Workstation for human biopsy sample acquisition and analysis

Abstract

An organizing workstation is provided for organizing one or more biological sample receiving vessels and one or more analyzers for the biological sample. The organizing workstation has a platform that defines one or more first slots for receiving one of the biological sample receiving vessels. The workstation also has one or more second slots that are substantially perpendicular to the first slots. The second slot is aligned with the first slot for receiving one of the one or more analyzers.

Description

WORKSTATION FOR HUMAN BIOPSY SAMPLE ACQUISITION AND ANALYSISField of the Invention

[0001] The invention relates to human biopsy sample acquisition, in which a biopsy tissue specimen or aspirate is removed from the subject and transferred to a receiving device for subsequent cellular and molecular analysis.Background

[0002] There is a need for a workstation that can be implemented generally in biological laboratories and clinical settings where samples are processed or transferred for immediate testing, such as point of care testing. This is relevant for clinical or testing environments in which bench space is at a premium.Summary of the Invention

[0003] The invention is a workstation for organizing one or more biological sample receiving vessels and one or more analyzers for the biological sample. The workstation includes a platform that defines one or more first slots for receiving one or more receiving vessels that receive a quantity of the biological sample. The workstation preferably also has one or more second slots for receiving an analyzer for analyzing the biological sample. Each of the first slots is preferably in alignment with a corresponding one of the second slots to facilitate the use of the analyzer in analyzing the biological sample in the corresponding receiving vessel.

[0004] The workstation can be used for Fine Needle Aspiration biopsies across multiple anatomical sites, including organs, nodules and lymph nodes.

[0005] Each receiving vessel to which a biological specimen is added is sterile, preferably with a removal cap that a technician can remove prior to use.

[0006] The receiving vessel is designed to receive specimen expelled or delivered by a needle.

[0007] The specimen type includes biological materials in homogeneous or heterogeneousform: liquid, whole blood, plasma, cellular material, cerebral spinal fluid, tears, lymph fluid, biopsy tissue aspirate.

[0008] The receiving vessel may contain a fluid for receiving, stabilizing or treating the specimen. Preferably, the fluid is a buffer solution which may serve to:

[0009] stabilize the specimen;

[0010] extract components from the specimen, for example proteins or chemicals components from a heterogenous sample;

[0011] lyse cellular materials to release the interior cellular components of the specimen; and / or

[0012] otherwise prepare the sample for subsequent analysis.

[0013] In certain embodiments, the receiving vessel may serve to transfer the specimen or sample, directing it into an analyzer which may be a testing vessel, for example a point of care cartridge. The receiving vessel preferably has a seal to ensure a positive internal pressure when the receiving vessel is squeezed. This internal pressure allows the sample or specimen to be expelled with high operator control. One or more droplets can be delivered from the receiving vessel with controlled operator squeezing.

[0014] The seal can be created by a snap cap closure, or a threaded screw cap. In another embodiment, the receiving vessel has a removable closure component which can be twisted off to create a dropper function.

[0015] If more than one receiving vessel is used, the first slots for receiving the receiving vessels can be labeled with the numbers sequentially increasing from the number 1.

[0016] The spacing of the first slots is defined to create sufficient space to handle the receiving vessels and to maximize space efficiency.

[0017] The first slots into which the receiving vessels are placed can be internally slotted to ensure a preferred and consistent fit of corresponding to the dimensions of receiving vessels. The internally slotted nature of the first slots minimizes rotational and vertical movement of the receiving vessel to allow an operator to close caps with one hand.

[0018] In another embodiment, the platform of the workstation defines a bin, to the left or to the right, or on both sides, of the first slots in the platform. The bin, or bins, may serve as an organizing space, and / or a disposal bin for the materials used in the clinical workflow.

[0019] The analyzers in the form of point of care testing cartridges can be held, or temporarily affixed, in close proximity of the receiving device. The holding function is achieved with the one or more second slots which may be in the form of cartridge docking receptacles that permit a friction fit of the cartridge into the workstation device. The holding function can also be achieved with a magnetic strip embedded in the workstation platform and with a magnetic metal in the tip of the cartridge.

[0020] The workstation platform preferably has a plurality of cartridge docking receptacles referred to herein as second slots in registration with a plurality of receiving vessel holders referred to herein as the first slots.

[0021] In an embodiment, the workstation platform can be packaged with the intended receiving vessels (one, or more) to be customized to a specific clinical use model. For example, for lung biopsy specimen testing, up to nine receiving vessels may preferably be used for one patient.

[0022] The workstation platform can be stackable to ensure efficient packaging and storage volumes.

[0023] In another embodiment, the workstation platform can be fitted to a base which has sufficient weight and friction with surface to stabilize the workstation platform on a work surface (laboratory bench top, table, etc.).

[0024] In another embodiment, the base can accommodate both a workstation platform and an analyzer, for example in the form of a small point of care reader functioning as the analyzer. This arrangement brings the key components of a sample testing workstation system in an organized close proximity to each other.

[0025] In yet another embodiment, the base can provide a power source to the point of care test instrument, minimizing the use of power cords in the clinical or testing environment.

[0026] According to one aspect of the invention there is provided organizing workstation for organizing one or more biological sample receiving vessels and one or more analyzers for thebiological sample. The organizing workstation comprises a platform defining at least one first slot for receiving one of said one or more biological sample receiving vessels; and at least one second slot being substantially perpendicular to the first slot, the second slot being aligned with said first slot for receiving one of said one or more analyzers.Brief Description of the Drawings

[0027] FIG. 1 is a perspective view of a workstation platform in cooperation with a point of care cartridge and receiving vessels;

[0028] FIG. 2 is a perspective view of an alternate embodiment of the workstation platform;

[0029] FIG. 3 is a cross-sectional view taken along the line 2-2 of figure 2;

[0030] FIG. 4 is a perspective view of a second alternate embodiment of the workstation platform;

[0031] FIG. 5 is a cross-sectional view taken along the line 4-4 of figure 4;

[0032] FIG. 6 is a second perspective view of the workstation platform;

[0033] FIG. 7 is a cross-sectional view taken along the line 1-1 of figure 1 ;

[0034] FIG. 8 is a perspective view of a receiving vessel with a cap in an open position;

[0035] FIG. 9 is a cross-sectional view taken along the line 8-8 of figure 8;

[0036] FIG. 10 is a perspective view of the receiving vessel with a cap in a closed position;

[0037] FIG 11 is a perspective view of an alternate embodiment of a receiving vessel with a cap in an open position

[0038] FIG. 12 is a perspective view of a base;

[0039] FIG 13 is a perspective view of a workstation platform in cooperation with a point of care cartridge, a receiving vessel and a reader received in an alternate embodiment of the base; and

[0040] FIG 14 is a perspective view of a workstation platform in cooperation with a point of care cartridge, a receiving vessel and a reader and received in the alternate embodiment of the base in cooperation with a needle holder assist mechanism.Detailed Description of the Invention

[0041] The present disclosure is directed to a workstation 1 . An embodiment of the workstation1 is shown in figures 1 , 6, 13 and 14. The workstation 1 includes a platform 2. As shown in figure 6, the platform 2 defines a plurality of first slots 4 that extend into the platform 2. The first slots 4 are proportioned to receive sample receiving vessels 30 as shown in figure 1. Th receiving vessels 30 may include a removable top seal 76, as shown in figure 1. The first slots 4 are dimensioned to cooperate in shape to a receiving vessel 30 received in a first slot 4 as shown in cross section figure 7. The spacing of the first slots 4 provides sufficient space for a user to handle the receiving vessels 30 and to maximize space efficiency. A top surface 40 of platform 2 allows a user sufficient space to use a finger to position the hand to guide accurate delivery of sample into sample receiving vessels 30. The top surface 40 is also preferably textured to minimize slippage of the user’s finger.

[0042] The platform 2 also defines a plurality of second slots 6 that extend into the platform 2. The second slots 6 are dimensioned to each receive an analyzer which is preferably a point of care cartridge 24 as shown in figure 1. The second slots 6 are preferably substantially perpendicular to the first slots 4. As shown in figures 1 and 6, each of the first slots 4 align with a corresponding second slot 6. The second slots 6 can also be configured to hold cytopathology glass slides for receiving biopsy samples.

[0043] The platform 2 preferably defines a bin 8, which is an indentation formed in the platform2 and which functions as an organizing space, and / or a disposal bin for the materials used in the clinical workflow. The first slots 4 may be numbered with the numbers sequentially increasing from the number 1 to the number 4 as shown in figures 1 , 6, 13 and 14.

[0044] The platform 2 is preferably supported by a base 12 which is dimensioned to receive andsupport the platform 2. The base 12 is shown in isolation in figure 12. As shown in figure 12, the base 12 defines an indentation 14 for receiving the platform 2. The base 12 preferably has sufficient weight and friction with surface to stabilize the platform 2 on a work surface which may be a laboratory bench top, table, for example. The base 12 is preferably made from a material that is easily disinfected. When the base 12 is used with the workstation platform 2, the workstation platform can be disposable for example, if contaminated, simplifying the disinfection process.

[0045] In an alternate embodiment, the base 12 may include lighting which can illuminate the area around the platform 2 and / or provide task lighting when the intended use environment lighting is dim. The lighting can be a strip of LED lighting at a base-workstation perimeter. The lighting can be situated underneath each first slot 4 for the receiving vessels 30 formed in the platform 2 to provide task lighting for specimen loading of the receiving vessels. The lighting can be powered by batteries or by mains electricity.

[0046] Figure 2 shows an alternate embodiment 100 of the workstation where a platform 102 defines six first slots 104 and six corresponding second slots 106. The platform of the alternate embodiment 100 does not include a bin. However, a bin can be included in a further alternate embodiment. The cross-sectional shape of the first slots 104 are illustrated in figure 3 which shows receiving vessels 30 within the first slots 104.

[0047] A second alternate embodiment 200 of the workstation with a platform 202 having only one first slot 204 is shown in figure 4. Figure 5 shows the internal dimension of first slot 204 with a receiving vessel 30 within the first slot 204. The second alternate embodiment 200 preferably includes a second slot (not shown) that is formed in the platform 202 which is substantially perpendicular to the first slot 204. The second slot is preferably proportioned to receive a point of care cartridge.

[0048] Figures 8 and 10 show a receiving vessel 30 for receiving a biological sample preferably in fluid form mixed with a stabilizing buffer. The receiving vessel 30 is shown in cross section in figure 9. The receiving vessel 30 has an opening 26 at a first end thereof 32 for receiving the biological sample in fluid form typically from a needle of a syringe. A second end 22 of the receiving vessel 30 is closed by a removable closure component 20. The biological sample is held in a body 16 of the receiving vessel 30. A cap 18 is opened when the biological sample isdeposited into the receiving vessel 30 and is preferably closed when the biological sample is held in the receiving vessel 30. When the closure 20 is removed, the biological sample may be deposited from the second end 22 of the receiving vessel 30. For example, the biological sample may be deposited into a point of care cartridge 24. The biological sample may be delivered to a point of care cartridge 24 through a top portion 38 of the cap 18 which may be opened to deliver the biological sample from the receiving vessel 30. In alternate embodiments, the top portion 38 can be fitted with a filter to remove any inhomogeneous particles or materials top portion 38. The opening 26 is wide relative to the body 16 which is narrower than the opening 26 in order to facilitate a clinician’s ability to position a biopsy needle in the opening 26.

[0049] The receiving vessel 30 preferably has a flange 64 formed thereon. The flange 64 is received in a receiving slot 68 formed in the first slot 4 as shown in figure 7. This provides for the receiving vessel to be securely received in first slot 4 with additional stability.

[0050] An alternate embodiment of a receiving vessel 80 is shown in figure 11. The alternate embodiment of the receiving vessel 80 has an opening 76 at a first end thereof 82 for receiving the biological sample in fluid form typically from a needle of a syringe. A second end 120 of the receiving vessel 80 is closed by a removable closure component 94. The biological sample is held in a body 86 of the receiving vessel 80. A threaded region 92 is formed on an external surface of the body 86 near the second end 120. The threaded region cooperates with a receiving groove or internal slot formed in an alternate embodiment of the first slot for locking the receiving vessel 80 in the first slot. The receiving vessel 80 may also have a flange 84 formed thereon. The flange 84 may be received in a receiving slot formed in a first slot in which the receiving vessel 80 is received. This would provide additional stability.

[0051] A cap 78 is opened when the biological sample is deposited into the receiving vessel 80 and is preferably closed when the biological sample is held in the receiving vessel 80. When the closure 94 is removed, the biological sample may be deposited from the second end 120 of the receiving vessel 80. For example, the biological sample may be deposited into a point of care cartridge 24. The biological sample may be delivered to a point of care cartridge 24 through a top portion 88 of the cap 78 which may be opened to deliver the biological sample from the receiving vessel 80. The opening 76 is wide relative to the body 86 which is narrower than the opening 76 in order to facilitate a clinician’s ability to position a biopsy needle in the opening 76.

[0052] Figure 13 shows an alternate embodiment of a base 98 which defines indentations for receiving the platform 2 in addition to a point of care reader 70 functioning as the analyzer. The alternate embodiment of the base 98 includes electrical power inputs for supplying power to the reader.

[0053] As shown in figure 14, a guiding stage 92 can be fitted on the alternate embodiment of the base 98 so that a biopsy needle 94 can be positioned above the receiving vessel 30 to help a clinician to properly inject fluid into the opening 26 of the receiving vessel 30. In an alternate embodiment, the guiding stage 92 can be fitted on the platform 2. The guiding stage can be operated manually or robotically, for example as an interface to a robotic biopsy sample acquisition system which can be configured to deliver from the needle 94 a drop of aspirate to the receiving vessel 30.

[0054] In operation, receiving vessels 30 holding a biological sample are placed in the first slots 4 of the platform 2 of the workstation. Analyzers preferably in the form of a point of care cartridge 24 are stored in the second slots 6. In an alternate embodiment, a point of care reader 70 functioning as an analyzer may also be provided to process information from the point of care cartridge 24. The workstation 2 is arranged such that each of the receiving vessels 30 holding a biological sample is placed in close proximity to a corresponding point of care cartridge 24. The bin 8 when present provides organizing space, and / or a disposal bin for the materials used in the clinical workflow. This arrangement provides increased workspace efficiency for the processing and testing of biological samples.

[0055] The present disclosure is not to be limited in scope by the specific embodiments described herein. Indeed, various modifications of the invention in addition to those described herein will become apparent to those skilled in the art from the foregoing description and the accompanying figures. Such modifications are intended to fall within the scope of the appended claims.

Claims

CLAIMS1. An organizing workstation for organizing one or more biological sample receiving vessels and one or more analyzers for the biological sample, the organizing workstation comprising: a platform defining at least one first slot for receiving one of said one or more biological sample receiving vessels; and at least one second slot being substantially perpendicular to the first slot, the second slot being aligned with said first slot for receiving one of said one or more analyzers.

2. The organizing workstation of claim 1 wherein the platform defines a plurality of said at least one first slot and a plurality of said at least one second slot, each of the first slots being aligned with a corresponding one of the second slots.

3. The organizing workstation according to claim 1 or claim 2 wherein the platform further defines an indentation which functions as a receiving bin.

4. The organizing workstation according to any one of claims 1-3 further defining a horizontal base which defines an indentation for receiving and supporting said platform.

5. The organizing workstation according to claim 2 wherein said first slots are spaced apart for efficient handling of the receiving vessels.

6. The organizing workstation according to any one of claims 1-5 wherein the receiving vessels have a first end, a second end and a body between the first end and the second end, the first end defining an opening for receiving a biological sample in fluid form, the second end being closed by a removable closure component, wherein fluid may be deposited from the second end when the closure is removed.

7. The organizing workstation according to claim 6 wherein the removable closure is a cap, a snap cap closure, a threaded screw cap or a removable closure component which can be twisted off to create a dropper function.

8. The organizing workstation according to claim 6 wherein the opening is wide relative tothe body for facilitating a clinician’s ability to position a biopsy needle in the opening.

9. The organizing workstation according to any one of claims 1-8 wherein each of the first slots define an internal slot formed therein, the receiving vessels having a flange formed thereon receivable in the internal slot for securing the receiving vessel in the first slot.

10. The organizing workstation according to claim 4 wherein the base defines a second indentation for receiving a point of care reader.

11. The organizing workstation according to claim 4 wherein the base includes lighting for illuminating an area around the platform.

12. The organizing workstation according to claim 11 wherein the lighting can is a strip of LED lighting at a base-workstation perimeter.

13. The organizing workstation according to any one of claims 1-8 wherein the first slots are internally slotted for ensuring a preferred and consistent fit corresponding to the dimensions of the receiving vessels.

14. The organizing workstation according to claim 13 wherein the receiving vessel has a threaded region formed on an external surface of the body for cooperating with the internal slots of the first slots.

15. The organizing workstation according to claim 4 further including a guiding stage attached to the base for positioning a biopsy needle above a receiving vessel located in one of said first slots.

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