Medical devices and related methods

Abstract

The medical device includes an expandable tool configured to extend from the distal end of the medical device. The expandable tool includes a plurality of wires extending from the proximal end of the expandable tool to the distal end of the expandable tool, a plurality of fins extending outward from each of the plurality of wires, and a plurality of protrusions extending outward from each of the plurality of fins.

Description

Technical Field

[0001] Various aspects of the present disclosure generally relate to medical systems, medical devices, and related methods. Specifically, embodiments of the present disclosure relate to devices for collecting tissue samples, such as tissue samples within the common bile duct and pancreatic duct. This application claims the benefit of priority based on U.S. Provisional Patent Application No. 63 / 494,960, filed on April 7, 2023, the entire contents of which are incorporated herein by reference.

Background Art

[0002] Endoscopic retrograde cholangiopancreatography (ERCP) is a means of diagnosing and / or treating conditions of the biliary and pancreatic duct systems, such as strictures, using endoscopy and fluoroscopy. In an exemplary ERCP procedure, an endoscope is inserted into the patient's mouth, passed down the esophagus, through the stomach, and advanced into the duodenum to reach the papilla where each of the common bile duct (of the biliary system) and the pancreatic duct converge into the duodenum. Then, by being able to inject a contrast agent, an operator can visualize strictures within the biliary or pancreatic duct system on an X-ray image using fluoroscopy. Then, the operator can use an instrument, such as a cytology brush, to collect a tissue sample from the stricture for use in diagnosing a malignant stricture.

[0003] Cytological brushes used during ERCP procedures are often too large in diameter to be used with endoscopes that include imaging devices. This is because the working channel of such endoscopes is typically reduced in diameter to accommodate the imaging device. Therefore, cytological brushing performed during ERCP is often done by feel after the operator has positioned the endoscope near the narrowing. As a result, the brush may be mistakenly inserted into the wrong duct (e.g., the bile duct instead of the pancreatic duct) or may not make contact with the narrowing even after repeated probing, making it difficult for the operator to accurately collect a suitable tissue sample from the narrowing. Such difficulties caused by a lack of visualization can lead to prolonged procedures or the collection of inappropriate tissue samples. Other procedures may also involve biopsies using cytological brushes, but similar difficulties may arise. Therefore, equipment for collecting tissue samples is required. [Overview of the project]

[0004] Each aspect disclosed herein may include one or more features described in relation to any of the other aspects disclosed. Aspects of this disclosure relate, in particular, to systems, apparatus, and methods for collecting tissue samples, such as tissue samples from the common bile duct and pancreatic duct, during medical procedures. Aspects of this disclosure also relate, in particular, to expandable tools having features such as bristles or wires for collecting increased amounts of tissue.

[0005] According to one embodiment, the medical device may include an expandable tool configured to extend from the distal end of the medical device. The expandable tool includes a plurality of wires extending from the proximal end of the expandable tool to the distal end of the expandable tool, a plurality of fins extending outward from each of the plurality of wires, and a plurality of protrusions extending outward from each of the plurality of fins.

[0006] Any of the medical devices described herein may include any of the following features: The plurality of wires define the plurality of legs, each of which branches from a central trunk located at the proximal end of the expandable tool. The plurality of legs are joined to one another at the distal end of the expandable tool. The expandable tool is configured to transition from a folded configuration to an extended configuration. Each of the plurality of fins is configured to fold inward toward the plurality of wires in the folded configuration. Each of the plurality of wires is configured to have a concave shape by curving outward in the extended configuration. In the folded configuration, the outer diameter of the expandable tool is 1.5 mm or less. In the extended configuration, the width of the expandable tool is in the range of 1 mm to 15 mm. The plurality of wires comprises a first material, and the plurality of fins comprises a second material. The first material is the same as the second material. The plurality of protrusions comprises a third material. The third material is the same as the second material. The plurality of fins are integrally formed with the plurality of wires. The plurality of protrusions extend radially outward with respect to the longitudinal axis of each of the plurality of fins. In the folded configuration of the expandable tool, the plurality of wires extend substantially parallel to the longitudinal axis of the expandable tool.

[0007] According to another embodiment, the medical device may include an expandable tool configured to extend from the distal end of the medical device. The expandable tool includes a plurality of wires extending from the proximal end to the distal end of the expandable tool. Each of the plurality of wires may be configured to curve outward in the expandable configuration of the expandable tool to form a basket. Each of the plurality of wires may include a first portion configured to extend inward relative to the profile of the wire and a second portion configured to extend outward relative to the profile of the wire. The plurality of wires may be configured to be joined together at the distal end of the expandable tool.

[0008] Any of the medical devices described herein may include any of the following features: The plurality of wires includes a plurality of sharp wires. The plurality of wires includes a plurality of textured wires. Each of the plurality of textured wires includes a plurality of projections extending outward from the longitudinal axis of each of the plurality of textured wires. Each of the plurality of projections includes a free end configured to form a return extending radially away from the longitudinal axis of each of the plurality of textured wires. Each of the plurality of wires includes a shape memory material. In the folded configuration of the expandable tool, the outline of the wires extends substantially parallel to the longitudinal axis of the expandable tool.

[0009] According to another embodiment, a method for collecting a tissue sample using a medical device may include moving an expandable tool to a target site in a patient's lumen. The expandable tool may include a plurality of wires extending from the proximal end to the distal end of the expandable tool, a plurality of fins extending outward from each of the plurality of wires, and a plurality of projections extending outward from each of the plurality of fins. The method may include transitioning the expandable tool from a folded configuration to an expanded configuration, and bringing the plurality of projections into contact with the wall of the lumen so that the tissue sample is collected on the plurality of projections.

[0010] Any method described herein may include any of the following features: After contacting the wall of the lumen, the expandable tool transitions from the expanded configuration to the folded configuration. Transitioning the expandable tool from the folded configuration to the expanded configuration includes activating an actuating wire coupled to the expandable tool.

[0011] Both the general description above and the detailed description below are illustrative and descriptive only and do not limit the claimed invention. The terms “equipped with,” “included,” or any other variations thereof as used herein are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements may include not only those elements but also other elements not expressly enumerated or specific to such process, method, article, or apparatus. The term “diameter” may also refer to the width if the element is not circular. The term “top” refers to the direction or side of the apparatus relative to the orientation of the apparatus in use, and the term “bottom” refers to the direction or side of the apparatus opposite to the “top” relative to the orientation of the apparatus in use. The term “distal” refers to the direction away from the operator / towards the treatment site, and the term “proximal” refers to the direction towards the operator. The term “exemplary” is used to mean “example” rather than “ideal.” The term “approximately” or similar terms (e.g., “substantially”) include values ​​within + / - 10% of the stated values.

[0012] The accompanying drawings incorporated herein and forming part thereof illustrate aspects of the present disclosure and, together with this description, are useful in illustrating the principles of the present disclosure. [Brief explanation of the drawing]

[0013] [Figure 1] Figure 1 shows a perspective view of an exemplary medical device according to several embodiments. [Figure 2A] Figure 2A shows a side view of an exemplary cytology brush in a folded configuration according to several embodiments. [Figure 2B] Figure 2B shows a side view of the cytology brush of Figure 2A in an extended configuration according to several embodiments. [Figure 3A] Figure 3A shows a side view of an exemplary cytology basket in a folded configuration according to several embodiments. [Figure 3B] Figure 3B shows a side view of the cytology basket of Figure 3A in an extended configuration according to several embodiments. [Figure 4] Figure 4 shows top and side views of wires used in exemplary cytology baskets according to several embodiments. [Figure 5] Figure 5 shows top and side views of different wires used in exemplary cytology baskets according to several embodiments. [Figure 6A] Figure 6A shows a side view of an exemplary cytological snare in a folded configuration according to several embodiments. [Figure 6B] Figure 6B shows a side view of the cytological snare of Figure 6A in an extended configuration according to several embodiments. [Modes for carrying out the invention]

[0014] Embodiments of this disclosure relate to medical devices including a structure configured to collect tissue samples from the lumen of a patient's body (e.g., within the common bile duct and / or pancreatic duct) during a medical procedure, for example, during an endoscopic retrograde cholangiopancreatography (ERCP) procedure. During an ERCP procedure, a physician or other operator can diagnose and treat problems occurring in the common bile duct and pancreatic duct by utilizing both endoscopic and fluoroscopic methods. In some cases, these problems may include the presence of strictures that need to be analyzed to determine whether they are malignant. To analyze the strictures, it may be necessary to collect tissue samples from the affected area. Although this specification refers to an ERCP procedure, the disclosed devices and methods may also be used in the course of other medical procedures (e.g., during medical procedures involving obtaining biopsy samples of lesions).

[0015] Figure 1 shows exemplary medical devices 100 according to several embodiments. In some examples, the medical device 100 may be a scope (such as a duodenoscope, endoscope, cholangioscopy, ureteroscope, bronchoscope, cystoscope, colonoscope, laparoscope, or laryngoscope), a tome, a catheter, or a sheath. The medical device 100 may include a handle 102 and an insertion portion 104. The medical device 100 may also include an umbilical portion 106 for the purpose of connecting the medical device 100 to a power source such as air, water, suction, or power, and to image processing and / or viewing equipment.

[0016] The insertion portion 104 may include a sheath or shaft 108 and a distal tip 110. In some embodiments, the distal tip 110 may include one or more imaging devices 112 (e.g., one or more cameras) for capturing images, and one or more illumination devices 114 (e.g., one or more light-emitting diodes (LEDs) or optical fibers) for providing illumination to facilitate image capture and visualization. The distal tip 110 may be oriented laterally so that the imaging devices 112 and illumination devices 114 can be oriented radially outward, perpendicular, substantially perpendicular, or transverse with respect to the longitudinal axis of the shaft 108 and the distal tip 110. However, the distal tip 110 may alternatively be "forward-facing" (i.e., distal-facing), as shown, for example, in Figures 2, 3, and 6. Figure 1 shows one imaging device 112 and two illumination devices 114, but any suitable number of imaging devices 112 and / or illumination devices 114 may be used. Alternatively, the imaging device 112 and the illumination device 114 can be combined within a single device.

[0017] In some embodiments, an elevator 116 may be positioned at the distal tip 110. The elevator 116 may be configured to change the orientation of a tool, such as a cytology tool, inserted into a working channel of the medical device 100 (e.g., the working channel 140 shown in Figures 2, 3, and 6). The elevator 116 may alternatively be referred to as a swing stand, pivot stand, raising base, or any other appropriate term. In some embodiments, the elevator 116 may be pivotable, for example, via an actuation wire or other control element extending from a handle 102 through a shaft 108 to the elevator 116.

[0018] Furthermore, the distal tip 110 may include multiple components in addition to, or instead of, the components described above. For example, the distal tip 110 may include an additional or alternative illumination source and / or an additional or alternative imaging component (e.g., an additional camera). The distal tip 110 may also include additional types of sensors that may be useful during medical procedures, such as a moisture sensor, a temperature sensor, a pressure sensor, or other types of sensors.

[0019] In some embodiments, the distal portion of the shaft 108 connected to the distal tip 110 may have a steerable portion 118. The steerable portion 118 may be, for example, an articulated joint. The shaft 108 and the steerable portion 118 may include various structures that are or may become known in the art.

[0020] The handle 102 may have one or more actuators / control mechanisms 120. The control mechanism 120 may provide control for the steerable portion 118 or enable the provision of air, water, suction, etc. For example, the handle 102 may include control knobs 122, 124 for controlling the steerable portion 118 in the left, right, up, and / or downward directions. For example, one of the knobs 122, 124 may provide control for the left / right direction of the steerable portion 118, and the other of the knobs 122, 124 may provide control for the up / down direction of the steerable portion 118. The handle 102 may further include one or more locking mechanisms 126 (e.g., knobs or levers) for preventing the steering of the steerable portion 118 in at least one of the up, down, left, or right directions. In some embodiments, the handle 102 may further include an elevator control lever 128. The elevator control lever 128 may raise and / or lower the elevator 116 through a connection between the lever 128 and an operating wire (not shown) that extends from the lever 128 through the shaft 108 to the elevator 116. The port 130 may allow a tool to pass through the port 130, enter the working channel of the medical device 100 (e.g., the working channel 140 shown in FIGS. 2, 3, and 6), and reach the distal tip 110 through the shaft 108. Although not shown, the handle 102 may further include one or more valves, buttons, actuators, etc. for controlling the provision of air, water, suction, etc.

[0021] During use, the operator may insert at least a portion of the shaft 108 into the body lumen of the patient so that the distal tip 110 can be moved to the target site within the body lumen. In the case of an ERCP procedure, the distal tip 110 may be inserted into the patient's mouth, pass through the stomach, descend through the esophagus, and enter the duodenum until it reaches the position of the stenosis. Then, the operator may insert a tool into the port 130 and pass the tool through the working channel and the shaft 108 to the distal tip 110. The tool may exit the working channel through an opening at the distal tip 110. The operator may change the angle of the tool towards the location of the stenosis by using the elevator control lever 128 to raise the elevator 116.

[0022] However, conventional cytology tools are typically too large in diameter or width to pass through the working channel of a medical device where the imaging and illumination devices are disposed at the distal tip. This is because the working channels of these medical devices are often smaller than those in endoscopes or choledochoscopes that do not have these features. On the other hand, small conventional cytology tools that can pass through the working channel of such medical devices having illumination and imaging devices may not be able to capture an appropriate sample (e.g., when too few cells are captured, when sufficient pressure cannot be applied to the tissue being sampled (e.g., stenosis), or other inappropriate cases may occur). Therefore, cytology tools are typically used with endoscopes and choledochoscopes that do not incorporate an imaging device. As a result, when a cytology tool is used to collect a tissue sample, it may be necessary to remove the imaging device from the working channel before the cytology tool can be inserted, and thus, in many cases, the use of the cytology tool is performed blindly.

[0023] There can be limitations to blindly collecting a tissue sample. For example, since the operator cannot accurately see where the cytology tool is positioned, it can be difficult for the operator to accurately collect a tissue sample from a stenosis, and there is also a high possibility that the operator may misplace the tool. This can lead to the tool being inadvertently advanced into the pancreatic duct.

[0024] The cytology tool described herein can be foldable and can have a size that can pass through the working channel of a medical device (such as medical device 100) having a distal tip that includes an imaging and illumination device. Also, the cytology tool described herein can facilitate visualization of sample collection since the cytology tool does not block the field of view of the imaging device.

[0025] For example, Figures 2A and 2B show exemplary side views of cytology brushes according to several embodiments. In some embodiments, the cytology brush 200 may be configured to transition from a folded configuration, as shown in Figure 2A, to an extended configuration, as shown in Figure 2B. While in the folded configuration, the cytology brush 200 may have an outer diameter small enough to pass through the working channel of a medical device in which an imaging and illumination device is located at its distal tip. For example, the outer diameter of the cytology brush 200 may be small enough to pass through the working channel 140 of the medical device 100 described above. In some embodiments, the maximum outer diameter of the cytology brush 200 may be in the range of 1 mm to 2 mm (including partial ranges) when in the folded configuration. In some embodiments, the maximum outer diameter of the cytology brush 200 may be approximately 1.5 mm when in the folded configuration. Therefore, the cytology brush 200 can be used together with the imaging device of the medical device 100, for example, the imaging device 112, which allows for direct visualization of the stricture during the placement of the cytology brush 200, enabling the operator to more accurately position the cytology brush 200 next to the stricture.

[0026] Once the cytology brush 200 is positioned as desired, it can transition to an expanded configuration, as shown in Figure 2B, for example. In the expanded configuration, the width of the cytology brush 200 (in the direction perpendicular to the longitudinal axis of the medical device 100 / cytology brush 200) can range from approximately 1 mm to a maximum of approximately 15 mm, including a partial range (e.g., approximately 1.0 mm to approximately 10.0 mm). This width can be considerably larger than that of a typical cytology brush. Thus, the cytology brush 200 can expand within the body lumen until it contacts the constriction, thus making contact with the constriction easier. Direct contact with the constriction during expansion helps minimize trauma by significantly avoiding repeated forward and backward movement of the cytology brush 200 against the constriction. Furthermore, the larger surface area of ​​the cytology brush 200 can enable the collection of an appropriate (i.e., sufficiently large) number of sample cells without repeated forward and backward movement of the cytology brush 200.

[0027] As shown in Figure 2B, the cytology brush 200 may be in the form of a basket having multiple wires 202 that can be configured to extend from the proximal end to the distal end of the cytology brush 200 to form a basket shape. In some embodiments, the cytology brush may contain up to eight wires, but any number of wires suitable for forming the basket may be used. The wires 202 may be formed from a shape memory material (e.g., nitinol), but any material suitable for use in a cytology tool may be used. The wires 202 may define multiple legs 220 that can branch off from one or more central stems 230. The multiple legs 220 may be joined together at the distal tip 204. The multiple legs 220 may branch off from the stem 230 at the same location. Alternatively, as shown in Figure 2B, the multiple legs 220 may branch off from the stem 230 at locations along the stem 230 that are arranged alternately proximal / distal. Therefore, the multiple legs 220 can be joined to each other at their proximal and distal ends, and can branch outward from each other at multiple locations between the proximal and distal ends. In the folded configuration, the multiple wires 202 can extend substantially parallel to the longitudinal axis of the cytology brush 200. In the extended configuration, the multiple wires 202 can be curved outward to have a concave shape.

[0028] In some embodiments, multiple fins 210 may extend outward from each wire 202 (i.e., from each leg 220). Each of the multiple fins 210 may include multiple outwardly extending projections 212. The fins 210 may be configured to extend outward from each wire 202 when the cytology brush 200 is in an extended configuration, but optionally, the fins 210 may be foldable when the cytology brush 200 is in a folded configuration, and the fins 210 may be foldable inward relative to the wire 202 while the cytology brush 200 is advancing through the working channel of the medical device. The number of fins 210 on each wire 202 may vary, and to the extent feasible, any number of fins 210 may be mounted on each wire 202.

[0029] In some embodiments, the projection 212 may be bristles, for example, bristles typically used in cytology brushes, and may be made of a polymer material that has sufficient rigidity to remove cells from constrictions while being flexible enough to avoid damage to the tube wall. For example, in some embodiments, the bristles may be made of materials such as nylon, polypropylene, polyimide, or polyetheretherketone (PEEK). The bristles may also optionally include braided or wound filaments. The fin 210 may be similar to a smaller form of a conventional cytology brush formed on a wire 202. The fin 210 may be formed integrally (monolithically) with the wire 202, or alternatively, it may be a separate element fixed to the wire 202. The wire 202 and the fin 210 may be constructed of the same material or different materials. The projection 212 may be formed integrally (monolithically) with the fin 210, or it may be formed separately from the fin 210 and attached to the fin 210. The projections 212 and fins 210 may be formed from the same material as the fins 210, or from different materials. In some examples, the projections 212 may be formed from any material that forms the bristles of the cytology brush.

[0030] As shown in Figure 2B, the projection 212 may extend in only one direction from the fin 210. For example, as shown in Figure 2B, the fin 210 may extend substantially perpendicularly from the wire 202 in the extended configuration of the cytology brush 200. The projection 212 may extend from the side of the fin 210 facing proximal. The projection 212 may extend substantially parallel to the wire 202. If the wire 202 extends substantially parallel to the longitudinal axis of the cytology brush 200 (i.e., substantially along the axis extending proximal / distal), the projection 212 may extend substantially proximal (i.e., substantially parallel to the wire 202 extending in the proximal direction). The projection 212 may be configured to collect a sample as the cytology brush 200 moves in the proximal direction. Additionally or alternatively, the projections 212 may extend in other directions (distally or perpendicular to the longitudinal axis of the cytology brush 200). In some examples, the projections 212 may extend radially outward with respect to the longitudinal axis of each fin 210. Each fin 210 may include one or more rows of projections 212.

[0031] Since tissue can be collected on the surface of each projection 212 facing / contacting the stricture or other structure being sampled, or on a subset of the projections 212, the surface area of ​​the cytology brush 200 can be increased by mounting the fins 210 on the wire 202. This increased surface area can help collect larger tissue samples than a typical cytology brush and may be useful in analyzing whether the stricture is malignant. Samples can be collected on projections 212 from multiple fins 210, and can also be captured on projections 212 of multiple fins 210 mounted on multiple different wires 202.

[0032] Furthermore, in some embodiments, the length of the cytology brush 200 may be longer than that of a typical cytology brush. The increased length of the cytology brush 200 allows the cytology brush 200 to be present across the length of the working channel of the medical device, while also allowing the cytology brush 200 to extend beyond the imaging device, for example, the imaging device 112, and remain within its field of view. In some embodiments, the length of the cytology brush 200 is in the range of 230 cm to 240 cm (including partial ranges). Also, the length 215 of the portion of the cytology brush 200 including the fins 210 may be in the range of 5 mm to 15 mm (including partial ranges).

[0033] In some embodiments, the distal tip 204 of the cytology brush 200 may include a non-traumatic distal tip 204 located at the most distal end of the cytology brush 200. As described above, the distal tip 204 can help prevent undesirable tissue trauma during ERCP procedures by being able to connect the wires 202 to each other and by providing a blunt surface at the distal end of the cytology brush 200.

[0034] During an ERCP procedure, a shaft 108 may be inserted into the patient's body lumen to collect a tissue sample from a stenosis using, for example, a medical device 100. The distal tip 110 may be moved to a target site, such as the location of the stenosis, using an imaging device 112 and an illumination device 114. When the distal tip 110 is adjacent to the stenosis, a cytology brush 200 in a folded configuration may be inserted into the port 130. The cytology brush 200 then passes through the working channel 140 to the shaft 108 and exits the shaft 108 upon reaching the distal tip 110. The operator may then use the imaging device 112 to advance the cytology brush 200 to a position adjacent to the stenosis before transitioning the cytology brush 200 from a folded configuration to an extended configuration. In some embodiments, an elevator 116 may be used to assist in positioning the cytology brush 200.

[0035] To transition the cytology brush 200 from a folded configuration to an extended configuration, the operator may actuate an actuating wire (not shown) that can be connected to the cytology brush 200. For example, the operator may extend the cytology brush 200 by pulling the actuating wire proximal. Once the cytology brush 200 is in the extended configuration, the operator may bring the fins 210 into contact with the lumen wall at the location of the constriction so that a tissue sample can be collected from the constriction by the bristles 212. For example, in some embodiments, the legs 220 may be moved proximal to the stem 230. Additionally or alternatively, the stem 230 may be moved distal to the legs 220. Additionally or alternatively, the wire 202 may have shape memory properties (for example, it may be biased into the extended configuration).

[0036] After the tissue sample has been collected, the cytology brush 200 may be moved back to its folded configuration. This allows the cytology brush 200 to be removed from the medical device 100 via the shaft 108 and through the port 130. For example, the legs 220 may be moved distally to the stem 230, and / or the stem 230 may be moved proximal to the legs 220. Additionally or alternatively, a sheath may be deployed to restrain the wire 202.

[0037] The cytological tools described herein may include a cytological basket. For example, Figures 3A and 3B show side views of exemplary cytological baskets according to several embodiments. Similar to the cytology brush 200 described above, the cytology basket 300 may be configured to transition from a folded configuration, as shown in Figure 3A, to an extended configuration, as shown in Figure 3B. Unless otherwise specified herein, the cytology basket 300 may have any of the same features as the cytology brush 200. While in the folded configuration, the cytology basket 300 may have an outer diameter small enough to pass through the working channel of a medical device in which an imaging and illumination device is located at its distal end. For example, the outer diameter of the cytology basket 300 may be small enough to pass through the working channel 140 of the medical device 100 described above. Thus, the cytology basket 300 can be used with the imaging device of the medical device 100, for example, the imaging device 112.

[0038] The cytology basket 300 may include a plurality of wires 302 extending from the proximal end to the distal end of the cytology basket 300. In the expanded configuration, the cytology basket 300 may form a basket shape by curving outward with respect to the central longitudinal axis 310 of the cytology basket 300. Although the cytology basket 300 is shown to have four wires, any number of wires may be used. As shown in Figure 3B, the wires 302 may include portions that extend inward / outward / project / project relative to the overall shape of the wire 302. Each wire 302 may define a longitudinal axis. Multiple projections may extend away from their respective longitudinal axes in any direction (e.g., a direction extending radially away from the longitudinal axis 310). For example, as shown, the wires 302 may have an irregularly undulating or wavy shape. The wire 302 may have such irregular shapes (e.g., having protrusions / wavy shapes) in both folded and extended configurations. This shape may have any desired form having any number of protrusions / ridges.

[0039] The shape of the wire 302 may help remove tissue from constrictions because the irregular surface may increase the surface area and thus increase tissue agitation. Protrusions / ridges of the wire 302 (e.g., protrusions / ridges extending away from the longitudinal axis 310) may engage with tissue to collect a sample. Alternatively, in some embodiments, the wire 302 may have a regular shape. For example, the wire 302 may have a linear configuration in the folded configuration of the cytology basket 300. In other words, each wire 302 may define a longitudinal axis and extend along its respective longitudinal axis without protrusions / ridges. In some embodiments, the wire 302 may be formed from a shape memory material, such as nitinol, but any material suitable for use in a cytology tool may be used.

[0040] In some embodiments, the cytology basket 300 may additionally or alternatively include a plurality of wires 302 having different textures configured to improve tissue collection. For example, Figure 4 shows a top and side view of a sharp wire 400, and Figure 5 shows a top and side view of a textured wire 500. Some or all of the plurality of wires 302 of the cytology basket 300 may include the features shown in Figures 4 and 5. Alternatively, the wires 302 may not have the features shown in Figures 4 and 5.

[0041] As shown in the top view 402A and side view 402B of the sharp wire 400, the sharp wire 400 may have a top surface 404 and a side surface 406. In some embodiments, the top surface 404 may be substantially flat, while the side surface 406 may include a sharp edge configured to cut tissue. The side surface 406 may be oriented on the cytology basket 300 so that it faces the tissue to be sampled (e.g., a constriction). For example, the side surface 406 may be oriented substantially radially outward with respect to the longitudinal axis 310. In some examples, the position of the side surface 406 may vary over the length of the sharp wire 402 so that different portions of the wire 302 in the basket 300 have sharp side surfaces 406 oriented in different directions. Different wires 302 in the basket 300 may include features of the wire 400 having side surfaces 406 oriented in different directions.

[0042] The textured wire 500 may include a plurality of notches 504, as shown in the top view 502A and the side view 502B of the textured wire 500, respectively. In some embodiments, the notches 504 may be configured to catch on or cut tissue. The notches 504 may also be configured to collect a small sample of tissue inside. As shown in the side view 502B, the textured wire 500 may further include projections 506 extending outward away from the longitudinal axis of the textured wire 500. The projections 506 may include free ends that form a return extending radially away from the longitudinal axis of the textured wire 500. The wire (such as wire 302) may include a textured portion, like the textured wire 500, and a portion that is smooth or has the sharp edges of wire 400. The features of wires 400 and 500 can be used in any combination on the same wire or different wires of the same apparatus, and / or can be combined with smooth sections on the same wire and / or different wires of the same apparatus.

[0043] The sharp wire 400 and the textured wire 500 may be formed with either a corrugated or straight outline. As described above, the wire 302 of the cytology basket 300 may incorporate any of the features of the wires 400 and 500. The wire 202 of the cytology brush 200 may also include the features of the wires 400 and 500.

[0044] In some embodiments, the cytology basket 300 may include a non-traumatic tip 304 located at the distal end of the cytology basket 300. The non-traumatic tip 304 can connect the wires 302 to each other and can provide a blunt surface at the distal end of the cytology basket 300, thereby helping to prevent undesirable tissue trauma during ERCP procedures. The cytology basket 300 may also include a joint 306 located at its proximal end. This joint 306 may be configured to connect the cytology basket 300 to the actuation wire 308 or sheath.

[0045] In some embodiments, the cytology basket 300 may be used during ERCP procedures in a manner similar to that of the cytology brush 200 described above. For example, once the shaft 108 is inserted into the patient's body lumen and the distal tip 110 is moved to the target site, e.g., the location of the stenosis, the cytology basket 300 may be inserted into the port 130 while in its folded configuration. The cytology basket 300 then passes through the working channel 140 along the shaft 108 and exits the shaft 108 once it reaches the distal tip 110. The operator may then use the imaging device 112 to advance the cytology basket 300 to a position adjacent to the stenosis before transitioning it from the folded configuration to the extended configuration. In some embodiments, an elevator 116 may be used to assist in positioning the cytology basket 300.

[0046] To transition the cytology basket 300 from a folded configuration to an expanded configuration, the operator may actuate the actuate wire 308. For example, the operator may expand the cytology basket 300 by pulling the actuate wire 308 proximal (or distal). Alternatively, the cytology basket 300 may be transitioned using other alternative methods, including any of the methods described above with respect to the cytology brush 200. Once the cytology basket 300 is transitioned to the expanded configuration, the operator may bring the wire 302 into contact with the constriction or other tissue, thereby allowing the wire 302 to scrape or cut the tissue at the constriction or other tissue. In some embodiments, the cytology basket may be twisted relative to the tissue so that the edge of the wire 302 scrapes the constriction. Alternatively, the cytology basket 300 may be actuated horizontally. In other words, once the cytology basket 300 is moved into the expanded configuration, the operator can position the wire 302 against the tissue in the stricture and then move the cytology basket 300 forward and backward so that the wire 302 scrapes the tissue multiple times. Once the tissue in the stricture has been removed by the wire 302, the suction mechanism of the medical device 100 can be used to aspirate the removed tissue into the biopsy trap through the working channel 140.

[0047] After the tissue sample has been collected, the cytology basket 300 may be moved back to its folded configuration (for example, by moving the actuation wire 308 in the opposite direction to the direction in which the actuation wire 308 was moved to expand the cytology basket 300). The cytology basket 300 may then be removed from the medical device 100 through the shaft 108 and the port 130. Alternatively or additionally, any of the methods described above for the cytology basket 300 may be used to fold the cytology basket 300.

[0048] Alternatively, some embodiments of the cytological tools described herein may include a cytological snare. For example, Figures 6A and 6B show side views of exemplary cytological snare 600 according to some embodiments.

[0049] Similar to the cytology brush 200 and cytology basket 300 described above, the cytology snare 600 can also be configured to transition from a folded configuration, as shown in Figure 6A, to an extended configuration, as shown in Figure 6B. While in the folded configuration, the cytology snare 600 may have an outer diameter small enough to pass through the working channel of a medical device in which an imaging and illumination device is located at its distal tip. For example, the outer diameter of the cytology snare 600 may be small enough to pass through the working channel 140 of the medical device 100 described above. Thus, the cytology snare 600 can be used with an imaging device, such as the imaging device 112 of the medical device 100.

[0050] The cytology snare 600 may include a snare wire 602 in the form of a loop extending from the proximal end 604 to the distal end 606 of the cytology snare 600. The snare wire 602 may function similarly to the wire 302 of the cytology basket 300 described above. For example, the snare wire 602 may be used to scrape or cut tissue within a constriction or other anatomical structure. In some embodiments, the snare wire 602 may be formed from a shape-memory material, such as nitinol, but any material suitable for use in a cytology tool may be used.

[0051] The cytology snare 600 may further include an actuation wire 610 that extends from a proximal end 604 to a distal end 606 and is connected to the snare wire 602 at the distal end 606. During use, the actuation wire 610 may be pulled proximally relative to a medical device, such as the medical device 100 described above, to transition the cytology snare 600 from a folded configuration to an extended configuration. For example, by pulling the actuation wire 610 proximally, the distal end 606 of the snare 602 may be pulled proximally by the actuation wire 610, causing the snare wire 600 to expand into a loop, as shown in Figure 6B. In addition, the tension generated by pulling the actuation wire 610 proximally provides additional rigidity to the snare wire 602, which can assist in the process of removing tissue from the stenosis. Furthermore, the amount of tension applied to the actuation wire 610 may function to adjust the diameter of the cytology snare 600. For example, the greater the amount of tension applied to the actuating wire 610, the larger the diameter of the cytology snare 600 may be, while the smaller the amount of tension applied to the actuating wire 610, the smaller the diameter of the cytology snare 600 may be. Therefore, the cytology snare 600 can be adjusted to fit into body lumens of various diameters. The snare wire 602 may have any of the characteristics of the wires 302, 400, and 500 described above (e.g., wavy shape, sharp edges, and / or textured edges).

[0052] In some embodiments, the cytology snare 600 may include a release mechanism, such as a clip, located at its proximal end 604. The release mechanism may allow the cytology snare 600 to be easily released from the wire or catheter after tissue collection is complete. The cytology brush 200 and / or cytology basket 300 may also include such a release mechanism.

[0053] During ERCP procedures, the cytology snare 600 can be used in a similar manner to the cytology brush 200 and cytology basket 300 described above. For example, once the shaft 108 is inserted into the patient's body lumen and the distal tip 110 is moved to the target site, e.g., the location of the stenosis, the cytology snare 600 can be inserted into the port 130 while in its folded configuration. The cytology snare 600 then passes through the working channel 140 to the shaft 108 and exits the shaft 108 once it reaches the distal tip 110. The operator can then use the imaging device 112 to advance the cytology snare 600 to a position adjacent to the stenosis before transitioning it from the folded configuration to the extended configuration. In some embodiments, an elevator 116 may be used to assist in positioning the cytology snare 600.

[0054] When the cytology snare 600 is adjacent to a structure, it can be transitioned from a folded configuration to an extended configuration by the actuarial wire 610 as described above. The operator can then use the snare wire 602 to scrape or cut tissue from the stricture. Once the tissue within the stricture has been removed by the snare wire 602, the suction mechanism of the medical device 100 can be used to aspirate the removed tissue into the biopsy trap through the working channel 140.

[0055] After the tissue sample has been collected, the cytology snare 600 can be moved back into its folded configuration. The cytology snare 600 can then be removed from the medical device 100 via the shaft 108 and through the port 130.

[0056] While the principles of this disclosure have been described herein with reference to exemplary examples of their applications, this disclosure is not limited thereto. For example, this disclosure refers to ERCP as an exemplary procedure and to the bile duct and pancreatic duct as typical lumens for the systems and methods of this disclosure. However, the systems, apparatus and methods of this disclosure may be used, for example, in any appropriate medical procedure in any lumen or cavity within the body to remove any unwanted substance from the body. Those skilled in the art and those with access to the teachings provided herein will recognize that all additional modifications, applications, and substitutions of equivalents are within the scope of the examples described herein. Therefore, the invention should not be considered limited by the foregoing description.

Claims

1. It is a medical device, The medical device comprises an extendable tool configured to extend from the distal end, wherein the extendable tool is A plurality of wires extending from the proximal end to the distal end of the expandable tool, A plurality of fins extending outward from each of the plurality of wires, Multiple protrusions extending outward from each of the aforementioned multiple fins, Medical devices, including those mentioned above.

2. The medical device according to claim 1, wherein the plurality of wires define a plurality of legs, and each of the plurality of legs branches from a central trunk located at the proximal end of the expandable tool.

3. The medical device according to claim 2, wherein the plurality of legs are joined to each other at the distal end of the expandable tool.

4. The medical device according to any one of claims 1 to 3, wherein the expandable tool is configured to transition from a folded configuration to an expanded configuration.

5. The medical device according to claim 4, wherein each of the plurality of fins is configured to fold inward toward the plurality of wires in the folding configuration.

6. The medical device according to claim 4 or 5, wherein each of the plurality of wires is configured to have a concave shape by curving outward in the extended configuration.

7. The medical device according to any one of claims 4 to 6, wherein the outer diameter of the expandable tool in the folding configuration is 1.5 mm or less.

8. The medical device according to any one of claims 4 to 7, wherein the width of the expandable tool in the expansion configuration is in the range of 1 mm to 15 mm.

9. The medical device according to any one of claims 1 to 8, wherein the plurality of wires comprises a first material and the plurality of fins comprises a second material.

10. The medical device according to claim 9, wherein the first material is the same as the second material.

11. The medical device according to claim 9 or 10, wherein the plurality of protrusions include a third material.

12. The medical device according to claim 11, wherein the third material is the same as the second material.

13. The medical device according to any one of claims 1 to 12, wherein the plurality of fins are integrally formed with the plurality of wires.

14. The medical device according to any one of claims 1 to 13, wherein the plurality of protrusions extend radially outward with respect to the longitudinal axis of each of the plurality of fins.

15. The medical device according to any one of claims 1 to 14, wherein the plurality of wires extend substantially parallel to the longitudinal axis of the expandable tool in the folded configuration of the expandable tool.

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