Abstract: The present invention provides medical devices comprising nanocomposite materials. By utilizing nanocomposites in the production thereof, the inventive medical devices can be produced with various advantageous properties. Methods of producing the inventive medical devices are also provided. Inasmuch as the inventive devices are expected to provide certain advantages in their use, there is also provided a method of medical care including methods of treatment or diagnosis, wherein the inventive devices are brought into therapeutic contact with a body to be treated or diagnosed thereby.

Abstract: A radially expandable device having a body constructed of a generally inelastic, expanded fluoropolymer material is described. The body is deployable upon application of a radial expansion force from a reduced diameter, collapsed configuration to an expanded configuration having a pre-defined and fixed increased diameter. The body has a singular, unitary construction of generally homogenous material that is characterized by a seamless construction of expanded fluoropolymer material, such as expanded polytetrafluoroethylene (ePTFE), and is preferably constructed through an extrusion and expansion process. The body is further characterized by a microstructure of nodes interconnected by fibrils in which substantially all the nodes of the body are oriented generally perpendicularly to the longitudinal axis of the body.

Abstract: An interventional catheter for angioplasty and the like, including a catheter tube including an outer tubular member, an inner tubular member disposed within the lumen of the outer tubular member, and a balloon attached to the distal end of the outer tubular member and the distal end of the inner tubular member. The outer tubular member includes a first portion having a first stiffness and a second portion having a second stiffness less than the first stiffness. The inner tubular member has an inner surface having a first coefficient of friction and an outer surface having a second coefficient of friction greater than the first coefficient of friction.

Abstract: A balloon catheter system for the intraluminal advancement of conventional guidewires beyond partially or fully occluded or stenosed lesions in body passages, such as CTOs in the vasculature, is provided. Balloons are provided. In certain embodiments of the invention, a balloon having relatively thickened proximal tapers is provided. In certain embodiments of the invention, balloons having a tapered midsection are provided. The balloons are preferably useful with crossing balloon catheter systems. In certain embodiments of the invention, the balloons preferably reduce or minimize trauma to the vascular wall or wall of other body passage in which it is used.

Abstract: A balloon catheter having an improved profile by placing the proximal balloon neck inside the outer catheter shaft. This outer catheter shaft to balloon neck joint allows for a smaller outer diameter at the joint between the outer catheter shaft and the balloon, thus providing a reduced catheter profile with improved crossability, trackability and stiffness. The balloon may be a no-fold balloon having a uniform wall thickness, a uniform inner diameter, and a uniform outer diameter along its full length in an unexpanded configuration. A balloon with such uniform dimensions provides for a more flexible balloon by eliminating the thicker neck and taper portions of the balloon. Further, the no-fold aspect of the balloon reduces the profile of the balloon catheter thus resulting in improved crossability and trackability.

Abstract: A medical balloon for attachment to a catheter tube, and method of making the balloon. The balloon comprises a plurality of co-extruded and coextensive layers of different polymeric materials (20A, 20B) at least one of which is a base structural layer (20B) and the other of which (20A) is formed of polyethylene and copolymers thereof or of SELAR. The base structural layer is thicker than the other layer.

Abstract: A device may include a hollow needle, a dilator mounted coaxially on the needle, and a sheath mounted coaxially on the dilator. The dilator may be slideably displaceable relative to the sheath.

Abstract: A multi-membrane balloon (10) for a catheter having an at least double membrane sleeve (20, 40) comprising at least one fillable and emptiable expansion space (46) between a proximal end (12) and a distal end (14), wherein a stiff supporting element (60) surrounds the at least double membrane sleeve (20, 40) and the outer membrane sleeve (20) surrounds one or more inner membrane sleeves (40). The supporting element (60) at least partially takes hold with the outer membrane sleeve (20).

Abstract: Balloon catheters and methods of making and using the same. A balloon catheter may include a catheter shaft and a balloon coupled thereto. A traction member may be coupled to the balloon catheter adjacent the balloon and may extend along a portion or all of the length of the balloon. The traction member can improve traction between the balloon and a target site.

Abstract: The present invention relates to a medical device for angioplasty or parts thereof, which is made of elastomeric material, wherein the elastomeric material comprises a polyamide-based polymer obtained from the polymerization of a compound forming polyamide blocks that is selected from the group consisting of an aminocarboxylic acid of Formula (1) and a lactam of Formula (2): with a polyether diamine triblock compound of Formula (3): and a dicarboxylic acid of Formula (4): HOOC—(R3)m—COOH??(4) wherein the groups R1, R2 and R3 are each binding groups comprising a hydrocarbon chain therein that may be interrupted by one or more amide groups; x is an integer from 1 to 20; y is an integer from 4 to 50, z is an integer from 1 to 20; m is 0 or 1.

Abstract: A directional balloon is provided that can be used for a medical intervention of a body lumen. In one aspect, the directional balloon inflates in a distal to proximal direction and deflates in a proximal to distal direction. In another aspect, the directional balloon inflates in a proximal to distal direction and deflates in a distal to proximal direction. The directional balloon is capable of providing an occlusive seal to protect against embolization. A suction catheter with a control means is provided to provide suction in a controlled fashion in a body lumen. The suction catheter is used during periods of a medical intervention that risks distal embolization. When turned on, the suction catheter is capable of removing unwanted materials. The suction means could be operated by a control means.

Abstract: A balloon catheter comprises a catheter body, a balloon at a distal end of the catheter body, and a guidewire tube within the balloon and separate from the catheter body. A catheter may be introduced over a guidewire by passing the guidewire through a guidewire lumen in the guidewire tube. No guidewire lumen is provided within the catheter body.

Abstract: A medical device (10) includes a catheter shaft (11) including inner and outer catheter shafts (12 and 14), and an expandable balloon (18) carried by the catheter shaft (11). The balloon (18) is made from an irradiation cross-linked mixture of a polyamide elastomer and at least one additional cross-linking reactant. The polyamide elastomer can be a polyester amide, a polyether ester amide or a polyether amide, and is preferably a nylon block copolymer. The cross-linking reactant can be: (a) a difunctional material, (b) a trifunctional material, (c) a tetrafunctional material, or (d) an aromatic molecule containing at least two ring substituents, each of the ring substituents having labile hydrogens at a benzylic site therein. The cross-linking reactant can also be diallyl phthalate or meta-phenylene dimaleimide. Irradiation is carried out by exposure to an electron beam or to ultraviolet, X- or gamma radiation, preferably at a total fluence of about 0.5 to about 20 megarads.

Abstract: The medical devices of the present invention include self-reinforcing polymer materials, based on the rigid-rod paraphenylene copolymer chemistry. Accordingly, the materials of the present invention provide a unique combination of physical properties that are advantageous for use in various medical devices. The medical devices may include those for maneuvering through the body passages of a patient, such as for example the circulatory system, to a desired site for treatment.

Abstract: A balloon catheter may include a multi-lumen tube having an inflation lumen and a guide wire lumen. The multi-lumen tube may include a proximal end and a distal end and may terminate at a distal tip. The catheter may include an extension tube extending distally from the distal tip of the multi-lumen tube and a dilatation balloon disposed about the multi-lumen tube and the extension tube. The distal tip of the multi-lumen tube may be under the balloon.

Abstract: A balloon catheter comprises a shaft including a tubular having a relatively rigid proximal shaft section and a distal shaft section, each section connected to one another through a flexible transition member, and an inflatable balloon extending at a distal portion of the distal shaft section. The proximal and distal shaft sections define an inflation lumen extending therein which is in fluid communication with an interior of the balloon to allow inflation pressure to the balloon. The distal shaft further comprises a guide wire lumen to receive a guide wire. The guide wire lumen has a guide wire inlet, located between the end portion of the proximal shaft section and the balloon, and a guide wire outlet, located distally to the balloon and leading to an exterior of the catheter. The balloon catheter can be used for coronary angioplasty.

Abstract: A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing the internal pressure within the balloon. The balloon comprises a balloon layer having an outer surface, the balloon layer including a base layer, a first reinforcing layer and a second reinforcing layer. The base layer is formed of a polymer material. The first reinforcing layer is one of either a plurality of discrete inelastic fibers oriented substantially parallel to the long axis of the balloon and a first layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric. The second reinforcing layer is one of either at least one inelastic fiber wrapped around the circumference of the balloon substantially transverse to the long axis of the balloon and a second layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric.

Abstract: The present invention provides a balloon having a non-uniform thickness that is adapted to facilitate folding of the balloon. The balloon comprises at least one relatively thin section formed between inner and outer surfaces of the balloon, and at least one relatively thick section formed between the inner and outer surfaces. The balloon may be formed from a balloon preform that similarly comprises at least one relatively thin section and at least one relatively thick section. The shape of the balloon preform may be formed, for example, by extrusion. The balloon preform may be placed in a balloon mold having a substantially cylindrical interior surface, and blow-molded to form the finished balloon configuration. The balloon comprises a non-uniform thickness, while comprising a substantially cylindrical outer diameter both after removal from the balloon mold and in an inflated state.

Abstract: Medical devices, and particularly intracorporeal devices for therapeutic or diagnostic uses, having a component chemically modified by plasma polymerization. The medical device comprises a substrate with a plasma polymerized functionality bonded to a surface of at least a section thereof. The plasma polymerized film on a first component of the medical device allows for bonding an agent or a second component to the first component. In one embodiment, the plasma polymerized film facilitates fusion or adhesive bonding of a first component to a second component formed of a material which is dissimilar to, incompatible with, or otherwise not readily bondable to the substrate material of the first component. In another embodiment, a bioactive agent is bonded to the plasma polymerized film on the component, for presenting or delivering the bioactive agent within a body lumen of the patient.

Abstract: A medical device in which a melt processed part has different crystallized properties at different locations. The part is formed of a polymer composition by inclusion a of polymer crystallization modifier in the composition making up at least a portion of such part, the amount of the polymer crystallization modifier is varied at different locations on the part in accordance with the desired difference in crystallization behavior.

Abstract: A catheter balloon with integral non-distending regions having a plurality of layers which wind around the balloon material and overlap to form an angle of between 45 and 90 degrees relative to each other upon inflation, and methods of making the non-distending regions are provided.

Abstract: Balloons are provided which are formed of at least one balloon material with micropleats distributed about the circumference of the balloon. The micropleats reduce the profile of the balloon and pull taut upon inflation to provide an essentially radial symmetry.

Abstract: An inflatable toroidal-shaped balloon for medical use is provided with a central opening traversing the balloon in an inflated state. The balloon is useful to achieve larger outer diameters than conventional balloons.

Abstract: A non-compliant medical balloon includes a balloon layer having an outer surface and a strengthening rod connected to the outer surface of the balloon layer. The strengthening rod may be connected longitudinally on the outer surface of the balloon layer. Typically, the balloon is formed of a polymer like polyethylene terephthalate.

Abstract: Apparatus and method are provided for treatment of a bifurcation of a body lumen. The apparatus includes an elongated catheter body having a proximal end and a distal end. A balloon is associated with the distal end of the balloon catheter. The balloon includes a main vessel balloon for treating a main vessel of the bifurcation, and a branch vessel balloon for treating a branch vessel of the bifurcation. The branch vessel balloon includes an accordion configuration capable of being expanded from an unexpanded collapsed accordion configuration to an expanded accordion configuration extending into the branch vessel.

Abstract: A balloon catheter having a balloon with a thickened wall portion extending along at least a portion of the working length section of the balloon in a noninflated configuration. The balloon has a first layer formed of a first polymeric material and a second layer formed of a second, different polymeric material, the second layer having a wall thickness which is greater along the central working length section than the wall thickness of the second layer along a section proximal and/or a section distal to the central working length of the balloon. In a presently preferred embodiment, the first layer is formed of a porous material such as expanded polytetrafluoroethylene (ePTFE), and the second layer of the balloon is formed of an elastomeric polymer. The balloon catheter has a highly flexible distal section and a relatively high strength, low profile balloon, due to the balloon configuration of the invention.

Abstract: An active cannula which does more than merely maintain a passage is usable to create and/or enlarge a passage, to position a scope or instrument, to move or locate tissue, etc. The cannula can vary in size or shape as needed, intraoperatively. Because a cannula of the present invention is expandable, the surgeon can make a relatively small incision, stretch the tissue with the expandable cannula, contract the cannula and remove it, allowing the skin to come back to its unstretched condition. Thus, a smaller incision can be made to fit the same size instrument. The cannulas can assume such a non-circular shape, to fit into a natural skin opening and cause less trauma. The devices can be used to seal off a space, expand an existing space or a potential space for working or visualization, move tissue (for example, to stretch an incision), or protect tissue.

Abstract: A balloon catheter having a balloon with a porous polymer layer and one or more filamentary members which are on or in the porous polymer layer and which form ridges protruding outwardly from a surface of the balloon in the inflated configuration. In a presently preferred embodiment, the balloon has a wingless noninflated configuration.

Abstract: The present invention relates to a balloon portion for a balloon catheter for radially expanding a vessel in the body of a mammal, which catheter comprises a tube portion with a passage therethrough and a hollow expandable balloon portion defined by a fluid impervious wall and secured to the tube portion, which balloon portion can be inflated and deflated by means of a fluid passed through the passage, characterized in that: a. the wall of the balloon portion is formed from a flexible substantially fluid impervious material having reinforcing fibers formed integrally with the wall material; and b. the balloon portion is preformed to the desired radial diameter at its inflated state having smaller diameter end portions and a wider diameter portion intermediate the said ends and has a substantially uniform wall thickness. The invention also provides a balloon catheter in which the balloon portion is a balloon of the invention.

Abstract: A device for fixing a tube member in a cavity of a patient. The device includes a body that surrounds the tube member and has a casing that at least partly forms an inner space. The body is expandable by supplying a fluid to the inner space in such a way that the fluid in the inner space has a working pressure. Furthermore, the body has, in a non-expanded state, a relatively small outer extent, which permits the introduction into said cavity, and in an expanded state, a relatively large outer extend, which permits fixing in said cavity by abutment with a contact pressure against a tubular wall of the cavity. In order to ensure a tight abutment against the wall of the cavity, the body has such a geometrical shape that the contact pressure is substantially constant independent of variations of the working pressure within a normal working range.

Abstract: Balloon catheters such as guide catheters can be configured to provide distal occlusion, while still providing sufficient interior lumen space for device delivery. Such catheters can provide a desired level of balloon expansion, yet prevent vessel damage caused by balloon over-expansion. A catheter can include an elongate shaft having a distal region, a proximal region and a lumen extending therebetween. A balloon is inflated to a desired expansion configuration with a desired diameter. Over-inflation of the balloon causes longitudinal expansion instead of increased radial expansion, thus maintaining the diameter of the balloon.

Abstract: A method of making a catheter balloon, and a balloon catheter formed thereby, in which a layer of a catheter balloon is formed by providing a tubular member to serve as a non porous liner for cooperation with a polymeric tube, and enlarging radially a central or working section of the tubular member such that a first end of the tubular member is smaller in the radial direction with respect to the working section. The tubular member may also have a thickness at the working section that is less than a thickness of the first and second end portions. The first end section of the tubular member is bonded to a catheter shaft having a first outer diameter to form at least a portion of a skirt section of the balloon, and the second end section is bonded to the catheter shaft having a second outer diameter to form a portion of a skirt section, where the skirt sections have an improved high rupture pressure.

Abstract: A balloon catheter includes a long-sized body extending between a proximal end and a distal end, the body internally having at least one lumen, and a balloon made from a composite material composed of short-fibers for reienforcement and a matrix resin, the balloon being disposed on the distal side of the long-sized body.

Abstract: A balloon for a catheter and a method of making the balloon, having a layer of a porous polymeric material with a modified outer surface and a lubricious coating bonded to the modified outer surface. In one embodiment, the modified outer surface is formed by a polymer impregnated in the porous polymeric material, and the subsequently applied lubricious coating bonds to the impregnating polymer. In another embodiment, the modified outer surface is formed by a functionality deposited on the porous polymeric material which bonds to the subsequently applied lubricious coating. The modified outer surface provides an improved strong bond between the lubricious coating and the balloon, for improved catheter performance.

Abstract: A catheter for use in an emboli containment system includes a flexible elongate member having self-expanding sealing means mounted on its distal extremity. This self-expanding sealing means can take any suitable form, such as a braided structure formed of a suitable shape memory material such as a nickel titanium alloy. In order to prevent abrasion of a vessel, it is desirable to cover the braided structure with a covering of a suitable material such as a polymer which extends over the braided structure and which moves with the braided structure as it expands and contracts.

Abstract: A balloon catheter and a method of making a balloon catheter, having a balloon with a first layer and a second layer, the first layer having at least one impregnated section impregnated with a polymeric material compatible with a polymeric material forming the catheter shaft. At least a portion of the impregnated section is fusion bonded to the shaft. In a presently preferred embodiment, the impregnated section is adjacent to a section of the first layer which is not impregnated with the compatible polymeric material. The impregnated section provides improved bonding of the balloon to the catheter shaft while minimizing the effect of the bond on catheter performance characteristics such as profile and flexibility.

Abstract: Embodiments of the present invention are directed to a method and apparatus for accurate positioning of a dual balloon catheter. In one embodiment of the present invention, a first balloon provides an anchoring point. In one embodiment, the first balloon has protrusions to help secure its position. In one embodiment, once the first balloon is inflated, it provides a fixed position relative to which a second balloon is accurately positioned in the treatment region. In another embodiment, a second balloon imparts a radial force. In another embodiment, a second balloon imparts an axial force, using the first balloon as an anchor against which the force is applied. The force may be applied in a forward or a backward direction. In yet another embodiment, a second balloon imparts a rotational force, using the first balloon as an anchor against which the force is applied.

Abstract: The invention features a method for triggering release of a drug from a hydrogel polymer to tissue at a desired location of the body using a catheter. A portion of the catheter is coated on its outer surface with a polymer having the capacity to incorporate a predetermined substantial amount of drug which is immobilized in the polymer until released by a triggering agent or condition that is different from physiological conditions. Upon contact with a triggering agent or condition, the polymer reacts, e.g., swells or contracts, such that the drug is delivered to the desired body tissue. A balloon catheter is shown in which the hydrogel is carried on the exterior surface of the balloon.

Abstract: An apparatus having an inflatable balloon near a distal end of a multi-lumen catheter, with a plurality of blood flow passageways formed through the interior of the balloon from a proximal face of the inflated balloon to a distal face of the inflated balloon. A heat transfer solution is introduced through a supply lumen of the catheter to inflate the balloon in a selected blood vessel; this allows blood to flow through the blood flow passageways of the balloon, from one exterior face of the balloon to another exterior face. The heat transfer solution continues to circulate around the blood flow passageways inside the balloon, to change the blood temperature, eventually exiting the balloon through a return lumen of the catheter.

Abstract: A tie layer insert is disclosed to aid in bond formation between an expandable balloon and a distal portion of a catheter shaft. The tie layer insert can be a single layer applied directly to the structural surfaces, or alternatively, the tie layer may be incorporated into a preformed polymeric insert. In the latter embodiment, the polymeric insert may include several layers of polymeric material. During the manufacturing process, the preformed polymeric insert is positioned between the distal portion of the expandable balloon and the catheter shaft. The entire distal region is then processed to form a sealably bonded expandable balloon to the distal end of the catheter shaft.

Abstract: A method of making a catheter balloon, and a balloon catheter formed thereby, in which a layer of a catheter balloon is formed by decreasing the inner diameter of a first end section of a polymeric tube, so that the tube has a reduced diameter first end section with an inner diameter less than the inner diameter of a central section of the tube. The reduced diameter first end section of the tube is bonded to a catheter shaft to form at least a portion of a skirt section of the balloon, and the skirt section has an improved high rupture pressure.

Abstract: Balloons for use on medical devices such as catheter balloons are formed from polymer blend products which include a liquid crystal polymer (LCP), a crystallizable thermoplastic polymer, especially thermoplastic polyesters such as PET, and a compatabilizer. The compatabilizer may be an ethylene-maleic anhydride copolymer, an ethylene-methyl acrylate copolymer, an ethylene-methyl acrylate copolymer, an ethylene-methyl acrylate-maleic anhydride terpolymer, an ethylene-methyl-methacrylic acid terpolymer, an acrylic rubber, an ethylene-ethyl acrylate-glycidyl methacrylate terpolymer or a mixture of two or more such polymers.

Abstract: A balloon catheter comprises a catheter body, a balloon at a distal end of the catheter body, and a guidewire tube within the balloon and separate from the catheter body. A catheter may be introduced over a guidewire by passing the guidewire through a guidewire lumen in the guidewire tube. No guidewire lumen is provided within the catheter body.

Abstract: A balloon catheter having a balloon with a thickened wall portion extending along at least a portion of the working length section of the balloon in a noninflated configuration. The balloon has a first layer formed of a first polymeric material and a second layer formed of a second, different polymeric material, the second layer having a wall thickness which is greater along the central working length section than the wall thickness of the second layer along a section proximal and/or a section distal to the central working length of the balloon. In a presently preferred embodiment, the first layer is formed of a porous material such as expanded polytetrafluoroethylene (ePTFE), and the second layer of the balloon is formed of an elastomeric polymer. The balloon catheter has a highly flexible distal section and a relatively high strength, low profile balloon, due to the balloon configuration of the invention.

Abstract: A device for occluding a vessel employs one of a number of different expansion members joined to one or more elongate members. The expansion member may include a braid, one or more coils, ribs, a ribbon-like structure, a slotted tube, or a filter-like mesh. If the expansion member is enclosed by a suitable membrane, the device seals with the vessel wall to partially or completely occlude the vessel. A perforated membrane may be used to permit the perfusion of blood. The expansion member may be self-expanding, or it may be expanded by engaging it with one of the elongate members. Alternatively, the expansion member may be expanded by heating it.

Abstract: The present invention is a balloon catheter used primarily in treatment and surgery for the purpose of dilating lesion sites such as strictures or blockages in passages in the human body. The balloon catheter of the present invention has a structure wherein a guide wire passing tubular member is deployed passing through the interior of the expansion body, and the outer surface of the tubular member and the expansion body are concentrically fused near the distal end of the catheter. This is a balloon catheter that is characterized by the fact that the Shore hardness of the material configuring the outermost surface of the tubular member is smaller than the Shore hardness of the material configuring the expansion body. It is therefore possible to flexibly adjust the tip portion formed by securing the expansion body and the guide wire passing tubular member.

Abstract: An interventional catheter for angioplasty and the like, comprising a catheter tube formed of two superposed layers of materials different from one another. The inner layer is comprised of a low friction nonkinkable material to avoid risk of clogging of a guide wire in the longitudinal lumen. The outer layer is comprised of a material with higher friction coefficient than the material forming the inner layer. The balloon is welded at its distal end to the outer layer of the catheter tube. The proximal end of the balloon is welded to a tube surrounding the catheter tube.

Abstract: A catheter balloon formed of a polymeric material such as expanded polytetrafluoroethylene (ePTFE) bonded to a second layer formed of a low tensile set polymer and/or impregnated with a low tensile set polymer. In a presently preferred embodiment, the low tensile set polymer is a silicone-polyurethane copolymer elastomer or a diene polymer elastomer. The low tensile set polymer has high strength, low modulus, high elongation, and low tensile set. The diene or silicone-polyurethane has a low tensile set, which facilitates deflation of the balloon to a low profile deflated configuration. One aspect of the invention provides improved attachment of the diene to the ePTFE. In one embodiment, the second layer is formed of a diene mixed with a bonding promoter such as a vulcanizing agent which is covalently bonded to the diene.

Abstract: A balloon catheter having an elongated shaft and a balloon mounted on the distal portion of the shaft, the balloon having a working section and proximal and distal end portions that extend inwardly with respect to the working section and which are secured to the catheter shaft within the working section. The end portions are therefore inverted recesses on each end of the balloon. A stent may be disposed about the balloon to form a stent deploying system. The proximal and distal end portions may contain a tapered portion, which tapers from the balloon working section to the catheter shaft with decreasing transverse dimension. The end portions may be connected to the working section with connecting fibers. This design allows for improved expansion and stent placement in the vasculature.

Abstract: A balloon catheter having a balloon disposed upon an elongate shaft near a relatively rigid distal insertion tip, a fluid lumen for fluid communication with a body cavity and an inflation lumen for fluid communication with the balloon. The balloon holds the catheter tip within a body cavity such as the stomach for long-term enteral feeding. The balloon is configured such that upon inflation, the balloon distends distally to cover the distal tip thus insulating it from sensitive anatomy.