Abstract:
Multilayer balloon for a catheter comprises a first layer made of a first polymer material having a first Shore durometer hardness, a second layer made of a second polymer material having a second Shore durometer hardness greater than the first Shore durometer hardness, wherein the second layer is an inner layer relative to the first layer, and a third layer made of a third polymer material having a third Shore durometer hardness less the first Shore durometer hardness, wherein the third layer is an inner layer relative to the second layer. Method of making a multilayer balloon for a catheter and a balloon catheter are also provided.
Abstract:
Methods for forming a “coating gradient” on medical devices, such as a balloon catheter or guidewire are disclosed. The balloon portion of the catheter has a protective covering initially placed over it to prevent the balloon from receiving a first hydrophilic coating. After a first hydrophilic coating is applied, the protective covering is removed. A second hydrophilic coating could be applied to the catheter. A guidewire having less lubricity at the distal end portion also can be created. A first hydrophilic coating is applied to the elongated shaft and distal shaft section of the guidewire. After the first hydrophilic coating cures, the first hydrophilic coating is removed from a portion of the distal shaft section of the guidewire. A second hydrophillic coating can then be applied to the elongated shaft and distal shaft section of the guidewire. The second hydrophilic coating can be allowed to cure.
Abstract:
Balloon catheter includes an outer shaft including a hypotube and a monolithic multilayer distal outer member and having an inflation lumen defined therethrough, a balloon in fluid communication with the inflation lumen, and an inner tubular member having a guidewire lumen defined therethrough. The monolithic multilayer distal outer member has a proximal end portion and a distal end portion. The monolithic multilayer distal outer member has an inner layer comprising a first polymer having a tensile strength greater than about 8,000 psi and an outer layer comprising a second polymer having a flexural modulus of less than about 130,000 psi at room temperature. A proximal end of the monolithic multilayer distal outer member is coupled to the hypotube. The monolithic multilayer distal outer member is necked to a reduced diameter along at least a portion of a length thereof. The balloon has a proximal balloon shaft coupled to a distal end of the monolithic multilayer distal outer member. The inner tubular member extends distally from a proximal port in the proximal end portion of the monolithic multilayer distal outer member through at least a portion of the balloon.
Abstract:
A balloon catheter having a soft distal tip member having a non-tacky inner (liner) layer material and a soft flexible outer layer material, with both materials being readily thermally bondable to the catheter balloon.
Abstract:
A balloon catheter having a soft distal tip member having a non-tacky inner (liner) layer material and a soft flexible outer layer material, with both materials being readily thermally bondable to the catheter balloon.
Abstract:
Methods for forming a “coating gradient” on medical devices, such as a balloon catheter or guidewire are disclosed. The balloon portion of the catheter could have a protective covering initially placed over it to prevent the balloon from receiving a first hydrophilic coating. After a first hydrophilic coating is applied to the catheter, the protective covering can be removed exposing the uncoated surface of the balloon. Next, after the protective covering has been removed, a second hydrophilic coating could be applied to the catheter. A guidewire having less lubricity at the distal end portion of the guidewire than the shaft portion which extends proximally away from the distal end section can be created. The method includes the application of a first hydrophilic coating on the elongated shaft and distal shaft section of the guidewire. This first hydrophilic coating is then allowed to cure. Next, the first hydrophilic coating is removed from a portion of the distal shaft section of the guidewire. After the first coating has been removed, a second hydrophillic coating can be applied to the elongated shaft and distal shaft section of the guidewire. The second hydrophilic coating can be allowed to cure.
Abstract:
A balloon catheter having a soft distal tip member having a non-tacky inner (liner) layer material and a soft flexible outer layer material, with both materials being readily thermally bondable to the catheter balloon.
Abstract:
Balloon catheter includes an outer shaft including a hypotube and a monolithic multilayer distal outer member and having an inflation lumen defined therethrough, a balloon in fluid communication with the inflation lumen, and an inner tubular member having a guidewire lumen defined therethrough. The monolithic multilayer distal outer member has a proximal end portion and a distal end portion. The monolithic multilayer distal outer member has an inner layer comprising a first polymer having a tensile strength greater than about 8,000 psi and an outer layer comprising a second polymer having a flexural modulus of less than about 130,000 psi at room temperature. A proximal end of the monolithic multilayer distal outer member is coupled to the hypotube. The monolithic multilayer distal outer member is necked to a reduced diameter along at least a portion of a length thereof. The balloon has a proximal balloon shaft coupled to a distal end of the monolithic multilayer distal outer member. The inner tubular member extends distally from a proximal port in the proximal end portion of the monolithic multilayer distal outer member through at least a portion of the balloon.
Abstract:
Method for fabricating a balloon catheter including providing an inner tubular member having a distal section and a distal end with a lumen extending therein and forming a balloon having a distal leg with a first segment having a first diameter and a first wall thickness and a second segment having a second wall thickness. The second diameter is greater than the first diameter and the first wall thickness is greater than the second wall thickness. The distal end section of the inner tubular member can be positioned in the balloon and bonded to the first segment while reducing the diameter of the second segment. Method also provided for fabricating a multilayer balloon catheter including removing at least a portion of an outer layer from the distal leg of the balloon.
Abstract:
Elongate, flexible catheter includes an elongated shaft having a proximal end, a distal end, and a lumen defined therein. The shaft includes a tubular member having an outer layer and an inner layer. The outer layer includes a first polymer selected from the group consisting of nylon 12, polyether block amide, and combinations thereof. The inner layer includes a second polymer having a heat deflection temperature greater than about 53° C. selected from the group consisting of nylon 11, nylon 6, nylon 6,6, nylon 6,12, polyamide-imide, polyetherimide, polypropylene, polyethylene terephthalate, polybutylene terephthalate, polyethereetherketone, and combinations thereof. Method of making an elongate, flexible catheter is also provided.