A system for real-time visualization of biopsy needles and target tissues

Abstract

The present disclosure relates to the field of endoscopy. In particular, the present disclosure relates to systems and methods for real-time visualization of target tissue, which allows the position / orientation of a biopsy needle to be determined before its first actuation.

Description

[0001] This application is a divisional application of application number 201780073632.2, filed on December 6, 2017, entitled "System for Real-time Visualization of Biopsy Needles and Target Tissue".

[0002] Cross-reference to related applications

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 430,987, filed December 7, 2016, the entire contents of which are incorporated herein by reference for all purposes. Technical Field

[0004] This disclosure relates to the field of endoscopy. In particular, this disclosure relates to systems and methods that allow for real-time visualization of target tissue and enable efficient and accurate positioning / orientation of the biopsy needle prior to initial actuation and sample collection. Background Technology

[0005] When clinical presentation indicates that a tissue biopsy within the lung access is necessary, radial endobronchial ultrasound (R-EBUS) offers a minimally invasive option. Traditional R-EBUS transbronchial needle aspiration (TBNA) involves delivering a radial ultrasound probe through the working channel of the bronchoscope to the target airway, visualizing the target lung nodule on the R-EBUS, locking the insertion cannula, removing the radial ultrasound probe from the cannula, and then blindly advancing the biopsy needle to obtain cellular material for cytological evaluation. Visualizing the biopsy needle only after the tissue sampling procedure has begun often results in the needle completely missing the target nodule. To ensure successful biopsy of the target nodule, healthcare professionals typically actuate the biopsy needle into the lung tissue multiple times while rotating the bronchoscope. This repeated actuation of the biopsy needle can lead to a variety of negative medical outcomes, including unnecessary trauma to healthy tissue, excessive bleeding, pleural sac perforation (e.g., pneumothorax), vascular perforation, increased procedure duration and / or cost, and potential misdiagnosis (e.g., false negatives).

[0006] Tissue sampling systems that allow medical professionals to visualize the biopsy needle and target tissue in real time before the first needle aspiration may have clinical advantages, especially in the field of pulmonary endoscopy. Summary of the Invention

[0007] This disclosure offers advantages in various aspects of the medical field, such as the field of pulmonary endoscopy, for a sampling system that allows for real-time visualization of pulmonary nodules, and that allows the biopsy needle to be effectively and accurately located / oriented before initial actuation and sample collection.

[0008] In one aspect, this disclosure relates to an apparatus comprising a first assembly having a proximal end, a distal end, and a lumen extending therebetween, and a tissue sampling element attached to the distal end of the first assembly. The proximal end of the first assembly may include a recessed portion. The tissue sampling element may include, for example, a biopsy needle. The tissue sampling element may include a substantially linear configuration. The tissue sampling element is movable between a substantially linear configuration and a substantially curved configuration.

[0009] In another aspect, this disclosure relates to a system comprising a first assembly having a proximal end, a distal end, and a lumen extending therebetween, and a second assembly having a proximal end, a distal end, and a lumen extending therebetween. The proximal end of the first assembly is removably attached to the distal end of the second assembly to form a continuous lumen. An ultrasonic catheter may extend through the continuous lumens of the first and second assemblies. An outer tube may be slidably disposed around the first assembly, the second assembly, and the ultrasonic catheter. The ultrasonic catheter may include an ultrasonic probe slidably disposed within a sheath that forms an interference fit with the lumen of the second assembly. A tissue sampling element may be attached to the distal end of the first assembly. The proximal end of the first assembly may include a recessed portion configured to receive a post extending from the distal end of the second assembly. The post of the second assembly may form an interference fit with the recessed portion of the first assembly. When the post is disposed within the recessed portion, the lumen of the first assembly may be aligned with the lumen of the second assembly to form a continuous lumen. A portion of the sheath may extend distally beyond the ultrasonic probe. A portion of the sheath may include a braided material. The braided material may extend along the proximal portion of the ultrasonic probe. The portion of the cannula extending distally beyond the ultrasound probe may include a non-woven material. The cannula may include a proximal end, a distal end, and an inner lumen extending therebetween. The inner lumen of the cannula may include a first diameter portion and a second diameter portion. The system may also include a delivery device comprising a working channel configured to slidably receive the outer tube. The proximal end of the ultrasound probe may be connected to a motor drive unit. The system may also include a delivery device comprising a working channel configured to slidably receive the outer tube.

[0010] In another aspect, this disclosure relates to a method comprising: advancing a tissue sampling system through a body channel, wherein the tissue sampling system includes first and second components removably disposed around an ultrasonic catheter and interlocked; imaging target tissue within the body channel using the ultrasonic catheter; advancing the tissue sampling system such that a portion of the first component penetrates the target tissue; and removing the tissue sampling system from the body channel. The method may further include: rotating the tissue sampling system to align the first component with the target tissue before advancing the tissue sampling system. The tissue sampling system can image the target tissue while advancing. Attached Figure Description

[0011] Non-limiting examples of this disclosure have been described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, identical or substantially identical components are generally represented by a single number. For clarity, not every component is labeled in every figure, and not every component of every embodiment of this disclosure is shown; such depiction is not essential for those skilled in the art to understand this disclosure. In the drawings:

[0012] Figure 1 A schematic diagram of an tissue sampling system according to an embodiment of the present disclosure is provided.

[0013] Figure 2 A schematic diagram of the distal portion of an ultrasonic catheter according to one embodiment of the present disclosure is provided.

[0014] Figure 3 A schematic diagram of a connector assembly according to one embodiment of the present disclosure is provided.

[0015] Figures 4A-4B An embodiment of the present disclosure is provided, including a straight ( Figure 4A ) or curved ( Figure 4B A schematic diagram of the sampling component of the tissue acquisition element.

[0016] Figure 5 An enlarged schematic diagram of a connector assembly and a sampling assembly interlocked to an ultrasonic catheter, according to one embodiment of the present disclosure, is provided.

[0017] Figure 6 A schematic diagram of the distal portion of an outer tube according to an embodiment of the present disclosure is provided.

[0018] Figures 7A-7F The steps involved in sampling a lung nodule are shown according to one embodiment of the present disclosure.

[0019] Figures 8A-8C The steps involved in removing a tissue sample from a tissue collection element according to one embodiment of the present disclosure are illustrated.

[0020] It should be noted that the accompanying drawings are intended to depict only typical or exemplary embodiments of the invention. Therefore, the drawings should not be considered as limiting the scope of this disclosure. The disclosure will now be described in more detail with reference to the accompanying drawings. Detailed Implementation

[0021] Before proceeding with a further detailed description of the invention, it should be understood that the invention is not limited to the specific embodiments described and is therefore subject to variation. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope beyond the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. Finally, although embodiments of the disclosure are described specifically with reference to real-time visualization and sampling of lung nodules, the systems and methods disclosed herein can be used to obtain biopsy samples from various body cavities, including, for example, the heart, vascular system, circulatory system, gastrointestinal (GI) tract, stomach, esophagus, genitourinary system, etc.

[0022] As used herein, the singular forms “a” and “the” are also intended to include the plural forms, unless the context clearly indicates otherwise. It should be further understood that the terms “comprising” and / or “including” as used herein specify the presence of the stated feature, region, step element, and / or component, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups thereof.

[0023] As used herein, the term "distal" refers to the end furthest from a medical professional when the device is introduced into the patient, while the term "proximal" refers to the end closest to a medical professional when the device is introduced into the patient.

[0024] This disclosure generally provides a tissue sampling system including a sampling assembly reversibly (e.g., removably) connected to an ultrasound catheter via a keying or press-fit interaction with a connector assembly attached to the outer surface of an ultrasound catheter. The coupling geometry of the connector assembly and the sampling assembly prevents rotation and / or translation of the sampling assembly relative to the ultrasound catheter and provides a fixed alignment, allowing healthcare professionals to know in which quadrant of the radial ultrasound image the sampling assembly will appear relative to the target nodule prior to each tissue sampling step.

[0025] Reference Figure 1In one embodiment, this disclosure provides a tissue sampling system 100 including a first component 110 (e.g., a sampling component) and a second component 120 (e.g., a connector component) disposed around an ultrasonic catheter 130 (e.g., a radial ultrasonic catheter). The first component 110 may further include a tissue sampling element 118 (e.g., a biopsy needle, a fine aspiration needle, a biopsy brush, etc.) extending from a distal end 124. An outer tube 150 may be slidably disposed around the ultrasonic catheter 130 and the first and second components 110, 120. The ultrasonic catheter 130 may include an ultrasonic transducer 136 disposed at a distal end 132 of an ultrasonic probe 138 (e.g., a radial ultrasonic probe). The ultrasonic transducer 136 and the ultrasonic probe 138 are slidably disposed within a cannula 140, the cannula 140 including a proximal end (not shown), a distal end 144, and an inner lumen 146 extending therebetween. The proximal end (not shown) of the ultrasound probe 138 may be attached to a motor drive unit (MDU) configured to advance (e.g., move distally) and retract (e.g., move proximally) the ultrasound probe 138 and the ultrasound transducer 136 within a retaining sleeve 140. The sleeve 140 may be formed of a variety of materials that provide the necessary mechanical properties for navigation through narrow and tortuous body passages.

[0026] In various embodiments, the positioning of the first and second assemblies 110, 120 around the ultrasound catheter 130, due to the close proximity of the tissue sampling element 118 to the ultrasound transducer 136, provides significant advantages over conventional tissue sampling systems. Specifically, due to the generation (e.g., in real-time) of radial ultrasound images of the target tissue, configurations such as those depicted allow the tissue sampling element 118 to be positioned close to the target tissue (e.g., within 5 cm or less). This close proximity to the target tissue allows the tissue sampling element 118 to be significantly shorter than conventional biopsy needles. For example, a conventional lung biopsy needle may be 50 cm or longer, but the tissue sampling element of this disclosure may be less than 25 cm in length (e.g., 20 cm or less, 15 cm or less, 10 cm or less, 5 cm or less, 2.0 cm or less). The significantly shorter length of the tissue sampling element 118 allows for lower manufacturing costs and also allows for more reliable and accurate sampling of the target tissue.

[0027] like Figure 2As shown, the portion of the cannula 140 extending proximally from the ultrasonic transducer 136 may include a braided material 140a (e.g., interwoven strands of flexible polymers, carbon fibers, metals, and / or textile materials, etc.) providing enhanced stiffness (e.g., maneuverability) and torsion to allow the ultrasonic conduit 130 attached to the cannula 140, along with the first and second components, to be advanced distally within the outer tube and retracted proximally through the outer tube by actuation (e.g., pushing and pulling) of the proximal end (not shown) of the cannula 140. Alternatively, the portion of the cannula 140 extending distally beyond the ultrasonic transducer 136 may include a non-braided material 140b (e.g., transparent plastic, silicone, and / or rubber materials, etc.) that does not affect the quality of the ultrasonic image and visualization of the target nodule, while simultaneously providing a conduit through which a suitable fluid (e.g., isotonic saline, etc.) can be intermittently flushed to continuously and reliably propagate ultrasonic energy. The unwoven material 140b also provides sufficient flexibility and / or deformability to bend or deflect during the tissue collection step, allowing the tissue sampling element to pierce the target nodule without obstruction or hindrance.

[0028] In one embodiment, the portion of the cannula 140 extending distally beyond the ultrasonic transducer 136 may include a “strip” of hyperechoic (e.g., radiopaque) material that appears as a dark portion (e.g., a slice) on a radial ultrasound image. For example, the hyperechoic material may include a suitable powdered material (e.g., barium sulfate, etc.) mixed into the polymeric material constituting the cannula 140 prior to the extrusion process. Alternatively, the hyperechoic material may include a thin strip of metallic material (e.g., copper, brass, stainless steel, etc.) embedded or otherwise adhered and / or secured to the portion of the cannula 140 extending distally beyond the ultrasonic transducer 136. Because the first assembly 110 and the cannula 140 are fixed to each other in both axial and rotational directions, and the orientation of the ultrasonic catheter 130 is rotationally fixed relative to the first assembly 110, the location of the hyperechoic strip on the radial ultrasound image allows a medical professional to identify the relative position of the tissue sampling element 118, even when the tissue sampling element is located behind (e.g., proximal to) the ultrasonic transducer 136. For example, a "strip" of hyperechoic material can be positioned on the portion of the cannula 140 directly opposite (e.g., offset by 180 degrees) the tissue sampling element. While visualizing radial ultrasound images, the outer tube 150 of the tissue sampling system 100 can be rotated in real time to position the "strip" of hyperechoic material directly opposite the target nodule before advancing the ultrasound probe distally to deliver the tissue sampling element 118 into the target nodule.

[0029] Figure 3 Provided Figure 1A schematic diagram of the isolation of the second component 120. The second component 120 may include a proximal end 122, a distal end 124, and an inner lumen 126 extending therebetween. The second component 120 may also include a post 128 (e.g., arm, tab, etc.) extending from the distal end 124. Figure 4A Provided Figure 1 A schematic diagram of the isolation of the first component 110. The first component 110 may include a proximal end 112, a distal end 114, and an inner cavity 116 extending therebetween. The proximal end 112 may include a recessed portion 113 (e.g., a pouch, etc.) configured to receive a post 128 of the second component 120 by keying or press-fitting, thereby interlocking the first and second components 110, 120 together. Figure 5 In some embodiments, the recessed portion 113 may be a through lumen extending from the proximal end of the first component 110 to the proximal end of the sampling element 118 to provide a continuous lumen from which a sample can be extracted once acquired, as further described below. The first component 110 may also include a substantially straight tissue sampling element 118 (e.g., biopsy needle, fine aspiration needle, biopsy brush, etc.) extending from the distal end 124 for sampling concentric target nodules. Alternatively, as Figure 4B As shown, the first component 110 may include a tissue sampling element 118 configured to move from a straight configuration to a curved configuration as it is advanced distally beyond the outer tube and released from the constraints of the outer tube for sampling an eccentric target nodule. Figure 4A and Figure 4B The tissue sampling element can be embedded into the material forming the first component, for example, during polymer co-extrusion, and / or fixed using a suitable resin, adhesive, or epoxy resin. Alternatively, the tissue sampling element 118 can be removed from the first component after tissue collection to remove the sample using another device as described below.

[0030] Reference Figure 5 By advancing (e.g., sliding) the ultrasound catheter through the lumen 126 of the second component 120, the second component 120 can be attached to the distal portion of the cannula 140 of the ultrasound catheter 130 to form an interference fit between the outer surface of the cannula 140 and the inner surface of the lumen 126. The interference fit between the second component 120 and the outer surface of the cannula 140 is strong enough to prevent the second component from moving axially and / or rotating along the ultrasound catheter 130 during the medical procedure, but weak enough for a medical professional to be able to access the catheter by using a single...

[0031] (Or both) hands simultaneously apply twisting and pulling / pushing forces to move (e.g., reposition) or remove (e.g., disassemble or detach) the second component 120. Alternatively, the second component 120 may be permanently fixed to the cannula 140 of the ultrasonic catheter 130 by suitable welding, brazing, soldering, adhesives, glues and / or resins. Still refer to Figure 5Since the second component 120 is securely attached to the ultrasonic catheter 130, the first component 110 can be advanced over the distal portion of the ultrasonic catheter 130 such that the recessed portion 113 of the first component 110 receives and forms an interference fit with the post 128 of the second component 120. The interference fit between the recessed portion 113 and the post 128 establishes a reversible interlock that properly aligns and couples the first and second components 110, 120 to prevent radial and / or axial movement of the first component 110 relative to the cannula 140 of the ultrasonic catheter 130 throughout the medical procedure. Rotational and / or axial movement of the first component 110 along and / or around the cannula 140 of the ultrasonic catheter 130 can be further limited by frictional forces between the outer surface of the cannula 140 and the inner wall of the lumen 116. As described above, the interference fit between the first component 110, the second component 120, and the ultrasound catheter 130 (e.g., the outer surface of the cannula 140) is strong enough to prevent the first component from moving axially and / or rotating along the ultrasound catheter 130 during a medical procedure (e.g., inside the patient's body), but weak enough to allow a medical professional to remove or detach the first component 110 from the second component 120 and the ultrasound catheter 130 by applying sufficient force (e.g., torsional and / or pulling force) with one (or two) hands.

[0032] Reference Figure 6 In one embodiment, the outer tube 150 may include a proximal end (not shown), a distal end 154, and a variable-diameter lumen extending therebetween. For example, the distal portion of the outer tube 150 may include a lumen having a first diameter 156a configured to receive and protect (e.g., assemble) the second assembly 120, the first assembly 110, and the ultrasound catheter 130. The remainder of the outer tube 150 may have a second diameter 156b, smaller than the first diameter 156a, configured to slidably receive the ultrasound catheter. The smaller second diameter 156b may provide increased wall thickness to the outer tube 150 to improve maneuverability, maneuverability, and resistance to bending and / or kinking. Alternatively or additionally, the smaller diameter second diameter 156b may constrain the ultrasound catheter along its length to prevent excessive bending of the ultrasound catheter within the outer tube as the tissue sampling system advances through narrow and tortuous body passages. The outer tube 150 may be formed of a variety of materials that provide the necessary mechanical properties (e.g., stiffness, maneuverability, flexibility, torsion) to navigate through curved body channels without bending, kinking, and / or breaking. The outer tube 150 may also include one or more braided materials (e.g., interwoven strands of flexible polymers, carbon fibers, metals, and / or textile materials) to provide enhanced stiffness, torsion, and / or flexibility along all (or a portion) of the outer tube. The outer tube may have an outer diameter.

[0033] 158, which is configured to pass through the working channel of a conventional bronchoscope (e.g., approximately 2.0 mm to approximately 4.0 mm). The outer tube 150 is by no means limited to a dual-diameter lumen, but may include various lumen diameters, including but not limited to a single-diameter lumen, a tapered diameter lumen, etc.

[0034] Reference Figures 7A-7F In use, and as an example, the bronchoscope 2 can advance through the trachea and enter the bronchial passage near the target lung nodule. Figure 7A Depending on the type of lung nodule visualized via bronchoscopy (e.g., concentric or eccentric), an appropriate first component 110 (e.g., straight or curved, respectively) can be press-fitted onto a second component 120 already attached to the ultrasound catheter 130. As described above, by advancing the MDU, the ultrasound transducer 136 can be positioned distally beyond the end of the tissue sampling element 118. The tissue sampling system 100 can then be retracted proximally to a predetermined position, for example by retracting the cannula 140 proximally, to position the outer tube 150 over the ultrasound catheter 130 (e.g., covering the distal end of the cannula 140 and the ultrasound transducer 136) and the tissue sampling element 118 of the first component 110. Enclosing the ultrasound transducer 136 and the tissue sampling element 118 within the outer tube 150 protects the ultrasound transducer and prevents the tissue sampling element 118 from engaging the endoscopic lumen and / or prematurely puncturing lung tissue before identifying the target lung nodule. Then, the outer tube 150 can be advanced (e.g., twisted, pushed, etc.) through and distally pushed beyond the working channel 4 of the bronchoscope 2 into the bronchial channel adjacent to the lung nodule 8. Figure 7B Then the proximal end of the cannula 140 (not shown) (e.g., including a portion of the braided material 140a) can be advanced distally to position the ultrasound transducer 136 outside (e.g., externally) the distal end 154 of the outer tube 150 and provide an ultrasound image of the lung nodule 8. Figure 7C Having determined the location and orientation of the lung nodule 8, the ultrasound probe 138 can be retracted proximally through the fixation cannula 140 via the MDU to position the ultrasound transducer 136 slightly behind (e.g., close to) the end of the tissue sampling element 118. Figure 7DThis allows visualization of the tissue sampling element 118 (and lung nodule 8) on radial ultrasound images. The tissue sampling system 100 can be rotated as needed to align the tissue sampling element 118 with the lung nodule 8. Alternatively, the position of the tissue sampling element 118 relative to the ultrasound transducer 136 can be determined by visualizing a hyperechoic material “strip” integrally formed within a portion of the cannula 140 on a radial ultrasound image, rather than visualizing the tissue sampling element by retracting the ultrasound probe proximally. As described above, based on the position of the hyperechoic material “strip,” the tissue sampling system can be rotated as needed to align the tissue sampling element 118 with the lung nodule 8. The tissue sampling element 118 can then be advanced into the lung nodule 8 through the proximal end (not shown) of the actuating cannula 140, causing the ultrasound catheter 130 and the attached first and second assemblies 110, 120 to move distally through the outer tube 150 ( Figure 7E The cannula 140 can be actuated multiple times as needed (e.g., extended and retracted) to obtain sufficient tissue sample within the tissue sampling element 118. (See reference...) Figure 7F It can use, including, such as Figure 4B The tissue sampling element 118, as shown, is configured in a bent or twisted manner to obtain tissue samples from eccentric pulmonary nodules. When a healthcare professional determines that the tissue sampling element 118 contains a sufficient amount of tissue sample for cytological analysis, the proximal end (not shown) of the cannula 140 can be retracted proximally to position the ultrasound transducer 136 and the tissue sampling element 118 within the outer tube 150. Because the ultrasound transducer 136 and the tissue sampling element 118 are positioned (e.g., protected) within the outer tube 150, the outer tube 150 can be retracted proximally to remove the tissue sampling system 100 from the body passage and through the working channel of the endoscope.

[0035] Reference Figure 8A After the tissue sampling system 100 has been removed from the patient, the first component 110 can be detached from its keyed or press-fit interlock with the second component 120. The tissue sampling element 118 can then be removed from the first component and attached to a corresponding accessory 80 (e.g., a Luer lock) of the ejection system 70. Figure 8B For example, the ejection system 70 (e.g., a needle gun, syringe assembly, etc.) may include a plunger 72 attached to an elongated needle 74 that passes through a spring 76 housed within a chamber 78. In one embodiment, a recess 113 may extend through the length of (not shown) the first assembly 110 such that the lumen of the tissue sampling element 118 aligns with and extends therewith the recess 113. When the plunger 72 is depressed, the spring 76 moves within the chamber 78 to a compression configuration and actuates the elongated needle 74 to pass through the lumen of the fitting 80 and the tissue sampling element 118, thereby ejecting a tissue sample 82 for cytological analysis. Figure 8CAlternatively, pressing down the plunger can force a pulse of compressed air through fitting 80 and the lumen of the tissue sampling element (instead of the core needle) to eject the tissue sample.

[0036] The medical device disclosed herein is not limited to a bronchoscope, but may include various medical devices for accessing the body, including, for example, catheters, ureteroscopes, duodenoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, etc. Alternatively, the tissue sampling system of this disclosure may be positioned inside a patient without accompanying medical devices.

[0037] Various components of the tissue sampling system (e.g., first component 110, second component 120, sleeve 140, outer tube 150) and ejection system 70 may be integrally formed from suitable polymer materials using extrusion (e.g., injection molding) and / or die casting techniques as known in the art. Non-limiting examples of suitable materials may include: polyolefins; polyamides (e.g., nylon, such as nylon 12, nylon 11, nylon 6 / 12, nylon 6, nylon 66); polyesters (e.g., polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyethylene naphthalate (PEN), polypropylene terephthalate (PTT)); polyethers; polyurethanes; polyethylene; polyacrylic acid; fluoropolymers; copolymers and block copolymers thereof, such as block copolymers of polyether and polyamide (e.g., PEBAX); and mixtures thereof. UV-curable polymers, such as polyimide and acrylic or methacrylic acid polymers and copolymers, may also be used. Other examples of suitable polymers for use in balloons include polyethylene, polyethylene ionomers, polyethylene copolymers, polyetheretherketone (PEEK), and thermoplastic polyester elastomers (e.g. ) and combinations thereof. Additionally or alternatively, any or all of these components may include metal, ceramic or hardened plastic materials as known in the art.

[0038] The size, shape, and / or configuration of the various components are not limited to those shown in the figures. For example, the first and second components 110, 120 are not necessarily limited to the circular and / or elliptical shapes and / or openings depicted.

[0039] According to this disclosure, all the apparatuses and / or methods disclosed and claimed herein can be manufactured and implemented without excessive experimentation. Although the apparatuses and methods of this disclosure have been described with reference to preferred embodiments, it will be apparent to those skilled in the art that variations may be made to the apparatuses and / or methods described herein, as well as the steps or order of steps of the methods, without departing from the concept, spirit, and scope of this disclosure. It will be apparent to those skilled in the art that all such similar substitutions and modifications are considered to be within the spirit, scope, and concept of this disclosure as defined by the appended claims.

Claims

1. An apparatus comprising: An elongated member having a woven portion, an unwoven portion, and an inner cavity extending through the woven portion and the unwoven portion, wherein the woven portion is proximal to the unwoven portion, and the inner cavity is configured to receive an ultrasonic transducer; The tissue sampling element is rotated and fixed relative to the elongated member, and High-echo material disposed in the unwoven portion of the elongated member. The woven portion of the elongated member is configured to transmit torque to rotate the high-echo material when the elongated member is disposed within the body cavity, and The highly echogenic material of the elongated member appears as a dark portion in the radial ultrasound image generated by the ultrasound transducer to identify the relative position of the tissue sampling element.

2. The device of claim 1, wherein the unbraided portion comprises a portion of a polymer sleeve.

3. The apparatus of claim 2, wherein the high-echo material comprises strips of metal material disposed in the unwoven portion of the elongated member.

4. The apparatus of claim 3, wherein the metal strip comprises one or more of stainless steel, copper, and brass.

5. The apparatus of claim 2, wherein the high-echo material comprises a powder material mixed into said portion of the polymer sleeve.

6. The apparatus of claim 5, wherein the powder material comprises barium sulfate.

7. The apparatus of claim 1, wherein the high-echo material is non-transmissive to light.

8. The apparatus of claim 1, wherein the unwoven portion extends distally beyond the distal end of the ultrasonic transducer.

9. The apparatus of claim 1, wherein the cavity is configured to allow a flushing fluid to continuously and reliably propagate ultrasonic energy.

10. The apparatus of claim 1, wherein the braided portion comprises interwoven strands of metallic material.

11. A medical device, comprising: A sleeve with high echo material and an inner cavity; An ultrasonic transducer is installed in the inner cavity of the sleeve; and The tissue sampling element is rotated and fixed relative to the cannula, wherein the hyperechoic material of the cannula appears as a dark portion on a radial ultrasound image generated by the ultrasound transducer to identify the relative position of the tissue sampling element.

12. The medical device of claim 11, wherein the tissue sampling element is located proximal to or distal to the ultrasound transducer in the radial ultrasound image.

13. The medical device of claim 12, wherein the position indicated in the radial ultrasound image generated by the ultrasound transducer is at a predetermined angle to the position of the tissue sampling element.

14. The medical device of claim 11, wherein the hyperechoic material indicates the quadrant in which the tissue sampling element will appear in the radial ultrasound image.

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