Medical sampling device

Abstract

A medical sampling device for use with an endoscope or catheter for flushing a body cavity and / or sampling a body fluid and / or body tissue, the endoscope or catheter having a suction channel and a suction connector in fluid communication with the suction channel, the sampling device comprising a suction inlet for connection to the suction connector, a suction outlet for connection to a vacuum source, a sampling outlet for connection to a sample container, a sampling inlet for connection to the sample container, and a valve having a valve member and a valve housing, wherein the valve member has a first chamber and a second chamber and is rotatable relative to the valve housing between a first position in which the first chamber establishes fluid communication between the suction inlet and the sampling inlet, a second position in which the second chamber establishes fluid communication between the sampling outlet and the suction outlet, and a third position in which one of the first chamber and the second chamber establishes fluid communication between the suction inlet and the suction outlet.

Description

TECHNICAL FIELD

[0001] The present invention relates to a medical sampling device for use with an endoscope or catheter for irrigating a body cavity and / or sampling body fluids and / or body tissue, the endoscope or catheter having a suction channel and a suction connector in communication with the suction channel. BACKGROUND

[0002] Endoscopes are well-known devices for visually inspecting possibly inaccessible parts of the human or animal body, for example body cavities of the human body. Typically, an endoscope comprises an elongated insertion tube with a handle at the proximal end from the operator's perspective and a visual inspection means (e.g. a built-in camera) at the distal end of the elongated insertion tube. In this specification the terms "distal" and "proximal" are always used with this definition, i.e. proximal is the end closest to the operator and distal is the end away from the operator, as generally used herein for endoscopes. Electrical wiring for the camera and other electronic devices (e.g. LED illumination) typically extends along the inside of the elongated insertion tube from the handle to the tip at the distal end. Instead of using a camera, the endoscope can also be optical, in which case an optical fiber typically extends along the inside of the elongated insertion tube. A working channel or suction channel can extend along the inside of the insertion tube from the handle to the tip, allowing liquid to be removed from the body cavity or allowing surgical instruments etc. to be inserted into the body cavity. The suction channel can be connected to a suction connector, typically located at the handle proximal end of the insertion tube.

[0003] The above-mentioned medical sampling device is especially used in procedures such as bronchial lavage (BL), bronchial wash (BW) or bronchoalveolar lavage (BAL), which are commonly used procedures to obtain an organic material sample from a segment of a patient's lung. These procedures can be performed by irrigating a segment of the lung with sterile water (typically a sterile saline solution) and then aspirating the water into a sample container. More specifically, the distal end of the endoscope insertion tube is advanced into the lung to the location where the sample is to be taken. In bronchoalveolar lavage, the distal end is then pressed into firm engagement against the inside of the lung in a process commonly referred to as wedging, to help fix the location.

[0004] Through the aspiration channel of the endoscope, fluid (such as sterile water, e.g., 0.9% saline solution or isotonic saline) is dripped into the sample site in the lung and extracted as much as possible, thus now containing organic material in the form of bodily fluids and / or tissue, and therefore constituting a medical sample. Typically, this is accomplished by attaching a filled syringe with a volume between 20 ml and 60 ml (e.g., 50 ml) to the aspiration channel of the endoscope via a connecting port in the endoscope handle. The syringe is then used for each drip and subsequent extraction. This process is generally repeated several times consecutively using a new syringe, e.g., three to four times, with samples suited for different purposes depending on the number of samples in the sequence, as the composition of the organic material varies. If the syringe is used for extraction, the sample is transferred to a sample container suitable for immobilizing biological material. Therefore, the sample container is generally labeled accordingly upon extraction.

[0005] As an alternative to using a syringe for extraction, extraction can be performed in-line using external aspiration and, for example, a Lukens trap disclosed in US 4643197.

[0006] Using a Lukens trap attached to an endoscope in the manner disclosed in US 4643197, i.e., inserted into a flexible aspiration line leading from the endoscope to a vacuum source or aspiration source (these two terms are used synonymously in this specification), can have several disadvantages when performing this procedure. One such disadvantage is that the operator may be little aware of and pay little attention to the orientation of the trap suspended on the line, as the operator's attention may be focused on other parts of the procedure, such as delicate parts of the procedure inside the patient. Therefore, it is possible for the Lukens trap to inadvertently end up in a sample-loss orientation as the sample is aspirated from the trap by the aspiration source. Another disadvantage is that a significant amount of work is involved in connecting and disconnecting the tubing and other parts, for example, if the operator needs to change between obtaining a sample and aspiration for cleaning without sampling.

[0007] US 6375625 discloses an in-line sample trap having a cap coupled to a sample container. A rotatable member in the cap includes a through opening and can be rotated to provide fluid communication between an inlet and an outlet. Summary of the Invention

[0008] In this context, it can be seen that the object of the present invention is to provide a medical sampling device that can be manufactured more cheaply or simply, provides improved sealing performance, provides easier or simpler operation, improves sample retrieval, and / or reduces the risk of sample loss.

[0009] One or more of these objectives can be achieved by the invention described below.

[0010] A first aspect of the invention relates to a medical sampling device for use with an endoscope for flushing body cavities and / or sampling body fluids and / or body tissues, the endoscope or catheter having an aspiration channel and an aspiration connector in fluid communication with said aspiration channel.

[0011] The sampling device includes

[0012] The suction inlet for connecting to the suction connector.

[0013] A suction outlet for connecting to a vacuum source.

[0014] Sampling outlet for connecting to the sample container

[0015] The sampling inlet for connecting to the sample container, and

[0016] A valve having valve components and a valve body,

[0017] The valve component has a first chamber and a second chamber and is rotatable relative to the valve housing between a first position and a second position.

[0018] In this first position, the first chamber establishes fluid communication between the suction inlet and the sampling inlet.

[0019] In this first position, the second chamber establishes fluid communication between the sampling outlet and the suction outlet.

[0020] In the second position, one of the first and second chambers establishes fluid communication between the suction inlet and the suction outlet.

[0021] Advantages associated with the medical sampling device according to the present invention may include one or more of the following:

[0022] The medical sampling device can effectively provide a sampling mode in a first position and a closed or bypass mode in a second position. In the sampling mode, fluid can flow from the suction inlet to the sampling inlet, potentially into the connected sample container, to the sampling outlet, and back to the suction inlet. In the closed or bypass mode, fluid can flow from the suction inlet to the suction outlet, bypassing both the sampling inlet and outlet. Thus, sampling can be performed in the first position and bypassed in the second position. For example, the first position can be used for sampling, and the second position for flushing only. The medical sampling device can be configured such that the valve and the device itself are effectively sealed to be fluid-tight relative to the surrounding environment, and / or to provide efficient and effective fluid flow between the respective inlet and outlet, and / or to prevent any other fluid from flowing through the medical sampling device in the first and second positions, respectively. The medical sampling device can be made of low-cost materials such as plastic. Additionally, the medical sampling device can be configured for easy assembly using a low-cost procedure. For these and other reasons, the medical sampling device can be configured for single-use purposes and / or for use with disposable endoscopes or catheters. The valve body may include several or all of the stationary portions of the medical sampling device, including fluid passages extending through the device, thereby allowing these portions to be integrally formed and / or molded and / or cast, with associated cost and assembly advantages. The valve may be configured such that a vacuum pressure applied to the suction outlet improves the valve's fluid tightness, as explained further below. The medical sampling device may be configured such that when the valve is in the second position and no sample container is connected to the medical sampling device, particularly when the sampling inlet and outlet are not connected to a sample container, no fluid flow occurs through the medical sampling device; that is, no fluid communication is established between the sampling inlet and outlet. The valve may be configured such that friction between the valve components and the valve body is minimized, particularly under operating conditions where a vacuum pressure is applied to the suction outlet.

[0023] In some embodiments, the valve member can be in a first position and a second position, respectively, substantially blocking all other fluid communication between the inlet and outlet of the medical sampling device. Thus, in the first position, the valve member can block fluid communication between the first and second inlet-outlet pairs, the first pair being an aspiration inlet and a sampling inlet, and the second pair being a sampling outlet and an aspiration outlet. Correspondingly, in the second position, the valve member can block fluid communication between the third and fourth inlet-outlet pairs, the third pair being an aspiration inlet and aspiration outlet, and the fourth pair being a sampling outlet and a sampling inlet.

[0024] In the second position, either the first or second chamber establishes fluid communication between the aspiration inlet and the aspiration outlet. Which chamber establishes fluid communication in the second position can depend on the manner and degree of rotation of the valve member, such that rotating the valve member from its first position to its second position and vice versa. For example, in some embodiments, the medical sampling device is configured such that when the valve member is rotated approximately 90° clockwise from the first position, the valve member takes the second position, and the second chamber establishes fluid communication between the aspiration inlet and the aspiration outlet. Alternatively, the valve member can be rotated approximately 90° counterclockwise from the first position, thereby establishing fluid communication between the first chamber and the aspiration outlet in the second position. Accordingly, the valve member can be configured to rotate clockwise or counterclockwise by, for example, 70° to 110° or 80° to 100° or approximately 90° when rotating from the first position to the second position, and to rotate counterclockwise or clockwise by a similar angle when rotating from the second position to the first position, i.e., in the opposite direction.

[0025] One or more valve member stop elements may be provided to limit the rotational movement of the valve member. For example, the one or more valve member stop elements are configured such that when the valve member has been rotated from the first position to the second position, further rotation in that direction is not allowed, and / or when the valve member has been rotated from the second position to the first position, further rotation in that direction is not allowed.

[0026] The valve member can be generally disc-shaped and / or have a substantially circular, cylindrical, and / or cylindrical shape. The valve member may include a potential fluid-sealing wall separating two chambers from each other. The first chamber and / or the second chamber may each be substantially cylindrical, possibly having cylindrical side surfaces extending substantially in a direction parallel to the axial direction defined by the axis around which the valve member rotates, and / or may be substantially crescent-shaped, rectangular, or triangular in shape in a cross-section perpendicular to the axis of rotation of the valve member. The aforementioned valve member wall can separate the two chambers from each other so as to block fluid communication between the two chambers. The wall can be linear in a cross-section perpendicular to the axis of rotation of the valve member, and if the chamber is crescent-shaped, it can provide a linear side surface in a crescent shape. Corresponding circular or semi-circular walls can then form crescent-shaped circular portions. These walls can form portions of the circumferential walls of the valve member that can extend along the cylindrical side surfaces in the axial direction.

[0027] The valve housing can be the stationary part of the medical sampling device, and the valve components can rotate relative to this stationary part. When the medical sampling device is fixed to the endoscope, the fixed part can remain stationary relative to the endoscope or its handle.

[0028] The valve housing may be configured as a single integral and / or integrally molded portion, or may comprise several portions fixed and / or attached to each other to provide the valve housing. The valve housing may include valve housing portions that may include and / or accommodate a suction inlet, and / or a channel for connecting the suction inlet to a suction connector and / or a suction outlet, and / or a channel for connecting the suction outlet to a vacuum source and / or a sampling outlet, and / or a channel for connecting the sampling outlet to a sample container, and / or a sliding pitch for a sliding locking member as further described below, and / or a flange or latching member as further described below, and / or a valve member spacing in which valve members may be positioned. Any one or more of these may be integrally and / or integrally molded with the valve housing. The valve housing may also include a valve housing shell, which may potentially be positioned around and / or surround and / or accommodate a valve housing portion or any one or more portions of the valve housing portion, and / or may form one or more outer surfaces of the valve housing. During the assembly of a medical sampling device, configuring the valve housing outer shell separately from the valve housing portion offers the advantage that the valve member can initially be positioned within the valve member spacing of the valve housing, and subsequently the valve housing outer shell can be positioned to at least partially cover and / or retain the valve member in place and / or cover part or all of the valve housing portion. The valve housing outer shell can potentially be irreversibly snap-fitted and / or latched onto the valve housing portion.

[0029] The valve body or valve body portion may include sealing surfaces, and valve members include corresponding sealing surfaces. These sealing surfaces abut against each other and seal the valve chambers and internal portions (such as passageways and valve ports) through which fluid flows from the surrounding environment. Sealing surfaces may be disposed on one or more gasket members, see also below. Sealing surfaces may be configured to extend along the outer peripheral edge of the valve member and / or along the wall separating the two chambers.

[0030] The valve housing may include an aspiration inlet and / or an aspiration outlet and / or a sampling outlet and / or a sampling inlet. The aspiration inlet and / or aspiration outlet and / or sampling outlet and / or sampling inlet may be located on the surface of the valve housing and / or the medical sampling device. Any one or more of these inlets and outlets may be configured as a fluid port of the medical sampling device, potentially a fluid port of the valve housing, a portion of the valve housing, or a shell of the valve housing. The aspiration inlet may be positioned radially at a distance from the axis of rotation of the valve member and from the valve member, or positioned in a direction parallel to such a radial direction, potentially aligning the insertion direction of the endoscope's aspiration connector with said direction. Similarly, the sampling inlet and sampling outlet may be positioned radially at a distance from the axis of rotation of the valve member and from the valve member, or positioned in a direction parallel to such a radial direction, potentially aligning the insertion direction of the medical sampling device's sampling connector and / or sampling container with said direction, wherein such a sampling connector may include one or both of the sampling inlet and sampling outlet. The aspiration outlet can be positioned at a distance from the valve member in the axial direction of the axis of rotation of the valve member, or in a direction parallel to this axial direction, potentially aligning the insertion direction of the aspiration connector or aspiration source tube of the medical sampling device with said direction. One or more of these positions can allow the medical sampling device to be configured such that the connection of the endoscope and / or sample container and / or aspiration source to the corresponding inlet and outlet of the medical sampling device facilitates and is advantageous for the operation of the medical sampling device and / or the medical system including the medical sampling device and / or endoscope and / or sample container and / or aspiration source.

[0031] A medical sampling device, specifically a valve housing, may include multiple internal fluid channels or conduits that allow fluid to flow through the device and connect inlets and outlets to valve ports of the valve. Depending on the rotational position of the valve member, these valve ports establish fluid communication between the respective channels and a first chamber and / or a second chamber. These channels may be configured to be fluid-tight relative to each other and / or disposed within the valve housing. Thus, a first aspiration channel may connect an aspiration inlet to a first valve port, and / or a first sampling channel may connect a sampling inlet to a second valve port, and / or a second sampling channel may connect a sampling outlet to a third valve port, and / or a second aspiration channel may connect an aspiration outlet to a fourth valve port. The first to fourth valve ports may be configured to be distributed in a first to fourth order in a clockwise circumferential direction about the rotational axis of the valve member. In a first position of the valve member, one or more openings of the first chamber may be aligned with the first and second valve ports, and / or one or more openings of the second chamber may be aligned with the third and fourth valve ports. In the second position of the valve assembly, one or more openings of the first chamber may be aligned with the first and fourth valve ports, and / or one or more openings of the second chamber may be aligned with the second and third valve ports; alternatively, one or more openings of the second chamber may be aligned with the first and fourth valve ports, and / or one or more openings of the first chamber may be aligned with the second and third valve ports. The openings of the first and second chambers may each include: at least one top opening providing fluid communication between the respective inlet and outlet via the corresponding first and second chambers in the first and second positions of the valve assembly; a bottom surface positioned relative to the top opening; and lateral surfaces surrounding and connecting to the bottom surface, the bottom surface and the lateral surfaces establishing a potential fluid-tight inner surface for the respective chamber. The top opening may alternatively be configured as one or two or more top openings per chamber.

[0032] One or more of the first, second, third, and fourth valve ports may be disposed in a substantially planar surface of the valve body or a portion thereof. This planar surface may extend substantially in a plane extending radially relative to the axis of rotation of the valve member. Thus, the valve ports may be configured to be properly aligned with the corresponding opening (which may be the aforementioned top opening) of each of the first and second chambers. As discussed further below, the sealing surface of the valve body may be a portion of this planar surface and may surround all four valve ports.

[0033] One or more channels may include potentially bends of approximately 90 degrees, allowing the channel to extend from the corresponding valve port to the corresponding inlet or outlet when the corresponding inlet or outlet is the end of the channel segment, the channel segment extending in a direction at an angle (e.g., right angle) to the axis of rotation of the valve member. Aspiration inlets and / or sampling inlets and / or sampling outlets and / or aspiration outlets may respectively form the ends of a first aspiration channel, a first sampling channel, a second sampling channel, and a second aspiration channel, i.e., where the corresponding channel ends. Similarly, the aforementioned valve ports may form the corresponding ends of the corresponding channels and are located at the other end of the corresponding channels. When the medical sampling device is configured in this way, the channel segments leading to the aspiration inlets and the channel segments leading to the first and second sampling outlets may extend in a direction at an angle (e.g., substantially right angle) to the axis of rotation of the valve member, while the channel segment leading to the aspiration outlet may extend in a direction substantially parallel to the axis of rotation of the valve member. This allows for convenient attachment to endoscopes, sample containers, and vacuum sources.

[0034] A potentially hand-rotatable knob may be attached to and / or integrally formed with a valve member or part thereof. During assembly of the medical sampling device, the knob may be attached to or snapped to a valve housing, valve housing portion, valve housing shell, and / or valve member for rotation relative to the valve housing. For example, the valve housing, valve housing portion, and / or valve housing shell may include one or more retaining elements that engage one or more corresponding retaining elements of the knob when the knob is attached to form part of the medical sampling device. These retaining elements, or one or more of these corresponding retaining elements, may be configured to barb and / or provide a snap-locking mechanism for the knob when it is attached to form part of the medical sampling device. For example, the knob may include part or all of a circumferential edge, which may be beveled or chamfered, and may actuate one or more legs, which may be part of a valve body, valve body portion, valve body shell, and / or valve member. The one or more legs may have barbs that extend outward or inward relative to the valve member when the knob is pushed into place, allowing the legs to be pushed outward or inward. After the knob is positioned, the legs may spring back, causing the barbs to snap into engagement with the circumferential edge. Alternatively, the circumferential edge may be provided on the valve body, valve body portion, valve body shell, and / or valve member, and one or more legs may be part of the knob to achieve the same effect.

[0035] Sampling devices are typically designed for single use. Therefore, they can be constructed from low-cost materials such as plastic, as they do not require the ability to withstand harsh environments for cleaning and sterilization, such as the high temperatures of an autoclave.

[0036] The suction inlet may be or include a female connector or socket, or a male connector or tube connector, defining the insertion direction of the suction connector adapted to receive the endoscope in the insertion direction, potentially for forming a fixed connection as further described below, and the sampling device may be additionally adapted to engage the endoscope in a manner that prevents rotation about the suction connector. Therefore, good orientation can be maintained at all angles.

[0037] Medical sampling devices can be configured to engage endoscopes in a manner that prevents them from rotating around the suction connector.

[0038] The sampling inlet may be or include a sample container connector adapted for connection to a sample container. This allows for easy attachment, removal, and / or replacement of the sample container during sampling. The sample container connector may extend in a direction parallel to or coinciding with the insertion direction.

[0039] Medical sampling devices can be used to flush one or more body parts, such as the lungs, to sample bodily fluids, and / or to sample tissue portions, potentially tissue portions cut by instruments applied through the aspiration channel of an endoscope. Such tissue portions are typically removed endoscopically, but can also be removed by flushing using the medical sampling device according to the invention. The design of the sample container can vary depending on whether the tissue is to be separated from the liquid or the liquid from the air.

[0040] Medical sampling devices may be suitable for or used for bronchial lavage (BL), bronchial flushing (BW), or bronchoalveolar lavage (BAL).

[0041] The term "endoscope" can be defined as a device suitable for insertion and examination of natural and / or artificial body openings, such as those suitable for probing or flushing or for sampling body fluids or tissues in body cavities such as the lungs.

[0042] The term "catheter" can be defined as a device suitable for insertion into natural and / or artificial body openings, such as for flushing or sampling of bodily fluids or tissues.

[0043] In addition, or alternatively, the terms "endoscope" and "catheter" can respectively refer to "medical device".

[0044] As used in this specification, the term "establishing fluid communication between two openings" refers to an opening that is potentially an inlet or outlet and can be defined as allowing fluid to flow between two fluid openings. An alternative term could be "establishing a fluid connection between two openings." In this context, an alternative term for the term "establish" could be "provide."

[0045] In an embodiment of the first aspect of the invention, the medical sampling device is configured such that when a vacuum pressure from a vacuum source is applied to the second chamber at a first position and to either the first or second chamber at a second position, the vacuum pressure pulls at least a portion of the valve member toward the suction outlet.

[0046] In another embodiment, the valve member includes an outer portion and an inner portion, and the inner portion is potentially a gasket member configured to be separate from and movably attached to the outer portion so as to be potentially movable relative to the valve member in the axial direction of the valve member. The gasket member is potentially laterally positioned around a first chamber and / or a second chamber such that when vacuum pressure is applied to the suction outlet at the first and / or second position, the vacuum pressure potentially causes the gasket member to move in the direction toward the suction outlet.

[0047] The gasket component can be moved by sliding as described.

[0048] The internal component can be rotatably fixed to the external part, so that when the valve component rotates, both components rotate.

[0049] The gasket member may surround the first and second valve ports and / or the first chamber in a first position of the valve member. The valve member may include an additional gasket member that surrounds the third and fourth valve ports in the first position and potentially surrounds the second and third valve ports or the first and fourth valve ports in a second position.

[0050] The gasket assembly may surround the first to fourth valve ports and / or surround the first and second chambers.

[0051] The gasket member can be configured as two separate gasket member portions, each potentially surrounding a corresponding one of the first and second chambers. The first gasket member portion may surround the first and second valve ports at a first position on the valve member, and surround either the first and fourth valve ports at a second position. Correspondingly, the second gasket member portion may surround either the third and fourth valve ports at a first position on the valve member, and surround either the first and fourth valve ports at a second position.

[0052] Alternatively, the gasket member may be configured as an integral gasket member surrounding the first chamber and the second chamber, and / or may extend to separate the first chamber and the second chamber from each other, in which case the gasket member may include a wall separating the first chamber and the second chamber.

[0053] The aforementioned knob can be attached to an external part in a rotatable manner or provided integrally with an external part.

[0054] The valve body and any one or all of the external parts can typically be made of the same material.

[0055] Alternatively or additionally, the gasket component may be made of a thermoplastic polymer or elastomer (such as a thermoplastic elastomer (e.g., silicone resin or silicone rubber)), substantially composed of or comprising a thermoplastic polymer or elastomer.

[0056] Any one or more or all of the valve body and external portions may generally be made of, substantially constitute of or include the material of a material having a Shore A hardness greater than 90 or a Shore D hardness greater than 75 or 100 as measured according to standard ASTM D2240.

[0057] Any one or more or all of the valve body and external portions may generally be made of, substantially constitute of or include thermoplastic polymers or elastomers, such as thermoplastic elastomers, such as polyoxymethylene (POM) and / or methyl methacrylate acrylonitrile butadiene styrene (MABS).

[0058] Gasket components can be made of, substantially composed of, or comprise TPE, and can be medical-grade and / or low-friction, such as... TPE, MC / LF series, product name M, specifically, is one of the following types: TM7LFT, TM6LFT, TM5LFT, TM4LFT, and TM3LFT (datasheet, May 27, 2014). Low-friction TPEs can reduce the torque required to turn knobs during operation of medical sampling devices. TPEs have been shown to generally provide favorable frictional properties and are suitable for use with the aforementioned MABS or POM.

[0059] Alternatively or additionally, the gasket component material may be a material having a Shore A value of 10 to 100, 20 to 100, 30 to 100, 40 to 90, 50 to 90, 60 to 80, or 65 to 75 as measured according to standard ASTM D2240 or DIN ISO 7619. A Shore A value of approximately 70 has been shown to offer a good trade-off between material hardness and injection molding manufacturing of the gasket component.

[0060] Alternatively or additionally, the gasket component material may be a material having a tensile strength of 3 to 20, 5 to 18, 7 to 14, 9 to 14, 10 to 13 or 11 to 13 MPa as measured according to standard DIN 53504 / ISO 37.

[0061] Alternatively or additionally, the gasket component material may be a material having a compression set of 10% to 50%, 20% to 40%, 25% to 35%, or 28% to 32% for 72 h / RT, as measured according to DIN ISO 815. Smaller compression sets will affect the pressure tension of the gasket component over time.

[0062] Alternatively or additionally, any one or more or all portions of the valve body, as well as the external portions and / or gasket portions, may be injection molded. Higher Shore A hardness may be advantageous in the injection molding of gasket components.

[0063] Alternatively or additionally, any one or more or all of the valve body and external portions may be injection molded.

[0064] Alternatively or additionally, any one or more or all of the valve body and external portions may be made of a material having a higher Shore A value than that of the gasket components.

[0065] In this embodiment, each of the first chamber and the second chamber includes: at least one top opening that provides fluid communication between a respective inlet and outlet via the respective first and second chambers in the first and second positions of the valve member; a bottom surface positioned relative to the top opening; and a lateral surface surrounding and connected to the bottom surface, the bottom surface and the lateral surface forming the inner surface of the respective chamber, wherein the lateral surface and / or the bottom surface is configured as a portion of the gasket member.

[0066] In another or further development of this embodiment, the gasket member includes a lip that extends at least partially between the outer portion and the sealing surface of the valve housing and / or is compressed between the outer portion and the sealing surface of the valve housing.

[0067] This lip improves the seal and reduces friction between the sealing surfaces of the valve components and the valve body.

[0068] The lip may extend over the entire perimeter of the opening (such as the top opening described above) into the first and / or second chambers.

[0069] The lip can extend outward and / or inward from the side wall of the gasket member, potentially extending in a radial direction defined by the axial direction relative to the axis of rotation of the valve member. This can further improve the seal and / or reduce friction.

[0070] In another embodiment, the valve member is rotatable about an axis defining an axial direction, and a first valve port connected to the suction inlet and / or a second valve port connected to the sampling outlet and / or a third valve port connected to the suction outlet and / or a fourth valve port connected to the sampling inlet are disposed in a valve housing surface that extends substantially radially relative to the axial direction.

[0071] As described above, each of the first and second chambers may include at least one top opening that provides fluid communication between a corresponding inlet and outlet via the respective first and second chambers in the first and second positions of the valve member. In this embodiment, the top opening may be appropriately aligned with the corresponding valve port in the first and second positions of the valve member.

[0072] In another embodiment, the medical sampling device is configured to be secured to the endoscope when connected to the suction connector of the endoscope.

[0073] Other aspects of this invention not currently claimed relate to medical sampling devices for use with an endoscope for sampling bodily fluids, wherein the endoscope or catheter has an aspiration channel and an aspiration connector communicating with said aspiration channel.

[0074] The sampling device includes

[0075] The suction inlet for connecting to the suction connector.

[0076] A suction outlet for connecting to a vacuum source.

[0077] The medical sampling device is configured to be fixed to the endoscope when connected to the suction connector of the endoscope.

[0078] The developments described below relate to both current embodiments of the first aspect of the invention and aspects that are not currently claimed.

[0079] Therefore, in the current embodiment of the first aspect of the invention and the unclaimed aspects, the sampling device is configured such that the valve housing can be secured to the endoscope, specifically to the endoscope handle. Securing to the endoscope allows the orientation of the sampling device to be associated with and / or matched to the orientation of the endoscope. This, in turn, provides the endoscope operator with a more direct and instinctive sense of the orientation of the sampling device, as the orientation follows the orientation of the endoscope, which the operator typically grips firmly on the endoscope handle.

[0080] The sampling device can be additionally configured to be fixed to the endoscope in a manner that prevents rotation around the suction connector.

[0081] The suction connector can be so securely and firmly attached to the endoscope that a properly secure connection is achieved when the medical sampling device is fixed to the endoscope. Where a stronger attachment is desired, the sampling device may include one or more flanges or latching members configured to conform to the shape or outer surface of the endoscope, specifically its handle. In the fixed position of the medical sampling device, the flange members may be configured to extend around at least a portion of the endoscope handle, with the inner surface of the flange members potentially abutting the outer surface of the handle. The flange members may be made of a relatively rigid material and potentially suitable flexibility and elasticity (e.g., a hard plastic material), for example, the same material as the rest of the valve housing, to enable snap-fit ​​engagement with the endoscope handle and potentially further ensure that the sampling device is fixed and does not move relative to the endoscope handle. Thus, the medical sampling device can follow the movement of the endoscope handle. Because endoscope operators are frequently used to grip the endoscope handle and are generally familiar with its orientation, the risk of the endoscope ending up in an undesirable orientation (e.g., loss of sample from the sample container) can be reduced.

[0082] In this embodiment, when connected to the endoscope's suction connector via a movable locking member, the medical sampling device is adapted to be fixed to the endoscope.

[0083] Therefore, in both the current embodiment of the first aspect of the invention and the unclaimed aspect, the medical sampling device can be adapted to be fixed to the endoscope when connected to the aspiration connector of the endoscope via a movable locking member.

[0084] The movable locking member can be a slidable locking member of a medical sampling device, which is configured to slide within and / or relative to the valve housing between a locked position and an unlocked position, wherein in the locked position the medical sampling device is fixed to the endoscope, and in the unlocked position the sampling device can be positioned to be fixed to and / or released from the endoscope.

[0085] As described above, the valve housing may include a male or female connector or socket defining an insertion direction, which is adapted to engage, in the insertion direction, a female or male suction connector of an endoscope, such as a standard suction connector for an endoscope. The female or male suction connector may be of the type including one or more circumferentially extending barbs for engaging and retaining the connection with the tubing.

[0086] A movable locking member can be configured to engage one or more of these circumferentially extending barbs of the suction connector, potentially as a snap-fit ​​connection. In the case of a slidable locking member, the locking member may include one or more (e.g., two) locking supports that are slidably engaged with one or more circumferentially extending barbs of the suction connector, particularly when the suction connector is inserted into the socket of the valve housing. The slidable locking member may include a notch that allows the locking member to slide into a locked position, through which the suction connector may extend when the locking member is in the locked position. In this case, the locking support may be a protrusion extending into or toward the notch, such that after the suction connector is inserted into the socket of the valve housing, the protrusion slides into the locked position of the locking member by sliding to a position abutting against the barbs of the suction connector.

[0087] The sliding locking member can be configured to be separate from or as a separate part of the valve housing, and can potentially be attached to be slidable relative to the valve housing or the rest of the valve housing, but potentially not removable from the valve housing. This can be achieved by a retaining member (such as a barb) configured as part of the sliding locking member, which engages a corresponding retaining member (such as a barb) on the valve housing when in the unlocked position to prevent the sliding locking member from being removed from the valve housing when in the unlocked position.

[0088] The slidable locking member may include an engagement portion that potentially extends beyond the valve housing in the release position. By engaging the engagement portion and sliding the locking member (e.g., by pushing or pulling the slidable locking member by hand), the slidable locking member can potentially slide between a locked position and a release position. When the slidable locking member is in the locked position, the engagement portion may be positioned substantially within the valve housing or a valve housing outer shell, potentially such that the outer surface of the slidable locking member (potentially the outer surface of the engagement portion) is substantially flush with the outer surface of the valve housing. The slidable locking member or engagement portion may include a gripping protrusion that potentially extends beyond the outer surface of the valve housing or valve housing outer shell. This gripping protrusion allows, for example, the slidable locking member to be gripped by a finger to potentially pull the slidable locking member toward the release position, such that the slidable locking member or engagement portion can be gripped by hand and slid the remaining distance to enter the release position.

[0089] In an alternative, or further, to allow the movable locking member to slide, the movable locking member may include a movable snap-lock member that allows the valve housing to snap onto the endoscope or its handle. This can be achieved by one or more snap-barbs, potentially disposed on flexible legs such that these legs or barbs flexibly allow insertion of the suction connector, these barbs potentially snapping into engagement with one or more circumferentially extending barbs of the suction connector.

[0090] In an alternative, or further, to allow the movable locking member to slide, the movable locking member may be hinged to the valve housing so as to be rotatable relative to the valve housing. Additionally, the movable locking member may be rotatable within and / or relative to the valve housing between a locked position and an unlocked position, in which the medical sampling device is secured to the endoscope, and in the unlocked position, the sampling device may be positioned to be secured to and / or released from the endoscope.

[0091] The rotatable locking member can be similarly configured to engage one or more circumferentially extending barbs of the suction connector, and may include a locking support that can be rotated to engage with one or more circumferentially extending barbs of the suction connector, particularly when the suction connector is inserted into a socket of the valve housing. The rotatable locking member can similarly include a notch allowing the locking member to slide into a locked position, wherein the suction connector can extend through the notch when the locking member is in the locked position. And similarly, the locking support can be a protrusion extending into the notch such that, after the suction connector is inserted into the socket of the valve housing, the protrusion slides into the locked position of the locking member by sliding to a position abutting against the barbs of the suction connector.

[0092] The rotatable locking member can be similarly configured as a separate portion from the valve housing and can potentially be attached to the valve housing via a hinge. The rotatable locking member may include an engagement portion similar to the engagement portion of the sliding locking member described above.

[0093] The second aspect of the present invention relates to a method for assembling a medical sampling device according to any of the above embodiments of the first aspect of the present invention, the method comprising the following steps:

[0094] Provides a valve component having a first chamber and a second chamber, and

[0095] A valve housing is provided with a suction inlet, a suction outlet, a sampling outlet, and a sampling inlet.

[0096] The valve component is attached to the valve component spacing of the valve housing so that it can rotate relative to the valve housing between a first position and a second position, such that in the first position, the first chamber establishes fluid communication between the suction inlet and the sampling inlet, and in the first position, the second chamber establishes fluid communication between the sampling outlet and the suction outlet, and in the second position, either the first chamber or the second chamber establishes fluid communication between the suction inlet and the suction outlet.

[0097] The method may further include the following steps:

[0098] Provides an outer portion and an inner portion of a valve component, the inner portion being a gasket component, and

[0099] The gasket member is positioned to be slidably attached to the external portion so that it can slide in the axial direction of the valve member.

[0100] The internal component or gasket member can be any of the embodiments described above regarding the internal component or gasket member.

[0101] Embodiments of this aspect of the invention include the following further steps: attaching a knob to the valve housing such that the valve component can be rotated between a first position and a second position by rotating the knob.

[0102] The knob can be positioned to rotate around the rotation axis of the valve component.

[0103] The knob may include legs that engage openings or slots in the valve member, potentially positioned along the periphery of the valve member, thereby allowing the knob to rotate the valve member as it is rotated.

[0104] The knob can be any of the embodiments of the knob described above in conjunction with the first aspect of the invention.

[0105] A third aspect of the invention relates to the use of a medical sampling device according to any of the above embodiments of the first aspect of the invention for sampling bodily fluids and / or body tissues.

[0106] The fourth aspect of the invention relates to the use of a medical sampling device according to any of the above embodiments of the first aspect of the invention, the medical sampling device being used for connection or attachment to an endoscope for flushing and / or sampling of body fluids and / or body tissues, and / or for connection or attachment to a sample container.

[0107] The fifth aspect of the invention relates to a medical kit comprising a medical sampling device according to any of the above embodiments of the first aspect of the invention, and an endoscope or catheter adapted to be attached to the sampling device and / or a sample container adapted to be attached to the sampling device.

[0108] A sixth aspect of the present invention relates to a medical system comprising:

[0109] An endoscope or catheter having a suction channel and a suction connector communicating with the suction channel.

[0110] According to any of the above embodiments of the first aspect of the present invention, a medical sampling device is attached to an endoscope or catheter, and

[0111] A sample container that is attached to the medical sampling device.

[0112] The seventh aspect of the present invention relates to a method for assembling a medical system according to the sixth aspect of the present invention, the method comprising the following steps:

[0113] An endoscope is provided having a handle, a suction channel, and a suction connector communicating with the suction channel.

[0114] Provide a medical sampling device according to any one of claims 1 to 8,

[0115] Provide sample containers,

[0116] Provide a vacuum source,

[0117] Connect the suction connector to the suction inlet of the sampling device.

[0118] Attach or secure the medical sampling device to the handle.

[0119] The suction outlet of the sampling device is connected to the vacuum source, and

[0120] Connect the sampling inlet and sampling outlet of the sampling device to the sample container.

[0121] Those skilled in the art will understand that any one or more of the above aspects of the present invention and their embodiments can be combined with any one or more of other aspects of the present invention and their embodiments. Attached Figure Description

[0122] The invention will now be described in more detail with reference to the accompanying drawings, in which:

[0123] Figure 1 It is a perspective view of an endoscope connected to a schematically drawn monitor, a medical sampling device according to a first aspect of the invention connected to a sample container, and a saline tank not connected to the endoscope.

[0124] Figure 2 This is a schematic diagram of a sampling system, which includes a valve component in an assembled state and positioned at a first position in the sampling device.Figure 1 Part of it;

[0125] Figure 3 It is located at the second position of the valve component of the sampling device. Figure 2 A schematic diagram of the sampling system;

[0126] Figure 4A and Figure 4B yes Figure 1 A perspective view of the sampling device, positioned in the second position of the valve component of the sampling device, and showing the locking component from... Figure 4A The unlock location in Figure 4B Movement at the locked position;

[0127] Figure 5A From Figure 4A and Figure 4B What you see on the left side of the middle Figure 1 Front view of the valve housing and locking components of the sampling device;

[0128] Figure 5B It is along Figure 5A A cross-sectional view of line BB;

[0129] Figure 6A From Figure 5A What you see at the bottom Figure 5A A bottom view of the valve housing portion;

[0130] Figure 6B It is along Figure 6A A cross-sectional view taken from line AA;

[0131] Figure 7 It is similar to Figure 1 Sampling device in an unassembled state Figure 4A and Figure 4B The exploded 3D view of those parts shows the assembly of the sampling device;

[0132] Figure 8A From Figure 4B The front view of sampling device 1 as seen from the left;

[0133] Figure 8B It is along Figure 8A A cross-sectional view taken from line CC;

[0134] Figures 9A to 9E yes Figure 1 Different views of the gasket component of the valve component of the sampling device;

[0135] Figures 10A to 10E yes Figure 1 Different views of the external portion of the valve component of the sampling device; and

[0136] Figures 11A to 11E yes Figure 1 Different views of the knob of the valve component of the sampling device. Detailed Implementation

[0137] Reference Figure 1 Endoscope 1 is a medical device suitable for examining natural and / or artificial body openings, such as those suitable for exploring the lung cavity. Endoscope 1 includes an operating handle 2, an insertion tube 3, and a suction connector 4. For illustrative purposes, the insertion tube 3 is... Figure 1 Only a portion is shown. The endoscope 1, sampling device 8, and sample container 16 are adapted and intended for single use. The sampling device 8 may be connected to a catheter instead of the endoscope 1.

[0138] Figure 2 and Figure 3 This is a schematic diagram of a sampling system, which includes valve components 10 in an assembled state and respectively positioned at first and second positions of the sampling device 8. Figure 1 The part.

[0139] Figure 3 This is a schematic diagram of saline box 17.

[0140] exist Figure 1 The sampling device 9 is schematically shown in the diagram. The sampling device 9 and its components are... Figures 4A to 11E It is shown in detail in the text.

[0141] Reference Figure 1 The insertion tube 3 is a slender member suitable for insertion into a patient (e.g., through the patient's mouth into the patient's lungs). The insertion tube 3 extends from the operating handle 2 to the distal end of the endoscope 1. The insertion tube 3 has a proximal end 31 connected to a handle housing of the handle 2 and a distal end 32 with a maneuverable, flexible tip 33 that allows the insertion tube 3 to be manipulated through a body cavity. This body cavity may include the patient's trachea and bronchi, especially when using… Figure 1 In medical systems for performing bronchoalveolar lavage or bronchoalveolar lavage, however, as those skilled in the art will understand, the use of the medical sampling device according to the invention is not necessarily limited to such procedures.

[0142] The distal tip of the tip portion 33 includes an opening connected to one or more channels, wherein at least one channel (e.g., a suction channel) can be used as a suction channel 34, see also Figure 2 and Figure 3 The suction channel 34 can be connected to a suction source or vacuum source via the suction connector 4 by actuation of valve 21, which is operated in a known manner by button 22 on the handle 2 of endoscope 1. The tip portion 33 also includes a light source and camera connected to monitor 7 via cable 6, which allows the operator and others to monitor the actions performed inside the patient.

[0143] The suction connector 4 is a standard type for attaching a flexible suction tube, which in turn connects to a vacuum or suction source, such as the wall-mounted suction devices commonly found in hospital rooms. The suction connector 4 is typically a tubular, truncated tapered male connector with a taper that allows for easy attachment of the flexible suction tube and circumferential folds or barbs that allow for a secure attachment of the flexible suction tube in a known manner. The connector 4 does not need to be a component of the endoscope 1; in some alternative endoscopes, the connector is a separate, interchangeable part. Additionally, in some alternative endoscopes, the connector can be a socket or receptacle, i.e., a female connector.

[0144] Figure 1 Also shown are a medical sampling device 8 and a saline tank 17, which are embodiments of the first aspect of the invention. Both are adapted to be attached to the endoscope 1 by moving in the corresponding direction of the arrows in the figure, wherein the saline tank 17 is positioned in fluid communication with the working channel or aspiration channel 34 of the endoscope.

[0145] exist Figure 2 and Figure 3 In the schematically illustrated sampling system, instead of directly connecting the flexible suction tube to the suction connector 4, the sampling device 8 is connected to the suction connector 4. The sampling device 8 is then connected to the flexible suction tube 5. For this purpose, the sampling device 8 has: an identical, similar, or at least corresponding tube connector or suction connector 85 to which the flexible suction tube 5 can be attached; and an opening or socket forming the suction inlet 81, serving as a socket for receiving and securing the suction connector 4. Clearly, if the connector 4 were the aforementioned separate, interchangeable part, the sampling device 8 could be adapted to be directly fitted into the endoscope 1, thus completely eliminating the need for the suction connector.

[0146] The sampling device 8 further includes a sample container connector 139, which includes a sampling inlet 83 and a sampling outlet 84, the sampling inlet and outlet being adapted to engage and insert into the wall of a preferably removable sample container 16, preferably through an opening covered by a membrane. Preferably, the sample container 16 is adapted to self-seal when removed from the sampling device 8.

[0147] The saline tank 17 is adapted to be attached to the endoscope 1 in fluid communication with the endoscope 1's suction channel 34 via the endoscope's inlet port 23. The saline tank 17 is a container pre-filled with a saline solution and has a known pressurization device for pressurizing the saline solution.

[0148] Referring now to all the figures, the sampling device 1 includes a suction inlet 81 for connection to the suction connector 4, a suction outlet 82 for connection to the vacuum source, a sampling outlet 83 for connection to the sample container 16, a sampling inlet 84 for connection to the sample container 16, and a valve 9 having a valve member 10 and a valve housing 13.

[0149] The valve component, specifically its gasket component 11, has a first chamber 10A and a second chamber 10B, as detailed below. Figure 9B and Figure 9E And it is rotatable relative to the valve housing 13 between the first position and the second position, the first position being... Figure 2 The second position is shown in the middle. Figure 3 As shown in the diagram. In the first position, the first chamber 10A establishes fluid communication between the suction inlet 81 and the sampling inlet 84, and the second chamber 10B establishes fluid communication between the sampling outlet 83 and the suction outlet 82. In the second position, the second chamber 10B... Figure 8A Turning the knob 15 90 degrees clockwise in the view establishes fluid communication between the suction inlet 81 and the suction outlet 82. Note that the device 8 can operate in a similar manner by rotating it 90 degrees counterclockwise, in which case the first chamber 10A will establish fluid communication between the suction inlet 81 and the suction outlet 82.

[0150] In the first and second positions respectively, valve component 10 substantially blocks all other fluid communication between the inlet and outlet 81-84 of sampling device 1.

[0151] Valve housing 13 is the stationary part of medical sampling device 8, and valve component 10 is rotatable relative to this stationary part about rotation axis 10C. See [reference needed] Figure 7 When the medical sampling device 8 is fixed to the endoscope 1, the stationary part is fixed to the endoscope handle 2 and remains stationary relative to it.

[0152] The valve housing 13 includes a valve housing portion 135, which includes a suction inlet 81, a channel for connecting the suction inlet 81 to a suction connector 85 and a suction outlet 82, a channel for connecting the suction outlet 82 to a sampling outlet 83, a sliding pitch 136 for a slidable locking member 14, a flange member 137, and a valve member pitch 133 in which the valve member 10 is located. All of these are integrally disposed in the valve housing portion 135. The valve housing 13 also includes a valve housing outer shell 138, which is positioned around the valve housing portion 135 to form certain outer surfaces of the outer surface of the valve housing 13.

[0153] During the assembly of the medical sampling device 1, the valve member 10 is first positioned within the valve member spacing 133. Then, the valve housing outer shell 138 is positioned to partially cover the valve member 10 to hold the valve member 10 in place and cover the valve housing portion 135. Next, the knob 15 is positioned to attach to the valve housing 13 together with the valve member 10 and to be rotatable relative to the valve housing 13. The valve housing outer shell 138 snaps irreversibly onto the valve housing portion 135. Each of the valve housing portion 135 and the valve housing outer shell 138 is a single molded part.

[0154] The valve housing portion 135 includes a circumferentially extending sealing surface 131 at the bottom of the valve component spacing 133, see [reference]. Figure 5A The valve component 10 includes a corresponding sealing surface 102, particularly see Figure 9A , Figure 9B and Figure 9E The sealing surfaces 131 and 102 abut against each other and seal the interior of the chambers 10A and 10B in which fluid flows and the interior of the valve 9 (such as the passage and valve port described below) from the surrounding environment. The sealing surface 102 is provided on the inner portion of the valve member 10 in the form of a gasket member 11 and extends along the outer peripheral wall 115 of the valve member 10 and along the linear wall 114 separating the two chambers 10A and 10B, as further described below.

[0155] The valve housing portion 135 includes a suction inlet 81, a suction outlet 82, a sampling outlet 84, and a sampling inlet 83, each configured as a fluid port on the surface of the valve housing 13, particularly on the surface of the valve housing portion 135, and therefore on the surface of the sampling device 1. The suction inlet 81 is positioned radially at a distance from the rotation axis 10C and from the valve member 10, such that the insertion direction of the endoscope 1's suction connector 4 is aligned with said direction. Similarly, the sampling inlet 84 and outlet 83 are positioned radially at a distance from the rotation axis 10C and from the valve member 10, such that the insertion direction of the sample container connector 139 of the valve housing portion 135 is aligned with said direction. The sample container connector 139 includes the sampling inlet 84 and the sampling outlet 83, see in particular... Figure 6B The suction outlet 82 is a certain distance from the valve member 10 in the axial direction of the rotation axis 10C, such that the insertion direction of the suction connector 85 to the suction tube of the vacuum source is aligned with the stated direction.

[0156] Reference Figure 7 When the sampling device 1 is assembled, the valve member 10 is moved into position within the valve member spacing 133 by sliding along the axial direction of the rotation axis 10C, such that the three protrusions 134 protruding from the valve housing surface 132 engage with the corresponding three recesses 101 in the periphery of the circular valve member 10. See also Figure 5A andFigure 7 And further see below. One or more valve member stop elements may be provided on the valve member 10 and on the valve housing surface 132 to restrict the rotational movement of the valve member 10. The valve member stop elements are configured such that when the valve member 10 has been rotated from the first position to the second position, further rotation in that direction is not permitted, and when the valve member 10 has been rotated from the second position to the first position, further rotation in that direction is not permitted.

[0157] Each of the valve member 10, the gasket member 11, and the outer portion 12 is substantially disc-shaped and has a substantially circular shape. The gasket member 11 includes a fluid-tight linear wall 114 separating the two chambers 10A and 10B from each other. The first chamber 10A and the second chamber 10B are substantially cylindrical and crescent-shaped in cross-section perpendicular to the axis of rotation 10C, see in particular. Figure 9C The cylindrical side surface extends in the axial direction defined by the axis of rotation 10C. Wall 114 is composed of a linear wall of the outer portion 12 and two walls forming a recess in the gasket member 11, the linear wall of the outer portion being positioned within the recess, see [reference needed]. Figure 7 and Figures 9A to 10E Wall 114 separates the two chambers 10A, 10B from each other to block fluid communication between them. Wall 114 extends linearly in a cross-section perpendicular to the axis of rotation 10C, thus providing crescent-shaped linear sides for the respective chambers 10A, 10B. Corresponding semi-circular walls 115 form crescent-shaped circular portions. These walls 115 form portions of the circumferential walls of the valve member 10 extending along the cylindrical side surface in the axial direction of the axis 10C.

[0158] Special reference Figures 9A to 9E The gasket member 11 further includes a circumferentially and circumferentially extending circular lip 113, which extends and is compressed between the circumferentially and laterally or radially outwardly projecting outer peripheral edge 121 of the outer portion 12 and the sealing surface 131 of the valve housing 13. The lip 113 extends outwardly from the semi-circular wall 115 along the entire periphery of the gasket member 11. Figures 9A to 9E The middle lip 113 is shown in an uncompressed state.

[0159] Special reference Figure 10A and Figure 10BThe outer portion 12 further includes three protrusions 122 projecting from its outer peripheral edge 121, such that, in the assembled state, these protrusions extend toward the valve housing surface 132. These protrusions are located at a radial distance on the outer peripheral edge 121 greater than the outer diameter of the gasket member 11, such that if the knob 15 or the outer portion 12 is pushed toward the valve housing surface 132, the protrusions 122 abut against the valve housing surface 132, thereby preventing the gasket portion 11 from being squeezed, which would otherwise lead to leakage.

[0160] Special Reference Figure 5A and Figure 6B The valve housing portion 135 includes a plurality of internal fluid channels or conduits 91-94 that allow fluid to flow through the sampling device 1 and connect inlets and outlets 81-84 to valve ports 95-98 of the valve 9. The valve ports 95-98 establish fluid communication between the respective channels 91-94 and the first chamber 10A and the second chamber 10B, depending on the rotational position of the aforementioned valve member 10. These channels 91-94 are configured to be fluid-tight against each other. Thus, a first suction channel 91 connects the suction inlet 81 to the first valve port 95, a first sampling channel 92 connects the sampling inlet 84 to the second valve port 96, a second sampling channel 94 connects the sampling outlet 83 to the third valve port 97, and a second suction channel 93 connects the suction outlet 82 to the fourth valve port 98. The first to fourth valve ports 95-98 are configured as follows: Figure 5A The objects are distributed sequentially in a clockwise circumferential direction around the rotation axis 10C.

[0161] Each of the first chamber 10A and the second chamber 10B includes top openings 111A and 111B, respectively, see details. Figure 9B and Figure 9E Each of these top openings 111A, 111B may alternatively be configured as one or two or more top openings for each chamber 10A, 10B. Each of the first chamber 10A and the second chamber 10B includes a bottom surface 112A, 112B respectively positioned relative to the corresponding top opening 111A, 111B, and a corresponding lateral inner surface surrounding and connected to the wall 115 of the corresponding bottom surface 112A, 112B, which establish a fluid-tight inner surface for the corresponding chamber 10A, 10B.

[0162] In the first position of valve member 10, the top opening 111A is aligned with the first valve port 95 and the second valve port 96, thereby providing fluid communication between the suction inlet 81 and the sampling inlet 84, and the top opening 111B is aligned with the third valve port 97 and the fourth end valve port 98, thereby providing fluid communication between the sampling outlet 83 and the extraction outlet 82. In the second position of valve member 10 (e.g. Figure 4A and Figure 4BAs shown), the top opening 111B is aligned with the first valve port 95 and the fourth valve port 98, and the top opening 111A is aligned with the second valve port 96 and the third valve port 97.

[0163] refer to Figure 5A Valve ports 95-98 are disposed in the valve housing surface 132 of the valve housing portion 135. This surface 132 is planar and extends in a plane that extends radially relative to the axis of rotation 10C. Therefore, valve ports 95-98 are configured to be properly aligned with the top openings 111A, 111B. The sealing surface 131 of the valve housing portion 135 is also included in this plane to surround all four valve ports 95-98.

[0164] refer to Figure 6B Channels 91, 92, and 94 each include a bend of approximately 90 degrees, allowing each channel to extend from the corresponding valve port to the corresponding inlet or outlet.

[0165] The valve body 13 and the outer portion 12 are made of POM. The gasket assembly 11 is made of the above-mentioned... TPE, MC / LF series, product name Made of M, TM7LFT type.

[0166] The gasket member 11 is configured as a single integral member surrounding the first chamber 10A and the second chamber 10B, and it separates the first chamber 10A and the second chamber 10B from each other by a linear wall 114 separating the first chamber 10A and the second chamber 10B.

[0167] Therefore, the sampling device 8 is configured such that when a vacuum pressure from a vacuum source is applied to the second chamber 10B at the first and second positions of the valve member 10, the vacuum pressure at least pulls the gasket member 11 toward the fourth valve port 98 and the suction outlet 82. To achieve this, the gasket member 11 is configured to be separate from and movably attached to the outer portion 12 so that it can slide relative to the valve member 10 in the axial direction, see in particular. Figures 9A to 10E The gasket member 11 defines a first chamber 10A and a second chamber 10B on all sides except for the respective top openings 11A, 11B, such that when a vacuum pressure is applied to the suction outlet 82 in the first and second positions, the vacuum pressure causes the gasket member 11 or a plurality of portions thereof to move and / or be suctioned in the direction toward the suction outlet 82.

[0168] A hand-rotatable knob 15 is attached to the outer portion 12 of the valve member 10 in a rotatable manner. A gasket member 11 is rotatably fixed to the outer portion 12 such that when the outer portion 12 is rotated via the knob 15, both members 11 and 12 rotate.

[0169] The suction inlet 81 is a female connector forming a socket that defines an insertion direction suitable for receiving the suction connector 4 in the insertion direction to form a fixed connection. Additionally, the sampling device 8 is adapted to engage the endoscope 1 in a manner preventing rotation around the suction connector 4.

[0170] A sampling inlet 84 is disposed in a sample container connector 18 adapted for connection to a sample container 16. The sample container connector 18 extends in a direction parallel to the insertion direction.

[0171] The sampling device 8 is adapted to be fixed to the endoscope 1 by means of a locking member 14, which can be used to secure the endoscope 1. Figure 4B The lock position shown is the same as Figure 4A The sampling device 8 slides relative to the valve housing portion 13 between the unlocked positions shown. In the locked position, the sampling device 8 is fixed to the endoscope 1. In the unlocked position, the sampling device 8 can be positioned to be fixed to or released from the endoscope 1.

[0172] like Figure 8B Best viewed, the suction connector 4 includes one or more circumferentially extending barbs for engaging and maintaining a connection with the tube. The locking member 14 is configured to engage one of these barbs of the suction connector 4. For this purpose, the locking member 14 includes two locking supports 141 that slide to engage with the barbs of the suction connector 4 when the suction connector 4 is inserted into the suction inlet 81 socket, see [link to relevant documentation]. Figure 5B The locking member 14 includes a cutout 142 that allows the locking member 14 to slide into a locked position, through which the suction connector 4 extends. The locking support 141 can be considered as a protrusion extending into or toward the cutout 142, such that after insertion of the suction connector 4, the locking support 141 slides into the locked position of the locking member 14 by sliding to a position abutting against a barb of the suction connector 4.

[0173] The locking member 14 is configured as a separate portion from the valve housing 13 and is attached such that it can slide relative to the valve housing 13, but cannot be detached from the valve housing 13. The barb 143 of the locking member 14 engages the corresponding barb 135a of the valve housing portion 135 when in the unlocked position, thereby preventing the locking member 14 from being removed from the valve housing 13 when in the unlocked position. See [reference needed] Figure 5B .

[0174] The locking member 14 further includes an engagement portion 144 that extends out of the valve housing 13 in the released position, allowing the locking member 14 to slide between a locked position and a released position by pushing or pulling by hand. When the locking member 14 is in the locked position, the engagement portion 144 is substantially inside the valve housing 13, and the outer surface of the engagement portion 144 is substantially flush with the outer surface of the valve housing 13. The engagement portion 144 includes a gripping protrusion that allows the locking member 14 to be gripped by pulling it toward the released position with a finger.

[0175] The valve housing portion 135 further includes a flange member 137 configured to match the shape or outer surface of the endoscope handle 2. In the fixed position of the sampling device 8, the flange member 137 is configured to extend around a portion of the handle 2, with the inner surface of the flange member 137 abutting against the outer surface of the handle 2 to ensure that the sampling device 8 is fixed and does not move relative to the handle 2 when it is locked to the endoscope handle 2 by the locking member 14 as described above.

[0176] Special Reference Figure 7 and Figure 8B The sampling device 8 can be assembled according to the method of the second aspect of the invention in such a way that the valve member 10 is positioned in the valve member spacing 133 so as to be rotatable relative to the valve housing 13 between a first position and a second position of the valve member 10. Before, after, or simultaneously with the preceding step, the gasket member 11 is positioned to be slidably attached to the outer portion 12 as explained, and the knob 15 is attached to the valve housing 13 and the outer portion 12.

[0177] Special Reference Figure 7 and Figures 11A to 11E The knob 15 includes three legs 151 that engage with slots 101 positioned along the periphery of the outer portion 12 to secure the outer portion 12 and the knob 15 to each other and allow the knob 15 to rotate the valve member 10 when the knob 15 is rotated.

[0178] refer to Figure 2 and Figure 3 The sampling system shown is operated as follows:

[0179] The operator activates the saline tank 17 to drain fluid through the inlet port 23 of the endoscope 1. The drained fluid is distributed into the aspiration channel 34 and dripped into the desired location within the patient at the distal end 32. Once the saline solution has been dripped into the patient, a partial fluid sample can now be extracted using the system, which includes the endoscope 1, sampling device 8, sample container 16, and flexible aspiration tube 5 connected to the aspiration source as explained below.

[0180] If it is not yet in the first position, the operator rotates the valve component 10 to the first position using knob 15. Figure 2 The first position is shown. The operator then presses button 22 on endoscope 1 to open valve 21 on the endoscope, and thus open the passageway 34 of the aspiration channel 1. Liquid from the sampling site (e.g., in the lungs), or a fluid consisting of air, liquid, and possibly solid tissue samples, is now drawn through aspiration channel 34 via valve 21 to aspiration connector 4, further to aspiration inlet 81, further to the first chamber 10A, withdrawn from sampling outlet 83, and enters sample container 16. In sample container 16, as the liquid and tissue samples fall to the bottom under gravity, their main components are captured, while the remaining fluid (mainly air) is drawn out through sampling outlet 83, into the second chamber 10B, into aspiration outlet 83, and exits through aspiration tube 5.

[0181] When a suitable volume of sample has been accumulated in sample container 16, release button 5 and valve 22 closes.

[0182] Sample container 16 can now be removed and replaced with a new empty container, and the process can be repeated.

[0183] When sampling is no longer needed, valve component 10 is rotated via knob 15 to... Figure 3 The second position, as shown, closes the passage to sample container 16. Fluid from the sampling site is now drawn through suction channel 34 via valve 21 to suction connector 4, further to suction inlet 81, further to second chamber 10B, to suction outlet 83, and exits via suction tube 5. Normal suction of fluid through suction channel 34 can then be performed without removing sampling device 8; that is, normal operation of endoscope 1 (which may be unrelated to sampling) can still be performed without first removing sampling device 9. Additionally, placing valve member 10 in this bypass or diversion position allows the user to prevent any sample loss, such as if the user anticipates movement, by directing the flow directly to the wall-mounted suction device without removing sample container 16 from the assembly. By resetting valve member 10 to the first position to disconnect the diversion, the operator will be able to continue sampling.

[0184] After the sampling procedure is completed, the endoscope 1 and the sampling device 8 can be discarded.

[0185] The sampling device 8 and sample container 16 can be used independently of the therefore optional saline box 17. Instead, a suitably sized syringe can be attached to the inlet port 23 to provide liquid.

[0186] In an embodiment of the third aspect of the invention, the sampling device 8 is used to sample body fluids and / or body tissues as described above.

[0187] In an embodiment of the fourth aspect of the invention, the sampling device 8 is used to connect to or attach to the endoscope 1 for rinsing and / or sampling of body fluids and / or body tissues, and / or to connect to or attach to the sample container 16.

[0188] A fifth aspect of the invention relates to a medical kit comprising the aforementioned sampling device 8 and an endoscope 1 and / or a sample container 16.

[0189] A sixth aspect of the present invention relates to a medical system comprising an endoscope 1, a sampling device 8 attached to the endoscope 1, and a sample container 16 attached to the sampling device 8.

[0190] A seventh aspect of the present invention relates to a method of assembling the medical system described above, the method comprising the steps of: connecting a suction connector 4 to a suction inlet 81 of a sampling device 8; securing the sampling device 8 to a handle 2 of an endoscope 1; connecting a suction outlet 82 to a vacuum source; and connecting a sampling inlet 84 and a sampling outlet 83 to a sample container 16.

[0191] List of reference numerals

[0192] 1. Endoscope

[0193] 2. Operating handle

[0194] 21 Endoscopic valve

[0195] 22 buttons

[0196] 23 Entry Port

[0197] 3. Insertion tube

[0198] 31 Proximal end

[0199] 32 Remote

[0200] 33 Controllable tip

[0201] 34 Suction Channels

[0202] 4. Suction connector

[0203] 5. Suction tube

[0204] 6 Cables

[0205] 7 monitors

[0206] 8 Sampling device

[0207] 81 Suction Inlet

[0208] 82 Suction outlet

[0209] 83 Sampling outlet

[0210] 84 Sampling Inlet

[0211] 85 Suction Connector

[0212] 9 valves

[0213] 91 First suction channel

[0214] 92 First Sampling Channel

[0215] 93 Second suction channel

[0216] 94 Second Sampling Channel

[0217] 95 First valve port

[0218] 96 Second valve port

[0219] 97 Third valve port

[0220] 98 Fourth valve port

[0221] 10 Valve components

[0222] 10A First Chamber

[0223] 10B Second Chamber

[0224] 10C Rotation Axis

[0225] 101 recess

[0226] 102 Sealing Surface

[0227] 11 Gasket Components

[0228] Top opening of chamber 10A 111A

[0229] Top opening of chamber 10B, 111B

[0230] 112A Bottom Surface

[0231] 112B Bottom Surface

[0232] 113 Lips

[0233] 114 Linear Wall

[0234] 115 Semicircular wall

[0235] 12 External Parts

[0236] 121 Edge

[0237] 122 Protrusion

[0238] 13 valve housing

[0239] 131 Sealing Surface

[0240] 132 Valve housing surface

[0241] 133 Valve component spacing

[0242] 134 Protrusion

[0243] 135 Valve housing section

[0244] 135a edge

[0245] 136 Sliding interval

[0246] 137 Flange component

[0247] 138 Valve housing outer shell

[0248] 139 Sample Container Connector

[0249] 14 Locking components

[0250] 141 Locking support

[0251] 142 Incision

[0252] 143 Barbed Hook

[0253] 144 Joint portion

[0254] 15 knobs

[0255] 151 outriggers

[0256] 16 Sample Containers

[0257] 17. Saltwater box

Claims

1. A medical sampling device for use with an endoscope or catheter to flush body cavities and / or sample body fluids and / or body tissues, the endoscope or catheter having an aspiration channel and an aspiration connector in fluid communication with said aspiration channel. The sampling device includes The suction inlet for connecting to the suction connector. A suction outlet for connecting to a vacuum source. Sampling outlet for connecting to the sample container The sampling inlet for connecting to the sample container, and A valve having valve components and a valve body, in, The valve component has a first chamber and a second chamber and is rotatable relative to the valve housing between a first position providing a sampling mode and a second position providing a closed or bypass mode to allow flushing of the body cavity around the sample container. In this first position, the first chamber establishes fluid communication between the suction inlet and the sampling inlet. In this first position, the second chamber establishes fluid communication between the sampling outlet and the suction outlet. In the second position, one of the first and second chambers establishes fluid communication between the suction inlet and the suction outlet.

2. The medical sampling device according to claim 1, wherein, The medical sampling device is configured such that when a vacuum pressure from the vacuum source is applied to the second chamber at the first position and to the first or second chamber at the second position, the vacuum pressure pulls at least a portion of the valve member toward the suction outlet.

3. The medical sampling device according to claim 1 or 2, wherein, The valve member includes an outer portion and an inner portion, and the inner portion is a gasket member configured to be separate from and movably attached to the outer portion so as to be movable relative to the valve member in the axial direction of the valve member. The gasket member laterally surrounds the first chamber and / or the second chamber such that when a vacuum pressure is applied to the suction outlet at the first position and / or the second position, the vacuum pressure causes the gasket member to move in the direction toward the suction outlet.

4. The medical sampling device according to claim 3, wherein, Each of the first and second chambers includes: at least one top opening that provides fluid communication between a respective inlet and outlet via the respective first and second chambers in a first and a second position of the valve member; a bottom surface positioned relative to the top opening; and a lateral surface surrounding and connected to the bottom surface, the bottom surface and the lateral surface forming an inner surface of the respective chamber, wherein the lateral surface and / or the bottom surface is configured as a portion of the gasket member.

5. The medical sampling device according to claim 3 or 4, wherein, The gasket component includes a lip that extends at least partially between the outer portion and the sealing surface of the valve housing and / or is compressed between the outer portion and the sealing surface of the valve housing.

6. The medical sampling device according to any one of the preceding claims, wherein, The valve component is rotatable about an axis defining an axial direction, and a first valve port connected to the suction inlet and / or a second valve port connected to the sampling outlet and / or a third valve port connected to the suction outlet and / or a fourth valve port connected to the sampling inlet are disposed in a valve housing surface that extends substantially radially relative to the axial direction.

7. The medical sampling device according to any one of the preceding claims, wherein, The medical sampling device is configured to be secured to the endoscope when connected to the suction connector of the endoscope.

8. The medical sampling device according to claim 7, wherein, When connected to the endoscope's suction connector via a movable locking member, the medical sampling device is adapted to be fixed to the endoscope.

9. A method for assembling a sampling device according to any one of the preceding claims, the method comprising the following steps: A valve component having first and second chambers is provided, and Provides a valve body with a suction inlet, a suction outlet, a sampling outlet, and a sampling inlet. The valve component is attached to the valve component spacing of the valve housing so that it can rotate relative to the valve housing between a first position and a second position, such that in the first position, the first chamber establishes fluid communication between the suction inlet and the sampling inlet, and in the first position, the second chamber establishes fluid communication between the sampling outlet and the suction outlet, and in the second position, either the first chamber or the second chamber establishes fluid communication between the suction inlet and the suction outlet.

10. The method of claim 9, further comprising attaching a knob to the valve housing and / or valve member such that the valve member can rotate between the first position and the second position by rotation of the knob.

11. A medical kit comprising a medical sampling device according to any one of claims 1 to 8, and an endoscope or catheter adapted for attachment to said sampling device and / or a sample container adapted for attachment to said sampling device.

12. A medical system comprising: An endoscope or catheter having a suction channel and a suction connector communicating with the suction channel. The medical sampling device according to any one of claims 1 to 8, wherein the medical sampling device is attached to the endoscope or catheter, and A sample container that is attached to the medical sampling device.

13. A method of assembling the medical system according to claim 12, the method comprising the following steps: An endoscope is provided having a handle, a suction channel, and a suction connector communicating with the suction channel. Provide a medical sampling device according to any one of claims 1 to 8, Provide sample containers, Provide a vacuum source, Connect the suction connector to the suction inlet of the sampling device. Attach or secure the medical sampling device to the handle. The suction outlet of the sampling device is connected to the vacuum source, and Connect the sampling inlet and sampling outlet of the sampling device to the sample container.

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