Patent Description:
The present invention, in some embodiments thereof, relates to the field of bariatric surgery and more particularly, to endoluminal placement of gastric sutures.

Obesity and related pathologies such as type <NUM> diabetes are of growing concern worldwide. Gastrointestinal weight-loss surgery (bariatric surgery) has been shown to be effective in achieving sustained weight loss and amelioration of type <NUM> diabetes. Gastric volume reductions via open surgical- or laparoscopic sleeve-gastrectomy have proven to be one of the most effective forms of treatment.

Any surgical approach, however, no matter how minimally invasive, will still struggle to meet demand due to the magnitude of this pandemic. Moderately obese patients, as well as vulnerable patients (children, for instance) are underserved patient populations. Procedural cost-which can reach tens of thousands of dollars in the US, for example-is also prohibitive in places worldwide.

Furthermore, surgical procedures themselves are not without risks. Complications such as procedure-related leak, severity of co-morbidities, and surgeon learning curve are but a few of the factors that have been, and will be, limiting extensive adoption of this approach.

In addition to being a relatively non-invasive form of gastric volume reduction procedure, endoluminal gastric sleeve formation carries the potential for reduced risk of leakage from the stomach. Because the stomach itself is optionally left intact, another potential advantage of an endoluminal technique over sleeve formation by surgical resection is reversibility, for example, in case of complications. Devices and methods for endoluminal gastric sleeve formation are described, for example, in: <CIT>; <CIT>; <CIT>; and <CIT>.

<CIT> "relates to a suture needle having a helical structure for more easily and accurately suturing a wound such as a fracture and the like, and a suturing apparatus allowing a user to effectively use the suture needle. The suture needle includes: a spiral needle body having a pointed tip for stitching up body tissues such as skin while rotating in a screwed manner; and a needle hole provided on at least one of a distal end or a rear end of the needle body for inserting a suture thread" (abstract). <CIT> discloses a bougie for shaping a wall of a body cavity to receive longitudinally extending suturing from within the bougie, and configured for release of the sutured portion after suturing, comprising: (a) a lumenal wall; (b) a wall opening open to the exterior of the bougie, and extending longitudinally along the lumenal wall; (c) at least one laterally crossing blocker having a region of continuous extent passing laterally between two regions of the bougie, dividing the wall opening into a plurality of longitudinally separated fenestrations; and (d) a control member attached to the laterally crossing blocker, and operable to create a gap in between the longitudinally separated fenestrations sized to allow release of the longitudinally extending suturing extending across the laterally crossing blocker.

The invention is defined in appended claim <NUM> which preferred embodiments defined in dependent claims.

Some embodiments of the present disclosure are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example, and for purposes of illustrative discussion of embodiments of the present disclosure. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the present disclosure may be practiced.

Potentially, the structure of the inward-protruding portion provides an advantage by preventing total filling of the hollow area with tissue, and thereby maintaining an open vacuum channel along the longitudinal extent of the tissue-receiving space resistant to tissue blockage.

Another potential advantage of the inward-protruding portion is to serve as a "tissue lock". Tissue sucked into the tissue-receiving space is partially wrapped around the inward-protruding portion (e.g., wrapped around two or more sides of its laterally extending portion, optionally including suction into the hollow area). This wrapping potentially converts suction force into anchoring by convolution of the tissue so that a force applied by a suturing needle (e.g., around an inner circumference of the suction clamping domain) is resisted by an adjacent surface contact of the tissue.

It is noted that, in some embodiments, tissue sucked into the tissue-receiving space is partially blocked from intrusion by structures forming fenestrations at entrances into the tissue-receiving space (e.g., longitudinal blocker, lateral blocker, flaps, and/or outriggers). Tissue intruding into the space past these structures is then further guided, in some embodiments, by the shape of the inward-protruding portion.

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

Reference is now made to <FIG>, which schematically represents a bougie <NUM> configured for shaping and intra-cavity suturing of tissue of a body cavity, according to some embodiments of the present disclosure.

Three main sections of bougie <NUM> are represented as bougie capsule section <NUM> (distally), bougie main body <NUM>, and bougie control handle <NUM> (proximally).

Bougie capsule section <NUM> (herein, a bougie capsule section is also referred to herein as a "capsule"), in some embodiments, comprises a suction clamping domain <NUM>, which in turn comprises one or more fenestrations <NUM>, configured to receive tissue from the body cavity under suction, and to hold and/or position it in preparation for one or more surgical modifications such as suturing. Herein, embodiments of suction clamping domain <NUM> are described using terminologies distinguished with reference to different structures. The same embodiment is optionally described by more than one of these terminologies.

The three terminologies should be understood to be equally applicable to all embodiments of the invention. Even with an extremely thin spine (for example), there is still a "cavity" framed within surfaces of the suction clamping domain, albeit the cavity may be a space largely defined by the extents of a framework of open fenestrations (for example, as next explained). Conversely, even with a relatively narrow aperture region in a tubular body, remaining material of the tubular body framing the aperture region can be understood as forming the "spine" of the suction clamping domain, albeit the "ventral-facing surface" in this case is also an internal surface of the tubular body.

Accordingly, for example, it may be equivalently said that upon application of suction to a suction clamping domain, tissue collapses down onto supporting surfaces positioned along its cavity or along its spine. The supporting surfaces comprise, e.g.: surfaces of longitudinal blocker(s), lateral blocker(s), flaps, outrigger(s), and/or tissue support(s); for example, tissue supports formed from material of a tubular body. These different types of supporting structures are described in more detail in relation to the embodiments of the present disclosure.

In another example: a helical needle moving along the "space" (in terms of the third terminology) of the "cavity" (in terms of the first terminology) is equivalently moving along "a ventral-facing surface of the spine" (in terms of the second terminology). In some embodiments, accordingly, the space is also known as a "suturing space".

For the sake of consistency, descriptions herein use the aperture-in-a-tubular body terminology as the primary terminology, even for embodiments in which the spine is narrow. In some relevant examples, specific relative circumferences are described. For example, in some embodiments, a body of bougie capsule section has a circumferential extent in the suction clamping domain of more than half, less than half, more than a third, less than a third, more than a quarter, and/or less than a quarter of a full circumference.

Herein, fenestrations <NUM> are part of the aperture region of a bougie capsule section <NUM>. Fenestrations, in some embodiments, are configured to be changed in size, shape, and/or topology by actuation of one or more aperture shaping elements. Such fenestrations are also referred to herein as "dynamic" fenestrations.

Aperture shaping element actuation and concomitant changes in dynamic fenestrations <NUM> are used, in some embodiments, to control one or more aspects of lumen tissue attachment, lumen tissue positioning, or lumen tissue suction depth (e.g., in preparation for suturing); or of tissue release. In some embodiments, tissue release includes release of suturing or other surgical material which may be attached (e.g., sewn, clipped, and/or stapled) to the lumen tissue while it is engaged with the bougie capsule section <NUM>.

Examples of aperture shaping elements, in some embodiments, include a longitudinal blocker <NUM>, and/or lateral blockers <NUM>.

A longitudinal blocker <NUM>, in some embodiments, comprises an element such as a stiffened strip or rod that longitudinally spans at least a portion of suction clamping domain <NUM>, substantially dividing it into two sides of fenestrations <NUM> which extend longitudinally alongside one another. Longitudinal blocker <NUM> is optionally removable, re-joining the divided fenestrations <NUM>. This is a potential advantage in tissue and/or suture release; for example to release of the suction clamping domain <NUM> from suturing which crosses between two body cavity lumen tissue portions, and on an internal side of the longitudinal blocker <NUM>.

Lateral blockers <NUM>, in some embodiments, comprise one or more elements, such as lengths of cord, which cross laterally across suction clamping domain <NUM>. A crossing element creates a division of the suction clamping domain that separates different fenestrations <NUM> on either side of the element. Lateral blockers <NUM>, in some embodiments, are releasable and/or removable to remove the separation.

Examples of longitudinal blocker <NUM> and lateral blockers <NUM> are described, for example, in International Patent Publication No. <CIT>, the contents of which are included by reference in their entirety.

Optionally, a distal tip <NUM> of bougie capsule section <NUM> is provided which is transparent, and/or terminates in an aperture large enough (for example, about <NUM>-<NUM> in diameter) to pass the distal end of an endoscope probe or other tool out of.

Bougie main body <NUM>, in some embodiments, comprises a tube <NUM>, along which one or more longitudinally extended control members <NUM> pass, externally and/or internally. In some embodiments, control members <NUM> interconnect between actuatable elements of the bougie capsule section <NUM> (e.g., longitudinal blocker <NUM> and/or lateral blocker <NUM>), and the bougie control handle <NUM> (e.g., control knobs <NUM>). In some embodiments, tube <NUM> has an inner diameter large enough (for example, about <NUM>-<NUM>) to insert an endoscope probe or other tool through.

Distal tip <NUM> is preferably provided with a tapered shape to assist in insertion of bougie <NUM> along a natural body passage such as an esophagus. Bougie capsule section <NUM> and bougie main body <NUM> are preferably sized (in diameter and length) and shaped (at least in an insertion configuration) to allow insertion along a natural body passage such as an esophagus to reach a target organ such as a stomach.

Bougie control handle <NUM>, in some embodiments, comprises one or more control knobs <NUM>, configured to control manipulation of control members <NUM>. Optionally, one or more ports <NUM> are provided, sized to allow insertion of an endoscope or other tool, for passage along the lumen of tube <NUM> into bougie capsule section <NUM>, and optionally to and/or out of distal tip <NUM>.

Reference is now made to <FIG>, which schematically represents a needle drive configured to drive a helical needle <NUM> proximally along the interior of a bougie capsule section <NUM>, according to some embodiments of the present disclosure. <FIG> shows a bougie capsule section <NUM> of a bougie <NUM>, which may be configured substantially as described in relation to <FIG>, with differences/additions as now explained.

Reference is also made to <FIG>, which schematically represents helical needle <NUM> in relation to a shaft <NUM> and selected surfaces <NUM> of bougie capsule section <NUM>, according to some embodiments of the present disclosure.

In some embodiments, helical needle <NUM> is configured to be driven from a distal end <NUM> of a bougie capsule section <NUM> by the rotation of a shaft <NUM> against which helical needle <NUM> is pressed at one or more locations. As shaft <NUM> rotates, helical needle <NUM> rotates along with it. The rotating motion of helical needle <NUM> is accompanied by advance along a longitudinal axis of bougie capsule section <NUM>; e.g., proximal advance from an initially more distal position.

According to the invention, bougie capsule section <NUM> is configured so that friction between shaft <NUM> and helical needle <NUM> transfers torque from the rotating shaft <NUM> to helical needle <NUM>, sufficient for needle advance through tissue while carrying suture.

Optionally, friction is developed in part by pressing helical needle <NUM> between shaft <NUM> and one or more surfaces of a body of bougie capsule section <NUM>. These may be, for example, internal surfaces <NUM> of a dorsal side of bougie capsule section <NUM> (in the "cutaway tube" interpretation of the device's structure); alternatively described as ventral-side surfaces <NUM> of a spine of capsule section <NUM> (in the "spine" interpretation of the device's structure). Optionally, helical needle <NUM> extends around shaft <NUM>, so that shaft <NUM> and helical needle <NUM> rotate in the same circumferential direction. This configuration provides a potential advantage by creating a two-sided pinch immediately at (e.g., as shown for surfaces 211B of <FIG>) and/or closely adjacent (e.g., as shown for surfaces 211A) the position of friction interactions between shaft <NUM> and helical needle <NUM>. Additionally, in some embodiments, needle <NUM> may be pressed against shaft <NUM> by another method, e.g., by squeezing or pulling from a different location, by being forced through a channel that guides helical needle <NUM> against shaft <NUM>, or another method.

Alternatively, in some embodiments, shaft <NUM> is external to the space defined within helical needle <NUM>, so that shaft <NUM> and helical needle <NUM> counter-rotate.

According to the invention, helical needle <NUM> comprises a relatively high-friction surface 201A, and a relatively low-friction surface 201E. In some embodiments, the two surfaces extend along the curving needle shaft so that part of the needle shaft circumference is higher-friction, and part is lower-friction. Surface 201A, in some embodiments, includes surface portions that come into contact with cable <NUM>, but not surface portions that come in contact with bougie surface(s) <NUM>, 211A, 211B. Optionally, surface 201A circumferentially comprises about half of the surface area of helical needle <NUM>.

Roughening may be, e.g., by a treatment such as sputter coating or chemical bath, coating with a high-friction material such as a rubber, or another method. The un-roughened surface of the needle 201B may be protected (e.g., by pre-coating) from the roughening treatment, and/or restored to a smooth finish after treatment. Optionally, the un-roughened surface 201E is given a friction reducing treatment, such as a PTFE coating.

Other parts of needle <NUM> shown in <FIG> include suture 201D, suture connection 201C, and needle tip 201B.

Optionally some slippage occurs between movement of helical needle <NUM> and shaft <NUM> as it turns. In some embodiments, the maximum average slippage (e.g., average slippage needle <NUM> experiences while penetrating tissue and pulling a suture behind it) is, for example, up to no more than <NUM>%, <NUM>%, <NUM>%, <NUM>% or <NUM>% slippage. In some embodiments, there is no slippage, so that the minimum average slippage is <NUM>%. Optionally, the minimum average slippage is at least, for example, <NUM>%, <NUM>%, <NUM>%, or <NUM>% slippage.

It should be noted that features described with respect to helical needle <NUM> moving both rotationally within and longitudinally along bougie capsule section <NUM> are optionally embodied, changed as necessary, in a non-helical arcuate needle moving rotationally within bougie capsule section <NUM>.

In some embodiments, an arcuate needle which is not helical (optionally, more than one) is be driven around a circumference of the bougie body (e.g., guided by a circumferential channel of the bougie body), optionally without longitudinal advance.

Shaft <NUM>, in some embodiments, extends from a distal starting point of needle <NUM> (e.g., within capsule portion 200A), to a proximal side of bougie capsule section <NUM> and out along the bougie main body <NUM> to a handle <NUM> which remains external to a patient during insertion of the bougie to a body cavity such as a stomach. Handle <NUM>, in some embodiments, comprises a knob or other control allowing rotational actuation of the shaft <NUM>.

In some embodiments, shaft <NUM> comprises a flexible portion 205A, which may be, for example, a twisted cable, e.g., a cable in a 1x8 configuration (one central strand surrounded by <NUM> outer strands), a 1x12 configuration, or another cable configuration.

In being flexible, flexible portion 205A provides a potential advantage for allowing flexibility of portions of bougie capsule section <NUM>.

For example, in some embodiments, one or more portions of bougie capsule section <NUM> comprise a plurality of articulated segments, e.g., segments <NUM>. The articulation allows the segments <NUM> to change angle relative to each other so as to induce a bend along the bougie capsule section <NUM>. In some embodiments, segments <NUM> are defined by cutouts formed (not necessarily formed by cutting; optionally formed by molding or additive manufacturing methods such as <NUM>-D printing, for example) to leave material between segments <NUM> sufficient to retain mechanical integrity, but thin enough to flex.

In some embodiments, the cutouts also serve as needle channels <NUM> through which needle <NUM> moves as it spirally advances. It should be noted that cutouts can formed on either side of bougie capsule section <NUM>, for example, cutouts 207A in <FIG> are formed on the bougie capsule section outer side. Cutouts may be formed on both sides. Optionally, cutouts fully penetrate the bougie's distal end <NUM> in some locations. In some embodiments, segments <NUM> are formed of separate pieces fitted together.

In some embodiments, one or both sidewalls of the suction clamping domain 200B comprise housings <NUM> for lateral blockers <NUM> and/or actuatable elements that control the release of the lateral blockers <NUM>. Optionally, gaps 311A between housings <NUM> increase device flexibility, and/or provide apertures (optionally along with apertures <NUM>) between which lateral blockers <NUM> cross. For clarity of viewing details of the needle drive mechanism, lateral blockers <NUM> are not shown in <FIG>. Lateral blockers <NUM> are optionally configured, for example, as shown in any of the figures herein which illustrate them, with additional modifications as necessary for the specifics of the design (for example, use of expandable flaps and/or outriggers).

Optionally, flexible portion 205A directly interacts with needle <NUM>. Optionally, shaft <NUM> comprises a pin 205B, e.g., a pin 205B which distally terminates shaft <NUM>. Pin 205B, in some embodiments, is stiffer and/or less deformable in cross-section than flexible portion 205A, e.g., comprising a solid rod. This provides a potential advantage for use in a needle drive, by increasing dimensional stability that maintains friction with the needle. This in turn potentially delivers greater and/or more predictable torque to the needle. A rod potentially maintains its shape better than a twisted cable when flexed, so that changing of bougie shape (e.g., as described in relation to <FIG>.

In some embodiments, pin 205B is tapered, for example a diameter taper of between <NUM> and <NUM> along a portion of its length. The taper, in some embodiments, allows the pin to be moved (by translation in a direction along the longitudinal extent of suction clamping domain 200B) to a position which selectably gives a tighter or looser friction fit against the needle <NUM>. A tighter fit potentially provides an advantage for increasing the torque which can be applied to the needle <NUM>, while a looser fit potentially provides an advantage to mitigate a case when friction is so high that the pin and/or needle bind.

In some embodiments, a control <NUM> is configured (e.g., with a screw) to withdraw shaft <NUM> as it rotates, along a pitch that keeps the needle <NUM> and pin 205B at matched longitudinal positions, such that the needle <NUM> maintains contact with the pin 205B. The matching optionally allows some amount of relative longitudinal movement, e.g., to allow for some amount of slippage of the needle <NUM> against pin 205B without pin 205B becoming disengaged with needle <NUM>.

Reference is now made to <FIG>, which is a schematic flowchart of a method of intraluminal suturing, according to some embodiments of the present disclosure.

The flowchart begins, and at block <NUM>, in some embodiments, a suction clamping domain 200B of a bougie capsule section <NUM> is inserted to a body lumen (such as a stomach).

At block <NUM>, in some embodiments, suction is applied. Under the force of suction, body lumen tissue is collapsed onto supporting surfaces of the suction clamping domain 200B. Some of the body lumen tissue is sucked into a suturing space defined at the level of suction clamping domain 200B by apertures between the supporting surfaces; for example, sucked into the suturing space through fenestrations. In some embodiments, the collapsed tissue is arranged so that tissue from one portion of a body lumen wall is sucked into a left lateral set of fenestrations, and tissue from another (e.g., facing) portion of a body lumen wall is sucked into a right lateral set of fenestrations. Optionally, the midline between right and left is defined by a longitudinal blocker <NUM>.

At block <NUM>, in some embodiments, a shaft <NUM> is rotated. Shaft <NUM> presses against a surface of needle <NUM>, so that rotation of shaft <NUM> induces, by frictional interaction, a rotation of needle <NUM>. Needle <NUM>, upon rotating, is also longitudinally translated along suction clamping domain 200B.

Reference is now made to <FIG>, which schematically represent a flexing mechanism of a bougie capsule section <NUM>, according to some embodiments of the present disclosure. Reference is also made to <FIG>, which schematically represent another flexing mechanism of a bougie capsule section <NUM>, according to some embodiments of the present disclosure.

Bougie capsule section <NUM> (an example of bougie capsule section <NUM>), in some embodiments, comprises a distal section of a bougie <NUM>. It should be understood that the flexing mechanism described in relation to <FIG> and/or <FIG> is optionally provided, changed as necessary, together with features of any other bougie capsule section of a bougie <NUM> described herein. Each mechanism (the more proximal mechanism of <FIG>, and the more distal mechanism of <FIG>) is optionally provided alone, or the two may be provided in combination.

The flexing mechanism, in some embodiments, operates by longitudinal movement (e.g. pulling or pushing; shortening or lengthening) a control member <NUM>, <NUM> to introduce bending along a segmented portion of bougie capsule section <NUM>. In <FIG>, the control member <NUM> is at its relaxed length, and bougie capsule section <NUM> is straight. In <FIG>, the control member <NUM> is shortened, and bougie capsule section <NUM> is curved along a portion of its body. In <FIG>, the control member <NUM> is at its relaxed length, and bougie capsule section <NUM> is straight. In <FIG>, the control member <NUM> is shortened, and bougie capsule section <NUM> is curved nearer to its distal end.

The flexing mechanism, in some embodiments, comprises control member <NUM> and/or <NUM> (examples of control members <NUM>), and at least one control attachment <NUM>, 303B of control member <NUM>, <NUM> to bougie capsule section <NUM> (optionally one or more additional attachments 303A, 303D are provided, e.g., to help direct bending forces). Also provided are one or more segments <NUM> defined by cutouts 305A which are formed from a single continuous piece interconnecting segments <NUM>, e.g., by cutting, molding, and/or additive manufacture. Thinned material left alongside the cutouts 305A acts as an articulation joint. In some embodiments, segments <NUM> are formed of separately manufactured pieces fitted together, with the cutouts 305A defined by gaps between the fitted pieces. Optionally, cutouts 305B are provided on an opposite side of the bougie capsule section <NUM>.

In some embodiments, the segment cutouts 305A are positioned on a side of bougie capsule section <NUM> opposite control member <NUM>, <NUM> (a ventral side, as shown in <FIG> and 5A-5B), so that shortening of control member <NUM>, <NUM> (e.g., pulling from handle <NUM>) causes expansion on that side. In some embodiments, the segment cutouts 305B are positioned on a side of bougie capsule section <NUM> the same as control member <NUM>, <NUM> (a dorsal side, as shown in <FIG> and 5A-5B), so that shortening of control member <NUM> (e.g., pulling from handle <NUM>) causes compression on that side. Hinges 305C, in some embodiments, are defined with a relatively thin dorsal-ventral dimension (for example, <NUM>-<NUM>). Optionally, hinges 305C, 207B are defined by segmenting material on the lateral sides of bougie capsule section <NUM> with additional cutout slots.

In some embodiments the functions of control members <NUM>, <NUM> are combined. For example control member <NUM> is attached so that shortening/pulling also bends the segments <NUM> which are located more proximally. Optionally, both the proximal segments and the distal segments are operated together. Optionally, the one set of segments is provided on more flexible hinges 305C, so that bending occurs first there, and then, with greater shortening/pulling force, on the other set of segments.

Also indicated in <FIG> and 5A-5B are positions of segments <NUM>, cutouts 207A, distal tip <NUM>, longitudinal blocker <NUM>, and lateral blockers <NUM>, which operate, for example, as described in relation to <FIG>.

Reference is now made to <FIG>, which schematically represent a flexing mechanism of a bougie capsule section <NUM>, according to some embodiments of the present disclosure.

Bougie capsule section <NUM> (an example of bougie capsule section <NUM>), in some embodiments, comprises a distal section of a bougie <NUM>. It should be understood that the flexing mechanism described in relation to <FIG> is optionally provided, changed as necessary, together with features of any other bougie capsule section of a bougie <NUM> described herein, including together with other flexing mechanisms.

The flexing mechanism, in some embodiments, operates by shortening or lengthening a control member <NUM> to introduce bending along a segmented portion of bougie capsule section <NUM>. In <FIG>, the control member <NUM> is at its relaxed length, and bougie capsule section <NUM> is straight. In <FIG>, the control member <NUM> is shortened, and bougie capsule section <NUM> is curved. Segmentation of a portion of bougie capsule section <NUM> into segments <NUM> separated by cutouts 207A (and optionally other cutouts not shown, e.g., cutouts internal to bougie capsule section <NUM>) is optionally as described in relation to other figures herein, for example <FIG> and/or 3A-3B.

In some embodiments, control member <NUM> is attached to longitudinal blocker <NUM>, such that shortening (pulling on) control member <NUM> causes longitudinal blocker <NUM> to pull on bougie capsule section <NUM> at attachment <NUM>, and in turn introduce a curvature to bougie capsule section <NUM>. It should be noted that longitudinal blocker <NUM> optionally is released from attachment <NUM> by operation of a separate mechanism (e.g., via a different control member <NUM>). Once released from attachment <NUM>, control member <NUM> operates to withdraw longitudinal blocker <NUM>, rather than to introduce curvature to bougie capsule section <NUM>. In some embodiments, longitudinal blocker <NUM> is released by pulling on control member <NUM> past/above a predefined position/tension, and that predefined position/tension is predefined so that bending can be reliably induced without accidentally triggering attachment release.

Also indicated in <FIG> are positions of segments <NUM>, cutouts 207A, distal tip <NUM>, and longitudinal blocker <NUM>, which operate, for example, as described in relation to <FIG>.

Reference is now made to <FIG>, which is a flowchart of a method of intraluminal positioning of a bougie capsule section, according to some embodiments of the present disclosure.

At block <NUM>, in some embodiments, a bend is induced along a suturing space defined by supporting surfaces of the suction clamping domain 200B. In some embodiments, the bend is induced by longitudinal movement of a control member <NUM>. Optionally, the control member <NUM> induces bending by movement of a longitudinal blocker <NUM>. In some embodiments, the suction clamping domain 200B comprises articulated segments <NUM>, and the bending comprises induction of a change in the angle(s) at which the articulated segments <NUM> meet.

At block <NUM>, in some embodiments, suction is applied. Under the force of suction, body lumen tissue is collapsed onto supporting surfaces of the suction clamping domain 200B. Some of the body lumen tissue is sucked into a suturing space defined at the level of suction clamping domain 200B by apertures between the supporting surfaces; for example, sucked into the suturing space through fenestrations. In some embodiments, the collapsed tissue is arranged so that tissue from one portion of a body lumen wall is sucked into a left lateral set of fenestrations, and tissue from another (e.g., facing) portion of a body lumen wall is sucked into a right lateral set of fenestrations. Optionally, the midline between right and left is defined by the longitudinal blocker <NUM>.

Optionally, in some embodiments, the method of <FIG> continues with block <NUM>, in which a helical needle <NUM> is longitudinally advanced by rotation along the bent portion of the suturing space. In some embodiments, helical needle <NUM> is longitudinally advanced by frictional contacts with a rotating shaft <NUM>, wherein the frictional contacts occur at positions along the bent portion of the suturing space.

Reference is now made to <FIG>, which schematically represents an overtube for use with a gastric surgery bougie, according to some embodiments of the present disclosure.

Overtube <NUM>, in some embodiments, is sized to pass along an access way (e.g., an esophagus) to a body cavity (e.g., a stomach) targeted for suturing, with the eventual orientation of aperture <NUM> within the body cavity being controlled in part by the direction and degree of a bend induced to the overtube, e.g., by use of control members 301A, 301B.

Overtube <NUM> is sized to accept bougie capsule section <NUM> passing within it from a proximal end, and out through aperture <NUM> at a distal end of overtube <NUM>. In use, overtube <NUM> bending and position has the effect of adjusting the angulation of bougie capsule section <NUM> as it passes out of overtube aperture <NUM>. This is a potential advantage for steering bougie capsule section <NUM> to an intended suturing site within a body cavity such as a stomach, optionally without or auxiliary to the use of a steering mechanism provided on the bougie <NUM> itself.

In some embodiments, control members 301A, 301B (examples of control member <NUM>) are affixed to the body of a flexible overtube <NUM>. Shortening (pulling on) one of the control members 301B, 301A operates to bend the overtube in the direction of the side on which the control member attaches (e.g., control members 301A and 301B attach at attachments 303E and 303F, respectively). The overtube <NUM> is optionally locked into position once a suitable bend has been introduced.

Reference is now made to <FIG>, which schematically represents a collapsible bougie orientation projection <NUM> according to some embodiments of the present disclosure.

In some embodiments, orientation projection <NUM> is configured to be controllably extended from the side of bougie distal end <NUM>, e.g., by manipulation of control member <NUM> (which is an example of a control member <NUM>). When extended within a suitably shaped body cavity, (e.g., a body cavity such as a stomach which lacks radial symmetry so that it is longer in one direction than in another) orientation projection <NUM> helps to force the bougie distal end <NUM> into a predetermined orientation relative to the body cavity. Optionally, orientation projection <NUM> also operates to stretch out tissue of the body cavity, e.g., to position it in preparation for attachment by suction.

In some embodiments of the present disclosure, bougie <NUM> is provided with a collapsible orientation projection <NUM>. By advancing (distally) control member <NUM>, orientation projection <NUM>, which is normally stowed collapsed against the side of bougie capsule section <NUM>, is induced to protrude. In some embodiments, orientation projection <NUM> is formed of a shape memory allow such as nitinol. It takes up a predetermined shape, e.g., comprising a bend <NUM>, upon receiving sufficient slack from distally advancing control member <NUM> to allow it to relax into its preformed shape. Optionally, the shape is at least partially pushed into shape, e.g., by generating pressure of orientation projection <NUM> against attachment <NUM>.

Also indicated in <FIG> are positions of segments <NUM>, cutouts 207A, distal tip <NUM>, longitudinal blocker <NUM>, and lateral blocker <NUM>, which operate, for example, as described in relation to <FIG>.

In some embodiments, projection <NUM> is also controllable by twisting to change the relative circumferential positions of its distal and proximal ends. Potentially, this assists in device positioning, for example, by inducing pressing against a tissue wall to re-orient the bougie distal end <NUM>.

Reference is now made to <FIG>, which schematically represent a bougie capsule section <NUM> comprising a capsule-expanding blocker <NUM>, according to some embodiments of the present disclosure. Reference is also made to <FIG>, which schematically represent a bougie capsule section <NUM> comprising capsule-expanding blocker <NUM> with a collapsible bougie orientation projection <NUM>, according to some embodiments of the present disclosure. Bougie capsule sections <NUM>, <NUM> are examples of bougie capsule section <NUM>.

In some embodiments, a capsule-expanding blocker <NUM> is configured to change shape (e.g., bulge) to expand a size of suction clamping domain <NUM>; for example, to open fenestrations <NUM> of the aperture domain <NUM> to a larger size. This has the potential advantage of increasing the amount and/or depth of lumen wall tissue that is held (potentially more securely) under vacuum. For example, by lengthening each fenestration <NUM> (in a direction both laterally across and radially outward from suction clamping domain <NUM>) a greater depth of tissue can potentially be taken in by suction at the positions where needle penetration (e.g., by a helical needle <NUM>) will occur during suturing.

In some embodiments, a doubled thickness of tissue is drawn in to a fenestration <NUM> by vacuum to a sufficient depth as to allow the needle to fully penetrate inside-to-outside, and then inside-to-outside the body lumen tissue (e.g., stomach wall) as it passes through the "bite" of tissue which has been drawn into the fenestration by vacuum.

In some embodiments, capsule-expanding blocker <NUM> comprises an instance of a longitudinal blocker <NUM>, arranged to extend longitudinally along a midline of the bougie capsule section <NUM> which is configured to change shape by bulging outward under external control. For example, control member <NUM> (an example of a control member <NUM>) advances distally to allow expand capsule-expanding blocker <NUM> to expand, and/or is pulled proximally (shortened) to flatten it. Capsule-expanding blocker <NUM> optionally comprises a shape memory alloy such as nitinol, which returns to a predetermined shape upon being allowed to relax when control member <NUM> advances (lengthens). Optionally, control member <NUM> actively pushes blocker <NUM>.

Optionally, lateral blockers <NUM> are long and loose enough when longitudinal blocker <NUM> is in the collapsed configuration to allow longitudinal blocker <NUM> to expand. Alternatively, they are initially strung more tightly, and slack is payed out as longitudinal blocker <NUM> expands. In some embodiments, the lateral blockers <NUM> are adjustable in tension to accommodate different degrees of expansion of longitudinal blocker <NUM>. In some embodiments, a control member <NUM> (not shown) is provided that can be manipulated to tighten/loosen slack in lateral blockers <NUM>.

In some embodiments, a collapsible bougie orientation projection <NUM> is provided along with capsule-expanding blocker <NUM>, for example as shown collapsed in <FIG>, and expanded in <FIG>. Collapsible bougie orientation projection <NUM> is operable, in some embodiments, by manipulation of control member <NUM>, substantially as described in relation to collapsible bougie orientation projection <NUM> and control member <NUM> in relation to <FIG>. Optionally, a spacing of bougie capsule section <NUM> from a nearby tissue wall is controlled by a degree of expansion of bougie orientation projection <NUM>, pressing against the nearby tissue wall.

Reference is now made to <FIG>, which schematically represent a bougie capsule section <NUM> comprising a capsule-expanding blocker <NUM>, along with a plurality of capsule-expanding flaps <NUM>, according to some embodiments of the present disclosure. Bougie capsule section <NUM> is an example of a bougie capsule section <NUM>. <FIG> show perspective views of bougie capsule section <NUM>. <FIG> show cross sectional views of bougie capsule section <NUM>, at the level of a pair of the flaps <NUM>. There may be provided, for example, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or another number of flaps <NUM>.

In some embodiments, a capsule-expanding blocker <NUM> and capsule expanding flaps <NUM> are configured to move to expand a size of suction clamping domain <NUM> and a tissue-receiving space <NUM> therein; for example, to open fenestrations <NUM> of the aperture domain <NUM> to a larger size. As shown, fenestrations <NUM> are bounded on two sides by lateral blockers <NUM> (examples of lateral blockers <NUM>), on one side by capsule-expanding blocker <NUM>, and on another side by flap edge 1013B.

The expansion has the potential advantage of increasing the amount and/or depth of lumen wall tissue that is held (potentially more securely) under vacuum. For example, by expanding each fenestration <NUM>, a greater depth of tissue can potentially be taken in by suction at the positions where needle penetration (e.g., by a helical needle <NUM>) will occur during suturing.

Expansion of aperture domain <NUM> by movement of blocker <NUM>, in some embodiments, is substantially as described for blocker <NUM> of <FIG> (e.g., by operation of control member <NUM>). In some embodiments, movement of blocker <NUM> away from flaps <NUM> allows tension in spring <NUM> to cause flaps <NUM> to open. Flaps <NUM> may stop opening upon a stopping region <NUM> contacting another part of the aperture domain <NUM> (e.g., spine region <NUM>).

Additionally, in the example of <FIG>, flaps <NUM> are expandable, for example, by operation of (e.g., pulling) of control member <NUM>. Control member <NUM> is an example of a control member <NUM>.

In some embodiments, operation of control member <NUM> causes flaps <NUM> to swing (e.g., on a hinge) from a collapsed position to an expanded position. In some embodiments, the collapsed position comprises being arranged to point toward a midline plane that divides the aperture domain <NUM> along a dorsal/ventral plane of the aperture domain <NUM>. In some embodiments, the expanded position comprises being arranged to point away from that midline plane. Optionally, each segment <NUM> is provided with a pair of flaps <NUM>. Optionally, flaps <NUM> are provided just at the ends of the aperture domain, at the ends and in the middle of the aperture domain, or in another configuration.

Lateral blockers <NUM> optionally comprise cords sized so that they become taut when aperture domain <NUM> is fully expanded. In some embodiments, the lateral blockers <NUM> are adjustable in tension to accommodate different degrees of expansion of longitudinal blocker <NUM>. In some embodiments, a control member <NUM> (not shown) is provided that can be manipulated to tighten/loosen slack in lateral blockers <NUM>.

In the example shown, <FIG> show the flaps <NUM> in fully collapsed positions. <FIG> shows flaps partially expanded, and <FIG> shows flaps <NUM> fully expanded.

In some embodiments, the expanded aperture domain <NUM> is placed under vacuum to cause attachment to tissue.

As shown in <FIG>, fenestrations <NUM> are oriented substantially perpendicular to a plane passing in a ventral-to-dorsal direction through aperture domain <NUM>. To attach to tissue walls, the device is optionally first oriented such that the fenestrations are substantially orthogonal to the tissue walls (e.g., gastric walls) which are to be attached to the device; one wall on either side. Upon application of suction, the collapsing tissue walls fold over flap edges 1013B onto the fenestrations <NUM> and are secured. The two opposite tissue walls preferably meet at about the position of longitudinal blocker <NUM>. Optionally, the device is rocked during application of vacuum by slight rotations around its longitudinal axis, to help encourage filling of each fenestration <NUM> by tissue from just one of the tissue walls.

Optionally, fenestrations <NUM> expand to a more lateral-facing orientation than is shown in <FIG>. For example, capsule expanding blocker <NUM> expands to a greater distance from a dorsal side of aperture domain <NUM>, flaps <NUM> are shorter, and/or flaps <NUM> are oriented upon expansion so that flap edges 1013B lay closer to a dorsal side of aperture domain <NUM> than expanded capsule expanding blocker <NUM>, when flaps <NUM> are expanded.

Reference is now made to <FIG>, which schematically represent a bougie capsule section <NUM> comprising a capsule-expanding blocker <NUM>, along with a plurality of capsule-expanding outriggers <NUM>, according to some embodiments of the present disclosure.

<FIG> illustrate a different structure for expanding aperture domain <NUM>, comprising supports 1113A which swivel from a flattened or relatively flattened position (e.g., as shown <FIG>) to a raised position having a position more perpendicular (<FIG>) or perpendicular (<FIG>) to a longitudinal axis (along a distal-proximal direction) of bougie capsule section <NUM>.

Supports 1113A along each side, in some embodiments, are coupled to each other by stabilizing bars 1113B, which rise or fall as supports 1113A swivel around a swivel point attached to the capsule body. Actuation to change the expansion state of outriggers <NUM>, in some embodiments, comprises operation of a control member <NUM>. In some embodiments, capsule-expanding blocker <NUM> is expanded (e.g., via control member <NUM>), and optionally this expansion also induces expansion of outriggers <NUM>; e.g., by tension placed on lateral blockers <NUM>.

Fenestrations <NUM> are defined, in some embodiments, as spaces bordered on two sides (e.g., the longitudinal axis borders) by lateral blockers <NUM>, on a medial side by capsule-expanding blocker <NUM>, and on a laterally outward side by a stabilizing bar 1113B.

Distal tip <NUM> and segments <NUM> are configured, for example, as described in relation to other figures herein.

Actuation to change the expansion state of outriggers <NUM>, in some embodiments, comprises operation of a control member <NUM>.

<FIG> illustrate a different structure for expanding aperture domain <NUM> (i.e., a variation of the capsule-expanding outriggers <NUM> described in relation to <FIG>), comprising crossed supports 1213A which swivel from a flattened or relatively flattened position (e.g., as shown <FIG>) to a raised position (<FIG>).

In some embodiments, some of supports 1213A along each side are oriented to point in a more distal direction, and some in a more proximal direction, forming lattices, with separate supports 1213A formed as pieces coupled to each other via their crossings.

Alternatively, in some embodiments, lattice of supports 1213A is formed from a piece of shape-memory metal such as nitinol; for example, a piece which is normally collapsed (as in the configuration of <FIG>), but which deforms into an expanded shape, e.g., upon longitudinal compression (that is, compression along a distal-proximal axis of bougie capsule section <NUM>), and/or upon dorsal-ventral stretching (e.g., stretching induced through lateral blockers <NUM> upon expanding capsule-expanding blocker <NUM> (e.g., via control member <NUM>).

Fenestrations <NUM> are defined, in some embodiments, as spaces bordered on two sides (e.g., the longitudinal axis borders) by lateral blockers <NUM>, on a medial side by capsule-expanding blocker <NUM>, and on a laterally outward side by portions of outriggers <NUM>.

Reference is now made to <FIG>, which is a flowchart of a method of intralumenal use of a bougie capsule section, according to some embodiments of the present disclosure.

At block <NUM>, in some embodiments, a suturing space of the bougie capsule section, along the suction clamping domain, is expanded. In some embodiments, the expansion comprises use of a control member <NUM> to actuate movement of supports, for example, outriggers such as outriggers <NUM>, <NUM>, <NUM>. Additionally or alternatively, in some embodiments, the expansion comprises use of a control member to change the shape of a longitudinal blocker <NUM> extending longitudinally along the suction clamping domain. In some embodiments, the outriggers <NUM>, <NUM>, <NUM> and/or longitudinal blocker <NUM> are also provided with lateral blockers <NUM>. Together, these structures, upon expansion, define supporting surfaces onto which tissue collapses upon application of suction (in block <NUM>), and define fenestrations <NUM> through which the collapsing tissue enters into a suturing space located along the suction clamping domain.

At block <NUM>, in some embodiments, suction is applied. Under the force of suction, body lumen tissue collapses onto the expanded supporting surfaces of the suction clamping domain 200B. Some of the body lumen tissue is sucked into the suturing space defined at the level of suction clamping domain 200B by apertures between the supporting surfaces; for example, sucked into the suturing space through fenestrations. In some embodiments, the collapsed tissue is arranged so that tissue from one portion of a body lumen wall is sucked into a left lateral set of fenestrations, and tissue from another (e.g., facing) portion of a body lumen wall is sucked into a right lateral set of fenestrations. Optionally, the midline between right and left is defined by the longitudinal blocker <NUM>.

Optionally, in some embodiments, the method of <FIG> continues with block <NUM>, in which a helical needle <NUM> is longitudinally advanced by rotation along the expanded portion of the suturing space. In some embodiments, helical needle <NUM> is longitudinally advanced by frictional contacts with a rotating shaft <NUM>, wherein the frictional contacts occur at positions along the bent portion of the suturing space.

Reference is now made to <FIG>, which schematically represent internal structures of a bougie suction clamping domain 200B affecting vacuum distribution, tissue clogging, and/or tissue clamping, according to some embodiments of the present disclosure. <FIG> shows bougie suction clamping domain 200B from a ventral side looking dorsally. <FIG> shows bougie suction clamping domain 200B from a perspective view. <FIG>13D show side-views of bougie suction clamping domain 200B. <FIG> shows a side-view from proximal end <NUM> of suction clamping domain 200B, and <FIG> shows a side-view from distal end <NUM> of suction clamping domain 200B.

In some embodiments, features of bougie aperture domain 200B include housings <NUM>, gaps 311A, needle channels <NUM>, cavity <NUM>, segments <NUM>, and apertures <NUM>, for example as described in relation to <FIG>, herein.

In some embodiments, segments <NUM> include inward-protruding portions <NUM> defined between needle channels <NUM>, and protruding into an interior area (tissue receiving space <NUM>) of suction clamping domain 200B from a dorsal side <NUM> of suction clamping domain 200B. Inward-protruding portions <NUM>, in some embodiments, comprise laterally projecting branches <NUM>, defining spaces <NUM> between branches <NUM> and dorsal side <NUM>, to which tissue access (upon application of suction) is restricted by a relatively narrow slot 1302B. For example, slot 1302B is about <NUM>-<NUM> across. Potentially, the narrowness of slot 1302B helps ensure that spaces <NUM> remain at least partially open when suction is applied, which in turn assists in ensuring that low pressure due to applied suction is distributed uninterruptedly along bougie aperture domain 200B. In some embodiments, applied suction bends tissue so that it contact branches <NUM> from both within space <NUM>, and outside of space <NUM>, e.g., along a ventrally-facing surface <NUM> which is within a tissue-receiving space defined by suction clamping domain 200B.

In some embodiments, the convolution of tissue around inward-protruding portion <NUM> as it deforms under vacuum to fill into the shape of spaces <NUM> acts to help hold tissue in place during suturing. Potentially, this helps to keep tissue from being "bunched up" by movement of the needle, and/or to help reduce a risk of tissue tearing as the needle is advanced through the tissue.

Optionally, surface <NUM> is shaped with a curvature and placed at an inset from the inner dorsal side of suction clamping domain 200B so that an endoscope (e.g., of up to about <NUM>-<NUM> in diameter) can be passed through the tissue-receiving space <NUM> of suction clamping domain 200B.

In some embodiments, inward-protruding portion <NUM> is hollowed on a ventrally-facing surface. This potentially acts to help receive a sufficient thickness of tissue upon activation of suction.

Aperture <NUM>, in some embodiments, is sized for the admittance of shaft <NUM> and/or pin 205B, for example as these elements are described in relation to <FIG>.

Reference is now made to <FIG>, which schematically represent a suction clamping domain 200B of a bougie capsule section <NUM> comprising offset fenestrations defined by tissue supports 1403A, 1405B, according to some embodiments of the present disclosure. Reference is also made to <FIG>, which schematically represent variations of suction clamping domain 200B of a bougie capsule sections <NUM>, <NUM>, <NUM> comprising offset fenestrations defined by tissue supports 1503A, 1503B, 1523C, 1523B, 1523D, 1523E, according to some embodiments of the present disclosure.

Tissue supports 1403A, 1405B, 1503A, 1503B, 1523C, 1523B, 1523D, 1523E, in some embodiments, are distributed in alternation along two sides of a longitudinal midline of bougie capsule section <NUM>. The tissue supports can be of different longitudinal lengths along one side of the midline, and/or of different longitudinal lengths along different sides of the midline.

In use, when suction clamping domain 200B is engaged with tissue walls under suction inside a body cavity, a suturing needle (for example, suturing needle <NUM> of <FIG>) is spirally advanced along suction clamping domain 200B. Needle <NUM> alternately penetrates tissue intrusions on either side of the midline.

In some embodiments, a longitudinal blocker (not shown, but received, for example, by anchoring cavity <NUM> of <FIG>, <FIG>) is provided to help define and maintain boundaries between fenestrations <NUM>. The extent of medial protrusion of tissue supports 1403A, 1405B, 1523D, 1523C may be restricted, for example, and the space left partially filled in by a longitudinal blocker such as longitudinal blocker <NUM>.

Optionally, no longitudinal blocker is used, and the shapes of tissue supports 1503A, 1503B, 1523C, 1523B are sized and spaced to ensure separation of tissue on alternate sides.

Suture may be disengaged by passing out in the gaps <NUM> between adjacent corners of tissue supports 1403A, 1405B.

Reference is now made to <FIG>, which schematically represent an arrangement of a suction clamping domain <NUM> allowing progressive unblocking of a fenestration <NUM> by longitudinal blocker <NUM>, according to some embodiments of the present disclosure. Reference is also made to <FIG>, which schematically represent an alternative arrangement of a suction clamping domain <NUM> allowing progressive unblocking of a fenestration <NUM> by a longitudinal blocker <NUM>, according to some embodiments of the present disclosure. <FIG> represent different stages of withdrawal of longitudinal blocker <NUM>. <FIG> represents a cross-section at a level of longitudinal blocker <NUM>, according to some embodiments of the present disclosure. Further reference is made to <FIG>, which schematically represent an alternative arrangement of a suction clamping domain <NUM> allowing progressive unblocking of a fenestration <NUM> by longitudinal blocker <NUM>, according to some embodiments of the present disclosure. <FIG> represent different stages of withdrawal of longitudinal blocker <NUM>.

In some embodiments, a portion of a bougie body <NUM>, <NUM>, <NUM> defines a large fenestration <NUM>, <NUM>, <NUM> (optionally a single large fenestration) which is gradually lengthened along a longitudinal axis of the bougie body by longitudinal movement (e.g., by withdrawal proximally) of longitudinal blocker <NUM>, <NUM>, <NUM> e.g., actuated by control member <NUM>, <NUM>, <NUM>. In some embodiments, the large fenestration <NUM>, <NUM>, <NUM> has a length along the longitudinal axis of, for example, at least <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. The length, in some embodiments, is long enough to allow placement of at least <NUM>, <NUM>, <NUM>, <NUM> or more sutures, for example by proximally advancing spiral needle <NUM>. After positioning within a body cavity: as the longitudinal blocker <NUM>, <NUM>, <NUM> is withdrawn to reveal more of fenestration <NUM>, <NUM>, <NUM>; more tissue is suctioned inside, and made available for suturing, for example by a proximally advancing spiral needle <NUM>.

In some embodiments (<FIG>, <FIG>), longitudinal blocker <NUM>, <NUM> comprises a wide portion 1601A, <NUM> and a narrow portion 1601B, <NUM>. Narrow portion 1601B, <NUM> helps to define two laterally separated sides of fenestration <NUM>, <NUM>, so that tissue-from, for example, opposite body cavity walls-is guided into one side or the other of fenestration <NUM>, <NUM>, without one body cavity wall side completely filling the available space.

Optionally, (<FIG>), longitudinal blocker <NUM> also comprises a divider <NUM> which intrudes into the internal space defined by bougie body <NUM>, and acts to also block internally intruding tissue under suction so that it is prevented from crossing a midline of bougie body <NUM>.

In <FIG>, a portion of the internal structure of a longitudinal blocker <NUM> is shown, comprising internal supporting struts <NUM> (curved and/or straight). Optionally, longitudinal blocker <NUM> is shaped so that it is locked to shape of body <NUM>, for example, using inward protruding portion <NUM> as a guide rail.

In some embodiments, wide portion <NUM> is slit along its lengths by slits <NUM>. This potentially helps to maintain flexibility of bougie body <NUM>, and/or to assist in the vacuum collapse under suction of body tissue walls of a body cavity to which bougie body <NUM> is inserted.

As used herein with reference to quantity or value, the term "about" means "within ±<NUM>% of".

The terms "comprises", "comprising", "includes", "including", "having" and their conjugates mean: "including but not limited to".

The term "consisting of" means: "including and limited to".

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

Any particular embodiment of the present disclosure may include a plurality of "optional" features except insofar as such features conflict.

Throughout this application, embodiments may be presented with reference to 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 descriptions of the present disclosure. For example, description of a range such as "from <NUM> to <NUM>" should be considered to have specifically disclosed subranges such as "from <NUM> to <NUM>", "from <NUM> to <NUM>", "from <NUM> to <NUM>", "from <NUM> to <NUM>", "from <NUM> to <NUM>", "from <NUM> to <NUM>", etc.; as well as individual numbers within that range, for example, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>.

Although descriptions of the present disclosure are 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, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present disclosure. To the extent that section headings are used, they should not be construed as necessarily limiting.

Claim 1:
A bougie capsule section (<NUM>) configured for shaping and suturing of tissue of a body lumen from within the body lumen, the bougie capsule section comprising:
a capsule body (<NUM>), extending longitudinally between a distal side (<NUM>) and a proximal side of the bougie capsule section (<NUM>);
an arcuate needle (<NUM>) within the capsule body; and
a shaft (<NUM>), extending longitudinally along the capsule body (<NUM>), and fitted to press against the arcuate needle (<NUM>), and rotatable to drive, by friction between the shaft (<NUM>) and the arcuate needle (<NUM>), rotation of the arcuate needle (<NUM>) around a longitudinal axis of the capsule body (<NUM>);
characterized in that:
said arcuate needle includes a first surface (201A) and a second surface (201B), wherein said first surface has more friction than said second surface;
wherein said shaft is fitted to press against said first surface (201A) of said arcuate needle (<NUM>) and is rotatable to drive, by friction between said shaft (<NUM>) and said first surface (201A) of said arcuate needle (<NUM>), rotation of said arcuate needle (<NUM>) around the longitudinal axis of said capsule body (<NUM>); and
wherein said second surface (201B) of said arcuate needle (<NUM>) is configured to be pressed against one or more surfaces of said capsule body (<NUM>).