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: 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 vascular clip includes a peripheral body defining a plane, and tines extending from the body transversely with respect to the plane, the tines biased towards a planar configuration. The clip includes expandable elements disposed along its periphery that are biased to expand from compressed to expanded states for increasing a diameter of the clip upon deployment. The clip is provided within a housing slidably mounted on an introducer sheath. The sheath is introduced through a puncture into a blood vessel, and after a procedure is performed via the sheath, the housing is advanced into the puncture and the clip deployed until the tines engage tissue adjacent the opening in the vessel wall. The sheath is withdrawn from the patient, leaving the clip in place. The tines at least partially move towards the planar configuration to pull the engaged tissue together and close the opening.

Abstract: An apparatus for positioning an introducer sheath includes a sheath having a distal end including first and second ports, the second port being located distally from the first port. An obturator is slidable within the sheath that includes a distal region that sealingly engages an interior surface of the sheath. The obturator includes first and second openings in the distal region that are alignable with the first and second ports in the sheath. A housing is slidable on the exterior of the sheath that releasably holds a closure element. The sheath may be inserted into an incision communicating with a blood vessel, the first and second ports providing backbleed indication of the depth of the insertion of the sheath into the vessel. The housing is actuated to deploy the closure element to engage and close the incision.

Abstract: The present invention relates to a method of making clips which can be used to engage body tissue for the purpose of closing wounds. Such clips are generally annular in shape and have radially inwardly extending tines. It is often desirable for such clips to have a small lateral dimension, but manufacturing difficulty has been encountered in making small clips because of the difficulty in cutting materials accurately when attempting to produce a clip with closely packed elements. The present invention avoids these difficulties by first forming a precursor which, in one embodiment, has the tines extending radially outwardly from the annular body and then forms the clip by inverting the precursor such that the tines extend radially inwardly. In an alternate embodiment, the precursor is formed with an over-sized lateral dimension and then compressed inwardly to bring the tines closer together and to reduce the lateral dimension of the precursor.

Abstract: An apparatus for delivering a clip includes an introducer sheath including an outer surface extending between its proximal and distal ends, and a hub on the proximal end that includes spacer elements spaced away from the outer surface. An annular clip includes a plurality of tines extending from its distal end and its proximal end is held away from the outer surface of the sheath by the spacer elements. A handle assembly is attached to the hub that includes an actuator member slidable between the spacer elements and the outer surface of the sheath. The actuator member includes radial protrusions for coupling with the clip, whereby distal movement of the actuator member advances the clip towards the distal end of the sheath. Optionally, a skin overlies the outer surface of the sheath and the clip that is separable from the outer surface as the clip is advanced.

Abstract: Apparatus and methods are provided for use in sealing a vascular puncture site. The invention comprises an introducer sheath with an integrated closure component. The closure component includes an advanceable resilient spring clip with an expanded delivery configuration in which opposing sides do not contact one another, and an unstressed deployed configuration, in which opposing sides close towards one another. The clip is advanced along the sheath until it pierces opposing sides of a vessel wall at a puncture site. The sheath then is withdrawn, thereby causing the clip to resiliently return to its unstressed deployed configuration and draw opposing sides of the puncture together to seal the wound.

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 clip includes an introducer sheath including an outer surface extending between its proximal and distal ends, and a hub on the proximal end that includes spacer elements spaced away from the outer surface. An annular clip includes a plurality of tines extending from its distal end and its proximal end is held away from the outer surface of the sheath by the spacer elements. A handle assembly is attached to the hub that includes an actuator member slidable between the spacer elements and the outer surface of the sheath. The actuator member includes radial protrusions for coupling with the clip, whereby distal movement of the actuator member advances the clip towards the distal end of the sheath. Optionally, a skin overlies the outer surface of the sheath and the clip that is separable from the outer surface as the clip is advanced.

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: Apparatus and methods are provided for use in sealing a vascular puncture site. The invention comprises an introducer sheath with an integrated closure component. The closure component includes a fastener and an advanceable, deformable clip having a delivery configuration in which opposing sides do not contact one another, and a deployed configuration, in which the fastener causes opposing sides of the deformable clip to close towards one another. The clip is advanced along the sheath until it pierces opposing sides of a vessel wall at a puncture site. The clip is then deformed with the fastener to draw opposing sides of the puncture together, and the sheath is withdrawn to seal the wound. The clip and fastener preferably are bioabsorbable.

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 device for closing a septal defect, such as a patent foramen ovale, includes a clip formed from a superelastic material that is inserted into a septum wall of a heart. The clip is advanced through a patient's vasculature, e.g., within a delivery apparatus, until the clip is disposed within a first chamber adjacent the septal defect. Tines of the clip are directed through a flap of tissue of the septal defect until the tines of the clip are disposed within a second opposing chamber. The clip then transforms into its relaxed state, wherein the tines of the clip engage with a surface of the second chamber, thereby substantially closing the septal opening.

Abstract: A band of biocompatible and/or bioabsorbable material is provided including threads on one or both of its ends. An area adjacent a spinal disc is accessed, and the band of material is wrapped around the disc to stabilize the disc and/or to facilitate healing. An elongate member is inserted around a posterior region of the disc, e.g., through tubular guide members. An end of the band is connected to a distal end of the elongate member, and the elongate member is pulled back around the disc to direct the band around the disc. The band is secured around the disc overlapping vertebrae adjacent the disc. Optionally, a relative location of the vertebrae is adjusted relative to the disc before wrapping the band around the disc, for example, using a fork member or traction. Energy may also be applied to the disc to enhance healing.

Abstract: Apparatus and methods are provided for reducing the volume of a lung using a clip including a plurality of tines. The clip is advanced along an interior of a bronchial passage to a predetermined location with the tines in a contracted condition. The tines are expanded outwardly to engage surrounding tissue, and then collapsed towards the contracted condition, thereby drawing the surrounding tissue inwardly to substantially close the bronchial passage from air flow therethrough. Optionally, electrical energy may be applied to the surrounding tissue after collapsing the tines to the contracted condition, thereby fusing the surrounding tissue together. The clip is then released within or removed from the passage.

Abstract: A lung-assist apparatus includes a tubular housing, a tubular nozzle therein, and a first valve disposed between the housing and nozzle. The housing is implanted across a bifurcation such that the nozzle extends from a first branch communicating with a healthy region of a lung towards a main passage, and terminates proximate a lateral opening in the housing that is disposed within a second branch communicating with a damaged region of the lung. During inhalation, the first valve opens to allow air flow into the first branch, and closes during exhalation to force air through the nozzle, thereby inducing a vacuum for drawing air from the damaged region. A second valve in the second branch opens during exhalation to draw air from the diseased region, and closes during inhalation to prevent air from being drawn into the damaged region.

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: 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 energy delivery device includes a handle member having a connector on its distal end, the connector including an electrically conductive region. An electrically insulated elongate element extends from the distal that terminates in an uninsulated distal tip. During use, a needle connected to a syringe is inserted through tissue, e.g., into the interior of a spinal disc. A therapeutic agent is delivered through the needle, and then the syringe is disconnected from the needle. The elongate element is inserted into the needle until the distal tip extends beyond the distal end of the needle, and the connector connects the needle to the conductive region. Electrical energy is delivered from a source of electrical energy via the distal tip and the needle to tissue surrounding the passage to close the passage as the needle is withdrawn.