Abstract: Instruments, systems and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include a safe access needle injection instrument, a submucosal tunneling instrument, a submucosal dissection instrument, a mucosal resection device. Systems include a combination of one or more of such instruments with or without injectable agents. Embodiments of various methods for performing the procedures are also provided.

Abstract: Instruments, systems and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include a safe access needle injection instrument, a submucosal tunneling instrument, a submucosal dissection instrument, a mucosal resection device. Systems include a combination of one or more of such instruments with or without injectable agents. Embodiments of various methods for performing the procedures are also provided.

Abstract: Devices, systems and methods are provided for performing intra-lumenal medical procedures in a desired area of the body. Thrombectomy systems and methods of performing medical procedures to re-establish the intravascular flow of blood are provided for the treatment of ischemic disease states.

Abstract: Devices, systems and methods are provided for performing intra-lumenal medical procedures in a desired area of the body. Stents, stent delivery devices and methods of performing medical procedures to redirect and or re-establish the intravascular flow of blood are provided for the treatment of hemorrhagic and ischemic disease states.

Abstract: A system is provided that includes an elongated introducer navigable through body vessels of a human subject and a pusher component for incorporation within the introducer. The pusher component includes a tubular portion with a spiral ribbon. A radiopaque marker is secured to at least a portion of the spiral ribbon such that an outer surface of the radiopaque marker is substantially flush with an outer surface of the tubular portion immediately proximal and/or immediately distal the radiopaque marker. According to a method of manufacturing such a component, the spiral ribbon is formed by a spiral cutting operation and a pre-assembly radiopaque marker member is crimped onto the spiral ribbon. According to another method of manufacturing such a component, the spiral ribbon is formed by winding a filament and a pre-assembly radiopaque marker member is crimped onto the spiral ribbon.

Abstract: A suture cinch, cinch applicator, and cinch loader for loading the cinch into the cinch applicator are provided and permit re-use of the applicator with multiple cinches during an endoscopic procedure. The applicator can be loaded with a first cinch, apply the first cinch onto a portion of suture to fix the portion of suture relative to anatomical tissue, reloaded with a second cinch optionally using the loader, and subsequently used to apply the second cinch to fix another portion of suture to fix the other portion of suture relative to anatomical tissue. The cinch is a tubular member through which the suture can be advanced when the cinch is loaded within the applicator. The cinch defines multiple ribs and cutter defined in a wall thereof. Operation of the applicator deforms the ribs inward to retain the cinch on the suture, and displaces the cutter to sever the suture.

Abstract: An implantable medical device delivery system is provided with a carrier member having a proximal portion, a distal portion, and a frangible portion intermediate the proximal and distal portions. The frangible portion includes at least one notch providing a break hinge. A locking member is fixedly secured to the proximal portion of the carrier member and is releasably connected to an implantable medical device at or adjacent to the distal portion of the carrier member. In use, the implantable medical device is positioned generally adjacent to a target location of a body vessel and the frangible portion is broken about the break hinge. The proximal portion of the carrier member is then moved away from the distal portion to retract the locking member, thereby deploying the implantable medical device.

Abstract: Devices, systems and methods are provided for performing intra-lumenal medical procedures in a desired area of the body. Thrombectomy systems and methods of performing medical procedures to re-establish the intravascular flow of blood are provided for the treatment of ischemic disease states.

Abstract: Devices, systems and methods are provided for performing intra-lumenal medical procedures in a desired area of the body. Stents, stent delivery devices and methods of performing medical procedures to redirect and or re-establish the intravascular flow of blood are provided for the treatment of hemorrhagic and ischemic disease states.

Abstract: A needle capture device includes a flexible tubular member, a flexible shaft extending through the tubular member, a proximal handle for moving the shaft and tubular member relative to each other, a housing at the distal ends of the shaft and tubular member, and a capture mechanism situated within housing. The housing has an alternating arrangement of flights and spaces radially arrayed about its exterior dimensioned to be closely received within an endoscopic instrument channel so as to coaxially orient said housing with the instrument channel. The capture mechanism has a first configuration in which it is adapted to receive and retain a needle presented into the distal end of the instrument channel, and a second configuration in which it is adapted to release the needle from the instrument channel.

Abstract: A two-part suture cinch includes a collar and a plug. A cinch applicator is also provided, and includes an elongate tubular member, a plunger engaged within the distal end of the tubular member, a flexible shaft extending through the tubular member and plunger, and a proximal handle for moving the shaft longitudinally relative to the tubular member. The plunger includes a distal housing for the collar of the cinch, and the plug is coupled to the distal end of the flexible shaft. The suture is thread through the collar and a portion of the applicator. Operation of the applicator draws the plug into the collar and clamps the suture between the plug and collar. In addition, once the plug is coupled in to the collar, the plunger is displaced proximally to release the two-part cinch form the applicator. A method for applying the cinch is also provided.

Abstract: A medical implant deployment system for placing an implant at a preselected site within a vessel, duct or body lumen of a mammal comprising a reloadable deployment system includes a mechanical coupling assembly at the distal end of a delivery member, having an extended configuration in which the coupling assembly is adapted to receive or release the implant proximal end and a retracted configuration where the coupling assembly distal end is interlockingly engaged with the implant proximal end. Once the implant is properly positioned the coupling assembly is actuated, thereby releasing the implant at a desired position within the body.

Abstract: A medical implant deployment system for placing an implant at a preselected site within a vessel, duct or body lumen of a mammal. The reusable deployment system includes a mechanical coupling assembly at the distal end of a positioning member, having a first configuration in which the coupling assembly distal end is insertable or removable from the implant proximal end and a second configuration where the coupling assembly distal end is interlockingly engaged with the implant proximal end. Once the implant is properly positioned the coupling assembly is actuated, thereby releasing the implant at a desired position within the body.

Abstract: An access system includes a proximal handle, an overtube coupled to the handle, and an endoscope port extending through handle and overtube sized for receiving an endoscope therethrough. The overtube includes anatomic wall securing system that secures a distal portion of the overtube within a hole in the anatomic wall. The overtube is provided with a shaped distal portion or a controllably shapeable distal portion that aids in directing an endoscope inserted through the port to a particular location within the peritoneal cavity. The access system includes a system for insufflating/deflating the peritoneal space separately from the body cavity accessible via a natural orifice. The access system includes a closure system to cinch closed the hole made in the anatomical wall after the access system has been removed from the hole. Methods are provided for inserting the access system through the anatomical wall to perform intra-abdominal surgery.

Abstract: A medical device for placing an embolic device, such as an embolic coil, at a predetermined site within a vessel of the body including a delivery catheter and a flexible pusher member slidably disposed within the lumen of the catheter. An embolic device having a headpiece coupled to the proximal end is releasably disposed within the distal end of the pusher member and retained in place by a retractable fiber, having a coiled distal portion. When the embolic device is advanced to the predetermined site within the vessel, the detachment fiber is retracted from around the headpiece of the embolic device to thereby release the embolic device.

Abstract: A two-part suture cinch includes a collar and a plug. A cinch applicator is also provided, and includes an elongate tubular member, a plunger engaged within the distal end of the tubular member, a flexible shaft extending through the tubular member and plunger, and a proximal handle for moving the shaft longitudinally relative to the tubular member. The plunger includes a distal housing for the collar of the cinch, and the plug is coupled to the distal end of the flexible shaft. The suture is thread through the collar and a portion of the applicator. Operation of the applicator draws the plug into the collar and clamps the suture between the plug and collar. In addition, once the plug is coupled in to the collar, the plunger is displaced proximally to release the two-part cinch form the applicator. A method for applying the cinch is also provided.

Abstract: A self-expanding aneurysm cover device which takes the form of an outwardly biased cylindrical skeletal frame in which the proximal end of the cylindrical skeletal frame forms a loop which extends at an oblique angle to the axis of the cylindrical skeletal frame. A positioning tab extends from the proximal end of the skeletal frame which when pulled causes the cylindrical skeletal frame to collapse to a reduced diameter for removal of the device from a vessel.

Abstract: Instruments, systems, implants, and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include a safe access needle injection instrument, a submucosal tunneling instrument, a submucosal dissection instrument, and a mucosal resection device. A submucosal implant device for diagnosing and treating disorders of the body may be implanted. A passive submucosal implant device may take the form of a drug delivery depot in which a therapeutic agent within the depot elutes from the depot according to a predetermined elution profile. An active submucosal implant device may take the form of a drug delivery device that incorporates a self-contained diagnostic system to determine the appropriate delivery time and dosage of a therapeutic agent to be administered.

Abstract: A vascular occlusion device deployment system for placing an occlusion device at a preselected site within the vasculature of a patient. The deployment system employing a pusher having a lumen with an opening at the distal end of the pusher. A vascular occlusion device is connected to the distal end of the pusher by a portion that is removeably disposed within the opening. The portion of the occlusion device is forced out of the opening by an expandable reaction chamber, thereby deploying the occlusion device. The expandable reaction chamber, prior to deployment, has multiple chambers separated by a heat-dissolvable membrane. When the membrane is dissolved, components from the chambers react and expand, leading to deployment.

Abstract: Use of an interventional medical device system operable while within a body vessel is provided with a generally hollow tubular proximal portion, distal portion, and intermediate portion. The proximal portion and at least part of the distal portion remains outside of the body in use, with the remainder of the distal portion positioned within the body. The intermediate portion includes a spiral ribbon having adjacent turns, with at least one frangible bridge member between two adjacent turns. The proximal and distal portions are movable away from each other by elongating the spiral ribbon and, eventually, breaking the frangible bridge member. According to the method of using such a system to deploy an implantable medical device, such as an embolic coil, an actuation member is moved proximally with the proximal portion to disengage a bond or joint between the actuation member and the implantable medical device.