Device for entering the peripheral region of the lung using a tool attachment for direct visualization

Abstract

The present invention generally relates to the field of medical devices. In particular, the present invention relates to modular components, systems, and methods for the direct visualization and biopsy of peripheral lung nodules. In one example, the modular component of the present invention may include a double-lumen catheter attached to the distal end of a body, a first lumen may extend through the body, the first lumen being adjacent to the first lumen of the double-lumen catheter, a second lumen may extend through the body, the second lumen being adjacent to the second lumen of the double-lumen catheter; and an attachment member formed within the body at the proximal end of the second lumen.

Description

[0001] Related Applications

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 849,311, filed May 17, 2019, entitled "Device for Using a Tool Attachment to Access the Peripheral Regions of the Lung for Direct Visualization", the entire content of which is incorporated herein by reference.

[0003] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 849,649, filed May 17, 2019, entitled "Device for Providing an Adjustable Mechanism for a Radial Ultrasound Port and a Flush Port", the entire content of which is incorporated herein by reference.

[0004] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 849,307, filed May 17, 2019, entitled "Radial Ultrasound Needle Biopsy Device", the entire content of which is incorporated herein by reference. TECHNICAL FIELD

[0005] The present invention generally relates to the field of medical devices. In particular, the present invention relates to modular components, systems, and methods for the direct visualization and biopsy of peripheral lung nodules. BACKGROUND OF THE INVENTION

[0006] Due to the complex anatomy of the pulmonary system, one complicating factor in accurately and effectively obtaining a biopsy sample from a pulmonary nodule in the peripheral region of the lung is the inability to maintain direct visualization of the target pulmonary nodule when the biopsy sample is taken and / or when the biopsy instrument is repositioned or exchanged through the working channel of the bronchoscope.

[0007] Accordingly, various advantageous medical outcomes can be achieved through the modular components, systems, and methods of the present invention. SUMMARY OF THE INVENTION

[0008] In one aspect, a modular component of the present invention may include a dual-lumen catheter attached to the distal end of a body. A first lumen may extend through the body. The first lumen may be adjacent to the first lumen of the dual-lumen catheter. A second lumen may extend through the body. The second lumen may be adjacent to the second lumen of the dual-lumen catheter. An attachment member may be formed within the body at the proximal end of the second lumen.

[0009] In the described and other embodiments, the body and the first lumen of the dual-lumen catheter may be configured to receive a first endoscopic instrument therethrough. The body and the second lumen of the dual-lumen catheter may be configured to receive a second endoscopic instrument therethrough. A first support structure may be attached to the proximal end of the body at the proximal end of the first lumen. A second support structure may be attached to the distal end of the body at the distal end of the first lumen. An attachment member may be configured to receive the handle assembly of the second endoscopic instrument in a latching configuration.

[0010] In another aspect, the present invention relates to a system that includes modular components. The modular components may include a dual-lumen catheter attached to the distal end of a body. A first lumen may extend through the body. The first lumen may be adjacent to the first lumen of the dual-lumen catheter. A second lumen may extend through the body. The second lumen may be adjacent to the second lumen of the dual-lumen catheter. An attachment member may be formed within the body at the proximal end of the second lumen. A first endoscopic instrument may extend through the body and the first lumen of the dual-lumen catheter. A second endoscopic instrument may extend through the body and the second lumen of the dual-lumen catheter.

[0011] In the described and other embodiments, the first endoscopic instrument may include a radial ultrasound probe and the second endoscopic instrument may include a biopsy needle. The second endoscopic instrument may be configured to move laterally between a first and a second position within the dual-lumen catheter. The attachment member may be configured to receive the handle assembly of the second endoscopic instrument in a latching configuration. The handle assembly may be configured to move laterally along the body of the modular component. The handle assembly may be configured to move from a first position where the distal end of the second endoscopic instrument may be disposed within the second lumen of the dual-lumen catheter to a second position where the distal end of the second endoscopic instrument may extend beyond the distal end of the dual-lumen catheter. The handle assembly may include a plunger configured to move the second endoscopic instrument between the first and second positions. The dual-lumen catheter may be configured to extend through the working channel of a bronchoscope. The second endoscopic instrument may provide columnar support to the dual-lumen catheter. A first support structure may be attached to the proximal end of the body at the proximal end of the first lumen. A second support structure may be attached to the distal end of the body at the distal end of the first lumen. The first and second support structures may provide a leak-proof seal for the first lumen.

[0012] In yet another aspect, the present invention relates to a method that may include advancing a bronchoscope into a patient's lung passage. A dual-lumen catheter may be advanced through the working channel of the bronchoscope such that the distal end of the dual-lumen catheter may extend beyond the distal end of the bronchoscope. A first lung nodule may be visualized using a first endoscopic instrument that may extend through the first lumen of the dual-lumen catheter. A biopsy sample of the first lung nodule may be obtained using a second endoscopic instrument that extends through the second lumen of the dual-lumen catheter.

[0013] In the described and other embodiments, visualization of the first pulmonary nodule and acquisition of a biopsy sample of the first pulmonary nodule can occur without exchanging the first instrument with another instrument. The method can also include removing a second endoscopic instrument from a second lumen of a double-lumen catheter without changing the position of the first endoscopic instrument within the pulmonary passageway. The method can also include expelling a biopsy sample from the second endoscopic instrument. The method can also include advancing the second endoscopic instrument through the second lumen of the double-lumen catheter. The method can also include advancing the double-lumen catheter through the pulmonary passageway to visualize a second pulmonary nodule. The method can also include acquiring a biopsy sample of the second pulmonary nodule with the second endoscopic instrument. The first pulmonary nodule can include an eccentric pulmonary nodule. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Non-limiting embodiments of the invention are described by way of example with reference to the accompanying schematic and not-to-scale drawings. In the drawings, each identical or nearly identical component shown is generally represented by a single numeral. For clarity, not every component is labeled in every figure, nor is every component of every embodiment shown where illustration is not necessary to enable those of ordinary skill in the art to understand the invention. In the drawings:

[0015] Figures 1 to 3 A perspective view of a direct visualization and biopsy assembly according to one embodiment of the invention is provided.

[0016] Figures 4A to 4C A perspective view of the distal portion of a direct visualization and biopsy assembly according to one embodiment of the invention is provided.

[0017] Figure 5 A schematic view of a direct visualization and biopsy assembly for acquiring a biopsy sample according to one embodiment of the invention is provided. DETAILED DESCRIPTION

[0018] The invention is not limited to the specific embodiments described herein. The terms used herein are only for the purpose of describing particular 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 this invention belongs.

[0019] Although embodiments of the invention are specifically described with reference to modular components, systems, and methods designed to provide dual-functional visualization and diagnostic sampling of pulmonary nodules within the peripheral regions of the lung, it should be understood that such components, systems, and methods can be used to visualize and manipulate various tissues within a variety of different body cavities and / or body passageways.

[0020] As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. It will also be understood that when used herein, the terms "comprises" and / or "comprising" or "includes" and / or "including" specify the presence of the stated features, regions, steps, elements and / or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and / or groups.

[0021] As used herein, the term "distal" refers to the end that is farthest from the medical professional when the device is introduced into a patient's body, while the term "proximal" refers to the end that is closest to the medical professional when the device is introduced into a patient's body.

[0022] In various embodiments, the present invention generally relates to a direct visualization and biopsy modular component (e.g., a modular tool attachment) that can include an ergonomic handle and a catheter configured for dual-functional use during an endoscopic procedure. As a non-limiting example, the modular component can be configured to be used within the working channel of a bronchoscope to provide real-time visualization (e.g., radial ultrasound imaging) and manipulation (e.g., diagnostic biopsy sampling) of an isolated pulmonary nodule in the peripheral region of the lung. As disclosed herein, in various embodiments, the modular component can be configured to reposition and / or exchange endoscopic tools / instruments (e.g., a second endoscopic instrument) within the peripheral region of the lung while maintaining direct visualization of the pulmonary nodule (e.g., with a first endoscopic instrument). Additionally or alternatively, the modular component can be configured to allow a medical professional to access, lock and / or manipulate an endoscopic tool / instrument attached thereto with a single hand.

[0023] Reference Figure 1, in one embodiment, the modular component 100 of the present invention may include a flexible double-lumen catheter 112 (e.g., a double-lumen elongate shaft, etc.), which is attached to or otherwise extends from the proximal end of the body 110 (e.g., a housing, an ergonomic handle, etc.). The first and second lumens 114, 116 may extend through the body 110 such that the first lumen 114 is adjacent to (e.g., coextensive with) the first lumen 115 of the double-lumen catheter 112, and the second lumen 116 is adjacent to the second lumen 117 of the double-lumen catheter 112. In various embodiments, the continuous first lumens 114, 115 of the body 110 and the double-lumen catheter 112 may be configured to receive a first endoscopic instrument 140 (e.g., a radial ultrasound probe) therethrough, e.g., in a rotatable manner, and the continuous second lumens 116, 117 of the body 110 and the double-lumen catheter 112 may be configured to slidably and / or rotatably receive a second endoscopic instrument 150 (e.g., a biopsy needle) therethrough. An attachment member 118 may be formed within or adjacent to the proximal end of the second lumen 116 in the body 110 or otherwise attached to the body 110. As discussed below, in various embodiments, the attachment member 118 may be configured to receive / engage a corresponding surface (e.g., the handle assembly 154 of the second endoscopic instrument) of the second endoscopic instrument 150 in a latching configuration such that the second endoscopic instrument 150 may move laterally (e.g., back and forth) along / relative to the longitudinal axis of the body 110.

[0024] In one embodiment, the first support structure 120 may be attached to or integrally formed with the body 110 at or near the proximal end of the first lumen 114, and the second support structure 122 may be attached to or integrally formed with the body 110 at or near the distal ends of the first and second lumens 114, 116. In various embodiments, the first and second support structures 120, 122 may be configured to eliminate, minimize, or reduce bending or kinking of the first endoscopic instrument 140 (e.g., a radial ultrasound probe) extending through the continuous first lumens 114, 115, which bending or kinking may impair the ultrasound image quality or otherwise have a negative impact thereon. For example, the first and second support structures 120, 122 may limit the degree to which the first endoscopic instrument 140 bends or flexes within the body 110 and / or the proximal portion of the dual-lumen catheter 112, such as to permit the high-speed rotation necessary for a radial ultrasound probe to pass through the entire length of the dual-lumen catheter 112. Additionally or alternatively, the first and second support structures 120, 122 may provide a damping or insulating function to prevent, minimize, or eliminate external forces acting on the body 110, e.g., contact by other medical devices and / or the hands of a medical professional operating modular components, such that they do not propagate through the body 110 and interfere with or otherwise corrupt the ultrasound signal. In various additional embodiments, the first and second support structures 120, 122 may provide leak-proof seals at the proximal and distal ends of the first lumen 114 of the body 110, such that fluid flushed through the continuous first lumens 114, 115 of the body 110 and the dual-lumen catheter 112 (e.g., to remove air from within the first lumens 114, 115 and / or improve the propagation of the ultrasound signal using the pulmonary passage) does not leak into the patient's body and / or the continuous second lumens 116, 117 of the body 110 and the dual-lumen catheter 112.

[0025] Reference Figure 2 , in one embodiment, the system 200 of the present invention may include a first endoscopic instrument 140 (e.g., a radial ultrasound probe) disposed within the first lumens 114, 115 of the body 110 and the dual-lumen catheter 112, such that an ultrasound transducer 142 disposed at the distal end of the first endoscopic instrument 140 extends beyond the distal end of the dual-lumen catheter 112 ( Figure 4A ). In various additional embodiments, a second endoscopic instrument 150 (e.g., a slender biopsy needle) may be slidably disposed within the second lumens 116, 117 of the body 110 and the dual-lumen catheter 112 to move the sharp distal end 152 of the second endoscopic instrument 150 between a first position (e.g., retracted proximally, shielded, or protected within the second lumen 117) ( Figure 4A ) and a second position (e.g., extending distally beyond or exposed from the second lumen 117) ( Figure 4B ).

[0026] In one embodiment, the handle assembly 154 of the second endoscopic instrument 150 ( Figure 3 ) may engage with the attachment member 118 of the body 110 in a latching configuration. In various embodiments, the proximal portion of the second endoscopic instrument 150 may extend through the handle assembly 154 such that the proximal end of the second endoscopic instrument 150 is attached to a plunger 156 that extends beyond the proximal end of the handle assembly 154. A spring 158 may be disposed around the outer circumference of a portion of the second endoscopic instrument 150 such that the plunger 156 may move between a first position (e.g., non-depressed, non-deployed) and a second position (e.g., depressed, deployed, etc.).

[0027] Reference Figures 4A to 4C , in various embodiments, the handle assembly 154 may be laterally moved (e.g., slid back and forth) along the longitudinal axis of the body 110 of the modular assembly 100 between a proximal retracted position and a distal extended position, in the proximal retracted position, the sharp distal end 152 of the second endoscopic instrument 150 is in a first position ( Figure 4A ), and in the distal extended position, the sharp distal end 152 of the second endoscopic instrument 150 is in a second position ( Figure 4B ). In various additional embodiments, when the handle assembly 154 is in the distal extended position and the sharp distal end 152 of the second endoscopic instrument 150 is in the second position, the plunger 156 may move from the first position to the second position to further distally advance the sharp distal end 152 of the second endoscopic instrument 150 relative to the ultrasonic transducer 142 ( Figure 4C ).

[0028] Reference Figure 5, in use and by way of example, a bronchoscope (not shown) can be advanced into a patient's lung passage (e.g., through the esophagus). The dual-lumen catheter 112 of the modular assembly 100 can then be introduced into the working channel of the bronchoscope and advanced distally through the working channel, e.g., by a medical professional holding the body 110 of the modular assembly 100. The dual-lumen catheter 112 can be advanced distally beyond the distal end of the bronchoscope and into the peripheral region of the lung (e.g., where early cancerous lung nodules tend to form) under the guidance of radial ultrasound direct imaging provided by the ultrasound transducer 142 that extends beyond the distal end of the dual-lumen catheter 112 to identify the first lung nodule 160. Subsequently, the handle assembly 154 of the second endoscopic instrument 150 can be laterally moved from a proximal retracted position to a distal extended position along the longitudinal axis of the body 110 of the modular assembly 100 to expose the sharp distal end 152 of the second endoscopic instrument 150 from within the second lumen 117 of the dual-lumen catheter 112. In various embodiments, the sharp distal end 152 of the second endoscopic instrument 150 can be substantially adjacent to the ultrasound transducer 142 or extend slightly distally beyond the ultrasound transducer 142 such that the lung nodule 160 and the sharp distal end 152 can be imaged simultaneously. In various embodiments, the body 110 of the modular assembly 100 can be rotated and / or advanced distally to position / align the sharp distal end 152 of the second endoscopic instrument 150 with the lung nodule 160. The plunger 156 can then be repeatedly moved between a first and a second position to extend / advance the sharp distal end 152 of the second endoscopic instrument 150 into the lung nodule 160. In various embodiments, the plunger 156 can be depressed multiple times (e.g., 12 to 15 times) to ensure that a biopsy sample 150 of the lung nodule 160 of sufficient volume and location is obtained within the lumen of the sharp distal end 152 of the second endoscopic instrument for diagnostic analysis.

[0029] In various embodiments, the handle assembly 154 can then be detached from the attachment member 118 of the body 110 and the second endoscopic instrument 150 can be withdrawn / retracted through the continuous second lumens 116, 117 of the body 110 and the dual-lumen catheter 112 while the dual-lumen catheter 112 remains disposed within the working channel of the bronchoscope. Then, the biopsy sample can be ejected from the lumen of the second endoscopic instrument for diagnostic analysis and the second endoscopic instrument 150 can be reinserted / inserted (e.g., the same second endoscopic instrument or a different / second endoscopic instrument) through the continuous second lumens 116, 117 such that the sharp distal end 152 returns to a first position within the dual-lumen catheter 112 ( Figure 4A)And the ultrasound transducer 142 is maintained adjacent to and visualizes the first lung nodule 160. In various embodiments, additional biopsy samples can be obtained from the first lung nodule 160 by repeating the steps described above. Alternatively, the dual-lumen catheter 112 can be repositioned within the peripheral region of the lung (e.g., advanced to a more distal peripheral region or a different peripheral branch) to visualize a second lung nodule (not shown). The handle assembly 154 and the plunger 156 can then be actuated, and the sharp distal end 152 of the second endoscopic instrument 150 can be repositioned and / or rotated, as discussed above, to obtain a biopsy sample from the second lung nodule.

[0030] In various embodiments, the modular components 100 and system 200 described above can offer a number of advantages compared to conventional components and systems. As a non-limiting example, a first advantage can be provided by the second endoscopic instrument 150 extending through the second lumen 117 of the dual-lumen catheter 112, which can provide columnar support for the dual-lumen catheter 112 to protect the first endoscopic instrument 140 from excessive bending, twisting, or kinking within the narrow and tortuous lung passages. A second advantage can be provided by maintaining the sharp distal end 152 of the second endoscopic instrument 150 within the dual-lumen catheter 112 when imaging a lung nodule, thereby allowing a biopsy sample to be obtained during imaging without the need for device exchange. A third advantage can be provided by the plunger and spring of the handle assembly, which can allow a healthcare professional to actuate the second endoscopic instrument with one hand, e.g., to obtain a sufficient biopsy sample from a lung nodule. A fourth advantage can be provided by the side-by-side configuration of the first and second lumens 115, 117 of the dual-lumen catheter 112, which can allow a healthcare professional to rotate the body 110 of the modular component 100 to align the sharp distal end 152 of the second endoscopic instrument 150 with an off-center lung nodule while maintaining visualization of the lung nodule (e.g., when the second endoscopic instrument 150 is rotated about / relative to the axis of the first endoscopic instrument 140). A fourth advantage can be provided by the body 110 of the modular component 100 being configured for single-user control or multi-user control. For example, multi-user control can allow a first healthcare professional (e.g., a physician) to position the first endoscopic instrument 140 adjacent to a target lung nodule and allow a second healthcare professional (e.g., a medical assistant) to manipulate the second endoscopic instrument 150 (e.g., obtain a biopsy sample and remove the second endoscopic instrument through the working channel) under the direction of the first healthcare professional. Alternatively, single-user control can allow a healthcare professional to manipulate the first endoscopic instrument 140 with one hand and the second endoscopic instrument 150 with the other hand.

[0031] In various embodiments, the second endoscopic instrument 150 of the present invention is not limited to a biopsy needle, but may include a variety of medical devices configured to manipulate target tissue within a body passage, including, for example, an electrocautery knife, a clip, a brush, scissors, a grasper, forceps, a laser ablation element, and the like. Other peripheral lung nodule visualization and / or biopsy techniques, features, and / or components that may be used herein are disclosed in U.S. Non - Provisional Patent Application No. 8150.0600, entitled "Device Providing Adjustable Mechanisms for Radial Ultrasound Ports and Flush Ports," filed on the same day (the entire content of which is incorporated herein by reference) and / or U.S. Non - Provisional Patent Application No. 8150.0746, entitled "Medical Imaging Devices, Systems, and Methods," filed on the same day (the entire content of which is incorporated herein by reference).

[0032] According to the present invention, all of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation. While the devices and methods of the present invention have been described in terms of preferred embodiments, it will be apparent to those skilled in the art that changes can be made to the devices and / or methods and to the steps of the methods described herein or to the sequence of the steps without departing from the concepts, spirit, and scope of the present invention. All such similar substitutions and modifications that are obvious to those skilled in the art are considered to be within the spirit, scope, and concept of the present invention as defined by the appended claims.

Claims

1. A modular component, comprising: A body having a first cavity and a second cavity extending therethrough, the body configured to receive a first endoscopic instrument in the first cavity and a second endoscopic instrument in the second cavity; A double-lumen catheter attached to the distal end of the body, the double-lumen catheter having a shaft with a first cavity and a second cavity disposed therein; The first cavity of the body is adjacent to the first cavity of the double-lumen catheter; The second cavity of the body is adjacent to the second cavity of the double-lumen catheter; An attachment member formed within the body at the proximal end of the second cavity of the body, the attachment member configured to engage with the second endoscopic instrument such that the second endoscopic instrument can move laterally along the longitudinal axis of the body; And A first support structure attached to the proximal end of the body at the proximal end of the first cavity of the body and a second support structure attached to the distal end of the body at the distal end of the first cavity of the body, wherein the first support structure and the second support structure provide a leak-proof seal for the first cavity of the body; Wherein the body can be rotated and / or advanced distally to position / align the distal end of the second endoscopic instrument with a pulmonary nodule; Wherein the first endoscopic instrument is a radial ultrasound probe and the second endoscopic instrument is a biopsy needle; Wherein the double-lumen catheter is configured to extend through the working channel of a bronchoscope.

2. The modular component according to claim 1, wherein the first cavities of the body and the double-lumen catheter are configured to receive a first endoscopic instrument therethrough, and wherein the second cavities of the body and the double-lumen catheter are configured to receive a second endoscopic instrument therethrough.

3. The modular component according to claim 2, wherein the attachment member is configured to receive the handle assembly of the second endoscopic instrument in a snap-lock configuration.

4. A system, comprising: A first endoscopic instrument and a second endoscopic instrument; And A modular component, the modular component comprising: A body having a first cavity and a second cavity extending therethrough, the body configured to receive the first endoscopic instrument in the first cavity and the second endoscopic instrument in the second cavity, A double-lumen catheter attached to the distal end of the body, the double-lumen catheter having a shaft with a first cavity and a second cavity disposed therein, The first cavity of the body is adjacent to the first cavity of the double-lumen catheter, The second cavity of the body is adjacent to the second cavity of the double-lumen catheter, An attachment member formed within the body at the proximal end of the second cavity of the body, the attachment member configured to engage with the second endoscopic instrument such that the second endoscopic instrument can move laterally along the longitudinal axis of the body, and A first support structure attached to the proximal end of the body at the proximal end of the first cavity of the body and a second support structure attached to the distal end of the body at the distal end of the first cavity of the body, wherein the first support structure and the second support structure provide a leak-proof seal for the first cavity of the body; Wherein the body can be rotated and / or advanced distally to position / align the distal end of the second endoscopic instrument with a pulmonary nodule; wherein the first endoscopic instrument extends through the body and the first lumen of the double-lumen catheter; wherein the second endoscopic instrument extends through the body and the second lumen of the double-lumen catheter; wherein the first endoscopic instrument is a radial ultrasound probe and the second endoscopic instrument is a biopsy needle; wherein the double-lumen catheter is configured to extend through the working channel of a bronchoscope.

5. The system according to claim 4, wherein the second endoscopic instrument is configured to move laterally between a first and a second position within the double-lumen catheter.

6. The system according to claim 4, wherein the attachment member is configured to receive the handle assembly of the second endoscopic instrument in a snap-lock configuration.

7. The system according to claim 6, wherein the handle assembly is configured to move laterally along the body of the modular assembly.

8. The system according to claim 7, wherein the handle assembly is configured to move from a first position, in which the distal end of the second endoscopic instrument is disposed within the second lumen of the double-lumen catheter, to a second position, in which the distal end of the second endoscopic instrument extends beyond the distal end of the double-lumen catheter.

9. The system according to claim 8, wherein the handle assembly includes a plunger configured to move the second endoscopic instrument between the first and second positions.

10. The system according to any one of claims 4 to 9, wherein the second endoscopic instrument provides columnar support to the double-lumen catheter.

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