TISSUE MANIPULATION WITH AN ENDOLUMINAL GASTROPLASTY DEVICE

Devices and methods of endolumenal formation of gastric sleeves are described. In some embodiments, a bougie capsule section comprises one or more mechanisms to allow flexing that induces a bend through a suction clamping domain that grabs, positions, and holds body lumen tissue (e.g., gastric wall tissue). In some embodiments, a needle drive is configured to allow longitudinal movement of a helical needle through a suturing space defined by the suction clamping domain, optionally while the suction clamping domain is bent. In some embodiments, the suction clamping domain can insert to the stomach in a collapsed configuration, then expanded once in the stomach. Potentially, this allows grabbing and positioning larger and/or deeper folds of tissue for suturing.

FIELD AND BACKGROUND OF THE INVENTION

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 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 amelioration of type 2 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: U.S. Patent Publication 2008/0249404 by Mikkaichi et al. filed Dec. 27, 2007; U.S. Pat. No. 6,558,400 to Deem et al. filed May 30, 2001; U.S. Pat. No. 7,896,890 to Ortiz et al. filed Mar. 1, 2011; and U.S. Pat. No. 7,083,629 to Weller et al. filed Aug. 1, 2006.

SUMMARY OF THE INVENTION

There is provided, in accordance with some embodiments of the present disclosure, a bougie capsule section configured for shaping and suturing of tissue of a body lumen from within the body lumen, the bougie capsule section comprising: a capsule body, extending longitudinally between a distal side and a proximal side of the bougie capsule section; an arcuate needle within the capsule body; and a shaft, fitted longitudinally along the capsule body to press against the arcuate needle, and rotatable to drive, by friction between the shaft and the arcuate needle, rotation of the arcuate needle around a longitudinal axis of the capsule body.

In some embodiments, the arcuate needle is a helical needle, and the rotation of the helical needle is accompanied by translation of the helical needle along the longitudinal axis of the capsule body.

In some embodiments, the capsule body defines a helical arrangement of channels along which the helical needle rotates and advances longitudinally; and the shaft presses against the helical needle in at least one position where the shaft crosses the helical arrangement of channels.

In some embodiments, the shaft is radially within an arc of the arcuate needle where the shaft presses against the arcuate needle.

In some embodiments, the shaft is radially outside an arc of the arcuate needle where the shaft presses against the arcuate needle.

In some embodiments, the capsule body and shaft are flexible along a region where the shaft presses against the arcuate needle.

In some embodiments, the arcuate needle comprises a relatively high-friction surface and a relatively low-friction surface; and wherein the shaft presses against the high-friction surface.

In some embodiments, the low-friction surface presses against surfaces of the capsule body.

In some embodiments, the shaft comprises a cable section comprising a plurality of strands, and a pin section comprising a solid piece, positioned along the capsule body where the pin presses against the arcuate needle.

In some embodiments, the pin has a fixed and uniform diameter.

In some embodiments, the pin is tapered.

In some embodiments, the shaft is configured to move longitudinally as it rotates.

In some embodiments, the longitudinal movement of the pin maintains contact of the pin with the needle during a longitudinal movement of the needle.

In some embodiments, the capsule body comprises a plurality of longitudinally aligned lumens arranged along the capsule body, and through which the shaft passes; wherein the shaft is held against the arcuate needle at one or more positions between the longitudinally aligned lumens.

In some embodiments, the capsule body defines a suction clamping domain defined by supporting surfaces positioned along the suction clamping domain, configured to receive the tissue of the body lumen collapsed onto the supporting surfaces upon application of suction to the suction clamping domain while the bougie capsule section is inserted to the body lumen.

There is provided, in accordance with some embodiments of the present disclosure, a method of intraluminal suturing, comprising: rotating a helical needle by frictional interaction with a rotating shaft to advance the helical needle along a bougie capsule section.

In some embodiments, the shaft is fitted longitudinally along the bougie capsule section to press against the helical needle.

There is provided, in accordance with some embodiments of the present disclosure, a bougie capsule section configured for shaping and suturing of tissue of a body lumen from within the body lumen, the bougie capsule section comprising: a capsule body, extending along a longitudinal axis through a suction clamping domain between a distal side and a proximal side of the bougie capsule section; and a suturing space defined by supporting surfaces of the suction clamping domain, configured to receive the tissue of the body lumen collapsed onto the supporting surfaces upon application of suction to the suction clamping domain while the bougie capsule section is inserted to the body lumen; wherein the capsule body comprises articulated segments, configured to change angle with respect to each other to produce a bend in the capsule body.

In some embodiments, the suction clamping domain comprises the articulated segments.

In some embodiments, the articulated segments are longitudinally interconnected in a single continuous piece, and the articulation between segments comprises thinning of material of the single continuous piece to form articulation joints.

In some embodiments, the articulated segments define a helical arrangement of channels, and comprising a helical needle, configured to advance longitudinally as it rotates through the helical arrangement of channels, while the articulated segments are bent.

In some embodiments, the bougie capsule section comprises a shaft, fitted to extend longitudinally through the suction clamping domain and press against the helical needle; and rotatable to drive the rotation of the helical needle by friction between the shaft and the helical needle, while the articulated segments are bent on either side of a position at which the shaft presses against the helical needle.

In some embodiments, the bend is produced by operation of a control member is attached to the capsule body via a longitudinal blocker that extends longitudinally through the suction clamping domain to provide a portion of the supporting surfaces, and longitudinally divides an aperture region leading into the suturing space into separate fenestrations on either side of the longitudinal blocker; and wherein movement of the longitudinal blocker upon the longitudinal movement of the control member produces the bend in the capsule body.

There is provided, in accordance with some embodiments of the present disclosure, a method of intraluminal suturing, comprising: inserting to a body lumen a suction clamping domain of a bougie capsule section configured for shaping and suturing of tissue of a body lumen from within the body lumen; inducing a bend along the suction clamping domain; applying suction to collapse tissue of the body lumen onto supporting surfaces of the suction clamping domain, and into a suturing space within the bent bougie capsule section; and advancing a helical needle through the suturing space and through the bend by a rotation of the helical needle.

There is provided, in accordance with some embodiments of the present disclosure, a bougie capsule section configured for shaping and suturing of tissue of a body lumen from within the body lumen, the bougie capsule section comprising: a capsule body, extending along longitudinal axis through a suction clamping domain between a distal side and a proximal side of the bougie capsule section; and a suturing space defined by supporting surfaces of the suction clamping domain, configured to receive the tissue of the body lumen collapsed onto the supporting surfaces upon application of suction to the suction clamping domain while the bougie capsule section is inserted to the body lumen; wherein the bougie capsule section is expandable by movement of the supporting surfaces.

In some embodiments, expansion of the bougie capsule section increases a cross-sectional size of the suturing space by outward movement of the supporting surfaces.

In some embodiments, the suturing space comprises a dorsal side, a ventral side, and a ventral midline of the ventral side, and wherein at least some of the supporting surfaces attach on sides of the suturing space lateral to the ventral midline, and the supporting surfaces move laterally outward from capsule body upon actuation by a control member.

In some embodiments, the supporting surfaces attach to the capsule body by swivels.

In some embodiments, the suturing space comprises a dorsal side, a ventral side, and a ventral midline of the ventral side, and wherein at least some of the supporting surfaces are surfaces of outriggers attached on sides of the suturing space lateral to the ventral midline, and the outriggers are configured to move the supporting surfaces in a ventral direction from capsule body upon actuation by a control member.

In some embodiments, the outriggers comprise a lattice of separate supports, coupled to each other via their crossings.

In some embodiments, the outriggers comprise a lattice of supports, formed from a piece of shape-memory metal.

In some embodiments, each outrigger comprises a plurality of supports attached to the capsule body by swivels, and joined by a stabilizer bar.

In some embodiments, at least some of the supporting surfaces are surfaces of a longitudinal blocker which is configured to bulge outward from along the ventral midline of the capsule body upon actuation by a control member.

In some embodiments, the bougie comprises a collapsible bougie orientation projection, anchored on a distal side and configured to expand outward upon distal advancing of a control member attached to the collapsible bougie orientation projection.

There is provided, in accordance with some embodiments of the present disclosure, a bougie capsule section of a bougie for intralumenal suturing comprising: a tissue receiving space framed within tissue support structures extending along either side of a longitudinal axis of the capsule section, and a dorsal wall extending between and along the tissue supports at a position dorsally offset from the tissue support structures; wherein an inwardly projecting portion projects from the dorsal wall into the tissue receiving space, dividing it to define channels on either side of the inwardly projecting portion.

In some embodiments, inwardly projecting portion branches to a laterally projecting portion on either side, and the laterally projecting portion defines a hollow between the inwardly projecting portion and the dorsal wall.

There is provided, in accordance with some embodiments of the present disclosure, a bougie capsule section configured for shaping and suturing of tissue of a body lumen from within the body lumen, the bougie capsule section comprising: a capsule body, extending longitudinally to define a suction clamping domain between a distal side and a proximal side of the bougie capsule section; and a suturing space framed by supporting surfaces positioned along the suction clamping domain, configured to receive the tissue of the body lumen collapsed onto the supporting surfaces upon application of suction to the suction clamping domain while the bougie capsule section is inserted to the body lumen; wherein the supporting surfaces comprise a longitudinal blocker that extends longitudinally along the suction clamping domain to longitudinally divide an aperture region leading into the suturing space into separate fenestrations on either side of the longitudinal blocker; and wherein the longitudinal blocker is configured so that movement of the longitudinal blocker produces a bend in the capsule body.

In some embodiments, the longitudinal blocker is removable from over the aperture region to remove the longitudinal division into separate fenestrations.

There is provided, in accordance with some embodiments of the present disclosure, a bougie capsule section configured for shaping and suturing of tissue of a body lumen from within the body lumen, the bougie capsule section comprising: a capsule body, extending longitudinally to define a suction clamping domain between a distal side and a proximal side of the bougie capsule section; and a suturing space framed by supporting surfaces positioned along the suction clamping domain, configured to receive the tissue of the body lumen collapsed onto the supporting surfaces upon application of suction to the suction clamping domain while the bougie capsule section is inserted to the body lumen; wherein the supporting surfaces comprise a closing portion of a longitudinal blocker that extends through a proximal side of an aperture region leading into the suturing space to close the proximal portion of the aperture region; and wherein the longitudinal blocker is configured to be withdrawn proximally, gradually opening the proximal portion of the aperture region.

In some embodiments, the aperture region opened by full withdrawal of the longitudinal blocker comprises a single aperture at least 5 cm long.

In some embodiments, the longitudinal blocker comprises a narrow portion of a longitudinal blocker, narrower than the closing portion, that extends distally from the closing portion and along the suction clamping domain to longitudinally divide an aperture region leading into the suturing space into separate fenestrations on either side of the longitudinal blocker.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

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

Overview

An aspect of some embodiments of the present disclosure relates to a needle drive and arcuate needle, configured to drive the arcuate needle along an interior of a bougie body, according to some embodiments of the present disclosure. In some embodiments, the arcuate needle is a helical needle.

In some embodiments, the needle drive comprises a drive shaft securely mounted along a capsule body of the bougie body, so that it presses against the needle. Upon rotation of the shaft, friction between shaft and needle induces the needle to rotate. The needle, in some embodiments, is constrained by a helical arrangement of one or more channels (optionally continuous or interrupted) causing rotational motion to be translated also into longitudinal advance of the helical needle along bougie body.

In some embodiments, the shaft is flexible, and maintains friction drive contact with the helical needle sufficient to drive it, even when the bougie body is bent through a region in which the shaft passes, making contact with the helical needle. In some embodiments, the shaft comprises a dual construction along its longitudinal extent: a cable portion, and a pin portion. The pin portion is the portion making frictional contact with the helical needle. The cable portion, in some embodiments, potentially provides the shaft with flexibility along most of its length. The pin portion, in some embodiments, potentially provides dimensional stability helps to ensure tight and predictable engagement with the needle where the two are in contact.

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.

An aspect of some embodiments of the present disclosure relates to a suction clamping domain of a bougie capsule section, configured with articulations to allow bending, according to some embodiments of the present disclosure.

In some embodiments, the articulations divide articulated segments which are interconnected along a single continuous piece, and the articulation between the segments comprises thinning of material of the single continuous piece to form articulation joints.

In some embodiments, the bougie capsule section includes a helical needle, flexible enough that it can be driven longitudinally (by rotation) along a bend induced in the suction clamping domain. Optionally, the helical needle is driven by frictional interaction with a rotating shaft, which is configured (e.g., clamped into place and with sufficient structural resilience) to maintain a driving connection with the needle even along the region of the bend.

In some embodiments, other parts of the bougie capsule section (e.g., distal and/or proximal to the suction clamping domain) are also articulated, with a bend controllable by movement of a control member.

An aspect of some embodiments of the present disclosure relates to a suction clamping domain of a bougie capsule section, expandable after insertion to a body lumen, according to some embodiments of the present disclosure.

In some embodiments, the suction clamping domain is expandable by movements of one or more flaps and/or outriggers. In some embodiments, the flaps and/or outriggers swivel laterally outward (e.g. away from a ventral midline that extends along a longitudinal axis of the bougie capsule section) and/or expand ventrally (e.g., ventrally along a dorsal-ventral axis of the bougie capsule section perpendicular to the longitudinal axis). It should be understood that references to “longitudinal axis” herein refer to an axis which curves to follow the general curve of the bougie body, if any, and not necessarily an axis which is perfectly straight.

In some embodiments, the suction clamping domain is expandable by flexing movements of a longitudinal blocker, extending longitudinally along the bougie body as a strip or rod of stiff material; for example, a shape-memory metal such as nitinol. In some embodiments, the flexing is controlled by a control member that advances to make the longitudinal blocker bulge, and is retracted to pull the longitudinal blocker flatter again.

An aspect of some embodiments of the present disclosure relates to the division of a tissue-receiving space of a suction clamping domain into separate channels extending along a longitudinal axis of the suction clamping domain.

In some embodiments, a tissue-receiving space defined within a suction clamping domain is partially divided by an inward-protruding portion that protrudes inwardly from a dorsal side of the tissue-receiving space, and then extends laterally within the tissue-receiving space (optionally to form a “branched” or roughly T-shaped structure). A hollow area is left open underneath a laterally extending portion of the inward protruding portion (that is, between the laterally extending portion and the dorsal inner wall of the tissue-receiving space). This hollow region forms a tissue intrusion-restricted channel extending along a longitudinal extent of the suction clamping domain, beyond a main channel of the tissue-receiving space into which tissue is first pulled; e.g., pulled past structures defining fenestrations which lead into the tissue-receiving space from outside the suction clamping domain.

Access to the hollow area by tissue sucked into the tissue-receiving space is restricted to be via a relative narrow opening defined between the laterally-extending portion, and a lateral inner wall of the tissue-receiving space.

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.

Bougies with Bougie Capsule Section

Reference is now made toFIG. 1, which schematically represents a bougie100configured for shaping and intra-cavity suturing of tissue of a body cavity, according to some embodiments of the present disclosure.

Three main sections of bougie100are represented as bougie capsule section101(distally), bougie main body102, and bougie control handle103(proximally).

Bougie capsule section101(herein, a bougie capsule section is also referred to herein as a “capsule”), in some embodiments, comprises a suction clamping domain110, which in turn comprises one or more fenestrations111, 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 domain110are described using terminologies distinguished with reference to different structures. The same embodiment is optionally described by more than one of these terminologies.Aperture-in-a-tubular body terminology: Suction clamping domain110comprises a tubular body having an aperture region (that is, a region comprising one or more openings) that opens into a cavity which receives tissue upon application of suction to the cavity.Spine terminology: Additionally or alternatively, suction clamping domain110comprises a spine having a dorsal side and a ventral side. For example, when the aperture of the tubular body becomes large enough, the remaining portion of the tubular body may be readily understood as comprising a spine. Upon application of suction to the region of the spine (in use inserted to a suitable body cavity), tissue is collapsed down onto structures supported along the spine, for example collapsed onto longitudinal blocker(s), lateral blocker(s), flaps, outrigger(s), and/or tissue support(s)).Space-and-supporting surface terminology: This terminology generalizes from the other two terminologies. Supporting surfaces include surfaces of any structures positioned along the tubular body/spine onto which tissue collapses when suction is applied to the device in use. This may be, for example, the tubular body, the spine, and/or other features such as blockers, flaps, and/or outriggers, for example, as described with various of the embodiments disclosed herein. The “cavity” of the first terminology is at the same time also a space of this third terminology, defined as the space within the structures which provide supporting surfaces. Additionally or alternatively, this space is positioned along a ventral-facing surface of the “spine” of the second terminology.

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, fenestrations111are part of the aperture region of a bougie capsule section101. 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 fenestrations111are 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 section101.

Examples of aperture shaping elements, in some embodiments, include a longitudinal blocker115, and/or lateral blockers117.

A longitudinal blocker115, in some embodiments, comprises an element such as a stiffened strip or rod that longitudinally spans at least a portion of suction clamping domain110, substantially dividing it into two sides of fenestrations111which extend longitudinally alongside one another. Longitudinal blocker115is optionally removable, re-joining the divided fenestrations111. This is a potential advantage in tissue and/or suture release; for example to release of the suction clamping domain110from suturing which crosses between two body cavity lumen tissue portions, and on an internal side of the longitudinal blocker115.

Lateral blockers117, in some embodiments, comprise one or more elements, such as lengths of cord, which cross laterally across suction clamping domain110. A crossing element creates a division of the suction clamping domain that separates different fenestrations111on either side of the element. Lateral blockers117, in some embodiments, are releasable and/or removable to remove the separation.

Examples of longitudinal blocker115and lateral blockers117are described, for example, in International Patent Publication No. WO 2016/056016, the contents of which are included by reference in their entirety.

Optionally, a distal tip112of bougie capsule section101is provided which is transparent, and/or terminates in an aperture large enough (for example, about 6-8 mm in diameter) to pass the distal end of an endoscope probe or other tool out of.

Bougie main body102, in some embodiments, comprises a tube121, along which one or more longitudinally extended control members120pass, externally and/or internally. In some embodiments, control members120interconnect between actuatable elements of the bougie capsule section101(e.g., longitudinal blocker115and/or lateral blocker117), and the bougie control handle103(e.g., control knobs122). In some embodiments, tube121has an inner diameter large enough (for example, about 6-10 mm) to insert an endoscope probe or other tool through.

Distal tip112is preferably provided with a tapered shape to assist in insertion of bougie100along a natural body passage such as an esophagus. Bougie capsule section101and bougie main body102are 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 handle103, in some embodiments, comprises one or more control knobs122, configured to control manipulation of control members120. Optionally, one or more ports124are provided, sized to allow insertion of an endoscope or other tool, for passage along the lumen of tube121into bougie capsule section101, and optionally to and/or out of distal tip112.

Needle Drives

Reference is now made toFIG. 2A, which schematically represents a needle drive configured to drive a helical needle201proximally along the interior of a bougie capsule section200, according to some embodiments of the present disclosure.FIG. 2Ashows a bougie capsule section200of a bougie100, which may be configured substantially as described in relation toFIG. 1, with differences/additions as now explained.

Reference is also made toFIG. 2B, which schematically represents helical needle201in relation to a shaft205and selected surfaces211of bougie capsule section200, according to some embodiments of the present disclosure.

In some embodiments, helical needle201is configured to be driven from a distal end230of a bougie capsule section200by the rotation of a shaft205against which helical needle201is pressed at one or more locations. As shaft205rotates, helical needle201rotates along with it. The rotating motion of helical needle201is accompanied by advance along a longitudinal axis of bougie capsule section200; e.g., proximal advance from an initially more distal position.

In some embodiments, bougie capsule section200is configured so that friction between shaft205and helical needle201transfers torque from the rotating shaft205to helical needle201, sufficient for needle advance through tissue while carrying suture.

Optionally, friction is developed in part by pressing helical needle201between shaft205and one or more surfaces of a body of bougie capsule section200. These may be, for example, internal surfaces211of a dorsal side of bougie capsule section200(in the “cutaway tube” interpretation of the device's structure); alternatively described as ventral-side surfaces211of a spine of capsule section200(in the “spine” interpretation of the device's structure). Optionally, helical needle201extends around shaft205, so that shaft205and helical needle201rotate in the same circumferential direction. This configuration provides a potential advantage by creating a two-sided pinch immediately at (e.g., as shown for surfaces211B ofFIG. 2B) and/or closely adjacent (e.g., as shown for surfaces211A) the position of friction interactions between shaft205and helical needle201. Additionally or alternatively, in some embodiments, needle201may be pressed against shaft205by another method, e.g., by squeezing or pulling from a different location, by being forced through a channel that guides helical needle201against shaft205, or another method.

Alternatively, in some embodiments, shaft205is external to the space defined within helical needle201, so that shaft205and helical needle201counter-rotate.

In some embodiments, helical needle201comprises a relatively high-friction surface201A, and a relatively low-friction surface201E. 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.

In some embodiments, a surface region201A of one or both of helical needle201and shaft205is treated to increase friction. For example, surface201A of helical needle201is optionally roughened. Surface201A, in some embodiments, includes surface portions that come into contact with cable205, but not surface portions that come in contact with bougie surface(s)211,211A,211B. Optionally, surface201A circumferentially comprises about half of the surface area of helical needle201.

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 needle201B 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 surface201E is given a friction reducing treatment, such as a PTFE coating.

Optionally some slippage occurs between movement of helical needle201and shaft205as it turns. In some embodiments, the maximum average slippage (e.g., average slippage needle201experiences while penetrating tissue and pulling a suture behind it) is, for example, up to no more than 20%, 30%, 40%, 50% or 60% slippage. In some embodiments, there is no slippages, so that the minimum average slippage is 0%. Optionally, the minimum average slippage is at least, for example, 5%, 10%, 20%, or 30% slippage.

It should be noted that features described with respect to helical needle201moving both rotationally within and longitudinally along bougie capsule section200are optionally embodied, changed as necessary, in a non-helical arcuate needle moving rotationally within bougie capsule section200.

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.

Shaft205, in some embodiments, extends from a distal starting point of needle201(e.g., within capsule portion200A), to a proximal side of bougie capsule section200and out along the bougie main body102to a handle103which remains external to a patient during insertion of the bougie to a body cavity such as a stomach. Handle103, in some embodiments, comprises a knob or other control allowing rotational actuation of the shaft205.

In some embodiments, shaft205comprises a flexible portion205A, which may be, for example, a twisted cable, e.g., a cable in a 1×8 configuration (one central strand surrounded by 8 outer strands), a 1×12 configuration, or another cable configuration.

In being flexible, flexible portion205A provides a potential advantage for allowing flexibility of portions of bougie capsule section200.

For example, in some embodiments, one or more portions of bougie capsule section200comprise a plurality of articulated segments, e.g., segments207. The articulation allows the segments207to change angle relative to each other so as to induce a bend along the bougie capsule section200. In some embodiments, segments207are defined by cutouts formed (not necessarily formed by cutting; optionally formed by molding or additive manufacturing methods such as 3-D printing, for example) to leave material between segments207sufficient to retain mechanical integrity, but thin enough to flex.

In some embodiments, the cutouts also serve as needle channels311through which needle201moves as it spirally advances. It should be noted that cutouts can formed on either side of bougie capsule section200, for example, cutouts207A inFIGS. 3A-3Bare formed on the bougie capsule section outer side. Cutouts may be formed on both sides. Optionally, cutouts fully penetrate the bougies distal end200in some locations. In some embodiments, segments207are formed of separate pieces fitted together.

In some embodiments, one or both sidewalls of the suction clamping domain200B comprise housings310for lateral blockers117and/or actuatable elements that control the release of the lateral blockers117. Optionally, gaps311A between housings310increase device flexibility, and/or provide apertures (optionally along with apertures206) between which lateral blockers117cross. For clarity of viewing details of the needle drive mechanism, lateral blockers117are not shown inFIG. 2A. Lateral blockers117are 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 portion205A directly interacts with needle201. Optionally, shaft205comprises a pin205B, e.g., a pin205B which distally terminates shaft205. Pin205B, in some embodiments, is stiffer and/or less deformable in cross-section than flexible portion205B, 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 toFIGS. 3A-5.

In some embodiments, pin205B is tapered, for example a diameter taper of between 100 μm and 1 mm 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 domain200B) to a position which selectably gives a tighter or looser friction fit against the needle201. A tighter fit potentially provides an advantage for increasing the torque which can be applied to the needle201, 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 control122is configured (e.g., with a screw) to withdraw shaft205as it rotates, along a pitch that keeps the needle201and pin205B at matched longitudinal positions, such that the needle201maintains contact with the pin205B. The matching optionally allows some amount of relative longitudinal movement, e.g., to allow for some amount of slippage of the needle201against pin205B without pin205B becoming disengaged with needle201.

Other elements shown inFIG. 2Ainclude:Channel208; configured, in some embodiments, as part of the anchor of one side of a longitudinal blocker115(not shown).Channel209; configured, in some embodiments, to hold a distal end of a control member (e.g., a wire) used to anchor longitudinal blocker115. For example, a wire passes distally through channel209, then optionally across (e.g., inside) the bougie body to an aperture of the longitudinal blocker115held in channel208. To unlock longitudinal blocker115, the wire is withdrawn proximally along channel209.Channels224and222, along which suture may move as it is pulled along by a needle201to which it is attached. Optionally, channel222,224are made of a low-friction polymer material, for example, polytetrafluoroethylene (PTFE). Optionally, suture is rolled/folded and stored within channel222and/or224. Optionally, suture is stored elsewhere (for example, rolled on a bobbin and/or stored extending back along a longitudinal length of bougie100).

Reference is now made toFIG. 2C, which is a schematic flowchart of a method of intraluminal suturing, according to some embodiments of the present disclosure.

The flowchart begins, and at block250, in some embodiments, a suction clamping domain200B of a bougie capsule section200is inserted to a body lumen (such as a stomach).

At block252, in some embodiments, suction is applied. Under the force of suction, body lumen tissue is collapsed onto supporting surfaces of the suction clamping domain200B. Some of the body lumen tissue is sucked into a suturing space defined at the level of suction clamping domain200B 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 blocker115.

At block254, in some embodiments, a shaft205is rotated. Shaft205presses against a surface of needle201, so that rotation of shaft205induces, by frictional interaction, a rotation of needle201. Needle201, upon rotating, is also longitudinally translated along suction clamping domain200B.

Steering Mechanisms

Reference is now made toFIGS. 3A-3B, which schematically represent a flexing mechanism of a bougie capsule section302, according to some embodiments of the present disclosure. Reference is also made toFIG. 5A-5B, which schematically represent another flexing mechanism of a bougie capsule section302, according to some embodiments of the present disclosure.

Bougie capsule section302(an example of bougie capsule section101), in some embodiments, comprises a distal section of a bougie100. It should be understood that the flexing mechanism described in relation toFIGS. 3A-3Band/orFIGS. 5A-5Bis optionally provided, changed as necessary, together with features of any other bougie capsule section of a bougie100described herein. Each mechanism (the more proximal mechanism ofFIGS. 3A-3B, and the more distal mechanism ofFIGS. 5A-5B) 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 member301,331to introduce bending along a segmented portion of bougie capsule section302. InFIG. 3B, the control member301is at its relaxed length, and bougie capsule section302is straight. InFIG. 3A, the control member301is shortened, and bougie capsule section302is curved along a portion of its body. InFIG. 5A, the control member331is at its relaxed length, and bougie capsule section302is straight. InFIG. 5B, the control member331is shortened, and bougie capsule section302is curved nearer to its distal end.

The flexing mechanism, in some embodiments, comprises control member301and/or331(examples of control members120), and at least one control attachment303,303B of control member301,331to bougie capsule section302(optionally one or more additional attachments303A,303D are provided, e.g., to help direct bending forces). Also provided are one or more segments305defined by cutouts305A which are formed from a single continuous piece interconnecting segments305, e.g., by cutting, molding, and/or additive manufacture. Thinned material left alongside the cutouts305A acts as an articulation joint. In some embodiments, segments305are formed of separately manufactured pieces fitted together, with the cutouts305A defined by gaps between the fitted pieces. Optionally, cutouts305B are provided on an opposite side of the bougie capsule section302.

In some embodiments, the segment cutouts305A are positioned on a side of bougie capsule section302opposite control member301,331(a ventral side, as shown inFIGS. 3A-3B and 5A-5B), so that shortening of control member301,331(e.g., pulling from handle103) causes expansion on that side. In some embodiments, the segment cutouts305B are positioned on a side of bougie capsule section302the same as control member301,331(a dorsal side, as shown inFIGS. 3A-3B and 5A-5B), so that shortening of control member301(e.g., pulling from handle103) causes compression on that side. Hinges305C, in some embodiments, are defined with a relatively thin dorsal-ventral dimension (for example, 1-3 mm). Optionally, hinges305C,207B are defined by segmenting material on the lateral sides of bougie capsule section302with additional cutout slots.

In some embodiments the functions of control members301,331are combined. For example control member331is attached so that shortening/pulling also bends the segments305which 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 hinges305C, so that bending occurs first there, and then, with greater shortening/pulling force, on the other set of segments.

Also indicated inFIGS. 3A-3B and 5A-5Bare positions of segments207, cutouts207A, distal tip112, longitudinal blocker115, and lateral blockers117, which operate, for example, as described in relation toFIG. 1.

Reference is now made toFIGS. 4A-4B, which schematically represent a flexing mechanism of a bougie capsule section322, according to some embodiments of the present disclosure.

Bougie capsule section322(an example of bougie capsule section101), in some embodiments, comprises a distal section of a bougie100. It should be understood that the flexing mechanism described in relation toFIGS. 4A-4Bis optionally provided, changed as necessary, together with features of any other bougie capsule section of a bougie100described herein, including together with other flexing mechanisms.

The flexing mechanism, in some embodiments, operates by shortening or lengthening a control member321to introduce bending along a segmented portion of bougie capsule section322. InFIG. 4A, the control member321is at its relaxed length, and bougie capsule section302is straight. InFIG. 4B, the control member321is shortened, and bougie capsule section302is curved. Segmentation of a portion of bougie capsule section322into segments207separated by cutouts207A (and optionally other cutouts not shown, e.g., cutouts internal to bougie capsule section322) is optionally as described in relation to other figures herein, for exampleFIGS. 2A and/or 3A-3B.

In some embodiments, control member321is attached to longitudinal blocker115, such that shortening (pulling on) control member321causes longitudinal blocker115to pull on bougie capsule section322at attachment333, and in turn introduce a curvature to bougie capsule section322. It should be noted that longitudinal blocker115optionally is released from attachment333by operation of a separate mechanism (e.g., via a different control member120). Once released from attachment333, control member321operates to withdraw longitudinal blocker115, rather than to introduce curvature to bougie capsule section322. In some embodiments, longitudinal blocker115is released by pulling on control member321past/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 inFIGS. 4A-4Bare positions of segments207, cutouts207A, distal tip112, and longitudinal blocker115, which operate, for example, as described in relation toFIG. 1.

Reference is now made toFIG. 19, which is a flowchart of a method of intralumenal positioning of a bougie capsule section, according to some embodiments of the present disclosure.

The flowchart begins, and at block2100, in some embodiments, a suction clamping domain200B of a bougie capsule section200is inserted to a body lumen (such as a stomach).

At block2102, in some embodiments, a bend is induced along a suturing space defined by supporting surfaces of the suction clamping domain200B. In some embodiments, the bend is induced by longitudinal movement of a control member120. Optionally, the control member120induces bending by movement of a longitudinal blocker115. In some embodiments, the suction clamping domain200B comprises articulated segments207, and the bending comprises induction of a change in the angle(s) at which the articulated segments207meet.

At block2104, in some embodiments, suction is applied. Under the force of suction, body lumen tissue is collapsed onto supporting surfaces of the suction clamping domain200B. Some of the body lumen tissue is sucked into a suturing space defined at the level of suction clamping domain200B 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 blocker115.

Optionally, in some embodiments, the method ofFIG. 19continues with block2106, in which a helical needle201is longitudinally advanced by rotation along the bent portion of the suturing space. In some embodiments, helical needle201is longitudinally advanced by frictional contacts with a rotating shaft205, wherein the frictional contacts occur at positions along the bent portion of the suturing space.

Reference is now made toFIG. 6, which schematically represents an overtube for use with a gastric surgery bougie, according to some embodiments of the present disclosure.

Overtube302, 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 aperture312within 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 members301A,301B.

Overtube302is sized to accept bougie capsule section101passing within it from a proximal end, and out through aperture312at a distal end of overtube302. In use, overtube302bending and position has the effect of adjusting the angulation of bougie capsule section101as it passes out of overtube aperture312. This is a potential advantage for steering bougie capsule section101to 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 bougie100itself.

In some embodiments, control members301A,301B (examples of control member120) are affixed to the body of a flexible overtube302. Shortening (pulling on) one of the control members301B,301A operates to bend the overtube in the direction of the side on which the control member attaches (e.g., control members301A and301B attach at attachments303E and303F, respectively). The overtube302is optionally locked into position once a suitable bend has been introduced.

Orientation Projections

Reference is now made toFIG. 7, which schematically represents a collapsible bougie orientation projection340according to some embodiments of the present disclosure.

In some embodiments, orientation projection340is configured to be controllably extended from the side of bougie distal end342, e.g., by manipulation of control member341(which is an example of a control member120). 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 projection340helps to force the bougie distal end342into a predetermined orientation relative to the body cavity. Optionally, orientation projection340also 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, bougie100is provided with a collapsible orientation projection340. By advancing (distally) control member341, orientation projection340, which is normally stowed collapsed against the side of bougie capsule section342, is induced to protrude. In some embodiments, orientation projection340is formed of a shape memory allow such as nitinol. It takes up a predetermined shape, e.g., comprising a bend343, upon receiving sufficient slack from distally advancing control member341to 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 projection340against attachment333.

Also indicated in Figure are positions of segments207, cutouts207A, distal tip112, longitudinal blocker115, and lateral blocker117, which operate, for example, as described in relation toFIG. 1.

In some embodiments, projection340is 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 end342.

Expandable Capsule Sections

Reference is now made toFIGS. 8A-8B, which schematically represent a bougie capsule section800comprising a capsule-expanding blocker815, according to some embodiments of the present disclosure. Reference is also made toFIGS. 9A-9B, which schematically represent a bougie capsule section900comprising capsule-expanding blocker815with a collapsible bougie orientation projection940, according to some embodiments of the present disclosure. Bougie capsule sections800,900are examples of bougie capsule section101.

In some embodiments, a capsule-expanding blocker815is configured to change shape (e.g., bulge) to expand a size of suction clamping domain110; for example, to open fenestrations802of the aperture domain110to 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 fenestration802(in a direction both laterally across and radially outward from suction clamping domain110) a greater depth of tissue can potentially be taken in by suction at the positions where needle penetration (e.g., by a helical needle201) will occur during suturing.

In some embodiments, a doubled thickness of tissue is drawn in to a fenestration802by 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 blocker815comprises an instance of a longitudinal blocker115, arranged to extend longitudinally along a midline of the bougie capsule section800which is configured to change shape by bulging outward under external control. For example, control member801(an example of a control member120) advances distally to allow expand capsule-expanding blocker815to expand, and/or is pulled proximally (shortened) to flatten it. Capsule-expanding blocker815optionally comprises a shape memory alloy such as nitinol, which returns to a predetermined shape upon being allowed to relax when control member801advances (lengthens). Optionally, control member801actively pushes blocker815.

Optionally, lateral blockers117are long and loose enough when longitudinal blocker815is in the collapsed configuration to allow longitudinal blocker815to expand. Alternatively, they are initially strung more tightly, and slack is payed out as longitudinal blocker815expands. In some embodiments, the lateral blockers117are adjustable in tension to accommodate different degrees of expansion of longitudinal blocker815. In some embodiments, a control member120(not shown) is provided that can be manipulated to tighten/loosen slack in lateral blockers117.

In some embodiments, a collapsible bougie orientation projection940is provided along with capsule-expanding blocker815, for example as shown collapsed inFIG. 9A, and expanded inFIG. 9B. Collapsible bougie orientation projection940is operable, in some embodiments, by manipulation of control member941, substantially as described in relation to collapsible bougie orientation projection340and control member341in relation toFIG. 7. Optionally, a spacing of bougie capsule section900from a nearby tissue wall is controlled by a degree of expansion of bougie orientation projection340, pressing against the nearby tissue wall.

Reference is now made toFIGS. 10A-10D, which schematically represent a bougie capsule section1000comprising a capsule-expanding blocker1015, along with a plurality of capsule-expanding flaps1013, according to some embodiments of the present disclosure. Bougie capsule section1000is an example of a bougie capsule section101.FIGS. 10A and 10Dshow perspective views of bougie capsule section1000.FIGS. 10B and 10Dshow cross sectional views of bougie capsule section1000, at the level of a pair of the flaps1013. There may be provided, for example, 2, 4, 6, 8, 10, 12, or another number of flaps1013.

In some embodiments, a capsule-expanding blocker1015and capsule expanding flaps1013are configured to move to expand a size of suction clamping domain110and a tissue-receiving space1020therein; for example, to open fenestrations1002of the aperture domain110to a larger size. As shown, fenestrations1002are bounded on two sides by lateral blockers1017(examples of lateral blockers117), on one side by capsule-expanding blocker1015, and on another side by flap edge1013B.

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 fenestration1002, a greater depth of tissue can potentially be taken in by suction at the positions where needle penetration (e.g., by a helical needle201) will occur during suturing.

Expansion of aperture domain110by movement of blocker1015, in some embodiments, is substantially as described for blocker815ofFIGS. 8A-9B(e.g., by operation of control member801). In some embodiments, movement of blocker1015away from flaps1013allows tension in spring1014to cause flaps1013to open. Flaps1013may stop opening upon a stopping region1016contacting another part of the aperture domain110(e.g., spine region1031).

Additionally, in the example ofFIGS. 10A-10B, flaps1013are expandable, for example, by operation of (e.g., pulling) of control member1001. Control member1001is an example of a control member120.

In some embodiments, operation of control member1001causes flaps1013to 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 domain110along a dorsal/ventral plane of the aperture domain110. In some embodiments, the expanded position comprises being arranged to point away from that midline plane. Optionally, each segment207is provided with a pair of flaps supports1013. Optionally, flaps1013are 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 blockers1017optionally comprise cords sized so that they become taut when aperture domain110is fully expanded. In some embodiments, the lateral blockers117are adjustable in tension to accommodate different degrees of expansion of longitudinal blocker1015. In some embodiments, a control member120(not shown) is provided that can be manipulated to tighten/loosen slack in lateral blockers1017.

In some embodiments, the expanded aperture domain110is placed under vacuum to cause attachment to tissue.

As shown inFIG. 10C, fenestrations1002are oriented substantially perpendicular to a plane passing in a ventral-to-dorsal direction through aperture domain110. To attach to tissue walls, the device is optionally first oriented 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 edges1013B onto the fenestrations1002and are secured. The two opposite tissue walls preferably meet at about the position of longitudinal blocker1015. Optionally, the device is rocked during application of vacuum by slight rotations around its longitudinal axis, to help encourage filling of each fenestration1102by tissue from just one of the tissue walls.

Optionally, fenestrations1002expand to a more lateral-facing orientation than is shown inFIG. 10C. For example, capsule expanding blocker1015expands to a greater distance from a dorsal side of aperture domain110, flaps1013are shorter, and/or flaps1013are oriented upon expansion so that flap edges1013B lay closer to a dorsal side of aperture domain110than expanded capsule expanding blocker1015, when flaps1013is expanded.

Reference is now made toFIGS. 11A-11D, which schematically represent a bougie capsule section1100comprising a capsule-expanding blocker1115, along with a plurality of capsule-expanding outriggers1113, according to some embodiments of the present disclosure.

FIGS. 11A-11Dillustrate a different structure for expanding aperture domain110, comprising supports1113A which swivel from a flattened or relatively flattened position (e.g., as shownFIG. 11A) to a raised position having a position more perpendicular (FIGS. 11B, 11C) or perpendicular (FIG. 11D) to a longitudinal axis (along a distal-proximal direction) of bougie capsule section1100.

Supports1113A along each side, in some embodiments, are coupled to each other by stabilizing bars1113B, which rise or fall as supports1113A swivel around a swivel point attached to the capsule body. Actuation to change the expansion state of outriggers1113, in some embodiments, comprises operation of a control member1101. In some embodiments, capsule-expanding blocker1115is expanded (e.g., via control member801), and optionally this expansion also induces expansion of outriggers1113; e.g., by tension placed on lateral blockers1117.

Fenestrations1102are defined, in some embodiments, as spaces bordered on two sides (e.g., the longitudinal axis borders) by lateral blockers1117, on a medial side by capsule-expanding blocker1115, and on a laterally outward side by a stabilizing bar1113B.

Distal tip112and segments207are configured, for example, as described in relation to other figures herein.

Reference is now made toFIGS. 12A-12B, which schematically represent a bougie capsule section1200comprising a capsule-expanding blocker1215, along with a plurality of capsule-expanding outriggers1213, according to some embodiments of the present disclosure.

Actuation to change the expansion state of outriggers1213, in some embodiments, comprises operation of a control member1201.

FIGS. 12A-12Billustrate a different structure for expanding aperture domain110(i.e., a variation of the capsule-expanding outriggers1013described in relation toFIGS. 10A-10D), comprising crossed supports1213A which swivel from a flattened or relatively flattened position (e.g., as shownFIG. 12A) to a raised position (FIG. 12B).

In some embodiments, some of supports1213A along each side are oriented to point in a more distal direction, and some in a more proximal direction, forming lattices, with separate supports1213A formed as pieces coupled to each other via their crossings.

Alternatively, in some embodiments, lattice of supports1213A is formed from a piece of shape-memory metal such as nitinol; for example, a piece which is normally collapsed (as in the configuration ofFIG. 12A), but which deforms into an expanded shape, e.g., upon longitudinal compression (that is, compression along a distal-proximal axis of bougie capsule section1200), and/or upon dorsal-ventral stretching (e.g., stretching induced through lateral blockers117upon expanding capsule-expanding blocker1115(e.g., via control member801).

Fenestrations1202are defined, in some embodiments, as spaces bordered on two sides (e.g., the longitudinal axis borders) by lateral blockers1217, on a medial side by capsule-expanding blocker1215, and on a laterally outward side by portions of outriggers1213.

Distal tip112and segments207are configured, for example, as described in relation to other figures herein.

Reference is now made toFIG. 20, which is a flowchart of a method of intralumenal use of a bougie capsule section, according to some embodiments of the present disclosure.

The flowchart begins, and at block2100, in some embodiments, a suction clamping domain200B of a bougie capsule section200is inserted to a body lumen (such as a stomach).

At block2202, 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 member120to actuate movement of supports, for example, outriggers such as outriggers1013,1113,1213. Additionally or alternatively, in some embodiments, the expansion comprises use of a control member to change the shape of a longitudinal blocker115extending longitudinally along the suction clamping domain. In some embodiments, the outriggers1013,1113,1213and/or longitudinal blocker115are also provided with lateral blockers117. Together, these structures, upon expansion, define supporting surfaces onto which tissue collapses upon application of suction (in block2204), and define fenestrations111through which the collapsing tissue enters into a suturing space located along the suction clamping domain.

At block2204, in some embodiments, suction is applied. Under the force of suction, body lumen tissue collapses onto the expanded supporting surfaces of the suction clamping domain200B. Some of the body lumen tissue is sucked into the suturing space defined at the level of suction clamping domain200B 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 blocker115.

Optionally, in some embodiments, the method ofFIG. 20continues with block2206, in which a helical needle201is longitudinally advanced by rotation along the expanded portion of the suturing space. In some embodiments, helical needle201is longitudinally advanced by frictional contacts with a rotating shaft205, wherein the frictional contacts occur at positions along the bent portion of the suturing space.

Vacuum Distribution

Reference is now made toFIGS. 13A-13D, which schematically represent internal structures of a bougie suction clamping domain200B affecting vacuum distribution, tissue clogging, and/or tissue clamping, according to some embodiments of the present disclosure.FIG. 13Ashows bougie suction clamping domain200B from a ventral side looking dorsally.FIG. 13Bshows bougie suction clamping domain200B from a perspective view.FIGS. 13C-13Dshow side-views of bougie suction clamping domain200B.FIG. 13Cshows a side-view from proximal end1320of suction clamping domain200B, andFIG. 13Dshows a side-view from distal end1321of suction clamping domain200B.

In some embodiments, features of bougie aperture domain200B include housings310, gaps311A, needle channels311, cavity208, segments207, and apertures206, for example as described in relation toFIGS. 2A-2B, herein.

In some embodiments, segments207include inward-protruding portions1300defined between needle channels311, and protruding into an interior area (tissue receiving space1330) of suction clamping domain200B from a dorsal side1303of suction clamping domain200B. Inward-protruding portions1300, in some embodiments, comprise laterally projecting branches1305, defining spaces1302between branches1305and dorsal side1303, to which tissue access (upon application of suction) is restricted by a relatively narrow slot1302B. For example, slot1302B is about 2-3 mm across. Potentially, the narrowness of slot1302B helps ensure that spaces1302remain 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 domain200B. In some embodiments, applied suction bends tissue so that it contact branches1305from both within space1302, and outside of space1302, e.g., along a ventrally-facing surface1307which is within a tissue-receiving space defined by suction clamping domain200B.

In some embodiments, the convolution of tissue around inward-protruding portion1300as it deforms under vacuum to fill into the shape of spaces1302acts 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 tis sue.

Optionally, surface1307is shaped with a curvature and placed at an inset from the inner dorsal side of suction clamping domain200B so that an endoscope (e.g., of up to about 6-8 mm in diameter) can be passed through the tissue-receiving space1330of suction clamping domain200B.

In some embodiments, inward-protruding portion1300is hollowed on a ventrally-facing surface. This potentially acts to help receive a sufficient thickness of tissue upon activation of suction.

Aperture1301, in some embodiments, is sized for the admittance of shaft205and/or pin205B, for example as these elements are described in relation toFIGS. 2A-2B.

Reference is now made toFIGS. 14A-14B, which schematically represent a suction clamping domain200B of a bougie capsule section1401comprising offset fenestrations defined by tissue supports1403A,1405B, according to some embodiments of the present disclosure. Reference is also made toFIGS. 15A-15C, which schematically represent variations of suction clamping domain200B of a bougie capsule sections1501,1522,1543comprising offset fenestrations defined by tissue supports1503A,1503B,1523C,1523B,1523D,1523E, according to some embodiments of the present disclosure.

Tissue supports1403A,1405B,1503A,1503B,1523C,1523B,1523D,1523E, in some embodiments, are distributed in alternation along two sides of a longitudinal midline of bougie capsule section1401. 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 domain200B is engaged with tissue walls under suction inside a body cavity, a suturing needle (for example, suturing needle201ofFIGS. 2A-2B) is spirally advanced along suction clamping domain200B. Needle201alternately penetrates tissue intrusions on either side of the midline.

In some embodiments, a longitudinal blocker (not shown, but received, for example, by anchoring cavity208ofFIGS. 14A-14B, 15C) is provided to help define and maintain boundaries between fenestrations1402. The extent of medial protrusion of tissue supports1403A,1405B,1523D,1523C may be restricted, for example, and the space left partially filled in by a longitudinal blocker such as longitudinal blocker115.

Optionally, no longitudinal blocker is used, and the shapes of tissue supports1503A,1503B,1523C,1523B are sized and spaced to ensure separation of tissue on alternate sides.

Suture may be disengaged by passing out in the gaps1407between adjacent corners of tissue supports1403A,1405B.

Reference is now made toFIGS. 16A-16B, which schematically represent an arrangement of a suction clamping domain1605allowing progressive unblocking of a fenestration1603by longitudinal blocker1601, according to some embodiments of the present disclosure. Reference is also made toFIGS. 17A-17E, which schematically represent an alternative arrangement of a suction clamping domain1700allowing progressive unblocking of a fenestration1705by a longitudinal blocker1701, according to some embodiments of the present disclosure.FIGS. 17A-17Drepresent different stages of withdrawal of longitudinal blocker1701.FIG. 17Erepresents a cross-section at a level of longitudinal blocker1701, according to some embodiments of the present disclosure. Further reference is made toFIGS. 18A-18B, which schematically represent an alternative arrangement of a suction clamping domain1800allowing progressive unblocking of a fenestration1802by longitudinal blocker1801, according to some embodiments of the present disclosure.FIGS. 18A-18Brepresent different stages of withdrawal of longitudinal blocker1801.

In some embodiments, a portion of a bougie body1600,1702,1806defines a large fenestration1603,1705,1802(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 blocker1601,1701,1801e.g., actuated by control member1602,1707,1821. In some embodiments, the large fenestration1603,1705,1802has a length along the longitudinal axis of, for example, at least 4 cm, 5 cm, 6 cm, 10 cm, or 15 cm. The length, in some embodiments, is long enough to allow placement of at least 2, 3, 4, 5 or more sutures, for example by proximally advancing spiral needle201. After positioning within a body cavity: as the longitudinal blocker1601,1701,1801is withdrawn to reveal more of fenestration1603,1705,1802; more tissue is suctioned inside, and made available for suturing, for example by a proximally advancing spiral needle201.

In some embodiments (FIGS. 16A-16B, 18A-18B), longitudinal blocker1601,1801comprises a wide portion1601,1803and a narrow portion1603,1805. Narrow portion1603,1805helps to define two laterally separated sides of fenestration1603,1802, so that tissue—from, for example, opposite body cavity walls—is guided into one side or the other of fenestration1603,1802, without one body cavity wall side completely filling the available space.

Optionally, (FIGS. 18A-18B), longitudinal blocker1801also comprises a divider1807which intrudes into the internal space defined by bougie body1806, and acts to also block internally intruding tissue under suction so that it is prevented from crossing a midline of bougie body1806.

InFIG. 17E, a portion of the internal structure of a longitudinal blocker1701is shown, comprising internal supporting struts1704(curved and/or straight). Optionally, longitudinal blocker1701is shaped so that it is locked to shape of body1702, for example, using inward protruding portion1706as a guide rail.

In some embodiments, wide portion1803is slit along its lengths by slits1810. This potentially helps to maintain flexibility of bougie body1802, and/or to assist in the vacuum collapse under suction of body tissue walls of a body cavity to which bougie body1802is inserted.

General

As used herein with reference to quantity or value, the term “about” means “within ±10% of”.

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.

The word “optionally” is used herein to mean “is provided in some embodiments and not provided in 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. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range/ranging/ranges between” a first indicate number and a second indicate number and “range/ranging/ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

In addition, any priority document(s) of this application is/are hereby incorporated herein by reference in its/their entirety.