摘要:
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. The amount of the cross-linking reactant is selected to avoid the formation of gelling during the process by which the balloon (18) is made, and the amount of the cross-linking agent and the irradiation fluence are selected to give the balloon a strength generally about equal to that which would be obtained by mere irradiation.
摘要:
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. In a preferred embodiment, a short strut interconnects longitudinal segments and an adjacent interconnection segment. Each interconnection strut attaches to the longitudinal segment within a region (27) at the end (17) of a longitudinal strut (15) dividing two adjacent closed cells.
摘要:
Balloon catheters, and methods of treatment therewith, are provided including an inflatable first balloon at least partially enclosed by an expandable second balloon that has holes. The annular space between the first balloon and the second balloon is configured to promote delivery of the fluid evenly through holes in the second balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The first balloon may have various configurations including being tapered relative to the second balloon. The second balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.
摘要:
A balloon catheter is provided to minimize curving of the balloon when the balloon is expanded with an inflation media. The balloon catheter has an elastic inner shaft that stretches longitudinally as inflation pressure in the balloon is increased. The balloon catheter may also have an inner shaft with a portion that is corrugated to allow longitudinal stretching of the inner shaft.
摘要:
Balloon catheters, and methods of treatment therewith, are provided including an inflatable first balloon at least partially enclosed by an expandable second balloon that has holes. The annular space between the first balloon and the second balloon is configured to promote delivery of the fluid evenly through holes in the second balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The first balloon may have various configurations including being tapered relative to the second balloon. The second balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.
摘要:
Multiple-balloon catheters, and methods of treatment therewith, are provided including an inflatable inner balloon at least partially enclosed by an expandable outer balloon that has holes. The annular space between the inner balloon and the outer balloon is configured to promote delivery of the fluid evenly through holes in the outer balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The inner balloon may have various configurations including being tapered relative to the outer balloon. The outer balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.
摘要:
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.
摘要:
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. The amount of the cross-linking reactant is selected to avoid the formation of gelling during the process by which the balloon (18) is made, and the amount of the cross-linking agent and the irradiation fluence are selected to give the balloon a strength generally about equal to that which would be obtained by mere irradiation.
摘要:
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. The cross-linking reactant can also be diallyl phthalate or meta-phenylene dimaleimide.
摘要:
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). Longitudinal movement of the bulbous catheter end (24) with respect to the sleeve (16) splits at least the sleeve portion (18), permitting expansion of the stent (14). As further alternatives, the mechanism (20) can include a garrote (66) connected to the sleeve or a partial segment (62) of the sleeve (16) folded back alongside the stent (14). The sleeve (16) can be the same length as the catheter (12) or can be shorter than the catheter (12). In the former case, the mechanism (20) can include a pair of graspable wings (56) for splitting the full length of the sleeve (16). It is preferred that at least the portion (18) of the sleeve (16) extending over the stent (14) includes a longitudinally extending structure 46 for ensuring that the sleeve portion (18) will in fact split upon operation of the mechanism (20).