Abstract: Inflatable medical devices and methods for making and using the same are disclosed. The inflatable medical devices can be medical balloons. The balloons can be configured to have a through-lumen or no through-lumen and a wide variety of geometries. The device can have a high-strength, non-compliant, fiber-reinforced, multi-layered wall. The inflatable medical device can be used for angioplasty, kyphoplasty, percutaneous aortic valve replacement, or other procedures described herein.

Abstract: Methods of varying the stiffness of polymeric medical tubes.

Abstract: An aortic occlusion and perfusion device includes an expandable member configured to expand within the aorta to secure the device within the aorta, and a catheter extending proximally from the expandable member and in fluid communication with the expandable member. The catheter can define a plurality of openings along its length through which blood can pass with one or more of the openings located proximal to the expandable member and one or more of the openings located within the expandable member. The device can also include a flow control sheath disposed around the catheter member such that axial movement of the flow control sheath relative to the catheter selectively occludes or uncovers one or more of the openings located proximal to the expandable member.

Abstract: An example medical device includes a balloon that is inflatable to an inflated configuration. The balloon includes a non-compliant layer coextruded on an inner layer, and an outer layer coextruded on the non-compliant layer. The non-compliant layer is configured to delaminate from the inner and the outer layers in the inflated configuration. The non-compliant layer may be configured to rupture in the inflated configuration. An example technique includes inflating the balloon to a predetermined pressure sufficient to rupture the non-compliant layer and insufficient to rupture both the inner and outer layers. The example technique further includes deflating the balloon, and introducing the balloon into a vasculature. Another example technique includes coextruding a non-compliant layer on an inner layer, coextruding an outer layer on the non-compliant layer, and forming a balloon from the inner layer, the non-compliant layer, and the outer layer.

Abstract: The present invention discloses a urinary catheter that utilizes balloons to generate a method of urine drainage. The disclosed invention does not implement a traditional drainage port and avoids an exposed catheter tip. Rather, this invention consists of a multi-lumen shaft with a divided tip that generates a horizontal aperture for urine drainage when separated. The invention utilizes retention members that can take the form of multiple expandable balloons or a singular, expandable, central balloon. The balloon element can consists of balloons that are attached separately to each divided tip or one balloon shared with adjacent divided tips so that when the balloon element expands, a communication channel is revealed between the bladder and the central lumen of the shaft, ultimately generating a method of urine drainage.

Abstract: A device for introducing an implant (1) into blood vessels or hollow organs of the human or animal body. The device includes an implant (1), an insertion wire (14) and a release tube (13), wherein the implant (1) is deformable so that it fits into a microcatheter (8) and expands once the external constraint of the microcatheter (8) disappears, adapting to the diameter of the blood vessel or hollow organ, wherein a holding element (2) is arranged on the insertion wire (14) and the holding element (2) has at its periphery at least one groove (3) set into the holding element (2), running along the circumference of the holding element (2) and forming tracks in the form of curved lines, wherein the implant (1) has holding wired (5) extending proximally, which are fitted into the grooves (3).

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

Abstract: Embodiments of the invention include bioactive agent eluting devices. In an embodiment the invention includes a bioactive agent delivery device including a substrate, a hydrophilic polymer disposed on the substrate, and a substantially amorphous bioactive agent disposed on the surface of the hydrophilic polymer. In an embodiment, the invention includes a method of making a bioactive agent delivery device including depositing a hydrophilic polymer on a substrate forming a hydrophilic surface and depositing a substantially amorphous bioactive agent on the hydrophilic surface. In an embodiment, the invention includes a bioactive agent-eluting catheter including a catheter shaft and an expandable balloon disposed on the catheter shaft. Other embodiments are included herein.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a pulmonary biopsy needle having a proximal end, a distal end, and an elongated body extending between the proximal end and the distal end. The needle may be configured to access a periphery of a patient's lungs and the elongated portion may have a first portion, a second portion, and a piercing tip. The first portion may have a first flexibility and the second portion may have a second flexibility that is more flexible than the first flexibility. The second portion may extend distally of the first portion and the second flexibility may be constant along a length of the second portion. The first portion of the needle may have a wall-thickness different than a wall-thickness of the second portion of the needle.

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: Inflatable devices are disclosed including a surface which has a network of polymer chains and is configured to be inflatable into a therapeutically or diagnostically useful shape, and at least one ultrashort laser pulse-formed modification in the surface. The network can, for example, include a network morphology that is substantially unchanged by modification with the ultrashort pulse laser. Ultrashort laser pulses can be laser pulses equal to or less than 1000 picoseconds in duration. Advantageously, the etching process uses a relatively low-heat laser to avoid significant heating of surrounding polymers while modifying the surface (and other structures) of the device. The process is configured so that the polymer chain morphology adjacent the modification is substantially unaffected by the low-heat laser. The resulting inflatable device has customized surface features while still retaining substantially homogenous polymer network morphology.

Abstract: Embodiments of the invention provide drug packaging and methods for producing drug packaging which can be sealed at room temperature and/or without the need for elevated temperatures above room temperature. Many embodiments provide drug packaging comprising pierceable tubing having a capsule shape (also referred to herein as a pierceable capsule and/or pierceable drug capsule) containing a solid drug such as a drug pellet and methods for producing pierceable drug capsules which can be sealed at room temperature. Embodiments are particularly useful for the packaging and delivery of drugs used in implantable drug delivery devices as well as packaging of drugs that are easily thermally degraded.

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

Abstract: A medical balloon for a balloon pump is disclosed. The medical balloon has a first end and a second end and a port at one of the ends for engaging a catheter for receiving an inflation fluid into the balloon. The balloon has one or more exterior walls defining, when the balloon is inflated at substantially a standard operating pressure, a taper along at least a part of the length of the balloon. The taper has two or more consecutive tapering sections, each tapering section having a different, substantially constant, angle of tapering. The balloon is substantially asymmetrical about a mid-point between the first and second ends when inflated.

Abstract: A system for delivering an implantable medical device to a treatment site within a patient includes an implantable medical device including a rigid body, and a delivery device. The delivery device includes an elongated catheter shaft and an expandable balloon connected to the elongated catheter shaft adjacent a distal end of the elongated catheter shaft, where the expandable balloon includes a proximal region, a distal region, and an implant retaining portion disposed between the proximal region and the distal region. The delivery device also includes a compression element connected to the implant retaining portion of the expandable balloon, where the compression element is adapted to limit expansion of the implant retaining portion of the expandable balloon when the expandable balloon is at least partially inflated. At least a portion of the compression element and the implant retaining portion are disposed within a lumen of the implantable medical device.

Abstract: A balloon including an outer circumferential portion which dilates to form a hollow circular cross-section and deflates when the internal pressure is reduced, an inner circumferential portion positioned inside the outer circumferential portion, and support portions positioned between the outer circumferential portion and the inner circumferential portion to support deflating the outer circumferential portion while compressing the outer circumferential portion. The support portions form first compression portions, which have a high compressive strain, and second compression portions, which have a compressive strain lower than the first compression portions.

Abstract: Methods are provided for partial aortic obstruction for cerebral perfusion augmentation in patients suffering from global or focal cerebral ischemia. Alternatively, the methods can be used to partially obstruct aortic blood flow to condition the spinal cord to secrete neuroprotective agents prior to abdominal aortic aneurysm repair. Partial obstruction of a vessel can be accomplished by a device comprising an elongate catheter and a distally mounted expandable member. The expandable member may comprise one or two balloons. Other medical devices, such as an angioplasty, stent, or atherectomy catheter, can be inserted distal the expandable member to provide therapeutic intervention.

Abstract: The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

Abstract: A stent delivery system can include a core member, a stent, and a stent engagement member. The engagement member can be positioned along a distal segment of the core member and be coupled to the core member. The engagement member can have an outer surface. The stent can extending along the core member distal segment such that the outer surface of the engagement member engages an inner surface of the stent along at least a portion of only a distal half of the stent for transmitting an axial force from the core member to only the stent distal half of the stent.

Abstract: Methods for crimping a stent on an expandable member of a delivery catheter, and devices and methods for treating a bifurcation are disclosed. A method for crimping includes positioning a stent having a first portion and a second portion over the expandable member, and non-uniformly crimping the stent to the expandable member. The method can include routing an elongate shaft under the second portion of the stent and through the side hole so as to be routed external to the first portion. The stent second portion can be crimped so that the elongate shaft can be slidably disposed relative to the stent second portion prior to deployment of the stent.

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 system for moving particles suspended in a first fluid, and for infusing them into the stream of a second fluid, includes a catheter with a multi-lumen distal separator. The separator is formed with a plurality of parallel lumens, wherein each lumen has a predetermined diameter to reduce particle flocculation. An inflatable balloon, affixed to the outside of the catheter, can be provided to regulate flow of the second fluid and thereby facilitate entry of the particles into the stream of the second fluid. A reinforcing member is employed to strengthen the catheter wall under the inflatable balloon. With this arrangement, the catheter does not kink or collapse due to the pressure exerted on the catheter wall when the balloon is inflated. In one embodiment, the reinforcing member includes an annular shaped ring. In another embodiment, the separator is positioned under the balloon and acts as the reinforcing member.

Abstract: An inflatable balloon cuff may be adapted to seal a patient's trachea when associated with an endotracheal tube. These cuffs may include features that facilitate detection or visualization of the cuff, for example with ultrasound devices, to ensure proper placement of the cuff and the tube. Such surface features may include particular types of materials or shaped or protruding features that may be detected in the environment of the trachea.

Abstract: Balloon catheter comprises an elongate catheter shaft having a proximal section, a distal section, and an inflation lumen defined therein and a multilayer balloon on the distal section of the shaft comprising a first layer made of a first polymer material having a first Shore durometer hardness, a second layer made of a second polymer material having a second Shore durometer hardness greater than the first Shore durometer hardness, wherein the second layer is an inner layer relative to the first layer, and a third layer made of a third polymer material having a third Shore durometer hardness less the first Shore durometer hardness, wherein the third layer is an inner layer relative to the second layer. Method of making a balloon catheter is also provided.

Abstract: The present disclosure describes implantable medical devices comprising covers, such as a balloon cover. Such devices can comprise a first layer of a porous polymeric material, such as ePTFE, surrounded by layers of a porous polymeric material having an imbibed elastomer, such as polyurethane. The cover can be used to assist in deployment of an expandable implant, such as a stent-graft, within the body of the patient.

Abstract: A balloon cover is provided to enhance the performance of a medical balloon, the cover, in accordance with an embodiment, having overlapping portions and opposed apertures located at apexes of tapered ends of the balloon cover. A method of making balloon covers is also disclosed.

Abstract: Various embodiments of tracheal tube assemblies disclosed herein may include a tubular body having an open distal end for ventilating a patient and a cuff disposed around the tubular body above the open distal end. The cuff may be adapted to be inflated to seal the cuff against a wall of a trachea of the patient. The cuff may include a first portion that spaces the tubular body a first distance from the tracheal wall when inflated and a second portion that spaces the tubular body a second distance from the tracheal wall when inflated. The second distance may be greater than the first distance.

Abstract: Balloon catheter comprises an elongate catheter shaft having a proximal section, a distal section, and an inflation lumen, and a multilayer balloon on the distal section of the shaft. The multilayer balloon comprises at least a first layer and a second layer having a combined wall thickness and an outer-most layer. The first layer is made of a first polymer material having a first maximum blow-up-ratio. The second layer is made of a second polymer material having a second maximum blow-up-ratio greater than the first maximum blow-up-ratio and the second layer is an inner layer relative to the first layer. The at least first and second layers define a compliance less than that of a single layer balloon made of the first polymer material with a wall thickness equal to the combined wall thickness. The outer-most layer is made of a third polymer material.

Abstract: Medical devices, such as medical balloons, and methods of making the devices, are disclosed. In some embodiments, the balloons include a portion, e.g., a layer, that varies in thickness.

Abstract: A cuff-equipped tube formed by providing a cuff to the outer periphery of a flexible tube, the cuff being expanded by introducing an operation fluid thereinto or being contracted by discharging the operation fluid therefrom. The cuff is provided with a cuff affixing portion expanded outward by the introduction of the operation fluid thereinto, and also with one mounting portion and the other mounting portion that are mounted to the outer peripheral surface of the tube. The connecting portions of the cuff affixing portion and the one mounting portion is affixed in a constricted shape to the outer peripheral surface of the tube, and the connecting portions of the cuff affixing portion and the other mounting portion is affixed in a constricted shape to the outer peripheral surface of the tube.

Abstract: Balloon catheter comprises an elongate catheter shaft having a proximal section, a distal section, and an inflation lumen, and a multilayer balloon on the distal section of the shaft. The multilayer balloon comprises a first layer made of a first polymer material having a first Shore durometer hardness, a second layer made of a second polymer material having a second Shore durometer hardness lower than the first shore durometer hardness, wherein the second layer is an inner layer relative to the first layer, and an outer-most layer made of a third polymer material having a third Shore durometer hardness lower than the second Shore durometer hardness.

Abstract: The present invention relates to medical devices for dilating or enlarging strictures or narrowed regions of body vessels. Specifically, the present invention relates to a high pressure dilation balloon catheter that includes an elongate shaft extending between a proximal end and a distal end, the proximal end being adapted for attachment to a source of inflation fluid, and a lumen extending through the shaft adapted for the passage of the inflation fluid; and a balloon disposed on the distal end of the shaft and having a balloon body extending between a proximal end and a distal end of the balloon.

Abstract: Method of making a balloon catheter includes melt-extruding a thermoplastic polymeric material into a tube, cooling the extruded tube, placing the extruded tube within a capture member and biaxially orienting the polymeric material of the extruded tube while simultaneously tapering at least a section of the extruded tube by radially expanding the extruded tube with pressurized media in the tube lumen and axially expanding the extruded tube with an external load applied on at least one end of the tube as an external heat supply traverses longitudinally from a first end to a second end of the extruded tube in the capture member, wherein an overall axial load on the tubing is varied as at least a section of the tube is heated. The method includes cooling the expanded tube to form a tapered biaxially oriented nonporous thermoplastic polymer tubular member and sealingly securing a balloon proximate a distal end of the tubular member.

Abstract: A catheter balloon and a balloon catheter in which compliance characteristics of a membrane are improved in its entirety. The catheter balloon includes a membranous body that can dilate and contract by fluid supplied from a catheter. The membranous body includes an intermediate layer which is formed of a non-elastomer, an outer layer which is arranged on an outer surface of the intermediate layer and contains an elastomer, and an inner layer which is arranged on an inner surface of the intermediate layer and contains an elastomer. The average wall thickness of the intermediate layer is within 30% to 70% of the wall thickness of the balloon in its entirety.

Abstract: Reinforced angioplasty balloon having an external elastic sheath. The elastic sheath maintains, along its length, a substantially uniform circular cross-section during balloon inflation and forces a deflated balloon into a compacted, substantially circular, wingless profile.

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

Abstract: Balloon systems for treating bifurcated lumens include desirable burst and folding characteristics. In some cases, the balloon systems can be formed by varying the wall thickness of a balloon parison.

Abstract: A controlled volume inflation-deflation device to inflate a balloon to occlude a blood vessel by dialing a knob that locks at rotational positions to locate a plunger at equally spaced locations within a syringe of the inflation-deflation device. The inflation-deflation device includes a releasable latch to lock the proximal and distal housings together to hold the plunger forward for occlusion, and to separate and hold the proximal and distal housings to retract the plunger for perfusion. When the inflation-deflation device is returned to the latched position, the balloon is re-inflated to its previous occlusive diameter. Also, an extension tube made of a lower modulus outer material co-extruded over and miscible with a higher modulus inner material may be used to produce a suitably low compliance extension tube for the inflation-deflation device.

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: 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 tamponade trocar includes an elongate balloon having a closed distal end and is adapted to expand from a small diameter to a large diameter. A cannula is positioned at a proximal portion within the balloon lumen. A rigid stylet is removably positioned within the balloon and cannula lumens. A distal end of the stylet supported balloon is inserted into a perforation in a body wall and advanced into a body cavity while the balloon is unexpanded. The balloon is expanded and the cannula is advanced to a distal portion of the balloon lumen and across the body wall. At this stage, the perforation is dilated and in compressive tamponade. The proximal portion of the balloon may be removed and a seal housing may be coupled to the proximal end of the cannula. The distal end of the balloon may be punctured and opened, making the trocar ready for use.

Abstract: A reinforced composite balloon may comprise a body layer and a reinforcing layer. The reinforcing layer may comprise a single-layer structural network having a plurality of apertures. The reinforcing layer may be molded from a reinforcing tube having a plurality of apertures or aperture precursor holes.

Abstract: A non-compliant medical balloon, where the non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon, is made with a first fiber layer, a second fiber layer over said first fiber layer such that the fibers of the first fiber layer and the fibers of the second fiber layer form an angle and a binding layer coating the first fiber layer and said second fiber layer. The interior surface area of the non-compliant medical balloon remains unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: A drug introduction sleeve is disclosed that includes a selectively expandable body portion. The body portion is defined by a first open end and a second open end. A hollow interior is formed within the body portion. The body portion is selectively expandable from a first unexpanded configuration to a second expanded configuration whereby the volume of the hollow interior is increased when the body portion is expanded to the second expanded configuration, sufficient to temporarily retain a drug bolus.

Abstract: A dual-layer dilatation balloon, and a process of making such balloon, which includes an inner layer that includes a plasticizer and a polymer selected from the group consisting of a polyamide, a copolymer thereof, and a combination thereof, and an outer layer that includes an ethylene-propylene rubber. The dual-layer balloon optionally further includes a stent disposed on the balloon. The stent is optionally a drug-eluting stent.

Abstract: Medical balloons are energetically treated to form regions that facilitate deflation to a desirable configuration.

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: 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: According to one aspect of the disclosure, a medical device may include a dilation device. The dilation device may include an expandable member configured to extend at least partially into an opening in tissue. The expandable member may also be configured to expand the opening when the expandable member moves from an unexpanded state to an expanded state. The dilation device may also include one or more markings on the expandable member. The one or more markings may be configured to provide a visual indication of a characteristic of the opening in the tissue when the expandable member extends at least partially into the opening. The medical device may also include a feeding device configured to extend at least partially into the opening in the tissue. At least a portion of the dilation device may be configured to be received within the feeding device.

Abstract: A medical device for insertion and expansion within a bifurcated lumen is described. An expansion region of the device has regions thereon which, in some cases, enable the device to fold into a predetermined configuration upon deflation. The regions may be defined by differing modulus of the device material.