Endoscopic submucosal dissection cap

Abstract

The present disclosure relates to the field of endoscopy. In particular, the present disclosure relates to systems and methods suitable for resecting or dissecting large areas of mucosal or submucosal tissue. The system can apply tension to the mucosal tissue and continuously manipulate the mucosal tissue so that large lesions can be resected or dissected by a cutting element disposed at the distal end of an endoscope.

Description

[0001] This application is a divisional application of Chinese patent application No. 201680057563.1, filed on October 24, 2016, entitled "Endoscopic Submucosal Dissection Cover".

[0002] priority

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 245,472, filed October 23, 2015, pursuant to 35 U.S. SC § 119, the entire contents of which are incorporated herein by reference and for all purposes. Technical Field

[0004] This disclosure relates to the field of endoscopy. Specifically, this disclosure relates to systems and methods for endoscopic submucosal dissection (ESD) and / or endoscopic mucosal resection (EMR). More specifically, this disclosure relates to an endoscope hood that provides enhanced visualization of a working area in which tissue engagement elements and tissue cutting elements operate to dissect or resect mucosal and submucosal lesions. Background Technology

[0005] Physicians are increasingly willing to perform interventional and therapeutic endoscopic procedures, including, for example, full-thickness removal of large tissue lesions such as cancer, submucosal tunneling in the gastrointestinal (GI) or respiratory system to treat submucosal tissue, repair of postoperative complications (such as postoperative leakage, suture damage, and / or anastomotic leakage), thoracic surgery, and airway / pleural cavity surgery. Specialized tools can be used to enable physicians to perform these complex procedures more quickly and easily. A common method of integrating these specialized tools into the distal endoscope is through the use of an endoscope hood or cap. The fully circumferential design of currently available endoscope hoods tends to obstruct visualization of target tissues and provides limited workspace, making it difficult to operate multiple tools simultaneously. While dual-channel endoscopes may be available in some medical facilities, the individual articulated tools within each channel are often ergonomically difficult to control, especially by a single physician. Summary of the Invention

[0006] This disclosure provides a high-visibility endoscope cover that allows medical professionals to manipulate mucosal tissue, exposing the entire submucosal lesion for removal.

[0007] In one aspect, this disclosure relates to an endoscope system comprising: 1) an endoscope including an elongated body having a proximal end and a distal end, and a working channel disposed within the elongated body; 2) an endoscope shroud coupled to the distal end of the endoscope, the endoscope shroud including: a first portion including a proximal end, a distal end, and first and second cavities extending therebetween, wherein the first cavity is in open communication with the endoscope working channel; and a second portion extending from the distal end of the first portion, the second portion including a wall and defining a working area adjacent to the wall and the first cavity; 3) a first shaft having a proximal end and a distal end disposed within the working channel and the first cavity; and 4) a second shaft having a proximal end and a distal end disposed adjacent to the elongated body and extending through the second cavity. The wall may include a curved wall, and the working area may be adjacent to a concave surface of the curved wall and the first cavity. The curved wall may include a variety of shapes, such as including a partially hollow conical segment, a partially hollow cylinder, or a partially hollow sphere. The cross-section of the wall may be in the form of an arc ranging from about 90 degrees to about 180 degrees. The wall can be formed of a transparent material. The endoscope system may also include a support member extending into the first lumen. The support member may define an aperture having a non-circular cross-section, configured to slidably receive a first axis. The first axis may be slidably but non-rotatably disposed within the working channel, the first lumen, and the aperture. The distal end of the first axis may include a shape memory material configured to adopt a curved configuration when not constrained by an outer sheath or core wire. Alternatively or additionally, the distal end of the first axis may be configured to bend upon operative actuation. The distal end of the first axis may also include a tissue cutting element. A second axis may be slidably and rotatably disposed within the second lumen. The distal end of the second axis may include a tissue engaging element. Rotation of the proximal end of the second axis in a first direction may move the tissue engaging element toward the working area, and rotation of the proximal end of the second axis in a second direction may move the tissue engaging element away from the working area.

[0008] On the other hand, the present invention relates to an endoscope cover configured at the distal end of an endoscope, the endoscope including an endoscope body and a working channel disposed within the endoscope body, the endoscope cover comprising: 1) a first portion including a proximal end, a distal end, and first and second cavities extending therebetween; and 2) a second portion extending from the distal end of the first portion, the second portion including a wall and defining a working area adjacent to the wall and the first cavity, wherein the first cavity is configured to receive an axis of a first device disposed in the working channel of the endoscope, and wherein the second cavity is configured to receive an axis of a second device disposed along an elongated body of the endoscope. The wall may include a curved wall, and the working area may be adjacent to a concave surface of the curved wall and the first cavity. The curved wall may include a variety of shapes, such as including a partially hollow conical segment, a partially hollow cylinder, or a partially hollow sphere. The cross-section of the wall may be in the form of an arc ranging from about 90 degrees to about 180 degrees. The wall may be formed of a transparent material. The endoscope cover may further include a support member extending into the first cavity. The support member can define a hole with a non-circular cross-section.

[0009] On the other hand, this disclosure relates to a method of removing or dissecting tissue, comprising inserting an endoscopic system into a patient’s body cavity, placing the endoscope cover of the endoscopic system on the surface of the target tissue, and removing or peeling the target tissue with a tissue cutting element while engaging the tissue with a tissue joining element. Attached Figure Description

[0010] Non-limiting embodiments of the present disclosure have been 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 substantially identical component shown is generally represented by a single number. For clarity, not every component is labeled in every drawing, and every component of each embodiment of the present disclosure is not shown unless necessary to illustrate it, so that those skilled in the art can understand the disclosure. In the figures:

[0011] Figure 1 A perspective view of an endoscope cover according to an embodiment of the present disclosure is provided.

[0012] Figure 2 Provided according to embodiments of the present disclosure, which is attached to the distal end of an endoscope in a delivery configuration. Figure 1 A three-dimensional view of the endoscope cover.

[0013] Figure 3A -C provides the following according to this disclosure. Figure 2 A three-dimensional view of the endoscope cover and endoscope, in which tissue cutting elements are deployed into the workspace defined by the endoscope cover.

[0014] Figure 4A-C provides an endoscope cover according to another embodiment of the invention ( Figure 4A A cross-sectional view of the support member within the lumen of -B), which guides the tissue cutting element within the workspace of the endoscope cover. Figure 4C ).

[0015] Figure 5A -C provides Figure 4A -C is an alternative structure for support components and tissue cutting elements.

[0016] Figure 6 A side view of a control handle attached to the proximal end of an endoscope according to an embodiment of the present disclosure is provided, which allows a physician to simultaneously manipulate tissue cutting elements and tissue joining elements.

[0017] Figure 7 Embodiments according to this disclosure are provided. Figure 2 A schematic partial perspective view of an alternative design for a clip attached to an endoscope, as depicted in the figure.

[0018] It should be noted that the accompanying drawings are intended only to depict typical or exemplary embodiments of the present disclosure. It should also be noted that the drawings may not necessarily be drawn to scale. Therefore, the drawings should not be considered as limiting the scope of the present disclosure. The present disclosure will now be described in more detail with reference to the accompanying drawings. Detailed Implementation

[0019] Before proceeding with a further detailed description of this disclosure, it should be understood that this disclosure is not limited to the specific embodiments described and therefore can be varied. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope beyond 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 disclosure pertains. Finally, although embodiments of this disclosure are described specifically with reference to an endoscope cover attached to the distal end of an endoscope, it should be understood that the endoscope cover disclosed herein can be attached to various medical devices inserted into a patient's cavity, including, for example, guide cavities, ports, optical rods, etc. As used herein, the term "distal" refers to the end furthest from the medical professional when the device is introduced into the patient, and the term "proximal" refers to the end closest to the medical professional when the device is introduced into the patient.

[0020] In one embodiment, this disclosure provides a system for performing interventional and therapeutic procedures, including but not limited to the removal of large lesions such as cancer, the creation of tunnels under the mucosal layer of the GI or respiratory tract to treat submucosal tissue, and endoscopic repair of postoperative complications such as postoperative leakage, suture breakage, and / or anastomotic leakage. Figure 1As shown, in one embodiment, this disclosure includes an endoscope cover 20, which includes a first portion 21 having a proximal end 22, a distal end 23, and a first cavity 24 and a second cavity 25 extending therebetween. The first cavity 24 is configured to receive a first shaft 40, and the second cavity 25 is configured to receive a second shaft 50. Figure 2 The endoscope cover 20 further includes a second portion 26 extending from the distal end 23 of the first portion 21. The second portion 26 may include a wall 27 defining a working area 29 adjacent to the wall 27 and the first lumen 24. The wall 27 may include curvature defining a concave inner surface 28. For example, the concave inner surface 28 may include a partially hollow conical segment, a partially hollow cylinder, or a partially hollow sphere, and one or more other configurations. The cross-section of the wall 27 may form an arc ranging from approximately 90 degrees to approximately 180 degrees. The wall may be formed of a transparent or translucent material, such as transparent polymer-based materials (i.e., transparent plastics, etc.) known in the art. Still referring to… Figure 1 The support member 30 may extend into a first cavity 24 at the distal end 23 of the first portion 21. The support member 30 may define a hole 31 having a non-circular cross-section configured to receive the distal end 44 of the first shaft 40. Figure 2 ).

[0021] refer to Figure 2 In one embodiment, this disclosure includes an endoscope system comprising components coupled to... Figure 1 The endoscope 10 comprises the distal end 23 of the endoscope cover 20. The endoscope 10 may include an elongated body 12 having a proximal end (not shown), a distal end 16, and a working channel 18 extending therethrough. A first axis 40, including a proximal end (not shown) and a distal end 44, is disposed within the working channel 18 of the endoscope 10. The distal end 44 of the first axis 40 is supported by a hole 31 of a support member 30 and slidably disposed therein. A second axis 50, including a proximal end (not shown) and a distal end 54, is disposed alongside the elongated body 12 of the endoscope 10. The distal end 54 of the second axis 50 extends through a second cavity 25 of the endoscope cover 20 and is slidably and rotatably disposed therein. The first and second axes 40, 50 may be formed of a material having sufficient flexibility and torsional rigidity to allow the axes to bend and / or be flexible as the endoscope advances and / or retracts through the patient's cavity, while still being able to transmit motion to the tissue cutting and tissue joining elements 48, 58 (discussed below). The second axis 50 can be secured to the outer surface of the elongated body 12 along the length of the endoscope 10 by one or more clips 62. Although Figure 2 The clip 62 engages with a portion of the outer surface of the elongated body 12, but this disclosure covers various clip configurations, including, for example... Figure 7The second axis 40 includes a circumferential clamp 62. The distal end 44 of the first axis 40 may include a tissue cutting element 48. The tissue cutting element 48 may be a mechanical tissue cutting element, including, for example, a scalpel, blade, scissors, or blunt dissecting instrument. The tissue cutting element may be an energy-based tissue cutting element, including, for example, RF energy, monopolar DC current, bipolar DC current, ultrasonic energy, laser energy, cryogenic energy, or water jet energy. The distal end 54 of the second axis 50 may include a tissue engaging element 58, such as (by way of non-limiting example) a gripper, clamp, screwdriver, hook, or suction device. Figure 2 The tissue cutting element 48 and tissue engaging element 58 are depicted in their delivery configuration, which minimizes the profile of the endoscope system to reduce the risk of perforation during movement through the patient's lumen. Specifically, the second axis 50 rotates such that the tissue engaging element 58 is positioned within the working area 29. The first axis 40 retracts into the working channel 18 of the endoscope 10, wherein the distal end 44 of the first axis 40 is supported within the hole 31 of the support member 30.

[0022] like Figures 3A-3C As shown, the tissue cutting element 48 and the tissue engaging element 58 are configured to operate within the working area 29 on one side of the endoscope cover, rather than extending beyond the distal end of the endoscope cover as is the case with a conventional endoscope cover. The distal end 44 of the first axis 40 may include a shape memory material (e.g., nitinol, shape memory polymer, heat-set core wire, etc.) which is flexed as it advances through the first lumen 24 into the working area 29. For example, the tissue cutting element 48 may have a flexed configuration with a predetermined angle of about 45 degrees to about 110 degrees relative to the first axis 40. The physician can extend ( Figure 3B ) and / or retraction ( Figure 3A The first axis 40 alters the position of the tissue cutting element 48 within the working area 29. The physician can also extend, retract, and rotate the tissue engagement element 58 relative to the working area 29 to move away from and toward the working area 29. Figure 3C For example, tissue engagement element 58 can be used to grasp (i.e., engage, grip, hold, etc.) tissue by rotational lifting or lowering motion and / or longitudinal pushing / pulling motion to pull tissue away from or into tissue cutting element 48.

[0023] like Figure 3B and 3CIn the best example shown, once extended to the desired location within the working area 29, the tissue cutting element 48 is configured to move in a sweeping (i.e., side-to-side) or stabbing manner within a single plane. The physician can control the sweeping motion of the tissue cutting element 48 by extending and / or retracting an outer sheath (not shown) that holds a portion of the distal end 44 of the first axis 40. The physician can also control the sweeping motion of the tissue cutting element 48 by actuating (i.e., pushing / pulling) a core line (not shown) extending along the length of the first axis 40. This core line may include a series of pivot points or segments with greater flexibility relative to the rest of the core line to facilitate sweeping of the tissue cutting element 48. Additional flexibility in tissue cutting is achieved by simultaneously advancing or retracting (i.e., from left to right and / or from right to left) the first axis 40 while sweeping the tissue cutting element. Because the actuation of the tissue cutting and tissue engagement elements 48, 58 is not associated with the endoscope distal joint, the physician can position the endoscope over the area of ​​interest and then control the operation of one (or both) tools with a single hand.

[0024] like Figures 4A-4B As shown, the endoscope cover can guide tissue cutting elements within the working area using a support member 30 (i.e., an alignment channel) that defines an aperture 31 having a non-circular cross-section. For example, the aperture 31 may have a substantially circular cross-section, except for the flat portion 31a. (Reference) Figure 4C The distal end 44 of the first shaft 40 may include a generally circular cross-section having a corresponding flat portion 44a configured to slide within the bore 31. Figures 5A-5B As shown, except for the recessed portion 31b, the hole 31 may have a substantially circular cross-section. (Reference) Figure 5C The distal end 44 of the first shaft 40 may include a generally circular cross-section having a corresponding protrusion 44b. Figure 5C The endoscope cover 20 is configured to slide within the aperture 31. In any embodiment, the non-circular configuration of the aperture 31 ensures that the tissue cutting element 48 is aligned within the working area 29 in a single plane. Unlike conventional devices that guide tools through multiple planes, the endoscope cover 20 of this disclosure provides improved control over tissue manipulation by controlling the tissue cutting element 48 in a single plane.

[0025] The transparent (i.e., clear) walls 27 and large working area 29 of the endoscope hood 20 provide the physician with a large, unobstructed field of vision, which is impossible with a circumferential endoscope hood. (Reference) Figure 6The proximal ends 42, 52 of the first axis 40 and the second axis 50 can be actuated using the handle 60 at the proximal end 14 of the endoscope 10. The ability of the physician to simultaneously manipulate the tissue cutting element 48 and the tissue engaging element 58 using small, independent movements not associated with the endoscope distal joint allows for tissue resection or dissection with greater speed and precision. While the endoscope distal joint is used only to guide and position the tissue cutting element 48 and the tissue engaging element 58 onto the target tissue, it should be understood that the curved shape of the wall 27 of the endoscope shroud 20 can be used to press against tissue when necessary during the medical procedure. For example, the physician can align the endoscope such that the curved wall 27 presses against a portion of the tissue, thereby lifting and / or exposing another portion of the tissue for grasping and / or cutting with appropriate tools.

[0026] Based on this disclosure, all devices and / or methods disclosed and claimed herein can be made and performed without excessive experimentation. Although the devices and methods of this disclosure have been described with reference to preferred embodiments, it will be apparent to those skilled in the art that modifications can be made to the devices and / or methods, and to the steps or order of steps of the methods described herein, without departing from the concept, spirit, and scope of this disclosure. All such similar substitutions and modifications that will be apparent to those skilled in the art are considered to be within the spirit, scope, and concept of this disclosure as defined by the appended claims.

Claims

1. A sheath configured to be disposed about a distal end of a scope, the scope comprising an elongate body and a working channel disposed within the body, the sheath comprising: a first portion comprising a proximal end, a distal end, and first and second lumens extending therebetween; and a second portion comprising a curved wall extending distally from the distal end of the first portion, the curved wall defining a concave surface adjacent the curved wall and a working area of the first lumen; wherein the first lumen is configured to receive a portion of a first device inserted along the working channel of the scope, and wherein the second lumen is external to the second portion and is configured to slidably and rotatably receive a portion of a second device along an outer surface of the scope, the second portion configured to enable positioning of the portion of the second device within the working area by rotation about a longitudinal axis of the second lumen.

2. The sheath of claim 1, wherein the curved wall comprises one of a partial hollow conical segment or a partial hollow cylinder.

3. The sheath of claim 1 or 2, wherein the curved wall has a cross-section that forms an arc that is a portion of a circle.

4. The sheath of claim 3, wherein the arc has an angle relative to the circle that is in a range of about 90 degrees to about 180 degrees.

5. The sheath of claim 1 or 2, wherein the curved wall has an open distal end.

6. A scope system comprising: a scope comprising an elongate body having a proximal end, a distal end, and a working channel disposed within the elongate body; a sheath coupled to the distal end of the scope, the sheath comprising: a first portion comprising a proximal end, a distal end, and first and second lumens extending therebetween, wherein the first lumen is in communication with the working channel of the scope; a second portion extending from the distal end of the first portion, defining a working area adjacent a surface of the second portion and the first lumen; and a support member extending with the first lumen, wherein the support member defines a non-circular aperture adjacent the second portion; a first device having a proximal end and a distal end, the first device insertable through the working channel and first lumen; and a second device having a proximal end and a distal end, the second device slidably and rotatably extendable along an outer surface of the elongate body and through the second lumen, the second device rotatable about a longitudinal axis of the second lumen into and out of the working area; wherein the second lumen is external to the second portion.

7. The scope system of claim 6, wherein the first device comprises a non-circular cross-section that substantially matches a cross-section of the non-circular aperture.

8. The scope system of claim 6 or 7, wherein the non-circular aperture comprises a recessed portion.

9. The scope system of claim 6 or 7, wherein the non-circular aperture comprises a flat portion.

10. The scope system of claim 6 or 7, wherein the non-circular aperture of the support member is configured to prevent rotation of the first device.

11. The endoscopic system of claim 6 or 7, wherein the non-circular aperture of the support member is configured to slidably receive the first device.

12. The endoscopic system of claim 10, wherein the non-circular aperture is configured to constrain articulation of the first device to a single longitudinal plane.

13. The endoscopic system of claim 6 or 7, wherein the support member extends radially from the first portion within the first lumen.

14. The endoscopic system of claim 6 or 7, wherein the support member is substantially axially aligned with the second portion.

15. The endoscopic system of claim 6 or 7, wherein a distal end of the second device is curved relative to a longitudinal axis of the second device and the second lumen.

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