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: An introducer sheath for deploying a stent to a target site within a body passageway of a patient. The introducer sheath includes a tubular inner liner having a proximal portion, a distal portion, and an outer surface. A first reinforcing element, and a second reinforcing element are positioned along the outer surface of the inner liner. The first reinforcing element comprises a braid the second reinforcing element comprises a coil. The braid is positioned at the proximal portion of the inner liner and extends distally therefrom. The coil is positioned at the distal portion longitudinally adjacent the braid. The braid has a length that may extend about 90% of the length of the sheath. An outer jacket is positioned longitudinally around the reinforcing elements, and is connected to the inner liner between the respective wires of the braid and the coil.

Abstract: The disclosure relates to a woven fabric for use in an implantable medical device. The woven fabric comprises shape memory element strands woven with textile strands. At least one of the shape memory element strands has at least one float of at least five textile strands between binding points.

Abstract: Introducer sheath (10,30,40) having a flexible kink-resistant distal tip portion (26,32,42). A multilayer sheath structure is used, with an inner tube (12) such as PTFE having a coil (14) of wire wound therearound. A first length of outer tubing (20) such as of nylon is inserted over most of the coil-wound inner tube (12) in a manner exposing a distal length of coil-wound inner tube. A second length of outer tubing (22) with a softer durometer than first outer tubing length (20), is inserted over the exposed coil-wound inner tube and extends for a slight distance beyond the end of the coil. During heat application, the outer tubing lengths (20, 22) are melted to bond to each other and to flow between the spacings of the coil turns to bond to the roughened outer surface of the inner tube (12). The distal tip region corresponding to the second tubing length is flexible and is kink-resistant due to the coil (14).

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 two-stage method of compressing a stent entails providing an expandable stent (100,105) in a radially expanded state. An outward pressure is applied to an inner surface of the tubular framework to support the stent, and a diameter of the stent is reduced to a first compressed diameter (D1) while applying the outward pressure. The outward pressure is halted after reaching the first compressed diameter. According to an embodiment in which the stent is balloon-expandable, a delivery balloon catheter (130) comprising an uninflated balloon in a delivery configuration is inserted into the lumen after halting the outward pressure. The diameter of the stent is reduced to a second compressed diameter (D2) smaller than the first compressed diameter to crimp the stent onto the delivery balloon catheter.

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: The disclosure relates to a woven fabric for use in an implantable medical device. The woven fabric comprises shape memory element strands woven with textile strands. At least one of the shape memory element strands has at least one float of at least five textile strands between binding points.

Abstract: An improved delivery system for an implantable medical device includes a retention sheath having a proximal end, a distal end, and an inner lumen extending from the proximal end to the distal end. The implantable medical device is disposed within the inner lumen of the retention sheath, which restrains the implantable medical device. A plurality of substantially incompressible rings are disposed within the inner lumen of the retention sheath in a stacked co-axial configuration that extends from the proximal end of the retention sheath in a pre-deployment position to a proximal end of the implantable medical device. Each ring in the plurality of separate rings abuts at least a portion of an adjacent ring. The plurality of separate rings is configured to prevent the implantable medical device from moving toward a proximal end of the retention sheath when the retention sheath is moved from the pre-deployment position to a deployment position.

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: The disclosure relates to a woven fabric for use in an implantable medical device. The woven fabric has shape memory element strands woven with textile strands. At least one of the shape memory element strands has at least one float of at least five textile strands between binding points.

Abstract: A medical device including a tube having a coil fitted around at least a part of an inner liner, such as PTFE, and a braid extending over at least part of the coil. A polymeric layer is positioned over the braid to adhere to the inner liner. A portion of the coil advantageously comprises a polymer, such as PEEK, while the coil may also have a metal portion. The polymer coil may extend along at least at the proximal region of the tube, and the metal coil may extend along at least at the distal region of the tube. A polymer coil, a metal coil or any combination thereof can extend along the intermediate region of the tube. The polymer coil can be configured so that the tube is longitudinally splittable with a cutting instrument.

Abstract: Introducer sheath (10,30,40) having a flexible kink-resistant distal tip portion (26,32,42). A multilayer sheath structure is used, with an inner tube (12) such as PTFE having a coil (14) of wire wound therearound. A first length of outer tubing (20) such as of nylon is inserted over most of the coil-wound inner tube (12) in a manner exposing a distal length of coil-wound inner tube. A second length of outer tubing (22) with a softer durometer than first outer tubing length (20), is inserted over the exposed coil-wound inner tube and extends for a slight distance beyond the end of the coil. During heat application, the outer tubing lengths (20, 22) are melted to bond to each other and to flow between the spacings of the coil turns to bond to the roughened outer surface of the inner tube (12). The distal tip region corresponding to the second tubing length is flexible and is kink-resistant due to the coil (14).

Abstract: Introducer sheath (10,30,40) having a flexible kink-resistant distal tip portion (26,32,42). A multilayer sheath structure is used, with an inner tube (12) such as PTFE having a coil (14) of wire wound therearound. A first length of outer tubing (20) such as of nylon is inserted over most of the coil-wound inner tube (12) in a manner exposing a distal length of coil-wound inner tube. A second length of outer tubing (22) with a softer durometer than first outer tubing length (20), is inserted over the exposed coil-wound inner tube and extends for a slight distance beyond the end of the coil. During heat application, the outer tubing lengths (20,22) are melted to bond to each other and to flow between the spacings of the coil turns to bond to the roughened outer surface of the inner tube (12). The distal tip region corresponding to the second tubing length is flexible and is kink-resistant due to the coil (14).

Abstract: A coated stent (20) for use in a medical procedure and methods of manufacturing the coated stent (20) are described. A stent component (30) has an expanded state in which an inner diameter (ds) of the stent (30) is less than or equal to an outer diameter (dc2) of a coating (40), thereby causing an inner surface (35) of the stent (30) to engage the outer surface (42) of the coating (40). In one exemplary method of manufacture, the stent (30) is disposed over the coating (40) when the coating (40) is provided with a first, smaller outer diameter (dc1). The coating (40) then is radially expanded to a second, larger outer diameter (dC2), which is greater than or equal to the inner diameter (ds) of the stent (30), to cause the outer surface (42) of the coating (40) to engage the inner surface (35) of the stent (30).

Abstract: A method of embolic protection during a medical procedure in a patient's body vessel includes inserting a medical device having an outer tubular member and an inner tubular member into the body vessel. A flexible filter portion has one end attached to the distal end of the inner tubular member and the other end attached to the distal end of the outer tubular member. The filter portion is deployed within the body vessel so that the filter portion extends distally from the outer tubular member and expands radially outward to engage the filter body with an enclosing body vessel wall. A medical instrument is inserted through the inner tubular member to perform the medical procedure. The filter portion allows the passage of blood cells to surrounding vessels and prevents emboli from entering surrounding vessels. After removing medical instrument, the medical device is also removed from the body vessel.

Abstract: A vascular introducer for accessing a circulatory system of a patient includes a sheath and a dilator. The sheath includes a fitting attached at a proximal end, and includes a liner that is longer than a core tube. A proximal segment of the liner is attached to an inner surface of the core tube, but a distal segment of the liner is everted to cover an outer surface of a distal segment of the core tube. The dilator is positioned in the sheath and includes a tapered distal segment that extends beyond a distal end of the sheath. A handle is attached to the proximal end of the dilator and extends proximally from the fitting. During a procedure, a blood vessel may constrict and grip the sheath. During withdrawal of the sheath, the core tube is slid within a first portion of the everted distal segment of the liner while another portion of the liner is de-everting.

Abstract: A catheter tip assembly (50) is provided with a catheter tip (56) and an inner catheter (54). The catheter tip (56) has a tapered proximal end, an elongate center portion, and a tapered distal end. The inner catheter (54) includes a narrow proximal portion, a narrow elongate center portion (66), and a wide distal end (68). The catheter tip (56) is disposed within the wide distal end (68) of the inner catheter (54). One advantage of the catheter tip assembly is that no proximal-facing edge is formed at the transition between the narrow elongate center portion of the inner catheter and the catheter tip, which may help reduce the risk of the catheter tip snagging on a stent during use.

Abstract: A stent deployment system includes a handle and a flexible sheath coupled the handle. A flexible tube extends from the handle through the sheath. A tapered flexible extension is coupled to the flexible tube, the tapered flexible extension has a taper angle of between about 5 degrees and 15 degrees towards the handle. A bead of adhesive can be supplied at an end of the tapered flexible extension. A thrust block is coupled to the flexible tube, and an endoluminal prosthesis is positioned around the flexible tube between the thrust block and the tapered flexible extension with a space situated between the endoluminal prosthesis and the thrust block.

Abstract: A medical device for embolic protection within a patient's body vessel is provided. The device includes inner and outer tubular members each having proximal and distal ends and a lumen formed through the proximal and distal ends. A flexible everting filter portion includes a body having a first end attached to the distal end of the inner tubular member and a second end attached to the distal end of the outer tubular member. The inner and outer tubular members are movable relative to one another to position the filter portion within the body vessel. The filter portion is movable from a collapsed, everted delivery and removal configuration to an expanded, generally non-everted deployed configuration. The filter portion expands radially outward to engage the filter body with the body vessel. The filter portion allows the passage of blood cells and prevents the passage of emboli or thrombi through the body vessel.