Suturing device using an intraluminal gastroplasty device

Abstract

A plurality of suture clips are configured to be placed in a predetermined path of a suture needle, the suture needle being advanced by a device inserted into the integral cavity and remotely operated from said location to secure and clamp the suture device. In some embodiments, a suture tightening device is placed in the predetermined path and is configured to capture the suture and shorten a length of the suture engaged with the tissue by pulling on the suture. In some embodiments, a plurality of sensors are placed along the needle path and are used to provide an indication of needle position and / or status.

Description

[0001] Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 981,573, filed on February 26, 2020, the contents of which are hereby incorporated by reference in their entirety.

[0003] Technical field and background technology

[0004] The present invention, in some embodiments thereof, relates to the field of bariatric surgery; and more particularly, to the intraluminal placement of multiple gastric sutures.

[0005] Obesity and multiple related conditions such as type 2 diabetes are of growing concern worldwide. Gastrointestinal bariatric surgery (weight loss surgery) has been shown to be effective in achieving sustained weight loss and improving type 2 diabetes. Reducing gastric volume by open surgical-gastrectomy or laparoscopic sleeve-gastrectomy has been shown to be one of the most effective forms of treatment.

[0006] Many surgical procedures are not without risk. Complications such as procedure-related leaks, severity of multiple comorbidities, and the surgeon’s learning curve are just a few factors that limit widespread adoption of this approach.

[0007] In addition to being a relatively non-invasive form of gastric volume reduction procedure, endoluminal sleeve formation also has the potential to reduce the risk of gastric leaks. Because the stomach itself is optionally left intact, another potential advantage of an endoluminal technique compared to sleeve formation by surgical resection is reversibility, for example, in the event of multiple complications. Summary of the invention

[0008] According to one aspect of some embodiments of the present disclosure, a bougie is provided, which is configured to place a suturing device in a body cavity wall, the bougie comprising: a vacuum clamping area, which is sized to be inserted into the body cavity and comprises multiple surfaces defining an interior space and multiple holes leading to the interior space, wherein the multiple holes are configured to receive tissue of the body cavity wall when suction is applied thereto; a needle, which is within the interior space, and a suture is attached to the needle; and a suture clamp, which is within the interior space; wherein the needle can be actuatable to displace along a path within the interior space while passing the suture through the tissue; and wherein the suture clamp is positioned to capture the suture at a position along the path and is operable to clamp the captured suture.

[0009] According to some embodiments of the present disclosure, the suture clamp includes a seam hole, and the predetermined path extends through the seam hole.

[0010] According to some embodiments of the present disclosure, the needle comprises a spiral needle, the predetermined path comprises a spiral path, wherein the spiral needle is rotationally displaced along the spiral path, and the suture clip is positioned along the spiral path.

[0011] According to some embodiments of the present disclosure, a suture capturing portion of the suture clip is configured such that after capturing the suture, the suture remains free to pass through the suture clip in a loose longitudinal displacement.

[0012] According to some embodiments of the present disclosure, the suture clamp includes a plurality of clamping parts, and the suture is clamped by moving the plurality of clamping parts closer to each other.

[0013] According to some embodiments of the present disclosure, the plurality of clamping parts are configured to insert one clamping part into another clamping part, and the clamping action includes inserting one clamping part into another clamping part.

[0014] According to some embodiments of the present disclosure, the clamping action includes rotating one of the plurality of clamping parts relative to another.

[0015] According to some embodiments of the present disclosure, the rotating includes moving the plurality of holes of the plurality of clamping parts out of alignment with each other.

[0016] According to some embodiments of the present disclosure, the bougie includes a suture tightener at least partially within the interior space, which is also positioned to capture the suture at a location along the path and is operable from outside the bougie to move to apply a tension to the suture to reduce a length of the suture engaged with the tissue.

[0017] According to some embodiments of the present disclosure, the bougie comprises a plurality of sensing locations positioned along the path, each sensing location being configured with a sensor configured to sense the adjacent presence of the needle.

[0018] According to one aspect of some embodiments of the present disclosure, a bougie is provided, which is configured to place a suturing device in a body cavity wall, the bougie comprising: a vacuum clamping area, which is sized to be inserted into the body cavity and comprises multiple surfaces defining an interior space and multiple holes leading to the interior space, wherein the multiple holes are configured to receive tissue of the body cavity wall when suction is applied thereto; a needle, which is within the interior space and a suture is attached to the needle; and a suture tightener, which is at least partially within the interior space; wherein the needle is actuatable to displace along a path within the interior space while passing the suture through the tissue; and wherein the suture tightener is positioned to capture the suture at a position along the path and can be operated from the outside of the bougie to move to apply a tension to the suture to reduce a length of the suture engaged with the tissue.

[0019] According to some embodiments of the present disclosure, the captured suture is free to slide relative to the suture tightener while the suture tightener moves to reduce the length of suture engaged with tissue.

[0020] According to some embodiments of the present disclosure, when the suture tightener is moved to reduce the length of the suture engaged with the tissue, the suture is folded so that both ends of the suture are on the same side of the suture tightener.

[0021] According to some embodiments of the present disclosure, the suture tightener comprises a mandrel, wherein the folded suture slides on the mandrel.

[0022] According to some embodiments of the present disclosure, the middle of the mandrel is narrower than the ends.

[0023] According to some embodiments of the present disclosure, the mandrel is rotatably mounted to the suture tightener.

[0024] According to some embodiments of the present disclosure, the suture cincher includes a hole positioned along the path, and the suture cincher captures the suture when the needle pulls the suture through the hole.

[0025] According to one aspect of some embodiments of the present disclosure, there is provided a bougie configured for placing a suturing device in a body cavity wall, the bougie comprising: a vacuum clamping area sized to be inserted into the body cavity and comprising a plurality of surfaces defining an interior space and a plurality of holes leading to the interior space, wherein the plurality of holes are configured to receive tissue of the body cavity wall when suction is applied thereto; a needle within the interior space with a suture attached to the needle; wherein the needle is actuatable to displace along a path within the interior space while passing the suture through the tissue; and a plurality of sensing locations positioned along the path, wherein each sensing location is configured with a sensor configured to sense the adjacent presence of the needle.

[0026] According to some embodiments of the present disclosure, each sensing location has a separate corresponding sensor.

[0027] According to some embodiments of the present disclosure, the sensor includes a Hall effect sensor.

[0028] According to some embodiments of the present disclosure, the needle is magnetized.

[0029] According to some embodiments of the present disclosure, the sensor includes an electrical conductor.

[0030] According to some embodiments of the present disclosure, sensing includes detecting a break in the electrical conductor.

[0031] According to some embodiments of the present disclosure, the fracture detection includes sensing a change in impedance of the electrical conductor.

[0032] According to some embodiments of the present disclosure, the fracture detection includes sensing a break in an electrical circuit due to the fracture of the electrical conductor.

[0033] According to some embodiments of the present disclosure, the sensor senses electrical contact between the sensor and the needle.

[0034] According to some embodiments of the present disclosure, the multiple sensing positions share a sensor.

[0035] According to some embodiments of the present disclosure, the sensor senses a cumulative number of the plurality of sensing positions adjacent to the needle.

[0036] According to some embodiments of the present disclosure, the sensor includes a tube extending between the plurality of sensing locations, and senses pressure within the tube.

[0037] According to some embodiments of the present disclosure, the needle includes a spiral needle, the path includes a spiral path, the spiral needle is rotationally displaced along the spiral path, and the plurality of sensing positions are also arranged along a longitudinal axis of the vacuum clamping region.

[0038] According to some embodiments of the present disclosure, the bougie includes a needle position indicator configured to indicate the position of the needle based on the presence of a portion of the needle adjacent to each of the plurality of sensing locations.

[0039] According to some embodiments of the present disclosure, the needle position indicator is configured to indicate the position of the needle in a plurality of steps corresponding to the adjacent presence or adjacent absence of the needle.

[0040] According to some embodiments of the present disclosure, the bougie includes a needle position indicator configured to indicate a plurality of signals generated by a plurality of fluctuations in the interaction of the needle with the plurality of sensing locations, the signals being smaller than a plurality of fluctuations indicating a difference between the presence and absence of the needle at the plurality of sensing locations.

[0041] According to some embodiments of the present disclosure, the bougie includes a suture clip positioned within the interior space and configured to capture the suture at a location along the path and operable to clamp the captured suture.

[0042] According to some embodiments of the present disclosure, the bougie includes a suture tightener at least partially within the interior space, positioned to capture the suture at a position along the path and operably movable from outside the bougie to apply a tension to the suture to reduce a length of the suture engaged with the tissue.

[0043] According to one aspect of some embodiments of the present disclosure, a method for fixing a suture placed in a single cavity wall is provided, the method comprising: displacing a needle through tissue along a predetermined path within an internal space of a bougie; displacing the needle along the predetermined path through and / or along a suture capture portion of a suture clamp pre-positioned in the internal space; displacing the needle through the suture capture portion to bring a portion of the suture to a capture area of ​​the suture clamp defined by the suture capture portion; and actuating the suture clamp to clamp the portion of the suture.

[0044] According to some embodiments of the present disclosure, the predetermined path is a spiral path, and the needle is a spiral needle.

[0045] According to some embodiments of the present disclosure, the method includes releasing the suture clip from the interior space.

[0046] According to some embodiments of the present disclosure, the suture capturing portion includes a hole, and the predetermined path extends through the hole.

[0047] According to some embodiments of the present disclosure, the method includes displacing the needle further along the predetermined path to bring the suture to a capture portion of a suture tightener; and, prior to the actuation, operating the suture tightener to reduce a length of the suture engaged with the tissue.

[0048] According to one aspect of some embodiments of the present disclosure, there is provided a method for monitoring the placement of a suture within a cavity wall, the method comprising: displacing a needle through tissue along a predetermined path within an internal space of a bougie; sensing the presence of the needle at each of a plurality of sensing positions positioned along the path; and indicating the needle position based on the sensing.

[0049] According to some embodiments of the present disclosure, the sensing includes mechanically disrupting an element of at least one of the plurality of sensing locations.

[0050] According to some embodiments of the present disclosure, the sensing includes detecting a pressure change in a tube caused by movement of the needle against the tube.

[0051] According to some embodiments of the present disclosure, the sensing includes detecting a change in a magnetic field.

[0052] According to some embodiments of the present disclosure, the sensing includes detecting an electrical contact between the needle tip and an electrical conductor located at one or more of the plurality of sensing locations.

[0053] Unless otherwise defined, all technical and / or scientific terms used herein have the same meanings as those generally understood by those of ordinary skill in the art to which the present disclosure belongs. Although methods and materials similar or equivalent to the various methods and materials described herein can be used in the practice or testing of multiple embodiments of the present disclosure, multiple exemplary methods and / or materials are described below. In the event of a conflict, the patent specification (including definitions) shall prevail. In addition, these materials, methods and examples are illustrative only and are not necessarily meant to be restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Some embodiments of the present disclosure are described herein with reference to the drawings by way of example only. With specific reference now to the drawings in detail, it is emphasized that the various details shown are by way of example and for the purpose of illustrative discussion of various embodiments of the present disclosure. In this regard, the description in conjunction with the drawings makes it apparent to those skilled in the art how to implement various embodiments of the present disclosure.

[0055] In the drawings:

[0056] Figures 1A to 1B Schematically illustrates a bougie configured for shaping and intracavitary suturing of tissue of a cavity according to some embodiments of the present disclosure;

[0057] Figure 1C is a schematic flow chart of a method of suturing from within a tissue fixation device according to some embodiments of the present disclosure;

[0058] Figures 1D to 1I Schematically showing the Figure 1C The multiple stages in the method of suturing;

[0059] Figures 1J to 1M showing various alternative methods of threading a seam clip according to some embodiments of the present disclosure;

[0060] Figures 2A to 2D Schematically illustrates the various stages of advancing a needle along a suction clamping area to enter and pass through a suture clamp body according to some embodiments of the present disclosure;

[0061] Figures 2E to 2G schematically illustrates multiple stages of clamping a suture clip to a suture according to some embodiments of the present disclosure;

[0062] Figure 3A Showing details of a needle according to some embodiments of the present disclosure, in a position where it is spirally advanced through a clamp body and a hole of a tightening head of a suture tightener;

[0063] Figure 3B Shows a detail of a needle according to some embodiments of the present disclosure, in a position where it has been screwed through a body and a hole of a tightening head of a suture tightener;

[0064] Figure 3C Showing the clip plug and clip body of a suture clip in a clamped configuration according to some embodiments of the present disclosure;

[0065] Figures 4A to 4D Schematically illustrates multiple components and a clamping mechanism of a cylindrical clamping suture clip according to some embodiments of the present disclosure;

[0066] Figures 5A to 5D Schematically illustrates multiple components and assembly configurations of a suture tightener according to some embodiments of the present disclosure;

[0067] Figures 6A to 6D Schematically showing a suture clamp that is clamped by a rotational movement according to some embodiments of the present disclosure;

[0068] Figures 7A to 7D schematically illustrates a pressure sensor arrangement for measuring movements and / or positions of a needle according to some embodiments of the present disclosure;

[0069] Figures 8A to 8C schematically illustrates a magnetic sensor arrangement for measuring movements and / or positions of a needle according to some embodiments of the present disclosure;

[0070] Figures 9A to 9D schematically illustrates a circuit board based sensor arrangement for measuring multiple movements and / or positions of a needle according to some embodiments of the present disclosure;

[0071] Fig.10 is a schematic flow chart of a method for guiding suture clip placement within a bougie according to some embodiments of the present disclosure;

[0072] Fig.11 is a schematic flow chart of a method for guiding a needle along a bougie according to some embodiments of the present disclosure;

[0073] Fig.12 A block diagram showing a suturing subsystem including a needle and a suture clip according to some embodiments of the present disclosure; and

[0074] Fig.13 A needle position sensing subsystem of an intracorporeal suturing device according to some embodiments of the present disclosure is schematically shown. DETAILED DESCRIPTION

[0075] The present invention, in some embodiments thereof, relates to the field of bariatric surgery; and more particularly, to the intraluminal placement of multiple gastric sutures.

[0076] Overview

[0077] One aspect of some embodiments of the present disclosure relates to a plurality of suture clips configured to be placed in a predetermined path of a suture needle that is advanced through a device inserted into an integral cavity and remotely operated from said location to secure and clamp the suture device.

[0078] In some embodiments, the suture clip is initially placed in position within a suture bougie that is used to device-guide suture tissue from a body cavity, such as a stomach. More specifically, in some embodiments, the suture bougie allows for placement of multiple stitches in tissue of the body cavity, using a needle that moves through an interior space defined by the suture bougie and at least partially longitudinally along the bougie. For example, tissue enters the bougie under suction. Optionally, the tissue is supported to obtain a specific pattern and / or suturing depth by arranging multiple surfaces of the bougie (e.g., through a pattern of multiple holes or "multiple apertures") to allow some tissue portions to enter the interior space while maintaining multiple adjacent tissue portions outside thereof.

[0079] In some embodiments, the predetermined path is defined by a plurality of mechanical arrangements within the interior space to guide a needle through a path therein. The combined configuration of the retained tissue and the predetermined path of the suture needle through the suture bougie determine a final pattern of a plurality of suture threads.

[0080] In some embodiments, the suture needle is helical and is advanced by spiral rotation along a helical path. The needle can be driven by a needle driver, which includes, for example, a cable, a screw, a ratchet and / or other mechanisms. Alternatively, the needle is another shape, for example, straight or planar curved, and moves along a path of a different shape, such as a straight path, a combination of a straight path and a planar curved path, or another arrangement.

[0081] A device-integrated suture clamp used with such a suture needle configuration encounters several potential problems in reliably capturing the suture, for remote manipulation to clamp onto the suture, and for ensuring that the clamp is clamped proximate the point where the suture exits the tissue to engage the suture to create multiple stitches.

[0082] In some embodiments, the suture clamp is initially positioned along a predetermined path of the needle so that the needle passes through a loop and / or hole of the suture clamp. This allows the suture clamp to reliably capture the suture (i.e., the suture passes through the loop and / or hole). In some embodiments, the needle passes through or near a structure that captures a portion of the opening of the suture, such as an arrangement of relatively positioned hooks. The capture includes ensuring that some portion of the suture remains (or reliably returns) to a predetermined area, where the suture clamp is then actuated to clamp, while the suture also remains free to slide longitudinally through the area, such as as the needle continues to move forward, and / or the suture is tightened to tighten. The suture clamp is preferably positioned so that the clamping area is near the place where the needle exits the tissue after forming a stitch. This helps to ensure that (at least once the suture is appropriately tightened) the suture clamp is positioned sufficiently close to the ends of the stitches and / or folds of the tissue cavity wall so that the suture stitches themselves remain tight.

[0083] In various embodiments, the suture is passed through a loop and / or hole, and the predetermined area optionally includes the multiple ranges of the loop or hole. The relatively small size of the predetermined area is a potential advantage, for example, because this allows the clamp to be smaller and / or operable to clamp from its original installed position. For example, clamping is performed by further constraining the loop / hole area, such as adjusting a shape of the loop / hole, by pressing another element into the loop / hole, or another method. Optionally, clamping includes twisting the suture, such as causing it to bend at least once, away from a direction in which force is transmitted to the suture at the point where the suture enters the clamp.

[0084] In some embodiments, the suture clip comprises a plurality of pieces, one of which is actuatable to be inserted into another piece in a cooperative manner, thereby pressing the suture (passing through one of the plurality of pieces) between the walls of the two pieces. Additionally or alternatively, in some embodiments, the suture clip comprises a plurality of pieces, one of which is actuatable to rotate relative to another piece, thereby twisting the suture into a shape that resists tension.

[0085] Preferably, the suture clip is clamped while it remains within the bougie, e.g., near the site where suturing is completed (i.e., the location where the needle exits the last suture hole it formed in the tissue). One or more clips may optionally be placed between multiple sutures, e.g., to allow multiple sutures to be cut individually and / or in smaller groups.

[0086] To achieve remote actuation, in some embodiments, at least one of the multiple suture clips is moved by a control member, for example, by pulling a wire, rope, rod and / or cable; rotating a perforated and / or threaded element; or another mechanism.

[0087] One aspect of some embodiments of the present disclosure is directed to a plurality of suture tightening devices configured to be placed in a predetermined path of a suture needle that is advanced through a suturing device (e.g., a bougie) inserted into an integral cavity and, once the suture is captured, can be remotely operated to pull up and shorten a length of the suture in a sutured area (suture engaged with tissue) engaged with a tissue. For example, the tightening is performed in preparation for applying a suture clip to the suture.

[0088] In some embodiments, the suture tightening device loosely captures the suture so that the suture continues to slide freely in the suture tightening device while the suture tightening device pulls up and shortens the length of suture engaged with tissue. The free movement of the suture relative to the suture tightening device provides a potential advantage because the needle attachment end of the suture remains stationary (and still attached to the needle) once the needle has completed its trajectory.

[0089] In conventional hand suturing, the suture needle itself is a "suture tightening device" and pulling it tightens the stitches it makes (by shortening the length of suture engaged with the tissue). However, mechanically driven suturing, such as using a spiral needle, presents a number of problems, and a separate suture tightening device offers a number of potential solutions.

[0090] A spiral needle may be well suited for creating multiple suture threads, for example, as long as its combined longitudinal and rotational path of motion passes horizontally (due to rotation) through one or more tissue thicknesses, and repeats such passes longitudinally. However, once the multiple suture threads are placed (i.e., once the suture is fully engaged with the tissue), it may be preferable to be able to tighten the multiple threads by a simple pull without the complexity of a spiral action. In some embodiments, a suture tightener provides controls, separate from the needle controls, allowing tightening to be performed using a non-spiral action.

[0091] For example, compared to a solution that transfers a spiral needle from a spiral drive mechanism for use with a pull-only drive mechanism, a separate suture tightening device offers the potential advantage that the relatively bulky spiral needle itself need not pass through the confined spaces of the bougie. The suture tightening device only has to move the suture itself. Optionally, it is tighter than the spiral needle.

[0092] In some embodiments, the suture tightening device folds the suture when the suture is moved (e.g., pulled proximally) so that both ends of the suture (e.g., a tissue attachment end and a needle attachment end) are on the same side (e.g., distally) of the suture tightening device. This is a potential advantage of shortening the tightening distance required by the device, for example, so that moving the suture tightening device by one centimeter shortens the length of the suture engaged with the tissue by about one to two centimeters.

[0093] In some embodiments, the suture tightening device comprises a mandrel (e.g., mounted to a sling) having a shape (e.g., flared to the multiple sides) such that tension on a suture wrapped around the mandrel tends to pull the suture toward a middle region of the mandrel. This is a potential advantage for controlling the position of the suture and / or keeping it away from sharp and / or multiple angles and multiple crevices. In some embodiments, the mandrel is free to rotate (e.g., rotatably mounted to the sling), facilitating the free movement of the suture. In some embodiments, a capture hole of the suture tightening device is at least partially defined by the mandrel and, optionally, also by a sling that holds the mandrel.

[0094] In some embodiments, a suture clamp and suture tightening device are arranged so that the position of the suture relative to the suture clamp is controlled by movement of the suture tightening device, such as to a predetermined position. For example, the suture tightening device, when pulled, optionally enters a channel, the size and positioning of the channel so that the portion of the suture extending directly from the suture tightening device to the position where it exits the tissue is forced through the clamping area of ​​the suture clamp. For example, the suture is constrained to be in close proximity to a member of the suture clamp that participates in the clamping. In such embodiments, the suture clamp itself need not include a loop or hole, as capture is managed by movement of the suture tightening device.

[0095] One aspect of some embodiments of the present disclosure relates to sensing the position of a suture needle using a plurality of sensors positioned along a predetermined path of the needle as the suture needle is advanced through a device inserted into an integral cavity.

[0096] In some embodiments, the plurality of sensors comprises a plurality of sensing sites configured to sense and indicate the presence / absence of a needle portion at the sites. In some embodiments, the plurality of sensors are placed at intervals shorter than a longitudinal length of the needle. In some embodiments, the needle is a spiral needle and the plurality of sensors are placed at intervals of about the size of the longitudinal distance spanned by one spiral turn of the needle and / or a multiple thereof.

[0097] Optionally, the multiple sensors sense the presence / absence of the needle through a change in pressure (e.g., pressure on a tubular member), multiple magnetic field changes (e.g., using a Hall effect sensor) and / or through multiple changes in the conductivity of the sensor (e.g., by disconnecting multiple elements of the sensor and / or establishing multiple new electrical contacts through the sensor).

[0098] In some embodiments, the position sensing is converted into multiple indications of needle position according to a plurality of steps defined by the presence / absence of the needle next to each individual sensing location. Additionally or alternatively, in some embodiments, the position sensing data is used to indicate information about needle status and / or position less than one step in length, such as by displaying multiple indications of multiple sensor fluctuations, such as in response to multiple needle movement instructions.

[0099] Before explaining at least one embodiment of the present disclosure in detail, it should be understood that the application of the present disclosure is not necessarily limited to the multiple details of the construction and the multiple components and / or the arrangement of multiple methods described in the following description and / or illustrated in the accompanying drawings. The multiple features described in the present disclosure, including the multiple features of the present invention, can have other multiple embodiments or be practiced or implemented in various ways.

[0100] Several exemplary suture clips

[0101] Reference now Figures 1A to 1B , Figures 1A to 1B A bougie 100 configured for shaping and intraluminal suturing of tissue of a lumen according to some embodiments of the present disclosure is schematically shown.

[0102] The three main parts of the bougie 100 are shown as the bougie capsule portion 101 (distal), the bougie body 102, and the bougie control handle 103 (proximal).

[0103] In some embodiments, the bougie capsule portion 101 (a bougie capsule portion is also referred to herein as a "capsule") comprises a suction clamping region 110, which in turn comprises one or more openings 111 configured to receive tissue from the body cavity under suction and to hold and / or position it in preparation for one or more surgical modifications, such as suturing. In some embodiments, the suction clamping region 110 comprises a plurality of support surfaces upon which tissue collapses when suction is applied to the device in use. The plurality of support surfaces comprises a body 110A of the clamping region 110 (e.g., formed as a portion of a tube and / or ridge) and / or other features along the clamping region 110 such as a plurality of hole-forming elements, optionally including longitudinal barriers 115, and / or a plurality of lateral barriers 117. A space (also referred to herein as a cavity) is defined within the plurality of support surfaces, the space receiving and positioning tissue under suction, and the space suturing is performed on the positioned tissue within the space.

[0104] In some embodiments, during suturing, a spiral needle moves along the space in a similar spiral motion, suturing the positioned tissue by alternately passing through a first tissue portion of tissue that collapses into the space from one side of the body cavity as it advances, and then passing through a second tissue portion from the other side of the body cavity that also collapses into the space next to the first tissue portion.

[0105] In this document, the plurality of openings 111 are also part of the hole area of ​​a bougie capsule portion 101. In some embodiments, the plurality of openings 111 are configured to change size, shape and / or topology by actuation of one or more hole-forming elements. Such openings are also referred to herein as a plurality of "dynamic" openings.

[0106] In some embodiments, actuation of the hole forming element and the concomitant changes in the plurality of dynamic openings 111 are used to control one or more aspects of luminal tissue attachment, luminal tissue positioning, or luminal tissue aspiration depth (e.g., in preparation for suturing); or tissue release. In some embodiments, tissue release includes the release of sutures or other surgical materials that can be attached (e.g., sutured, clamped, and / or stapled) to the luminal tissue when it is engaged with the bougie capsule portion 101.

[0107] In some embodiments, instances of the hole forming elements include a longitudinal barrier 115 and / or lateral barriers 117 .

[0108] In some embodiments, a longitudinal barrier 115 comprises an element, such as a reinforcing strip or rod, that longitudinally spans at least a portion of the suction clamping region 110, substantially dividing it into two sides of a plurality of openings 111 that extend longitudinally side by side with each other. The longitudinal barrier 115 is optionally removable, reconnecting the plurality of separated openings 111. This is a potential advantage for tissue and / or suture release; for example, releasing the suction clamping region 110 from a suture that passes between two luminal tissue portions (i.e., the first and second tissue portions mentioned above) and on an inner side of the longitudinal barrier 115 (i.e., in the interior space of the suction clamping region 110).

[0109] In some embodiments, the plurality of lateral barriers 117 comprise one or more elements, such as lengths of cord, that cross transversely across the suction nip region 110 (optionally directly transversely or diagonally). The crossing elements create a division of the suction nip region that separates the plurality of distinct openings 111 on either side of the element. In some embodiments, the plurality of lateral barriers 117 are releasable and / or removable to remove the separation.

[0110] Examples of the longitudinal barrier 115 and the lateral barriers 117 are described in, for example, International Publication No. WO 2016 / 056016, the contents of which are incorporated by reference in their entirety.

[0111] In some embodiments, a distal tip 112 is provided at the bougie capsule portion 101. The distal tip 112 is optionally transparent and / or terminates in a sufficiently large hole (e.g., about 6 to 8 mm in diameter) to allow the distal end of an endoscopic probe or other tool to pass therethrough.

[0112] In some embodiments, the bougie body 102 includes a tube 121 along which one or more longitudinally extending control members 120 pass externally and / or internally. In some embodiments, a plurality of control members 120 are interconnected between a plurality of actuatable elements (e.g., longitudinal stopper 115 and / or a plurality of lateral stops 117) of the bougie capsule portion 101 and the bougie control handle 103 (e.g., a plurality of control knobs 122). In some embodiments, the tube 121 has an inner diameter large enough (e.g., about 6 to 10 mm) to insert an endoscopic probe or other tool.

[0113] Any control member 120, control knob 122 or other control device is optionally provided with an encoder 121A that senses the operation of the control member. In some embodiments, data from the encoder 121A is used to determine an operating state of the bougie 100. In some embodiments, the deflection between the movement measured by the encoder 121A and a plurality of sensed results (e.g., within the bougie capsule portion 101) is monitored. Optionally, the occurrence of the measured deflection is considered as an indication of the presence of mechanical resistance, and this is further indicated to the operator, for example, by logic circuitry and one or more indicators on or connected to the bougie 100 itself.

[0114] Distal tip 112 is preferably provided with a tapered shape to facilitate insertion of bougie 100 along a natural body passage, such as an esophagus. The size (diameter and length) and shape (at least in an insertion configuration) of bougie capsule portion 101 and bougie body 102 are preferably determined to allow insertion along a natural body passage, such as an esophagus, to reach a target organ, such as a stomach.

[0115] In some embodiments, the bougie control handle 103 includes one or more control knobs 122 configured to control manipulation of the plurality of control members 120. Optionally, one or more ports 124 are provided that are sized to allow insertion of an endoscope or other tool for entering the bougie capsule portion 101 along the lumen of the tube 121 and optionally to and / or away from the distal tip 112.

[0116] Reference now Figure 1C , which is a schematic flow chart of a method for performing suturing from within a tissue fixation device according to some embodiments of the present disclosure. Figures 1D to 1I , which schematically shows the Figure 1C Further references Figures 1J to 1M , which schematically shows various alternative methods of threading a seam clip according to some embodiments of the present disclosure. Fig.12 , which shows a block diagram of a suturing subsystem 1200 including a needle 116 and a suture clip 130 according to some embodiments of the present disclosure.

[0117] In some embodiments, Figure 1C At block 152 of the present invention, the tissue is captured on a suturing device, for example, by vacuum forming the stomach tissue 50 around a vacuum clamping region 110 of a capsule 101 of a bougie 100 supported by multiple surfaces of the body 110A and the retaining members 115, 117. In some embodiments, this corresponds to Figure 1D115 (optionally, without the needle 116 having been advanced to the position shown). A first portion 50A of the stomach tissue 50 is vacuum clamped along one side of the plurality of openings defined by the barriers 115, 117, and a second portion 50B of the stomach tissue 50 is vacuum clamped along the other side (i.e., on either side of the longitudinal barrier 115). The needle 116 is attached to the suture 118 and pulls the suture 118 as it is advanced. Figure 1E Shows Figure 1D A bougie 100 is shown without the stomach tissue 50 formed around it, thereby revealing more of the underlying details.

[0118] In some embodiments, at block 154, the suture 118 is pulled through the tissue 118 by advancing the needle 116 in a spiral motion. In some embodiments, this corresponds to Figures 1F to 1G The situation described ( Figure 1G yes Figure 1F In some embodiments, a needle driver 1208 is used to advance the needle 116 along a path 1210 ( Fig.12 ). Needle driver 1208 optionally includes, for example, a cable and / or gear arrangement that strikes needle 116 and advances needle 116 by spiral rotation when actuated (eg, by rotation and / or pulling).

[0119] In some embodiments, at block 156, the spiral needle 116 passes through and / or abuts against a suture catch 132 of the suture clip 130. In some embodiments, this corresponds to Figures 1H to 1I The situation described ( Fig. 1I yes Figure 1H (a version of the present invention, the appearance of the stomach tissue 50 is suppressed). It is a potential advantage to install the suture clip 130 near the needle exit of the last stitch (e.g., within 10 mm or less). This may reduce the slack of the suture.

[0120] In some embodiments, a suture catcher 132 includes a portion of a suture clip 130, and a portion of a suture 118 reliably passes through / presses against a portion of a suture clip 130 when the needle 116 is fully advanced. A suture catcher 132 optionally has a ring structure, circumferentially closed to define a hole, and the suture 118 enters through a hole passing through the ring. Alternatively, the suture catcher 132 includes an open structure, which allows the suture 118 to enter it (e.g., through a lateral opening of the suture catcher), optionally even after the needle has passed through it.

[0121] Because the needle 116 passes through the loop (i.e., the suture passes through the loop), a loop construction has the potential advantage of capturing the suture 118 without leaving an outlet that allows the transverse suture to escape, while the suture 118 remains loosely held. In addition, in order to achieve such capture, the suture catcher 132 does not need to be actuated. Because the suture 118 is initially only loosely held, it can be tightened later in the procedure, optionally without being significantly interfered with by clamp friction. As further described below, a number of more specific embodiments of the loop-type suture catchers 133, 131 are described in detail below. Figures 1J to 1M Shown together with suture clips 130A, 130B.

[0122] An open loop catcher configuration has the potential advantage of only requiring the suture 118 to pass by it (rather than through it); allowing, for example, the needle 116 to be brought in from the side after it has passed. Such a configuration is also compatible with implementation as a pair of clamping jaws, for example. However, an open configuration is associated with a potential risk of the suture 118 disengaging from the suture catcher 132 before the clamping is actuated. If a separate retaining mechanism is also provided to prevent such disengagement, this itself may interfere with subsequent suture release and / or increase the complexity of the device. If the clamping of the suture catcher 132 is at least partially actuated immediately upon the passage of the needle 116 (e.g., by the resetting of a spring displaced by the passage of the needle 116), this can reduce the chance of the suture 118 disengaging, but the suture clamp 130 itself may interfere with the tightening of the suture.

[0123] Figures 1J to 1K ( Figure 1K yes Figure 1J ) shows a clamp 130A having a hole 133 defined by a ring-shaped catch configured as a cylinder 134. Clamping (e.g., as described with respect to block 160) optionally includes inserting a matching plug into the cylinder 134, e.g., as described with respect to Figure 3C and / or as described in 4A to 4D.

[0124] Figures 1L to 1M ( Figure 1M yes Figure 1L ) shows a clamp 130B having a hole defined by a ring-type catcher configured as a protruding ring 131. Clamping (e.g., as described with respect to block 160) optionally includes withdrawing the ring 134 into a clamp body 132 that includes a plurality of tight restrictions that press against the ring 134 and / or captured suture 118.

[0125] In some embodiments, at block 158, the suture 118 is tightened. This includes pulling the suture 118 so that the portion of the suture 118 that is engaged within the stitch length 118A of the suture 118 is tightened (and effectively shortened because more of the suture 118 is pulled longitudinally out of the area where the suture 118 is engaged with the tissue 50). In some embodiments, tightening the suture 118 is performed using an auxiliary tightening mechanism (optional suture tightener 220, which is optionally actuated by tightening actuator 1206), such as described herein with respect to Figures 3A to 3B and / or as described in 5A to 5D.

[0126] In some embodiments, at block 160, the suture clamp 130 is clamped. Clamping can optionally be mechanically implemented in a number of different ways. The various principles of mechanical clamping used in some embodiments of the present disclosure include squeezing the suture 116 between multiple surfaces to create friction, and bending the clamped suture 116 to interfere with the direct transmission of multiple pulling forces applied thereto. In some embodiments, the suture clamp 130 is configured such that the holding force applied by one or both of these principles is itself enhanced by pulling on the suture. For example, with respect to Figure 3C and 4A to 4D; and Figures 6A to 6D Described as clamp 1204 ( Fig.12 ) multiple examples of multiple suture clamping mechanisms.

[0127] In various embodiments, a clamp actuator 1202 can optionally be mechanically implemented in various ways. For example, in some embodiments, the suture clip 130 includes multiple parts that are brought closer to each other (e.g., closed to each other and / or inserted one inside the other) by actuation of a control member 120 (e.g., a wire or string that receives longitudinal tension from a control side of the bougie held outside the body cavity). Additionally or alternatively, in some embodiments, the suture clip 130 includes multiple parts that rotate relative to each other, such as sockets and screws and / or rotate about an axis. The rotation can optionally be actuated using a control member 120 that rotates or receives longitudinal tension from a control side of the bougie.

[0128] In some embodiments, at block 162, the suture 118 is severed. In some embodiments, a cutter is provided as part of the bougie 100 (e.g., within the interior space of the suction clamping region 110, or within another interior space of the bougie 110). Alternatively, the clamp 130 itself includes a cutter.

[0129] In some embodiments, at block 164, the stapled tissue is released from the bougie 100. In some embodiments, this includes releasing suction, removing the longitudinal barrier 115 (e.g., by withdrawing longitudinally), and removing the plurality of lateral barriers 117 (e.g., by releasing them from one side and optionally losing them by pulling them back from the other side).

[0130] Although the embodiments described herein are related to a spiral needle 116, it should be understood that the needle can alternatively be another shape, such as a straight or curved needle. The clip suture catcher is pre-positioned within an interior space of the bougie to receive the suture as the straight or curved needle is displaced through it (e.g., for a circular suture catcher) and / or displaced beside it (e.g., for an open suture catcher).

[0131] Reference now Figures 2A to 2D , which schematically illustrates the various stages of advancing a needle 116 along a suction clamping area 110 into and through a suture clamp body 204 according to some embodiments of the present disclosure.

[0132] exist Figure 2A , the needle 116 is shown as being close to the starting point of its longitudinal movement along the suction clamping area 110. In some embodiments, the needle 116 is spiral. Optionally, the advancement of the needle 116 is guided by a plurality of needle guide tracks 201 that are spaced and angled to match a spiral pitch of the needle 116.

[0133] exist Figure 2B In the embodiment shown in FIG. 1 , needle 116 has been advanced to just before the position of suture clamp body 204. Suture clamp body 204 is oriented so that advancing needle 116 enters therein as it continues its spiral forward motion ( Figure 2C ), and furthermore, continue through it without interfering with the further forward motion of the spiral ( Figure 2D ).

[0134] It should be noted that Figures 2A to 2D The display of the middle suture 118 is suppressed; it is usually attached to a trailing end of the needle 116, such as Figure 2E shown.

[0135] Reference now Figures 2E to 2G , which schematically illustrates multiple stages of clamping a suture clip 210 to a suture 118 according to some embodiments of the present disclosure. The suture clip 210 is a more specific example of a suture clip 130.

[0136] exist Figure 2E In (from Figure 2DContinuing with the above configuration), the needle 116 is now fully advanced through the suture clamp body 204, so that the suture 118 attached to a trailing end of the needle 116 now passes through the suture clamp body 204. The needle 116 has also passed through a hole (e.g., about 220) of the suture tightener. Figures 3A to 3B and / or 5A to 5D as further described).

[0137] Exemplary Suture Tightening and Clamping

[0138] Brief reference Figure 3A , which shows details of the needle 116 according to some embodiments of the present disclosure, in a position where it is spirally advanced through the collet 204 and a hole 537 of the tightening head 530 of the suture tightener 220. It is particularly noted that the collet 204 is retained within the predetermined path of the needle 116 by the collet shell 206 (which is in turn attached to the bougie 100, optionally fixedly attached). The tightening head 530 is also initially positioned at a position within the bougie along a predetermined path of the needle 116. However, it is not fixedly positioned; for example, it can be pulled proximally by applying tension on the control member 540.

[0139] Also briefly refer to Figure 3B , which shows details of the needle 116 in a position where it has been screwed through the clamp body 204 and a hole 537 of the tightening head 530 of the suture tightener 220, according to some embodiments of the present disclosure. The suture 118 is entrained behind the needle 116 and now passes through the hole 537 of the tightening head 530 and through the hole 203 of the suture clamp 210.

[0140] exist Figure 2F In the embodiment of the present invention, the suture 118 has been shortened by the proximal movement of the suture tightener 220. The needle 116 serves as an anchor for one end of the suture 118 so that when the suture threaded suture tightener 220 is pulled proximally, the passage (e.g., spiral passage) of the needle 116 through the tissue 50 removes slack from the plurality of needle threads left.

[0141] As the suture slack is removed from the plurality of needles, the suture is also further pulled through and / or passed through the suture clip 210. It should be noted that although the suture clip 210 has captured the suture (e.g., the suture has passed through it), the suture clip 210 has not yet clamped the suture, so the sliding movement of the suture is not disturbed.

[0142] In some embodiments, the clamping of the suture clip 210 (eg Figure 2G ) includes moving the clamp plug 202 into a hole 203 of the clamp body 204, for example Figures 4A to 4D Described in .

[0143] Brief reference Figure 3C , which shows the clip plug 202 and the clip body 204 of the suture clip 210 in a clamped configuration according to some embodiments of the present disclosure. The suture 118 extends within the clip body 204 and between the clip body 204 and the clip plug 202. Also shown is the hole 301; used to manipulate the clip plug 202 to produce a clamp, such as described herein with respect to Figures 4A to 4D As explained in .

[0144] Reference now Figures 4A to 4D , which schematically illustrates multiple components and a clamping mechanism of a cylindrical clamping suture clip 210 according to some embodiments of the present disclosure. Figures 2A to 2G 3A to 3C, also describe various aspects of suture clamp operation applicable to, for example, suture clamp 210.

[0145] In some embodiments, the suture clip 210 includes a clip plug 202 and a clip body 204, and the clip plug 202 can be appropriately inserted into the clip body 204 (for example, Figures 4A to 4C 204). The assembly portion includes a clamping portion 209 that presses against an inner wall of the hole 203 of the clamp body 204. When the suture 118 passes through the hole 203, the clamping portion 209 and / or the clamp body 204 are loose and / or elastic enough to fit together even on the obstacles where the suture 118 exists; in some embodiments, the elastic deformation of the clamp body 204 and / or the clamp plug 202 thus causes multiple clamping forces on the suture 118. In some embodiments, the clamping portion 209 includes a parallel cylindrical outer wall.

[0146] One aspect of the operation of suture clip 210 is that its closing can be actuated by manipulating a control member (e.g., control member 120) from a location remote from the suture clip 210 (e.g., the suture clip 210 can be closed by pulling a thread or cord portion outside the body while the suture clip 210 itself remains within a cavity of the body and within the bougie 100). The control member passes through the hole 203 between the clip plug 202 and a portion of the control member exerting tension thereon, thereby shortening the control member to bring the clip plug 202 and clip body 204 together.

[0147] In some embodiments, the clamp plug 202 is configured for remote actuation by implementing one or more of a plug guide tip 208 , aperture 301 , and insertion stop 207 .

[0148] In some embodiments, the plug guide tip 208 is located at an insertion end of the clip plug 202 and is rounded and / or tapered to self-center the clip plug 202 as it is advanced into the hole 203 .

[0149] In some embodiments, one or more holes 301 are optionally open at both ends and extend along a longitudinal axis of the clamp plug 202. The hole 301 receives a control member (not shown in the multiple figures) inserted therein and optionally passes therethrough. Optionally, the control member is anchored to the clamp plug 202 and then released, for example, by cutting. Alternatively, in some embodiments, the hole is configured to allow a control member to enter the clamp plug 202 from, for example, the end including the plug guide tip 208, exit from the other end, then return to the same end and pass out again at the end including the plug guide tip 208. When both ends of the control member are pulled up simultaneously, the clamp plug is pushed into the hole 203 of the clamp body 204. If one end of the control member is released and the other end is pulled up, the control member eventually slides completely through both of the holes it passes through and is released from the clamp.

[0150] In some embodiments, the insertion stop 207 comprises a widened portion on the trailing side of the insertion plug 202 that prevents the plug 202 from being pulled completely through the hole 203 and out the other side.

[0151] In some embodiments, the pod 205 holds and positions the pod 204 within the bougie 100. For example, the pod 205 optionally includes a mounting tab 206 that is attached to the bougie 100, such as by a pin, screw, and / or other arrangement.

[0152] Figure 4D Suture clip 210 is shown released from its housing 205. In some embodiments, release of suture clip 210 from housing 205 is a result of withdrawing bougie 100 from the body after suture clip 210 has been clamped. Tension from the tissue-attached suture retains suture clip 210 so that it detaches when bougie 100 is withdrawn. Optionally, housing 205 is shaped to prevent suture clip 210 from exiting from the wrong side, such as during clamping.

[0153] Reference now Figures 5A to 5D , which schematically illustrates multiple components and assembly configurations of a suture tightener 220 according to some embodiments of the present disclosure. The operation of a suture tightener 220 is described herein, for example, with respect to Figures 2E to 2G and / or 3A to 3B are described.

[0154] In some embodiments, the suture cinch 220 includes a control member 540 (eg, an example of a control member 120 ) and a cinch head 530 .

[0155] The tightening head 530 is configured to capture (e.g., by threading) the suture 118 from a position after the needle 116 is advanced, such as through a loop or open suture catcher (e.g., as described herein with respect to the suture catcher 132 of a suture clip). In the example shown, the suture 118 is captured (threaded) when the needle 116 at one end of the suture 118 is pulled through a hole 537 defined by a sling 531 and a mandrel 533.

[0156] Mandrel 533 is optionally fixed, or rotates to form a pulley. In some embodiments, mandrel 533 narrows toward the middle and flares toward the ends. This helps center the suture 118 under tension, potentially avoiding pulling the suture from a sharp inner corner of the tensioning head 530, and / or preventing snagging in a gap between mandrel 533 and sling 531. In some embodiments, tensioning head 530 is attached to its control member 540 by a strain relief 535. Optionally, strain relief 535 is tapered, for example to help it enter a channel of bougie 100 along which tensioning head 530 is pulled.

[0157] The control member 540 optionally includes a reinforcement member 534 that extends through at least a region of the bougie that is passed through the needle 116. The reinforcement member 534 stiffens the control member 540 sufficiently to prevent the control member 540 from becoming entangled with the needle 116.

[0158] The optional flexible (e.g., rope or thread-like) distal portion 532 of the control member 540 is attached between the tightening head 530 and the reinforcement member 534. Being flexible, it allows the tightening head 530 to self-adjust its position and direction during tightening according to the direction of pulling from the suture 118. Being short, it is possible to avoid entanglement with the needle 116. The proximal portion 536 of the control member 540 optionally includes a thread, rope, cable or other structure. Optionally, the proximal and distal portions 532, 536 are joined below the reinforcement member 534 or included in a single piece.

[0159] In some embodiments, cutting the suture 118 is performed using a tool of an endoscope inserted through the bougie. Optionally, cutting the suture 118 is performed using a sharp blade placed in the bougie 100 at a location between a suture clip 130 and the needle 116, which allows it to press against, clamp on, and / or saw on the suture. For example, the sharp blade is partially placed on an interior space of the bougie 100 on a distal side of the fully advanced needle 116. As the bougie 100 is withdrawn, the suture 118 is stretched between the needle 116 and a suture clip 130. Once it is stretched, the bougie is moved to bring the sharp blade against the suture 118, cutting it. In some embodiments, the suture clip 130 itself contains a cutting blade.

[0160] Exemplary Rotating Clamp Suture Clip

[0161] Reference now Figures 6A to 6D , which schematically illustrates a suture clamp 600 that is clamped by a rotational movement according to some embodiments of the present disclosure.

[0162] In some embodiments, suture clip 600 includes a clip body 620, a clip insert 610, and an optional clip retaining ring 630. Clip insert 610 is attached to clip body 620 via a plurality of threads 613 that mate with a plurality of threads within clip body 620. Clip body 620 remains attached to bougie body 110A, such as by mating insertion of a plurality of protrusions 623 into a plurality of receiving locations of bougie body 110A, or by another method.

[0163] Installed in the bougie, the suture clip 600 is positioned so that the plurality of holes 611 (of the clip insert 610) and 622 (of the clip body 620) are aligned with each other and with a predetermined path of the needle 116 so that the needle 116 enters the holes 611, 622 as it is advanced; for example, Fig.6D The clamp body 620 can be said to have two holes, each hole being opposite to each other on the wall of the clamp body 620 .

[0164] After the needle 116 passes through the holes 611, 622, the suture clamp 600 can be operated to clamp the suture 118. To do this, the hole 611 is rotated relative to the hole 622 (out of alignment with it), for example in the direction 640. This twists the suture 118 and pulls it within the clamp body 620, clamping it between the plurality of threads of the clamp body 620 and the clamp insert 610. Optionally, a clamp stop ring 630 is attached to one end of the clamp insert 610 and prevents excessive rotation.

[0165] The rotational force may optionally be applied by rotation of a control member 650 (an example of a control member 120). The control member 650, for example, mates with a distal end 615 of the insert 610. The keying protrusion 617 mates with a matching recess in a socket end of the control member 650 to allow the rotational force to be transmitted.

[0166] Suture clip 600, once clamped to suture 118, may optionally slide out of its receiving position upon removal of the bougie from the body cavity, due to being retained, for example, by a suture made using suture 118.

[0167] Optionally, an edge of one or more of the holes 611, 622 is sharpened. Optionally, rotating to clamp also cuts the suture 118 on the proximal side. Optionally, the rotation itself does not cut the suture 118; instead, the suture must also be kept tight, for example, stretched using a suture tightener 220.

[0168] Exemplary Multiple Sensor Arrangements and Operations

[0169] Reference now Fig.13 , which schematically illustrates a needle position sensing subsystem 1300 of an intracorporeal suturing device according to some embodiments of the present disclosure.

[0170] In some embodiments, the position sensing subsystem 1300 includes a detector assembly 1302 positioned within a capsule portion 101 of a suture bougie along a needle path 1210. The needle 116 is configured to move along a path 1210 (e.g., actuated by a needle driver 1208), thereby pulling the suture 118. The path 1210 may be spiral. The detector assembly 1302 is configured to detect the presence, arrival, and / or departure of the needle 116 at a plurality of locations 1306 along the path 1210. The position indicator 1305 interprets the plurality of signals from the detector assembly and accordingly provides an indication of a current position of the needle 116.

[0171] In some embodiments, the position sensing subsystem 1300 allows tracking and / or confirmation of multiple needle movements actuated by the needle driver 1208. One potential advantage of doing so is that the needle driver 1208 itself need not be deterministic in how its own multiple movements are translated into movement of the needle 116. For example, there may be slip and / or hysteresis in the interaction between the needle driver 1208 and the needle 116. The position sensing subsystem 1300 provides positive feedback of the actual movement that occurred, and / or multiple indications of how much movement occurred. The sensing subsystem 1300 optionally includes a single elongated sensor or multiple sensors; for example, as described herein with respect to Figures 7A to 9D Implemented as described.

[0172] Reference now Figures 7A to 7D , which schematically illustrates a pressure sensor arrangement for measuring multiple movements and / or positions of a needle 116 according to some embodiments of the present disclosure.

[0173] In some embodiments of the present disclosure, a suction clamping area 110 is provided with sensing for determining the presence and / or position of a needle 116. In some embodiments, the needle 116 is spiral, and sensing is provided that allows for per-turn sensing of the advancement of the spiral needle. Needle presence and / or position sensing provides a potential advantage, particularly for verifying that the needle has passed through the suction clamping area 110, such as so that further steps, such as suture tightening and suture clamping, are not performed until the needles are fully in place.

[0174] In addition, knowing the distance the needle 116 has advanced is a potential advantage; for example, if it gets stuck or slows during advancement, corrective action can be taken more quickly if the position sensing resolution is more detailed than "suture completed / suture not completed". In some embodiments, needle position is measured stepwise over the width of a spiral winding, such as by discretely sensing at 2, 3, 4, 5 or more locations. Multiple needle positions are optionally distinguished by a pattern of multiple activated sensors. For example: initially, none of the four sensors are along a longitudinal axis of spiral advancement. As the multiple desired advances, one, two, three, and then four sensors are activated. As the needle advances further, the multiple trailing sensors are deactivated one by one until three, two, one, and then no sensors are activated. Thus, in this example, eight different needle positions are identified. It should be understood that different numbers of sensors are optionally used, and multiple sensors are optionally activated at the beginning or end of the needle movement. Optionally, multiple sensor lines are placed on either side of the bougie body 110A on the needle path, allowing for finer sensing resolution. Optionally, multiple sensor activation patterns are sensed, for example, by receiving multiple individual inputs from each sensor, or by sensing a cumulative input from several sensors (e.g., as described with respect to Figures 7A to 7D as described in detail in the pressure sensor of FIG.

[0175] In some embodiments, a needle position sensor 700 comprises a flexible tube 705 extending longitudinally along the bougie body 110A. The tube 705 is attached to a pressure sensor 710 (e.g., at one end of the tube), and the other end of the tube 705 is sealed. Thus, compression of the tube 705 causes the sensed pressure to increase. The tube 705 is held in place (e.g., by tightening a plurality of tubes 704) so ​​that the needle 116 compresses it at a plurality of intermittent sensing locations 702 as it moves (e.g., spirally) along its predetermined path. Optionally, the needle 116 directly presses against a covering cap 703 at each sensing location 702, which in turn compresses the tube 705. There are a number of potential advantages to this including: the shape of the cap 703 can ensure that it protrudes far enough into the interior of the bougie body 110 to press against it; the shape of the cap 703 can ensure that the needle 116 presses it to the side rather than piercing it; the cap 703 can be made longer than the width of the needle 116 so that more of the tube 702 is compressed (creating a greater pressure change).

[0176] The sensor indicator 712 indicates the needle position status based on the plurality of readings from the pressure sensor 710. The sensor indicator 712 optionally comprises an LED indicator, such as one segment lighting up for each triggered sensing position 702. Optionally, the sensor indicator 712 indicates the position using a plurality of tones. Optionally, the sensor indicator 712 comprises a user interface for a computer, the user interface being configured to display a graphical and / or visual indication based on the plurality of signals transmitted from the pressure sensor 710.

[0177] Optionally, for each sensing location 702 at which the needle 116 begins to press against the tube 705, the sensor 710 records one step of pressure change (and optionally displayed by the sensor indicator 712). This allows the described advancement of the sensing needle 116 to be sensed, first as multiple sensing locations 702 are pressed against (increasing pressure) in sequence, and then as multiple sensing locations 702 are released from pressure in sequence.

[0178] Optionally, pressure sensor 710 also reports multiple small (less than a step length) changes in pressure. Optionally, sensor indicator 712 displays these small changes, which can provide multiple clues to the device operator about the state of the needle. For example, if the needle driver repeatedly slides during a particular portion of the rotation cycle, a corresponding (possibly small) change in the pressure indication may occur as the force on the needle is redistributed. An operator can respond, for example by changing the manner in which the advancement is controlled and / or adjusting the angle and / or bend of the device, using the pattern of multiple pressure changes as a guide to the effect of such multiple adjustments. Even if there is no slippage, a pattern may be seen in multiple pressure readings that is related to when a needle begins to press against the next tissue layer, when it slides through it, and / or when it successfully passes through it. Optionally, the device operator adjusts multiple operations based in part on such patterns to advance the needle and / or manipulate the angle and / or bend of the bougie itself.

[0179] It is worth noting that some suture tighteners themselves can be used as multiple sensors. Once a needle 116 enters the hole of a suture tightener, the suture tightener is partially locked in place, preventing free operation until the needle passes through it again. Multiple dedicated sensors can be used additionally or alternatively to determine the position of the needle 116 by using multiple gentle tugs to test this situation.

[0180] Reference now Figures 8A to 8C , which schematically illustrates a magnetic sensor arrangement for measuring multiple movements and / or positions of a needle 116A according to some embodiments of the present disclosure.

[0181] In some embodiments, a plurality of magnetic field sensors 802 (e.g., a plurality of Hall Effect sensors) are mounted, for example, on a circuit board 800, which in turn is mounted to the body 110A of the bougie in the suction clamping area 110. The plurality of sensors 802 are preferably placed at the position closest to the needle 116A. The needle 116A is magnetized, for example, along its entire length (which may optionally be implemented as, for example, a needle 116 that has been magnetized). As the needle 116A approaches each sensor 802 in turn, the sensor 802 registers a change in the magnetic field, outputs a signal, which is in turn sensed by a signal processing circuit 810 to generate a position indication displayed by a sensor indicator 812 (which may generate multiple indications, for example, as described for the sensor indicator 810, appropriately adjusted for multiple magnetic signals rather than multiple pressure signals).

[0182] The plurality of signals generated by the plurality of sensors 802 are optionally processed and / or displayed as an indication of the "presence" or "absence" of needle approach. Additionally or alternatively, the plurality of signal components generated by the plurality of sensors 802 that are less than the size of a full step are processed and / or displayed, for example, as a plurality of effectively continuous valued signals (e.g., a plurality of analog signals and / or a plurality of digital signals encoded with a bit depth of a plurality of bits, e.g., 5 or more bits). The plurality of stresses and / or strains applied to the needle 116 to cause it to advance may slightly change its shape as it moves, e.g., with respect to Figures 7A to 7D The plurality of nearby magnetic field sensors 802 may in turn have slight fluctuations in the plurality of signals they generate. An operator of a device may optionally use indications of such fluctuations to guide device operation, for example, regarding Figures 7A to 7D as described.

[0183] Reference now Figures 9A to 9D , which schematically illustrates a circuit board-based sensor arrangement for measuring multiple movements and / or positions of a needle 116A according to some embodiments of the present disclosure.

[0184] In some embodiments, the sensor board 900 includes a circuit board configured with a plurality of leads 901A, 901B, 901C, 901D connected to a sensing circuit 910. A portion of each lead extends along an edge 904 of the sensor board 900, each along a different longitudinal portion of the sensor board 900.

[0185] In some embodiments, each lead 901A-901D has a characteristic impedance associated therewith that changes when the lead is shortened. Additionally or alternatively, one end of each lead is grounded (eg, from the other side of the circuit board 900, not shown).

[0186] The sensor plate 900 is positioned on the bougie body 110A of the suction clamping area 110 at a location where a tip 902C of the needle 116 sequentially strikes each of the individual leads 901A to 901D near the edge 904 as it spirals forward. The strikes in turn damage the struck leads. Optionally, the plate 900 is weakened near the location of the strike 903, thereby knocking a notch out of the plate upon strike.

[0187] Sensing circuit 910 senses the impedance change and / or open circuit of the ground circuit and provides a signal that is in turn indicated by sensor indicator 912 , such as described with respect to sensor indicator 712 .

[0188] Additionally or alternatively, in some embodiments, leads 901A-901D comprise a foil, spring or other conductive element that needle 116 contacts (and optionally deforms and / or breaks) as it rotates. Electrical contact can thereby be established between the various leads by needle 116, and this contact serves as the basis for position sensing (via sensing circuit 910) and indication (via sensor indicator 712). Optionally, as the needle moves, the conduction of the area of ​​electrical contact changes slightly. This change itself optionally comprises an indication of needle movement.

[0189] Optionally, needle 116 is at least partially coated with an insulating polymer (e.g., on side 902D, as compared to side 902E, which may be uncoated). The polymer coating is optionally interrupted at regular intervals to expose the metal. In some embodiments, this serves to allow needle 116 to act as an encoder of its own progress by counting multiple events of establishing and / or breaking electrical contact as coated and uncoated needle portions pass by the sensor.

[0190] It is worth noting that a sensor at a single location can be used with such a needle 116, for example by providing it with two contacts (and sensing conduction between them through the needle), or by providing it with one contact and creating a circuit through the body of the needle to a conductor in electrical contact with the needle, such as a wire attached to the needle, or a drive cable for driving the needle. In order to track the needle 116 over a distance longer than the length of the needle 116 itself, multiple such sensors are optionally provided.

[0191] Reference now Fig.10 , which is a schematic flowchart of a method for guiding suture clip placement within a bougie 100 according to some embodiments of the present disclosure.

[0192] At block 1002, in some embodiments, a needle positioned within a body cavity is advanced. In some embodiments, the advancement is in turn controlled by operation of a control member external to the body cavity. Optionally, the needle is helical and positioned within a needle guide such as a bougie 100. In some embodiments, the needle is advanced by operation (e.g., rotation) of a control member that drives the needle along a predetermined path defined by the needle guide.

[0193] One or more sensors are positioned along the predetermined path and sense the presence of the needle; for example, according to Figures 7A to 9D One of the multiple embodiments described.

[0194] At block 1004, in some embodiments, a check is made (e.g., by a circuit connected to the plurality of sensors) as to whether the needle has passed through the area in which it is configured to suture. In some embodiments, the check comprises verifying that the needle was first sensed by at least one sensor but is no longer sensed by the sensor (i.e., the needle has passed through the sensor). Additionally or alternatively, a sensor is placed far enough along the predetermined path (e.g., about the length of the needle, measured along its longitudinal direction of travel) that when a front portion of the needle is sensed, a rear portion of the needle has passed through the suture area.

[0195] At block 1006, in some embodiments: if the needle has not passed through the suture area, the flowchart returns to block 1002. Otherwise, an indication is provided that the procedure can continue; for example, by clamping a suture clamp, such as described herein with Figure 1C The multiple boxes starting from box 158 are related.

[0196] Reference now Fig.11 , which is a schematic flowchart of a method for guiding a needle along a bougie 100 according to some embodiments of the present disclosure.

[0197] At block 1102, in some embodiments, a needle positioned within a body cavity is advanced by operating a control member outside the body cavity. The configuration of the bougie 100 and needle is, for example, Fig.10 The operation of advancing the needle is performed to an extent that is considered likely to bring the needle into the sensing range of a sensor of the bougie 100 (and / or move it out of the sensing range of a sensor). For example, if a sensor is spaced at each turn of a spiral needle, the control member is optionally operated sufficiently to anticipate the spiral needle to advance approximately one turn, assuming there is no restriction on needle advancement to prevent this from occurring. Optionally, the operation of the control member is also sensed, for example using an encoder 121A.

[0198] At block 1104, in some embodiments, it is checked whether the needle has indeed reached and / or moved out of the sensing range of the sensor according to the expected result. If yes, the process returns to block 1102 and continues to further advance the needle.

[0199] Otherwise, at block 1106, a corrective action is taken. For example, this may include one or more of the following:

[0200] • Reversing the direction of needle travel.

[0201] - Adjusting the needle drive (e.g. longitudinally displacing a needle drive cable so that a different portion of it acts on the needle).

[0202] • Otherwise, change the way the force is applied to induce needle advancement (eg, operate the needle advancement control member faster or slower).

[0203] • Changing an angle of the bougie 100, for example, changing the forces applied to the needle.

[0204] • Changing the curvature of the bougie 100, for example changing the forces applied to the needle.

[0205] After and / or while taking the corrective action, the flowchart returns to block 1102. The flowchart continues until it is no longer necessary to advance the needle, e.g., until Fig.10 The result of block 1004 indicates to continue with the trimming.

[0206] General

[0207] As used herein, with respect to quantities or values, the term "about" means "within ±10%."

[0208] The terms "comprise," "comprising," "include," "including," "having" and their cognates mean "including but not limited to."

[0209] The term "consisting of" means "including and limited to."

[0210] The term "essentially consisting of" means that the composition, method or structure may include additional ingredients, steps and / or parts, but only when the additional ingredients, steps and / or parts do not substantially change the basic characteristics and novel characteristics of the claimed composition, method or structure.

[0211] As used herein, the singular forms "a", "an" and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including a plurality of mixtures thereof.

[0212] As used herein, the words "example" and "exemplary" mean "serving as an example, instance, or illustration." Any embodiment described as an "example" or "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments and / or to exclude the combination of features from other embodiments.

[0213] The word “optionally” is used herein to mean “provided in some embodiments and not provided in other embodiments.” Any particular embodiment of the present disclosure may include a number of “optional” features, unless such features conflict.

[0214] As used herein, the term "method" refers to various manners, means, techniques and procedures for accomplishing a specific task, including but not limited to those manners, means, techniques and procedures that are known or are readily developed by practitioners in the fields of chemistry, pharmacology, biology, biochemistry and medicine from known manners, means, techniques and procedures.

[0215] As used herein, the term "treating" includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating the clinical or aesthetic symptoms of a condition or substantially preventing the appearance of clinical or aesthetic symptoms of a condition.

[0216] Throughout this application, multiple embodiments of the present disclosure may exist in the form of a range. It should be understood that the description in the form of a range is only for convenience and brevity, and should not be understood as a rigid limitation on the scope of the present disclosure. Therefore, it should be considered that the range description has specifically disclosed all possible sub-ranges and single numerical values ​​within the range. For example, it should be considered that the range description of "from 1 to 6" has specifically disclosed sub-ranges, such as "from 1 to 3", "from 1 to 4", "from 1 to 5", "from 2 to 4", "from 2 to 6", "from 3 to 6", etc., as well as single numbers within the range, such as 1, 2, 3, 4, 5 and 6. This applies regardless of the range.

[0217] Whenever a numerical range is indicated herein (e.g., "10-15," "10 to 15," or any pair of numbers linked by such another such range indication), it is meant to include any number (fractional or integer) within the specified range limits, including the range limits, unless the context clearly dictates otherwise. The phrases "range between" a first indicated number and a second indicated number, and "range from" a first indicated number, "to," "until," "up to," or "through" (or another such range indicating term) a second indicated number are interchangeable herein and are meant to include the first and second indicated numbers, and all fractions and integers therebetween.

[0218] Although the present disclosure has been described in conjunction with specific embodiments thereof, it is apparent that many alternatives, modifications and variations will be apparent to those skilled in the art. It is therefore intended to embrace all alternatives, modifications and variations that fall within the scope of the appended claims.

[0219] All publications, patents and patent applications mentioned in this specification are incorporated herein by reference in their entirety. The extent is as if each individual publication, patent or patent application was specifically and individually indicated and incorporated herein by reference. In addition, any reference cited or indicated should not be construed as admitting that these references can be used as the prior art of the present disclosure. The title part in this application is used to make this specification easy to understand in this article, and should not be construed as a necessary limitation. In addition, any priority document of the present application is incorporated herein by reference in its entirety.

[0220] It is understood that certain features of the present disclosure, which for clarity are described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features described in the present disclosure in the context of a single embodiment for brevity may also be provided separately, or in any suitable subcombination, or in any other described embodiment applicable to the present disclosure. Certain features described in the context of various embodiments are not considered essential features of those embodiments unless the embodiment does not function without those elements.

Claims

1. A bougie configured to place a suturing device in a cavity wall, characterized in that: The bougie comprises: a vacuum clamping region sized to be inserted into the body cavity and comprising a plurality of surfaces defining an interior space and a plurality of apertures opening into the interior space, wherein the plurality of apertures are configured to receive tissue of a wall of the body cavity when suction is applied thereto; a needle within the interior space, with a suture attached to the needle; and a suture clip within the interior space; wherein the needle is actuatable to displace along a path within the interior space while passing the suture through the tissue; and Wherein the suture clamp is positioned to capture the suture at a location along the path and is operable to clamp the captured suture.

2. The bougie according to claim 1, characterized in that: The suture clip includes a seam hole, and the path extends through the seam hole.

3. The bougie according to claim 1 or 2, characterized in that: The needle comprises a helical needle, the path comprises a helical path, wherein the helical needle is rotationally displaced along the helical path, and the suture clip is positioned along the helical path.

4. The bougie according to claim 1 or 2, characterized in that: A suture capturing portion of the suture clip is configured such that after capturing the suture, the suture remains free to be loosely displaced longitudinally through the suture clip.

5. The bougie according to claim 1 or 2, characterized in that: The suture clamp includes a plurality of clamping parts, and the suture is clamped by moving the plurality of clamping parts closer to each other.

6. The bougie according to claim 5, characterized in that: The plurality of clamping parts are configured to be inserted one clamping part into another clamping part, and the clamping action includes inserting one clamping part into another clamping part.

7. The bougie according to claim 5, characterized in that: The clamping action includes rotating one of the plurality of clamping parts relative to another.

8. The bougie according to claim 7, characterized in that: The rotating includes moving the plurality of apertures of the plurality of clamping portions out of alignment with each other.

9. The bougie according to claim 1 or 2, characterized in that: The bougie includes a suture tightener at least partially within the interior space, which is also positioned to capture the suture at a location along the path and is operable from outside the bougie to move to apply a tension to the suture to reduce a length of the suture engaged with the tissue.

10. The bougie according to claim 1 or 2, characterized in that: The bougie includes a plurality of sensing locations positioned along the path, each sensing location being provided with a sensor configured to sense the adjacent presence of the needle.

11. The bougie according to claim 9, characterized in that: The captured suture is free to slide relative to the suture tightener while the suture tightener moves to reduce the length of suture engaged with tissue.

12. The bougie according to claim 11, characterized in that: When the suture tightener is moved to reduce the length of suture engaged with tissue, the suture is folded so that both ends of the suture are on the same side of the suture tightener.

13. The bougie according to claim 12, characterized in that: The suture tightener comprises a mandrel, wherein the suture is folded over the mandrel.

14. The bougie according to claim 13, characterized in that: The mandrel is narrower in the middle than at the ends.

15. The bougie according to claim 13, characterized in that: The mandrel is rotatably mounted to the suture tightener.

16. The bougie according to claim 9, characterized in that: The suture cinch includes an aperture located along the path, and the suture cinch captures the suture when the needle pulls the suture through the aperture.

17. The bougie according to claim 10, wherein: Each sensing location has a separate corresponding sensor.

18. The bougie according to claim 10, wherein: The sensor includes at least one of the group consisting of: A pressure sensor, an impedance sensor of the impedance of an electrical conductor, a contact sensor in contact with an electrical conductor, a break sensor for a break in an electrical conductor, and A Hall Effect Sensor.

19. The bougie according to claim 10, characterized in that: The multiple sensing locations share a single sensor.

20. The bougie of claim 10, wherein: The needle includes a spiral needle, the path includes a spiral path, the spiral needle is rotationally displaced along the spiral path, and the plurality of sensing locations are also arranged along a longitudinal axis of the vacuum clamping area.

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