Abstract: A balloon catheter assembly (10) includes a balloon structure (20) formed of an inner balloon (40) and an outer balloon (70) which entirely envelops the inner balloon (40). The inner balloon (40) can be filled with air or other echogenic fluid and inflates to a diameter substantially less than the inflated diameter of the outer balloon (70), typically to a diameter of no more than 50% of the inflated diameter of the outer balloon (70). The inner balloon (40) can be inflated with air or other echogenic fluid, enabling the balloon structure (20) to be visible under ultrasonic imaging. The inner balloon (40) is protected within the outer balloon (70) and is shorter than the outer balloon (70). The assembly (10) can be used for PTA procedures, for deploying an implantable medical device or for other medical applications.

Abstract: A balloon catheter is provided for dilating hardened stenoses. The balloon catheter has dilation elements integrally formed on the outer surface of the balloon. The dilation elements have cross-sectional shapes that improve the performance of the balloon catheter.

Abstract: A cutting or scoring balloon (10) of elongate shape and provided at its periphery with a plurality of scoring elements (12) extending longitudinally along the balloon. The scoring elements (12) are formed integrally with the balloon wall (14) and in the preferred embodiment are of the same material. A raw material form (20) for producing the balloon (10) is provided with a series of zones (26, 28) of greater thickness compared to the remainder of the balloon wall (24). These zones (26, 28) are located adjacent respective ribs (22) and extend longitudinally along the balloon wall for substantially the same distance as the ribs (22). The zones (26, 28) ensure that these will expand (stretch) preferentially compared to the remainder of the raw material form (20) and in particular the ribs (22), with the effect that the ribs (22) will not tend to be stretched.

Abstract: A medical balloon assembly includes a balloon fitted to a balloon catheter. The balloon includes a balloon wall (which is a co-extrusion) with ribs or strengthening elements including amorphous polymer material.

Abstract: A medical balloon for a balloon catheter is described. The balloon has at least a first layer made from a first material and a second layer made from a second material, said first and second layers being in overlying relationship with one another and being integral with one another; wherein the first layer has a softening or melting temperature which is higher than a softening or melting temperature of the second layer. A method of forming the medical balloon is also described, including locating a raw tubing in a mold; preheating and inflating the raw tubing so as to cause it to stretch; heating the raw tubing to soften or melt the second layer; setting the inflated raw tubing to form the medical balloon; and cooling the set balloon.

Abstract: A balloon catheter is provided for dilating hardened stenoses. The balloon catheter has dilation elements integrally formed on the outer surface of the balloon. The dilation elements have cross-sectional shapes that improve the performance of the balloon catheter.

Abstract: A wire guide for feeding a medical catheter through the body passage of a patient to a distant target site within the body has a variably flexible distal portion. The distal portion facilitates threading the guidewire in a tortuous path through acute bends at branch junctions in the body passages of the patient. The wire guide end is able to feed into very delicate vessels such as ventricles of the brain and the spinal canal without puncturing the wall or damaging organs.

Abstract: An introducer assembly (10) includes a balloon catheter (12) for deploying a medical device (19) in a body lumen or for dilating a body lumen at a range of diameters from a minimum deployment diameter to a maximum deployment diameter. The balloon catheter includes an outer balloon (42) and an inner balloon (40) located within the outer balloon (42). The outer balloon (42) has an unstretched diameter equivalent to the minimum deployment diameter and the inner balloon (40) has an unstretched diameter equivalent to the maximum deployment diameter. The outer balloon (42) is made of an elastic material able to stretch from the minimum deployment diameter to the maximum deployment diameter, while the inner balloon (40) is preferably of an non-compliant material.

Abstract: A medical balloon (30) includes a balloon wall (60) in a plurality of strips (50) of amorphous polymer material. The strips (50) may be textured, for example roughened, or shaped. The texturing or shaping of the strips (50) is retained upon inflation of the balloon (30) to inflation pressures, producing a structure which will ensure reliable positioning of the balloon (30) in a vessel and reliable retention of a medical device on the balloon. Moreover, the strips (50) can increase the tear resistance of the balloon (30) in particular can prevent the propagation of circumferential tears around the balloon (30).

Abstract: A drug delivery device (10) includes expandable element (12) formed of a braided structure having a body portion (16) and first and second end cones (18, 20). The end cones are attached at their necks (22, 24) to a catheter assembly (14). The expandable element (12) can expand to a vessel contacting configuration, in which the body portion (16) contacts the vessel wall. Bioactive agent (28) covers at least the outer surface of the body portion (16) such that bioactive material can be administered to a vessel wall. The end cones (18, 20) have an open structure allowing unrestricted passage of blood through the device (10) in the deployed configuration, such that blood flow can be maintained during the administration of bioactive agent (28) from the device (10). The expandable element (12) can be radially contracted by extending it in the longitudinal direction, both for deployment endoluminally to the treatment site and also for retrieval following the administration of the bioactive material.

Abstract: A catheter or sheath includes an inner layer made of a relatively hard material, an intermediate layer formed of a strengthening member and being provided with interstitial material in the spaces between the elements of the strengthening member. Overlying the intermediate layer is an outer layer of, for example, polyamide. The interstitial material is relatively soft, which allows the catheter to be bent to smaller radii of curvature than prior art catheters with reduced risk of kinking.

Abstract: There are disclosed various dispensing mechanisms for dispensing filamentary material (24) through a catheter (12) into a treatment site of a patient, for example into an aneurysm sack (20) in a patient's vessel (22). In one embodiment the assembly (100) includes a conical material carrier (150) which is substantially aligned with the dispensing direction, thereby avoiding the need to have a rotating carrier. Another embodiment has a carrier (340) which is at least partially cylindrical. The carrier (150, 340) provides for efficient dispensation of filamentary material at substantial dispensing speeds.

Abstract: There are disclosed various dispensing mechanisms for dispensing filamentary material (24) through a catheter (12) into a treatment site of a patient, for example into an aneurysm sack (20) in a patient's vessel (22). In one embodiment, the dispensing assembly (30) includes a chamber having a spherical carrier (50) onto which filamentary material (24) is wound. Upon injecting driving fluid into the dispensing assembly (30) filamentary material (24) unwinds from the spherical carrier (50) and is pulled through the catheter (12) to be dispensed from the distal end (18) of the catheter.

Abstract: A non-compliant high strength balloon (10) includes a reinforcement member (30) formed of a sleeve of woven or braided strengthening elements (32, 34). There are provided circumferential strengthening elements (32) which are pre-tensed in order to remove any undulations within the strengthening elements (32) and to ensure that these have a precise annular size. On the other hand, the longitudinal strengthening elements (34) have undulations therein. The pre-tensing of the strengthening elements (32) ensures that the balloon will not stretch during pressurization thereof, which can occur when the circumferential strengthening elements have undulations therein, which will be natural artefacts of a weaving or braiding process. The undulations in the longitudinal strengthening elements (34) provides the balloon with increased longitudinal flexibility.

Abstract: A balloon catheter assembly comprises a balloon having attached to or in its wall one or more filar elements, extending from one end of the balloon to the other. The filar elements are made of a material which is at least as flexible as the material forming the walls of the balloon. In the event of circular burst of the balloon, the filar element(s) prevent disconnection of the material of the balloon into two or more separate pieces. The filar element(s) become attached to or in the material of the balloon wall when the raw material is inflated to the shape of a mold. The filar elements may comprise a natural fiber, a synthetic fiber or a metal wire.

Abstract: A delivery system includes an inflatable delivery balloon formed with a plurality of constraining elements which create constrained regions in a body portion of the balloon, interposed between unconstrained regions. The constrained regions create recesses for receiving a medical device or part of a medical device. The constraining elements are preferably formed by woven or braided material, advantageously embedded within the wall of the inflatable balloon. The constraining elements provide a structure that will not flatten upon inflation of the balloon and also a structure which can readily be folded or wrapped for endoluminal delivery purposes, and which retains flexibility of the delivery device.

Abstract: In at least one embodiment of the present invention a balloon catheter is provided. The balloon catheter comprises a shaft having a lumen formed therethrough. Connected to the shaft is an inflatable balloon. The inflatable balloon has a balloon wall defining a balloon interior surface and a balloon exterior surface that is opposite the interior surface. In fluid communication with the balloon wall is the lumen for inflating the balloon to define an inflated state and for collapsing the balloon to define a deflated state. The balloon wall is textured in the deflated state such that the balloon interior surface is spatially registered with the balloon exterior surface. The balloon in the inflated state is tensioned to have a surface roughness substantially less than a surface roughness of the balloon in the deflated state.

Abstract: A balloon catheter is provided that may be used to dilate hardened regions of a stenosis on a vessel wall. The balloon catheter is provided with cutting elements that extend along a surface of a balloon. At least one bioactive is present, either on the cutting element, within the interior of the balloon, within the material of the balloon or on an outside surface of the balloon. The bioactive is delivered to the vessel wall upon dilation of the balloon.

Abstract: In at least one embodiment of the present invention a balloon catheter is provided. The balloon catheter comprises a shaft having a lumen formed therethrough. Connected to the shaft is an inflatable balloon. The inflatable balloon has a balloon wall defining a balloon interior surface and a balloon exterior surface that is opposite the interior surface. In fluid communication with the balloon wall is the lumen for inflating the balloon to define an inflated state and for collapsing the balloon to define a deflated state. The balloon wall is textured in the deflated state such that the balloon interior surface is spatially registered with the balloon exterior surface. The balloon in the inflated state is tensioned to have a surface roughness substantially less than a surface roughness of the balloon in the deflated state.

Abstract: The technical disclosure relates to catheters useful for engaging a vessel from within a lumen defined by the vessel. A catheter includes an elongate shaft, an inflatable balloon disposed on the distal end of the elongate shaft, a guide disposed on the external surface of the balloon, and an engaging member having a distal end releasably secured by the guide such that the guide maintains the engaging member distal end adjacent the outer surface of the balloon when the balloon is in an uninflated configuration but releases the engaging member distal end as the balloon moves from an uninflated configuration to an inflated configuration. The technical disclosure also relates to methods of using a catheter.