Suturing with an intraluminal gastroplasty device

Abstract

A suture clip configured to be positioned in a predetermined path of a suture needle advanced through a device inserted into a body cavity and remotely operated from that position to secure and clamp the suture. In some embodiments, a suture clamping device is positioned in the predetermined path and configured to capture the suture and tension the suture, thereby shortening the length of the suture engaged in the tissue. In some embodiments, sensors are positioned along the needle path and used to provide an indication of needle position and / or status.

Description

[Technical Field]

[0001] Related Applications This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 981,573, filed February 26, 2020, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] The present invention, in some embodiments thereof, relates to the field of bariatric surgery, and more particularly to the intraluminal placement of gastric sutures.

[0003] Obesity and obesity-related conditions, such as type 2 diabetes, are of growing concern worldwide. Gastrointestinal weight loss surgery (bariatric surgery) has been shown to be effective in achieving sustained weight loss and reversal of type 2 diabetes. Gastric volume reduction by open surgery or laparoscopic sleeve gastrectomy has proven to be one of the most effective forms of treatment.

[0004] The surgical procedure is not without risk: complications such as surgery-related leakage, severity of comorbidities, and the surgeon's learning curve are some of the factors that have limited, and may limit, the widespread adoption of this approach.

[0005] In addition to being a relatively non-invasive form of gastric volume reduction surgery, intraluminal gastric sleeve formation has the potential to reduce the risk of gastric leakage. Another potential advantage of the intraluminal technique over sleeve formation via surgical resection is reversibility in the event of complications, for example, since the stomach itself is optionally left intact. Summary of the Invention

[0006] In accordance with an aspect of some embodiments of the present disclosure, there is provided a bougie configured to place a suture within a wall of a body cavity, the bougie including: a vacuum clamping domain sized for insertion into the body cavity and including a surface defining an interior space and an opening to the interior space configured to receive tissue of the wall of the body cavity upon application of suction to the vacuum clamping domain; a needle within the interior space, the needle having a suture attached to the needle; and a suture clip within the interior space, the needle operable to translate along a path within the interior space while carrying the suture through the tissue, the suture clip positioned to capture the suture at a location along the path and operable to clamp the captured suture.

[0007] According to some embodiments of the present disclosure, the suture clip includes a suture catch opening, and the predetermined pathway extends through the suture catch opening.

[0008] According to some embodiments of the present disclosure, the needle includes a helical needle, the predetermined path includes a helical path along which the helical needle translates by rotation, and the suture clip is positioned along the helical path.

[0009] According to some embodiments of the present disclosure, the suture catch portion of the suture clip is configured such that after capture of the suture, the suture remains free to gently translate longitudinally past the suture clip.

[0010] According to some embodiments of the present disclosure, the suture clip includes multiple clamping portions, and the suture is clamped by movement of the clamping portions closer together.

[0011] According to some embodiments of the present disclosure, the clamping portions are configured to be inserted one inside the other, and the clamping movement includes inserting one clamping portion inside the other clamping portion.

[0012] According to some embodiments of the present disclosure, the clamp movement includes rotating one of the clamp portions relative to the other clamp portion.

[0013] According to some embodiments of the present disclosure, the rotating includes moving openings of the multiple clamp portions out of alignment with one another.

[0014] According to some embodiments of the present disclosure, the bougie includes a suture clamp at least partially within the interior space and positioned to capture the suture at a location along the pathway, the suture clamp being operable to move from outside the bougie to apply tension to the suture to reduce the length of the suture engaged in the tissue.

[0015] According to some embodiments of the present disclosure, the bougie includes a plurality of sensing locations positioned along the path, each sensing location comprising a sensor configured to detect the adjacent presence of a needle.

[0016] In accordance with an aspect of some embodiments of the present disclosure, there is provided a bougie configured to place a suture within a wall of a body cavity, the bougie including: a vacuum clamp domain sized for insertion into the body cavity and including a surface defining an interior space and an opening to the interior space configured to receive tissue of the wall of the body cavity upon application of suction to the vacuum clamp domain; a needle within the interior space, the needle having a suture attached to the needle; and a suture clamp at least partially within the interior space, the needle operable to translate along a path within the interior space while carrying the suture through the tissue, the suture clamp positioned to capture the suture at a location along the path and operable to move from outside the bougie to apply a tension force to the suture to reduce a length of the suture engaged with the tissue.

[0017] According to some embodiments of the present disclosure, the captured suture slides freely relative to the suture clamp while the suture clamp moves to reduce the length of the suture engaged in the tissue.

[0018] According to some embodiments of the present disclosure, when the suture clamp is moved to reduce the length of the suture engaged in the tissue, it doubles the suture so that both ends of the suture are on the same side of the suture clamp.

[0019] According to some embodiments of the present disclosure, the suture clamp includes a spindle over which the bifurcated suture slides.

[0020] According to some embodiments of the present disclosure, the spindle is narrower towards the middle than at the ends.

[0021] According to some embodiments of the present disclosure, the spindle is rotatably mounted to the suture clamp.

[0022] According to some embodiments of the present disclosure, the suture clamp includes an opening positioned along the pathway, the suture clamp capturing the suture as the needle pulls the suture through said opening.

[0023] In accordance with an aspect of some embodiments of the present disclosure, there is provided a bougie configured to place a suture within a wall of a body cavity, the bougie including: a vacuum clamp domain sized for insertion into the body cavity and including a surface defining an interior space and an opening to the interior space configured to receive tissue of the wall of the body cavity upon application of suction to the vacuum clamp domain; a needle in the interior space having a suture attached to the needle, the needle being operable to translate along a path within the interior space while carrying the suture through the tissue; and a plurality of sensing locations positioned along the path, each sensing location comprising a sensor configured to detect the adjacent presence of the needle.

[0024] According to some embodiments of the present disclosure, each sensing location has a separate respective sensor.

[0025] According to some embodiments of the present disclosure, the sensor includes a Hall effect sensor.

[0026] According to some embodiments of the present disclosure, the needle is magnetized.

[0027] According to some embodiments of the present disclosure, the sensor includes an electrical conductor.

[0028] According to some embodiments of the present disclosure, the sensing includes detecting a break in the electrical conductor.

[0029] According to some embodiments of the present disclosure, break detection includes sensing a change in impedance of the electrical conductor.

[0030] According to some embodiments of the present disclosure, the sensor includes detecting an open electrical circuit due to a break in an electrical conductor.

[0031] According to some embodiments of the present disclosure, the sensor detects electrical contact between the sensor and the needle.

[0032] According to some embodiments of the present disclosure, multiple sensing locations share a single sensor.

[0033] According to some embodiments of the present disclosure, the sensor senses a cumulative number of sensing locations adjacent to the needle.

[0034] According to some embodiments of the present disclosure, the sensor includes a tube extending between the sensing locations and senses pressure within the tube.

[0035] According to some embodiments of the present disclosure, the needle comprises a helical needle, the path comprises a helical path along which the helical needle translates by rotation, and the plurality of sensing locations are also disposed along the longitudinal axis of the vacuum clamping domain.

[0036] 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 each of a plurality of sensing locations.

[0037] According to some embodiments of the present disclosure, the needle position indicator is configured to indicate the position of the needle in steps corresponding to the adjacent presence or adjacent absence of the needle.

[0038] According to some embodiments of the present disclosure, the bougie includes a needle position indicator configured to indicate a signal generated by a variation in the interaction of the needle with a plurality of sensing locations that is smaller than the variation indicating the difference between the presence and absence of the needle at the sensing locations.

[0039] According to some embodiments of the present disclosure, the bougie includes a suture clip positioned within the interior space, configured to capture a suture at a location along the pathway, and operable to clamp the captured suture.

[0040] According to some embodiments of the present disclosure, the bougie includes a suture clamp at least partially within the interior space and positioned to capture the suture at a location along the pathway, the suture clamp being operable to move from outside the bougie to apply tension to the suture to reduce the length of the suture engaged in the tissue.

[0041] According to an aspect of some embodiments of the present disclosure, there is provided a method of securing a suture disposed within a body cavity wall, the method including: translating a needle through tissue along a predetermined path within an interior space of a bougie; translating the needle along the predetermined path through and / or alongside a suture catch portion of a suture clip pre-positioned within the interior space; translating the needle past the suture catch portion to bring a portion of the suture into a capture zone of the suture clip defined by the suture catch portion; and actuating the suture clip to clamp the portion of the suture.

[0042] According to some embodiments of the present disclosure, the predetermined path is a helical path and the needle is a helical needle.

[0043] According to some embodiments of the present disclosure, the method includes releasing the suture clip from the interior space.

[0044] According to several embodiments of the present disclosure, the suture catch portion includes an opening through which the predetermined path extends.

[0045] According to some embodiments of the present disclosure, the method includes further translating the needle along a predetermined path to bring the suture into a capture portion of the suture clamp, and operating the suture clamp to reduce the length of the suture engaged in the tissue prior to actuation.

[0046] In accordance with an aspect of some embodiments of the present disclosure, there is provided a method of monitoring suture placement within a body cavity wall, the method including translating a needle through tissue along a predetermined path within an interior space of a bougie, detecting at each of a plurality of detection locations positioned along the path the presence of the needle at the respective detection location, and indicating the needle position based on the detection.

[0047] According to some embodiments of the present disclosure, the sensing includes mechanically breaking an element of at least one of the plurality of sensing locations.

[0048] According to some embodiments of the present disclosure, sensing includes detecting pressure changes induced in the vessel by movement of the needle relative to the vessel.

[0049] According to some embodiments of the present disclosure, the sensing includes detecting a change in a magnetic field.

[0050] According to some embodiments of the present disclosure, the sensing includes detecting electrical contact between the needle and an electrical conductor positioned at one or more of the plurality of sensing locations.

[0051] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present disclosure, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. Furthermore, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0052] Some embodiments of the present disclosure are herein described, by way of example only, with reference to the accompanying drawings. Referring now specifically to the drawings in detail, it is emphasized that the details shown are by way of example and for purposes of illustrative discussion of embodiments of the present disclosure. In this regard, the description with reference to the drawings will make apparent to those skilled in the art how embodiments of the present disclosure may be practiced. [Brief explanation of the drawings]

[0053] [Figure 1A] 1A-1C schematically illustrate a bougie configured for shaping and intraluminal suturing of tissue in a body cavity, according to some embodiments of the present disclosure. [Figure 1B] 1A-1C schematically illustrate a bougie configured for shaping and intraluminal suturing of tissue in a body cavity, according to some embodiments of the present disclosure. [Figure 1C]1 is a schematic flow chart of a method of suturing from within a tissue fixation device, according to some embodiments of the present disclosure. [Figure 1D] 1D schematically illustrates stages in the suturing method of FIG. 1C, according to some embodiments of the present disclosure. [Figure 1E] 1D schematically illustrates stages in the suturing method of FIG. 1C, according to some embodiments of the present disclosure. [Figure 1F] 1D schematically illustrates stages in the suturing method of FIG. 1C, according to some embodiments of the present disclosure. [Figure 1G] 1D schematically illustrates stages in the suturing method of FIG. 1C, according to some embodiments of the present disclosure. [Figure 1H] 1D schematically illustrates stages in the suturing method of FIG. 1C, according to some embodiments of the present disclosure. [Figure 1I] 1D schematically illustrates stages in the suturing method of FIG. 1C, according to some embodiments of the present disclosure. [Figure 1J] 10 illustrates an alternative method of threading a suture clip according to some embodiments of the present disclosure. [Figure 1K] 10 illustrates an alternative method of threading a suture clip according to some embodiments of the present disclosure. [Figure 1L] 10 illustrates an alternative method of threading a suture clip according to some embodiments of the present disclosure. [Figure 1M] 10 illustrates an alternative method of threading a suture clip according to some embodiments of the present disclosure. [Figure 2A] 10A-10C schematically depict stages as a needle advances along a suction clamp domain and enters and passes through a suture clip body, according to some embodiments of the present disclosure; [Figure 2B] 10A-10C schematically depict stages as a needle advances along a suction clamp domain and enters and passes through a suture clip body, according to some embodiments of the present disclosure; [Figure 2C] 10A-10C schematically depict stages as a needle advances along a suction clamp domain and enters and passes through a suture clip body, according to some embodiments of the present disclosure; [Figure 2D]10A-10C schematically depict stages as a needle advances along a suction clamp domain and enters and passes through a suture clip body, according to some embodiments of the present disclosure; [Figure 2E] 10A-10C schematically depict stages in clamping a suture clip to a suture, according to some embodiments of the present disclosure; [Figure 2F] 10A-10C schematically depict stages in clamping a suture clip to a suture, according to some embodiments of the present disclosure; [Figure 2G] 10A-10C schematically depict stages in clamping a suture clip to a suture, according to some embodiments of the present disclosure; [Figure 3A] 10A-10C show details of a needle in a position where the needle has passed by helical advancement through both the clip body and the openings in the clamping head of the suture clamper, according to some embodiments of the present disclosure. [Figure 3B] 10 shows a detail of a needle in a position where the needle has already passed by helical advancement through both the clip body and the opening in the clamping head of the suture clamper, according to some embodiments of the present disclosure. [Figure 3C] 10 illustrates a clip plug and clip body of a suture clip in a clamped configuration according to some embodiments of the present disclosure. [Figure 4A] 1A-1C schematically depict components and a clamping mechanism of a cylindrically clamping suture clip according to some embodiments of the present disclosure. [Figure 4B] 1A-1C schematically depict components and a clamping mechanism of a cylindrically clamping suture clip according to some embodiments of the present disclosure. [Figure 4C] 1A-1C schematically depict components and a clamping mechanism of a cylindrically clamping suture clip according to some embodiments of the present disclosure. [Figure 4D] 1A-1C schematically depict components and a clamping mechanism of a cylindrically clamping suture clip according to some embodiments of the present disclosure. [Figure 5A]1A and 1B schematically represent components and an assembled configuration of a suture clamp according to some embodiments of the present disclosure. [Figure 5B] 1A and 1B schematically represent components and an assembled configuration of a suture clamp according to some embodiments of the present disclosure. [Figure 5C] 1A and 1B schematically represent components and an assembled configuration of a suture clamp according to some embodiments of the present disclosure. [Figure 5D] 1A and 1B schematically represent components and an assembled configuration of a suture clamp according to some embodiments of the present disclosure. [Figure 6A] 10A-10C schematically depict a suture clip that clips by rotational movement, according to some embodiments of the present disclosure; [Figure 6B] 10A-10C schematically depict a suture clip that clips by rotational movement, according to some embodiments of the present disclosure; [Figure 6C] 10A-10C schematically depict a suture clip that clips by rotational movement, according to some embodiments of the present disclosure; [Figure 6D] 10A-10C schematically depict a suture clip that clips by rotational movement, according to some embodiments of the present disclosure; [Figure 7A] 10A-10C schematically illustrate pressure sensor arrangements for measuring needle movement and / or positioning, according to some embodiments of the present disclosure. [Figure 7B] 10A-10C schematically illustrate pressure sensor arrangements for measuring needle movement and / or positioning, according to some embodiments of the present disclosure. [Figure 7C] 10A-10C schematically illustrate pressure sensor arrangements for measuring needle movement and / or positioning, according to some embodiments of the present disclosure. [Figure 7D] 10A-10C schematically illustrate pressure sensor arrangements for measuring needle movement and / or positioning, according to some embodiments of the present disclosure. [Figure 8A] 10A-10C schematically illustrate magnetic sensor arrangements for measuring needle movement and / or positioning, according to some embodiments of the present disclosure. [Figure 8B]10A-10C schematically illustrate magnetic sensor arrangements for measuring needle movement and / or positioning, according to some embodiments of the present disclosure. [Figure 8C] 10A-10C schematically illustrate magnetic sensor arrangements for measuring needle movement and / or positioning, according to some embodiments of the present disclosure. [Figure 9A] 10A-10C schematically illustrate circuit board-based sensor arrangements for measuring needle movement and / or positioning, according to some embodiments of the present disclosure. [Figure 9B] 10A-10C schematically illustrate circuit board-based sensor arrangements for measuring needle movement and / or positioning, according to some embodiments of the present disclosure. [Figure 9C] 10A-10C schematically illustrate circuit board-based sensor arrangements for measuring needle movement and / or positioning, according to some embodiments of the present disclosure. [Figure 9D] 10A-10C schematically illustrate circuit board-based sensor arrangements for measuring needle movement and / or positioning, according to some embodiments of the present disclosure. [Figure 10] 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. [Figure 11] 1 is a schematic flowchart of a method for guiding needle advancement along a bougie, according to some embodiments of the present disclosure. [Figure 12] FIG. 1 shows a block diagram of a suturing subsystem comprising a needle and a suture clip, according to some embodiments of the present disclosure. [Figure 13] 10A-10C schematically represent a needle position sensing subsystem of an intracorporeal suturing device, according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0054] The present invention, in some embodiments thereof, relates to the field of bariatric surgery, and more particularly to the intraluminal placement of gastric sutures.

[0055] overview An aspect of some embodiments of the present disclosure relates to a suture clip configured to be positioned in a predetermined path of a suture needle advancing through a device inserted into a body cavity and to be remotely operated from that location to secure and clamp the suture.

[0056] In some embodiments, the suture clip is initially placed in a suture bougie used for device-guided suturing of tissue from within a body cavity, such as the stomach. More specifically, in some embodiments, the suture bougie allows for the placement of multiple stitches in tissue of the body cavity using a needle that passes through an interior space defined by the suture bougie and moves longitudinally at least partially along the bougie. The tissue enters the bougie, for example, under suction. Optionally, the tissue is supported to achieve a particular pattern and / or depth of suture by a surface of the bougie (e.g., by a pattern of openings or "fenestrations") that is arranged to retain adjacent tissue portions outside the bougie while allowing some tissue portions to enter the interior space.

[0057] The predetermined path, in some embodiments, is a path defined by a mechanical arrangement within the interior space through which the needle is guided. The combined configuration of the held tissue and the predetermined path of the suture needle through the suture bougie determines the resulting pattern of the suture stitches.

[0058] In some embodiments, the suture needle is helical and advances by helical rotation along a helical path. The needle may be driven by a needle driver including, for example, a cable, a screw, a ratchet, and / or other mechanism. Optionally, the needle is another shape, for example, straight or curved planar, and moves along a path of a different shape, for example, a straight path, a combination of a straight path and a curved planar path, or another configuration.

[0059] Device-integrated suture clips used with such suture needle configurations encounter potential problems in securely capturing the suture, in remote manipulation to clamp onto the suture, and in ensuring that the clip clamps at a location near the point where the suture exits the tissue being engaged to form the stitch.

[0060] In some embodiments, the suture clip is initially positioned along the predetermined needle path so that the needle passes through the loop and / or opening in the suture clip. This ensures that the suture clip captures the suture (i.e., the suture is threaded through the loop and / or opening). In some embodiments, the needle passes through or alongside a partially open-sided structure that captures the suture, such as an arrangement of hooks positioned on opposite sides. The capture involves ensuring that some portion of the suture remains (or is reliably returned to) a predetermined zone where the suture clamp is later actuated to securely clamp the suture, while the suture also remains free to slide longitudinally through that zone, for example, as the needle continues to move forward and / or the suture is pulled to tighten. The suture clip is preferably positioned so that the clamping zone is close to where the needle exits the tissue after forming the stitch. This helps ensure that the suture clip is positioned close enough to the end of the suture and / or plication in the tissue lumen wall so that the suture stitches themselves remain tight (at least after the suture has been suitably tightened).

[0061] In embodiments in which the suture is threaded through a loop and / or opening, the predetermined zone then optionally comprises the extent of that loop or opening. For example, a relatively small predetermined zone is potentially advantageous because it allows the clip to be smaller and / or operable to clamp from its native application position. Clamping may be performed, for example, by further constraining the loop / opening area, for example, by adjusting the shape of the loop / opening, by pressing another element into the loop / opening, or by another method. Optionally, clamping includes twisting the suture, for example, to bend the suture at least once away from the direction of force transmission to the suture at the point where the suture enters the clamp.

[0062] In some embodiments, the suture clip includes multiple parts, one of which is operable to matingly insert into another part, thereby pushing the suture between the walls of the two parts (threading one of the parts). Additionally or alternatively, in some embodiments, the suture clip includes multiple parts, one of which is operable to rotate relative to another part, thereby twisting the suture into a shape that resists pulling.

[0063] Clamping is preferably performed while a suture clip remains within the bougie, e.g., near the site where the suture terminates (i.e., where the needle exits the last suture hole made in the tissue). One or more clips are optionally placed between the sutures, e.g., to allow the sutures to be trimmed individually and / or in smaller groups.

[0064] To achieve remote actuation, in some embodiments, at least one of the suture clip components is moved by a control member, for example, by pulling a wire, string, rod, and / or cable, by rotating a socketed and / or threaded element, or by another mechanism.

[0065] An aspect of some embodiments of the present disclosure relates to a suture clamping device configured to be positioned in a predetermined path of a suturing needle advancing through a suturing device (e.g., a bougie) inserted into a body cavity and remotely operated to tension and shorten the length of a suture engaged at a sutured region of tissue (the suture engaged to the tissue) once the suture is captured. Clamping may be performed, for example, in preparation for applying a suture clip to the suture.

[0066] In some embodiments, the suture clamping device loosely captures the suture such that the suture continues to slide freely through the suture device while the suture clamping device tensions the suture engaged in tissue, shortening its length. Free movement of the suture relative to the suture clamping device offers a potential advantage by allowing the needle-attached end of the suture to remain stationary (and still attached to the needle) once the needle has completed its trajectory.

[0067] In conventional hand suturing, the suture needle itself is a type of "suture clamping device," and pulling on it (by shortening the length of suture engaged in the tissue) tightens the stitch it makes. However, machine-driven suturing, using, for example, a helical needle, poses problems for which a separate suture clamping device offers a potential solution.

[0068] A helical needle, for example, is potentially well-suited for forming suture stitches insofar as its combined longitudinal and rotational path of movement passes horizontally (due to rotation) and longitudinally through one or more tissue thicknesses, repeating such passes. However, once the suture is placed (i.e., after the suture is fully engaged with the tissue), it is potentially desirable to be able to tighten the suture by simply pulling, without generating complex helical motions. In some embodiments, the suture tightener provides control separate from the needle control, thereby allowing tightening using a non-helical motion.

[0069] For example, compared to solutions that transition the helical needle from the helical drive mechanism and use a pull-only drive mechanism, a separate suture clamping device offers the potential advantage of not requiring the relatively cumbersome helical needle itself to move through the tight space of the bougie. The suture clamping device only needs to move the suture itself. Optionally, the suture clamping device is more compact than the helical needle.

[0070] In some embodiments, the suture clamping device doubles the suture as it moves (e.g., pulled proximally) so that both ends of the moving suture (e.g., the end attached to the tissue and the end attached to the needle) are on the same side (e.g., the distal side) of the suture clamping device, a potential advantage that shortens the clamping distance required by the device; for example, 1 cm of movement of the suture clamping device reduces the length of suture engaged in the tissue by approximately 2 cm.

[0071] In some embodiments, the suture clamping device comprises a spindle (e.g., mounted on a harness) that is shaped (e.g., flared out to the sides) so that tension on the suture line looped over the spindle tends to pull the suture toward the mid-region of the spindle. This is a potential advantage for controlling the position of the suture and / or for keeping the suture away from sharp and / or pinching corners and crevices. In some embodiments, the spindle is free to rotate (e.g., rotatably mounted on a harness), aiding in free movement of the suture. In some embodiments, the capture opening of the suture clamping device is defined at least in part by the spindle, and optionally also by the harness that holds the spindle.

[0072] In some embodiments, the suture clip and suture clamping device are arranged so that the position of the suture relative to the suture clip is controlled, for example, by movement of the suture clamping device to a predetermined position. For example, the suture clamping device optionally enters a channel sized and positioned such that, when tensioned, the portion of the suture extending directly from the suture clamping device to the location where the suture exits the tissue is forced through a clamping zone of the suture clip. For example, the suture is clampingly constrained against the member of the suture clip involved in the clamping. In such embodiments, the suture clip itself need not include loops or openings, since capture is managed by movement of the suture clamping device.

[0073] An aspect of some embodiments of the present disclosure relates to sensing needle position using sensors positioned along a predetermined path of the suture needle as it advances through a device inserted into a body cavity.

[0074] In some embodiments, the sensor comprises multiple sensing sites and is configured to detect and indicate the presence / absence of the needle portion at the sites. In some embodiments, the multiple sensors are spaced apart at intervals less than the longitudinal length of the needle. In some embodiments, the needle is a helical needle and the sensors are spaced apart at intervals the size of and / or multiples of the longitudinal distance spanned by one helical turn of the needle.

[0075] Optionally, the sensor detects the presence / absence of the needle by a change in pressure (e.g., pressure on the tubular member), by a change in magnetic field (e.g., using a Hall Effect sensor), and / or by a change in electrical conductivity through the sensor (e.g., by breaking an element of the sensor and / or by making a new electrical contact through the sensor).

[0076] In some embodiments, the position sensing is converted into an indication of needle position based on steps defined by the presence / absence of the needle next to each individual sensed position. Additionally or alternatively, in some embodiments, the position sensing data is used to indicate information regarding the needle state and / or position in smaller steps, for example, by indicating an indication of sensor fluctuations, for example, in response to a needle movement command.

[0077] Before describing at least one embodiment of the present disclosure in detail, it can be understood that the present disclosure is not necessarily limited to the details of construction and the arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings in its application. Features described in the present disclosure, including features of the present invention, are capable of other embodiments or of being practiced or carried out in various ways.

[0078] Exemplary Suture Clip 1A-1B, which schematically illustrate a bougie 100 configured for shaping and intraluminal suturing of tissue in a body cavity, according to some embodiments of the present disclosure.

[0079] The three main sections of the bougie 100 are designated as the bougie capsule section 101 (distal), the bougie main body 102, and the bougie control handle 103 (proximal).

[0080] The bougie capsule section 101 (also referred to herein as the "capsule"), in some embodiments, comprises a suction clamp domain 110, which comprises one or more fenestrations 111 configured to receive tissue from a body cavity under suction and then hold and / or position it in preparation for one or more surgical alterations, such as suturing. The suction clamp domain 110, in some embodiments, comprises a support surface against which tissue folds when suction is applied to the device during use. The support surface comprises the body 110A of the clamp domain 110 (e.g., formed as a partial tube and / or spine) and / or other features along the clamp domain 110, such as aperture-forming elements, optionally including longitudinal blockers 115 and / or lateral blockers 117. A space (also referred to herein as a cavity) is defined within the support surface to receive and position tissue under suction, and within which sutures are performed on the positioned tissue.

[0081] During suturing, in some embodiments, the helical needle moves in a similar spiral motion along the space, suturing the positioned tissue by alternately passing through a first tissue portion folded into the space from one side of the body cavity and then a second tissue portion also folded into the space alongside the first tissue portion from the other side of the body cavity as the helical needle advances.

[0082] Here, fenestrations 111 are also part of the aperture region of bougie capsule section 101. Fenestrations 111 are, in some embodiments, configured to change size, shape, and / or topology upon actuation of one or more aperture-shaping elements. Such fenestrations are also referred to herein as "dynamic" fenestrations.

[0083] Actuation of the aperture forming element and the attendant change in dynamic fenestration 111 is used in some embodiments to control one or more aspects of luminal tissue attachment, luminal tissue positioning, or luminal tissue suction depth (e.g., in preparation for suturing), or tissue release. In some embodiments, tissue release includes the release of sutures or other surgical material that may be attached (e.g., sewn, clipped, and / or stapled) to the luminal tissue while the luminal tissue is engaged with the bougie capsule section 101.

[0084] In some embodiments, examples of aperture shaping elements include longitudinal blockers 115 and / or lateral blockers 117 .

[0085] The longitudinal blocker 115, in some embodiments, comprises an element such as a reinforced strip or bar that extends longitudinally across at least a portion of the suction clamp domain 110, essentially dividing the suction clamp domain 110 into two sides of the fenestration 111 that run longitudinally alongside one another. The longitudinal blocker 115 is optionally removable, thereby rejoining the divided fenestration 111. This is a potential advantage in tissue and / or suture release, for example, release of the suction clamp domain 110 from a suture that crosses between two intraluminal tissue portions (i.e., the first and second tissue portions described above), and release inside the longitudinal blocker 115 (i.e., within the interior space of the suction clamp domain 110).

[0086] Lateral blockers 117, in some embodiments, comprise one or more elements, such as lengths of cord, that cross laterally (optionally directly laterally or diagonally) across the suction clamp domain 110. The crossing elements form a division of the suction clamp domain that separates the different fenestrations 111 on either side of the element. Lateral blockers 117, in some embodiments, are releasable and / or removable to remove the separation.

[0087] Examples of longitudinal blockers 115 and lateral blockers 117 are described, for example, in International Patent Publication No. WO2016 / 056016, the contents of which are incorporated by reference in their entirety.

[0088] In some embodiments, a distal tip 112 is provided of the bougie capsule section 101. The distal tip 112 is optionally transparent and / or terminates in an opening large enough (e.g., about 6-8 mm in diameter) to allow the distal end of an endoscopic probe or other tool to pass therethrough.

[0089] The bougie main body 102, in some embodiments, comprises a tube 121 along which one or more longitudinally extending control members 120 pass externally and / or internally. In some embodiments, the control members 120 interconnect actuatable elements of the bougie capsule section 101 (e.g., longitudinal blocker 115 and / or lateral blocker 117) and the bougie control handle 103 (e.g., control knob 122). In some embodiments, the tube 121 has an inner diameter large enough (e.g., about 6-10 mm) to allow insertion of an endoscopic probe or other tool.

[0090] Any control member 120, control knob 122, or other control device is optionally provided with an encoder 121A that senses movement of the control member. Data from the encoder 121A is used in some embodiments to determine the operational state of the bougie 100. In some embodiments, the skew between the movement measured by the encoder 121A and the sensed result (e.g., within the bougie capsule section 101) is monitored. Optionally, the occurrence of the measured skew is treated as an indication that there is mechanical resistance, which is further indicated to an operator, for example, by logic circuitry and one or more indicators on or connected to the bougie 100.

[0091] The distal tip 112 is preferably provided with a tapered shape to aid in insertion of the bougie 100 along a natural body passageway, such as the esophagus. The bougie capsule section 101 and the bougie main body 102 are preferably sized (in diameter and length) and shaped (at least in the insertion configuration) to allow insertion along a natural body passageway, such as the esophagus, to reach a target organ, such as the stomach.

[0092] The bougie control handle 103, in some embodiments, comprises one or more control knobs 122 configured to control the operation of the control member 120. Optionally, one or more ports 124 are provided sized to allow insertion of an endoscope or other tool for passage along the lumen of the tube 121 into the bougie capsule section 101 and optionally to and / or out of the distal tip 112.

[0093] Referring next to FIG. 1C, this figure is a schematic flow chart of a method of suturing from within a tissue fixation device, according to some embodiments of the present disclosure. Referring also to FIGS. 1D-1I, these figures schematically illustrate stages in the suturing method of FIG. 1C, according to some embodiments of the present disclosure. Referring further to FIGS. 1J-1M, these figures illustrate an alternative method of threading a suture clip, according to some embodiments of the present disclosure. Referring additionally to FIG. 12, this figure illustrates 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.

[0094] At block 152 of FIG. 1C , in some embodiments, tissue is captured onto the suturing device, for example, by vacuum formation of the gastric tissue 50 around the vacuum clamping domain 110 of the capsule 101 of the bougie 100 supported by the surface of the body 110A and by the blockers 115, 117. This situation, in some embodiments, corresponds to that shown in FIG. 1D (optionally, the needle 116 has not yet been advanced to the position shown). A first portion 50A of the gastric tissue 50 is vacuum clamped along one side of the fenestration defined by the blockers 115, 117, and a second portion 50B of the gastric tissue 50 is vacuum clamped along the other side (i.e., on either side of the longitudinal blocker 115). The needle 116 is attached to a suture 118 and pulls on the suture 118 as it is advanced. FIG. 1E shows the bougie 100 as shown in FIG. 1D without the gastric tissue 50 formed around it, revealing more of the underlying detail.

[0095] At block 154, in some embodiments, the suture 118 is pulled through the tissue 118 by advancing the needle 116 in a spiral motion. This, in some embodiments, corresponds to the situation in FIGS. 1F-1G (FIG. 1G is a version of FIG. 1F in which the appearance of the stomach tissue 50 is hidden). In some embodiments, the needle 116 is advanced along a path 1210 using a needle driver 1208 (FIG. 12). The needle driver 1208 optionally includes cabling and / or a transmission that, when actuated (e.g., actuated by rotation and / or pulling), impinges on and advances the needle 116 by a spiral rotation, for example.

[0096] At block 156, in some embodiments, the helical needle 116 passes through and / or impinges on the suture catcher 132 of the suture clip 130. This corresponds, in some embodiments, to the situation shown in FIGS. 1H-1I (FIG. 1I is a version of FIG. 1H in which the appearance of the stomach tissue 50 is hidden). It is potentially advantageous to attach the suture clip 130 close to (e.g., within 10 mm of) the needle exit point of the last stitch, thereby potentially reducing slack in the suture line.

[0097] The suture catcher 132, in some embodiments, comprises a portion of the suture clip 130 through which / against which a portion of the suture 118 is securely passed upon sufficient advancement of the needle 116. The suture catcher 132 optionally has a loop configuration that closes circumferentially to define an opening into which the suture 118 enters by passing through the opening in the loop. Alternatively, the suture catcher 132 has an open-sided configuration that allows the suture 118 to enter the suture catcher (e.g., across a side opening in the suture catcher) optionally even after the needle has passed through the suture catcher.

[0098] The loop configuration has the potential advantage that, as a result of threading the needle 116 through the loop (i.e., threading the suture through the loop), the suture 118 is captured while being held loosely, without leaving an exit point for the suture to escape to the side. Furthermore, actuation of the suture catcher 132 is not required to achieve this capture. Because the suture 118 is only held loosely initially, it can optionally be tightened later in the procedure without significant interference from clip friction. More specific embodiments of loop-type suture catchers 133, 131 are shown in conjunction with suture clips 130A, 130B in FIGS. 1J-1M, as further described below.

[0099] An open-sided loop catcher configuration has the potential advantage of simply requiring the suture 118 to pass alongside it (rather than through it), allowing the suture 118 to be presented from the side after the needle 116 has passed. Such a configuration is more compatible with implementation as, for example, a pair of clamp jaws. However, an open-sided configuration is associated with the potential risk of the suture 118 escaping from the suture catcher 132 before the clamp is actuated. If a separate retention mechanism is also provided to prevent such escape, this may itself hinder later release of the suture and / or make the device more complicated. If the clamping by the suture catcher 132 is at least partially actuated immediately after the needle 116 has passed (e.g., by the return of a spring displaced by the needle 116), this may reduce the chance of the suture 118 escaping, but the suture clip 130 may itself hinder the clamping of the suture.

[0100] 1J-1K (FIG. 1K is an enlarged cross-sectional view of FIG. 1J) show clip 130A having opening 133 defined by a loop-shaped catcher configured as a cylinder 134. The clamp (e.g., as described with respect to block 160) optionally includes inserting a corresponding plug into cylinder 134, e.g., as described with respect to FIG. 3C and / or 4A-4D.

[0101] 1L-1M (FIG. 1M is an enlarged cross-sectional view of FIG. 1L) show clip 130B having an opening defined by a loop-shaped catcher configured as a protruding loop 131. The clamp (e.g., as described with respect to block 160) optionally includes retracting loop 134 into clip body 132, including a tight region that compresses loop 134 and / or captured suture 118.

[0102] At block 158, in some embodiments, the suture 118 is tightened. This involves pulling the suture 118 such that the portion of the suture 118 engaged within the suture length 118A of the suture 118 tightens (and effectively shortens as the suture 118 is pulled longitudinally away from the region of the suture 118 that engages the tissue 50). In some embodiments, tightening of the suture 118 is performed using a secondary tightening mechanism (optional suture clamp 220, optionally actuated by a tightening actuator 1206), for example, as described herein with respect to FIGS. 3A-3B and / or 5A-5D.

[0103] At block 160, in some embodiments, the suture clip 130 is clamped. The clamp is optionally implemented mechanically in various ways. Mechanistic clamping principles used in some embodiments of the present disclosure include compressing the suture 116 between surfaces to create friction and bending the clamped suture 116 to prevent direct transmission of tension applied thereto. In some embodiments, the suture clip 130 is configured such that the holding force exerted by one or both of these principles is itself strengthened by tensioning the suture. Examples of suture clamping mechanisms that function as clamp 1204 (FIG. 12) are described, for example, with respect to FIGS. 3C and 4A-4D, and 6A-6D.

[0104] Clamp actuator 1202 is optionally mechanically implemented in different ways in different embodiments. For example, in some embodiments, suture clip 130 comprises multiple parts that are moved closer together (e.g., closed against each other and / or inserted one inside the other) by actuation of control member 120 (e.g., a wire or string under longitudinal tension from the control side of the bougie that remains outside the body cavity). Additionally or alternatively, in some embodiments, suture clip 130 comprises multiple parts that rotate relative to each other, e.g., as a socket and screw and / or about an axis. Rotation is optionally actuated using control member 120, which is rotated from the control side of the bougie or under longitudinal tension.

[0105] At block 162, in some embodiments, the suture 118 is cut. In some embodiments, the cutting edge is provided as part of the bougie 100 (e.g., within an interior space of the suction clamp domain 110 or within another interior space of the bougie 110). Optionally, the clip 130 itself includes a cutting edge.

[0106] At block 164, in some embodiments, the sutured tissue is released from the bougie 100. In some embodiments, this includes releasing the suction, removing the longitudinal blockers 115 (e.g., by pulling them out longitudinally), and removing the lateral blockers 117 (e.g., by releasing them from one side and optionally pulling them off, then pulling them back on the other side).

[0107] While the embodiments described herein relate to a helical needle 116, it should be understood that the needle is optionally another shape, e.g., a straight or curved needle. The clip suture catcher is pre-positioned within the interior space of the bougie, which receives the suture upon translation of the straight or curved needle therethrough (e.g., in the case of a loop-type suture catcher) and / or alongside it (e.g., in the case of an open-sided suture catcher).

[0108] 2A-2D, which schematically depict stages as the needle 116 advances along the suction clamp domain 110 and enters and passes through the suture clip body 204, according to some embodiments of the present disclosure.

[0109] 2A, needle 116 is shown near the beginning of its longitudinal movement along suction clamp domain 110. In some embodiments, needle 116 is helical. Optionally, the advancement of needle 116 is guided by needle guide trajectory 201, which is spaced and angled to match the helical inclination of needle 116.

[0110] In Figure 2B, the needle 116 has advanced to just before the location of the suture clip body 204. The suture clip body 204 is oriented so that the advancing needle 116 enters it as a result of continuing its helical forward motion (Figure 2C) and continues past it without interfering with further helical forward motion (Figure 2D).

[0111] 2A-2D, the view of the suture 118 is hidden. The suture 118 is typically attached to the rear end of a needle 116, for example, as shown in FIG. 2E.

[0112] 2E-2G, which schematically depict stages in clamping a suture clip 210 to a suture 118, according to some embodiments of the present disclosure. Suture clip 210 is a more specific example of suture clip 130.

[0113] 2E (continuing from the configuration of FIG. 2D), the needle 116 is then advanced completely through the suture clip body 204 such that the suture 118 attached to the rear side of the needle 116 is then threaded through the suture clip body 204. The needle 116 has also been advanced through an opening in the suture clamp 220 (e.g., as further described with respect to FIGS. 3A-3B and / or 5A-5D).

[0114] Exemplary Suture Tightening and Clamping 3A, this figure shows details of the needle 116, according to some embodiments of the present disclosure, in a position where the needle has passed by helical advancement through both the clip body 204 and the opening 537 of the clamping head 530 of the suture clamper 220. In particular, note that the clip body 204 is held within the predetermined path of the needle 116 by the clip case 206 (which is then attached, optionally fixedly attached, to the bougie 100). The clamping head 530 is also initially positioned within the bougie at a location along the predetermined path of the needle 116. However, the clamping head 530 is not fixedly positioned and can be pulled proximally, for example, by exerting tension on the control member 540.

[0115] 3B, which shows details of needle 116, according to some embodiments of the present disclosure, in a position where it has already passed, by helical advancement, through both clip body 204 and opening 537 in clamping head 530 of suture clamper 220. Suture 118 follows behind needle 116, then is threaded through opening 537 in clamping head 530 and through opening 203 in suture clip 210.

[0116] 2F, the suture 118 is pulled shorter by proximal movement of the suture clamp 220. The needle 116 acts as an anchor for one end of the suture 118 so that as the suture-laden suture clamp 220 is pulled proximally, slack is taken up from the stitch left by the passage (e.g., helical passage) of the needle 116 through the tissue 50.

[0117] As the suture slack is removed from the stitches, the suture is also pulled further past and / or through the suture clip 210. Note that the suture clip 210 has already captured the suture (e.g., the suture is threaded through the suture), but has not yet clamped it, so the sliding movement of the suture is not impeded.

[0118] In some embodiments, clamping of the suture clip 210 (shown in FIG. 2G) involves moving the clip plug 202 into the opening 203 of the clip body 204, for example, as described with respect to FIGS. 4A-4D.

[0119] Referring briefly to Figure 3C, this figure shows clip plug 202 and clip body 204 of suture clip 210 in a clamped configuration, according to some embodiments of the present disclosure. Suture 118 extends within clip body 204 and between clip body 204 and clip plug 202. Also shown is aperture 301, which is used in manipulating clip plug 202 to create a clamp, for example, as described in connection with Figures 4A-4D herein.

[0120] 4A-4D, which schematically depict components and a clamping mechanism of cylindrically clamping suture clip 210, according to some embodiments of the present disclosure. Aspects of suture clip operation applicable to suture clip 210 are also described, for example, in connection with FIGS. 2A-2G and 3A-3C.

[0121] Suture clamp 210, in some embodiments, comprises clip plug 202 and clip body 204, with clip plug 202 matingly insertable into clip body 204 (e.g., as shown in the sequence of FIGS. 4A-4C ). The mating portion comprises a clamping portion 209 that presses against the inner wall of opening 203 in clip body 204. When suture 118 is threaded through opening 203, clamping portion 209 and / or clip body 204 are loose and / or sufficiently resilient to mating with each other despite the obstruction posed by suture 118. In some embodiments, the resulting elastic deformation of clip body 204 and / or clip plug 202 contributes to a clamping force on suture 118. In some embodiments, clamping portion 209 comprises parallel cylindrical outer walls.

[0122] One aspect of the operation of suture clip 210 is that its clamp is actuatable by manipulating a control member (e.g., control member 120) from a location remote from suture clip 210 (e.g., suture clip 210 can be closed by pulling on a wire or cord portion outside the body, while suture clip 210 itself is still inside the cavity of the body and inside bougie 100). The control member passes through an opening 203 between clip plug 202 and the portion of the control member where pulling force is exerted, shortening the control member to force clip plug 202 and clip body 204 together.

[0123] In some embodiments, the clip plug 202 is configured for remote actuation by embodying one or more of the plug guide tip 208, the hole(s) 301, and the insertion stop 207.

[0124] In some embodiments, the plug guide tip 208 is positioned at the insertion end of the clip plug 202 and is rounded and / or tapered to self-center the clip plug 202 as the plug guide tip 208 is advanced into the opening 203.

[0125] In some embodiments, one or more holes 301, optionally open at both ends, extend along the longitudinal axis of the clip plug 202. The holes 301 allow a control member (not shown) to be inserted into and, optionally, through the holes. Optionally, the control member is anchored to the clip plug 202 and then released, e.g., by cutting. Alternatively, in some embodiments, the holes are configured to allow the control member to pass into the clip plug 202, e.g., from the end with the plug guide tip 208, exit the other end, then return to the same end and re-exit the end with the plug guide tip 208. Pulling both ends of the control member simultaneously pushes the clip plug into the opening 203 in the clip body 204. When one control member end is released and the other is pulled, the control member eventually slides completely through both holes through which it is threaded, releasing itself from the clip.

[0126] The insertion stop 207, in some embodiments, comprises an extension on the rear side of the insertion plug 202 to prevent the plug 202 from being pulled completely through the opening 203 and out the other side.

[0127] In some embodiments, clip case 205 holds clip body 204 and positions it within bougie 100. For example, clip case 205 optionally includes mounting protrusions 206 that are attached to bougie 100 by, for example, pins, screws, and / or other arrangements.

[0128] 4D shows the suture clip 210 released from its case 205. In some embodiments, release of the suture clip 210 from the clip case 205 occurs as a result of withdrawing the bougie 100 from the body after the suture clip 210 has been clamped. Tension from the sutures attached to the tissue holds the suture clip 210 together, causing the suture clip 210 to separate when the bougie 100 is withdrawn. Optionally, the clip case 205 is shaped to prevent the suture clip 210 from exiting from the wrong side, for example, during clamping.

[0129] 5A-5D, which schematically depict the components and assembled configuration of a suture clamp 220, according to some embodiments of the present disclosure. Operation of the suture clamp 220 is described herein, for example, in connection with FIGS. 2E-2G and / or 3A-3B.

[0130] The suture clamp 220, in some embodiments, includes a control member 540 (eg, an example of a control member 120) and a clamping head 530.

[0131] The clamping head 530 is configured to capture (e.g., thread) the suture 118 from a position behind the advancement of the needle 116, for example, by a loop or open-sided suture catcher (e.g., as described herein with respect to the suture catcher 132 of the suture clip). In the illustrated example, the suture 118 is captured (threaded) when the needle 116, pulling an end of the suture 118, passes through an opening 537 defined by the harness 531 and the spindle 533.

[0132] The spindle 533 is optionally fixed or rotates to form a pulley. In some embodiments, the spindle 533 narrows toward the middle and widens toward the ends. This helps center the suture 118 under tension, potentially avoiding pulling the suture 118 off a sharp inner corner of the clamping head 530, and / or preventing the suture 118 from getting caught in a gap between the spindle 533 and the harness 531. In some embodiments, the clamping head 530 is attached to its control member 540 through a strain relief 535. Optionally, the strain relief 535 is tapered to aid in entering a channel in, for example, the bougie 100, along which the clamping head 530 is pulled.

[0133] Control member 540 optionally includes a stiffener 534 that extends at least through the region of the bougie traversed by needle 116. Stiffener 534 reinforces control member 540 sufficiently to prevent control member 540 from becoming entangled with needle 116.

[0134] An optional flexible (e.g., string- or wire-like) distal section 532 of the control member 540 is attached between the clamping head 530 and the stiffener 534. The flexibility allows the clamping head 530 to self-adjust its position and orientation according to the direction of pull from the suture 118 during clamping. The short length potentially avoids entanglement with the needle 116. The proximal section 536 of the control member 540 optionally comprises a wire, string, cable, or other structure. Optionally, the proximal and distal sections 532 and 536 are joined below the stiffener 534 or are included in a single piece.

[0135] In some embodiments, severing of suture 118 is performed using an endoscopic tool inserted through the bougie. Optionally, severing of suture 118 is performed using a sharp edge disposed on bougie 100 in a position between suture clip 130 and needle 116 that allows bougie 100 to be pressed against, clamped on, and / or sawed on the suture. For example, the sharp edge is positioned partially across the interior space of bougie 100 distal to fully advanced needle 116. As bougie 100 is withdrawn, suture 118 is stretched between needle 116 and suture clip 130. As the bougie is extended, it is moved so that the sharp edge is applied to suture 118, severing the suture. In some embodiments, suture clip 130 itself comprises a cutting edge.

[0136] Exemplary Rotating Clamp Suture Clip 6A-6D, these figures schematically depict a suture clip 600 that clips by rotational movement, according to some embodiments of the present disclosure.

[0137] The suture clip 600, in some embodiments, comprises a clip body 620, a clip insert 610, and, optionally, a clip stopper ring 630. The clip insert 610 is attached to the clip body 620 by threads 613 that mate with internal threads of the clip body 620. The clip body 620 is held attached to the bougie body 110A, for example, by mating insertion of a protrusion 623 into a receiving position on the bougie body 110A, or by another method.

[0138] When loaded into the bougie, the suture clip 600 is positioned such that the openings of the hole 611 (in the clip insert 610) and the hole 622 (in the clip body 620) are aligned with one another and with the predetermined path of the needle 116, so that as the needle 116 advances, it passes through the holes 611, 622, as shown, for example, in Figure 6D. The clip body 620 can be said to have two holes, each facing each other, on the wall of the clip body 620.

[0139] After needle 116 has passed through holes 611, 622, suture clip 600 may be operated to clamp suture 118. To do this, hole 611 is rotated (out of alignment with) hole 622, for example, in direction 640. This distorts suture 118, pulling the suture within clip body 620 and clamping it between the threads of clip body 620 and clip insert 610. Optionally, a clip retaining ring 630 is attached to the end of clip insert 610 to prevent over-rotation.

[0140] The rotational force is optionally exerted by rotation of control member 650 (an example of control member 120). Control member 650 mates with, for example, distal end 615 of insert 610. Keying protrusion 617 mates with a corresponding notch in the socket end of control member 650, allowing the rotational force to be transmitted.

[0141] Once clamped to the suture 118, the suture clip 600 optionally slides from its receiving position upon removal of the bougie from the body cavity, for example, due to being held by a stitch made using the suture 118.

[0142] Optionally, the edges of one or more of holes 611, 622 are sharp. Optionally, rotation to clamp also severs suture 118 proximally. Optionally, rotation itself does not sever suture 118. Rather, the suture must be held tight, e.g., stretched using suture clamp 220.

[0143] Exemplary Sensor Placement and Operation Referring now to FIG. 13, this figure schematically illustrates a needle position sensing subsystem 1300 of an intracorporeal suturing device, according to some embodiments of the present disclosure.

[0144] The position sensing subsystem 1300, in some embodiments, comprises a detector assembly 1302 positioned along a needle path 1210 within the capsule section 101 of the suturing bougie. The needle 116 is configured to move (e.g., actuated by a needle driver 1208) along the path 1210 entraining the suture 118. The path 1210 may be helical. The detector assembly 1302 is configured to detect the presence, arrival, and / or departure of the needle 116 at multiple positions 1306 along the path 1210. A position indicator 1305 interprets signals from the detector assembly and, in response, provides an indication of the current position of the needle 116.

[0145] The position sensing subsystem 1300, in some embodiments, allows tracking and / or confirmation of movement of the needle actuated by the needle driver 1208. A potential advantage of this is that the needle driver 1208 itself does not need to be deterministic about how its own movement translates into movement of the needle 116. For example, there may be slippage and / or hysteresis in the interaction between the needle driver 1208 and the needle 116. The position sensing subsystem 1300 provides positive feedback that movement has actually occurred and / or an indication of how much movement has occurred. The sensing subsystem 1300 optionally comprises a single elongated sensor or multiple sensors. These sensors may be implemented, for example, as described in connection with FIGS. 7A-9D herein.

[0146] 7A-7D, these figures schematically illustrate pressure sensor arrangements for measuring movement and / or positioning of needle 116, according to some embodiments of the present disclosure.

[0147] In some embodiments of the present disclosure, the suction clamp domain 110 is provided with sensing capabilities to determine the presence and / or position of the needle 116. In some embodiments, the needle 116 is helical, and sensing is provided that allows for rotation-by-rotation detection of the advancement of the helical needle. Sensing the presence and / or position of the needle offers potential advantages, particularly for verifying that the needle has passed through the suction clamp domain 110, so that further steps, such as tightening the suture and clamping the suture clip, are not performed before the stitches are fully in place.

[0148] Additionally, knowing how far along the needle 116 it has advanced is a potential advantage. For example, if it gets stuck or slows down during advancement, having finer position sensing resolution than "sewn / not yet sewn" could allow for earlier corrective action. In some embodiments, the needle position is measured incrementally across the width of the spiral, e.g., by discretely sensing at two, three, four, five, or more positions. Needle positions are optionally distinguished by the pattern of activated sensors. For example, initially, none of the four sensors along the longitudinal axis of the spiral advance are active. As the necessary advancement occurs, one, two, three, and then four sensors are activated. As the needle advances further, subsequent sensors are deactivated one by one, down to 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 sensors are optionally activated at the beginning or end of needle movement. Optionally, sensor lines are placed on the needle path on either side of the bougie body 110A to allow finer sensing resolution. Sensor activation patterns are optionally sensed, for example, by receiving individual inputs from each sensor or by sensing cumulative inputs from several sensors (e.g., as detailed with respect to the pressure sensors in FIGS. 7A-7D).

[0149] In some embodiments, the 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, squeezing the tube 705 increases the sensed pressure. The tube 705 is held in place (e.g., by squeezing the tube 704) so ​​that the needle 116 compresses the tube 705 at intermittent sense locations 702 as the needle 116 moves along its predetermined path (e.g., spirally advances). Optionally, the needle 116 presses directly against an overlying cover 703 at each sense location 702, which in turn compresses the tube 705. Potential advantages of this are as follows: The cover 703 may be shaped to ensure that it protrudes sufficiently to be pressed into the interior of the bougie body 110. The cover 703 may be shaped to ensure that the needle 116 pushes it to the side instead of puncturing it. The cover 703 may be longer than the width of the needle 116 so that more of the tube 702 is compressed (creating a larger pressure change).

[0150] The sensor indicator 712 indicates a needle position status based on measurements from the pressure sensor 710. The sensor indicator 712 optionally comprises an LED indicator, for example, having a segment that lights up for each triggered sensed position 702. Optionally, the sensor indicator 712 indicates the position using a tone. Optionally, the sensor indicator 712 comprises a user interface for a computer configured to show a graphic and / or visual indication based on the signal transmitted from the pressure sensor 710.

[0151] Optionally, for each sensing location 702 where needle 116 begins to press against tube 705, a step of pressure change is recorded by sensor 710 (and optionally displayed by sensor indicator 712). This allows for detection of the advancement of needle 116 as first sequential sensing locations 702 are pressed (increasing pressure), and then sequential sensing locations 702 are released from pressure.

[0152] Optionally, the pressure sensor 710 also reports small (less than the step size) fluctuations in pressure. Optionally, the sensor indicator 712 may display these small fluctuations to provide hints to the device operator regarding the state of the needle. For example, if the needle driver repeatedly slips during a particular portion of its rotational cycle, a corresponding (potentially small) change in pressure indication may occur as the force on the needle is redistributed. The operator may respond, for example, by changing the method of controlling advancement and / or adjusting the angle and / or bending of the device, using the pattern of pressure changes as a guide to the effect of such adjustments. Even without slippage, there may potentially be a pattern in the pressure measurements that correlates to when the needle begins to press against the next tissue layer, when the needle has slid through the next tissue layer, and / or when the needle has successfully passed the next tissue layer. Optionally, the device operator adjusts the operation to advance the needle and / or manipulate the angulation and / or bending of the bougie itself based in part on such patterns.

[0153] It should be noted that certain suture clamps themselves can be used as sensors. When the needle 116 enters the opening of the suture clamp, the suture clamp is partially locked in place, preventing free movement until the needle passes through it again. Testing this condition by using a gentle tag can be used in addition to or instead of using a dedicated sensor to determine the position of the needle 116.

[0154] 8A-8C, these figures schematically illustrate pressure sensor arrangements for measuring movement and / or positioning of needle 116A, according to some embodiments of the present disclosure.

[0155] In some embodiments, the magnetic field sensors 802 (e.g., Hall effect sensors) are mounted, for example, on a circuit board 800, which is in turn mounted to the bougie body 110A of the suction clamp domain 110. The sensors 802 are preferably positioned at the location closest to the needle 116A. The needle 116A is, for example, magnetized along its entire length (e.g., optionally embodied as a magnetized needle 116). As the needle 116A approaches each sensor 802 in turn, the sensor 802 registers a change in the magnetic field and outputs a signal that is then detected by the signal processing circuitry 810 to generate a position indication displayed by the sensor indicator 812 (which may, for example, generate an indication as described for the sensor indicator 810 suitably tuned for magnetic signals rather than pressure signals).

[0156] The signal generated by the sensor 802 is optionally processed and / or displayed as a "presence" or "absence" indication of needle proximity. Additionally or alternatively, signal components generated by the sensor 802 that are smaller than the size of an entire step are processed and / or displayed, for example, as effectively continuous-valued signals (e.g., analog signals and / or digital signals encoded with a bit depth of several bits, e.g., 5 bits or more). Stress and / or strain applied to the needle 116 to advance it potentially causes the needle 116 to slightly change its shape as it moves, as described, for example, with respect to the embodiment of FIGS. 7A-7D. Nearby magnetic field sensors 802 may then cause the signals they generate to fluctuate slightly. An indication of such fluctuations is optionally used by a device operator to guide device operation, as described, for example, with respect to FIGS. 7A-7D.

[0157] 9A-9D, these figures schematically illustrate circuit board-based sensor arrangements for measuring movement and / or positioning of needle 116A, according to some embodiments of the present disclosure.

[0158] In some embodiments, the sensor substrate 900 comprises a circuit board made up of multiple leads 901A, 901B, 901C, 901D connected to a sensing circuit 910. A portion of each lead extends along an edge 904 of the sensor substrate 900, each along a different longitudinal portion of the sensor substrate 900.

[0159] In some embodiments, each lead 901A-901D has a characteristic impedance associated with it that changes as the lead becomes shorter. Additionally or alternatively, the end of each lead is connected to ground (e.g., from the other side of circuit board 900, not shown).

[0160] The sensor substrate 900 is positioned on the bougie body 110A of the suction clamp domain 110 at a location where the tip 902C of the needle 116, as it spirals forward, subsequently impacts near the edge 904 of each individual lead 901A-901D. This impact then breaks the impacted lead. Optionally, the substrate 900 is weakened near the location of impact 903 so that a notch is knocked out of the substrate upon impact.

[0161] The sensing circuit 910 senses the change in impedance and / or the open circuit to ground and then provides a signal that is indicated by the sensor indicator 912, for example, as described with respect to the sensor indicator 712.

[0162] Additionally or alternatively, in some embodiments, the leads 901A-901D comprise foils, springs, or other conductive elements that contact (and optionally deform and / or break) as the needle 116 rotates. This establishes electrical contact between the different leads through the needle 116, which can be used as the basis for position sensing (by the sensing circuitry 910) and indication (by the sensor indicator 712). Optionally, the conductance across the electrical contact area changes slightly as the needle moves. This variation itself optionally comprises an indication of needle movement.

[0163] Optionally, needle 116 is at least partially coated with an insulating polymer (e.g., on side 902D compared to side 902E, which may remain uncoated). The polymer coating is optionally interrupted at intervals to expose the metal. In some embodiments, this is used to allow needle 116 to act as an encoder of its own advancement by counting events where electrical contact is made and / or broken as coated and uncoated needle portions pass over a sensor.

[0164] It should be noted that a sensor at a single location can be used with such a needle 116, for example, by providing two contacts on the needle 116 (and sensing conduction between them through the needle), or by providing it with one contact and forming a circuit through the body of the needle to a conductor that maintains electrical contact with the needle, such as a wire attached to the needle or a driver cable used to drive the needle. Multiple such sensors are optionally provided to track the needle 116 over distances longer than its own length.

[0165] Reference is now made to FIG. 10, which is a schematic flow chart of a method for guiding suture clip placement within a bougie 100, according to some embodiments of the present disclosure.

[0166] At block 1002, in some embodiments, a needle positioned inside the body cavity is advanced. The advancement is then, in some embodiments, controlled by operation of a control member outside the body cavity. Optionally, the needle is helical and positioned within a needle guidance device, such as a bougie 100. The needle is advanced, in some embodiments, by operation (e.g., rotation) of a control member that drives the needle along a predetermined path defined by the needle guidance device. One or more sensors are positioned along the predetermined path to detect the presence of the needle, for example, according to one of the embodiments of FIGS. 7A-9D.

[0167] At block 1004, in some embodiments, a check is made (e.g., by circuitry connected to the sensors) to determine whether the needle has passed through the area configured to be sutured. In some embodiments, the check includes verifying that the needle was initially detected by at least one sensor but is now no longer detected by that sensor (i.e., the needle has passed the sensor). Additionally or alternatively, the sensors are positioned far enough along the predetermined path (e.g., about the length of the needle measured along the direction of longitudinal movement of the needle) that the rear portion of the needle has passed through the suture area when the front portion of the needle is detected.

[0168] In block 1006, in some embodiments, if the needle has not yet passed through the suture area, the flowchart returns to block 1002. Otherwise, an indication is provided that the procedure can continue, e.g., with clamping of the suture clip, as described herein, e.g., with reference to block 158 and subsequent blocks of FIG. 1C.

[0169] Reference is now made to FIG. 11, which is a schematic flow chart of a method for guiding needle advancement along a bougie 100, according to some embodiments of the present disclosure.

[0170] In block 1102, in some embodiments, a needle positioned within a body cavity is advanced by actuation of a control member outside the body cavity. The configuration of the bougie 100 and needle may be, for example, as described with respect to FIG. 10 . The act of advancing the needle is performed to an extent that is deemed likely to move the needle into (and / or out of) the detection range of a sensor in the bougie 100. For example, if there are sensors spaced at each turn of the helical needle, the control member is optionally actuated sufficiently to be expected to advance the helical needle approximately one turn, assuming no constraints on needle advancement preventing this. Optionally, actuation of the control member is also sensed, for example, using encoder 121A.

[0171] In block 1104, in some embodiments, it is checked whether the needle has actually reached and / or moved into the sensing range of the sensor(s) according to the expected outcome. If so, the procedure returns to block 1102 to continue further advancement of the needle.

[0172] If not, corrective action is taken at block 1106. This may include, for example, one or more of the following: Reverse the direction of the needle. Adjusting the needle driver (e.g., translating the needle driver cable longitudinally so that a different portion of the needle driver cable acts on the needle). Otherwise, change the way forces are exerted to guide needle movement (e.g., operate the needle advancement control member faster or slower). Varying the angle of the bougie 100, for example, to vary the force exerted on the needle. Varying the curvature of the bougie 100, for example, to vary the force exerted on the needle.

[0173] After and / or while corrective action is taken, the flowchart returns to block 1102. The flowchart continues until there is no longer a need to advance the needle, for example, until the outcome of block 1004 of Figure 10 indicates that clipping should continue.

[0174] General As used herein in reference to an amount or value, the term "about" means "within ±10% of."

[0175] The terms "comprises," "comprising," "includes," "including," "having," and combinations thereof mean "including but not limited to."

[0176] The term "consisting of" means "including and limited to."

[0177] The term "consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or components, but only if the additional ingredients, steps, and / or components do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0178] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly indicates otherwise. For example, the term "a compound" or "at least one compound" can include multiple compounds, including mixtures thereof.

[0179] The words "example" and "exemplary" are used herein to mean "serving as an example, instance, or illustration." Any embodiment described as "example" or "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments, and / or should not be used to exclude the incorporation of features from other embodiments.

[0180] As used herein, the word "optionally" is used to mean "provided in some embodiments and not provided in other embodiments." Any particular embodiment of the present disclosure may include multiple "optional" features, except for any inconsistency in such features.

[0181] As used herein, the term "method" refers to methods, means, techniques, and procedures for accomplishing a given task, including, but not limited to, methods, means, techniques, and procedures that are known or that can be readily developed from known methods, means, techniques, and procedures by those skilled in chemistry, pharmacology, biology, biochemistry, and medicine.

[0182] As used herein, the term "treating" includes negating, substantially inhibiting, slowing, or reversing the progression of a condition, substantially ameliorating the clinical or cosmetic symptoms of a condition, or substantially preventing the appearance of clinical or cosmetic symptoms of a condition.

[0183] Throughout this application, embodiments may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the description of the present disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all possible subranges and individual numerical values ​​within that range. For example, a description of a range such as "1 to 6" should be considered to have specifically disclosed subranges such as "1 to 3," "1 to 4," "1 to 5," "2 to 4," "2 to 6," "3 to 6," etc., as well as individual numerical values ​​within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0184] Whenever a numerical range (e.g., "10-15," "10-15," or any pair of numbers linked by these or another such range designators) is given herein, it is meant to include any number (fractional or integer) within the indicated range limit, inclusive, unless the context clearly dictates otherwise. The first and second designators of a "range / ranges / range between," and the first designator of a "range / ranges / range from," and the second designator of "up to," "up to," "until," or "through" (or another such range designator) are used interchangeably herein and include the first and second designators and all fractional and integer numbers therebetween.

[0185] While the description of this disclosure has been provided in conjunction with specific embodiments, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, the present invention is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0186] All publications, patents, and patent applications mentioned in this specification are incorporated by reference herein in their entirety, as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference herein. In addition, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present disclosure. Section headings, if used, should not be construed as necessarily limiting. Additionally, any priority document(s) of this application are incorporated by reference herein in their entirety.

[0187] It is understood that certain features described in this disclosure that are, for clarity, described in the context of separate embodiments, can also be provided in combination in a single embodiment. Conversely, various features that are, for brevity, described in the context of a single embodiment can also be provided separately or in any suitable subcombination, or as suitable in any other described embodiment of this disclosure. Particular features described in the context of various embodiments should not be considered essential features of those embodiments, unless the embodiment cannot function without those elements.

Claims

1. 1. A bougie configured to place a suture within a wall of a body cavity, comprising: a vacuum clamping domain sized for insertion into the body cavity, the vacuum clamping domain comprising a surface defining an interior space and an opening to the interior space configured to receive tissue of the wall of the body cavity upon application of suction to the vacuum clamping domain; a needle within the interior space, the needle having a suture attached thereto; a suture clip mounted on the bougie within the interior space; the needle is operable to translate along a path within the interior space while carrying the suture through the tissue; The bougie, wherein the suture clip includes a clamping zone through which the suture is forced to pass, the suture clip operable to clamp the captured suture at the clamping zone.

2. The bougie of claim 1 , wherein the suture clip includes a suture catch opening, and the pathway extends through the suture catch opening.

3. 3. The bougie of claim 1, wherein the suture catch portion of the suture clip is configured such that after capture of the suture and before clamping of the suture, the suture remains free to slowly translate longitudinally past the suture clip.

4. The bougie of any one of claims 1 to 3, wherein the suture clip comprises a plurality of clamping portions, the suture being clamped by movement of the clamping portions closer together.

5. 5. The bougie of claim 4, wherein the clamp portions are configured to be inserted one inside the other, and movement of the clamp includes inserting one clamp portion inside the other clamp portion.

6. The bougie of claim 4 or 5, wherein moving the clamp includes rotating one of the clamp portions relative to the other.

7. The bougie of claim 6 , wherein the rotating includes moving openings of the clamping portions out of alignment with one another.

8. The bougie of any one of claims 1 to 7, comprising a suture clamp at least partially within the interior space and positioned to capture the suture at a location along the path, the suture clamp being operable to move from outside the bougie to apply a tension force to the suture to reduce a length of the suture engaged in the tissue.

9. A bougie according to any one of claims 1 to 8, comprising a plurality of sensing locations positioned along the path, each sensing location comprising a sensor configured to detect the presence of the needle adjacent to the sensor.

10. 9. The bougie of claim 8, wherein the captured suture slides freely relative to the suture clamp while the suture clamp moves to reduce the length of the suture engaged in the tissue.

11. 11. The bougie of claim 8 or 10, wherein when the suture clamp is moved to reduce the length of the suture engaged in the tissue, the suture is doubled so that both ends of the suture are on the same side of the suture clamp.

12. The bougie of claim 11, wherein the suture clamp comprises a spindle, the suture being doubled over the spindle.

13. 13. The bougie of claim 12, wherein the spindle is narrower towards the middle than at the ends.

14. The bougie of claim 12 or 13, wherein the spindle is rotatably mounted to the suture clamp.

15. The bougie of any one of claims 8 and 10-14, wherein the suture clamp includes an opening positioned along the pathway, the suture clamp capturing the suture as the needle pulls the suture through the opening.

16. 10. The bougie of claim 9, wherein each sensing location has a separate respective sensor.

17. The sensor pressure sensors, an impedance sensor for measuring the impedance of a conductor; a contact sensor for contact with a conductive object; Break sensors for conductor breaks, Hall effect sensors, 17. The bougie of claim 9 or 16, comprising at least one of the group consisting of:

18. The bougie of any one of claims 9 and 16-17, wherein the multiple sensing locations share a single sensor.

19. A bougie as described in any one of claims 9 and 16 to 18, wherein the needle comprises a helical needle, the path comprises a helical path along which the helical needle translates by rotation, and the multiple sensing locations are also arranged along the longitudinal axis of the vacuum clamp domain.

20. A bougie according to any one of claims 1 to 19, wherein the needle comprises a helical needle, the path comprises a helical path along which the helical needle translates by rotation, and the suture clip is positioned along the helical path.

Images