal or foil may be placed at the opening (27) of the storage container. Alternatively, and in the configuration as shown where the storage container (10) is held by the sample collected body (8), the sample collected body may include an opening (30) that leads to the storage container (10). The opening (30) may be sealed in the pre sampling condition of the sampling cartridge (2) such as by way of a plug or foil seal, to prevent contaminants from reaching the opening (27) of the storage container (10). As can be seen in FIG. 8 for example, the storage container (10) is preferably also of an elongate form in direction LL. In the preferred form, the sampling cartridge body (8) also includes a bore (31) in which at least part of the storage container (10) can be located and preferably snugly supported thereby. The bore (31) is preferably of a size so that it can rigidly and snugly hold, yet allow for removal, of the storage container (10) from the sampling cartridge body (8).

[0104] In the preferred form, the bore is capped by a cap (32) that can secure on to the sampling cartridge body (8). The cap (32) preferably encloses the storage container (10) within the sampling cartridge body (8). The cap (32) is removable from the sampling cartridge body (8) and preferably is threadingly engaged therewith. A tamper evident ring (33) is preferably provided so that an indication of the removal of the cap (32) from the sampling cartridge body can be indicated. The tamper evident ring (33) may be part of the cap (32) or part of the sampling container body (8). Alternatively, it may be a foil seal that is located over the interface between the cap (32) and the sampling container body (8).

[0105] Once the cap (32) has been removed from the sampling cartridge body, the storage container can be drawn out from the bore (31) to then remove the storage container from the sampling cartridge body. This will typically happen when sampling has occurred, the sample carrying sample collector (9) having been driven into the storage container (10) and retained thereby with the sample in the containment region (22). Such removal may occur, for example, at a laboratory. This means, for example, once a sample has been collected from an animal (eg from the ear of an animal) by a farmer, the entire sampling cartridge still retaining the storage container and sample holding sample collector may then be shipped to a laboratory as a single unit. At the laboratory, the cap (32) may be removed to gain access to the sample holding storage container and this may then be opened to gain access to the sample for analysis.

[0106] The sampling cartridge body (8) includes a trough region (35) that bridges the gap (11). The trough region (35) connects the storage container holding region (36) and the sample collector holding region (37) together. A bridge section extends across the trough region to connect the storage container holding region (36) and the sample collector holding region (37) together. The trough region (35) also provides a secondary purpose. During the process of sampling, hair and/or blood from the animal may shed from the animal and/or the sample collected from the animal. The trough region (35) provides shielding to the body (3) of the sampling device from such contaminants. This will help keep the body (3) of the sampling device clean or cleaner than it would otherwise be.

[0107] Preferred forms of the sample collector (9) and the storage container (10) will now be described.

[0108] In a preferred form, the sample collector (9) comprises of a punch (38) that at one end presents a cutter (39). The cutter may, for example, be of a cylindrical configuration and have a leading edge that is sharp for the purposes of penetrating into the tissue of an animal. The cutter (39) may include a bore (40) at where a sample can be retained upon the penetration of the cutter into the item from which the sample is to be removed. The bore (40) can retain the so removed sample with the punch (38). The punch (38) is preferably of an elongate configuration and is preferably of a cylindrical perimeter. In the preferred form, the punch may carry a plunger (41). The plunger (41) is preferably held in a bore (42) of the punch (38). The plunger can be caused to move within this bore.

[0109] In the preferred form, in the pre sampling condition the plunger is in a retracted condition as seen in FIG. 8. In this retracted condition, the plunger and the cutter define the bore (40). The bore (40) is hence a blind bore. In an extended condition as seen in FIG. 10, the plunger has moved relative to the punch and into the bore (40). This has caused the sample (43) to be ejected from the bore (40) and into the containment region (22). In the sample storage container registered condition as seen in FIG. 10, the punch has also severed the frangible web (29) to open the containment region (22) to the sample (43). In the preferred form, the plunger (41) carries an ID such as an EID (44) that may, for example, be an RFID. This RFID carries a unique identifier that is machine readable and remains associated with the plunger (41), and hence the punch (38) of the sample collector (9).

[0110] In the preferred form, the plunger (41) and the punch (38) cannot be separated.

[0111] As can be seen in FIG. 38, a cross-contamination sleeve/rod (45) may be provided in a removable association with the sample collector (9). The cross-contamination sleeve/rod provides an intermediary between the driver (7) of the sampling device (1) and the sample collector (9). The driver (7) may penetrate into the bore (46) of the cross-contamination sleeve/rod (45) in a manner to isolate it from contact with the item to be sampled. This hence provides a further measure against cross-contamination that might otherwise arise from contaminants touching the driver (7) of the sampling device (1). In the preferred form, the cross-contamination sleeve/rod (45) is engaged with the punch (38) at the driving end (47) of the punch so that it can drive the sample collector from its pre-use stored condition as seen in FIG. 8 to its sample storage container registered condition as seen in FIG. 10. The cross-contamination sleeve/rod may be removably engaged by way of a snapfit or interference fit configuration (48) that can registered at the driving end (47) of the punch (38). It can be released upon the retraction of the driver (7) and be carried back with the driver after the sample has been taken and the sample collector is in the storage container, as can for example be seen in FIG. 10. Alternatively, the cross-contamination sleeve/rod (45) may be ejected from the sampling cartridge (2) after sampling.

[0112] The driver (7) is preferably held relative to the body (3) in a manner to be actuable by the trigger (5) to cause it to move in a reciprocating manner between a retracted condition as seen in FIG. 11, and an extended condition as seen in FIG. 12. A rack and pinion-like arrangement (49) may be provided to facilitate the movement of the driver. A quick-release feature may be provided so that once the driver has been moved to its fully extended position a spring or other device may quickly retract the driver from its extended position back its retracted condition.

[0113] When a sample is being taken, the sample collector (9) may drive and/or press the item to be sampled (12) towards the storage container holding region of the sampling cartridge (2). As can be seen in FIG. 9, the item to be sampled (12) is pressed against a die surface (50) of the storage container holding region (36) of the sampling cartridge body (8). The die surface (50) acts as a stop for the item to be sampled (12) as the sample collector is driven towards its sample storage container registered condition. The die surface (50) together with the cutter (39) act as a punch and die set to facilitate the removal of a sample from the item to be sampled (12). Hence in the preferred form, the opening (30) is sufficiently sized to allow for it to receive the cutter, and preferably the entire sample collector (9), yet act in a sheer fashion with the cutter (39) for the purposes of removing the sample. Hence the sizing of the opening (30) is sufficiently snug about the cutter to facilitate this sheering-like removal of the sample from the item to be sampled.

[0114] Upon a driving of the sample collector into the cap (21) of the storage container (10), the punch preferably locates very snugly within the passage (28) to thereby provide a seal to the passage (28). An interference fit ring (51) and groove (52) configuration may be provided by the punch (38) and cap (21) respectively, to facilitate such sealing. The ring and groove configuration will also help with retention of the sample collector with the storage container after the sample collector has been moved to its sample storage container registered condition, as can be seen in FIG. 10.

[0115] To facilitate such snug/interference fit between the sample collector and the storage container, the material selection of one or both of the sample collector and the storage container (preferably the punch and the cap) needs to be such as to allow for such a snap-fit type relationship to be established. Therefore, preferably one or both of the punch and cap are of a relatively soft and preferably plastic material, to allow for a certain degree of deformation of features of one or both of these items to occur. Hence in the preferred form, the cap (21) is preferably of a plastics material and shape and configuration that can to some extent deform on its own, or preferably together with features of the sample collector to establish a snug, and preferably sealed relationship between the cap and the sample collector at the passage (28). In the preferred form, to ensure an efficient punch and die set-like relationship is established between the cutter (39) and the die surface (50), the die surface (50) is defined by a material which is rigid and preferably will not deform. In the preferred form, the die surface is part of the storage container body. Preferably, the die surface is of a material that is harder than that of the cap (21) of the storage container (10). Hence the present invention allows for an efficient punch and die set-like features to be provided for the purposes of taking the sample, without such being compromised by needing to use a material that may be softer of the cap of the storage container (10). Hence in the preferred form, the storage container cap is of a softer plastics material than the material used at the die surface (50) (preferably the material used for the storage container body). It will be appreciate that a separate insert may be provided to the storage container body to act as the die surface. A co-moulding of different plastics materials may be possible, or an insert of, for example, a metal insert may be provided for the purposes of providing the die surface (50).

[0116] One or both of the sampling cartridge body (8) and tube (20) may include a unique identifier. For example, a barcode or number or alphanumeric string may be provided on a surface of the sampling cartridge body. Alternatively, or additionally, an EID component may be provided on the sampling cartridge body. In addition, a unique barcode or other visual identifier or an EID may also be provided on the tube (20). This may for example be provided at the end wall (24) of the storage tube (20). Any one or more, and preferably all of the identifiers mentioned herein (EID/barcode or other) are preferably matched such a pre-matched to each other. It may be of the same identification or different identification that are matched with each other. The sample collector ma also include such identifier. Preferably the identifiers relate to each other. They may be identical identifiers or via a database or other related to each other.

[0117] Upon the taking of a sample from an animal, a reading of an identifier of the animal (such as an RFID or visual ID of an ear tag of the animal) may be matched to the identifiers of the sampling cartridge (2) and/or tube and/or sample collector. This allows for a matching between the animal identification and the sample to be established.

[0118] In a laboratory, such matching can then verify whether the sample in the storage container is a valid sample that matches that of the animal from which the sample has been taken. The reading of the animal's identification may occur before, during or after the sample being taken from the animal.

[0119] In the preferred form, the cap (32) is of a transparent material. This allows for a visual inspection to occur to ensure that a sample is within the storage tube. Hence preferably the storage tube is also at least partially transparent.