Medical device for tissue collection

Abstract

A medical device can include a sheath and an expandable member. The expandable member can include a support member and a liner coupled to the support member. The liner can include a plurality of teeth. Proximal movement of the sheath can be configured to expose the expandable member such that the expandable member transitions from a constrained configuration to an expanded configuration.

Description

Cross-reference to related applications

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 583,641, filed September 19, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure generally relates to medical devices and related methods. More specifically, this disclosure relates to medical devices for tissue collection, such as in biopsy or other surgical procedures, and methods of using such devices. Background Technology

[0003] During medical procedures, such as endoscopic surgery, tissue can be obtained from within a subject, for example, from the walls of a body cavity. These tissue samples are typically biopsied to determine the presence of pathological disorders. Endoscopic biopsy forceps can be used in conjunction with an endoscope to collect tissue samples from a subject's body cavity for analysis. However, samples often must be obtained from hard-to-reach locations deep within the body using standard clamp jaws (e.g., tissue from areas accessible only via a tortuous bile duct path). In some cases, the quality or quantity of tissue accessible to the physician using standard clamps may be insufficient for an accurate diagnosis. Furthermore, the clamp jaws can sometimes be difficult to manipulate to achieve tangential or perpendicular occlusion as needed. The apparatus and methods described herein alleviate these drawbacks, as well as one or more other drawbacks in the art. However, the scope of this disclosure is defined by the appended claims, and not by the ability to solve any particular problem. Summary of the Invention

[0004] Various aspects of this disclosure relate in particular to a tissue collection apparatus (e.g., for biopsy applications) and related methods. These aspects may include one or more of the features described below.

[0005] In one example, the medical device may include: a sheath; and an expandable member. The expandable member may include a support member; and a liner coupled to the support member. The liner may include a plurality of teeth. Proximal movement of the sheath may be configured to expose the expandable member, such that the expandable member changes from a constrained configuration to an expanded configuration.

[0006] Any medical device disclosed herein may possess any of the following features, individually or in any combination: The support member may include a mesh. The support member may include multiple struts. The liner may include a first proximal toothed row and a second distal toothed row. In a constrained configuration, the second distal toothed row may form a generally flat surface. Distal movement of the sheath may be configured to convert the expandable member from an expansion configuration to a constrained configuration. When the expandable member converts from an expansion configuration to a constrained configuration, the first toothed row may close before the second toothed row closes. The teeth may be at least partially oriented proximally. The proximal end of the sheath may include a gripping portion projecting radially outward from the proximal end of the outer sheath. The gripping portion may be configured to be manipulated by a user to move the sheath proximally or distally. In an expansion configuration, the distal portion of the expandable member may have a width greater than the proximal portion of the expandable member. In an expansion configuration, the expandable member may be conical or cylindrical. The medical device may include an anchoring assembly comprising an anchoring element. The anchor may be corkscrew-shaped. The medical device may further include a handle. The handle may include a first actuator configured to move the anchor proximally and distally. The handle may include a second actuator configured to rotate the anchor. The medical device may include a collar coupled to the distal end of the expandable member.

[0007] In another example, the medical device may include an expandable member with a support member, and a liner coupled to the support member. The liner may include multiple teeth. The medical device may further include an anchoring assembly, which may include an anchor and a control line.

[0008] Any device disclosed herein may include any of the following features in any combination. The medical device may further include a handle. The handle may include a first actuator coupled to a control line and configured to move an anchor proximally or distally. The handle may include a second actuator coupled to the control line and configured to rotate the anchor.

[0009] Medical methods may include: moving the sheath proximally to expand the expandable member; extending the anchor distally to contact the tissue; moving the anchor proximally so that the tissue is located within the expandable member; and moving the sheath distally to contract the expandable member so that the teeth of the expandable member secure the tissue to the expandable member.

[0010] Any method disclosed herein may include any of the following steps, alone or in any combination. The method may include, after extending the anchor distally, rotating the anchor to secure the tissue to the anchor. Attached Figure Description

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary embodiments and, together with the textual description, serve to explain the principles of this disclosure.

[0012] Figure 1A and 1B An exemplary organization collection device of this disclosure is shown;

[0013] Figure 2A-2B , Figures 3A-3E , Figures 4A-4C Draw the various aspects of the distal end of the tissue collection device in Figure 1;

[0014] Figure 5 Draw Figures 3A-4C The distal end and tissue anchors;

[0015] Figures 6A-6C The handle of the tissue collection device in Figure 1 is shown in various aspects;

[0016] Figures 7A-7F Draw the steps for performing a medical procedure using the tissue collection device shown in Figure 1;

[0017] Figures 8A-8C Draw the alternative distal end for use with the tissue collection device in Figure 1;

[0018] Figure 9 An alternative distal end of the tissue collection device of Figure 1 is shown. Detailed Implementation

[0019] The present disclosure will now be described with reference to exemplary tissue collection devices that can be used in endoscopic procedures (e.g., biopsies). However, it should be noted that reference to this particular procedure is for convenience only and is not intended to limit the scope of the disclosure. Those skilled in the art will recognize that the basic concepts of the disclosed apparatus and methods of application can be applied to any suitable procedure, medical procedure, etc. The disclosure may be understood with reference to the following description and accompanying drawings, wherein similar elements are referred to by the same reference numerals where feasible.

[0020] Exemplary embodiments of this disclosure describe a medical device that can be advanced into a body cavity via an insertion device (e.g., through the working channel of an endoscope, duodenoscope, or other type of endoscopic device, including but not limited to colonoscopes, endoscopic ultrasound (EUS) endoscopes, cystoscopes, ureteroscopes, bronchoscopes, catheters, etc.). Exemplary embodiments of the medical device include an expandable member having teeth on its inner surface. An anchoring element (e.g., a hook) can extend through the center of the expandable member. Compared to conventional devices, the disclosed medical device can increase the volume of tissue available. The disclosed medical device can improve surgical hit rates. More definitive tissue samples can be obtained in a shorter surgical time. Embodiments of the disclosed device can also improve maneuverability of the device through tortuous lumens within a subject's body. Furthermore, the disclosed device can facilitate tissue acquisition in a single operation without repeated tissue fusion. This can reduce damage or trauma to surrounding tissues due to multiple insertions of alternative medical devices. Additionally, the disclosed device may shorten surgical procedures. Because it uses fewer parts, the device disclosed herein also improves cost-effectiveness and manufacturability compared to biopsy forceps.

[0021] It is understood that the foregoing general description and the following detailed description are exemplary and illustrative only, and not intended to limit the claimed invention. The terms “comprising,” “including,” or any other variations thereof as used herein are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements may include not only those elements but also other elements not expressly listed or inherent to such a process, method, article, or apparatus. The term “diameter” may refer to the width of an element when it is not circular. The term “exemplary” is used in the meaning of “example” rather than “ideal.” For ease of description, portions / regions / ends of an apparatus and / or its components are referred to as proximal and distal ends / regions. It should be noted that the term “proximal” means the end / region closer to the user of the apparatus, and the term “distal” as used herein refers to the end / region further away from the user. Similarly, reference to a component extending “distally” means that the component extends in a distal direction (away from the user), and reference to a component extending “proximal” means that the component extends in a proximal direction (towards the user). Furthermore, the terms “approximately,” “roughly,” and “substantially” as used herein refer to values ​​within a range of + / -10% of the declared or implied values. Additionally, terms describing the geometry of a part / surface refer only to an approximate shape.

[0022] Figure 1A and Figure 1B An exemplary embodiment of an organization collecting medical devices (“medical devices”) 100 is shown. Figure 1A Details of the proximal portion of the medical device 100 are shown, and Figure 1BDetails of the distal portion of the medical device 100 are shown. (As shown) Figure 1A As shown, the medical device 100 may include a proximal assembly 104, which includes a handle 106. The medical device 100 may include, for example, a shaft 108 extending from a distal end of the handle 106. The medical device 100 may also include a distal assembly 110 at the distal end of the shaft 108. As discussed in detail below, movement of the various portions of the handle 106 may enable the components of the distal assembly 110 to be steered, articulated, and / or manipulated.

[0023] The handle 106 may include a body 114. The proximal end of the body 114 may include a ring 116 (e.g., a thumb ring). The handle 106 may also include multiple actuators. For example, the handle 106 may include a first movable member / actuator, which may be a spool 118. The handle 106 may further include a second movable member / actuator, which may be a knob 124. As discussed in detail below, the spool 118 and the knob 124 can be used to actuate elements of the distal assembly 110.

[0024] Shaft 108 may include an outer sheath 112 made of any suitable material, such as a stainless steel coil, polytetrafluoroethylene (PTFE), braided polymer, or nitinol (nickel-tin) tubing (e.g., a thiocyanate tube). The proximal end of sheath 112 may include an actuator, which may be a gripper 113. Gripper 113 may project radially outward from the proximal end of sheath 112. As discussed below, in order to move sheath 112 proximally and / or distally, a user may access and move gripper 113 proximally or distally.

[0025] Figure 2A A partial cross-sectional (torn) view of the distal component 110 in the first constraint / contraction configuration is shown. Figure 1B As shown, in the constrained configuration, the outer sheath 112 can extend to the most distal end of the shaft 108. This can be applied when navigating the shaft 108 to the surgical site (e.g., through the working channel of an endoscope) or when withdrawing the shaft 108 from the surgical site. Figure 2A The constrained configuration.

[0026] like Figure 2AAs shown, the inner member 140 may extend within the outer sheath 112. The distal end of the inner member 140 may include an expandable member 130. In some examples, the inner member 140 may extend proximally to the proximal end of the shaft 108. In other examples, the inner member 140 may be disposed only on the distal portion of the shaft 108. The expandable member 130 may include a mesh 142 and a liner 144. The mesh 142 may be a support member that supports the liner 144 and imparts a desired shape to the liner 144. The mesh 142 may include threads of a shape memory material, such as nitinol (NiTi) or other suitable materials. The mesh 142 may have any suitable pattern, such as braided, cross-stitched, woven, knitted, etc. As discussed in further detail below, the mesh 142 may be biased into an expanded configuration ( Figure 3B For example, mesh 142 can be biased by heat setting. The outer sheath 112 can hold mesh 142 in place. Figure 2A In the constrained configuration, the outer sheath 112 can move in the proximal direction in order to convert the expandable member 130 into an expandable configuration. Figure 2B The outer sheath 112 is shown to be partially retracted but not retracted to a extent sufficient to allow the expandable member 130 to begin transitioning to an expandable configuration.

[0027] Liner 144 may be coupled (e.g., fixedly coupled) to mesh 142. As shown in some examples, liner 144 may be coupled to the inner surface of mesh 142 such that mesh 142 is located on the outer surface of liner 144. Alternatively, liner 144 may be coupled to the outer surface of mesh 142 such that mesh 142 is coupled to the inner surface of mesh 142. Liner 144 may be made of PTFE or any other suitable material. In some examples, liner 144 may be elastic so that it can stretch and... Figure 2A and Figure 2B The contraction configuration is transformed into Figure 3B An expanded configuration. In other examples, the liner 144 may not be elastic and may include... Figure 2A and Figure 2B The folds in the contraction configuration. Liner 144 can be thin enough so that when grid 142 automatically expands to the offset expansion configuration ( Figure 3B When this is done, lining 144 also transforms into an expanded configuration. Lining 144 can also be thin enough to be compressed within outer sheath 212. Lining 144 can be thick enough or additionally resilient to allow it to bond with structures, as discussed below.

[0028] In some examples, the liner 144 may be omitted. In other examples, a portion of the liner 144 may be omitted, and a portion of the mesh 142 may include the liner 144. The mesh structure of the mesh 142 allows fluids (such as blood, bile, etc.) to pass through the mesh 142 without the liner 144 being provided. The mesh 142 eliminates the need for separate openings on the medical device 100.

[0029] Figures 3A-3E The characteristics of the expandable member 130 at various stages of conversion to the biased expansion configuration are shown. Figures 3A-3E For ease of explanation, grid 142 is omitted. It should be understood that grid 142 may be positioned on the outer surface of liner 144. Alternatively, liner 144 may have shape memory properties such that liner 144 is biased into an expanded configuration, and grid 142 may be omitted.

[0030] exist Figure 3A In the middle, the outer sheath 212 can be partially retracted in the proximal direction as indicated by the arrow. The distal portion of the expandable member 130 (including the liner 144) can begin to expand radially outward. Figure 3A The configuration can be partially open (or partially closed).

[0031] exist Figure 3B In this configuration, the outer sheath 112 has been further retracted proximally so that the expandable member 130 is in a fully expanded configuration. The expandable member 130 defines a cavity 146. The cavity 146 may have an open distal end. In some examples, the inner surface of the liner 144 may define the surface of the cavity 146. Figure 3B In the expanded configuration, the expandable member 130 can be trumpet-shaped. In other words, the lining 144 and / or the mesh 142 can radially expand outward in the distal direction, such that the expandable member 130 has a conical shape. The outer surface of the lining 144 and / or the mesh 142 can be concave, such that the expandable member 130 flares outward. In the expanded configuration, the proximal portion of the expandable member 130 can have a smaller diameter / width than the distal portion of the expandable member 130. In other words, the distal portion of the expandable member 130 can have a larger diameter / width than the proximal portion of the expandable member 130. Alternatively, the expandable member 130 can have other shapes, such as generally hemispherical, bell-shaped, conical, cylindrical, or spherical.

[0032] The inner surface of the liner 144 may have a plurality of teeth 150 that extend radially inward into the cavity 146. Figure 3C The lining 144 is made transparent to reveal the details of the teeth 150, at which point the expandable member 130 is in an expanded configuration. Figure 3E A partial view of the expandable member 130 facing proximal is shown, in which the tooth 150 is shown. (As shown) Figure 3C and Figure 3E As shown, teeth 150 can be arranged in a first proximal row 152 and a second distal row 154. Although two rows 152 and 154 are depicted in the figures and described below, it should be understood that the expandable member 130 can include any suitable number of rows of teeth. The first row 152 and the second row 154 can have any suitable number of teeth. For example, as Figure 3C and Figure 3E As shown, each of the first row 152 and the second row 154 may include five teeth. However, this number is merely exemplary. The two rows 152 and 154 of teeth 150 can help improve the success rate of surgery using the medical device 100.

[0033] A first row 152 of teeth 150 may extend around the circumference of the liner 144 at a first axial / longitudinal position, such that the first row 152 forms a loop of teeth 150. A first plane perpendicular to the longitudinal axis of the expandable member 130 may extend through all the teeth 150 of the first row 152. A second row 154 of teeth 150 may extend around the circumference of the liner 144 at a second axial / longitudinal position, such that the second row 154 forms a loop of teeth 150. A second plane perpendicular to the longitudinal axis of the expandable member 130 may extend through all the teeth 150 of the second row 154. For example, as shown, the second row 154 may extend around the distal edge 160 of the liner 144.

[0034] In extended configuration ( Figure 3B , Figure 3C and Figure 3E In the configuration, teeth 150 in the first row 152 and the second row 154 can be spaced apart from other teeth in the same row 152 and 154. In the contracted configuration (see...), Figure 2B In the second row 154, the teeth 150 can be closer to each other. For example, teeth 150 can contact adjacent teeth 150, and the tips of teeth 150 can contact or nearly contact each other at the center of the expandable member 130 (e.g., near the central longitudinal axis of shaft 108). Therefore, the teeth 150 of the second row 154 can form approximately closed distal ends in the contracted configuration. Although Figure 2B Not shown in the text, but as mentioned above for Figure 4B The teeth 150 of the first row 152 discussed may have a similar configuration in the contraction configuration.

[0035] The teeth 150 may be evenly spaced around the inner surface of the liner 144. As disclosed below, the evenly spaced teeth 150 avoid the formation of localized pressure points that could potentially cause tissue damage when the teeth 150 engage tissue. Because the diameter / width of the expandable member 130 is relatively small at the location of the first proximal row 152, the teeth 150 of the first proximal row 152 can be closer together than the teeth 150 of the second distal row 154. The teeth 150 may have any suitable shape. For example, as Figure 3D As shown, the tooth 150 may have a curved sickle shape. Point 156 of the tooth 150 may face proximally to increase gripping of tissue. Additionally or alternatively, point 156 may face radially inward toward the central longitudinal axis of the expandable member 130. The tooth 150 may have a radius of curvature that helps reduce tissue trauma. Figure 3D The shape is merely illustrative, and the teeth 150 can have any suitable shape. Each tooth 150 can have the same shape or can have different shapes (e.g., straight, triangular, serrated, barbed, or other shapes). The teeth 150 can have any suitable size (e.g., from approximately 0.3 mm to approximately 1.0 mm), which depends, for example, on how many teeth 150 are used.

[0036] Figure 3D An exemplary shape of the tooth 150 is shown. The tooth can be curved or sickle-shaped. The curvature can be proximal and / or radially inward. The curvature of the tooth 150 helps to encapsulate tissue, thereby more firmly gripping the target tissue. The sickle shape of the tooth 150 allows for controlled cutting and minimizes damage to surrounding healthy tissue. The radius of the tooth can be between 0.3 mm and 1 mm to assist in precisely targeting smaller tissue areas and reducing tissue trauma while achieving encapsulation.

[0037] Figures 4A-4C This illustrates the transformation of the expandable member 430 from an expandable configuration to a constrained configuration. Figure 4A and Figure 4B In the middle, the outer sheath 112 moves distally to convert the expandable member 430 into a partially contracted configuration. The sheath 112 can restrain the proximal portion of the expandable member 430. Figure 4A and Figure 4B The configuration can be with Figure 3A The partially expanded configurations shown are similar. Figure 4B A view slightly angled towards the proximal side is shown to illustrate the details of tooth 150. (As shown) Figure 4BAs shown, when the expandable member 130 begins to contract, as the outer sheath 112 approaches the axial position of the first row 152, the teeth 150 of the first row 152 may gradually approach each other. As discussed below, when the teeth 150 of the first row 152 move closer together (i.e., close), the teeth 150 of the first row 152 can grip into tissue and can help retain tissue within the expandable member 130. As the sheath 112 continues to move distally, the teeth 150 of the first row 152 can transition to a fully closed configuration (as discussed below). Figure 4C (The configuration of the second row 154 shown is similar). For example, the first row 152 of the teeth 150 can be formed in a generally planar shape, with or without gaps between the teeth 150. When tissue is received within the expandable member 130, the teeth 150 of the first row 152 can remain in a partially open configuration to accommodate the tissue.

[0038] Figure 4C An expandable member 130 in a fully constrained / collapsed configuration is shown. This configuration is similar to... Figure 2A The configuration shown is similar. This is to allow the expandable member 130 to... Figures 4A-4B Partial expansion configuration transformation Figure 4C With a fully constrained / collapsed configuration, the outer sheath 112 can move further proximally until it reaches a position near the farthest end of the expandable member 130 (e.g., near edge 160). As described above, the teeth 150 of the second row 154 can move together (close). In some examples, the teeth 150 of the second row 154 can form a near-planar wall that is able to retain tissue within the cavity 146.

[0039] As described in further detail below, the teeth 150 can be configured to grasp and / or sever tissue received within the expandable member 130. Because the first row 152 and the second row 154 of the teeth 150 have a generally planar arrangement in the withdrawal configuration and grasp tissue around a central point (e.g., along the central longitudinal axis of the expandable member 130), the expandable member 130 produces less tissue compression artifacts in tissue samples compared to biopsy forceps. The two rows 152, 154 of the teeth 150 can improve anchoring and tissue retention compared to a single row of teeth or the tooth arrangement of a biopsy forceps.

[0040] Figure 5 An anchoring assembly 230 of medical device 100 is shown. Anchoring assembly 230 can help anchor tissue and achieve deeper, larger volume tissue in a single operation. Anchoring assembly 230 may include anchoring element 232 coupled to control line 234. Figure 6A and Figure 6CIn some examples, anchor 232 may include a metal wire that may be integrally formed with control wire 234, or formed separately from and connected to control wire 234. Control wire 234 (or another control member, such as a cable) may extend through inner sheath 240. Inner sheath 240 may extend through the cavity of inner member 140 (and outer sheath 112) and through cavity 146 of expandable member 130. Inner sheath 240 may be a tubular structure defining the cavity. Control wire 234 may extend through the cavity of inner sheath 240 (e.g., a sleeve). In some examples, inner sheath 240 may include a coil or thiourea tube of any suitable material (e.g., PTFE). As discussed below, at least a portion of inner sheath 240 may have a square or other non-circular cross-section.

[0041] Anchor 232 can be configured to move distally (extend) and / or proximally (retract) relative to the inner member 140 by moving the distal and / or proximal sides of the control line 234. In the example, as Figure 5 As shown, anchor 232 can move proximally and distally along with the inner sheath 240. In other examples, anchor 232 can move relative to the inner sheath 240. Anchor 232 may include a helical structure, hook structure, barbed structure, spear-like structure, cannula needle structure, or other structure. Anchor 232 may be formed of metal. Figure 5 In the example shown, anchor 232 may be helical (e.g., spiral-shaped) and may have a sharp distal tip. As discussed in further detail below, anchor 232 may be used to grasp and position tissue relative to expandable member 130 such that the tissue can be captured within expandable member 130. In some examples, anchor 232 may be rotated into the tissue to secure anchor 232 to the tissue. The material of anchor 232 may be the same as or different from the remaining portion of control line 234.

[0042] Figures 6A-6C Details of the proximal component 104 are shown. Figure 6A and Figure 6C It is a cross-sectional view, and Figure 6B A portion of the proximal component 104 is made transparent to reveal details of the proximal component 104. As discussed above, the proximal component 104 may include a handle 106 having one or more actuators for manipulating various aspects of the distal component 110, as discussed below.

[0043] The spool 118 of the handle 106 can be designed to a size and shape for a user to grip. The body 114 of the handle 106 may include a slot 120 that extends longitudinally through a portion of the body 114. The distal end of the slot 120 may be spaced distally from the ring 116. A portion of the spool 118 may extend into a portion of the slot 120 such that the spool 118 can move along the slot 120 (e.g., longitudinally, distally and / or proximally). The slot 120 may define a range of movement for the spool 118. As discussed in detail below, the spool 118 may move within the slot 120, for example, proximally and / or distally, to control one or more aspects of the medical device. Furthermore, the handle 106 may include a spring or other type of biasing element 122 that may bias the spool 118 to a proximal or distal position.

[0044] The spool 118 may include an internal protrusion 170 (in) Figure 6C (as indicated by the reference numeral), for example, it extends within a portion of slot 120. An internal protrusion 170 or another portion of spool 118 may be coupled to the proximal end of control line 234, for example, by a crimp or other suitable structure (e.g., a clamp) securing it to control line 234. The proximal end of biasing element 122 may be coupled to the proximal end of protrusion 170. Alternatively, biasing element 122 may not be coupled to protrusion 170, but biasing element 122 may abut or further interact with protrusion 170 as spool 118 is advanced distally within slot 120. Biasing element 122 may bias spool 118 proximally. For example, biasing element 122 may compress as spool 118 moves distally, and once the distal force on spool 118 is removed, biasing element 122 may push spool 118 proximally (e.g., to). Figure 6A (The location shown).

[0045] As described in further detail below, movement of the spool 118 can control actuation of the distal assembly 110. For example, longitudinal movement of the spool 118 in a first direction (e.g., in the distal direction) can actuate the control line 234 to move it in the distal direction and advance the anchor 232 distally relative to the inner member 140 and the expandable member 130. Movement of the spool 118 in the distal direction can advance the anchor 232 until it contacts the subject's body tissue. Longitudinal movement of the spool 118 in a second opposite direction (e.g., in the proximal direction) can retract the control line 234 and the anchor 232 relative to the inner member 140 and the expandable member 130. For example, the control line 234 and the anchor 232 can move proximally such that they are covered by the inner member 140 and the outer sheath 112. As discussed below, movement of the spool 118 in the proximal direction allows the tissue T anchored to the anchor 232 to be pulled into the expandable member 130.

[0046] A knob 124 may be located on the distal portion of the body 114 of the handle 106. As discussed in detail below, the knob 124 is rotatable, for example, it may be rotated clockwise and / or counterclockwise to control one or more aspects of the distal assembly 110, as discussed below. For example, the knob 124 may be rotated about the longitudinal axis (e.g., the central longitudinal axis) of the medical device 100.

[0047] As in Figure 6C Specifically shown, the proximal portion of the control line 234 can be fixedly coupled to the knob 124. A coupling (e.g., an inner sheath 240) can be attached or otherwise positioned around the proximal portion of the control line or around the entire length of the control line 234. A portion (or the entire length of) the inner sheath 240 within the knob 124 can include one or more flat outer surfaces. For example, a portion or all of the inner sheath 240 can include a square cross-section having four flat outer surfaces. In some cases, the inner sheath 240 can extend proximally to the spool 118, for example, through the biasing element 122 and / or to the internal protrusion 170. In other examples, the inner sheath 240 can terminate within the knob 124, or just proximal to the knob 124. The knob 124 may surround the control line 234 and the inner sleeve 240 such that the knob 124 engages with the inner sleeve 240, thereby aiding in the rotation of the inner sleeve 240 and the control line 234 when the knob 124 is rotated. For example, the knob 124 may define a cavity 172 that is keyed to the inner sleeve 240 (e.g., the cavity 172 may have a square cross-section). The control line 234 and / or the inner sleeve 240 may be movable proximally and / or distally relative to the knob 124 and may be rotatably fixed relative to the knob 124.

[0048] In these respects, rotation of knob 124 (e.g., clockwise or counterclockwise) can also rotate control line 234 (e.g., clockwise or counterclockwise about the center of the longitudinal axis of control line 234 and / or the central longitudinal axis of axis 108). For example, a user can rotate knob 124 (e.g., about the central longitudinal axis of knob 124) to rotate control line 234 (through inner sheath 240). Rotation of control line 234 can rotate anchor 232 so that anchor 232 engages with and secures the tissue. For example, rotation of knob 124 may cause the spiral anchor 232 to twist into the tissue, thereby securing anchor 232 to the tissue.

[0049] The furthest portion of the handle 106 may include a connecting portion 174 that connects the proximal end of the internal member 140 to the handle 106. To illustrate the details of the connecting portion 174, the connecting portion 174 is located in... Figure 6BThe internal component 140 is drawn in a transparent state. The proximal end of the internal component 140 may include a crimp sleeve 176, a bearing, a clamp, or another structure for connecting the internal component 140 to the connecting portion 174. The connecting portion 174 may include threads 178 for connecting the connecting portion 174 to the body 114 of the handle 106. When the connecting portion 174 is screwed onto (or otherwise connected to) the handle 106, the connecting portion 174 may engage with the crimp sleeve 176 to connect the internal component 140 to the connecting portion 174.

[0050] As shown in Figure 1 and Figure 6A As shown, the proximal component 104 may also include a proximal portion of the outer sheath 112. As described above, the proximal end 115 of the outer sheath 112 may include a gripping portion 113. The gripping portion 113 protrudes radially outward from the proximal end 115 of the outer sheath 112. The size and shape of the gripping portion 113 may be designed for contact with a user's hand. The user can manipulate the gripping portion 113 to move the outer sheath 112 proximally and / or distally. As discussed above, proximal movement of the outer sheath 112 may cause the expandable member 130 to transform into an expanded configuration of the expandable member 130 (e.g., Figure 3B , Figure 3C , Figure 3E and Figure 5 (As shown in Figure 1). The distal movement of the outer sheath 112 may gradually cover the expandable member 130, transforming it into a constrained / collapsed configuration (as shown in Figure 1). Figure 2A , Figure 2B and Figure 4C (as shown in the diagram). Alternatively, the handle 106 may include one or more other actuators to control the extension (distal movement) and retraction (proximal movement) of the outer sheath 112.

[0051] Figures 7A-7F A method for collecting / acquiring tissue samples using a medical device 100 is described. Although Figures 7A-7F The following description depicts and illustrates a specific order of method steps, but it should be understood that some or all of the steps described below may be repeated or may be performed in an alternative order. Figures 7A-7E In some of the drawings, the lining 144 is depicted as transparent for ease of explanation.

[0052] Figure 7A The distal assembly 110 of the medical device 100 is shown, wherein the expandable member 130 is in a restrained / contracted configuration. An outer sheath 112 may extend to the distal end (e.g., the most distal end) of the expandable member 130, thereby restraining the expandable member 130 within the outer sheath 112. An anchor 232 (in...) Figure 7A (Not shown in the image) It can also be retracted proximally within the outer sheath 112 and the expandable member 130. In some examples, in Figure 7AIn the configuration, the anchor 232 can be located near the nearest end of the expandable member 130.

[0053] An insertion device (e.g., any type of endoscopic device) can be inserted into the subject's body (e.g., through a body orifice) and positioned such that it is properly positioned within the body cavity. The shaft 108 of the medical device 100 can then be inserted into the body cavity via the insertion device. Alternatively, the shaft 108 can be inserted into the subject's body without using the insertion device. During insertion of the medical device 100, the distal component 110 can be in a restrained configuration, as described above with reference to FIG1. Figure 2A , Figure 2B and Figure 4C As stated above.

[0054] like Figure 7B As shown, the expandable member 130 can then be converted into an expandable configuration. To convert the expandable member 130 into the expandable configuration, the user contacts the gripping portion 113 of the outer sheath 112, causing the outer sheath 112 to move proximally relative to the expandable member 130, as shown... Figure 7B As indicated by the arrow in the diagram. Alternatively, the outer sheath 112 can be retracted by manipulating other controls on the handle 106 of the medical device.

[0055] As the outer sheath 112 moves proximally, it may gradually expose the expandable member 130. The expandable member 130 can be converted into an offset expansion configuration, as described above. Figures 3A-3E As described above. The user can optionally stop the expansion of the expandable member 130 in a partially expanded configuration, such as... Figure 3A As shown. For example, a user may want the expandable member 130 to have a smaller size than the fully expandable configuration.

[0056] like Figure 7C As shown, the user can then move the spool 118 distally (as indicated by the arrow) to move the anchor 232 distally toward the tissue T. The anchor 232 can extend such that it is located distal to the distal end of the expandable member 130. Therefore, the anchor 232 can be used to engage with the tissue T without pushing the expandable member 130 against the tissue T. The knob 124 can be rotated as indicated by the arrow to rotate the anchor 232 so that it engages with and is secured / anchored to the tissue T. For example, the spiral anchor 232 can be screwed into the tissue T.

[0057] Subsequently, as Figure 7D As shown, in order to move the anchor 232 proximally relative to the expandable member 130, the user can move the spool 118 proximally (as indicated by the arrow). For example, the anchor 232 can be retracted within the expandable member 130. (See reference...) Figure 7CThe anchor 232 discussed may have been fixed to the tissue T such that when the anchor 232 moves proximally, the tissue T is pulled into the expandable member 130.

[0058] After that, as Figure 7E As shown, the operator can use the gripping part 113 to move the outer sheath 112 distally, as indicated by the arrow. (See above reference.) Figure 4A and Figure 4B As discussed, the proximal portion of the expandable member 130 can begin to contract. The first row 152 of the teeth 150 can engage with tissue T pulled into the expandable member 130, as described above. The first row 152 of the teeth 150 can grip / anchor the tissue T within the expandable member 130, thereby securing the tissue to the expandable member 130. Figure 7E As shown, tissue T can extend proximally to the first row 152 of teeth 150 within the expandable member 130. The proximally portion of tissue T can be located within the collapsed portion of the expandable member 130.

[0059] like Figure 7F As shown, the user can continue to move the gripping part 113 distally (as indicated by the arrow) to move the outer sheath 112 distally on the expandable member 130. The outer sheath 112 can move distally until it completely covers the expandable member 130. As referenced above... Figure 4C In order to retain tissue T within the expandable member 130, the second row 154 of the teeth 150 (in) Figure 7F (Not shown in the image) can be closed. The second row 154 of the teeth 150 can provide further gripping / anchoring on the tissue T and can provide a distal closed end of the expandable member 130.

[0060] like Figure 7F As shown, to retrieve the collected tissue T from the body, the user can move the handle 106 proximally (as indicated by the arrow). The handle 106 can be pulled sharply backward to apply tissue gripping force. In some examples, the second row 154 of the teeth 150 can aid in cutting the tissue T. The handle 106 can be moved further proximally to retract the shaft 108 holding the collected tissue T from the body cavity (e.g., through the working channel of the infeed device).

[0061] Figures 8A-8C An alternative distal component 410 is illustrated herein. Unless otherwise stated herein, the distal component 410 may have any of the features of the distal component 110 and may be used with any of the methods described herein. The distal component 410 may be used in conjunction with the proximal component 104 described above. Figure 8A The expandable member 430 of the distal component 410 in a contracted configuration is shown. Figure 8BThe expandable member 430 is shown in a partially expanded configuration. Figure 8C The expandable member 430 is shown in its fully expanded configuration.

[0062] Expandable member 130 includes a grid 142, while expandable member 430 of distal assembly 410 may include a plurality of struts 442. The struts 442 may be support members that provide shape to liner 444 and give structure to liner 444. In some examples, the plurality of struts 442 may be understood as constituting a single support member. The struts 442 may include a plurality of longitudinally extending members (e.g., wires, cables, etc.). The struts 442 may be coupled to the outer surface of liner 444, which has any of the characteristics of liner 144 described above. In a contracted configuration ( Figure 8A In the expansion configuration, the struts 442 can be approximately parallel to each other and approximately parallel to the central longitudinal axis of the expandable member 430. Figure 8B and Figure 8C In the liner 444, the struts 442 can open outward in a distal direction, radially outward from the central longitudinal axis of the expandable member 430. The struts 442 can be curved and can be curved radially outward. The struts 442 can be evenly spaced around the outer surface of the liner 444. Any suitable number of struts 442 can be used to provide the required support to the liner 444.

[0063] Similar to grid 142, strut 442 can have shape memory properties (e.g., it can be made of nitinol and heat-set into an expanded configuration or otherwise have a biased expanded configuration). Strut 442 can be biased into... Figure 8C The expanded configuration.

[0064] In some examples, the expandable member 430 may be unlined, and the strut 442 may be the expandable member 430 alone. The strut 442 may have one or more teeth integrated therein (e.g., embedded).

[0065] Figure 9 Another alternative distal component 610 is illustrated. Unless otherwise stated herein, distal component 610 may have any of the characteristics of distal components 10, 410 and may be used with any of the methods described herein. Distal component 610 may be used in conjunction with proximal component 104.

[0066] The distal component 610 may include an expandable member 630. The expandable member 630 may have any of the characteristics of the expandable members 130 and 430 described above. The expandable member 630 may include a snare 680 attached to the distal end (e.g., the distal edge 690) of the expandable member 630. The snare 680 may have any features of any snare known in the art and may be biased into an expanded configuration (e.g., Figure 9 (As shown). The snare 680 can be secured to the expandable member 630 by any suitable means. For example, mechanical fasteners such as screws, rivets, rings, or clips, or adhesives, can be used to attach the snare 680 to the expandable member 630. In some examples, the snare 680 can be secured to the edge 690 (e.g., by a ring along the edge 690) so that the snare 680 can move relative to the edge 690.

[0067] Shaft 682 can extend proximally from collar 680. A control line (not shown) or other control element (e.g., cable, thread, etc.) can be received within the cavity of shaft 682 and operatively coupled to collar 680. Proximity retraction of the control line may cause collar 680 to convert to a closed configuration (not shown), thereby collapsing collar 680. Distal movement of the control line may cause collar 680 to convert to an open configuration (e.g., ...). Figure 9 (As shown), thereby expanding the snare 680. The control line 234 can be actuated by an element of the handle 106, or by a separate handle or actuator. Alternatively, the snare 680 can be passively controlled, such that the snare 680 contracts with the contraction of the expandable member 630 and expands with the expansion of the expandable member 630.

[0068] The distal component 610 can be particularly useful for tumor resection. The snare 680 can be actuated to remove tissue (similar to other snares), and the expandable member 630 can preserve the removed tissue. Because the tissue is preserved within the expandable member 630, the distal component 610 can help expose the spread of cancer cells (seeding).

[0069] Although biopsies and tissue resections have been mentioned above, it should be understood that the devices disclosed herein can be used for other procedures, such as removing or crushing stones (e.g., gallstones) or retrieving foreign bodies. Furthermore, the devices disclosed herein can be used for procedures such as mechanical thrombectomy. Alternatively, tissue can be drawn into the expandable member described herein using aspiration. In such examples, the anchoring component 230 may be omitted.

[0070] Although the principles of this disclosure have been described herein with reference to illustrative examples for a particular application, it should be understood that this disclosure is not limited thereto. Those skilled in the art and who have access to the teachings provided herein will recognize that additional modifications, applications, and substitutions of equivalents 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: jacket; as well as Expandable member, the expandable member comprising: Supporting components; and A liner connected to the support member, wherein the liner includes a plurality of teeth; The sheath is configured to move proximal to expose the expandable member, thereby converting the expandable member from a constrained configuration to an expanded configuration.

2. The medical device according to claim 1, wherein, The supporting component includes a grid.

3. The medical device according to claim 1, wherein, The supporting structure includes multiple pillars.

4. The medical device according to any one of claims 1 to 3, wherein, The lining includes a first proximal toothed row and a second distal toothed row.

5. The medical device according to claim 4, wherein, In the constrained configuration, the second distal tooth row forms a generally flat surface.

6. The medical device according to claim 4 or 5, wherein, The distal movement of the sheath is configured to convert the expandable member from the expansion configuration to the constraint configuration, and wherein, when the expandable member converts from the expansion configuration to the constraint configuration, the first tooth row closes before the second tooth row closes.

7. The medical device according to any one of claims 4 to 6, wherein, The teeth are at least partially oriented in the proximal direction.

8. The medical device according to any one of claims 1 to 7, wherein, The proximal end of the sheath includes a gripping portion that projects radially outward from the proximal end of the outer sheath, wherein the gripping portion is configured to be manipulated by a user to move the sheath proximal or distally.

9. The medical device according to any one of claims 1 to 8, wherein, In the expanded configuration, the distal portion of the expandable member has a wider width than the proximal portion of the expandable member.

10. The medical device according to any one of claims 1 to 9, wherein, In the expanded configuration, the expandable member has a conical or cylindrical shape.

11. The medical device according to any one of claims 1 to 10, further comprising an anchoring assembly, the anchoring assembly including an anchoring element.

12. The medical device according to claim 11, wherein, The anchoring element is spiral-shaped.

13. The medical device according to any one of claims 11 to 12, further comprising a handle, wherein, The handle includes a first actuator configured to move the anchor proximally and distally.

14. The medical device according to claim 13, wherein, The handle includes a second actuator configured to rotate the anchor.

15. The medical device according to any one of claims 1 to 14, further comprising a snare ring coupled to the distal end of the expandable member.

Images