System for real-time visualization of a biopsy needle and a target tissue

Abstract

To provide an invention in the field of endoscopy.SOLUTION: In particular, the present disclosure relates to systems and methods for real-time visualization of a target tissue, where the methods allow the location and orientation of a biopsy needle to be determined prior to its first actuation.SELECTED DRAWING: None

Description

Technical Field

[0001] The present invention relates to the field of endoscopic examination. In particular, the present invention relates to a system and method that enable real-time visualization of a target tissue, and that enable efficient and accurate placement and orientation of a biopsy needle before the biopsy needle is first actuated and before a specimen is collected.

Background Art

[0002] Radial endobronchial ultrasound (R-EBUS) is provided as a minimally invasive option when clinical findings indicate that tissue biopsy within the lung passage is necessary. Conventional R-EBUS transbronchial needle aspiration (TBNA) involves delivering a radial ultrasound probe through the working channel of a bronchoscope to a target airway, visualizing a target lung nodule with R-EBUS, locking the placement of an access sheath, removing the radial ultrasound probe from the access sheath, and then advancing a biopsy needle blindly to collect cellular material for cytological evaluation. If the biopsy needle cannot be visualized until after the tissue sampling procedure has been initiated, it is often the case that the biopsy needle fails to find the target nodule at all. To assist in ensuring a biopsy without problems with the target nodule, medical professionals typically operate the biopsy needle multiple times into the lung tissue while rotating the bronchoscope. Such repeated actuation of the biopsy needle can result in various medical negative outcomes including unnecessary trauma to healthy tissue, excessive bleeding, puncture of the pleural sac (e.g., pneumothorax), puncture of blood vessels, increased procedure duration and / or cost, and the possibility of misdiagnosis (e.g., false negative).

[0003] Particularly in the field of pulmonary endoscopy, there can be clinical advantages to a tissue sampling system that allows a medical professional to visualize a biopsy needle and a target tissue in real time before the first actuation of the needle.

Summary of the Invention

[0004] In various aspects, the present invention provides an advantage in the medical field such as the field of pulmonary endoscopy for a sampling system that enables real-time visualization of pulmonary nodules and enables efficient and accurate determination of the placement and orientation of a biopsy needle before the first actuation and before specimen collection of the biopsy needle.

[0005] In one aspect, the present invention relates to an apparatus comprising a first component having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, and a tissue sampling element attached to the distal end of the first component. The proximal end of the first component may include a recess. The tissue sampling element may include, for example, a biopsy needle. The tissue sampling element may include a generally linear posture. The tissue sampling element may transition between a generally linear posture and a generally curved posture.

[0006] In another aspect, the present invention relates to a system comprising a first component having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, and a second component having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end. The proximal end of the first component is removably attached to the distal end of the second component to form a continuous lumen. An ultrasonic catheter can extend through the continuous lumen of the first and second components. A sheath tube can be slidably disposed around the first component, the second component, and the ultrasonic catheter. The ultrasonic catheter can include an ultrasonic probe slidably disposed within a sheath that forms an interference fit within the lumen of the second component. A tissue sampling element can be attached to the distal end of the first component. The proximal end of the first component can include a recess configured to receive a post extending from the distal end of the second component. The post of the second component can form an interference fit within the recess of the first component. The lumen of the first component can align with the lumen of the second component when the post is disposed within the recess to form a continuous lumen. A portion of the sheath can extend distally beyond the ultrasonic probe. A portion of the sheath can include braided material. The braided material can extend along the proximal portion of the ultrasonic probe. The portion of the sheath extending distally beyond the ultrasonic probe can include non-braided material. The sheath can include a proximal end, a distal end, and a lumen extending between the proximal end and the distal end. The lumen of the sheath can include a first diameter portion and a second diameter portion. The system can further include a delivery device having a working channel configured to slidably receive the sheath tube. The proximal end of the ultrasonic probe can be connected to a motor drive unit. The system can further include a delivery device having a working channel configured to slidably receive the sheath tube.

[0007] In another aspect, the present invention relates to a method that includes advancing through a body lumen a tissue sampling system comprising an interlocked first component and a second component that is removably disposed around an ultrasonic catheter; imaging a target tissue with the ultrasonic catheter along with the body lumen; advancing the tissue sampling system such that a portion of the first component penetrates the target tissue; and withdrawing the tissue sampling system from the body lumen. The method may further include rotating the tissue sampling system prior to advancing the tissue sampling system to align the first component with the target tissue. The tissue sampling system may be advanced simultaneously with imaging of the target tissue.

[0008] Non-limiting examples of the present invention are described, by way of example, with reference to the accompanying drawings, which are schematic and are not intended to be to scale. In the drawings, each identical or nearly identical component that is illustrated may generally be represented by a single reference numeral. For clarity, not all components may be labeled in all drawings, nor may all components of each embodiment of the present invention be shown, where it is not necessary for those of ordinary skill in the art to understand the present invention by the description.

Brief Description of the Drawings

[0009]

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DETAILED DESCRIPTION OF THE INVENTION

[0010] It should be noted that the drawings show only typical or exemplary embodiments of the present invention. Therefore, the drawings should not be considered as limiting the scope of the present invention. Here, the present invention will be described in detail with reference to the accompanying drawings.

[0011] Before further describing the present invention in detail, it is to be understood that the present invention is not limited to the specific embodiments described and can vary as such. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting beyond the scope of 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 technical field to which the present invention belongs. Finally, although embodiments of the present invention are described with particular reference to real-time visualization and sampling of pulmonary nodules, the systems and methods disclosed herein can be used, for example, to obtain biopsy specimens from various body lumens including the heart, vasculature, circulatory system, gastrointestinal (GI) tract, stomach, esophagus, urogenital system, and the like.

[0012] As used herein, the singular forms "a," "an," and "the" include the plural forms as well, unless the context clearly dictates otherwise. The terms "comprises" and / or "comprising" or "includes" and / or "including," when used herein, specify the presence of the stated mechanism, 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.

[0013] As used herein, the term "distal end" refers to the end that is farthest from the medical professional when introducing the device into the patient, while the term "proximal end" refers to the end that is closest to the medical professional when introducing the device into the patient.

[0014] The present invention generally provides a tissue sampling system that includes a sampling component reversibly (e.g., removably) connected to an ultrasonic catheter by keying or press-fitting interaction with a connector component attached to the outer surface of the ultrasonic catheter. The geometric shape of the coupling of the connector component and the sampling component prevents rotation and / or translation of the sampling component relative to the ultrasonic catheter and provides a fixed alignment, thereby enabling a medical professional to know in which quadrant of the radial ultrasonic image the sampling component will appear with respect to the target nodule prior to each tissue sampling procedure.

[0015] Referring to FIG. 1, in one embodiment, the present invention provides a tissue sampling system 100 that includes 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 thin aspiration needle, a biopsy brush, etc.) extending from a distal end 124. An outer sheath 150 may be slidably disposed around the ultrasonic catheter 130 and the first and second components 110 and 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 sheath 140, which may include a proximal end (not shown), a distal end 144, and a lumen 146 extending between the proximal and distal ends 144. The proximal end (not shown) of the ultrasonic 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 ultrasonic probe 138 and the ultrasonic transducer 136 within the fixed sheath 140. The sheath 140 may be formed from various materials that provide the mechanical properties necessary to navigate through thin and tortuous body passages.

[0016] In various embodiments, the positions of the first component 110 and the second component 120 around the ultrasonic catheter 130 can provide a significant advantage over conventional tissue sampling systems by virtue of the tissue sampling element 118 being very close to the ultrasonic transducer 136. Specifically, a configuration as shown can allow the tissue sampling element 118 to be placed very close to the target tissue (e.g., within a range of 5 mm or less) when a radial ultrasonic image of the target tissue is being generated (e.g., in real time). By bringing it very close to the target tissue, the tissue sampling element 118 can be made much shorter than a conventional biopsy needle. For example, a conventional lung biopsy needle can include a length of 50 centimeters or more, while the tissue sampling element of the present invention can include a length of less than 25 cm (e.g., 20 cm or less, 15 cm or less, 10 cm or less, 5 cm or less, 2.0 cm or less). By dramatically shortening the length of the sampling element 118, the production cost can be reduced and more reliable and accurate sampling of the target tissue can be enabled.

[0017] As shown in FIG. 2, a portion of the sheath 140 extending proximally from the ultrasonic transducer 136 may include braided material 140a (e.g., a woven twist of flexible polymer, carbon fiber, metal, and / or textile material, etc.). The braided material 140a provides high rigidity (e.g., pushability) and torqueability to move the ultrasonic catheter 130, the first component and the second component attached to the sheath 140 distally through the outer tube by operating (e.g., pushing and pulling) the proximal end (not shown) of the sheath 140, and to be retracted proximally. Additionally, or alternatively, a portion of the sheath 140 extending distally beyond the ultrasonic transducer 136 may include unbraided material 140b (e.g., at least any one of transparent plastic, silicone, and rubber materials, etc.). The unbraided material 140b may provide a conduit through which a fluid (e.g., isotonic saline, etc.) suitable for consistently and reliably propagating ultrasonic energy can flow intermittently, while not affecting the quality of the ultrasonic image or the visualization of the target nodule. The unbraided material 140b also provides sufficient flexibility and / or deformability to bend, i.e., flex, during the tissue sampling process so that the tissue sampling element is not obstructed or interfered with in penetrating the target nodule.

[0018] In one embodiment, a portion of the sheath 140 that extends distally beyond the ultrasonic transducer 136 may include a "band-shaped" hyperechoic (e.g., radiopaque) material. The hyperechoic material appears as a dark portion (e.g., a slice) on the radial ultrasonic image. For example, the hyperechoic material may include a suitable powdery substance (e.g., barium sulfate, etc.) mixed with one or more polymeric materials constituting the sheath 140 before the extrusion process. Additionally, or alternatively, the hyperechoic material may include a thin band-shaped metallic material (e.g., copper, brass, stainless steel, etc.) embedded in or otherwise adhered and / or attached to a portion of the sheath 140 that extends distally beyond the ultrasonic transducer 136. Since the first component 110 and the sheath 140 are fixed to each other so as not to rotate axially, and moreover, the orientation of the ultrasonic catheter 130 is fixed around the first component 110, even when the tissue sampling element is disposed behind (e.g., proximally) the ultrasonic transducer 136, a medical professional can identify the relative position of the tissue sampling element 118 based on the position of the hyperechoic band on the radial ultrasonic image. For example, the "band-shaped" hyperechoic material may be disposed at a portion of the sheath 140 that is directly opposite (e.g., 180 degrees offset) from the tissue sampling element. While visualizing the radial ultrasonic image, the outer tube 150 of the tissue sampling system 100 is rotated in real time to place the "band-shaped" hyperechoic material at a position directly opposite the target nodule before advancing the ultrasonic probe distally to deliver the tissue sampling element 118 into the target nodule.

[0019] FIG. 3 shows a schematic view of the second component 120 of FIG. 1 separated therefrom. The second component 120 may include a proximal end 122, a distal end 124, and a lumen 126 extending between the proximal end 122 and the distal end 124. The second component 120 may further include a post 128 (e.g., an arm, tab, etc.) extending from the distal end 124. FIG. 4A shows a schematic view of the first component 110 of FIG. 1 separated therefrom. The first component 110 may include a proximal end 112, a distal end 114, and a lumen 116 extending between the proximal end 112 and the distal end 114. The proximal end 112 may include a recess 113 (e.g., a pocket, etc.), and the recess 113 is configured to receive the post 128 of the second component 120 in a keyed or press-fit manner to interlock the first component 110 and the second component 120 (FIG. 5). In some embodiments, the recess 113 may be a through-lumen, as will be further described below, and the through-lumen extends from the proximal end of the first component 110 to the proximal end of the sampling element 118 to provide a continuous lumen for removing the collected specimen. The first component 110 may further include a generally linear tissue sampling element 118 (e.g., a biopsy needle, a thin aspiration needle, a biopsy brush, etc.) extending from the distal end 114 for sampling concentric target nodules. Alternatively, as shown in FIG. 4B, the first component 110 may include a tissue sampling element 118 configured to move from a linear posture to a curved posture when advancing distally beyond the outer tube and being released from the restraint within the outer tube for sampling an eccentric target nodule. The tissue sampling elements of FIGS. 4A and 4B may be embedded in the material forming the first component, for example, during a polymer coextrusion process, and / or may be fixed using a suitable resin, paste, or epoxy, etc. Alternatively, the tissue sampling element 118 may be removable from the first component after tissue collection for removing the specimen with another device such as those described below.

[0020] Referring to FIG. 5, the second component 120 attaches the ultrasonic catheter to the distal portion of the sheath 140 of the ultrasonic catheter 130 by advancing (e.g., sliding) the ultrasonic catheter through the lumen 126 of the second component 120, and a press fit can be formed between the outer surface of the sheath 140 and the inner surface of the lumen 126. The press fit between the second component 120 and the outer surface of the sheath 140 can be strong enough to prevent the second component from moving axially and / or rotating along the ultrasonic catheter 130 during a medical procedure, but weak enough that a medical professional can move (e.g., reposition) or remove (e.g., disconnect or separate) the second component 120 by applying a twisting and pulling / pushing force with one (both) hand(s) simultaneously. Alternatively, the second component 120 can be permanently attached to the sheath 140 of the ultrasonic catheter 130 by suitable welding, soldering, brazing, adhesives, glues, and / or resins. Continuing to refer to FIG. 5, with the second component 120 securely attached to the ultrasonic catheter 130, the first component 110 can advance outside the distal portion of the ultrasonic catheter 130 while the recess 113 of the first component 110 receives the post 128 of the second component 120, thereby forming a press fit (e.g., key fit or press fit). The press fit between the recess 113 and the post 128 establishes a reversible interlock that properly aligns and couples the first component 110 and the second component 120, and can prevent radial and / or axial movement of the first component 110 relative to the sheath 140 of the ultrasonic catheter 130 while the medical procedure continues. Rotational and / or axial movement of the first component 110 along and / or around the sheath 140 of the ultrasonic catheter 130 can be further restricted by the frictional force between the outer surface of the sheath 140 and the inner wall of the lumen 116.As described above, one or more interference fits combined between the first component 110, the second component 120, and the ultrasonic catheter 130 (e.g., the outer surface of the sheath 140) can be strong enough to prevent the first component from moving axially and / or rotating along the ultrasonic catheter 130 during a medical procedure (e.g., within a patient), but weak enough that a medical professional can remove or disconnect the first component 110 from the second component 120 and the ultrasonic catheter 130 by applying sufficient force with one hand (or both hands) (e.g., twisting and / or pulling).

[0021] Referring to FIG. 6, in one embodiment, the outer sheath 150 may include a proximal end (not shown), a distal end 154, and a variable diameter lumen extending between the proximal end and the distal end 154. For example, the distal portion of the outer sheath 150 may include a lumen having a first diameter 156a configured to house (e.g., fit) and protect the second component 120, the first component 110, and the ultrasonic catheter 130. The remaining portion of the outer sheath 150 may include a second diameter 156b that is smaller than the first diameter 156a and is configured to slidably receive the ultrasonic catheter. The smaller second diameter 156b may thicken the wall thickness of the outer sheath 150 to enhance pushability, operability, and resistance to bending and / or entanglement. Additionally, or alternatively, the smaller diameter second diameter 156b may constrain the ultrasonic catheter along its length to prevent excessive bending within the outer sheath as the tissue sampling system advances through a narrow and tortuous body passageway. The outer sheath 150 may be formed from various materials to provide the mechanical properties (e.g., stiffness, pushability, flexibility, torqueability) necessary to navigate through a tortuous body passageway without bending, entangling, and / or breaking. The outer sheath 150 may further include one or more braided materials (e.g., woven strands such as flexible polymers, carbon fibers, metals, and / or textile materials) to enhance stiffness, torqueability, and / or flexibility along all (or a portion) of the outer sheath. The outer sheath may include an outer diameter 158 (e.g., from about 2.0 mm to about 4.0 mm) configured to pass through the working channel of a conventional bronchoscope. The outer sheath 150 is not limited to a double diameter lumen and may include various lumen diameters including, but not limited to, a single diameter lumen, a tapered diameter lumen, and the like.

[0022] Referring to FIGS. 7A-7F, by way of example, during use, the bronchoscope 2 can be advanced through the trachea into the airway of the bronchus near the target pulmonary nodule (FIG. 7A). Depending on the type of pulmonary nodule visualized by the bronchoscope (e.g., concentric or eccentric), an appropriate (e.g., straight or curved respectively) first component 110 is press-fitted into a second component 120 already attached to the ultrasonic catheter 130. The ultrasonic transducer 136 can be disposed distally beyond the tip of the tissue sampling element 118 by advancing the MDU as described above. Then, the tissue sampling system 100 can be retracted proximally to a predetermined position, for example, by retracting the sheath 140 proximally, to cover the ultrasonic catheter 130 and the tissue sampling element 118 of the first component 110 (e.g., covering the distal ends of the sheath 140 and the ultrasonic transducer 136) with the outer tube 150. By surrounding the ultrasonic transducer 136 and the tissue sampling element 118 within the outer tube 150, the ultrasonic transducer can be protected and the tissue sampling element 118 can be prevented from engaging the endoscope lumen and / or prematurely puncturing the lung tissue before the target pulmonary nodule is identified. Then, the outer tube 150 can be advanced (e.g., screwed in, pushed in, etc.) through the working channel 4 of the bronchoscope 2 and advanced distally beyond the working channel 4 into the airway of the bronchus adjacent to the pulmonary nodule 8 (FIG. 7B). Then, the proximal end of the sheath 140 (not shown) (e.g., the portion including the braided material 140a) is advanced distally so that the ultrasonic transducer 136 can be disposed beyond (e.g., outside of) the distal end 154 of the outer tube 150 and provide an ultrasonic image of the pulmonary nodule 8 (FIG. 7C). With the position and orientation of the pulmonary nodule 8 determined, the ultrasonic probe 138 can be retracted proximally via the fixed sheath 140 by the MDU so that the ultrasonic transducer 136 can be disposed slightly behind (e.g., proximally to) the tip of the tissue sampling element 118, enabling the tissue sampling element 118 (and the pulmonary nodule 8) to be visualized on the radial ultrasonic image.The tissue sampling system 100 can be rotated as needed to align the tissue sampling element 118 with the pulmonary nodule 8. Alternatively, instead of retracting the ultrasound probe proximally to visualize the tissue sampling element, the relative position of the tissue sampling element 118 with respect to the ultrasound transducer 136 can be determined by visualizing a "strip-shaped" highly echogenic material integrally formed on a portion of the sheath 140 on a radial ultrasound image. As described above, the tissue sampling system can be rotated as needed to align the tissue sampling element 118 with the pulmonary nodule 8 based on the position of the "strip-shaped" highly echogenic material. The tissue sampling element 118 is then advanced to the pulmonary nodule 8 by actuating the proximal end (not shown) of the sheath 140 such that the ultrasound catheter 130 and the attached first component 110 and second component 120 can move distally through the outer tube 150 (FIG. 7E). The sheath 140 can be actuated (e.g., extended and retracted) the number of times necessary to obtain a sufficient tissue specimen within the tissue sampling element 118. Referring to FIG. 7F, a tissue specimen can be obtained from an eccentric pulmonary nodule using the tissue sampling element 118 that is bent, i.e., in a curved configuration, as shown in FIG. 4B. When a medical professional determines that the tissue sampling element 118 contains a sufficient amount of tissue specimen for cytological analysis, the proximal end (not shown) of the sheath 140 can be retracted proximally to dispose the ultrasound transducer 136 and the tissue sampling element 118 within the outer tube 150. With the ultrasound transducer 136 and the tissue sampling element 118 disposed (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 lumen through the working channel of the endoscope.

[0023] Referring to FIG. 8A, after the tissue sampling system 100 has been removed from the patient, the first component 110 can be separated from a 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 fitting 80 of the discharge system 70, such as a luer lock (FIG. 8B). For example, the discharge system 70 (e.g., a stylet gun, a syringe assembly, etc.) can include a plunger 72 attached to a elongate stylet 74 that passes through a spring 76 housed within a chamber 78. In one embodiment, a recess 113 extends through a longitudinal portion of the first component 110 (not shown) such that the lumen of the tissue sampling element 118 aligns with and has the same extent as the recess 113. When the plunger 72 is depressed, the spring 76 moves to a compressed position within the chamber 78 and actuates the elongate stylet 74 to pass through the fitting 80 and the lumen of the tissue sampling element 118 to expel a tissue specimen 82 for cytological analysis (FIG. 8C). Alternatively, by depressing the plunger, a pulse of compressed air (instead of a stylet) can be forced through the fitting 80 and the lumen of the tissue sampling element to expel the tissue specimen.

[0024] The medical device of the present invention is not limited to a bronchoscope and can include various medical devices for accessing an in-body passageway, such as a catheter, a ureteroscope, a duodenoscope, a colonoscope, an arthroscope, a cystoscope, a hysteroscope, etc. Alternatively, the tissue sampling system of the present invention can be placed within a patient in the absence of an accompanying medical device.

[0025] The various components of the tissue sampling system (e.g., the first component 110, the second component 120, the sheath 140, the outer tube 150) and the discharge system 70 can be integrally formed from a suitable polymeric material using extrusion (e.g., injection molding) and / or die casting techniques as known in the art. Non-limiting examples of suitable materials include polyolefins; polyamides (e.g., nylons 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), polytrimethylene terephthalate (PTT)); polyethers; polyurethanes; polyvinyls; polyacrylic acids; fluoropolymers; copolymers, and block copolymers of copolymers such as block copolymers of polyethers and polyamides (e.g., Pebax (PEBAX) (registered trademark)); and mixtures thereof. UV curable polymers such as polyimides and acrylic or methacrylic polymers and copolymers can also be used. Other examples of suitable polymers that can be used for the balloon include polyethylene, polyethylene ionomers, polyethylene copolymers, polyetheretherketone (PEEK), thermoplastic polyester elastomers (e.g., Hytrel (registered trademark)) and combinations thereof. Additionally, or alternatively, any or all of these components can include metals, ceramics or cured plastic materials as known in the art.

[0026] The size, shape and / or configuration of the various components are not limited to those shown in the drawings. For example, the first component 110 and the second component 120 are not necessarily limited to the circular and / or oval shapes and / or openings shown in the figures. (Appendix) As a preferred embodiment, the technical idea that can be grasped from the above embodiments will be described below. [Item 1] a proximal end, a distal end, a lumen extending between the proximal end and the distal end A first component, and a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, A second component, wherein the proximal end of the first component is removably attached to the distal end of the second component to form a continuous lumen, the first component and the second component; An ultrasonic catheter extending through the continuous lumen of the first component and the second component; An outer tube including a variable-diameter lumen having a first diameter portion and a second diameter portion, the second diameter portion having a second diameter smaller than a first diameter of the first diameter portion; The first diameter portion of the variable-diameter lumen is included in a distal portion of the outer tube slidably disposed around the first component, the second component, and the ultrasonic catheter; The second diameter portion of the variable-diameter lumen thickens a wall thickness of the outer tube on a proximal side of the distal portion. [Item 2] The ultrasonic catheter according to item 1, comprising an ultrasonic probe slidably disposed within a sheath forming an interference fit within the lumen of the second component. [Item 3] The system according to item 1 or 2, further comprising a tissue sampling element attached to the distal end of the first component. [Item 4] The system according to any one of items 1 to 3, wherein the proximal end of the first component includes a recess configured to receive a post extending from the distal end of the second component. [Item 5] The system according to item 4, wherein the post of the second component forms an interference fit within the recess of the first component. [Item 6] The lumen of the first component forms a continuous lumen in alignment with the lumen of the second component when the post is disposed within the recess, as described in item 4 or 5 of the system. [Item 7] A portion of the sheath extends distally beyond the ultrasonic probe, as described in item 2 of the system. [Item 8] A portion of the sheath includes braided material, as described in item 2 of the system. [Item 9] The braided material extends along a proximal portion of the ultrasonic probe, as described in item 8 of the system. [Item 10] The portion of the sheath that extends distally beyond the ultrasonic probe includes non-braided material, as described in item 7 of the system. [Item 11] The sheath includes a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, as described in item 2 of the system. [Item 12] The proximal end of the ultrasonic probe is connected to a motor drive unit, as described in item 2 of the system. [Item 13] The system according to any one of items 1 to 12 further includes a delivery device having a working channel configured to slidably receive the outer tube. [Item 14] The tissue sampling element includes a biopsy needle, as described in item 3 of the system.

[0027] All of the apparatus and / or methods disclosed and claimed in this specification can be made and executed without undue experimentation in light of the present invention. The apparatus and methods of the present invention are described with reference to preferred embodiments, and it may be apparent to those skilled in the art that variations in the apparatus and / or methods and in the steps or sequence of steps of the methods may be applied without departing from the concept, spirit, and scope of the present invention. All such similar substitutions and modifications that are obvious to those skilled in the art may be considered to be within the spirit, scope, and concept of the present invention as defined by the appended claims.

Claims

1. Comprising a long member, the long member comprising: A first lumen extending along the axial direction of the long member, the first lumen configured to receive a tissue sampling element; and A sheath comprising a braided portion and an unbraided portion distal to the braided portion; and A second lumen extending through the braided portion and the unbraided portion of the sheath, the second lumen configured to receive an ultrasonic probe; and A strip of highly echogenic material disposed in the unbraided portion and disposed along the axial direction of the long member; The braided portion of the long member is configured to provide high rigidity and torque to the unbraided portion and the highly echogenic material when the long member is disposed in a body lumen; The long member is configured to maintain the first lumen and the second lumen in fixed radial positions relative to each other to maintain the tissue sampling element and the ultrasonic probe in fixed radial positions relative to each other; The strip of highly echogenic material is disposed at a point on the circumference of the sheath; The point is radially offset from the first lumen. A device.

2. The device according to claim 1, wherein the unbraided portion comprises a part of a polymeric sheath.

3. The device according to claim 2, wherein the strip of highly echogenic material comprises a strip of metallic material.

4. The device according to claim 3, wherein the strip of metallic material comprises one or more of stainless steel, copper, and brass.

5. The device according to claim 2, wherein the strip of highly echogenic material comprises a powder material mixed into a part of the polymeric sheath.

6. The device according to claim 5, wherein the powder material comprises barium sulfate.

7. The device according to claim 1, wherein the strip of highly echogenic material is radiopaque.

8. The device according to claim 1, wherein the unbraided portion extends distally beyond the distal end of the ultrasonic transducer of the ultrasonic probe.

9. The device according to claim 1, wherein the second lumen is configured to intermittently flow fluid when the ultrasonic probe is disposed within the second lumen.

10. The device according to claim 1, wherein the braided portion comprises a braid made of a woven metallic material.

11. A medical device, The medical device comprises a sheath, and the sheath comprises a braided portion and an unbraided portion distal to the braided portion. The sheath further comprises a strip of highly echogenic material disposed on the unbraided portion of the sheath and a lumen extending through the braided portion and the unbraided portion of the sheath. The medical device comprises an ultrasonic transducer disposed within the lumen of the sheath and configured to generate a plurality of radial ultrasonic images. The medical device comprises a tissue sampling element rotatably attached relative to the sheath, and the strip of highly echogenic material of the sheath indicates, in a first radial ultrasonic image of the plurality of radial ultrasonic images generated by the ultrasonic transducer, the position of the tissue sampling element where it may appear in a second radial ultrasonic image of the plurality of radial ultrasonic images when the tissue sampling element is advanced.

12. The medical device according to claim 11, wherein the tissue sampling element is located proximal to the ultrasonic transducer in the first radial ultrasonic image and adjacent to or distal to the ultrasonic transducer in the second radial ultrasonic image.

13. The medical device according to claim 12, wherein the position displayed in the first radial ultrasonic image is separated from the position of the tissue sampling element in the second radial ultrasonic image by a predetermined angle.

14. The medical device according to claim 11, wherein the strip of highly echogenic material displays quadrants in the first radial ultrasonic image where the tissue sampling element may appear in the second radial ultrasonic image.

15. The medical device according to claim 11 further comprises an outer tube surrounding at least a portion of the sheath, the ultrasonic transducer, and the tissue sampling element, and the outer tube is rotatably attached relative to the sheath.

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