A sample collecting device

Abstract

The described technology pertains to a sampling device (100) designed for fine-needle aspiration, addressing challenges in obtaining high-quality cytological samples. The device comprises a body (110) configured to hold a disposable syringe (120), a first actuator (130) for sliding the syringe housing (121) along its longitudinal axis (122), and a second actuator (140) for sliding the syringe plunger (123) along the same axis. A control arrangement (160) operates the device in various modes, including loading, idle, ready, sampling, and unloading, by controlling actuator movements within predefined stroke limits. The device facilitates precise sample collection through synchronized or independent actuator motions, creating vacuum conditions and enabling reciprocating movements for tissue extraction. The assembly includes a disposable syringe and needle (150), and the method involves sequential operational modes for sample collection and preparation for analysis. The described technology enhances diagnostic accuracy, reduces operator dependency, and minimizes patient risks.

Description

[0001] A SAMPLE COLLECTING DEVICE

[0002] TECHNICAL FIELD

[0003] The present invention relates to collecting of samples, in particular to Fine-Needle Aspiration, FNA, also referred to as fine-needle biopsy.

[0004] BACKGROUND

[0005] The International Agency for Research on Cancer (IARC) estimates that the number of cancer diagnoses made each year worldwide. According to their latest report, Globocan 2020, approximately 19.3 million new cancer cases were recorded in 2020. This number is expected to increase to 28.4 million annual cases by 2040, primarily due to an aging and growing population. High-income countries have higher numbers of cancer diagnoses due to better diagnostic tools, but the incidence is also rapidly increasing in low- and middle-income countries. The most common types of cancer are breast cancer, lung cancer, colorectal cancer, prostate cancer, and stomach cancer, which account for a significant portion of the diagnoses. Diagnostic techniques typically comprises inserting a needle into a target volume to obtain a sample, the sample comprising cels and / or tissue from a target volume such as a tumor. Diagnostic techniques such as Fine Needle Aspiration (FNA with needles 0.4-0.7 mm) and Core Needle Biopsy (CNB with needles 1.3-3.0 mm) are commonly used for solid tumors. FNA provides isolated individual cells, whereas CNB yields a tissue sample with intact cellular architecture.

[0006] The advantage of the FNA method is its ability to extract individual cancer cells, which are more loosely connected to one another compared to healthy cells, into the needle. These cells remain completely intact, preserving both the nucleus and cytoplasm. Advanced and highly sensitive techniques, such as antibody staining for biomarker analysis of individual cells, enable precise diagnoses and provide valuable guidance for personalized and precision cancer treatments. During cytological preparation, the extracted cells are arranged in a monolayer, positioned individually side by side, facilitating accurate and rapid data analysis.

[0007] A drawback of the FNA method in its current implementation is the need for physicians to undergo specialized training to skillfully manipulate the handheld device. This requires performing rapid back-and-forth movements while maintaining a short stroke length, particularly for smaller tumors. If the stroke length is too long, excessive sampling of normal cells outside the tumor occurs, compromising the quality of the sample. This challenge has contributed to a limited number of physicians adopting FNA as a diagnostic technique.

[0008] The disadvantage of CNB, despite its intact architecture, is that many cells are cut during the preparation of pathological samples, resulting in some cells being sliced in half or otherwise altered. This can lead to partially inaccurate results in biomarker analysis.

[0009] Another drawback of CNB is that it uses a larger, hollow needle, which releases a rapid, explosive force at the needle tip when the instrument's compressed springs are discharged. This mechanism quickly propels both the mandrel and the needle into the tumor. Consequently, circulating cancer cells have been detected in the peripheral blood of patientsfollowing CNB sampling (Franzen, Bo & Sennerstam, Roland & Wiksell, Hans & Auer, Gert. (2016). Significance of Diagnostic Needle Biopsy for the Development of Inflammation, Tumour Progression and Metastasis. Journal of Diagnostic Molecular Biomarkers & Diagnosis, www. DOI:10.4172 / 2155-9929. S2-021). The thick needle poses a greater risk of bleeding and infections compared to FNA.

[0010] Additionally, CNB requires a larger number of pathologists for accurate diagnoses, but there is a significant shortage of these professionals due to the extensive training needed to achieve proficiency in cell evaluation. While advancements in image analysis techniques are expected to help address this challenge and improve the situation, the inherent drawback of using thick needles remains.

[0011] Therefore, there is a need for an improved sampling device and assembly to address these drawbacks associated with conventional solutions for taking samples.

[0012] OBJECTS OF THE INVENTION

[0013] An objective of embodiments of the present invention is to provide a solution which mitigates or solves the drawbacks and problems described above.

[0014] SUMMARY OF THE INVENTION

[0015] The above and further objectives are achieved by the subject matter described herein. Further advantageous implementation forms of the invention are further defined herein. The invention is set out in the appended claims. The scope of the invention is defined by the claims, which are incorporated into this section by reference.

[0016] In one embodiment, there is a sampling device for fine-needle aspiration comprising a body configured to slidably receive a disposable syringe, a first actuator operable to slide the syringe housing along the longitudinal axis, a second actuator operable to slide the syringe plunger along the same axis, and a control arrangement communicatively coupled to both actuators. The body further incorporates a linkage with a housing holder and a plunger holder, each arranged to slide parallel to the longitudinal axis. The control arrangement is configured to operate the device in loading, idle, ready, sampling and unloading modes by driving each actuator within predefined stroke end-points. In the loading mode, the housing holder is driven to a first intermediate position and the plunger to the maximum extension; in the idle mode, both positions are maintained; in the ready mode, the housing holder remains at the first intermediate position while the plunger is retracted to create a vacuum in the syringe housing; in the sampling mode, the housing actuator performs a reciprocating motion to obtain tissue; and in the unloading mode, the actuators cooperate to expel the collected sample. Mode transitions are effected in response to received control signals.

[0017] In another embodiment, there is an assembly for performing fine-needle aspiration biopsy comprising the aforementioned sampling device, a disposable syringe having an outlet, and a needle attached to that outlet.

[0018] In a further embodiment, a method of fine-needle aspiration comprises placing a disposable syringe with attached needle into the sampling device; providing a first user indication to enter idle mode; positioning the needle tip in a target area of a subject; providing a second user indication to enter ready mode and subsequently sampling mode to obtain a sample;providing a third user indication to return to ready mode; and removing the needle tip from the subject. The method may further include removing the syringe from the device and returning the device to idle mode, inserting the outlet or needle into a container of sampleretaining liquid, drawing liquid into the syringe, injecting the sample-liquid mixture back into the container, and forwarding the container for analysis.

[0019] These and other aspects will be more fully understood with reference to the detailed description and accompanying figures.

[0020] Further applications and advantages of embodiments of the invention will be apparent from the following detailed description.

[0021] BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Fig. 1 shows an assembly configured to collect a sample from a target volume according to one or more embodiments of the present disclosure.

[0023] Fig. 2A-C shows linkage of the device according to one or more embodiments of the present disclosure.

[0024] Fig.3A-D illustrates use of a sampling device in different phases.

[0025] Fig.4A-C illustrates use of the sampling device in further phases.

[0026] Fig.5A-B illustrates examples of a motions performed by actuators according to one or more embodiments of the present disclosure.

[0027] Fig. 6A-B illustrates examples of the second motion according to one or more embodiments of the present disclosure.

[0028] Fig. 7A and 7B shows examples of the first and second movement according to one or more embodiments of the present disclosure.

[0029] Fig.8 shows a computer according to one or more embodiments of the present disclosure.

[0030] Fig.9 shows a flowchart for a method according to one or more embodiments of the present disclosure.

[0031] Fig. 10A-C shows views of the sampling device provided with a casing.

[0032] Fig.11 shows an exploded view of the sampling device according to one or more embodiments of the disclosure.

[0033] Fig.12A-C shows different views of the housing holder according to one or more embodiments of the disclosure.

[0034] Fig.13A-F shows different views of the plunger holder according to one or more embodiments of the disclosure.

[0035] Fig. 14 shows an example of the sampling device 100 with part of the casing removed according to one or more embodiments of the disclosure.

[0036] A more complete understanding of embodiments of the invention will be afforded to those skilled in the art, as well as a realization of additional advantages thereof, by a consideration of the following detailed description of one or more embodiments. It should be appreciatedthat like reference numerals are used to identify like elements illustrated in one or more of the figures.

[0037] DETAILED DESCRIPTION

[0038] Sixten Franzen was a Swedish physician and pathologist who played a significant role in the development and popularization of Fine Needle Aspiration (FNA). He worked at Radiumhemmet, Karolinska University Hospital, in Stockholm and began using FNA as a method for sampling tissue from tumors during the 1950s and 1960s. His work was instrumental in establishing Fine Needle Aspiration (FNA) as a safe, simple, and effective diagnostic technique for examining suspicious masses and lesions, particularly in the breast, thyroid, and lymph nodes. Thanks to his contributions, FNA became an accepted but not widely used method in diagnostics worldwide, due to the limited number of trained cytologists. Pathologists argued that pathological samples with tissue structure provide better clinical guidance for diagnosis. New innovations are underway, where individual cells stained for biomarker analysis will provide reliable clinical guidance and rapid results through automated image analysis. Fine needles used in FNA typically have an outer diameter of 0.4 to 0.7 mm (26-21 gauge) and vary in length from approximately 2,5 cm (for sampling superficial lesions, such as skin lesions) to 10 cm (for deeper lesions, such as those in the prostate). For several decades, the one-handed syringe pistol handle, designed in the 1960s by Sixten Franzen for 10-20 ml disposable plastic syringes, has remained the standard tool for this procedure.

[0039] The technique for aspirating cellular material from solid lesions can vary significantly depending on the lesion's size, configuration, and firmness, as well as the experience and skill of the practitioner performing the biopsy. Once the needle is inserted into the lesion, the operator guides it back and forth through the tissue, typically making five to ten passes, to release cells into the needle for collection.

[0040] Core needle biopsy (CNB) was first introduced into clinical practice in the 1950s using manual needles, primarily to enhance the diagnosis of breast cancer and other tumors. A major breakthrough came in the 1980s with the development of automated core biopsy systems, such as the spring-loaded Tru-Cut® device, which significantly improved the efficiency and precision of the procedure.

[0041] Core biopsy is a diagnostic procedure that uses a relatively large, hollow needle to extract a core of tissue for analysis. The needle diameter typically ranges from 1.3 mm to over 3 mm, depending on the specific application. This technique was developed to address the need for more comprehensive tissue samples than those obtained through fine needle aspiration (FNA), enabling more accurate histological diagnoses.

[0042] The development of core biopsy as a standardized technique was not the work of a single individual but rather the result of gradual advancements in medical technology and imaging methods. The introduction of stereotactic and ultrasound-guided core biopsies represented a significant leap forward, improving the precision and reliability of the procedure. Today, core biopsy is widely recognized as a cornerstone in the diagnostic workup of various cancers, particularly in oncology.Vacuum-assisted biopsy (VAB) is often combined with the core needle biopsy (CNB) technique, particularly in breast diagnostics, as it reduces the ballistic, spring-loaded effect typical of classical CNB. VAB enables multiple tissue samples to be collected with a single needle insertion. Once inserted, the needle remains largely stationary but rotates during the procedure. A vacuum or low-pressure system then draws tissue into the needle for sampling. In recent years, antibody staining of cells, known as ImmunoHistoChemistry (IHC), has become a cornerstone in cancer diagnostics. This method employs specific antibodies that bind to target proteins in cells, allowing the visualization and identification of these proteins under a microscope.

[0043] KEY DIAGNOSTIC ADVANTAGES OF IMMUNOHISATOCHEMISTRY INCLUDE

[0044] 1. Identification of Cancer Type: IHC aids in determining the specific cancer type, which is crucial for tailoring treatment. For instance, it can identify hormone receptors in breast cancer or specific oncoproteins in various sarcomas.

[0045] 2. Determination of Tumor Origin: For metastases with an unknown primary tumor, IHC helps establish the tissue of origin by characterizing the cell types within the tumor.

[0046] 3. Prognostic Information: Proteins detected through IHC can provide insights into tumor aggressiveness and potential progression. For example, HER2 overexpression in breast cancer suggests a more aggressive disease.

[0047] 4. Treatment Guidance: IHC identifies specific receptors or proteins that inform targeted therapies, such as HER2-targeted treatments in breast cancer or immunotherapy options. 5. Distinction Between Benign and Malignant Lesions: IHC helps differentiate benign (non-cancerous) from malignant (cancerous) lesions, ensuring accurate diagnoses and treatment plans.

[0048] In summary, IHC enhances our understanding of cancer's molecular and cellular characteristics, improving diagnostics, guiding treatment choices, and aiding in prognosis. COMPARIOSON OF DIAGNOSTIC TECHNIQUES IHC on individual cells offers better guidance for selecting treatment options compared to tissue samples used in traditional histological diagnoses, which rely on cellular relationships within the tissue. However, CNB with a larger, hollow needle presents challenges. The compressed springs in the device release a rapid, explosive force, propelling the mandrel and needle into the tumor. This process has been associated with the detection of circulating cancer cells in peripheral blood in 20-30% of patients analyzed.

[0049] By contrast, the fine-needle aspiration (FNA) technique has minimal side effects and is sufficient for obtaining individual cells for Immunohistocytology. However, FNA requires significant expertise, as the quality of the sample depends on the operator's skill. Precision in performing small, controlled needle movements is especially critical for smaller tumors, and this proficiency can only be developed through extensive practice.

[0050] MOVING TOWARD GLOBAL ADAPTION

[0051] To enable the widespread adoption of advanced immunohistochemical diagnostic methods, it is vital to provide physicians with user-friendly instruments. These tools would facilitate high-quality sampling and accelerate the global implementation of this transformative diagnostic approach.The present disclosure present such an instrument and more.

[0052] Fig. 1 shows an assembly 10 configured to collect a sample from a target volume, such as performing a fine needle biopsy from a subject, according to one or more embodiments of the present disclosure. The assembly is particularly suitable for cytology.

[0053] The assembly 10 comprises a syringe 120, typically a disposable syringe configured with an outlet 124. The assembly 10 further comprises a needle 150 configured to be attached to the outlet 124. In a non-limiting example, the needle outer diameter is selected in the range 0.4 to 0.7 mm (26-21 gauge). In a further non-limiting example, the needle is selected with a length of 1cm to 20 cm.

[0054] The assembly 10 further comprises a sampling device 100. The sampling device 100 is configured to collect a sample from a target volume. The sampling device 100 comprises an elongated body 110 having a first end and a second end arranged at an opposite end of the elongated body 110. The sampling device 100 further configured to slidably hold the syringe 120 at the first end of the body 110. In other words, the syringe 120, when held by the sampling device 100, protrudes from the first end of the body 110.

[0055] In one example, the body 110 comprises a substantially U-shaped clip configured to hold the body 121 of the syringe, where the inner side of the clip is adapted to the diameter of the housing and the legs of the clip is folded inward to attach the syringe to the body and prevent it from falling out.

[0056] In one further example, the body 110 comprises a clip designed as a semi-circle or tube and configured to hold the body 121 of the syringe, where the inner side of the clip is adapted to the diameter of the housing and is adapted to extend around more than half of the body of the housing 121 to attach the syringe to the body and prevent it from falling out.

[0057] Any suitable clip capable of slidably holding the housing of the syringe may be envisioned without departing from the present disclosure.

[0058] The sampling device 100 may further comprise a casing, housing or enclosure (not shown) configured to protect moving parts and provide an easily gripped shape for the user or a robotic arm to hold. The casing is further described in relation to Fig. 10A-C.

[0059] The syringe 120 typically comprise a housing 121, a plunger 123 configured to move inside the housing 121, and a plunger tip 125 configured to form a seal to the inside walls of the housing 121.

[0060] The sampling device 100 further comprises a first actuator 130 configured to be coupled to the body 110. The first actuator 130 is further configured to be coupled to the housing 121 of the syringe 120, optionally rotationally coupled. Optionally, the first actuator 130 is arranged at the second end of the elongated body 110 and / or is coupled to the body 110 at the second end of the body 110. The first actuator 130 is configured to perform a first motion to slide the housing 121 along a longitudinal axis 122 of the disposable syringe when held by the body 110. In Fig. 1 the longitudinal axis 122 of the disposable syringe is aligned with a longitudinal axis of the body 110, however it is understood that other arrangements may be envisioned without departing from the present disclosure.

[0061] The sampling device 100 further comprises a second actuator 140 configured to be coupled to the body 110. The second actuator 140 is further configured to be coupled to the plunger 123 of the syringe 120, optionally rotationally coupled. Optionally, the second actuator 140 isarranged at the second end of the elongated body 110 and / or is coupled to the body 110 at the second end of the body 110. The second actuator 140 is further configured to perform a second motion to slide the plunger along the longitudinal axis 122. Optionally, the second actuator 140 is arranged at a second end or distal end of the body 110.

[0062] The first actuator 130 is configured to perform the first motion with a stroke or a limited linear movement. The first movement is limited to movement between a first end point of the stroke where the first actuator 130 is extended to a maximum position and a second end point where the first actuator 130 is extended to a minimum position.

[0063] The second actuator 140 is configured to perform the second motion with a stroke or a limited linear movement. The second movement is limited to movement between a third end point of the stroke where the first actuator 130 is extended to a maximum position and a fourth end point where the first actuator 130 is extended to a minimum position.

[0064] The limitation of the linear movement of the actuators 130, 140 may be physical, e.g., stoppers in the actuators or external to the actuators. The limitation of the linear movement of the actuators 130, 140 may alternatively be controlled by parameters of the control arrangement 160. In other words, the end points, or positions of the actuators 130, 140 may be determined as parameters defining minimum extension and maximum extension of the actuators 130, 140.

[0065] The assembly 10 further optionally comprises a power source. The first and second actuators 130, 140 are further configured to be coupled to the power source. The power source may be a battery (not shown) configured to be in electrical connection to the first and second actuators 130, 140. The first and second actuators 130, 140 may be electrically powered actuators, such as linear motors or other suitable actuators. The battery may be external to the sampling device 100 or may optionally be integrated with the sampling device 100.

[0066] The assembly 10 further comprises a control arrangement 160 communicatively coupled to the first actuator 130 and the second actuator 140. Additional lly, or alternatively, the control arrangement 160 communicatively coupled to user input devices, e.g., one or more buttons on the sampling device 100. Additionally, or alternatively, the control arrangement 160 communicatively coupled to an external computer, such as a mobile phone or laptop. The control arrangement 160 may be integrated with the sampling device 100 or arranged externally to the sampling device 100.

[0067] In other words, the control arrangement 160 control the first and second actuators 130, 140, when performing respective motions, by sending control signals.

[0068] In one example, the second actuator 140, in a first phase of the second motion, moves in a direction towards the second or distal end of the body 110 to partially slide the plunger 123 int the housing 121 of the syringe 120 and create an under-pressure or vacuum. The first actuator 130, in the first phase, remains stationary, to maintain the position of the housing 121. In a second phase, the first actuator 130 and the second actuator 140 performs a synchronized motion and moves in a direction towards the second or distal end of the body 110, effectively moving the housing 121 and the needle 150 to a safer position away from the subject or patient, when held by the body 110. In other words, the user such as a physician, can feel safe that the carefully selected depth of the needle will not suddenly increase and "stab" the patient, when sampling begin. In a third phase, the first and second motion performs a synchronized reciprocating motion, effectively moving the housing 121 and theneedle 150 to obtain samples from the target volume. The different phases are further described in relation to Fig. 3A-D and 4A-C.

[0069] The sampling device 100 may typically be used in a loading mode, when attaching the syringe to the device 100. The sampling device may further be used in an idle mode, before used on a subject or patient. The device may further be used in a sampling mode when samples are collected from the subject or patient. Finally, the collected sample may be extracted from the device in an unloading mode, either at the sample location as the samples were collected or later at a lab for analysis.

[0070] Fig. 2A shows linkage 200 of the device 100 according to one or more embodiments of the present disclosure. In this embodiment, the device 100 and / orthe body 110 comprises linkage 200 and a base 210. The linkage 200 further comprises a first part 220 and a second part 230. Additionally, or alternatively, the first part 220 of the linkage 200 comprises a housing holder 221 configured to couple the first actuator 130 to the housing 121. The second part 230 of the linkage 200 comprises a plunger holder 231 configured to couple the second actuator 140 to the plunger 123. The housing holder 221 is arranged to slide along a second axis parallel to the longitudinal axis 122. The plunger holder 231 is arranged to slide along a third axis parallel to the longitudinal axis 122. Optionally, the housing holder 220 and the plunger holder 230 are configured or arranged to slide along a respective sliding member 222, 232.

[0071] In the example shown in Fig. 2, the first part 220 further comprises a sliding member 222 comprising a rod 222, along which the housing holder 221 is configured to slide. The second part 230 further comprises a sliding member 232 also comprising a rod 232 along which the housing holder 221 is configured to slide. The body 110 and / or base 210 are configured to hold the rods 222, 232 at each respective end, effectively forming an outer limit of a stroke of the housing holder 221 and plunger holder 231.

[0072] In one non-limiting example, the rods 222, 232 are provided with threads matching threads in the housing holder 221 and plunger holder 231, causing the housing holder 221 and plunger holder 231 to slide when the rods 222, 232 are rotated by the actuators 130, 140.

[0073] The implementation of the linkage shown in Fig. 2A is for illustrative purposes. Any suitable housing holder, plunger holder sliding member may be used without departing from the present disclosure.

[0074] Fig 2B shows details of an example of the housing holder 221. As can be seen, the housing holder 221 is formed like an u-shaped clip configured to receive the barrel and barrel flange of the syringe.

[0075] Fig 2C shows details of an example of the plunger holder 231. As can be seen, the plunger holder 231 is formed like an u-shaped clip configured to receive the plunger stem and the plunger flange.

[0076] Fig. 3A-D illustrates use of the sampling device 100 in different phases. Movement of the actuators 130, 140 are further described in Fig. 5A-Fig. 7B.

[0077] Fig. 3A illustrates use of the sampling device 100 in a first phase, where the control arrangement 160 is configured to operate in a loading mode. The assembly 10 is assembled by placing a sterile syringe 120 to be held by the body 110. Further a needle 150 is attached to the housing 121 of the syringe 120. The control arrangement 160 is further configured to control the first actuator 130 to hold the housing 121 in a position corresponding to a first endpoint (illustrated in Fig. 5A) of the stroke of the first actuator 130. The control arrangement 160 is further configured to control the second actuator 140 to hold the plunger 123 in a position where the tip 125 is fully inserted into the housing. In other words, the plunger 123 is pushed as far as it is possible into the housing 121. This is further illustrated in Fig. 6A. Fig. 3B illustrates use of the sampling device 100 in a second phase, where the control arrangement 160 is configured to operate in an idle mode. The needle 150 of the assembly 10 is placed in or pushed into a target volume 310 of a subject 311 from which the sample is about to be collected. The control arrangement 160 is further configured to control the first and second actuators 130, 140 to maintain the positions described in relation to Fig. 3A. Fig. 3C illustrates use of the sampling device 100 in a third phase, where the control arrangement 160 is configured to operate in a ready mode. The control arrangement 160 is further configured to control the first actuator 130 to hold and / or maintain the housing 121 in the position described in relation to Fig. 3A. The control arrangement 160 is further configured to control the second actuator 140 to hold the plunger 123 in a position where the tip 125 is pulled back to create an under pressure or vacuum in the housing 121 and / or needle 150. This allows for any cells released to be sucked into the housing 121. It is envisioned that the first actuator 130 could be configured to hold the housing 121 at any intermediate point, between the respective end points, without departing from the present disclosure.

[0078] Fig. 3D illustrates use of the sampling device 100 in a fourth phase, where the control arrangement 160 is configured to operate in a sampling mode. The control arrangement 160 is further configured to control the first actuator 130 to perform the first motion as a first reciprocating motion, effectively moving back and forth, thereby moving the housing 121 and the needle 150 to obtain samples from the target volume 310. In other words, the control arrangement 160 is further configured to control the first actuator 130 to move between end points of the stroke of the first actuator 130 when performing the first reciprocating motion. For safety reasons, the reciprocating motion is initiated by moving the first actuator 130 towards the second end position corresponding to the housing being retracted from the subject or patient. This is to avoid accidental "stabbing" of the subject.

[0079] In one alternative, the control arrangement 160 is further configured to control the second actuator 140 to hold the plunger 123 in a fixed or constant position where the tip 125 is held in a position where the under pressure or vacuum in the housing 121 and / or needle 150 is maintained.

[0080] In one further alternative, the control arrangement 160 is further configured to control the second actuator 140 to perform a second reciprocating motion synchronized with the first reciprocating motion performed by the first actuator 130. In other words, the housing 121 and plunger is moved back and forth in a synchronized manner to obtain samples from the target volume 310 of the subject 311.

[0081] In one example, the first reciprocating motion and the second reciprocating motion are performed with identical stroke lengths, typically having different stroke end points.

[0082] In one embodiment, use of the sampling device 100 may be described as a method. The method comprising:

[0083] placing a disposable syringe 120 having an attached needle 150 to be held by the sampling device 100 described herein, further described in relation to Fig. 3A. Optionally, this also comprises closing a lid securing the syringe 120 within a casing of the sampling device 100.Optional ly, providing a first user indication to place the sampling device 100 in an idle mode. In one embodiment, the idle mode comprises providing the control arrangement 160 and or actuators 130, 140 with electric power. E.g., by activating a power switch, further described in relation to Fig. 10.

[0084] Placing a tip of the needle 150 in a target area 310 of a subject 311. Further described in relation to Fig. 3B.

[0085] Optionally, providing a second user indication to place the sampling device 100 in a ready mode, and / or to place the sampling device 100 in a sampling mode to obtain a sample from the target area 310. Further described in relation to Fig. 3C. In one embodiment, the ready mode comprises providing the control arrangement 160 and or actuators 130, 140 with electric power. In other words, sampling device 100 may be placed in an active state before or after placing the tip of the needle 150 in a target area 310.

[0086] In one example, this involves pushing and holding an input device, such as a button.

[0087] Additionally, or alternatively, providing a third user indication to place the sampling device 100 back in the ready mode. In one example, this involves releasing the input device, such as the button.

[0088] Additionally, or alternatively, removing the tip of the needle 150 from the target area 310 and the subject 311. Further described in relation to Fig. 4A.

[0089] Additionally, or alternatively, removing the disposable syringe 120 from the sampling device 100.

[0090] Additionally, or alternatively, placing the sampling device 100 in the idle mode after the disposable syringe 120 has been removed.

[0091] Additionally, or alternatively, inserting the outlet (124) or the needle (150) into a container comprising sample retaining liquid.

[0092] Additionally, or alternatively, sucking liquid into the syringe 120, and then injecting the sample mixed with the liquid back into the container.

[0093] Additionally, or alternatively, sending the container, comprising the sample mixed with the liquid, off for analysis.

[0094] Fig. 4A-C illustrates use of the sampling device 100 in further phases.

[0095] Fig. 4A illustrates use of the sampling device 100 in a fifth phase, where the control arrangement 160 is configured to operate in the ready mode. The control arrangement 160 is further configured to control the first actuator 130 to hold the housing 121 in the first end position of the stroke of the first actuator 130. The control arrangement 160 is further configured to control the second actuator 140 to hold the plunger 123 in constant position relative to the housing 121 where the tip 125 of the plunger 123 is pulled back to maintain an under pressure or vacuum in the housing 121 and / or needle 150. The needle 150 of the assembly 10 is then withdrawn from the target volume 310 of the subject 311 from which the sample has been collected.

[0096] Optionally, the assembly 10 is disassembled by removing the syringe 120 held by the body 110. Typically, the needle 150 is also removed from the syringe 120. The control arrangement 160 is further configured to control the second actuator 140 to hold the plunger 123 in a position where the tip 125 is fully inserted into the housing. In other words, after removal thesyringe 120, the second actuator 140 is controlled to the third end position of its stroke corresponding that a coupled plunger 123 is pushed as far as it is possible into the housing 121. The sampling device 100 is then ready to receive a syringe again.

[0097] Fig. 4B illustrates use in a sixth phase. In this alternative embodiment, the syringe 120 has been removed from the sampling device 100.

[0098] The outlet 124 or the needle 150 is inserted into a small container comprising liquid, e.g., fixative or culture medium. The liquid is sucked up into the syringe 120 and then injected back into the container to be identified before the sample is sent off for analysis, e.g., to a cytology laboratory. Alternatively, the syringe can be ID marked and sent directly to the cytology lab.

[0099] Fig. 4C illustrates alternative use of the sampling device 100 in the sixth phase, where the control arrangement 160 is configured to operate in an unloading mode. The outlet 124 or the needle 150 is inserted into a small container comprising liquid, e.g., fixative or culture medium. The control arrangement 160 is further configured to control the first actuator 130 to hold the housing 121 in the first end position of the stroke of the first actuator 130. The control arrangement 160 is further configured to control the second actuator 140 to move the plunger 123 back to suck the liquid into the syringe 120 and then forward to injected all the content in the housing 121 back into the container. In other words, control arrangement 160 is configured to control the second actuator 140 to move the plunger 123 towards the fourth end point to suck the liquid into the syringe 120 and then forward towards the third end-point to injected all the content in the housing 121 back into the container.

[0100] Fig. 5A-B illustrates examples of the first motion according to one or more embodiments of the present disclosure. The first motion slides the housing 121 along a longitudinal axis 122 of the syringe 120 when held by the body 110.

[0101] Fig 5A illustrates a first end point of the stroke of the first motion of the first actuator 130. The first end point symbolizes the first actuator 130 extended to a maximum position / first end position when performing the first motion. A distance DI illustrates the extension of the first actuator 130 from a minimum position / second end position of the first actuator 130. As can be seen in Fig 3A, the housing 121, when held by the body 110, slides along the longitudinal axis 122.

[0102] Fig 5B illustrates a second end point of the stroke of the first motion. The second end point symbolizes the first actuator 130 extended to a minimum position when performing the first motion. A distance D2 illustrates the extension of the first actuator 130 from a fully retracted position of the first actuator 130. As can be seen in Fig 3A, the housing 121, when held by the body 110, slides along the longitudinal axis 122. In other words, minimum position of the first actuator 130 must not necessarily be limited by the actuator itself, rather limited by the sampling device 100.

[0103] The relative stroke, or distance travelled by the first actuator 130 may be calculated using DI and D2, e.g., as an absolute value of (D1-D2).

[0104] It is understood that when the syringe is held by the body 110 and further attached to the needle 150, the stroke and / or travel of the needle may be calculated in the same manner as shown above for the relative stroke, or distance travelled by the first actuator 130.

[0105] Fig 5B also illustrates an intermediate point D3, basically a point where the extension of the first actuator 130 is at an intermediate point or position, not at any of the end points.The minimum / maximum position or end position of the first / second actuator 130,140 may be defined by physical limitations to the actuator or be defined as limiting parameters in the control arrangement 160.

[0106] Fig. 6A-B illustrates examples of the second motion according to one or more embodiments of the present disclosure. The second motion slides the plunger 123 along the longitudinal axis 122 of the syringe 120, when held by the body 110.

[0107] Fig 6A illustrates a third end point of the stroke of the second motion having an amplitude D4. The third end point symbolizes the second actuator 140 extended to a maximum position when performing the second reciprocating motion. A distance D4 illustrates the extension of the second actuator 140 from a minimum position / fourth end position of the second actuator 140. As can be seen in Fig 6A, the plunger 123, when the housing 121 is held by the body 110, slides along the longitudinal axis 122.

[0108] Fig 6B illustrates the other end point of the stroke of the second motion. The other end point symbolizes the second actuator 140 extended to a minimum position when performing the second motion. A distance D5 illustrates the extension of the second actuator 140 from a fully retracted position of the second actuator 140. As can be seen in Fig 4B, the plunger 123, when the housing 121 is held by the body 110, slides along the longitudinal axis 122. In other words, minimum position of the second actuator 140 must not necessarily be limited by the actuator itself, rather limited by the sampling device 100.

[0109] The relative stroke, or distance travelled by the second actuator 140 may be calculated using D4 and D5, e.g., as an absolute value of (D5-D4).

[0110] Fig 6B also illustrates an intermediate point D6, basically a point where the extension of the first actuator 130 is at an intermediate point, not at any of the end points.

[0111] The minimum / maximum position or end position of the first / second actuator 130,140 may be defined by physical limitations to the actuator or be defined as limiting parameters in the control arrangement 160.

[0112] Fig. 7A and 7B shows examples of the first and second movement according to one or more embodiments of the present disclosure.

[0113] In a first alternative of the sampling mode, the actuators are controlled such that the housing of the held syringe moves back and forth, and the plunger stays stationary.

[0114] The first and second movements performed by the first and second actuators 130, 140 respectively, may be dynamically adapted by the control arrangement 160. In other words, the stroke, the amplitude of the stroke, the frequency of the stroke, and associated end points may be pre-programmed in the control arrangement 160, received as user input by the control arrangement 160 or received from other nodes over a communication network. In one example, the amplitude illustrated in Fig. 7A and Fig. 7B is typically selected from the range [2-15] mm.

[0115] In Fig. 7. A and Fig. 7B, the reciprocating motion is shown as a sinusoidal movement, however any suitable reciprocating motion may be used, e.g., motion mimicking a square wave or triangular signal, without departing from the present disclosure.

[0116] Fig. 7A shows examples of first and second movements when operating in sampling mode according to one or more embodiments of the present disclosure.In Fig. 7A, the control arrangement 160 is configured to operate in the sampling mode. In this mode the sampling device 100 collects samples, e.g., cytology samples from the target volume 310.

[0117] Fig. 7A shows a diagram showing amplitude A of movement performed by the actuators 130, 140 on the vertical axis, and further shows elapsed time T on the horizontal axis. In this example, different phases, phase three P3, phase four, P4, of use is separated by vertical dotted lines.

[0118] The user or operator of the sampling device typically initially force the needle into the target area. See Fig. 3B and related text for further details.

[0119] In the third phase, illustrated in Fig. 3C, the second actuator 140 is controlled to move in a direction towards the second end of the body 110 to at least partially slide the plunger 123 in the housing 121 of the syringe 120 and create an under-pressure or vacuum. This part of the second movement is shown as a linear movement 710, but may be selected to be any suitable movement that draws the plunger back to create under-pressure or vacuum. In this example, it is assumed that the syringe 120 is typically initially placed in the sampling device with the plunger 123 fully pressed into the housing 121, as shown in Fig. 3B.

[0120] The first actuator 130, is controlled to remain stationary, to maintain the position of the housing 121, illustrated by the flat line 720.

[0121] In an initial part of the fourth phase, the first actuator 130 performs a motion 760 and moves in a direction towards the second end of the body 110, effectively moving the housing 121 and the attached needle 150 to a safer position away from the subject or patient, when held by the body 110. In other words, the user such as a physician, can feel safe that the carefully selected depth of the needle will not suddenly increase and "stab" the patient, when sampling begin. The second actuator 140 is controlled to remain stationary, to maintain the position of the plunger 123 relative to the body 110, illustrated by the flat line 750.

[0122] Collecting of samples then begin and the first motion by the first actuator 130 performs a first reciprocating motion, effectively moving the housing 121 and the needle 150 back and forth between end points, to obtain samples from the target volume. The first reciprocating motion typically moves the actuator and / or the housing 121 in a stroke between two end points having a maximum amplitude DI and a minimum amplitude D2.

[0123] In Fig. 7. A, the reciprocating motion is shown as a sinusoidal movement, however any suitable reciprocating motion may be used, e.g., motion mimicking a square wave or triangular signal, without departing from the present disclosure.

[0124] In a second alternative of the sampling mode, the actuators are controlled such that the housing of the held syringe moves back and forth, and the plunger moves in a synchronized manner with the housing.

[0125] Fig. 7B shows a further example of first and second movement when operating in sampling mode according to one or more embodiments of the present disclosure.

[0126] In Fig. 7B, the control arrangement 160 and the device 100 is configured to operate in the sampling mode. In this mode the sampling device 100 collects samples, e.g., from the target volume 310.Fig. 7B shows a diagram showing amplitude A of movement performed by the actuators 130, 140 on the vertical axis, and further shows elapsed time T on the horizontal axis. In this example, phases of use is separated by vertical dotted lines.

[0127] The user or operator of the sampling device typically initially force the needle into the target area. See Fig. 3B and related text for further details.

[0128] In the third phase, the second actuator 140 is controlled to move in a direction towards the second end of the body 110 to at least partially slide the plunger 123 in the housing 121 of the syringe 120 and create an under-pressure or vacuum. See Fig. 3C and related text for further details. This part of the second movement is shown as a linear movement 710, but may be selected to be any suitable movement that draws the plunger back to create under-pressure or vacuum. In this example, it is assumed that the syringe 120 is typically initially placed in the sampling device with the plunger 123 fully pressed into the housing 121.

[0129] The first actuator 130, is controlled to remain stationary, to maintain the position of the housing 121, illustrated by the flat line 720.

[0130] In the initial part of the fourth phase, the first actuator 130 is controlled to perform a motion synchronized with the second actuator 140 and move in a direction towards the second or distal end of the body 110, effectively moving the housing 121 and the attached needle 150 to a safer position away from the subject or patient, when held by the body 110. . In other words, the user such as a physician, can feel safe that the carefully selected depth of the needle will not suddenly increase and "stab" the patient, when sampling begin. The second actuator 140 is controlled to remain stationary, to maintain the position of the plunger 123 relative to the body 110, illustrated by the flat line 750.

[0131] Collecting of samples begin and the first motion by the controlled first actuator 130 performs a first reciprocating motion 760, effectively moving the housing 121 and the needle 150 back and forth, to obtain samples from the target volume 310. The second motion by the second actuator 140 performs a second reciprocating motion 750, synchronized with the first reciprocating motion, to maintain a constant position of the plunger 123 within the housing 121. In other words, to maintain a substantially constant distance between the position of the first actuator 130 and the position of the second actuator 140. It can be seen that the distance in fact differs, by the distance is sufficient to maintain the under-pressure or vacuum.

[0132] The first reciprocating motion typically moves the actuator 130 and / or the housing 121 in a stroke between the first and second end points having a maximum amplitude DI and a minimum amplitude D3. The second reciprocating motion typically moves the actuator 140 and / or the plunger 123 in a stroke between the third and fourth end points having a maximum amplitude D3 and a minimum amplitude D4.

[0133] Fig.8 shows a computer 800 according to one or more embodiments of the present disclosure. The computer may e.g., be in the form of or comprised by an Electronic Control Unit, a server, an on-board computer or a control arrangement.

[0134] The computer may e.g., be in the form of any hardware or hardware / firmware device implemented using processing circuity such as, but not limited to, a processor, Central Processing Unit (CPU), a controller, an arithmetic logic unit (ALU), a digital signal processor, a microcomputer, a field programmable gate array (FPGA), a System-on-Chip (SoC), a programmable logic unit, a microprocessor, an application-specific integrated circuit, or any other device capable of electronically performing operations in a defined manner.The computer may comprise a processor or processing means 812 communicatively coupled to a transceiver 804 configured for wired or wireless communication. Further, the computer may further comprise at least one optional antenna (not shown in figure). The antenna may be coupled to the transceiver 804 and is configured to transmit and / or emit and / or receive wireless signals in a wireless communication system, e.g., wireless signals comprising data. In one example, the processor 812 may be any of a selection of processing circuitry and / or a central processing unit and / or processor modules and / or multiple processors configured to cooperate with each-other. Further, the computer may further comprise a memory 815. The memory 815 may contain instructions executable by the processor to perform any of the methods described herein. The memory and / or computer-readable storage medium referred to herein may comprise of any memory, such as a ROM (Read-Only Memory), a PROM (Programmable Read-Only Memory), an EPROM (Erasable PROM), a Flash memory, an EEPROM (Electrically Erasable PROM), or a hard disk drive.

[0135] In a further embodiment, the computer may further comprise and / or be coupled to one or more sensors configured to e.g., receive and / or obtain and / or measure physical properties pertaining to the waste processing system and send one or more sensor signals indicative of the physical properties to the processing means 812 or any other assembly, unit or device disclosed herein.

[0136] In one or more embodiments the computer may further comprise an input device 817, configured to receive input or indications from a user and send a user-input signal indicative of the user input or indications to the processor or processing means 812.

[0137] In one or more embodiments the computer may further comprise a display 818 configured to receive a display signal indicative of rendered objects, such as text or graphical user input objects, from the processor or processing means 812 and to display the received signal as objects, such as text or graphical user input objects.

[0138] In one embodiment the display 818 is integrated with the user input device 817 and is configured to receive a display signal indicative of rendered objects, such as text or graphical user input objects, from the processing means 812 and to display the received signal as objects, such as text or graphical user input objects, and / or configured to receive input or indications from a user and send a user-input signal indicative of the user input or indications to the processing means 812.

[0139] In embodiments, the processing means 812 is communicatively coupled to a selection of any of the memory 815 and / or the communications interface and / or transceiver and / or the input device 817 and / or the display 818 and / or the one or more sensors. In embodiments, the transceiver 804 communicates using wired and / or wireless communication techniques. The wired or wireless communication techniques may comprise any of a CAN bus, Bluetooth, WiFi, GSM, UMTS, LTE or LTE advanced communications network or any other wired or wireless communication network known in the art.

[0140] The control arrangement, 160, described herein may comprise all or a selection of the features described in relation to Fig. 8. The computer 800 may be comprised in the control arrangement, 160.

[0141] In one embodiment, a control arrangement 160 is provided, the control arrangement comprising:a processor, and a memory, said memory containing instructions executable by said processor, whereby said control arrangement is operative to perform any of the methods described herein.

[0142] In one embodiment, a computer program / program product is provided and comprises instructions which, when the program is executed by a computer, cause the computer to carry out the methods described herein.

[0143] In one embodiment, a computer-readable medium is provided and comprises instructions which, when executed by a computer, cause the computer to carry out the methods described herein.

[0144] In some embodiments, the computer-readable medium may be a non-transitory computer-readable medium, such as a tangible electronic, magnetic, optical, infrared, electromagnetic, and / or semiconductor system, apparatus, and / or device.

[0145] The computer may be any hardware or hardware / firmware device implemented using processing circuity such as, but not limited to, a processor, Central Processing Unit (CPU), a controller, an arithmetic logic unit (ALU), a digital signal processor, a microcomputer, a field programmable gate array (FPGA), a System-on-Chip (SoC), a programmable logic unit, a microprocessor, an application-specific integrated circuit, or any other device capable of electronically performing operations in a defined manner.

[0146] In embodiments, the communications network communicate using wired or wireless communication techniques that may include at least one of a Local Area Network (LAN), Metropolitan Area Network (MAN), Global System for Mobile Network (GSM), Enhanced Data GSM Environment (EDGE), Universal Mobile Telecommunications System, Long term evolution, High Speed Downlink Packet Access (HSDPA), Wideband Code Division Multiple Access (W-CDMA), Code Division Multiple Access (CDMA), Time Division Multiple Access (TDMA), Bluetooth®, Zigbee®, Wi-Fi, Voice over Internet Protocol (VoIP), LTE Advanced, IEEE802.16m, Wireless MAN-Advanced, Evolved High-Speed Packet Access (HSPA+), 3GPP Long Term Evolution (LTE), Mobile WiMAX (IEEE 802.16e), Ultra Mobile Broadband (UMB) (formerly Evolution-Data Optimized (EV-DO) Rev. C), Fast Low-latency Access with Seamless Handoff Orthogonal Frequency Division Multiplexing (Flash-OFDM), High Capacity Spatial Division Multiple Access (iBurst®) and Mobile Broadband Wireless Access (MBWA) (IEEE 802.20) systems, High Performance Radio Metropolitan Area Network (HIPERMAN), Beam-Division Multiple Access (BDMA), World Interoperability for Microwave Access (Wi-MAX) and ultrasonic communication, etc., but is not limited thereto.

[0147] Moreover, it is realized by the skilled person that the system and / or devices described herein may comprise the necessary communication capabilities in the form of e.g., functions, means, units, elements, etc., for performing the present solution. Examples of other such means, units, elements and functions are: processors, memory, buffers, control logic, encoders, decoders, rate matchers, de-rate matchers, mapping units, multipliers, decision units, selecting units, switches, interleavers, de-interleavers, modulators, demodulators, inputs, outputs, antennas, amplifiers, receiver units, transmitter units, DSPs, MSDs, encoder, decoder, power supply units, power feeders, communication interfaces, communication protocols, etc. which are suitably arranged together for performing the present solution. Especially, the processor and / or processing means of the present disclosure may comprise one or more instances of processing circuitry, processor modules and multiple processorsconfigured to cooperate with each-other, Central Processing Unit (CPU), a processing unit, a processing circuit, a processor, an Application Specific Integrated Circuit (ASIC), a microprocessor, a Field-Programmable Gate Array (FPGA) or other processing logic that may interpret and execute instructions. The expression "processor" and / or "processing means" may thus represent a processing circuitry comprising a plurality of processing circuits, such as, e.g., any, some or all the ones mentioned above. The processing means may further perform data processing functions for inputting, outputting, and processing of data comprising data buffering and device control functions, such as user interface control, or the like.

[0148] Fig. 9 shows a flowchart for a method 900 according to one or more embodiments of the present disclosure. The method performed by a control arrangement 160 configured to collect a sample from a target volume, e.g., to perform fin needle aspiration biopsy.

[0149] The control arrangement 160 is configured to operate in a selection of any of a loading mode, an idle mode, a ready mode, a sampling mode, and an unloading mode by controlling the first actuator 130 and / or the second actuator 140 to move within a respective stroke. For details on the respective strokes see Fig. 5A-B and 6A-B.

[0150] The control arrangement 160 is configured to control the first actuator 130 to perform the first motion within the respective stroke, wherein the first movement is limited between a first end point of the respective stroke where the first actuator 130 is extended to a maximum stroke and a second end point where the first actuator 130 is extended to a minimum stroke. The control arrangement 160 is configured to control the second actuator 140 to perform the second motion within the respective stroke, wherein the second movement is limited between a third end point D4 of the respective stroke where the second actuator 140 is extended to a maximum stroke and a fourth end point D5 where the first actuator 130 is extended to a minimum stroke.

[0151] The method 900 comprising:

[0152] Operating 910, during a first phase of use of the sampling device 100, in a loading mode by controlling the first actuator 130 to a first end point or position D3 (of the respective stroke). It is envisioned that the first actuator 130 could alternatively be controlled to either of the first or second end points DI, D2, without departing from the present disclosure. However, by controlling the first actuator 130 to the first end point or position D3, risk to the patient is reduced.

[0153] Optionally, further also controlling the second actuator 140 to a third end point or position D4 (of the respective stroke).

[0154] The control arrangement 160 is typically triggered to operate in the loading mode by a user input, e.g., a input device such as a user pressing a button. Alternatively, the device is automatically placed in loading mode at power-down or in a sleep mode. Optionally, the control arrangement 160 may optionally be triggered to operate in the loading mode in response to a control signal, e.g., a wireless control signal received from a different device, e.g., from an app of a mobile device.

[0155] Operating 920, during a second phase of use of the sampling device 100, in an idle mode by maintaining the first actuator 130 in the first intermediate point DI, and maintaining the second actuator 140 at the third end point D4. This allows for user of the assembly 10 to place a needle in the target volume 310, see. e.g., Fig. 3B.The control arrangement 160 is typically triggered to operate in the idle mode by a user input, e.g., a user pressing a button. However, the control arrangement 160 may optionally be triggered to operate in the idle mode in response to a control signal, e.g., a wireless control signal received from a different device, e.g., from an app of a mobile device.

[0156] In some embodiments, the loading mode and idle mode is implemented as one mode.

[0157] Operating 930, during a third phase of use of the sampling device 100, in a ready mode by maintaining the first actuator 130 in the first intermediate point, and controlling the second actuator 140 to a second intermediate point or position D6 (of the respective stroke) to create a vacuum in a housing 121 of the syringe 120. This is further illustrated in relation to Fig. 3C. This makes the assembly 10 ready to obtain a sample from the target volume.

[0158] The control arrangement 160 is typically triggered to operate in the ready mode by a user input via an input device, e.g., a user pressing a button. However, the control arrangement 160 may optionally be triggered to operate in the loading mode in response to a control signal, e.g., a wireless control signal received from a different device, e.g., from an app of a mobile device.

[0159] Operating 940, during a fourth phase of use of the sampling device 100, in a sampling mode by controlling the first actuator 130 to perform the first motion as a first reciprocating motion to obtain samples.

[0160] In one alternative, the control arrangement 160 is further configured to operate in sampling mode by controlling the second actuator 140 to hold the plunger 123 in a fixed or constant intermediate point or position, e.g., D6, where the tip 125 is held in a position where the under pressure or vacuum in the housing 121 and / or needle 150 is maintained. In other words, the housing 121 is moved back and forth and the plunger 125 is held stationary to obtain samples from the target volume 310 of the subject 311.

[0161] In one further alternative, the control arrangement 160 is further configured to operate in sampling mode by controlling the second actuator 140 to perform a second reciprocating motion synchronized with the first reciprocating motion performed by the first actuator 130. In other words, the housing 121 and plunger is moved back and forth in a synchronized manner to obtain samples from the target volume 310 of the subject 311.

[0162] The control arrangement 160 is typically triggered to operate in the sampling mode by a user input via an input device, e.g., a user pressing a button. However, the control arrangement 160 may optionally be triggered to operate in the loading mode in response to a control signal, e.g., a wireless control signal received from a different device, e.g., from an app of a mobile device.

[0163] In one embodiment, the first and / or second reciprocating motion is paused if no user input or control signal is received, e.g., a user releases the button. The first and / or second reciprocating motion is resumed when user input or control signal is received again. This allows for the physician to adjust the tip of the needle, and resume taking samples.

[0164] Optionally, operating 950, during a sixth phase of use of the sampling device 100, in an unloading mode by controlling the first actuator 130 to the first intermediate point D3, and control the second actuator 140 to a third intermediate point, and then to in the opposite direction the third end point D4 to force a collected sample in the held housing out through the outlet 124 (of the housing 121).Fig. 10A shows a first perspective view of the sampling device provided with a casing 1010 according to one or more embodiments of the disclosure. The casing encloses all internal parts described in relation to Fig. 1. And Fig. 2. The casing is further provided with a slidable lid or hatch 1020. The slidable lid is configured to move between a first / loading position and a second / securing position. In the loading position, a syringe may be placed in the sampling device 100. When the lid is moved to the securing position, the loaded syringe is secured in the sampling device 100.

[0165] In one embodiment, the casing 1010 may be adapted to be held by robotic arm. E.g., provided with a shape that matches a gripper attachment of a robot.

[0166] In one embodiment, the casing 1010 may be adapted to be held by user, e.g., be provided with a grip surface, such as being provided with a grip surface. The casing surface may include a pattern engraved therein, thereby forming a grip surface providing an increased coefficient of friction. The grip surface typically includes recessed portions and non-recessed portions, e.g., arranged as stripes or a mesh.

[0167] Fig. 10B shows a second perspective view of the sampling device provided with a casing 1010 according to one or more embodiments of the disclosure.

[0168] Fig. 10C shows a third perspective view of the sampling device provided with a casing 1010 according to one or more embodiments of the disclosure.

[0169] Fig. 10C shows the opposite side of the sampling device to where the lid 1020 is located. The casing 1010 is provided with an input device 1030, in this case a push-button. Any suitable input device 1030 may be envisioned, e.g., touch button, microphone etc.

[0170] The sampling device 100 may further be provided with a power switch 1040, configured to connect or disconnect the power source / battery.

[0171] The sampling device 100 may further be provided with a power port or charging port or interface 1050, configured to couple receive power, e.g., to the control unit or the power unit or battery. Additionally, or alternatively, The charging port or interface 1050 is further configured to couple to external nodes or computers and exchange data, e.g., end point of strokes or selection of operational modes. This allows for an external control arrangement to be coupled to the sampling device 100. In one example, this may be a Universal Serial Bus connector, e.g., type A, B or C.

[0172] Fig. 11 shows an exploded view of the sampling device 100 according to one or more embodiments of the disclosure.

[0173] Fig. 11 shows:

[0174] A first part 1 and a second part 2 of the casing 1010

[0175] Screws 14, 21, 22. Lead screws 3-4. Housing holder 5, 221. Plunger holder 6, 231. Threaded sleeve 7. Lid 9, 1020. Input device 10, 1030. Indicator arm 11. Lid frame 12. Sensor axle 13. Battery 15. Actuator 16. Torsion spring 17, 18. Groove ball bearing 19. Groove ring 20.

[0176] It is understood that the sampling device 100 in Fig. 11 is for illustrative purposes, and alternative implementations is envisioned.

[0177] Fig. 12A-C shows different views of the housing holder 221 according to one or more embodiments of the disclosure.Fig. 12A a front view of the housing holder 221 according to one or more embodiments of the disclosure. As can be seen, the housing holder 221 is formed like a u-shaped clip configured to receive the barrel and barrel flange of the syringe. The figure further shows through holes with diameters corresponding to a respective sliding member or rod. A section A-A is further illustrated.

[0178] Fig. 12B a side view of the housing holder 221 according to one or more embodiments of the disclosure.

[0179] Fig. 12C a section view of the housing holder 221 according to one or more embodiments of the disclosure. The section A-A of the housing holder 221 further shows details of the u-shaped clip configured to receive the barrel and barrel flange of the syringe.

[0180] The measurements in provided Fig. 12A-C are to be seen as non-limiting example of how the housing holder 221 may be implemented. Different sizes of syringes may be used, and the measurements of the sampling device 100 may be adapted accordingly.

[0181] Fig. 13A-F shows different views of the plunger holder 231 according to one or more embodiments of the disclosure. As can be seen, the plunger holder 231 is formed like an u-shaped clip configured to receive the plunger stem and the plunger flange.

[0182] Fig. 13A shows a bottom view of the plunger holder 231 according to one or more embodiments of the disclosure.

[0183] Fig. 13B shows a side view of the plunger holder 231 according to one or more embodiments of the disclosure.

[0184] Fig. 13C shows a top view of the plunger holder 231 according to one or more embodiments of the disclosure. A section B-B through the clip adapted to receive the barrel flange of the syringe 120 is further illustrated.

[0185] Fig. 13D shows a section view of the plunger holder 231 according to one or more embodiments of the disclosure. The figure illustrates a section B-B.

[0186] Fig. 13E shows a front view of the plunger holder 231 according to one or more embodiments of the disclosure.

[0187] Fig. 13D shows a section view of the plunger holder 231 according to one or more embodiments of the disclosure. The figure illustrates a section E-E.

[0188] Fig. 14 shows an example of the sampling device 100 with part of the casing removed according to one or more embodiments of the disclosure. In Fig. 14, a syringe 120 is held by the sampling device 100. The first and second actuators 130, 140 are coupled to the body 110, and to the housing holder 221 and plunger holder 231 respectively. Further the input device 1030, in this case a push-button, is also shown as being arranged so that it protrudes through the casing 1010. Also the arrangement of the battery 1410 and the charging port or interface 1050 is shown.

[0189] Finally, it should be understood that the invention is not limited to the embodiments described above, but also relates to and incorporates all embodiments within the scope of the appended independent claims.

Claims

CLAIMS1. A sampling device (100) configured to perform fin needle aspiration, wherein the sampling device comprises:a body (110) configured to slidably hold a disposable syringe (120) at a first end of the body (110),a first actuator (130) coupled to the body (110), and configured to be coupled to a housing (121) of the disposable syringe (120), the first actuator configured to perform a first motion to slide the housing (121) along a longitudinal axis (122) of the disposable syringe when held by the body (110),a second actuator (140) coupled to the body (110), and configured to be coupled to a plunger (123) of the disposable syringe (120), the second actuator configured perform a second motion to slide the plunger along the longitudinal axis (122), a control arrangement (160) communicatively coupled to the first actuator (130) and the second actuator (140).

2. The sampling device according to claim 1, wherein the body (110) further comprises linkage (200) and a base (210), wherein the linkage (200) comprises a first part (220) and a second part (230).

3. The sampling device according to claim 2,wherein the first part (220) of the linkage (200) comprises a housing holder (220) configured to couple the first actuator (130) to the housing (121), andwherein the second part (230) of the linkage (200) comprises a plunger holder (230) configured to couple the second actuator (140) to the plunger (123),wherein the housing holder (220) is arranged to slide along a second axis parallel to the longitudinal axis (122),wherein the plunger holder (230) is arranged to slide along a third axis parallel to the longitudinal axis (122).

4. The sampling device according to any of the preceding claims, wherein the control arrangement (160) is configured to operate in a selection of any of a loading mode, an idle mode, a ready mode, a sampling mode and an unloading mode by controlling the first actuator (130) and / or the second actuator 140 to move within a respective stroke.

5. The sampling device according to claim 4, wherein the control arrangement (160) is configured to control the first actuator (130) to perform the first motion within the respective stroke, wherein the first movement is limited between a first end point of the respective stroke where the first actuator (130) is extended to a maximum stroke and a second end point where the first actuator (130) is extended to a minimum stroke.

6. The sampling device according to any of claims 4-5 , wherein the control arrangement (160) is configured to control the second actuator 140 to perform the second motion within the respective stroke, wherein the second movement is limited between a third end point of the respective stroke where the second actuator 140 is extended to a maximum stroke and a fourth end point where the first actuator 130 is extended to a minimum stroke.

7. The sampling device according to claim6, wherein the control arrangement (160) in a first phase is configured to operate in a loading mode, wherein the control arrangement (160) operating in the loading mode is configured to control the first actuator (130) to a first intermediate point, and control the second actuator (140) to the third end point.

8. The sampling device according to any of claims 6-7, wherein the control arrangement (160) in a second phase is configured to operate in an idle mode, wherein the control arrangement (160) operating in the idle mode is configured to maintain the first actuator (130) in the first intermediate point, and maintain the second actuator (140) at the third end point.

9. The sampling device according to any of claims 6-8, wherein the control arrangement (160) in a third phase is configured to operate in a ready mode, wherein the control arrangement (160) operating in the ready mode is configured to maintain the first actuator (130) in the first intermediate point, and control the second actuator (140) to a second intermediate point to create a vacuum in a housing (121) of the syringe (120).

10. The sampling device according to any of claims 6-9, wherein the control arrangement (160) in a fourth phase is configured to operate in a sampling mode, wherein the control arrangement (160) operating in the ready mode is configured to control the first actuator (130) to perform the first motion as a first reciprocating motion to obtain samples.

11. The sampling device according to any of claims 6-10, wherein the control arrangement (160) in a fifth phase is configured to operate in the ready mode, wherein the control arrangement (160) operating in the ready mode is configured to maintain the first actuator (130) in the first intermediate point, and control the second actuator (140) to a second intermediate point to maintain a vacuum in a housing (121) of the syringe (120).

12. The sampling device according to any of claims 6-11, wherein the control arrangement (160) in a sixth phase is configured to operate in an unloading mode, wherein the control arrangement (160) operating in the unloading mode is configured to control the first actuator (130) to the first intermediate point, and control the second actuator (140) to a third intermediate point and then to the third end point to force a collected sample in the held housing out through an outlet (124).

13. The sampling device according to any of the preceding claims, wherein the control arrangement (160) is configured to operate in a selection of any of a loading mode, an idle mode, a ready mode, a sampling mode, and an unloading mode in response to a received control signal.

14. An assembly configured to perform fin needle aspiration biopsy, the assembly comprising:the sampling device (100) according to any of claims 1-13,a disposable syringe (120) configured with an outlet (124),a needle (150) configured to be attached to the outlet (124),wherein the disposable syringe (120) is held by the sampling device (100), and the needle is attached to the outlet (124) of the disposable syringe (120).

15. A method to perform fin needle aspiration, the method comprising:placing a disposable syringe (120) having an attached needle (150) to be held by the sampling device (100) according to any of claims 1-13,providing a first user indication to place the sampling device (100) in an idle mode, placing a tip of the needle (150) in a target area (310) of a subject (311),providing a second user indication to place the sampling device (100) in a ready mode, and subsequently to place the sampling device (100) in a sampling mode to obtain a sample from the target area (310),providing a third user indication to place the sampling device (100) back in the ready mode,removing the tip of the needle (150) from the target area (310) and the subject (311).

16. The method according to claim 15, further comprising:removing the disposable syringe (120) from the sampling device (100),place the sampling device (100) in the idle mode after the disposable syringe (120) has been removed,17. The method according to claim 16, further comprising:inserting the outlet (124) or the needle (150) into a container comprising sample retaining liquid.sucking liquid into the syringe (120), and then injecting the sample mixed with the liquid back into the container,send the container for analysis.

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