Abstract: Devices, systems, and methods for delivery of therapeutics, in particular thrombolytic agents, in particular plasmin, are provided. The devices, systems, and methods also provide for occlusion of a vessel or graft distal and/or proximal to a treatment zone. Also provided are devices, systems, and methods that trap emboli.

Abstract: Adjustable balloon catheter including an inner tubular member having a proximal end portion, a distal end portion, an inflation lumen and a fluid lumen defined therein. An expandable member is coupled to the distal end portion and has an inner chamber defined therein in fluid communication with the inflation lumen, the expandable member transitionable between a deflated and inflated configuration. The expandable member further has an exterior surface, the exterior surface having at least one pore structure defined therein in fluid communication with the fluid lumen. An outer tubular member is movable relative to the inner tubular member, the outer tubular member, the outer tubular member being moveable between an extended position and a retracted position, the outer tubular member being selectively positioned between the extended position and the retracted position to define an exposed length of the working length of the expandable member.

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: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The distal end of the sheath is maintained in the first, low cross-sectional configuration and expanded using a radial dilatation device. In an exemplary application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as ureteroscopy or stone removal.

Abstract: An infusion catheter assembly has the ability to infinitely titrate the length of a porous fluid distribution section in situ. The infusion catheter assembly thereby provides a length of infusion that can be infinitely varied over a prescribed range, to control the effective infusion length and the rate of infusion. Using the infusion catheter assembly, a physician has the capability to treat only the length of the vessel desired, thereby preventing excessive drug/patient exposures. The porous fluid distribution section can include an array of spaced apart apertures that vary in size and/or density along the length of the porous fluid distribution section, such that the flow rate remains essentially constant for a given inlet pressure independent of the effective infusion length.

Abstract: Medical devices for delivering a bioactive agent and methods of use thereof are provided. The device includes a balloon having micro-needles for delivery of the bioactive agent.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a loading tool. The loading tool may include a tubular member that is configured to be disposed about a balloon catheter. The tubular member may include a distal portion and a proximal portion. The tubular member may be configured to shift between a first configuration and a shortened configuration.

Abstract: The invention is directed to delivery medical devices that enable consistent “on-demand” delivery of therapeutic agents to a vessel. The medical device of the current invention comprises retractable sheath comprising neckable elements. The design and methods disclosed herein ensures that therapeutic agent delivery occurs essentially only upon necking of the outer sheath, minimizing coating and/or therapeutic agent loss to the bloodstream and providing controlled delivery to the treatment site.

Abstract: The invention is directed to delivery medical devices that enable consistent “on-demand” delivery of therapeutic agents to a vessel. The medical device of the current invention comprises retractable sheath comprising neckable elements. The medical device of the current invention comprises an expandable member, a hydrophilic coating comprising at least one therapeutic agent about the expandable member or structural layer and a retractable outer sheath with a selectively permeable microstructure. The design and methods disclosed herein ensures that therapeutic agent delivery occurs essentially only during retraction of the outer sheath, minimizing coating and/or therapeutic agent loss to the bloodstream and providing controlled delivery to the treatment site.

Abstract: An inflatable structure for use in biological lumens and methods of making and using the same are disclosed. The structure can have an inflatable balloon encircled by a shell. The shell can have proximal and distal tapered necks, longitudinally-oriented flutes, and apertures at the proximal and distal ends of the shell. The apertures can be recessed in the flutes in the necks. The shell can also have fiber reinforced walls.

Abstract: A reperfusion system and method of perfusing a blood vessel using the reperfusion system are provided. A sheath has a sheath wall and a lumen that each extend to a distal end to define a distal opening. A distal portion of the sheath wall has at least one wall opening. A balloon catheter has a lumen that extends to the distal end to define a distal opening. The balloon catheter has an inflatable balloon attached to a distal portion. A conduit has a first end in fluid communication with the lumen of the sheath and a second end in fluid communication with the lumen of the balloon catheter. The reperfusion system is configured to allow blood to enter each of the distal opening and the at least one wall opening of the sheath, flow through the sheath, the conduit, and the balloon catheter, and exit through the distal opening of the balloon catheter. The sheath is introduced into body tissue. The balloon catheter is advanced through the sheath to the blood vessel. The balloon is inflated.

Abstract: Methods and apparatus for a free-standing biodegradable patch suitable for medical applications, especially intravascular, minimally-invasive and intraoperative surgical applications are provided, wherein the patch comprises a free-standing film or device having a mixture of a solid fibrinogen component and a solid thrombin component that, when exposed to an aqueous environment, undergoes polymerization to form fibrin. In alternative embodiments the patch may comprise a solid fibrinogen component, with or without an inorganic calcium salt component. The patch may take a non-adherent form during delivery to a target location within a vessel or tissue, and thereafter may be activated to adhere to vessel wall or tissue, and may include a number of additives, including materials to improve the mechanical properties of the patch, or one or more therapeutic or contrast agents.

Abstract: The present invention relates to balloon catheters for treating a luminal system of a patient. Specifically, the invention relates to catheters having a flexible membrane positioned at a distal portion of the catheter, the flexible membrane retained in a substantially unexposed conformation prior to deployment. Preferably the flexible membrane is capable of delivering a therapeutic agent to a localized environment when deployed to an exposed conformation.

Abstract: A method for facilitating insertion of a balloon-carrying end of a catheter includes folding the balloon-carrying end while the balloon is in an uninflated condition. A length of soluble material is provided about the folded balloon-carrying end of the catheter and the material includes perforations or scalloped regions. Once the folded balloon-carrying end is inserted into a patient, the balloon can be inflated to brake the soluble material and unfold the balloon-carrying end.

Abstract: Embodiments are presented of a balloon assembly operable to provide a balloon diameter vs. balloon pressure profile generally depicting a balloon inflation sequence providing at least one intermediate inflated diameter and a final inflated diameter of a balloon such that the balloon attains the at least one intermediate diameter at a predetermined pressure, and attains the final diameter at a final predetermined pressure that is lower than a predetermined pressure of a last intermediate pressure.

Abstract: A catheter assembly may comprise a guide catheter, a balloon catheter with a steering balloon and a stabilizing balloon and a guide wire. The stabilizing balloon secures the balloon catheter to the guide catheter while the steering balloon secures the catheter assembly to the vessel wall. In another embodiment, the balloon catheter has three balloons engaged to the exterior surface, a steering balloon, a stabilizing balloon and an anchoring balloon.

Abstract: Coaxial balloon catheters are described herein. The balloon catheter can include outer and inner tubes in a coaxial relationship, with a balloon attached to an end thereof. A support sleeve can be disposed around the inner tubular member proximate the proximal end of the balloon. The support sleeve can have a channel formed therein to communicate with an inflation lumen and a balloon interior. The channel may be formed by separation of two longitudinal edges extending through the support sleeve. The support sleeve can include an outward extending portion that is sized to engage the distal end of the outer tube in order to limit relative movement between the inner and outer tubes. The support sleeve can be configured to orient the inner tube eccentrically or concentrically relative to the outer tube. The support sleeve can have an elongate body that can be extended in proximal or distal direction.

Abstract: A balloon catheter is configured so that a balloon can be easily inserted into the interior of a human body without using a separate wire.

Abstract: In some embodiments, a recapturing sheath comprises an elongate shaft having a proximal end and a distal end. The shaft defines a lumen therein. The distal end comprises a flare and a slit. A first portion of said flare overlaps a second portion of said flare.

Abstract: A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A sheath pair is placed over the crimped scaffold after crimping to reduce recoil of the crimped polymer scaffold and maintain scaffold-balloon engagement relied on to hold the scaffold to the balloon when the scaffold is being delivered to a target in a body. The sheath pair is removed by a health professional before placing the scaffold within the body.

Abstract: An indwelling urinary catheter assembly is disclosed having an indwelling catheter and a sheath enclosing an insertable portion of the indwelling catheter.

Abstract: A catheter configured for delivering an agent to a patient's vessel wall is described. The catheter includes an inflatable balloon substantially covered by a expandable cage such that when the inflatable balloon is inflated the expandable cage substantially surrounds an outer surface of the inflated balloon. The inflatable balloon is configured to be deployed within a lumen against a lumen wall and separated from the lumen wall by the expandable cage in an expanded state, and is adapted to provide an agent delivery to a treatment site, and the expandable cage is further collapsible and is removable from said lumen.

Abstract: Devices, systems, and methods for delivery of therapeutics, in particular thrombolytic agents, in particular plasmin, are provided. The devices, systems, and methods also provide for occlusion of a vessel or graft distal and/or proximal to a treatment zone. Also provided are devices, systems, and methods that trap emboli.

Abstract: An angioplasty assembly having a guidewire device for use in peripheral vascular and coronary angioplasty applications. The guidewire invention has one or more angioplasty devices mounted directly on the distal tip of the guidewire. In one embodiment the angioplasty device includes an angioplasty balloon. In another embodiment, the device includes a stent balloon with expandable stent, or a self-expanding stent, or combinations of these. Preferably, the guidewire is housed within a hypotube. Optionally, the hypotube may house a retractable piercing element with a distal loop 3 suitable for piercing a vessel wall. The guidewire allows an angioplasty procedure to be completed using a single device.

Abstract: A tear-away sheath (8) having a tubular element (10) with a distal end and a proximal end, at least one axial fault line (12), and an integral stop (16) is disclosed. The tear-away sheath may also have a handle (14) or closing element at the proximal end. An angioplasty balloon catheter (22) having the disclosed tear-away sheath is also disclosed.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The distal end of the sheath is maintained in the first, low cross-sectional configuration and expanded using a radial dilatation device. In an exemplary application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as ureteroscopy or stone removal.

Abstract: To perform treatment by readily introducing a device causing minimal invasion even where approach from the body surface is difficult, a medical device includes a guide that is inserted into a lumen; a first balloon at a distal end of the guide, connected to a first flow path extending to a proximal end of the guide; a second balloon on the guide, separated from the first balloon on the proximal-end side and connected to a second flow path extending to the proximal end of the guide; a third balloon extending along the guide from a point between the first balloon and the second balloon to the proximal end and having a port for supplying or discharging fluid at the proximal end; and a cleansing flow path having a discharge port between the first balloon and the second balloon and extending to the proximal end of the guide.

Abstract: A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A sheath pair is placed over the crimped scaffold after crimping to reduce recoil of the crimped polymer scaffold and maintain scaffold-balloon engagement relied on to hold the scaffold to the balloon when the scaffold is being delivered to a target in a body. The sheath pair is removed by a health professional before placing the scaffold within the body.

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: A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A sheath pair is placed over the crimped scaffold after crimping to reduce recoil of the crimped polymer scaffold and maintain scaffold-balloon engagement relied on to hold the scaffold to the balloon when the scaffold is being delivered to a target in a body. The sheath pair is removed by a health professional before placing the scaffold within the body.

Abstract: A medical device includes a sheath having a proximal end and a distal end, the sheath having an opening at both the proximal end and the distal end, and a removable dilator having a distal end and a proximal end, the dilator having at least one blood detector disposed on a tapered portion of the distal end of the dilator, the dilator positionable within the sheath such that the tapered portion of the distal end of the dilator extends through the opening in the distal end of the sheath, the proximal end of the dilator extends through the opening in the proximal end of the sheath, and at least a portion of the at least one blood detector is adjacent to the distal end of the sheath.

Abstract: A multi-layer inflatable balloon cuff may be adapted to seal a patient's trachea when associated with an endotracheal tube. The outer layer and the inner layer of the balloon cuff may have different material properties that may enhance a cuff's mechanical pressure seal by reducing wrinkles or folds that may form against a patient's tracheal walls.

Abstract: An apparatus is presented for use with a biologically-compatible-fluid pressure source.

Abstract: A dilatation balloon is fabricated according to a process that forms cavities and indentations in the balloon and/or catheter sections. A length of tubing is axially elongated and radially expanded in a form to provide the requisite biaxial orientation and strength. Then, an excimer laser or another type of laser or mechanical material removal tool is used to remove the polymeric material, virtually without thermal effects. Cavities in the sleeve sections of the balloon are defined and if desired, indentations in the cone sections are defined. Material removal, particularly near the balloon sleeves enables a thinner, more flexible bonding area between the catheter shaft and the balloon. Further, the indentations along the cone sections enables tighter wrapping of the balloon for a reduced delivery profile. Rigidity near the sleeves is reduced for better maneuverability of the catheter in tortuous passageways.

Abstract: A balloon catheter includes a balloon support member having a hollow axial lumen and open distal end for allowing passage of a guidewire therethrough, a balloon disposed around the balloon support member, and an annular balloon seal disposed proximate to a distal end of the balloon catheter. The seal defines a central passageway for allowing passage therethrough of a guidewire extending out the distal end of the balloon support member, and is configured to form a substantially fluid tight seal around each of a plurality of guidewires having different outer diameters.

Abstract: A bone grafting delivery device, method and kit is provided. The bone grafting material delivery device may include a needle having a cutting edge located at a distal end of the needle. The needle may be configured to be inserted within a bone via an entry point created through the skin of a patient. Additionally, the bone grafting material delivery device may include a plurality of dilators attachable sequentially to the needle using a swivel assembly. The plurality of dilators may be configured to articulate relative to needle in a plurality of directions via the swivel assembly. Furthermore, a final dilator of the plurality of dilators may include an opening at a distal end of the final dilator for depositing bone grafting material onto the bone or in a void.

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

Abstract: Medical devices including a substrate that are expandable from a compressed state to an expanded state; a coating on the substrate, the coating having a drug agent incorporated therein; and a sheath over the coating. The sheath is expandable from a compressed state to an expanded state and has at least one perforation therein. The medical devices are configured such that when the substrate is in a compressed state, the sheath is also in a compressed state and the perforation is substantially closed. When the substrate is in an expanded state, the sheath is also in an expanded state and the perforation is substantially open. The invention also includes a method of using the medical devices for the controlled, localized delivery of a drug agent to a target location within a mammalian body.

Abstract: A gastric space filler device effective for reducing stomach volume comprises at least one inflatable space filler and a sleeve to prevent leakage out of the gastric space filler device. The gastric space filler device may be inflated with an insufflation fluid and with mineral oil, which further has the effect of reducing leakage. Delivery systems and methods are effective for inserting a gastric space filler device into a patient. The gastric space filler device may be provided with sheaths and methods for covering the gastric space filler device during delivery into a patient.

Abstract: A medical device for the treatment of a sinus opening includes a handle, a grooming sheath, a rail, a guide wire, a balloon catheter and a balloon catheter movement mechanism. A method for treating a sinus opening includes inserting a medical device for the treatment of a sinus opening partially into a patient's anatomy, positioning a guide wire operatively extending from a rail of the medical device into a sinus opening of the patient, advancing a balloon catheter from an annular lumen of the medical device and along both the rail of the medical device and the guide wire with a balloon catheter movement mechanism, and inflating the balloon catheter.

Abstract: A device (1) comprises a sheath (9) for protecting a balloon catheter (2) from contamination with bodily fluids and other matter during the carrying out of a procedure or investigation at a remote site in a human or animal body. The sheath (9) defines a catheter accommodating portion (14) and a balloon accommodating portion (15) for accommodating a catheter (4) and a balloon (8) of the balloon catheter (2) therein. The sheath (9) is of a flexible material having a closed distal end (11) and a proximal opening (13) at a proximal end (10) thereof to a hollow interior region (12) within which the balloon catheter (2) is accommodated. A guide wire engaging distal portion (19) engages and locates a guide wire (7) within the sheath (9). The balloon accommodating portion (15) permits inflating of the balloon (8) to a predefined volume.

Abstract: Medical devices for delivering a bioactive agent(s) and methods of use thereof are provided.

Abstract: A catheter balloon having improved steerability is disclosed having a transition between a soft distal tip and a relatively stiffer working portion of a balloon carrying a stent, in the form of a support sleeve on the inner member. The support sleeve provides stiffness to the taper portion of the balloon and also allows precise location of a radio opaque marker. The support sleeve can have a varying thickness or be made of a combination of materials to yield an increasing or decreasing stiffness along the support sleeve to provide an even smoother transition along the balloon's length.

Abstract: A catheter assembly includes an expandable and collapsible structure having an outer surface. The expandable and collapsible structure is adapted to expand between a contracted state and a dilated state. A coating is disposed on the outer surface of the expandable and collapsible structure. The coating includes a bioactive agent. A sleeve is disposed over the coating. The sleeve is adapted to expand between a compressed state and an enlarged state and to return to the compressed state. The sleeve defines a plurality of openings in the compressed state. An outer diameter of the coating is less than an outer diameter of the sleeve when the expandable and collapsible structure is in the contracted state and greater than the outer diameter of the sleeve when the expandable and collapsible structure is in the dilated state.

Abstract: A reperfusion catheter system with an introducer sheath having an inner wall defining a longitudinal opening extending from a proximal portion to a distal end. A balloon catheter has an outer wall and has a longitudinal opening extending from a proximal portion to a distal end. The balloon catheter is disposed through the opening in the introducer sheath, and the balloon catheter has an inflatable balloon at the distal end. A conduit has a first end disposed in fluid communication with the area inside the introducer sheath between the inner wall of the introducer sheath and the outer wall of the balloon catheter. The conduit also has a second end disposed in fluid communication with the inside of the balloon catheter.

Abstract: A catheter used for treatment of complex vasculature, such as a bifurcated aneurysm, is provided with an inflatable balloon at a distal portion thereof. The shape, location and material of the inflatable balloon are selected such that when inflated, the balloon conforms to the shape of the complex vasculature, or at least a portion thereof, without appreciably deforming the vessel walls. In this manner, the balloon can be used to control flow in the vasculature, for example occluding a selected branch of the vasculature during introduction of material in order concentrate the material and minimize its disbursement by blood flow.

Abstract: A balloon is inflated from a collapsed configuration, then deflated. A polymeric stent is then disposed over the deflated balloon and the stent crimped to the balloon.

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

Abstract: A protective sleeve for a medical device including a main body which has a distal end and a proximal end and on the lateral surface of which at least one stop element is disposed, which during insertion of the protective sleeve into an introducer limits the insertion depth of the protective sleeve into the introducer and which preferably is disposed at the distal end of the main body.

Abstract: A dilatation balloon is fabricated according to a process that forms cavities and indentations in the balloon and/or catheter sections. A length of tubing is axially elongated and radially expanded in a form to provide the requisite biaxial orientation and strength. Then, an excimer laser or another type of laser or mechanical material removal tool is used to remove the polymeric material, virtually without thermal effects. Cavities in the sleeve sections of the balloon are defined and if desired, indentations in the cone sections are defined. Material removal, particularly near the balloon sleeves enables a thinner, more flexible bonding area between the catheter shaft and the balloon. Further, the indentations along the cone sections enables tighter wrapping of the balloon for a reduced delivery profile. Rigidity near the sleeves is reduced for better maneuverability of the catheter in tortuous passageways.