Abstract: An example cutting balloon is disclosed. The example cutting balloon includes an expandable member having an outer surface and longitudinal axis, a first cutting member disposed along the outer surface of the expandable member and a covering encapsulating the expandable member and the first cutting member.

Abstract: A delivery catheter system includes an anchor catheter, a collapsible and expandable anchor, a balloon catheter, and a needle. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The anchor may be configured to be received within the anchor catheter. The balloon catheter may be positioned radially inward of the anchor catheter, and may include an inflatable balloon at a distal end thereof. The balloon may be in fluid communication with the balloon catheter. The needle may be positioned radially inward of the balloon catheter and may be translatable relative to the balloon, the needle having a sharp distal tip.

Abstract: An occlusion catheter system includes a proximal hub having an inflation connection port and an inflation pathway. An inflation catheter member is connected to the proximal hub and has an inflation lumen. A stiffener member defines a longitudinal axis. The proximal end of the stiffener member is connected to the proximal hub. The stiffener member extends through a portion of the inflation lumen. An occlusion balloon has a proximal balloon end and a distal balloon end. A distal catheter member is positioned substantially on the longitudinal axis and is connected to the distal end of the stiffener member. An atraumatic tip is positioned on a distal end of the distal catheter member. The atraumatic tip has a substantially circular profile in a relaxed configuration. A pressure sensor is connected to the occlusion catheter system distally relative to the occlusion balloon and is connected to a processor by electrical wiring.

Abstract: A connector (1) includes: a tube (10) configured to be arranged in an interior of a vascular channel; a tubular body (30) having an inner wall surface configured to, together with an outer wall surface of the tube (10), sandwich the vascular channel when the tube (10) is arranged in the interior of the vascular channel; and a balloon (20), configured to be arranged on the outer wall surface of the tube (10) or the inner wall surface of the tubular body (30), and radially expand for performing sealing (i) between the soft tubular member and the inner wall surface of the tubular body (30) and (ii) between the soft tubular member and the outer wall surface of the tube (10). A fluid supply system (100) may include the connector (1), and a perfusion solution supply device (120) connected to the connector (1) and configured to supply a perfusion solution into the interior of the vascular channel.

Abstract: Medical devices including balloons and balloons are provided that include an elongate body and an inflatable balloon defining a longitudinal axis, the inflatable balloon being attached to and partially surrounding at least a section of the elongate body. The medical device further includes a plurality of protrusions extending from the inflatable balloon. When the inflatable balloon is in an unstrained state, each of the plurality of protrusions extends in a first transverse direction relative to the longitudinal axis. In certain implementations, the inflatable balloon may also be configured to collapse such that, when in a collapsed state, an untextured portion of the inflatable balloon extends to a radius and the plurality of protrusions does not extend beyond the radius.

Abstract: Described is a catheter for being retained inside the body for extended periods, and a catheter mating device that can connect to the catheter to move the catheter inside of the body or remove it from the body. The catheter mating device has a stem with an apparatus at its distal end. The apparatus is moveable between a first position and a second position. When in its first position, the distal end is configured to fit in the proximal end of the catheter. When in its second position, the distal end engages the proximal end of the catheter and connects the catheter mating device to the catheter.

Abstract: A dilator device including an elongated flexible material sleeve having a hollow interior extending along a distal portion and a proximal portion thereof. An expandable or inflatable bladder is connected to the distal portion and disposable radially outward from an exterior of the sleeve when in an expanded and/or inflated orientation. The elongated sleeve including a tip having a predetermined configuration that facilitates positioning the elongated sleeve within an intended body part. A fluid input is structured for removable connection to a fluid source and is disposed on the sleeve, in fluid communication with the bladder. An access opening is formed on the proximal portion and is cooperatively dimensioned with the hollow interior to removably receive any one of a plurality of different types of positioning instruments within the sleeve.

Abstract: A structure of aligned (e.g., radially and/or polygonally aligned) fibers, and systems and methods for producing and using the same. One or more structures provided may be created using an apparatus that includes one or more first electrodes that define an area and/or partially circumscribe an area. For example, a single first electrode may enclose the area, or a plurality of first electrode(s) may be positioned on at least a portion of the perimeter of the area. A second electrode is positioned within the area. Electrodes with rounded (e.g., convex) surfaces may be arranged in an array, and a fibrous structure created using such electrodes may include an array of wells at positions corresponding to the positions of the electrodes.

Abstract: A system with at least one inflatable member configured for being arranged in a part of the patient's respiratory tract includes a catheter carrying the at least one inflatable member. The catheter includes a fluid line for filling the inflatable member with a fluid; and a pressure monitoring and control member to be arranged outside the patient's body. The pressure monitoring member is in fluid communication with the inflatable member and is configured to receive, during operation, fluid from the inflatable member when the pressure increases above a predetermined threshold pressure and to return the received fluid when the pressure decreases below said predetermined threshold pressure. The pressure monitoring and control member is an elastically expandable balloon made from a material configured to expand elastically when the pressure in the balloon increases above a predetermined threshold pressure and to contract when the pressure decreases below said predetermined threshold pressure.

Abstract: A medical device system includes a medical device that is configured to be delivered to a lesion area in a body lumen, a guide wire that is configured to guide the medical device, a port member that is configured to introduce the guide wire and the medical device into a living body, a proximal-end fixing member that is configured to fix the guide wire and the port member and is provided with an operation unit that is configured to cause the guide wire to move in an insertion/pulling-out direction from the fixed state, an anchor device provided with an anchor portion in a distal portion thereof, and an anchor-device guide wire that is configured to guide the anchor device.

Abstract: A balloon catheter is disclosed capable of effectively delivering a drug to living body tissue and a manufacturing method of the balloon catheter, and a treatment method. The balloon catheter has a balloon at a distal portion of a catheter shaft, and is provided on a surface of the balloon with elongate bodies which are crystals of a water-insoluble drug extending in a longitudinal direction. The surface of the balloon is provided with crystal conjugates formed of a plurality of elongate bodies united to one another while being in a tilted state.

Abstract: A medical device includes an elongate body and an inflatable balloon attached to and partially surrounding at least a section of the elongate body. The inflatable balloon is selectively inflatable between a deflated state and an inflated state. Engagement between the balloon and a physiological lumen is provided, in part, by multiple protrusions extending from the inflatable balloon and having various physical and functional characteristics. In certain implementations, the balloon may be configured to exhibit various separation forces by applying different strains to the balloon, such as by varying the degree to which the balloon is inflated or deflated.

Abstract: A balloon for medical treatments such as percutaneous transluminal coronary angioplasty (PTCA), delivery of a vascular stents or stent grafts, employs reinforcement materials that are patterned so as to promote consistent folding of the balloon. Also disclosed are methods and apparatus for biocidal treatment using a balloon, including balloons with fiber fabric reinforcements.

Abstract: A method of localized delivery of a therapeutic and/or diagnostic agent to nasal tissue or cavities includes inserting a catheter into a nasal cavity, the catheter having an outer balloon with at least one opening therethrough and an inner surface, and an inner balloon disposed in the outer balloon and at least partially enclosing an inflation chamber and having an outer surface defining a space between the outer surface of the inner balloon and the inner surface of the outer balloon, supplying the agent to the space between the outer surface of the inner balloon and the inner surface of the outer balloon via a first lumen of the catheter, and inflating the inner balloon by supplying fluid to the inflation chamber via a second lumen of the catheter to urge the agent out of the opening in the wall of the outer balloon and into nasal tissue.

Abstract: A stoma extender includes a first end for insertion into a stoma for diverting stomal effluent into the stoma extender before the effluent exits the stoma; a second end for remaining external of the stoma, for providing a discharge exit for stomal effluent; and a conduit portion coupled between the first and second ends for communicating stomal effluent through the stoma extender, wherein the length of the conduit portion is adjustable stably, to permit adaptation of the stoma extender to an individual's stoma.

Abstract: A stent delivery device is provided that includes an inner member defining a distal tip and a stent holding region, and an outer tubular member slidingly disposed over the inner member and configured to engage the distal tip. Seal members may be disposed on one or more of an outer surface of the inner member, the distal tip, and the outer tubular member. The seal members define a liquid-tight sealed chamber surrounding the stent holding region.

Abstract: The present disclosure relates to woven and knitted fabrics including boron nitride nanotubes and to methods of manufacturing and using such materials. In one embodiment, these materials are incorporated into implantable medical devices such as stent graft devices and the like.

Abstract: A medical balloon catheter including a catheter shaft and an inflatable balloon secured to a distal portion of the catheter shaft. One or more cutting blades are secured to the inflatable balloon by a first polymeric adhesive material forming a mounting pad encasing a base portion of the cutting blade therein, and a second polymeric adhesive material adhesively bonding the mounting pad to a surface of the balloon. The first polymeric adhesive material has a first ductility and the second polymeric adhesive material has a second ductility greater than the first ductility.

Abstract: A catheter is provided with a distal portion, a proximal portion, and a plurality of drainage eyes disposed at a junction between the distal portion and the proximal portion. The distal portion includes a tip, a plurality of elongated ribs, and a plurality of external flow paths. The proximal portion includes an internal lumen and a proximal end. The plurality of drainage eyes communicate with the plurality of external flow paths and the internal lumen.

Abstract: A stent delivery assembly includes a delivery balloon defining a balloon axis, and a stent disposed around the delivery balloon. The stent has interconnected struts, and the delivery balloon has a balloon surface with a number of strips that are disposed on the balloon surface and extend along the balloon axis, the strips having an unhydrated state and a hydrated state, the strips having a smaller volume in the unhydrated state than in the hydrated state. For a stent composed of axially aligned segments connected via connectors disposed between adjacent ones of the segments, the strips have a length greater than an axial distance between axially outermost connectors connecting the adjacent ones of the segments.

Abstract: Catheters with weeping balloons can be used for various medical purposes. For example, in some embodiments provided herein weeping balloons are used for catheter visualization devices. In some embodiments, weeping balloons are used to deliver therapeutic agents. Weeping balloons can include openings of a selected size and shape through which a fluid gradually flows or “weeps.” The design of the openings can affect performance characteristics such as, but not limited to, fluid flow rate, tear resistance, and mitigation of counter-flow.

Abstract: Systems and methods can remove material of interest, including blood clots, from a body region, including but not limited to the circulatory system for the treatment of pulmonary embolism (PE), deep vein thrombosis (DVT), cerebrovascular embolism, and other vascular occlusions.

Abstract: An apparatus for performing an endovascular procedure using ultrasonic energy includes a catheter comprising a wave guide including an expandable portion for delivering the ultrasonic energy from a source for performing the endovascular procedure. The expandable portion may comprise a plurality of wires formed of a shape memory material. A retractable sheath may be provided for receiving the plurality of wires in the non-deployed position and for being withdrawn to expose the wires in the deployed position. A linear actuator for moving the plurality of wires in a longitudinal direction or a rotary actuator for rotating the plurality of wires may also be provided.

Abstract: A medical balloon comprises a first end, a second end spaced apart from the first, and a generally cylindrical balloon wall extending therebetween to define an inflation chamber. The balloon wall is adapted for inflation from a first folded configuration having a first plurality of pleats to an expanded, unpleated configuration, and deflation therefrom to a second folded configuration having a second plurality of pleats. The balloon wall includes a first layer formed of a polymer and having a substantially constant radial thickness. A second layer is firmly attached to the first layer and has a plurality of first regions of greater radial thickness interleaved with a plurality of second regions of reduced radial thickness. During deflation from the expanded, unpleated configuration to the second folded configuration, the balloon wall folds along the regions of reduced radial thickness of the second layer to form the second plurality of pleats.

Abstract: Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on the substrate, wherein the coating comprises at least one polymer and at least one pharmaceutical agent in a therapeutically desirable morphology and/or at least one active biological agent and optionally, one or more pharmaceutical carrying agents; wherein substantially all of pharmaceutical agent and/or active biological agent remains within the coating and on the substrate until the implantable device is deployed at an intervention site inside the body of a subject and wherein upon deployment of the medical device in the body of the subject a portion of the pharmaceutical agent and/or active biological agent is delivered at the intervention site along with at least a portion of the polymer and/or a at least a portion of the pharmaceutical carrying agents.

Abstract: A dilator device including an elongated flexible material sleeve having a hollow interior extending along a distal portion and a proximal portion thereof. An expandable or inflatable bladder is connected to the distal portion and disposable radially outward from an exterior of the sleeve when in an expanded and/or inflated orientation. The elongated sleeve comprising a tip having a predetermined configuration that facilitates positioning the elongated sleeve within an intended body part. A fluid input is structured for removable connection to a fluid source and is disposed on the sleeve, in fluid communication with the bladder and a flow restrictor is structured to restrict fluid flow from the bladder to an exterior of the sleeve. An access opening is formed on the proximal portion and is cooperatively dimensioned with the hollow interior to removably receive any one of a plurality of different types of positioning instruments within the sleeve.

Abstract: A device for emptying stool from the rectum of a patient by means of a shaft body which is introduced into the bowel via the anus and is able to buckle or fold axially and radially, and which is provided with a dumbbell- or hourglass-shaped balloon body for assuring the transanal positioning of the device. The invention comprising a design of, and choice of material, for the shaft body and the balloon envelope, and by the positioning of the balloon body on the shaft body, wherein the axial deflection of the free forward end of the shaft body is limited and an uncontrolled deflection of the shaft is prevented, and the probability of perforation of the bowel wall under the effect of force acting on the shaft body from an axial direction is reduced by the intestinal tube.

Abstract: A system for dilating a stenosed vessel is provided. The system includes a balloon mounted on a catheter shaft, the balloon being composed of a first material and fibers forming a grid attached to a surface of the balloon or integrated within a wall thereof. The fibers are composed of a second material having less elasticity than the first material such that when the balloon is inflated beyond a predetermined pressure balloon regions protrude from the grid formed by the fibers.

Abstract: A complete flow diversion intestinal ostomy surgery kit, comprising an ostomy tube, the ostomy tube comprising a tube body; near the front end of the tube body is provided with a deformable balloon; a fine tube is provided within the tube wall of the tube body or inside the tube body; the front end of the fine tube penetrates the tube wall of the tube body and is in communication with the inner cavity of the balloon; when filled with fluid via a connector, the balloon and the intestinal wall form a sealed structure that blocks matters inside of the intestine; the complete flow diversion intestinal ostomy surgery kit further comprises a ring-shaped fixing plate; the exterior wall of the tube body is provided with a ring-shaped groove; the ostomy tube is fixedly connected to the abdominal wall of a patient via the ring-shaped fixing plate that matches the ring-shaped groove.

Abstract: A handle component of a medical device is disclosed for delivering a material to an enclosed cavity or space. The handle component includes a self-contained mechanism for holding the material and for providing or releasing the material to the enclosed cavity. The handle component also includes a pressure relief valve in fluid communication with the mechanism and the enclosed cavity. The pressure relief valve is configured to indicate when delivery of the material to the enclosed cavity reaches a preselected or set pressure and to thereby assure precise filling of the enclosed cavity with the material.

Abstract: Embodiments of the present disclosure comprise occlusion and drug delivery devices and methods. One aspect of the disclosure comprises a drug delivery device comprising an inner expansion member and an outer drug delivery component. Another aspect of the disclosure comprises bioabsorbable, lumen-occluding implants.

Abstract: A catheter device having a shaft that extends from a proximal end to a distal end to carry on its distal end a self-expanding implant for intraluminal advance on a guidewire and delivery of the implant to an implant site by proximal withdrawal of a sheath that lies radially outside the implant in the catheter, the catheter including a first shaft element to pull the sheath proximally and a second shaft element to push the implant distally to prevent the implant moving proximally with the sheath when the sheath is pulled proximally, wherein the second shaft element comprises a pusher-guider tube having a wall thickness with a plurality of discrete slits, the slits extending through the wall thickness of the pusher-guider tube.

Abstract: The invention relates to a tissue ablation system including an ablation device having a deployable applicator head configured to be delivered to a tissue cavity and ablate marginal tissue surrounding the tissue cavity. The deployable applicator head is configured to be delivered to a tissue cavity while in a collapsed configuration and ablate marginal tissue surrounding the tissue cavity while in an expanded configuration.

Abstract: Flexible high-pressure angioplasty balloons are disclosed herein which utilize an inflatable balloon positioned upon the catheter and a supporting structure secured over or along the catheter at a first location proximal to the balloon and at a second location distal to the balloon. Inflation of the balloon reconfigures the supporting structure to urge the first location and the second location towards one another thereby inhibiting longitudinal elongation of the balloon relative to the catheter. The supporting structure may surround, support, or otherwise extend over the entire length of the balloon and allows for the balloon to retain increased flexibility which enables the balloon to bend or curve even at relatively high inflation pressures.

Abstract: A method of fabrication of a medical balloon, and a balloon device useful for various medical balloon procedures, such as gastrointestinal, vascular, reproductive system, urinary system and pulmonary applications. At least two layers of a thermoplastic film are sealed at their peripheral edges and heat sealed at one or more locations inside an area enclosed by the sealed edges at predetermined locations, in one implementation of the balloon device. Such configuration enables the balloon to articulate to a desired shape upon inflation, with the desired shape being selected to accommodate a specific medical application.

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: Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on the substrate, wherein the coating comprises at least one polymer and at least one pharmaceutical agent in a therapeutically desirable morphology and/or at least one active biological agent and optionally, one or more pharmaceutical carrying agents; wherein substantially all of pharmaceutical agent and/or active biological agent remains within the coating and on the substrate until the implantable device is deployed at an intervention site inside the body of a subject and wherein upon deployment of the medical device in the body of the subject a portion of the pharmaceutical agent and/or active biological agent is delivered at the intervention site along with at least a portion of the polymer and/or a at least a portion of the pharmaceutical carrying agents.

Abstract: A clot removal system includes first and second barriers that each have an expanded configuration forming an occlusion within a vessel and a collapsed configuration. At least one deployment device distally deploys the first barrier relative to a clot, and proximally deploys the second barrier relative to the clot. The at least one deployment device also delivers a thrombolytic agent into an isolated segment defined at least in part by the first and second barriers in the expanded configurations, and positions an impeller within the isolated segment. The impeller includes a substantially cylindrical hub having at least two impeller blades attached to rotate with the cylindrical hub. Each of the at least two impeller blades has a proximal end attached to the cylindrical hub and a distal end attached to the cylindrical hub.

Abstract: A method for performing elastographic deformation mapping of tissues and plaques comprises: introducing a distal portion of a catheter to an interior of an interior body of a patient; applying, from a palpator in the distal portion, one of a directed fluid or a mechanical indenter to produce a surface-applied palpation force to a target area of the interior body to mechanically displace the interior body and cause elastographic deformation of the target area of one or more surface and subsurface tissues and plaques; and directing and delivering an OCT (optical coherence tomography) beam, from an OCT imaging sensor in the distal portion, for OCT deformation detection including elastographic deformation measurement to provide elastographic mapping of the target area.

Abstract: The invention relates to a device for sealing and draining an intestinal outlet, the device comprising an inflatable balloon of a generally toroidal structure, whose two ends extend one inside the other, creating a sealed-off volume inside the balloon, whereby the filling of the volume can be adjusted from outside and a draining lumen radially inside the inner layer of the balloon, the outer layer of the tube comprising a radially expanded intra-rectal device which is placed inside the rectum or the intestine of a patient during use, and comprising a trans-anal device which extends through the anus of the patient or his abdominal wall, and a stiffening sleeve element positioned inside the draining lumen of the device, keeping the lumen open and facilitating the uptake and passage of feces through the intra-rectal segment of the draining lumen.

Abstract: A catheter having a balloon (10) which has at least one wing (12) in the undilated state, the balloon having at least one fold element (11, 11?, 31, 32, 41, 42) running essentially in the longitudinal direction for each wing (12), such that in folding the balloon (10), the fold element is arranged in an area of the wing (12) with a minimum in the bending radius, said area running in the longitudinal direction. Also disclosed is a system for introducing an intraluminal endoprosthesis, preferably a stent, into a body cavity consisting of an intraluminal endoprosthesis and a catheter having the balloon as described. Further, disclosed are methods of producing such a catheter and such a system.

Abstract: A hemostasis component for an invasive medical device has an inflatable cylinder affixed to the medical device at a location aligned with an ingress point of a patient. An inflation source is in fluid communication with the inflatable cylinder and a flow control valve that is effective to regulate the flow of fluid from the inflation source to the inflatable cylinder is provided. The flexible cylinder is located on the proximal end of a tunneling catheter, where it exits the skin. A thin tube is provided to inflate the flexible cylinder. In the event of bleeding, the flexible cylinder is inflated for as long as is needed to achieve hemostasis, without having to place sutures. Inflation is a simple procedure that can be done by the patient, as opposed to having to place a suture, which must be performed by a physician or a physician's delegate, under sterile conditions.

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

Abstract: A parison for being blow molded into a medical balloon for a catheter includes a first tubular layer having a functional modification and a second tubular layer adapted for bonding with the first tubular layer to form the blow molded balloon. Related methods are also disclosed.

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

Abstract: A semi-compliant fiber-reinforced medical balloon having a folded wall thickness of from about 0.0010 to about 0.0060 inches and a rated burst pressure of at least 15 atmospheres and exhibiting compliance in the radial direction of from 0.5% expansion per atmosphere to about 1.0% expansion per atmosphere when pressurized from a fully inflated diameter to the rated burst pressure of the balloon includes a base balloon formed from a semi-elastic polymer material having an elongation to break of from about 10% to about 20%, a fiber layer is disposed over the base balloon with fibers having an elongation to break of from about 10% to about 20% and an outer layer formed from a semi-elastic polymer material having an elongation to break of from about 10% to about 20% disposed over the fiber layer.

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

Abstract: Balloon catheters and methods of making and using the same. A balloon catheter may include a catheter shaft and a balloon coupled thereto. A traction member may be coupled to the balloon catheter adjacent the balloon and may extend along a portion or all of the length of the balloon. The traction member can improve traction between the balloon and a target site.

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.