Tissue manipulation using a transluminal gastroplasty device

Abstract

Various devices and methods for forming within a gastric sleeve cavity are disclosed. In some embodiments, a bougie capsule section includes one or more mechanisms to allow it to bend by guiding a bend through a suction forceps domain, which grasps, positions, and holds body cavity tissue (e.g., stomach wall tissue). In some embodiments, a suture needle driver is configured to allow longitudinal movement of a spiral needle through a suturing space defined by the suction forceps domain. Optionally, the suction forceps domain is curved at the same time. In some embodiments, the suction forceps domain can be inserted into the stomach in a collapsed configuration and then expanded upon entering the stomach. Potentially, this allows grasping and positioning of larger and deeper tissue folds for suturing.

Description

[0001] Related Applications

[0002] This application claims priority under 35 USC §119(e) to U.S. Provisional Application No. 62 / 790,070, filed on January 9, 2019, the entire contents of which are incorporated herein by reference.

[0003] Technical Field and Background Art

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

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

[0006] However, due to the severity of this pandemic, any surgical approach, no matter how minimally invasive, will continue to struggle to meet demand. Moderately obese patients, as well as vulnerable patients such as children, are underserved patient populations. Procedural costs—which can reach tens of thousands of dollars in the United States, for example—are also prohibitive around the world.

[0007] Furthermore, surgery itself is not without risk. Complications such as surgery-related leaks, severity of comorbidities, and surgeon learning curve have been or will be factors that limit the widespread adoption of this approach.

[0008] In addition to being a relatively non-invasive form of gastric volume reduction surgery, endoluminal gastric sleeve formation has the potential to reduce the risk of gastric leaks. Because the stomach itself can be left intact, another potential advantage of an endoluminal technique over a sleeve formed by surgical resection is reversibility, for example, in the event of complications. Apparatus and methods for forming an endoluminal gastric sleeve are described, for example, in U.S. Patent Publication No. 2008 / 0249404, filed December 27, 2007, to Mikkaichi et al.; U.S. Patent No. 6,558,400, filed May 30, 2001, to Deem et al.; U.S. Patent No. 7,896,890, filed March 1, 2011, to Ortiz et al.; and U.S. Patent No. 7,083,629, filed August 1, 2006, to Weller et al. Summary of the invention

[0009] According to some embodiments of the present disclosure, a bougie capsule segment is provided, which is configured to shape and sew tissue of a body cavity from within the body cavity, and the bougie capsule segment includes: a capsule body, which longitudinally extends between a distal side and a proximal side of the bougie capsule segment; an arcuate suture needle, which is within the capsule body; and an axis handle, which is longitudinally adapted to press on the arcuate suture needle along the capsule body, and can be rotated to drive the arcuate suture needle to rotate around a longitudinal axis of the capsule body through friction between the axis handle and the arcuate suture needle.

[0010] In some embodiments, the arcuate suture needle is a spiral needle, and the rotation of the spiral needle is accompanied by the displacement of the spiral needle along the longitudinal axis of the capsule body.

[0011] In some embodiments, the capsule body defines a spiral arrangement of multiple channels, the spiral needle rotates along the channels and advances longitudinally; and the shaft handle is pressed onto the spiral needle in at least one position where the shaft handle intersects the spiral arrangement of the multiple channels.

[0012] In some embodiments, the shaft handle is within an arc of the arc-shaped suture needle in the radial direction, wherein the shaft handle is pressed on the arc-shaped suture needle.

[0013] In some embodiments, the shaft handle is radially outside an arc of the arc-shaped suture needle, wherein the shaft handle is pressed on the arc-shaped suture needle.

[0014] In some embodiments, the capsule body and the shaft handle are flexible along a region where the shaft handle presses on the arc-shaped suture needle.

[0015] In some embodiments, the arcuate needle comprises a relatively high friction surface and a relatively low friction surface; and wherein the shaft handle is pressed against the high friction surface.

[0016] In some embodiments, the low friction surface presses against multiple surfaces of the capsule body.

[0017] In some embodiments, the shaft handle includes a cable segment and a probe segment, the cable segment includes a plurality of wire bundles, the probe segment includes a solid piece, and the probe segment is positioned along the capsule body, wherein the probe is pressed against the arc-shaped suture needle.

[0018] In some embodiments, the probe has a fixed and uniform diameter.

[0019] In some embodiments, the probe is tapered.

[0020] In some embodiments, the shaft handle is configured to move longitudinally when the shaft handle is rotated.

[0021] In some embodiments, the longitudinal movement of the probe maintains contact between the probe and the needle during a longitudinal movement of the needle.

[0022] In some embodiments, the capsule body comprises a plurality of longitudinally aligned cavities arranged along the capsule body, and the shaft handle passes through the cavities; wherein the shaft handle is held against the arcuate suture needle at one or more positions between the plurality of longitudinally aligned cavities.

[0023] In some embodiments, the capsule body defines a suction clamp region, the suction clamp region being defined by a plurality of support surfaces positioned along the suction clamp region, and being configured to receive the tissue of the body cavity collapsed onto the support surfaces when the bougie capsule segment is inserted into the body cavity by applying suction to the suction clamp region.

[0024] According to some embodiments of the present disclosure, there is provided a method of intracavitary suturing, comprising: rotating a spiral needle through frictional interaction with a rotating shaft handle to advance the spiral needle along a bougie capsule section.

[0025] In some embodiments, the shaft is adapted longitudinally along the bougie capsule section to press against the helical needle.

[0026] According to some embodiments of the present disclosure, a bougie capsule segment is provided, configured to shape and sew tissue of a body cavity from within a cavity, the bougie capsule segment comprising: a capsule body extending along a longitudinal axis through a suction clamp region between a distal side and a proximal side of the bougie capsule segment; and a suturing space defined by a plurality of support surfaces of the suction clamp region, configured to receive the tissue of the body cavity collapsed on the support surfaces when the bougie capsule segment is inserted into the body cavity by applying suction to the suction clamp region; wherein the capsule body comprises a plurality of hinge pieces, the hinge pieces being configured to change angles relative to each other to create a bend in the capsule body.

[0027] In some embodiments, the suction clamp domain comprises the plurality of hinged pieces.

[0028] In some embodiments, the plurality of hinged panels are longitudinally interconnected to a single continuous piece, and the nodes between the plurality of petals comprise thinnings of material of the single continuous piece to form the plurality of hinged joints.

[0029] In some embodiments, the hinge plate defines a helical arrangement of channels and includes a helical needle configured to be advanced longitudinally as it rotates through the helical arrangement of channels while the hinge plate is curved.

[0030] In some embodiments, the bougie capsule section includes a shaft handle adapted to extend longitudinally through the suction clamp region and press on the spiral needle; and through friction between the shaft handle and the spiral needle, the shaft handle can be rotated to drive the rotation of the spiral needle, and the hinge piece is bent on both sides of a position where the shaft handle presses on the spiral needle.

[0031] In some embodiments, the bend is produced by operation of a control member, wherein the control member is attached to the capsule body via a longitudinal barrier, the longitudinal barrier extends longitudinally through the suction clamp region to provide a portion of the support surface, and divides an opening interval introduced into the suture space longitudinally into a plurality of separate windows on both sides of the longitudinal barrier; and wherein based on the longitudinal movement of the control member, the movement of the longitudinal barrier produces the bend in the capsule body.

[0032] According to some embodiments of the present disclosure, a method for intracavitary suturing is provided, comprising: inserting a suction forceps domain of a bougie capsule segment into a body cavity, the bougie capsule segment being configured to shape and suturing tissue of the body cavity from within the body cavity; guiding a curve along the suction forceps domain; applying suction to collapse the tissue of the body cavity onto multiple support surfaces of the suction forceps domain and enter a suturing space within the curved bougie capsule segment; and advancing the spiral needle through the suturing space and the curve by rotating a spiral needle.

[0033] According to some embodiments of the present disclosure, a bougie capsule segment is provided, which is configured to shape and sew tissue of a body cavity from within a cavity, the bougie capsule segment comprising: a capsule body extending along a longitudinal axis through a suction clamp region between a distal side and a proximal side of the bougie capsule segment; and a suturing space defined by a plurality of support surfaces of the suction clamp region, configured to receive the tissue of the body cavity collapsed on the support surfaces when the bougie capsule segment is inserted into the body cavity by applying suction to the suction clamp region; wherein the bougie capsule segment is expandable by movement of the support surfaces.

[0034] In some embodiments, expansion of the bougie capsule segment increases a cross-sectional size of the suture space through outward movement of the support surface.

[0035] In some embodiments, the suture space includes a dorsal side, a ventral side, and a ventral midline of the ventral side, and at least some of the support surfaces are attached to multiple side edges of the suture space laterally to the ventral midline, and the support surfaces move laterally outward from the capsule body when braked by a control member.

[0036] In some embodiments, the support surface is attached to the capsule body via a plurality of swivels.

[0037] In some embodiments, the suture space includes a dorsal side, a ventral side, and a ventral midline of the ventral side, and at least some of the support surfaces are multiple surfaces of multiple outriggers, the outriggers are attached to the sides of the suture space lateral to the ventral midline, and the outriggers are configured to move the support surfaces from the capsule body in an abdominal direction when braked by a control member.

[0038] In some embodiments, the outriggers comprise a grid of a plurality of independent supports, the grid of the plurality of independent supports being joined to one another through their intersections.

[0039] In some embodiments, the outrigger comprises a grid of a plurality of supports, the grid of the plurality of supports being formed from a block of shape memory metal.

[0040] In some embodiments, each outrigger comprises a plurality of supports attached to the capsule body via a plurality of swivels and joined by a stabilizing rod.

[0041] In some embodiments, at least some of the support surfaces are surfaces of a longitudinal barrier configured to bulge outwardly from along the ventral midline of the capsule body when actuated by a control member.

[0042] In some embodiments, the bougie includes a collapsible bougie orienting protrusion anchored at a distal end and configured to expand outwardly upon distal advancement of a control member, the control member being attached to the collapsible bougie orienting protrusion.

[0043] According to some embodiments of the present disclosure, a bougie capsule section of a bougie is provided for intracavitary suturing, the bougie capsule section comprising: a tissue receiving space framed by: a plurality of tissue support structures extending along both sides of a longitudinal axis of the capsule section, and a back wall extending between the tissue supports and along the tissue supports at a position away from the tissue support structures; wherein an inwardly protruding portion protrudes from the back wall into the tissue receiving space, dividing it to define a plurality of channels on both sides of the inwardly protruding portion.

[0044] In some embodiments, the inward protrusion branches on both sides to a lateral protrusion, and the lateral protrusion defines a hollow portion between the inward protrusion and the back wall.

[0045] According to some embodiments of the present disclosure, a bougie capsule segment is provided, which is configured to shape and sew tissue of a body cavity from within a cavity, the bougie capsule segment comprising: a capsule body, which extends longitudinally to define a suction clamp area between a distal side and a proximal side of the bougie capsule segment; and a suturing space, which is framed by a plurality of support surfaces, the support surfaces being positioned along the suction clamp area, and the suturing space being configured to receive the tissue of the body cavity collapsed onto the support surfaces when the bougie capsule segment is inserted into the body cavity by applying suction to the suction clamp area; wherein the support surface comprises a longitudinal barrier, the longitudinal barrier extending longitudinally along the suction clamp area to longitudinally divide an opening section introduced into the suturing space into a plurality of separate windows on both sides of the longitudinal barrier; and wherein the longitudinal barrier is configured so that movement of the longitudinal barrier creates a bend in the capsule body.

[0046] In some embodiments, the longitudinal blocking member is removable from above the opening interval to remove the individual opening windows that are longitudinally divided.

[0047] According to some embodiments of the present disclosure, a bougie capsule segment is provided, which is configured to shape and sew tissue of a body cavity from within a cavity, the bougie capsule segment comprising: a capsule body, which extends longitudinally to define a suction clamp region between a distal side and a proximal side of the bougie capsule segment; and a suturing space, which is framed by a plurality of support surfaces, the support surfaces being positioned along the suction clamp region, and the suturing space being configured to receive the tissue of the body cavity collapsed onto the support surfaces when the bougie capsule segment is inserted into the body cavity by applying suction to the suction clamp region; wherein the support surface comprises a closing portion of a longitudinal barrier, the longitudinal barrier extending through a proximal side of an opening interval introduced into the suturing space to close a proximal portion of the opening interval; and wherein the longitudinal barrier is configured to be retracted proximally to gradually open the proximal portion of the opening interval.

[0048] In some embodiments, the open area is opened by fully retracting the longitudinal barrier, and the open area includes a single opening at least 5 cm long.

[0049] In some embodiments, the longitudinal barrier includes a narrow portion of the longitudinal barrier, which is narrower than the closing portion, extends distally from the closing portion, and is longitudinally divided into a plurality of separate windows along the suction forceps region on both sides of the longitudinal barrier to introduce an opening interval into the suture space.

[0050] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the present invention relates. Although methods and materials similar or equivalent to those described herein may be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In the event of a conflict, the patent specification, including definitions, will control. In addition, materials, methods, and examples are illustrative only and are not intended to necessarily limit them. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Some embodiments of the present invention are described herein, by way of example only, with reference to the accompanying drawings and images. The following description will now be made in detail with specific reference to the accompanying drawings, emphasizing that the details shown are by way of example and for the purpose of illustrative discussion of the embodiments of the invention. In this regard, the description made in conjunction with the drawings will make it apparent to those skilled in the art how the embodiments of the present invention may be implemented.

[0052] In the attached picture:

[0053] Figure 1 Schematically illustrates a bougie configured for shaping and intraluminally suturing tissue of a lumen, according to some embodiments of the present disclosure;

[0054] Figure 2A Schematically illustrates a needle driver configured to drive a helical needle proximally along an interior of a bougie, according to some embodiments of the present disclosure;

[0055] Figure 2B schematically illustrates a spiral needle relative to a shaft, and selected surfaces of a bougie capsule segment, according to some embodiments of the present disclosure;

[0056] Figure 2C is a schematic flow chart of a method for intracavitary suturing according to some embodiments of the present disclosure;

[0057] Figures 3A to 3B Schematically illustrates a bending mechanism of a bougie capsule section, according to some embodiments of the present disclosure;

[0058] Figures 4A to 4B Schematically illustrates a bending mechanism of a bougie capsule section, according to some embodiments of the present disclosure;

[0059] Figures 5A to 5B Schematically illustrates another bending mechanism of a bougie capsule segment, according to some embodiments of the present disclosure;

[0060] Figure 6 Schematically illustrates an outer cannula for use with a gastric surgery bougie, according to some embodiments of the present disclosure;

[0061] Figure 7 Schematically illustrates a foldable bougie orientation protrusion, according to some embodiments of the present disclosure;

[0062] Figures 8A to 8B Schematically illustrates a bougie capsule section, including a capsule expansion barrier, according to some embodiments of the present disclosure;

[0063] Figures 9A to 9B Schematically illustrates a bougie capsule segment including a capsule expansion barrier having a foldable bougie orienting protrusion, according to some embodiments of the present disclosure;

[0064] Figures 10A to 10D Schematically illustrates a bougie capsule segment, including a capsule expansion barrier, and a plurality of capsule expansion valves, according to some embodiments of the present disclosure;

[0065] Figures 11A to 11D Schematically illustrates a bougie capsule section, including a capsule expansion barrier, and a plurality of capsule expansion outriggers, according to some embodiments of the present disclosure;

[0066] Figures 12A to 12B Schematically illustrates a bougie capsule section, including a capsule expansion barrier, and a plurality of capsule expansion outriggers, according to some embodiments of the present disclosure;

[0067] Figures 13A to 13D Schematically illustrates various internal structures of a bougie clamp domain that affect vacuum distribution, tissue occlusion, and / or tissue clamping, according to some embodiments of the present disclosure;

[0068] Figures 14A to 14B schematically illustrates a suction forceps region of a bougie capsule section including a plurality of offset fenestrations defined by a plurality of tissue supports, according to some embodiments of the present disclosure;

[0069] Figures 15A to 15C Schematically illustrates changes in a suction forceps domain of a bougie capsule segment including a plurality of offset fenestrations defined by a plurality of tissue supports, according to some embodiments of the present disclosure;

[0070] Figures 16A to 16B Schematically showing an arrangement of a suction clamp zone, allowing gradual unblocking of a fenestration through a longitudinal barrier, according to some embodiments of the present disclosure;

[0071] Figures 17A to 17E Schematically illustrating an alternative arrangement of a suction clamp field, allowing for gradual unblocking of a fenestration through a longitudinal barrier, according to some embodiments of the present disclosure;

[0072] Figures 18A to 18BSchematically illustrating an alternative arrangement of a suction clamp field, allowing for gradual unblocking of a fenestration through a longitudinal barrier, according to some embodiments of the present disclosure;

[0073] Fig.19 is a flow chart of a method for intracavitary positioning of a bougie capsule segment according to some embodiments of the present disclosure; and

[0074] Fig. 20 is a flow chart of a method for intracavitary use of a bougie capsule segment according to some embodiments of the present disclosure. DETAILED DESCRIPTION

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

[0076] Overview:

[0077] One aspect of some embodiments of the present disclosure relates to a needle driver and an arcuate needle, which, according to some embodiments of the present disclosure, is configured to drive the arcuate needle along an interior of a bougie body. In some embodiments, the arcuate needle is a spiral needle.

[0078] In some embodiments, the needle driver comprises a drive shaft, and a capsule body along the bougie body is firmly mounted so that it presses on the bougie. The friction between the shaft and the needle guides the needle to rotate by the rotation of the shaft. In some embodiments, the needle is constrained by a spiral arrangement of one or more channels (optionally continuous or interrupted) so that the rotational motion is also converted into the longitudinal advancement of the spiral needle along the bougie body.

[0079] In some embodiments, the shaft is flexible and maintains frictional driving contact with the spiral needle sufficient to drive it, even when the bougie body is bent through a zone through which the shaft passes to contact the spiral needle. In some embodiments, the shaft comprises a dual construction along its longitudinal extent: a cable portion and a probe portion. The probe portion is the portion that is in frictional contact with the spiral needle. In some embodiments, the cable portion may provide flexibility to the shaft along most of its length. In some embodiments, the probe portion may provide dimensional stability to help ensure a tight and predictable engagement with the suture needle where the two are in contact.

[0080] In some embodiments, an arcuate needle that is not helical (optionally, more than one) is driven around a circumference of the bougie body (eg, guided by a circumferential channel of the bougie body), optionally without longitudinal advancement.

[0081]

[0013] An aspect of some embodiments of the present disclosure relates to a suction clamp region of a bougie capsule section configured with multiple nodes to allow bending according to some embodiments of the present disclosure.

[0082] In some example implementations, the nodes divide a plurality of hinged tabs interconnected along a single continuous piece, and the nodes between the plurality of petals comprise thinnings of material of the single continuous piece to form the hinged joints.

[0083] In some embodiments, the bougie capsule section includes a helical needle that is flexible enough to be driven longitudinally (via rotation) along a bend guided in the clamp region. Optionally, the helical needle is driven by frictional interaction with a rotating shaft that is configured (e.g., clamped in place and having sufficient structural flexibility) to maintain a driving connection with the suture needle even along the section of the bend.

[0084] In some embodiments, other portions of the bougie capsule section (eg, the distal and / or proximal ends of the suction clamp region) are also articulated, having a bend controllable by movement of a control member.

[0085]

[0013] An aspect of some embodiments of the present disclosure relates to a suction clamp region of a bougie capsule section that is expandable upon insertion into a body cavity according to some embodiments of the present disclosure.

[0086] In some embodiments, the suction forceps domain is expandable by movement of one or more valves and / or outriggers. In some embodiments, the valves and / or outriggers are laterally turned outward (e.g., away from an abdominal midline extending along a longitudinal axis of the bougie capsule segment) and / or expanded abdominally (e.g., abdominally along a dorsoventral axis of the bougie capsule segment, perpendicular to the longitudinal axis). It should be understood that "longitudinal axis" herein refers to an axis that bends along an axis that follows the general curve of the bougie body, if any, and is not necessarily a completely straight axis.

[0087] In some embodiments, the suction forceps region is expandable by a bending motion of a longitudinal barrier, extending longitudinally along the body of the bougie as a strip or strand of hard material; for example, a shape memory metal such as nitinol. In some embodiments, the bending is controlled by a control member, advanced to bulge the longitudinal barrier, and retracted to flatten the longitudinal barrier again.

[0088] An aspect of some embodiments of the present disclosure relates to dividing a tissue receiving space of a suction forceps region into a plurality of separate channels extending along a longitudinal axis of the suction forceps region.

[0089] In some embodiments, a tissue receiving space defined within a suction forceps domain is partially divided by an inwardly projecting portion that projects inwardly from a dorsal side of the tissue receiving space and then extends laterally within the tissue receiving space (optionally to form a "branch" or generally T-shaped structure). A hollow region remains open below a lateral extension of the inwardly projecting portion (i.e., between the lateral extension and the dorsal inner wall of the tissue receiving space). This hollow region forms a channel for limited tissue invasion that extends along a longitudinal extent of the suction forceps domain beyond a main channel of the tissue receiving space, and tissue is first pulled into the tissue receiving space; for example, through a structure defining a plurality of fenestrations that lead from outside the suction forceps domain into the tissue receiving space.

[0090] Access to the hollow region by being drawn into the tissue receiving space is limited by a relatively narrow opening defined between the laterally extending portion and a lateral inner wall of the tissue receiving space.

[0091] Potentially, the configuration of the inwardly projecting portion provides a potential advantage by preventing tissue from completely filling the hollow region, thereby maintaining an open vacuum channel along the longitudinal extent of the tissue receiving space, preventing tissue clogging.

[0092] Another potential advantage of the inwardly projecting portion is that it acts as a "tissue lock." Tissue drawn into the tissue receiving space is partially wrapped around the inwardly projecting portion (e.g., wrapped around two or more sides of its lateral extension, optionally including being drawn into the hollow region). This wrapping may convert suction into anchoring through convolution of tissue, so that a force applied by a suture needle (e.g., around an inner circumference of the suction forceps region) is resisted by contact with an adjacent surface of the tissue.

[0093] It is worth noting that in some embodiments, the tissue sucked into the tissue receiving space is partially prevented from invading through the fenestration structure (e.g., longitudinal blocking member, lateral blocking member, valve and / or outrigger) formed at the entrance of the tissue receiving space. In some embodiments, the tissue invading the space through these structures is then further guided by the shape of the inwardly protruding portion.

[0094] Before explaining at least one embodiment of the present disclosure in detail, it should be understood that the application of the present disclosure is not necessarily limited to the details of the construction and arrangement of the components and / or methods described in the following description and / or drawings. The features described in the present disclosure, including the features of the present invention, can be used in other embodiments or practiced or implemented in various ways.

[0095] Bougie with bougie capsule section:

[0096] Reference now Figure 1 , which schematically shows a bougie 100 according to some embodiments of the present disclosure, configured for shaping and intracavitary suturing of tissue of a cavity.

[0097] The three main sections of the bougie 100 are the bougie capsule section 101 (distal end), the bougie body 102, and the bougie control handle 103 (proximal end).

[0098] Bougie capsule assembly 101 (a bougie capsule section is also referred to herein as a "capsule"), in some embodiments, includes a suction forceps region 110, which in turn includes one or more fenestrations 111, configured to receive tissue from the body cavity under suction and hold and / or position it in preparation for one or more surgical modifications, such as suturing. Herein, different structural terms are used to distinguish and describe embodiments of the suction forceps region 110. The same embodiment is optionally described by more than one of these terms.

[0099] Aperture-in-a-tubular body terminology: The forceps domain 110 comprises a tubular body having an aperture region (i.e., a region comprising one or more openings) opening into a cavity that receives tissue when suction is applied to the cavity.

[0100] Spine terminology: Additionally or alternatively, the suction forceps domain 110 includes a spine having a dorsal side and a ventral side. For example, when the opening of the tubular body becomes large enough, the remainder of the tubular body can be easily understood to include a spine. By applying suction to the spine region (inserted into a suitable body cavity when used), tissue collapses downwardly onto structures supported along the spine, such as longitudinal barriers, lateral barriers, valves, outriggers and / or tissue supports).

[0101] Space and Support Surface Terms: This term is a generalization of the other two terms. The support surface includes the surface of any structure positioned along the tubular body / spine onto which tissue collapses when suction is applied to the device in use. For example, this can be the tubular body, the spine and / or other features, such as barriers, valves and / or outriggers, for example, as described in the various embodiments disclosed herein. The "cavity" of the first term is also a space of the third term, defined as the space within the structure that provides the support surface. Additionally or alternatively, this space is located on a surface along the "spine" of the second term that faces the abdomen.

[0102] These three terms should be understood to apply equally to all embodiments of the present invention. Even with an extremely thin spine (for example), there is still a "cavity" framed within the surface of the suction domain, although the cavity may be a space defined primarily by the confines of a framework of multiple open fenestrations (for example, as explained below). Conversely, even with a relatively narrow open space in a tubular body, the remaining material of the tubular body framing the open space can also be understood to form the "spine" of the suction domain forceps, although the "abdominal-facing surface" in this case is also an inner surface of the tubular body.

[0103] Thus, for example, it can be equivalently said that when suction is applied to a suction forceps domain, the tissue collapses onto a plurality of support surfaces located along its cavity or along its spine. The support surfaces include, for example, longitudinal barriers, lateral barriers, valves, outriggers and / or surfaces of tissue supports; for example, tissue supports formed from the material of a tubular body. These different types of support structures are described in more detail with respect to the embodiments of the present disclosure.

[0104] In another example: a spiral needle moves along the "space" (according to the third term) of the "cavity" (according to the first term) equivalent to moving along "a surface of the spine facing the abdomen" (according to the second term). In some embodiments, therefore, the space is also understood to be a "suture space".

[0105] For consistency, the term "opening in the tubular body" is used as the primary term in the description herein even for embodiments where the spine is narrow. In some related examples, specific relative circumferences are described. For example, in some embodiments, a body of the bougie capsule segment has a circumferential extent in the suction forceps domain that is more than half, less than half, more than one-third, less than one-third, more than one-quarter, and / or less than one-quarter of the entire circumference.

[0106] Herein, the fenestration 111 is a portion of the fenestration interval of a bougie capsule section 101. The fenestration, in some embodiments, is configured to be changed in size, shape and / or anatomically by actuation of one or more fenestration shaping elements. Such fenestration is also referred to herein as a "dynamic" fenestration.

[0107] The use of the aperture shaping element actuation and the accompanying changes in the dynamic fenestration 111 are used, in some embodiments, to control one or more aspects of luminal tissue attachment, luminal tissue positioning, or luminal tissue aspiration depth (e.g., in preparation for suturing); or tissue relaxation. In some embodiments, tissue relaxation includes loosening sutures or other surgical materials that may be attached (e.g., sewn, clamped, and / or stapled) to the luminal tissue while the luminal tissue is engaged with the bougie bag segment 101.

[0108] In some embodiments, examples of the opening shaping element include a longitudinal blocking member 115 and / or a lateral blocking member 117 .

[0109] A longitudinal barrier 115, in some embodiments, comprises an element such as a rigid bar or rod that spans at least a portion of the suction forceps region 110, generally dividing it into two sides of the fenestration 111 extending longitudinally side by side. The longitudinal barrier 115 is optionally removable to allow the separated fenestrations 111 to rejoin. This potential advantage is that tissue and / or sutures are released; for example, the suction forceps region 110 is released from a suture spanning between two body cavity luminal tissue portions and on an inner side of the longitudinal barrier 115.

[0110] The lateral barriers 117, in some embodiments, include one or more elements, such as multiple lengths of rope, that pass laterally through the suction clamp region 110. A cross element creates a partition in the suction clamp region, separating different openings 111 on both sides of the element. In some embodiments, the lateral barriers 117 are releasable and / or removable to remove the partition.

[0111] Examples of longitudinal barriers 115 and lateral barriers 117 are described, for example, in International Patent Publication No. WO 2016 / 056016, the contents of which are incorporated by reference in their entirety.

[0112] Optionally, a distal tip 112 of the bougie capsule section 101 is provided that is transparent and / or terminates in an opening large enough (eg, about 6 to 8 mm in diameter) to pass the distal end of an endoscopic probe or other tool.

[0113] In some embodiments, the bougie body 102 includes a tube 121 along which one or more longitudinally extending control members 120 pass externally and / or internally. In some embodiments, the control members 120 interconnect the plurality of actuatable elements (e.g., longitudinal stoppers 115 and / or lateral stoppers 117) of the bougie capsule section 101 with the bougie control handle 103 (e.g., a plurality of control knobs 122). In some embodiments, the tube 121 has an inner diameter large enough (e.g., about 6 to 10 mm) to insert an endoscopic probe or other tool.

[0114] Distal tip 112 preferably has a tapered shape to assist in inserting bougie 100 along a natural body passage, such as the esophagus. Bougie capsule section 101 and bougie body 102 are preferably sized (diameter and length) and shaped (at least in an insertion configuration) to allow insertion along a natural body passage, such as the esophagus, to reach a target organ, such as the stomach.

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

[0116] Needle Driver:

[0117] Reference now Figure 2A , Figure 2A A needle driver is schematically shown, which is configured to drive a helical needle 201 proximally along the interior of a bougie capsule section 200, according to some embodiments of the present disclosure. Figure 2A A bougie 100 is shown with a bougie capsule section 200, which may be generally as described with respect to Figure 1 Having configured as described, the differences / additions are now explained.

[0118] Also referred to Figure 2B , Figure 2B The helical needle 201 is schematically illustrated in relation to a shaft 205 and selected surfaces 211 of a bougie capsule section 200, according to some embodiments of the present disclosure.

[0119] In some embodiments, the spiral needle 201 is driven from a distal end 230 of a bougie capsule section 200 by rotation of a shaft 205, which presses against the spiral needle 201 at one or more locations. As the shaft 205 rotates, the spiral needle 201 rotates accordingly. The rotational movement of the spiral needle 201 is accompanied by advancement along a longitudinal axis of the bougie capsule section 200; for example, from an initially more distal position to the proximal end.

[0120] In some embodiments, bougie capsule section 200 is configured such that friction between shaft 205 and helical needle 201 transfers torque from the rotating shaft 205 to helical needle 201 sufficient to advance the needle through tissue while carrying suture.

[0121] Optionally, the friction is partially created by pressing the spiral needle 201 between the shaft 205 and one or more surfaces of a body of the bougie capsule segment 200. These can be, for example, multiple inner surfaces 211 of a dorsal side of the bougie capsule segment 200 (in the "cross-section tube" interpretation of the device structure); or, multiple ventral surfaces 211 described as a spine of the capsule segment 200 (in the "spine" interpretation of the device structure). Optionally, the spiral needle 201 extends around the shaft 205 so that the shaft 205 and the spiral needle 201 rotate in the same circumferential direction. This configuration, by being located (for example, as Figure 2BA potential advantage is provided by creating a two-sided contraction immediately at the location of frictional interaction between the shaft 205 and the spiral needle 201 (e.g., as shown in multiple surfaces 211B) and / or immediately adjacent (e.g., as shown in multiple surfaces 211A) to the shaft 205. Additionally or alternatively, in some embodiments, the suture needle 201 can be pressed onto the shaft 205 by another method, for example, by squeezing or pulling from a different location, or other methods to force through a channel that guides the spiral needle 201 against the shaft 20.

[0122] Alternatively, in some embodiments, shaft handle 201 is outside the space defined within spiral needle 201 , such that shaft handle 205 rotates in the opposite direction to spiral needle 201 .

[0123] In some embodiments, the spiral needle 201 includes a relatively high friction surface 201A and a relatively low friction surface 201E. In some embodiments, the two surfaces extend along the curved needle shaft, so that a portion of the circumference of the needle shaft is high friction and a portion is low friction.

[0124] In some embodiments, a surface area 201A of one or both of the spiral needle 201 and the shaft 205 is treated to increase friction. For example, the surface 201A of the spiral needle 201 is optionally rough. In some embodiments, the surface 201A includes a surface portion that contacts the cable 205, but does not include a surface portion that contacts the bougie surface 211, 211A, 211B. Optionally, the surface 201A circumferentially includes about half of the surface area of ​​the spiral needle 201.

[0125] Roughening can be, for example, by a treatment such as sputter coating or a chemical bath, coating with a high friction material such as rubber, or another method. The unroughened surface of the needle 201B can be protected (e.g., by a pre-coating) from the roughening treatment, and / or restored to a smooth finish after treatment. Optionally, the unroughened surface 201E is given a friction reducing treatment, such as a PTFE coating.

[0126] Figure 2B Other parts of the suture needle 201 shown include a suture 201D, a suture connecting portion 201C, and a suture needle tip 201B.

[0127] Optionally, during rotation, some slippage may occur between the movement of the spiral needle 201 and the shaft handle 205. In some embodiments, the maximum average slippage (e.g., the average slippage of the suture needle 201 while penetrating the tissue and pulling a suture behind it) is, for example, no more than 20%, 30%, 40%, 50% or 60% slippage. In some embodiments, there is no slippage, so the minimum average slippage is 0%. Optionally, the minimum average slippage is at least 5%, 10%, 20% or 30% slippage.

[0128] It should be noted that the characteristic description of the spiral needle 201 rotating in the bougie capsule section 200 and moving longitudinally along the bougie capsule section 200 is optional and can be changed as needed, embodying a non-spiral arcuate suture needle rotating and moving in the bougie capsule section 200.

[0129] In some embodiments, a non-helical (optionally, more than one) arcuate needle is driven around a circumference of the bougie body (eg, guided by a circumferential channel of the bougie body), optionally without longitudinal advancement.

[0130] The shaft handle 205, in some embodiments, extends from a distal origin of the suture needle 201 (e.g., within the capsule portion 200A) to a proximal side of the bougie capsule section 200, and extends outwardly along the bougie body 102 to a handle 103, which remains outside the patient's body during insertion of the bougie into a cavity such as a stomach. The handle 103, in some embodiments, includes a knob or other control member that allows the rotation of the shaft handle 205 to be braked.

[0131] In some embodiments, the shaft 205 includes a flexible portion 205A, which can be, for example, a stranded cable, such as a cable in a 1x8 configuration (a center strand surrounded by 8 outer strands), a 1x12 configuration, or another configuration.

[0132] In terms of flexibility, the flexible portion 205A provides a potential advantage of allowing flexibility of portions of the bougie capsule section 200 .

[0133] For example, in some embodiments, one or more portions of the bougie capsule segment 200 include a plurality of articulated pieces, such as a plurality of segments 207. The articulation allows the segments 207 to change angles relative to each other, thereby inducing a bend along the bougie capsule assembly 200. In some embodiments, the segments 207 are defined by a plurality of cuts formed (not necessarily by cutting; alternatively, such as by molding or additive manufacturing methods such as 3D printing) to leave enough material between the segments 207 to maintain mechanical integrity, but thin enough to bend.

[0134] In some embodiments, the incisions also serve as a plurality of suture needle channels 311 through which the suture needle 201 moves when the spiral advances. It should be noted that a plurality of incisions may be formed on both sides of the bougie capsule section 200, for example Figures 3A to 3B Multiple cutouts 207A are formed on the outside of the capsule section of the bougie. Multiple cutouts can be formed on both sides. Optionally, multiple cutouts completely penetrate the distal end 200 of the bougie at some locations. In some embodiments, the segment 207 is formed by multiple separate components that fit together.

[0135] In some embodiments, one or both side walls of the suction forceps region 200B include multiple housings 310 for lateral barriers 117 and / or actuatable elements for controlling the release of the lateral barriers 117. Optionally, multiple gaps 311A ​​between the multiple housings 310 increase the flexibility of the device and / or provide multiple openings (optionally with multiple openings 206) between which the lateral barriers 117 pass. To clearly view the details of the needle driver mechanism, Figure 2A The lateral blocks 117 are not shown in FIG. The lateral blocks 117 are optionally configured, for example, as shown in any of the figures describing them herein, with additional modifications as required by the design details (eg, use of expandable valves and / or outriggers).

[0136] Optionally, the flexible portion 205A interacts directly with the suture needle 201. Optionally, the shaft 205 includes a stylet 205B, for example, a stylet 205B terminates the shaft 205 at the distal end. In some embodiments, the stylet 205B is stiffer and / or less deformable in cross-section than the flexible portion 205B, for example, comprising a solid rod. This provides potential advantages for use in a suture needle driver by increasing dimensional stability to maintain friction with the suture needle. This in turn potentially delivers greater and / or more predictable torque to the suture needle. When bent, a rod may hold its shape better than a twisted cable, thereby changing the shape of the bougie (for example, Figures 3A to 5B Related description).

[0137] In some embodiments, the probe 205B is tapered, for example with a diameter taper of between 100 micrometers (μm) and 1 millimeter (mm) along a portion of its length. In some embodiments, the taper allows the probe to be moved (by displacement in a direction along the longitudinal extent of the clamp region 200B) to a position that selectively provides a tighter or looser friction fit against the needle 201. A tighter fit potentially provides an advantage of increasing the torque that can be applied to the needle 201, while a looser fit potentially provides an advantage of alleviating situations where the friction is too high to cause the probe and / or needle to bind.

[0138] In some embodiments, a control 122 is configured (e.g., using a screw) to withdraw the shaft 205 as the shaft 205 is rotated, along a pitch that maintains the needle 201 and the probe 205B in a matched longitudinal position so that the needle 201 remains in contact with the probe 205B. The matching optionally allows some amount of relative longitudinal movement, for example, allowing some amount of slippage of the needle 201 relative to the probe 205B without separating the probe 205B from the needle 201.

[0139] exist Figure 2A Other elements shown in the diagram include:

[0140] In some embodiments, channel 208 is configured as part of an anchor on one side of a longitudinal barrier 115 (not shown).

[0141] In some embodiments, channel 209 is configured to hold a distal end of a control member (e.g., a wire) used to anchor longitudinal barrier 115. For example, a wire is passed distally through channel 209 and then optionally across (e.g., inside) the bougie body to an opening of the longitudinal barrier 115 held within channel 208. To unlock longitudinal barrier 115, the wire is retracted proximally along channel 209.

[0142] A plurality of channels 224 and 222 along which the suture can move when it is pulled by a needle 201 attached thereto. Optionally, the channels 222, 224 are made of a low friction polymer material, such as polytetrafluoroethylene (PTFE). Optionally, the suture is rolled / folded and stored in the channels 222 and / or 224. Optionally, the suture is stored elsewhere (e.g., rolled on a spool and / or stored along a longitudinal length of the bougie 100).

[0143] Reference Figure 2C , which is a schematic flow chart of a method of intracavitary suturing, according to some embodiments of the present disclosure.

[0144] In some embodiments, the flowchart begins, at block 250, by inserting a suction clamp region 200B of a bougie capsule section 200 into a body cavity (eg, a stomach).

[0145] At block 252, in some embodiments, suction is applied. Under the action of the suction, the body cavity tissue collapses onto the multiple support surfaces of the suction forceps domain 200B. Some of the body cavity tissue is sucked into a suture space through the multiple openings between the support surfaces, and the suture space is defined at the level of the suction forceps domain 200B; for example, it is sucked into the suture space through multiple fenestrations. In some embodiments, the collapsed tissue is arranged so that tissue from a portion of the integral cavity wall is sucked into a left set of fenestrations, and tissue from another (e.g., facing) portion of the integral cavity wall is sucked into a right set of fenestrations. Optionally, the midline between the left and right is defined by a longitudinal barrier 115.

[0146] At block 254, in some embodiments, a shaft handle 205 is rotated. The shaft handle 205 presses against a surface of the suture needle 201, so that the rotation of the shaft handle 205 guides the rotation of the suture needle 201 through friction interaction. The suture needle 201 is also displaced longitudinally along the suction forceps domain 200B when it rotates.

[0147] Steering mechanism:

[0148] Reference now Figures 3A to 3B , which schematically shows a bending mechanism of a bougie capsule section 302, according to some embodiments of the present disclosure. Figures 5A to 5B , schematically illustrates another bending mechanism of a bougie capsule segment 302, according to some embodiments of the present disclosure.

[0149] Bougie capsule segment 302 (an example of bougie capsule segment 101), in some embodiments, comprises a distal segment of a bougie 100. Figures 3A to 3B and / or Figures 5A to 5B The bending mechanisms described in connection therewith are optional and may be varied as desired and provided in conjunction with any other features of the bougie capsule section of a bougie 100 described herein. Each mechanism may optionally be provided separately ( Figures 3A to 3B more proximal institutions, and Figures 5A to 5B or a combination of the two.

[0150] The bending mechanism, in some embodiments, operates a control member 301, 331 by longitudinal movement (e.g., pulling or pushing; shortening or lengthening) to guide bending along a segmented portion of the bougie capsule section 302. Figure 3B In FIG, the control member 301 is at its relaxed length and the bougie capsule section 302 is straight. Figure 3A In the embodiment of the present invention, the control member 301 is shortened and the bougie capsule section 302 is bent along a portion of its body. Figure 5A In , the control member 331 is at its relaxed length and the bougie capsule section 302 is straight. Figure 5B In the embodiment of the present invention, the control member 331 is shortened and the bougie capsule section 302 is bent closer to its distal end.

[0151] The bending mechanism, in some embodiments, includes control members 331 and / or 331 (examples of control members 120), and at least one control attachment 303, 303B of control members 301, 331 attached to the bougie capsule section 302 (optionally one or more additional attachments 303A, 303D are provided, for example, to help guide the bending force). One or more segments 305 defined by a plurality of cutouts 305A are also provided, the cutout 305A being formed by a plurality of segments 305 interconnected by a single continuous piece, the segments being formed, for example, by cutting, molding and / or additive manufacturing. The thinned material remaining next to the cutout 305A acts as an articulated joint. In some embodiments, the segment 305 is formed by assembling together a plurality of separately manufactured parts, with the cutout 305A defined by the gap between the assembled parts. Optionally, a plurality of cutouts 305B are provided on an opposite side of the bougie capsule section 302.

[0152] In some embodiments, the segmental cutout 305A is positioned between the bougie capsule section 302 and the control member 301, 331 (a ventral side, such as Figures 3A to 3B 5A to 5B) so that shortening the control members 331, 331 (e.g., pulling from the handle 103) causes expansion on that side. In some embodiments, the segmental cutout 305B is positioned between the bougie capsule section 302 and the control members 301, 331 (a dorsal side, such as Figures 3A to 3B 5A-5B) such that shortening of the control member 301 (e.g., pulling from the handle 103) results in compression on that side. In some embodiments, the hinge 305C is defined to have a relatively thin dorsoventral dimension (e.g., 1 to 3 mm). Optionally, the hinge 305C, 207B is defined on the side of the bougie capsule section 302 by segmenting the material and adding a cutout slot.

[0153] In some embodiments, the functions of the control members 301, 331 are combined. For example, the control member 331 is attached so that shortening / pulling also bends the more proximal segments 305. Optionally, the proximal segments and the distal segments operate together. Optionally, one set of segments is set on the more flexible hinge 305C, so that bending occurs there first, and then occurs on the other set of segments with greater shortening / pulling force.

[0154] exist Figures 3A to 3B 5A to 5B also indicate the locations of the segments 207, the cutouts 207A, the distal tip 112, the longitudinal barriers 115, and the lateral barriers 117, for example, as shown in FIG. Figure 1 Operate as described.

[0155] Reference now Figures 4A to 4B , Figures 4A to 4BA bending mechanism of a bougie capsule segment 322 is schematically shown, according to some embodiments of the present disclosure.

[0156] Bougie capsule segment 322 (an example of bougie capsule segment 101), in some embodiments, comprises a distal segment of a bougie 100. It should be understood that Figures 4A to 4B The described bending mechanisms may optionally be provided along with any of the features of any other bougie capsule section of a bougie 100 described herein, including other bending mechanisms, as desired.

[0157] The bending mechanism, in some embodiments, operates by shortening or lengthening a control member to guide bending along a segmented portion of the bougie capsule segment 322. Figure 4A In , the control member 321 is at its relaxed length and the bougie capsule section 302 is straight. Figure 4B In the embodiment, the control member 321 is shortened and the bougie capsule section 302 is bent. The segmentation of a portion of the bougie capsule section 322 to form a plurality of segments 207 separated by a plurality of cutouts 207A (and optionally other cutouts not shown, such as cutouts within the bougie capsule section 322) is optionally described in other related figures herein, such as Figure 2A and / or 3A to 3B.

[0158] In some embodiments, the control member 321 is attached to the longitudinal barrier 115, such that shortening (pulling up) the control member 321 causes the longitudinal barrier 115 to pull up the bougie capsule section 322 at the attachment 333, thereby introducing a curvature to the bougie capsule section 322. It should be noted that the longitudinal barrier 115 is optionally released from the attachment 333 by operation of a separate mechanism (e.g., by a different control member 120). Once released from the attachment 333, the control member 321 operates to withdraw the longitudinal barrier 115, rather than introducing a curvature to the bougie capsule section 322. In some embodiments, the longitudinal barrier 115 is released by pulling up the control member 321 past / exceeding a predefined position / tension, and the predefined position / tension is predefined so that the bend can be reliably induced without accidentally triggering the attachment release.

[0159] Figures 4A to 4B The positions of the segments 207, the cutouts 207A, the distal tip 112, and the longitudinal stop 115 are also indicated, for example, as shown in FIG. Figure 1 Operate as described.

[0160] Reference now Fig.19 , is a flow chart of a method of intracavitary positioning of a bougie capsule segment, according to some embodiments of the present disclosure.

[0161] The flowchart begins at block 2100 where, in some embodiments, a suction clamp region 200B of a bougie capsule section 200 is inserted into a body cavity (eg, a stomach).

[0162] At block 2102, in some embodiments, a bend is induced along a suture space defined by a plurality of support surfaces of the suction clamp domain 200B. In some embodiments, the bend is induced by longitudinal movement of a control member 120. Optionally, the control member 120 induces the bend by movement of a longitudinal barrier 115. In some embodiments, the suction clamp domain 200B comprises a plurality of hinged tabs 207, and the bend comprises inducing a change in the angle at which the plurality of hinged tabs 207 intersect.

[0163] At block 2104, in some embodiments, suction is applied. Under the action of the suction, the body cavity tissue collapses onto the support surface of the suction forceps domain 200B. Some of the body cavity tissue is sucked into a suture space defined at the level of the suction forceps domain 200B through the openings between the support surfaces; for example, it is sucked into the suture space through the fenestrations. In some embodiments, the collapsed tissue is arranged so that tissue from a portion of the integral cavity wall is sucked into a left set of fenestrations, and tissue from another (e.g., facing) portion of the integral cavity wall is sucked into a right set of fenestrations. Optionally, the midline between the left and right is defined by the longitudinal barrier 115.

[0164] Optionally, in some embodiments, Fig.19 The method continues to block 2106, wherein a spiral needle 201 is rotated along the curved portion of the suture space and is advanced longitudinally. In some embodiments, the spiral needle 201 is advanced longitudinally by frictionally contacting a rotating shaft handle 205, wherein the frictional contact occurs at multiple positions along the curved portion of the suture space.

[0165] Reference now Figure 6 , which schematically illustrates an overtube for use with a gastric surgery bougie, according to some embodiments of the present disclosure.

[0166] The outer sleeve 302, in some embodiments, is sized to extend along an access passage (e.g., the esophagus) to a body cavity (e.g., the stomach) for suturing, and the ultimate orientation of multiple openings 312 in the body cavity is controlled in part by the direction and degree of a bend introduced into the outer sleeve, for example, by using control members 301A, 301B.

[0167] The outer sleeve 302 is sized to receive the bougie capsule section 101 therein from a proximal end and out through an opening 312 at a distal end of the outer sleeve 302. In use, the flexure and position of the outer sleeve 302 has the effect of adjusting the angle of the bougie capsule section 101 as it emerges through the outer sleeve opening 312, which is a potential advantage for diverting the bougie capsule section 101 to a site to be sutured within a cavity such as the stomach, optionally without or in addition to the use of a diverting mechanism provided by the bougie 100 itself.

[0168] In some embodiments, control members 301A, 301B (examples of control member 120) are attached to the body of a flexible outer sleeve 302. One of the control members 301B, 301A is operated to shorten (pull up) to bend the outer sleeve in the direction of the side to which the control member is attached (e.g., control members 301A and 301B are attached at attachments 303E and 303F, respectively). Once a suitable bend is guided, the outer sleeve 302 is optionally locked in place.

[0169] Directional protrusions:

[0170] Reference now Figure 7 , Figure 7 Schematic representation of a foldable bougie orienting protrusion 340 according to some embodiments of the present disclosure.

[0171] In some embodiments, the orienting protrusion 340 is configured to controllably extend from the side of the bougie distal end 342, for example, by manipulating a control member 341 (which is an example of a control member 120). When extended within a suitably shaped body cavity, (e.g., a cavity such as a stomach that lacks radial symmetry and is thus longer in one direction than in another), the orienting protrusion 340 helps to force the bougie distal end 342 into a predetermined orientation relative to the body cavity. Optionally, the orienting protrusion 340 also operates to stretch out tissue of the body cavity, for example, to position it in preparation for attachment by suction.

[0172] In some embodiments of the present disclosure, the bougie 100 is provided with a foldable directional projection 340. By advancing (distal) the control member 341, the directional projection 340, which is usually folded and stowed against the side of the bougie capsule section 342, is guided to protrude. In some embodiments, the directional projection 340 is formed of a shape memory alloy such as Nitinol. Upon receiving sufficient slack from the distal advancement control member 341 to allow it to relax into its pre-formed shape, it assumes a predetermined shape, for example, including a bend 343. Optionally, the shape is a shape that is at least partially pushed into, for example, by generating pressure on the directional projection 340 of the attachment 333.

[0173] Figure 7 Also indicated are the locations of the segments 207, the cutouts 207A, the distal tip 112, the longitudinal barriers 115, and the lateral barriers 117, for example, as described with respect to FIG. Figure 1 Operate as described.

[0174] In some embodiments, the protrusion 340 is also controllable, by twisting to change the relative circumferential position of its distal and proximal ends. Potentially, this helps position the device, for example, by directing pressure against a tissue wall to reorient the distal end 342 of the bougie.

[0175] Expandable capsule section:

[0176] Reference now Figures 8A to 8B , which schematically shows a bougie capsule section 800 according to some embodiments of the present disclosure, including a capsule expansion barrier 815. Also refer to Figures 9A to 9B , which schematically shows a bougie capsule segment 900 including a capsule expansion barrier 815 and a foldable bougie orientation protrusion 940 according to some embodiments of the present disclosure. Bougie capsule segments 800, 900 are several examples of bougie capsule segments 101.

[0177] In some embodiments, a capsule expansion barrier 815 is configured to change shape (e.g., bulge) to expand a size of the suction clamp region 110; for example, to open the plurality of fenestrations 802 of the aperture region 110 to a larger size. This has the potential advantage of increasing the amount and / or depth of lumen wall tissue that is retained (potentially more safely) under vacuum. For example, by lengthening each fenestration 802 (in a direction laterally through the suction clamp region 110 and radially outward from the suction clamp region 110), a greater depth of tissue can potentially be brought in by suction at the location of needle penetration (e.g., by a spiral needle 201) that would occur during suturing.

[0178] In some example implementations, twice the thickness of tissue is vacuumed into a fenestration 802 to a sufficient depth to allow the suture needle to fully penetrate from the inside out, and then the body cavity tissue (e.g., stomach wall) from the inside out is vacuumed into the fenestration as it passes through the "bite point" of the tissue.

[0179] In some embodiments, the capsule expansion barrier 815 comprises an example of a longitudinal barrier 115, arranged to extend along a midline of the bougie capsule section 800, and configured to bulge outwardly to change shape under external control. For example, the control member 801 (an example of a control member 120) is advanced distally to allow the expansion capsule expansion barrier 815 to expand, and / or is pulled proximally (shortened) to flatten it. The capsule expansion barrier 815 optionally comprises a shape memory alloy, such as Nitinol, which returns to a predetermined shape when the control member 801 is advanced (extended) and allowed to relax. Optionally, the control member 801 actively pushes the barrier 815.

[0180] Optionally, the lateral barriers 117 are long enough and loose enough to allow the longitudinal barriers 815 to expand when the longitudinal barriers 815 are in the folded configuration. Alternatively, they are initially strung tighter, gradually reducing the slack as the longitudinal barriers 815 expand. In some embodiments, the lateral barriers 117 can adjust the tension to accommodate different degrees of expansion of the longitudinal barriers 815. In some embodiments, a control member 120 (not shown) is provided that can be manipulated to tighten / loosen the slack in the lateral barriers 117.

[0181] In some embodiments, a foldable bougie orientation protrusion 940 and a capsule expansion barrier 815 are provided, such as Fig.9A The fold shown in Fig. 9B The foldable bougie orientation protrusion 940 is operable, in some embodiments, by manipulation of a control member 941, see the foldable bougie orientation protrusion 340 and the control member 341 for details. Figure 7 Optionally, a spacing of the bougie capsule section 900 from a nearby tissue wall is controlled by a degree of expansion of the bougie orienting protrusion 340, pressing against the nearby tissue wall.

[0182] Reference now Figures 10A to 10D , which schematically shows a bougie capsule segment 1000, including a capsule expansion barrier 1015, together with a plurality of capsule expansion valves 1013, according to some embodiments of the present disclosure. Bougie capsule segment 1000 is an example of a bougie capsule segment 101. Fig. 10A and 10D A perspective view of a bougie capsule segment 1000 is shown. Fig. 10B and 10D A cross-sectional view of a bougie capsule segment 1000 is shown, at the level of a pair of valves 1013. For example, 2, 4, 6, 8, 10, 12 or other numbers of valves 1013 may be provided.

[0183] In some embodiments, a capsule expansion barrier 1015 and a capsule expansion valve 1013 are configured to move to expand a size of the suction forceps region 110 and a tissue receiving space 1020 therein; for example, to open the plurality of fenestrations 1002 of the opening region 110 to a larger size. As shown, the plurality of fenestrations 1002 are bounded on both sides by a plurality of lateral barriers 1017 (several examples of the plurality of lateral barriers 117), on one side by the capsule expansion barrier 1015, and on the other side by the valve edge 1013B.

[0184] Such expansion has the potential advantage of increasing the amount and / or depth of lumen wall tissue that can be retained (potentially more safely) under vacuum. For example, by expanding each fenestration 1002, a greater depth of tissue can potentially be brought in by suction at the location of needle penetration (e.g., by a spiral needle 201) that would occur during suturing.

[0185] The movement of the blocking member 1015 expands the aperture region 110, in some embodiments, Figures 8A to 9B The stopper 815 of the embodiment of the present invention is substantially the same as described above (e.g., by operation of the control member 801). In some embodiments, the movement of the stopper 1015 away from the plurality of valves 1013 allows the tension in the spring 1014 to cause the valves 1013 to open. The valves 1013 can stop opening when a stop interval 1016 contacts another portion of the opening area 110 (e.g., the spine interval 1031).

[0186] In addition, Figures 10A to 10B In the example of FIG. 1 , valve 1013 is expandable, for example, by operating (eg, pulling) control member 1001 . Control member 1001 is an example of control member 120 .

[0187] In some embodiments, operation of the control member 1001 causes the valve 1013 to swing (e.g., on a hinge) from a folded position to an expanded position. In some embodiments, the folded position comprises being arranged to point toward a midline plane that divides the aperture field 110 along a dorsal / ventral plane of the aperture field 110. In some embodiments, the expanded position comprises being arranged to point away from the midline plane. Optionally, each segment 207 is provided with a pair of valve supports 1013. Optionally, multiple valves 1013 are provided only at multiple ends of the aperture field, multiple ends of the aperture field and in the middle, or another configuration.

[0188] The plurality of lateral barriers 1017 may optionally include a plurality of cords sized to become taut when the open area 110 is fully expanded. In some embodiments, the lateral barriers 117 may be adjustable in tension to accommodate varying degrees of expansion of the longitudinal barriers 1015. In some embodiments, a control member 120 (not shown) is provided that may be manipulated to tighten / loosen the slack of the lateral barriers 1017.

[0189] In the example shown, Fig. 10A and 10B Multiple valves 1013 are shown in a fully collapsed position. Fig. 10D The partially expanded valve is shown, and Fig. 10C The fully deployed valve 1013 is shown.

[0190] In some embodiments, the expanded open pore region 110 is placed under a vacuum to induce attachment of tissue.

[0191] like Fig. 10C As shown, multiple fenestrations 1002 are oriented substantially perpendicular to a plane passing through the orifice field 110 in a ventral to dorsal direction. To attach to a tissue wall, the device is optionally first oriented with the fenestrations substantially orthogonal to the tissue wall (e.g., stomach wall) to which the device is to be attached; one wall on each side. Upon application of suction, the collapsed tissue wall folds over the valve edge 1013B onto the fenestrations 1002 and is secured. The two opposing tissue walls preferably meet approximately at the location of the longitudinal barrier 1015. Optionally, during the application of vacuum, the device is shaken by slight rotation about the longitudinal axis of the device to help promote tissue from only one of the tissue walls to fill each fenestration 1102.

[0192] Optionally, the plurality of windows 1002 are expanded to Fig. 10C For example, the capsule expansion barrier 1015 is expanded to a greater distance from a back side of the orifice region 110, the plurality of valves 1013 are shorter, and / or the valves 1013 are oriented by expansion such that the valve edges 1013B are closer to a back side of the orifice region than the expanded capsule expansion barrier 1015 when the valves 1013 are deployed.

[0193] Reference Figures 11A to 11D , which schematically illustrates a bougie capsule segment 1100, including a capsule expansion barrier 1115, and a plurality of capsule expansion outriggers 1113, according to some embodiments of the present disclosure.

[0194] Figures 11A to 11D A different structure for expanding the open area 110 is shown, including a plurality of support members 1113A, which are extended from a flat or relatively flat position (e.g., Fig.11A ) to a raised position having a more vertical ( Fig. 11B , 11C ) or perpendicular to ( Fig.11D )A longitudinal axis (along a distal-proximal direction) of the bougie capsule section 1100.

[0195] In some embodiments, the supports 1113A along each side are interconnected by a plurality of stabilizing rods 1113B that rise or fall as the supports 1113A turn about a turning point that is attached to the capsule body. In some embodiments, actuation to change the expansion state of the plurality of outriggers 1113 comprises operating a control member 1101. In some embodiments, the capsule expansion barrier 1115 is expanded (e.g., by the control member 801) and optionally this expansion also causes expansion of the outriggers 1113; for example, by tension applied to the lateral barriers 1117.

[0196] In some embodiments, the window 1102 is defined as a space bounded on two sides (e.g., the longitudinal axis boundaries) by a lateral barrier 1117, a space bounded on an inner side by a capsule expansion barrier 1115, and a space bounded on a lateral outward edge by a stabilizing rod 1113B.

[0197] The distal tip 112 and segments 207 are configured, for example, as described with respect to other figures herein.

[0198] Reference now Figures 12A to 12B , which schematically illustrates a bougie capsule segment 1200, including a capsule expansion barrier 1215, and a plurality of capsule expansion outriggers 1213, according to some embodiments of the present disclosure.

[0199] In some embodiments, activation to change the expansion state of the outrigger 1213 includes operating a control member 1201 .

[0200] Figures 12A to 12B A different structure for expanding the open area 110 is shown (ie, Figures 10A to 10D A variation of the multiple capsule expansion outriggers 1013 described herein) includes cross supports 1213A which extend from a flat or relatively flat position (e.g., Fig. 12A to a raised position ( Fig. 12B ).

[0201] In some embodiments, some of the supports 1213A along each side are oriented to a point in a more distal direction and some are oriented in a more proximal direction, forming multiple grids having multiple independent supports 1213A formed as components that are interconnected through their intersections.

[0202] Alternatively, in some embodiments, the mesh of support member 1213A is formed from a piece of shape memory metal such as Nitinol; for example, a piece that is generally folded (eg, Fig. 12A configuration), but will deform into an expanded shape, such as upon longitudinal compression (i.e., compression along a distal-proximal axis of the bougie capsule segment 1200), and / or upon dorso-ventral stretching (e.g., by lateral barriers 117 when the expanded capsule expansion barrier 1115 causes stretching (e.g., by control member 801).

[0203] In some embodiments, multiple windows 1202 are defined as spaces bounded on two sides (e.g., the longitudinal axis boundaries) by lateral barriers 1217, on an inner side by capsule expansion barriers 1215, and on a lateral outward edge by portions of multiple outriggers 1213B.

[0204] The distal tip 112 and segments 207 are configured, for example, as described with respect to other figures herein.

[0205] Reference now Fig. 20 , is a flow chart of a method for intracavitary use of a bougie capsule segment, according to some embodiments of the present disclosure.

[0206] The flowchart begins at block 2100 where, in some embodiments, a suction clamp region 200B of a bougie capsule section 200 is inserted into a cavity (eg, the stomach).

[0207] At block 2202, in some embodiments, a suture space of the bougie capsule segment is expanded along the suction clamp region. In some embodiments, the expansion includes using a control member 120 to activate movement of a support member, such as a plurality of outriggers, such as outriggers 1013, 1113, 1213. Additionally or alternatively, in some embodiments, the expansion includes using a control member to change the shape of a longitudinal barrier 115, which extends longitudinally along the suction clamp region. In some embodiments, the plurality of outriggers 1013, 1113, 1213 and / or longitudinal barrier 115 are also provided with a plurality of lateral barriers 117. These structures together define a plurality of support surfaces upon expansion, upon application of suction (in block 2204), and define a plurality of fenestrations 111, through which the collapsed tissue enters a suture space located along the suction clamp region.

[0208] At block 2204, in some embodiments, suction is applied. Under the action of the suction, the body cavity tissue collapses onto the expanded support surface of the suction forceps domain 200B. Some of the body cavity tissue is sucked into the suture space defined at the level of the suction forceps domain 200B through the openings between the support surfaces; for example, it is sucked into the suture space through multiple fenestrations. In some embodiments, the collapsed tissue is arranged so that tissue from a portion of the integral cavity wall is sucked into a left set of fenestrations, and tissue from another (e.g., facing) portion of the integral cavity wall is sucked into a right set of fenestrations. Optionally, the midline between left and right is defined by the longitudinal barrier 115.

[0209] Optionally, in some embodiments, Fig. 20 The method continues to block 2206, wherein a spiral needle 201 is rotated along the expansion portion of the suture space and is advanced longitudinally. In some embodiments, the spiral needle 201 is advanced longitudinally by frictionally contacting a rotating shaft handle 205, wherein the frictional contact occurs at multiple locations along the curved portion of the suture space.

[0210] Vacuum distribution:

[0211] Reference now Figures 13A to 13D , which schematically illustrates the internal structure of the bougie suction forceps domain 200B that affects vacuum distribution, tissue occlusion, and / or tissue clamping, according to some embodiments of the present disclosure. Fig.13A The bougie suction forceps domain 200B is shown viewed from a ventral to dorsal perspective. Fig. 13B A perspective view of the bougie clamp area 200B is shown. Figures 13C to 13D A side view of the bougie suction forceps field 200B is shown. Fig. 13C A side view of the suction forceps domain 200B from the proximal end 1320 is shown, and Fig.13DA side view of the suction forceps domain 200B from the distal tip 1321 is shown.

[0212] In some embodiments, the features of the bougie aperture field 200B include a plurality of shells 310, a plurality of gaps 311A, a plurality of needle channels 311, a cavity 208, a plurality of segments 207, and a plurality of apertures 206, such as those described herein. Figures 2A to 2B As described in the relevant description.

[0213] In some embodiments, the segment 207 includes a plurality of inwardly projecting portions 1300 defined between a plurality of needle channels 311, and a dorsal side 1303 that projects into an interior region (tissue receiving space 1330) of the suction forceps domain 200B from a dorsal side 1303. In some embodiments, the plurality of inwardly projecting portions 1300 include a plurality of laterally projecting branches 1305 that define a plurality of spaces 1302 between the branches 1305 and the dorsal side 1303, and tissue access (when suction is applied) is limited by a relatively narrow slot 1302B. For example, the slot 1302B spans about 2 to 3 millimeters. Potentially, the narrowness of the slot 1302B helps ensure that the space 1302 remains at least partially open when suction is applied, which in turn helps ensure that the low pressure caused by the applied suction is continuously distributed along the bougie aperture domain 200B. In some embodiments, applying suction bends tissue to contact multiple branches 1305 from within and outside of the space 1302, such as along a ventral surface 1307 located within a tissue receiving space 200B defined by the suction forceps domain.

[0214] In some embodiments, the convolution of tissue around the inwardly protruding portion 1300 helps to hold the tissue in place during suturing as it deforms under vacuum to fill the shape of the space 1302. Potentially, this helps prevent tissue from "bunching up" due to movement of the suture needle and / or helps reduce the risk of a tissue tear during advancement of the suture needle through tissue.

[0215] Optionally, the surface 1307 is shaped to have a curvature and placed at an insertion site on the inner back side of the suction forceps domain 200B so that an endoscope (eg, having a diameter of up to about 6 to 8 mm) can pass through the tissue receiving space 1330 of the suction forceps domain 200B.

[0216] In some embodiments, the inwardly protruding portion 1300 is hollowed out on one ventral surface. This may serve to help receive a sufficiently thick tissue when suction is activated.

[0217] The opening 1301, in some embodiments, is sized to allow the shaft 205 and / or the probe 205B to enter, for example, Figures 2A to 2B These elements are described in detail below.

[0218] Offset window opening:

[0219] Reference Figures 14A to 14B , which schematically illustrates a suction forceps region 200B of a bougie capsule segment 1401 including a plurality of offset fenestrations defined by a plurality of tissue supports 1403A, 1405B, according to some embodiments of the present disclosure. Figures 15A to 15C , which schematically illustrates variations in a suction forceps domain 200B of a bougie capsule segment 1501, 1522, 1543 comprising a plurality of offset fenestrations defined by tissue supports 1503A, 1503B, 1523C, 1523B, 1523D, 1523E, according to some embodiments of the present disclosure.

[0220] In some embodiments, tissue supports 1403A, 1405B, 1503A, 1503B, 1523C, 1523B, 1523D, 1523E are alternately distributed along both sides of a longitudinal midline of the bougie capsule section 1401. The tissue supports may be of different longitudinal lengths along one side of the midline and / or of different longitudinal lengths along different sides of the midline.

[0221] In use, when the suction forceps region 200B engages the tissue wall in a cavity under suction, a suture needle (e.g. Figures 2A to 2B The suture needle 201 in the suture clamp is spirally advanced along the suction forceps domain 200B. The suture needle 201 alternately penetrates the tissue and invades the two sides of the midline.

[0222] In some embodiments, a longitudinal barrier is provided (not shown, but it is accepted that, for example, Figures 14A to 14B , 15C) to help define and maintain the boundaries between the plurality of fenestrations 1402. The extent of the medial projections of the tissue supports 1403A, 1405B, 1523D, 1523C may be limited, and the space left partially filled by a longitudinal barrier such as longitudinal barrier 115, for example.

[0223] Optionally, rather than employing longitudinal barriers, the shapes, dimensions, and spacing of the tissue supports 1503A, 1503B, 1523C, 1523B are made to ensure tissue separation on alternating sides.

[0224] The sutures may be removed by passing through the plurality of gaps 1407 between adjacent corners of the tissue supports 1403A, 1405B.

[0225] Progressive window opening:

[0226] Reference now Figures 16A to 16B, schematically showing an arrangement of a suction clamp region 1605, allowing a window 1603 to be gradually unblocked through a longitudinal barrier 1601, according to some embodiments of the present disclosure. Figures 17A to 17E , which schematically illustrates an alternative arrangement of a suction clamp region 1700, allowing for gradual unblocking of a fenestration 1705 through a longitudinal barrier 1701, according to some embodiments of the present disclosure. Figures 17A to 17D Different stages of withdrawal of the longitudinal barrier 1701 are shown. Fig.17E 1701 at a horizontal cross section, according to some embodiments of the present disclosure. Figures 18A to 18B , schematically illustrates an alternative arrangement of a suction clamp region 1800, allowing for gradual unblocking of a fenestration 1802 via a longitudinal barrier 1801, according to some embodiments of the present disclosure. Figures 18A to 18B They represent different withdrawal stages of the longitudinal blocking member 1801 .

[0227] In some embodiments, a portion of a bougie body 1600, 1702, 1806 defines a large window 1603, 1705, 1802 (optionally a single large window) that is gradually elongated along a longitudinal axis of the bougie body by longitudinal movement of the longitudinal stop 1601, 1701, 1801 (e.g., by proximal withdrawal), for example, driven by a control member 1602, 1707, 1821. In some embodiments, the large window 1603, 1705, 1802 has a length along the longitudinal axis, for example, at least 4 centimeters (cm), 5 cm, 6 cm, 10 cm, or 15 cm. In some embodiments, the length is long enough to allow placement of at least 2, 3, 4, 5, or more sutures, for example, by a proximally advanced spiral needle 201. After positioning in the integral cavity: when the longitudinal barriers 1601, 1701, 1801 are retracted to reveal more fenestrations 1603, 1705, 1802; more tissue is drawn into the interior and is available for suturing, for example, by a spiral suture needle 201 that is pushed proximally.

[0228] In some embodiments ( Figures 16A to 16B , 18A to 18B), the longitudinal barrier 1601, 1801 includes a wide portion 1601, 1803 and a narrow portion 1603, 1805. The narrow portion 1603, 1805 helps define two laterally separated sides of the fenestration 1603, 1802 so that tissue—from, for example, opposing body cavity walls—is directed to one side or the other of the fenestration 1603, 1802 without one body cavity wall side completely filling the available space.

[0229] Optionally, ( Figures 18A to 18B), the longitudinal blocking member 1801 further comprises a partition 1807, which invades the internal space defined by the bougie body 1806 and simultaneously serves to block the internally invaded tissue under suction and prevent it from crossing a center line of the bougie body 1806.

[0230] exist Fig.17E , a portion of the internal structure of a longitudinal barrier 1701 is shown, including a plurality of internal support columns 1704 (curved and / or straight). Optionally, the longitudinal barrier 1701 is shaped so that it locks to the shape of the body 1702, for example, using the inward protrusion 1706 as a guide.

[0231] In an exemplary implementation, the wide portion 1803 is cut along its length by a plurality of slits 1810. This may help maintain flexibility of the bougie body 1802 and / or help the bougie body 1802 collapse in a vacuum under suction of the tissue walls of a body cavity when inserted into the body cavity.

[0232] generally:

[0233] As used herein, the term "about" with respect to a quantity or value means "within ±10% of."

[0234] The terms "comprises," "comprising," "includes," "including," "having" and conjugations thereof mean "including but not limited to."

[0235] The term "consisting of" means "including and limited to."

[0236] The term "consisting essentially of" means that the composition, method or structure may include additional ingredients, steps and / or components, but only if the additional ingredients, steps and / or components do not substantially change the basic and novel characteristics of the claimed composition, method or structure.

[0237] As used herein, the singular forms a, an, and the include the plural forms unless the context clearly indicates otherwise. For example, the term a compound or at least one compound may include a plurality of compounds, including mixtures thereof.

[0238] The terms "exemple" and "exemplary" are used herein to mean "serving as an example, instance, or illustration." Any embodiment described as an example or illustration is not necessarily to be construed as preferred or advantageous over other embodiments and / or to exclude incorporation of features from other embodiments.

[0239] The term optionally is used herein to indicate that something is provided in some embodiments but not in other embodiments.Any particular embodiment of the present disclosure may include a number of optional features unless such features conflict.

[0240] The term "method" as used herein refers to ways, means, techniques and procedures for accomplishing a given task, including but not limited to those ways, means, techniques and procedures known to practitioners in the fields of chemistry, pharmacology, biology, biochemistry and medicine or readily developed from known ways, means, techniques and procedures.

[0241] As used herein, the term "treating" includes abrogating, substantially inhibiting, slowing or reversing the progression of a disorder, substantially ameliorating the clinical or aesthetic symptoms of a disorder or substantially preventing the appearance of clinical or aesthetic symptoms of a disorder.

[0242] Throughout the application, the present invention may present various embodiments in a range format. However, it should be understood that the description in range format is only for convenience and simplification and should not be interpreted as a mandatory limitation on the scope of the present invention. Therefore, the description of the range should be considered to have specifically disclosed all possible sub-ranges and individual numerical values ​​within the range. For example, the description of the range, such as "from 1 to 6", should be considered to have specifically disclosed sub-ranges, such as "from 1 to 3", "from 1 to 4", "from 1 to 5", "from 2 to 4", "from 2 to 6", "from 3 to 6", etc., as well as individual numbers within the range, such as 1, 2, 3, 4, 5 and 6. No matter how wide the range is, it is applicable.

[0243] Whenever a numerical range is indicated herein (e.g., "10-15," "10 to 15," or any set of numbers, any pair of numbers linked by such another such range indicator) it is intended to include any number (fractional or integer) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases "range / ranging / ranges between" and "range / ranging / ranged from" between a first indicating number and a second indicating number—a first indicating number, "to," "up to," "until," or "through" (or another such range indicating term)—a second indicating number are used interchangeably herein and are intended to include the first and second indicating numbers, and all fractions and integers therebetween.

[0244] Although the disclosure has been described in conjunction with specific embodiments, it is apparent that many substitutions, modifications and variations will be apparent to those skilled in the art. Therefore, the disclosure is intended to cover all substitutions, modifications and variations that fall within the spirit and scope of the appended claims.

[0245] All publications, patents and patent applications described in this specification are hereby incorporated in their entirety into this specification for reference to the same extent that each single publication, patent or patent application is specifically and individually indicated as being incorporated herein by reference. In addition, the citation of any reference or definition in this application should not be interpreted as an admission that this reference is available as a prior art of the present invention. In the case where the section title is used, it should not be interpreted as a necessary limitation.

[0246] It should be appreciated that certain features of the invention, which, for clarity, are described in the context of separate embodiments, may also be provided in combination in a single embodiment.

[0247] For the sake of brevity, what is described in the context of a single embodiment may also be provided separately or in any suitable subcombination, or as applicable to any other described embodiment of the invention. Certain features described in the context of various embodiments should not be considered essential features of the embodiment, unless the embodiment is non-functional without the elements.

[0248] In addition, any priority documents of the present application are hereby incorporated by reference in their entirety.

Claims

1. A bougie capsule section configured to shape and sew tissue of a body cavity from within the body cavity, characterized in that: The bougie capsule section comprises: a capsule body extending along a longitudinal axis through a suction clamp region between a distal side and a proximal side of the bougie capsule section; and a suturing space defined by a plurality of support surfaces of the suction forceps region, configured to receive the tissue of the body cavity collapsed onto the plurality of support surfaces when the bougie capsule section is inserted into the body cavity by applying suction to the suction forceps region; wherein the capsule body comprises a plurality of hinged pieces, the hinged pieces being configured to change angles relative to each other to create a bend in the capsule body; a spiral needle located inside the bougie capsule section, the spiral needle comprising a relatively high friction surface and a relatively low friction surface, wherein the low friction surface presses against multiple surfaces of the capsule body; wherein the bougie capsule section comprises a shaft adapted to extend longitudinally through the suction clamp region and press against the spiral needle; and the shaft is rotatable by friction between the shaft and the spiral needle to drive the rotation of the spiral needle, and the hinge is curved on both sides of a position where the shaft presses against the spiral needle; and The spiral needle is pressed between the shaft handle and multiple surfaces of the capsule body.

2. The bougie capsule section according to claim 1, characterized in that: The suction forceps domain includes the plurality of hinged pieces.

3. The bougie capsule section according to any one of claims 1 to 2, characterized in that: The plurality of hinge tabs are a single continuous piece longitudinally interconnected by thin material between the hinge tabs, and the thin material between the hinge tabs is thin enough to allow flexure of the plurality of hinge joints.

4. The bougie capsule section according to any one of claims 1 to 2, characterized in that: The hinge plate defines a plurality of helically arranged channels, and the helical needle is configured to be advanced longitudinally as it rotates through the helically arranged channels while the hinge plate is curved.

5. The bougie capsule section according to any one of claims 1 to 2, characterized in that: The bend is produced by longitudinal movement of a control member, the control member being attached to the capsule body through a longitudinal barrier, the longitudinal barrier extending longitudinally through the suction clamp region to provide a portion of the plurality of support surfaces and dividing an opening section introduced into the suture space longitudinally into a plurality of separate openings on both sides of the longitudinal barrier; And wherein movement of the longitudinal barrier creates the bend in the capsule body based on the longitudinal movement of the control member.

6. The bougie capsule section according to any one of claims 1 to 2, characterized in that: The helical needle extends around the shaft.

7. The bougie capsule section according to any one of claims 1 to 2, characterized in that: The capsule body and the shaft handle are flexible, and when the capsule body is bent, the shaft handle contacts the spiral needle at a section of the capsule body and the shaft handle passes through the section.

8. The bougie capsule section according to any one of claims 1 to 2, characterized in that: The shaft handle includes a cable segment and a probe segment, wherein the cable segment includes a plurality of wire bundles and the probe segment includes a solid piece, and the probe segment is positioned along the capsule body, wherein the probe segment is pressed onto the spiral needle.

9. The bougie capsule section of claim 8, wherein: The probe segment has a fixed and uniform diameter.

10. The bougie capsule section of claim 8, wherein: The probe section is tapered.

11. The bougie capsule section of claim 8, wherein: The shaft handle is configured to move longitudinally when the shaft handle is rotated.

12. The bougie capsule section of claim 11, wherein: The longitudinal movement of the probe segment maintains the contact of the probe segment with the helical needle during a longitudinal movement of the helical needle.

13. The bougie capsule section according to any one of claims 1 to 2, characterized in that: The capsule body includes a plurality of longitudinally aligned cavities arranged along the capsule body, and the shaft extends through the cavities; wherein the shaft is held against the spiral needle at one or more locations between the plurality of longitudinally aligned cavities.

14. The bougie capsule section according to any one of claims 1 to 2, characterized in that: The shaft stem includes a surface region that is treated to increase friction.

15. The bougie capsule section according to any one of claims 1 to 2, characterized in that: The relatively high friction surface of the helical needle includes a high friction coating.

16. The bougie capsule section of claim 1, wherein: The arbor directly contacts the relatively high friction surface of the spiral needle.

17. The bougie capsule section according to any one of claims 1 to 2, characterized in that: The bougie capsule section is expandable by movement of the plurality of support surfaces.

18. The bougie capsule section of claim 17, wherein: Expansion of the bougie capsule section by outward movement of the plurality of support surfaces increases a cross-sectional size of the suture space.

19. The bougie capsule section of claim 17, wherein: The suture space includes a dorsal side, a ventral side and a ventral midline of the ventral side, and at least some of the multiple support surfaces are attached to multiple side edges of the suture space laterally to the ventral midline, and the multiple support surfaces move laterally outward from the capsule body when braked by a control member.

20. The bougie capsule section of claim 19, wherein: The plurality of support surfaces are attached to the capsule body via a plurality of swivels.

21. The bougie capsule section of claim 17, wherein: The suture space includes a dorsal side, a ventral side and a ventral midline of the ventral side, and at least some of the multiple support surfaces are multiple surfaces of multiple outriggers, the outriggers are attached to the side edges of the suture space lateral to the ventral midline, and the outriggers are configured to move the multiple support surfaces from the capsule body in an abdominal direction when braked by a control member.

22. The bougie capsule section of claim 17, wherein: At least some of the support surfaces are surfaces of a longitudinal barrier configured to project outwardly from along a ventral midline of the capsule body when actuated by a control member.

23. The bougie capsule section of claim 22, wherein: The bougie includes a collapsible bougie orienting tab anchored at a distal end and configured to expand outwardly upon distal advancement of a control member, the control member being attached to the collapsible bougie orienting tab.

24. The bougie capsule section according to any one of claims 1 to 2, characterized in that: The suture space is framed by: a plurality of tissue support structures extending along both sides of a longitudinal axis of the bougie capsule section, and a back wall extending between the tissue support structures and along the tissue support structures at a position facing away from the tissue support structures; One of the inwardly protruding portions protrudes from the back wall into the suture space, dividing it to define a plurality of channels on both sides of the inwardly protruding portion.

25. The bougie capsule section of claim 24, wherein: The inward protrusion is branched on both sides to a lateral protrusion, and the lateral protrusion defines a hollow portion between the inward protrusion and the back wall.

26. The bougie capsule section according to any one of claims 1 to 2, characterized in that: The plurality of support surfaces include a longitudinal barrier extending longitudinally along the suction clamp region to longitudinally divide an opening section introduced into the suture space into a plurality of separate openings on both sides of the longitudinal barrier; and Wherein the longitudinal barrier is configured such that movement of the longitudinal barrier creates a bend in the capsule body.

27. The bougie capsule section of claim 26, wherein: The longitudinal blocking member is removable from above the opening interval to remove the individual opening windows divided longitudinally.

28. The bougie capsule section according to any one of claims 1 to 2, characterized in that: The plurality of support surfaces include a closing portion of a longitudinal barrier extending through a proximal side of an open section introduced into the suture space to close a proximal end portion of the open section; and The longitudinal blocking member is configured to be retracted toward the proximal end to gradually open the proximal portion of the opening section.

29. The bougie capsule section of claim 28, wherein: The open area is opened by fully retracting the longitudinal blocking member, and the open area includes a single opening of at least 5 cm in length.

30. The bougie capsule section of claim 28, wherein: The longitudinal barrier comprises a narrow portion of the longitudinal barrier, which is narrower than the closing portion, extends distally from the closing portion, and is longitudinally divided into a plurality of separate windows along the suction forceps region on both sides of the longitudinal barrier so as to introduce an opening section into the suture space.

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