Apparatus and method for use in minimally invasive anastomosis creation and / or endoluminal navigation - Patents.com

Abstract

An apparatus (10) that is intraluminally insertable into a body lumen, such as the gastrointestinal tract, and operable to manipulate body lumen tissue to create a target site for an anastomosis by bringing sections of the body lumen tissue into close relationship with one another, the apparatus comprising: an anchor assembly (12) including an anchor for fixing at a selected location within the body lumen; at least a first tensioning assembly (14a, 14b) configured to retract a portion of the body lumen longitudinally from within the body lumen by pulling the separated tissue towards the anchor assembly; a lateral movement device (22, 24) configured to move first and second sections of the body lumen tissue that are longitudinally spaced apart along the body lumen laterally into wall-to-wall engagement with one another; and a deployment device for deploying one or more instruments and / or devices for creating the anastomosis.

Description

[Technical field]

[0001] FIELD OF THEINVENTION The present invention relates to the fields of (i) anastomosis creation using minimally invasive techniques, and (ii) endoluminal navigation. Some embodiments relate to an endoluminal device for use in anastomosis creation. [Background technology]

[0002] 2. Background of the Invention An anastomosis is a surgical cross-connection or bridge between two different compartments of a body lumen. The gastrointestinal tract is the luminal pathway in the body from the esophagus to the anus. Anastomoses formed along or anywhere in the gastrointestinal tract are a form of therapy used to treat digestion-related problems such as diabetes, obesity, bowel disease and blockages. Anastomoses can be used to bypass parts of the gastrointestinal tract, such as parts of the small intestine, to avoid sensitive areas or to affect or reduce the absorption of nutrients.

[0003] Currently, laparotomy provides the most comprehensive access to internal anatomical structures for creating anastomoses. However, laparotomy is highly invasive and not suitable for many patients and conditions to be treated. Although minimally invasive procedures have been proposed, significant challenges remain in creating anastomoses equally effectively by minimally invasive procedures, especially intraluminally. In intraluminal procedures, one or more instruments are introduced into the body, primarily through the body tract where the anastomosis is to be performed. Current intraluminal techniques are best suited for anastomosis procedures that are relatively shallow within the body tract and are formed between wall sections that are already naturally located close to each other. This limits the versatility of procedures of, for example, the small intestine, which can have a length of up to 6 or 7 meters in most adults and is folded many times within the abdomen.

[0004] Current techniques for endoluminal navigation within the gastrointestinal tract also depend on the ease of following the tube within the anatomy and passing the tube from one section to another. However, there are areas of the anatomy where the natural tendency of the device to follow the path of least curvature can impede ease of navigation unless complex and expensive maneuvers are implemented. Summary of the Invention [Problem to be solved by the invention]

[0005] Summary of the Invention It would be desirable to address and / or alleviate one or more of the above problems. [Means for solving the problem]

[0006] Aspects of the invention are defined in the claims. Broadly speaking, one aspect of the present invention provides a device that is insertable into a body tract (e.g., the gastrointestinal tract) and operable to manipulate the body tract tissue by bringing sections of the body tract tissue into close proximity to one another to create a target site for anastomosis.

[0007] The apparatus can include an anchor assembly and at least a first tensioning assembly.

[0008] The anchor assembly includes an anchor for fixation at a selected location within a body vessel. The first tensioning assembly is configured to contract a portion of the body lumen longitudinally from within the body lumen by pulling the remote tissue towards the anchor assembly. Contracting the tissue longitudinally may also be referred to herein as foreshortening.

[0009] In some embodiments, the first tensioning assembly comprises at least one elongate member expandable and contractible for movement within the body lumen and at least one distal balloon expandable to frictionally engage an inner surface of the body lumen to allow the frictionally engaged tissue to be pulled towards the anchor assembly.

[0010] Such a configuration can greatly facilitate manipulation of the body lumen tissue, allowing tissue wall sections that naturally separate from the anchor to be brought much closer to the anchor assembly by atraumatically drawing the tissue from within the body lumen itself. The body lumen contracts longitudinally, effectively folding or gathering the body wall tissue like a concertina, drawing the separated tissue closer. Optionally, the device is configured for intraluminal introduction into the body lumen.

[0011] In some embodiments, the elongate member may be extendable from the anchor assembly within the body lumen to access remote tissue. The balloon may be expanded to frictionally engage tissue at the remote location. The elongate member may be retracted toward the anchor assembly to pull the frictionally engaged tissue toward the anchor assembly, thereby longitudinally contracting the body lumen and bringing the remote tissue closer to the anchor assembly.

[0012] In some embodiments, the first tensioning assembly optionally comprises a first and a second elongated member, each carrying a respective (first and second, respectively) inflatable balloon. This can allow for gradual contraction of the body lumen tissue and / or is particularly suitable for tortuous body lumen such as the small intestine. For example, in use, the first elongated member may be stretched with its balloon in a deflated state, and the second elongated member remains retracted, and optionally its balloon inflates to hold any pre-contracted tissue. When the first elongated member is stretched to access the distant tissue, the first balloon may inflate to engage the distant tissue and secure it. The second balloon may be deflated, the second elongated member is stretched adjacent to the first elongated member and the balloon, and the second balloon is inflated to engage the tissue adjacent to the first balloon. The first and second members may be retracted with at least one balloon, and optionally both balloons, frictionally engaging the luminal tissue to allow the tissue to be pulled towards the anchor assembly during retraction. The first balloon is then deflated and the first member is again extended to access the next area of ​​distant tissue, while the second balloon holds the deflated luminal tissue in its contracted state. This process may be repeated multiple times to contract the luminal tissue in longitudinal steps, thus facilitating access to distant folded tissue, even deep within the small intestine, for example.

[0013] In some embodiments, the first and second elongate members of the first tensioning assembly may be nested within one another. At least one, and optionally both, of the elongate members may be tubular. For example, the first elongate member may be nested within the second elongate member and longitudinally slidable relative to the second elongate member.

[0014] At least one elongate member of the first tensioning assembly may be at least partially deflectable and / or steerable, for example at its distal end, to facilitate guidance as it extends into the body lumen.

[0015] The term "balloon" is used herein to refer to any inflatable body or inflatable cuff that can be inflated by an inflation fluid. The inflation fluid may be a liquid (e.g., saline) or a gas (e.g., air). At least one, and optionally each, balloon may be generally spherical (e.g., generally frusto-conical) in shape, or may be generally ovoid in shape, or may be generally cylindrical in shape. Any other shape of balloon may be used as desired to fit the body lumen.

[0016] The anchors of the anchor assembly can be deployable from a collapsed state to a deployed state. The deployable anchors can include, for example, an inflatable retention balloon.

[0017] One or more assemblies of the device may comprise or consist of polyetheretherketone, polyethyleneterephthalate, polyimide and / or polyamide.

[0018] Regardless of how the first tensioning assembly and / or anchor assembly are implemented, the apparatus may optionally further include a lateral movement device and / or deployment device for deploying one or more instruments and / or devices for creating the anastomosis.

[0019] The lateral movement device, if provided, may be configured to move first and second sections of body canal tissue that are longitudinally spaced apart along the body canal laterally toward and / or into wall-to-wall engagement with one another.

[0020] The lateral movement device can allow two sections of body conduit tissue, e.g., previously separated sections that have been brought closer together by a first pulling assembly, to be pulled (e.g., further) toward and / or retracted into wall-to-wall engagement with one another so as to be suitable as target sites for anastomosis. For example, if two wall sections are close together but offset from one another, a second pulling assembly can pull the two sections into wall-to-wall engagement such that the outer surfaces of the wall sections engage. The lateral movement device can, for example, bend the body conduit so that the wall sections are brought closer together.

[0021] By initially using the first tensioning assembly to longitudinally contract the body canal, thus drawing the separated tissues closer together, the lateral movement device need only move the tissue a relatively short distance to move the tissue toward or into wall-to-wall engagement.

[0022] The combination of the first pulling assembly and lateral movement device allows for tissue access and manipulation even deep within the anatomy, which can increase the versatility and effectiveness of minimally invasive procedures, particularly endoluminal, for anastomosis creation.

[0023] Various types of lateral movement devices are possible. For example, the lateral movement device can be implemented as part of an elongate member of a first tensioning assembly configured to allow for the application of a lateral force to move or bend the tube laterally. In some embodiments, the lateral movement device comprises a second tensioning assembly configured to span locations along the body tube by passing outside the body tube and to pull the spanned locations toward one another wall-to-wall engagement, e.g., an outer wall-to-wall engagement.

[0024] As already described above, by first using a first tensioning assembly to longitudinally contract the body canal, thus drawing the separated tissues closer together, the second tensioning assembly need only span a relatively short distance to connect and draw the tissue into wall-to-wall engagement. Movement of the second spanning assembly across tissue locations outside the canal requires only local guidance, e.g., fluoroscopy or ultrasound imaging, because the distance is relatively short.

[0025] In some embodiments, the second tensioning assembly comprises an expandable cross-bridge element for passing through and spanning the distance between the tissue wall at two different sections. The second tensioning assembly further comprises a connection device in the form of a deployable distal shoulder for engaging behind one of the tissue wall sections to allow the tissue wall sections to be pulled towards wall-to-wall engagement with one another. Additionally or alternatively, a connection device in the form of a suction port may be used to allow the cross-bridge element to be externally connected to the tissue wall using negative pressure to maintain the connection.

[0026] In some embodiments, the spanning element is configured to penetrate the tissue wall when extended. Optionally, the spanning element is at least partially deflectable and / or steerable, e.g., at its tip, to guide it as it extends to span the distance between the first and second sections.

[0027] In some embodiments, the cross element may be extendable from the anchor assembly and advanceable to pass outside the body lumen through an adjacent tissue wall. The cross element may be advanceable toward a distal end of the first tensioning assembly for penetrating rearwardly through the tissue wall proximate or at the first tensioning assembly.

[0028] Alternatively, the crossing elements may be extendable from the first tensioning assembly and advanceable through an adjacent tissue wall past the exterior of the body lumen. The crossing elements may be advanceable toward the anchor assembly so as to pass back through the tissue wall near or at the anchor assembly.

[0029] In either case, the distal shoulder may be deployed to anchor behind the pierced tissue wall, thereby allowing the tissue wall to be tensioned when the cross elements are retracted.

[0030] The expandable shoulder may include, for example, an inflatable balloon or an expandable mechanical structure, such as a self-expanding frame or stent.

[0031] The partially deployed stent may include deployable shoulders that can be used to retract a vessel segment in at least a partially deployed state, and function as an implantable stent to create an anastomosis in a fully deployed state. The stent optionally creates a temporary through-channel anastomosis.

[0032] The temporary penetration channel allows the products of digestion to pass through the gastrointestinal tract until a permanent anastomosis is created, thereby obviating the need for a second operative procedure.

[0033] In addition to or instead of the second tensioning assembly, the deployment device may be configured to deploy one or more instruments and / or devices for creating the anastomosis. For example, the deployment device may be configured to deploy one or more instruments and / or devices into a position established by the second tensioning assembly where a section of the vessel wall is pulled toward wall-to-wall engagement.

[0034] The device for creating the anastomosis may optionally include a stent for creating a stent anastomosis and / or a magnetic device for creating a magnetic compression anastomosis.

[0035] The stent for creating an anastomosis can be configured to be monolithic (a single fully connected piece) so that the stent is deployed on both sides of the inside of the body vessel where the vessel wall is penetrated. The magnetic device may be configured to apply force from both sides of the adjacent tissue wall, or the device may be one component of a pair of separate devices that are deployable in alignment with each other at different locations within the vessel and are attracted to each other by magnetic attraction. The other components may also be deliverable and deployable by the same device (e.g., by a second deployment device of the device).

[0036] Instruments for creating the anastomosis may optionally include tissue cutters and / or tissue fixation devices for inserting sutures and / or staples or other tissue fasteners to join tissue of opposing vessel wall sections together around the reciprocal openings that define the anastomosis channel.

[0037] Devices and / or instruments for creating an anastomosis may be introduceable through a working channel of the apparatus and / or may be loadable or loaded into a receiving area of ​​the deployment device, where the devices and / or instruments are deployable from the receiving area upon actuation of the deployment device.

[0038] In some embodiments, the deployment device is positioned proximally from the anchoring assembly. In alternative embodiments, the deployment device is positioned distally from either the first advanceable balloon and / or the second advanceable balloon. This positioning allows for deployment of an instrument for creating an anastomosis outside of the region of the contracted body lumen between the anchoring assembly and the advanceable balloons.

[0039] In some embodiments, the apparatus comprises a connection device which may comprise a second tensioning device.

[0040] The connection device can be configured to bring the outer surfaces of two sections of a body tube into close contact with each other at a target site to form an anastomosis by bending the body tube and fixing the target sites of the outer surface sections relative to each other.

[0041] The connection device may include a suction device for aligning and / or positioning the body lumen walls relative to one another and / or deploying the tissue cutter by applying negative pressure.

[0042] In one embodiment, at least a portion of the device, preferably the inner assembly, is capable of assuming a bent configuration without piercing the body vessel, thereby providing closer contact to the target site for anastomosis of two sections of the body vessel.

[0043] The retention assembly and / or balloon can be thought of as assuming a predetermined shape designed with an angle such that the contracted portion of the body vessel assumes an arc that brings the sections of the body vessel closer together. In one embodiment, the retention assembly and / or balloon is configured to be asymmetric about the inner assembly or the outer assembly. The retention assembly and / or balloon can be configured to have a longer longitudinal extension on one side of the inner assembly, tensioning assembly and / or outer assembly than the other side in the deployed and / or inflated state to allow the device to assume a bent shape.

[0044] The tissue cutter may comprise a cutting element, a piercing element, an electrical or optical ablation element. The tissue cutter may further comprise a cutting element comprising a laterally expandable and / or collapsible profile and / or periphery. In one embodiment, the cutting element comprises an opposing surface that may be deployed on the opposite side of the body vessel to be cut. The opposing surface covers the target area of ​​the body vessel wall, thereby preventing leakage. In one embodiment of the device, the opposing surface also comprises a laterally expandable and / or collapsible profile and / or periphery.

[0045] The laterally extended contour and / or periphery of the cutting element and / or the facing surface may preferably be of predetermined dimensions.

[0046] The cutting element may further be configured to be rotatable along its circumferential direction, optionally in a helical motion along its longitudinal direction.

[0047] The device may include a temporary compression element for creating the compression anastomosis. In one embodiment, the temporary compression element includes a magnetic element. The temporary compression element is preferably positionable on either side of the body lumen tissue at the target site to create the compression anastomosis.

[0048] The connection device may include a cross element. The deployable shoulders can be reversibly converted to a stowed configuration and an expanded configuration. The deployable shoulders can comprise balloon elements, shape memory alloys, wire mesh, monolithic structures, frame structures, and / or polygonal structures, which allow the cross elements to increase their lateral dimensions in the expanded configuration to a greater lateral dimension than in the stowed configuration.

[0049] The increased lateral dimension provided by the deployable shoulder in the expanded configuration is preferably greater than the incision, piercing and / or cutting provided by the tissue cutter.

[0050] The increase in the lateral dimension is greater than 200%, optionally greater than 300%, particularly optionally greater than 400%.

[0051] Balloons and / or assemblies and / or elements that are reversibly transformable by expanding to a predetermined lateral dimension allow for the use of non-elastic materials, which are tougher in terms of wear and tear, thus increasing patient safety.

[0052] The non-collapsible balloons and / or assemblies and / or elements can have fixed, predetermined maximum and minimum lateral dimensions upon application of appropriate pressure and can frictionally engage the tissue being tensioned with the greatest possible tightness.

[0053] In such embodiments, different geometric shapes may be envisaged, such as a folded zigzag and / or concertina structure.

[0054] Since such non-foldable balloons and / or assemblies and / or elements do not rely on elastic deformation, the materials used can be radially rigid.

[0055] The non-collapsible balloons and / or assemblies and / or elements may comprise or consist of polyamide, polyethylene terephthalate and / or polyether block amide.

[0056] In one embodiment, the apparatus may comprise a pressurizing device, optionally arranged in a region of the proximal end of the apparatus, capable of fluid communication with at least one balloon, such that fluid can be transferred from the pressurizing device into the balloons, preferably into the at least two balloons independently of each other. The pressurizing device is capable of reversibly transforming the at least one balloon from a collapsed state to an expanded state.

[0057] The pressurizing device can include a simple system of multiple syringes or a more advanced system of automated pumps.

[0058] The pressurizing device may also be equipped with a communication interface that allows the device to operate automatically without the user having to manually control the fluid delivery. A user may enter inputs into the communication interface, such as the length to be contracted of a portion of a body vessel.

[0059] It is also conceivable that a pressurizing device is arranged within the apparatus with a predetermined source of compressed fluid.

[0060] The balloons are placed in fluid communication with the pressurization device via at least one flow path. In a preferred embodiment, the balloons are in fluid communication with the pressurization device via individual flow paths. However, it is contemplated that the pressurization device can be used to transfer fluid directly from one balloon to another.

[0061] The device may include at least one visualization element, and preferably includes at least one of: (i) a camera; (ii) a radiopaque material; and (iii) an ultrasound opaque material.

[0062] An optional visualization element may make it possible to identify the location of the delivery device. The visualization element may preferably enable one to identify the relative position of at least one balloon, preferably a plurality of balloons, with respect to the fixation assembly.

[0063] A further aspect of the invention, which may optionally be used independently of the preceding aspects or in combination with any of the preceding aspects, relates to intraluminal guidance within the gastrointestinal tract.

[0064] This aspect relates to a device for insertion through the mouth of a patient into the gastrointestinal tract and guidance at the pylorus, the device optionally according to any of the previous aspects, the device comprising: a first elongated tubular member having a distal end insertable into the patient's mouth and into the gastric antrum, the tube including a first region carrying an inflatable balloon configured to displace the first region of the tube away from the stomach wall upon inflation of the balloon; a second elongated member slidable within the first elongated tubular member, extending from a distal end of the first tubular member, and translatable from a position spaced from the stomach wall by the balloon to pass through the pylorus; Equipped with.

[0065] The shape of the anatomy in the region of the gastric antrum and pylorus can pose problems with intraluminal navigation of a device introduced through a patient's mouth, through the stomach, and into the small intestine. By displacing the tip away from the stomach wall, such as at the fundus of the antrum, the tip can be better aligned with the pylorus, for example, to avoid the tip becoming lodged in the pyloric antrum and allow for more direct, atraumatic navigation through the pylorus.

[0066] The first portion may be near or at the distal end of the first elongate tubular member. In some embodiments, the device is configured to deliver the device through the pylorus for placement at least partially in the duodenum and / or for at least partially traversing the pylorus. Optionally, the device may comprise a duodenal liner sheath and / or an anchor for anchoring near or at the pylorus. The device may optionally be part of an apparatus.

[0067] A further aspect of the invention provides a method of endoscopically manipulating a body lumen tissue to create a target site for anastomosis by bringing sections of the body lumen tissue into close relationship with one another using an intraluminally insertable device within the body lumen, the device optionally being as defined in any preceding aspect, the method comprising: deploying an anchor for the device to secure the device at a selected location within the body lumen; activating a first tensioning assembly of the device to retract a portion of the body lumen longitudinally from within the body lumen by pulling the loose tissue toward the anchor assembly; the method further comprising: operating a lateral movement device of the apparatus to move first and second sections of body canal tissue that are spaced apart longitudinally along the body canal laterally toward and / or into wall-to-wall engagement with one another; and / or Operate the deployment device to deploy one or more instruments and / or devices for creating an anastomosis. Includes at least one of the following.

[0068] The step of operating the first tensioning assembly may include longitudinally contracting a portion of the body lumen such that the first and second sections of the body lumen tissue move from a longitudinally spaced apart relationship to a closer relationship.

[0069] The optional step of operating the lateral movement device can further move the first and second sections of the body duct tissue from a closer relationship into wall-to-wall engagement by moving one or both of the first and second sections laterally relative to the other.

[0070] A further aspect of the invention provides a method of endoscopically navigating within a patient's gastrointestinal tract, the method optionally including any of the method steps and / or apparatus of any of the preceding aspects, the method comprising: advancing a first elongated tubular member within the gastrointestinal tract to position a first portion of the first member within the restricted region of the tract to be traversed; inflating a balloon on the first elongated tubular member to displace a first portion of the first elongated tubular member away from a wall of the vessel; advancing a second elongated member within the first elongated member to pass through the restriction in the vessel at a location spaced from the tissue wall by the balloon of the first elongated tubular member; Includes.

[0071] The first portion of the first elongate member may be at or near a tip of the first elongate member.

[0072] In some embodiments, the restriction in the gastrointestinal tract is the pylorus. The method may optionally further include deploying an implant in the gastrointestinal tract. Optionally, the implant comprises at least one selected from a duodenal sleeve, a duodenal anchor for the duodenal sleeve, a transpylorus anchor for the duodenal sleeve, and a gastric anchor for the duodenal sleeve.

[0073] In any of the embodiments disclosed herein, the device or any component may optionally be formed by three-dimensional printing.

[0074] Although certain ideas, features and advantages have been emphasized above, protection is claimed for any novel features disclosed in the specification and / or drawings, whether or not emphasis has been applied. [Brief description of the drawings]

[0075] [Figure 1] 1 is a schematic side view of a distal region of an intraluminal device. [Diagram 2] 2 is a schematic cross-sectional view illustrating the introduction of the device of FIG. 1 through the esophagus and stomach toward the small intestine. [Diagram 3] 3 is a schematic cross-sectional view similar to FIG. 2 showing advancement of the device of FIG. 1 to a selected location within the small intestine. [Figure 4] 4 is a schematic cross-sectional view similar to FIG. 3 showing fixation of the device of FIG. 1 at a selected location within the small intestine and a first stage of operation of a first tensioning assembly of the device to access distant tissue. [Diagram 5] 5 is a schematic cross-sectional view similar to FIG. 4 showing a second stage of operation of the first tensioning assembly of the device to longitudinally contract a region of the intestine. [Figure 6] 6 is a schematic cross-sectional view similar to FIG. 5 showing a third stage of operation of the first tensioning assembly to access distant tissue. [Figure 7] FIG. 7 is a schematic cross-sectional view similar to FIG. 6, showing a fourth stage of operation of the first tensioning assembly. [Figure 8] FIG. 8 is a schematic cross-sectional view similar to FIG. 7 showing a fifth stage of operation of the first tensioning assembly to further contract the intestine longitudinally. [Figure 9] 9 is a schematic cross-sectional view similar to FIG. 8, showing a first stage of operation of the lateral movement device. [Figure 10] 10 is a schematic cross-sectional view similar to FIG. 9, showing a second stage of operation of the lateral movement device. [Figure 11]11 is a schematic cross-sectional view similar to FIG. 10, showing a third stage of operation of the lateral movement device. [Figure 12] 12 is a schematic cross-sectional view similar to FIG. 11, showing a fourth stage of operation of the lateral movement device. [Figure 13] 13 is a schematic cross-sectional view similar to FIG. 12 showing deployment of the anastomotic device. [Figure 14] 14 is a schematic cross-sectional view similar to FIG. 13, showing the implanted anastomosis device after removal of the intraluminal apparatus. [Figure 15a] 2A to 2C are schematic cross-sectional views showing the operational steps of the device of FIG. 1 in greater detail. [Figure 15b] 2A to 2C are schematic cross-sectional views showing the operational steps of the device of FIG. 1 in greater detail. [Figure 15c] 2A to 2C are schematic cross-sectional views showing the operational steps of the device of FIG. 1 in greater detail. [Figure 15d] 2A to 2C are schematic cross-sectional views showing the operational steps of the device of FIG. 1 in greater detail. [Figure 15e] 2A to 2C are schematic cross-sectional views showing the operational steps of the device of FIG. 1 in greater detail. [Figure 15f] 2A to 2C are schematic cross-sectional views showing the operational steps of the device of FIG. 1 in greater detail. [Figure 15g] 2A to 2C are schematic cross-sectional views showing the operational steps of the device of FIG. 1 in greater detail. [Figure 15h] 2A to 2C are schematic cross-sectional views showing the operational steps of the device of FIG. 1 in greater detail. [Figure 15i] 2A to 2C are schematic cross-sectional views showing the operational steps of the device of FIG. 1 in greater detail. [Figure 16a] 16 is a schematic cross-sectional view similar to FIG. 15, showing in isolation and in greater detail a further operational step of the apparatus of FIG. 1; [Figure 16b] 16 is a schematic cross-sectional view similar to FIG. 15, showing in isolation and in greater detail a further operational step of the apparatus of FIG. 1; [Figure 16c] 16 is a schematic cross-sectional view similar to FIG. 15, showing in isolation and in greater detail a further operational step of the apparatus of FIG. 1; [Figure 16d]16 is a schematic cross-sectional view similar to FIG. 15, showing in isolation and in greater detail a further operational step of the apparatus of FIG. 1; [Figure 16e] 16 is a schematic cross-sectional view similar to FIG. 15, showing in isolation and in greater detail a further operational step of the apparatus of FIG. 1; [Fig. 16f] 16 is a schematic cross-sectional view similar to FIG. 15, showing in isolation and in greater detail a further operational step of the apparatus of FIG. 1; [Figure 17] FIG. 11 is a schematic cross-sectional view showing the introduction of a catheter towards the pylorus in a further example. [Figure 18] FIG. 13 is a schematic cross-sectional view showing the deployment of a balloon in the pyloric antrum. [Figure 19] FIG. 13 is a schematic cross-sectional view showing pylorus crossing after balloon deployment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0076] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Non-limiting embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which the same reference numerals are used to denote the same or equivalent features, whether or not explicitly described in detail, and in which:

[0077] 1, an intraluminal device 10 is shown that is insertable into a body lumen and operable to manipulate body lumen tissue by bringing sections of the tissue into intimate relationship with one another to create a target site for anastomosis. The device 10 generally comprises at least an anchor assembly 12 and one or more inner assemblies 14a, 14b that (e.g., collectively) form a first tensioning assembly. In this embodiment, two inner assemblies 14a and 14b are shown, although in other embodiments, only a single inner assembly 14 or three or more inner assemblies 14 may be used.

[0078] Each inner assembly 14a, 14b generally comprises a respective elongate member 16a, 16b carrying a respective distal balloon 18a, 18b (shown diagrammatically in its deflated or collapsed state in solid lines and in its inflated state in dashed lines). The inner assemblies 14a, 14b are slidably nested within one another, and the elongate members 16a, 16b are tubular. The innermost assembly 14a extends distally of its surrounding assembly 14b. Each assembly 14a, 14b is slidable at least partially independently of one another and the surrounding anchor assembly 12.

[0079] At least one of the inner assemblies (eg, at least the innermost assembly 14a), and optionally both inner assemblies 14a and 14b, are at least partially deflectable and / or steerable, eg, at their tips.

[0080] The anchor assembly 12 further comprises a deployable anchor 20 and, optionally, an inflatable anchor balloon 20, shown generally in its deflated or collapsed state by a solid line and in its inflated state by a dashed line.

[0081] The apparatus 10 further comprises a lateral movement device (described below), a part of which is a second tensioning assembly collectively formed by cross elements 22 having deployable distal shoulders 24. The cross elements 22 are extendable relative to the anchor assembly 12 via apertures 26. The apertures 26 may optionally communicate with a working channel or receiving area of ​​the apparatus described below. The cross elements 22 may be at least partially deflectable and / or steerable, for example at their tips.

[0082] The deployable distal shoulder 24 may comprise, for example, an inflatable balloon, or may comprise a self-expanding structure carried by the cross element 22, such as an deployable structure, for example, a stent.

[0083] Device 10 optionally further comprises at its proximal end a handle and / or operator unit 28 capable of manually or remotely controlling the different elements mentioned above. For example, unit 28 may comprise manual controls and / or ports for manipulating elongate members 16a and 16b, for collectively or independently controlling the inflation of balloons 18a and 18b, for controlling the steering of the steerable elements, for manipulating cross element 22, and for controlling the inflation of balloons 20 and 24.

[0084] Balloons 20, 18a, 18b and 24 may have any suitable shape selected from, for example, spherical (or partial spherical), donut-shaped, cuff-shaped, and the like.

[0085] Figures 2-16 show the use of the device 10 in a body vessel 40 for intraluminal manipulation of the vessel to create a target site for anastomosis. Figures 2-14 show the technique in a curved vessel. Figures 15 and 16 show the operational steps more separated so that more detail can be appreciated. Figures 15 and 16 may be for a straight vessel, or Figures 15 and 16 may represent a straightened view of the vessel of Figures 2-14. The same reference numbers are used in both sets of figures, and the same descriptions apply universally.

[0086] 2, 3, and 15a, device 10 can be introduced into the lumen of a body vessel in which it is desired to form an anastomosis. Device 10 can be configured for introduction by disposing balloons 20, 18a, 18b, and 24 in their deflated state, retracting inner assemblies 14a and 14b to their retracted positions, and completing retraction of cross elements 22 relative to anchor assembly 12. During advancement of device 10 within the body vessel, and / or during advancement of any of inner assemblies 14, the distal end may be steered or deflected from handle 28 to facilitate navigation within the body vessel.

[0087] By way of example, the body passage may be the gastrointestinal tract 40 of a patient. The device 10 may be introduceable through the mouth and esophagus and advanced through the stomach 42 toward the pylorus and small intestine 44 until a distal end region of the device reaches a selected location in the body passage (FIG. 3). For example, the device may extend through the duodenum to a selected location in the jejunum. With reference to FIGS. 4 and 15b, the device 10 is secured at a selected location by inflating the anchor balloon 20 to engage surrounding body tissue.

[0088] 4-8 and 15b-16d illustrate operation of the first tensioning assembly to retract a portion of the body lumen longitudinally from within the body lumen by pulling the distant tissue towards the anchor assembly 12. With reference to FIGS. 4 and 15b, after fixation at a selected location, at least the innermost assembly 14a may be advanced distally (e.g., with respective balloons 18a deflated) to access the distant tissue relative to the anchor assembly 12, and then the balloons 18a may be inflated to frictionally engage the distant tissue.

[0089] First, prior to any contraction of the body lumen, the other inner assembly 14by may be optionally advanced together with the innermost assembly 14a, as shown in FIG. 4. Both balloons 18a and 18b may be inflated to frictionally engage the distant tissue. Alternatively, the assemblies 14a and 14b may be advanced individually, one after the other, as shown in FIGS. 15b-15f. Referring to FIG. 15b, the inner assembly 14a is advanced first to access the distant tissue, and the balloon 18a is inflated (FIG. 15c) to frictionally engage the distant tissue. Referring to FIG. 15d, the inflatable balloon 18b of the other assembly 14b is deflated and the assembly 14b is advanced toward the distant tissue (FIG. 15e). The balloon 18b is then inflated adjacent to the balloon 18a of the innermost assembly 14a. This two-step procedure may be preferred to facilitate easier navigation in tortuous ducts. The same two-step procedure may also be used once a portion of the body lumen tissue has been longitudinally contracted, as described below.

[0090] 5 and 15g, retraction of inner assemblies 14a and 14b pulls the frictionally engaged, separated tissue toward anchor assembly 12, thereby longitudinally contracting or shortening the vessel. The vessel wall tissue folds or gathers in a concertina-like fashion near anchor assembly 12, as shown at 46.

[0091] 6 and 15h, one inner assembly 14b remains inflated to hold the retracted tissue in a retracted state and overcome the tendency of the retracted tissue to rebound or re-expand longitudinally, while the other (innermost) assembly 14a is again extended with the balloon 18a deflated to access the next area of ​​remote tissue. The elongate member 16a of the inner assembly 14a may be steered to help guide travel within the body lumen along a curved or tortuous path and also to avoid pulling on the retracted tissue during distal advancement.

[0092] Once the distant tissue is reached, the distal balloon 18a of the inner assembly 14a may be re-inflated to frictionally engage the tissue (FIG. 15i). The balloon 18b of the other inner assembly 18b may then be deflated (FIG. 16a) and the elongate member 18b may be stretched to approximate the distant tissue (FIG. 16b). The balloon 18b may then be re-inflated to engage the distant tissue next to the balloon 18a (FIG. 16c).

[0093] 8 and 16d, when the inner assemblies 14a and 14b are optionally retracted in unison, the frictionally engaged, loose tissue is pulled toward the anchor assembly 12, thereby adding tissue to the concertina-like folded tissue that has gathered near the anchor assembly 12, thereby further contracting the tube longitudinally.

[0094] The above steps may be repeated an appropriate number of times to gradually move the loose tissue toward the anchor assembly 12, for example, until a desired location along the canal is reached and / or until a sufficient bypass length of the body canal has been accumulated in the concertina-folded tissue.

[0095] Providing both balloons 18a and 18b aids in frictional engagement with forces that are strong enough to pull tissue walls, but distributed and atraumatic to the tissue walls. Providing both balloons 18a and 18b (and assemblies 14a and 14b in general) also allows for a stepwise approach to be used to pull apart tissue, with one balloon being used to hold the pre-contracted tissue, while the other balloon (in its deflated state) can be advanced to access other apart tissue. Providing both balloons 18a and 18b (and assemblies 14a and 14b in general) also facilitates the contraction of non-linear tissues by using a stepwise approach. However, in other embodiments, a single inner assembly 14 and a single balloon 18 may be used instead.

[0096] 9-12 and 16e-16g illustrate the operation of one or more lateral movement devices to move first and second sections of body canal tissue spaced apart from one another longitudinally of the canal laterally toward and / or into wall-to-wall engagement with one another. Two different types of lateral movement devices are described, which may each be used independently of one another or together in the same apparatus (as in the examples of FIGS. 9-12).

[0097] 9, a first example of a lateral movement device is shown in the form of a bending mechanism in one or both of the inner assemblies 14a, 14b for bending the body lumen tissue (represented by arrow 48) to reduce the angle relative to the anchor assembly 12 and thus reduce the separation between the wall sections. The bending mechanism may be implemented, for example, by the steering and / or deflection capabilities of the respective assemblies.

[0098] 10-12 and 16e-16g, a second example of a lateral movement device is shown in the form of a second tensioning assembly comprising a cross-spanning element 22 extendable from the anchor assembly 12. The cross-spanning element 22 is configured to penetrate the vessel wall tissue as the cross-spanning element 22 extends from the anchor assembly 12, passing outside the body vessel to span the distance between two sections of wall tissue. The cross-spanning element 22 may optionally be steerable to allow fine adjustment of the location where the cross-spanning element 22 contacts the opposing tissue wall and to avoid interference with other adjacent body tissue. By first using the first tensioning assembly to longitudinally contract the body vessel, thus drawing the separated tissues closer together, and by additional flexing provided by optionally deflecting the first tensioning assembly, the cross-spanning element 22 need only span a relatively short distance to connect to the opposing tissue. Extension of the cross elements 22 across tissue locations outside the vessel requires only local guidance, such as fluoroscopy or ultrasound imaging, because the distance is relatively short.

[0099] In the illustrated example, the cross elements 22 penetrate the opposing tissue wall segments and then the distal shoulders 24 are deployed to engage behind the tissue wall (FIGS. 11 and 16f), allowing the tissue wall to be pulled by the cross elements 22. In an alternative embodiment, the cross elements 22 may carry suction ports (not shown) that allow the opposing tissue wall segments to be engaged and pulled using negative pressure applied via appropriate conduits within the device.

[0100] 12 and 16g, retraction of the cross element 22 toward the anchor assembly 12 draws the two sections of body lumen tissue into wall-to-wall engagement, e.g., outer wall-to-outer wall engagement, thereby creating a target site for anastomosis within the cavity. During such movement, one or both of the inflatable balloons 18a and 18b of the inner assemblies 14 and 14b may be deflated so as not to impede bending of the body lumen toward the wall-to-wall engagement (FIG. 12). Additionally or alternatively, one or both of the inner assemblies may be retracted and removed from the tissue region 46 (FIGS. 16f and 16g).

[0101] With reference to FIG. 13, a deployment device and / or instrument 50 may be used to create an anastomosis at a target site. In the illustrated example, the device 50 may be deployed by parachuting or guiding the cross members 22. The device 50 may comprise an anastomotic stent for forming a stent anastomosis and / or a magnetic device for forming a magnetic compression anastomosis. The device 50 may comprise a single piece or multiple pieces that function collectively. Each piece or portion of the device 50, e.g., magnetically attracted pieces or portions, may be deployed on opposite sides of apposed tissue wall sections to sandwich the tissue wall sections together, optionally connected by a structure that passes through the body lumen tissue wall, and optionally not directly connected to each other. The device 50 may be a permanent or temporary implant. Additionally or alternatively, one or more instruments (not shown) may be deployed to create the anastomosis, e.g., a tissue cutting instrument and / or a tissue fastening instrument. Tissue fastening may be achieved by sutures or staples or other tissue fastening elements. The device or instrument 50 may be advanced through a working channel of the apparatus 10 which communicates with the opening 26 of the anchor assembly 12, or may be loaded into a receiving area (not shown) near the distal end region of the apparatus ready for deployment and / or use.

[0102] Referring to FIG. 14, when the apparatus 10 is withdrawn, the created anastomosis or anastomotic device 50 remains in place providing a bypass within the body lumen.

[0103] It will be appreciated that the above techniques can facilitate substantially intraluminal techniques for anastomosis creation. Lumbar tissue deep within an anatomical structure, for example deep within the small intestine, can be accessed and manipulated to create a target site for anastomosis, even if the tissue is not yet in close proximity to one another. The technique of longitudinally retracting lumen tissue from within the lumen by pulling the spaced tissue toward the anchor assembly 12 and subsequently moving the spaced tissue laterally toward and / or into wall-to-wall engagement greatly expands the practitioner's ability to create minimally invasive anastomoses.

[0104] 17-19 show a further example in which an inflatable balloon 102 of a catheter 100 is used to aid in intraluminal guidance of the catheter 100 (or components) to cross a restriction in the gastrointestinal tract. In the illustrated example, the restriction is the pylorus 104. The catheter 100 may optionally be or include the device 10 described above, or may be a different device. For example, the catheter 100 may be a delivery catheter configured to deliver an implant at least partially through the pylorus. The implant may include any of a duodenal sleeve, an anchor for a duodenal sleeve, a duodenal anchor for a sleeve, a gastric anchor for a sleeve, or a transpylorus anchor for a sleeve.

[0105] Referring to Fig. 17, a catheter 100 is introduced into the patient's stomach through the patient's mouth and advanced toward the antrum. As shown in Fig. 17, particularly with unguided catheters, the catheter 100 may tend to assume a shape with minimal curvature, such that the tip of the catheter is not optimally aligned with the pylorus through-path. In some cases, such catheters may tend to remain in the pylorus antrum and / or may be awkward to cross the pylorus 104.

[0106] 18, in this example, elongate tubular member 106 of catheter 100 includes, for example near or at the distal end, an inflatable balloon 102. Inflation of balloon 102 displaces the distal end away from the tissue wall, enhancing alignment of catheter 100 with pylorus 104.

[0107] Referring to FIG. 19, following inflation of the balloon 102, the second elongate member 108 is slidable within the first elongate member and extends beyond the tip, crossing the pylorus 104 from a position spaced from the tissue wall by the inflated balloon.

[0108] Balloon 102 may optionally be one of the inflatable balloons described in the previous examples used herein to facilitate guidance of the device across the pylorus toward the target site.

[0109] It will be appreciated that the use of the balloon 102 can facilitate navigation even of the guideless catheter 100 through a ductal restriction, such as the pylorus.

[0110] It is emphasized that the above description refers only to non-limiting examples of the invention, and that many modifications and equivalents may be used within the scope and / or principles of the invention.

Claims

**Claim 1** An apparatus (10) that is insertable into a body tube and operable to manipulate body tube tissue to create a target site for anastomosis by bringing sections of the body tube tissue into close relationship with each other, the apparatus comprising: an anchor assembly (12) including an anchor (20) for fixing at a selected position within the body tube; at least a first tension assembly (14a, 14b) configured to contract a portion of the body tube longitudinally from within the body tube by pulling apart tissue toward the anchor assembly, the first tension assembly comprising at least one elongate member (16a, 16b) that is extensible and contractible for movement within the body tube and at least one distal balloon (18a, 18b) that is inflatable to frictionally engage an inner surface of the body tube and pull the frictionally engaged tissue toward the anchor assembly; The apparatus (10) comprising. **Claim 2** The first tension assembly comprises a first elongate member (16a) carrying a first distal inflatable balloon (18a); and a second elongate member (16b) carrying a second distal inflatable balloon (18b). Comprising, Optionally, the first and second elongate members are at least partially nested within each other and slidable relative to each other, the apparatus according to claim 1. **Claim 3** The at least one elongate member (16a, 16b) of the first tension assembly is at least partially deflectable and / or steerable for guiding when extending within the body tube, the apparatus according to claim 1. **Claim 4** The deployable anchor (20) of the anchor assembly comprises an inflatable balloon, the apparatus according to claim 1. **Claim 5** The apparatus according to claim 1, further comprising a lateral movement device (22, 24) configured to move first and second sections of the body tube tissue longitudinally spaced along the body tube toward and / or into wall-to-wall engagement with each other laterally. **Claim 6** The apparatus according to claim 5, wherein the transverse movement device is configured to span between the first and second compartments by passing outside the body tube and is configured to pull the spanned compartments towards a wall-to-wall engagement, optionally an outer wall-to-outer wall engagement, with each other.

7. The apparatus according to claim 6, wherein the second pulling assembly comprises an extensible cross-member (22) for passing through at least one, optionally both, of the tissue wall compartments and spanning the distance outside the body tube between the tissue wall compartments.

8. The apparatus according to claim 7, wherein the cross-member is deflectable and / or steerable for guiding when extending to span between the first and second compartments.

9. The second pulling assembly further comprises a connection device for connecting to the tissue wall compartment so as to enable the tissue wall compartment to be pulled, the connection device being (i) a deployable distal shoulder (24) for engaging behind the tissue in one of the compartments to enable the tissue wall compartment to be pulled, and / or (ii) a suction port for connecting to the tissue by applying a negative pressure that sucks the tissue towards the suction port, the apparatus according to claim 6 comprising at least one of the above. The apparatus according to claim 6, wherein the deployable shoulder (24) comprises an element selected from one or more of an inflatable balloon, a stent, a mechanical structure, a self-expanding element.

10. The apparatus according to claim 9, wherein the deployable shoulder (24) comprises an element selected from one or more of an inflatable balloon, a stent, a mechanical structure, a self-expanding element.

11. The apparatus according to claim 1, further comprising a deployment device (50) for deploying an anastomosis device, and optionally, the anastomosis device comprises one or more of a temporary anastomosis device, a permanent anastomosis device, a stent, a magnetic device.

12. The apparatus according to claim 1, further comprising a deployment device for deploying an instrument for use in creating an anastomosis, and optionally, the instrument comprises one or more of a tissue cutter, for example a tissue fixation device for attaching tissues to each other by suturing or stapling.

13. An apparatus insertable into a body tube and operable to manipulate the body tube tissue to create a target site for anastomosis by bringing the compartments of the body tube tissue into a close relationship with each other, the apparatus optionally according to claim 1, the apparatus being An anchor assembly (12) including an anchor for fixing at a selected position within the tube; At least a first tension assembly (14a, 14b) configured to longitudinally contract a portion of the tube from within the tube by pulling a distant tissue toward the anchor assembly; Comprising, the device further comprising; A lateral movement device (22, 24) configured to move first and second sections of the tube tissue longitudinally spaced along the tube toward and / or into wall-to-wall engagement with each other laterally, and / or A deployment device (50) for deploying one or more instruments and / or devices for creating an anastomosis; A device comprising one or optionally both of the above. **Claim 14** The device according to claim 13, wherein the lateral movement device comprises a second tension assembly (22, 24) configured to span along the tube by passing outside the tube and to pull the spanned positions toward wall-to-wall engagement with each other, optionally outer wall-to-outer wall engagement. **Claim 15** A device for insertion through a patient's mouth into the gastrointestinal tract and guided by the pylorus, wherein the device optionally according to claim 1, the device comprising: A first elongate tubular member having a tip insertable into the patient's mouth and into the gastric antrum, the tube including a first region carrying an inflatable balloon configured to displace the first region of the tube away from the gastric wall upon inflation of the balloon; A second elongate member slidable within the first elongate tubular member, extending from the tip of the first elongate tubular member, and translatable through the pylorus from a position spaced from the gastric wall by the balloon; Comprising, a device. **Claim 16** The device according to claim 15, wherein the first portion is near or at the tip of the first elongate tubular member. **Claim 17** The device according to claim 15, wherein the device is configured to deliver the device through the pylorus for at least partial placement within the duodenum and / or for at least partial transection of the pylorus. **Claim 18** The device according to claim 17, further comprising the device, wherein the device comprises a duodenal liner sheath. **Claim 19** The device according to claim 17, further comprising the device, wherein the device comprises an anchor for fixing near or at the pylorus.

20. A method of endoscopically manipulating the body tube tissue to create a target site for anastomosis by bringing sections of the body tube tissue into close relationship with each other using a device that can be inserted into the body tube lumen, wherein the device is optionally according to any of claims 1 to 19, and the method comprises: deploying an anchor of the device to fix the device at a selected position within the body tube; operating a first pulling assembly of the device to contract a portion of the body tube longitudinally from within the body tube by pulling apart tissue towards the anchor assembly; including, and the method further comprises: operating a transverse movement device of the device to move first and second sections of the body tube tissue longitudinally spaced along the body tube towards and / or into wall-to-wall engagement with each other transversely, and / or operating a deployment device to deploy one or more instruments and / or devices for creating an anastomosis. A method comprising at least one step of

21. The step of operating the first pulling assembly includes contracting a portion of the body tube longitudinally such that the first and second sections of the body tube tissue move from a separated relationship in the longitudinal direction to a closer relationship. The optional step of operating the transverse movement device further brings the first and second sections of the body tube tissue into wall-to-wall engagement from a closer relationship by moving one or both of the first and second sections relative to the other transversely. The method according to claim 20.

22. A method of endoscopically guiding within a patient's gastrointestinal tract, wherein the method is optionally according to claim 20, and the method comprises: advancing a first elongate tubular member within the gastrointestinal tract and positioning a first portion of the first elongate tubular member within a restricted region of the gastrointestinal tract to be traversed; inflating a balloon of the first elongate tubular member to displace the first portion of the first elongate tubular member away from the tissue wall of the gastrointestinal tract; Advancing a second elongate member within the first elongate member and passing through a restricted portion of the gastrointestinal tract from a position spaced apart from the tissue wall by the balloon of the first elongate tubular member A method comprising. **Claim 23** The method according to claim 22, wherein the first portion of the first elongate member is at or near the tip of the first elongate member. **Claim 24** The method according to claim 22, wherein the restricted portion of the gastrointestinal tract is the pylorus. **Claim 25** The method according to claim 22, further comprising the step of deploying an implant within the gastrointestinal tract, the implant comprising at least one selected from a duodenal sleeve, a duodenal anchor for a duodenal sleeve, a pylorus penetrating anchor for a duodenal sleeve, and a gastric anchor for a duodenal sleeve.

Images