Valve assembly

Abstract

A valve assembly for controlling fluid flow in a passage (135) extending along a longitudinal proximal and distal axial central axis (CA) is disclosed. The valve assembly (150) includes a switcher (152), a deformable tube (170) enclosing a channel (135), and a spheroid (160) disposed within the tube (170) between a distal channel portion (133) and a proximal channel portion (137) of the channel (135). The valve assembly (150) is in a closed state when the tube (170) is in an undeformed rest state, the spheroid (160) is in direct contact with the tube (170) forming a fluid seal with the tube (170), and the valve assembly (150) is in an open state when a force is applied to the switcher (152), the tube (170) is in a deformed non-rest state, the valve assembly (150) being in an open state, thereby allowing fluid to pass through the spheroid (160). The invention also relates to a biopsy syringe comprising a 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. Furthermore, the present invention relates to a biopsy syringe comprising said valve assembly. Background Art

[0002] A biopsy, such as a 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 body organ or a mass under the skin. Fine needle aspiration can also be used to identify the type of cells within a mass or to see how well treatment is working for an existing mass. FNAs are often used to check for masses in the breast or thyroid (a gland in the neck), but can be used in other areas of the body. A core needle biopsy (CNB) is similar to an FNAB. A slightly larger, hollow needle is used to extract a small column of tissue (or tissue core). A CNB is usually done in a healthcare provider's office with local anesthesia. The needle is inserted 3 to 6 times to obtain a sample or core. This is more time-consuming than an FNAB but is more likely to give a clear result because more tissue is sampled for analysis. These methods are very useful ways to detect cancer.

[0003] One biopsy technique used to evaluate breast tissue involves inserting a biopsy probe into an area of ​​breast tissue of interest to obtain one or more tissue samples. This biopsy technique can use a vacuum to draw the tissue to be sampled into a sampling port of 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. Typically, a syringe is attached to the needle.

[0004] WO2017 / 129735A1 discloses a convenient biopsy syringe for extracting fluid and / or tissue, which includes a syringe with a proximal inner cavity and a distal inner cavity for collecting the aspirated fluid / tissue. The plunger head of the plunger is sealingly engaged in the syringe, and the valve is located in the syringe, between the plunger head and the distal end of the syringe, so as to separate the proximal inner cavity from the distal inner cavity. The valve regulates the airflow between the distal inner cavity and the proximal inner cavity and is operated by a valve switcher. Therefore, the valve enables the biopsy syringe to obtain two configurations; one configuration is an open state, in which air can flow between the distal inner cavity and the proximal inner cavity, and a closed state, in which air cannot flow between the distal inner cavity and the proximal inner cavity.

[0005] However, although the biopsy syringe disclosed in WO2017 / 129735A1 is an improvement over other existing solutions, the biopsy sample technology remains delicate. Any interruption in the airflow regulated by the valve assembly may damage the sample being drawn and may therefore lead to misleading results during analysis. In addition, the several valves available on the market are complex, resulting in a cumbersome manufacturing process. Therefore, there is a need for an improved valve assembly for a biopsy syringe that is reliable and easy to produce. Summary of the invention

[0006] In view of the above-mentioned shortcomings, an object of the present invention is to provide a valve assembly for controlling the flow of fluid in a channel, the channel extending along a central axis of a longitudinal proximal-distal axis. The valve assembly includes a switch, a deformable tube encapsulating the channel, and a spherical body arranged in the tube between the distal channel portion and the proximal channel portion of the channel. When the tube is in an undeformed static state, the valve assembly is in a closed state, and the spherical body is in direct contact with the tube, thereby forming a fluid seal with the tube. When a force is applied to the switch, the tube is in a deformed non-static state, and the valve assembly is in an open state, thereby allowing fluid to pass through the spherical body.

[0007] This is advantageous because the valve assembly and its mechanism are designed in such a way that the components are always forced to deform in the same way. Therefore, the valve assembly provides reproducibility for switching between the open configuration and the closed configuration, and the function of the valve assembly is therefore very reliable. Other valve mechanisms in the prior art usually rely on the movement of components within the mechanism to establish a fluid flow path. In addition, this valve assembly is easy to manufacture and can be applied to several different types of syringes in the prior art.

[0008] In one embodiment, when the valve assembly is in its open state, the tube is stretched transversely perpendicular to the extension of the passageway.

[0009] In another embodiment, an opening is arranged between at least a portion of the ball and the tube when the valve assembly is in its open state.

[0010] In other embodiments, the tube has a platform extending laterally from the tube, wherein the platform is in communication with the switch and is 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 transferring a force applied to the switch to the platform.

[0012] In one embodiment, the channel is made of a material that is more rigid than the material from which the tube is formed.

[0013] In another 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, wherein the distal slit and the proximal slit face the spheroid. The distal slit and the proximal slit may extend transversely to the channel portion. Furthermore, the distal slit and the proximal slit may have a U-shape in a direction transverse to the distal channel portion and the proximal channel portion.

[0014] In one embodiment, the valve assembly is arranged in the syringe.Preferably, the valve assembly is arranged in the distal end portion of the syringe, between the distal tip and the barrel.

[0015] In other embodiments, the syringe comprises a platform receiving recess configured to receive the platform when a force is applied to the switch.Preferably, the platform receiving recess is arranged in the distal end portion of the syringe.

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

[0017] In a second aspect, a biopsy syringe is provided having a central axis extending along a longitudinal proximal-distal axis. The biopsy syringe comprises a valve assembly as disclosed herein. This is advantageous because the use of a biopsy syringe requires precision and is a delicate process, and a biopsy syringe comprising such a valve assembly is very beneficial due to the advantages of the valve assembly described above. Due to the reproducibility of the valve assembly switching between an open configuration and a closed configuration, it is easy to produce and can provide 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 its embodiments are set forth in the dependent claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] These and other aspects, features and advantages that can be achieved by the present invention will become apparent and elucidated from the following description of non-limiting embodiments of the present invention, with reference to the accompanying drawings, in which:

[0021] Figure 1 is a longitudinal cross-section of a biopsy syringe;

[0022] Figure 2 is a longitudinal cross-sectional view of the distal portion of a biopsy syringe;

[0023] Figure 3 is a side cross-sectional view of a distal end portion of a biopsy syringe shown from a distal direction; and

[0024] Figure 4 is a side cross-sectional view of the distal portion of a biopsy syringe shown from a proximal direction. DETAILED DESCRIPTION

[0025] 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 implement the present invention. However, the present invention can be implemented in many different forms and should not be construed as being limited to the embodiments set forth herein. On the contrary, these embodiments are provided to make this disclosure detailed and complete, and to 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 attached patent claims. In addition, the terms used in the detailed description of the specific embodiments shown in the accompanying drawings are not intended to limit the present invention.

[0026] Now refer to Figures 1 to 4 Embodiments of the present invention are described.

[0027] Reference Figure 1 A biopsy syringe 100 is provided, which has a central axis C along the proximal and distal axis. A The syringe 100 extends from the central axis C and has a proximal end 102 and a distal end 104. A The lateral axis L extending vertically A Biopsy syringe 100 may also be referred to herein as needle extraction syringe 100, and may be a fine needle aspiration syringe.

[0028] 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 push element 124. The plunger stopper 122 is in fluid-tight engagement with the interior surface wall 115 of the barrel 110 such that no liquid or gas can pass through the barrier formed between the interior surface wall 115 and the plunger stopper 122.

[0029] When a distal force is applied to the proximal push element 124, the plunger 120 moves toward the distal end 104 of the biopsy syringe 100. In addition, the plunger 120 includes a spring member 125 that provides a rebound characteristic to the plunger 120. The direction of movement of the plunger 120 is determined by Figure 1 The double-headed arrow in .

[0030] exist Figure 1 A sealing element 123 is provided on the proximal side of the plunger stopper 122 in the embodiment. The plunger stopper 122 and the sealing element 123 are provided with check valves 121a, 121b. In addition, the plunger stopper 122 is equipped with an umbrella-shaped check valve 127, which is in fluid communication with the internal channel 111 in an open state. The internal channel 111 is arranged along the central axis C A Furthermore, the inner channel 111 extends through the proximal lumen 112 .

[0031] Figure 1 The syringe 100 in the embodiment further comprises a pressure channel 105 between the distal lumen 114 and the proximal lumen 112. The pressure channel 105 extends through the pressure conversion valve 103. At the distal end of the pressure channel 105, a deckbill check valve 106 is provided.

[0032] In addition, the biopsy syringe 100 also includes a distal end portion 130 and a distal tip 140 having a threaded inner portion 143 for connecting a needle or cannula (not shown) to the biopsy syringe 100. A passage 135 extends from the distal tip 140 to the barrel 110. Thus, the passage 135 provides communication between the distal tip 140 and the distal lumen 114 of the hollow barrel 110.

[0033] In addition, if Figures 1 to 4 As shown, the distal end portion 130 is provided with a valve assembly 150 including a switch 152. The valve assembly 150 can be configured between an open state and a closed state, and will be referred to below. Figures 2 to 4 More explanation.

[0034] Figure 1 The biopsy syringe 100 disclosed in is an exemplary biopsy syringe 100, and it should be understood that the valve assembly 150 can be included in other types of biopsy syringes, such as the biopsy syringe disclosed in WO2017 / 129735A1.

[0035] Preferably, the barrel 110, plunger 120, distal end portion 130 and distal tip 140 are made of a polymer material, such as polypropylene (PP).

[0036] The valve assembly 150 is a ball valve assembly and is Figure 2 As shown in more detail, Figure 2 yes Figure 1 An enlarged view of the distal end portion 130 of the syringe 100 is shown. The valve assembly 150 is configured to control fluid and / or vacuum flow in the channel 135, which is along the longitudinal proximal-distal central axis C AIn extension, the valve assembly 150 includes a switch 152, a deformable tube 170 enclosing a channel 135, and a ball 160, which is arranged in the tube 170 between the distal channel portion 133 and the proximal channel portion 137 of the channel 135. When the tube 170 is in an undeformed static state, the valve assembly 150 is in a closed state, and the ball 160 is in direct contact with the tube 170, thereby forming 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 non-static state, and the valve assembly 150 is in an open state, thereby allowing fluid to pass through the ball 160.

[0037] like Figure 2 As shown, valve assembly 150 includes a spheroid or ball 160 disposed within tube 170 in lumen 177. Spheroid 160 is preferably formed of a polymer material such as PP or a metal such as stainless steel. Preferably, spheroid 160 is formed of stainless steel.

[0038] The tube 170 is formed of a deformable flexible material and may be formed, for example, of a polymer material, silicone, or rubber. The tube 170 may be formed of an elastomer. Therefore, the tube 170 is formed of a material that is more flexible than the channel 135. The channel 135 is made of a material that is more rigid than the tube 170. Therefore, compared to the tube 170, the channel 135 can withstand a higher pressure or force applied thereto.

[0039] When the tube 170 is subjected to strain, the material will deform, and when the force is no longer applied and the tube 170 is no longer subjected to strain, the material will flex back to its resting state. In the valve assembly 150 , the tube 170 is subjected to such strain through interaction with the switch 152 .

[0040] Reference Figures 2 to 4 , the tube 170 is provided with a tube platform 175 and a longitudinal projection 176, both arranged at opposite lateral sides of the tube 170. The tube platform 175 and / or the longitudinal projection 176 are preferably formed integrally with the tube 170. For example, the tube 170 together with the tube platform 175 and the longitudinal projection 176 are molded as a single piece.

[0041] The outer surface of the ball 160 is in direct contact with the inner surface of the lumen 177, thereby preventing fluids (such as liquids and gases) from entering the syringe 110. The diameter of the ball 160 is equal to or slightly larger than the diameter of the lumen 177. When the tube 170 is not deformed (i.e., when the tube 170 is in its resting state), this size relationship establishes a fluid seal between the inside surface of the lumen 177 and the ball 160. The fluid seal is a seal that prevents liquids and gases from passing through the valve assembly 150. Therefore, the valve assembly 150 can retain a pressure differential (such as a vacuum or near vacuum).

[0042] The tube 170 and its lumen 177 enclose a portion of the channel 135. The channel 135 has a distal channel portion 133 and a proximal channel portion 137. The distal channel portion 133 is provided with a distal slit 173 at its proximal end. The distal slit 173 extends transversely to the channel 135 and the distal channel portion 133. Correspondingly, the proximal channel portion 137 is provided with a proximal slit 174 at its distal end. The proximal slit 174 extends transversely to the channel 135 and the proximal channel portion 137. The channel 135 extends between and connects the distal tip 140 and the syringe 110, and is configured to receive fluid aspirated or discharged by the syringe 100. Figure 2 As shown, the channel 135 is partially embedded within the tube 170.

[0043] The switch 152 is disposed in the distal end portion chamber 131 of the distal end portion 130 and projects laterally from the distal end portion 130 through an opening 134 in the distal end portion 130 of the syringe 100 .

[0044] Figure 3 It is along Figure 2 The cross-sectional view of the distal end portion 130 is taken along the dotted line CS1 in FIG. Figure 4 It is along Figure 2 FIG. 1 is a cross-sectional view of the distal end portion 130 taken along the dashed line CS2 in FIG. Figure 3 and Figure 4 As shown, the switch 152 includes two switch legs 154a, 154b. Figure 3 As shown, each leg 154a, 154b is provided with a lateral leg protrusion 156a, 156b.

[0045] The distal end portion cavity 131 has an interior surface 132 extending perpendicular to the axis A and laterally from the exterior distal portion surface 136 toward the opposite side of the distal end portion 130 . Opposite the opening 134 , the interior structure of the distal end portion cavity 131 defines a platform receiving recess 138 .

[0046] Switching the open / closed state of the valve assembly 150

[0047] Reference Figures 2 to 4 , the use of the ball valve assembly 150 will be described in more detail. The valve assembly 150 allows switching between two different configurations; a first configuration, which is a closed state, in which no fluid and / or vacuum can pass through the valve 150, and a second configuration, which is an open state, in which fluid (such as liquid, tissue, gas or vacuum) can pass through the valve 150 and enter or leave the syringe 110.

[0048] As described above, valve assembly 150 is disposed in distal end portion 130 of needle extraction syringe 100. Thus, valve assembly 150 is located between distal tip 140 and barrel 110 and controls fluid / vacuum flow in passage 135 therebetween. Thus, fluid, such as liquid or tissue sample, is drawn into syringe 100 by the vacuum created in syringe 100. However, valve assembly 150 may be disposed in another passage in another portion of syringe 100.

[0049] In a first configuration (see e.g. Figure 3 ), the valve assembly 150 is in its 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. Therefore, the deformable tube 170 is not deformed or stretched. The ball 160 forms a fluid and / or vacuum seal with the inner surface of the lumen 177 of the tube 170, thereby preventing fluid from passing through the valve assembly 150.

[0050] To place the valve assembly 150 into its actuated, open state, the user moves toward the longitudinal central axis C A The switch 152 is pressed laterally. Therefore, the force is along the lateral axis L A Therefore, the switch 152 is oriented along the lateral axis L A 170. This causes the switch legs 154a, 154b to apply a force directed in the lateral direction to the tube platform 175. This in turn causes the platform 175 to move in the lateral direction toward and into the platform receiving chamber 138. Therefore, the open state of the valve assembly 150 is a deformed non-stationary state of the valve assembly 150. The switch 152 is arranged substantially perpendicular to the tube 170 so that the switch 152 can apply a force directed in the lateral direction to the tube 170 along the lateral axis L. A Directed force.

[0051] Since the platform 175 is formed as a single piece with the tube 170, and since the tube 170 is made of a deformable material, the applied force and the resulting movement of the platform 175 causes the tube 170 to deform. The channel 135 is not affected by the forces directed in the lateral direction because it is formed of a material that is more rigid than the tube 170. Since the tube 170 surrounds the channel 135, the channel 135 is substantially unaffected by the user pushing the switch 152, thereby achieving lateral stretching of the tube 170. The distal channel portion 133 and the proximal channel portion 137 thus act as reaction force elements. Thus, the channel 135 is moved along the lateral axis L. A The applied thrust causes tube 170 to deform in the area surrounding lumen 177 .

[0052] In this open, deformed, stretched state, the tube 170 acquires a more elliptical lateral cross-section in the lumen region 177. The shape of the ball 160 located within the lumen 177 is not affected by the applied force. Therefore, the deformation results in the loss of the fluid seal between the interior surface of the lumen 177 and the outer surface of the ball 160, and at least one opening is formed between the ball 160 and the interior surface of the lumen, and fluid can pass through the ball valve 150. Therefore, the deformation of the tube 170 results in an opening arranged between the ball 160 and the tube 170.

[0053] When the user removes the force applied to the switch 152, the tube 170 will rebound to its resting state and return the valve assembly 150 to its first configuration, ie, its closed state.

[0054] In addition, if Figure 2 As shown, the distal slit 173 and the proximal slit 174 have a concave oval shape to prevent the ball 160 from blocking the passage 135. Therefore, if the ball 160 is in direct contact with one of the slits 173, 174 when the valve assembly 150 is in its open configuration, there will still be an opening for fluid flow around the ball 160. The distal slit 173 and the proximal slit 174 can have other shapes that allow fluid to pass when the ball 160 is in direct contact with the distal or proximal channel portion 133, 137 in the open state of the valve assembly 150, such as a cone or triangle.

[0055] Since the tube 170 is formed of an elastic material, the shape of the tube 170 will immediately return to its original shape after the force applied to the switch 152 is released. Therefore, the user can adjust the amount of gas / liquid that the user wants to allow to flow through the valve assembly 150 by selectively pressing the switch 152 more or less. This makes it possible to easily adjust the valve assembly 150.

[0056] like Figure 3 As shown, the lateral leg projections 156a, 156b hold the switch 152 in place by abutting the interior chamber surface 132. When the platform 175 has been pressed as far as possible into the platform receiving recess 138, the user cannot press the switch 152 any further, and the valve assembly 150 has reached the open state of the maximum flow capacity through the valve assembly 150.

[0057] In addition, the valve assembly 150 disclosed herein is easy to produce and can be designed to fit a variety of devices and can be adaptively modified in size. The size of the valve assembly 150 can be easily adjusted as needed. More importantly, the valve assembly 150 is volume efficient and can therefore be incorporated into a small space while still being easy to manufacture.

[0058] Vacuum accumulation

[0059] The present disclosure also relates to accumulating a vacuum in the syringe 100 by repeatedly pushing and releasing the plunger 120. To this end, the syringe 100 preferably includes a spring 125, which can be located between the sealing element 123 and the proximal push element 124 in the plunger 120, or any part fixedly connected to the proximal push element 124.

[0060] The possibility of cumulatively creating a vacuum brings several advantages to the user. One advantage is that a higher level of vacuum can be obtained by repeatedly removing air. Another advantage is that instead of one long movement of the plunger 120, additional smaller movements can produce the same effect, which allows the syringe 100 to be designed to be shorter. From the ergonomic point of view of the user, it may also be more preferable to use several short movements instead of one long movement.

[0061] A vacuum is accumulated by repeatedly pushing the plunger 120 toward the distal end 104 of the syringe 100 and releasing it toward the proximal end 102 of the syringe 100. The syringe 100 can be open in the distal end 104, thereby drawing added tissue and / or fluid with each stroke (or building up vacuum until the suction force is greater than the limit required to begin the process of drawing tissue into the distal lumen 114), or, if the syringe 100 is closed in the distal end 104, an accumulated vacuum can be created within the distal lumen 114, which is released when the distal end 104 is opened.

[0062] The syringe 100 disclosed herein also includes a valve assembly 150 at the distal end 104 of the syringe 100 for maintaining and releasing a vacuum generated in the distal lumen 114 via the tip 140. In this manner, a vacuum can be generated through one or more strokes when the valve assembly 150 is closed such that there is no connection between the distal lumen 114 and the environment outside the syringe 100 via the tip 140. When an appropriate level of vacuum has been generated in the distal lumen 114, which can thus serve as an accumulation tank in this configuration, the valve assembly 150 can be opened such that the distal lumen 114 is fluidly connected to the environment outside the syringe 100 (typically when a first hollow needle (not shown) is inserted into the area from which 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 generated within the syringe 100.

[0063] In connection with the possibility of switching the syringe 100 between closed and open in the distal end portion 130, the syringe 100 can be used in a variety of situations involving "loading" the syringe 100, which would be interpreted as creating a vacuum that is not immediately released.

[0064] In one embodiment, biopsy syringe 100 thus has a loaded configuration and a released configuration, in which valve assembly 105 holds tip 140 in a closed position (in which ball 160 blocks passage 135) and the resulting vacuum is maintained in syringe 110, and in which valve assembly 150 holds tip 140 in an open position (in which switch 152 has been depressed and tube 170 has been laterally deformed such that ball 160 is no longer at least partially in direct contact with the interior surface of tube 170).

[0065] In one case, the syringe 100 can be loaded with a vacuum as described above before the hollow needle is inserted into the area from which fluid and / or tissue is aspirated. This has the advantage that the creation of a vacuum can be achieved without the risk of moving the first hollow needle in the patient's body. Once the vacuum has been created, i.e., the syringe 100 has been loaded, the needle can be carefully inserted, preferably without having to push or press any buttons. After the first hollow needle has been positioned, the valve assembly 150 can be changed from closed to open (by pressing the switch 152 in the center), which allows the vacuum in the syringe 110 to aspirate fluid and / or tissue into the distal lumen 114. "Loading" can include a single stroke to create a vacuum or several strokes of cumulative vacuum as described above.

[0066] Alternatively, or in conjunction with this method, the loading function can be used when the first hollow needle is already in the area from which fluid and / or tissue is to be aspirated. In this example, the vacuum generated within the syringe 110 can be used immediately to aspirate tissue - in this case, the valve assembly 150 holds the tip 140 in the open position - or can be held in the closed position to accumulate an appropriate level of vacuum and then release it. This process can be repeated.

[0067] Use of Biopsy Syringe 100

[0068] As described above, the presently disclosed biopsy syringe 100 can create a vacuum within the barrel 110 by pushing the plunger 120 toward the distal end 104 of the syringe 100. Optionally, the distal tip 140 is equipped with a needle (not shown) removably attached via the threaded portion 143.

[0069] To use the syringe 100, first, by pressing the proximal push element 124 to generate a vacuum, the syringe 100 is pumped multiple times, such as 10 times. Next, the patient's lesion is punctured with a needle. If necessary, an ultrasound probe can be used to guide the needle. Press the switch 152 to open the valve assembly 150 so that the tissue and / or liquid in the lesion is sucked into the syringe 100 by the vacuum generated. In an optional third step, while pressing the front end of the activation rod to obtain a biopsy sample, the needle can be oriented along multiple different tangential directions without leaving the lesion. In this way, the lesion is "fan-shaped". Fourth, if a larger vacuum is needed, the syringe 100 can be pumped again without leaving the lesion. Then, the third and fourth steps can be repeated until enough samples are obtained therefrom. In the fifth step, the syringe 100 is withdrawn from the lesion and the syringe 100 is placed in the discharge mode. Finally, the user pushes the proximal push element 124 again to discharge the sample onto, for example, a slide.

[0070] Thus, when using the syringe 100, one possible one-handed grip is to close the index, middle, ring, and pinky fingers around the barrel 110, while keeping the thumb relatively relaxed. Typically, the pinky finger is placed on the distal portion 104 of the syringe 100 and toward the attached needle, while the index finger is placed on the upper portion and toward the proximal end 102. With this grip, the thumb is typically more powerful and moves more precisely downward toward the user's palm.

[0071] The principle of the currently disclosed biopsy syringe 100 allows a vacuum to be created inside the syringe barrel 110 by pushing the plunger 120 toward the distal end 104 of the syringe 100) - rather than pulling the plunger 120 away from the distal end 104 of the syringe 100 and toward the proximal end 102 as when using a conventional syringe - the above principle includes using the following plunger 120, which has a plunger head 122 that is sealingly engaged with the inside of the syringe barrel 110 and encloses the internal channel 111.

[0072] The enclosed volume on the proximal side of the plunger head 122, between the plunger head 122 and the sealing element 123, constitutes a vacuum chamber (not shown) having a variable volume, which depends on the distance that the plunger 120 has moved distally. The volume of the vacuum chamber is defined by the plunger head 122, the syringe 110, and the sealing element 123. When the proximal push element 124 is pressed, the proximal push element 124 pushes the plunger head 122 in the direction toward the distal end 104 of the syringe 100, and the vacuum chamber expands mechanically. Therefore, when the vacuum chamber expands, the volume of the proximal lumen 112 decreases. Figure 1 In the embodiment shown in FIG. 1 , the proximal lumen 112 is expanded so that the vacuum chamber is not visible.

[0073] As described above, the use of a biopsy syringe requires precision and is a delicate process. The valve assembly 150 and its mechanism are designed in such a way that the components are forced to always deform in the same way. Therefore, the valve assembly 150 provides reproducibility for switching between the open configuration and the closed configuration, and the function of the valve assembly 150 is therefore reliable, which is important in the art. Other valve mechanisms in the prior art typically rely on the movement of components within the mechanism to establish a fluid flow path. However, some of these valves have components with more than one degree of freedom, resulting in the risk of configuration changes that are different at different times.

[0074] The vacuum in the present disclosure should not be construed as an absolute vacuum, but rather a reduced pressure inside the syringe that allows aspiration of tissue.

[0075] In the claims, the term "comprises / comprising" does not exclude the presence of other elements or steps. Furthermore, although listed separately, multiple means, elements or method steps may be implemented by, for example, a single unit or processor. Additionally, although individual features may be included in different claims, these features may be advantageously combined, and the inclusion in different claims does not mean that the combination of features is not feasible and / or disadvantageous. Furthermore, references to the singular do not exclude the plural. The terms "a", "an", "first", "second", etc. do not exclude a plurality. The reference numerals in the claims are provided merely as clarifying examples and should not be interpreted as limiting the scope of the claims in any way.

Claims

1. A valve assembly for controlling fluid flow in a channel (135) having a central axis (C A ) extends, the valve assembly (150) comprising: - Switch (152); - a deformable tube (170) enclosing said channel (135); as well as a spherical body (160) arranged in the tube (170) between the distal channel portion (133) and the proximal channel portion (137) of the channel (135); wherein, when the tube (170) is in an undeformed static state, the valve assembly (150) is in a closed state, and the spherical body (160) is in direct contact with the tube (170), thereby forming a fluid seal with the tube (170); and When a force is applied to the switch (152), the tube (170) is in a deformed non-stationary state and the valve assembly (150) is in an open state, thereby allowing fluid to pass through the ball (160).

2. The valve assembly according to claim 1, wherein: When the valve assembly (150) is in its open state, the tube (170) stretches transversely perpendicular to the extension of the passage (135).

3. The valve assembly according to claim 1 or 2, wherein: When the valve assembly (150) is in its open state, an opening is disposed between at least a portion of the ball (160) and the tube (170).

4. The valve assembly according to any one of claims 1 to 3, wherein: The tube (170) has a platform (175) extending laterally from the tube (170), wherein the platform (175) is in communication with the switch (152) and is configured to receive a 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 (154a, 154b) in contact with the platform (175), the leg transmitting a force applied to the switch (152) to the platform (175).

6. A valve assembly according to any one of the preceding claims, wherein: The passage (135) is made of a material that is more rigid than the material forming the tube (170).

7. A valve assembly according to any one of the preceding claims, 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, wherein the distal slit and the proximal slit (173, 174) face the spherical body (160).

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

9. The valve assembly according to claim 7 or 8, wherein: The distal slit and the proximal slit (173, 174) have a U-shape in a direction transverse to the distal channel portion and the proximal channel portion (133, 137).

10. A valve assembly according to any one of the preceding claims, wherein: The valve assembly (150) is arranged in the syringe (100), preferably, the valve assembly (150) is arranged in the distal end portion (130) of the syringe (100), between the distal tip (140) and the syringe (110).

11. The valve assembly according to claim 10, wherein: The syringe (100) includes a platform receiving recess (138), which is configured to receive the platform (175) when a force is applied to the switch (152). Preferably, the platform receiving recess (138) is arranged in the distal end portion (130) of the syringe (100).

12. A valve assembly according to any one of the preceding claims, wherein: The tube (170) is made of an elastomer, preferably rubber or silicone.

13. A biopsy syringe having a central axis (C A ) extends, where The biopsy syringe (100) comprises a valve assembly (150) according to any one of claims 1 to 12.

14. The biopsy syringe of claim 13, wherein: The biopsy syringe (100) is a fine needle aspiration syringe or a thick needle biopsy syringe.

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