Abstract: A method of forming a medical device, the method including the steps of providing a substrate, depositing a metallic layer on the substrate by a vapor deposition process, and removing the metallic layer from the substrate. The metallic layer thus removed is the medical device or serves as a basis for forming the medical device. In another aspect, the present invention includes a medical device formed by the process of the present invention.

Abstract: An intravascular catheter that exhibits the combined features of superior flexibility, softness, radiopacity and oval/kink resistance. The catheter includes an elongate shaft having a proximal region, a distal region and a lumen extending therethrough. The proximal region of the shaft includes an inner lubricious polymer layer, a reinforcement layer and an outer layer. The reinforcement layer comprises a braid having one or more metallic members and a plurality of polymer members wherein each polymer member comprises a plurality of monofilaments, preferably formed of LCP. The polymer members of the braid provide improved flexibility and softness in addition to high burst pressure. The metallic member(s) of the braid provide improved radiopacity and oval/kink resistance. The catheter may also include a longitudinal member extending along the reinforcement layer.

Abstract: A coaxial cable (coax) has successive layers of a hollow non-conductive inner core, a conductive inner layer, an insulating layer, a conductive outer layer, and a non-conductive outer layer.

Abstract: The present invention provides ultrasound-guided ablation catheters and methods for their use. In one embodiment, a tissue ablation apparatus (2) includes a flexible elongate body (12) having proximal (14) and distal (12) ends. A plurality of spaced-apart electrodes (24) are operably attached to the flexible body near the distal end. A plurality of transducer elements (28) are disposed between at least some of the electrodes. Transducers assist the physician in determining whether or not the ablation elements are in contact with the tissue to be ablated.

Abstract: A method and device for improving blood circulation to an area of interest within a patient' heart is described. The method comprises inserting a guidable elongated flexible ultrasound device into a patient's vasculature, applying ultrasonic energy to an area in need of improved circulation, and injecting materials such as angiogenic materials or contrasting agents into the area of interest. The device, suitable for performing the method, comprises an elongated tubular body, a distal head of the elongated tubular body for introducing ultrasonic energy to an area of interest, and a needle to deliver materials to an area of interest.

Abstract: A reinforced intravascular catheter adapted for use in performing minimally invasive medical procedures. A catheter, in accordance with the present invention, comprising an inner tubular member having an outer surface, a proximal end, a distal end, and a lumen extending therethrough. The catheter further including a support member overlaying the inner tubular member and conforming to the outer surface thereof, the support member including at least one filament forming a plurality of turns. The support member further including at least one multi-layered portion having a first layer and a plurality of additional layers, each layer comprising a plurality of turns formed by at least one filament, the plurality of additional layers each overlaying at least the first layer. The catheter also including an outer layer overlaying both the support member and the inner tubular member. A method of fabricating a catheter in accordance with the present invention is also disclosed.

Abstract: This is an implant for placement in the human body and an assembly for so placing that implant. Most desirably, it is an implant for use in the vasculature of the human body and is used to occlude some space in that vasculature as a portion of a treatment regimen. The implant itself is preferably a component of a deployment device using an electrolytically severable joint. The implant is electrically isolated from the electrolytically severable joint by a highly resistive or insulative layer. Such isolation and minimization of the conductive pathway from the placement apparatus to the body's fluids appears to enhance the susceptibility of the electrolytic joint to quick erosion and detachment of the implant from the deployment media. Although the implant itself is preferably a vaso-occlusive device, it may instead be a stent, a vena cava filter, or other implant which may be installed in this manner.

Abstract: An improved vascular introducer sheath having a hemostasis valve assembly which provides tailored distribution of compressive forces along one of the top and bottom edges of each slit to avoid puckering of the slit(s) and to provide balanced performance in terms of bi-directional sealing effectiveness and device movement therethrough.

Abstract: An assembly for delivery and deployment of an inflation expandable stent within a vessel is comprised of a catheter, an inflation expandable stent, an expandable balloon, and a securement device such as a corrugated tube component or an expandable tube component. The tube component is mounted on the inner shaft beneath the balloon and provides increased securement to the stent in a reduced delivery diameter to maintain the stent on the catheter during delivery to the deployment site. The tube component is adhered to the inner shaft and has a plurality of ribs or is fluid expandable to no more than the delivery diameter, and may be comprised of more than one separately inflatable pouch expandable to provide the stent with a substrate seat with increased friction and to decrease the slack in stent recoil crimping. The assembly is used in a method for delivering and deploying a stent, and also adds safety when loading/crimping the stent onto a balloon.

Abstract: A stent for reinforcement of the lumen of a peristaltic organ is formed by knitting preferably a nitinol wire into a pattern of overlapping loops selected such that from a relaxed state each row of loops may shift axially relative to and independently of the rows on either side. This local lengthening and shortening accommodate peristalsis of the organ without migrating within the organ. A stent is also shown which comprises two resilient cylindrical mesh layers and a semi-permeable compliant membrane such as expanded polytetrafluoroethylene, sandwiched between. The two mesh layers may be knit of a flexible filament, and the knit may be configured so that the stent can adapt to peristalsis of the body lumen. A method is also shown of manufacturing a delivery system for a resilient tubular device such as a stent so that the device can be inserted into the body in a substantially reduced diameter. The method uses a confining block having a bore and a slot leading into the bore.

Abstract: Disclosed herein is an implantable or insertable therapeutic agent delivery device comprising a coating material provided on at least a portion of said device, said coating material prohibiting substantial release therefrom of a therapeutic agent at or below about a physiological pH and allowing substantial release therefrom of a therapeutic agent at or above about said physiological pH. Also disclosed herein are coating materials for the implantable or insertable therapeutic agent delivery device. The coating materials are preferably polymers derivatized to contain moieties that are cationically charged at a pH below their pKa values and which thus can attract negatively charged therapeutically agents at pH values below their pKa values and which become predominantly uncharged at pH values above about their pKa values and thus substantially release the negatively charged therapeutic agents at such pH values, which are preferably about physiological pH.

Abstract: A stent may be constructed comprising a plurality of interconnected circumferential bands each bands comprising a plurality of concave and/or convex M-shaped segments joined together by loops.

Abstract: An improved ePTFE material and method of preparing the improved ePTFE material provides a tubular structure with enhanced axial elongation, radial expansion, and physical recovery characteristics.

Abstract: An intravascular catheter having a multi-layered distal tip including an inner layer, an intermediate layer and an outer layer wherein the intermediate layer is formed of a polymeric material loaded with a high percentage of radiopaque agent, and the inner and outer layers are formed of readily bondable materials which substantially cover the intermediate layer to thereby increase surface area contact and bond strength therebetween.

Abstract: A catheter is disclosed providing a balloon catheter having a distal tip that is flexible while additionally incorporating high column strength. The present invention additionally provides a distal tip region that accommodates for various sized guidewires. In preferred embodiments, the distal tip region is initially configured for accommodating the passage of 0.12-inch guidewires only. Through specific manufacturing processes, however, the distal tip is modified so that it also may be expanded to accommodate the passage of 0.14-inch guidewires. In additional preferred embodiments, an elastomeric sleeve is disposed over the modified distal tip to allow the tip to return to the initial 0.12-inch accommodating profile when the larger 0.

Abstract: Distal catheter assemblies, catheters, and methods for minimizing damage to heat and/or magnetically sensitive components are provided. A distal catheter assembly comprises a composite housing having a cavity formed therein and first and second complementary lateral housing sections. A first component, e.g., a sensor, is mounted within the first housing section. Optionally, a second component, e.g., a steering assembly or RF wire, can also be mounted to the first housing section. The open housing section allows the first and second components to be mounted in any order. Thus, if the first component is mounted last, any adverse effects on the first component that may otherwise result from mounting the components in the reverse order may be minimized. After the first and second components are mounted, the first and second housing sections are affixed to each other in a suitable manner, e.g., by using a pin and hole arrangement.

Abstract: An elongate polymer member having molecular helical orientation formed by rotation immediately after passing through the extrusion head. The elongate polymer member is rotated downstream of the extrusion head in the molten state prior to solidification in order to impart the molecular helical orientation. Rotating the polymer member in the molten state allows the helical orientation to be imparted at the molecular level, and allows for more rotations per lineal foot of extrusion.

Abstract: Distal catheter assemblies, catheters, and methods for minimizing damage to heat and/or magnetically sensitive components are provided. A distal catheter assembly comprises a distal housing having a cavity and a separate proximal mounting member. A first component, e.g., a sensor, is mounted within the cavity of the housing, and a second component, e.g., a steering assembly or RF wire, is mounted to the proximal mounting member. If the proximal mounting member is hollow, it may have a window to provide access to the inner surface of the proximal mounting member to facilitate mounting of the second component. After the first and second components are mounted, the proximal mounting member can then be affixed to the distal housing, thereby minimizing any adverse affects on the sensitive component that may otherwise result from mounting the first and second components on a single member.

Abstract: A tubular extruded member particularly suitable for use in medical devices such as intravascular catheters and guide wires, wherein the extruded tubular member includes multiple layers having biaxial helical orientation in different directions. A counter-rotation extrusion process may be used to orient the layers in different biaxial helical directions. The counter-rotation extrusion process provides orientation in two different circumferential directions in addition to a longitudinal direction. By combining the dual direction or biaxial helical orientation with multiple layers, different layers of the tubular member may be tailored to have the desired mechanical properties.

Abstract: A thin-walled reinforced catheter shaft having polymers that are reinforced with a variable wire size radiopaque braid which maintains the thin-wall of the shaft while providing improved properties in terms of radiopacity, kink resistance, tortional rigidity, column strength and burst strength.