Abstract: A constraining sheath for use around an endoprosthesis (e.g., a stent device, with or without a graft covering), which may be a balloon expandable endoprosthesis but more preferably is a self-expanding prosthesis. The endoprosthesis is coaxially enclosed within the constraining sheath, which is an outer, disruptable, preferably implantable tubular sheath, preferably made of ePTFE. The constraining sheath and endoprosthesis are preferably mounted together as an assembly on an angioplasty balloon for delivery. Deployment of the endoprosthesis entails inflating the angioplasty balloon to a pressure sufficient to disrupt or break the constraining sheath in a prescribed fashion, thereby allowing a self-expanding endoprosthesis to spontaneously deploy. The constraining sheath of ePTFE may be attached to the endoprosthesis and implanted along with the device, or alternatively attached to the balloon catheter shaft and removed with the balloon catheter.

Abstract: A catheter provided with a guidewire catheter lumen having a thin covering that is easily punctured by a guidewire at virtually any desired point along the catheter length. The thin covering may be integral with the catheter shaft, or may be a separate component that covers only the portion of the catheter shaft immediately adjacent the outer portion of the guidewire lumen, or may be a thin tubular construct that surrounds the entire catheter shaft. The covering is preferably relatively translucent, allowing for good visualization of the location of the end of the guidewire to enable puncturing of the covering at the desired location along the length of the catheter shaft. The covering is also preferably tear resistant at puncture sites. The catheter shaft is preferably made of a material having a color that provides good visibility against an operating field, and more preferably is phosphorescent either entirely or in part.

Abstract: A catheter provided with an adjustable length guidewire catheter lumen, located proximal of a therapeutic device or agent positioned at the distal end of the catheter. The length of the adjustable length guidewire catheter lumen is controlled by the physician, allowing the benefits of both over-the-wire and rapid exchange systems to be provided in one catheter. The adjustable length is provided with a thin-walled tube that corrugates under axial compression. The tube may optionally be pre-corrugated or may be allowed to corrugate non-uniformly under the axial compression. The catheter length may change by, for example, over 100% of its original length between full axial compression and full axial extension.

Abstract: The present invention is directed to a deployment system for an endoluminal device. The deployment system includes a confining sheath placed around a compacted endoluminal device. A deployment line is provided in the system that is an integral extension of the sheath. As the deployment line is actuated, the sheath retracts from around the compacted endoluminal device. As the sheath retracts from around the endoluminal device, material from the sheath may be converted into deployment line. Once the sheath is retracted from around the compacted endoluminal device, the endoluminal device expands in configuration and repairs vascular or cardiac structures of an implant recipient. Any remaining sheath material is removed from the implantation site along with the deployment line. The deployment system also includes an endo-prosthesis mounting member placed between the endoluminal device and an underlying catheter.

Abstract: The present invention is directed to a deployment system for an endoluminal device. The deployment system includes a confining sheath placed around a compacted endoluminal device. A deployment line is provided in the system that is an integral extension of the sheath. As the deployment line is actuated, the sheath retracts from around the compacted endoluminal device. As the sheath retracts from around the endoluminal device, material from the sheath may be converted into deployment line. Once the sheath is retracted from around the compacted endoluminal device, the endoluminal device expands in configuration and repairs vascular or cardiac structures of an implant recipient. Any remaining sheath material is removed from the implantation site along with the deployment line.

Abstract: An improved embolic filter frame having looped support struts. The frame configuration provides enhanced longitudinal compliance, improved sealing against a vessel wall, low profile delivery, and a short deployed length. The looped support struts have a high degree of “radial” stiffness with a low degree of “longitudinal” stiffness. In the deployed state, the frame exerts a relatively high stress onto a vessel wall to maintain an effective seal, yet remains compliant in the longitudinal direction. Minor displacements of the support wire or catheter are therefore not translated to the filter. The looped support struts elongate when tensioned and assume a compressed and essentially linear form. While constrained in this linear state by a delivery catheter, the support struts exert minimal stress onto the delivery system. The overall delivery profile and stiffness are therefore reduced.

Abstract: A constraining sheath for use around an endoprosthesis (e.g., a stent device, with or without a graft covering), which may be a balloon expandable endoprosthesis but more preferably is a self-expanding prosthesis. The endoprosthesis is coaxially enclosed within the constraining sheath, which is an outer, disruptable, preferably implantable tubular sheath, preferably made of ePTFE. The constraining sheath and endoprosthesis are preferably mounted together as an assembly on an angioplasty balloon for delivery. Deployment of the endoprosthesis entails inflating the angioplasty balloon to a pressure sufficient to disrupt or break the constraining sheath in a prescribed fashion, thereby allowing a self-expanding endoprosthesis to spontaneously deploy. The constraining sheath of ePTFE may be attached to the endoprosthesis and implanted along with the device, or alternatively attached to the balloon catheter shaft and removed with the balloon catheter.

Abstract: The present invention is directed to a device that permits a permanent aperture to be formed in a wall, or other partition, of an implantable medical device. The present invention maintains the continuity and fluid-retaining properties of the implantable medical device by providing a breachable barrier material fully covering an opening delimited by a deformable framework. The invention is accessed with conventional interventional surgical instruments that disrupt and displace the barrier material. Following disruption of the barrier material, the opening is enlarged with surgical instruments to form a permanent framed aperture in the wall of the implantable medical device. The permanent framed aperture provides fluid communication across the wall of the implantable medical device.

Abstract: An improved stent design is disclosed that employs a series of helically oriented expansion elements encircling the stent. Each of the expansion elements includes a stepped pattern employing two distinct pitch angles. The expansion elements are oriented to cooperate with each other to form a series of virtual radially expandable rings that provide suitable outward force for proper stent function, but which are not connected together to form a continuous coherent ring if separated from the stent as a whole. In this manner, a distinctive stent design is provided that has numerous functional benefits over stents described in the prior art.

Abstract: A medical device provided with at least a partial surface coating of a thermoplastic copolymer of tetrafluoroethylene and perfluoroalkylvinylether that is free of cross-linking monomers and curing agents. The fluoropolymer coating is preferably an amorphous thermoplastic, is highly inert and biocompatible, has elastomeric characteristics that provide desirable mechanical properties such as good flexibility and durability. These characteristics allow the coating to be considered “functionally transparent” because it withstands mechanical deformations required for the assembly, deployment, expansion, and placement of medical devices, without any adverse effect on the mechanical and biological functionality of the coated device. Further, its inertness, derived from the perfluorocarbon structure, contributes to its functionally transparent nature.

Abstract: An endoprosthesis expansion system having, in combination, a delivery component such as a length of catheter tubing having at its distal end an intermediate sheath component, and an inner tube within the full length of the delivery catheter and intermediate sheath component. The inner tube has a protrusion affixed to its distal end, and an expandable endoprosthesis is fitted in a compacted state about the intermediate sheath, immediately proximal to the protrusion. If the endoprosthesis is a self-expanding endoprosthesis (as is preferred), an exterior constraining sheath is required around the outer surface of the endoprosthesis.

Abstract: The present invention is an improved endovascular device particularly useful for use in transjugular intrahepatic portosystemic shunt (TIPS) procedures. The device employs a two-part stent-graft construction that provides a low permeability membrane to line the shunt and an uncovered stent portion designed to reside in the portal vein. The device provides numerous benefits over previous stents and stent-grafts used in TIPS procedures, including being more compact to deliver, being easier to accurately deploy, a controlled compacted surface with tucked apices, an improved stent winding pattern, and being more flexible in delivery and use.

Abstract: A seamless, self-expanding implantable device having a low profile is disclosed along with methods of making and using the same. The implantable device includes a frame cut out of a single piece of material that is formed into a three-dimensional shape. The implantable device may comprise an embolic filter, stent, or other implantable structure. The present invention also allows complicated frame structures to be easily formed from planar sheets of starting material, such as through laser cutting, stamping, photo-etching, or other cutting techniques.

Abstract: The present invention is an improved endovascular device particularly useful for use in transjugular intrahepatic portosystemic shunt (TIPS) procedures. The device employs a two-part stent-graft construction that provides a low permeability membrane to line the shunt and an uncovered stent portion designed to reside in the portal vein. The device provides numerous benefits over previous stents and stent-grafts used in TIPS procedures, including being more compact to deliver, being easier to accurately deploy, a controlled compacted surface with tucked apices, an improved stent winding pattern, and being more flexible in delivery and use.

Abstract: Large diameter self-expanding endoprosthetic devices, such as stents and stent grafts for delivery to large diameter vessels, such as the aorta, are disclosed having very small compacted delivery dimensions. Devices with deployed dimensions of 26 to 40 mm or more are disclosed that are compacted to extremely small dimensions of 5 mm or less, enabling percutaneous delivery of said devices without the need for surgical intervention. Compaction efficiencies are achieved by combining unique material combinations with new forms of restraining devices, compaction techniques, and delivery techniques. These inventive devices permit consistent percutaneous delivery of large vessel treatment devices. Additionally, small endoprosthetic devices are disclosed that can be compacted to extremely small dimensions for delivery through catheter tubes of less than 1 mm diameter.

Abstract: A constraining sheath for use around an endoprosthesis (e.g., a stent device, with or without a graft covering), which may be a balloon expandable endoprosthesis but more preferably is a self-expanding prosthesis. The endoprosthesis is coaxially enclosed within the constraining sheath, which is an outer, disruptable, preferably implantable tubular sheath, preferably made of ePTFE. The constraining sheath and endoprosthesis are preferably mounted together as an assembly on an angioplasty balloon for delivery. Deployment of the endoprosthesis entails inflating the angioplasty balloon to a pressure sufficient to disrupt or break the constraining sheath in a prescribed fashion, thereby allowing a self-expanding endoprosthesis to spontaneously deploy. The constraining sheath of ePTFE may be attached to the endoprosthesis and implanted along with the device, or alternatively attached to the balloon catheter shaft and removed with the balloon catheter.

Abstract: An improved device for use in a conduit, such as a blood vessel, is provided. The device uniquely combines desirable properties from two distinct previous devices. The device of the present invention assumes and is constrained to a first diametrical dimension for insertion into the conduit. Once inserted and properly positioned in the conduit the device expands to a second diametrical dimension within the conduit when the constraint is removed. The device can then be dilated to one or more enlarged third diametrical dimensions by using a balloon catheter or similar device. The result is a device that provides desirable properties of both self-expanding stents and balloon-expandable endoprostheses. The device can be employed in a variety of applications.

Abstract: An improved device for use in a conduit, such as a blood vessel, is provided. The device uniquely combines desirable properties from two distinct previous devices. The device of the present invention assumes and is constrained to a first diametrical dimension for insertion into the conduit. Once inserted and properly positioned in the conduit the device expands to a second diametrical dimension within the conduit when the constraint is removed. The device can then be dilated to one or more enlarged third diametrical dimensions by using a balloon catheter or similar device. The result is a device that provides desirable properties of both self-expanding stents and balloon-expandable endoprostheses. The device can be employed in a variety of applications.

Abstract: A system and method for performing balloon angioplasty treatment on a patient. The system includes a catheter for insertion into an artery of the patient, a balloon coupled to the catheter with the balloon expandable by fluid passed through the catheter in order to apply pressure to plaque lesions deposited on vascular tissue of the artery. The balloon includes a PVDF piezoelectric transducer for sensing acoustic emission signals generated by deformation of the plaque lesions and the vascular tissue. The acoustic emission signals can be analyzed by frequency analysis, time domain analysis and wavelet analysis followed by neural net correlation evaluation.

Abstract: This invention relates to tissue specific acoustically reflective oligolamellar liposomes containing internally separated bilayers and methods to make and to use the same, alone as a perfusion ultrasonic contrast agent or conjugated to a ligand for tissue-specific ultrasonic image enhancement.