Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Abstract: A stent deployment device (110) is provided for deploying a stent in a lumen of a patient. The device can include a catheter (112), a first balloon (122) positioned near a distal end of the catheter and a second balloon (123) adjacent to the first balloon. Alternatively, the second balloon can be positioned over the first balloon. The device also includes an expandable stent (210) positioned over the first balloon and the second balloon. The first balloon comprises a semi-compliant material, a noncompliant material or a compliant material. Similarly, the second balloon comprises a semi-compliant material, a noncompliant material or a compliant material. The first balloon is expandable to a first diameter, while the second balloon can be expandable to a second diameter.

Abstract: A stent graft system for intraluminal deployment in an aorta and a branch vessel that includes an aorta stent graft for deployment within the aorta and defining a lumen for the passage of blood therethrough, and having a fenestration positioned and sized so as to allow blood to flow to a contiguous branch vessel. The system also includes a branch vessel prosthesis, preferably a stent graft, having a tubular portion and a flaring portion, such that, when deployed, the flaring portion is located within the lumen of the aorta stent graft and the tubular portion passes through the fenestration and into the branch vessel. A balloon expansion catheter expands the tubular portion and flare the flaring portion. The expansion of the tubular portion and the flaring of the flaring portion may occur sequentially or simultaneously.

Abstract: A branch vessel prosthesis for use with an aorta stent graft defining a lumen and having a fenestration aligned with a branch vessel, includes an expandable stent that has a tubular portion, a flareable portion, and at least one bending portion located between the tubular and the flareable portions. Upon deployment of the branch vessel prosthesis, the flareable portion is flared by bending of the bending portion.

Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Abstract: A coated medical device adapted for introduction into a passage or vessel of a patient is provided. The medical device is preferably an implantable balloon with a bioactive deposited or within the balloon. The balloon can further include a hydrophilic material positioned between the balloon and a bioactive material posited on the balloon.

Abstract: A medical device (110) including a catheter shaft (111) and a unitarily and continuously formed portion (108) having a varying durometer, and optionally including an expandable balloon (18, 118). One or both of the unitarily and continuously formed portion (108) and the balloon (18, 118) are made from an irradiation cross-linked or cross-linkable mixture of a polyamide elastomer and at least one additional cross-linking reactant. The polyamide elastomer can be a polyester amide, a polyether ester amide or a polyether amide, and is preferably a nylon block copolymer. The aromatic molecule can be 1,3,5 triethyl benzene; 1,2,4 triethyl benzene; and 1,3,5 triisopropyl benzene. The cross-linking reactant can be: (a) a difunctional material, (b) a trifunctional material, (c) a tetrafunctional material, or (d) an aromatic molecule containing at least two ring substituents, each of the ring substituents having labile hydrogens at a benzylic site therein.

Abstract: An apparatus and method for inserting an article into a body opening. A radially expandable introducer sheath is delivered in a non-expanded condition into a body opening. A release mechanism releases the introducer sheath from the non-expanded condition into a condition that permits radial expansion of the introducer sheath upon introduction of a medical device through the sheath into the body opening. An optional handle having a circumferential opening may be provided for withdrawing the sheath from the body opening, while leaving the medical device in place.

Abstract: A medical device (10) includes a catheter shaft (11) including inner and outer catheter shafts (12 and 14), and an expandable balloon (18) carried by the catheter shaft (11). The balloon (18) is made from an irradiation cross-linked mixture of a polyamide elastomer and at least one additional cross-linking reactant. The polyamide elastomer can be a polyester amide, a polyether ester amide or a polyether amide, and is preferably a nylon block copolymer. The cross-linking reactant can be: (a) a difunctional material, (b) a trifunctional material, (c) a tetrafunctional material, or (d) an aromatic molecule containing at least two ring substituents, each of the ring substituents having labile hydrogens at a benzylic site therein. The cross-linking reactant can also be diallyl phthalate or meta-phenylene dimaleimide. Irradiation is carried out by exposure to an electron beam or to ultraviolet, X- or gamma radiation, preferably at a total fluence of about 0.5 to about 20 megarads.

Abstract: A method for producing a radially expandable prosthesis by cutting a pattern in a tubular member, which member has an outer diameter at least as great as the expanded diameter of the prosthesis.

Abstract: A medical device (110) including a catheter shaft (111) and a unitarily and continuously formed portion (108) having a varying durometer, and optionally including an expandable balloon (18, 118). One or both of the unitarily and continuously formed portion (108) and the balloon (18, 118) are made from an irradiation cross-linked or cross-linkable mixture of a polyamide elastomer and at least one additional cross-linking reactant. The polyamide elastomer can be a polyester amide, a polyether ester amide or a polyether amide, and is preferably a nylon block copolymer. The aromatic molecule can be 1,3,5 triethyl benzene; 1,2,4 triethyl benzene; and 1,3,5 triisopropyl benzene. The cross-linking reactant can be: (a) a difunctional material, (b) a trifunctional material, (c) a tetrafunctional material, or (d) an aromatic molecule containing at least two ring substituents, each of the ring substituents having labile hydrogens at a benzylic site therein.

Abstract: A medical device (10) includes a catheter shaft (11) including inner and outer catheter shafts (12 and 14), and an expandable balloon (18) carried by the catheter shaft (11). The balloon (18) is made from an irradiation cross-linked mixture of a polyamide elastomer and at least one additional cross-linking reactant. The polyamide elastomer can be a polyester amide, a polyether ester amide or a polyether amide, and is preferably a nylon block copolymer. The cross-linking reactant can be: (a) a difunctional material, (b) a trifunctional material, (c) a tetrafunctional material, or (d) an aromatic molecule containing at least two ring substituents, each of the ring substituents having labile hydrogens at a benzylic site therein. The cross-linking reactant can also be diallyl phthalate or meta-phenylene dimaleimide. Irradiation is carried out by exposure to an electron beam or to ultraviolet, X- or gamma radiation, preferably at a total fluence of about 0.5 to about 20 megarads.

Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Abstract: An apparatus and method for inserting an article into a body opening. A radially expandable introducer sheath is delivered in a non-expanded condition into a body opening. A release mechanism releases the introducer sheath from the non-expanded condition into a condition that permits radial expansion of the introducer sheath upon introduction of a medical device through the sheath into the body opening. An optional handle having a circumferential opening may be provided for withdrawing the sheath from the body opening, while leaving the medical device in place.

Abstract: A medical device (110) including a catheter shaft (111) and a unitarily and continuously formed portion (108) having a varying durometer, and optionally including an expandable balloon (18, 118). One or both of the unitarily and continuously formed portion (108) and the balloon (18, 118) are made from an irradiation cross-linked or cross-linkable mixture of a polyamide elastomer and at least one additional cross-linking reactant. The polyamide elastomer can be a polyester amide, a polyether ester amide or a polyether amide, and is preferably a nylon block copolymer. The aromatic molecule can be 1,3,5 triethyl benzene; 1,2,4 triethyl benzene; and 1,3,5 triisopropyl benzene. The cross-linking reactant can be: (a) a difunctional material, (b) a trifunctional material, (c) a tetrafunctional material, or (d) an aromatic molecule containing at least two ring substituents, each of the ring substituents having labile hydrogens at a benzylic site therein.

Abstract: A medical device (10) includes a catheter shaft (11) including inner and outer catheter shafts (12 and 14), and an expandable balloon (18) carried by the catheter shaft (11). The balloon (18) is made from an irradiation cross-linked mixture of a polyamide elastomer and at least one additional cross-linking reactant. The polyamide elastomer can be a polyester amide, a polyether ester amide or a polyether amide, and is preferably a nylon block copolymer. The cross-linking reactant can be: (a) a difunctional material, (b) a trifunctional material, (c) a tetrafunctional material, or (d) an aromatic molecule containing at least two ring substituents, each of the ring substituents having labile hydrogens at a benzylic site therein. The cross-linking reactant can also be diallyl phthalate or meta-phenylene dimaleimide. Irradiation is carried out by exposure to an electron beam or to ultraviolet, X- or gamma radiation, preferably at a total fluence of about 0.5 to about 20 megarads.

Abstract: A stent deployment device (10) includes a catheter (12), a stent (14) positioned on the catheter (12), and a sleeve (16) carried on the catheter (12). The sleeve (16) has a portion (18) extending fully over and containing the stent (14). The stent deployment device (10) also includes a mechanism (20) for splitting at least the portion (18) of the sleeve (16) extending over the stent (14) and, preferably, for splitting the entire sleeve (16). Splitting of the sleeve portion (18) permits expansion of the stent (14). The mechanism (20) can include an inflatable, nondistending balloon (22) carried on the catheter (12), the stent (14) and the sleeve portion (18) being positioned over the balloon (22). The stent (14) can be self-expanding or can be expanded by the balloon (22) itself. Alternatively, the mechanism (20) can include a bulbous end (24) on the catheter (12).

Abstract: A radially expandable stent (10) made from a cannula or sheet of biocompatible material that includes at least one longitudinal segment (14) comprised of a series of laterally interconnected closed cells (13). Each closed cell of a longitudinal segment is defined laterally by a pair of longitudinal struts (15, 16) that are interconnected at each end by a circumferentially adjustable member (19, 20). When the stent is expanded using a balloon (47), the opposing circumferentially adjustable members deform to allow circumferential expansion of the longitudinal segment, while the length of the segment, as defined by the longitudinal struts, is maintained. Self-expanding versions of the stent utilize a nickel-titanium alloy. Adjacent longitudinal segments are joined by flexible interconnection segments (21) that permit the stent to bend laterally. The flexible interconnection segment is comprised of curvilinear struts (22, 23) that form a series of serpentine bends (81) that distribute lateral bending forces.