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tip to allow the tip to return to the initial 0.12 -inch accommodating profile when the larger 0.14-inch guidewire is withdrawn from the catheter.

Abstract: A low profile surgical access device includes an elongated cannula having an opening defined at a proximal end thereof including an inner peripheral surface dimensioned to facilitate passage of instrumentation therethrough and an outer peripheral surface configured to operatively engage and removably secure to tissue via, e.g., fixation ribs, adhesive, anchors, clips, suction elements, expandable materials and/or combinations thereof. A valve is operatively coupled to the elongated cannula and provides a substantially fluid tight seal when instrumentation is inserted through the cannula. A seal housing is included which is positionable relative to the cannula and which is configured to operatively engage and removably secure to tissue. The instrument seal in the seal housing is positioned in vertical registry with the valve in the elongated cannula.

Abstract: Described is a medical device and method for allowing fenestration of the aortic wall while maintaining distal perfusion and preventing external bleeding. The device isolates a segment of the aortic wall from the flowing column of blood using a balloon mounted on a metal alloy strut assembly. The strut assembly expands radially from a collapsed, low-profile configuration when uncovered by a constraining outer sheath. Aortic blood flow is allowed through the flow passage thus contained by the strut assembly within the center of the balloon. The balloon is inflated to contact the aortic wall. The balloon contains a pocket shaped to allow aortic fenestration. The balloon contains radiopaque markers to facilitate orientation and positioning of the pocket within the aorta. Other embodiments using spaced balloons are also disclosed.

Abstract: A guidewire lumen for a catheter includes a tubular portion and a sleeve bonded over less than an entire length of the tubular portion. The tubular portion is formed of a first material and the sleeve is formed of a second material. The second material may bond better to certain materials than the first material.

Abstract: A shaft for a balloon dilation catheter comprises a proximal portion wherein a guidewire tubular member is disposed coaxially within an outer tubular member, a shaft transitional portion, wherein the guidewire member is disposed within the outer member, with at least one distal tubular member not present in the proximal portion, a shaft distal portion, wherein the guidewire member and the distal members are disposed side-by-side and encased within a distal body, and fluid-tight barrier within a proximal lumen blocking the flow of fluid in the proximal lumen, but allowing the proximal lumen to remain in fluid communication with a distal lumens.

Abstract: A rapid ex balloon dilation catheter includes a catheter shaft with a proximal tubular member defining a proximal inflation/deflation lumen for conveying fluids therethrough with a distal portion of the bore of proximal tubular member filled with a fluid-impervious barrier, a distal body extending from the fluid-impervious barrier to the distal end of the shaft, a plurality of distal tubular members defining distal inflation/deflation lumens in fluid communication with the proximal inflation/deflation lumen and extending through the fluid-impervious barrier and the distal body to the distal end of the shaft distal portion, a guidewire tubular member having a bore extending from a side aperture formed in the distal body through the distal body alongside the distal tubular members in a multi-lumen arrangement, and a plurality of stiffening members extending from within the fluid-impervious barrier into the distal body to a point within the shaft distal portion.

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: A balloon catheter assembly includes a first tubular member with a proximal portion and a distal portion and a lumen extending between the proximal portion and the distal portion. A balloon has a proximal waist length, a distal waist length and an expandable region therebetween disposed about the distal portion. A tie layer is disposed between the proximal waist length or distal waist length and the first tubular member. The tie layer comprises a polyester polymer and a polyamide polymer.

Abstract: The end cap is preferably formed of a relatively high durometer material with an inner surface on an outer surface of the shaft and on an outer surface of the balloon skirt section, and contacts a compression member on the balloon outer surface. The configuration prevents or inhibits failure at the balloon seals which otherwise results from the compression member moving or the balloon pulling off the shaft and out from under the compression member during inflation of the balloon. As a result, the balloon catheter of the invention has an improved consistent burst pressure and/or failure mode.

Abstract: Devices, methods, and systems for measuring the size of gastric pouches. At least some embodiments include a catheter comprising an outer elongate tube, an inner elongate tube disposed within the outer elongate tube, a proximal balloon attached to the outer elongate tube, a distal balloon having a first end attached to the outer elongate tube and a second end attached to the inner elongate tube, at least two detection electrodes positioned on the outer elongate tube relative to at least two excitation electrodes, and a pressure transducer positioned on the outer elongate tube.

Abstract: A low-profile rapid-exchange catheter device having desirable strength between joined proximal and distal portion may be constructed using a method that includes a textile sleeve and a thermoplastic polymer overlay.

Abstract: A catheter device including an elongate tubular shaft having a consistent material composition for a substantial proportion of its length. The device includes a proximal shaft portion having a first flexibility and a distal shaft portion having a second flexibility, wherein the second flexibility is greater than the first flexibility and wherein at least the distal shaft portion comprises at least one score in a surface thereof. The device includes a wholly external wire guide structure secured to the tubular shaft by a figure-eight polymer sleeve.

Abstract: A balloon catheter assembly includes a first tubular member with a proximal portion and a distal portion and a lumen extending between the proximal portion and the distal portion. A balloon has a proximal waist length, a distal waist length and an expandable region therebetween disposed about the distal portion. A tie layer is disposed between the proximal waist length or distal waist length and the first tubular member. The tie layer comprises a polyester polymer and a polyamide polymer.

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: The present invention relates to the attachment of balloon walls to catheters in order to provide a balloon catheter. In particular it relates to adhering the balloon walls to the catheters in order to optimize an even inflation of the balloon.

Abstract: A thin sheath of flexible, flaccid material is introduced through openings in the body of an animal or human patient to permit surgical tools or fluids to be inserted and removed, or debris removed, during surgeries anywhere in the body to protect the tissue of the body from the instruments used. The sheath is inserted by an obturator which holds the sheath thereon by suction through an aperture in the obturator at its distal end. Once the sheath is inserted, suction is removed to release the sheath. Then a balloon on the distal end of the sheath is expanded to hold the sheath in place in the body while the obturator is removed. The sheath then remains in place with the balloon holding the distal end in the open position to enable fluids to flow through the sheath. After a procedure, the balloon is deflated and the sheath removed.

Abstract: The invention generally relates to internal (e.g., implantable, insertable, etc.) drug delivery devices which contain the following: (a) one or more sources of one or more therapeutic agents; (b) one or more first electrodes, (c) one or more second electrodes and (d) one or more power sources for applying voltages across the first and second electrodes. The power sources may be adapted, for example, to promote electrically assisted therapeutic agent delivery within a subject, including electroporation and/or iontophoresis. In one aspect of the invention, the first and second electrodes are adapted to have tissue of a subject positioned between them upon deployment of the medical device within the subject, such that an electric field may be generated, which is directed into the tissue. Furthermore, the therapeutic agent sources are adapted to introduce the therapeutic agents into the electric field.

Abstract: The invention provides design, material, manufacturing method, and use alternatives for medical devices. An example medical device includes a first elongated member having a proximal end, a distal end, and a lumen extending therebetween and a second elongated member having a proximal end, a distal end, and a lumen extending therebetween. The proximal end of the second elongated member may be disposed adjacent to the distal end of the first elongated member forming an actuatable junction. In some cases, the actuatable junction may be actuatable between a first state and a second state. When in the first state, the first elongated member may be rotatable relative to the second elongated member and, when in the second state, the first elongated member may be fluidly sealed to the second elongated member.

Abstract: A catheter having an elongated shaft with a proximal end, a distal end, and at least one lumen, and a distal portion of the shaft being at least in part within an outer sheath having a wedge-shaped distal end. In one embodiment, the outer sheath around the distal end of the shaft is the distal skirt section of the balloon. In an alternative embodiment, the outer sheath is a sleeve member having at least a portion located distal to the distal end of the balloon.

Abstract: A catheter assembly comprises a catheter shaft, a balloon and a pair of collars. The collars may be fixed or rotatable about a catheter shaft prior to exposure to an electric current. Where the collars are fixed to the shaft, the balloon is rotatable about the collars. When exposed to the electric current the collars expand to engage the waists of the balloon thereby sealing the balloon. Where the collars are rotatable about the shaft, the each waist of the balloon is engaged to a respective collars. When the rotatable collars are exposed to the electric current the collars expand to engage the shaft of the catheter thereby sealing 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 catheter device including an elongate tubular shaft having a consistent material composition for a substantial proportion of its length. The device includes a proximal shaft portion having a first flexibility and a distal shaft portion having a second flexibility, wherein the second flexibility is greater than the first flexibility and wherein at least the distal shaft portion comprises at least one score in a surface thereof.

Abstract: An interventional catheter for angioplasty and the like, comprising 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: The purpose of this invention is to provide an esophagus stoma button capable of safely forming and maintaining a stoma hole provided in an esophagus and reducing the discomfortableness of a patient. To achieve the object, in the present invention, the stoma button 9 is comprised of a shaft part 1 and a flange part 2 provide at the rear end of the shaft part rounded at the tip thereof. More specifically, in the esophagus stoma button 9, a flange part is provide at the rear end of the shaft part rounded at the tip thereof, and a lumen having a generally circular cross section in the area ranging from the shaft part to the flange part is provided, a means for fixing a catheter for infusion is provided in the flange part with a flat and generally circular shape and a means for tightly closing the opening of the flange part is provided at the opening thereof.

Abstract: A side catheter branch of a catheter assembly is oriented with respect to the main or side balloons of a catheter assembly. In some examples, the orientation is accomplished by connecting the side catheter branch to the main and/or side balloons or waste portions thereof. In other examples, the side catheter branch is positioned within the folds of the main or side balloons during assembly of the catheter assembly. In this manner, the side catheter branch remains in a known orientation with respect to the main and/or side balloons prior to and/or after deployment.

Abstract: The end cap is preferably formed of a relatively high durometer material with an inner surface on an outer surface of the shaft and on an outer surface of the balloon skirt section, and contacts a compression member on the balloon outer surface. The configuration prevents or inhibits failure at the balloon seals which otherwise results from the compression member moving or the balloon pulling off the shaft and out from under the compression member during inflation of the balloon. As a result, the balloon catheter of the invention has an improved consistent burst pressure and/or failure mode.

Abstract: A hub system comprising, in combination: a luer further comprising a luer channel, configured to accommodate a selected device, said luer channel further comprising a segment extending through an extension of said luer; and a nose further comprising a nose channel configured to selectively couple with said extension, wherein the inner diameter of at least a portion of said nose channel is less than the outer diameter of the extension. A method of using the same to secure a device within said system.

Abstract: Rapid exchange angioplasty catheters and methods of constructing rapid exchange angioplasty catheters including features that provide good pushability and kink resistance. In an illustrative embodiment, a catheter is provided, the illustrative catheter including a proximal hypotube section, which connects to a more distal braided catheter section. The braided catheter section connects to a midshaft portion that includes a guidewire entry port. Distal of the midshaft portion is a distal section having a cutting balloon disposed thereon. An inflation lumen extends the length of the catheter, while a guidewire lumen extends only from the guidewire entry port to the distal end of the catheter. Optionally, a core wire may extend across the joint from the hypotube, to the braided catheter section, and past the guidewire entry port.

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: The present invention is directed to distal tip designs for catheter, wherein distal tip material is positioned about an inner shaft. The distal tip material may also be used as a tie layer for thermally bonding two incompatible materials together, such as a waist portion of a balloon to the inner shaft.

Abstract: A toroidal balloon system apparatus and method for use in a vessel includes a catheter defining an inflation lumen and having an inflation port in communication with the inflation lumen; and a toroidal balloon attached to the catheter. The toroidal balloon defines a balloon lumen in communication with the inflation port to inflate the balloon and a central lumen which allows fluid flow through the balloon and the vessel when the toroidal balloon is inflated.

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 catheter having an multilayered shaft section with a first layer formed of a polyimide first material and a second layer formed of a second material. In a presently preferred embodiment, the polyimide material is a thermoset polyimide. However, in alternative embodiments, a thermoplastic polyimide is used. The thermoset polyimide has a very high glass transition temperature (Tg) of approximately 400° C. (as measured by differential scanning calorimetry), and excellent dimensional stability at the processing temperature of polyamides commonly used in catheter components. As a result, during formation and assembly of the catheter, production of a thin polyimide layer with controlled dimensions is facilitated. The polyimide has a high modulus and provides a thin walled yet highly pushable shaft section, while the second layer provides kink resistance. In one embodiment, the second material is selected from the group consisting of a polyamide material and a polyurethane material.

Abstract: A measuring device for measuring tunnel defects in tissue is disclosed. The measuring device can size the defect to aid future deployment of a tissue distension device. Exemplary tunnel defects are atrial septal defects, patent foramen ovales, left atrial appendages, mitral valve prolapse, and aortic valve defects. Methods for using the same are disclosed.

Abstract: A medical catheter assembly including a multi-piece connector. In one embodiment, the medical catheter assembly is a PEG implanting assembly comprising a tubular dilator and a silicone feeding tube having an internal bolster at its rear end. The assembly also comprises a multi-piece connector comprising an inner ring, a fitting and an outer ring. The inner ring has an outer diameter greater than the inner diameter of the feeding tube and is coaxially disposed within the feeding tube by a friction-fit. The fitting comprises a front portion, an intermediate portion and a rear portion, the intermediate portion including a shoulder having an outer diameter greater than the inner diameter of the feeding tube. The front portion of the fitting is inserted through the rear end of the dilator and is secured to the dilator by a plurality of barbs.

Abstract: A catheter having shaft segments which are joined together by a strong bond providing a low profile shaft section with a flexibility transition and/or a compositional transition. A balloon catheter embodying features of the invention has a distal tip member and a coupling band member surrounding a junction of an inner tubular member of the shaft, and has a gradual change in bending stiffness along a distal end section of the shaft which extends distally from a location within the balloon interior. Another catheter embodying features of the invention has shaft segments joined together by a diagonal seam.

Abstract: A rapid exchange balloon dilation catheter includes a catheter shaft with a proximal tubular member defining a proximal inflation/deflation lumen for conveying fluids therethrough with a distal portion of the bore of proximal tubular member filled with a fluid-impervious barrier, a distal body extending from the fluid-impervious barrier to the distal end of the shaft, a plurality of distal tubular members defining distal inflation/deflation lumens in fluid communication with the proximal inflation/deflation lumen and extending through the fluid-impervious barrier and the distal body to the distal end of the shaft distal portion, a guidewire tubular member having a bore extending from a side aperture formed in the distal body through the distal body alongside the distal tubular members in a multi-lumen arrangement, and a plurality of stiffening members extending from within the fluid-impervious barrier into the distal body to a point within the shaft distal portion.

Abstract: A medical device including a medical device thin metallic film component (such as a thin metallic angioplasty balloon), with perforations therethrough, attached to a medical device polymeric component (e.g., a polymeric tubular catheter) abutting the thin metallic film component. The medical device also includes a polymeric sleeve covering the perforations and at least a portion of the polymeric component abutting the thin metallic film component. Moreover, the polymeric sleeve intrudes into the perforations and joins the thin metallic film component to the polymeric component. A method for attaching a medical device thin metallic film component (for example a thin metallic film angioplasty balloon) to a medical device polymeric component (e.g., a tubular polymeric catheter) includes forming a plurality of perforations in the medical device thin metallic film component and abutting the medical device polymeric component against the medical device thin metallic component.

Abstract: A method for fixing one of a balloon and a tubular member to an object with a thread for a medical equipment, may include covering the object with an end of the one of the balloon and the tubular member, winding the thread at a first pitch in a first direction from an edge of the end of the one of the balloon and the tubular member toward an intermediate position of the one of the balloon and the tubular member, and winding the thread at a second pitch in a second direction opposite to the first direction, the second pitch being shorter than the first pitch.

Abstract: A shaft for a balloon dilation catheter comprises a proximal portion wherein a guidewire tubular member is disposed coaxially within an outer tubular member, a shaft transitional portion, wherein the guidewire member is disposed within the outer member, with at least one distal tubular member not present in the proximal portion, a shaft distal portion, wherein the guidewire member and the distal members are disposed side-by-side and encased within a distal body, and fluid-tight barrier within a proximal lumen blocking the flow of fluid in the proximal lumen, but allowing the proximal lumen to remain in fluid communication with a distal lumens.

Abstract: Multilayer medical devices, apparatuses for making such devices, and methods of making such devices are disclosed.

Abstract: The present invention relates generally to a catheter having a torque transmitting shaft which retains adequate flexibility. The catheter includes an elongate shaft having an outer surface. In a preferred embodiment, a raised pattern is disposed on the outer surface. Preferably, the raised pattern improves the transmission of torque along the elongate shaft by including a series of bearing points which contact other bearing points along the shaft when torqued.

Abstract: A method of producing a balloon of a balloon catheter includes the following method steps: providing a balloon body coupled to a proximal sleeve and a distal sleeve by transitional sections extending between the balloon body and the sleeves; creating folds in at least the distal sleeve; and stabilizing at least a distal section of the folds of the distal sleeve.

Abstract: A balloon catheter including an inflatable balloon affixed to a catheter. The proximal end of the balloon is affixed to the distal end of the catheter so as to provide an air tight seal there between. A stiffening member extends distally of the distal end of the catheter and forms a slip joint connection with the distal end of the balloon to permit the distal end of the balloon to axially move or translate relative to the distal end of the catheter. The slip joint allows the axial length of balloon to change during inflation or deflation without transferring tensile or compressive forces between the balloon and the catheter, thereby preventing transverse creases from forming in the surface of the balloon and preventing the catheter from bowing. The stiffening member provides alignment and lateral support to the distal end of the balloon.

Abstract: A releasably locking dilator and sheath assembly (10) and methods for releasing the dilator (12) from the sheath (14) and longitudinally splitting the sheath. The assembly includes a dilator having a dilator hub (20) and a sheath having a sheath hub (40). The sheath hub may have a valve and has two opposing winged tabs (42), each tab having a perpendicular portion (44) and an angled portion (46) as well as a female threaded portion (53). The dilator hub (20) has a male threaded portion (30) designed to engage the female threaded portion of the sheath hub. The dilator is released from the sheath by rotating the dilator 90° in relation to the sheath and pulling the dilator out of the sheath. The sheath is longitudinally split by creating a couple on each of the winged tabs (42) thereby forcing the sheath and the sheath hub to split longitudinally. With the sheath and sheath hub split longitudinally, the sheath is removed from around a catheter while leaving the catheter in place.

Abstract: A catheter assembly comprises an elongate shaft having a proximal end and a distal end. The assembly also comprises a flexible distal tip having a proximal end coupled to the distal end of the elongate shaft and having a distal end. The flexible distal tip has at least one groove in a surface thereof.

Abstract: A balloon catheter that comprises an inner shaft, a balloon and a sleeve that defines a lumen. A portion of the inner shaft is positioned within the lumen and the balloon is engaged to the sleeve at least two engagement points.

Abstract: A balloon catheter and a method of making the balloon catheter, having a balloon which is bonded to an elongated shaft, and which has a first layer and a second layer and an improved bond between the balloon and the shaft. One aspect of the invention is directed to a balloon in which the balloon first layer includes eUHMWPE and has at least a section that has been oxidized with a chromic acid solution to provide improved bondability.

Abstract: A guidewire lumen for a catheter includes a tubular portion and a sleeve bonded over less than an entire length of the tubular portion. The tubular portion is formed of a first material and the sleeve is formed of a second material. The second material may bond better to certain materials than the first material.

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.