Abstract: Anastomotic stents for connecting a graft vessel to a target vessel, and methods of use thereof. The anastomotic stents of the invention are suitable for use in a variety of anastomosis procedures, including coronary artery bypass grafting. One embodiment of the invention comprises a large vessel anastomotic stent for use with large diameter target vessels such as the aorta or its major side branches. Another embodiment of the invention comprises a small vessel anastomotic stent for use on a target vessel which has a small diameter such as a coronary artery. Another aspect of the invention involves applicators for use with the stents of the invention.

Abstract: An anastomosis system and method uses an anvil to control and support a tissue site during an anastomosis procedure. The anvil is particularly useful for supporting a wall of a coronary artery during attachment of a graft vessel to the coronary artery because the wall of the coronary artery is very thin, difficult to grasp, and susceptible to tearing. In one method, the anvil is inserted into a pressurized or unpressurized target vessel and is pulled against an inner wall of the target vessel causing tenting of the thin tissue of the vessel wall. A graft vessel is then advanced to the anastomosis site and an end of the graft vessel is positioned adjacent and exterior of the target vessel. Staples are inserted through the tissue of the graft vessel and the target vessel by pivoting the arms of a staple holder towards the anvil. When the ends of the staples engage staple bending features on the anvil, the ends of the staples bend over securing the graft vessel and target vessel together.

Abstract: A deployment system for forming an incision in a target vessel, for placement of an anastomosis device and for deployment of an anastomosis device having an inner flange formed by radial expansion of the device and an outer flange formed by axial compression of the device.

Abstract: Anastomotic stents for connecting a graft vessel to a target vessel, and methods of use thereof. The anastomotic stents of the invention are suitable for use in a variety of anastomosis procedures, including coronary artery bypass grafting. One embodiment of the invention comprises a large vessel anastomotic stent for use with large diameter target vessels such as the aorta or its major side branches. Another embodiment of the invention comprises a small vessel anastomotic stent for use on a target vessel which has a small diameter such as a coronary artery. Another aspect of the invention involves applicators for use with the stents of the invention.

Abstract: An anastomosis device is a one piece device for connecting a graft vessel to a target vessel without the use of conventional sutures. The anastomosis device includes an expandable tube configured to have a graft vessel secured to the tube. The device has an expandable linkage positioned at one end of the device and expansion of this linkage causes a first radially extending flange to fold outward. This first flange abuts an interior wall of a target vessel and a second flange is formed which abuts an exterior wall of the target vessel trapping the target vessel between the two flanges and secures the end of the graft vessel into an opening in the wall of the target vessel. The device greatly increases the speed with which anastomosis can be performed over known suturing methods and allows anastomosis to be performed in tight spaces.

Abstract: An everter and threadthrough system useful for attaching a graft vessel to a anastomosis device which can be used to attach a graft vessel to a target vessel without the use of conventional sutures. The threadthrough system engages an end of the graft vessel and pulls the graft vessel through a deployment tool until a portion of the graft vessel extends beyond a distal end of the anastomosis device mounted on the deployment tool. The everter includes a spreading mechanism which expands the end of the graft vessel and folds the expanded end over the anastomosis device. In the case where the anastomosis device includes barbs, the everter can effect penetration of the graft vessel by the barbs. Once the graft vessel is everted over the anastomosis device, the deployment tool can be used to attach the graft vessel to a target vessel.

Abstract: A method and system for performing anastomosis uses an anvil to control and support a tissue site during an anastomosis procedure involving tissue bonding techniques such as tissue welding and adhesive tissue bonding. The anvil is particularly useful for supporting a wall of a coronary artery during attachment of a graft vessel in a coronary artery bypass graft procedure. The anvil is inserted into a pressurized or unpressurized target vessel and is pulled against an inner wall of the target vessel causing tenting of the thin tissue of the vessel wall. A graft vessel is then advanced to the anastomosis site and an end of the graft vessel is positioned adjacent an exterior of the target vessel. When tissue welding is used, a graft vessel fixture is positioned over the tissue surfaces to be welded in order to clamp the graft and target vessel tissue together. The tissue contacting surfaces of the anvil and/or graft vessel fixture are provided with one or more energy applying surfaces.

Abstract: An anastomosis system and method uses an anvil to control and support a tissue site during an anastomosis procedure. The anvil is particularly useful for supporting a wall of a coronary artery during attachment of a graft vessel to the coronary artery because the wall of the coronary artery is very thin, difficult to grasp, and susceptible to tearing. In one method, the anvil is inserted into a pressurized or unpressurized target vessel and is pulled against an inner wall of the target vessel causing tenting of the thin tissue of the vessel wall. A graft vessel is then advanced to the anastomosis site and an end of the graft vessel is positioned adjacent and exterior of the target vessel. Staples are inserted through the tissue of the graft vessel and the target vessel by pivoting the arms of a staple holder towards the anvil. When the ends of the staples engage staple bending features on the anvil, the ends of the staples bend over securing the graft vessel and target vessel together.

Abstract: Osmotic delivery system semipermeable body assemblies that control the delivery rate of a beneficial agent from an osmotic delivery system incorporating one of the semipermeable body assemblies. A semipermeable body assembly or plug includes a semipermeable body which is positionable in an opening of an osmotic delivery system. The semipermeable body has a hollow interior portion having a size selected to obtain a predetermined liquid permeation rate through the semipermeable body. Because the beneficial agent in the osmotic delivery system is delivered at substantially the same rate the osmotic agent imbibes liquid which has permeated through the plug from a surrounding environment, the liquid permeation rate through the plug controls the delivery rate of the beneficial agent from the osmotic delivery system.

Abstract: Performance of delivery systems for delivering beneficial agents to an animal are monitored to determine the delivery rate of the beneficial agent and the proper operation of the beneficial agent delivery device. Performance monitoring can be achieved by monitoring the physical configuration of the implanted osmotic delivery device from the exterior of the body to determine the amount of beneficial agent delivered and/or the delivery rate of the beneficial agent. The monitoring of the physical configuration of the implanted osmotic delivery device may be performed in different manners such as by X-ray or fluoroscopic monitoring of the implant structure or magnetic determination of a piston location within the implant. Performance monitoring can also be achieved by use of a performance marker within the beneficial agent to produce a specifically detectable response which can be measured noninvasively in body fluids or by-products.

Abstract: An osmotic delivery system has a membrane plug retention mechanism which can also be used to control the delivery rate of a beneficial agent from the osmotic delivery system. The osmotic delivery device includes an implant capsule containing a beneficial agent and an osmotic agent. Holes are formed along a side wall of the implant capsule at an open end of the capsule. When the membrane plug is inserted into the open end of the capsule the membrane material swells into the holes in the capsule side wall creating a large frictional force which prevents expulsion of the membrane plug. A beneficial agent delivery rate of the osmotic delivery system is controllable by varying the size and number of the holes to change the amount of exposed surface area of the membrane plug. An increase in the surface area of the membrane plug exposed to the exterior environment causes a corresponding increase in the liquid permeation rate of the membrane and thus, increases the beneficial agent delivery rate.

Abstract: An implanter for inserting subcutaneous implants includes a handle for grasping the implanter during implantation, a hollow cannula receiving the implant, and a rod for releasing the implant from the cannula. The rod is longitudinally fixed within the handle while the cannula slides over the rod to release the implant. The cannula is moved over the rod by a sliding actuator mounted in a track of the handle. The actuator is locked in an extended position to prevent unintended release of the implant. Preferably, the implanter is a single-use device having a actuator locking feature preventing reuse.

Abstract: An osmotic delivery system for controlled delivery of a beneficial agent includes an implant capsule containing a beneficial agent and an osmotic agent which swells on contact with water causing the release of the beneficial agent over time. The osmotic delivery system has a membrane plug which allows water to pass through the plug from an exterior of the capsule while preventing the compositions within the capsule from passing out of the capsule. A delivery rate for delivery of the beneficial agent from the implant capsule is controlled by varying a core diameter of the membrane plug within a constant diameter capsule. The membrane plug has a variable water permeation rate depending on an extent to which the membrane plug is constrained by the capsule walls.