Cellular device

Abstract

This invention discloses systems and methods for use in medical devices. For example, the medical device may include a frame configured to transition from a contracted form to an expanded form; and a cover disposed on the frame. The cover may include a plurality of protrusions extending radially outward from the outer surface of the cover.

Description

Cross-references to related applications

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 578,502, filed August 24, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0002] The present invention generally relates to cytological devices and related methods. More specifically, embodiments of the invention relate to cytological devices for collecting tissue samples, such as tissue samples within the common bile duct and pancreatic duct. Background Technology

[0003] Endoscopic retrograde cholangiopancreatography (ERCP) is a surgical procedure that uses endoscopy and / or fluoroscopy to diagnose and / or treat diseases of the bile duct and pancreatic duct system, such as strictures. During an exemplary ERCP procedure, an endoscope (e.g., a duodenoscope) can be inserted into the subject's mouth and navigated down the esophagus, through the stomach, into the duodenum, and to the papilla, where the common bile duct (of the biliary system) and pancreatic duct enter the duodenum. The operator can cannulate through the subject's papilla to access the subject's bile duct tree. Contrast agent can then be injected, allowing the operator to visualize the stricture within the bile duct or pancreatic duct system using fluoroscopy and X-ray images. The operator can then perform surgery on the bile duct tree. For example, the operator can use instruments to collect tissue samples from the stricture to aid in the diagnosis of malignant strictures. Summary of the Invention

[0004] Each of the aspects disclosed herein may include one or more of the features described in combination with any of the other disclosed aspects.

[0005] Various aspects of the present invention relate to a medical device that may include a frame configured to transition from a contracted form to an expanded form, and a cover disposed on the frame. The cover may include a plurality of protrusions extending radially outward from the outer surface of the cover.

[0006] Any of the devices disclosed herein may include any of the following features in any combination. A medical device may include a control element coupled to a frame. Movement of the control element may be configured to change the frame from a constricted to an expanded state. The control element may be a hypotube configured to receive a guidewire. The frame may include a first proximal plurality of struts and a second distal plurality of struts. The inner surface of a cover may be coupled to the second distal plurality of struts. The distal ends of the second distal plurality of struts may be coupled to a U-clamp. The U-clamp may include a cavity configured to receive a guidewire. The cover may include an opening. The opening may be aligned with the cavity of the U-clamp. A plurality of protrusions may include at least one first protrusion having a first length and at least one second protrusion having a second length. The first length may be less than the second length. A plurality of protrusions may include a first plurality of protrusions having a first length and a second plurality of protrusions having a second length. The first plurality of protrusions may be located distal to the second plurality of protrusions. A plurality of protrusions may include at least one first protrusion having a first stiffness and at least one second protrusion having a second stiffness. The first stiffness may be greater than the second stiffness. The covering can be generally conical in the expanded configuration of the frame. The covering can be generally cylindrical in the contracted configuration of the frame. Multiple protrusions can be arranged in multiple columns. In the expanded configuration, the circumferential distance between adjacent columns in the multiple columns at the proximal end of the covering can be greater than the circumferential distance between adjacent columns in the multiple columns at the distal end of the covering. At the proximal end of the covering, the circumferential distance between adjacent columns in the expanded configuration can be greater than the circumferential distance between adjacent columns in the contracted configuration. The covering can be stretchable. The medical device can be configured to receive a guidewire along the central longitudinal axis of the frame.

[0007] In another example, a medical device may include a handle, a shaft, and a distal end, the distal end being coupled to the distal end of the shaft and configured to expand and contract. The distal end may include a cover. The cover may have a base and may include an outer surface with a plurality of protrusions extending radially outward therefrom.

[0008] Any of the devices disclosed herein may include, individually or in any combination, any of the following features. The distal end may also include a frame. A covering may be attached to the frame. The substrate may be flexible.

[0009] A method for collecting tissue samples may include: navigating a medical device to a target site within a body cavity of a subject; moving a control member proximally to change the distal end of the medical device from a contracted state to an expanded state; and, with the distal end in the expanded state, contacting the wall of the body cavity with a plurality of protrusions to collect the tissue sample. The medical device may include a distal end having a frame and a cover disposed on the frame. The cover may include a plurality of protrusions extending outwardly therefrom.

[0010] Any exemplary method disclosed herein may include any one of the following steps, alone or in any combination. The method may also include moving a control member distally to change the distal end of the medical device from an expanded to a contracted state; and, while the distal end is in the contracted state, contacting the wall of the body cavity with a plurality of protrusions to collect a tissue sample.

[0011] It is understood that the foregoing general description and the following detailed description are exemplary and explanatory only, and are not intended to limit the invention as claimed. As used herein, the terms “comprising,” “including,” or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements may include not only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term “diameter” may refer to the width of an element when it is not circular. The term “top” refers to the direction or side of the device relative to its orientation during use, and the term “bottom” refers to the direction or side of the device relative to its orientation during use, opposite to “top.” 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. Some of the figures include arrows labeled “distal” and “proximal,” which indicate directions distal and proximal, respectively. The term “exemplary” is used in the sense of “example” rather than “conventional.” The term “approximately” or similar terms (e.g., “roughly”) include a value of + / - 10% of the stated value. Attached Figure Description

[0012] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various aspects of the invention and, together with the description, serve to explain the principles of the invention.

[0013] Figure 1 A portion of an exemplary medical device in an expanded state according to various aspects of the present invention is shown.

[0014] Figures 2A to 2B It shows the first expansion mode. Figure 1 The remote end of an exemplary medical device.

[0015] Figure 3 It shows the state of being in the second contraction phase. Figure 1 The remote end of an exemplary medical device.

[0016] Figure 4 It shows Figure 1 The remote frame of the medical device.

[0017] Figures 5A to 5B Depicting Figure 1 A portion of the distal end of a medical device.

[0018] Figure 6 It shows Figure 1 An exemplary handle for a medical device.

[0019] Figure 7 It describes an alternative remote for medical devices.

[0020] Figure 8 It shows a replacement Figure 4 An alternative framework to the existing framework.

[0021] Figure 9 The use of exemplary medical devices, such as Figures 1 to 8 Methods related to medical devices.

[0022] Figures 10 to 12 It shows Figure 8 Aspects of the exemplary methods. Detailed Implementation

[0023] Embodiments of the present invention relate to a medical device comprising a structure configured to collect tissue samples from a lumen (e.g., within the common bile duct and / or pancreatic duct) of a subject during a medical procedure, such as endoscopic retrograde cholangiopancreatography (ERCP). During ERCP, a physician or other operator (hereinafter collectively referred to as the "operator") can utilize endoscopy and fluoroscopy techniques to diagnose and treat problems present within the common bile duct and / or pancreatic duct. In some cases, these problems may include the presence of stenosis, which may require analysis to determine whether it is malignant.

[0024] Diagnostic procedures may involve removing suspected cancerous tissue by collecting samples of the mucosal tissue layer from the surface of the bile duct lumen. For example, the operator may use a cellular brush to obtain cellular samples from the tissue. Existing cellular brushes may be associated with guidewire misalignment, making it difficult to pass through narrow areas. The ability of existing brushes to sample irregular surfaces is also limited. Poor sampling can lead to, for example, false negative diagnoses.

[0025] Although this article refers to ERCP procedures, it should be understood that the disclosed apparatus and methods can be used in the course of other medical procedures (e.g., during various medical procedures involving obtaining biopsy samples of lesions).

[0026] Figures 1 to 7A medical device 100 is depicted that can be configured to be mounted on a guidewire (not shown). The medical device 100 may resemble a cell brush. The medical device 100 may have a distal end that collapses, contracts, and / or expands via a frame. In an expanded configuration, the distal end of the medical device 100 may be conical. The medical device 100 can be configured to have a controlled angle of tissue interaction and to be deployed to a treatment site, where it collects tissue samples via movement through the controlled angle of tissue interaction, and then returns them to be removed from the subject's body, allowing a medical professional to collect and analyze the samples to obtain test results (e.g., biopsy, etc.).

[0027] Medical device 100 may include a distal end 105 (including, for example, a cover 110 and a frame 120), a control member 130, a shaft 135, and / or a control device 605 (hereinafter referred to). Figure 6 (To be described in more detail). The cover 110 may be configured, for example, to expand and collapse in response to movement of the control member 130 proximally or distally, as described in more detail below. The cover 110 may be composed of any suitable material, such as at least one polymer or combination of polymers (e.g., nylon, polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), etc.).

[0028] Shaft 135 can control device 605 ( Figure 6 The shaft 135 can have any nature of any shaft of a medical device. The shaft 135 may include, for example, a coil, which may optionally be covered by an outer sheath (e.g., a polymer outer sheath). The shaft 135 may define a cavity (not shown) that can accommodate at least one element of the medical device 100, such as control member 130. The shaft 135 may extend from the distal end of control member 605 to the proximal end of the proximal U-clamp of frame 120, discussed in more detail below. The shaft 135 may be fixedly coupled to the proximal U-clamp 125.

[0029] The distal end 105 may include a sheath or cover 110 positioned or disposed on the frame 120. The distal end 105 may be configured in a first expanded configuration ( Figure 1 A to Figure 2B ) and second contraction, collapse and other forms ( Figure 3 The conversion between () and (). In some examples, the distal end 105 can have an umbrella-like shape. For example... Figure 1 A to Figure 2BAs shown, when the distal end 105 is in the expanded configuration, the cover 110 can have an approximate or approximately conical shape. In the expanded configuration, the cover 110 can have any suitable dimensions (e.g., any suitable base circle radius, aperture, height, etc.). For example, in the contracted configuration, the diameter of the cover 110 can be about 1.0-4.0 mm, and in the expanded configuration, the diameter of the proximal end of the cover 110 can be about 1.0-4.0 mm. The length of the cover 110 can be about 5.0-20.0 mm. The base 305 of the cover 110 can have a thickness of about 0.1-0.5 mm. Alternatively, the cover 110 in the expanded configuration can have any suitable shape (e.g., truncated cone, pyramid, dome, or any other suitable shape).

[0030] Figure 3 The distal end 105 is depicted in a contracted state. (Example) Figure 3 As shown, the cover 110 may have an approximate or approximately cylindrical or tubular shape in its contracted state. In some examples, the cover 110 may be elastic or stretchable, such that the cover 110 is stretched when it transitions from a contracted state to an expanded state. The cover 110 may have shape memory properties, such that when it transitions to a contracted state, it adopts an approximate or approximately cylindrical or tubular shape. Alternatively, the cover 110 may be non-stretchable, and in its contracted state, it may have a pleated shape, similar to a closed umbrella.

[0031] Cover 110 may include a base 305 having a plurality of protrusions 115 (e.g., bristles). The base 305 may be flexible and may be formed of any suitable material. In some examples, as discussed above, the base 305 may be elastic or stretchable. Alternatively, the base 305 may not be stretchable / elastic. The base 305 may be formed as a single sheet of material (e.g., a single continuous sheet of material). The base 35 may extend between the protrusions 115 to form a barrier between the frame 120 and the space located distal to the cover 110.

[0032] The multiple protrusions 115 can have any suitable properties. In some examples, the protrusions 115 can be formed of the same material as the substrate 305. Alternatively, the protrusions 115 can be formed of a different material from the substrate 305 and attached to the substrate 305. In some examples, the protrusions 115 can be formed of nylon. In some examples, the protrusions 115 can be uniform, and each of the protrusions 115 can have the same properties. Alternatively, the protrusions 115 can have different properties and their size (length or thickness / diameter), stiffness / hardness, shape, etc., can vary, as discussed, for example, in relation to the following. Figure 7In this example, the stiffness and / or length of the protrusions 115 on the plurality of protrusions 115 increase from the distal end of the cover 110 to the proximal end of the cover 110, or vice versa. For example, the width / diameter of the protrusions 115, the length of the protrusions 115, and / or the material of the protrusions 115 can be varied to change the stiffness of the protrusions 115.

[0033] like Figures 1 to 3 As shown, the protrusions 115 can be arranged in multiple columns, extending from the proximal end of the cover 110 to the distal end of the cover 110. For example... Figure 3 As shown, in the contracted configuration, the protrusions 115 can be spaced approximately evenly on the surface of the cover 110, such that the distance between adjacent protrusions 115 is approximately uniform in the circumferential and / or longitudinal direction of the cover 110. In the expanded configuration ( Figures 1 to 2B In the cover 110, the protrusions 115 may have a larger circumferential spacing at the proximal end than at the distal end. The circumferential distance between a plurality of circumferentially adjacent protrusions 115 can taper downwards from the proximal end to the distal end of the cover 110. In other words, when the cover 110 is in an expanded form, the protrusions 115 may gradually move closer together circumferentially, thus moving in a distal direction. In other words, the rows of protrusions 115 are closer to each other at the distal end than at the proximal end. This is because the cover 110 can stretch more at the proximal end than at the distal end when the cover 110 transitions from a contracted form to an expanded form. The above-described arrangement of the protrusions 115 is merely exemplary, and the protrusions 115 can have any suitable arrangement. For example, the protrusions 115 may be arranged in a spiral pattern or any other suitable arrangement.

[0034] Multiple protrusions 115 may extend outward from the outer surface (hereinafter referred to as the "outer surface") 112 of the cover 110, for example, radially outward. The multiple protrusions 115 may extend outward at any suitable angle, for example, perpendicular to the outer surface 112, at an angle of less than 90 degrees relative to the outer surface 112 toward the proximal end of the cover 110, at an angle of less than 90 degrees relative to the outer surface 112 toward the distal end of the cover 110, etc., as discussed in more detail below (e.g., see...). Figure 7The angle at which the plurality of protrusions 115 extend outward from the outer surface 112 can remain constant from when the cover 110 is in an expanded state to when the cover 110 is in a contracted state, and / or the angle at which the plurality of protrusions 115 extend outward from the outer surface 112 can vary from when the cover 110 is in an expanded state to when the cover 110 is in a contracted state. For example, when the cover 110 is in a contracted state, the plurality of protrusions 115 can extend perpendicularly outward from the outer surface 112, and / or when the cover 110 is in an expanded state, the plurality of protrusions 115 can extend at another angle relative to the outer surface 112 (e.g., a 45-degree angle or any suitable angle). In some examples, when the cover 110 changes from an expanded form to a contracted form, as discussed above, the plurality of protrusions 115 can come closer together, which can improve the retention of the sample on the plurality of protrusions 115, for example, when the medical device 100 is removed from the body cavity of the subject.

[0035] like Figures 1 to 2B and Figure 4 As shown, frame 120 may include multiple pillars 122. In some examples, such as Figure 4 As depicted, the frame 120 may include a plurality of first pillars 405 and a plurality of second pillars 410. The plurality of first pillars 405 may be located proximal to the plurality of second pillars 410. Figure 4 As shown, the plurality of first pillars 405 may include four pillars 122, and the plurality of second pillars 410 may include four pillars 122. Alternatively, any suitable number of pillars may be used. For example, Figure 5A and Figure 5B The plurality of second pillars 410 are described as including eight pillars 410 (the plurality of first pillars 405 may include a corresponding number (e.g., eight) of pillars 410). Figure 4 A frame 120 in an expanded configuration is depicted, as discussed in further detail below. Each of the plurality of first pillars 405 can be connected to a corresponding pillar of the plurality of second pillars 410 via a plurality of connection points 415 to form a basket shape. The plurality of connection points 415 may include hinges, wheel bases (e.g., wheels located within a track in each of the plurality of second pillars 410 or within a track in each of the plurality of first pillars 405), etc.

[0036] The proximal end of each of the first pillars 405 may be connected to a proximal U-shaped clamp 125 via a plurality of hinges 420. The plurality of hinges 420 of the proximal U-shaped clamp 125 may be configured to allow articulated movement of the plurality of first pillars 405 relative to the proximal U-shaped clamp 125. The distal end of each of the second pillars 410 may be connected to a distal U-shaped clamp 235 via a plurality of hinges 440. Specifically, as... Figure 4 , Figure 5A and Figure 5BAs shown, the hinge 440 of the distal U-clamp 235 can be configured such that the plurality of second pillars 410 can be articulated relative to the distal U-clamp 235.

[0037] The distal end of shaft 135 can be coupled to the proximal end of proximal U-clamp 125. Control member 130 extends from the distal end of shaft 135, through the cavity of proximal U-clamp 125, along the longitudinal axis of distal end 105 through frame 120 to reach distal U-clamp 235. Control member 130 can be movable relative to proximal U-clamp 125. Control member 130 can be fixedly coupled to distal U-clamp 235 (e.g., to the proximal end of distal U-clamp 235). Control member 130 can be made of any suitable material, such as at least one polymer, a combination of polymers, metal, etc. In some examples, control member 130 can be a thiocyanate tube. Alternatively, control member 130 can include wire, cable, rigid rod, etc.

[0038] The proximal movement of the control member 130 causes the distal U-clamp 235 to move proximally toward the proximal U-clamp 125. As the distal U-clamp 235 moves toward the proximal U-clamp 125, the proximal end of the second strut 410 and the distal end of the first strut 405 (joined at connection point 415) can move radially outward. This movement causes the frame 120 to move from a retracted state to an expanded state. In the expanded state, the hinges 420 can be spaced apart, such that the frame 120 has a larger width / diameter at the hinge 420 positions than at the proximal end (near the proximal U-clamp 125) and the distal end (near the distal U-clamp). In the retracted state, the connection points 415 can be closer together (e.g., adjacent to each other), such that the frame 120 has a substantially uniform width / diameter near the proximal U-clamp 125, at the hinge 420, and near the distal U-clamp 235.

[0039] The distal movement of the control member 130 causes the distal U-clamp 235 to move distally away from the proximal U-clamp 125. As the distal U-clamp 235 moves away from the proximal U-clamp 125, the proximal end of the second strut 410 and the distal end of the first strut 405 (which are joined at connection point 415) can move radially inward closer to each other. This movement causes the frame 120 to move from an expanded state to a contracted state.

[0040] The support 122 can interact with the inner surface (hereinafter referred to as the "inner surface") 225 of the cover 110 (see [reference]). Figure 2A and Figure 2BIn some embodiments, the cover 110 may be attached to the struts 122 of the frame 120. For example, the inner surface 225 may be coupled (e.g., securely coupled via adhesive or any other suitable mechanism, such as a loop or metal ring) to each of the plurality of first struts 405. When the frame 120 is in an expanded state ( Figures 1 to 2B , Figure 4 When the covering 110 is in an expanded state, such as... Figures 1 to 2B As depicted. When the frame 120 is in the retracted state, the cover 110 can also be in the retracted state, such as... Figure 3 What is depicted.

[0041] Because the distance between the proximal ends of the plurality of first struts 405 in the expanded configuration can be greater than the distance between the distal ends of the plurality of first struts 405, as discussed above, the protrusions 115 can have a larger circumferential spacing between each other at the proximal end of the cover 110 compared to the distal end of the cover 110. In alternative embodiments, the frame 120 and / or the cover 110 can have alternative shapes. For example, the frame 120 can be any expansion / contraction structure, such as a Malecot conduit, a basket, etc. The following relates to... Figure 8 An alternative framework was discussed.

[0042] As discussed above, the control member 130 may be a thiocyanate tube. The control member 130 may define a cavity extending therethrough. In some embodiments, the cavity may extend from a proximal end of the control member 130 to a distal end of the control member 130. Alternatively, the cavity may extend to an opening located distal to the proximal end of the control member 130. In some examples, the distal U-clamp 235 may include a cavity 510 extending axially through the distal U-clamp 235. The cavity 510 may have openings located proximal and distal to the distal U-clamp 235. In various aspects, the control member 130 may be attached to an edge or margin of the cavity 510 such that the cavity of the control member 130 is in fluid communication with the cavity 510. Alternatively, the control member 130 may extend through the cavity 510 and may be coupled to an inner surface of the cavity 510. The cover 110 may also have an opening 505 at or near the center of the cover 110. In the example, opening 505 can be aligned with cavity 510 such that cavity 510 is exposed to a region of the subject's body cavity located distal to medical device 100.

[0043] The medical device 100 can travel along a guidewire. For example, the proximal end of the guidewire can be inserted into or received by the distal opening of lumen 510 and enter the lumen of control member 130. Thus, the guidewire can extend through the lumen of control member 130 and lumen 510 (e.g., guidewire lumen). The guidewire (not shown) can extend along the central longitudinal axis of the medical device 100, through the center of frame 120 and cover 110, and through opening 505. Because the guidewire extends along the central longitudinal axis of the medical device 100, the medical device 100 can have enhanced steering compared to a conventional cell brush. For example, it may be easier for an operator to extend the medical device 100 into and through a stenosis.

[0044] The expansion and contraction of the cover 100 and / or frame 120 can be actuated by the control device 605, such as Figure 6 As depicted. Control device 605 may be a handle and may be coupled to the proximal end of shaft 135. Control device 605 may have the features of any handle known in the art for controlling medical devices. Control device 605 may include spool 610, control device shaft 615, and thumb loop 620. Control member 130 may be coupled to spool 610 and extend distally therefrom. In some examples, such as Figure 6 As shown, coil 625 (e.g., spring) may extend around control member 130.

[0045] The operator can move the spool 610 proximally and / or distally along the control device axis 615 toward and away from the thumb ring 620. For example, the control device axis 615 may include a track 630 (e.g., a longitudinal opening). Proximally and distally moving the spool 610 can cause the control member 130 to move proximally and distally, respectively. As discussed above, proximally moving the control member 130 (achieved via proximally moving the spool 610) can cause the distal end 105 to move from a contracted position ( Figure 3 ) transforming into an expanded form ( Figures 1 to 2B The movement of the control member 130 to the distal end (achieved via the movement of the spool 610 to the distal end) can change the distal end 105 from an expanded state to a contracted state.

[0046] In some examples, coil 625 can deflect medical device 100 to a constricted configuration (e.g., where spool 610 is located relatively distally, such as at the distal end of track 630). When the operator moves spool 610 proximally, coil 625 may be compressed or extended compared to its natural length. When the operator releases spool 610, coil 625 can return to its natural length, thereby moving control member 130 distally and consequently moving cover 110 and / or frame 120 from an expanded state to a constricted state. The arrangement of control device 605 is merely exemplary and any suitable handle can be utilized.

[0047] Figure 7 An alternative cover 702 is depicted. Cover 702 can be used with medical device 100 in place of cover 110. In addition to those described below, cover 702 may have any of the features of cover 110, such as the composition and / or shape of the substrate. Cover 702 may include a plurality of protrusions 705, which may be arranged in multiple columns, a spiral pattern, or any other suitable arrangement, as discussed further in detail above. Protrusions 705 may have different lengths, compositions, angles, etc. For example, as... Figure 7 The first segment (hereinafter referred to as "first segment") 710a of the plurality of protrusions 705 depicted may have a different length than the second segment (hereinafter referred to as "second segment") 710b of the plurality of protrusions 705 (e.g., it may be shorter or longer). For example, as Figure 7 As shown, the protrusion 705 of the first segment 710a can have a shorter length than the protrusion of the second segment 710b. Figure 7 As shown, the protrusion 705 of segment 710a may have a first uniform length, and the protrusion 705 of segment 710b may have a second uniform length. Alternatively, the length of the protrusion 705 may vary within the first segment 710a and / or the second segment 710a. For example, the size of the protrusion 705 (e.g., in a spiral or columnar configuration) may gradually increase from the distal end of the cover 702 to the distal end of the cover 702, or vice versa.

[0048] Multiple protrusions 705 may extend outward from the outer surface (hereinafter referred to as the "outer surface") 715 of the cover 702, for example, radially outward. As discussed above with respect to the multiple protrusions 115, the multiple protrusions 705 may extend outward at any suitable angle, for example, perpendicular to the outer surface 715, at an angle of less than 90 degrees relative to the outer surface 715 toward the proximal end of the cover 702, at an angle of less than 90 degrees relative to the outer surface 715 toward the distal end of the cover 702, etc. For example, a first segment 710a may be perpendicular to the outer surface 715, and a second segment 710b may be angled toward the proximal end of the cover 702 at an angle of less than 90 degrees relative to the outer surface 715.

[0049] The angle at which the plurality of protrusions 705 extend outward from the outer surface 715 can vary from when the cover 702 is in an expanded state to when the cover 702 is in a contracted state. For example, when the cover 702 is in a contracted state, the first segment 710a can extend perpendicularly outward from the outer surface 112, and the second segment 710b can be substantially parallel to the outer surface 715. In another example, when the cover 702 is in an expanded and / or contracted state, the first segment 710a and the second segment 710b can extend relative to the outer surface 715 at other angles (e.g., a 45-degree angle or any suitable angle).

[0050] The multiple protrusions 705 can have any suitable properties. In some examples, the protrusions 705 of the first segment 710a can be formed of a first material, and the protrusions 705 of the second segment 710b can be formed of a second material. For example, the protrusions 705 of the first segment 710a can be formed of the same material as the substrate 712, and the protrusions 705 of the second segment 710b can be formed of a different material (e.g., nylon) and attached to the substrate 712 (or vice versa). In some examples, the multiple protrusions 705 can have different properties, and their size (length or thickness / diameter), stiffness / hardness, shape, etc., can vary. In examples, the stiffness and / or length of the multiple protrusions 705 can increase from the distal end to the proximal end of the cover 702, or vice versa. For example, the first segment 710a can have greater stiffness than the second segment 710b, or vice versa.

[0051] Figure 8 An alternative frame 802 is depicted. Frame 802 can replace frame 120 for use with medical devices, and in some examples, it can be used with... Figure 7 The covering 702 is combined. In addition to the features described below, frame 802 may have any of the features of frame 120. For example... Figure 8 As shown, the frame 802 may include a plurality of supports 815, an outer tubular member 805, and an inner tubular member 830. The inner tubular member 830 and / or the outer tubular member 805 may have any of the properties of the control member 130. The inner tubular member 830 may be movably received within the cavity of the outer tubular member 805.

[0052] although Figure 8 The middle frame 802 includes four pillars 815, but it should be understood that the frame 802 may also include any alternative number of pillars. The pillars 815 may be multiple filaments composed of shape memory material, such as nitinol, but any suitable material may also be used. The pillars 815 may be biased to an expanded shape, such as... Figure 8As shown. In some examples, in the biased expanded state, the support 815 can be a wire or may include multiple bend points 817. The bend points 817 can form a movable hinge. Alternatively, the support 815 can have any suitable shape in the expanded configuration. Figure 8 As shown, the support 815 may have a first segment 816a, a second segment 816b, and a third segment 816c. The first segment 816a may be a distal segment, the second segment 816b may be a proximal segment, and the third segment 816c may extend between the first segment 816a and the second segment 816b. Each of segments 816a, b, and c may be straight, such as... Figure 8 As shown. Alternatively, one or more of segments 816a, b, and c may be curved. The strut 815 may have fewer than (e.g., two) or more than (e.g., four or more) three segments.

[0053] The proximal end of each of the struts 815 may be fixedly connected at a first fixed position 810 to the distal end of the outer tubular member 805. The distal end of each of the struts 815 may be fixedly connected to a distal fixed position 820. The inner tubular member 830 may be made of any suitable material, such as at least one polymer, a combination of polymers, a metal, etc. In some examples, the inner tubular member 830 may be a hyaluronic acid tube. The cavity of the inner tubular member 830 may be sized and shaped to receive a guidewire or other auxiliary device, as described above with respect to the control member 130. Alternatively, the inner tubular member 830 may include a wire, cable, rigid rod, etc. The outer tubular member 805 may similarly be made of any suitable material, including any of the materials described above with respect to the inner tubular member 830. The cavity of the outer tubular member 805 may be sized and shaped to movably receive the inner tubular member 830.

[0054] The proximal movement of the outer tubular member 805 can cause the proximal end of the strut 815 to move proximal, thereby causing the strut 815 to collapse into a contracted shape (not shown). In the contracted state, the strut 815 can be relatively straightened, and the bending points 817 can be close to each other (e.g., adjacent to each other), such that the frame 802 can have a substantially uniform width / diameter near the first bending position 810, at the plurality of bending points 817, and near the second bending position 820.

[0055] The distal movement of the outer tubular member 805 can cause the proximal end of the strut 815 to move distally, thereby causing the strut 815 to move radially outward, for example, at multiple bend points 817. This movement can move the frame 802 from a contracted state to an expanded state, such as... Figure 8As shown. In the expanded state, the struts 815, including multiple bending points 817, can be spaced apart from each other, such that the frame 802 has a larger width / diameter at the third segment 816c than at the proximal end of the frame 802 (near the first bending position 810) and the distal end of the frame 802 (near the second bending position 820). Figure 8 In the expanded state, the first and second segments 816a and 816b can be at an angle relative to the third segment 816c.

[0056] Multiple supports 815 may interact with the inner surface 225 or the inner surface of the cover 702. In some embodiments, the cover 110 or the cover 702 may be attached to multiple supports 815 of the frame 802. For example, the inner surface 225 or the inner surface of the cover 702 may be coupled (e.g., securely coupled via adhesive or any other suitable mechanism, such as a wire loop or metal ring) to each of the supports 815. When the frame 802 is in an expanded state, the cover 110 or the cover 702 may be in an expanded state, similar to... Figures 1 to 2B and Figure 7 As depicted. When frame 802 is in the retracted state, cover 110 or cover 702 can also be in the retracted state, similar to... Figure 3 What is depicted.

[0057] Figure 9 The use of exemplary medical devices, such as medical device 100 (including a cover 110, a frame 120, ...), is illustrated. Figure 7 Covering 702 and / or Figure 8 (Using the framework 802 together) related methods 900. Figure 10 and Figure 11 Various aspects of method 900 are described. In step 902, the medical device can be navigated to a target site within the subject's body cavity. In some examples, a duodenoscope or other type of endoscope may be used. The guidewire may be pre-positioned to provide access to the target site. Step 902 may include inserting the guidewire into lumen 510 (or... Figure 8 The medical device is positioned within the corresponding cavity of the frame and the guidewire is extended through the cavity of the control member 130. The medical device can be advanced along the guidewire to the target site. Therefore, the medical device can have a controlled tissue attack angle. As in some examples, the medical device 100 may be in a retracted state as it moves to the target site, for example, to avoid multiple protrusions interacting with other sites within the cavity and potentially collecting unwanted tissue samples. In some examples, step 902 may include navigating the medical device to the proximal wall 907 of the narrow 905, such as... Figure 10 As shown.

[0058] In step 904, the medical device 100 can transition from a contracted state to an expanded state. As discussed herein, the operator can move the spool 610 proximally, thereby moving the control member 130 proximally. When the control member 130 moves proximally, the distal U-clamp 235 can be moved proximally, for example, toward the proximal U-clamp 125, thereby moving the frame 120 laterally outward relative to the central longitudinal axis of the control member 130 and / or the distal end 105, as described above. When the frame 120, for example, the plurality of connection points 415, moves laterally outward, the cover 110 can be moved from a contracted state to an expanded state.

[0059] In some examples, the cover 110 can be in a partially expanded state. For example, the cover 110 can be expanded by 10%, 25%, 50%, 75%, etc. In other words, the cover 110 can partially expand between a contracted state and an expanded state, for example, depending on the amount by which the spool 610 moves proximally. Examples of the cover 110 are in... Figure 12 The partial expansion state shown is discussed in more detail below.

[0060] In step 906, the wall of the cavity may contact the plurality of protrusions 115, such that tissue samples are collected on the plurality of protrusions 115. Step 906 may include contacting the proximal wall 907, such as... Figure 10 As shown. Alternatively or alternatively (e.g., after contacting the proximal sidewall 907), step 906 may include advancing the distal end 105 into the narrow 905 and contacting the wall within the narrow 905 (e.g., the interior of the narrow (hereinafter referred to as the "interior portion") 1007).

[0061] In step 908, after contacting the wall of the cavity, the distal end 105 (e.g., including the cover 110 and the plurality of protrusions 115) can be rotated. For example, as Figure 10 As depicted, the plurality of protrusions 115 can move against the narrow 905 (e.g., biliary stricture), the proximal wall 907, etc., for example, rotate against it.

[0062] Optionally, in step 910, the medical device 100 can transition from an expanded state to a contracted state. Upon completion of the transition, any of steps 904-908 can be repeated. For example, as... Figure 10 As depicted, the medical device 100 can be converted to a retracted state to contact the internal portion 1007.

[0063] Although the internal portion 1007 is depicted as relatively uniform, in some cases, such as Figure 11The depicted narrowing, for example, narrowing 1105 may include an irregularly shaped internal portion (hereinafter referred to as the "irregular internal portion") 1107. In some examples, the medical device 100 may iteratively move between a contracted state, an expanded state, and any partial degree of contraction or expansion in between, so that the operator can access surfaces with different shapes, thereby advantageously improving the quality of tissue samples and reducing false negatives of the collected tissue samples.

[0064] In step 912, the medical device 100 can be removed from the subject's body cavity, and tissue samples collected via the plurality of protrusions 115 can be collected. In some examples, the cover 110 can be removed from the plurality of protrusions 115 by detaching one or more removable connection points. In some examples, the distal end 105 can be removed from the medical device 100 by cutting the portion between the cover 110 and the spool 610. For example, the distal end 105 can be removed from the spool 135 (e.g., located at the proximal U-clamp 125).

[0065] While the principles of the invention have been described with reference to illustrative examples for specific applications, it should be understood that the invention is not limited thereto. For example, the invention refers to ERCP as an exemplary procedure and the bile duct and pancreatic duct as typical cavities used in the systems and methods of the invention. However, the systems, apparatus, and methods of the invention can be used for any suitable medical procedure in any cavity or hollow body, for example, to remove any unwanted material from the body. Those skilled in the art and who are able to access the teachings provided herein will recognize that additional modifications, applications, and substitutions of equivalents all fall within the scope of the examples described herein. Therefore, the invention should not be considered as limited to the foregoing description.

Claims

1. A medical device comprising: A frame configured to transition from a contracted state to an expanded state; as well as A cover disposed on the frame, wherein the cover includes a plurality of protrusions extending radially outward from the outer surface of the cover.

2. The medical device of claim 1, further comprising a control element coupled to the frame, wherein movement of the control element is configured to cause the frame to change from the contracted state to the expanded state, and wherein the control element is a thiopancreatography (THP) tube configured to receive a guidewire.

3. The medical device according to any one of the preceding claims, wherein the frame includes a first proximal plurality of pillars and a second distal plurality of pillars, and wherein the inner surface of the cover is coupled to the second distal plurality of pillars.

4. The medical device of claim 3, wherein the distal ends of the second distal plurality of struts are coupled to a U-clamp, and wherein the U-clamp includes a cavity configured to receive a guidewire.

5. The medical device according to any one of the preceding claims, wherein the cover includes an opening, and wherein the opening is aligned with the cavity of the U-shaped clip.

6. The medical device according to any one of the preceding claims, wherein the plurality of protrusions includes at least one first protrusion having a first length and at least one second protrusion having a second length, wherein the first length is less than the second length.

7. The medical device of claim 6, wherein the plurality of protrusions includes a first plurality of protrusions having the first length and a second plurality of protrusions having the second length, and wherein the first plurality of protrusions is located distal to the second plurality of protrusions.

8. The medical device according to any one of the preceding claims, wherein the plurality of protrusions includes at least one first protrusion having a first stiffness and at least one second protrusion having a second stiffness, wherein the first stiffness is greater than the second stiffness.

9. The medical device according to any one of the preceding claims, wherein the cover has a generally conical shape in the expanded form of the frame.

10. The medical device according to any one of the preceding claims, wherein the cover has a generally cylindrical shape in the contracted form of the frame.

11. The medical device according to any one of the preceding claims, wherein the plurality of protrusions are arranged in a plurality of columns.

12. The medical device according to any one of the preceding claims, wherein in the expanded configuration, the circumferential distance between adjacent columns in the plurality of columns is greater at the proximal end of the cover than at the distal end of the cover.

13. The medical device according to any one of the preceding claims, wherein at the proximal end of the cover, the circumferential distance between adjacent columns in the plurality of columns in the expanded form is greater than the circumferential distance between adjacent columns in the plurality of columns in the contracted form.

14. The medical device according to any one of the preceding claims, wherein the covering is stretchable.

15. The medical device according to any one of the preceding claims, wherein the medical device is configured to receive a guidewire along the central longitudinal axis of the frame.

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