Abstract: This invention relates to apparatus and methods used to seal a vascular puncture site, particularly sites of punctures that are the result of catheterization or other interventional procedures. The sealing device includes a sealing member and a tether. The sealing member occupies a space in an incision, puncture, or other wound and sealing the space that it occupies, to prevent further blood flow. The tether is attached to the sealing member, and provides the user with the ability to withdraw the sealing member if necessary. The sealing device further includes a restraining member associated with the sealing member. The restraining member provides the ability to more securely restrain the sealing member to prevent it from migrating from the deployment location within a tissue tract. The restraining member also provides an additional capability of manipulating the sealing member after deployment.

Abstract: The present invention is directed to a device which is capable of both locating a punctured blood vessel wall and sealing the puncture in the vessel and to the method of using the device as well. In one embodiment, the device includes an elongate deployment member having a sealing element releasably disposed within a distal end thereof, said deployment member being coupled to a first actuator configured to retract said deployment member relative to said sealing element, and an elongated indicator member having a proximal end and a distal end, said indicator member extending through a lumen in said deployment member such that the distal end of said indicator member extends distally of the distal end of the deployment member, and said indicator member being coupled to a second actuator configured to retract said indicator member relative to said deployment member.

Abstract: An apparatus for sealing a passage through tissue communicating with a blood vessel includes a bioabsorbable plug member coupled to the distal end of a carrier member. The plug member includes a lumen extending therethrough that communicates with a lumen extending through the carrier member. A sealing member is disposed in the plug member lumen for sealing the lumen. A guide member is slidable into the lumen such that edges of a groove extending between proximal and distal portions of the guide member engage a wall of the lumen to define a bleed back lumen. The guide member is inserted into the passage until the distal portion enters the vessel. The plug member is advanced over the guide member until the plug member enters the vessel, whereupon blood enters the bleed back lumen to identify the location of the vessel relative to the plug member.

Abstract: Embodiments are described for closing vascular access ports, such as arteriotomies, which involve placement and deployment of an expandable device configured to prevent blood flow across a subject arteriotomy while also keeping disturbance of intravascular flow to a minimum. Suitable prostheses may comprise one or more frames constructed from lengths of flexible materials, such as shape memory alloys or polymers. Such frames may be coupled to sheetlike or tube-like structures configured to spread loads, minimize thrombosis which may be related to intravascular flow, and maintain hemostasis.

Abstract: Configurations are described for conducting minimally invasive medical interventions utilizing elongate instruments and assemblies thereof to stabilize and/or fixate a sacro-iliac joint. In one embodiment, a tool assembly may be advanced from a posterior approach into the SI junction and configured to create a defect defined at least in part by portions of both the sacrum and the ilium, the defect having a three dimensional shape defined in part by at least one noncircular cross sectional shape in a plane substantially perpendicular to the longitudinal axis of the tool assembly. After a defect is created, the tool assembly may be retracted and a prosthesis deployed into the defect.

Abstract: Embodiments are described for closing vascular access ports, such as arteriotomies, which involve placement and deployment of an expandable device configured to prevent blood flow across a subject arteriotomy while also keeping disturbance of intravascular flow to a minimum. Suitable prostheses may comprise one or more frames constructed from lengths of flexible materials, such as shape memory alloys or polymers. Such frames may be coupled to sheetlike or tube-like structures configured to spread loads, minimize thrombosis which may be related to intravascular flow, and maintain hemostasis.

Abstract: An apparatus for sealing a passage through tissue includes a plug including external threads, a lumen extending between its proximal and distal ends, and an annular collet slidably disposed within the lumen. The plug is carried on a distal end of a handle device that includes an inner member with a distal end that is slidable axially within the lumen of the body for moving the collet into a reduced cross-sectional region of the lumen, thereby compressing the collet to seal the lumen, and for deploying the plug from the handle device. During use, the plug is delivered into a passage through tissue over a guide wire. Once a desired location is reached, the plug is deployed from the handle device, thereby compressing the collet and sealing the lumen. The guide wire and handle device are removed, leaving the plug to seal the passage.

Abstract: A clip for engaging tissue includes a generally annular-shaped body defining a plane and disposed about a central axis extending normal to the plane. The body includes alternating inner and outer curved regions, defining a zigzag pattern about a periphery of the clip. The body is biased towards a planar configuration lying in the plane and deflectable towards a transverse configuration extending out of the plane. Tines extend from the inner curved regions, the tines being oriented towards the central axis in the planar configuration, and parallel to the central axis in the transverse configuration. The tines may include primary tines and secondary tines that are shorter than the primary tines. The primary tines may be disposed on opposing inner curved regions and oriented towards one another such that they overlap in the planar configuration.

Abstract: Apparatus and methods for closing a septal defect including a flap of tissue partially detached from a septum of a heart. A needle is advanced through a patient's vasculature within a delivery apparatus until the needle is disposed within a first chamber adjacent the septum. The needle is directed through the flap of tissue until the needle is disposed within a second chamber opposite the septum. A filament attached to an intermediate region of the needle is pulled, thereby causing the needle to pivot about the intermediate region such that the ends of the needle straddle the septal opening. A locking element is secured to the filament to secure the flap of tissue against the septum, and the filament is cut. Alternatively, the filament is biased to coil to engage the flap of tissue and secure the needle against the septum to close the opening.

Abstract: A system for treating a septal defect having an implantable treatment apparatus and devices for delivering the implantable treatment apparatus and methods for treating a septal defect are provided. The implantable treatment apparatus is preferably implantable through a septal wall or portion thereof. The treatment system can include a flexible elongate body member, a delivery device configured to deliver the implantable apparatus, a stabilization device configured to stabilize the body member and a positioning device configured to position the delivery device in a desired location.

Abstract: A device which is capable of both locating a punctured blood vessel wall and sealing the puncture in the vessel and a method of using the device. In one embodiment, the device includes an elongate deployment member having a releasable sealing element disposed within a distal end and an elongated indicator member having a proximal end and a distal end. The deployment member is coupled to a first actuator configured to retract the deployment member relative to the sealing element. The indicator member extends through a lumen in the deployment member such that the distal end of said the indicator member extends distally of the distal end of the deployment member. The indicator member is also coupled to a second actuator configured to retract the indicator member relative to the deployment member.

Abstract: This invention relates to apparatus and methods for use in sealing a vascular puncture site, particularly sites of punctures that are the result of catheterization or other interventional procedures. In several of the preferred embodiments, the sealing device includes a sealing member and a tether. The sealing member generally performs the function of occupying a space in an incision, puncture, or other wound and sealing the space in the incision, puncture, or wound that it occupies, to prevent further blood flow. The tether is typically attached in some manner to the sealing member, and provides the user with the ability to withdraw the sealing member if necessary. In a particularly preferred form, the sealing device further includes a restraining member associated with the sealing member. The restraining member provides the ability to more securely restrain the sealing member to prevent it from migrating from the deployment location within a tissue tract.

Abstract: A clip for engaging tissue includes a generally annular-shaped body defining a plane and disposed about a central axis extending normal to the plane. The body includes alternating inner and outer curved regions, defining a zigzag pattern about a periphery of the clip. The body is biased towards a planar configuration lying in the plane and deflectable towards a transverse configuration extending out of the plane. Tines extend from the inner curved regions, the tines being oriented towards the central axis in the planar configuration, and parallel to the central axis in the transverse configuration. The tines may include primary tines and secondary tines that are shorter than the primary tines. The primary tines may be disposed on opposing inner curved regions and oriented towards one another such that they overlap in the planar configuration.

Abstract: An apparatus for sealing a passage through tissue communicating with a blood vessel includes a bioabsorbable plug member coupled to the distal end of a carrier member. The plug member includes a lumen extending therethrough that communicates with a lumen extending through the carrier member. A sealing member is disposed in the plug member lumen for sealing the lumen. A guide member is slidable into the lumen such that edges of a groove extending between proximal and distal portions of the guide member engage a wall of the lumen to define a bleed back lumen. The guide member is inserted into the passage until the distal portion enters the vessel. The plug member is advanced over the guide member until the plug member enters the vessel, whereupon blood enters the bleed back lumen to identify the location of the vessel relative to the plug member.

Abstract: A system for treating a septal defect having an implantable treatment apparatus and devices for delivering the implantable treatment apparatus, devices for controlling delivery of the treatment apparatus and methods for treating a septal defect are provided. The implantable treatment apparatus is preferably implantable through a septal wall or portion thereof. The treatment system can include a flexible elongate body member, a delivery device configured to deliver the implantable apparatus, and a proximal control device for controlling delivery of the implantable apparatus, among others.

Abstract: Apparatus and methods for closing a septal defect including a flap of tissue partially detached from a septum of a heart. A needle is advanced through a patient's vasculature within a delivery apparatus until the needle is disposed within a first chamber adjacent the septum. The needle is directed through the flap of tissue until the needle is disposed within a second chamber opposite the septum. A filament attached to an intermediate region of the needle is pulled, thereby causing the needle to pivot about the intermediate region such that the ends of the needle straddle the septal opening. A locking element is secured to the filament to secure the flap of tissue against the septum, and the filament is cut. Alternatively, the filament is biased to coil to engage the flap of tissue and secure the needle against the septum to close the opening.

Abstract: Embodiments are described for closing vascular access ports, such as arteriotomies, which involve placement and deployment of an expandable device configured to prevent blood flow across a subject arteriotomy while also keeping disturbance of intravascular flow to a minimum. Suitable prostheses may comprise one or more frames constructed from lengths of flexible materials, such as shape memory alloys or polymers. Such frames may be coupled to sheetlike or tube-like structures configured to spread loads, minimize thrombosis which may be related to intravascular flow, and maintain hemostasis.

Abstract: Embodiments are described for closing vascular access ports, such as arteriotomies, which involve placement and deployment of an expandable device configured to prevent blood flow across a subject arteriotomy while also keeping disturbance of intravascular flow to a minimum. Suitable prostheses may comprise one or more frames constructed from lengths of flexible materials, such as shape memory alloys or polymers. Such frames may be coupled to sheetlike or tube-like structures configured to spread loads, minimize thrombosis which may be related to intravascular flow, and maintain hemostasis.

Abstract: An apparatus for sealing a passage through tissue includes a plug including external threads, a lumen extending between its proximal and distal ends, and an annular collet slidably disposed within the lumen. The plug is carried on a distal end of a handle device that includes an inner member with a distal end that is slidable axially within the lumen of the body for moving the collet into a reduced cross-sectional region of the lumen, thereby compressing the collet to seal the lumen, and for deploying the plug from the handle device. During use, the plug is delivered into a passage through tissue over a guide wire. Once a desired location is reached, the plug is deployed from the handle device, thereby compressing the collet and sealing the lumen. The guide wire and handle device are removed, leaving the plug to seal the passage.

Abstract: An apparatus for delivering a closure element can include a splittable carrier tube and a splitter to split the tube. The carrier tube can have an outer surface retaining a closure element in a tubular configuration and can be split into radially-expandable flaps. A closure element can have a shape-memory body having a relaxed configuration with a planar-annular body defining a lumen with tines directed inwardly from the body. The clip can be held in a retaining configuration having a substantially asymmetrically-elongated tubular shape with a trapezoidal longitudinal cross-sectional profile and a proximal end having the tines being longitudinally directed with a first tine being more distally oriented compared to a substantially opposite second tine being more proximal, and retracting to a deploying configuration having a tubular shape with a rectangular longitudinal cross-sectional profile with the first tine being even with the second tine when being delivered.