Abstract: Medical systems and methods including balloons having nanotubes are disclosed. In some embodiments, a medical system includes an elongated shaft, and an expandable balloon carried by the shaft and including nanotubes. The medical system is capable of cooling the balloon to less than about 37° C. In some embodiments, a method includes providing a medical device having an elongated shaft, and an expandable balloon carried by the elongated shaft and including nanotubes; and cooling the balloon to less than about 37° C.

Abstract: An intravascular device can comprise a carrier and an expansion apparatus. The device can be used for intravascular treatment of atherosclerotic plaque. The carrier can be reversibly expandable and collapsible within a vessel and can have ribbon strips extending between opposite ends in a longitudinal direction of the carrier. The ribbon strips can each be formed with a plurality of elongated protrusions thereon. The expansion apparatus can be used to actuate the ribbon strips each with the plurality elongated protrusions to pierce a luminal surface of the plaque with lines or patterns of microperforations which act as serrations for forming cleavage lines or planes in the plaque.

Abstract: Catheter or guidewire mounted automatic vessel occlusion and fluid dispersion devices that expand to occlude or partially occlude a vessel when a fluid is flowing in the catheter or guidewire, and that automatically collapse when fluid flow is stopped. Each occlusion device has an elastic skeleton covered with a flexible cover coupled thereto and may have a hole(s) or openings in its distal or proximal end thereof to allow controlled flow through the desired end of the occlusion device. The fluid may be a flush fluid for enabling or improving the performance of imaging devices and image enhancing fluids, of treatment fluids for localized treatment of a vessel or tissues in communication with the vessel and/or of the transmission of energy to the vessel wall and adjacent tissues. Various embodiments are disclosed.

Abstract: A method of increasing blood flow through an obstructed blood vessel includes providing an expandable member substantially made of a mesh having a plurality of interstices. The expandable member is inserted into the blood vessel, positioned within the blood vessel with the proximal member end upstream of the distal member end and the member body located radially adjacent at least a portion of an obstruction, and expanded to bring at least a portion of the member body into contact with the obstruction. An outward radial force is exerted on the obstruction to dislodge at least one fragment from the obstruction and to enhance blood flow through the blood vessel past the obstruction. The at least one fragment is passed through at least one interstice of the member body in the radial direction, and is selectively retained within the expandable member.

Abstract: A non-polymeric or biological coating applied to a radially expandable interventional medical device in a collapsed, wrapped, or folded configuration, the coating applied within at least one fold. Properties of the coating material applied to the medical device are adjusted or varied to result in a desired combination of coverage of the surface of the medical device, drug loading, and coating thickness. The coating is sterile, and is capable of being carried by a sterile medical device to a targeted tissue location within the body following radial expansion. The therapeutic coating transfers off the medical device due in part to a biological attraction with the tissue and in part to a physical transference from the medical device to the targeted tissue location in contact with the medical device.

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: A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon. The non-compliant medical balloon is composed of randomly oriented fibers forming an angle. The angle remains substantially unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: A balloon catheter includes a catheter tube, an inflatable balloon, the ends of which are attached to the catheter tube, and a stent attached around the balloon. The stent extends at least partly along the length of the balloon. In an uninflated state, at least the outside surface of the balloon not covered by the stent is provided with a relief structure which is substantially disappeared in an inflated state of the balloon. A related method involves manufacturing a balloon catheter.

Abstract: The present invention generally relates to an intraluminal catheter device for use in angioplasty and delivery of a therapeutic agent. Particularly, the present invention is directed to a catheter having an expandable member having a therapeutic agent disposed thereon and a fibrous matrix covering for delivering a therapeutic agent and methods of using the same.

Abstract: Apparatus and methods are disclosed for medical treatment comprising bone, tissue or duct dilatation using inflatable dilatation elements together with apparatus and techniques for tensioning, stretching, folding, and/or wrapping the dilatation elements externally as well as in situ to facilitate insertion, positioning and withdrawal procedures.

Abstract: Medical devices and methods of making the devices are described. In some embodiments, a method of making a medical device includes addressing a member including a polymer with energy above an ablation threshold of the polymer, and using the member to make the medical device.

Abstract: Apparatus and methods are disclosed for medical treatment comprising bone, tissue or duct dilatation using inflatable dilatation elements together with apparatus and techniques for tensioning, stretching, folding, and/or wrapping the dilatation elements externally as well as in situ to facilitate insertion, positioning and withdrawal procedures.

Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Abstract: A rectal balloon apparatus has a shaft with a fluid passageway extending therethrough. A balloon is affixed over an end of the shaft such that the fluid passageway communicates with an interior of the balloon. The balloon has a laterally flat surface thereon when inflated. The laterally flat surface of the balloon has a longitudinal groove formed thereon. The balloon having a pair of bulges formed thereon when the balloon is inflated. A ring is affixed to the shaft adjacent the balloon. The shaft has a plurality of holes formed thereon opening to an interior of the balloon.

Abstract: Catheter devices having an expandable balloon for delivering a therapeutic agent to a body site. The balloon has one or more folds which serve as a reservoir for containing the therapeutic agent. The fold may have any of various configurations to hold the therapeutic agent. In some cases, the balloon comprises one or more lobes that forms the fold(s). The therapeutic agent may be provided in various ways. For example, the therapeutic agent may be contained in packets that rupture upon expansion of the balloon, or as a plurality of discrete bulk masses, or sealed within compartments.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Some embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. The device comprises a capsule sized to be swallowed and pass through the intestinal tract. The capsule can include at least one guide tube, one or more tissue penetrating members positioned in the guide tube, a delivery member, an actuating mechanism and a release element. The release element degrades upon exposure to various conditions in the intestine so as to release and actuate the actuating mechanism. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: A catheter having an elongate shaft including a plurality of apertures disposed along at least a length of the shaft to facilitate bending. The catheter includes an inflatable balloon, wherein a subset of the plurality of apertures provides fluid communication from an inflation lumen to the inflatable balloon.

Abstract: An intraluminal catheter device having an expandable member formed of a matrix of fiber elements with a therapeutic agent incorporated therein. The therapeutic agent can be coated on the fiber elements in a co-axial configuration. The fiber elements may also have a second coating including a protective substance surrounding the therapeutic agent. The matrix of fiber elements can be formed by electrospinning. A process of delivering a therapeutic agent to a target site includes providing an intraluminal catheter device having an expandable member formed of a matrix of fiber elements, the expandable member having a therapeutic agent dispersed therein, and advancing the catheter device at a desired treatment site. Once at the desired treatment site, fluid is introduced into the inflation lumen to expand the expandable member from a first profile to a second profile, and the therapeutic agent is delivered to the desired treatment site.

Abstract: A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon. The non-compliant medical balloon is composed of a woven fabric layer composed of at least two woven fabric fibers forming an angle. The angle remains substantially unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: A balloon catheter is provided with integral channels for securing dilation elements to the outside of the balloon. The dilation elements have an anchor portion and an intermediate portion that are disposed within first and second longitudinal cavities in the channels. The balloon may be manufactured by extruding a parison and blow molding the parison with the dilation elements installed within the channels.

Abstract: A method of increasing blood flow through an obstructed blood vessel includes providing an expandable member substantially made of a mesh having a plurality of interstices. The expandable member is inserted into the blood vessel, positioned within the blood vessel with the proximal member end upstream of the distal member end and the member body located radially adjacent at least a portion of an obstruction, and expanded to bring at least a portion of the member body into contact with the obstruction. An outward radial force is exerted on the obstruction to dislodge at least one fragment from the obstruction and to enhance blood flow through the blood vessel past the obstruction. The at least one fragment is passed through at least one interstice of the member body in the radial direction, and is selectively retained within the expandable member.

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: The invention relates to medical balloons, and methods of modifying said balloons by forming a void pattern in their exterior surfaces and filling the voids with a material, such as a fiber or a nanomaterial (e.g., nanotubes, such as carbon nanotubes) and a matrix material, e.g., a polymer.

Abstract: An intraluminal catheter device having an expandable member formed of a matrix of fiber elements, the expandable member including a hydrogel polymer having a therapeutic agent incorporated therein. The hydrogel polymer can be coated on the fiber elements in a co-axial configuration. The fiber elements may also have a second coating including a protective substance surrounding the hydrogel polymer having a therapeutic agent therein. The matrix of fiber elements can be formed by electrospinning. A process of delivering a therapeutic agent to a target site includes providing an intraluminal catheter device having an expandable member formed of a matrix of fiber elements, the expandable member including a hydrogel polymer having a therapeutic agent dispersed therein, and advancing the catheter device at a desired treatment site.

Abstract: A catheter balloon is formed from a mold process with a circumferential demarcation is formed on the outer surface using a groove or ridge on the mold surface. The demarcation is located at the transition between the body portion of the catheter balloon and the neck or taper section. The presence of the demarcation serves to identify the transition between the two regions for placing and positioning a visual marker inside the balloon.

Abstract: Medical device systems and related methods are disclosed.

Abstract: Multiple-balloon catheters, and methods of treatment therewith, are provided including an inflatable inner balloon at least partially enclosed by an expandable outer balloon that has holes. The annular space between the inner balloon and the outer balloon is configured to promote delivery of the fluid evenly through holes in the outer balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The inner balloon may have various configurations including being tapered relative to the outer balloon. The outer balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.

Abstract: The invention relates to multi-layer medical balloons. In one aspect, a medical device includes an inflatable balloon. The inflatable balloon includes a first layer including a material having a first modulus of elasticity, and a second layer adjacent the first layer, the second layer including a material having a second modulus of elasticity that differs from the first modulus of elasticity by at least about 2,000 psi. A cutting element is carried by the balloon.

Abstract: A medical balloon may be configured by at least partially inflating the medical balloon and forming at least one primary lobe in the balloon. The primary lobe extends from a central portion of the balloon. The primary lobe may be manipulated to form at least two secondary lobes therefrom. The balloon may then be deflated and the secondary lobes wrapped around the balloon.

Abstract: A catheter balloon is formed from a mold process in which raised dimples or shallow divots are formed on the outer surface using indentations or raised beads on the mold surface. The dimples or divots are located at the transition between the body portion of the catheter balloon and the neck or taper section. The presence of the dimples or divots serves the dual purpose of identifying the transition between the two regions for placing a visual marker on the balloon to be used in positioning the balloon, and also to assist in the retention of a vascular stent on the balloon.

Abstract: A non-polymeric or biological coating applied to a radially expandable interventional medical device in a collapsed, wrapped, or folded configuration. Properties of the coating material applied to the medical device are adjusted or varied to result in a desired combination of coverage of the surface of the medical device, drug loading, and coating thickness. The coating is sterile, and is capable of being carried by a sterile medical device to a targeted tissue location within the body following radial expansion. The therapeutic coating transfers off the medical device due in part to a biological attraction with the tissue and in part to a physical transference from the medical device to the targeted tissue location in contact with the medical device.

Abstract: A device for interventional surgical or medical procedures is presented. The device is generally in the form of a balloon and is used to position itself or other working elements up against or through lumen walls in the body. The balloon is comprised of at least two materials of different elastic modulus, which allows for a flexible but relatively non-distensible, unfolding component of the balloon as well as an elastomeric, inflatable component of the balloon. The elastomeric component is fixedly attached to the flexible but relatively non-distensible component and together they form a pressure vessel that can be inflated within the lumens of the body.

Abstract: Embolic protection and plaque removal apparatus and methods are provided wherein an aspiration device aspirates, filters and reperfuses blood using a closed fluid circuit having a bi-directional working lumen. The plaque removal device includes a plurality of self-expanding cutting elements that form a cage that self-centers within the blood vessel to reduce the risk of trauma to the vessel lining.

Abstract: A cannula for insertion through a biologic tissue. The cannula includes a shaft having proximal and distal end portions with a lumen therebetween. The cannula further includes a tip having a proximal end portion, a distal tip end, and a lumen therebetween. The proximal end portion of the tip is secured to the distal end portion of the shaft so that the lumen of the tip is in fluid communication with the lumen of the shaft. The tip includes an opening that extends proximally relative to the distal tip end to permit the flow of fluid into the lumen of the tip even in the event that the distal tip end becomes obstructed.

Abstract: A device for removing material from a patient's body comprising a shaft and an adhesive carrying surface extending from the shaft. The adhesive carrying surface is movable with respect to the shaft and has an adhesive on at least a portion of its outer surface. The adhesive has sufficient stickiness to adhere to a body material to remove the material when the shaft is removed from the patient's body.

Abstract: A cutting balloon catheter and method of using the same. The cutting balloon catheter may include a catheter shaft having a balloon coupled thereto. One or more cutting members or blades may be coupled to the balloon. The balloon may include one or more discrete points or areas of flexibility to enhance flexibility of the cutting balloon catheter. A break in the one or more cutting members may be aligned with the one or more discrete points of flexibility in the balloon.

Abstract: A method of preparing a cutting balloon comprises the steps of providing a balloon body having an exterior surface, an unexpanded state and an expanded state; and engaging at least one blade to the exterior surface when the balloon body is in the unexpanded state.

Abstract: A non-compliant medical balloon comprises a base balloon including a pair of spaced-apart, generally conical end sections and a generally cylindrical center section connected therebetween. A braided fabric sleeve surrounds at least a portion of the base balloon, wherein the sleeve is formed of at least three substantially inelastic fibers intertwined in such a way that no two of the three fibers are twisted exclusively around one another. The sleeve is permanently affixed to the outer surface of the base balloon so as to prevent excessive expansion of the base balloon when the base balloon is internally pressurized.

Abstract: A method and apparatus for uncoupling a wire guide from and elongate medical device comprising a catheter shaft having a wire guide lumen extending there through, wherein the material surrounding the wire guide lumen is selected or adapted to facilitate splittability for removal of the wire guide. The catheter shaft includes a wire guide port having a stress riser, the stress riser being configured to reduce the force necessary to rupture or split the portion of the shaft wall adjacent to the wire guide port. In a preferred embodiment, the catheter shaft is coextruded and comprises a plurality of materials. The portion of the shaft adjacent the wire guide lumen is formed from a material is selected or adapted to facilitate splittability as compared to the remaining shaft materials.

Abstract: A catheter balloon may include a proximal waist portion, a proximal cone portion, a first body portion, a second body portion, a third body portion, a distal cone portion and a distal waist portion. The second body portion may comprise a stepped-down section. An inflated diameter of the second body portion may be less than an inflated diameter of the first body portion or the third body portion. An outer surface of the second body portion may be provided with at least one implement, such as a blade or stiffening member.

Abstract: A balloon catheter that has at least one shaft, and a balloon. The balloon has a first weld region, a first cone region, a middle region, a second cone region and a second weld region where the first weld region engages the balloon to the at least one shaft, the first region is adjacent to the first weld region, the middle region is between the first cone region and the second cone region, the second cone region is adjacent to the second weld region, and the second weld region engages the balloon to at least one shaft. The balloon has an uninflated state and an inflated state, where the balloon has at least one fold extending from the first weld region to the second weld region in the uninflated state and the first and second cone regions of the balloon have at least one fold in the inflated state.

Abstract: A retrograde coronary sinus perfusion catheter including a tubular catheter body having a proximal end, a distal end, and an inner lumen, and an inflatable balloon spaced proximally from the distal end of the catheter body, wherein the balloon is echogenically enhanced.

Abstract: An instrument comprising a cable or tube, at a distal end of which a propulsion device is provided for moving the cable or tube in a hollow space, the propulsion device being shaped like a donut lying in a plane at right angles to the longitudinal direction of the cable or tube, wherein the donut-shaped propulsion device is, at least in part, externally delimited by at least one wire gauze that is rotatable about a closed axis of the donut body, which axis lies in the plane of the donut.

Abstract: A camera assembly for positioning within a bodily passageway, including a camera, a catheter adapted to retain the camera, and a rotary coupling interconnecting the catheter and the camera. The catheter is provided with helically-wound threads thereon. The rotary coupling permits the catheter to rotate and thereby move axially while the camera remains rotationally stationary.

Abstract: Described herein are medical devices which are configured for implantation or insertion into a subject, preferably a mammalian subject. The medical devices contain one or more multilayer regions, which contain: (a) one or more (typically a plurality of) charged nanoparticle layers and (b) one or more (typically a plurality of) charged polyelectroyte layers. Such multilayers have a number of desirable attributes, including high strength, non-compliance, and flexibility. Also described herein are methods of making such devices.

Abstract: A balloon catheter having multiple tubular members, an adaptor member connected thereto and a balloon for dilation of constricted blood vessel, wherein the peeling strength of the balloon surfaces when adheres to each other is 0.06 N or more and the modulus of the balloon in the axial direction is 100 N/mm2 or more, and wherein the coated resin composition contains a hydrophilic resin that is lubricating when wet. Furthermore, the outer surface of the balloon is made of a polyamide elastomer resin composition having a durometer hardness of 55 D or less. Thus, there can be provided a balloon catheter excelling in handling property, for which keeping the balloon highly penetrable through the stricture site as the accordion phenomenon of the balloon is prevented, and simultaneously preserving the other properties of the balloon (flexibility of balloon, wrapping dimension, and dilation/shrinkage response etc.).

Abstract: A catheter, formed in part of a polymer with a plurality of metal-coated nanotubes dispersed therein, is provided, along with methods of making and using such catheters. The method includes heating a polymer above a melting point of the polymer; dispersing a plurality of metal-coated nanotubes within the polymer; and forming the polymer having the plurality of metal-coated nanotubes dispersed therein into a catheter component. Methods of imaging a catheter including a polymer having a plurality of metal-coated nanotubes dispersed therein also is provided, which includes inserting a portion of a catheter into a body lumen; exposing the portion of the catheter to x-ray radiation; and obtaining an x-ray image of the portion of the catheter.

Abstract: Medical devices, for example, those that have balloons, and methods of making the devices are described. For example, in some embodiments, a medical device includes an elongated shaft, and an inflatable balloon carried by the shaft. The balloon includes a first recessed channel, a second recessed channel, a third recessed channel, and a fourth recessed channel, wherein the first recessed channel is spaced from the second recessed channel by a first distance, the third recessed channel is spaced from the fourth recessed channel by the first distance, and the second recessed channel is spaced from the third recessed channel by a second distance different than the first distance.

Abstract: A device for interventional surgical or medical procedures is presented. The device is generally in the form of a balloon and is used to position itself or other working elements up against or through lumen walls in the body. The balloon is comprised of at least two materials of different elastic modulus, which allows for a flexible but relatively non-distensible, unfolding component of the balloon as well as an elastomeric, inflatable component of the balloon. The elastomeric component is fixedly attached to the flexible but relatively non-distensible component and together they form a pressure vessel that can be inflated within the lumens of the body.

Abstract: An intraluminal catheter device having an expandable member formed of a matrix of fiber elements, the expandable member including a hydrogel polymer having a therapeutic agent incorporated therein. The hydrogel polymer can be coated on the fiber elements in a co-axial configuration. The fiber elements may also have a second coating including a protective substance surrounding the hydrogel polymer having a therapeutic agent therein. The matrix of fiber elements can be formed by electrospinning. A process of delivering a therapeutic agent to a target site includes providing an intraluminal catheter device having an expandable member formed of a matrix of fiber elements, the expandable member including a hydrogel polymer having a therapeutic agent dispersed therein, and advancing the catheter device at a desired treatment site.