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.

Abstract: An apparatus for delivering a closure element into an opening formed in a blood vessel or other body lumen and methods for manufacturing and using same. The apparatus is configured to retain the closure element such that the closure element is disposed substantially within the apparatus. The apparatus also can engage, and position the closure element substantially adjacent to, the blood vessel wall adjacent to the opening. During deployment of the closure element, the apparatus expands the closure element beyond a natural cross-section of the closure element such that the closure element, when deployed, is configured to engage a significant amount of the blood vessel wall and/or tissue. Engaging the blood vessel wall and/or tissue, the closure element is further configured to return to the natural cross-section, thereby drawing the engaged blood vessel wall and/or tissue substantially closed and/or sealed, such that hemostasis within the opening is enhanced.

Abstract: Systems and methods for treating internal tissue defects, such as septal defects, with clip-based devices are provided. An exemplary clip-based device includes a tubular body having at least a first and a second deflectable member coupled thereto. The first and second members are coupled on opposite ends of the tubular body and configured to deflect between an undeployed configuration and a deployed configuration. In the deployed configuration, each member extends outwardly away from the tubular body in a position configured to abut a tissue surface. The first and second members are preferably configured to maintain a tissue wall therebetween and at least partially close any opening in the tissue wall.

Abstract: A closure system and methods of use are provided for use in sealing an opening in a body tissue, such as a vascular puncture site. A method of closing the opening in the body tissue can be performed with the closure system having a closure clip. The method can include positioning the closure clip in a first closure clip position adjacent to the opening in the body tissue such that a plurality of spikes of the closure clip are inserted into the tissue at a location outward from a central axis of the opening. Subsequently, the closure clip can be positioned in a second closure clip position such that the plurality of spikes are pulled inward toward the central axis of the opening so as to pull the tissue between the opening and each of the spikes together and close the opening.

Abstract: Systems and methods for treating internal tissue defects, such as septal defects, with implantable devices are provided. An exemplary clip-based device includes a tubular body having at least a deflectable anchors coupled thereto. The anchors can be coupled on opposite ends of the tubular body and configured to deflect between an undeployed configuration and a deployed configuration. In the deployed configuration, each anchor extends outwardly away from the tubular body in a position configured to abut a tissue surface. The anchors are preferably configured to maintain a tissue wall therebetween and at least partially close any opening in the tissue wall. Also provided are delivery devices for delivering the implantable closure device and methods for using the various devices.

Abstract: A medical device that includes a plurality of strut members forming a plurality of generally diamond-shaped openings, the plurality of strut member being configured to form an annular shaped structure with the generally diamond-shaped openings extending generally longitudinally relative to a longitudinal axis of the medical device. A plurality of tissue engaging portions are associated with the plurality of struts, with each tissue engaging portion extending towards the longitudinal axis in a deployed configuration.

Abstract: A method that includes locating an opening in tissue by advancing a member through the opening in tissue and following locating the opening, deploying a medical device to aid with sealing the opening. The medical device includes a plurality of strut members forming a plurality of generally diamond-shaped openings, the plurality of strut member being configured to form an annular shaped structure with the generally diamond-shaped openings extending generally longitudinally relative to a longitudinal axis of the medical device. The medical device further includes a plurality of tissue engaging portions associated with the plurality of struts, each tissue engaging portion being disposed between adjacently positioned generally diamond-shaped openings.

Abstract: An apparatus for sealing a passage through tissue communicating with a body lumen is provided. The apparatus includes an elongate member having a proximal end a distal end and a lumen extending from the distal end toward the proximal end defining a longitudinal axis. A plug member is disposed on the distal end and extends distally from the elongate member in a pre-deployed and deployed configuration. The plug member includes a distal port therein in communication with the lumen and has a cross-sectional diameter at a plug proximal end and a plug distal end greater than a cross-sectional diameter of the distal end of the elongate member in the pre-deployed configuration. The apparatus also includes a member extendable distally from the distal port, the member including a proximal end and a distal end.

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: An apparatus for delivering a clip includes an introducer sheath including an outer surface extending between its proximal and distal ends. A clip is carried on the outer surface, e.g., on a carrier assembly that is slidable along the outer surface from the proximal end towards the distal end. A skin overlies the outer surface of the sheath and the carrier assembly that is separable from the outer surface as the carrier assembly is advanced from the proximal end towards the distal end of the sheath. During use, the distal end of the sheath is inserted into an opening through tissue, e.g., into a puncture communicating with a blood vessel. The carrier assembly is advanced towards the distal end of the sheath, causing the skin to separate from the outer surface of the elongate member, and the clip is deployed from the carrier to seal the opening.

Abstract: A method for closing an opening in a wall of a body lumen using a clip can include advancing a distal end of an elongate member within the body lumen, the elongate member having a distal portion that assists in presenting the wall for receiving a clip having a plurality of tissue engaging portions having tips that point generally toward a central axis of the clip. The clip can be advanced relative to the elongate member and the wall of the body lumen until the plurality of tissue engaging portions penetrate the wall of the body lumen. Once the clip penetrates the wall, the elongate member can be withdrawn from the body lumen, leaving the clip to substantially close the opening in the wall of the body lumen.

Abstract: The methods, devices and systems described herein relate to accessing a hollow organ with increased accuracy and safety. In one example, they relate to transseptal crossings of the atrial septal wall, preferably from the right atrium into the left atrium. Numerous different devices are described for performing access methods, each of which can be used with a piercing stylet that transitions to an atraumatic configuration after piercing the intervening tissue.

Abstract: The methods, devices and systems described herein relate to accessing a hollow organ with increased accuracy and safety. In one example, they relate to transseptal crossings of the atrial septal wall, preferably from the right atrium into the left atrium. Numerous different devices are described for performing access methods, each of which can be used with a piercing stylet that transitions to an atraumatic configuration after piercing the intervening tissue.

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: An apparatus for delivering a clip includes an introducer sheath including an outer surface extending between its proximal and distal ends. A clip is carried on the outer surface, e.g., on a carrier assembly that is slidable along the outer surface from the proximal end towards the distal end. A skin overlies the outer surface of the sheath and the carrier assembly that is separable from the outer surface as the carrier assembly is advanced from the proximal end towards the distal end of the sheath. During use, the distal end of the sheath is inserted into an opening through tissue, e.g., into a puncture communicating with a blood vessel. The carrier assembly is advanced towards the distal end of the sheath, causing the skin to separate from the outer surface of the elongate member, and the clip is deployed from the carrier to seal the opening.

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: 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: 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 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.

Abstract: Systems, devices and methods for treating internal tissue defects, such as septal defects, are provided. An exemplary method of treating an internal tissue defect, specifically a method of closing a patent foramen ovale (PFO), can include passing a closure element from a right atrium through a septal wall in a first location and into the left atrium. A capture device, which can be configured as a snare-like device, can be used to capture the closure element in the left atrium and pull the closure element back through the septal wall in a different, second location, such that the closure element is routed over the PFO. The closure element can then be anchored and/or locked against the septal wall such that the PFO is at least partially closed.