System and method for eccentric nodule tissue harvesting

Abstract

The present disclosure relates to the field of endoscopy. Specifically, the present disclosure relates to systems and methods for real-time visualization and sampling of target tissue within a body passage. In particular, the present disclosure relates to a system that provides real-time visualization of eccentric pulmonary nodules and allows determination of their position / orientation before the first actuation of a biopsy needle.

Description

[0001] This application is a divisional application of a patent application with an application date of December 6, 2017, application number 201780074288.9, and name “System and method for eccentric nodule tissue collection”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 62 / 431,006, filed on December 7, 2016, which is incorporated by reference in its entirety for all purposes. Technical Field

[0004] The present disclosure relates to the field of endoscopy. In particular, the present disclosure relates to systems and methods for real-time visualization and sampling of target tissue within a body passage. Technical Background

[0005] When clinical presentation indicates that tissue biopsy within a pulmonary passage is necessary, radial endobronchial ultrasound (R-EBUS) provides a minimally invasive alternative. Conventional R-EBUS transbronchial needle aspiration (TBNA) involves delivering a radial ultrasound probe through the working channel of a bronchoscope to the target airway, visualizing the target pulmonary nodule on the R-EBUS, locking the position of the access cannula, removing the radial ultrasound probe from the access cannula, and then blindly advancing the biopsy needle to obtain cellular material for cytological evaluation. This blind sampling may often cause the biopsy needle to miss the target nodule completely. In order to ensure that the target nodule is successfully biopsied, medical professionals typically actuate the biopsy needle into the lung tissue multiple times while rotating the endoscope. This repeated biopsy needle actuation may lead to a variety of negative medical outcomes, such as unnecessary trauma to healthy tissue surrounding the target nodule, decreased bleeding, increased likelihood of false-negative results, and increased duration and cost of the procedure. The inability to consistently and predictably obtain biopsy samples is particularly problematic for eccentric (e.g., offset) pulmonary nodules, which occur in approximately 40% of all lung surgeries. Sampling of eccentric pulmonary nodules requires the catheter or biopsy needle to be able to bend or turn within narrow lung passages.

[0006] Thus, various advantages may be achieved through a system that provides real-time visualization of eccentric pulmonary nodules and that allows the position / orientation of a biopsy needle to be determined prior to its first actuation. Summary of the invention

[0007] The present disclosure, in its various aspects, provides advantages in the medical field, such as the field of pulmonary endoscopy, allowing real-time visualization of sampling systems for eccentric lung nodules, and allowing the position / orientation of a biopsy needle to be determined before the first actuation. In various embodiments, an offset biopsy needle and a radial ultrasound transducer are disclosed that can allow accurate and efficient biopsy of eccentric lung nodule tissue.

[0008] In one aspect, the present disclosure relates to an end cap comprising: a proximal end; a distal end; a first lumen extending between the proximal end and the distal end to define a first opening; and a second lumen extending between the proximal end and an outer surface of the end cap to define a second opening. The first and second lumens may be separated by a variable thickness inner wall. The thickness of the inner wall may taper from the distal end to the proximal end to define an inclined surface within the second lumen. The inclined surface may include an angle of about 5 degrees to about 10 degrees relative to the longitudinal axis of the end cap. The first lumen may be configured to receive an ultrasonic transducer. The second lumen may be configured to receive a tissue sampling element. The end cap may include a variety of materials, including but not limited to metal or ceramic materials.

[0009] In another aspect, the present disclosure relates to a system, comprising: a delivery device including first and second working channels; and an end cap including first and second lumens, the first and second lumens defining first and second openings, respectively. The proximal end of the end cap can be attached to the distal end of the delivery device such that the first working channel is connected to the first lumen and the second working channel is connected to the second lumen. The first and second lumens can be separated by a variable thickness inner wall, wherein the thickness of the inner wall can taper from the distal end to the proximal end to define an inclined surface in the second lumen. The system can also include an ultrasonic transducer disposed in the first working channel and the first lumen. The ultrasonic transducer can extend distally beyond the distal end of the end cap. The system can also include a tissue sampling element slidably disposed in the second working channel and the second lumen. The proximal end of the end cap can be 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 can include a pocket in which the end cap is configured to fit. The pocket can include a cutout configured to align with the second opening. The ultrasonic transducer can be disposed within the cannula, wherein a portion of the cannula includes a radiopaque material. The radiopaque material can include, for example, a strip of radiopaque material extending along the length of the cannula. A portion of the cannula can extend distally beyond the ultrasonic transducer. The strip of radiopaque material and the second opening in the outer surface of the end cap can be offset by approximately 180 degrees.

[0010] In another aspect, the present disclosure is directed to a method comprising: advancing a tissue sampling system through a body passage, wherein the tissue sampling system comprises a delivery device and an end cap, the delivery device comprising first and second working channels, and the end cap comprising first and second lumens, the first and second lumens defining first and second openings, respectively, wherein a proximal end of the end cap is attached to a distal end of the delivery device such that the first working channel interfaces with the first lumen and the second working channel interfaces with the second lumen; imaging a target tissue within the body passage; advancing a tissue sampling element distally beyond the second opening of the end cap into the target tissue such that a portion of the target tissue is captured in 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 ultrasonic transducer. The tissue sampling element may be advanced into the target tissue while the target tissue is being imaged.

[0011] BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Non-limiting examples of the present disclosure are described with reference to the accompanying drawings, which are schematic and are not intended to be drawn to scale. In the drawings, each identical or nearly identical component shown is generally represented by a single numeral. For the purpose of clarity, not every component is labeled in every figure, and every component whose description is not necessary for a person skilled in the art to understand the present disclosure is not shown in every embodiment of the present disclosure. In the drawings:

[0013] Figure 1 A cross-sectional view of a catheter end cap according to one embodiment of the present disclosure is provided.

[0014] Figure 2A-2B According to one embodiment of the present disclosure, Figure 1 Schematic diagram of a catheter end cap attached to the distal end of a catheter.

[0015] Figure 3A-3B A schematic diagram of a tissue sampling system according to one embodiment of the present disclosure is provided.

[0016] Figure 4A-4B According to one embodiment of the present disclosure, a concentric Figure 4A ) and eccentricity ( Figure 4B ) Representative ultrasound images of pulmonary nodules.

[0017] Figures 5A-5F The steps involved in sampling an eccentric pulmonary nodule according to one embodiment of the present disclosure are shown.

[0018] Figures 6A-6D The steps involved in sampling an eccentric pulmonary nodule according to one embodiment of the present disclosure are shown.

[0019] It should be noted that the drawings are intended to depict only typical or exemplary embodiments of the present invention. Therefore, the drawings should not be considered to limit the scope of the present disclosure. The present disclosure will now be described in more detail with reference to the drawings. Specific embodiments

[0020] Before further describing the present invention in detail, it should be understood that the present invention is not limited to the specific embodiments described, because these embodiments can change.It should also be understood that the terms used herein are only used for the purpose of describing specific embodiments, and are not intended to limit the scope beyond the appended claims.Unless otherwise defined, all technical terms used herein have the same meaning as the meanings commonly understood by those of ordinary skill in the art to which the present disclosure belongs.Finally, although the embodiments of the present disclosure are described with specific reference to real-time visualization and sampling of eccentric pulmonary nodules, the systems and methods disclosed herein can be used to obtain biopsy samples from various body cavities, including, for example, heart, vascular system, circulatory system, gastrointestinal tract (GI), stomach, esophagus, urogenital system, etc.In various embodiments, in addition to the biopsy needle, the catheter end cap can also be applied to use with various tissue sampling tools (e.g., grasping or cutting elements).

[0021] As used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that when used herein, the terms "include" and / or "comprise" specify the presence of stated features, regions, step elements, and / or components, but do not exclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups.

[0022] As used herein, the term "distal" refers to the end farthest from the medical professional when the device is introduced into a patient, and the term "proximal" refers to the end closest to the medical professional when the device is introduced into a patient.

[0023] The present disclosure generally provides a dual-lumen catheter end cap that supports the side-by-side and simultaneous use of a tissue sampling element and a radial ultrasonic transducer. The tilted or angled configuration of one of the lumens can provide the ability to sample eccentric nodules without requiring the tissue sampling element to include a preformed curvature. The dual-lumen end cap has compatibility for use with a radial ultrasonic transducer that is configured to provide real-time visualization of a target lung nodule while indicating its position / orientation relative to the radial ultrasonic transducer before the first actuation of a biopsy needle. The dual-lumen end cap and radial ultrasonic transducer can also provide real-time visualization of a target lung nodule and the position / orientation of a biopsy needle for subsequent actuation into the same (or different) nodule.

[0024] Reference Figure 1In one embodiment, the present disclosure provides a catheter end cap 110, which includes a proximal end 112, a distal end 114, and first and second lumens 116, 118 separated by a variable thickness inner wall 122. The first lumen 116 may extend between the proximal and distal ends 112, 114 to define a first opening 116a. The second lumen 118 may extend between the proximal end 112 and the outer surface of the end cap 110 to define a second opening 118a. The first opening 116a and the second opening 118a are not limited to substantially circular and elliptical shapes, respectively, but may include various other shapes and / or configurations. The variable thickness inner wall 122 may taper from the distal end 114 to the proximal end 112, so that the second lumen 118 defines an inclined surface 122a (e.g., inclined, angled, etc.). The inclined surface 122a may include an angle of about 5 degrees to about 10 degrees relative to the longitudinal axis (L1) of the end cap 110, and may include any angle therebetween. As is known in the art, the end caps may be integrally formed from various metals, ceramics, or hardened plastic materials.

[0025] In one embodiment, the end caps of the present disclosure can be configured for attachment to a delivery device (eg, a catheter). Figure 2A , the delivery device 230 may include a distal portion 233 defining a recessed portion 233a (e.g., a pocket) configured to receive the end cap 210. The outer surface 220 of the end cap 210 may form an interference or friction fit within the recessed portion 233a sufficient to prevent the end cap from shifting during use (e.g., within a patient's body). Additionally or alternatively, the end cap 210 may be secured within the recessed portion 233a by suitable welding, soldering, brazing, adhesives, glues, and / or resins. The recessed portion 233a may also include a skived opening 233b configured to align with the second opening 218a of the end cap 210. Referring to Figure 2B , the proximal end 212 of the end cap 210 can be attached to the distal end 234 of the delivery device 230 by a bushing 235, which is 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 delivery device 230. The bushing 235 can cover a limited portion of the second opening 218a. In one embodiment, the bushing 235 can include a heat shrink material configured to secure the end cap 210 to the delivery device 230 without substantially increasing the thickness of the delivery device or the end cap. Additionally or alternatively, the bushing 235 can be secured to the delivery device and the end cap by an interference fit and / or a suitable weld, solder, braze, adhesive, glue, or resin.

[0026] Reference Figure 3A, the delivery device 330 may include first and second working channels 336, 338, such that when the end cap 310 is fixed to the delivery device, the first working channel 336 is aligned with the first lumen 316 and forms a contiguous lumen with the first lumen 316, and the second working channel 338 is aligned with the second lumen 318 and forms a contiguous lumen with the second lumen 318. The contiguous first working channel 336 and the first lumen 316 can be configured to receive an ultrasonic transducer 340 disposed in a flexible sleeve 344. The sleeve 344 can extend distally beyond the ultrasonic transducer 340 to protect the ultrasonic transducer when the delivery device 330 is advanced through a body passage. The sleeve 344 can also provide a conduit through which a medical professional can intermittently introduce a suitable fluid (e.g., isotonic saline, etc.) to consistently and reliably propagate ultrasonic energy. In one embodiment, the sleeve 344 and the ultrasonic transducer 340 can be fixedly disposed in the contiguous first working channel 336 and the first lumen 316. In another embodiment, the sleeve 344 and the ultrasonic transducer 340 can be slidably disposed within the connected first working channel 336 and the first inner cavity 316. In yet another embodiment, the ultrasonic transducer can include a radial ultrasonic probe that is rotatably disposed within the sleeve 344. The connected second working channel 338 and the second inner cavity 318 can be configured to slidably receive a tissue sampling element 350 (e.g., a biopsy needle). Figure 3B , the tissue sampling element 350 can be advanced distally along the inclined surface 322a of the end cap 310, such that the tissue sampling element 350 deflects (e.g., bends) away from the longitudinal axis of the end cap 310 when exiting the second opening 318a. When the tissue sampling element 350 is actuated beyond the distal end 314 of the end cap 310, the tissue sampling element 350 and the ultrasonic transducer 340 are offset by approximately 180 degrees relative to each other. In other words, the tissue sampling element 350 exits the second opening 318a at a position on the end cap 310 that is directly opposite (e.g., directly above) the ultrasonic transducer 340. Alternatively, the tissue sampling element and the ultrasonic transducer may be offset relative to each other by an angle 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) or an angle greater 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).

[0027] Figure 4A-4B Ultrasound images of the lungs show concentric pulmonary nodules occupying the central portion of the lung passages ( Figure 4A ) and eccentric pulmonary nodules located on the sides of the lung passages ( Figure 4B ) in terms of their morphological differences.

[0028] Reference Figures 5A-5F In use and by way of example, a bronchoscope (not shown) may be advanced through the trachea and into a bronchial passage proximate a target tissue site (eg, a lung nodule). Figure 3A The delivery device 330 (e.g., a catheter) can be advanced distally through the working channel of the bronchoscope and beyond the working channel of the bronchoscope to provide an ultrasound image of the bronchial passage. When the delivery device approaches the target tissue site, the ultrasound transducer 340 can provide an ultrasound image of the eccentric nodule 8 ( Figure 5A ).like Figure 5B As shown in FIG. 1 , the eccentric nodule 8 may appear as a dark lesion in the upper left quadrant of the ultrasound image, while the ultrasound transducer 340 may be identified as a black circle in the center of the ultrasound image. With the ultrasound transducer 340 positioned near the eccentric nodule 8, the medical professional may actuate (e.g., advance distally) the tissue sampling element 350 into the wall of the lung passage through the second opening 318a of the end cap 310. Figure 5C ).like Figure 5D As shown, the tissue sampling element 350 first appears on the ultrasound image after being actuated (e.g., advanced distally) beyond the ultrasound transducer 340. If the tissue sampling element 350 does not penetrate the eccentric nodule after the first actuation, the medical professional can retract the tissue sampling element 350 into the end cap 310 and rotate the entire delivery device 330 (e.g., the delivery device 330) based on the relative positions of the tissue sampling element 350 and the eccentric nodule 8. Figure 5C-5D ) so that the second opening 318a is aligned with the eccentric nodule 8 ( Figure 5E ), and then re-actuate the tissue sampling element 350 into the eccentric nodule 8 through the second opening 318a of the end cap 310 ( Fig. 5F ). The tissue sampling element 350 can then be retracted into the end cap 310 and the delivery device 330 retracted proximally into the bronchoscope and removed from the patient. The biopsy sample of the eccentric nodule can then be removed from the lumen of the tissue sampling element 350 for cytological evaluation. Figure 5C The tissue sampling element 350 is shown as penetrating the wall of the bronchial passage at a location that does not enter the eccentric nodule 8 (e.g., the target nodule is "missed"), in various embodiments, the tissue sampling element 350 can be actuated distally beyond the ultrasound transducer 340 so that the tip (e.g., a sharp point) of the tissue sampling element 350 appears on the ultrasound image but does not extend into the wall of the bronchial passage. The medical professional can then rotate the entire delivery device 330 to align the exposed tissue sampling element 350 with the eccentric nodule 8, and then actuate the tissue sampling element 350 completely or fully into the eccentric nodule 8. Although Figure 3AThe delivery device may have advantages over conventional needle aspiration systems, and it may be beneficial for a medical professional to determine the position / orientation of the biopsy needle relative to a target pulmonary nodule while the biopsy needle is contained within the end cap and / or delivery device (e.g., prior to its first actuation).

[0029] Reference Fig. 6A , in one embodiment, Figure 3A The delivery device may include an ultrasonic transducer 340 disposed within a flexible sleeve 344 that also includes a radiopaque material in a "strip" 346 disposed along a portion of the length of the sleeve. For example, the radiopaque material may be integrally formed within the sleeve 344 during an extrusion process. Figure 6B As shown, the strip 346 of radiopaque material can provide a radiopaque marker that is visible as a dark portion (e.g., a slice) on the ultrasound image. As described above, because the tissue sampling element 350 exits the second opening 318a of the end cap 310 and extends directly opposite the ultrasound transducer 340 (e.g., directly above it), the fixed position of the sleeve 344 and the radiopaque strip 346 allows the medical professional to identify the position where the tissue sampling element 350 will appear before it is actuated.

[0030] In use, and by way of example, a bronchoscope (not shown) can be advanced through the trachea and into a bronchial passageway proximate a target tissue site (e.g., a pulmonary nodule). A delivery device 330 (e.g., a catheter) including a cannula 344 and a radiopaque band 346 can be advanced through and distally beyond a working channel of the bronchoscope to provide an ultrasound image of the bronchial passageway. As the delivery device approaches the target tissue site, the ultrasound transducer 340 can provide an ultrasound image of the eccentric nodule 8 and the radiopaque band 346 ( Figure 6A-6B The delivery device 330 may then be rotated so that the radiopaque band 346 and the eccentric nodule 8 appear on opposite sides of the ultrasound image ( Figure 6C ). Then, the tissue sampling element 350 can be actuated through the second opening 318a of the end cap 310 into the eccentric nodule 8 ( Fig.6D ). Depending on the amount of biopsy tissue required, the tissue sampling element 350 can be repeatedly retracted and actuated into the eccentric nodule without worrying about surrounding healthy tissue. The tissue sampling element 350 can then be retracted into the end cap 310 and the delivery device 330 retracted proximally into the bronchoscope and removed from the patient. The biopsy sample of the eccentric nodule can then be removed from the lumen of the tissue sampling element 550 for cytological evaluation.

[0031] The medical devices of the present disclosure are not limited to bronchoscopes, and may include various medical devices for accessing body passages, including, for example, catheters, ureteroscopes, duodenoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, and the like.

[0032] Finally, although embodiments of the present disclosure have been described for use with a bronchoscope, the delivery devices of the present disclosure may be positioned within a patient without an accompanying medical device. For example, the medical device may be introduced into the patient through the working channel of the medical device itself.

[0033] According to the present disclosure, all devices and / or methods disclosed and claimed herein can be made and implemented without undue experimentation. Although the devices and methods of the present disclosure have been described according to preferred embodiments, it is obvious to those skilled in the art that the devices and / or methods described in the present application and the steps or step sequences of the methods can be changed without departing from the concept, essence and scope of the present disclosure. All such similar substitutions and modifications obvious to those skilled in the art are considered to be within the essence, scope and concept of the present disclosure as defined by the appended claims.

Claims

1. A tissue sampling device comprising: a tissue sampling element actuatable between an unactuated state and an actuated state; a cannula containing a radiopaque marker; a radial ultrasonic transducer disposed within the cannula and that images the radiopaque marker to generate a first image when the tissue sampling element is in an unactuated state and that images the radiopaque marker and the tissue sampling element to generate a second image when the tissue sampling element is in an actuated state; A delivery device including a first working channel and a second working channel; and an end cap attached to the delivery device, the end cap having a first lumen extending between a proximal end and a distal end thereof and a second lumen extending between a proximal end and an outer surface thereof, wherein the first and second working channels are aligned with and form contiguous lumens with the first and second lumens, wherein the cannula is disposed in a first working channel of the delivery device, and the tissue sampling element is disposed in a second working channel of the delivery device, wherein the position of the radiopaque marker in the first image is offset from the position of the tissue sampling element in the second image by a predetermined angle, and The first inner cavity and the second inner cavity of the end cap are separated by an inner wall of variable thickness, and the inner wall of variable thickness gradually tapers from the distal end to the proximal end, so that the second inner cavity defines an inclined surface, and the inclined surface includes an angle of 5 to 10 degrees relative to the longitudinal axis of the end cap.

2. The device according to claim 1, wherein: The position of the radiopaque marker in the first image indicates the position of the tissue sampling element in the second image.

3. The device according to claim 1, wherein: The predetermined angle is approximately 180 degrees.

4. The device according to claim 1, wherein: The tissue sampling element and the radial ultrasonic transducer are offset relative to each other by an angle of about 90 degrees, about 100 degrees, about 110 degrees, about 120 degrees, about 130 degrees, about 140 degrees, about 150 degrees, about 160 degrees, or about 170 degrees.

5. The device according to claim 1, wherein: The tissue sampling element and the radial ultrasonic transducer are offset relative to each other by an angle of about 190 degrees, about 200 degrees, about 210 degrees, about 220 degrees, about 230 degrees, about 240 degrees, about 250 degrees, about 260 degrees, or about 270 degrees.

6. The device according to claim 1, wherein: The angled surface is configured to bend the tissue sampling element away from a longitudinal axis of the end cap.

7. The device according to claim 1, wherein: The end cap is formed from one or more of metal, ceramic and hardened plastic material.

8. The device according to claim 1, wherein: The end cap includes an opening on an outer surface of the delivery device leading to the first working channel.

9. The device according to any one of claims 1 to 8, wherein: The radiopaque marker comprises a radiopaque strip.

10. A tissue sampling system comprising: a delivery device comprising first and second working channels; a cannula disposed within the first working channel of the delivery device; a tissue sampling element disposed within the second working channel; a radial ultrasonic transducer disposed within the cannula; and the cannula including a radiopaque marker positioned to indicate in an ultrasound image a projected position of a tissue sampling element when the tissue sampling element extends out of the second working channel; wherein the tissue sampling element is actuatable between an unactuated state in which the distal end of the tissue sampling element is within the second working channel and an actuated state in which the distal end of the tissue sampling element extends out of the second working channel, and the radial ultrasonic transducer is configured to image the radiopaque marker to generate a first image when the tissue sampling element is in the unactuated state, and to image the radiopaque marker and the tissue sampling element to generate a second image when the tissue sampling element is in the actuated state; wherein the position of the radiopaque marker in the first image is offset from the position of the tissue sampling element in the second image by a predetermined angle; The delivery device is attached to an end cap having a first lumen and a second lumen separated by a variable thickness inner wall, wherein the end cap is disposed at a distal end of the delivery device, the first lumen extending between a proximal end and a distal end of the end cap, the second lumen extending between a proximal end and an outer surface of the end cap, wherein the first working channel and the second working channel are aligned with and form adjacent lumens, and wherein the variable thickness inner wall tapers from the distal end to the proximal end such that the second lumen defines an inclined surface comprising an angle of 5 to 10 degrees relative to a longitudinal axis of the end cap.

11. The system according to claim 10, wherein: The position of the radiopaque marker in the first image indicates a projected position of the tissue sampling element in the actuated state.

12. The system according to claim 10, wherein: The predetermined angle is approximately 180 degrees.

13. The system according to claim 10, wherein: The radiopaque marker comprises a radiopaque strip.

Images