阅读说明：本技术 利用工具附接件以进入肺的外周区域进行直接可视化的装置 (Device for direct visualization with tool attachment for accessing peripheral regions of the lung ) 是由 凯文·沃尔什 杰瑞米·迪图利奥 道格拉斯·W·加里蒂 泰勒·诺伊斯 谢默斯·F·奥肖内西 于 2020-05-15 设计创作，主要内容包括：本发明总体涉及医疗装置的领域。特别地,本发明涉及用于外周肺结节的直接可视化和活检的模块化组件、系统和方法。在一个示例中,本发明的模块化组件可以包括附接到主体远端的双腔导管,第一腔可以延伸通过所述主体,所述第一腔与所述双腔导管的第一腔邻接,第二腔可以延伸通过所述主体,所述第二腔与所述双腔导管的第二腔邻接；以及在所述第二腔的近端处形成在所述主体内的附接构件。(The present invention relates generally to the field of medical devices. In particular, the present invention relates to modular assemblies, systems, and methods for direct visualization and biopsy of peripheral lung nodules. In one example, a modular assembly of the present invention may include a dual lumen catheter attached to a distal end of a main body through which a first lumen may extend, the first lumen being contiguous with a first lumen of the dual lumen catheter, through which a second lumen may extend, the second lumen being contiguous with a second lumen of the dual lumen catheter; and an attachment member formed within the body at a proximal end of the second lumen.)

1. A modular assembly, comprising:

a main body;

a dual lumen catheter attached to the distal end of the body;

a first lumen extending through the body, the first lumen contiguous with the first lumen of the dual lumen catheter;

a second lumen extending through the body, the second lumen contiguous with a second lumen of the dual lumen catheter; and

an attachment member formed within the body at a proximal end of the second lumen.

2. The modular assembly of claim 1, wherein the main body and the first lumen of the dual lumen catheter are configured to receive a first endoscopic instrument therethrough, and wherein the main body and the second lumen of the dual lumen catheter are configured to receive a second endoscopic instrument therethrough.

3. The modular assembly of any of claims 1-2, further comprising a first support structure attached to the proximal end of the body at the proximal end of the first cavity.

4. The modular assembly of any of claims 1-3, further comprising a second support structure attached to a distal end of the body at a distal end of the first lumen.

5. The modular assembly of any of claims 2-4, wherein the attachment member is configured to receive a handle assembly of the second endoscopic instrument in a snap-lock configuration.

6. A system, comprising:

a modular assembly, the modular assembly comprising:

a main body which is provided with a plurality of grooves,

a dual lumen catheter attached to the distal end of the body,

a first lumen extending through the body, the first lumen contiguous with the first lumen of the dual lumen catheter,

a second lumen extending through the body, the second lumen contiguous with the second lumen of the dual lumen catheter, an

An attachment member formed within the body at a proximal end of the second lumen;

a first endoscopic instrument extending through the body and the first lumen of the dual lumen catheter; and

a second endoscopic instrument extending through the main body and the second lumen of the dual lumen catheter.

7. The system of claim 6, wherein the first endoscopic instrument is a radial ultrasound probe and the second endoscopic instrument is a biopsy needle.

8. The system of claim 6 wherein the second endoscopic instrument is configured to move laterally between first and second positions within the dual lumen catheter.

9. The system of any one of claims 6 to 8, wherein the attachment member is configured to receive a handle assembly of the second endoscopic instrument in a snap-lock configuration.

10. The system of claim 9, wherein the handle assembly is configured to move laterally along the body of the modular assembly.

11. The system of claim 10, wherein the handle assembly is configured to move from a first position in which a distal end of the second endoscopic instrument is disposed within the second lumen of the dual lumen catheter to a second position in which the distal end of the second endoscopic instrument extends beyond a distal end of the dual lumen catheter.

12. The system of claim 11, wherein the handle assembly includes a plunger configured to move the second endoscopic instrument between the first and second positions.

13. The system of any of claims 6-12, wherein the dual lumen catheter is configured to extend through a working channel of a bronchoscope.

14. The system of any of claims 6-13, wherein the second endoscopic instrument provides columnar support to the dual lumen catheter.

15. The system of any one of claims 6-14, further comprising a first support structure attached to the proximal end of the body at the proximal end of the first lumen and a second support structure attached to the distal end of the body at the distal end of the first lumen, wherein the first and second support structures provide a leak-proof seal for the first lumen.

Technical Field

The present invention relates generally to the field of medical devices. In particular, the present invention relates to modular assemblies, systems, and methods for direct visualization and biopsy of peripheral lung nodules.

Background

Due to the complex anatomy of the lung system, one complicating factor in accurately and efficiently obtaining biopsy samples from lung nodules in the peripheral region of the lung is the inability to maintain direct visualization of the target lung nodule as the biopsy sample is withdrawn and/or as the biopsy instrument is repositioned or exchanged through the working channel of the bronchoscope.

Accordingly, a variety of beneficial medical results may be achieved by the modular assemblies, systems, and methods of use of the present invention.

Disclosure of Invention

In one aspect, the modular assembly of the present invention may include a dual lumen catheter attached to the distal end of the main body. The first lumen may extend through the body. The first lumen may be contiguous with the first lumen of the dual lumen catheter. The second cavity may extend through the body. The second lumen may be contiguous with 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.

In the described and other embodiments, the main 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. The first support structure may be attached to the proximal end of the main body at the proximal end of the first lumen. The second support structure may be attached to the distal end of the body at the distal end of the first lumen. The attachment member may be configured to receive a handle assembly of a second endoscopic instrument in a snap-lock configuration.

In another aspect, the invention relates to a system that includes a modular component. The modular assembly may include a dual lumen catheter attached to the distal end of the body. The first lumen may extend through the body. The first lumen may be contiguous with the first lumen of the dual lumen catheter. The second cavity may extend through the body. The second lumen may be contiguous with 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.

In the described and other embodiments, the first endoscopic instrument may comprise a radial ultrasound probe and the second endoscopic instrument may comprise a biopsy needle. The second endoscopic instrument may be configured to move laterally between first and second positions within the dual lumen catheter. The attachment member may be configured to receive a handle assembly of a second endoscopic instrument in a snap-lock configuration. The handle assembly may be configured to move laterally along the body of the modular assembly. The handle assembly may be configured to move from a first position in which the distal end of the second endoscopic instrument may be disposed within the second lumen of the dual lumen catheter to a second position in which 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 the bronchoscope. A second endoscopic instrument may provide columnar support to the dual lumen catheter. The first support structure may be attached to the proximal end of the main body at the proximal end of the first lumen. The 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 cavity.

In yet another aspect, the invention relates to a method that may include advancing a bronchoscope into a pulmonary tract of a patient. 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 with a first endoscopic instrument that may extend through a first lumen of a dual lumen catheter. A biopsy sample of the first lung nodule may be obtained with a second endoscopic instrument extending through a second lumen of the dual lumen catheter.

In the described and other embodiments, visualizing the first lung nodule and obtaining a biopsy sample of the first lung nodule may occur without exchanging the first instrument for another instrument. The method may further include removing a second endoscopic instrument from within a second lumen of the dual lumen catheter without changing a position of the first endoscopic instrument within the lung passageway. The method may further include discharging the biopsy sample from within the second endoscopic instrument. The method may further comprise advancing a second endoscopic instrument through a second lumen of the dual lumen catheter. The method may further comprise advancing a dual lumen catheter through the lung passageway to visualize the second lung nodule. The method may further include obtaining a biopsy sample of a second lung nodule with a second endoscopic instrument. The first lung nodule may comprise an eccentric lung nodule.

Drawings

Non-limiting embodiments of the present invention are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated is typically represented by a single numeral. For purposes of clarity, not every component may be labeled in every drawing, nor is every component of every embodiment shown where illustration is not necessary to allow those of ordinary skill in the art to understand the invention. In the drawings:

fig. 1-3 provide perspective views of a direct visualization and biopsy assembly according to one embodiment of the present invention.

Fig. 4A-4C provide perspective views of a distal portion of a direct visualization and biopsy assembly according to one embodiment of the invention.

Fig. 5 provides a schematic illustration of a direct visualization and biopsy assembly for obtaining a biopsy sample according to one embodiment of the present invention.

Detailed Description

The present invention is not limited to the specific embodiments described herein. 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 art to which this invention belongs.

While embodiments of the present invention have been described with particular reference to modular assemblies, systems and methods designed to provide dual function visualization and diagnostic sampling of lung nodules within peripheral regions of the lung, it should be understood that such assemblies, systems and methods may be used to visualize and manipulate a variety of tissues within a variety of different body lumens and/or body passageways.

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 the terms "comprises" and/or "comprising," or "includes" and/or "including," when used herein, specify the presence of 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 thereof.

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

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

Referring to fig. 1, in one embodiment, a modular assembly 100 of the present invention may include a flexible dual lumen catheter 112 (e.g., a dual lumen elongate shaft, etc.) attached to or otherwise extending from a proximal end (e.g., a housing, an ergonomic handle, etc.) of a body 110. The first and second lumens 114, 116 may extend through the body 110 such that the first lumen 114 is contiguous with (e.g., coextensive with) the first lumen 115 of the dual lumen catheter 112 and the second lumen 116 is contiguous with the second lumen 117 of the dual lumen catheter 112. In various embodiments, the continuous first lumens 114, 115 of the main body 110 and the dual 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 main body 110 and the dual 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 the body 110 at or adjacent the proximal end of the second lumen 116 or otherwise attached to the body 110. As discussed below, in various embodiments, the attachment member 118 can be configured to receive/engage a corresponding surface of the second endoscopic instrument 150 (e.g., the handle assembly 154 of the second endoscopic instrument) in a snap-lock configuration such that the second endoscopic instrument 150 can move laterally (e.g., back and forth) along/relative to the longitudinal axis of the body 110.

In one embodiment, the first support structure 120 may be attached to or integrally formed with the main 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 main 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., the radial ultrasound probe) extending through the continuous first lumen 114, 115 that may impair or otherwise negatively impact ultrasound image quality. 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, e.g., to allow the high speed rotation necessary to pass the radial ultrasound probe 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, for example, being contacted by other medical devices and/or the hands of a medical professional operating the modular assembly, from propagating through the body 110 and interfering with or otherwise damaging the ultrasound signals. In various further embodiments, the first and second support structures 120, 122 may provide a leak-proof seal at the proximal and distal ends of the first lumen 114 of the body 110 such that fluid flushed through the continuous first lumen 114, 115 of the body 110 and dual-lumen catheter 112 (e.g., to remove air from within the first lumen 114, 115 and/or to improve propagation of ultrasound signals with the pulmonary tract) does not leak into the patient and/or into the continuous second lumen 116, 117 of the body 110 and dual-lumen catheter 112.

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

In one embodiment, the handle assembly 154 (fig. 3) of the second endoscopic instrument 150 may engage the attachment member 118 of the body 110 in a snap-lock configuration. In various embodiments, a proximal portion of the second endoscopic instrument 150 may extend through the handle assembly 154 such that a 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 about an outer circumference of a portion of the second endoscopic instrument 150 such that the plunger 156 is movable between a first position (e.g., undepressed, undeployed) and a second position (e.g., depressed, deployed, etc.).

Referring to fig. 4A-4C, in various embodiments, handle assembly 154 can be laterally moved (e.g., slid back and forth) along the longitudinal axis of body 110 of modular assembly 100 between a proximally retracted position in which sharpened distal end 152 of second endoscopic instrument 150 is in a first position (fig. 4A) and a distally extended position in which sharpened distal end 152 of second endoscopic instrument 150 is in a second position (fig. 4B). In various further embodiments, with the handle assembly 154 in the distally extended position and the sharpened distal end 152 of the second endoscopic instrument 150 in the second position, the plunger 156 may be moved from the first position to the second position to further advance the sharpened distal end 152 of the second endoscopic instrument 150 distally relative to the ultrasonic transducer 142 (fig. 4C).

Referring to fig. 5, in use and by way of example, a bronchoscope (not shown) may be advanced into a pulmonary tract of a patient (e.g., through the esophagus). Dual lumen catheter 112 of modular assembly 100 may then be introduced into the working channel of the bronchoscope and advanced distally through the working channel, for example, by a medical professional holding main body 110 of modular assembly 100. The dual lumen catheter 112 may be advanced distally beyond the distal end of the bronchoscope and into peripheral regions of the lung (e.g., where early cancerous lung nodules tend to form) under radial ultrasound direct imaging guidance provided by the ultrasound transducer 142 extending 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 may be moved laterally along the longitudinal axis of the body 110 of the modular assembly 100 from a proximally retracted position to a distally extended position 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 may 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 may be simultaneously imaged. In various embodiments, the body 110 of the modular assembly 100 may 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 may then be repeatedly moved between the first and second positions 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 may be depressed multiple times (e.g., 12 to 15 times) to ensure that a sufficient volume and location of the biopsy sample 150 of the lung nodule 160 is obtained within the lumen of the sharp distal end 152 of the second endoscopic instrument for diagnostic analysis.

In various embodiments, handle assembly 154 may then be detached from attachment member 118 of main body 110 and second endoscopic instrument 150 withdrawn/retracted through successive second lumens 116, 117 of main body 110 and dual lumen catheter 112 while dual lumen catheter 112 remains disposed within the working channel of the bronchoscope. The biopsy sample may then be pushed out of the lumen of the second endoscopic instrument 150 for diagnostic analysis and reinserted/inserted through the successive second lumens 116, 117 into the second endoscopic instrument 150 (e.g., the same second endoscopic instrument or a different/second endoscopic instrument) such that the sharp distal end 152 returns to the first position within the dual lumen catheter 112 (fig. 4A) and the ultrasound transducer 142 remains adjacent to and visualizes the first lung nodule 160. In various embodiments, additional biopsy samples may be obtained from the first lung nodule 160 by repeating the above steps. Alternatively, the dual lumen catheter 112 may be repositioned within a 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 plunger 156 may then be actuated and the sharp distal end 152 of the second endoscopic instrument 150 repositioned and/or rotated, as discussed above, to obtain a biopsy sample from the second lung nodule.

In various embodiments, the modular assembly 100 and system 200 described above may provide a number of advantages over conventional assemblies and systems. By way of non-limiting example, a first advantage may be provided by the second endoscopic instrument 150 extending through the second lumen 117 of the dual lumen catheter 112, which may 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 pulmonary passage. A second advantage may be provided by retaining the sharpened distal end 152 of the second endoscopic instrument 150 within the double lumen catheter 112 while imaging a lung nodule, thereby allowing a biopsy sample to be taken while imaging without the need for device swapping. A third advantage may be provided by the plunger and spring of the handle assembly, which may allow a medical professional to use a single hand to actuate the second endoscopic instrument, e.g., to obtain a sufficient biopsy sample from a lung nodule. A fourth advantage may be provided by the side-by-side configuration of the first and second lumens 115, 117 of the dual-lumen catheter 112, which may allow a medical professional to rotate the body 110 of the modular assembly 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., as the second endoscopic instrument 150 is rotated about/relative to the axis of the first endoscopic instrument 140). A fourth advantage may be provided by the body 110 of the modular assembly 100 being configured for single-user control or multi-user control. For example, the multi-user control may allow a first medical professional (e.g., physician) to position the first endoscopic instrument 140 adjacent to the target pulmonary nodule and a second medical professional (e.g., medical assistant) to manipulate the second endoscopic instrument 150 (e.g., take a biopsy sample and remove the second endoscopic instrument through the working channel) at the direction of the first medical professional. Alternatively, a single user control may allow a medical professional to manipulate the first endoscopic instrument 140 with one hand and the second endoscopic instrument 150 with the other hand.

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 instruments configured to manipulate target tissue within a body passage, including, for example, electrocautery knives, clips, brushes, scissors, graspers, forceps, laser ablation elements, and the like. Other peripheral lung nodule visualization and/or biopsy techniques, features, and/or assemblies that may be used herein are disclosed in U.S. non-provisional patent application attorney docket No. 8150.0600 entitled "apparatus providing adjustable mechanism for radial ultrasound and irrigation ports," filed on even date, the entire contents of which are incorporated herein by reference, and/or U.S. non-provisional patent application attorney docket No. 8150.0746, entitled "medical imaging device, system, and method," filed on even date, the entire contents of which are incorporated herein by reference.

All of the devices and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the apparatus and methods of this invention have been described in terms of preferred embodiments, it will be apparent to those of skill in the art that variations may be applied to the apparatus and/or methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the invention. All such 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.