Abstract:
Porous fluoropolymer films, such as PTFE films, formed by a method comprising the steps of (a) forming a fluoropolymer (e.g., PTFE) paste (10), (b) extruding, calendaring, or otherwise processing the paste to form a film extrudate (12), (c) causing the film extrudate to be calendared in a first directional axis (14), (d) subsequently calendaring the film extrudate in a second directional axis which is different form the first directional axis (16), (e) subsequently calendaring the film extrudate in at least one additional direction axis which is different from said first and second directional axes, thereby forming a multiaxially calendared film extrudate (18), (f) drying the multiaxially calendared film extrudate (20), and (g) radially expanding the multiaxially calendared film extrudate (22) to form a radially oriented fluoropolymer (e.g., PTFE) film. The porous fluoropolymer films formed by this method are multiaxially oriented and exhibit isotropic strength properties.
Abstract:
A method for improving the radial enlargeability and other properties of tape-reinforced tubular vascular graft formed of sintered fluoropolymer(s), such as expanded, sintered PTFE. Broadly, the method comprises the step of radially shrinking the reinforcement tape layer of the graft, or the entire tape-reinforced graft, after sintering thereof. Such radial shrinkage of the reinforcement tape layer, or of the entire graft, renders the graft subsequently radially enlargeable by more than 5 %, without tearing or breaking of the reinforcement tape layer of the graft. Radially enlargeable grafts of the present invention may be combined with various types of stents or anchoring systems, to form endovascular graft devices which are transluminally insertable and implantable within the lumen of a host blood vessel. Alternatively, radially enlargeable grafts of the present invention may be implanted by way of traditional surgical graft implantation techniques, without any radial enlargement of the graft at the time of implantation, so as to take advantage of the improved strength properties and suture-holding properties of the radially-shrunken tape-reinforced grafts of the present invention.
Abstract:
An externally supported, tape-reinforced tubular prosthetic graft and method of manufacturing therefore. The graft comprises a tubular base graft formed of expanded, sintered fluoropolymer material, a strip of reinforcement tape helically wrapped about the outer surface of the tubular base graft and attached thereto, and, an external support member helically wrapped around the outer surface of the reinforcement tape and attached thereto. The helical pitch of the reinforcement tape is different from the helical pitch of the external support member. Preferably, the helical pitch of the reinforcement tape is in a direction which is opposite the direction of the external support member.
Abstract:
A method for preparing thin fluoropolymer (PTFE) films, said method generally comprising the steps of: a) providing an unsintered fluoropolymer film; b) pre-sintering expansion of the film; c) sintering the expanded film with dimensional restraint to prevent shrinkage; and d) post-sintering stretching of the film to a final thickness preferably less than 0.002 inches. The post-sintering stretching of the film in step d may be accomplished in a single step, or may comprise a series of post-sintering stretching steps. Steps b and c of the method may be carried out by passing the calendared film through a machine direction orienter device and, thereafter, step d of the method may be accomplished by subsequently repassing the sintered film through the machine direction orienter device, one or more additional times.
Abstract:
Porous fluoropolymer films, such as PTFE films, formed by a method comprising the steps of (a) forming a fluoropolymer (e.g., PTFE) paste (10), (b) extruding, calendaring, or otherwise processing the paste to form a film extrudate (12), (c) causing the film extrudate to be calendared in a first directional axis (14), (d) subsequently calendaring the film extrudate in a second directional axis which is different form the first directional axis (16), (e) subsequently calendaring the film extrudate in at least one additional direction axis which is different from said first and second directional axes, thereby forming a multiaxially calendared film extrudate (18), (f) drying the multiaxially calendared film extrudate (20), and (g) radially expanding the multiaxially calendared film extrudate (22) to form a radially oriented fluoropolymer (e.g., PTFE) film. The porous fluoropolymer films formed by this method are multiaxially oriented and exhibit isotropic strength properties.
Abstract:
A method for preparing thin fluoropolymer (PTFE) films, said method generally comprising the steps of: a) providing an unsintered fluoropolymer film; b) pre-sintering expansion of the film; c) sintering the expanded film with dimensional restraint to prevent shrinkage; and d) post-sintering stretching of the film to a final thickness preferably less than 0.002 inches. The post-sintering stretching of the film in step d may be accomplished in a single step, or may comprise a series of post-sintering stretching steps. Steps b and c of the method may be carried out by passing the calendared film through a machine direction orienter device and, thereafter, step d of the method may be accomplished by subsequently repassing the sintered film through the machine direction orienter device, one or more additional times.
Abstract:
An externally supported, tape-reinforced tubular prosthetic graft and method of manufacturing therefore. The graft comprises a tubular base graft formed of expanded, sintered fluoropolymer material, a strip of reinforcement tape helically wrapped about the outer surface of the tubular base graft and attached thereto, and, an external support member helically wrapped around the outer surface of the reinforcement tape and attached thereto. The helical pitch of the reinforcement tape is different from the helical pitch of the external support member. Preferably, the helical pitch of the reinforcement tape is in a direction which is opposite the direction of the external support member.
Abstract:
A method for improving the radial enlargeability and other properties of tape-reinforced tubular vascular graft formed of sintered fluoropolymer(s), such as expanded, sintered PTFE. Broadly, the method comprises the step of radially shrinking the reinforcement tape layer of the graft, or the entire tape-reinforced graft, after sintering thereof. Such radial shrinkage of the reinforcement tape layer, or of the entire graft, renders the graft subsequently radially enlargeable by more than 5 %, without tearing or breaking of the reinforcement tape layer of the graft. Radially enlargeable grafts of the present invention may be combined with various types of stents or anchoring systems, to form endovascular graft devices which are transluminally insertable and implantable within the lumen of a host blood vessel. Alternatively, radially enlargeable grafts of the present invention may be implanted by way of traditional surgical graft implantation techniques, without any radial enlargement of the graft at the time of implantation, so as to take advantage of the improved strength properties and suture-holding properties of the radially-shrunken tape-reinforced grafts of the present invention.