Valve Assembly

Abstract

The present invention discloses a valve assembly for controlling the flow of fluid in a channel (135) extending along a longitudinal central distal axis. The valve assembly (150) includes a switch (152), a deformable tube (170) surrounding the channel (135), and a sphere (160) disposed within the tube (170) between a distal channel portion (133) and a proximal channel portion (137) of the channel (135). When the tube (170) is in an undeformed, resting state, the valve assembly (150) is in a closed state and the sphere (160) is in direct contact with the tube (170) forming a fluid seal therewith, and when a force is applied to the switch (152), the tube (170) is in a deformed, non-resting state and the valve assembly (150) is in an open state, thereby allowing fluid to pass from the sphere (160). The present invention further relates to a biopsy syringe including the valve assembly (150).

Description

[Technical field]

[0001] The present invention relates to a valve assembly for regulating the flow of a fluid in a channel, and further to a biopsy syringe including said valve assembly. [Background technology]

[0002] A biopsy, such as fine needle aspiration biopsy (FNAB or FNA), fine needle aspiration cytology (FNAC), or core needle biopsy (CNB), is a diagnostic procedure used to remove a sample of tissue or fluid from a mass found in an organ or under the skin of the body. Fine needle aspiration biopsy may also be performed to identify the type of cells within a mass or to see how well a treatment for an existing mass is working. FNA is commonly used to study masses found in the breast or thyroid (a gland found in the neck), but can also be used in other parts of the body. A core needle biopsy (CNB) is similar to an FNAB. A slightly larger, hollow needle is used to remove a small cylinder (or core) of tissue. CNBs are always performed using local anesthesia in a health care provider's office. The needle is inserted 3-6 times to obtain a sample or core. This takes longer than an FNAB, but more tissue is sampled for analysis, so there is a higher chance of a clearer result. These methods are very useful ways to detect cancer.

[0003] One biopsy technique used to evaluate breast tissue involves inserting a biopsy probe into the breast tissue in the area of ​​interest to obtain one or more tissue samples. Such biopsy techniques may use a vacuum to place the tissue to be sampled into a sample notch in the biopsy probe, after which the tissue is cut and collected. A thin, hollow needle is inserted through the skin into the area of ​​interest. The needle is usually attached to a syringe.

[0004] WO 2017 / 129735 discloses a convenient biopsy syringe for extracting fluids and / or tissues, comprising a barrel with a proximal lumen and a distal lumen for collecting aspirated fluid / tissue. A plunger head of a plunger sealingly engages within the barrel, and a valve is located between the plunger head and the distal end of the syringe within the barrel, separating the proximal and distal lumens. The valve regulates the flow of air between the distal and proximal lumens and is operated by a valve switch. The valve thus allows the biopsy syringe to achieve two configurations: an open state in which air can flow between the distal and proximal lumens, and a closed state in which air cannot flow therebetween.

[0005] However, although the biopsy syringe disclosed in WO 2017 / 129735 is an improvement over other existing solutions, the technique of biopsy samples is delicate. Any disturbance in the air flow regulated by the valve assembly may damage the extracted sample, which may result in erroneous results during analysis. Furthermore, the multiple valves available on the market are complex, which makes the manufacturing process cumbersome. Therefore, there is a need for an improved valve assembly for a biopsy syringe that is reliable and easy to manufacture. Summary of the Invention

[0006] In view of the above drawbacks, it is an object of the present invention to provide a valve assembly for controlling the flow of fluid in a channel extending along a longitudinal central axis. The valve assembly includes a switch, a deformable tube surrounding a channel, and a sphere disposed within the tube between a distal channel portion and a proximal channel portion of the channel. When the tube is in an undeformed, resting state, the valve assembly is in a closed state and the sphere is in direct contact with the tube to form a fluid seal with the tube. When a force is applied to the switch, the tube is in a deformed, non-resting state and the valve assembly is in an open state, thereby allowing fluid to pass from the sphere.

[0007] This is advantageous because the valve assembly and its mechanism are designed such that the parts always deform in the same way. Thus, the function of the valve assembly is very reliable because it provides repeatable switching between open and closed configurations. Other valve mechanisms in the art often rely on the movement of parts within the mechanism to establish a fluid flow path. Furthermore, this valve assembly is easy to manufacture and can be adapted to multiple different types of syringes in the art.

[0008] In one embodiment, when the valve assembly is in an open state, the tube is pulled laterally, perpendicular to the extension of the channel.

[0009] In a further embodiment, when the valve assembly is in an open state, an opening is disposed between at least a portion of the sphere and the tube.

[0010] In another embodiment, the tube has a platform extending laterally from the tube, the platform in communication with the switch and configured to receive a force applied to the tube by the switch.

[0011] The switch may include at least one leg in contact with the platform, the leg transmitting a force applied to the switch to the platform.

[0012] In one embodiment, the channel is made of a material that is stiffer than the material forming the tube.

[0013] In a further embodiment, the distal channel portion has a distal channel slit at its proximal end and the proximal channel portion has a proximal channel slit at its distal end, the distal and proximal slits facing the sphere. The distal and proximal slits may extend transversely to the channel portions. Furthermore, the distal and proximal slits may have a U-shaped configuration transverse to the distal and proximal channel portions.

[0014] In one embodiment, the valve assembly is disposed within a syringe, preferably at the distal end of the syringe between the distal tip and the barrel.

[0015] In another embodiment, the syringe includes a platform receiving recess configured to receive the platform when a force is applied to the switch, preferably the platform receiving recess is located at the distal end of the syringe.

[0016] The tube is made of an elastomer, preferably rubber or silicone.

[0017] In a second aspect, a biopsy syringe is provided that extends along a longitudinal central distal axis. The biopsy syringe includes a valve assembly as disclosed herein. This is advantageous because use of a biopsy syringe is a precise and delicate process, and the advantages of the valve assembly make a biopsy syringe including such a valve assembly highly beneficial. The valve assembly is easy to manufacture, and the repeatability of switching the valve assembly between open and closed configurations provides reliable results.

[0018] In one embodiment, the biopsy syringe is a fine needle aspiration syringe or a core needle biopsy syringe.

[0019] Further features of the invention and embodiments thereof are set out in the accompanying claims. [Brief description of the drawings]

[0020] These and other possible aspects, features and advantages of the present invention will become apparent and elucidated from the following description of non-limiting embodiments of the invention, taken in conjunction with the accompanying drawings.

[0021] [Figure 1] FIG. 2 is a longitudinal sectional view of a biopsy syringe. [Diagram 2] FIG. 2 is a longitudinal cross-sectional view of the distal portion of the biopsy syringe. [Diagram 3] FIG. 2 is a cross-sectional view of the distal portion of the biopsy syringe viewed from the distal direction. [Figure 4] FIG. 2 is a cross-sectional view of the distal portion of the biopsy syringe viewed from the proximal direction. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] The embodiments of the present invention will be described in more detail below with reference to the accompanying drawings so that those skilled in the art can practice the present invention. However, the present invention may be embodied in many different forms and should not be construed as being limited to the embodiments described herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present invention to those skilled in the art. These embodiments do not limit the present invention, which is limited only by the scope of the appended claims. Furthermore, the terminology used in the detailed description of the specific embodiments shown in the accompanying drawings is not intended to limit the present invention.

[0023] Hereinafter, an embodiment of the present invention will be described with reference to FIGS.

[0024] As shown in Figure 1, the perspective central axis C A 1, a biopsy syringe 100 is shown extending along a central axis C and having a proximal end 102 and a distal end 104. Additionally, the syringe 100 is oriented along a central axis C. A A horizontal axis L extending perpendicular to AThe biopsy syringe 100 is also referred to herein as a needle extraction syringe 100 and may be a fine needle aspiration syringe.

[0025] The biopsy syringe 100 includes a hollow barrel 110 having a proximal lumen 112 and a distal lumen 114. A plunger 120 is disposed within the hollow barrel 110 and has a distal plunger stopper 122 and a proximal pusher element 124. The plunger stopper 122 fluid-tightly engages an inner wall 115 of the barrel 110 such that liquid or gas cannot pass through a barrier formed between the inner wall 115 and the plunger stopper 122.

[0026] When a distal force is applied to the proximal pusher element 124, the plunger 120 moves towards the distal end 104 of the biopsy syringe 100. Additionally, the plunger 120 includes a spring member 125 that gives the plunger 120 elastic properties. The direction of movement of the plunger 120 is indicated by a double-headed arrow in FIG.

[0027] A seal element 123 is provided proximal to the plunger stopper 122 in FIG. 1. Check valves 121a, 121b are provided on the plunger stopper 122 and the seal element 123. Additionally, the plunger stopper 122 is equipped with an umbrella-type check valve 127, which, in an open state, is in fluid communication with the internal channel 111. The internal channel 111 is oriented along a central axis C. A It extends along.

[0028] Additionally, the internal channel 111 extends through the proximal lumen 112. The syringe 100 of Figure 1 further includes a pressure channel 105 between the distal lumen 114 and the proximal lumen 112. The pressure channel 105 extends through the pressure shift valve 103. A deck bill check valve 106 is provided at the distal end of the pressure channel 105.

[0029] Additionally, the biopsy syringe 100 further includes a distal end 130 and a distal tip 140, the distal tip having internal threads 143 for connecting a needle or cannula (not shown) to the biopsy syringe 100. A channel 135 extends from the distal tip 140 to the barrel 110. Thus, the channel 135 provides communication between the distal tip 140 and the distal lumen 114 of the hollow barrel 110.

[0030] 1-4, distal end 130 is provided with a valve assembly 150 that includes a switch 152. Valve assembly 150 is configurable between an open state and a closed state, and is further described below with reference to FIGS.

[0031] It should be understood that the biopsy syringe 100 disclosed in FIG. 1 is an exemplary biopsy syringe 100, and that the valve assembly 150 may be included in other types of biopsy syringes, such as the biopsy syringe disclosed in WO 2017 / 129735.

[0032] Preferably, barrel 110, plunger 120, distal end 130, and distal tip 140 are manufactured from a polymeric material, such as polypropylene (PP).

[0033] The valve assembly 150 is a ball valve assembly and is shown in more detail in FIG. 2, which is an enlarged view of the distal end 130 of the syringe 100 shown in FIG. 1. The valve assembly 150 is oriented along a central longitudinal axis C. AThe valve assembly 150 is configured to control the flow of fluid and / or vacuum within a channel 135 extending along the distal channel portion 133 and a proximal channel portion 137 of the channel 135, the valve assembly 150 including a switch 152, a deformable tube 170 surrounding the channel 135, and a sphere 160 disposed within the tube 170 between a distal channel portion 133 and a proximal channel portion 137 of the channel 135. When the tube 170 is in an undeformed, resting state, the valve assembly 150 is in a closed state and the sphere 160 is in direct contact with the tube 170 to form a fluid and / or vacuum seal with the tube 170. When a force is applied to the switch 152, the tube 170 is in a deformed, unresting state and the valve assembly 150 is in an open state, thereby allowing fluid to pass from the sphere 160.

[0034] 2, the valve assembly 150 includes a sphere or ball 160 disposed within a tube 170 within a tube lumen 177. The sphere 160 is preferably formed of a polymeric material, such as PP, or a metal, such as stainless steel. Preferably, the sphere 160 is formed of stainless steel.

[0035] Tube 170 is formed of a deformable, flexible material, and may be formed of, for example, a polymeric material, silicone, or rubber. Tube 170 may be formed of an elastomer. Thus, tube 170 is formed of a more flexible material than channel 135. Channel 135 is made of a material that has a higher stiffness than tube 170. Thus, channel 135 can withstand a higher pressure or force applied thereto than that of tube 170.

[0036] When a strain is applied to the tube 170, the material deforms and when no force is applied and no strain is applied to the tube 170, the material flexes back to its rest state. In the valve assembly 150, the tube 170 is subjected to such strain due to its interaction with the switch 152.

[0037] 2 to 4, the tube 170 is provided with a tube platform 175 and a longitudinal protrusion 176 disposed on both sides of the tube 170. The tube platform 175 and / or the longitudinal protrusion 176 are preferably formed integrally with the tube 170. For example, the tube 170 including the tube platform 175 and the longitudinal protrusion 176 is integrally molded.

[0038] The outer surface of ball 160 is in direct contact with the inner surface of tube lumen 177 to prevent fluids (such as liquids and gases) from entering barrel 110. The diameter of ball 160 is equal to or slightly larger than the diameter of tube lumen 177. This dimensional relationship achieves a fluid seal between the inner surface of tube lumen 177 and ball 160 when tube 170 is not deformed (i.e., when tube 170 is at rest). A fluid seal is a seal that prevents liquids and gases from passing through valve assembly 150. Thus, valve assembly 150 may sustain a pressure differential (such as a vacuum or near vacuum).

[0039] The tube 170 and its tube lumen 177 surround a portion of the channel 135. The channel 135 has a distal channel portion 133 and a proximal channel portion 137. A distal slit 173 is provided at the proximal end of the distal channel portion 133. The distal slit 173 extends transversely to the channel 135 and the distal channel portion 133. Similarly, a proximal slit 174 is provided at the distal end of the proximal channel portion 137. The proximal slit 174 extends transversely to the channel 135 and the proximal channel portion 137. The channel 135 extends between the distal tip 140 and the barrel 110, connects the distal tip 140 and the barrel 110, and is configured to receive fluid aspirated or expelled by the syringe 100. As shown in FIG. 2, the channel 135 is partially embedded within the tube 170.

[0040] The switch 152 is disposed within a distal end cavity 131 of the distal end 130 and protrudes laterally from an opening 134 in the distal end 130 of the syringe 100 .

[0041] Figure 3 shows the dashed line CS in Figure 2. 1 2. FIG. 4 is a cross-sectional view of the distal end 130 taken along dashed line CS in FIG. 2 3 and 4, the switch 152 includes two switch legs 154a, 154b. As shown in FIG. 3, each leg 154a, 154b is provided with a lateral leg projection 156a, 156b.

[0042] Distal end cavity 131 has internal surfaces 132 that extend laterally from an outer distal surface 136 toward an opposite side of distal end 130, perpendicular to axis A. Opposite opening 134, the internal structure of distal end cavity 131 defines a platform receiving recess 138.

[0043] The valve assembly 150 is switched between an open and closed state.

[0044] 2-4, the use of ball valve assembly 150 will be described in more detail. Valve assembly 150 is switchable between two different configurations: a first configuration in a closed state in which fluid and / or vacuum cannot pass through valve 150, and a second configuration in an open state in which fluid (such as liquid, tissue, gas, or vacuum) can pass through valve 150 into and out of barrel 110.

[0045] As described above, the valve assembly 150 is disposed at the distal end 130 of the needle extraction syringe 100. The valve assembly 150 is thus located between the distal tip 140 and the barrel 110 and controls the flow of fluid / vacuum in the channel 135 therebetween. Thus, fluid, such as a liquid or tissue sample, is drawn into the syringe 100 by the vacuum created within the syringe 100. However, the valve assembly 150 may be disposed in another channel in another portion of the syringe 100.

[0046] In a first configuration (see FIG. 3), the valve assembly 150 is in a closed state. The closed state is the resting state of the valve assembly 150. The switch legs 154a, 154b are in direct contact with the tube platform 175. No force is applied to the switch 152. Thus, the deformable tube 170 is not deformed or strained. The sphere 160 forms a fluid and / or vacuum seal with the inner surface of the tube lumen 177 of the tube 170 to prevent fluid from passing through the valve assembly 150.

[0047] To actuate the valve assembly 150 in an open state, a user rotates the switch 152 along the central longitudinal axis C A 170. The switch 152 is thus actuated by a force applied along the transverse axis LA. This causes the switch legs 154a, 154b to exert a lateral force on the tube platform 175. This in turn causes the platform 175 to move laterally towards and into the platform receiving cavity 138. The open state of the valve assembly 150 is thus the deformed, non-resting state of the valve assembly 150. The switch 152 is disposed substantially perpendicular to the tube 170, thereby causing the tube 170 to be forced to move laterally along the transverse axis L. A A force directed along the

[0048] Because platform 175 is integrally formed with tube 170 and tube 170 is fabricated from a deformable material, a force applied to tube 170 and the resulting movement of platform 175 causes deformation of tube 170. Channel 135 is formed from a material that has a higher stiffness than tube 170 and is therefore not subject to lateral forces. Because tube 170 surrounds channel 135, channel 135 is substantially unaffected by a user pressing switch 152 to achieve lateral tension of tube 170. Thus, distal channel portion 133 and proximal channel portion 137 function as force counter acting elements. Thus, the transverse axis L A A pushing force applied along causes tube 170 to deform in the area surrounding tube lumen 177 .

[0049] In this open, deformed, tensioned state, tube 170 achieves a more elliptical cross-section at tube lumen region 177. The shape of sphere 160 within tube lumen 177 is not affected by the applied force. This deformation therefore results in a loss of the fluid seal between the inner surface of tube lumen 177 and the outer surface of sphere 160, and creates at least one opening between sphere 160 and the inner surface of the tube lumen through which fluid may pass through ball valve 150. The deformation of tube 170 therefore places an opening between sphere 160 and tube 170.

[0050] When the user removes the force applied to switch 152, tube 170 returns to its resting state, restoring valve assembly 150 to the first configuration, ie, closed state.

[0051] 2, the distal slit 173 and the proximal slit 174 have a concave elliptical shape to prevent the ball 160 from blocking the channel 135. As a result, when the valve assembly 150 is in an open configuration, there is still an opening for fluid to flow around the ball 160 if the ball 160 is in direct contact with one of the slits 173, 174. The distal slit 173 and the proximal slit 174 may have other shapes, such as a tapered shape or a triangular shape, that allow fluid to pass when the ball 160 is in direct contact with the distal channel portion 133 or the proximal channel portion 137 in the open state of the valve assembly 150.

[0052] Because tube 170 is formed of an elastic material, the shape of tube 170 returns to its initial shape when the force applied to switch 152 is released. Thus, a user may adjust the amount of gas / liquid flowing through valve assembly 150 by selectively pressing switch 152 more or less, thereby facilitating adjustment of valve assembly 150.

[0053] The lateral leg projections 156a, 156b hold the switch 152 in place by abutting the interior cavity surface 132, as shown in Figure 3. When the platform 175 is pressed as far as possible into the platform-receiving recess 138, the user cannot compress the switch 152 any further and the valve assembly 150 reaches an open state with maximum flow rate through the valve assembly 150.

[0054] Additionally, the valve assembly 150 disclosed herein is easy to manufacture, may be designed to fit a variety of devices, and is adjustable in size. The dimensions of the valve assembly 150 are easily adjusted as needed. Additionally, the valve assembly 150 is volume efficient, allowing it to be incorporated into tight spaces, and is easy to manufacture.

[0055] Cumulative creation of vacuum The present disclosure further relates to accumulatively creating a vacuum within the syringe 100 by repeatedly pressing and releasing the plunger 120. To this end, the syringe 100 preferably includes a spring 125, which may be located within the plunger 120 between the sealing element 123 and the proximal push element 124, or in any portion fixedly connected to the proximal push element 124.

[0056] The possibility of generating a vacuum cumulatively offers several advantages to the user. One advantage is that a higher level of vacuum can be obtained by repeatedly removing air. A further advantage is that instead of one long movement of the plunger 120, additional small movements can achieve the same effect, allowing the syringe 100 to be designed to be shorter. From a user ergonomic point of view, using multiple short movements instead of one long movement is more preferable.

[0057] A vacuum is built up by repeatedly pushing the plunger 120 towards the distal end 104 of the syringe 100 and releasing it towards the proximal end 102 of the syringe 100. The syringe 100 may be opened at the distal end 104, which allows additional tissue and / or fluid to be aspirated with each stroke (or the vacuum is built up until the suction force exceeds a limit necessary to begin the process of drawing tissue into the distal lumen 114). Alternatively, when the syringe 100 is closed at the distal end 104, a built up vacuum may be created in the distal lumen 114 and released when the syringe 100 is opened at the distal end 104.

[0058] The syringe 100 disclosed herein further includes a valve assembly 150 at the distal end 104 of the syringe 100, which maintains and releases the vacuum generated within the distal lumen 114 via the tip 140. In this manner, a vacuum is generated by one or more strokes while the valve assembly 150 is closed, thereby disconnecting the distal lumen 114 from the environment outside the syringe 100 via the tip 140. When an appropriate level of vacuum is generated within the distal lumen 114, which in this configuration may act as an accumulator tank, the valve assembly 150 is opened to fluidly connect the distal lumen 114 with the environment outside the syringe 100 (typically when a first hollow needle (not shown) is inserted into the area where fluid and / or tissue is to be collected), thereby using the generated vacuum to draw fluid and / or tissue into the distal lumen 114. Thus, fluid and / or tissue is drawn into the syringe 100 by the vacuum created within the syringe 100 .

[0059] With regard to the ability to switch syringe 100 between a closed state and an open state at distal end 130, syringe 100 may be used in a number of scenarios, including scenarios for "filling" syringe 100, which should be construed as creating a vacuum that is not immediately released.

[0060] Thus, in one embodiment, biopsy syringe 100 has a loaded configuration in which valve assembly 105 maintains tip 140 in a closed position (sphere 160 blocks channel 135) and the generated vacuum is maintained within barrel 110, and a released configuration in which valve assembly 150 maintains tip 140 in an open position (switch 152 is pressed and tube 170 is deformed laterally such that sphere 160 is at least partially out of direct contact with the inner surface of tube 170).

[0061] In one scenario, the syringe 100 may be loaded by vacuum as described before the hollow needle is inserted into the area where fluid and / or tissue is to be aspirated. This has the advantage that the vacuum can be created without the risk of dislodging the first hollow needle into the patient. Once the vacuum is created, i.e., the syringe 100 is filled, the needle can be inserted carefully, preferably without pushing or pressing any buttons. Once the first hollow needle is positioned, the valve assembly 150 can be changed (by pressing the center switch 152) from a closed state to an open state, which allows the vacuum in the barrel 110 to aspirate fluid and / or tissue into the distal lumen 114. "Loading" includes both a single stroke to create a vacuum and multiple strokes to build up a vacuum, as described.

[0062] Alternatively, in combination with this approach, the fill function can be used when the first hollow needle is already positioned in an area to aspirate fluid and / or tissue. In this example, the vacuum created within the barrel 110 can be used immediately to aspirate tissue, in which case the valve assembly 150 can maintain the tip 140 in an open position, or the tip 140 can be maintained in a closed position to build up an appropriate level of vacuum and then released. This procedure can be repeated.

[0063] Use of Biopsy Syringe 100 As previously discussed, the biopsy syringe 100 of the present disclosure is capable of creating a vacuum within the barrel 110 by pushing the plunger 120 towards the distal end 104 of the syringe 100. Optionally, the distal tip 140 is equipped with a needle (not shown) that is removably attached by a threaded portion 143.

[0064] To use the syringe 100, first pump the syringe 100 multiple times, for example 10 times, by pressing the proximal pressing element 124 to generate a vacuum. Next, the patient's lesion is pierced with the needle. If necessary, an ultrasound probe can be used to guide the needle. The generated vacuum draws tissue and / or liquid within the lesion into the syringe 100 by pressing the switch 152 to open the valve assembly 150. In an optional third step, while pressing the front end of the actuation lever, the needle can be guided along many different tangents that are not present in the lesion to obtain a biopsy sample. In this way, the lesion is "segmented". Fourth, if more vacuum is needed, the syringe 100 can be pumped again without exiting the lesion. Steps 3 and 4 can then be repeated until a sufficient sample is obtained. In a fifth step, the syringe 100 is extracted from the lesion and the syringe 100 is set to ejection mode. Finally, the user presses the proximal push element 124 again to eject the sample onto a slide or the like.

[0065] As a result, one possible one-handed grip when using the syringe 100 is to grip the barrel 110 with the index, middle, ring and pinky fingers, while keeping the thumb relatively free. Typically, the pinky finger is placed at the distal portion 104 of the syringe 100, toward the attached needle, and the index finger is placed at the top, toward the proximal end 102. With such a grip, the thumb typically moves more firmly and more precisely downward, toward the palm of the user's hand.

[0066] The principle of the biopsy syringe 100 of the present disclosure includes the use of a plunger 120 having a plunger head 122 that sealingly engages within the barrel 110 and surrounds an internal channel 111, whereby a vacuum can be created within the barrel 110 by pushing the plunger 120 toward the distal end 104 of the syringe 100 instead of pulling the plunger 120 away from the distal end 104 toward the proximal end 102 of the syringe 100 as is the case with conventional syringes.

[0067] The enclosed volume proximal to the plunger head 122, between the plunger head 122 and the sealing element 123, constitutes a vacuum chamber (not shown) whose volume is variable depending on the distance the plunger 120 is moved distally. The volume of the vacuum chamber is defined by the plunger head 122, the barrel 110, and the sealing element 123. When the proximal pushing element 124 is pressed, it pushes the plunger head 122 towards the distal end 104 of the syringe 100 and the vacuum chamber is mechanically expanded. Thus, when the vacuum chamber is expanded, the volume of the proximal lumen 112 decreases. In FIG. 1, the vacuum chamber is not visible because the proximal lumen 112 is expanded.

[0068] As mentioned above, using a biopsy syringe is a delicate process that requires precision. The valve assembly 150 and its mechanism are designed so that the parts always deform in the same way. Therefore, the function of the valve assembly 150 is reliable, which is important in this field, because the valve assembly 150 provides repeatability in switching between open and closed configurations. Other valve mechanisms in the art often rely on the movement of parts within the mechanism to establish a fluid flow path. However, some of these valves have parts with multiple degrees of freedom, so there is a risk that the configuration will be different each time.

[0069] Vacuum in this disclosure should not be interpreted as an absolute vacuum, but rather as a drop in pressure within the syringe through which tissue can be aspirated.

[0070] In the claims, the term "comprises" does not exclude the presence of other elements or steps. Furthermore, although individually listed, a plurality of means, elements or method steps may be implemented by, for example, a single unit or processor. Furthermore, although individual features may be included in different claims, they may be advantageously combined where possible, and the inclusion of different claims does not imply that a combination of features is not feasible and / or advantageous. Moreover, a reference to the singular does not exclude a plurality. The terms "a", "an", "first", "second", etc. do not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.

Claims

1. Longitudinal and peripheral central axis (C Ａ A valve assembly (150) that controls the flow of fluid in a channel (135) extending along a ) Switch (152), A deformable tube (170) surrounds the channel (135), The tube (170) between the distal channel portion (133) and the proximal channel portion (137) of the channel (135) includes a sphere (160), When the tube (170) is in a stationary state without deformation, the valve assembly (150) is in a closed state, and the sphere (160) is in direct contact with the tube (170), forming a fluid seal with the tube (170). A valve assembly that, when a force is applied to the switch (152), allows fluid to pass through the sphere (160) by having the tube (170) in a deformed, non-static state and the valve assembly (150) in an open state.

2. The valve assembly according to claim 1, wherein when the valve assembly (150) is in the open position, the tube (170) is pulled laterally perpendicular to the extending direction of the channel (135).

3. The valve assembly according to claim 1, wherein when the valve assembly (150) is in the open position, the opening is located between at least a portion of the sphere (160) and the tube (170).

4. The valve assembly according to claim 1, wherein the tube (170) has a platform (175) extending laterally from the tube (170), the platform (175) is in communication with the switch (152) and is configured to receive the force applied to the tube (170) by the switch (152).

5. The valve assembly according to claim 4, wherein the switch (152) includes at least one leg portion (154a, 154b) that contacts the platform (175), the leg portion transmitting a force applied to the switch (152) to the platform (175).

6. The valve assembly according to claim 1, wherein the channel (135) is manufactured from a material having higher rigidity than the material forming the tube (170).

7. The valve assembly according to claim 1, wherein the distal channel portion (133) has a distal channel slit (173) at its proximal end, and the proximal channel portion (137) has a proximal channel slit (174) at its distal end, and the distal slit and the proximal slit (173, 174) face the sphere (160).

8. The valve assembly according to claim 7, wherein the distal slit and proximal slit (173, 174) extend laterally with respect to the channel portion (133, 137).

9. The valve assembly according to claim 7, wherein the distal slit and proximal slit (173, 174) have a U-shape in a direction that crosses the distal channel portion and proximal channel portion (133, 137).

10. The valve assembly according to claim 1, wherein the valve assembly (150) is located inside the syringe (100), preferably located inside the distal end (130) between the distal tip (140) and the barrel (110) of the syringe (100).

11. The valve assembly according to claim 10, wherein the syringe (100) includes a platform receiving recess (138) configured to receive a platform (175) when force is applied to the switch (152), preferably the platform receiving recess (138) is located at the distal end (130) of the syringe (100).

12. The valve assembly according to claim 1, wherein the tube (170) is made of an elastomer, preferably rubber or silicone.

13. A valve assembly (150) according to claim 1, comprising a longitudinal near-far central axis (C Ａ A biopsy syringe (100) extending along the ).

14. The biopsy syringe (100) according to claim 13, which is a fine-needle aspiration syringe or a core needle biopsy syringe.

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