Tissue sample devices and methods

Abstract

A tissue collection system for collecting a sample from a body is disclosed. The system may include an outer tubular member having a proximal end region and a distal end region and defining a lumen extending from the proximal end region to the distal end region; an inner tubular member slidably disposed within the lumen of the outer tubular member, the inner tubular member defining a lumen extending from a proximal region to a distal region of the inner tubular member; and an expandable tissue collection device disposed proximate the distal end region of the inner tubular member.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 438,377, filed on January 11, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present application relates generally to medical devices for tissue sample collection, and more particularly to medical devices for tissue sample collection resulting in a greater yield of cells or other tissue. Background Art

[0004] Certain medical tests require sampling of cells from a target area of a subject's body. For example, a screening test for detecting potential precancerous and cancerous tissue in a subject's body may include obtaining a sample of tissue or cells from a target area of the subject's body. A tissue collection device can be used to collect cells or other tissue from the target area. Tissue collection from some parts of the anatomy can be difficult. There is a need to provide alternative medical devices and alternative methods for making and using medical devices. Summary of the Invention

[0005] The present invention provides alternatives in design, materials, manufacturing methods, and use of medical devices.

[0006] In a first example, a tissue collection system may include an outer tubular member having a proximal region and a distal region and defining a lumen extending from the proximal region to the distal region; an inner tubular member slidably disposed within the lumen of the outer tubular member, the inner tubular member defining a lumen extending from the proximal region to the distal region of the inner tubular member; and a tissue collection device disposed adjacent the distal region of the inner tubular member, the tissue collection device including an expandable basket. The tissue collection device is movable between a retracted delivery position and an extended sample collection position.

[0007] Alternatively or additionally to any of the above examples, in another example, the expandable basket can include a plurality of longitudinally extending struts.

[0008] Alternatively or additionally to any of the above examples, in another example, one or more edges of at least one of the plurality of struts can have a sharp surface.

[0009] Alternatively or additionally to any of the above examples, in another example, a surface of at least one strut in the plurality of struts can be textured.

[0010] Alternatively or additionally to any of the above examples, in another example, the tissue collection system can further include one or more barbs coupled to at least one strut of the plurality of struts.

[0011] Alternatively or additionally to any of the above examples, in another example, one or more barbs can comprise a wire wrapped around at least one strut.

[0012] Alternatively or additionally to any of the above examples, in another example, at least one free end of the wire can extend radially from at least one strut.

[0013] Alternatively or additionally to any of the above examples, in another example, the tissue collection system can further include one or more teeth extending from at least one strut.

[0014] Alternatively or additionally to any of the above examples, in another example, one or more teeth can be formed as a single, unitary structure with at least one strut.

[0015] Alternatively or additionally to any of the above examples, in another example, the plurality of struts can include a plurality of individual filaments that are coupled or connected to each other at their respective proximal and distal ends.

[0016] Alternatively or additionally to any of the above examples, in another example, the tissue collection device can include a cutting tube.

[0017] Alternatively or additionally to any of the above examples, in another example, the tissue collection device can be a unitary structure with the inner tubular member.

[0018] Alternatively or additionally to any of the above examples, in another example, a tissue collection device can be coupled to the inner tubular member.

[0019] Alternatively or additionally to any of the above examples, in another example, the tissue collection device can be self-expanding.

[0020] Alternatively or additionally to any of the above examples, in another example, the tissue collection system can further include an actuation mechanism coupled to the proximal end or the distal end of the tissue collection device.

[0021] Alternatively or additionally to any of the above examples, in another example, the inner tubular member can further include one or more cutout regions, and the one or more cutout regions can be adjacent to the tissue collection device.

[0022] Alternatively or additionally to any of the above examples, in another example, the plurality of struts can have a generally flat, ribbon-like shape.

[0023] Alternatively or additionally to any of the above examples, in another example, the plurality of struts can have a generally linear shape.

[0024] Alternatively or additionally to any of the above examples, in another example, the proximal end of each strut in the plurality of struts can be coupled to a proximal collar, and the distal end of each strut in the plurality of struts can be coupled to a distal collar.

[0025] Alternatively or additionally to any of the above examples, in another example, at least one of the proximal or distal loops can be movably disposed on the inner tubular member.

[0026] Alternatively or additionally to any of the above examples, in another example, in the expanded configuration, a mid-region of each strut in the plurality of struts can flex radially outward.

[0027] Alternatively or additionally to any of the above examples, in another example, each strut in the plurality of struts can each include a proximal region and a distal region.

[0028] Alternatively or additionally to any of the above examples, in another example, the proximal regions of the plurality of struts can intersect with the distal regions at an intersection.

[0029] Alternatively or additionally to any of the above examples, in another example, in the expanded configuration, the proximal regions of the plurality of struts may extend at a first angle relative to the longitudinal direction of the expandable basket, and the distal regions of the plurality of struts may extend at a second angle relative to the longitudinal direction of the expandable basket.

[0030] Alternatively or additionally to any of the above examples, in another example, the first angle may be different from the second angle.

[0031] Alternatively or additionally to any of the above examples, in another example, in the expanded configuration, the struts can flex radially outward such that the proximal and distal regions of the expandable basket can extend at non-parallel angles relative to the longitudinal axis of the expandable basket, and the intermediate region can extend generally parallel to the longitudinal axis of the expandable basket.

[0032] In another example, a tissue collection system may include an outer tubular member having a proximal region and a distal region and defining a lumen extending from the proximal region to the distal region; an inner tubular member slidably disposed within the lumen of the outer tubular member, the inner tubular member defining a lumen extending from the proximal region to the distal region of the inner tubular member; and a tissue collection device disposed adjacent the distal region of the inner tubular member, the tissue collection device including a radially expandable basket having a plurality of longitudinally extending struts extending between a proximal collar and a distal collar. The tissue collection device is movable between a retracted, collapsed delivery position and an extended, expanded, sample collection position.

[0033] Alternatively or additionally to any of the above examples, in another example, the tissue collection device can be a cutting tube.

[0034] Alternatively or additionally to any of the above examples, in another example, at least one strut of the plurality of struts can include a radially extending tissue-disrupting feature.

[0035] In another example, a tissue collection system may include an outer tubular member having a proximal region and a distal region and defining a lumen extending from the proximal region to the distal region; an inner tubular member slidably disposed within the lumen of the outer tubular member, the inner tubular member defining a lumen extending from the proximal region to the distal region of the inner tubular member; and a tissue collection device disposed adjacent the distal region of the inner tubular member, the tissue collection device comprising a radially expandable basket having a plurality of longitudinally extending wires extending between a proximal collar and a distal collar, and at least one barb coupled to at least one of the plurality of longitudinally extending wires, the at least one barb including a radially extending free end. The tissue collection device is movable between a retracted, collapsed delivery position and an extended, expanded, sample collection position.

[0036] The above summary of some example embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] The present invention may be more fully understood upon consideration of the following detailed description of various embodiments in conjunction with the accompanying drawings, in which:

[0038] Figure 1 showing a partial cross-sectional side view of an illustrative tissue collection device system for delivering a tissue collection device to a target area in a retracted or delivery configuration;

[0039] Figure 2 Show Figure 1 A perspective view of an illustrative tissue collection device;

[0040] Figure 3 shows a perspective view of another illustrative tissue collection device;

[0041] Figure 4 showing a side view of another illustrative tissue collection device system for delivering a tissue collection device to a target area in a deployed configuration; and

[0042] Figure 5 is used Figures 1 to 4 An illustrative flow chart of a method for systematically collecting tissue samples.

[0043] While the present invention is susceptible to various modifications and alternative forms, specific details thereof have been shown by way of example in the drawings and will be described in greater detail. However, it should be understood that the present invention is not intended to limit its aspects to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0044] All numerical values herein are assumed to be modified by the term "about", whether or not expressly indicated otherwise. The term "about" generally refers to a range of numbers that one skilled in the art would consider equivalent to the referenced number (i.e., having the same function or result). In many cases, the term "about" may indicate that the number is rounded to the nearest significant figure.

[0045] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0046] While some suitable sizes, ranges and / or values are disclosed for various components, features and / or specifications, those skilled in the art, in light of this disclosure, will understand that desired sizes, ranges and / or values may be derived from those explicitly disclosed.

[0047] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise.

[0048] The term "distal" refers to the portion of the device that is farthest from the user when the device is introduced into the patient's body. Conversely, the term "proximal" refers to the portion of the device that is closest to the user when the device is placed in the patient's body. As used herein, the terms "comprises," "comprising," or any other variations thereof are intended to be non-exclusive, such that a process, method, article, or apparatus that includes a list of elements does not necessarily include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Additionally, terms referring to component / surface geometry refer to both exact shapes and approximate shapes.

[0049] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different figures are numbered the same. The detailed description and the accompanying drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the invention. The depicted illustrative embodiments are exemplary only. Unless expressly stated to the contrary, selected features of any illustrative embodiment may be incorporated into additional embodiments.

[0050] Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure that utilizes both endoscopic and fluoroscopic techniques to diagnose and treat problems in the common bile duct (CBD) and pancreatic duct (PD). One of the main problems currently treated is strictures in the CBD, which are caused by conditions such as, but not limited to, primary sclerosing cholangitis (PSC), cholangiocarcinoma, damage to the bile duct due to gallstones, and scarring. However, biliary structures can have a low sensitivity to cancer, which can lead to false-negative diagnoses during the ERCP procedure. In some cases, this low sensitivity may be related to insufficient tissue sampling, a major limitation in detecting potential malignancies. When clinicians need to sample a stricture, one of the most common methods is to use a cytology brush. However, the sensitivity of a cytology brush can range from approximately 30-60%. The sensitivity of a cytology brush may be primarily related to insufficient sample volume. One reason a cytology brush may not collect an adequate sample is because of the use of soft bristles. Another reason may be that the sample is lost during the procedure.

[0051] It is desirable to have a sample collection device that can collect a sufficient amount of sample to better predict biliary tract cancer. Although the present invention is described with respect to the common bile duct and pancreatic duct, the devices and methods are not limited to such uses. For example, the devices and methods described herein can be used in any part of the anatomy as desired. Furthermore, the devices and methods described herein can be used in endoscopic or non-endoscopic anatomy. Some illustrative anatomy can include, but are not limited to: the mouth, esophagus, stomach, duodenum, other parts of the gastrointestinal tract, pathways to the lungs, other parts of the respiratory system, the urinary tract, the cervix, other reproductive anatomy, etc.

[0052] Figure 1FIG2 is a partial cross-sectional side view of an illustrative tissue collection device system 10 for delivering a tissue collection device 12 in a retracted or delivery configuration to a target area, such as, but not limited to, the common bile duct or pancreatic duct. The tissue collection system 10 may include an outer or external elongated shaft or tubular member 14 and an inner elongated shaft or tubular member 16. The inner tubular member 16 may be slidably disposed within a lumen 18 of the outer tubular member 14. The outer tubular member 14 may extend proximally from a distal region 20 to a proximal region 22 configured to remain outside the patient's body. A first hub or handle 24 may be coupled to the proximal region 22 of the outer tubular member 14. In some cases, a port 32, such as an injection port, may be provided in the outer tubular member 14. Other structures may be provided to facilitate connection to other medical devices (e.g., syringes, stopcocks, Y-adapters, etc.) and to provide access to the lumen 18. The inner tubular member 16 may extend proximally from the distal region 26 to a proximal region 28 configured to remain outside the patient's body. A second hub or handle 30 can be coupled to the proximal end region 28 of the inner tubular member 16 .

[0053] The outer tubular member 14 may include a lumen 18 extending from a distal region 20 to a proximal region 22. The lumen 18 may also extend through a first handle 24. The lumen 18 of the outer tubular member 14 and the first handle 24 may be configured to slidably receive the inner tubular member 16. The inner tubular member 16 may include a lumen 40 extending from the distal region 26 to the proximal region 28. The lumen 40 of the inner tubular member 16 may also extend through the second handle 30. If desired, the lumen 40 of the inner tubular member 16 may be configured to receive a guidewire 42. In other examples, the guidewire 42 may be received within the lumen 18 of the outer tubular member 14. It is contemplated that the system 10 may be arranged such that the guidewire 42 extends within the lumen along the entire length of the outer tubular member 14 or the inner tubular member 16 in an "over-the-wire" manner, or that the guidewire 42 may exit a side port of the outer tubular member 14 distal to its proximal region 22 in a "quick exchange" manner.

[0054] The tissue collection device 12 can be disposed around or formed from a portion of the inner tubular member 16 at or near the distal region 26 thereof. The tissue collection device 12 can extend around the entire circumference of the inner tubular member 16. In other embodiments, the tissue collection devices 12 can be radially spaced in a uniform pattern or eccentrically around the circumference of the inner tubular member 16, as desired. In some embodiments, the tissue collection device 12 can include a collapsed delivery configuration ( Figure 1 ) and expanded usage forms ( Figure 2 ) a radially expandable frame or basket 44 that moves between the tissue collection device 12. Although the tissue collection device 12 is described as an expandable basket, it is contemplated that other tissue collection devices may be used as desired.

[0055] Additional references Figure 2, which shows a perspective view of an illustrative tissue collection device 12, an expandable basket 44 can extend from a proximal end 48 to a distal end 50 and include a plurality of longitudinally extending struts 46a-e (collectively, 46). In some embodiments, the proximal end 48 of the basket 44 can extend proximally to a position configured to remain outside the body, such that the tissue collection device 12 can be manipulated by actuation of the proximal end 48, however, this is not required. The expandable basket 44 can include any desired number of struts 46, such as, but not limited to, one, two, three, four, five, six, or more. The struts 46 can have a generally flat, ribbon-like shape (e.g., having a width greater than thickness). In other examples, the struts 46 can have a generally linear shape (e.g., having a similar width and thickness). However, the struts 46 can take any desired shape. The struts 46 can be evenly spaced around the circumference of the expandable basket 44. However, this is not required. In some cases, the struts 46 can be eccentrically spaced.

[0056] The proximal end of the strut 46 can be secured to the proximal collar 52, and the distal end of the strut 46 can be secured to the distal collar 54. In some embodiments, the strut 46 can be formed as a single, unitary structure with the proximal collar 52 and / or the distal collar 54. For example, the strut 46 and collars 52, 54 can be cut from a single tube. It is also contemplated that the strut 46 and collars 52, 54 can be formed from or as part of a portion of the inner tubular member 16. In other words, the inner tubular member 16, strut 46, and collars 52, 54 can be formed as a single, unitary structure. For example, the cut tubing can be the inner tubular member 16 or a separate tube, as desired. In other embodiments, one or more of the proximal and distal collars 52, 54 and the strut 46 can be formed as separate structures that are coupled together. For example, the strut 46 can be welded, brazed, soldered, bonded, etc. to the proximal and / or distal collars 52, 54. Other coupling techniques can be used as desired. It is contemplated that the coupling mechanism may depend, at least in part, on the materials of the struts 46 and / or the collars 52, 54. When the expandable basket 44 is a separate component from the inner tubular member 16, at least one of the proximal collar 52 or the distal collar 54 may be fixedly secured to the outer surface of the inner tubular member 16, while the other of the proximal collar 52 or the distal collar 54 may be movably disposed on the inner tubular member 16 to allow radial expansion of the basket 44. In one example, the proximal collar 52 may be fixedly secured to the inner tubular member 16, while the distal collar 54 may be slidably disposed on the inner tubular member 16. In this configuration, the distal collar 54 may be moved distally to collapse the expandable basket 44 and proximally to expand the expandable basket 44. The opposite configuration is also contemplated, wherein the distal collar 54 may be fixedly secured to the inner tubular member 16, while the proximal collar 52 may be slidably disposed on the inner tubular member 16.

[0057] The expandable basket 44 may be self-expandable or may require an external force to expand from a collapsed state. A self-expandable member may be formed from any material or structure that, when a force is applied, is compressed and, when the force is released, is expanded. Such a member may be formed from, for example, a shape memory alloy such as Nitinol, or any other self-expandable material. When such a shape memory material is employed, the expandable basket 44 may be heat-set into an expanded state and then subsequently compressed to fit within, for example, the outer tubular member 14. In another embodiment, a spring may be provided to facilitate expansion. It is contemplated that Nitinol may provide kink-resistant folding and self-expansion. In other examples, the expandable basket 44 may be formed from magnetic alloys, metals, metal alloys, polymers, composite materials, and the like.

[0058] In other cases, manual force applied to the inner tubular member 16 can manipulate or actuate the expandable basket 44 between the expanded and collapsed states. For example, the actuating element can include a center wire or rod extending through the expandable basket 44 and coupled to the distal collar 54. Alternatively, an external force, such as, but not limited to, pneumatics, compressed fluid, a pull wire, a push wire, a rod, etc., can be used to expand the expandable basket 44. According to this embodiment, a proximal pulling force applied to the wire can allow the struts 46 to expand and move the expandable basket 44 to the expanded state. A distal pushing force applied to the wire can move and extend the struts 46 and / or otherwise cause the expandable basket 44 to transition between the compressed or extended state. Other actuating mechanisms can also be utilized. For example, a guidewire 42 can be used to apply a proximal pushing force to the distal end of the distal collar 52. In such a case, the guidewire 42 may include an enlarged region having a diameter greater than the diameter of the lumen of the tissue collection device 12, such that proximally actuating the guidewire 42 causes the enlarged region of the guidewire 42 to contact the distal loop 52, and further proximally actuating the guidewire 42 causes the distal loop 52 to move proximally and expand the expandable basket 44. It is contemplated that manually actuating the expandable basket 44 using a wire, rod, or the like may exert a higher force on the expandable basket 44, which may allow the basket to achieve greater engagement with the target tissue.

[0059] When the tissue collection device 12 is disposed within the outer tubular member 14, the expandable basket 44 can be constrained in a compressed, reduced diameter or delivery configuration by the outer tubular member 14 surrounding the tissue collection device 12. In other examples, the expandable basket 44 can assume a collapsed configuration until an actuation force is applied to the expandable basket 44. In the collapsed configuration, the tissue collection device 12 can have a smaller diameter than in the expanded, deployed configuration. The distal region 20 of the outer tubular member 14 can be positioned such that the outer tubular member 14 surrounds and covers the length of the tissue collection device 12 during delivery. The outer tubular member 14 can have sufficient hoop strength to maintain the tissue collection device 12 in its reduced diameter state. In the expanded configuration, the intermediate regions of the struts 46 can flex radially outward such that the struts 46 form an arcuate or curved configuration.

[0060] As needed, the tissue collection system 10 can be advanced through the body toward the target site. The tissue collection system 10 can be advanced with or without the use of a guidewire 42. Once the tissue collection device 12 is positioned near the target area, the restraining force holding the tissue collection device 12 in the radially compressed configuration can be removed to deploy the tissue collection device 12.

[0061] The tissue collection device 12 can be deployed by actuating the second handle 30, for example, by pushing the second handle 30 distally, while maintaining the first handle 24 in a fixed position. As a result, the inner tubular member 16 can be advanced distally relative to the outer tubular member 14. In other words, the inner tubular member 16 can be advanced distally while the outer tubular member 14 remains stationary. The opposite configuration is also contemplated. For example, the outer tubular member 14 can be retracted proximally while the inner tubular member 16 remains stationary. As the inner tubular member 16 is advanced distally, the biasing force is removed from the exterior of the tissue collection device 12, and the expandable basket 44 can assume its radially expanded, unbiased deployed configuration, as shown. Figure 2 Alternatively, the expandable basket 44 may remain collapsed until an actuation force is applied to the expandable basket 44 (eg, using a pull wire or other actuation mechanism) to move the expandable basket 44 to the radially expanded deployed configuration.

[0062] In the radially expanded configuration, struts 46 can be arched radially outward, giving expandable basket 44 a generally oval shape. However, expandable basket 44 can adopt other shapes in the expanded configuration, as desired. The size and shape of expandable basket 44 can be configured such that struts 46 can interface with a collection site when expandable basket 44 is in the expanded configuration. In some cases, expandable basket 44 can be expanded until at least a portion of struts 46 contact the collection site. It is contemplated that in some cases, expandable basket 44 may not fully expand before contacting the collection site.

[0063] Once the tissue collection device 12 is deployed from the outer tubular member 14 and the expandable basket 44 is expanded, the second handle 30 can be actuated to repeatedly advance distally, retract proximally, and / or rotate the tissue collection device 12 along the target collection site. This allows the struts 46 to brush against the tissue surface to dislodge and capture cells. It is contemplated that the edges 56a, 56b of the struts 46 can be angled or sharpened to scrape the collection site. In the illustrated embodiment, for simplicity and ease of understanding, not every edge of the multiple struts 46 is labeled. In some examples, the struts 46 may also include a texture 58 on their outer and / or inner surfaces, such as, but not limited to, a rough or granular surface. The texture can be configured to release and capture cells from a stenosis. The texture 58 can be macrotextured or microtextured, as desired. In some examples, the texture 58 may include pores or modified pores having openings extending partially radially from the surface of the struts 46, such that the edges of the modified pores scrape tissue into the pores. In other examples, the struts 46 may include barbs. The barbs may extend radially inward or radially outward from the struts 46 and may be configured to further disrupt the collection site to release cells for collection. The barbs may be similar in form and function to those associated with Figure 3 Barbs 122 are shown and described. It is also contemplated that one or more of the struts 46 may include other tissue engaging features such as, but not limited to, teeth or bristles, at any location along the length of the stent 46.

[0064] The tissue collection device 12 may also include one or more optional tissue capture mechanisms 60. The tissue capture mechanism 60 may include a brush or membrane that can collect or capture cells that have been removed from the expandable basket 44. Some illustrative brushes are described in commonly assigned U.S. Patent Application No. 63 / 309,818, entitled "Tissue Sample Devices and Methods," the disclosure of which is incorporated herein by reference. It is contemplated that the tissue capture mechanism 60 may be positioned proximal to the expandable basket, distal to the expandable basket 44, or anywhere along the length of the expandable basket 44, as desired.

[0065] Once the clinician has captured cells from the target site, the inner tubular member 16 can be retracted proximally until the tissue collection device 12 is disposed within the lumen 18 of the outer tubular member 14. When the expandable basket 44 is self-expanding, proximally retracting the inner tubular member 16 can cause the basket 44 to collapse as the basket 44 is pulled into the lumen 18 of the outer tubular member 14. When the expandable basket 44 is manually expandable, the basket 44 can be moved to the collapsed configuration prior to proximally retracting the inner tubular member 16. In some embodiments, the inner tubular member 16 can include one or more windows or cutout areas to capture cells or tissue therein when the expandable basket 44 is collapsed. The windows can be similar in form and function to those associated with the expandable basket 44. Figure 4 The cutout area 234 .

[0066] Figure 3A perspective view of another illustrative tissue collection device 100 including an expandable basket 102 is shown in an expanded configuration that can be used with Figure 1 The expandable basket 102 can be used in conjunction with the system 10. The expandable basket 102 can extend from a proximal end 104 to a distal end 106 and include a plurality of longitudinally extending struts 108a-g (collectively, 108). In some embodiments, the proximal end 104 of the basket 102 can be extended proximally to a position configured to remain outside the body, allowing the tissue collection device 100 to be manipulated by actuating the proximal end 104, however, this is not required. The expandable basket 102 can include any desired number of struts 108, such as, but not limited to, one, two, three, four, five, six, seven, or more. Each strut 108 can be formed from a wire or filament. Although the struts 108 are described as being formed from a wire, the struts 108 can have any number of cross-sectional shapes, including, but not limited to, circular, square, rectangular, polygonal, oval, oblong, and the like. In other examples, the struts 108 can have a generally flat, ribbon-like shape (e.g., having a width greater than thickness). However, the struts 108 can take any desired shape. The struts 108 can be evenly spaced around the circumference of the expandable basket 102. However, this is not required. In some cases, the struts 108 may be eccentrically spaced. The expandable basket 102 may include one or more radiopaque markers positioned anywhere along its length to allow the position of the expandable basket 102 to be viewed on a fluoroscopic screen or another imaging technique.

[0067] The proximal end of the strut 108 can be secured to the proximal collar 110, and the distal end of the strut 108 can be secured to the distal collar 112. In some embodiments, the strut 108 can be formed as a single, unitary structure with the proximal collar 110 and / or the distal collar 112. For example, the strut 108 and collars 110, 112 can be cut from a single tube. It is also contemplated that the strut 108 and collars 110, 112 can be formed from the inner tubular member 16. For example, the cut tube can be the inner tubular member 16 or a separate tube, as desired. In other embodiments, one or more of the proximal and distal collars 110, 112 and the strut 108 can be formed as separate structures that are coupled together. For example, the strut 108 can be welded, brazed, soldered, bonded, etc. to the proximal and / or distal collars 110, 112. Other coupling techniques can be used as desired. It is contemplated that the coupling mechanism can depend at least in part on the materials of the strut 108 and / or collars 110, 112. When the expandable basket 102 is a separate component from the inner tubular member 16, at least one of the proximal collar 110 or the distal collar 112 can be fixedly secured to the outer surface of the inner tubular member 16, while the other of the proximal collar 110 or the distal collar 112 can be movably disposed on the inner tubular member 16 to allow radial expansion of the basket 102. In one example, the proximal collar 110 can be fixedly secured to the inner tubular member 16, while the distal collar 112 can be slidably disposed on the inner tubular member 16. In this configuration, the distal collar 112 can be moved distally to collapse the expandable basket 102 and proximally to expand the expandable basket 102. The opposite configuration is also contemplated, wherein the distal collar 112 can be fixedly secured to the inner tubular member 16, while the proximal collar 110 can be slidably disposed on the inner tubular member 16. Alternatively, the proximal loop 110 and / or the distal loop 112 can be coupled to a centrally extending tubular member 120. The tubular member 120 can be used in place of the inner tubular member 16 or in addition thereto.

[0068] The struts 108 can each include a proximal region 114a-g (collectively, 114) and a distal region 116a-g (collectively, 116). The proximal region 114 can intersect the distal region 116 at intersections 118a-g. In the expanded configuration, the proximal region 114 of the strut 108 can extend at a first angle relative to the longitudinal direction of the expandable basket 102, and the distal region 116 can extend at a second angle relative to the longitudinal direction of the expandable basket 102. The first angle can be different from the second angle.

[0069] The struts 108 can each include one or more barbs 122a-g (collectively, 122) wrapped around the strut 108. Although each strut 108 is shown as including a single barb 122, it is contemplated that each strut 108 can have more than one barb 122. It is also contemplated that some struts 108 can have no barbs 122. The struts 108 can each have the same number of barbs 122 or a different number of barbs 122, as desired. In the illustrated embodiment, the barbs 122 can be a wire wrapped or coiled around the strut 108 with a free end extending radially away from the strut 108. The free end can extend radially inward, radially outward, or a combination thereof, as desired. It is contemplated that the barbs 122 can be configured to disrupt and capture tissue from a target collection site.

[0070] The expandable basket 102 may be self-expandable or may require an external force to expand from a collapsed state. The self-expandable member may be formed from any material or structure that, when a force is applied, is compressed and, when the force is released, is expanded. Such a member may be formed from, for example, a shape memory alloy such as Nitinol, or any other self-expandable material. When such a shape memory material is employed, the expandable basket 102 may be heat-set into an expanded state and then subsequently compressed to fit within, for example, the outer tubular member 14. In another embodiment, a spring may be provided to facilitate expansion. It is contemplated that Nitinol alloys may provide for kink-resistant folding and self-expansion. In other examples, the expandable basket 102 may be formed from magnetic alloys, metals, metal alloys, polymers, composite materials, and the like.

[0071] In other cases, manual force applied to the inner tubular member 16 can manipulate or actuate the expandable basket 102 between the expanded and collapsed states. For example, the actuating element can include a center wire or rod extending through the expandable basket 102 and coupled to the distal collar 112. Alternatively, an external force, such as, but not limited to, pneumatics, compressed fluid, a pull wire, a push wire, a rod, etc., can be used to expand the expandable basket 102. According to this embodiment, applying a proximal pulling force on the wire can allow the struts 108 to expand and move the expandable basket 102 to the expanded state. Applying a distal pushing force on the wire can move and extend the struts 108 and / or otherwise transition the expandable basket 102 to the compressed or extended state. Other actuating mechanisms can also be utilized. For example, the guidewire 42 can be used to apply a proximal pushing force on the distal end of the distal collar 110. In such cases, the guidewire 42 may include an enlarged region having a diameter greater than the diameter of the lumen of the tissue collection device 100, such that proximally actuating the guidewire 42 causes the enlarged region of the guidewire 42 to contact the distal collar 110, and further proximally actuating the guidewire 42 causes the distal cannula 110 to move proximally and expand the expandable basket 102. It is contemplated that manually actuating the expandable basket 102 using a wire, rod, or the like may exert a higher force on the expandable basket 102, which may allow the basket to achieve greater engagement with the target tissue.

[0072] When the tissue collection device 100 is disposed within the outer tubular member 14, the expandable basket 102 can be constrained in a compressed, reduced diameter or delivery configuration by surrounding the outer tubular member 14 of the tissue collection device 100. In other examples, the expandable basket 102 can assume a collapsed configuration until an actuation force is applied to the expandable basket 102. In the collapsed configuration, the tissue collection device 100 generally has a smaller diameter than in the expanded, deployed configuration. The distal region 20 of the outer tubular member 14 can be positioned such that the outer tubular member 14 surrounds and covers the length of the tissue collection device 100 during delivery. The outer tubular member 14 can have sufficient hoop strength to maintain the tissue collection device 100 in its reduced diameter state.

[0073] The expandable basket 102 can be deployed in a manner similar to the expandable basket 44 described herein. In the radially expanded configuration, the struts 108 can be bent at the intersections 118 to radially expand the expandable basket 102. The expandable basket 102 can be sized and shaped such that the struts 108 can interface with a collection site when the expandable basket 102 is in the expanded configuration. In some cases, the expandable basket 102 can be expanded until at least a portion of the struts 108 contact the collection site. It is contemplated that in some cases, the expandable basket 102 may not be fully expanded before contacting the collection site.

[0074] Once the tissue collection device 100 is deployed from the outer tubular member 14 and the expandable basket 102 is expanded, the second handle 30 can be actuated to repeatedly advance distally, retract proximally, and / or rotate the tissue collection device 100 along the target collection site. This can cause the struts 108 to brush the tissue surface to dislodge and capture cells. It is contemplated that the edges of the struts 108 can be angled or sharpened to scrape the collection site. In the illustrated embodiment, for simplicity and ease of understanding, not every edge of the multiple struts 108 is labeled. In some examples, the struts 108 can also include a texture on their outer and / or inner surfaces, such as, but not limited to, a rough or granular surface. The texture can be configured to release and capture cells from the stenosis. The texture can be macrotextured or microtextured, as desired. It is also contemplated that one or more of the struts 108 can include other tissue-engaging features, such as, but not limited to, teeth or bristles, at any location along the length of the stent 108.

[0075] The tissue collection device 100 may also include one or more optional tissue capture mechanisms (not explicitly shown). The tissue capture mechanism may include a brush or membrane that can collect or capture cells that have been removed from the expandable basket 102. Some illustrative brushes are described in commonly assigned U.S. Patent Application No. 63 / 309,818, entitled "Tissue Sample Devices and Methods," the disclosure of which is incorporated herein by reference. It is contemplated that the tissue capture mechanism may be positioned proximal to the expandable basket, distal to the expandable basket 102, or anywhere along the length of the expandable basket 102, as desired.

[0076] Once the clinician has captured cells from the target site, the inner tubular member 16 can be retracted proximally until the tissue collection device 100 is disposed within the lumen 18 of the outer tubular member 14. When the expandable basket 102 is self-expanding, proximally retracting the inner tubular member 16 can cause the basket 102 to collapse as the basket 102 is pulled into the lumen 18 of the outer tubular member 14. When the expandable basket 102 is manually expandable, the basket 102 can be moved to the collapsed configuration prior to proximally retracting the inner tubular member 16. In some embodiments, the inner tubular member 16 and / or the central tubular member 120 can include one or more windows or cutout areas to capture cells or tissue therein when the expandable basket 102 is collapsed. The windows can be similar in form and function to those associated with the expandable basket 102. Figure 4 The cutout area 234 .

[0077] Figure 42 is a side view of another illustrative tissue collection device system 200 for delivering a tissue collection device 202 to a target area, such as, but not limited to, the common bile duct or pancreatic duct, in a retracted or delivery configuration. Tissue collection system 200 may include an outer or external elongated shaft or tubular member 204 and an inner elongated shaft or tubular member 206. Inner tubular member 206 may be slidably disposed within a lumen 208 of outer tubular member 204. Outer tubular member 204 may extend proximally from a distal region 210 to a proximal region (not explicitly shown) configured to remain outside the patient's body. A first hub or handle, similar in form and function to handle 24 described herein, may be coupled to the proximal region of outer tubular member 204. In some cases, a port, such as an injection port, may be provided in outer tubular member 204. Other structures may be provided to facilitate connection to other medical devices (e.g., syringes, stopcocks, Y-adapters, etc.) and provide access to lumen 208. The inner tubular member 206 can extend proximally from the distal region 212 to a proximal region (not expressly shown) configured to remain outside the patient's body. A second hub or handle (not expressly shown) can be coupled to the proximal region of the inner tubular member 206.

[0078] The outer tubular member 204 may include a lumen 208 extending from a distal region 210 to a proximal region. The lumen 208 may also extend through the first handle. The lumen 208 of the outer tubular member 204 and the first handle may be configured to slidably receive the inner tubular member 206. The inner tubular member 206 may include a lumen 214 extending from a distal region 212 to a proximal region. The lumen 214 of the inner tubular member 206 may also extend through the second handle. Optionally, the lumen 214 of the inner tubular member 206 may be configured to receive a guidewire 216. In other examples, the guidewire 216 may be received within the lumen 208 of the outer tubular member 204. It is contemplated that the system 200 may be arranged such that the guidewire 216 extends within the lumen along the entire length of the outer tubular member 204 or the inner tubular member 206 in an "over-the-wire" manner, or the guidewire 216 may exit a side port 218 in the outer tubular member 204 distal to its proximal region 22 in a "quick exchange" manner.

[0079] The tissue collection device 202 can be disposed around or formed from a portion of the inner tubular member 206 at or near the distal region 212 thereof. The tissue collection device 202 can extend around the entire circumference of the inner tubular member 206. In other embodiments, the tissue collection devices 202 can be radially spaced in a uniform pattern or eccentrically around the circumference of the inner tubular member 206, as desired. In some embodiments, the tissue collection device 202 can include a collapsed delivery configuration (not explicitly shown) and an expanded use configuration (not explicitly shown). Figure 4 ) a radially expandable frame or basket 220 that moves between the tissue collection device 202. Although the tissue collection device 202 is described as an expandable basket, it is contemplated that other tissue collection devices may be used as desired.

[0080] The expandable basket 220 may extend from a proximal region (not explicitly shown) to a distal end 222 and include a plurality of longitudinally extending struts 224a-c (collectively, 224). In some embodiments, the proximal end of the basket 220 may extend proximally to a position configured to remain outside the body, such that the tissue collection device 202 may be manipulated by actuating the proximal end, however, this is not required. The expandable basket 220 may include any desired number of struts 224, such as, but not limited to, one, two, three, four, five, six, or more. The struts 224 may have a generally flat, ribbon-like shape (e.g., having a width greater than thickness). In other examples, the struts 224 may have a generally linear shape. However, the struts 224 may take any desired shape. The struts 224 may be evenly spaced around the circumference of the expandable basket 220. However, this is not required. In some cases, the struts 224 may be eccentrically spaced. The expandable basket 220 may include one or more radiopaque markers positioned anywhere along its length to allow the position of the expandable basket 220 to be viewed on a fluoroscopic screen or another imaging technique.

[0081] The proximal end of the strut 224 can be secured to the proximal collar 226, and the distal end of the strut 224 can be secured to the distal collar 228. In some embodiments, the strut 224 can be formed as a single, unitary structure with the proximal collar 226 and / or the distal collar 228. For example, the strut 224 and the collars 226, 228 can be cut from a single tube. It is also contemplated, although not explicitly shown, that the strut 224 and the collars 226, 228 can be formed from the inner tubular member 206. For example, the cut tube can be the inner tubular member 206 or a separate tube, as desired. In other embodiments, one or more of the proximal and distal collars 226, 228 and the strut 224 can be formed as separate structures that are coupled together. For example, the strut 224 can be welded, brazed, soldered, bonded, etc. to the proximal and / or distal collars 226, 228. Other coupling techniques can be used as desired. It is contemplated that the coupling mechanism may depend, at least in part, on the material of the struts 224 and / or the collars 226, 228. When the expandable basket 220 is a separate component from the inner tubular member 206, at least one of the proximal collar 226 or the distal collar 228 may be fixedly secured to the outer surface of the inner tubular member 206, while the other of the proximal collar 226 or the distal collar 228 may be movably disposed on the inner tubular member 206 to allow radial expansion of the basket 220. In one example, the proximal collar 226 may be fixedly secured to the inner tubular member 206, while the distal collar 228 may be slidably disposed on the inner tubular member 206. In this configuration, the distal collar 228 may be moved distally to collapse the expandable basket 220 and proximally to expand the expandable basket 220. The opposite configuration is also contemplated, wherein the distal collar 228 may be fixedly secured to the inner tubular member 206 , while the proximal collar 226 may be slidably disposed on the inner tubular member 206 .

[0082] The expandable basket 220 may be self-expandable or may require an external force to expand from a collapsed state. A self-expandable member may be formed from any material or structure that, when a force is applied, is compressed and, when the force is released, is expanded. Such a member may be formed from, for example, a shape memory alloy such as Nitinol, or any other self-expandable material. When utilizing such a shape memory material, the expandable basket 220 may be heat-set in an expanded state and subsequently compressed to fit within, for example, the outer tubular member 204. In another embodiment, a spring may be provided to facilitate expansion. It is contemplated that Nitinol alloys may provide for kink-resistant folding and self-expansion. In other examples, the expandable basket 220 may be formed from magnetic alloys, metals, metal alloys, polymers, composite materials, and the like.

[0083] In other cases, manual force applied to the inner tubular member 206 can manipulate or actuate the expandable basket 220 between the expanded and collapsed states. For example, the actuating element can include a center wire or rod extending through the expandable basket 220 and coupled to the distal collar 228. Alternatively, an external force, such as, but not limited to, pneumatics, compressed fluid, a pull wire, a push wire, a rod, etc., can be used to expand the expandable basket 220. According to this embodiment, a proximal pulling force applied to the wire can expand the struts 224 and move the expandable basket 220 to the expanded state. A distal pushing force applied to the wire can extend the struts 224 and / or otherwise transition the expandable basket 220 to the compressed or extended state. Other actuating mechanisms can also be utilized. For example, the guidewire 216 can be used to apply a proximal pushing force to the distal end of the distal collar 226. In such cases, the guidewire 216 may include an expanded region having a diameter greater than the diameter of the lumen of the tissue collection device 202, such that proximally actuating the guidewire 216 causes the expanded region of the guidewire 216 to contact the distal collar 226, and further proximally actuating the guidewire 216 causes the distal cannula 226 to move proximally and expand the expandable basket 220. It is contemplated that manually actuating the expandable basket 220 using a wire, rod, or the like may exert a higher force on the expandable basket 220, which may allow the basket to achieve greater engagement with the target tissue.

[0084] When the tissue collection device 202 is disposed within the outer tubular member 204, the expandable basket 220 can be constrained in a compressed, reduced diameter or delivery configuration by the outer tubular member 204 surrounding the tissue collection device 202. In other examples, the expandable basket 220 can assume a collapsed configuration until an actuation force is applied to the expandable basket 220. In the collapsed configuration, the tissue collection device 202 can have a smaller diameter than in the expanded, deployed configuration. The distal region 210 of the outer tubular member 204 can be positioned such that the outer tubular member 204 surrounds and covers the length of the tissue collection device 202 during delivery. The outer tubular member 204 can have sufficient hoop strength to retain the tissue collection device 202 in its reduced diameter state.

[0085] As needed, the tissue collection system 200 can be advanced through the body toward the target site. The tissue collection system 200 can be advanced with or without the use of a guidewire 216. Once the tissue collection device 202 is positioned near the target area, the restraining force holding the tissue collection device 202 in the radially compressed configuration can be removed to deploy the tissue collection device 202.

[0086] The tissue collection device 202 can be deployed by actuating the second handle, for example, by pushing the second handle distally, while maintaining the first handle in a fixed position. As a result, the inner tubular member 206 can be advanced distally relative to the outer tubular member 204. In other words, the inner tubular member 206 can be advanced distally while the outer tubular member 204 remains stationary. The opposite configuration is also contemplated. For example, the outer tubular member 204 can be retracted proximally while the inner tubular member 206 remains stationary. As the inner tubular member 206 is advanced distally, the biasing force is removed from the exterior of the tissue collection device 202, and the expandable basket 220 can assume its radially expanded, unbiased deployed configuration, as shown in FIG. Figure 4 Alternatively, the expandable basket 220 may remain collapsed until an actuation force is applied to the expandable basket 220 (eg, using a pull wire or other actuation mechanism) to move the expandable basket 220 to the radially expanded deployed configuration.

[0087] In the radially expanded configuration, the struts 224 can flex radially outward such that the proximal and distal regions of the expandable basket 220 extend at non-parallel angles relative to the longitudinal axis of the expandable basket 220, and the intermediate region extends generally parallel to the longitudinal axis of the expandable basket 220. However, the expandable basket 220 can adopt other shapes in the expanded configuration as desired. The expandable basket 220 can be sized and shaped such that the struts 224 can interface with a collection site when the expandable basket 220 is in the expanded configuration. In some cases, the expandable basket 220 can be expanded until at least a portion of the struts 224 contact the collection site. It is contemplated that in some cases, the expandable basket 220 may not fully expand before contacting the collection site.

[0088] Once the tissue collection device 202 is deployed from the outer tubular member 204 and the expandable basket 220 is expanded, the second handle can be actuated to repeatedly advance distally, retract proximally, and / or rotate the tissue collection device 202 along the target collection site. This can cause the struts 224 to brush the tissue surface to dislodge and capture cells. It is contemplated that the edges 230a, 230b of the struts 224 can be angled or sharpened to scrape the collection site. In the illustrated embodiment, for simplicity and ease of understanding, not every edge of the plurality of struts 224 is labeled. In some examples, the struts 224 can also include a texture on their outer and / or inner surfaces, such as, but not limited to, a rough or granular surface. The texture can be configured to release and capture cells from the stenosis. The texture can be a macrotexture or a microtexture, as desired. In other examples, the struts 224 can include barbs. The barbs can extend radially inward or radially outward from the struts 224 and can be configured to further disrupt the collection site to release cells for collection. The barbs can be similar in form and function to those associated with Figure 3Barbs 122 are shown and described. It is also contemplated that one or more of the struts 224 may include other tissue engaging features such as, but not limited to, bristles, at any location along the length of the strut 224.

[0089] The struts 224 may also include one or more teeth 232a-c (collectively, 232) extending from one or more of the struts 224. The teeth 232 may be formed as a single, integral structure with the struts 224. For example, the struts 224 and teeth 232 may be formed from a cut tube, wherein the struts 224 and teeth 232 are formed by cutting regions from the tube. The teeth 232 may be coupled to the struts 224 at their first ends and extend to free ends. The free ends may be sharpened to engage tissue at the collection site. However, this is not required. In some embodiments, the free ends may be rounded or have another form, as desired. While each strut 224 is shown as including three teeth 232, it is contemplated that the struts 224 may include fewer than three or more than three teeth 232, as desired. In some examples, one or more of the struts 224 may lack teeth 232. It is also contemplated that the struts 224 may have different numbers of teeth 232 from one another. Furthermore, while the teeth 232 are shown as being located in a mid-region of the strut 224, the teeth 232 may be positioned anywhere along the length of the strut 224 as desired.

[0090] The tissue collection device 202 may also include one or more optional tissue capture mechanisms (not explicitly shown). The tissue capture mechanism may include a brush that collects or captures cells that have been removed from the expandable basket 220. Some illustrative brushes are described in commonly assigned U.S. Patent Application No. 63 / 309,8208, entitled "Tissue Sample Devices and Methods," the disclosure of which is incorporated herein by reference. It is contemplated that the tissue capture mechanism may be positioned proximal to the expandable basket, distal to the expandable basket 220, or anywhere along the length of the expandable basket 220, as desired.

[0091] Once the clinician has captured cells from the target site, the inner tubular member 206 can be retracted proximally until the tissue collection device 202 is disposed within the lumen 208 of the outer tubular member 204. When the expandable basket 220 is self-expanding, proximally retracting the inner tubular member 206 can cause the basket 220 to collapse as the basket 220 is drawn into the lumen 208 of the outer tubular member 204. When the expandable basket 220 is manually expandable, the basket 220 can be moved to a collapsed configuration before proximally retracting the inner tubular member 206. In some embodiments, the inner tubular member 206 can include one or more windows or cutout areas 234 to capture cells or tissue therein when the expandable basket 220 is collapsed. The cutout areas 234 can be generally aligned with the tissue collection device 202 such that when the tissue collection device 202 is collapsed or retracted, the collapsed tissue collection device 202 draws cells or tissue into the cutout areas 234. In some embodiments, teeth 232 may also be placed within the incision area 234. It is contemplated that the guidewire 216 may be removed from the lumen 214 of the inner tubular member 206 prior to collapsing the expandable basket 220 to allow more tissue or cells to be drawn into the incision area 234.

[0092] Figure 5 is used Figures 1 to 4 10. An illustrative flow chart of a method 300 for collecting a tissue sample using a tissue collection system 10, 200 and / or tissue collection device 12, 100, 202 is provided. First, the tissue collection system 10, 200 may be advanced to a target location within the body, as shown at block 310. In some embodiments, the tissue collection system 10, 200 may be advanced through a working channel of an endoscope, with its distal end positioned near the target location. For example, to obtain a sample from the common bile duct, the endoscope may be advanced through the esophagus, through the stomach, and into the duodenum. The tissue collection system 10, 200 may be positioned within the endoscope while the endoscope is positioned, or may be subsequently advanced through the endoscope. The guidewire 42, 216 of the tissue collection system 10, 200 may then be advanced distally to cannulate the common bile duct. The inner tubular member 16, 206 may then be advanced distally over the guidewire to deploy the tissue collection device 12, 100, 202, as shown at block 320. As described above, the inner tubular member 16, 206 can be advanced distally when the outer tubular member 14, 204 is stationary, so that the tissue collection device 12, 100, 202 leaves the outer tubular member 14, 204. It is conceivable that when the guide wire 42, 216 is centrally located within the tissue collection system 10, 200, the inner tubular member 16, 206 may not be biased to one side as in a tissue collection system that advances a brush through a channel separate from the guide wire. The coaxial arrangement of the guide wire 42, 216 and the inner tubular member 16, 206 can allow the tissue collection device to easily pass through the ampulla, bends, and stenosis. In other examples, the tissue collection system 10, 200 and / or the tissue collection device 12, 100, 202 can be attached to one side of the endoscope.

[0093] Once the tissue collection device 12, 100, 202 is positioned at the target location, the inner tubular member 16, 206 can be actuated (e.g., using the second handle 30) back and forth (e.g., proximally and distally) to drag the struts 46, 18, 208, 224 along the collection site to collect cells, as shown at block 330. In some cases, the inner tubular member 16, 206 can be rotated in addition to or in lieu of the proximal and distal movements. Once the sample has been collected, the inner tubular member 16, 206 can be retracted proximally to pull the tissue collection device 12, 100, 202 back into the lumen 18, 208 of the outer tubular member 14, 204, as shown at block 340. The tissue collection system 10, 200 can be removed from the body, as shown at block 350. The inner tubular member 16 , 206 may then be cut (eg, using a wire cutter or other cutting device) at a location proximal to the tissue collection device 12 , 100 , 202 so that the tissue collection device 12 , 100 , 202 may be placed into a sample container, as shown at block 360 .

[0094] The materials that can be used for the various components and various elements of the medical device systems 10, 200 (and / or other systems disclosed herein) disclosed herein may include those commonly associated with medical devices. For simplicity, the following discussion refers to the tissue collection system 10, 200 and / or the tissue collection device 12, 100, 202. However, this is not intended to limit the devices and methods described herein, as the discussion is applicable to other elements, components, parts or devices disclosed herein, such as, but not limited to, the inner and outer tubular members 16, 206, 14, 204, the handles 24, 30, the guide wire 42, 216, etc. and / or their elements or parts.

[0095] In some embodiments, the tissue collection system 10, 200 and / or tissue collection device 12, 100, 202 and / or components thereof may be made of metal, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or the like, or other suitable materials.

[0096] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxyethylene (POM, e.g., commercially available from DuPont), ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., commercially available from DSM Engineering Plastics ), ether- or ester-based copolymers (e.g., butylene phthalate / poly(alkylene ether) and / or other polyester elastomers such as those commercially available from DuPont ), polyamides (e.g., commercially available from Bayer or commercially available from Elf Atochem ), elastomeric polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name Commercially available), ethylene-vinyl acetate copolymer (EVA), silicone resin, polyethylene (PE), High-density polyethylene, Low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., ), polysulfone, nylon, nylon-12 (such as commercially available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc. thereof.

[0097] Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steel; low carbon steel; nickel titanium alloys, such as linear elastic and / or superelastic nitinol; other nickel alloys, such as nickel chromium molybdenum alloys (e.g., UNS: N06625, such as 625, UNS:N06022, such as UNS:N10276, such as other alloys, etc.), nickel copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as ALLOY ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.); platinum-rich stainless steel; titanium; combinations thereof; etc.; or any other suitable material.

[0098] As mentioned herein, within the family of commercially available nickel-titanium or Nitinol alloys, there is a class designated as "linear elastic" or "non-superelastic," which, while chemically similar to traditional shape memory and superelastic classes, may also exhibit different and useful mechanical properties. Linear elastic and / or non-superelastic Nitinol can be distinguished from superelastic Nitinol in that linear elastic and / or non-superelastic Nitinol does not exhibit a significant "superelastic plateau" or "flag region" in its stress / strain curve as superelastic Nitinol does. Rather, in linear elastic and / or non-superelastic Nitinol, as recoverable strain increases, stress continues to increase in a substantially linear or somewhat, but not necessarily completely, linear relationship until plastic deformation begins or at least proceeds in a more linear relationship than the superelastic plateau and / or flag region that may be seen with superelastic Nitinol. Therefore, for the purposes of the present invention, linear elastic and / or non-superelastic Nitinol may also be referred to as "substantially" linear elastic and / or non-superelastic Nitinol.

[0099] In some cases, linear elastic and / or non-superelastic nitinol can also be distinguished from superelastic nitinol because linear elastic and / or non-superelastic nitinol can accept strains up to about 2-5% while remaining substantially elastic (e.g., before plastic deformation), while superelastic nitinol can accept strains up to about 8% before plastic deformation. Both of these materials can be distinguished from other linear elastic materials, such as stainless steel (which can also be distinguished based on its composition), which can accept strains of only about 0.2 to 0.44% before plastic deformation.

[0100] In some embodiments, linear elastic and / or non-superelastic nitinol is an alloy that does not exhibit any martensite / austenite phase transformation detectable by differential scanning calorimetry (DSC) and dynamic metallographic thermal analysis (DMTA) over a wide temperature range. For example, in some embodiments, there may be no martensite / austenite phase transformation detectable by DSC and DMTA analysis in a linear elastic and / or non-superelastic nitinol alloy within the range of about −60 degrees Celsius (° C.) to about 120° C. Therefore, the mechanical bending properties of such materials are generally inert to temperature effects within this temperature range. In some embodiments, the mechanical bending properties of linear elastic and / or non-superelastic nitinol alloys at ambient or room temperature are substantially the same as their mechanical properties at, for example, body temperature because they do not exhibit superelastic plateaus and / or flag regions. In other words, over a wide temperature range, linear elastic and / or non-superelastic nitinol alloys maintain their linear elastic and / or non-superelastic characteristics and / or properties.

[0101] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being primarily titanium. In some embodiments, the composition contains nickel in the range of about 54 to about 57 weight percent. An example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa TechnoMaterial Co. of Kanagawa, Japan. Other suitable materials include ULTANIUM TM (available from Neo-Metrics) and GUMMETAL TM (Available from Toyota.) In some other embodiments, superelastic alloys, such as superelastic Nitinol, may be used to achieve the desired properties.

[0102] In at least some embodiments, some or all of the tissue collection system 10, 200 and / or tissue collection device 12, 100, 202 and / or its components may also be doped with, made of, or otherwise include radiopaque materials. Radiopaque materials should be understood as materials that are capable of producing a relatively bright image on a fluorescent screen or with another imaging technique during a medical procedure. This relatively bright image helps the user of the tissue collection system 10, 200 and / or tissue collection device 12, 100, 202 determine its position. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of the tissue collection system 10, 200 and / or tissue collection device 12, 100, 202 to achieve the same result.

[0103] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the tissue collection system 10, 200 and / or tissue collection device 12, 100, 202. For example, the tissue collection system 10, 200 and / or tissue collection device 12, 100, 202 and / or components or portions thereof can be made of a material that does not substantially distort the image and create a substantial amount of artifacts (i.e., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in the MRI image. The tissue collection system 10, 200 and / or tissue collection device 12, 100, 202 or portions thereof can also be made of a material that can be imaged by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), Nitinol, etc.

[0104] In some embodiments, the outer surface of the medical device system 10 (including, for example, the outer surface of the delivery system) can be sandblasted, bead blasted, sprayed with sodium bicarbonate, electropolished, etc. In these and other embodiments, a coating can be applied over part or all of the outer sheath, for example, a lubricity, hydrophilicity, protectiveness or other type of coating, or in some embodiments, there is no outer sheath over part of the delivery system or other parts of the medical device system 10. Hydrophobic coatings, such as fluoropolymers, provide dry lubricity, which improves the handling of the device and the exchange of the device. Lubricity coatings improve steerability and improve lesion penetration ability. Suitable lubricity polymers are well known in the art and can include silicones, etc., hydrophilic polymers, such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinyl pyrrolidone, polyvinyl alcohol, hydroxyalkyl cellulose, algae, sugars, caprolactone, etc., and mixtures and combinations thereof. Hydrophilic polymers can be mixed with each other or with a formulated amount of water-insoluble compounds (including some polymers) to produce a coating with appropriate lubricity, adhesion and solubility.

[0105] The coating and / or sheath can be formed, for example, by coating, extrusion, co-extrusion, interrupted layer co-extrusion (ILC), or fusing several segments end to end. The layer can have a uniform stiffness or a gradually decreasing stiffness from its proximal end to its distal end. The gradual decrease in stiffness can be continuous, as formed by ILC, or can be stepped, as formed by fusing together separate extruded tubular segments. The outer layer can be impregnated with a radiopaque filler material to facilitate radiographic visualization. Those skilled in the art will recognize that these materials can vary widely without departing from the scope of the invention.

[0106] It should be understood that the present invention is in many respects merely illustrative. Changes may be made in the details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the invention. To the extent appropriate, this may include employing any of the features of one example embodiment in other embodiments. The scope of the invention is, of course, defined by the language of the appended claims.

Claims

1. A tissue collection system, comprising: an outer tubular member having a proximal region and a distal region and defining a lumen extending from the proximal region to the distal region; an inner tubular member slidably disposed within the lumen of the outer tubular member, the inner tubular member defining a lumen extending from a proximal region to a distal region of the inner tubular member; as well as a tissue collection device disposed proximate the distal region of the inner tubular member, the tissue collection device comprising an expandable basket; The tissue collection device is movable between a retracted delivery position and an extended sample collection position.

2. The tissue collection system of claim 1, wherein the expandable basket comprises a plurality of longitudinally extending struts.

3. The tissue collection system of claim 2, wherein one or more edges of at least one of the plurality of struts have a sharp surface.

4. The tissue collection system of any one of claims 2 to 3, wherein a surface of at least one strut of the plurality of struts is textured.

5. The tissue collection system of any one of claims 2 to 4, further comprising one or more barbs coupled to at least one of the plurality of struts.

6. The tissue collection system of claim 5, wherein the one or more barbs comprise a wire wrapped around the at least one strut.

7. The tissue collection system of claim 6, wherein at least one free end of the wire extends radially from the at least one strut.

8. The tissue collection system of any one of claims 2 to 7, further comprising one or more teeth extending from at least one strut.

9. The tissue collection system of claim 8, wherein the one or more teeth are formed as a single unitary structure with the at least one strut.

10. The tissue collection system of any one of claims 2 to 9, wherein the plurality of struts comprises a plurality of individual filaments coupled to one another at their respective proximal and distal ends.

11. The tissue collection system of any one of claims 1 to 9, wherein the tissue collection device comprises a cutting tube.

12. The tissue collection system according to any one of claims 1 to 9 or 11, wherein the tissue collection device is a unitary structure with the inner tubular member.

13. The tissue collection system of any one of claims 1 to 11, wherein the tissue collection device is coupled to the inner tubular member.

14. The tissue collection system of any one of claims 1 to 13, wherein the tissue collection device is self-expanding.

15. The tissue collection system of any one of claims 1 to 13, further comprising an actuation mechanism coupled to a proximal end or a distal end of the tissue collection device.

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