Wound closure and tissue engagement systems and methods

Abstract

Surgical assemblies and related methods are provided for using an actuator to deploy an adapter configured to close a tissue puncture or a natural opening of a human body. A surgical assembly includes an actuator assembly having an elongate shaft including an outer shaft and an inner shaft coaxially disposed within the outer shaft to define a fluid flow path therebetween, and a deployable engagement member engaged to a distal end of the outer shaft. The deployable joint has a plurality of proximal slits and a plurality of distal slits formed therein and configured to form proximal and distal flanks. The proximal slit and the distal slit are configured to allow blood to flow therethrough into the interior lumen of the deployable adapter and through the fluid flow path to a fluid outlet port formed in the actuator assembly.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Application No. 18 / 087,498, filed on December 22, 2022, entitled “Wound Closure and tissue Coupling Systems and Methods,” U.S. Application No. 18 / 087,598, filed on December 22, 2022, entitled “Large-pore wound closure and tissue coupling systems and methods,” and U.S. Application No. 18 / 087,559, filed on December 22, 2022, entitled “Wound Closure and Tissue Coupling Systems and Methods,” all of which claim the benefit of U.S. Provisional Application No. 18 / 087,559, filed on December 22, 2022, entitled “Wound Closure and Anastomosis Device for Sealing or Anastomosing Hollow Structures,” filed on May 26, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention provides methods and devices for wound closure and creation of anastomoses. Background Art

[0004] Many surgical procedures involve puncturing or anastomosing tissue at the surgical site to form an anastomosis, for example, an intestinal anastomosis or an arteriovenous fistula between an artery and a vein. In the case of fistula formation, the purpose of the connection is either to create a high-flux connection or to create a pathway for blood around an obstruction in a replacement conduit or bypass. The conduit or bypass can generally be a vein, artery, or prosthetic graft.

[0005] During a surgical procedure, an anastomosis can be formed by placing two blood vessels or guide tubes (e.g., intestines) in direct contact with each other and then connecting them with sutures, clips, or other methods. The anastomosis can be end-to-end, end-to-side, or side-to-side. When a vascular anastomosis is completed, the anastomosis is typically oval in shape and connected manually with sutures. Other methods of anastomosis formation may include carbon dioxide lasers, prostheses, clips, and stents. A type of fistula, an arteriovenous fistula, is formed by connecting an artery to a vein. This type of connection can be used for hemodialysis, improving training tolerance, treating high blood pressure, maintaining an arterial or venous opening, as an interventional channel for chemotherapy, etc.

[0006] Various devices have been proposed for percutaneously sealing tissue openings in a patient or for connecting hollow structures, including biodegradable plugs, sutures, surgical fasteners, and other devices. However, these devices and related methods have many disadvantages, including surgical risks, high failure rates, complexity, etc. Therefore, there remains a need for improved devices and related methods for closing tissue perforations and anastomosing tissue structures in a patient, or for deploying such devices in a simple and effective manner. Summary of the invention

[0007] Generally, the present invention provides methods and systems for creating anastomosis and wound closure.

[0008] In one embodiment, a surgical assembly is provided, the assembly including an actuator assembly having an elongated shaft, the elongated shaft including an outer shaft and an inner shaft coaxially disposed within the outer shaft to define a fluid flow path therebetween, and a deployable engagement member coupled to the distal end of the outer shaft. The deployable engagement member may have a plurality of proximal slits and a plurality of distal slits formed therein, and may be configured to form proximal and distal wings. The proximal and distal slits may be configured to allow blood to flow therethrough into the fluid flow path to a fluid outlet port formed in the actuator assembly.

[0009] The surgical assembly can be modified in a variety of ways and can include any of the following features, alone or in combination. For example, the actuator assembly can include a handle operatively coupled to the deployable engagement member. In some aspects, the handle can include an actuator that can be rotated in a first direction to deploy the distal wing and can be rotated in a second direction to deploy the proximal wing. In another aspect, the handle can include a deployment rod configured to disengage the deployable engagement member from the distal end of the outer shaft. For example, the surgical assembly can include a delivery sheath configured to engage the actuator assembly. The delivery sheath can define a central lumen configured to receive the elongated shaft. For example, the distal end of the outer shaft can include at least two opposing longitudinal gaps to allow blood to flow from the deployable engagement member into the fluid flow path. In some aspects, the outer shaft can include a crown disposed around the at least two opposing longitudinal gaps. In some variations, the crown can include a toothed portion, and the deployable engagement member can be coupled to the toothed portion. For example, each of the plurality of proximal slits and the plurality of distal slits can be generally s-shaped.

[0010] In another embodiment, a surgical method is provided. The surgical method may include inserting the elongated shaft of the actuator assembly through the guide assembly extending through the puncture hole in the body lumen, so as to position the deployable joint piece engaged to the distal end of the elongated shaft in the body lumen, so that blood flows into the deployable joint piece, passes through the elongated shaft, and flows out from the port at the proximal end of the actuator assembly. The surgical method may also include subsequently actuating the actuator assembly so that the distal wing on the deployable joint piece is radially expanded outward. The surgical method may also include retracting the actuator assembly to pull the distal wing against the inner wall of the body lumen so that blood stops flowing into the deployable joint piece. The surgical method may also include actuating the actuator assembly so that the proximal wing on the deployable joint piece is radially expanded outward near the outer wall of the body lumen, thereby sealing the puncture hole in the body lumen. The surgical method also includes disengaging the deployable joint piece from the distal end of the elongated shaft.

[0011] The surgical method can be varied in a variety of ways and can include any of the following features, alone or in combination. For example, the surgical method can include, after actuating the actuator to expand the distal wing radially outward, and before actuating the actuator assembly to expand the proximal wing radially outward, pivoting the elongated shaft to position the distal wing relative to the inner wall of the body lumen. For example, the elongated shaft can include an inner shaft and an outer shaft coaxially disposed around the inner shaft, and blood can flow between the inner shaft and the outer shaft. In some aspects, the distal end of the outer shaft can include a pair of fused C-tubes that define a gap through which blood flows. For example, the expansion of the proximal wing can include rotating the actuator assembly in a first direction. In some aspects, the expansion of the distal wing can include rotating the actuator assembly in a second direction relative to the first direction.

[0012] In another embodiment, a surgical assembly is provided. The surgical assembly may include an actuator assembly including an elongated shaft and a deployable engagement member coupled to the elongated shaft distal end. The deployable engagement member may include a plurality of proximal slits configured to form proximal wings and a plurality of distal slits configured to form distal wings. The actuator assembly may be configured to convert the deployable engagement member from a delivery configuration in which the proximal wings and distal wings are generally parallel to the elongated shaft into a fully deployed configuration in which one of the proximal wings and distal wings is generally perpendicular to the elongated shaft and one of the proximal wings and distal wings is tilted to the elongated shaft.

[0013] The surgical assembly can be changed in many ways and may include any of the following features, either alone or in combination. For example, each of a plurality of proximal slits may include a first incision and a second incision having substantially equal lengths. The substantially equal lengths may cause the proximal wing to be substantially perpendicular to the elongated shaft in the deployment configuration. For example, each of a plurality of distal slits may include a first incision and a second incision having substantially unequal lengths. The substantially unequal lengths may cause the distal wing to be substantially inclined to the elongated shaft in the deployment configuration. For example, converting the deployable engagement piece from the delivery configuration to the deployment configuration may cause the proximal wing and the distal wing to collapse around their intermediate region. For example, a plurality of proximal slits and a plurality of distal slits may be substantially s-shaped. For example, the surgical assembly may include an auxiliary handle configured to engage the proximal end of the actuator assembly. The auxiliary handle may have a plug extending distally, the plug configured to pass through a central lumen defined at least in part by the elongated shaft and positioned in the central hole of the deployable engagement piece. In certain aspects, the distally extending plug can be configured to seal the central aperture.

[0014] In another embodiment, a surgical assembly is provided. The surgical assembly may include a delivery tool comprising an elongated shaft extending from its distal end, and a deployable engagement member engaged to the distal end of the elongated shaft. The deployable engagement member may have a proximal wing defined by a first proximal incision and a first distal incision and a distal wing defined by a second proximal incision and a second distal incision. The delivery tool may be configured to convert the deployable engagement member between a delivery configuration and a deployment configuration, in which the elongated shaft is generally parallel to the first wing and the second wing, and in the deployment configuration, the elongated shaft is generally transverse to the first wing and the second wing. The deployment angle of the proximal wing may be at least partially defined by the length ratio of the first proximal incision and the first distal incision, and the deployment angle of the distal wing may be at least partially defined by the length ratio of the second proximal incision and the second distal incision.

[0015] The surgical assembly can be varied in a variety of ways and can include any of the following features, alone or in combination. For example, the length ratio of the first proximal incision to the first distal incision can be substantially equal to 1, and can be configured so that the first wing portion has a deployment angle of approximately 90 degrees. For example, the length ratio of the second proximal incision to the second distal incision can be substantially greater than 1, and can be configured so that the deployment angle of the second wing portion is substantially an acute angle.

[0016] In another embodiment, a surgical joint is provided. The surgical joint may include a first tubular portion having a plurality of first longitudinal cuts, a second tubular portion having a plurality of second longitudinal cuts, and a connecting portion disposed between the first tubular portion and the central tubular portion. Each of the plurality of first longitudinal cuts may have a proximal cut and a distal cut having a length ratio of approximately 1:1. Each of the plurality of second longitudinal cuts may have a proximal cut and a distal cut having a length ratio of substantially less than 1:1. The first tubular portion and the second tubular portion and the connecting portion may define a central lumen.

[0017] The surgical joint can be changed in many ways and may include any of the following features, alone or in combination. For example, the first tubular portion can be configured to reversibly form a wing that is substantially perpendicular to the longitudinal axis of the central lumen. For example, the second tubular portion can be configured to reversibly form a wing that is substantially inclined to the longitudinal axis of the central lumen. For example, the diameter of the connecting portion can be greater than the diameter of the first tubular portion and the diameter of the second tubular portion. In some aspects, the diameter of the first tubular portion can be less than the diameter of the second tubular portion. For example, the joint can be configured to be coupled to an actuator tool. The actuator tool can be configured to reversibly form the first tubular portion and the second tubular portion into a wing. In some aspects, the actuator tool can be configured to receive a blockage that is configured to prevent fluid from flowing into the central lumen.

[0018] In another embodiment, a method is provided. The method may include inserting a delivery sheath through a puncture in an artery over a guide wire to position a deployable coupling attached to the distal end of the delivery sheath within the artery. The method may also include pivoting the guide sheath from an insertion orientation in which blood flows upward along the coupling to an inclined orientation in which blood cannot flow upward along the coupling. The method also includes actuating an actuator attached to the proximal end of the delivery sheath to deploy a distal wing. The distal wing may be positioned within an artery near the puncture. The method may also include actuating an actuator to deploy a proximal wing on the deployable coupling to position the proximal wing outside the artery near the puncture. The method also includes removing the guide wire from the central lumen. The method also includes advancing a plug into the central lumen of the deployable coupling to seal the puncture.

[0019] The method can be varied in a variety of ways and can include any of the following features, alone or in combination. For example, the obstruction can be operably coupled to an auxiliary handle having a deployment rod located thereon, the deployment rod being configured to deploy the obstruction into a deployable joint. In certain aspects, the method can include, after advancing the obstruction into the central lumen, thereby actuating the deployment rod to separate the obstruction from the auxiliary handle. For example, the method can also include positioning the joint relative to the puncture site using an external imaging system, the external imaging system detecting the radiation capability of the joint.

[0020] In another embodiment, a surgical method is provided. The surgical method may include advancing a first engaging member through the small intestine to an area of ​​the small intestine near the gallbladder. The first engaging member may be coupled to the distal end of the elongated shaft. The surgical method may also include puncturing the small intestine and gallbladder area using a puncture member advanced through the elongated shaft and the first engaging member. The surgical method may also include at least partially advancing the first engaging member within the gallbladder. The surgical method also includes deploying a first distal wing of the first engaging member within the gallbladder. The surgical method may also include retracting the elongated shaft so that the first distal wing contacts the inner surface of the gallbladder. The surgical method may also include deploying a first proximal wing of the first engaging member within the small intestine to removably secure the first engaging member to the gallbladder and the small intestine. The surgical method also includes ejecting the first engaging member from the distal end of the elongated shaft.

[0021] The surgical method may be varied in a variety of ways and may include any of the following features, alone or in combination. For example, the surgical method may include advancing a second engaging member through the small intestine into a distal ileum loop segment proximal to the proximal ileum loop segment. The second engaging member may be coupled to the distal end of the elongated shaft. The surgical method may also include puncturing through the inner wall of the distal ileum loop segment using a puncture member that is advanced through the elongated shaft and the second engaging member to enter the proximal ileum loop segment. The surgical method also includes deploying a second distal wing of the second engaging member within the proximal ileum loop segment. The surgical method may also include retracting the elongated shaft so that the second distal wing contacts the inner surface of the proximal ileum loop segment. The surgical method may also include deploying a second proximal wing of the second engaging member within the distal ileum loop segment to removably secure the second engaging member to the proximal ileum loop segment and the distal ileum loop segment. The surgical method may also include ejecting the second engaging member from the distal end of the elongated shaft. For example, at least one of the first proximal wing and the first distal wing may be deployed at an acute angle relative to the longitudinal axis of the elongated shaft. In certain aspects, the other of the first proximal wing and the first distal wing may be deployed at an acute angle relative to the longitudinal axis of the elongated shaft. In other aspects, the radial tip of the first proximal wing may contact the inner wall of the small intestine in the deployed configuration, and the radial tip of the first distal wing may contact the inner wall of the gallbladder in the deployed configuration. For example, the deployment angle of the first proximal wing and the deployment angle of the first distal wing may be substantially equal. The length of the first proximal wing and the length of the first distal wing may be substantially equal. For example, the first proximal wing may include a plurality of first flaps, and the first distal wing may include a plurality of second flaps. The plurality of first flaps are rotatably offset from the plurality of second flaps.

[0022] In another embodiment, a method is provided. The method may include deploying a first distal wing of a first engaging member in the gallbladder and deploying a first proximal wing of the first engaging member in the ileum by an actuator tool having an elongated shaft and a first engaging member coupled to the distal end of the elongated shaft. The method may also include deploying a second distal wing of a second engaging member in a first ileal loop segment at the distal end of the deployed first engaging member by an actuator tool having a second engaging member coupled to the distal end, and deploying a second proximal wing of the second engaging member in a second ileal loop segment at the proximal end of the deployed first engaging member. The first engaging member may define a first central lumen configured to connect the gallbladder and the ileum through its fluid. The second engaging member may define a second central lumen configured to connect the first ileal loop segment and the second ileal loop segment through its fluid.

[0023] The method may be varied in a variety of ways and may include any of the following features, alone or in combination. For example, the method may include puncturing through the ileum wall and the gallbladder wall with a puncture member coupled to the distal end of the elongated shaft to position the first engagement member at least partially within the gallbladder and at least partially within the ileum. In some aspects, at least one of the first proximal wing and the first distal wing may be deployed at an acute angle relative to the longitudinal axis of the elongated shaft. In some variations, the other of the first proximal wing and the first distal wing may be deployed at an acute angle relative to the longitudinal axis of the elongated shaft. In other variations, the radial tip of the first proximal wing may contact the inner wall of the small intestine in the deployed configuration, and the radial tip of the first distal wing may contact the inner wall of the gallbladder in the deployed configuration. In other aspects, the deployment angle of the first proximal wing and the deployment angle of the first distal wing may be substantially equal. The length of the first proximal wing and the length of the first distal wing may be substantially equal. In other aspects, the first proximal wing can include a plurality of first flaps and the first distal wing can include a plurality of second flaps. The plurality of first flaps are rotationally offset from the plurality of second flaps.

[0024] In another embodiment, a method is provided. The method may include introducing a first engaging member into the ileum. The first engaging member may be attached to an elongated shaft extending distally from an actuator tool. The first engaging member and the elongated shaft may define a first central lumen through the first engaging member. The method may also include contacting the outer wall of the ileum near the outer wall of the gallbladder with the distal end of the first engaging member. The method also includes extending the first puncture member through the first central lumen to puncture the inner wall of the ileum and the outer wall of the gallbladder. The method also includes advancing the first engaging member from the ileum and into the gallbladder. The method may also include deploying the distal wing of the first engaging member in the gallbladder with the actuator tool. The method may also include retracting the first engaging member to contact the inner wall of the gallbladder with the distal wing. The method may also include deploying the proximal wing of the first engaging member in the ileum with the actuator tool. The gallbladder and the ileum may be fluidically connected through the first engaging member. The method also includes disengaging the first engaging member from the elongated shaft.

[0025] The method may be varied in a variety of ways and may include any of the following features, alone or in combination. For example, the method may include introducing a second engaging member into an ileal loop segment distal to the first engaging member. The second engaging member may be attached to an elongated shaft. The second engaging member and the elongated shaft may define a second central lumen through the second engaging member. The method also includes cutting an area of ​​the proximal ileal loop segment proximal to the first engaging member. The method may also include contacting the outer wall of the distal ileal loop segment near the cut area of ​​the proximal ileal loop segment. The method also includes extending a second puncture member through the second central lumen to puncture the inner wall and the incision area of ​​the distal ileal loop segment. The method also includes advancing the second engaging member from the distal ileal loop segment through the incision area into the proximal ileal loop segment. The method may also include deploying the distal wing of the second engaging member in the proximal ileal loop segment with an actuator tool. The method may also include retracting the second engaging member to contact the inner wall of the proximal ileal loop segment with the distal wing. The method may also include deploying the proximal wing of the second engaging member in the distal ileum loop segment with an actuator tool. The proximal ileum loop segment and the distal ileum loop segment may be in fluid communication through the second engaging member. The method also includes disengaging the second engaging member from the elongated shaft.

[0026] In another embodiment, a method is provided, comprising inserting a sheath through the ileum and into the gallbladder, advancing an expandable engagement member coupled to a distal end of an actuator tool through the sheath and into the gallbladder, retracting the sheath from the gallbladder, deploying a distal wing of the expandable engagement member within the gallbladder with the actuator tool, deploying a proximal wing of the expandable engagement member within the ileum with the actuator tool, and detaching the expandable engagement member from the actuator tool. The gallbladder and the ileum may be in fluid communication through the deployed expandable engagement member.

[0027] The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the detailed description below. Other features and advantages of the subject matter described herein are apparent from the description, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] These and other features will be more readily understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

[0029] Figure 1 is a perspective view of a portion of a closure assembly including an actuator assembly according to one embodiment;

[0030] Figure 2 yes Figure 1 a perspective view of an introducer assembly of a closure assembly;

[0031] Figure 3 yes Figure 1 a perspective view of a distal end of a flexible guide tube of a closure assembly of FIG. 1 with an anastomotic engagement member not attached thereto;

[0032] Figure 4 yes Figure 3 a perspective view of a distal end of a flexible or rigid guide tube of a device with a deployable engagement member attached thereto;

[0033] Figure 5 yes Figure 1 a partial cross-sectional view of a closure assembly;

[0034] Figure 6 yes Figure 4 A perspective view of a deployable engagement member having a deployable distal wing;

[0035] Figure 7 yes Figure 4 A perspective view of a deployable engagement member of the present invention having a distal wing and a proximal wing deployed;

[0036] Figure 8 yes Figure 1 A partial perspective view of a closure assembly of FIG. 1 with a deployable engagement member inserted into an arterial lumen;

[0037] Fig. 9 yes Figure 4 a perspective view of a distal end of a flexible guide tube of the embodiment of the present invention, wherein blood flows through a deployable coupling;

[0038] Fig.10 yes Figure 4 a perspective view of the distal end of the flexible guide tube of FIG. 1 with the deployable engagement member removed and blood flowing into the flexible guide tube;

[0039] Fig.11 yes Figure 4 a partial cross-sectional view of a flexible guide tube of the embodiment of the present invention with the deployable engagement member removed and blood flowing through the flexible guide tube;

[0040] Fig.12 yes Figure 4 A partial cross-sectional view of a flexible guide tube including blood flowing through a blood flow signal outlet;

[0041] Fig.13 yes Figure 1 The actuator assembly of the closure assembly is inserted into Figure 1 A perspective view of an introducer sheath of a closure assembly, the introducer sheath being at least partially positioned within the lumen of an artery;

[0042] Fig.14 yes Fig.13 a perspective view of a closure assembly of wherein the deployable engagement member has a deployed distal wing, wherein an insert of the deployed distal wing is partially enlarged;

[0043] Fig.15 yes Fig.13A perspective view of a closure assembly of the invention, wherein the deployed distal wings abut against the inner wall of the arterial lumen and the closure assembly is moved to a raised angle;

[0044] Fig.16 yes Fig.13 A perspective view of a closure assembly of the invention, wherein the deployed distal and proximal wings secure tissue therebetween, wherein the insertion of the deployed distal and proximal wings is partially magnified;

[0045] Fig.17 yes Fig.13 A perspective view of the closure assembly of FIG. 1 with the ejector rod actuated and a partial enlargement of the insert securing the tissue;

[0046] Fig.18 yes Fig.13 A perspective view of the closure assembly of FIG. 1 being removed from the surgical field after the deployable engagement member is ejected, with a partial enlargement of the insert of the ejected engagement member;

[0047] Fig.19 is a perspective view of a closure assembly according to another embodiment, comprising an actuator assembly and an introducer sheath;

[0048] Fig. 20 It is available with Fig.19 A perspective view of a guidewire used with a closure assembly;

[0049] Fig.21 yes Fig.19 Perspective view of the introducer sheath of the closure assembly.

[0050] Fig. 22 yes Fig.19 a perspective view of an actuator assembly of a closure assembly;

[0051] Fig.23 yes Fig. 22 a perspective view of a distal end of an actuator assembly of the invention comprising a fixed deployable engagement member;

[0052] Fig.24 yes Fig. 22 a side view of a distal end of an actuator assembly of the invention having a fixed anastomotic engagement member therein, the anastomotic engagement member including a proximal end having a diameter greater than a distal end diameter;

[0053] Fig.25 yes Fig.23 a cross-sectional view of a deployable engagement member;

[0054] Fig.26 yes Fig.23 a side view of a deployable engagement member in a delivery configuration, the engagement member having a proximal slit and a distal end, wherein according to certain variations, the two halves of the slit have a distance ratio substantially equal to 1:1;

[0055] Fig. 27 yes Fig.26 a cross-sectional view of a deployable engagement member in a deployed configuration, the engagement member being secured to an actuator assembly;

[0056] Fig.28 yes Fig.23 a side view of a deployable engagement member in a delivery configuration wherein, according to certain variations, the two halves of the slit have a spacing ratio substantially equal to 1:1, and having a proximal slit wherein the two halves of the slit have a spacing ratio substantially less than 1:1;

[0057] Fig.29 yes Fig.28 a cross-sectional view of a deployable engagement member in a deployed configuration, the engagement member being secured to an actuator assembly;

[0058] Fig.30 It is available with Fig.19 A perspective view of a plugging tool used with a closure assembly;

[0059] Fig.31 Yes Fig.19 Insertion of the introducer sheath Fig. 20 A perspective view of the arterial lumen above the guidewire;

[0060] Fig.32 Yes Fig.19 A perspective view of the actuator assembly inserted into the introducer sheath and arterial lumen;

[0061] Fig.33 yes Fig.19 A perspective view of the actuator assembly and introducer assembly of FIG. 1 raised to a deployed position;

[0062] Fig.36 yes Fig.19 A perspective view of an actuator assembly of wherein the distal wing is transformed into a deployed configuration within an arterial lumen;

[0063] Fig.34 yes Fig.19 A perspective view of a proximal portion of the actuator assembly after the distal wing is transformed into a deployed configuration;

[0064] Fig.35 yes Fig.19 A rear perspective view of the actuator assembly of FIG. 1 and a newly formed gap after the distal wing is transformed into a deployed configuration;

[0065] Fig.36 yes Fig.19 A perspective view of an actuator assembly of wherein the distal wing is tensioned against the inner wall of the arterial lumen;

[0066] Fig.37 yes Fig.19A perspective view of an actuator assembly of , wherein the proximal wing is transformed into a deployed configuration;

[0067] Fig.38 The nearside wing is transformed into the deployed configuration by Fig.19 A perspective view of the actuator assembly injecting contrast fluid;

[0068] Fig.39 yes Fig.30 Insertion of plugging tool Fig.19 A partial perspective view of an actuator assembly;

[0069] Fig.40 is a partial perspective view of the bracket of the plugging tool engaging the removable rod lock of the actuator assembly, as shown Fig.39 As shown, the plugging tool is inserted into the actuator assembly;

[0070] Fig.41 yes Fig.30 A partial cross-sectional view of an occlusion tool comprising an ejectable occlusion inserted into a central lumen of an expanded deployable engagement member;

[0071] Fig.42 yes Fig.41 a partial cross-sectional view of the deployed deployable joint in FIG. 1 , wherein the ejectable plug has been fully inserted into the central lumen of the deployed deployable joint;

[0072] Fig.43 yes Fig.30 A partial perspective view of a blocking tool of , wherein the blocking lock is moved to an unlocked position and the blocking rod is actuated;

[0073] Fig.44 yes Fig.42 A partial cross-sectional view of an ejectable plug and a deployable engagement member, wherein the ejectable plug is ejected from the plugging tool;

[0074] Fig.45 yes Fig.30 A perspective view of the plugging tool removed from the actuator assembly after plugging is ejected, wherein the rod lock is removed with the plugging tool while being secured to a bracket of the plugging tool;

[0075] Fig.46 yes Fig.19 A perspective view of a closure assembly of FIG. 1 with the ejector rod actuated;

[0076] Fig.47 yes Fig.19 A perspective view of a closure assembly being removed from a surgical site after deploying a deployable engagement member;

[0077] Fig.48 yes Fig.19a perspective view of a closure assembly of illustrating improper deployment of the proximal and distal wings of a deployable engagement member returning to a partial delivery configuration after premature deployment of the proximal and distal wings within a lumen of an artery;

[0078] Fig.49 yes Fig.19 a partial cross-sectional view of a closure assembly of FIG. 1 in a pre-deployment position during a deployment process;

[0079] Fig.50 yes Fig.19 The closure components are Fig.49 A partial cross-sectional view of a first wing deployment step during a deployment process of FIG.

[0080] Fig.51 yes Fig.19 The closure components are Fig.49 A partial cross-sectional view of a second wing deployment step during a deployment process of;

[0081] Fig.52 yes Fig.19 The closure components are Fig.49 A partial cross-sectional view of an initial first stage of a spring release tensioning mechanism during a deployment process;

[0082] Fig.53 yes Fig.19 The closure components are Fig.52 A partial cross-sectional view of an initial second stage of a spring release tensioning mechanism;

[0083] Fig.54 yes Fig.19 The closure components are Fig.49 a partial cross-sectional view of the first stage of the resetting step during the deployment process;

[0084] Fig.55 yes Fig.19 The closure components are Fig.54 A partial cross-sectional view of the second stage during the resetting step;

[0085] Fig.56 A partial front view of a patient's digestive system showing the ileum being moved near the gallbladder as part of a surgical procedure.

[0086] Fig.57 yes Fig.56 A partial front view of the digestive system of FIG. 1 , wherein the anastomotic adapter is inserted through the incision into the ileum and toward the gallbladder;

[0087] Fig.58 yes Fig.56A partial front view of a digestive system of the present invention, wherein the distal end of the anastomotic joint is located in the ileum and adjacent to the gallbladder, and a puncture member is inserted through the anastomotic joint to cut the ileum and gallbladder;

[0088] Fig.59 yes Fig.56 A partial front view of the digestive system of FIG. 1, wherein the anastomotic joint is inserted from the ileum through the incision formed by the puncture member into the gallbladder;

[0089] Fig.60 yes Fig.56 a partial front view of a digestive system of , wherein a distal wing of an anastomotic engagement member engaged with an actuator assembly is transformed into a deployed configuration within a gallbladder;

[0090] Fig.61 yes Fig.56 A partial front view of the gallbladder and ileum of , showing the closure assembly retracted to allow the distal wings to contact the inner wall of the gallbladder;

[0091] Fig.62 yes Fig.56 A partial front view of the digestive system of FIG. 1 , wherein the proximal wing of the anastomotic joint is transformed into a deployed configuration within the ileum;

[0092] Fig.63 yes Fig.56 A partial front view of the gallbladder and ileum of FIG. 1 , showing the gallbladder wall and the ileum wall being sandwiched between the proximal and distal wings of the anastomotic joint;

[0093] Fig.64 yes Fig.56 a partial front view of a digestive system of the present invention, wherein the anastomotic joint is deployed and the actuator assembly of the closure assembly is retracted from the ileum;

[0094] Fig.65 yes Fig.56 A partial front view of the gallbladder and ileum of FIG. 1 with the anastomotic joint deployed and separated from the actuator assembly;

[0095] Fig.66 yes Fig.65 a cross-sectional view of a deployed anastomotic joint;

[0096] Fig.67 is a cross-sectional view of a deployed anastomotic engagement member with a compression ring having proximal and distal wings of different lengths and deployed at different angles according to another embodiment;

[0097] Fig.68 yes Fig.56 A partial front view of a digestive system of FIG. 1 , wherein the actuator assembly is inserted into a first incision and directed toward a second incision created in a proximal ileal loop segment;

[0098] Fig.69 yes Fig.56 A partial front view of the digestive system of FIG. 1 , wherein the piercing member is inserted into the actuator assembly to pierce the inner wall created in the distal ileal loop segment and enter the second incision;

[0099] Fig.70 yes Fig.56 A partial front view of the digestive system of FIG. 1, wherein the distal wing of the second anastomotic joint is transformed from a delivery configuration to a deployed configuration within the proximal ileal loop segment;

[0100] Fig.71 yes Fig.56 A partial front view of a digestive system of the present invention, wherein the proximal wing of the second anastomotic joint is transformed from a delivery configuration to a deployed configuration within the distal ileum loop segment, thereby connecting the proximal ileum loop segment and the distal ileum loop segment;

[0101] Fig.72 yes Fig.56 A partial front view of a digestive system of , showing a first flow path from the gallbladder through a deployed anastomotic joint, and a second flow path from a proximal ileal loop segment to a distal ileal loop segment through a deployed second anastomotic joint;

[0102] It should be noted that the drawings are not necessarily drawn to scale. The drawings are intended to depict only typical aspects of the subject matter disclosed herein, and therefore should not be considered limiting of the scope of the disclosure. DETAILED DESCRIPTION

[0103] Certain illustrative embodiments will now be described to provide an overall understanding of the principles of structure, function, manufacture, and use of the apparatus and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. It will be understood by those skilled in the art that the apparatus and methods specifically described herein and illustrated in the accompanying drawings are non-limiting illustrative embodiments, and the scope of the invention is limited only by the claims. Features associated with an illustrative embodiment illustrated or described may be combined with features of other embodiments. These modifications and variations are included within the scope of the invention.

[0104] In addition, in the present disclosure, similar elements in some embodiments generally have similar features, and therefore, in a particular embodiment, each feature in each similar element may not necessarily be fully described. In addition, in the range of linear dimensions or circular dimensions used in the description of the disclosed systems, devices and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices and methods. Those skilled in the art will recognize that for any geometric shape, dimensions equivalent to such linear dimensions and circular dimensions can be easily determined.

[0105] The present invention provides a surgical assembly for anastomotic joints and closed joints. Generally, the surgical assembly may include an actuator device, which is configured to expand the anastomotic joint in the patient's body to connect and fluidly communicate tissue. The actuator device may include a handle, which has an elongated shaft extending distally therefrom. The distal end of the elongated shaft may have an anastomotic joint fixed thereto, and the handle may be actuated to reversibly expand one or more proximal wings and / or distal wings of the fixed joint to engage tissue therebetween. Then, the joint may be disengaged from the elongated shaft. In the case of a closed joint, before expanding one or more proximal wings and / or distal wings, the surgical assembly may use a blood flow signal, which may be used to determine the position and / or orientation of the joint relative to the tissue to ensure the correct expansion of the joint. According to the position of the joint, blood may flow through the joint and flow along the elongated shaft to provide a visual indication of the position of the joint to the surgeon.

[0106] In certain embodiments, the joint piece can have a larger, centrally arranged aperture. This aperture can promote fluid flow between the connecting area of ​​the tissue, which can be required for various surgical operations. When fluid flow through the joint piece is not desired, the blockage can be advanced into the larger aperture by the actuator device. The blockage can then be permanently or reversibly fixed to the larger aperture to prevent fluid from flowing therethrough.

[0107] The closure assembly can be used in various surgical procedures. For example, the closure assembly can be used for percutaneous closure of a common femoral artery resection or phlebectomy after a diagnostic and / or interventional therapeutic intra-arterial surgical procedure (e.g., peripheral or coronary angiography, arterial stenting, balloon angioplasty, and atherectomy surgical procedure), wherein the artery resection is located in the common femoral artery and the closure assembly has been used. In addition, the closure assembly can also be used for other surgical treatments, including, for example, surgery to promote weight loss and / or treatment of type 2 diabetes.

[0108] Figure 1 and Figure 2 The embodiment of closure assembly 10 is illustrated. The illustrated closure assembly 10 comprises an actuator assembly 100, a deployable joint 140 and a guide sheath 150. The actuator assembly 100 is configured to operate to reversibly convert the deployable joint 140 from a delivery configuration to a deployment configuration to close tissue or engage tissue, and then once the deployable joint 140 is located at a desired position, the deployable joint 140 is ejected from the actuator assembly 100. The deployable joint 140 can connect tissues, and can also form a fluid channel between connected tissues, as will be described in more detail below. The closure assembly 10 can be used with the sizes of various guide sheaths 150.

[0109] The actuator assembly 100 may include a proximal actuator 102 and a distal flexible guide tube 120 extending therefrom. The proximal actuator 102 may include a generally cylindrical body 104 to which a proximal handle 106 is rotatably connected. The proximal handle 106 may be rotated in either a first direction or a second direction (e.g., clockwise and counterclockwise) to reversibly deploy one or more portions of a deployable engagement member 140 as required by a surgical procedure. An ejector rod 108 may extend outwardly and upwardly from the cylindrical body 104 and may pivot relative to the cylindrical body 104. Actuating the ejector rod 108 may cause the proximal actuator 102 to eject the deployable engagement member 140. To prevent premature actuation of the proximal handle 106, a removable locking tab 110 may be fixedly attached to the cylindrical body 104 and the proximal handle 106. The removable locking tab 110 may be rotationally engaged to the proximal handle 106 relative to the cylindrical body 104. The removable locking tab may be secured to both the cylindrical body 104 and the proximal handle 106 by one or more protrusions and / or recesses (not shown) on the bottom side of the proximal actuator 102. The removable locking tab 110 may also wrap around the proximal handle 106 to be secured to the proximal actuator 102 until removed by an operator. The operator may remove the removable locking tab 110 from the cylindrical body 104 and the proximal handle 106, and may then actuate the proximal handle 106 and / or the ejector rod 108 as desired. The proximal actuator 102 may include information for guiding the user through the surgical procedure. For example, the proximal actuator 102 may include arrows indicating the direction of actuation and order of use during a surgical procedure, i.e., an arrow labeled "1" points in a first direction to indicate that the proximal handle 106 should be rotated in that direction first, and an arrow labeled "2" points in a second direction to indicate that the proximal handle 106 should be rotated in that direction next.

[0110] A pair of sheath latches 112 may extend from the distal side of the cylindrical body 104. The sheath latches 112 may take a variety of forms and arrangements, but they may generally be a single or a pair of opposed linear stents, wherein the inwardly facing ends 114 are configured to grip and retain the guide sheath 150, as described in more detail below. The blood flow signal outlet 116 may be located on the upper side of the cylindrical body 104, such as Figure 5 As shown, or it can be located at any other position on the periphery of the cylindrical body 104. The blood flow signal outlet 116 may include a central hole 116A, which leads to an internal flow path, and the internal flow path is configured to communicate with the patient's body fluid. The blood flow signal outlet 116 may also include one or more expansion ports 118 or a neck or a pipe extending downward from the cylindrical body 104. The operation of the blood flow signal and the blood flow signal outlet 116 will be described in more detail below.

[0111] The flexible guide tube 120 extends distally from the cylindrical body 104 between the sheath latches 112 and is generally linear. In some variations, the flexible guide tube 120 can be structurally rigid. The flexible guide tube 120 can include a center pin 122 surrounded by an outer sheath 124 to define a flow path 126 in a space between the center pin 122 and the outer sheath 124. The flow path 126 can extend through the entire length of the flexible guide tube 120. Figure 3 In more detail, the central pin 122 may include an outwardly flared distal end cap 128. The outer sheath 124 may have a length less than the central pin 122 so that the deployable engagement member 140 may be positioned around a portion of the central pin 122 extending beyond the distal end of the outer sheath 124. The outer sheath 124 may include a pair of opposing extensions 130 with a gap therebetween, thereby forming a C-tube. The distal end portion of the outer sheath 124 may also include a retaining portion 132 disposed around the C-tube portion of the outer sheath 124, which retaining portion 132 may include a plurality of tooth-shaped portions 134.

[0112] Figure 4 A partial enlarged view of the flexible guide tube 120 is shown with the deployable engagement member 140 seated, Figure 5 A cross-sectional view of a flexible guide tube 120 is provided with a seated deployable engagement member 140 fixed thereto. The seated deployable engagement member 140 can be generally cylindrical, defining a central lumen that is configured to receive a central pin 122 of the flexible guide tube 120 when seated to the flexible guide tube 120. The seated deployable engagement member 140 can be made of a variety of materials, including various metals, plastics, or combinations thereof. Specific materials may include stainless steel, titanium, or any biocompatible material. The seated deployable engagement member 140 may include a proximal end having a complementary toothed portion 141 that can engage with a toothed portion 134 on a retaining portion 132. The seated deployable engagement member 140 may also include a plurality of slits 144 located at a proximal end 140P and a distal end 140D. The proximal slits 144P and the distal slits 144D can take a variety of forms, for example, they can be straight, curved, irregular, etc. In some variations, the slits 144 can be generally mirror images of each other and generally s-shaped or z-shaped or similar shapes, for example, Figure 4 The slit 144 may also be sized to provide a gap large enough for blood to flow through and into the flexible guide tube 120, as will be described in more detail below.

[0113] The seated deployable engagement member 140 can be reversibly transformed between a delivery configuration and a deployment configuration. In the delivery configuration, the seated deployable engagement member 140 can have a generally linear shape, for example, Figure 1 and Figure 4As shown, when the deployable engagement member 140 seated has been seated to the flexible guide tube 120. By actuating the proximal handle 106 to rotate it in the first direction and the second direction in turn, the deployable engagement member 140 seated is converted into a deployment configuration. As described below, the proximal handle 106 rotates in the first direction to apply torsional force and compression force to the deployable engagement member 140 seated, thereby causing the deployment of one or more wings. In a generally linear delivery configuration, the deployable engagement member 140 seated can have a generally consistent diameter along its length, and in a generally deployed configuration, the deployable engagement member 140 seated is converted into having at least one proximal wing and at least one distal wing configured to retain tissue therebetween.

[0114] By actuating the proximal handle 106, the conversion between the delivery configuration and the deployment configuration can be achieved. During the conversion process, the proximal handle 106 can be rotated in a first direction to rotate the outer sheath 124 of the flexible guide tube 120. The rotation of the flexible guide tube 120 can cause the engaged toothed portions of the retaining portion 132 and the seated deployable joint 140 to be subjected to torsional force. The engaged toothed portions 134, 141 of the retaining portion 132 and the seated deployable joint 140 can cause the outer sheath 124 to apply a torsional force to the seated deployable joint 140. Synchronously, starting from the distal end cap 128, a linear compressive force can also be applied to the seated deployable joint 140 in a proximal direction. For example, the proximal handle 106 can be rotated in a first direction (e.g., clockwise or counterclockwise) to rotate the end cap 128 in the first direction to generate torque and then compress the seated deployable joint 140 and cause the distal end 140D to expand radially outward to form the distal wing 148D. When the deployable joint 140 is fully compressed and forms the distal wing 148D (generated by providing the necessary force to compress the deployable joint 140 by the actuator spring (not shown) engaged to the proximal handle 106), the proximal wing 148P can be formed. The proximal handle 106 can be rotated in a second direction (which can be the same or different from the first direction) to further compress the joint and apply torque in the opposite direction to cause the proximal end 140P to expand outward to form the proximal wing 148P. The proximal and distal wings 148P, 148D can have a variety of forms. For example, the wings 148P, 148D may include one or more flaps or segments that form the shape of the wings 148P, 148D.

[0115] The seated deployable joint 140 and the proximal actuator 102 can together define a blood flow path that can be used as a blood flow signal during a surgical procedure to inform the surgeon of the position and / or orientation of the seated deployable joint 140 within the patient's body. Proper positioning and orientation of the seated deployable joint 140 can ensure that the wings of the seated deployable joint 140 do not improperly deploy in an ineffective or harmful manner.

[0116] Figure 7-11 1 and 2 illustrate exemplary blood flow through the blood flow path defined by the seated deployable joint 140 and the proximal actuator 102 during a surgical procedure. Figure 8 As shown by the arrows in FIG. 1 , blood in the patient may be driven by the patient's blood pressure into the seated deployable joint 140 and flow through the proximal actuator 102 to be ejected from the cylindrical body 104 of the proximal actuator 102. Fig. 9 As shown by the arrows in FIG. 1 , blood can enter the joint through the proximal and distal slits and openings 144P, 144D. Figure 10-11 As shown, once the blood has entered the seated deployable coupling 140, it can flow through the gaps in the C-shaped tube portion of the outer sheath 124 and flow below the retaining portion 132. From here, the blood will flow upward along the flexible guide tube 120 in the space between the central pin 122 and the outer sheath 124. Fig.12 As shown, eventually, the blood will reach a turning point where the blood flow path 126 is directed toward the blood flow signal outlet 116. The blood may eventually be ejected from the blood flow signal outlet 116 and discharged in a controlled manner.

[0117] Reference Figure 2 , the introducer sheath 150 may include a generally elongated sheath 152 having a central lumen 154 sized to receive a flexible guide tube 120 with a seated deployable engagement member 140 secured thereto. The introducer sheath 150 may include a proximal funnel 156 having an outwardly flared base 158 that may be received by the sheath latch 112 to engage the proximal actuator 102 and the introducer sheath 150 together. During a surgical procedure, the introducer sheath 150 may provide access to the actuator assembly 102. The introducer sheath 150 may take a variety of forms, such as a cannula with any or all of the features described herein.

[0118] exist Figure 13-18 During the exemplary surgical procedure shown, the actuator assembly 100 can be used to engage tissue 40 located in the arterial lumen 32. At any or all stages of the surgical procedure, various imaging techniques (i.e., using fluoroscopy, etc.) can be used to confirm positioning, deployment, etc. before proceeding to the next step. The prepared introducer sheath 150 can be inserted into the patient's arterial lumen 32 to access the treatment area. Fig.13, the flexible guide tube 120 and the deployable joint 140 can be inserted into the guide sheath 150 and then advanced until the sheath latch 112 connects the cylindrical body 104 of the proximal actuator 102 to the guide sheath 150 through the outwardly expanded base 158. Initially, the angle between the tissue surface and the actuator assembly 100 can be shallow (e.g., less than 90 degrees relative to the lumen axis, and more preferably less than 45 degrees) so that during insertion, the deployable joint 140 does not "bottom out" in the arterial lumen 32, that is, so that the deployable joint 140 does not hit the opposite side of the arterial lumen 32 and possibly injure the patient. When the proximal actuator 102 and the deployable joint 140 are in place, blood can flow through the deployable joint 140 into the flexible guide tube 120 and then out of the blood flow signal outlet 116. Fig.14 Blood is depicted flowing through the deployable coupling 140 and the proximal actuator 102, with a partially enlarged view of the deployable coupling 140 and the upper side of the proximal actuator 102, which partially enlarges the blood flow signal outlet 116. Once blood flows out of the blood flow signal outlet 116, the removable locking tab 110 can be separated from the proximal actuator 102.

[0119] Fig.15 Deployment of the distal wing 148D within the arterial lumen 32 by rotationally actuating the proximal handle 106 is described. By removing the removable locking tab 110, the proximal handle 106 can be actuated in a first direction (e.g., clockwise) to deploy the distal wing 148D of the deployable joint 140 within the arterial lumen 32. After the distal wing 148D is deployed, the actuator assembly 100 can be withdrawn from the patient's body so that the distal wing 148D contacts the inner surface of the arterial lumen 32, thereby positioning the slit 144 of the deployable joint 140 outside the arterial lumen, thereby preventing blood from flowing into the slit 144 and stopping the blood flow signal. If necessary, the actuator assembly 100 can be reinserted into the arterial lumen 32 to allow blood to flow back through the flexible guide tube 120 and out of the blood flow signal outlet 116, and retracted again to stop the blood flow signal to reconfirm the correct positioning of the deployable joint 140. If reinsertion occurs, blood can flow through the proximal slit 144P to promote blood flow signals. Fig.15 As seen in , when the position of the deployable coupling 140 is confirmed to be correct, the actuator assembly 100 can be pivoted to a more perpendicular orientation relative to the tissue to increase the angle A between the tissue surface and the actuator assembly 100. This angle can vary depending on the patient, the size of the arterial lumen, the size of the deployable coupling 140, etc., and can be at least 30 degrees. In some embodiments, the angle A can be between 40 and 60 degrees. Pivoting in this manner can allow the deployed distal wing 148D to more securely contact the inner wall of the arterial lumen 32. As shown in FIG. Fig.16As shown in , once in place, the proximal handle 106 can be rotated in a second direction (e.g., counterclockwise) to deploy the proximal wing 148P and capture tissue between the distal wing 148D and the proximal wing 148P. Actuating the proximal handle 106 in the second direction to the correct limit can cause a gap 106A to appear between the proximal handle 106 and the cylindrical body 104, thereby indicating that the proximal handle 106 is properly actuated to deploy the proximal and distal wings 148P, 148D of the deployable joint 140. After the proximal wing 148P is deployed, a dissection "push and pull" test can be performed by gently swinging the actuator assembly 100 toward or away from the captured tissue. If the deployment is performed correctly, it may be impossible to push the deployed joint into the arterial lumen 32 during the push and pull test. Furthermore, when performing the push-pull test, blood flow signals should not be visible because the entry point of the blood flow path - the slit 144 of the deployable joint 140 - has been defined into the proximal and distal wings 148P, 148D, and blood cannot enter the flexible guide tube 120. By confirming the correct positioning, the ejector rod 108 can be actuated by pulling the ejector rod 108 proximally toward the proximal handle 106 to eject the deployable joint 140 from the flexible guide tube 120. Fig.17 and 18 As shown in , the proximal actuator 102 and the introducer sheath 150 can be removed from the surgical site.

[0120] Reference now Figure 19-30 , a closure assembly 20 for larger aperture closure is shown. Closure assembly 20 can be used for larger punctures than closure assembly 10, which may be necessary for certain surgical procedures. If the puncture is too large, closing and / or engaging the puncture or surrounding tissue may be risky or even impossible. Closure assembly 20 may include guide wire 30, actuator assembly 200, deployable joint 240, guide sheath 250, plugging tool 260 and angiography port 270. Actuator assembly 200 may include actuator 202 and guide tube 220. Actuator assembly 200 may also include a central lumen 203 that runs through actuator 202 and guide tube 220, which will be described in more detail below. Generally, many elements and features of closure assembly 20 are similar to closure assembly 10, and for the sake of brevity, similar elements are no longer described in detail.

[0121] Fig. 20 A guide wire 30 is described. The guide wire 30 can be any standard guide wire known to those skilled in the art. The guide wire 30 can be pre-inserted into tissue and / or a cavity to help guide surgical tools to a surgical site or site of interest. Although the guide wire 30 can vary in size depending on the rest of the closure assembly 20, in certain embodiments, the guide wire 30 has a size between approximately 0.01 inches and 0.05 inches. For example, the guide wire has a diameter of approximately 0.035 inches.

[0122] Fig.21 An introducer sheath 250 is described. The introducer sheath 250 may include an elongated shaft 252 having its proximal end attached to a relay 256. The elongated shaft 252 may define an inner lumen 254, and the distal end of the elongated shaft 252 may include one or more fluid holes 253 located on its sidewall. The relay 256 may be trumpet-shaped in shape and may have a port 258 extending from one side that leads to a valve assembly 259 for use as a blood flow signal during the surgical procedure. The port 258 and the valve assembly 259 may be configured to provide a connection point for connecting the introducer sheath 250 to the actuator 202. The introducer sheath 250 may have a variety of sizes, and each size of the introducer sheath 250 may be suitable for a variety of puncture sizes.

[0123] Fig. 22 The actuator assembly 200 is described in more detail. The actuator assembly 200 can be similar to the actuator assembly 100, and it can include an actuator 202 having a guide tube 220 extending from a distal end thereof. The actuator 202 generally includes a body 204, a handle 206, and an ejector rod 208, just like the actuator 102 described above. The actuator 202 can also include a removable locking tab 210 configured to prevent premature actuation of the handle 206 and a removable rod lock 211 configured to prevent premature actuation of the ejector rod 208. The actuator 202 can include a sheath retaining portion 232 extending proximate to the guide tube 220 configured to be connected to the introducer sheath 250.

[0124] In some embodiments, the sheath retainer 232 may include a central track having a plurality of engagement zones (not shown) configured to engage the guide sheath 250 at a plurality of distances, thereby allowing the guide tube 220 to be inserted into the guide sheath 250 at generally discrete insertion depths to promote blood flow through the blood flow signal outlet 216. The actuator 202 may have a variable number of engagement zones, for example, one, two, three, or more. The assembly 200 may also include a removable sheath stop 213 configured to prevent over-insertion of the guide tube 220 into the guide sheath 250. The removable sheath stop 213 may be coupled to the actuator 202 near the sheath retainer 232, and it may block the (multiple) more proximal engagement zones to prevent over-insertion of the guide tube 220 into the guide sheath 250. If more than one more proximal engagement zone is used, more than one removable sheath stop 213 may be used. When additional depth is required, the removable sheath stop 213 may be disengaged from the actuator 202 to expose the (multiple) more proximal engagement zones. After being engaged with the guide sheath 250, the guide tube 220 may then be further inserted into the guide sheath 250. The blood flow signal outlet 216 may be located at a side of the body 204. The blood flow signal outlet 216 may include a blood flow signal cap 216A to seal the blood flow signal outlet 216.

[0125] The guide tube 220 may extend distally from the actuator 202. The guide tube 220 may be generally tubular, and may be coupled to a large-bore coupling member 240 at an end thereof. Figure 23-25 A partial enlarged view of the end of the guide tube 220 is illustrated, which has a large-aperture joint 240 fixed thereto. The guide tube 220 may include at least one blood inlet 221, which is located proximal to the fixed joint 240, which can be in fluid communication with the blood flow signal outlet on the device 216A. Proximal to the blood inlet 221, there may be a seal 222 disposed circumferentially around the guide tube 220. When the guide tube 220 is inserted into the guide sheath 250, the seal 222 can prevent blood from flowing back to the interior of the guide sheath 250.

[0126] The coupling 240 may be generally cylindrical and may include a generally tubular first end 240A and a generally tubular second end 240B connected by a middle region 241. The middle region 241 may take the form of a compression ring or similar structure. The first end 240A, the second end 240B and the middle region 241 may define a central lumen 242 extending through the center of the coupling 240 about its longitudinal axis, and the central lumen 242 may be co-linear with the central lumen 203 of the actuator assembly 200. For example, as shown in FIG. Fig.23 and 24 As shown in , the first and second ends 240A, 240B may have the same or different diameters. The middle region 241 may also have the same or different diameters, and in some embodiments, the diameter of the middle region 241 may be greater than the diameter of each of the first end 240A and the second end 240B.

[0127] Each of the first end 240A and the second end 240B may include a plurality of slits 244. The shape of the slits 244 may vary, but for example, Fig.26 and 28 As seen in FIG. 1 , the slits 244 may be generally mirror images of each other and may be generally s-shaped or z-shaped or similar. Each of the slits 244 may be divided into two halves, and the length ratio of the two halves of each slit 244 may vary. For example, Fig.26 As seen in FIG. 1 , in some embodiments, the length ratio may be substantially 1:1, where the length of each half is represented as “A”. Fig.28 As seen in , in other embodiments, the ratio may be substantially less than or greater than 1:1, where half the length is represented as "B" and the other half of the length is represented as "C", and the ratio of B:C is substantially less than 1:1.

[0128] As described above, similar to the deployable coupling 140, the coupling 240 can be transformed between a delivery configuration and a deployed configuration. Fig.26 and 28As seen in FIG. 1 , the engaging member 240 may be generally linear, and in the deployed configuration, as shown in FIG. Fig. 27 and 29 As seen in FIG. 1 , the joint 240 may have proximal and distal wings 248P, 248D that flare radially outward from the joint 240. The shape of the slit 244 may affect the shape of the wings 248P, 248D when deployed. In addition, the length ratio of each half of the slit 244 may affect the deployment angle of the wings 248P, 248D relative to the longitudinal axis of the joint 240. For example, if the length ratio is substantially equal to 1:1, for example, Fig.26 In the embodiment of the present invention, the proximal wing 248P and / or the distal wing 248D can be deployed at an angle substantially equal to 90 degrees relative to the longitudinal axis. Fig. 27 This expansion can be seen in . If the length ratio is roughly greater or less than 1:1, e.g. Fig.28 In the embodiment of the present invention, the proximal wing 248P and / or the distal wing 248D can be deployed at an angle generally inclined to the longitudinal axis. Fig.29 Such deployment can be seen in FIG. 2 , where the proximal wing 248P is generally deployed at an acute angle α. In other embodiments, each of the wings 248P, 248D can be deployed at an obtuse angle, an acute angle, a right angle, or a combination thereof. In addition, the deployment angle (such as angle α) between the wings 248P, 248D can also be changed.

[0129] Fig.30 The blocking tool 260 is described in more detail. The blocking tool 260 can be used to block the central lumen 242 of the joint 240 to prevent or block the passage of fluid. Although the blocking tool 260 is not necessarily required in surgical procedures where it is desired to block or prevent the flow of fluid, the blocking tool can provide additional diversity for treating various diseases. The illustrated blocking tool 260 includes a generally cylindrical blocking tool handle 264 having a blocking shaft 262 extending from it to the distal end. The blocking tool handle 264 may include a distal slit 266 from which the blocking shaft 262 extends, and the distal slit 266 may be sized to removably receive the handle 206 of the actuator 202. The ejectable plug 268 can be removably fixed to the distal end of the blocking shaft 262. The handle 264 may also include a rod 265 extending from one side thereof. When actuated, the rod 265 may be configured to eject the ejectable plug 268 from the distal end of the blocking shaft 262. To prevent premature ejection and to hold the rod in the pre-deployed position, an occlusion lock 265A may be coupled to the proximal end of the handle 264 and interfere with actuation of the rod 265 until a predetermined time during the surgical procedure. A set of prongs 267 may extend from the distal end of the handle 264 to the outside of the distal slit 266. When the occlusion tool 260 is secured to the actuator 202, the shape and configuration of the prongs 267 may engage with the removable rod lock 211 on the actuator 202, thereby securing the occlusion tool 260 to the actuator 202.

[0130] During the surgical procedure, as described above, the plugging tool 260 can be coupled to the actuator 202 and used to plug the central lumen 242 of the joint 240 to prevent or block the passage of fluid. After the guidewire 30 is removed from the central lumen 203 of the actuator assembly 200, the plugging tool 260 (plug 268 first) is extended into the central lumen 203. The plugging tool 260 can be inserted until the handle 206 of the actuator assembly 200 is fixed to the gap 266 of the plugging tool 260 and until the fork 267 engages with the removable rod lock 211. At this depth, the ejectable plug 268 can be coaxially disposed in the central lumen 242 of the joint 240. During the removal process, the plugging tool 260 can be disengaged from the actuator 202. The plugging tool 260 is disengaged from the actuator 202, and the fork 267 can be engaged with the removable rod lock 211 so that the removal of the plugging tool 260 can also remove the removable rod lock 211 at the same time. An exemplary surgical procedure using occlusion tool 260 is described below.

[0131] Figure 31-48 An exemplary procedure using the actuator assembly 200 is shown, which involves deploying the engaging member 240 within the arterial lumen 32 of the patient to engage tissue. The engaging member 240 can be used to connect more or less tissue at other locations of the patient, so the surgical procedure described herein is not intended to limit the overall variety of devices described herein. Individual steps of the surgical procedure or the entire surgical procedure itself can be adjusted to suit the needs of the patient and / or surgeon.

[0132] The guide wire 30 can be inserted into the arterial lumen 32 proximal to the surgical site. The guide sheath 250 can be inserted into the guide wire 30 and enter the arterial lumen 32. During insertion, the guide sheath 250 can have an expansion piece 251 inserted therethrough to block the central lumen of the guide sheath 250 and prevent blood from flowing back. Removing the expansion piece 251 can allow blood to flow up to the guide sheath 250 through the blood inlet 253 and flow out of the valve assembly 259 through the inner lumen 254. The valve assembly 259 can be closed as needed. The tip of the slender shaft 252 of the actuator assembly 200 can be inserted into the guide sheath 250, and the slender shaft has a coupling 240 fixed to its distal end. The actuator assembly 200 can be advanced until the actuator assembly 200 is connected to the guide sheath 250 and the deployable coupling 240 is located in the arterial lumen.

[0133] The position of the engaging member 240 in the arterial lumen can be determined by an external imaging system (e.g., ultrasound). The pressure ring 241 can be as close to the puncture site as possible, wherein the proximal portion of the engaging member 240 is at least partially located outside the external lumen. The correct positioning of the engaging member 240 can be determined as needed.

[0134] In certain embodiments as described above, the actuator assembly may include one or more engagement areas for use with the blood flow signal outlet 216. The actuator assembly 200 can be inserted until the guide sheath 250 engages with the sheath retaining portion 232 and is positioned in the first engagement area. In this position, the engagement member 240 can be hidden by the guide sheath 250. Once correctly positioned, as long as the valve assembly 259 is opened, blood can flow out of the blood outlet 216 on the actuator 202 in addition to flowing out of the guide sheath 250. The entire assembly, the guide sheath 250 and the actuator assembly 200 can be pulled back until the blood flow signal disappears. The disappearance of the blood flow signal can be used to confirm the correct positioning of the assembly in the tissue.

[0135] Once in place, assembly 200 can be pivoted upward and away from the surface of the patient's tissue until the angle B between introducer sheath 250 and the surface is at least 30 degrees. Fig.33 As seen in FIG. 8 , in some embodiments, angle B may be between approximately 50 and 60 degrees.

[0136] If included, in the raised position, the movable sheath stop 213 can be removed from the actuator assembly 200 and the guide sheath 250 can be locked into the second engagement region 232A of the center track, thereby exposing the joint 240 from the distal end of the guide assembly 250. While maintaining the raised angle, the locking tab 210 can be removed and the handle 206 of the actuator 202 can be rotated in a first direction (e.g., clockwise) to deploy the distal wing 248D of the joint 240 within the arterial lumen 32. The deployment of the distal wing 248D can be observed under fluoroscopy, ultrasound, angiography, and / or other imaging techniques. Successful deployment of the distal wing 248D can cause the handle 206 to be proximally advanced to form a gap 206A between the handle 206 and the body 204 of the actuator 202. Once the distal wings 248D are deployed, the assembly can be withdrawn until resistance is felt, indicating that the distal wings 248D have contacted the inner surface of the arterial lumen 32. Fig.37 As seen in , while this resistance is maintained, the handle 206 can be actuated in a second direction relative to the first direction (e.g., counterclockwise) to deploy the proximal wing 248P and "sandwich" the tissue 40 between the distal wing 248D and the proximal wing 248P. The deployment of the proximal wing 248P is observed under fluoroscopy or under ultrasound. After the proximal wing 248P is deployed, the gap 206A between the handle 206 and the body 204 of the actuator 202 can increase, thereby further providing confirmation that the deployment was successful.

[0137] The contrast port 270 can be connected to the actuator assembly 200 before the surgical procedure and can be advanced through the guide wire 30. The contrast port 270 generally includes a connecting arm 272 with a valve system extending therefrom. The connecting arm 272 can be configured to be removably coupled to the handle 206 of the actuator assembly 200, for example, by a Luer lock, a threaded connection, a snap fit, a friction fit, etc. The valve system 274 can include a flexible tube 276 connected to the connecting arm 272 at one end and connected to the valve 274 at the other end. The contrast port 270 may include a flow path (not shown) therethrough that can be in fluid communication with the central lumen 203 of the actuator assembly 200. During the surgical procedure, contrast fluid or other fluid can be injected into the valve 274 and then flow through the tube 276, the connecting arm 272 and the central lumen 203, 242. The injected contrast fluid can be used to check for leaks or improper engagement, etc. During the surgical procedure, the connecting arm 272 can be engaged or disengaged from the handle 206 as needed.

[0138] Prior to occluding the central lumen 242 of the joint 240, contrast fluid may be injected through the contrast port 270 to confirm that the arterial lumen 32 is in the correct state while the guidewire is still in place. If the contrast fluid indicates a problem, e.g., damage to the arterial lumen 32, improper positioning of the joint 240, etc., the joint 240 may be returned to the delivery configuration, if necessary, or other measures may be taken to correct the indicated problem. After correction, the surgical procedure may be continued from any point thus far.

[0139] In embodiments that rely on the use of contrast port 270, after contrast fluid is injected and position is confirmed, or if contrast port 270 is not used, the surgical procedure can continue. The guidewire 30 and contrast port 270 can be removed from the actuator assembly 200, and the occlusion tool 260 can be advanced to eject the occlusion 268 to the proximal end of the actuator 202. Figure 39-40 As seen in FIG. 2 , the occlusion tool 260 can be advanced so that the handle 206 of the actuator 202 is fully received by the distal slit 266 of the occlusion tool 260 and the prongs 267 are engaged to the removable rod lock 211. Figure 41-42 As seen in FIG. 2 , such full insertion also securely positions the ejectable plug 268 within the central lumen 242 of the coupling 240. Figure 43-44 As seen in FIG. 2 , once the plugging tool 260 and the ejectable plug 268 are correctly positioned in sequence, the plugging lock 265A can be rotated about the distal end of the plugging tool 260 to disengage from the rod 265, and then the rod 265 can be actuated to eject the ejectable plug 268 from the plugging shaft 262. Once the plug 268 is ejected, the plugging tool 260 can be removed from the actuator 202 by sliding the plugging tool 260 in the proximal direction. Fig.45As seen in FIG. 2 , the plug removal tool 260 can be disengaged from the tine 267 of the removable rod lock 211 so that the plug removal tool 260 also removes the removable rod lock 211 from its position fixed to the rod 265. Figures 46-47 , by removing the occlusion tool 260, the ejector rod 208 can be actuated to disengage the coupling 240 from the elongated shaft 252, thereby deploying the coupling 240. If desired, the separation of the coupling 240 from the elongated shaft 252 can be viewed under fluoroscopy. The introducer sheath 250 and the actuator 202 can be removed from the patient's body.

[0140] During the surgical procedure, the coupling 240 may not be properly fully deployed within the arterial lumen 32, also referred to as "fully deployed within the artery." If such deployment occurs, the coupling 240 may be collapsed to a substantially pre-deployed state and then removed from the patient's body, leaving the guidewire 30 in place. Figure 48-55 The deflation procedure in which this occurs is described, and an internal view of the mechanism for deploying and deflation of the coupling 240 is provided, which mechanism can simultaneously lock the subsequent deployment of the coupling 240. Fig.49 An internal view of the actuator assembly 200 is depicted in a pre-deployed position. In this position, the locking tab 210 is in place. Fig.50 The actuator assembly 200 is depicted with the proximal or distal wings 248P, 248D (depending on which wing is deployed first for the surgical procedure) deployed, and the gap 206A can be clearly seen. In this position, the guide pin 280 is locked to the actuator cylinder 281 of the actuator 282, thereby preventing the handle 206 from moving forward. Fig.51 The actuator assembly 200 is depicted after the second of the proximal or distal wings 248P, 248D is deployed, and Fig.50 By comparison, it can be seen that the size of gap 206A has increased. In this position, guide pin 280 is again locked to just in front of actuator cylinder 281 of actuator 282, thereby preventing handle 206 from moving forward. At this point, if joint 240 is correctly deployed, the surgical procedure can continue as desired. If joint 240 must be collapsed, for example, as a result of incorrect deployment, the collapsed surgical procedure can continue.

[0141] like Fig.52 and 53As seen in , to deflate the joint 240, the spring release plate 284 can be depressed and slid distally to allow access to the actuator cylinder plate 286. The actuator cylinder plate 286 can be compressed, and the actuator cylinder 282 can move distally without restriction. The handle 206 can be pushed distally and rotated in a first direction (e.g., clockwise) and a second direction (e.g., counterclockwise) to simultaneously flatten both the proximal and distal wings 248P, 248D. The handle 206 can then be pushed distally again and rotated in a second direction (e.g., counterclockwise) to begin / continue flattening the other of the proximal and distal wings 248P, 248D. As shown in FIG. Fig.48 As shown in , the proximal and distal wings 248P, 248D can be collapsed into a generally shallow oval shape, and then the introducer sheath 250 and actuator assembly 200 can be removed, leaving the guidewire 30 in place. Fig.55 As shown in , the action of flattening the joint 240 to a generally pre-deployed state causes the guide pin 280 in the actuator assembly 200 to actuate to interact with the ratchet 282A located on the actuator 282 and to emerge as a result of the actuator cylinder 282 being held in the proximal position. This interaction prevents the joint 240 from being deployed again after the initial deployment failure. A new actuator assembly 200 can be inserted into the patient, thereby starting the first step of the surgical procedure and proceeding sequentially therefrom.

[0142] Both deployable couplers 140 and couplers 240 are described for use in an exemplary surgical procedure to couple a portion of an arterial lumen 32. These couplers 140, 240 and the various embodiments described herein may be used in a variety of surgical procedures to achieve a variety of desired outcomes.

[0143] Figure 56-72 The use of one or more joints 340 to promote weight loss and / or treatment of type 2 diabetes in accordance with one embodiment is illustrated. The medical procedure involves a cholecystostomy plus or minus an entero-enteric anastomosis, and it may be performed laparoscopically or percutaneously through the liver. Although joint 340 is mentioned, the procedure may be performed by any combination of the assemblies and devices described herein, including deployable joints 140 and joints 240. The operation of joint 340 may be similar to deployable joints 140 and 240, and it may be used in conjunction with an associated actuator assembly 300, the operation of which is similar to actuator assemblies 100 and actuator assemblies 200.

[0144] To begin the surgical procedure, one or more incisions may be made in the patient's body to gain access to the patient's small intestine 50 and gallbladder 60. Fig.56, the surgeon can then grasp a portion of the patient's ileum 52 and bring it to a position anterior to or posterior to the transverse colon, near the gallbladder 60. This orientation can then define a distal ileum loop 52D located distal to the ileum region near the gallbladder 60, and a proximal ileum loop 52P located proximal to the ileum region near the gallbladder 60. In addition, an incision 54 can be made distal to the portion of ileum 52 grasped by the surgeon, for example, in the form of an enterotomy opposing the mesenteric small intestine, and as shown in FIG. Fig.57 As shown, an anastomotic joint 340 fixed to the distal end of a flexible guide tube 320 can be inserted through the incision 54 toward the gallbladder 60. Once inserted, the distal tip 320D of the guide tube 320, i.e., the distal end of the anastomotic joint 340, can be advanced until it is positioned against the walls of both the ileum 52 and the gallbladder 60.

[0145] Once in place, a puncturing member 321 (e.g., a cutting needle, a radiofrequency probe, or an equivalent known in the art) is inserted through the actuator assembly 300 until the distal tip 320D emerges from the central lumen 322 thereof to puncture both the ileum 52 and the gallbladder 60. Fig.60 Such puncture can be seen in FIG. After the puncture member 321 punctures the gallbladder 60, the anastomotic joint 340 can be advanced into the gallbladder 60. In certain embodiments, an introducer sheath (e.g., via an introducer sheath 250, not shown) can be inserted into the ileum and then into the gallbladder. Through the introducer sheath, a self-expanding anastomotic joint (not shown) can be advanced into the gallbladder. The introducer sheath can be retracted, and the distal wings of the self-expanding anastomotic joint can be deployed. The introducer sheath and the self-expanding anastomotic joint can then be further retracted, and the proximal wings of the self-expanding anastomotic joint can be deployed into the ileum.

[0146] After the engagement member 340 has been successfully punctured and advanced into the gallbladder 60, the puncturing member 321 can be partially retracted from the gallbladder 60 in preparation for the deployment of the anastomotic engagement member 340. The locking tab 310 that prevents the anastomotic engagement member 340 from being deployed prematurely can be removed from the actuator assembly 300. Figure 60-61 By removing the locking tab 310, the handle 304 on the actuator assembly 300 can be actuated, for example, by rotating clockwise to deploy the distal wing 344D of the engaging member 340 within the gallbladder 60. Fig.61 As seen in FIG. 3 , once the distal wing 344D is deployed, the actuator assembly 300 can be pulled proximally to bring the distal wing 344D into contact with the interior of the gallbladder 60. From here, the proximal wing 344P of the anastomotic joint 340 can be deployed by the actuation handle 304, for example, by rotating it counterclockwise, as shown in FIG. Figure 62-63 , thereby connecting the gallbladder 60 and the ileum 52 together. In some embodiments, the deployment of the proximal and distal wings 344P, 344D can be reversed so that the proximal wing 344P is deployed first in the ileum and the distal wing 344D is then deployed in the gallbladder.

[0147] After the proximal wings 344P are deployed, the puncture member 321 can be completely removed from the actuator assembly 300. Next, a dye, such as methylene blue or a similar dye, can be injected through the same lumen 322 into which the puncture member 321 was inserted to check for leaks in the anastomosis. If a leak is detected, one or both of the proximal and distal wings 344P, 344D of the anastomotic joint 340 can be re-actuated to partially return to the pre-deployed state, and the anastomotic joint 340 can be re-deployed to a more suitable position. If necessary, the actuator assembly 300 can be removed before re-deployment to resolve any other problems that may be causing the ileum and gallbladder 60 to be improperly connected.

[0148] If the connection is successful, the ejector rod 308 on the actuator assembly 300 can be actuated to eject the anastomotic joint 340 from the actuator assembly 300. The anastomotic joint 340 has a central lumen 341 that allows the gallbladder 60 and the ileum 50 to be in fluid communication.

[0149] Figure 66-67 A cross-sectional view of an anastomotic joint 340 according to certain embodiments is depicted. In this surgical procedure, the proximal and distal wings 344P, 344D of the anastomotic joint 340 can have similar dimensions to each other. In addition, the proximal and distal wings 344P, 344D of the joint 340 can be deployed at different angles relative to the axis of the central lumen 341. These deployment angles can be configured to promote fusion of the gallbladder 60 and the ileum 52 while simultaneously preventing squeezing of tissue, which can lead to serious complications such as necrosis and infection. For example, in Fig.66 In the embodiment of the present invention, the proximal wing 344P is deployed at a certain angle so that the radial end of the proximal wing 344P passes through the middle of the anastomotic joint 340, and the length of the proximal wing 344P is much greater than the length of the distal wing 344D. This causes the walls of the gallbladder 60 and the ileum 52 to be stretched, thereby potentially causing damage. In contrast, Fig.67 One embodiment of anastomotic junction 340 is illustrated in which the proximal and distal wings 344P, 344D are of similar length and their respective deployment angles are insufficient to tension the walls of the gallbladder 60 and ileum 52.

[0150] In some embodiments, the wings 344P, 344D can be placed in contact with each other (e.g., by increasing in length and / or by changing their deployment angles) to help form a compressive anastomosis, which can lead to tissue necrosis. During this necrotic healing process, the outer walls of the ilium and gallbladder can fuse to each other. The anastomotic joint 340 can fall off and be expelled from the patient's body distally through the ileum, leaving a temporary or permanent fluid passageway between the two.

[0151] After ejection of the anastomotic engagement member 340, the actuator assembly 300 may be completely removed from the patient's body.

[0152] like Figures 68-72 From here, an entero-enterostomy can be performed. Fig.68 As shown in , first, the second anastomotic joint 340 ′ can be delivered into the ileum 52 through the incision 54 by the actuator assembly 300. Using the clamping mechanism 70 (e.g., forceps, etc., not shown), the proximal ileum loop segment 52P is manipulated into the proximal position of the distal ileum loop segment 52D. Once the proximal ileum loop segment 52P is in place, the second incision 55 can be opened to the proximal ileum loop segment 52P in a manner similar to that used to open the incision 54, for example, a 5 mm enterotomy.

[0153] The actuator assembly 300 can then be oriented as shown to contact a portion of the ileum 52 while aligning the contact portion with the second incision 55. As described above, once aligned, the piercing member 321 can be inserted through the actuator assembly 300 and the incision can be made in the distal ileal loop segment proximal to the second incision 55. Fig.69 As can be seen, the anastomotic joint 340' can then be inserted, thereby connecting the two ileal loop segments 52D, 52P, and the puncturing member 321 can be partially withdrawn.

[0154] Thereafter, the anastomotic joint 340' may be deployed in a similar manner as described above. Figure 70-71 As shown in , the locking tab 310 can be removed and the handle 304 can be actuated (e.g., by rotating clockwise) to deploy the distal wing 344D within the proximal ileal loop segment 52P. Next, the actuator assembly 300 is withdrawn to allow the distal wing 344D to contact the inner wall of the distal ileal loop segment 52D. Once in place, the handle 304 can be actuated again (e.g., by rotating counterclockwise) to deploy the proximal wing 344P of the anastomotic joint 340 within the distal ileal loop segment 52D, thereby connecting the proximal ileal loop segment 52P and the distal ileal loop segment 52D together.

[0155] The connection is checked using a methylene blue procedure similar to that previously described. From this point, the rod 308 of the actuator assembly 300 can be actuated to separate the actuator assembly 300 and the anastomotic joint 340'. The actuator assembly 300 can then be withdrawn from the patient's body and the various incisions closed during the surgical procedure.

[0156] Fig.72 The newly formed fluid pathway for bile after the medical procedure is depicted. Fluid normally flows from the gallbladder 60 into the small intestine 50 and through each of the anastomotic joints 340, 340'.

[0157] Certain illustrative embodiments have been described to provide an overall understanding of the structure, function, manufacture, and use principles of the systems, devices, and methods disclosed herein. One or more examples of these embodiments have been illustrated in the accompanying drawings. Those skilled in the art will understand that the systems, devices, and methods specifically described herein and illustrated in the accompanying drawings are non-limiting illustrative embodiments, and the scope of the invention is limited only by the claims. The features illustrated or described in connection with an illustrative embodiment may be combined with the features of other embodiments. These modifications and variations are all included within the scope of the invention. In addition, in the present disclosure, similarly named components in the embodiments generally have similar features, and therefore, in a particular embodiment, it is not necessary to fully elaborate on every feature in each similarly named component.

[0158] Approximate terms used herein throughout the specification and claims may be used to modify any quantitative statements that may be allowed to change without causing a change in the basic function associated therewith. Therefore, values ​​modified by one or more terms such as "approximately", "approximately" and "substantially" are not limited to the exact numerical values ​​specified. Approximate terms may correspond to the accuracy of the instrument used to measure the numerical value, at least in some cases. Here and throughout the specification and claims, range definitions may be combined and / or interchanged, and unless the context or language indicates otherwise, these ranges are determined and include all subranges contained therein.

[0159] Those skilled in the art will understand other features and advantages of the present invention based on the above-described embodiments. Therefore, except for the contents indicated by the appended claims, the present application is not limited by the contents specifically shown and described. The full contents of all publications and references cited herein are expressly incorporated by reference.

Claims

1. A surgical assembly comprising: an actuator assembly having an elongated shaft including an outer shaft and an inner shaft coaxially disposed within the outer shaft and defining a fluid flow path therebetween; as well as A deployable engagement member coupled to the distal end of the outer shaft and having a plurality of proximal slits and a plurality of distal slits formed therein and configured to form proximal and distal wings, the proximal and distal slits configured to allow blood to flow therethrough into the fluid flow path and to a fluid outlet port formed in the actuator assembly.

2. The surgical assembly of claim 1, wherein the actuator assembly includes a handle operably coupled to the deployable engagement member.

3. The surgical assembly of claim 2, wherein the handle includes an actuator rotatable in a first direction to deploy the distal wings and rotatable in a second direction to deploy the proximal wings.

4. The surgical assembly of claim 2, wherein the handle includes a deployment rod configured to disengage the deployable engagement member from the distal end of the outer shaft.

5. The surgical assembly of claim 1, further comprising a delivery sheath configured to be coupled to the actuator assembly, the delivery sheath defining a central lumen configured to receive the elongated shaft.

6. The surgical assembly of claim 1, wherein the distal end of the outer shaft includes at least two opposing longitudinal gaps to allow blood to flow from the deployable joint into the fluid flow path.

7. The surgical assembly of claim 6, wherein the outer shaft includes a crown disposed about at least two opposing longitudinal gaps.

8. The surgical assembly of claim 7, wherein the crown includes a toothed portion, and wherein the deployable engagement member is engaged to the toothed portion.

9. The surgical assembly of claim 1, wherein each of the plurality of proximal slits and the plurality of distal slits is generally s-shaped.

10. A surgical method comprising: inserting the elongated shaft of the actuator assembly through a guide assembly extending through a puncture in a body lumen to position a deployable engagement member coupled to a distal end of the elongated shaft within the body lumen so that blood flows into the deployable engagement member, through the elongated shaft, and out of a port at a proximal end of the actuator assembly; subsequently actuating the actuator assembly to expand the distal wings of the deployable engagement member radially outward; retracting the actuator assembly to pull the distal wings against an inner wall of the body lumen to stop blood flow into the deployable coupler; actuating the actuator assembly to cause the proximal wings of the deployable engagement member to expand radially outwardly adjacent to the outer wall of the body lumen, thereby sealing the puncture in the body lumen; as well as The deployable engagement member is disengaged from the distal end of the elongated shaft.

11. The method according to claim 10, further comprising, After actuating the actuator to deploy the distal wings radially outward, and before actuating the actuator assembly to deploy the proximal wings radially outward, the elongated shaft is pivoted to position the distal wings relative to an inner wall of the body lumen.

12. The method of claim 10, wherein the elongated shaft comprises an inner shaft and an outer shaft coaxially disposed around the inner shaft, wherein blood flows between the inner shaft and the outer shaft.

13. The method of claim 12, wherein the distal end of the outer shaft comprises a pair of fused C-tubes defining a gap through which blood flows.

14. The method of claim 10, wherein deploying the proximal wing comprises rotating an actuator assembly in a first direction.

15. The method of claim 14, wherein deploying the distal wing comprises rotating the actuator assembly in a second direction opposite to the first direction.

16. A surgical assembly comprising: an actuator assembly including an elongated shaft; as well as a deployable engagement member coupled to the distal end of the elongated shaft, the deployable engagement member including a plurality of proximal slits therein configured to form proximal wings, and a plurality of distal slits therein configured to form distal wings; wherein the actuator assembly is configured to transform the deployable coupling from a delivery configuration in which the proximal wing and the distal wing are generally parallel to the slender shaft to a fully deployed configuration in which one of the proximal wing and the distal wing is generally perpendicular to the slender shaft and the other of the proximal wing and the distal wing is oblique to the slender shaft.

17. The surgical assembly of claim 16, wherein each of the plurality of proximal slits comprises a first cutout and a second cutout having substantially equal lengths, and wherein the substantially equal lengths cause the proximal wings to be substantially perpendicular to the elongated shaft in the deployed configuration.

18. The surgical assembly of claim 16, wherein each of the plurality of distal slits comprises a first cutout and a second cutout having substantially unequal lengths, and wherein the substantially unequal lengths cause the distal wings to be generally oblique to the elongated shaft in the deployed configuration.

19. The surgical assembly of claim 16, wherein transformation of the deployable engagement member from the delivery configuration to the deployed configuration causes the proximal and distal wings to collapse about a middle region thereof.

20. The surgical assembly of claim 16, wherein the plurality of proximal slits and the plurality of distal slits are generally s-shaped.

21. The surgical assembly of claim 16, further comprising an auxiliary handle configured to engage the proximal end of the actuator assembly, the auxiliary handle having a distally extending plug configured to extend through a central lumen at least partially defined by the elongated shaft and positioned within a central hole of the deployable coupling.

22. The surgical assembly of claim 21, wherein the distally extending plug is configured to seal the central aperture.

23. A surgical assembly comprising: a delivery tool comprising an elongated shaft extending from a distal end thereof; as well as a deployable engagement member coupled to the distal end of the elongated shaft, the deployable engagement member having a distal wing defined by a first proximal cutout and a first distal cutout and a proximal wing defined by a second proximal cutout and a second distal cutout; wherein the delivery tool is configured to transform the deployable engagement member between a delivery configuration in which the elongated shaft is generally parallel to the distal wing and the proximal wing and a deployed configuration in which the elongated shaft is generally transverse to the distal wing and the proximal wing; as well as The deployment angle of the distal wing is at least partially determined by the length ratio of the first proximal incision and the first distal incision, and the deployment angle of the proximal wing is at least partially determined by the length ratio of the second proximal incision and the second distal incision.

24. The surgical assembly of claim 23, wherein a ratio of the lengths of the first proximal cutout to the first distal cutout is substantially equal to 1 and configured such that a deployment angle of the distal wings is approximately 90 degrees.

25. The surgical assembly of claim 23, wherein a ratio of lengths of the second proximal cutout to the second distal cutout is substantially greater than 1 and configured such that a deployment angle of the proximal wings is substantially acute.

26. A surgical fastener comprising: a first tubular portion having a plurality of first longitudinal cuts, each of the plurality of first longitudinal cuts having a proximal cut and a distal cut with a length ratio of about 1:1; a second tubular portion having a plurality of second longitudinal cuts, each of the plurality of second longitudinal cuts having a proximal cut and a distal cut having a length ratio of substantially less than 1:1; a connecting portion disposed between the first tubular portion and the central tubular portion; and The first tubular portion, the second tubular portion and the connecting portion define a central lumen.

27. The surgical joint of claim 26, wherein the first tubular portion is configured to reversibly form wings that are generally perpendicular to the longitudinal axis of the central lumen.

28. The surgical joint of claim 26, wherein the second tubular portion is configured to reversibly form wings that are generally oblique to the longitudinal axis of the central lumen.

29. The surgical fastener of claim 26, wherein a diameter of the connecting portion is greater than a diameter of the first tubular portion and a diameter of the second tubular portion.

30. The surgical fastener of claim 29, wherein the diameter of the first tubular portion is smaller than the diameter of the second tubular portion.

31. The surgical fastener of claim 26, wherein the surgical fastener is configured to be coupled to an actuator tool configured to reversibly form the first tubular portion and the second tubular portion into wings.

32. The surgical fastener of claim 31 , wherein the actuator tool is configured to receive a blockage configured to prevent fluid flow into the central lumen.

33. A method comprising: inserting a delivery sheath through a puncture site in the artery and over the guidewire to position a deployable engagement member coupled to a distal end of the delivery sheath within the artery; pivoting the introducer sheath from an insertion orientation in which blood can travel along the engagement member to an inclined orientation in which blood cannot travel along the engagement member; actuating an actuator coupled to the proximal end of the delivery sheath to deploy the distal wing and position the distal wing within the artery proximate the puncture site; actuating the actuator to expand the proximal wing of the deployable engagement member to position the proximal wing outside of the artery near the puncture site; removing the guidewire from the delivery sheath; as well as A plug is advanced into the central lumen of the deployable adaptor to seal the puncture site.

34. The method of claim 33, wherein the plug is operatively coupled to an auxiliary handle having a deployment rod located thereon, the deployment rod configured to deploy the plug into the deployable engagement member.

35. The method of claim 34, further comprising actuating a deployment rod to detach the obstruction from the assist handle after the obstruction has been advanced into the central lumen.

36. The method of claim 33, further comprising positioning the coupler relative to the puncture site using an external imaging system that detects the radioactivity of the coupler.

37. A surgical method comprising: advancing a first engagement member through the small intestine to an area of ​​the small intestine adjacent to the gallbladder, the first engagement member being engaged to the distal end of the elongated shaft; piercing the area of ​​the small intestine and gallbladder using a piercing member advanced through the elongated shaft and the first engagement member; advancing the first engagement member at least partially within the gallbladder; deploying a first distal wing of a first engagement member within the gallbladder; retracting the elongated shaft so that the first distal wing contacts the inner surface of the gallbladder; deploying a first proximal wing of the first fastener within the small intestine to removably secure the first fastener to the gallbladder and the small intestine; as well as The first engagement member is ejected from the distal end of the elongated shaft.

38. The method of claim 37, further comprising: advancing a second engagement member through the small intestine into an ileal loop segment distal to the proximal ileal loop segment, the second engagement member being engaged to the distal end of the elongated shaft; piercing the inner wall of the distal ileal loop segment using a piercing member advanced through the elongated shaft and the second engaging member to access the proximal ileal loop segment; deploying a second distal wing of a second fastener within the proximal ileum loop segment; retracting the elongated shaft so that the second distal wing contacts the inner surface of the proximal ileal loop segment; deploying a second proximal wing of the second fastener within the distal ileum loop segment to removably secure the second fastener to the proximal ileum loop segment and the distal ileum loop segment; as well as The second engagement member is ejected from the distal end of the elongated shaft.

39. The method of claim 38, wherein at least one of the first proximal wing and the first distal wing extends at an acute angle relative to the longitudinal axis of the elongated shaft.

40. The method of claim 39, wherein the other of the first proximal wing and the first distal wing extends at an acute angle relative to the longitudinal axis of the elongated shaft.

41. The method of claim 39, wherein the radial tip of the first proximal wing contacts an inner wall of the small intestine in the deployed configuration and the radial tip of the first distal wing contacts an inner wall of the gallbladder in the deployed configuration.

42. The method of claim 37, wherein a deployment angle of the first proximal wing and a deployment angle of the first distal wing are substantially equal, and wherein a length of the first proximal wing and a length of the first distal wing are substantially equal.

43. The method of claim 37, wherein the first proximal wing comprises a first plurality of flaps and the first distal wing comprises a second plurality of flaps, and wherein the first plurality of flaps are rotationally displaced from the second plurality of flaps.

44. A method comprising: deploying a first distal wing of the first engagement member within the gallbladder and a first proximal wing of the first engagement member within the ileum with an actuator tool having an elongated shaft and a first engagement member coupled to a distal end of the elongated shaft; Deploying a second distal wing of the second fastener in a first ileum loop distal to the deployed first fastener and deploying a second proximal wing of the second fastener in a second ileum loop proximal to the deployed first fastener using an actuator tool having a second fastener coupled to the distal end; wherein the first engagement member defines a first central lumen configured to fluidly connect the gallbladder and the ileum therebetween; The second joint defines a second central lumen configured to fluidly connect the first ileum loop segment and the second ileum loop segment therebetween.

45. The method of claim 44, further comprising: The ileum wall and the gallbladder wall are pierced with a piercing member coupled to the distal end of the elongated shaft to position a first engaging member at least partially within the gallbladder and at least partially within the ileum.

46. ​​The method of claim 45, wherein at least one of the first proximal wing and the first distal wing extends at an acute angle relative to the longitudinal axis of the elongated shaft.

47. The method of claim 46, wherein the other of the first proximal wing and the first distal wing extends at an acute angle relative to the longitudinal axis of the elongated shaft.

48. The method of claim 46, wherein the radial tip of the first proximal wing contacts an inner wall of the small intestine in the deployed configuration and the radial tip of the first distal wing contacts an inner wall of the gallbladder in the deployed configuration.

49. The method of claim 45, wherein a deployment angle of the first proximal wing and a deployment angle of the first distal wing are substantially equal, and wherein a length of the first proximal wing and a length of the first distal wing are substantially equal.

50. The method of claim 45, wherein the first proximal wing comprises a first plurality of flaps and the first distal wing comprises a second plurality of flaps, and wherein the first plurality of flaps are rotationally offset from the second plurality of flaps.

51. A method comprising: introducing a first engagement member into the ileum, the first engagement member being attached to an elongated shaft extending distally from the actuator tool, the first engagement member and the elongated shaft defining a first central lumen therebetween; contacting the outer wall of the ileum proximal to the outer wall of the gallbladder with the distal end of the first engagement member; extending the first piercing member through the first central lumen to pierce the inner wall of the ileum and the outer wall of the gallbladder; Advancing the first engaging member from the ileum into the gallbladder; deploying the distal wing of the first engagement member within the gallbladder using an actuation tool; retracting the first engagement member to contact the inner wall of the gallbladder with the distal wing; deploying a proximal wing of a first engaging member in the ileum using an actuating tool, the gallbladder and the ileum being in fluid communication via the first engaging member; as well as The first engagement member is disengaged from the elongated shaft.

52. The method of claim 51 further comprising: introducing a second engaging member into the ileal loop segment distal to the first engaging member, the second engaging member being attached to the elongated shaft, the second engaging member and the elongated shaft defining a second central lumen therebetween; cutting the region of the proximal ileal loop proximal to the first fastener; contacting the outer wall of the distal ileum loop segment near the incised area of ​​the proximal ileum loop segment; extending a second piercing member through the second central lumen to pierce the inner wall of the distal ileal loop segment and the incised area; Advancing a second engaging member from the distal ileal loop segment through the incised area into the proximal ileal loop segment; deploying a distal wing of a second engagement member within the proximal ileal loop segment using an actuator tool; retracting the second engaging member to contact the inner wall of the proximal ileal loop segment with the distal wing; deploying a proximal wing of a second engagement member within the distal ileum loop segment with an actuator tool, the proximal ileum loop segment and the distal ileum loop segment being in fluid communication via the second engagement member; as well as The second engagement member is disengaged from the elongated shaft.

53. A method comprising: The sheath is inserted through the ileum and into the gallbladder; advancing an expandable engagement member coupled to a distal end of an actuator tool through the sheath and into the gallbladder; retracting the sheath from the gallbladder to expose the expandable engagement member; deploying a distal wing of the expandable engagement member within the gallbladder with an actuator tool; deploying the proximal wing of the expandable engagement member within the ileum using an actuator tool, the gallbladder and the ileum being in fluid communication via the deployed expandable engagement member; as well as The expandable engagement member is disengaged from the actuator tool.

Images