Abstract: An introducer assembly includes a distal sheath and a proximal sheath. A splitting element is located at a proximal end of the distal sheath and is arranged to split the distal sheath in a distal direction, so as to deploy first a branch element of a medical device and thereafter the distal end of the medical device. The proximal sheath can then be retracted to release the proximal end of the medical device. Deployment of the medical device from the branch element first enables accurate positioning of the branch element prior to deployment of the main body portion of the medical device.

Abstract: An implantable medical device such as a filter includes a plurality of struts arranged in a generally conical form with each strut having a first end, a second end, and an operative length between the first and second ends. Each strut is able to flex along its operative length and includes a strut skeleton having a first flexural modulus and a reinforcement element extending along the operative length and attached to the strut skeleton. The reinforcement element and the strut skeleton together have a second flexural modulus greater than the first flexural modulus. One of the reinforcement element and the strut skeleton varies in one of amount and composition continuously along the operative length such that the second flexural modulus varies in a continuous manner along the operative length. The reinforcement element is biodegradable thereby changing the flexural modulus from the second flexural modulus to the first flexural modulus.

Abstract: An introducer assembly includes a distal sheath and a proximal sheath. A splitting element is located at a proximal end of the distal sheath and is arranged to split the distal sheath in a distal direction, so as to deploy first a branch element of a medical device and thereafter the distal end of the medical device. The proximal sheath can then be retracted to release the proximal end of the medical device. Deployment of the medical device from the branch element first enables accurate positioning of the branch element prior to deployment of the main body portion of the medical device.

Abstract: A stent deployment system, handle, and method of loading of a medical device are provided. The system includes an outer catheter having an inner liner extending past the end of the outer catheter and an inner catheter disposed within the outer catheter. The inner liner is inverted and attached to the inner catheter. Relative movement between the outer and the inner catheters can urge the inner liner to peel away from the medical device. A handle is disposed at the proximal end of the outer catheter, and may include a splitter configured to slice the wall of the tubular member. The handle may also include a rotatable mechanism that can be attached to the tubular member. Rotation of the rotatable mechanism retracts a portion of the tubular member into the handle and winds the sliced portion about the rotatable mechanism.

Abstract: A stent, for example, is provided with a plurality of frame elements, which may have an undulating form. The stent is provided with a plurality of magnetic elements between adjacent stent elements. The magnetic elements on opposing circumferentially facing portions or sides of the strut elements have the same polarities so as to produce repulsive forces biasing the stent structure into a radially expanded configuration. The magnetic elements provide an alternative opening force on the stent, enabling the stent to be made of struts of thinner and weaker material or of a non-sprung material. The magnetic elements also provide a constant opening force in order to retain the stent reliably in position within a vessel. The stent could be made of a biodegradable material.

Abstract: A stent introducer apparatus comprises a sheath for surrounding a stent member, with the sheath having a longitudinal slit extending from one end along at least a substantial part of the length thereof, and a sheath withdrawal device comprising a reel for winding up the sheath. A second sheath may surround the slit portion of the sheath. An intermediate guide member can smooth the withdrawal procedure and flatten the sheath before it is wound on the reel. The intermediate guide member may include at least one of a second reel or a slot-defining member. The reel may be operated by means of a gear system. A method of deploying a stent member is also provided.

Abstract: A stent, for example, is provided with a plurality of frame elements, which may have an undulating form. The stent is provided with a plurality of magnetic elements between adjacent stent elements. The magnetic elements on opposing circumferentially facing portions or sides of the strut elements have the same polarities so as to produce repulsive forces biasing the stent structure into a radially expanded configuration. The magnetic elements provide an alternative opening force on the stent, enabling the stent to be made of struts of thinner and weaker material or of a non-sprung material. The magnetic elements also provide a constant opening force in order to retain the stent reliably in position within a vessel. The stent could be made of a biodegradable material.

Abstract: An introducer assembly (40) for use in the deployment of implantable medical devices such as stents and stent grafts includes a carrier element (20), a dilator tip (18) located at the distal end of the carrier element (40) and sheath (32) movable between a device covering position and a device deployment position. In the device deployment position, a restricted annular gap (34) is created between the distal end (36) of the sheath (32) and the proximal end (38) of the dilator tip (18). The gap (34) is restricted by a restriction mechanism (50) located at the proximal, external end, of the introducer assembly (40). The gap (34) allows for the progressive deployment of the medical device from the introducer (40) and for simultaneous retraction of the dilator tip (18) thereby avoiding snagging of the dilator tip (18) against the wall of a patient's vessels and of the medical device.

Abstract: A stent deployment system, handle, and method of loading of a medical device are provided. The system includes an outer catheter having an inner liner extending past the end of the outer catheter and an inner catheter disposed within the outer catheter. The inner liner is inverted and attached to the inner catheter. Relative movement between the outer and the inner catheters can urge the inner liner to peel away from the medical device. A handle is disposed at the proximal end of the outer catheter, and may include a splitter configured to slice the wall of the tubular member. The handle may also include a rotatable mechanism that can be attached to the tubular member. Rotation of the rotatable mechanism retracts a portion of the tubular member into the handle and winds the sliced portion about the rotatable mechanism.

Abstract: A stent deployment system, handle, and method of loading of a medical device are provided. The system includes an outer catheter having an inner liner extending past the end of the outer catheter and an inner catheter disposed within the outer catheter. The inner liner is inverted and attached to the inner catheter. Relative movement between the outer and the inner catheters can urge the inner liner to peel away from the medical device. A handle is disposed at the proximal end of the outer catheter, and may include a splitter configured to slice the wall of the tubular member. The handle may also include a rotatable mechanism that can be attached to the tubular member. Rotation of the rotatable mechanism retracts a portion of the tubular member into the handle and winds the sliced portion about the rotatable mechanism.

Abstract: A deployment assembly (10) for an introducer used for introducing into a patient a stent or other device, the deployment assembly including a housing 30 carrying a sprung loaded (90) actuator (44,50). The actuator includes a toothed wheel (50) carrying a spool (48) around which a retraction strap (44) can be wound. The strap (44) is coupled to a body member (26) of the introducer and through this to the outer sheath (14) thereof. A trigger (16) is provided for operating the actuator (44, 50). When the trigger (16) is pressed, the actuator winds, under the force produced by the spring (90), the strap (44) to thereby retract the outer sheath (14) so as to expose and then deploy the device carried on the introducer. The mechanism is such that a surgeon need not expend his own energy to retract the outer sheath (14) since this force is provided by the spring (90).

Abstract: A stent (10) is provided with a plurality of stent rings (12) formed of a plurality of interconnected struts (14). Adjacent stent rings (12) are coupled to one another by a plurality of tie bars (16). Within each tie bar (16) there is provided a hinge (36) which facilitates the curving of the stent (10) in its longitudinal direction and minimizes the generation of returning force to a non-curved configuration by the stent (10). The hinge could, for example, be formed by heat treating a portion of the tie bar (16). This arrangement is particularly suitable for stents or other medical devices intended to be placed in delicate vessels, such as cerebral vessels.

Abstract: A prosthesis (110) comprises a plurality of stent members which are formed of strut elements (120) connected by apexes, wherein at least the proximal apexes of the first stent member or the distal apexes of the second stent member have a shaped portion which is flat or concave. The proximal apexes (122) of a first stent member (116a) are arranged to engage the distal apexes (124) of an adjacent second stent member (116b) when the prosthesis is subjected to longitudinal compression forces. The shaped portion of the apexes prevents interdigitation of the stent members, which could lead to lateral deflection of the prosthesis.

Abstract: A process to load a medical device comprising a shape memory material into a delivery system is described herein. According to one aspect, the method includes applying a force to the medical device to obtain a delivery configuration thereof, where the device is at a first temperature within an R-phase temperature range of the shape memory material during application of the force. The medical device is cooled in the delivery configuration to a second temperature at or below a martensite finish temperature of the shape memory material. The force is then removed from the medical device, and the device is loaded into a delivery system. Preferably, the medical device substantially maintains the delivery configuration during the loading process.

Abstract: A stent deployment system, handle, and method of loading of a medical device are provided. The system includes an outer catheter having an inner liner extending past the end of the outer catheter and an inner catheter disposed within the outer catheter. The inner liner is inverted and attached to the inner catheter. Relative movement between the outer and the inner catheters can urge the inner liner to peel away from the medical device. A handle is disposed at the proximal end of the outer catheter, and may include a splitter configured to slice the wall of the tubular member. The handle may also include a rotatable mechanism that can be attached to the tubular member. Rotation of the rotatable mechanism retracts a portion of the tubular member into the handle and winds the sliced portion about the rotatable mechanism.

Abstract: A stent introducer apparatus comprises a sheath for surrounding a stent member, with the sheath having a longitudinal slit extending from one end along at least a substantial part of the length thereof, and a sheath withdrawal device comprising a reel for winding up the sheath. A second sheath may surround the slit portion of the sheath. An intermediate guide member can smooth the withdrawal procedure and flatten the sheath before it is wound on the reel. The intermediate guide member may include at least one of a second reel or a slot-defining member. The reel may be operated by means of a gear system. A method of deploying a stent member is also provided.

Abstract: An introducer assembly (40) for use in the deployment of implantable medical devices such as stents and stent grafts includes a carrier element (20), a dilator tip (18) located at the distal end of the carrier element (40) and sheath (32) movable between a device covering position and a device deployment position. In the device deployment position, a restricted annular gap (34) is created between the distal end (36) of the sheath (32) and the proximal end (38) of the dilator tip (18). The gap (34) is restricted by a restriction mechanism (50) located at the proximal, external end, of the introducer assembly (40). The gap (34) allows for the progressive deployment of the medical device from the introducer (40) and for simultaneous retraction of the dilator tip (18) thereby avoiding snagging of the dilator tip (18) against the wall of a patient's vessels and of the medical device.

Abstract: A rapid exchange balloon catheter having a proximal end and a distal end, the catheter including a tubular metal shaft body extending from the proximal end along a majority of the total length and having an inflation lumen arranged therein, a plastics distal end portion bonded to the metal body in extension thereof, the distal end portion being provided with an inflation lumen in communication with a balloon, and a guide wire lumen, the guide wire lumen extending from a proximal side port to a distal end opening. To reduce the resistance to kinking, the metal body includes a transitional region having reduced stiffness at the position of bonding to the plastics distal end portion compared to a more proximal position along the metal body.

Abstract: A rapid exchange balloon catheter having a proximal end and a distal end, said catheter comprising: a tubular metal shaft body extending from the proximal end along a majority of the total length and having an inflation lumen arranged therein, a plastics distal end portion bonded to the metal body in extension thereof, said distal end portion being provided with an inflation lumen in communication with a balloon, and a guide wire lumen, said guide wire lumen extending from a proximal side port to a distal end opening. To reduce the resistance to kinking, the metal body comprises a transitional region having reduced stiffness at the position of bonding to the plastics distal end portion compared to a more proximal position along the metal body.

Abstract: An intracranial stent formed from Nitinol has variable flexibility. The stent (10) is formed from a plurality of stent rings (12) connected by tie bars (14). The tie bars (14) in a central soft zone (16) are heat treated so as to confer a higher transition temperature on the Nitinol. As a result, at body temperature, the soft zone (16) has reduced longitudinal stiffness as compared to the stiffer zones (18) found at the ends of the stent (10).