Patent Description:
Endoscopic mucosal resection (EMR) and/or endoscopic submucosal dissection (ESD) procedures may be used to resect benign or diseased tissue, e.g., lesions, cancerous tumors, and/or other anomalies, from a patient's gastrointestinal system. In some patients, full thickness resection (FTR), which may be partially or fully circumferential in a body lumen, may be necessary to ensure complete removal of the diseased tissue, as opposed to removal of only mucosal layers of the gastrointestinal system.

However, FTR procedures may pose additional challenges such as anatomical difficulties of removing tissue adjacent critical internal organs and other sensitive structures, as well as risk of post-operative leakage, potentially increasing a patient's health risk in undergoing an FTR procedure.

<CIT> discloses a FTR device designed for receiving a noncircular endoscope.

This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter. No methods are claimed.

According to an exemplary embodiment of the present disclosure, a device for tissue resection in a body lumen may include a body extending along an axis, and a distal cap positioned distally of the body and coupled to an inner shaft extending along the axis. The body and the distal cap may be movable relative to each other. The device for tissue resection may further include an anchoring mechanism capable of engaging the body and the distal cap proximate a selected tissue for resection in the body lumen. The device for tissue resection may further include a tissue capture device deployable from the tissue resection device, and the selected tissue for resection may be securable by the tissue capture device. The device for tissue resection may further include a tissue resecting device for resecting the selected tissue for resection.

In various of the foregoing and other embodiments of the present disclosure, the tissue resection device may further include a tissue closure device. The anchoring mechanism may include a first balloon disposed on the distal cap and a second balloon disposed on the body. The first and second balloons may be expandable to engage the body lumen such that the selected tissue for resection is between the first and second balloons. The tissue capture device may include one or more posts disposed circumferentially around a surface of the body and extendable from the body in a direction along the axis for securing the selected tissue for resection against the distal cap. the tissue closure device may include a closure mechanism for joining portions of the body lumen. The tissue resecting device may include a blade disposed circumferentially around a surface of the body and extendable from the body in a direction along the axis for resecting the selected tissue for resection. The tissue resecting device may include a blade disposed circumferentially around a surface of the distal cap and extendable from the distal cap in a direction along the axis for resecting the selected tissue for resection. The tissue resecting device is disposed on an outer shaft and the distal cap is disposed on the inner shaft. The tissue resecting device is extendable from the distal cap in response to the inner shaft being movable relative to the outer shaft.

The present disclosure is not limited to the particular 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 the disclosure belongs.

It may be understood that references to "proximal" may be defined as an end of the systems and devices closest to the entry point of the patient and "distal" may be defined as an end of the systems and devices closest to the desired location of the system and devices in the patient (e.g., a patient's gastrointestinal system).

As described above, patients with diseased or other tissue in the gastrointestinal system may require resection. Referring to <FIG>, various sized lesions are illustrated in a body lumen (e.g., gastrointestinal system) of a patient. As shown, earlier stages of diseased tissue may not extend through all the layers of the body lumen, which may allow for resection of only the affected tissue layers. However, as diseased tissue advances to later stages, resection of the entire tissue portion (e.g., full thickness resection) may be needed to fully excise the diseased tissue from the patient. Exemplary embodiments of devices, systems, and methods for partial or full thickness tissue resection in accordance with the present disclosure may allow for a selected tissue section containing diseased tissue to be contained and resected from surrounding tissue, the surrounding tissue then being joined together to close a gap formed by the resection of the selected tissue. In some embodiments, the tissue resection may be fully circumferential, e.g., extending <NUM>° around a body lumen. In other embodiments, the tissue resection may be partially circumferential, e.g., extending less than <NUM>° around a body lumen. Although "resection" is used throughout the disclosure, exemplary embodiments of the present disclosure may encompass resecting, dissecting, removing, ablating, cutting vaporizing, freezing, etc., and may be full thickness, partial thickness, and in instances of a procedure occurring in a body lumen, may be partial and/or fully circumferential.

Referring now to <FIG>, an exemplary embodiment of a resection device <NUM>, e.g., an endoluminal resection device, in accordance with the present disclosure is shown. The device <NUM> may be delivered to a site in a patient for resecting a selected portion of tissue. In some embodiments, the selected tissue may be in a body lumen such as an intestine, colon, and/or other gastrointestinal system. The resection device <NUM> may be configured for full thickness resection of a large intestine, although it is envisioned that the resection device <NUM> may be configured for other anatomical resecting as well. The device <NUM> may include a body <NUM> extending along an axis <NUM> and having a proximal end 205a and a distal end 205b. In some embodiments, the body <NUM> may be a lumen, or hollow tube. A handle (not shown) may be coupled to the proximal end 205a for actuation of the distal end 205b by a medical professional. Although the body lumen is described with respect to the gastrointestinal system, including but not limited to an intestine, colon, duodenum, and/or other gastrointestinal system, it is understood that exemplary embodiments of devices, systems, and methods of the present disclosure may apply to any body lumen in a patient.

The body <NUM> may include a shaft <NUM>, extending coaxial to the body <NUM> along the axis <NUM>. In embodiments, the shaft <NUM> may be movable relative to the body <NUM> along the axis <NUM>. An anchoring mechanism <NUM> may be coupled to the body <NUM>, e.g., to anchor the device <NUM> to an inner surface of the body lumen. In embodiments, a portion of the anchoring mechanism <NUM> may be coupled to a distal end 210b of the shaft <NUM> as a distal cap <NUM>, extending distal of the distal end 205b of the body <NUM>. For example, as the shaft <NUM> moves along the axis <NUM>, a portion of the anchoring mechanism <NUM> coupled to the shaft <NUM>, e.g., on the distal cap <NUM>, may be movable relative to another portion of the anchoring mechanism <NUM>, e.g., coupled to the body <NUM>.

In some embodiments, the anchoring mechanism <NUM> may be one or more expandable balloons 220a, 220b,. Although a first balloon 220a and a second balloon 220b are illustrated in <FIG>, it may be understood that any number "n" of balloons may be utilized in the anchoring mechanism. A first balloon 220a may be disposed on a proximal portion of the distal end 205b of the body <NUM>, e.g., coupled to the body <NUM>. A second balloon 220b may be disposed on a distal portion of the distal end 205b, e.g., coupled to the shaft <NUM> on the distal cap <NUM>, and distal of the first balloon 220a. The first and second balloons 220a, 220b may be positionable along the axis <NUM>, e.g., by the body <NUM> and/or the shaft <NUM>. For example, the shaft <NUM> may extend the distal cap <NUM> and second balloon 220b apart from the first balloon 220a on the body <NUM>.

As described below, the anchoring mechanism, e.g., first and second balloons 220a, 220b, may surround and/or encapsulate a selected tissue portion site. For example, the first and second balloons 220a, 220b may engage the body <NUM> and the distal cap <NUM> proximate a selected tissue for resection in the body lumen. the first and second balloons 220a, 220b may be positioned a distance "d" apart from each other. When the first and second balloons 220a, 220b are in the desired site or position, the balloons may be expanded radially with respect to axis <NUM> to fill the body lumen and contact the inner surface of the body lumen. The expanded balloons may be held by friction against the inner surface of the body lumen, and movement of the shaft <NUM> and/or body with the balloons 220a, 220b in an expanded configuration may pleat or otherwise fold the selected diseased tissue and isolate the selected tissue. In some embodiments, the balloons 220a, 220b may be formed of a material to maximize frictional contact with a body lumen. It is envisioned that the first and/or second balloons may be formed of a same or similar material and in some embodiments may be formed of different materials. It is understood that the balloons 505a, 505b, 510a, 510b, 515a, 515b may be formed of any combination of materials. As shown in <FIG>, a first and/or second balloon 505a, 505b may be formed of a material <NUM> having a smooth elastic surface. <FIG>, illustrates a first and/or second balloon 510a, 510b being formed of a material <NUM> having a texturized elastic surface. <FIG> shows a first and/or second balloon 515a, 515b having a mesh covered surface <NUM>. The mesh covered surface <NUM> may be an integrally formed material of the balloon 515a, 515b, and in other embodiments, may be a separate cover over a balloon 515a, 515b formed of a different material.

In some embodiments, the anchoring mechanism <NUM> may include tracking devices, to ensure accurate positioning in the body lumen. For example, a device <NUM> may include one or more markers <NUM> on an anchoring mechanism <NUM>. As shown in <FIG>, the first balloon 220a may include a first marker 305a, and the second balloon 220b may include a second marker 305b. It is understood that any number "n" of markers 305a, 305b,. 305n may be used in combination with any number "n" of balloons 220a, 220b,. 220n and/or anchoring mechanism <NUM>. The first marker 305a may be disposed on the first balloon 220a so that when the shaft <NUM> and the distal cap <NUM> is extended out from the body <NUM>, the second marker 305b disposed on the second balloon 220b is a distance "d" apart.

In embodiments, the one or more markers <NUM> may be a radiopaque marker and/or an echogenic marker. A medical professional may guide the device <NUM>, <NUM> in a body lumen of a patient to a desired position using direct visualization, fluoroscopy imaging and/or ultrasound-guided navigation via the one or more markers <NUM>. It may be advantageous to use the one or more markers <NUM> to ensure accurate positioning in the patient. The medical professional may desire to resect diseased tissue as well as a portion of healthy tissue surrounding the diseased tissue, to ensure full resection of any cancerous cells. Accurate positioning of the device <NUM>, <NUM>, e.g., selecting an accurate distance "d" may allow the medical professional to minimize the amount of healthy tissue required for resection.

Referring back to <FIG>, in some embodiments, the device <NUM> may further include one or more working channels <NUM> for extending additional accessories <NUM> to the site. For example, a visualization device such as a camera, fiber optic cable, and/or other imaging device, or an endoscope, may be delivered to the desired position, although any other accessories for use during the procedure, including but not limited to lighting devices, grasping tools, fluid delivery devices, suction devices and the like may utilize the working channels <NUM>. The accessory may be controlled and/or actuated by the medical professional at the proximal end 205a of the device <NUM>. In some embodiments, the accessory may lock on the handle to maintain a selected position while the medical professional is free to manipulate other accessories and/or adjust the device <NUM> to ensure the diseased tissue is selected for resection.

In some embodiments, the accessory may be delivered through the device <NUM> in various manners. As shown in <FIG>, a device <NUM> may include a working channel <NUM> extending along an interior of a shaft (not shown). An accessory <NUM> may then extend along this central working channel <NUM>, and extend out of a distal cap <NUM>. This may be advantageous so that an accessory, e.g., a visualization accessory such as an endoscope or other visualization device, may be utilized when the distal cap <NUM> is retracted. For example, the visualization accessory may be manipulatable when the shaft is not extended so that there is no gap, or distance "d", between the first and second balloons. In other embodiments, as shown in <FIG>, an accessory <NUM>, e.g., an endoscope or other visualization device, may be attachable to a device <NUM> on an external surface <NUM>. For example, mechanical fasteners such as rings <NUM> may be coupled to the external surface <NUM> of the device <NUM>, for coupling the accessory <NUM>. This configuration may be advantageous because the accessory may be utilized both when a distal cap <NUM> is in an extended and/or retracted position. For example, a medical professional may be able to utilize a visualization accessory when the device <NUM> is being positioned in a body lumen, as well as when the distal cap <NUM> is being positioned relative to selected tissue for resection. It is understood that selected tissue for resection may be an area of diseased tissue, e.g., including tumors and/or lesions, as well as a portion of healthy tissue immediately adjacent the diseased tissue. In some embodiments, the selected tissue for resection may include a benign cyst or legion. A portion of healthy tissue may be resected to minimize a risk of not fully capturing the diseased tissue and/or dislodging diseased tissue cells to potentially contaminate another tissue region.

Referring back to <FIG>, in some embodiments, the device <NUM> may further include a tissue capture device <NUM>. In some embodiments, a tissue capture device may be a suction device, mechanical grasping tool, and/or additional components for capturing tissue. For example, suction may be applied to grasp the tissue, and/or may be used in combination with an accessory <NUM> such as a mechanical grasping tool, so that tissue (e.g., the diseased tissue portion) may be engaged and held (e.g., grasped and/or sucked) inward towards the center of the body <NUM>. When the selected tissue is grasped and held between the balloons 220a, 220b, the tissue capture device <NUM> may be extended to hold the tissue in place. In some embodiments, one or more posts may be extended from the body (see <FIG>) for capturing the tissue. The posts may extend from the body <NUM> parallel to the axis <NUM>. The posts may be disposed in a circumferential pattern around the body <NUM>, and may be actuatable individually, so that tissue may be captured between the post and the distal cap <NUM>.

In some embodiments, the device <NUM> may further include one or more tissue closure devices <NUM>, for closing together the body lumen prior to the diseased tissue being resected. In embodiments, the tissue closure device <NUM> may be a stapler, although other types of closure systems are also envisioned. In some embodiments, the tissue closure device <NUM> may be part of the tissue capture device <NUM>. For example, when the posts extend toward the distal cap <NUM> to capture the tissue, a staple may be deployed from the distal cap <NUM> and/or the tissue capture device <NUM> or other portion of the body, e.g., a portion within the perimeter of the capture line with capture device or other portion of the body, e.g., a portion within the perimeter of the capture line with capture device and outside of the resecting line (e.g., cut line in the case of a blade) of the resecting device. The staple may conform to a closed shaped by forces against the tissue capture device <NUM> and/or the distal cap <NUM>, to secure the selected tissue.

The device <NUM> may further include one or more tissue resecting devices <NUM>, for detaching the diseased tissue. As described below (see <FIG>), tissue resecting devices <NUM> may be one or more blades, knives, cutting tool, cauterizing tool, or the like, and may be configured to extend from the body <NUM> once the device <NUM> is in position and the selected tissue is positioned for resection. For example, in embodiments, one or more blades may be extendable in a direction parallel to the axis <NUM>, e.g., from the proximal portion of the distal end 205b of the body <NUM> towards the distal portion of the distal end 205b of the body <NUM>. The blades may be movable circumferentially around the body <NUM>, e.g., to resect the selected tissue internal to the stapled portion, or may be a punch or cookie cutter configuration that resects a full circumference in one movement. It may be advantageous to resect the selected tissue after staples are deployed to secure the selected tissue, to prevent undesired tissue separation. It is also envisioned that in other embodiments, the tissue resecting device <NUM> may resect the tissue prior to the tissue closure device <NUM> securing the tissue.

As shown in <FIG>, a resection device <NUM> may include a tissue resecting device <NUM> extending from a body <NUM> in a direction parallel to axis <NUM>. In embodiments, the tissue resecting device <NUM> may be circumferential to the body <NUM>, so that tissue selected for resection may be resected when positioned between the anchoring mechanism <NUM>. For example, the anchoring mechanism may engage tissue proximate the selected tissue for resection. In embodiments, the tissue resecting device <NUM> may be in a retracted position, as shown at reference numeral <NUM>. In a retracted position, the tissue resecting device <NUM> may be fully retracted within the body <NUM> (e.g., below a surface <NUM>), so that no tissue may be resected. In an extended position, as shown at reference number <NUM>, the tissue resecting device <NUM> may be extended from the surface <NUM> of the body <NUM> toward the distal cap <NUM>. As described above, one or more tissue capture devices may hold the selected tissue for resection against the distal cap <NUM>. Once the tissue is secured by the tissue capture devices, the tissue resecting device <NUM> may extend, resecting the selected tissue for resection. In some embodiments, the tissue resecting device <NUM> may be a single blade, disposed circumferentially in the body <NUM>, which may be actuatable in a single motion. In other embodiments, a plurality of tissue devices may be utilized, disposed and actuatable individually around the body <NUM>.

Additionally, it is envisioned that a tissue resecting device may extend from the body <NUM>, <NUM>, as shown in <FIG> and 7A, and/or the distal cap <NUM>, <NUM>, as shown in <FIG>. The tissue resecting device <NUM>, <NUM>, <NUM>' may be the same or similar tools as the tissue resecting device <NUM> in <FIG>. In embodiments where the tissue resecting device <NUM>, <NUM>, <NUM>, <NUM>' is a blade, the blade may be formed in any shape, including but not limited to a straight blade edge, a tapered blade edge, crenellated, and/or saw tooth. For example, a tissue resecting device <NUM> may extend from the body <NUM> in a direction indicated by arrow <NUM>.

The tissue resecting device <NUM> may be extendable and/or retractable in a direction parallel to axis <NUM>. In other embodiments, a tissue resecting device <NUM>' may be disposed in the distal cap <NUM>'. The tissue resecting device <NUM>' may be extendable and/or retractable by an outer shaft <NUM>, in which the tissue resecting device <NUM>' is coupled to, and an inner shaft <NUM>, which is coupled to the distal cap <NUM>'. In a retracted position, the tissue resecting device <NUM>' may be nested in a gap <NUM> in the distal cap <NUM>'. To expose the tissue resecting device <NUM>', the inner shaft <NUM> may move in a distal direction, e.g., as shown by arrow <NUM>, while the outer shaft <NUM> and tissue resecting device <NUM>' remain stationary. In some embodiments, the inner shaft <NUM> may remain stationary while the outer shaft <NUM> and tissue resecting device <NUM>' move in a proximal direction toward the body <NUM>. In other embodiments, the inner shaft <NUM> may move in a distal direction and the outer shaft <NUM> and tissue resecting device <NUM>' may move in a proximal direction.

<FIG> illustrates a combination of the features described in <FIG>. For example, the device <NUM>" may include a tissue resecting device <NUM> disposed in body <NUM>, and a tissue resecting device <NUM>' disposed in the distal cap <NUM>'. The tissue resecting devices <NUM>, <NUM>' may be able to resect the selected tissue for resection from both directions, e.g., the tissue resecting device <NUM> may extend in a distal direction from the body <NUM>, and the tissue resecting device <NUM>' may extend in a proximal direction from the distal cap <NUM>'. In embodiments where the tissue resecting devices <NUM>, <NUM>' are blades, the blades may be formed in any shaped as described above, and in some embodiments may be configured to mate together.

Referring now to <FIG>, a process of tissue resection by an exemplary embodiment of a tissue resection device <NUM> in accordance with the present disclosure is shown. It is understood that any of the features described in the exemplary embodiments illustrated in <FIG> may also be incorporated in the device <NUM>. At step 805a, a scope, e.g., an endoscope, gastroscope, colonoscope, duodenoscope, and the like, may be inserted in a patient and delivered to a body lumen <NUM> having tissue for resection. In some embodiments, a visualization device <NUM>, e.g., an accessory such as a camera, fiber optic or other device, may be used for visualizing the tissue for resection. The device <NUM> may extend in the body lumen <NUM> in a direction along axis <NUM>. As described above, the tissue may have tumors, lesions and/or otherwise may be diseased. A medical professional may mark the tissue for resection, e.g., indicated by arrow <NUM>. Tissue may be marked by ink, radiopaque contrast, echogenic contrast, or other known techniques. In some embodiments, a medical professional may utilize fluoroscopy imaging and/or ultrasound guided navigation techniques for visualizing the tissue selected for resection. The tissue for resection may be marked as two circumferential bands, e.g., 825a, 825b, to bound the area of tissue for resection. It is understood that when tissue is resected from the body lumen <NUM>, it may be fully resected, so that the body lumen is separated into two portions. To prevent edges of the body lumen <NUM>, e.g., at bounds of markers 825a, 825b, from separating, tissue closure devices such as staples and/or adhesive may be used to join the edges of the body lumen <NUM>. This may minimize and/or prevent contamination of the body lumen <NUM> from surrounding body fluids.

At step 805b, as shown in <FIG>, the device <NUM> may be removed from the patient, and a tissue resection device <NUM> having a proximal end 800a and a distal end 800b and formed of a body <NUM> may be inserted and delivered to the body lumen <NUM> to the tissue marked for resection. The distal end 800b of the device <NUM> may have a distal cap <NUM> and may be positioned distal of the tissue marked for resection (the second marker band 825b). It may be understood that the proximal end 800a of the device <NUM> may be external to a patient, and the distal end 800b of the device <NUM> may be at the site for tissue resection. At step 805c, as shown in <FIG>, an anchoring mechanism such as a balloon 819b may be expanded to anchor the device <NUM> to the body lumen <NUM>. The balloon 819b may be disposed on the distal cap <NUM>, and the balloon 819b may contact an inner surface <NUM> of the body lumen <NUM>, e.g., in an area distal of the tissue marked for resection by markers 825a, 825b. The balloon 819b may be expandable in a radial direction relative to the axis <NUM>.

At step 805d, as shown in <FIG>, the device <NUM> may be extended so that the anchoring mechanism encompasses the tissue for resection as bounded by markers 825a, 825b. For example, the anchoring mechanism may engage tissue proximate the selected tissue for resection in the body lumen. As described above, a shaft <NUM> may be connected to the distal cap <NUM>, and may be movable along the axis <NUM> relative to the body <NUM>. In some embodiments, the body <NUM> may be movable relative to the shaft <NUM> and/or the distal cap <NUM>. For example, when the balloon 819b is expanded to anchor the distal cap <NUM> to the inner surface <NUM> of the body lumen <NUM>, the body <NUM> may move in a proximal direction away from the distal cap <NUM> and exposing the shaft <NUM>. The body <NUM> may be positionable to an area in the body lumen outside of the bounds of (e.g., proximal to) the marked tissue by markers 825a, 825b. A balloon 819a may be expanded to anchor the device <NUM> to the body lumen <NUM>. The body <NUM> and the distal cap <NUM> may be separated by a distance "d2", along the axis <NUM>, which may correspond to the selected tissue for resection, e.g., between markers 825a, 825b.

At step 805e, as shown in <FIG>, the distal cap <NUM> and/or the body <NUM> may be drawn together, to compress the tissue selected for resection between markers 825a, 825b. For example, the distal cap <NUM> may be moved in a proximal direction while the body <NUM> remains stationary, the body <NUM> may be moved in a distal direction while the distal cap <NUM> remains stationary, or both the body <NUM> and the distal cap <NUM> may be movable. It is understood that when the distal cap <NUM> and or the body <NUM> are moved with the balloons 819a, 819b in an expanded condition, friction between the respective balloon 819a, 819b, and the inner surface <NUM> of the body lumen <NUM> may minimize and/or prevent slippage of the balloon 819a, 819b so that the tissue selected for resection may become pleated as indicated at reference numeral <NUM>, and a distance "d3" between the body <NUM> and the distal cap <NUM> is less than the distance "d2" as shown in <FIG>.

At step 805f, as shown in <FIG>, the pleated tissue <NUM>, e.g., the tissue for resection, may be drawn radially inward towards the shaft <NUM>. In some embodiments, an accessory <NUM> such as a suction device or mechanical grasper tool may be utilized as a tissue capture device. The accessory may be movable in a circumferential direction to rotate about the axis <NUM>, pulling the selected tissue for resection inward until the entire circumferential section is drawn inward. As described above, this procedure may be advantageous for full thickness resection, e.g., resecting all tissue layers from a portion of a body lumen. At step <NUM> (see <FIG>), one or more tissue capture devices <NUM> may extend from the body <NUM> in a distal direction to capture and hold the tissue selected for resection against an inner surface <NUM> of the distal cap <NUM>, as indicated at reference numeral <NUM>. The tissue capture devices <NUM> may be disposed circumferentially around the device <NUM> with respect to axis <NUM>. In embodiments, the tissue pulled in by the accessory may be captured in the tissue capture device as each section of circumference of tissue is pulled in or the entire circumference of tissue may be pulled in before the capturing device is actuated. In embodiments, the tissue capture devices <NUM> may be posts, e.g., having a blunt distal ends to hold the tissue in place without damaging the tissue.

In some embodiments, when the posts extend to the distal cap <NUM>, a tissue closure device may close, or seal off the tissue bounded by markers 825a, 825b. For example, staples <NUM> may be delivered circumferentially against the posts to secure the tissue, e.g., bounding the tissue for resection by the markers 825a, 825b (see <FIG>). In other embodiments, adhesive or other closure mechanisms may be used to secure the tissue. In some embodiments, staples may be pre-loaded in the body <NUM> and the distal cap <NUM> may comprise or incorporate a forming anvil. When the body <NUM> and the cap <NUM> are closed, forces exerted on the staples as they are pressed into the anvil may close the staples around the tissue. In embodiments, a plurality of staples may be stapled simultaneously with an axially translated clamping mechanism or staple driving mechanism, e.g., as the body <NUM> and the distal cap <NUM> are moved together along the axis <NUM>. In other embodiments, a plurality of staples may be stapled sequentially, e.g., by a rotating wedge clamping or staple driving mechanism, thereby forming the staples one at a time as the wedge mechanism is rotated about the circumference of the body <NUM> and the wedge sequentially contacts, drives, and forms each staple. Such a mechanism may require reduced staple forming forces compared to other forming mechanisms and techniques. In some embodiments, staples may be pre-loaded in the distal cap <NUM>, with the body <NUM> acting as the forming anvil, and the staples may be spring-loaded, or hydraulically actuatable, or combinations thereof. Alternatively, a simultaneous or sequential (e.g., wedge) driver mechanism may be employed. The tissue capture device <NUM>, e.g., posts, may temporarily hold the tissue prior to stapling. The medical professional may be able to verify with tissue markers prior to stapling and/or resecting that the selected tissue for resection encompasses all of the desired tissue for resection, and may make adjustments as necessary. The tissue capture devices <NUM>, e.g., posts, may include tissue closure devices <NUM>, which may be forming anvils. As staples are deployed, staples may be formed by forces acting against the forming anvil to enclose the selected tissue for resection with the staples.

When the tissue is secured by the tissue capture devices <NUM> and/or the tissue closure device, at step <NUM> and as shown in <FIG>, a tissue resecting device <NUM> may be extended from the body <NUM> and/or the distal cap <NUM>. As described above with respect to <FIG> and <FIG>-7C, a tissue resecting device may be disposed circumferentially around the body <NUM> and/or distal cap <NUM> about the axis <NUM>. In embodiments, the tissue resecting device <NUM> may be positioned radially inward from the tissue capture device <NUM> and/or the tissue closure device, so that as the tissue is resected, the secured tissue is held by the tissue capture device <NUM> and/or staples of the tissue closure device. In this manner, the resected portion of the body lumen <NUM> may be prevented from separating during the procedure. At step 805i as shown in <FIG>, when the tissue is resected or otherwise cut, the distal cap <NUM> and the body <NUM> may be drawn together. The tissue capture device <NUM> and/or the tissue closure device may be retracted. The resected tissue may be removed from the patient through a working channel (see <FIG>), e.g., by a mechanical grasping tool or other retrieval device.

At step 805j as shown in <FIG>, when the procedure is complete, the balloons 819a, 819b may be deflated, so the device <NUM> is no longer anchored to the inner surface <NUM> of the body lumen <NUM>. The device <NUM> may then be removed from the patient, e.g., retracted proximally from the body lumen <NUM>. Staples <NUM>, or other closure mechanisms such as a suture and/or adhesive, may secure ends of the body lumen <NUM> from the tissue bounded by markers 825a, 825b. In embodiments, the closure mechanisms may be formed of a material that is bioabsorbable and/or biodegradable. As tissue regrowth occurs the closure mechanisms may naturally degrade. In some embodiments, the closure mechanisms may be removable from the patient.

Referring now to <FIG>, another exemplary embodiment of a tissue resection device <NUM> in accordance with the present disclosure, is shown. At <FIG>, the device <NUM> is shown in an extended position <NUM>, and <FIG> shows the device <NUM> in a retracted position <NUM>.

The device <NUM> may include a body portion <NUM> and a distal cap portion <NUM>. The body <NUM> may be a tubular shape, extending along axis <NUM>, and the distal cap <NUM> may be coupled to a shaft <NUM> movable along the axis <NUM>. The shaft <NUM> may be coaxial to the body <NUM> along axis <NUM>. In embodiments, the distal cap <NUM> may be at least partially spherical, e.g., dome-shaped, and coaxial to the body <NUM> and shaft <NUM>. The shaft <NUM> may be movable relative to the body <NUM>, so that the distal cap <NUM> and the body <NUM> may be formed a distance "d4" apart from each other for receiving tissue to be resected, e.g., similar to the embodiments described in <FIG>.

The device <NUM> may be configured to extend along an exterior surface of a scope <NUM>, e.g., an endoscope, colonoscope, gastroscope, and/or duodenoscope. For example, a distal end 930b of the scope <NUM> may be first positioned in a body lumen at the desired position, with a proximal end 930a being external to the patient. The device <NUM> may then be delivered to the distal end 930b. In embodiments, the scope <NUM> may be internal to shaft <NUM> of the device <NUM>. In embodiments, the scope <NUM> may have a visualization device <NUM> (e.g., a camera, fiber optic cable, and the like). In embodiments, the visualization device <NUM> may be disposed on a distal end of the scope <NUM>, although it is envisioned that the visualization device <NUM> may be disposed on a side portion of the scope <NUM>. In some embodiments a visualization device independent of the scope <NUM> may be used for visualizing the positioning of the device <NUM>.

In embodiments, when the device <NUM> is delivered to the body lumen of the patient, the device <NUM> may be anchored to an inner surface of the body lumen by suction, e.g., by an anchoring mechanism <NUM>. The anchoring mechanism <NUM> may be in the body <NUM> and/or the distal cap <NUM>, for engaging body lumen tissue. In some embodiments, the anchoring mechanism <NUM> may be configured to have a plurality of suction channels <NUM>, extending around an outer circumference <NUM> of the body <NUM> and/or the distal cap <NUM>. A vacuum may initiate suction by drawing in and holding the tissue at the body <NUM> and/or the distal cap <NUM> as a tissue capture device (see <FIG>). It is also understood that other attachment mechanisms may be used as an anchoring mechanism <NUM> to engage the distal cap <NUM> and/or the body <NUM> to an inner surface of the body lumen. For example, mechanical fasteners such as hooks, needles (e.g., j-shaped needles) suture, and/or T-tags may be configured to extend radially from openings on an outer circumference <NUM> of the distal cap <NUM> and/or the body <NUM> to anchor the device <NUM>. The mechanical fasteners may extend circumferentially to engage the body lumen.

Referring now to <FIG>, a process for resecting tissue using an exemplary embodiment of a tissue resection device <NUM> in accordance with the present disclosure. It is understood that any of the features described in <FIG> may be included in the device <NUM>. At step 1005a as shown in <FIG>, an endoscope <NUM> may be delivered to a body lumen <NUM> having a tissue section for resection. As described above, a full thickness tissue portion may be resected by circumferentially resecting a selected tissue of the body lumen <NUM>. When the endoscope <NUM> is in the desired position, e.g., the medical professional has visually determined the tissue for resection by the endoscope <NUM>, the device <NUM> may be extended to an open position. As shown at step 1005b in <FIG>, the distal cap <NUM> and/or the body <NUM> may be extended by the shaft <NUM> so that the distal cap <NUM> and the body <NUM> are spaced a distance "d5" apart. The distance "d5" may encompass tissue of the body lumen <NUM> selected for resection.

When the device <NUM> is positioned as desired, suction may be initiated by the suction device <NUM> in the body <NUM> and/or the distal cap <NUM> as a tissue capture device. An inner surface <NUM> of the body lumen <NUM> may be drawn toward and engaged with the suction device <NUM>. In some embodiments, a plurality of suction channels <NUM> may engage the inner surface <NUM> of the body lumen <NUM> so that an entire circumferential portion of the body lumen is engaged with the device <NUM>. In embodiments, a suction device <NUM> may be disposed in both the distal cap <NUM> and the body <NUM>, so that tissue selected for resection may be bounded by a distal portion of tissue engaged with the distal cap <NUM>, and a proximal portion of tissue engaged with the body <NUM>. When the device <NUM> is engaged with the distal cap <NUM> and the body <NUM>, the device <NUM> may be engaged, or anchored, to the body lumen <NUM>.

At step 1005d as shown in <FIG>, the distal cap <NUM> and the body <NUM> may be drawn together, to gather body lumen tissue bounded by the distal and proximal engaged tissue portions as shown at reference numeral <NUM>. As described above in <FIG>, an accessory such as a mechanical grasper tool or further suction device may be utilized to draw the tissue radially inward. When the tissue selected for resection is positioned between the body <NUM> and the distal cap <NUM>, a tissue closure device <NUM> and/or a tissue resecting device <NUM> may be used as described above with respect to <FIG>. For example, a tissue closure device <NUM> may be a circular ring disposed on the distal cap <NUM> and/or the body <NUM>, e.g., having a blunt edge. As the distal cap <NUM> and/or the body <NUM> are drawn together, the tissue selected for resection may be held by the tissue closure device to clamp the tissue closure device against the tissue.

When the tissue selected for resection is clamped between the distal cap <NUM> and the body <NUM>, a tissue resecting device <NUM> may be utilized to resect the selected tissue. For example, in some embodiments, a blade or other resecting device such as an electrocautery device, and/or radially expandable wire, may be extendable from the distal cap <NUM> and/or the body <NUM>. The tissue resecting device <NUM> may be movable circumferentially around the distal cap <NUM> and/or the body <NUM> about axis <NUM>. For example, the tissue resecting device <NUM> may begin resecting tissue at <NUM>° and finish resecting tissue at <NUM>° for full tissue resection of a portion of the body lumen <NUM>. In embodiments, the blade may resemble a hole punch, as described above.

In some embodiments, a tissue closure device <NUM> may be used to join edges of the body lumen <NUM> from the portion for resection. For example, a tissue closure device <NUM> may include staples, a suture, clips, and/or adhesive as a closure mechanism. The closure mechanisms may be pre-loaded in the device <NUM> for deployment. The tissue closure device <NUM> may be deployed circumferentially around the tissue, similar to <FIG>. It is understood that the tissue closure device <NUM> may insert staples or other closure mechanisms prior to the tissue being resected by a tissue resecting device <NUM>. Sealing the body lumen prior to resecting the selected portion of tissue may minimize and/or prevent contamination of the body lumen by surrounding bodily fluid and/or the surrounding area from fluid in the body lumen. When the selected tissue for resection has been resected, the device <NUM> may detach from the inner surface <NUM> of the body lumen <NUM>, e.g., by stopping the vacuum. The device <NUM> may then be removed from the patient, by retracting in a proximal direction.

Referring now to <FIG>, <FIG>, and <FIG>, another embodiment of a tissue resection device <NUM>, <NUM> and a process for resecting tissue is shown. The device <NUM>, <NUM> may include a body portion <NUM> extending along an axis <NUM>. The body portion <NUM> may be substantially cylindrical and in embodiments may be a hollow tube, e.g., for receiving a portion of body lumen <NUM>. A distal cap <NUM> may be disposed distal of the body <NUM> along the axis <NUM>, and may be substantially circular, cylindrical, or any other shape to be configured to couple with the body <NUM>. In some embodiments, the distal cap <NUM> may be coupled to a sheath, or lumen <NUM>, which may be extendable along the axis 1102a and manipulatable at a proximal end (e.g., outside of the patient) for positioning relative to the body <NUM>. In some embodiments, the lumen <NUM> may be coupled to a connector <NUM> of the distal cap <NUM>. The connector <NUM> may be integrally formed on the distal cap <NUM>, on a proximal side, for coupling to the lumen <NUM>. In some embodiments, the connector <NUM> may be attached to the distal cap <NUM>. The body <NUM> and/or the distal cap <NUM> may be formed of a material such as steel, nitinol, plastic, expandable balloons, and/or any other material configured to contain the selected tissue for resection. In some embodiments, a proximal end 1110a of the body <NUM> may have an opening <NUM>, which may be utilized for delivery of additional tools and/or devices, including but not limited to a resecting device such as a knife, an attachment tool such as a t-tag, or other components of the tissue resection device <NUM>, <NUM>. For example, a scope such as an endoscope, gastroscope, colonoscope, duodenoscope, and the like, may be receivable in the opening <NUM>, which may include one or more tools for tissue resection and one or more working channels.

In embodiments, the body <NUM> and the distal cap <NUM> may be delivered in a coupled configuration to the body lumen <NUM>, and the distal cap <NUM> and the body <NUM> may then be decoupled to position for tissue resection. For example, at step 1105a, 1205a the distal cap <NUM> may be positioned in the body lumen <NUM> distal of a selected tissue for resection <NUM>, and the body <NUM> may be positioned in the body lumen <NUM> proximal to the selected tissue for resection <NUM>, so that the body portion <NUM> and the distal cap <NUM> are a distance "d6" apart. In some embodiments, a medical professional may mark the tissue for resection, as described above, e.g., by ink, radiopaque contrast, echogenic contrast, or other known techniques, and/or utilizing fluoroscopy imaging and/or ultrasound guided navigation techniques for visualizing the tissue selected for resection. Additionally, a medical professional may be able to visualize positioning of the device <NUM>, <NUM> by a visualization device such as a camera, fiber optic cable, and/or other imaging device may be delivered to the desired position.

As described above, in some embodiments, the device <NUM>, <NUM> may be deliverable over an endoscope <NUM>, and a visualization device may be used by delivering to the treatment site by a working channel of the endoscope. For example, an endoscope <NUM> may be extendable along the axis 1102a and receivable in the opening <NUM>. As shown in <FIG>, an endoscope <NUM> may include one or more working channels for delivering the lumen <NUM>, a resecting device such as a knife, and/or a mechanical fastener <NUM> such as a t-tag. In some embodiments, the device <NUM>, <NUM> may be a separate accessory of an endoscope. In other embodiments, the body <NUM> and the distal cap <NUM> may be deliverable to a treatment site through a working channel of an endoscope, and may be extendable to fit an inner diameter of the body lumen. The lumen <NUM>, which in some embodiments may be a guidewire or other rigid or semi-rigid pushing tool, may allow the medical professional to articulate the body <NUM> and/or the distal cap <NUM>. In some embodiments, the body <NUM> and/or the cap <NUM> may be delivered to the treatment site by being pushed over an imaging device such as an endoscope. In this fashion, the endoscope may act as a guidewire for enabling a medical professional to position the body <NUM> and the cap <NUM> as desired, and the endoscope may include one or more working channels, which may be used for delivery of additional instruments/accessories to the treatment site. In some embodiments, the cap <NUM> may be manipulatable via forceps or other accessory inserted into a working channel of the endoscope, by the medical professional from the proximal end (e.g., external to the patient). In some embodiments, the device and/or accessories may be manipulatable through exterior access points by inserting transcutaneously with a laparoscopic approach to the target tissue.

The body <NUM> and/or the distal cap <NUM> may include an anchoring mechanism <NUM> for engaging an inner surface 1120a of the body lumen <NUM>. The anchoring mechanism <NUM> may be disposed around an outer circumferential surface <NUM>, <NUM> of the respective body <NUM> and/or distal cap <NUM>. The anchoring mechanism <NUM> may embed to secure and stabilize the body <NUM> and/or distal cap <NUM> in the inner surface 1120a of the body lumen <NUM> but not perforate, e.g., extend beyond the outer surface 1120b, of the body lumen <NUM>. It is understood that the body <NUM> and/or distal cap <NUM> may be engageable with a healthy tissue portion in the body lumen <NUM>, so that all diseased tissue may be positioned in the selected tissue for resection <NUM> (such that the positioning of the body <NUM> and the distal cap <NUM> a distance "d6" apart from each other surround the selected tissue for resection) and removed by the device <NUM>.

The anchoring mechanism <NUM> may be one or more mechanical fasteners including but not limited to clips, clamps, quills, barbs, and the like. In some embodiments, the anchoring mechanism <NUM> may be a suture or other device for securing the body <NUM> and/or distal cap <NUM> to the inner surface 1120a of the body lumen <NUM>. In some embodiments, the anchoring mechanism <NUM> may be quills disposed in a direction so that the body portion <NUM> and/or distal cap <NUM> may be rotatable about the axis <NUM> in a first direction indicated by arrow <NUM> to embed, or lock the quills into the inner surface 1120a of the body lumen <NUM>. If the body <NUM> and/or distal cap <NUM> needs readjustment, the body <NUM> and/or distal cap <NUM> may be rotatable about the axis <NUM> in a second direction opposite the first direction (arrow <NUM>) to release the quills from the inner surface 1120a of the body lumen <NUM>.

When the body <NUM> and the distal cap <NUM> are positioned in the body lumen <NUM> along the axis <NUM> and secured to the inner surface 1120a of the body lumen <NUM>, the selected tissue for resection <NUM> may be drawn inward to the body <NUM> by suction, in addition to and/or supplemented by mechanical grasping methods as described above with respect to <FIG>, <FIG>, <FIG>, and <FIG>. In some embodiments, a grasping tool may grasp the inner surface 1120a of the selected tissue for resection <NUM> and draw the tissue radially inward from the body lumen <NUM>, as shown at step 1105b in <FIG>. For example, as described above, in some embodiments a grasping tool may be delivered to a treatment site through a working channel of an endoscope. The endoscope may allow for articulation of the grasping tool in the distance "d6" between the distal cap <NUM> and the body <NUM>. A medical professional may articulate the grasping tool for grasping selected tissue and drawing the tool inward into the body <NUM>.

In some embodiments, one or more fasteners such as hooks, barbs, and the like may be disposed on an inner circumferential surface <NUM> for securing the selected tissue for resection <NUM> (see <FIG>). In some embodiments, a suction device as a tissue capture device may be engageable with the body <NUM> and initiated to draw the selected tissue for resection <NUM> radially inward into the body <NUM>. For example, suction may be applied to draw the selected tissue for resection <NUM> in a proximal direction along the axis <NUM> as indicated by arrow <NUM>.

In some embodiments, an expandable ring <NUM> (see <FIG>) may be deployable to the selected tissue for resection <NUM>. The ring <NUM> may be attachable to an inner surface 1120a of the tissue, e.g., by hooks, rings, or other mechanical fasteners. The ring <NUM> may have a variable diameter, e.g., be formed of a flexible material, so that the ring <NUM> may be collapsible and expandable. The ring <NUM> may be attached to the selected tissue for removal (see <FIG>), and may be drawn into the body <NUM>. In some embodiments, a grasping tool <NUM> may be used, e.g., having a proximal end outside of the patient for articulation by a medical professional, to draw the selected tissue inward. The grasping tool <NUM> may be extendable along the axis <NUM>, and be pulled in a proximal direction so that the ring may decrease radially to be drawn into the body <NUM>, thereby drawing the selected tissue into the body <NUM> (see <FIG>).

In some embodiments, one or more balloons may be utilized to draw the selected tissue for resection <NUM> into the body <NUM>. Referring now to <FIG>, a balloon <NUM> may be expanded in the body lumen <NUM> and engaged with the selected tissue for resection <NUM>. The balloon <NUM> may include an anchoring mechanism <NUM> for engaging the inner surface 1120a of the body lumen at the selected tissue for resection <NUM>, e.g., by one or more mechanical fasteners, clips, clamps, barbs, hooks, and the like. When the balloon <NUM> is engaged with the selected tissue for resection <NUM>, the balloon <NUM> may be deflated, or super deflated (e.g., vacuum applied to fully evacuate the balloon), (see <FIG> at step 1205b) so the balloon <NUM> may have a webbing effect. For example, as shown in <FIG>, the balloon in a deflated state, indicated by reference numeral <NUM>' and still engaged with the inner surface 1120a of the body lumen at the selected tissue for resection <NUM>, may then be retracted in proximal direction to draw the tissue into the body <NUM>.

At step 1105c as shown in <FIG>, the distal cap <NUM> may be moved in a proximal direction towards the body <NUM> to secure the selected tissue for resection <NUM> within the body <NUM>. In some embodiments, the distal cap <NUM> and the body <NUM> may be coupled together. For example, the distal cap <NUM> and the body <NUM> may be coupled together by a mechanical fastener <NUM> such as clips, rivets (e.g., POP® rivets), snaps and the like. In some embodiments, T-tags, barbs, and/or hooks may couple the distal cap <NUM> and the body <NUM>.

At step 1205c in <FIG>, the distal cap <NUM> may be moved in a proximal direction towards the body <NUM> to secure the selected tissue for resection <NUM> within the body <NUM>. In some embodiments, the tissue may be captured by a mechanical fastener <NUM>, such as a t-tag for closure within the body <NUM> and the cap <NUM>. The mechanical fastener <NUM> may be deliverable through at least one cavity <NUM> in the body <NUM>. In some embodiments, the mechanical fastener <NUM> may be deliverable as an accessory by an endoscope, as described above with respect to other accessories such as tissue resecting devices, tissue grasping tools, and the like.

In embodiments, a tissue resecting device may be deployable for resecting the selected tissue for resection <NUM> in the body <NUM>. As described above with respect to <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>, the tissue resecting device may be a blade extendable from the distal cap <NUM>, electrocautery device, and/or radially expanding wire and be similarly operable for resecting the selected tissue for resection <NUM> from the body lumen <NUM>. As described above, a tissue resecting device may be deliverable to a treatment site via a working channel of an endoscope.

Claim 1:
A device (<NUM>') for tissue resection in a body lumen, comprising:
a body (<NUM>') extending along an axis (<NUM>);
a distal cap (<NUM>') positioned distally of the body and coupled to an inner shaft (<NUM>) extending along the axis, the body and the distal cap being movable relative to each other;
an anchoring mechanism (<NUM>) capable of engaging the body and the distal cap proximate a selected tissue for resection in the body lumen;
a tissue capture device (<NUM>) deployable from the tissue resection device such that the selected tissue for resection is securable by the tissue capture device; and
a tissue resecting device (<NUM>') for resecting the selected tissue for resection.
wherein the tissue resecting device is disposed on an outer shaft (<NUM>) and the distal cap (<NUM>') is disposed on the inner shaft (<NUM>), the tissue resecting device (<NUM>') being extendable from the distal cap (<NUM>') in response to the inner shaft (<NUM>) being movable relative to the outer shaft (<NUM>).