System for harvesting eccentric nodal tissue

Abstract

To provide a sampling system that enables determination of the position and direction of a biopsy needle. The present invention relates to the field of endoscopy. Specifically, the present invention relates to systems and methods for visualizing and sampling target tissue within a body passageway in real time. In particular, the present invention relates to a system for visualizing eccentric pulmonary nodules in real time, allowing for the determination of biopsy needle position and orientation prior to needle movement.

Description

[Technical field]

[0001] The present invention relates to the field of endoscopy, and more particularly to systems and methods for visualizing and sampling target tissue in real time within a body passageway. [Background technology]

[0002] Radial endobronchial ultrasound (R-EBUS) offers a minimally invasive option when clinical findings indicate the need for tissue biopsy within the pulmonary passages. Traditional radial endobronchial ultrasound-guided needle biopsy (TBNA) involves delivering a radial ultrasound probe to the target airway through the working channel of the bronchoscope, visualizing the target pulmonary nodule with the radial endobronchoscope, locking the placement of the access sheath, removing the radial ultrasound probe from the access sheath, and blindly advancing the biopsy needle to obtain cellular material for cytological evaluation. This blind sampling often results in the biopsy needle missing the target nodule entirely. To ensure that the target nodule is biopsied, the medical practitioner typically repeatedly inserts the biopsy needle into the lung tissue while rotating the endoscope. Such repeated biopsy needle insertions can lead to a variety of undesirable medical outcomes, including unnecessary damage to healthy tissue surrounding the target nodule, reduced bleeding, increased likelihood of false negative results, and increased procedure time and cost. The inability to reliably and accurately obtain biopsy samples is particularly problematic for eccentric (e.g., displaced) pulmonary nodules, which occur in approximately 40% of all pulmonary procedures. Sampling eccentric pulmonary nodules requires bending or bending either the catheter or the biopsy needle within the narrow pulmonary passageways.

[0003] Thus, a system for visualizing eccentric pulmonary nodules in real time would provide various improvements, for example, the system would allow for determination of the location or orientation of a biopsy needle prior to insertion. Summary of the Invention

[0004] The present invention in various aspects relates to a sampling system for enabling real-time visualization of eccentric pulmonary nodules in medical applications, such as pulmonary endoscopy, where the position or orientation of a biopsy needle can be determined prior to puncture. In various embodiments, the present invention discloses an offset biopsy needle and radial ultrasound transducer that allows accurate and efficient biopsy of eccentric pulmonary nodule tissue.

[0005] In one aspect, the invention relates to an end cap having a proximal end, a distal end, a first lumen extending between the proximal end and the distal end to form a first opening, and a second lumen extending between the proximal end and an outer surface of the end cap to form a second opening. The first and second lumens are separated by an inner wall having a variable thickness. The thickness of the inner wall decreases from the distal end to the proximal end to form a sloped surface in the second lumen. The sloped surface may have an angle of about 5-10 degrees with respect to a longitudinal axis of the end cap. The first lumen is configured to receive an ultrasound transducer. The second lumen is configured to receive a tissue sampling element. The end cap may comprise a variety of materials, such as, but not limited to, metallic and ceramic materials.

[0006] In another aspect, the invention relates to a system comprising a delivery device with a first working channel and a second working channel, and an end cap with a first lumen and a second lumen forming a first opening and a second opening, respectively. The proximal end of the end cap is attached to the distal end of the delivery device such that the first working channel is continuous with the first lumen and the second working channel is continuous with the second lumen. The first lumen and the second lumen are separated by an inner wall having a variable thickness, the thickness of the inner wall decreasing from the distal end to the proximal end to form a sloped surface in the second lumen. The system further comprises an ultrasonic transducer disposed within the first working channel and the first lumen. The ultrasonic transducer may extend distally beyond the distal end of the end cap. The system may further comprise a tissue sampling element slidably disposed within the second working channel and the second lumen. The proximal end of the end cap is attached to the distal end of the delivery device by a heat shrink sleeve disposed around an outer surface of the proximal portion of the end cap and an outer surface of the distal portion of the delivery device. The distal portion of the delivery device includes a pocket within which the end cap is bonded. The pocket includes a machined opening that coincides with the second opening. The ultrasound transducer is disposed within the sheath, a portion of the sheath including a radiopaque material. The radiopaque material may include, for example, a strip of radiopaque material extending along a length of the sheath. A portion of the sheath extends distally beyond the ultrasound transducer. The strip of radiopaque material and the second opening in the outer surface of the end cap may be offset at an angle of about 180 degrees.

[0007] In another aspect, the invention relates to a method, comprising: advancing a tissue sampling system through a body passage, the tissue sampling system including a delivery device comprising an end cap having a first lumen and a second lumen forming a first opening and a second opening, the proximal end of the end cap being attached to a distal end of the delivery device such that the first working channel is continuous with the first lumen and the second working channel is continuous with the second working channel, the method comprising: imaging a target tissue within the body passage; advancing a tissue sampling element distally into the target tissue beyond the second opening of the end cap such that a portion of the target tissue is captured within the lumen of the tissue sampling element; and removing the system from the body passage. The target tissue may be imaged under ultrasound using an ultrasound transducer. The tissue sampling element may be advanced into the target tissue while imaging the target tissue.

[0008] Non-limiting examples of the present invention are described with reference to the accompanying drawings, which are schematic and are not intended to be drawn to scale. In the drawings, identical or nearly identical components are generally labeled with a single numeral. For purposes of clarity, the drawings do not necessarily show all components, and do not necessarily show all components of each embodiment of the present invention, unless necessary for a person skilled in the art to understand the present invention. [Brief description of the drawings]

[0009] [Figure 1] FIG. 2 is a cross-sectional view showing an end cap of a catheter according to an embodiment of the present invention. [Figure 2A] 2 illustrates an end cap of the catheter of FIG. 1 attached to a distal end of the catheter, according to one embodiment of the present invention. [Figure 2B] 2 illustrates an end cap of the catheter of FIG. 1 attached to a distal end of the catheter, according to one embodiment of the present invention. [Figure 3A] 1 illustrates a tissue sampling system in accordance with one embodiment of the present invention. [Figure 3B] 1 illustrates a tissue sampling system in accordance with one embodiment of the present invention. [Figure 4A] 1 is an exemplary ultrasound image showing a concentric pulmonary nodule, according to an embodiment of the present invention. [Figure 4B] 1 is an exemplary ultrasound image showing an eccentric pulmonary nodule, according to an embodiment of the present invention. [Figure 5A] FIG. 1 illustrates the steps involved in sampling an eccentric pulmonary nodule according to one embodiment of the present invention. [Figure 5B] FIG. 1 illustrates the steps involved in sampling an eccentric pulmonary nodule according to one embodiment of the present invention. [Figure 5C] FIG. 1 illustrates the steps involved in sampling an eccentric pulmonary nodule according to one embodiment of the present invention. [Figure 5D] FIG. 1 illustrates the steps involved in sampling an eccentric pulmonary nodule according to one embodiment of the present invention. [Figure 5E] FIG. 1 illustrates the steps involved in sampling an eccentric pulmonary nodule according to one embodiment of the present invention. [Figure 5F] FIG. 1 illustrates the steps involved in sampling an eccentric pulmonary nodule according to one embodiment of the present invention. [Figure 6A] FIG. 1 illustrates the steps involved in sampling an eccentric pulmonary nodule according to one embodiment of the present invention. [Figure 6B] FIG. 1 illustrates the steps involved in sampling an eccentric pulmonary nodule according to one embodiment of the present invention. [Figure 6C] FIG. 1 illustrates the steps involved in sampling an eccentric pulmonary nodule according to one embodiment of the present invention. [Figure 6D] FIG. 1 illustrates the steps involved in sampling an eccentric pulmonary nodule according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] It should be noted that the drawings are intended to illustrate general or exemplary embodiments of the present invention, and therefore should not be considered as limiting the scope of the present invention. In the following, the present invention will be described in more detail with reference to the attached drawings.

[0011] Before describing the invention in further detail, it should be understood that the invention is not limited to the specific embodiments described, as such may vary. Additionally, the terms used herein are for the purpose of describing the specific embodiments, and are 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 art to which the invention pertains. Finally, although the embodiments of the invention are described with particular reference to real-time visualization and sampling of eccentric pulmonary nodules, the systems and methods described herein may be used to obtain biopsy samples from various body cavities, such as the heart, vascular system, circulatory system, gastrointestinal system, stomach, esophagus, genitourinary system, etc. In various embodiments, the catheter end cap is also suitable for use with various sampling devices (e.g., grasping or cutting elements, etc.) in addition to biopsy needles.

[0012] As used in this specification, singular forms such as "a," "an," and "the" include the plural unless expressly stated to the contrary. The terms "comprise," "comprising," "includes," or "including," as used in this specification, specify the presence of a feature, region, element, or component, but do not exclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, or groups thereof.

[0013] As used in this specification, "distal" refers to the end of the device that is furthest from the medical practitioner when inserting the device into the patient's body, and "proximal" refers to the end of the device that is closest to the medical practitioner when inserting the device into the patient's body.

[0014] The present invention generally provides a dual lumen catheter end cap that supports simultaneous use of a tissue sampling element and a radial ultrasound transducer adjacent to one another. One of the two lumens has an angled or oblique configuration to allow sampling of eccentric nodules without pre-curving the tissue sampling element. The dual lumen end cap is adapted for use with a radial ultrasound transducer configured to provide real-time visualization of the target pulmonary nodule prior to penetration while indicating placement and orientation of the biopsy needle relative to the radial ultrasound transducer. The dual lumen end cap and radial ultrasound transducer also provide real-time visualization of the target pulmonary nodule and the location and orientation of the biopsy needle for subsequent penetration into the same (or different) nodule.

[0015] With reference to FIG. 1, in one embodiment, the present invention provides a catheter end cap 110 having a proximal end 112, a distal end 114, and first and second lumens 116, 118 separated by an inner wall 122 of variable thickness. The first lumen 116 extends between the proximal and distal ends 112, 114 and forms a first opening 116a. The second lumen 118 extends between the proximal end 112 and an outer surface of the end cap 110 and forms a second opening 118a. The first and second openings 116a, 118a are not limited to circular or elliptical shapes, but may include a variety of other shapes and configurations. The inner wall 122 of variable thickness is tapered from the distal end 114 to the proximal end 112 such that the second lumen 118 forms an inclined surface 122a (e.g., a beveled surface). The inclined surface 122a is aligned with the long axis (L 1 ) can have any angle between about 5-10 degrees. The end caps can be formed as a unitary piece from a variety of metal, ceramic, or hardened plastic materials well known in the art.

[0016] In one embodiment, the end cap of the present invention is attached to a delivery device (e.g., a catheter). See FIG. 2A. The delivery device 230 includes a distal portion 233 that defines a recess 233a (e.g., a pocket) that receives the end cap 210. The outer surface 220 of the end cap 210 achieves sufficient interference or friction within the recess 233a to prevent the end cap from becoming dislodged during use (e.g., within the patient's body). Additionally or alternatively, the end cap 210 may be secured within the recess 233a by a suitable weld, solder, braze, adhesive, glue, and / or resin. The recess 233a further includes a machined opening 233b aligned with the second opening 218a of the end cap 210. See FIG. 2B. The proximal end 212 of the end cap 210 is attached to the distal end 234 of the carrier 230 with a sleeve 235 disposed around the outer surface 220 of the proximal portion 212a of the end cap 210 and the outer surface of the distal portion 233 of the carrier 230. The sleeve 235 may cover a portion of the second opening 218a. In one embodiment, the sleeve 235 may comprise a heat shrink material that secures the end cap 210 to the carrier 230 without increasing the thickness of the carrier or the end cap. Additionally or alternatively, the sleeve 235 is secured to the carrier and the end cap by an interference bond and / or a suitable weld, solder, braze, adhesive, glue, or resin.

[0017] 3A, the delivery device 330 includes a first working channel 336 and a second working channel 338 such that the first working channel 336 is aligned with the first lumen 316 to form a continuous lumen and the second working channel is aligned with the second lumen 318 to form a continuous second lumen when the end cap 310 is secured to the delivery device. The continuous first working channel 336 and first lumen 316 may receive an ultrasonic transducer 340 disposed within a flexible sheath 344. The sheath 344 extends distally beyond the ultrasonic transducer 340 to protect it as the delivery device 330 is advanced through the body passageway. The sheath 344 may also serve as a conduit for intermittent introduction of a suitable fluid (e.g., isotonic saline) to allow a medical practitioner to reliably and accurately transmit ultrasonic energy. In one embodiment, the sheath 344 and the ultrasonic transducer 340 are fixedly disposed within the continuous first working channel 336 and the first lumen 316. In another embodiment, the sheath 344 and the ultrasonic transducer 340 are slidably disposed within the continuous first working channel 336 and the first lumen 316. In yet another embodiment, the ultrasonic transducer comprises a radial ultrasonic probe rotatably disposed within the sheath 344. The continuous second working channel 338 and the second lumen 318 may slidably receive a tissue sampling element 350 (e.g., a biopsy needle). See FIG. 3B. The tissue sampling element 350 is advanced distally along the angled surface 322a of the end cap 310 such that upon exiting the second opening 318a, the tissue sampling element 350 is offset (e.g., curved) from the longitudinal direction of the end cap 310. When the tissue sampling element 350 is moved beyond the distal end 314 of the end cap 310, the tissue sampling element 350 and the ultrasonic transducer 340 are biased at an angle of approximately 180 degrees relative to one another. In other words, the tissue sampling element 350 exits the second opening 318a at a location on the end cap 310 directly opposite (e.g., directly above) the ultrasonic transducer 340.Alternatively, the tissue sampling element and the ultrasonic transducer are offset relative to one another at an angle of less than 180 degrees (e.g., about 90 degrees, about 100 degrees, about 110 degrees, about 120 degrees, about 130 degrees, about 140 degrees, about 150 degrees, about 160 degrees, about 170 degrees, etc.), or at an angle of more than 180 degrees (e.g., about 190 degrees, about 200 degrees, about 210 degrees, about 220 degrees, about 230 degrees, about 240 degrees, about 250 degrees, about 260 degrees, about 270 degrees, etc.).

[0018] The ultrasound images of Figures 4A-4B show morphological differences between concentric pulmonary nodules occupying the central portion of the pulmonary passages (Figure 4A) and eccentric pulmonary nodules located to the sides of the pulmonary passages (Figure 4B). See Figures 5A-5F. In use, illustratively, a bronchoscope (not shown) is advanced through the trachea into a bronchial passageway proximate a target tissue site (e.g., a pulmonary nodule). A delivery device 330 (e.g., a catheter) of Figure 3A is advanced distally through the working channel of the bronchoscope to obtain an ultrasound image of the bronchial passageway. As the delivery device approaches the target tissue site, an ultrasound transducer 340 may acquire an ultrasound image of the eccentric nodule 8 (Figure 5A). As shown in Figure 5B, the eccentric nodule 8 may be viewed as a dark lesion in the upper left quadrant of the ultrasound image, while the ultrasound transducer 340 may be viewed as a dark circle in the center of the ultrasound image. Once the ultrasound transducer 340 is positioned near the eccentric node 8, the medical practitioner may move (e.g., advance distally) the tissue sampling element 350 through the second opening 318a of the end cap 310 into the wall of the pulmonary passageway (FIG. 5C). As shown in FIG. 5D, once the tissue sampling element 350 is moved (e.g., advanced distally) beyond the ultrasound transducer 340, it appears in the ultrasound image. If the tissue sampling element does not penetrate the eccentric node upon advancing the tissue sampling element, the medical practitioner retracts the tissue sampling element 350 into the end cap 310 and, based on the relative positions of the tissue sampling element 350 and the eccentric node 8 (FIGS. 5C and 5D), rotates the entire conveying device 330 to align the second opening 318a with the eccentric node 8 (FIG. 5E), and then moves the tissue sampling element 350 through the second opening 318a of the end cap 310 and into the eccentric node (FIG. 5F). The tissue sampling element 350 is then retracted into the end cap 310 and the conveying device 330 is retracted proximally through the bronchoscope and removed from the patient's body. A biopsy sample of the eccentric node is then removed from within the lumen of the tissue sampling element 350 for cytological evaluation.Although the tissue sampling element 350 in FIG. 5C is shown penetrating the wall of the bronchial passageway at a location that does not enter the eccentric node 8 (e.g., the target node is "lost"), in various embodiments, the tissue sampling element 350 is moved distally beyond the ultrasound transducer 340 such that the end (e.g., sharp portion) of the tissue sampling element 350 is visible in the ultrasound image but does not extend into the wall of the bronchial passageway. The medical practitioner rotates the entire delivery device 330 to align the tissue sampling element 350 with the eccentric node 8 and then moves the tissue sampling element 350 completely or entirely into the eccentric node 8. The delivery system according to FIG. 3A has advantages over conventional needle aspiration systems and is useful to the medical practitioner because it allows the medical practitioner to determine the location and orientation of the biopsy needle relative to the target pulmonary nodule while the biopsy needle is housed within the end cap or delivery device (e.g., before the initial advancement).

[0019] See Figure 6A. In one embodiment, the delivery device of Figure 3A includes an ultrasound transducer 340 disposed within a flexible sheath 344, which further includes a radiopaque material disposed in a strip 346 along a portion of its length. For example, the radiopaque material may be integrally formed within the sheath 344 in an extrusion process. See Figure 6B. line The strips 346 of opaque material are configured to block radiation visible as dark areas (e.g., slices) in an ultrasound image. line As described above, the tissue sampling element 350 exits the second opening 318a in the end cap 310 and extends directly opposite (e.g., directly above) the ultrasound transducer 340 and is coupled to the sheath 344. line The fixed location with the impermeable strip 346 allows medical personnel to identify where the tissue sampling element 350 is located prior to actuating the tissue sampling element.

[0020] In use, illustratively, a bronchoscope (not shown) is advanced through the trachea and into the bronchial passages near a target tissue site (e.g., a pulmonary nodule). line The delivery device includes an opaque strip 346 and is advanced distally through the working channel of the bronchoscope to obtain ultrasound images of the bronchial passageway. As the delivery device approaches the target tissue site, the ultrasound transducer 340 contacts the eccentric node 8 and the radiating line An ultrasound image of both the opaque strip 346 may be taken (FIGS. 6A and 6B). The delivery device 330 is then rotated so that the radiopaque strip 346 and the eccentric nodule 8 appear on opposite sides of the ultrasound image (FIG. 6C). The tissue sampling element 350 is then moved through the second opening 318a of the end cap 310 into the eccentric nodule 8 (FIG. 6D). The tissue sampling element 350 can be repeatedly retracted and advanced into the eccentric nodule without disturbing the surrounding healthy tissue, depending on the amount of biopsy tissue required. The tissue sampling element 350 is then retracted into the end cap 310 and the delivery device 330 is retracted proximally into the bronchoscope and removed from the patient's body. A biopsy sample of the eccentric nodule is then removed from within the lumen of the tissue sampling element 550 for cytological evaluation.

[0021] The medical device of the present invention is not limited to a bronchoscope, but may also include various medical devices for accessing internal body passages, such as catheters, urethroscopes, duodenoscopes, rectoscopes, arthroscopes, cystoscopes, hysteroscopes, and the like.

[0022] Finally, although embodiments of the present invention have been described for use with a bronchoscope, the delivery device of the present invention may be placed within a patient without an associated medical device, for example, the medical device may be inserted into the patient through the working channel of the medical device itself.

[0023] All of the devices and methods described in this specification and claims can be made and executed in light of the present invention without undue experimentation. While the devices and methods of the present invention have been described as preferred embodiments, those skilled in the art will recognize that various changes can be made in the devices and methods, and in the steps or sequence of steps of the methods described herein, without departing from the concept, spirit and scope of the invention. Accordingly, all similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the invention as defined by the appended claims.

Claims

1. An apparatus comprising: The apparatus includes a tissue sampling element operable between an inactivated state and an activated state; The device includes a sheath having a radiological marker; The apparatus includes an ultrasound transducer disposed within the sheath; The apparatus comprises a delivery device including a first working channel and a second working channel, the first working channel and the second working channel extending between a proximal end and a distal end of the delivery device; The device comprises an end cap having a first lumen and a second lumen, the first lumen extending from a proximal end of the end cap to a distal end of the end cap, and the second lumen extending between the proximal end of the end cap and an exterior surface of the end cap proximal to the distal end; the first lumen is aligned with the first working channel to form a continuous first lumen and the second lumen is aligned with the second working channel to form a continuous second lumen; the tissue sampling element is disposed within the continuous second lumen; the sheath is disposed within the continuous first lumen such that the radiographic marker is disposed at a predetermined angle relative to an opening of the first lumen on the exterior surface of the end cap; the second lumen of the end cap includes an angled surface; the sheath being configured as a conduit for a fluid; the inclined surface includes an angle of 5 to 10 degrees relative to the longitudinal axis of the distal end of the transport device such that the tissue sampling element is offset from the longitudinal axis of the end cap when the tissue sampling element is in the actuated state; the ultrasound transducer is configured to image the radiographic marker to form a first radial image when the tissue sampling element is in the non-activated state, and to image the radiographic marker and the tissue sampling element to form a second radial image when the tissue sampling element is in the activated state.

2. The apparatus of claim 1 , wherein a location of the radiological marker in the first radial image indicates a location of the tissue sampling element in the second radial image.

3. 3. The apparatus of claim 2, wherein the position of the radiological marker in the first radial image is offset from the position of the tissue sampling element in the second radial image by the preset angle.

4. The apparatus of claim 3 , wherein the angle is 180 degrees.

5. The apparatus of claim 1 , wherein the preset angle is an angle between 90 and 180 degrees.

6. 2. The apparatus of claim 1, wherein the preset angles are offset from one another by an angle between 180 and 270 degrees.

7. The apparatus of claim 1 , wherein the end cap is formed from one or more of a metal, a ceramic, and a hardened plastic material.

8. The device according to any one of claims 1 to 7, wherein the radiological marker comprises a radiopaque strip.

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