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: An apparatus for sealing a passage through tissue includes a bioabsorbable body disposed on a distal end of a handle device. The plug member includes a helical thread on its outer surface and the plug member and handle device include cooperating lumens communicating with a distal port. A sealing member is disposed within the plug member lumen. An obturator is inserted through the lumens until its distal tip extends beyond the plug member, the distal tip including a bleed back port. The plug member is threaded into a passage towards a blood vessel until the bleed back indicator identifies the location of the vessel with respect to the plug member. The plug member is released from the handle device, the handle device and obturator are withdrawn, and the sealing member seals the lumen. The plug member is left within the passage to seal the passage until the tissue heals.

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: 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 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: An apparatus for delivering a clip to close an opening through tissue includes a sheath and a carrier assembly including a clip therein that is slidable on the sheath. An actuator assembly is connectable to the sheath, and telescoping actuator members extend from the handle that are connectable to the carrier assembly for advancing the carrier assembly along the sheath. An obturator on the actuator assembly includes splines that may be deployed beyond a distal end of the sheath, and expanded to a transverse expanded configuration for positioning the sheath before deploying the clip. The actuator members include cooperating detents that selectively release the actuator members as the carrier assembly reaches predetermined positions along the sheath for deploying the clip from the carrier assembly, and that collapse the splines to allow removal of the apparatus after deploying the clip.

Abstract: A catheter system has a balloon angioplasty device disposed about a common lumen near its distal end. The balloon catheter is pre-fitted with a stent which is deployed when the balloon is inflated. The common lumen is in communication with multiple lumens within a proximal region of the catheter body to allow for positioning of the catheter over a movable guide wire and convenient delivery of imaging or interventional devices to a desired region of a body passageway being treated. The procedure for stent deployment optionally includes steps of imaging a lumen by ultrasound before and after stent deployment to identify the site at which a stent is needed, to confirm that the stent is being and has been deployed at a longitudinal position which does not overlap a branched segment of the body passageway, and to ensure that the stent has been radially opened to an optimum diameter.

Abstract: An apparatus for delivering a clip to close an opening through tissue includes a sheath and a carrier assembly including a clip therein that is slidable on the sheath. An actuator assembly is connectable to the sheath, and telescoping actuator members extend from the handle that are connectable to the carrier assembly for advancing the carrier assembly along the sheath. An obturator on the actuator assembly includes splines that may be deployed beyond a distal end of the sheath, and expanded to a transverse expanded configuration for positioning the sheath before deploying the clip. The actuator members include cooperating detents that selectively release the actuator members as the carrier assembly reaches predetermined positions along the sheath for deploying the clip from the carrier assembly, and that collapse the splines to allow removal of the apparatus after deploying the clip.

Abstract: An apparatus for sealing a passage through tissue includes an elongate shaft and a cylindrical plug disposed on a distal end of the shaft, the plug including a helical thread on its outer surface. Intestinal submucosa may be secured to the plug, e.g., in a cavity in its distal end, that may be delivered into the passage. Alternatively, the plug may be formed from a bioabsorbable material and may be released from the shaft within the passage. The plug is threaded into the passage, thereby engaging the tissue to seal the passage. The shaft is rotated until it engages a blood vessel within the tissue while monitoring blood flow through the vessel. The shaft is rotated to thread the plug into the passage until blood flow ceases through the vessel, whereupon rotation of the shaft is reversed to back the plug until blood flow through the vessel resumes.

Abstract: An apparatus for sealing a passage through tissue includes a bioabsorbable body disposed on a distal end of a handle device. The plug member includes a helical thread on its outer surface and the plug member and handle device include cooperating lumens communicating with a distal port. A sealing member is disposed within the plug member lumen. An obturator is inserted through the lumens until its distal tip extends beyond the plug member, the distal tip including a bleed back port. The plug member is threaded into a passage towards a blood vessel until the bleed back indicator identifies the location of the vessel with respect to the plug member. The plug member is released from the handle device, the handle device and obturator are withdrawn, and the sealing member seals the lumen. The plug member is left within the passage to seal the passage until the tissue heals.

Abstract: Apparatus and methods for treating a spinal disc are disclosed. An opening is created in the annulus fibrosis, and nucleus pulposus is removed from the interior of the disc. The interior is lined with a nonporous, bioabsorbable liner, and filled with a fill material, such as nucleus pulposus, to cause the liner to expand to engage tissue surrounding the interior. The liner may be a sheet of extra-cellular matrix material that is introduced into the interior, or a bladder of extra-cellular matrix material including a neck communicating with an interior region of the bladder. The sheet or bladder may be carried by a delivery device, e.g., a catheter or rod. After the interior region is filled, the opening is closed using a plug or other closure device. The plug may include threads on its external surface for securing the plug in the opening.

Abstract: An apparatus for sealing a passage through tissue includes a bioabsorbable body disposed on a distal end of a handle device. The plug member includes a helical thread on its outer surface and the plug member and handle device include cooperating lumens communicating with a distal port. A sealing member is disposed within the plug member lumen. An obturator is inserted through the lumens until its distal tip extends beyond the plug member, the distal tip including a bleed back port. The plug member is threaded into a passage towards a blood vessel until the bleed back indicator identifies the location of the vessel with respect to the plug member. The plug member is released from the handle device, the handle device and obturator are withdrawn, and the sealing member seals the lumen. The plug member is left within the passage to seal the passage until the tissue heals.

Abstract: A catheter system has a balloon angioplasty device disposed about a common lumen near its distal end. The balloon catheter is pre-fitted with a stent which is deployed when the balloon is inflated. The common lumen is in communication with multiple lumens within a proximal region of the catheter body to allow for positioning of the catheter over a movable guide wire and convenient delivery of imaging or interventional devices to a desired region of a body passageway being treated. The procedure for stent deployment optionally includes steps of imaging a lumen by ultrasound before and after stent deployment to identify the site at which a stent is needed, to confirm that the stent is being and has been deployed at a longitudinal position which does not overlap a branched segment of the body passageway, and to ensure that the stent has been radially opened to an optimum diameter.

Abstract: An apparatus for delivering a clip to close an opening through tissue includes a sheath and a carrier assembly including a clip therein that is slidable on the sheath. An actuator assembly is connectable to the sheath, and telescoping actuator members extend from the handle that are connectable to the carrier assembly for advancing the carrier assembly along the sheath. An obturator on the actuator assembly includes splines that may be deployed beyond a distal end of the sheath, and expanded to a transverse expanded configuration for positioning the sheath before deploying the clip. The actuator members include cooperating detents that selectively release the actuator members as the carrier assembly reaches predetermined positions along the sheath for deploying the clip from the carrier assembly, and that collapse the splines to allow removal of the apparatus after deploying the clip.

Abstract: A catheter system has a balloon angioplasty device disposed about a common lumen near its distal end. The balloon catheter is pre-fitted with a stent which is deployed when the balloon is inflated. The common lumen is in communication with multiple lumens within a proximal region of the catheter body to allow for positioning of the catheter over a movable guide wire and convenient delivery of imaging or interventional devices to a desired region of a body passageway being Treated. The procedure for stent deployment optionally includes steps of imaging a lumen by ultrasound before and after stent deployment to identify the site at which a stent is needed, to confirm that the stent is being and has been deployed at a longitudinal position which does not overlap a branched segment of the body passageway, and to ensure that the stent has been radially opened to an optimum diameter.

Abstract: Apparatus and methods for treating a spinal disc are disclosed. An opening is created in the annulus fibrosis, and nucleus pulposus is removed from the interior of the disc. The interior is lined with a nonporous, bioabsorbable liner, and filled with a fill material, such as nucleus pulposus, to cause the liner to expand to engage tissue surrounding the interior. The liner may be a sheet of extra-cellular matrix material that is introduced into the interior, or a bladder of extra-cellular matrix material including a neck communicating with an interior region of the bladder. The sheet or bladder may be carried by a delivery device, e.g., a catheter or rod. After the interior region is filled, the opening is closed using a plug or other closure device. The plug may include threads on its external surface for securing the plug in the opening.

Abstract: A closure device includes a body defining a longitudinal axis, and a plurality of tissue engaging elements that are expandable between contracted and expanded conditions, and preferably biased to extend outwardly from the body in the expanded condition. The closure device may include a generally planar body including tines extending from its outer edge, an elongate body including annular flanges extending from its peripheral surface, or an annular body including tissue engaging elements extending from its proximal portion. An opening is created through the annulus fibrosis into a disc, and a procedure is performed within the disc. The closure device is introduced into the opening, and the tissue engaging elements are expanded to engage tissue surrounding the opening, thereby anchoring the closure device within the opening. Alternatively, the closure device may be a threaded plug that is threaded into the opening after completing the procedure to seal the opening.

Abstract: Apparatus and methods for treating a spinal disc are disclosed. An opening is created in the annulus fibrosis, and nucleus pulposus is removed from the interior of the disc. The interior is lined with a nonporous, bioabsorbable liner, and filled with a fill material, such as nucleus pulposus, to cause the liner to expand to engage tissue surrounding the interior. The liner may be a sheet of extra-cellular matrix material that is introduced into-the interior, or a bladder of extra-cellular matrix material including a neck communicating with an interior region of the bladder. The sheet or bladder may be carried by a delivery device, e.g., a catheter or rod. After the interior region is filled, the opening is closed using a plug or other closure device. The plug may include threads on its external surface for securing the plug in the opening.

Abstract: An apparatus for sealing a passage through tissue includes an elongate shaft and a cylindrical plug disposed on a distal end of the shaft, the plug including a helical thread on its outer surface. Intestinal submucosa may be secured to the plug, e.g., in a cavity in its distal end, that may be delivered into the passage. Alternatively, the plug may be formed from a bioabsorbable material and may be released from the shaft within the passage. The plug is threaded into the passage, thereby engaging the tissue to seal the passage. The shaft is rotated until it engages a blood vessel within the tissue while monitoring blood flow through the vessel. The shaft is rotated to thread the plug into the passage until blood flow ceases through the vessel, whereupon rotation of the shaft is reversed to back the plug until blood flow through the vessel resumes.

Abstract: An apparatus for sealing a passage through tissue includes a bioabsorbable body disposed on a distal end of a handle device. The plug member includes a helical thread on its outer surface and the plug member and handle device include cooperating lumens communicating with a distal port. A sealing member is disposed within the plug member lumen. An obturator is inserted through the lumens until its distal tip extends beyond the plug member, the distal tip including a bleed back port. The plug member is back indicator identifies the location of the vessel with respect to the plug member. The plug member is released from the handle device, the handle device and obturator are withdrawn, and the sealing member seals the lumen. The plug member is left within the passage to seal the passage until the tissue heals.