Abstract: Balloon catheters, and methods of treatment therewith, are provided including an inflatable first balloon at least partially enclosed by an expandable second balloon that has holes. The annular space between the first balloon and the second balloon is configured to promote delivery of the fluid evenly through holes in the second 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 first balloon may have various configurations including being tapered relative to the second balloon. The second 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: A method of manufacturing a coated low-friction medical device, such as low-friction medical tubing, including applying a coating to one or more selected portions of a surface of low-friction medical tubing to indicate at least one marking formed along the surface of the low-friction medical tubing, and simultaneously or substantially simultaneously: (a) curing the applied coating to a designated temperature (which is above the temperature at which the low-friction medical tubing begins to decompose and shrink) to adhere the applied coating to the surface of the low-friction medical tubing, (b) utilizing one or more anti-shrinking devices to counteract or otherwise inhibit the shrinking of the low-friction medical tubing, and (c) exhausting any harmful byproducts resulting from curing the low-friction medical tubing to a temperate above the temperature at which the low-friction medical tubing begins to decompose.

Abstract: A balloon catheter comprises an outer shaft having a distal end, an inner shaft situated therein to form an annular fluid line and projecting beyond the distal end of the outer shaft, and a balloon which is dilatable under the influence of a fluid introduced through the fluid line under pressure. At its proximal end the balloon is attached in a fluid-tight manner to the distal end region of the outer shaft at a first attachment zone, and at its distal end is attached in a fluid-tight manner to the distal end region of the inner shaft at a second attachment zone. Between the attachment zones, in the undilated state the balloon is placed in longitudinal folds along its length. The balloon, at least at its distal end, has an untapered design with a thin wall thickness (d) which is essentially unchanged over the length of the balloon, and the longitudinal folds extend into the attachment zone at that location.

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: A guiding catheter system employs a compliant shaft with an inflatable balloon affixed to a distal portion of the shaft. The inflatable balloon includes channels that allow some amount of blood to flow past the balloon when inflated in a blood vessel. One or more inflation lumens is in fluid contact with the balloon and allows inflating the balloon from a proximal end of the catheter. A series of perfusion orifices may be included on the shaft proximal to the balloon.

Abstract: A device and method for minimizing exposure of soft mucosa tissues to radiation, the device including a low-volume intracavity balloon catheter having multiple expansion portions, including an isometrically expanding portion and a substantially planar anterior portion.

Abstract: Method for fabricating a balloon catheter including providing an inner tubular member having a distal section and a distal end with a lumen extending therein and forming a balloon having a distal leg with a first segment having a first diameter and a first wall thickness and a second segment having a second wall thickness. The second diameter is greater than the first diameter and the first wall thickness is greater than the second wall thickness. The distal end section of the inner tubular member can be positioned in the balloon and bonded to the first segment while reducing the diameter of the second segment. Method also provided for fabricating a multilayer balloon catheter including removing at least a portion of an outer layer from the distal leg of the balloon.

Abstract: Medical devices having one or more micropatterned surfaces (e.g., micropatterned coatings).

Abstract: The present disclosure is directed toward a semi-compliant to non-compliant, conformable balloon useful in medical applications. Conformable balloons of the present disclosure exhibit a low or insignificant straightening force when in a curved configuration and at inflation pressures greater than 4 atm. Balloons of the present disclosure are constructed of material that can compress along an inner length when the balloon is in a curved configuration. In further embodiments, balloons of the present disclosure can be constructed of material that sufficiently elongates along an outer arc when the balloon is in a curved configuration. As a result, medical balloons, in accordance with the present disclosure, when inflated in a curved configuration, exhibit kink-free configurations and do not cause a significant degree of vessel straightening.

Abstract: This invention relates to a method that comprises the introduction of a catheter via left subclavian vein, advancing into the right atrium and then positioning it in the inferior vena cava, just at the cava-diaphragm junction, where it is anchored at its extreme; and thereafter an external inflation of a balloon positioned in said catheter takes place through a physiological solution to reach a diameter corresponding to half the diameter of the inferior vena cava, resulting in hemi-occlusion in the expiration phase (breath-out) and total occlusion for a short period during the inspiration phase (breath-in), regulating (normalizing) the venous return and decreasing the cardiac volume overload, as a treatment for heart failure. The invention also comprises hydromechanics devices to normalize the venous return in the circulatory system. Said venous return is increased in 90% of patients with heart failure.

Abstract: A method of manufacturing a balloon catheter involves applying a first application liquid, which contains a hydrophilic coating material, to the outer periphery of a balloon which is disposed on an elongated catheter and is held in an expanded state; folding the balloon; and applying a second application liquid, which contains the hydrophilic coating material, to the balloon with the balloon folded.

Abstract: The invention relates to a balloon catheter comprising 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. The invention also relates to a method for manufacturing such a balloon catheter.

Abstract: A system for delivering a medical instrument into a bodily cavity is provided, including an outer shaft having an aperture in a side wall thereof, wherein the aperture is provided at a distal portion of the outer shaft, an inner shaft positioned inside the outer shaft and having an inflatable balloon disposed at a distal portion thereof, and a needle member movably disposed in the outer shaft, wherein the needle member extends outwardly from the outer shaft through the aperture when the balloon is inflated.

Abstract: A balloon and method of making a balloon catheter is provided. The balloon for the balloon catheter may be made by slicing through an integral dilation element on a parison (10). The parison may then be stretched to spread the slices to form wider gaps (20). The gaps define separate dilation element segments (14), which may make the balloon more flexible.

Abstract: A method for manufacturing a balloon catheter assembly includes forming a balloon from a polymer selected from the group consisting of polyamide, polyether block amide, and polyethylene terephthalate, forming a plurality of pores in the polymer, and mounting the balloon onto a catheter shaft. The shaft is configured to supply a fluid to the balloon to inflate the balloon, and the pores are configured to prevent the fluid from passing through the balloon.

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: 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: Embodiments of the invention include apparatus and methods for coating medical devices. In an embodiment, the invention includes a coating apparatus including a coating application unit including a fluid applicator; a first rotation mechanism and a second rotation mechanism; and a controller, wherein the controller causes the first rotation mechanism and the second rotation mechanism to rotate a medical device at substantially the same speed, wherein the speed is greater than 500 rotations per minute. In an embodiment, the invention includes a method of coating a medical device including rotating a medical device with a rotation mechanism at a speed of greater than 500 rotations per minute; contacting the medical device with a fluid applicator; and applying a coating solution to the device. In an embodiment, the invention includes a medical device. In some embodiments a surface of a shaft of the device comprises high points and low points.

Abstract: A balloon carries a drug in drug-carrying regions, wherein the drug-carrying regions protect the drug during delivery through a patient's vasculature. Once at a target site, the balloon expands, causing the drug-carrying regions to expose the drug to the target site. One drug eluting balloon device includes a longitudinal sheath that defines an interior space having a balloon disposed therein. When the balloon expands, at least one push element at least partially inverts at least one pocket formed on an outer surface of the sheath. This inversion causes a drug contained within the at least one pocket to be released to the target site. In another embodiment, a plurality of bands is provided, each band made of material having a different resistance to elongation. Upon expansion, the bands invert to expose a drug provided on a surface of the bands.

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 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: This disclosure relates to medical devices and related methods. In some embodiments, the methods include applying a material to the balloon and then removing the material from one or more regions of the balloon.

Abstract: A valvuloplasty balloon assembly includes a balloon (50) provided with end shoulders (64, 66) preferably integral with end cones (54, 56) of the balloon (50). The end shoulders (64, 66) provide a substantially perpendicular stop shoulder (68) at either end of the cylindrical portion (52) of the balloon (50). The restraining shoulders (64, 66) act to hold the balloon (50) within a valve (16) of a heart (10), for instance. This prevents unwanted slippage of the balloon (50) during a valvuloplasty procedure and thus prevents possible damage caused as a result of such slippage.

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: This invention relates to a method that comprises the introduction of a catheter via left subclavian vein, advancing into the right atrium and then positioning it in the inferior vena cava, just at the cava-diaphragm junction, where it is anchored at its extreme; and thereafter an external inflation of a balloon positioned in said catheter takes place through a physiological solution to reach a diameter corresponding to half the diameter of the inferior vena cava, resulting in hemi-occlusion in the expiration phase (breath-out) and total occlusion for a short period during the inspiration phase (breath-in), regulating (normalizing) the venous return and decreasing the cardiac volume overload, as a treatment for heart failure. The invention also comprises hydromechanics devices to normalize the venous return in the circulatory system. Said venous return is increased in 90% of patients with heart failure.

Abstract: Devices and methods for delivering treatment fluids or particulates such as, stem cells, drugs, Botox and like, to an inner lining of a bladder for treatment of urinary tract disorders, including over active bladder. A balloon delivery system can include an inflation balloon having a plurality of micro-needles configured to pierce and otherwise puncture an inner bladder wall so as to deliver the treatment fluid to bladder tissue. The treatment fluid can be directly injected into the bladder tissue using the micro needles. Alternatively, the micro needles can be fabricated of bioabsorbable or bioresorbable materials such that the micro needles can remain embedded within the bladder tissue to deliver the treatment fluid or particulate.

Abstract: The invention provides a catheter system comprising a stomach probe for gastric decompression or drainage of stomach fluids, and a jejunal probe for nutriment supply during enteral feeding. The stomach probe comprises a drainage tube to be inserted into the stomach of a patient, the drainage tube having proximal and distal ends and defining a lumen for receiving and for guiding insertion of the jejunal probe into the small intestine of the patient. The jejunal probe is sized and adapted to be received within the lumen of the stomach probe for guided insertion to the small intestine. The catheter system further comprises support means for supporting the jejunal probe within the lumen of the stomach probe such that the feeding tube maintains a spaced relation to an inner wall surface of the lumen of the drainage tube.

Abstract: Medical devices for delivering a bioactive agent and methods of use thereof are provided. The medical devices include micro-needles integrated within a balloon of a catheter. The balloon can include dimples, cavities or a variable thickness membrane in which the micro-needles are integrated.

Abstract: An method and apparatus are disclosed including an expandable body having a diameter suitable for insertion into a blood vessel and capable of being modified from a first diameter to a second larger diameter in response to an inflation pressure. The expandable body includes an outer wall having a plurality of delivery outlets extending from a working length of the outer wall. The delivery outlets coincide with regions of a lesion exposed between a framework implanted within the vessel when the expandable body is in an expanded state. A treatment agent is delivered from the delivery outlets to regions of the lesion exposed between the implantable framework.

Abstract: Medical devices have material that that has a laser induced periodic surface structure (LIPSS) pattern on at least a portion thereof. The LIPSS pattern is provided by exposing a material surface to a pulsed polarized laser energy fluence below the ablation threshold. The LIPSS pattern is useful for purposes such as reducing contact areas on sliding surfaces, increasing total surface area for adhesions, providing anisotropic reinforcement of a material layer or layers, and to provide multiple channels for directing cell growth.

Abstract: A medical balloon of a balloon catheter has at least first and second layers in which the second, outer, layer is made of a material having a lower melting or softening temperature than the inner layer. The outer layer is provided with texturing or roughening on its outer surface, thereby to provide a textured roughened medical balloon. The inner layer supports the outer layer and in particular the texture or roughening of the outer surface of the outer layer. This support prevents or substantially reduces any flattening of any texture or roughening on the outside surface of the balloon when inflated.

Abstract: A balloon catheter includes a balloon having a plurality of layers. The inner layer acts as a support layer to the outer layer. Embedded within the outer layer is a plurality of particles or pellets which in one embodiment provide roughening of the outer surface of the balloon. The particles or pellets, particularly in conjunction with an inner support layer, ensure maintenance of the roughened outer surface of the balloon during inflation of the balloon. In another embodiment, the particles or pellets may be radiopaque and/or echogenic with or without creating surface roughening of the balloon.

Abstract: A drug delivery system that can be deployed from a catheter and retained within the bladder for delivery of treatment drug solutions over a period of time. The delivery system includes an inflatable or expandable delivery element that can be collapsed within the catheter tip for navigation into the bladder before being inflated or expanded within the bladder. The inflated or expanded delivery element can engage the bladder walls or sized to be too large to be passed from the bladder such that the delivery element is retained within the bladder after inflation or expansion to administer a treatment drug solution over an extended period of time.

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: A balloon dilatation catheter for use in a valvuloplasty procedure includes a catheter shaft and a spiral perfusion balloon mounted thereon. The perfusion balloon is formed from an inflatable tube that is in fluid communication with a catheter shaft inflation lumen. The inflatable tube is coiled into a series of windings that in an inflated configuration form a cylindrical or hourglass profile. In the inflated configuration, inner surfaces of the coiled windings of the inflatable tube define a perfusion lumen to allow blood flow through the perfusion balloon. Adjacent windings may be secured together with a flexible adhesive and/or a support weave formed from one or more filaments of material that criss-crosses between the adjacent windings along substantially the entire length of the spiral perfusion balloon.

Abstract: The invention relates to a balloon catheter comprising a catheter tube and an inflatable balloon. The ends of the balloon are attached to the catheter tube. The outside surface of the balloon in an uninflated state is provided with a relief structure which in an inflated state of the balloon is substantially disappeared. The invention also relates to a method for producing such a balloon catheter.

Abstract: Composite fiber reinforced balloons for medical devices are prepared by applying a web of fibers to the exterior of a preformed underlayer balloon, encasing the web with a matrix material to form an assembly, and inserting the assembly into a preformed outer layer balloon to form the composite balloon.

Abstract: Various embodiments provide a device comprising a balloon disposed at least partially along a template, the template including an aperture, wherein the template has a substantially cylindrical portion that resists deformation in a radial direction, wherein the balloon expands radially during inflation, wherein a portion of the balloon at least partially protrudes about the aperture. Other embodiments are directed toward balloons having textured surfaces.

Abstract: A loading dilator for positioning a medical apparatus across a stoma formed in a body wall of a patient. The medical apparatus, such as a tracheotomy tube, is sized to fit over a portion of the loading dilator during positioning of the apparatus across the stoma. The loading dilator includes an elongated dilator body having a tapered distal end for facilitating entry into the stoma. The dilator body has an inflatable balloon disposed along an outer surface at the distal end. The balloon is inflatable to a configuration such that a generally smooth diametrical transition is formed between the elongated dilator body and a leading end of the medical apparatus when the medical apparatus is fit over the loading dilator.

Abstract: The present invention relates to compositions which are suitable for selective filling or selective coating of folds of a folded balloon, and especially relates to compositions of a contrast agent and an active agent in a solvent for filling of folds of a folded catheter balloon as well as to methods for selective filling or selective coating of folds of a folded catheter balloon and to filled or coated folded catheter balloons which can be obtained according to one of these methods.

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: The invention relates to a preparation for restenosis prevention. The preparations for restenosis prevention known as yet do not reach sufficient active agent concentrations in the affected sections of the vascular walls as higher doses cause undesirable side effects. The present invention is a preparation to which at least one antihyperplastic agent is added that has a distribution ratio between butanol and water .gtoreq.0.5. The lipophilic active agent is absorbed by the vascular wall fast and in sufficient quantity. The preparation may be a liquid that can pass through capillaries and may contain a contrast agent so that the active agent is transferred into the vascular wall without any additional effort while the usually required contrast radiograms are taken. The preparation may also be applied to a catheter.

Abstract: An ostomy appliance is disclosed with an inflatable seal for sealing against the stoma. The inflatable seal has a first inflatable chamber portion for fitting inside the stoma to seal against the internal tissue. The inflatable seal also has a second inflatable chamber portion for sealing externally against the stoma and peristomal skin. In one embodiment, a tube extends through the inflatable seal to provide a communication passage for discharge of body waste without removing the inflatable seal. The tube floats with respect to an adhesive mounting member to allow a waist between the first and second inflatable chamber portions to self-locate in the stoma.

Abstract: A catheter assembly comprising a first polymer, a second polymer and a first weld region. The first polymer forms a balloon having a first waist. The second polymer forms a catheter shaft. The first waist is positioned about a portion of the catheter shaft thereby forming the first weld region. The first weld region comprises a first weld and a second weld which engage the first waist to the catheter shaft. The first weld has a first longitudinal position and the second weld has a second longitudinal position, where the first longitudinal position is different from the second longitudinal position.

Abstract: Percutaneous methods and apparatus for forming a venous valve from autologous tissue by creating at least one subintimal longitudinal dissection that forms at least one flap of intimal tissue are disclosed. In one method, a balloon catheter having a dissecting blade mounted thereon is delivered to a target site where a new venous valve is to be created. The balloon is inflated to deploy the blade against the vein wall, and the catheter is longitudinally translated such that the blade dissects a subintimal layer of the vein wall. The balloon is subsequently deflated such that the blade pulls a flap of the dissected tissue towards the vein lumen, thereby creating a leaflet and corresponding pocket/sinus in the vein that collectively act as a monocuspid venous valve. Methods of forming new bicuspid and tricuspid venous valves utilizing two or three dissecting blades mounted on the balloon are also disclosed.

Abstract: A method of occluding includes imbibing a porous elongate element comprised of ePTFE with a calcium-containing solution. The method also includes delivering, via a delivery catheter, the calcium-imbibed porous elongate element to a target occlusion site. The method further includes administering, after the calcium-imbibed porous elongate element has been completely delivered to the target occlusion site and resides entirely within a volume defined by the target occlusion site, an alginate-containing solution to the target occlusion site.

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: Apparatus for accessing a bodily passageway, the apparatus comprising: a flexible tube having a distal end and a proximal end, a longitudinal axis extending between the distal end and the proximal end, and a lumen extending from the distal end to the proximal end, the lumen being sized to receive matter to be transported through the bodily passageway; and an external thread disposed over the distal end of the tube, the external thread having a sufficient structural integrity, and a sufficient surface profile, such that when the tube is disposed in a bodily passageway, rotation of the tube about the longitudinal axis will result in longitudinal motion of the tube along said bodily passageway.

Abstract: There are disclosed apparatus and methods for treating tissue by delivering at least one therapeutic agent into the tissue. In one embodiment, the apparatus comprises a catheter (30, 40) and a balloon member (150) disposed on a distal region of the catheter. A plurality of pockets (164) are disposed on the balloon member (150), and a plurality of needles (180) are associated with each of the plurality of pockets. The plurality of needles (180) are configured to engage tissue when the balloon (150) is in the inflated state, and further are configured to disperse a therapeutic agent from an associated pocket (164) into the tissue when the balloon (150) is in the inflated state. A first needle (180a) of the plurality of needles may comprise a length that is different than a second needle (180b), permitting the delivery of first and second therapeutic agents to different depths within the tissue.

Abstract: A medical device for performing a surgical procedure on a patient including an elongate tubular shaft having an outer surface extending from a proximal end to a distal end and an inner passage in fluid communication with a fluid source during use of the device. The shaft further has a lateral hole in the outer surface in fluid communication with the inner passage for delivering fluid from the device in a lateral direction during surgery. The device further includes a distal balloon having an exterior surface connected to the shaft and a projection extending from the exterior surface. The device also includes a proximal balloon connected to the shaft between the distal end and the proximal end of the shaft and a locating structure connected to the shaft. The hole is positioned in the outer surface between the distal balloon and the proximal balloon.