Wound closure and tissue attachment systems and methods

Abstract

A surgical assembly and associated methods are provided for using an actuator to deploy a coupler configured to close a tissue puncture or natural opening in a body. The surgical assembly includes an actuator assembly and a deployable coupler, the actuator assembly having an elongate shaft including an outer shaft and an inner shaft concentrically disposed within the outer shaft and defining a fluid flow path therebetween, the deployable coupler being coupled to a distal end of the outer shaft. The deployable coupler has a plurality of proximal and distal slits formed therein and configured to form proximal and distal wings. The proximal and distal slits are configured to allow blood to flow therethrough into an inner lumen of the deployable coupler, through the fluid flow path, and to a fluid exit port formed in the actuator assembly.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 346,151, filed May 26, 2022, entitled "Wound Closure and Anastomosis Device for Sealing or Anastomosing Hollow Structures", which claims the benefit of U.S. Provisional Application No. 18 / 087,498, filed December 22, 2022, entitled "Wound Closure and tissue Coupling Systems and Methods", and U.S. Patent Application No. 18 / 087,598, filed December 22, 2022, entitled "Large-Bore Wound Closure and Tissue Coupling Systems and Methods", and U.S. Patent Application No. 18 / 087,559, filed December 22, 2022, entitled "Wound Closure and Tissue Coupling Systems and Methods", all of which are incorporated by reference in their entireties. [Technical field]

[0002] Methods and devices for wound closure and anastomosis are provided. [Background technology]

[0003] Many surgical procedures involve puncturing tissue at a surgical site to create a hole or anastomosis of tissue to create an anastomosis, such as an intestinal anastomosis or an arteriovenous fistula between an artery and a vein. In the case of fistula creation, the purpose of such a connection is to create a high flow connection or to route blood around an obstruction to an alternative conduit or bypass. The conduit or bypass is typically a vein, artery, or vascular graft.

[0004] An anastomosis can be created during surgery by bringing two blood vessels or conduits, such as the intestine, into direct contact and joining them with sutures, clips, or other means. Anastomoses can be end-to-end, end-to-side, or side-to-side. In blood vessels, anastomoses are typically oval in shape and are manually joined with sutures. Other techniques for creating an anastomosis include carbon dioxide laser, prostheses, clips, and stents. An arteriovenous fistula, a type of fistula, is created by connecting an artery and a vein. This type of connection can be used for hemodialysis, to improve exercise tolerance, to treat high blood pressure, to keep arteries and veins open, and as an access route for chemotherapy.

[0005] A variety of devices have been proposed for percutaneously sealing tissue openings or joining hollow structures within a patient's body, such as biodegradable plugs, sutures, surgical fasteners, and other devices. However, these devices and associated methods suffer from a number of drawbacks, including surgical risk, high failure rates, and complexity. Thus, there remains a need for improved devices and associated methods for closing tissue punctures and anastomotic tissue structures within a patient's body, or for deploying such devices in a simple and effective manner. Summary of the Invention

[0006] Generally, methods and systems for anastomosis and wound closure are provided.

[0007] In one embodiment, a surgical assembly is provided that includes an actuator assembly and a deployable coupler, the actuator assembly having an elongate shaft including an outer shaft and an inner shaft concentrically disposed within the outer shaft and defining a fluid flow path therebetween, the deployable coupler being coupled to a distal end of the outer shaft. The deployable coupler can have a plurality of proximal and distal slits formed therein and can be configured to form proximal and distal wings. The proximal and distal slits can be configured to allow blood to flow therethrough into a fluid flow path to a fluid exit port formed in the actuator assembly.

[0008] The surgical assembly can be varied in various ways and can include any of the following features, alone or in combination. For example, the actuator assembly can include a handle operably coupled to the deployable coupler. In some aspects, the handle can include an actuator rotatable in a first direction to cause deployment of the distal wing and rotatable in a second direction to cause deployment of the proximal wing. In another aspect, the handle can include a deployment lever configured to decouple the deployable coupler from the distal end of the outer shaft. For example, the surgical assembly can include a delivery sheath configured to couple to the actuator assembly. The delivery sheath can define a central lumen configured to receive the elongate 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 coupler to the fluid flow path. In some aspects, the outer shaft can include a crown disposed about the at least two opposing longitudinal gaps. In some variations, the crown can include castellations, and the deployable coupler can be coupled to the castellations. For example, each of the plurality of proximal and distal slits may be substantially S-shaped.

[0009] In another embodiment, a surgical method is provided. The surgical method can include inserting an elongate shaft of an actuator assembly through a guide assembly extending through a puncture hole in a body cavity, and positioning a deployable coupler coupled to a distal end of the elongate shaft within the body cavity such that blood flows into the deployable coupler, through the elongate shaft, and out a port at a proximal end of the actuator assembly. The surgical method can also include thereafter activating the actuator assembly to deploy distal wings of the deployable coupler radially outward. The surgical method can further include retracting the actuator assembly to attract the distal wings against an inner wall of the body cavity to stop blood from flowing into the deployable coupler. The surgical method can further include activating the actuator assembly to deploy proximal wings of the deployable coupler radially outward adjacent an outer wall of the body cavity, thereby sealing the puncture hole in the body cavity. The surgical method can further include decoupling the deployable coupler from the distal end of the elongate shaft.

[0010] The method of operation can be varied in various ways and can include any of the following features, alone or in combination. For example, the method of operation can include pivoting the elongate shaft to position the distal wings against an inner wall of the body cavity after actuating the actuator to deploy the distal wings radially outward and before actuating the actuator assembly to deploy the proximal wings radially outward. For example, the elongate shaft can include an inner shaft and an outer shaft concentrically disposed about 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 welded C-tubes that define a gap through which blood can flow. For example, the deployment of the proximal wings can include rotating the actuator assembly in a first direction. In some aspects, the deployment of the distal wings can include rotating the actuator assembly in a second direction opposite the first direction.

[0011] In another embodiment, a surgical assembly is provided. The surgical assembly can include an actuator assembly including an elongate shaft and a deployable coupler coupled to a distal end of the elongate shaft. The deployable coupler can include a plurality of proximal slits configured to form a pair of proximal wings and a plurality of distal slits configured to form a pair of distal wings therein. The actuator assembly can be configured to transform the deployable coupler from a delivery configuration in which the proximal and distal wings are substantially parallel to the elongate shaft to a fully deployed configuration in which one of the proximal and distal wings is substantially perpendicular to the elongate shaft and the other of the proximal and distal wings is oblique to the elongate shaft.

[0012] The surgical assembly can be varied in various ways and can include any of the following features, alone or in combination. For example, each of the plurality of proximal slits can include a first cut and a second cut having a substantially equal length. The substantially equal length can cause the proximal wings to be substantially perpendicular to the elongate shaft in the deployed configuration. For example, each of the plurality of distal slits can include a first cut and a second cut having a substantially unequal length. The substantially unequal length can cause the distal wings to be substantially oblique to the elongate shaft in the deployed configuration. For example, the transforming of the deployable coupler from the delivery configuration to the deployed configuration can cause the proximal and distal wings to fold about their mid-regions. For example, the plurality of proximal and distal slits can be substantially S-shaped. For example, the surgical assembly can include an auxiliary handle configured to couple to a proximal end of the actuator assembly. The auxiliary handle can have a distally extending plug configured to pass through a central lumen defined at least in part by the elongate shaft and to be disposed within a central bore of the deployable coupler, hi some aspects, the distally extending plug can be configured to seal the central bore.

[0013] In another embodiment, a surgical assembly is provided. The surgical assembly may include a delivery tool including an elongate shaft extending from a distal end thereof, and a deployable coupler coupled to the distal end of the elongate shaft. The deployable coupler may have a proximal wing defined by a first proximal cut and a first distal cut, and a distal wing defined by a second proximal cut and a second distal cut. The delivery tool may be configured to transform the deployable coupler between a delivery configuration in which the elongate shaft is substantially parallel to the first and second wings, and a deployed configuration in which the elongate shaft is substantially transverse to the first and second wings. A deployment angle of the proximal wing may be defined at least in part by a ratio of lengths of the first proximal cut and the first distal cut, and a deployment angle of the distal wing may be defined at least in part by a ratio of lengths of the second proximal cut and the second distal cut.

[0014] The surgical assembly may be varied in various manners and may include any of the following features, alone or in combination: For example, the ratio of the length of the first proximal cut to the first distal cut may be substantially equal to 1 and may be configured such that the first wing has a deployment angle of approximately 90 degrees; For example, the ratio of the length of the second proximal cut to the second distal cut may be substantially greater than 1 and may be configured such that the second wing has a deployment angle of substantially acute.

[0015] In another embodiment, a surgical coupler is provided. The surgical coupler can include a first tubular portion having a first plurality of longitudinal cuts, a second tubular portion having a second plurality of longitudinal cuts, and a connector portion disposed between the first tubular portion and the central tubular portion. Each of the longitudinal cuts of the first plurality of longitudinal cuts can have a proximal cut and a distal cut having a length ratio of about 1:1. Each of the longitudinal cuts of the second plurality of longitudinal cuts can have a proximal cut and a distal cut having a length ratio of substantially less than 1:1. The first tubular portion, the second tubular portion, and the connector portion can define a central lumen.

[0016] The surgical coupler can be varied in various ways and can include any of the following features, alone or in combination. For example, the first tubular portion can be configured to reversibly form wings that are substantially perpendicular to the longitudinal axis of the central lumen. For example, the second tubular portion can be configured to reversibly form wings that are substantially oblique to the longitudinal axis of the central lumen. For example, the connector portion can have a diameter that is greater than a diameter of the first tubular portion and a diameter of the second tubular portion. In some aspects, the diameter of the first tubular portion can be less than a diameter of the second tubular portion. For example, the coupler can be configured to couple with an actuator tool. The actuator tool can be configured to reversibly form the first tubular portion and the second tubular portion into wings. In some aspects, the actuator tool can be configured to receive a plug configured to block the inflow of fluid into the central lumen.

[0017] In another embodiment, a method is provided. The method can include inserting a delivery sheath over a guidewire through a puncture in an artery to position a deployable coupler coupled to a distal end of the delivery sheath within the artery. The method can also include pivoting the delivery sheath from an insertion orientation in which blood can travel up the coupler to an oblique orientation that prevents blood from traveling up the coupler. The method can further include actuating an actuator coupled to a proximal end of the delivery sheath to deploy a distal wing. The distal wing can be positioned within the artery adjacent the puncture. The method can further include actuating the actuator to deploy a proximal wing on the deployable coupler such that the proximal wing is located outside the artery adjacent the puncture. The method can further include removing the guidewire from the central lumen. The method can further include advancing a plug into the central lumen of the deployable coupler to seal the puncture.

[0018] The method may be varied in various ways and may include any of the following features, alone or in combination. For example, the plug may be operably coupled to an auxiliary handle having a deployment lever thereon configured to deploy the plug into the deployable coupler. In some aspects, the method may include actuating the deployment lever to separate the plug from the auxiliary handle after advancing the plug into the central lumen. For example, the method may further include positioning the coupler relative to the puncture site with an external imaging system that detects radiopacity of the coupler.

[0019] In another embodiment, a method of surgery is provided. The method of surgery can include advancing a first coupler through the small intestine to a region of the small intestine proximal to the gallbladder. The first coupler can be coupled to a distal end of the elongate shaft. The method of surgery can also include piercing the region of the small intestine and the gallbladder using a penetrator advanced through the elongate shaft and the first coupler. The method of surgery can further include advancing the first coupler at least partially into the gallbladder. The method of surgery can further include deploying a first distal wing of the first coupler within the gallbladder. The method of surgery can further include retracting the elongate shaft to contact the first distal wing with an inner surface of the gallbladder. The method of surgery can further include deploying a first proximal wing of the first coupler within the small intestine to releasably attach the first coupler to the gallbladder and the small intestine. The method of surgery can further include expelling the first coupler from the distal end of the elongate shaft.

[0020] The surgical method may be varied in various ways and may include any of the following features, alone or in combination. For example, the surgical method may include advancing a second coupler through the small intestine into the distal ileal loop adjacent to the proximal ileal loop. The second coupler may be coupled to a distal end of the elongate shaft. The surgical method may also include penetrators advanced through the elongate shaft and the second coupler to pierce an inner wall of the distal ileal loop and enter the proximal ileal loop. The surgical method may further include deploying a second distal wing of the second coupler within the proximal ileal loop. The surgical method may further include retracting the elongate shaft to contact the second distal wing with an inner surface of the proximal ileal loop. The method can further include deploying a second proximal wing of the second coupler within the distal ileal loop to removably attach the second coupler to the proximal and distal ileal loops. The method can further include expelling the second coupler from the distal end of the elongate shaft. For example, at least one of the first proximal wing and the first distal wing can be deployed at an acute angle relative to the longitudinal axis of the elongate shaft. In some aspects, the other of the first proximal wing and the first distal wing can be deployed at an acute angle relative to the longitudinal axis of the elongate shaft. In other aspects, the radial tip of the first proximal wing can contact an inner wall of the small intestine in the deployed configuration, and the radial tip of the first distal wing can contact an inner wall of the gallbladder in the deployed configuration. For example, a deployment angle of the first proximal wing and a deployment angle of the first distal wing can be substantially equal. A length of the first proximal wing and a length of the first distal wing can be substantially equal. For example, the first proximal wing can include a first plurality of petals and the first distal wing can include a second plurality of petals. The first plurality of petals can be rotatably offset from the second plurality of petals.

[0021] In another embodiment, a method is provided. The method can include deploying a first distal wing of the first coupler in the gallbladder and a first proximal wing of the first coupler in the ileum via an actuator tool having an elongate shaft and a first coupler coupled to a distal end of the elongate shaft. The method can also include deploying a second distal wing of the second coupler in a first loop of the ileum distal from the deployed first coupler and deploying a second proximal wing of the second coupler in a second loop of the ileum proximal from the deployed first coupler via an actuator tool having a second coupler coupled to a distal end. The first coupler can define a first central lumen configured to fluidly join the gallbladder and the ileum. The second coupler can define a second central lumen configured to fluidly join the first loop and the second loop.

[0022] The method can be varied in various ways and can include any of the following features, alone or in combination. For example, the method can include penetrating the wall of the ileum with a penetrator coupled to a distal end of the elongate shaft and drilling a hole through the wall of the gallbladder to position the first coupler 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 can be deployed at an acute angle relative to the longitudinal axis of the elongate shaft. In some variations, the other of the first proximal wing and the first distal wing can be deployed at an acute angle relative to the longitudinal axis of the elongate shaft. In other variations, the radial tip of the first proximal wing can contact the inner wall of the small intestine in the deployed configuration and the radial tip of the first distal wing can 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 can be substantially equal. The length of the first proximal wing and the length of the first distal wing can be substantially equal. In further aspects, the first proximal wing can include a first plurality of petals and the first distal wing can include a second plurality of petals. The first plurality of petals can be rotatably offset from the second plurality of petals.

[0023] In another embodiment, a method is provided. The method can include introducing a first coupler into the ileum. The first coupler can be attached to an elongate shaft extending distally from an actuator tool. The first coupler and the elongate shaft can define a first central lumen therethrough. The method can also include contacting a distal end of the first coupler with an outer wall of the ileum adjacent an outer wall of the gallbladder. The method can further include extending a first penetrator through the first central lumen to create a hole through the inner wall of the ileum and the outer wall of the gallbladder. The method can further include advancing the first coupler from the ileum into the gallbladder. The method can further include deploying a distal wing of the first coupler within the gallbladder with the actuator tool. The method can further include retracting the first coupler to contact the distal wing with the inner wall of the gallbladder. The method can further include deploying a proximal wing of the first coupler within the ileum with the actuator tool. The gallbladder and the ileum can be in fluid communication through the first coupler. The method can further include decoupling the first coupler from the elongate shaft.

[0024] The method may vary in various ways and may include any of the following features, alone or in combination. For example, the method may include introducing a second coupler into the distal ileal loop distal to the first coupler. The second coupler may be attached to an elongate shaft. The second coupler and the elongate shaft may define a second central lumen therethrough. The method may also include incising a region of the ileal loop proximal to the first coupler. The method may further include contacting an outer wall of the distal ileal loop adjacent the incised region of the proximal ileal loop. The method may further include extending a second penetrator through the second central lumen to pierce a hole through the inner wall of the distal ileal loop and the incised region. The method may further include advancing a second coupler from the distal ileal loop into the proximal ileal loop through the incised region. The method may further include deploying a distal wing of the second coupler within the proximal ileal loop with the actuator tool. The method may further include retracting the second coupler to contact the distal wing with an inner wall of the proximal ileal loop. The method may further include deploying a proximal wing of the second coupler within the distal ileal loop with the actuator tool. The proximal and distal ileal loops may be in fluid communication through the second coupler. The method may further include decoupling the first coupler from the elongate shaft.

[0025] In another embodiment, a method is provided that includes inserting a sheath into the gallbladder through the ileum, advancing an expandable coupler 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 expanding coupler in the gallbladder with the actuator tool, deploying a proximal wing of the expanding coupler in the ileum with the actuator tool, and decoupling the expanding coupler from the actuator tool. The gallbladder and ileum can be in fluid communication via the deployed expandable coupler.

[0026] The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will become apparent from the description and drawings, and from the claims. [Brief description of the drawings]

[0027] These and other features will be more readily understood from the following detailed description taken in conjunction with the accompanying drawings. [Figure 1] 1 is a perspective view illustrating a portion of a closure assembly including an actuator assembly according to one embodiment. [Diagram 2] 2 is a perspective view of an introducer assembly of the closure assembly of FIG. 1. [Diagram 3] FIG. 2 is a perspective view of the distal end of the flexible guide tube of the closure assembly of FIG. 1 without an anastomotic coupler mounted thereon. [Figure 4] FIG. 4 is a perspective view of the distal end of the flexible or rigid guide tube of FIG. 3, showing a deployable coupler mounted thereon. [Diagram 5] FIG. 2 is a partial cross-sectional view of the closure assembly of FIG. 1. [Figure 6] FIG. 5 is a perspective view of the deployable coupler of FIG. 4 with the distal wing deployed. [Figure 7] 5 is a perspective view of the deployable coupler of FIG. 4 with the distal and proximal wings deployed. [Figure 8] 2 is a partial perspective view of the closure assembly of FIG. 1 having a deployable coupler inserted into the arterial lumen. [Figure 9] FIG. 5 is a perspective view of the distal end of the flexible guide tube of FIG. 4 with blood flowing through the deployable coupler. [Figure 10]FIG. 5 is a perspective view of the distal end of the flexible guide tube of FIG. 4 with the deployable coupler removed and blood flowing into the flexible guide tube. [Figure 11] FIG. 5 is a partial cross-sectional view of the flexible guide tube of FIG. 4 with the deployable coupler removed and blood flowing through the flexible guide tube. [Figure 12] 5 is a partial cross-sectional view of the flexible guide tube of FIG. 4 with blood flowing through a blood signal outlet. [Figure 13] FIG. 2 is a perspective view of an actuator assembly of the closure assembly of FIG. 1, the actuator assembly being inserted into the introducer sheath of the closure assembly of FIG. 1 and positioned at least partially within the arterial lumen. [Figure 14] FIG. 14 is a perspective view of the closure assembly of FIG. 13 with a deployable coupler having deployed distal wings, with an inset highlighting the deployed distal wings. [Figure 15] FIG. 14 is a perspective view of the closure assembly of FIG. 13 with the deployed distal wings tensioned against the inner wall of the arterial lumen and the closure assembly moved to an elevation angle. [Figure 16] FIG. 14 is a perspective view of the closure assembly of FIG. 13 showing the deployed distal and proximal wings securing tissue therebetween, with an inset highlighting the deployed distal and proximal wings. [Figure 17] FIG. 14 is a perspective view of the closure assembly of FIG. 13 showing the ejection lever actuated, with an inset highlighting the secured tissue. [Figure 18] FIG. 14 is a perspective view of the closure assembly of FIG. 13, showing the closure assembly being removed from the surgical field after ejection of the deployable coupler, with an inset highlighting the ejected coupler. [Figure 19] 13 is a perspective view of a closure assembly including an actuator assembly and an introducer sheath according to another embodiment. [Figure 20] 20 is a perspective view of a guidewire that can be used with the closure assembly of FIG. 19. [Figure 21] 20 is a perspective view of an introducer sheath of the closure assembly of FIG. 19. [Figure 22] 20 is a perspective view of an actuator assembly of the closure assembly of FIG. 19. [Figure 23] FIG. 23 is a perspective view of the distal tip of the actuator assembly of FIG. 22, including an attached deployable coupler. [Figure 24] FIG. 23 is a side view of the distal tip of the actuator assembly of FIG. 22, showing an anastomotic coupler attached thereto, the anastomotic coupler including a proximal end having a larger diameter than the distal end. [Diagram 25] FIG. 24 is a cross-sectional view of the deployable coupler of FIG. 23. [Figure 26] FIG. 24 is a side view showing the deployable coupler of FIG. 23 in a delivery configuration according to some variations, including one having a proximal slit and a distal slit with slit halves having a distance ratio substantially equal to 1:1. [Figure 27] 27 is a cross-sectional view showing the deployable coupler of FIG. 26 in a deployed configuration attached to an actuator assembly. [Figure 28] FIG. 24 is a side view showing the deployable coupler of FIG. 23 in a delivery configuration according to some variations, including a distal slit having slit halves with a distance ratio substantially equal to 1:1 and a proximal slit having slit halves with a distance ratio substantially less than 1:1. [Figure 29] 29 is a cross-sectional view showing the deployable coupler of FIG. 28 in a deployed configuration attached to an actuator assembly. [Diagram 30] 20 is a perspective view of a plug tool usable with the closure assembly of FIG. 19. [Diagram 31] 21 is a perspective view showing the introducer sheath of FIG. 19 inserted into the arterial lumen over the guidewire of FIG. 20. [Diagram 32]FIG. 20 is a perspective view of the actuator assembly of FIG. 19, showing the actuator assembly inserted into an introducer sheath and into an arterial lumen. [Diagram 33] FIG. 20 is a perspective view of the actuator assembly and introducer assembly of FIG. 19 shown raised to a deployed position. [Diagram 36] FIG. 20 is a perspective view of the actuator assembly of FIG. 19 showing the distal wings being deformed to a deployed configuration within the arterial lumen. [Diagram 34] FIG. 20 is a perspective view of the proximal portion of the actuator assembly of FIG. 19 after deformation of the distal wings to a deployed configuration. [Diagram 35] FIG. 20 is a rear perspective view of the actuator assembly of FIG. 19 illustrating the new gap after deformation of the distal wing to the deployed configuration. [Diagram 36] FIG. 20 is a perspective view of the actuator assembly of FIG. 19 showing the distal wing in tension against the inner wall of the arterial lumen. [Figure 37] FIG. 20 is a perspective view of the actuator assembly of FIG. 19 showing the proximal wings deformed to a deployed configuration. [Figure 38] 20 is a perspective view illustrating contrast media being injected through the actuator assembly of FIG. 19 after transformation of the proximal wings to the deployed configuration. [Figure 39] 31 is a partial perspective view showing the plug tool of FIG. 30 being inserted into the actuator assembly of FIG. 19. [Diagram 40] FIG. 40 is a partial perspective view showing the protrusion of the plug tool engaging with the removable lever lock of the actuator assembly when the plug tool is inserted into the actuator assembly as shown in FIG. 39 . [Diagram 41] FIG. 31 is a partial cross-sectional view of the plug tool of FIG. 30 including an expellable plug, showing the expellable plug inserted into the central lumen of the deployed deployable coupler. [Diagram 42] FIG. 42 is a partial cross-sectional view of the deployable coupler of FIG. 41 unfolded, showing the expellable plug fully inserted into the central lumen of the unfolded deployable coupler. [Diagram 43] FIG. 31 is a partial perspective view of the plug tool of FIG. 30 showing the plug lock moved to an unlocked position and the plug lever actuated. [Diagram 44] FIG. 43 is a partial cross-sectional view of the ejectable plug and deployable coupler of FIG. 42, showing the ejectable plug being ejected from the plug tool. [Diagram 45] FIG. 31 is a perspective view of the plug tool of FIG. 30, showing the plug tool removed from the actuator assembly after ejection of the plug, and the lever lock removed together with the plug tool while still secured to the protrusion of the plug tool; [Figure 46] FIG. 20 is a perspective view of the closure assembly of FIG. 19, showing the ejection lever actuated; [Figure 47] 20 is a perspective view of the closure assembly of FIG. 19, showing the closure assembly of FIG. 19 being removed from the surgical site after deployment of the deployable couplers. [Figure 48] FIG. 20 is a perspective view of the closure assembly of FIG. 19 showing improper deployment of the proximal and distal wings of the deployable coupler, in which the proximal and distal wings are deployed prematurely within the arterial lumen and then returned to a partial delivery configuration. [Figure 49] 20A-20C are cross-sectional views of the closure assembly of FIG. 19, shown in a pre-deployment position during the deployment procedure. [Figure 50] 49 is a partial cross-sectional view of the closure assembly of FIG. 19 during the first wing deployment step of the deployment procedure of FIG. 49. FIG. [Figure 51] 49 is a partial cross-sectional view of the closure assembly of FIG. 19 during the second wing deployment step of the deployment procedure of FIG. 49. FIG. [Figure 52]49 is a partial cross-sectional view of the closure assembly of FIG. 19 during the first stage of initiation of the spring tension relief mechanism in the deployment procedure of FIG. 49. [Diagram 53] 53 is a partial cross-sectional view of the closure assembly of FIG. 19 during a second stage of initiation of the spring tension release mechanism of FIG. 52. FIG. [Figure 54] 49 is a partial cross-sectional view of the closure assembly of FIG. 19 during a first stage of the reset step in the deployment procedure of FIG. 49. FIG. [Figure 55] 55 is a partial cross-sectional view of the closure assembly of FIG. 19 during a second stage of the reset step of FIG. 54. FIG. [Figure 56] FIG. 2 is a partial front view of a patient's digestive system showing the ileum being moved adjacent to the gallbladder as part of a surgical procedure. [Figure 57] FIG. 57 is a partial front view of the digestive system of FIG. 56 showing the anastomotic coupler being inserted through an incision into the ileum and toward the gallbladder. [Figure 58] FIG. 57 is a partial front view of the digestive system of FIG. 56 showing the distal end of the anastomotic coupler positioned within the ileum and adjacent to the gallbladder while a penetrator is inserted through the anastomotic coupler to incise the ileum and gallbladder. [Figure 59] FIG. 57 is a partial front view of the digestive system of FIG. 56 showing an anastomotic coupler being inserted from the ileum, through the incision made by the penetrator, and into the gallbladder. [Figure 60] FIG. 57 is a partial front view of the digestive system of FIG. 56 showing a distal wing of the anastomotic coupler coupled to an actuator assembly transformed into a deployed configuration within the gallbladder. [Figure 61] FIG. 57 is a partial front view of the gallbladder and ileum of FIG. 56 with the closure assembly retracted so that the distal wings are in contact with the inner wall of the gallbladder. [Figure 62] FIG. 57 is a partial front view of the digestive system of FIG. 56 showing the proximal wing of the anastomotic coupler being transformed into a deployed configuration within the ileum. [Figure 63] FIG. 57 is a partial front view of the gallbladder and ileum of FIG. 56 showing the walls of the gallbladder and ileum captured between the proximal and distal wings of the anastomotic coupler. [Figure 64] FIG. 57 is a partial front view of the digestive system of FIG. 56 showing the anastomotic coupler deployed and the actuator assembly of the closure assembly being retracted from the ileum. [Figure 65] FIG. 57 is a partial front view of the gallbladder and ileum of FIG. 56 showing the anastomotic coupler deployed and separated from the actuator assembly. [Figure 66] FIG. 66 is a cross-sectional view showing the deployed anastomotic coupler of FIG. 65. [Figure 67] 13A-13C are cross-sectional views of a deployed anastomotic coupler according to another embodiment, including a press ring having proximal and distal wings with varying lengths and deployment angles. [Figure 68] FIG. 57 is a partial front view of the digestive system of FIG. 56 showing the actuator assembly inserted into a first incision toward a second incision made in the proximal ileal loop. [Figure 69] FIG. 57 is a partial front view of the digestive system of FIG. 56 showing the penetrator inserted through the actuator assembly such that the penetrator creates a hole through the inner wall of the distal ileal loop and is inserted into the second incision. [Figure 70] FIG. 57 is a partial front view of the digestive system of FIG. 56 showing the distal wing of the second anastomotic coupler being transformed from a delivery configuration to a deployed configuration within the proximal ileal loop. [Figure 71] FIG. 57 is a partial front view of the digestive system of FIG. 56 showing the proximal wing of the second anastomotic coupler transformed from a delivery configuration to a deployed configuration within the distal ileal loop, thereby joining the proximal and distal ileal loops. [Figure 72]FIG. 57 is a partial front view of the digestive system of FIG. 56 showing a first flow path from the gallbladder through an unfolded anastomotic coupler and a second flow path from the proximal ileal loop to the distal ileal loop through a second unfolded anastomotic coupler.

[0028] It should be noted that the drawings are not necessarily to scale: the drawings are intended to depict only typical aspects of the subject matter disclosed herein, and therefore should not be considered as limiting the scope of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] Certain exemplary embodiments will now be described to provide a general understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will appreciate that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of the invention is defined only by the claims. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be within the scope of the invention.

[0030] Furthermore, in this disclosure, like-named components of multiple embodiments generally have similar characteristics, and therefore, within a particular embodiment, each feature of each like-named component is not necessarily fully described. Furthermore, to the extent that linear or circular dimensions are used in describing 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 the equivalents of such linear or circular dimensions can be readily determined for any geometric shape.

[0031] A surgical assembly is provided for use with an anastomotic coupler and a closure coupler. In general, the surgical assembly can include an actuator device configured to deploy the anastomotic coupler in a patient to join and fluidly couple tissue. The actuator device can include a handle having an elongated shaft extending distally therefrom. A distal end of the elongated shaft can have an anastomotic coupler attached thereto, and the handle can be actuated to cause the attached coupler to reversibly deploy one or more proximal and / or distal wings to join tissue therebetween. The coupler can then be decoupled from the elongated shaft. In the case of a closure coupler, prior to deployment of one or more proximal and / or distal wings, the surgical assembly can employ a blood signal that can be used to determine the position and / or orientation of the coupler relative to the tissue to ensure proper deployment of the coupler. Depending on the position of the coupler, blood can flow through the coupler and up the elongated shaft to provide a visual indicator of the coupler's position to the surgeon.

[0032] In certain embodiments, the coupler can have a large centrally disposed bore. The bore can facilitate fluid flow between tissue joint areas, which may be required for various surgical procedures. When fluid flow through the coupler is not required, a plug can be advanced through the actuator device into the large bore. The plug can be permanently or reversibly attached to the large bore to prevent fluid flow therethrough.

[0033] The closure assembly can be used in a variety of surgical procedures. For example, the closure assembly can be used for percutaneous closure of a common femoral arteriotomy or venotomy following diagnostic and / or interventional therapeutic intra-arterial procedures such as peripheral or coronary angiography, arterial stenting, balloon angioplasty, and atherectomy procedures in which the arteriotomy is in the common femoral artery and the closure assembly is used. Additionally, the closure assembly can be used in additional procedures including, for example, procedures to promote weight loss and / or promote treatment of type 2 diabetes.

[0034] 1 and 2 illustrate one embodiment of a closure assembly 10. The illustrated closure assembly 10 includes an actuator assembly 100, a deployable coupler 140, and an introducer sheath 150. The actuator assembly 100 is configured to be operated to reversibly transform the deployable coupler 140 from a delivery configuration to a deployed configuration to close or join tissues, and then eject the deployable coupler 140 from the actuator assembly 100 once the deployable coupler 140 is positioned at a desired location. The deployable coupler 140 can join tissues and can provide a fluid passageway between the joined tissues, as described in more detail below. The closure assembly 10 can be used with introducer sheaths 150 of various sizes.

[0035] The actuator assembly 100 can include a proximal actuator 102 and a distal flexible guide tube 120 extending therefrom. The proximal actuator 102 can include a substantially cylindrical body 104 having a proximal handle 106 rotatably coupled thereto. The proximal handle 106 can be rotated in either a first direction or a second direction (e.g., clockwise and counterclockwise) to reversibly deploy one or more portions of the deployable coupler 140, depending on the needs of the surgical procedure. An ejection lever 108 extends outwardly and upwardly from the cylindrical body 104 and can pivot relative thereto. Actuation of the ejection lever 108 can cause the proximal actuator 102 to eject the deployable coupler 140. A removable locking tab 110 can be attached to the cylindrical body 104 and the proximal handle 106 to prevent premature actuation of the proximal handle 106. The removable locking tab 110 can rotatably secure the proximal handle 106 relative to the cylindrical body 104. The removable locking tab can be attached to both the cylindrical body 104 and the proximal handle 106 via one or more protrusions and / or recesses (not shown) found on the underside of the proximal actuator 102. The removable locking tab 110 can further be wrapped around the proximal handle 106 such that it is securely secured to the proximal actuator 102 until removed by an operator. The operator can remove the removable locking tab 110 from the cylindrical body 104 and the proximal handle 106, and then the operator can actuate the proximal handle 106 and / or the ejection lever 108 as desired. The proximal actuator 102 can include information to guide a user through a surgical procedure. For example, the proximal actuator 102 may include arrows indicating the actuation directions and sequence for use during a surgical procedure, i.e., an arrow marked "1" pointing a first direction indicating that the proximal handle 106 should be rotated first, and an arrow marked "2" pointing a second direction indicating that the proximal handle 106 should be rotated next.

[0036] 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 configurations, but may generally be a single or a pair of opposing linear protrusions having an inwardly facing end 114 configured to grip and retain the introducer sheath 150, as described in more detail below. The blood signal outlet 116 may be located on the top side of the cylindrical body 104, as shown in FIG. 5, or at any other location around the circumference of the cylindrical body 104. The blood signal outlet 116 may include a central bore 116A that leads to an internal flow passage configured to be in fluid communication with the patient's body. The blood signal outlet 116 may also include one or more horns 118 or collars or tubes or the like that extend downwardly from the cylindrical body 104. The operation of the blood signal and the blood signal outlet 116 are described in more detail below.

[0037] The flexible guide tube 120 extends distally from the cylindrical body 104 between the sheath latches 112 and may be substantially linear in configuration. In some variations, the flexible guide tube 120 may be a rigid structure. The flexible guide tube 120 may include a central dowel 122 surrounded by an outer sheath 124, defining a flow passage 126 in the space between the central dowel 122 and the outer sheath 124. The flow passage 126 may run the entire length of the flexible guide tube 120. The central dowel 122 may include an outwardly extending distal end cap 128, as shown in more detail in FIG. 3. The outer sheath 124 may have a length less than the length of the central dowel 122, such that the deployable coupler 140 may be disposed around the portion of the central dowel 122 that extends beyond the distal end of the outer sheath 124. The outer sheath 124 can include a pair of opposing extensions 130 with a gap therebetween to form a C-tube. The distal portion of the outer sheath 124 can further include a retainer 132 disposed about the C-tube portion of the outer sheath 124, which can include a number of castellations 134 thereon.

[0038] FIG. 4 provides an enlarged view of the flexible guide tube 120 with the seated deployable coupler 140, and FIG. 5 provides a cross-sectional view of the flexible guide tube 120 with the seated deployable coupler 140 mounted thereon. The seated deployable coupler 140 can be substantially cylindrical and define a central lumen configured to receive the central dowel 122 of the flexible guide tube 120 when the deployable coupler 140 is seated thereon. The seated deployable coupler 140 can be made of a variety of materials including various metals, plastics, or combinations thereof. Specific materials can include stainless steel, titanium, or any biocompatible material. The seated deployable coupler 140 can include a proximal end having a complementary castellation pattern 141 that can mate with the castellations 134 on the retainer 132. The seated deployable coupler 140 may also include a number of slits 144 located at the proximal end 140P and the distal end 140D. The proximal slits 144P and the distal slits 144D may take a variety of forms, such as straight, curved, irregular, etc. In some variations, the slits 144 may be substantially mirror images of one another, such as substantially S-shaped or Z-shaped or similar, as shown, for example, in FIG. 4. The slits 144 may also be sized to provide a gap large enough to allow blood to flow through and into the flexible guide tube 120, as described in more detail below.

[0039] The seated deployable coupler 140 can be reversibly transformed between a delivery configuration and a deployed configuration. In the delivery configuration, the seated deployable coupler 140 can have a substantially linear configuration, for example, when the seated deployable coupler 140 is seated on the flexible guide tube 120, as shown in Figures 1 and 4. The seated deployable coupler 140 can be transformed to the deployed configuration by actuating the proximal handle 106 to sequentially rotate the seated deployable coupler 140 in either a first direction or a second direction. Rotating the proximal handle 106 in the first direction can cause both torsional and compressive forces to be applied to the seated deployable coupler 140, as described below, resulting in the deployment of one or more wings. In a substantially straight delivery configuration, the seated deployable coupler 140 can have a substantially uniform diameter along its length, while in a substantially expanded deployed configuration, the seated deployable coupler 140 deforms to have at least one proximal wing and at least one distal wing configured to hold tissue therebetween.

[0040] The transformation between the delivery configuration and the deployed configuration can be effected via actuation of the proximal handle 106. During the transformation process, the proximal handle 106 can be rotated in a first direction, and the outer sheath 124 of the flexible guide tube 120 can be rotated as well. Rotation of the flexible guide tube 120 allows a torsional force to be applied to the mesh castellations of both the retainer 132 and the seated deployable coupler 140. The mesh castellations 134, 141 of both the retainer 132 and the seated deployable coupler 140 allow the outer sheath 124 to apply a torsional force to the seated deployable coupler 140. At the same time, a linear compressive force can be applied in a proximal direction to the seated deployable coupler 140, emanating from the distal end cap 128. For example, the proximal handle 106 can be rotated in a first direction (e.g., clockwise or counterclockwise) to rotate the distal end cap 128 in the first direction and apply a torque to the seated deployable coupler 140, further compressing and causing the distal end 140D to splay radially outward, thereby forming the distal wings 148D. Once the deployable coupler 140 is compressed sufficiently to form the distal wings 148D (which occurs via an actuator spring (not shown) coupled to the proximal handle 106 to provide the force necessary to compress the deployable coupler 140), the proximal wings 148P can be formed. The proximal handle 106 can be rotated in a second direction (which may be the same or different from the first direction) to further compress the coupler and apply a torque in the opposite direction, causing the proximal end 140P to splay outward, thereby forming the proximal wings 148P. The proximal and distal wings 148P, 148D can have a variety of configurations. For example, the wings 148P, 148D can include one or more petals or segments that form the angular shape of the wings 148P, 148D.

[0041] The seated deployable coupler 140 and the proximal actuator 102 can collectively define a blood flow path that can be used as a blood signal during a surgical procedure to inform a surgeon of the position and / or orientation of the seated deployable coupler 140 within the patient. Proper positioning and orientation of the seated deployable coupler 140 can prevent the wings of the seated deployable coupler 140 from being improperly deployed in a manner that would be ineffective or harmful.

[0042] 7-11 illustrate an exemplary blood flow through the blood flow path defined by the seated deployable coupler 140 and the proximal actuator 102 during surgery. Blood within the patient can be moved by the patient's blood pressure into the seated deployable coupler 140, through the proximal actuator 102, and out of the cylindrical body 104 of the proximal actuator 102, as shown by the arrows in FIG. 8. Blood can enter the coupler through the proximal and distal slits and the proximal and distal openings 144P and 144D, as shown by the arrows in FIG. 9. Once blood enters the seated deployable coupler 140, it can flow under the retainer 132 and through the gap in the C-tube portion of the outer sheath 124, as shown in FIGS. 10-11. From there, blood can travel up the flexible guide tube 120 through the space between the central dowel 122 and the outer sheath 124. Eventually, the blood reaches a turning point where the blood flow path 126 is directed towards the blood signal outlet 116, as shown in Figure 12. The blood can finally be released from the blood signal outlet 116 where it can be expelled in a controlled manner.

[0043] 2, the introducer sheath 150 can include a substantially elongated sheath 152 having a central lumen 154 sized to receive the flexible guide tube 120 with the seated deployable coupler 140 mounted thereon. The introducer sheath 150 can include a proximal funnel 156 having a flared base 158 that can be received by the sheath latch 112 to matingly couple the proximal actuator 102 and the introducer sheath 150. The introducer sheath 150 can provide an access passage for the actuator assembly 102 during a surgical procedure. The introducer sheath 150 can take a variety of forms, such as a cannula having any or all of the features described herein.

[0044] During the exemplary surgical procedure shown in FIGS. 13-18, the actuator assembly 100 can be used to join tissue 40 located in the arterial lumen 32. At any or all stages of the surgical procedure, positioning, deployment, etc. can be confirmed using various imaging techniques, i.e., fluoroscopy, etc., before proceeding to the next stage. A prepared introducer sheath 150 can be inserted into the patient's arterial lumen 32 to provide access to the treatment area. As shown in FIG. 13, the flexible guide tube 120 and the deployable coupler 140 can be inserted into the introducer sheath 150 and then advanced until the sheath latch 112 couples the cylindrical body 104 of the proximal actuator 102 to the introducer sheath 150 via the flared 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 axis of the lumen, and more preferably less than 45 degrees) to prevent the deployable coupler 140 from "bottoming out" in the arterial lumen 32 during insertion, i.e., the deployable coupler 140 from impacting the opposite side of the arterial lumen 32 and potentially injuring the patient. When the proximal actuator 102 and deployable coupler 140 are in the proper position, blood can flow through the deployable coupler 140 into the flexible guide tube 120 and then out the blood signal outlet 116. FIG. 14 illustrates the flow of blood through the deployable coupler 140 and proximal actuator 102 with a close-up view of both the deployable coupler 140 and the top side of the proximal actuator 102, highlighting the blood signal outlet 116. Once blood flows out of the blood signal outlet 116 , the removable locking tab 110 can be removed from the proximal actuator 102 .

[0045] 15 illustrates deployment of the distal wings 148D within the arterial lumen 32 via rotational actuation of the proximal handle 106. With the removable locking tab 110 removed, the proximal handle 106 can be actuated in a first direction (e.g., clockwise) to deploy the distal wings 148D of the deployable coupler 140 within the arterial lumen 32. After deployment of the distal wings 148D, the actuator assembly 100 can be withdrawn from the patient, causing the distal wings 148D to contact the inner surface of the arterial lumen 32, thereby positioning the slits 144 of the deployable coupler 140 outside of the arterial lumen and preventing blood flow into the slits 144 and stopping the blood 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 signal outlet 116, and then the actuator assembly 100 can be retracted again to stop the blood signal and reconfirm that the deployable coupler 140 is correctly positioned. If reinsertion is performed, blood can flow through the proximal slit 144P to prompt a blood signal. Once the position of the deployable coupler 140 is confirmed to be correct, the actuator assembly 100 can be pivoted to a more perpendicular orientation to the tissue, increasing the angle A between the surface of the tissue and the actuator assembly 100, as seen in FIG. 15. This angle can vary depending on the patient, the size of the arterial lumen, the size of the deployable coupler 140, etc., but can be at least 30 degrees. In some embodiments, the angle A can be between 40 degrees and 60 degrees. This pivoting can bring the deployed distal wings 148D into more firm contact with the inner wall of the arterial lumen 32. Once in position, the proximal handle 106 can be rotated in a second direction (e.g., counterclockwise) to deploy the proximal wing 148P to capture tissue between the distal wing 148D and the proximal wing portion 148P, as shown in FIG. 16.By actuating the proximal handle 106 in the second direction to the correct limit, a gap 106A may appear between the proximal handle 106 and the cylindrical body 104, indicating that the proximal handle 106 has been actuated correctly to deploy the proximal and distal wings 148P, 148D of the deployable coupler 140. After the proximal wings 148P are deployed, a sandwich "push-pull" test may be performed by gently rocking the actuator assembly 100 towards and away from the captured tissue. Even if the deployment is performed correctly, the deployed coupler may not be able to advance into the arterial lumen 32 during the push-pull test. Furthermore, no blood signal should be visible while performing the push-pull test, since the slit 144 of the deployable coupler 140, which is the entrance to the blood flow path, now defines the proximal and distal wings 148P, 148D, and blood cannot enter the flexible guide tube 120. Once proper positioning is confirmed, the ejection lever 108 can be articulated to eject the deployable coupler 140 from the flexible guide tube 120 by pulling the ejection lever 108 proximally towards the proximal handle 106. As shown in Figures 17 and 18, the proximal actuator 102 and introducer sheath 150 can be removed from the surgical site.

[0046] 19-30, a closure assembly 20 is shown for use in closing a large bore. The closure assembly 20 can be used in conjunction with a larger puncture hole than the closure assembly 10, which may be necessary for certain surgical procedures. If the puncture hole is too large, it may be dangerous or even impossible to occlude or connect the puncture and surrounding tissue. The closure assembly 20 may include a guidewire 30, an actuator assembly 200, a deployable coupler 240, an introducer sheath 250, a plug tool 260, and an imaging port 270. The actuator assembly 200 may include an actuator 202 and a guide tube 220. The actuator assembly 200 may further include a central lumen 203 extending through the actuator 202 and the guide tube 220, as described in more detail below. In general, many of the elements and features of the closure assembly 20 are similar to the closure assembly 10, and for the sake of brevity, similar components will not be described again in detail.

[0047] FIG. 20 illustrates a guidewire 30. The guidewire 30 can be any standard type of guidewire known to those of skill in the art. The guidewire 30 can be pre-inserted into tissue and / or cavities to help guide surgical instruments to a surgical site or site of interest. The guidewire 30 can be any guidewire depending on the rest of the closure assembly 20, but in some embodiments, the guidewire 30 can have a diameter between about 0.01-0.05 inches. For example, the guidewire can have a diameter of approximately 0.035 inches. FIG. 21 illustrates an introducer sheath 250. The introducer sheath 250 can include an elongate shaft 252 attached at its proximal end to a hub 256. The elongate shaft 252 can define an inner lumen 254, and the distal end of the elongate shaft 252 can include one or more fluid holes 253 disposed in its sidewall. The hub 256 can be flared and can have a port 258 extending from one side that leads to a valve assembly 259 for use during surgery as a blood signal. The port 258 and the valve assembly 259 can be configured to provide a connection point for coupling the introducer sheath 250 to the actuator 202. The introducer sheath 250 is available in a variety of sizes, each suitable for closing a puncture hole of a variety of sizes.

[0048] 22 illustrates the actuator assembly 200 in more detail. The actuator assembly 200 may be similar to the actuator assembly 100 and may include an actuator 202 having a guide tube 220 extending distally therefrom. The actuator 202 may generally include a body 204, a handle 206, and an ejection lever 208, similar to those described above with respect to the actuator 102. The actuator 202 may also include a removable locking tab 210 configured to prevent premature actuation of the handle 206, and a removable lever lock 211 configured to prevent premature actuation of the ejection lever 208. The actuator 202 may include a sheath retainer 232 extending proximate to the guide tube 220 configured to couple to an introducer sheath 250.

[0049] In some embodiments, the sheath retainer 232 can include a central track with multiple engagement zones (not shown) configured to engage the introducer sheath 250 at multiple distances to allow the guide tube 220 to be inserted into the introducer sheath 250 at substantially different insertion depths to encourage blood flow through the blood signal outlet 216. The actuator 202 can have a different number of engagement zones, such as one, two, three, or more. The assembly 200 can also include a removable sheath stop 213 configured to prevent over-insertion of the guide tube 220 into the introducer sheath 250. The removable sheath stop 213 can be coupled to the actuator 202 near the sheath retainer 232 and can block the more proximal engagement zone(s) to prevent the guide tube 220 from being over-inserted into the introducer sheath 250. If more than one more proximal engagement site is used, more than one removable sheath stop 213 can be used. If additional depth is required, the removable sheath stop 213 can be decoupled from the actuator 202 to expose the more proximal engagement zones. After coupling with the introducer sheath 250, the guide tube 220 can be further inserted into the introducer sheath 250. The blood signal outlet 216 can be located on a side of the body 204. The blood signal outlet 216 can include a blood signal cap 216A for sealing the blood signal outlet 216.

[0050] A guide tube 220 may extend distally from the actuator 202. The guide tube 220 may be substantially tubular and may have a large bore coupler 240 coupled to its end. FIGS. 23-25 ​​show enlarged views of the end of the guide tube 220 with the large bore coupler 240 attached. The guide tube 220 may include at least one blood inlet 221 located proximal to the attached coupler 240, which may be in fluid communication with the blood signal outlet 216A of the device. Just proximal to the blood inlet 221 may be a seal 222 disposed circumferentially around the guide tube 220. When the guide tube 220 is inserted into the introducer sheath 250, the seal 222 may prevent backflow of blood into the introducer sheath 250.

[0051] The coupler 240 may be generally cylindrical in shape and may include a substantially tubular first end 240A and a substantially tubular second end 240B connected by an intermediate region 241. The intermediate region 241 may take the form of a press ring or similar structure. The first end 240A, the second end 240B, and the intermediate region 241 may collectively define a central lumen 242 through the center of the coupler 240 about its longitudinal axis, which may be collinear with the central lumen 203 of the actuator assembly 200. The first end 240A and the second end 240B may have the same diameter or different diameters, as shown, for example, in FIGS. 23 and 24 . The intermediate region 241 may also have the same or different diameters, and in some embodiments, the diameter of the intermediate region 241 may be greater than the respective diameters of the first end 240A and the second end 240B.

[0052] Each of the first end 240A and the second end 240B may include a number of slits 244. The shapes of the slits 244 may vary, but may be substantially mirror images of one another and may be substantially S-shaped or Z-shaped or similarly shaped, as seen, for example, in FIG. 26 and FIG. 28. Each slit 244 may be separated into two halves, and the ratio of the lengths of the halves of each slit 244 may vary. For example, in some embodiments, the ratio of the lengths may be substantially 1:1, as seen, for example, in FIG. 26, where the length of each half is designated "A". In other embodiments, the ratio may be substantially less than or greater than 1:1, such as, for example, in FIG. 28, where the length of one half is designated "B" and the length of the other half is designated "C", where the ratio of B:C is substantially less than 1:1.

[0053] The coupler 240 is transformable between a delivery configuration and a deployed configuration, similar to the deployable coupler 140 described above. In the delivery configuration, seen in FIGS. 26 and 28, the coupler 240 can be substantially linear, while in the deployed configuration, seen in FIGS. 27 and 29, the coupler 240 can have deployed proximal and distal wings 248P and 248D that extend radially outward from the coupler 240. The shape of the slits 244 can inform the shape of the wings 248P, 248D when deployed during deployment verification. Additionally, the ratio of the half lengths of each slit 244 can inform the deployment angle of the wings 248P, 248D relative to the longitudinal axis of the coupler 240. For example, as in FIG. 26, when the length ratio is substantially equal to 1:1, the proximal wing 248P and / or the distal wing 248D may be deployed at an angle substantially equal to 90 degrees relative to the longitudinal axis. This deployment can be seen in FIG. 27. When the length ratio is greater than or less than substantially 1:1, as in FIG. 28, the proximal wing 248P and / or the distal wing 248D may be deployed at a substantially oblique angle relative to the longitudinal axis. This deployment can be seen in FIG. 29, where the proximal wing 248P is deployed at a generally 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 combinations thereof. Additionally, the deployment angle, e.g., angle α, can vary between the wings 248P, 248D.

[0054] FIG. 30 illustrates the plug tool 260 in greater detail. The plug tool 260 can be used to occlude the central lumen 242 of the coupler 240 to block or impede the flow of fluid therethrough. While the plug tool 260 may not be necessary in surgical procedures where occlusion or prevention of fluid flow is desired, the plug tool can provide additional versatility in the treatment of various conditions. The illustrated plug tool 260 includes a substantially cylindrical plug tool handle 264 having a plug shaft 262 extending distally therefrom. The plug tool handle 264 can include a distal crevice 266 through which the plug shaft 262 extends, and the distal crevice 266 can be sized to removably receive the handle 206 of the actuator 202. An expellable plug 268 can be removably attached to the distal end of the plug shaft 262. The handle 264 can also include a lever 265 extending from a side thereof. Upon actuation, the lever 265 can be configured to eject the ejectable plug 268 from the distal end of the plug shaft 262. To prevent premature ejection and also to hold the lever in its pre-deployed position, a plug lock 265A can be coupled to the proximal end of the handle 264 and can prevent actuation of the lever 265 until the intended time during the surgical procedure. A set of projections 267 can extend from the distal end of the handle 264 outside of the distal crevice 266. The projections 267 can be shaped and configured to mate with a removable lever lock 211 on the actuator 202 when the plug tool 260 is attached to the actuator 202, thereby securely securing the plug tool 260 to the actuator 202.

[0055] As introduced above, during a surgical procedure, the plug tool 260 can be coupled to the actuator 202 and used to occlude the central lumen 242 of the coupler 240 to block or impede the flow of fluid therethrough. After the guidewire 30 is removed from the central lumen 203 of the actuator assembly 200, the plug tool 260 can be extended into the central lumen 203 with the plug 268 at the forefront. The plug tool 260 can be inserted until the handle 206 of the actuator assembly 200 is secured within the crevice 266 of the plug tool 260 and the protrusion 267 engages with the removable lever lock 211. At this depth, the expellable plug 268 can be centrally disposed within the central lumen 242 of the coupler 240. In a removal process, the plug tool 260 can be decoupled from the actuator 202. When the plug tool 260 is decoupled from the actuator 202, the protrusion 267 can remain coupled to the removable lever lock 211 such that removal of the plug tool 260 simultaneously removes the removable lever lock 211. An exemplary surgical procedure using the plug tool 260 is described in more detail below.

[0056] 31-48 illustrate an exemplary procedure using actuator assembly 200, including deploying coupler 240 within a patient's arterial lumen 32 to join tissue. Coupler 240 may be used to join more or less tissue in other parts of the patient, and thus the procedure depicted herein is not intended to limit the overall versatility of the devices described herein. Individual steps of the procedure, and the procedure as a whole, may be tailored to suit the needs of the patient and / or surgeon.

[0057] The guidewire 30 can be inserted into the arterial lumen 32 proximate the surgical site. The introducer sheath 250 can be inserted over the guidewire 30 into the arterial lumen 32. During insertion, the introducer sheath 250 can occlude the central lumen of the introducer sheath 250 through which the dilator 251 is inserted, preventing backflow of blood. When the dilator 251 is removed, blood can flow up the introducer sheath 250 through the blood inlet 253 and out the valve assembly 259 through the inner lumen 254. The valve assembly 259 can be closed if desired. The tip of the elongated shaft 252 of the actuator assembly 200, having a coupler 240 attached to its distal end, can be inserted into the introducer sheath 250. The actuator assembly 200 can be advanced until the actuator assembly 200 connects with the delivery sheath 250 and the deployable coupler 240 is in the arterial lumen.

[0058] The location of coupler 240 within the arterial lumen can be determined with an external imaging system, such as ultrasound. Press ring 241 can be positioned as close to the puncture site as possible, with a proximal portion of coupler 240 located at least partially further outside the outer lumen. The appropriate location of coupler 240 can be determined as needed.

[0059] As discussed above, in some embodiments, the actuator assembly can include one or more engagement zones for use with the blood signal outlet 216. The actuator assembly 200 can be inserted until the introducer sheath 250 engages the sheath retainer 232 and is located within a first one of the engagement zones. In this position, the coupler 240 can remain hidden by the introducer sheath 250. Once properly positioned, blood can flow out of the blood outlet 216 on the actuator 202 in addition to flowing out of the introducer sheath 250 as long as the valve assembly 259 is open. The entire assembly, including the introducer sheath 250 and actuator assembly 200, can be pulled back until the blood signal disappears. The disappearance of the blood signal can be used to confirm that the assembly is properly positioned within the tissue.

[0060] Once in place, the assembly 200 can be pivoted upward and away from the surface of the patient's tissue until the angle B between the introducer sheath 250 and the surface is at least 30 degrees. In some embodiments, the angle B can be between approximately 50 and 60 degrees, as seen, for example, in FIG.

[0061] If included, the removable sheath stop 213 can be removed from the actuator assembly 200 while in the high position, and the introducer sheath 250 can be locked into the second engagement zone 232A of the central track, thereby exposing the coupler 240 from the distal end of the introducer assembly 250. While maintaining the high 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 wings 248D of the coupler 240 within the arterial lumen 32. The deployment of the distal wings 248D can be viewed under fluoroscopy, ultrasound, angiography, and / or other imaging techniques. Once the distal wings 248D are successfully deployed, the handle 206 can be advanced proximally 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. While maintaining this resistance, the handle 206 can be actuated in a second direction opposite the first direction (e.g., counterclockwise), as seen in FIG. 37, to deploy the proximal wings 248P, "sandwiching" the tissue 40 between the distal wings 248D and the proximal wings 248P. The deployment of the proximal wings 248P can be observed under fluoroscopy or ultrasound. After deployment of the proximal wings 248P, the gap 206A between the handle 206 and the body 204 of the actuator 202 increases, further confirming successful deployment.

[0062] The contrast port 270 can be connected to the actuator assembly 200 prior to surgery and advanced over the guidewire 30. The contrast port 270 can generally include a linking arm 272 having a valve system extending therefrom. The linking arm 272 can be configured to be removably coupled to the handle 206 of the actuator assembly 200 via a luer lock, threading, snap fit, friction fit, or the like. The valve system 274 can include a flexible tube 276 coupled at one end to the linking arm 272 and at the other end to the valve 274. The contrast port 270 can include a flow path therethrough (not shown), which can be in fluid communication with the central lumen 203 of the actuator assembly 200. During a surgical procedure, contrast or other fluid can be injected into the valve 274 and flow through the tube 276, the linking arm 272, and the central lumens 203, 242. The injected contrast fluid can be used to check for leaks, improper coupling, and the like. The connecting arm 272 can be connected or disconnected from the handle 206 as needed during a surgical procedure.

[0063] Contrast fluid may be injected through contrast port 270 to verify that arterial lumen 32 is in the proper condition prior to occluding central lumen 242 of coupler 240 and while the guidewire is still in place. If the contrast fluid indicates a problem, such as damage to arterial lumen 32, improper positioning of coupler 240, etc., coupler 240 may be returned to the delivery configuration as necessary, or additional steps may be taken to correct the indicated problem. Corrections may then be made and the process may proceed from any previous point.

[0064] In embodiments relying on the use of the contrast port 270, the procedure may proceed following injection of contrast and confirmation of position, or if the contrast port 270 is not used. The guidewire 30 and contrast port 270 may be removed from the actuator assembly 200 and the plug tool 260 may advance the expellable plug 268 into the proximal end of the actuator 202. The plug tool 260 may be advanced such that the handle 206 of the actuator 202 is fully received by the distal crevice 266 of the plug tool 260 and the protrusion 267 couples with the removable lever lock 211, as seen in FIGS. 39-40. This full insertion may also ensure that the expellable plug 268 is positioned within the central lumen 242 of the coupler 240, as seen in FIGS. 41-42. Once the plug tool 260, and thus the ejectable plug 268, are properly positioned, the plug lock 265A can be rotated about the distal end of the plug tool 260 to decouple the lever 265 which can be actuated to eject the ejectable plug 268 from the plug shaft 262, as seen in FIGS. 43-44. Once the ejectable plug 268 has been ejected, the plug tool 260 can be removed from the actuator 202 by sliding the plug tool 260 proximally. Removal of the plug tool 260 does not require disengaging the projection 267 from the removable lever lock 211, as seen in FIG. 45, to also remove the removable lever lock 211 from its attached position to the lever 265. With the plug tool 260 removed, the ejection lever 208 can be actuated to decouple the coupler 240 from the elongate shaft 252, thereby deploying the coupler 240, as seen in FIGS. 46-47. The separation of the coupler 240 from the elongate shaft 252 can be observed under fluoroscopy, if desired. The introducer sheath 250 and actuator 202 can then be removed from the patient.

[0065] During a surgical procedure, the coupler 240 may accidentally be fully deployed within the arterial lumen 32, also referred to as a "total intra-arterial deployment." If such deployment occurs, the coupler 240 may be collapsed to a pre-deployment state and then removed from the patient, leaving the guidewire 30 in place. FIGS. 48-55 illustrate the collapse procedure that occurs in such an event, providing an internal view of the mechanism used to deploy and collapse the coupler 240, which can simultaneously lock out future deployment of the coupler 240. FIG. 49 shows an internal view of the actuator assembly 200 in a pre-deployment position. In this position, the locking tab 210 is in place. FIG. 50 depicts the actuator assembly 200 after deployment of either the proximal wing 248P or the distal wing 248D first (depending on which wing is deployed first for the procedure), and the gap 206A can be clearly seen. In this position, the guide pin 280 is locked into position on the actuator cylinder 281 of the actuator 282, preventing the handle 206 from moving forward. FIG. 51 illustrates the actuator assembly 200 after deployment of the second wing, either the proximal wing 248P or the distal wing 248D, and it can be seen that the gap 206A has increased in size compared to FIG. 50. In this position, the guide pin 280 is again locked into position directly in front of the actuator cylinder 281 of the actuator 282, preventing the handle 206 from moving forward. At this point, if the coupler 240 is correctly positioned, the surgery can continue as desired. For example, if the coupler 240 must be folded as a result of incorrect deployment, the folding procedure can proceed.

[0066] 52 and 53, to fold the coupler 240, the spring-loaded release plate 284 can be depressed and slid distally to access the actuator cylinder plate 286. The actuator cylinder plate 286 can be depressed to allow the actuator cylinder 282 to be unrestricted from its distal movement. The handle 206 can be pushed distally and rotated in a first direction (e.g., clockwise) and then rotated in a second direction (e.g., counterclockwise) to simultaneously fold both the proximal wing 248P and the distal wing 248D. The handle 206 can then be pushed distally again and rotated in the second direction (e.g., counterclockwise) to initiate / continue folding of the other of the proximal wing 248P and the distal wing 248D. The proximal and distal wings 248P, 248D can be folded into a substantially shallow oval shape, as shown in FIG. 48, and the introducer sheath 250 and actuator assembly 200 can be removed, leaving the guidewire 30 in place. The act of folding the coupler 240 to a substantially pre-deployed state can actuate the guide pin 280 in the actuator assembly 200 to interact with a latch 282A located on the actuator 282, exposing the guide pin 280 as a result of the actuator cylinder 282 remaining in the proximal position, as shown in FIG. 55. This interaction prevents redeployment of the coupler 240 after an initial failed deployment. A new actuator assembly 200 can be inserted into the patient, starting with the first step of the procedure and proceeding from there.

[0067] Both the deployable coupler 140 and coupler 240 are described for use in an exemplary procedure to couple portions of the arterial lumen 32. These couplers 140, 240, as well as the various embodiments described herein, can be used in many procedures to achieve a variety of desired results.

[0068] 56-72 illustrate a medical procedure for promoting weight loss and / or treating type 2 diabetes using one or more of couplers 340, according to one embodiment. The medical procedure may be a cholecystoileostomy plus or minus an enteroenterostomy, performed laparoscopically or percutaneously from the liver. Although reference is made to coupler 340, the described procedure may be performed using any combination of assemblies and devices described herein, including deployable coupler 140 and coupler 240. Coupler 340 may operate similarly to deployable couplers 140 and 240, and may be used with an associated actuator assembly 300, which may operate similarly to actuator assembly 100 and actuator assembly 200.

[0069] To begin the procedure, one or more incisions may be made in the patient to provide access to the patient's small intestine 50 and gallbladder 60. The surgeon may then grasp a section of the patient's ileum 52 and bring it into an anterior or posterior colonic position adjacent the gallbladder 60, as seen in FIG. 56. This orientation may define a distal ileal loop 52D located distal to the region of the ileum adjacent the gallbladder 60 and a proximal ileal loop 52P located proximal to the region of the ileum adjacent the gallbladder 60. Alternatively, an incision 54 may be made in the ileum 52 distal to the portion grasped by the surgeon, such as an anterior mesenteric incision, and an anastomotic coupler 340 secured to the distal end of a flexible guide tube 320 may be inserted through the incision 54 toward the gallbladder 60, as shown in FIG. Once inserted, the distal tip 320D of the guide tube 320 distal to the anastomotic coupler 340 can be advanced until it abuts the walls of both the ileum 52 and the gallbladder 60.

[0070] Once in position, a penetrator 321 (e.g., a dissection needle, radiofrequency probe, or equivalent known in the art) can be inserted through the actuator assembly 300 to its distal tip 320D and out its central lumen 322 to penetrate both the ileum 52 and the gallbladder 60. This penetration can be seen in FIG. 60. After the penetrator 321 penetrates the gallbladder 60, an anastomotic coupler 340 can be advanced into the gallbladder 60. In some embodiments, an introducer sheath (e.g., introducer sheath 250, not shown) can be inserted into the ileum and then into the gallbladder. A self-expanding anastomotic coupler (not shown) can be advanced through the introducer sheath into the gallbladder. The introducer sheath can be retracted to deploy the distal wings of the self-expanding anastomotic coupler. The introducer sheath and the self-expanding anastomotic coupler can then be further retracted, allowing the proximal wing of the self-expanding anastomotic coupler to deploy within the ileum.

[0071] After successful insertion and advancement of the coupler 340 into the gallbladder 60, the penetrator 321 can be partially retracted from the gallbladder 60 in preparation for deployment of the anastomotic coupler 340. The locking tab 310, which prevents premature deployment of the anastomotic coupler 340, can be removed from the actuator assembly 300. With the locking tab 310 removed, the handle 304 of the actuator assembly 300 can be actuated, such as by rotating it clockwise, to deploy the distal wing 344D of the coupler 340 within the gallbladder 60, as seen in FIGS. 60-61. Once the distal wing 344D is deployed, the actuator assembly 300 can be drawn proximally such that the distal wing 344D contacts the interior of the gallbladder 60, as seen in FIG. From there, the proximal wing 344P of the anastomotic coupler 340 can be deployed by actuation of the handle 304, such as, for example, by counterclockwise rotation as seen in Figures 62-63, thereby joining the gallbladder 60 and the ileum 52 together. In some embodiments, deployment of the proximal wing 344P and the distal wing 344D can be reversed, such that the proximal wing 344P is deployed first at the ileum and the distal wing 344D is then deployed at the gallbladder.

[0072] After deployment of the proximal wing 344P, the penetrator 321 can be completely removed from the actuator assembly 300. A dye, such as methylene blue, can then be injected through the same lumen 322 through which the penetrator 321 was inserted to check for leaks at the anastomosis. If a leak is detected, either or both of the proximal and distal wings 344P, 344D of the anastomotic coupler 340 can be re-actuated to partially return to their pre-deployment state, and the anastomotic coupler 340 can be redeployed to a more suitable position. If necessary, the actuator assembly 300 can be removed prior to redeployment to address new issues that may be causing improper coaptation of the ileum and gallbladder 60.

[0073] If the attachment is successful, an ejection lever 308 disposed on the actuator assembly 300 can be actuated to eject the anastomotic coupler 340 from the actuator assembly 300. The anastomotic coupler 340 has a central lumen 341 that can place the gallbladder 60 in fluid communication with the ileum 50.

[0074] 66-67 show cross-sectional views of an anastomotic coupler 340 according to certain embodiments. The proximal and distal wings 344P, 344D of the anastomotic coupler 340 may be similarly sized relative to one another for this procedure. Additionally, the proximal and distal wings 344P, 344D of the coupler 340 may be deployed at various angles relative to the axis of the central lumen 341. These deployment angles may be configured to promote healing of the gallbladder 60 and the ileum 52 while simultaneously preventing pinching of tissue, which may cause serious complications such as necrosis or infection. For example, in FIG. 66, the proximal wing 344P is deployed at an angle such that the radial end of the proximal wing 344P passes through the middle of the anastomotic coupler 340, and the length of the proximal wing 344P is much greater than the length of the distal wing 344D. This places a risk of straining and damaging the walls of the gallbladder 60 and the ileum 52. In contrast, FIGURE 67 illustrates an embodiment of an anastomotic coupler 340 in which both the proximal and distal wings 344P, 344D are of similar length and the respective angles of deployment are not severe enough to strain the walls of the gallbladder 60 and ileum 52.

[0075] In some embodiments, the wings 344P, 344D can be brought into contact with one another (e.g., by increasing their length and / or changing their deployment angle), thereby contributing to the creation of a compression anastomosis that can result in tissue necrosis. During the healing process of such necrosis, the outer wall of the ileum can fuse with the outer wall of the gallbladder. The anastomotic coupler 340 can peel off and pass distally through the ileum and out of the patient, leaving behind a temporary or permanent fluid pathway.

[0076] After ejection of the anastomotic coupler 340, the actuator assembly 300 may be completely removed from the patient.

[0077] From there, an entero-enterostomy can be performed as shown in Figures 68-72. First, as shown in Figure 68, a second anastomotic coupler 340' can be delivered by actuator assembly 300 into ileum 52 through incision 54. A grasping mechanism 70 (e.g., forceps, not shown) can be used to manipulate proximal ileal loop 52P into a position proximal to distal ileal loop 52D. Once proximal ileal loop 52P is in place, a second incision 55 can be made in proximal ileal loop 52P, e.g., a 5 mm enterotomy, in a manner similar to the process for making incision 54.

[0078] The actuator assembly 300 can then be oriented as shown to contact a portion of the ileum 52 while aligning the contacted portion with the second incision 55. Once aligned, the penetrator 321 can be inserted through the actuator assembly 300 as described above and an incision can be made in the distal ileal loop proximate the second incision 55. An anastomotic coupler 340' can then be inserted to join both ileal loops 52D, 52P and the penetrator 321 can be partially withdrawn, as seen in FIG.

[0079] The anastomotic coupler 340' can then be deployed in a manner similar to that described above. As shown in Figures 70-71, the locking tab 310 can be released and the handle 304 can be actuated (such as through a clockwise rotation) to deploy the distal wing 344D within the proximal ileal loop 52P. The actuator assembly 300 can then be withdrawn to bring the distal wing 344D into contact with the inner wall of the distal ileal loop 52D. Once in position, the handle 304 can again be actuated (e.g., by a counterclockwise rotation) to deploy the proximal wing 344P of the anastomotic coupler 340' within the distal ileal loop 52D, thereby joining the proximal and distal ileal loops 52P and 52D.

[0080] The bond can be confirmed using a process similar to that previously described with methylene blue. From there, the lever 308 of the actuator assembly 300 can be actuated to separate the actuator assembly 300 and the anastomotic coupler 340'. The actuator assembly 300 can then be withdrawn from the patient and the various incisions made during the procedure can be closed.

[0081] 72 illustrates the newly created fluid pathway for bile after this medical procedure. Fluid can flow normally from the gallbladder 60 into the small intestine 50 and through each anastomotic coupler 340, 340'.

[0082] Certain exemplary embodiments have been described to provide a general understanding of the principles of the structure, function, manufacture, and use of the systems, devices, and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will appreciate that the systems, devices, and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and the scope of the present invention is defined only by the claims. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention. Furthermore, in this disclosure, components with the same name in multiple embodiments generally have similar features, and therefore, within a specific embodiment, each feature of each component with the same name is not necessarily fully described.

[0083] As used throughout this specification and the claims, approximation expressions can be applied to modify any quantitative expression that can vary within permissible limits without causing a change in the basic function to which it relates. Thus, values ​​modified with terms such as "about," "approximately," "substantially," etc. are not limited to the exact value specified. In at least some instances, approximation language can correspond to the precision of the instrument for measuring the value. Throughout this specification and the claims, range limitations can be combined and / or interchanged, and such ranges are specified and include all subranges contained therein, unless the context or language indicates otherwise.

[0084] Those skilled in the art will appreciate further features and advantages of the present invention based on the above-described embodiments. Accordingly, the present application is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated by reference in their entirety.

[0085] The claims are set forth below.

Claims

1. 1. A surgical assembly comprising: an actuator assembly having an elongated shaft, the actuator assembly including an outer shaft and an inner shaft concentrically disposed within the outer shaft to define a fluid flow path between the outer shaft and an inner shaft; and a deployable coupler coupled to a distal end of the outer shaft and having a plurality of proximal and distal slits formed therein configured to form proximal and distal wings, the proximal and distal slits configured to allow blood to pass therethrough and into a fluid flow path to a fluid exit port formed in the actuator assembly; A surgical assembly comprising:

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

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 lever configured to decouple the deployable coupler from the distal end of the outer shaft.

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

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

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

8. The surgical assembly of claim 7 , wherein the crown includes a castellation, and the deployable coupler is coupled to the castellation.

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

10. 1. A surgical method comprising: inserting an elongate shaft of an actuator assembly through a guide assembly extending through a puncture in a body cavity and positioning a deployable coupler coupled to a distal end of the elongate shaft within the body cavity such that blood flows into the deployable coupler, through the elongate shaft, and out a port at a proximal end of the actuator assembly; thereafter, actuating the actuator assembly to deploy distal wings of the deployable coupler radially outward; retracting the actuator assembly to draw the distal wing against an inner wall of the body cavity to stop the blood from flowing into the deployable coupler; actuating the actuator assembly to deploy proximal wings of the deployable coupler radially outwardly adjacent an outer wall of the body cavity, thereby sealing the puncture hole within the body cavity; decoupling the deployable coupler from the distal end of the elongate shaft; The method includes:

11. 11. The method of claim 10, further comprising the step of pivoting the elongate shaft to position the distal wings against the inner wall of the body cavity after actuating the actuator to deploy the distal wings radially outward and before actuating the actuator assembly to deploy the proximal wings radially outward.

12. The method of claim 10 , wherein the elongate shaft includes an inner shaft and an outer shaft concentrically disposed about the inner shaft, and blood flows between the inner shaft and the outer shaft.

13. The method of claim 12 , wherein the distal end of the outer shaft includes a pair of welded C-tubes that define a gap through which blood flows.

14. The method of claim 10 , wherein deploying the proximal wing comprises rotating the 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 the first direction.

16. 1. A surgical assembly comprising: An actuator assembly including an elongated shaft; and a deployable coupler coupled to a distal end of the elongate shaft, the deployable coupler including a plurality of proximal slits configured to form proximal wings and a plurality of distal slits configured to form distal wings; The actuator assembly can be configured to transform the deployable coupler from a delivery configuration in which the proximal and distal wings are substantially parallel to the elongate shaft to a fully deployed configuration in which one of the proximal and distal wings is substantially perpendicular to the elongate shaft and the other of the proximal and distal wings is oblique to the elongate shaft. Surgical assembly.

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

18. 17. The surgical assembly of claim 16, wherein each of the plurality of distal slits comprises a first cut and a second cut having substantially unequal lengths, the substantially unequal lengths causing the distal wings to be substantially oblique relative to the elongate shaft in the deployed configuration.

19. The surgical assembly of claim 16, wherein transformation of the deployable coupler from a delivery configuration to a deployed configuration causes the proximal and distal wings to fold about their intermediate regions.

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

21. 17. The surgical assembly of claim 16, further comprising an auxiliary handle configured to couple to a proximal end of the actuator assembly, the auxiliary handle having a distally extending plug configured to pass through a central lumen defined at least in part by the elongate shaft and to be disposed within a central bore of the deployable coupler.

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

23. 1. A surgical assembly comprising: a delivery tool including an elongate shaft extending from a distal end thereof; and a deployable coupler coupled to a distal end of the elongate shaft, the deployable coupler having a distal wing defined by a first proximal cut and a first distal cut and a proximal wing defined by a second proximal cut and a second distal cut; Equipped with the delivery tool is configured to transform the deployable coupler between a delivery configuration in which the elongate shaft is substantially parallel to the distal and proximal wings and a deployed configuration in which the elongate shaft is substantially transverse to the distal and proximal wings; and a deployment angle of the distal wing is defined at least in part by a ratio of lengths of the first proximal cut to the first distal cut, and a deployment angle of the proximal wing is defined at least in part by a ratio of lengths of the second proximal cut to the second distal cut.

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

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

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

27. 27. The surgical coupler of claim 26, wherein the first tubular portion is configured to reversibly form wings substantially perpendicular to a longitudinal axis of the central lumen.

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

29. 27. The surgical coupler of claim 26, wherein the connector portion has a diameter greater than a diameter of the first tubular portion and a diameter of the second tubular portion.

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

31. 27. The surgical coupler of claim 26, wherein the surgical coupler is configured to couple with the actuator tool, the actuator tool configured to reversibly form the first tubular portion and the second tubular portion into wings.

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

33. 13. A method comprising: inserting a delivery sheath over the guidewire through the puncture in the artery to position a deployable coupler coupled to a distal end of the delivery sheath within the artery; pivoting the delivery sheath from an insertion orientation that allows blood to flow up the coupler to an oblique orientation that prevents blood from flowing up the coupler; actuating an actuator coupled to a proximal end of the delivery sheath to deploy distal wings, the distal wings being positioned within the artery adjacent the puncture; activating the actuator to deploy a proximal wing of the deployable coupler such that the proximal wing is positioned outside of the artery adjacent the puncture; Removing the guidewire from the delivery sheath; and advancing a plug into the central lumen of the deployable coupler to seal the puncture hole; The method includes:

34. 34. The method of claim 33, wherein the plug is operably coupled to an auxiliary handle, the auxiliary handle having a deployment lever thereon configured to deploy the plug into the deployable coupler.

35. 35. The method of claim 34, further comprising the step of actuating the deployment lever to separate the plug from the auxiliary handle after advancing the plug into the central lumen.

36. 34. The method of claim 33, further comprising positioning the coupler relative to a puncture site using an external imaging system, the external imaging system detecting radiopacity of the coupler.

37. 1. A surgical method comprising: advancing a first coupler coupled to a distal end of the elongate shaft through the small intestine to a region of the small intestine proximate the gallbladder; piercing the region of the small intestine and the gallbladder using a penetrator advanced through the elongate shaft and the first coupler; advancing the first coupler at least partially into the gallbladder; deploying a first distal wing of the first coupler within the gallbladder; retracting the elongate shaft until the first distal wing contacts an inner surface of the gallbladder; deploying a first proximal wing of the first coupler within the small intestine to releasably attach the first coupler to the gallbladder and the small intestine; and ejecting a first coupler from the distal end of the elongate shaft; The method includes:

38. advancing a second coupler coupled to the distal end of the elongate shaft through the small intestine to an ileal loop distal to the proximal ileal loop; puncturing an inner wall of the distal ileal loop and entering the proximal ileal loop using the penetrator advanced through the elongate shaft and the second coupler; deploying a second distal wing of the second coupler within the proximal ileal loop; retracting the elongate shaft to cause the second distal wing to contact an inner surface of the proximal ileal loop; deploying a second proximal wing of the second coupler within the distal ileal loop to releasably attach the second coupler to the proximal ileal loop and the distal ileal loop; and ejecting the second coupler from the distal end of the elongate shaft; 38. The method of claim 37, further comprising:

39. 40. 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 a longitudinal axis of the elongate shaft.

40. 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 a longitudinal axis of the elongate shaft.

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

42. 38. 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 a length of the first proximal wing and a length of the first distal wing are substantially equal.

43. 38. The method of claim 37, wherein the first proximal wing comprises a first plurality of petals and the first distal wing comprises a second plurality of petals, the first plurality of petals being rotatably offset from the second plurality of petals.

44. 13. A method comprising: deploying a first distal wing of the first coupler within the gallbladder and a first proximal wing of the first coupler within the ileum via an actuator tool having an elongate shaft and a first coupler coupled to a distal end of the elongate shaft; deploying, via the actuator tool having a second coupler coupled to the distal end, a second distal wing of the second coupler within a first loop of the ileum distal from the deployed first coupler and deploying a second proximal wing of the second coupler within a second loop of the ileum proximal from the deployed first coupler; Including, the first coupler defines a first central lumen configured to fluidly couple the gallbladder and the ileum; and The second coupler defines a second central lumen configured to fluidly join the first loop and the second loop.

45. 45. The method of claim 44, further comprising using a penetrator coupled to the distal end of the elongate shaft to pierce a wall of the ileum and pierce a wall of the gallbladder to position the first coupler at least partially within the gallbladder and at least partially within the ileum.

46. 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 a longitudinal axis of the elongate shaft.

47. 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 a longitudinal axis of the elongate shaft.

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

49. 46. ​​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 a length of the first proximal wing and a length of the first distal wing are substantially equal.

50. 46. ​​The method of claim 45, wherein the first proximal wing comprises a first plurality of petals and the first distal wing comprises a second plurality of petals, the first plurality of petals being rotatably offset from the second plurality of petals.

51. 13. A method comprising: introducing a first coupler attached to an elongate shaft extending distally from an actuator tool into the ileum, the first coupler and the elongate shaft defining a first central lumen therethrough; contacting a distal end of the first coupler with an outer wall of the ileum adjacent an outer wall of the gallbladder; extending a first penetrator through the first central lumen to create a hole through the inner wall of the ileum and the outer wall of the gallbladder; advancing the first coupler from the ileum to the gallbladder; deploying a distal wing of the first coupler within the gallbladder using an actuator tool; retracting the first coupler to contact the distal wing against the inner wall of the gallbladder; deploying a proximal wing of the first coupler within the ileum using the actuator tool, the gallbladder and the ileum being in fluid communication through the first coupler; and decoupling the first coupler from the elongate shaft; The method includes:

52. introducing a second coupler attached to the elongate shaft into the distal ileal loop distal to the first coupler, the second coupler and the elongate shaft defining a second central lumen therethrough; incising a region of the proximal ileum loop proximal to the first coupler; contacting an outer wall of the distal ileal loop adjacent the incision area of ​​the proximal ileal loop; extending the second penetrator through the second central lumen to create a hole through the inner wall of the distal ileal loop and through the incision area; advancing the second coupler through the incision area from the distal ileal loop to the proximal ileal loop; deploying a distal wing of the second coupler within the proximal ileal loop using the actuator tool; retracting the second coupler to contact the distal wing against an inner wall of the proximal ileal loop; deploying a proximal wing of the second coupler within the distal ileal loop with the actuator tool, the proximal ileal loop and the distal ileal loop being in fluid communication through the second coupler; and decoupling the second coupler from the elongate shaft; 52. The method of claim 51 further comprising:

53. 13. A method comprising: inserting a sheath through the ileum into the gallbladder; advancing an expandable coupler 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 coupler; deploying a distal wing of the expandable coupler within the gallbladder using the actuator tool; deploying a proximal wing of the expandable coupler within the ileum with the actuator tool, the gallbladder and the ileum being in fluid communication through the deployed expandable coupler; and decoupling the expandable coupler from the actuator tool; The method includes:

Images